chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: diarrhea; Tachycardia; hypertensive episode; This is a spontaneous report from a contactable nurse (patient). A 60-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: FR8733) via an unspecified route of administration, administered in Arm Left on 29Mar2021 08:15 as dose 1, single for COVID-19 immunization. Medical history included depression and anxiety from an unknown date and unknown if ongoing. Concomitant medications included citalopram, clonazepam, estradiol and progesterone taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, Wellbutrin, Adderall and carbocaine and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. She was not diagnosed with covid prior vaccination and did not tested for covid post vaccination. On 29Mar2021 08:15 the patient experienced diarrhea, tachycardia and hypertensive episode. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included blood pressure measurement: 110/70. The outcome of the events was reported as recovering.  No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Hypertension, Tachycardia
Clinical narrative: diarrhea; Tachycardia; hypertensive episode; This is a spontaneous report from a contactable nurse (patient). A 60-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: FR8733) via an unspecified route of administration, administered in Arm Left on 29Mar2021 08:15 as dose 1, single for COVID-19 immunization. Medical history included depression and anxiety from an unknown date and unknown if ongoing. Concomitant medications included citalopram, clonazepam, estradiol and progesterone taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, Wellbutrin, Adderall and carbocaine and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. She was not diagnosed with covid prior vaccination and did not tested for covid post vaccination. On 29Mar2021 08:15 the patient experienced diarrhea, tachycardia and hypertensive episode. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included blood pressure measurement: 110/70. The outcome of the events was reported as recovering.  No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: racing heartbeat; difficulty breathing/Labored breathing; This is a spontaneous report from a contactable consumer (patient ). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN9581; Expiration Date: 31May2021) via an unspecified route of administration, administered in Arm Left on 16Feb2021 14:30 (at age of 67-year-old) as dose 1, 0.3 ML single for COVID-19 immunization. Medical history included acid reflux (for six years) from 2015 to an unknown date, chronic stomach problem (has a chronic stomach problem, which she has had for a while. Came from an antibiotic. She had MRSA in her toe and was on two very strong antibiotics. Thought she had small intestine bacterial overgrowth. Had been taking Probiotics, 20 billion. Probiotics did not cure it or get rid of the overgrowth but helped her eat more food than just a turkey sandwich day and night) from an unknown date and unknown if ongoing, couldn't walk (was on another antibiotic and was in such severe pain in her knee she couldn't walk for a week. Cannot remember the name of that antibiotic) from an unknown date and unknown if ongoing. Family history included heart trouble (everybody was dead on both sides of her family. There was a strong history of heart trouble of both sides of the family, but not racing heart. Stated she did not have heart troubles) from an unknown date and unknown if ongoing. The patient's concomitant medications included lactobacillus Nos (CULTURELLE) ongoing since Nov2020 (helps her eat more food and has definitely made an improvement. Stated culturelle was not a cure but had helped her to a certain point. She would not go off of it) for acid reflux and chronic stomach problem. The patient previously took xifaxan (clarified the only antibiotic to get rid of the C-bo was xifaxan. She did not take it because the side effects were like flagyl. Confirmed she has no NDC/Lot/Exp for xifaxan) and had experienced drug intolerance, metronidazole (clarified she took the generic of flagyl, metronidazole manufacturer: Teva; Dose: 500mg; one tablet every 12 hours. Took Metronidazole and the very next day had the blisters all over the place) and experienced blister. Reporter states after receiving the first dose on 20Feb2021 her heartbeat was racing and had difficulty in breathing, for 1 hour (reported as on the 5th day after getting the first dose of the vaccine) and again on the 6th day, lasted for 3 hours. Her heart was going like it was mad. Had trouble and labored breathing, but not to the point where she needed help. Felt like her whole body was vibrating. Heart was racing. It was terrible. Caller wanted to know if she should receive her second dose as scheduled next week, Tuesday 09Mar2021, after the AEs that she had experienced. The patient underwent lab tests and procedures on an unspecified date which included heart rate increased, racing. The outcome of both the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Laboratory test
