chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; Lethargic; Swollen lymph nodes under left arm, swelling in armpit was about the size of a baseball; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 12:00, the patient experienced fever, lethargic and swollen lymph nodes under the left arm; the swelling in her armpit was about the size of a baseball. 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 events. The clinical outcome of the events fever, lethargic and swollen lymph nodes under left arm about the size of a baseball were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: Arm has a 5-6 inch red rash; Swollen; Feels feverish to the touch; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 09:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 11Mar2021 at 13:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. 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 15Apr2021 at 06:00, 6 days after second dose of injection, the patient's arm had a 5-6 inch red rash, swollen and felt feverish to the touch. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events red rash, swollen and felt feverish to the touch were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: exhaustion; chills; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Apr2021 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and did not take any concomitant medications. The patient had no known allergies to medications, food or other products. 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 11Apr2021, the patient experienced exhaustion, chills and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events exhaustion, chills and joint pain was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Lacrimation increased, Visual impairment
Clinical narrative: Both eyes started burning; Both eyes started watering making; Both eyes started burning and watering making it difficult to see/read; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration on 13Apr2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included asthma, premature ventricular contractions (PVC). The patient was allergic to penicillin and statins. Concomitant medications were not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. 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 13Apr2021, approximately 3 hours after receiving the shot the patient experienced both eyes started burning and watering making it difficult to see/read. 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 events. The clinical outcome of the events both eyes started burning and watering making it difficult to see/read was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus
Clinical narrative: Shingles; Shingles pain; Shingles itch; Shingles burning; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 08:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 medications or vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 at 13:15, the patient experienced shingles pain, itch and burning. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of shingles pain, itch and burning included treatment with Valtrex. The clinical outcome of the event shingles pain, itch and burning was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Malaise, Rash
Clinical narrative: Lower back pain; Feeling unwell; Shingles on stomach and back; Rash; This is a spontaneous report from a contactable nurse, the patient. A 44-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 25Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tetanus vaccine toxoid; diphtheria vaccine toxoid; pertussis vaccine acellular (TDAP) received 14 days after (as reported) an unknown date in 2021. 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 04Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 12Apr2021, the patient started to experience lower back pain and felt unwell. She thought it was a urinary tract infection (UTI). The patient had shingles on her stomach and back and also reported that the rash started 3 days back (12Apr2021). Since the vaccination, the patient had not been tested for COVID-19. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of events and included treatment with steroids and antivirals. The clinical outcome of the events lower back pain, feeling unwell, shingles on stomach and back and rash was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Dizziness, Feeling abnormal, Feeling jittery
Clinical narrative: Constant brain confusion; Fast heart at night; Uneasiness; Anxious; Jittery; Immediate dizzy; Nausea; Constant headache; Brain tingling; This is a spontaneous report from a contactable consumer, the patient. A 61-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 29Mar2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation and 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 12Apr2021 at 03:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D3), zinc (MANUFACTURER UNKNOWN) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO), all taken for unspecified indications from unknown dates. Prior to the vaccination, it was unknown if 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 29Mar2021 at 10:45, the patient experienced immediate dizziness, nausea, headache and brain tingling. On 30Mar2021, a day later, the patient experienced constant brain confusion, fast heart at night, uneasiness, felt anxious, jittery, had continued dizziness and constant headache. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken as result of the events. The clinical outcome of the events dizziness, nausea, headache, brain tingling, constant brain confusion, fast heart at night, uneasiness, anxious and jittery were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Nausea, Paraesthesia
Clinical narrative: Constant brain confusion; Fast heart at night; Uneasiness; Anxious; Jittery; Immediate dizzy; Nausea; Constant headache; Brain tingling; This is a spontaneous report from a contactable consumer, the patient. A 61-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 29Mar2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation and 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 12Apr2021 at 03:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D3), zinc (MANUFACTURER UNKNOWN) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO), all taken for unspecified indications from unknown dates. Prior to the vaccination, it was unknown if 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 29Mar2021 at 10:45, the patient experienced immediate dizziness, nausea, headache and brain tingling. On 30Mar2021, a day later, the patient experienced constant brain confusion, fast heart at night, uneasiness, felt anxious, jittery, had continued dizziness and constant headache. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken as result of the events. The clinical outcome of the events dizziness, nausea, headache, brain tingling, constant brain confusion, fast heart at night, uneasiness, anxious and jittery were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dysarthria, Dyspnoea, Gait disturbance, Migraine
