chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Tongue swelling; Throat closed; Face swelling; A spontaneous report was received from a consumer concerning a 59-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue swelling, face swelling and throat closing  The patient's medical history was not reported.  Products known to have been used by the patient, within two weeks prior to the event, included Lisinopril, Simvastatin, Famotidine 150mg, Fluticasone Propionate, Vitamin C , Vitamin D , Fish Oil  all since an unknown date for an unknown indication and diphenhydramine hydrochloride  since 29 Jan 2021 for an unknown indication.   On 29 Jan 2021, approximately a few hours prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021, patient experienced tongue swelling, throat closing, and face swelling. where he  was hospitalized on same day(29 Jan 2021)  and was discharged on 01 Feb 2021.  Treatment for the event included Epinephrine, Prednisone Drip, Pepsin intravenously and Prednisone QD for 4 days.   The outcome of the events tongue swelling , throat closing, and face swelling were considered resolved on an unknown date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Blood iron, Blood iron decreased, Chills, Night sweats
Clinical narrative: Pericarditis; A-flutter; Severe night sweats; blood iron decreased; Nightly Chills; A spontaneous report was received from a consumer for a male patient (unspecified age)(reporter father) who experienced atrial flutter, pericarditis, chills and sweats.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date within few hours after receiving the vaccine, the reporter stated that his/her father came down with pericarditis as a vaccination side effect. Three weeks later patient still had it along with nightly chills and severe night sweats. The patient also developed atrial flutter and his iron levels dropped in his blood.   No treatment details were provided.  The seriousness criteria for the event pericarditis was medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, pericarditis, chills, and night sweats,  was not resolved.  The outcome of the events, atrial flutter and blood iron decreased, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; A-flutter; Severe night sweats; blood iron decreased; Nightly Chills; A spontaneous report was received from a consumer for a male patient (unspecified age)(reporter father) who experienced atrial flutter, pericarditis, chills and sweats.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date within few hours after receiving the vaccine, the reporter stated that his/her father came down with pericarditis as a vaccination side effect. Three weeks later patient still had it along with nightly chills and severe night sweats. The patient also developed atrial flutter and his iron levels dropped in his blood.   No treatment details were provided.  The seriousness criteria for the event pericarditis was medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, pericarditis, chills, and night sweats,  was not resolved.  The outcome of the events, atrial flutter and blood iron decreased, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypertension
Clinical narrative: breathing problem; high blood pressure; severe headaches; A spontaneous report  was received from a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events breathing problem, high blood pressure and severe headaches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03-Feb-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 010M-A (unknown numbers between M and A)) intramuscularly for prophylaxis of COVID-19 infection. On 10-MAR-2021, 1 month 7 days after receiving the vaccine, the patient reported a breathing problem which lasted for two weeks. The patient also experienced high blood pressure and severe headaches. The patient's physician contraindicated the patient to have the second dose.  No treatment information was provided.  The seriousness criteria for the event breathing problem was considered as medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, breathing problem was recovered/ resolved and the action taken for high blood pressure, severe headaches was unknown.; Reporter's Comments: Based on the current available information and lack of clear temporal association between the use of the product and the start date of the events, a causal relationship was assessed as unlikely related.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: numbness on left side of face, watery eyes, could not blink eyes, speech was slurry, Bell's palsy; A spontaneous report  was received from a consumer concerning herself, a 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's Palsy.  The patient's medical history was not provided. No concomitant medications were reported.   On 03 Mar 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029H21A) intramuscularly in the left non dominant deltoid for prophylaxis of COVID-19 infection.   On 03 Mar 2021, same day after vaccination, the patient had numbness on the left side of her face, watery eyes, could not blink the eyes, speech was slurry, visited ER where the physician diagnosed it as Bell's palsy and was treated with steroids,  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Cannot move his right cheek/Bell's palsy/Right side of his face was paralyzed; A spontaneous report was received from a consumer concerning a 67-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  Bell's palsy.  The patient's medical history was not provided. Concomitant medications were not provided by reporter.  On 06 Mar 2021, 2 days prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: 029A21A) in the left arm for prophylaxis of COVID-19 infection.   Patient received the vaccine on 06 Mar 2021. On 07 Mar 2021, the patient called to report biting of teeth and hard to swallow. On 08 Mar 2021 upon waking up he noticed he could not move his right cheek. He went to his doctor and an MRI was done of the brain. Doctors impression was Bell's palsy. On 09 Mar 2021, he noted that the right side of his face was paralyzed. He cannot close his right eye; the right side of his mouth was always downwards and his "eyeballs were not on the same level".  The patient was prescribed with prednisone 20mg 3 tabs to be once a day for 7 days, 2 tabs to be taken once a day for 3 days, and 1 tab to be taken once a day for 3 days.  Action taken with mRNA-1273 in response to the event was not applicable.  The event Bell's palsy was deemed medically significant.   