Clinical narrative: Heart palpitations/ palpitations on exertion; Shortness of breath; unusual feeling in relation to heart/chest area; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient received BNT162B2, via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EN5318) at the age of 32 years old as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient's medical history was not reported. 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 and since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Concomitant medication(s) included acyclovir [aciclovir] taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EK4176) on 13Jan2021 at the age of 32 years old for COVID-19 immunization. Heart palpitations began one week after second dose. On 10Feb2021, the patient experienced Shortness of breath and palpitations on exertion. Currently pending cardiology work up. Also, continuing to have unusual feeling in relation to heart/chest area (10Feb2021). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included Medications, EKG, bloodwork, cardiology referral. Outcome of events were not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations/ palpitations on exertion; Shortness of breath; unusual feeling in relation to heart/chest area; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient received BNT162B2, via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EN5318) at the age of 32 years old as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient's medical history was not reported. 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 and since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Concomitant medication(s) included acyclovir [aciclovir] taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EK4176) on 13Jan2021 at the age of 32 years old for COVID-19 immunization. Heart palpitations began one week after second dose. On 10Feb2021, the patient experienced Shortness of breath and palpitations on exertion. Currently pending cardiology work up. Also, continuing to have unusual feeling in relation to heart/chest area (10Feb2021). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included Medications, EKG, bloodwork, cardiology referral. Outcome of events were not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations
Clinical narrative: Heart palpitations/ palpitations on exertion; Shortness of breath; unusual feeling in relation to heart/chest area; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient received BNT162B2, via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EN5318) at the age of 32 years old as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient's medical history was not reported. 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 and since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Concomitant medication(s) included acyclovir [aciclovir] taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EK4176) on 13Jan2021 at the age of 32 years old for COVID-19 immunization. Heart palpitations began one week after second dose. On 10Feb2021, the patient experienced Shortness of breath and palpitations on exertion. Currently pending cardiology work up. Also, continuing to have unusual feeling in relation to heart/chest area (10Feb2021). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included Medications, EKG, bloodwork, cardiology referral. Outcome of events were not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Piercing tinnitus; sensation of fullness in left ear; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:00, the patient experienced piercing tinnitus and sensation of fullness in left ear. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with methylprednisolone pack (steroids). The clinical outcome of the events piercing tinnitus and sensation of fullness in left ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Piercing tinnitus; sensation of fullness in left ear; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:00, the patient experienced piercing tinnitus and sensation of fullness in left ear. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with methylprednisolone pack (steroids). The clinical outcome of the events piercing tinnitus and sensation of fullness in left ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular
Clinical narrative: fast heart beat; This is a spontaneous report from a contactable consumer (patient). A female patient of age 60, unit: unknown, received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 08Mar2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had the 1st dose of the Pfizer-Biontech Covid-19 Vaccine last 08Mar2021 via drive thru -After 15 minutes she experienced fast heart beat lasted for 10 minutes which prompted her to call asking if she can still get the 2nd dose of the vaccine. On 08Mar2021 patient underwent heart beat test resulted fast heart beat. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: fast heart beat; This is a spontaneous report from a contactable consumer (patient). A female patient of age 60, unit: unknown, received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 08Mar2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had the 1st dose of the Pfizer-Biontech Covid-19 Vaccine last 08Mar2021 via drive thru -After 15 minutes she experienced fast heart beat lasted for 10 minutes which prompted her to call asking if she can still get the 2nd dose of the vaccine. On 08Mar2021 patient underwent heart beat test resulted fast heart beat. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electroencephalogram, Feeling abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: Forehead and cheekbone area went numb, then left arm (opposite of shot site) and hand/fingers and front part of my left chest had intense numbing feeling.; Waves of spaciness; Weakness; Light intermittent thumb numbing/tingling; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8733) via an unspecified route of administration in the right arm on 28Mar2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing undiagnosed one sided angioedema which was in remission for years and cervical spine degeneration (c5, c6). The patient's history of known allergies was reported as unknown. The patient did not receive any concomitant medications withing two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 10:00, reportedly 28 mins after receiving shot, her forehead and cheekbone area went numb, then left arm (opposite of shot site) and hand/fingers and front part of her left chest had intense numbing feeling. That lasted 15 mins and subsided. Then subsequently throughout the day, she would have waves of "spaciness", weakness, reoccurring every 15 or so mins. Then again that afternoon, left arm went numb, hand as well, and back side this time. A little less intense than the first one, on a scale of 1-10, the first one was 10 and this one was 8. Also this time, patient right arm below elbow had these sensations, but a much lower intensity...a 2-3 range. Light intermittent thumb numbing/tingling continued throughout the day. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of the brain, Electrocardiography (EKG) and blood tests and the results were unknown. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head
Clinical narrative: Forehead and cheekbone area went numb, then left arm (opposite of shot site) and hand/fingers and front part of my left chest had intense numbing feeling.; Waves of spaciness; Weakness; Light intermittent thumb numbing/tingling; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8733) via an unspecified route of administration in the right arm on 28Mar2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing undiagnosed one sided angioedema which was in remission for years and cervical spine degeneration (c5, c6). The patient's history of known allergies was reported as unknown. The patient did not receive any concomitant medications withing two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 10:00, reportedly 28 mins after receiving shot, her forehead and cheekbone area went numb, then left arm (opposite of shot site) and hand/fingers and front part of her left chest had intense numbing feeling. That lasted 15 mins and subsided. Then subsequently throughout the day, she would have waves of "spaciness", weakness, reoccurring every 15 or so mins. Then again that afternoon, left arm went numb, hand as well, and back side this time. A little less intense than the first one, on a scale of 1-10, the first one was 10 and this one was 8. Also this time, patient right arm below elbow had these sensations, but a much lower intensity...a 2-3 range. Light intermittent thumb numbing/tingling continued throughout the day. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of the brain, Electrocardiography (EKG) and blood tests and the results were unknown. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Electrocardiogram, Feeling abnormal, Hypoaesthesia
Clinical narrative: Forehead and cheekbone area went numb, then left arm (opposite of shot site) and hand/fingers and front part of my left chest had intense numbing feeling.; Waves of spaciness; Weakness; Light intermittent thumb numbing/tingling; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8733) via an unspecified route of administration in the right arm on 28Mar2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing undiagnosed one sided angioedema which was in remission for years and cervical spine degeneration (c5, c6). The patient's history of known allergies was reported as unknown. The patient did not receive any concomitant medications withing two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 10:00, reportedly 28 mins after receiving shot, her forehead and cheekbone area went numb, then left arm (opposite of shot site) and hand/fingers and front part of her left chest had intense numbing feeling. That lasted 15 mins and subsided. Then subsequently throughout the day, she would have waves of "spaciness", weakness, reoccurring every 15 or so mins. Then again that afternoon, left arm went numb, hand as well, and back side this time. A little less intense than the first one, on a scale of 1-10, the first one was 10 and this one was 8. Also this time, patient right arm below elbow had these sensations, but a much lower intensity...a 2-3 range. Light intermittent thumb numbing/tingling continued throughout the day. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of the brain, Electrocardiography (EKG) and blood tests and the results were unknown. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Paraesthesia
Clinical narrative: Forehead and cheekbone area went numb, then left arm (opposite of shot site) and hand/fingers and front part of my left chest had intense numbing feeling.; Waves of spaciness; Weakness; Light intermittent thumb numbing/tingling; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8733) via an unspecified route of administration in the right arm on 28Mar2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing undiagnosed one sided angioedema which was in remission for years and cervical spine degeneration (c5, c6). The patient's history of known allergies was reported as unknown. The patient did not receive any concomitant medications withing two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 10:00, reportedly 28 mins after receiving shot, her forehead and cheekbone area went numb, then left arm (opposite of shot site) and hand/fingers and front part of her left chest had intense numbing feeling. That lasted 15 mins and subsided. Then subsequently throughout the day, she would have waves of "spaciness", weakness, reoccurring every 15 or so mins. Then again that afternoon, left arm went numb, hand as well, and back side this time. A little less intense than the first one, on a scale of 1-10, the first one was 10 and this one was 8. Also this time, patient right arm below elbow had these sensations, but a much lower intensity...a 2-3 range. Light intermittent thumb numbing/tingling continued throughout the day. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of the brain, Electrocardiography (EKG) and blood tests and the results were unknown. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Breast cyst, Breast swelling, Breast tenderness, Culture wound