Clinical narrative: Heart palpitations; Shortness of breath; tremor; stiff neck; gait dysfunction; slurred speech; Migraine; Visual impairment and changes; Itching over whole body; slurred speech progressing to inability to speak; Neurological effects; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 61-year-old via an unspecified route of administration, administered in the left arm on 31Mar2021 11:30 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included lyme (lyme disease), multiple chemical sensitivity, fibromyalgia and known allergies. The patient did not have covid prior vaccination. Concomitant medication included unspecified medications. On 31Mar2021 11:30, the patient experienced heart palpitations, shortness of breath, neurological effects, tremor, stiff neck, gait dysfunction, slurred speech progressing to inability to speak. migraine, visual impairment and changes and itching over whole body. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event included osteopathic manipulation. The patient has not been covid tested post vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neurological symptom, Palpitations, Pruritus, Tremor
Clinical narrative: Heart palpitations; Shortness of breath; tremor; stiff neck; gait dysfunction; slurred speech; Migraine; Visual impairment and changes; Itching over whole body; slurred speech progressing to inability to speak; Neurological effects; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 61-year-old via an unspecified route of administration, administered in the left arm on 31Mar2021 11:30 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included lyme (lyme disease), multiple chemical sensitivity, fibromyalgia and known allergies. The patient did not have covid prior vaccination. Concomitant medication included unspecified medications. On 31Mar2021 11:30, the patient experienced heart palpitations, shortness of breath, neurological effects, tremor, stiff neck, gait dysfunction, slurred speech progressing to inability to speak. migraine, visual impairment and changes and itching over whole body. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event included osteopathic manipulation. The patient has not been covid tested post vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Heart palpitations; Shortness of breath; tremor; stiff neck; gait dysfunction; slurred speech; Migraine; Visual impairment and changes; Itching over whole body; slurred speech progressing to inability to speak; Neurological effects; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 61-year-old via an unspecified route of administration, administered in the left arm on 31Mar2021 11:30 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included lyme (lyme disease), multiple chemical sensitivity, fibromyalgia and known allergies. The patient did not have covid prior vaccination. Concomitant medication included unspecified medications. On 31Mar2021 11:30, the patient experienced heart palpitations, shortness of breath, neurological effects, tremor, stiff neck, gait dysfunction, slurred speech progressing to inability to speak. migraine, visual impairment and changes and itching over whole body. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event included osteopathic manipulation. The patient has not been covid tested post vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: just mild muscle pain; injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 15Apr2021 at 10:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient previously received clindamycin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and experienced drug allergy to clindamycin and amoxicillin. 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 COVID vaccine. The patient had no known allergies to medications, food or other products. On 15Apr2021 at 19:00, the patient experienced just mild muscle pain and injection site pain. 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 events. The clinical outcome of the event mild muscle pain and injection site pain was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Feeding disorder
Clinical narrative: then it's getting worse and worse and sharper and then it started hurt, so would not eat; hard to breath; pain in her right upper quadrant of her abdomen; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration in left arm on 06Apr2021 at 16:00 (at the age of 49-year-old) as dose 1, single for COVID-19 immunisation. Medical history included polyps in gall bladder from an unknown date and unknown if ongoing (2 polyps in her gallbladder that she has monitored every few years), endometriosis from an unknown date and unknown if ongoing, mitral valve prolapse from an unknown date and unknown if ongoing, scoliosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had a little bit of a reaction. She think it was through the Pfizer vaccine (first shot) and just wondering if should get the second dose which am supposed to get on next "Tuesday" the 27th or if she should not get it, so what happened was, She got the vaccine on 06Apr2021 and after about three hours after got it, she started to get pain in right side under her rib cage, so the upper right quadrant and at first she was thinking it was probably nothing, may be something she ate and then it was getting worse and worse and sharper and then it started hurt, so would not eat, it became very painful, hard to breath and she was thinking maybe it was because of gas, so she lay down for a while. She laid down and it was just strong and was not sure if she goes emergency room or not and then after about 4 hours, she was staying in one position and then she thought it was getting a little bit better. I was able to fall asleep and when I woke up it was completely gone. I have never had pain in that spot before or after that day, that night and I do not know it felt to me the gall bladder area again. She never had pain before, she does have two small Polyps in gall bladder that she has monitored every few years but she never and they never