chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Muscle twitching (back, legs, arms); This is a spontaneous report from a non-contactable other health care professional, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), on an unspecified date (at the age of 24-year-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. 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 vaccination, the patient had not tested for COVID-19. Medical history of the patient included polycystic ovarian syndrome and obesity. The patient did not have any drug, food or other product allergy. Concomitant medications were not reported. On 26Mar2021, the patient had experienced muscle twitching (back, legs and arm as reported). The patient had not received any treatment for the clinical events. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event muscle twitching was recovering.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient Initials combined and entered in first name field. 2. Patient Country entered. 3. RMH Verbatim updated to match with source and Notes added as PCOS per source. 4. Final sentence updated as No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under right arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the right arm on 30Mar2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic. The patient had no allergies to medications, food, or other products. Concomitant medication included ibuprofen (ADVIL) since an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 09Mar2021 at 17:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccine. On 31Mar2021 at 22:30 the patient experienced swollen lymph nodes under the right arm. The adverse 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 event. The clinical outcome of the event swollen lymph nodes under the right arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased
Clinical narrative: speeding heart rate from the Pfizer vaccine; This is a spontaneous report from a contactable consumer. This reporter reported similar events for four patients. This is the second of four reports. This case is non-serious.  A patient of unspecified age and gender 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. When reporter did reporter's EKG, it was reported that she was the 4th person to come in with a rapid heartbeat after the vaccine. The patient experienced speeding heart rate from the pfizer vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021350648 same reporter/drug, similar event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased
Clinical narrative: Speeding heart rate from the Pfizer vaccine; This is a spontaneous report from a contactable consumer. This reporter reported similar events for four patients. This is the fourth of four reports. This case is non-serious.  A patient of unspecified age and gender 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. When reporter did reporter's EKG, it was reported that she was the 4th person to come in with a rapid heartbeat after the vaccine. The patient experienced speeding heart rate from the pfizer vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021350648 same reporter/drug, similar event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Herpes ophthalmic
Clinical narrative: I got an eye infection "Herpetic Infection"; I got an eye infection "Herpetic Infection"; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (Lot Number: en6206), dose 1 via an unspecified route of administration, administered in left arm on Mar2021 at 01:30 PM (at the age of 51 years old) as single dose for covid-19 immunization. Medical history included heart, Pancretic divisium, thryoid, diabetic and known allergies included sulfa, diuretics and gabapentin. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient got an eye infection "Herpetic Infection" on Mar2021 at 02:00 PM. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment for events included pills and eye drops. The outcome of events was recovering.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Disturbance in attention
Clinical narrative: Momentary loss of memory and lapse of time. Memory loss. Hard to concentrate; Momentary loss of memory and lapse of time. Memory loss. Hard to concentrate; This is a spontaneous report from a contactable consumer (patient).  A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 15Mar2021 15:00 (Batch/Lot Number: EN6206), age at vaccination of 76-years-old, as single dose, for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, coronary artery bypass from an unknown date and unknown if ongoing (6 years ago or more), mycotic allergy from an unknown date and unknown if ongoing (allergy medicine for mold weekly).  The patient previously took erythromycin and experienced drug hypersensitivity. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Right arm on 22Feb2021 16:00 (Batch/Lot Number: EN6198), age at vaccination of 76-years-old, as single dose, for covid-19 immunisation. The patient received unspecified concomitant medications (Other medications in two weeks: Too long to list - as reported). The patient experienced momentary loss of memory and lapse of time, memory loss, hard to concentrate, all on 29Mar2021; the events were serious as medically significant. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Extremely swollen lips the day after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included dermal filler injection; the patient had dermal filler in her lips, the last procedure had done was in early Feb2020. The patient did not have any allergies to medications, food, or other products. The patient did not receive concomitant medications. 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 30Mar2021 at 14:00, the day after vaccination, the patient experienced extremely swollen lips. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room visit. No therapeutic measures were taken as a result of event extremely swollen lips. The clinical outcome of the event extremely swollen lips was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Vaccination site swelling