Clinical narrative: Acute swelling of pre-existing small sebaceous cyst on left breast/then infection; Acute swelling of pre-existing small sebaceous cyst on left breast/then infection; Swollen lymph gland in left armpit; Joint aches; This is a spontaneous report from a contactable consumer.   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Mar2021 13:45 (Batch/Lot Number: EN6204) as dose 2, single (at the age of 65 years old) for COVID-19 immunisation.  Medical history included hypertension, high cholesterol, autoimmune hypothyroid disease, alpha1-antitrypsin deficiency, asthma, raynaud's, allergies to Sulfa antibiotics, allergies to avocados and sebaceous cyst. Concomitant medications included amlodipine, levothyroxine, rosuvastatin and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported.  The patient previously took Pheno Barbitol, Theophylline and experienced allergies and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number: EN6203) on 27Feb2021 12:30 PM on left arm for COVID-19 immunisation.  The patient experienced acute swelling of pre-existing small sebaceous cyst on left breast, becoming 5 times the size it had been for 12 years prior, with additional larger swelling behind it- started swelling 23Mar2021; extreme tenderness and redness developed with continued swelling, then infection, over the next two weeks, despite taking prescribed 10-day course of antibiotic (Cephalexin 500 mg) - ultimately required surgical lancing, irrigation, and draining and follow-up with breast surgery center # with held on 04Jul2021; Treatment continuing at the time of this report. Joint aches -starting 21Mar2021, lasting 24 hours. swollen lymph gland in left armpit - starting 22Mar2021, lasting 36 hours. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of joint ache and swollen lymph gland was recovered on Mar2021 and other events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermal cyst, Erythema, Incisional drainage, Lymphadenopathy
Clinical narrative: Acute swelling of pre-existing small sebaceous cyst on left breast/then infection; Acute swelling of pre-existing small sebaceous cyst on left breast/then infection; Swollen lymph gland in left armpit; Joint aches; This is a spontaneous report from a contactable consumer.   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Mar2021 13:45 (Batch/Lot Number: EN6204) as dose 2, single (at the age of 65 years old) for COVID-19 immunisation.  Medical history included hypertension, high cholesterol, autoimmune hypothyroid disease, alpha1-antitrypsin deficiency, asthma, raynaud's, allergies to Sulfa antibiotics, allergies to avocados and sebaceous cyst. Concomitant medications included amlodipine, levothyroxine, rosuvastatin and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported.  The patient previously took Pheno Barbitol, Theophylline and experienced allergies and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number: EN6203) on 27Feb2021 12:30 PM on left arm for COVID-19 immunisation.  The patient experienced acute swelling of pre-existing small sebaceous cyst on left breast, becoming 5 times the size it had been for 12 years prior, with additional larger swelling behind it- started swelling 23Mar2021; extreme tenderness and redness developed with continued swelling, then infection, over the next two weeks, despite taking prescribed 10-day course of antibiotic (Cephalexin 500 mg) - ultimately required surgical lancing, irrigation, and draining and follow-up with breast surgery center # with held on 04Jul2021; Treatment continuing at the time of this report. Joint aches -starting 21Mar2021, lasting 24 hours. swollen lymph gland in left armpit - starting 22Mar2021, lasting 36 hours. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of joint ache and swollen lymph gland was recovered on Mar2021 and other events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Infected cyst, Lymphadenopathy
Clinical narrative: Acute swelling of pre-existing small sebaceous cyst on left breast/then infection; Acute swelling of pre-existing small sebaceous cyst on left breast/then infection; Swollen lymph gland in left armpit; Joint aches; This is a spontaneous report from a contactable consumer.   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Mar2021 13:45 (Batch/Lot Number: EN6204) as dose 2, single (at the age of 65 years old) for COVID-19 immunisation.  Medical history included hypertension, high cholesterol, autoimmune hypothyroid disease, alpha1-antitrypsin deficiency, asthma, raynaud's, allergies to Sulfa antibiotics, allergies to avocados and sebaceous cyst. Concomitant medications included amlodipine, levothyroxine, rosuvastatin and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported.  