felt them before. It had never affected her, so anyway, I do not know if it has to do what she received or not (second dose). She was afraid if she should get second shot or not. She has not yet been seen by a doctor for her symptoms. Reporter seriousness for events was reported as unspecified. The outcome of pain in her right upper quadrant of her abdomen was reported as resolved on unknown date; then it was getting worse and worse and sharper and then it started hurt, so would not eat and hard to breath was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Upper lip swelling 24 hours after vaccination. Swollen for 2 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-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 on an unknown date in Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included previous upper lip filler 5 years prior, in 2016. The patient did not receive any medication 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 on an unknown date in Mar2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Allergies to medications, food, or other products was reported as N/A. 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 did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 the patient experienced upper lip swelling 24 hours after vaccination and was swollen for two days. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event upper lip swelling 24 hours after vaccination that was swollen for two days was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph node in left armpit (same arm as where vaccination received), started 18 hours after vaccination and persisted for ~24 hours, uncomfortable/painful but no doctor or emergency visit requi; Swollen lymph node in left armpit (same arm as where vaccination received), started 18 hours after vaccination and persisted for ~24 hours, uncomfortable/painful but no doctor or emergency visit requi; This is a spontaneous report from a contactable consumer or other non hcp .    A 40-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EW0162), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 13:45 for covid-19 immunisation.  Medical history included colitis ulcerative, hypothyroidism. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE). It was reported that the patient had no allergies.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm left on 21Mar2021 14:00 as DOSE 1, number=ER8727, lot unknown SINGLE for covid-19 immunisation. It was Reported that, the patient experienced swollen lymph node in left armpit (same arm as where vaccination received), started 18 hours after vaccination and persisted for ~24 hours, uncomfortable/painful but no doctor or emergency, swollen lymph node in left armpit started 18 hours after vaccination and persisted for ~24 hours, uncomfortable/painful but no doctor or emergency visit on 19Apr2021 19:00 with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 20Apr2021 Unknown result.    No follow up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I began menstruating on 4/16/21. I am nearly post-menopausal, with my last period beginning 8/19/2019.; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. This non-pregnant 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at 53-years-old) as a single dose for COVID-9 immunisation. Medical history was not reported. Concomitant medications included metformin, lisinopril, simvastatin, fluoxetine, and losartan potassium (LO), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EN6207) in the left arm on 19Mar2021 at 13:15 (at 53-years-old) for COVID-19 immunisation. Prior to vaccination the patient had not been diagnosed with COVID-19, had not received any other vaccines in four weeks, and had no known allergies. On 16Apr2021 the patient began menstruating; she reported she was nearly post-menopausal, and her last period began on 19Aug2019. No treatment was received for the event. The clinical outcome of the event was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 51-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 08Apr2021 at 16:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient known allergies included bactrim and penicillin. Concomitant medications included Tirosint on an unknown date for unknown indication and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 18Mar2021 at 15:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 09Apr2021 at 07:00, the patient experienced horrible headache & body pain especially in thighs and upper arms. On 3 occasions, felt like the patient was being stabbed. Twice in right leg, close to knee, and once in left arm. The patient seemed to have symptoms for 1.5 days, then they went away for a day, then felt sick with a runny nose, sore throat, & oddly scalp hurt on the right side only for about 3 days. The stabbing pain was really odd and extreme for a vaccination. The scalp pain was weird too. Hope it works. Can't say if the patient does this again if this becomes a yearly deal. No therapeutic measures were taken as a result of 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 being stabbed was recovered on 10Apr2021. The clinical outcome of the event scalp hurt on the right side was recovered on 12Apr2021. The clinical outcome of the events sick, runny nose, sore throat, horrible headache, and body pain especially in thighs and upper arms were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 51-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 08Apr2021 at 16:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient known allergies included bactrim and penicillin. Concomitant medications included Tirosint on an unknown date for unknown indication and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 18Mar2021 at 15:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 09Apr2021 at 07:00, the patient experienced horrible headache & body pain especially in thighs and upper arms. On 3 occasions, felt like the patient was being stabbed. Twice in right leg, close to knee, and once in left arm. The patient seemed to have symptoms for 1.5 days, then they went away for a day, then felt sick with a runny nose, sore throat, & oddly scalp hurt on the right side only for about 3 days. The stabbing pain was really odd and extreme for a vaccination. The scalp pain was weird too. Hope it works. Can't say if the patient does this again if this becomes a yearly deal. No therapeutic measures were taken as a result of 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 being stabbed was recovered on 10Apr2021. The clinical outcome of the event scalp hurt on the right side was recovered on 12Apr2021. The clinical outcome of the events sick, runny nose, sore throat, horrible headache, and body pain especially in thighs and upper arms were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills, White blood cell count, White blood cell count decreased