Clinical narrative: Swollen round spot around the area; Extreme itching in left armpit; Swollen lymph node; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EP7533) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included cannabis sativa (MARIJUANA), mitragyna speciosa (KRATOM), vitamin d nos (VITAMIN D) and melatonin (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 7 days of vaccination i.e., on 01Apr2021 at 08:00 the patient experienced swollen round spot around the area where she got the vaccine, and initially extreme itching in left armpit that turned to a swollen lymph node. The patient did not receive any treatment for the 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 events swollen round spot around the area, extreme itching in left armpit and swollen lymph node was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip swelling; This is a spontaneous report from a contactable physician. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via intramuscular route of administration in the right arm on 08Feb2021 at 11:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was allergic to fluoroquinolones (unspecified). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the right arm on 17Jan2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included glatiramer acetate (COPAXONE) taken for unspecified indication from an unknown date. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021, after three weeks of the second dose of vaccine (as reported), the patient experienced lip swelling. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received with unspecified steroids. The clinical outcome of the event lip swelling was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Has had some fatigue and a mild headache but so far nothing further; Has had some fatigue and a mild headache but so far nothing further; This is a spontaneous report from a contactable consumer, the parent. A 21-year-old male 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 01Apr2021 at 10:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included kostmann's syndrome, acute myeloblastic leukemia, bone marrow transplant (first of its kind), did not take as quickly as hoped and was immunocompromised. The patient has not been storing antibodies for vaccines. The patient also had multiple drug allergy. The list was quite extensive from antibiotics to Dextran 40. The patient was taking multiple medications (unspecified) for post BMT (bone marrow transplant). 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 reporter was not sure where to contact. The patient was compromised and a post bone marrow transplant (BMT) patient whose system did not recover quite like it should. They were iffy about giving the vaccine to the patient but his mother, the reporter insisted. He was doing great with it. Has had some fatigue and a mild headache on 01Apr2021 at 15:00, but nothing further 20 hours post shot. They said they don't have data on these patients. The reporter would keep track of any responses the patient has. Did not know if he would store the antibodies. He so far has not with any other vaccine. Therapeutic measures were taken as a result of fatigue and mild headache and included treatment with ibuprofen (MANUFACTURER UNKNOWN). 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 fatigue and mild headache was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Lip pain
Clinical narrative: extremely tired; hoarse in my speech; A cold sore on my lip; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included slightly high Blood Pressure (BP), slightly high low-density lipoprotein (LDL) cholesterol and cigarette smoker. The patient was not allergic to any medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), lisinopril dihydrate (LISINOPRIL) and zolpidem (MANUFACTURER UNKNOWN), all for an unspecified indications and from an unknown date. 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 30Mar2021 at 07:00, day 6 after the vaccination, the patient felt extremely tired, had hoarse speech and developed a cold sore on lip. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of the events extremely tired, hoarse speech and cold sore on lip were recovered on 31Mar2021 (day 7.75 after the vaccination).  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Right hand numbness; Right hand tingling; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male 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 01Apr2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. The patient did not have any allergies to food, medications, 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. Concomitant medications included glipizide (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. On 02Apr2021 at 03:00, the patient experienced right hand numbness and tingling. The events 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 events. The clinical outcome of the events right hand numbness and tingling were not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 23Mar2021 at 15:30 (at the age of 38-years-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. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included sucralfate (MANUFACTURER UNKNOWN), trilomarzia (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced soreness in arm where vaccine was administered, could not sleep on that side for 4-5 nights, had soreness for about a week, but did not keep the patient from her normal routine and did not keep her from working. 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 soreness in arm was recovered from an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain, Peripheral swelling
Clinical narrative: Left arm sore; scratchy/sore throat; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 42-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 01Apr2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The concomitant medications were not taken by the patient within two weeks prior to COVID-19 vaccine. The past drug history was 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 vaccine. 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. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 01Apr2021 at 15:15, the patient experienced left sore arm/swollen arm, scratchy/sore throat, fatigue and body aches. The patient did not receive any treatment for the reported events. The clinical outcome of the events swollen arm, sore throat, fatigue and body aches were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Sore arm; Severe tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP7533) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and tinnitus. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient received varicella zoster vaccine rgE (CHO) (SHINGRIX), dose number 1 in the arm on 27Mar2021 for an unknown indication. The patient previously took simvastatin and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 (day 1) at 18:00, the patient experienced sore arm with no other significant symptoms. On an unknown date in Apr2021 (day 5), the patient experienced sudden onset of fairly severe tinnitus in both ears, continued constantly through day 6. The patient had minor tinnitus from time to time before, but this was more intense. It was annoying, but not debilitating at the time of this report. 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 events. The clinical outcome of the events sore arm and severe tinnitus in both ears was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site erythema