The patient previously took Pheno Barbitol, Theophylline and experienced allergies and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number: EN6203) on 27Feb2021 12:30 PM on left arm for COVID-19 immunisation.  The patient experienced acute swelling of pre-existing small sebaceous cyst on left breast, becoming 5 times the size it had been for 12 years prior, with additional larger swelling behind it- started swelling 23Mar2021; extreme tenderness and redness developed with continued swelling, then infection, over the next two weeks, despite taking prescribed 10-day course of antibiotic (Cephalexin 500 mg) - ultimately required surgical lancing, irrigation, and draining and follow-up with breast surgery center # with held on 04Jul2021; Treatment continuing at the time of this report. Joint aches -starting 21Mar2021, lasting 24 hours. swollen lymph gland in left armpit - starting 22Mar2021, lasting 36 hours. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of joint ache and swollen lymph gland was recovered on Mar2021 and other events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Dizziness, Headache, Heart rate increased, Malaise
Clinical narrative: Headache; Dizziness; Nasal congestion; Rapid heartbeat; Unwell feeling; Bruising; Low grade fever; Rash; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) DOSE NUMBER UNKNOWN via an unspecified route of administration, administered in the left arm on 21Mar2021 at 14:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included decreased appetite from an unknown date and unknown if ongoing. Concomitant medications included psyllium fibre and probiotics, both for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rash (medically significant) on 21Mar2021 at 14:30. On 21Mar2021 at 15:00, the patient experienced headache, dizziness, nasal congestion, rapid heartbeat, unwell feeling, and bruising. On 22Mar2021, patient experienced low grade fever.  The patient experienced rash on right arm 30mins after shot that spread to 80% of body in the next 30 mins -hour. Also experienced headache, dizziness, nasal congestion, rapid heartbeat and general unwell feeling. Big bruising in about 10 places, and low grade fever the next morning. Treatment for events included 2 steroid shots, a steroid pack and antihistamines. The patient recovered from the events, rash, headache, dizziness, headache, dizziness, nasal congestion, rapid heartbeat, unwell feeling, bruising and low grade fever in 2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Pyrexia, Rash
Clinical narrative: Headache; Dizziness; Nasal congestion; Rapid heartbeat; Unwell feeling; Bruising; Low grade fever; Rash; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) DOSE NUMBER UNKNOWN via an unspecified route of administration, administered in the left arm on 21Mar2021 at 14:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included decreased appetite from an unknown date and unknown if ongoing. Concomitant medications included psyllium fibre and probiotics, both for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rash (medically significant) on 21Mar2021 at 14:30. On 21Mar2021 at 15:00, the patient experienced headache, dizziness, nasal congestion, rapid heartbeat, unwell feeling, and bruising. On 22Mar2021, patient experienced low grade fever.  The patient experienced rash on right arm 30mins after shot that spread to 80% of body in the next 30 mins -hour. Also experienced headache, dizziness, nasal congestion, rapid heartbeat and general unwell feeling. Big bruising in about 10 places, and low grade fever the next morning. Treatment for events included 2 steroid shots, a steroid pack and antihistamines. The patient recovered from the events, rash, headache, dizziness, headache, dizziness, nasal congestion, rapid heartbeat, unwell feeling, bruising and low grade fever in 2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Contusion, Dizziness, Headache, Heart rate increased
Clinical narrative: Headache; Dizziness; Nasal congestion; Rapid heartbeat; Unwell feeling; Bruising; Low grade fever; Rash; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) DOSE NUMBER UNKNOWN via an unspecified route of administration, administered in the left arm on 21Mar2021 at 14:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included decreased appetite from an unknown date and unknown if ongoing. Concomitant medications included psyllium fibre and probiotics, both for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rash (medically significant) on 21Mar2021 at 14:30. On 21Mar2021 at 15:00, the patient experienced headache, dizziness, nasal congestion, rapid heartbeat, unwell feeling, and bruising. On 22Mar2021, patient experienced low grade fever.  The patient experienced rash on right arm 30mins after shot that spread to 80% of body in the next 30 mins -hour. Also experienced headache, dizziness, nasal congestion, rapid heartbeat and general unwell feeling. Big bruising in about 10 places, and low grade fever the next morning. Treatment for events included 2 steroid shots, a steroid pack and antihistamines. The patient recovered from the events, rash, headache, dizziness, headache, dizziness, nasal congestion, rapid heartbeat, unwell feeling, bruising and low grade fever in 2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nasal congestion, Pyrexia, Rash