Clinical narrative: drop in white blood cells; temperature; Chills; This is a spontaneous report from a contactable other healthcare professional. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported drop in white blood cells, temperature and chills few days after covid vaccine on an unspecified date. The patient underwent lab tests and procedures which included white blood cell count: drop in white blood cells on an unspecified date. The outcome of all the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the  left arm on 01Apr2021 at 10:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient was tested positive prior to vaccination. Concomitant medications were not reported. The patient had no known allergies to medications, foods or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, a week after vaccination, the patient experienced a terrible sore throat that was not going away. The adverse event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat was not recovered at the time of report.   No follow attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: head hurts; body is sore all over.; This is a spontaneous report from a contactable healthcare professional. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma. The patient had no allergies to medications, food, or other products. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. 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 4 weeks prior to the COVID vaccine. On 15Apr2021 at 06:30, the patient experienced that her head hurts and her body was sore all over. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if therapeutic measures were taken as a result of the events. The clinical outcome of the events head hurts and body sore were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Extreme pain in injection arm; Not able to function; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm on 05Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included sulfonamide allergy (allergic to suplha-based medication). The patient received unspecified medication within two weeks of vaccination. 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. On 05Apr2021, the patient experienced extreme pain in injection arm lasted 48 hours. Not able to function. Pain began within one hour of injection. After 48 hours, pain was moderate for additional 24-36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with Tylenol, heat packs and cold packs. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events extreme pain in injection arm and not able to function were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vomiting
Clinical narrative: Violent vomiting 14 hours after second dose; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 14:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and the patient was not taking medication. The patient had no known allergies to medications, food, or other products. The patient did not receive any medications 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 right arm on 31Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. 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 15Apr2021 at 04:00, the patient experienced violent vomiting 14 hours after second dose. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event violent vomiting 14 hours after second dose was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest discomfort; This is a spontaneous report from a contactable consumer, the patient. A 27-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 13Apr2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary vasospasm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included vitamin b12 (MANUFACTURER UNKNOWN), clopidogrel bisulfate (MANUFACTURER UNKNOWN), diltiazem (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 04:30, the patient experienced chest discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event chest discomfort was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 27-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 on 08Apr2021 at 15:30 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced tiredness. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tiredness was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Exactly 9 days after the 1st vaccine developed painful welts and hives all over body.; This is a spontaneous report from a contactable consumer, the patient. A 47-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 right arm on 29Mar2021 at 16:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included multiple sclerosis and sleep apnea. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included natalizumab (TYSABRI), duloxetine hydrochloride (CYMBALTA), amitriptyline (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), cyanocobalamin (VIT B12) and "D"; all from unknown dates for unspecified indications and unknown if ongoing. The patient previously took COPAXONE and experienced an allergy. The patient previously took TYLENOL and experienced hives (which usually lasted for an hour). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 12:00, exactly 9 days after the first vaccine, the patient developed painful welts and hives all over the body. Even after one week of them not have gone away, the patient went to the primary care doctor who confirmed that it was hives. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with a 10 days course of prednisone taper pack. The clinical outcome of the event's painful welts and hives all over body was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Pain in jaw, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Er8737) via an unspecified route of administration in the arm left on 04Apr2021 at 12:30 (at the age of 54-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 09Apr2021, 6 days after vaccination, the patient experienced ear ache and jaw ache. On 11Apr2021, the patient experienced high fever with chills. On 15Apr2021, the patient experienced rash on arm. The patient did not receive any treatment for the reported events. The adverse 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 events ear ache, jaw ache, chills, high fever, and rash on arm was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.