Clinical narrative: At the injection site, red circle a little larger than a dollar coin; Swelling; Intermittent itchy feeling; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN) and phendimetrazine (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the right arm on 09Mar2021 (at the age of 47-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 01Apr2021, the patient experienced red circle a little larger than a dollar coin at the injection site, swelling and intermittent itchy feeling. The patient did not receive any treatment for the 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 events red circle a little larger than a dollar coin at the injection site, swelling and intermittent itchy feeling were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: a itchy red rash on the inner ...underside of myleft breast; a itchy red rash on the inner ...underside of myleft breast; This is a spontaneous report from a contactable consumer, the patient. A 63-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 left arm on 30Mar2021 at 09:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and obesity. The patient did not have any allergies to medications, food, or other products. Concomitant medications included elderberry (MANUFACTURER UNKNOWN) with zinc oxide (ZINC), ascorbic acid (VITAMINE C) and paracetamol (TYLENOL) all for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 day after the vaccine shot, the patient noticed a itchy red rash on the inner, underside of her left breast. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event itchy red rash on the inner, underside of her left breast was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Vision blurred
Clinical narrative: Vision went blurry, both eyes but right wasmore blurrier; Dry eyes; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15, (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ascorbic acid, rosa canina (VITAMIN C), colecalciferol (VITAMIN D3) and mecobalamin (VITAMIN B12) from an unknown date for unspecified indication. 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 22:30 the patient experienced vision went blurry, both eyes but right was more blurrier and dry eyes. Therapeutic measures were taken as a result of reported event, patient put eye drops for dryness and went to bed. No therapeutic measures were taken for event blurry. On 02Apr2021, the blurriness was still there. The clinical outcome of the event vision went blurry and dry eyes was not recovered.   No follow-up attempts are needed. No further information is expected
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer, the parent. A 25-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. It was unknown, if the patient was pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Mar2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever on 02Apr2021. The patient did not receive any treatment for the reported event. 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 fever was recovered .   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip Swelling; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and also allergy to nickel and sulfur.  Concomitant medications included thyroid (ARMOUR THYROID), escitalopram (MANUFACTURER UNKNOWN) 5 mg and progesterone  (MANUFACTURER UNKNOWN) 200 mg, all for unknown indications from unknown dates. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the  left arm on 10Mar2021 at 10:30 (at the age of 62-year-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 01Apr2021 at 21:00, the patient experienced lip swelling. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of lip swelling and included treatment with oral steroid progesterone. The clinical outcome of the event lip swelling was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm left on 02Apr2021 at 10:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history and 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 COVID vaccine. On 02Apr2021, the patient experienced Pain at site of injection. 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 event. The clinical outcome of the vaccination site pain was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersomnia, Urticaria, Vaccination site urticaria
Clinical narrative: Next day air headed (zombie like); Hives around vaccine entry left arm to arm pit; Hives at armpit and lower rib cage above stomach; hours after falling asleep repeatedly; This is a spontaneous report from a contactable consumer, the patient. A 68-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 28Mar2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), SUPER BETA PROSTATE and multivitamin from an unspecified date for an unknown indication. The patient was allergic to amlodipine (MANUFACTURER UNKNOWN) and oxybutynin (MANUFACTURER UNKNOWN). 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 14:00, the patient experienced falling asleep repeatedly. On 29Mar2021, on the next day of vaccination, the patient experienced air-headed (zombie like) and hives around vaccine entry left arm to arm pit and lower rib cage above stomach was seen at bedtime. 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 events. The clinical outcome of the event hours after falling asleep repeatedly, air headed (zombie like), hives around vaccine entry left arm to arm pit and hives at armpit and lower rib cage above stomach was recovered on an unspecified date 2021, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Night sweats, Pain in extremity
Clinical narrative: Muscle aches; Chills; Severe headache; Night sweats; Arm hurt more than normal; This is a spontaneous report from a contactable consumer, the patient. A 40-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 right on 01Apr2021 at 09:00(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. Concomitant medications included ethinylestradiol, norethisterone acetate (ESTROSTEP) from an unknown date for birth control.  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 01Apr2021 at 20:30 the patient experienced chills, severe headache then night sweats and at night the arm hurt more than normal. On 02Apr2021 the patient experienced muscle aches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event chills, headache, night sweats, arm hurt more than normal and muscle aches was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Erythema, Fatigue, Hypersomnia, Rash macular