Clinical narrative: Headache; Dizziness; Nasal congestion; Rapid heartbeat; Unwell feeling; Bruising; Low grade fever; Rash; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) DOSE NUMBER UNKNOWN via an unspecified route of administration, administered in the left arm on 21Mar2021 at 14:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included decreased appetite from an unknown date and unknown if ongoing. Concomitant medications included psyllium fibre and probiotics, both for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rash (medically significant) on 21Mar2021 at 14:30. On 21Mar2021 at 15:00, the patient experienced headache, dizziness, nasal congestion, rapid heartbeat, unwell feeling, and bruising. On 22Mar2021, patient experienced low grade fever.  The patient experienced rash on right arm 30mins after shot that spread to 80% of body in the next 30 mins -hour. Also experienced headache, dizziness, nasal congestion, rapid heartbeat and general unwell feeling. Big bruising in about 10 places, and low grade fever the next morning. Treatment for events included 2 steroid shots, a steroid pack and antihistamines. The patient recovered from the events, rash, headache, dizziness, headache, dizziness, nasal congestion, rapid heartbeat, unwell feeling, bruising and low grade fever in 2021.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on torso both front and back as well as upper thighs and arms; Redness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8732) via an unspecified route of administration in the right arm on 06Apr2021 at 10:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included angina, poor kidney function and sinus bradycardia. The patient had no known allergies. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN) etc. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 09:00, two days after receiving the vaccine, the patient developed rash on her torso both front and back as well as upper thighs and arms and redness at the injection site as well. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of rash on torso both front and back as well as upper thighs and arm and redness at the injection site and included treatment diphenhydramine (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events rash on torso both front and back as well as upper thighs and arm and redness at the injection site were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Vaccination site erythema
Clinical narrative: Rash on torso both front and back as well as upper thighs and arms; Redness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8732) via an unspecified route of administration in the right arm on 06Apr2021 at 10:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included angina, poor kidney function and sinus bradycardia. The patient had no known allergies. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN) etc. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 09:00, two days after receiving the vaccine, the patient developed rash on her torso both front and back as well as upper thighs and arms and redness at the injection site as well. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of rash on torso both front and back as well as upper thighs and arm and redness at the injection site and included treatment diphenhydramine (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events rash on torso both front and back as well as upper thighs and arm and redness at the injection site were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: 15 days post 2nd vaccine dizziness; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown), via an unspecified route of administration in the left arm on 19Mar2021 at 09:00 (at the age of 71-years-old) as single dose for COVID-19 immunisation. Medical history included hypertension and asthma. The patient previously took all sulfa drugs (UNSPECIFIED), radio contrast dye (UNSPECIFIED), Nsaids (UNSPECIFIED), oxaliplatine (OXALIPLATIN), ciprofloxacin lactate (CIPRO), sulfamethoxazole, trimethoprim (BACTRIM) and acetyl salicylic acid (ASPIRIN) for unknown indication on unknown dates and experienced drug allergy . Concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT), Metoprolol succinate (TOPROL) Fluticasone propionate (FLOVENT DISKUS), Levothyroxine sodium (SYNTHROID) and  spi (MANUFACTURER UNKNOWN) from an unknown date and for unknown indication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 26Febr2021 at 09:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. 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 had not been tested for COVID-19. On 03Apr2021 at 19:00 fifteen days post the second vaccine the patient experienced dizziness for several hours. There was no problem with blood pressure (BP) and was no history of dizziness. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event dizziness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Chills, Fatigue, Lymph node pain, Pain
Clinical narrative: Achy; Tired; Chills; Had pain in by left arm pit nearbreast and lymph nodes; Pain in lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 14:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient was not allergic to medications, food, or other products. Concomitant medications included vitamin d nos (VITAMIN D), HEALTH CONCERNS NASAL CAPS and multivitamin (MANUFACTURER UNKNOWN).  Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 14:15, 24 hours after receiving shot, the patient started to feel achy, tired, got the chills, pain in left arm pit near breast and lymph nodes. All the symptoms went away within 2 or 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events felt achy, tired, got the chills and had pain in by left arm pit near breast and lymph nodes were recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.