Clinical narrative: Interesting dreams while sleeping perhaps from extra sleep.; Interesting dreams while sleeping perhaps from extra sleep.; Blotchy face and blotchy around neck; Redness or flushed; Sore arm at injection site; Very tired; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6455 or EP6955), via an unspecified route of administration in the right arm on 20Mar2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and COVID-19. The patient did not receive any other medications in two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. 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 4 weeks prior to the vaccination. On 21Mar2021 at 09:00, the patient experienced sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep. 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 events. The clinical outcome of the events sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep were recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Interesting dreams while sleeping perhaps from extra sleep.; Interesting dreams while sleeping perhaps from extra sleep.; Blotchy face and blotchy around neck; Redness or flushed; Sore arm at injection site; Very tired; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6455 or EP6955), via an unspecified route of administration in the right arm on 20Mar2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and COVID-19. The patient did not receive any other medications in two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. 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 4 weeks prior to the vaccination. On 21Mar2021 at 09:00, the patient experienced sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep. 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 events. The clinical outcome of the events sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep were recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dissociation, Dizziness
Clinical narrative: light headedness; felt detached; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 31Mar2021 at 10:15 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfonamides (sulfa). 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 multi vitamins, fish oil (MANUFACTURER UNKNOWN) and collagen (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 10:45,  the patient experienced light headedness and feeling detached. It was reported that the patient waited in the pharmacy for more than 20 minutes after the vaccine, then left and got in the car. Patient  then experienced light headedness and  felt detached. So the patient sat in the car for another 20 minutes or so to see if it became worse. It did not get worse so the patient changed her plans, the patient was going to go food shopping and run some errands but did not because of the light headed feeling that she had experienced. The patient did not receive any treatment for the reported events. The clinical outcome of the events of  light headedness and feeling detached was recovered on 31Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus
Clinical narrative: Severe full body itching; Immediate headache; Mild nausea; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19266) via an unspecified route of administration in the left arm on 21Feb2021 at 12:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and thyroid removal. 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. Concomitant medications included ezetimibe; simvastatin (VYTORIN), dexlansoprazole (DEXILANT), levothyroxine sodium (UNITHROID) and azilsartan medoxomil; chlortalidone (EDARBYCLOR), all from unknown dates for unknown indications. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 21Feb2021, the patient experienced immediate headache, mild nausea and 4 days later on 25Feb2021, the patient experienced severe full body itching lasting over one week. It was severe enough to require medical intervention. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with prednisone of dose 40milligram for 5 days. The clinical outcome of the event severe full body itching was recovered on 04Mar2021 while the outcome of the events immediate headache and mild nausea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: large lump in arm opposite site of injection; This is a spontaneous report from a contactable consumer, the patient. A 75-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 arm right on 31Mar2021 at 14:15 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), telmisartan (MICARDIS), fish oil, tocopherol (OMEGA 3) and vitami (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 10Mar2021 at 14:15 (at the age of 75-year-old) as a single dose for COVID-19 Immunisation and previously took docetaxel (TAXOTERE) on unknown date for unknown indication and experienced drug allergy. 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 09:00 the patient experienced large lump in arm opposite site of injection. 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 event. The clinical outcome of the event large lump in arm opposite site of injection was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. A 43-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 01Apr2021 at 11:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included dietary supplements (MANUFATURER UNKNOWN) from unknown date for unspecified indication. 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 COVID vaccine. On 01Apr2021 the patient experienced slight sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the event. The clinical outcome of the pain in arm was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Hot flush
Clinical narrative: Lack Of Apeptite; Hot Flash; Severe Diarrhea; Fever; Chill; Extreme Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 40-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 left arm on 30Mar2021 at 17:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 31Mar2021 at 16:30 the patient experienced lack of appetite, hot flash, severe diarrhea, fever, chill and had extreme exhaustion. 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 event. The clinical outcome of the event lack of appetite, hot flash, severe diarrhea, fever, chill and extreme exhaustion were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.