The outcome of the events Bell's palsy was not recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Pin Stroke; A spontaneous report was received from a consumer concerning a 66-year-old,  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event  pin stroke.  The patients medical history was not provided. Products known to have been used by patient with in last two weeks included montelukast  , alendronate and varenicline tartrate.  On  04-Mar-2021, prior to the onset of the events, the patient received their first  of two planned doses of mRNA (Lot number: 010A21A ) through intramuscular route of administration in the left deltoid for prophylaxis of COVID-19 infection.  On 06-Mar-2021, patient experienced pin stroke and was hospitalized for four days. Laboratory tests performed included magnetic resonance imaging and electro cardiogram and the results was not provided. No treatment information was provided..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event pin stroke was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: Singular itchy bumps/ these shoes up on stomach area and left leg; This is a spontaneous report from a contactable other health care professional (HCP) (patient).  A 54-year-old female patient (no-pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number was unknown), via an unspecified route of administration at arm right on unspecified date at single dose for COVID-19 immunisation. Medical history included were none. The patient's concomitant medications were not reported. There was no other vaccine in four weeks and no other medications in two weeks. The patient experienced Singular itchy bumps within 5-7 days after the initial injection, these shoes up on stomach area and left leg on 20Jan2021 12: 00 AM.  They started to dry up, however, after the second dose (as prescribed) and after 5-7 days another outbreak. There was no covid prior vaccination. The patient underwent lab tests included covid test post vaccination, Nasal Swab: negative on 12Jan2021; Nasal Swab: negative on 26Jan2021; Nasal Swab: negative on 10Feb2021; Nasal Swab: negative on 16Feb2021; There was no treatment for event. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia
Clinical narrative: fever; Chills; Felt unwell; This is a spontaneous report from a contactable other healthcare professional.   A 63-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration, administered (at the age of 63 years old) in the right arm on 17Feb2021 11:00 (Lot Number: Unknown) as a SINGLE DOSE for covid-19 immunisation.  Medical history included covid from Apr2020 to an unknown date.  The patient had no known allergies.   The patient's concomitant medications included multivitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 18Feb2021 10:30, the patient experienced chills, felt unwell and fever of 99.3. Therapeutic measures were taken as a result of fever which included the patient took acetaminophen (TYLENOL), went to bed and rested. The patient underwent lab tests and procedures which included temperature: 99.3. on 18Feb2021. The patient did not receive treatment for chills and felt unwell. Outcome of the events chills, felt unwell and fever of 99.3 was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: I've had major aches in muscles (legs & arms) and hip joints; I've had major aches in muscles (legs & arms) and hip joints; This is a spontaneous report from a contactable consumer (the patient). This non-pregnant 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL 1283), via an unspecified route of administration, administered in the left arm on 12Jan2021 at 08:15 AM (at the age of 72 years) as a single dose for COVID-19 immunization. Medical history included Barrett's oesophagus. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported "I've had major aches in muscles (legs & arms) and hip joints on 23Jan2021. No treatment was given for the event. The clinical outcome of  major aches in muscles and hip joints was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lymph node pain, Lymphadenopathy
Clinical narrative: Light headedness; Swollen/ painful lymph nodes in armpit.; painful lymph nodes in armpit.; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 52-year-old, reported as currently 51-years-old, female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the left arm on 19Feb2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, and penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID. Concomitant medications include paracetamol (TYLENOL) and synthetic elderberry [Sambucus nigra] syrup, both from unknown dates for unknown indications. The patient had not received any other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (lot number EL9261) in the left arm on 29Jan2021 at 16:15 (at the age of 52-years-old) for COVID-19 immunisation. On 21Feb2021 at 08:30 the patient experienced swollen/painful lymph nodes in armpit and light headedness on the second day after the second dose. No treatment was provided for the events. The clinical outcomes of light headedness and swollen/painful lymph nodes in armpit were unknown. It was also reported that the patient had not been tested for COVID since vaccination.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Musculoskeletal stiffness
Clinical narrative: jerks left arm next day, next day small jerks fr head to toe at night. have lessened but still minor jerks especially arms and hands; stiffness in legs and back; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient (not pregnant) received BNT162B2 (lot number: em9809) second dose on 10Feb2021 10:30 at single dose on left arm for COVID-19 immunisation. Medical history included sleep apnea. Concomitant medications included lisinopril, acetylsalicylic acid (BABY ASPIRIN) and paracetamol (TYLENOL). The patient had allergies to Levaquin. The patient previously took BNT162B2 (lot number: el9261) first dose on 20Jan2021 (at the age of 82-year-old) on right arm for COVID-19 immunisation. Facility type vaccine was Hospital. Jerks left arm next day, next day small jerks from head to toe at night. have lessened but still minor jerks especially arms and hands. stiffness in legs and back. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. No treatment. No covid prior vaccination. No covid tested post vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia
Clinical narrative: Severe joint pain: knees, ankles, hips, elbows, wrists, shoulders. Only at night when lying down. The pain was such that I could not go back to sleep; Severe joint pain: knees, ankles, hips, elbows, wrists, shoulders. Only at night when lying down. The pain was such that I could not go back to sleep; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9267) via an unspecified route of administration on 12Feb2021 (at the age of 52-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Restless Legs Syndrome, anxiety/depression, and cold sores. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included gabapentin and venlafaxine. The patient previously received sulfa and hydrocodone from unspecified dates for unspecified indications and experienced allergy. The patient received dose 1 of BNT162B2 (lot number EL9261) on 20Jan2021 at 09:30 as a single dose in the left arm for COVID-19 immunization. On 15Feb2021 at 03:00, 56 hours after the second dose of BNT162B2, the patient experienced severe joint pain in the knees, ankles, hips, elbows, wrists and shoulders. It was only at night when lying down. The pain was such that she could not go back to sleep. It happened for several days then stopped. The patient had an appointment scheduled with her doctor but the symptoms resolved so she cancelled it. The patient did not receive any treatment for the events. The outcome of severe joint pain and could not go back to sleep was recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vision blurred
Clinical narrative: cannot focus with her eyes; full body aches and pains; This is a spontaneous report from a contactable consumer. A non-pregnant 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the right arm on 18Feb2021 at 15:00 (at the age of 97-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID. It was unknown if the patient had any allergies. Concomitant medications included pilocarpine hydrochloride 1% ophthalmic from an unknown date for an unknown indication and levothyroxine from an unknown date for an unknown indication. The patient had not received other vaccines in four weeks. The reporter stated that her mother said she could not focus with her eyes and had full body aches and pain on 21Feb2021 at 09:00; further reporting she is generally in good health without any complaints. No treatment was provided for the events. The clinical outcomes of cannot focus with her eyes and full body aches and pains were not recovered. It was also reported the patient was not COVID-tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unknown route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patent called to inquire if she could get her second dose of vaccine today (as of 21Feb2021) because she had a cold from having no heat for days. The clinical outcome of cold was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: There was brusing over several days that extended down the arm, past the elbow. Photos available.; This is a spontaneous report from a contactable consumer, the patient. A 91-years-old male patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown),  via an unspecified route of administration, administered in Arm Left on 06Feb2021 at 15:00 (at the age of 91-years-old) as SINGLE DOSE for covid-19 immunisation. Historical vaccine include Dose 1, on 16Jan2021 at 15:00, Left Arm. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient medical history were not reported. Concomitant medication were administered but drug names were not provided.  Patient has no known allergies. On 06Feb2021, The patient experienced there was bruising over several days that extended down the arm, past the elbow. Photos are available. The clinical outcome of the event Bruising was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness on her arm; This is a spontaneous report from a sponsored program. A non-contactable consumer(patient) reported this female patient of unspecified age received doses 1 and 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on unspecified dates as single doses for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates the patient experienced soreness on her arm after receiving doses 1 and 2 of BNT162B2. The patient did not feel any other side effects. She wanted to know if this meant the vaccine did not take effect. The outcome of soreness on her arm was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Head discomfort
Clinical narrative: Heavy Head; Tired; Chills; Diarrhea Symptoms; This is a spontaneous report from a contactable consumer (the patient). A 79-year-old female patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Jan2021 15:00 (lot number El 9269) and on 12Feb2021 17:30 (lot number EL9262), respectively, both via an unspecified route of administration in the left arm (at the age of 79-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: allergies to penicillium and sulphur. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: atorvastatin, multivitamin, "vitamin C K E calcium". The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 09:00, 4 days after the first dose, the patient experienced heavy head, tired, chills and diarrhea symptoms, lasted about 6 hours. The patient had to take 2 antidiarrhea pills. Seven days after the second dose, the patient experienced the same symptoms for the same amount of time. The patient did not receive treatment for heavy head, tired, chills. The clinical outcome of the events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable physician, based on information received  (manufacturer control number: EC-2021-087939).  A female patient of unspecified age received bnt162b2 first dose on 15Feb2021 at single dose for COVID-19 immunisation. Medical history included C55 Malignant neoplasm of the uterus (on Keytruda). Concomitant medications included lenvatinib mesylate (LENVIMA) 10 mg from 11Feb2021 to 12Feb2021 for Endometrial cancer (action taken was Temporarily Withdrawn). Patient reported she received a COVID shot on 15Feb2021, and she has a sore arm on 15Feb2021. Patient will get the second dose in Mar2021. The outcome of the event was unknown.  No follow-up attempts are needed. Information about batch/lot number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Lymphadenopathy, Off label use, Pain in extremity
Clinical narrative: Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; First dose on 02Feb2021, second dose on 19Feb2021; This is a spontaneous report from a contactable healthcare professional reported for herself. This 48-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El9262) on 19Feb2021 at 08:45 AM single dose at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin, sulfa and Pre diabetic. Historical vaccine was 1st dose of BNT162B2 (lot number El3247) for COVID-19 immunisation on 02Feb2021 at 08:00 AM at left arm. Concomitant drugs included semaglutide (OZEMPIC), pravastatin sodium (PRAVASTINE), metformin and losartan potassium (LOSARTIN). On 19Feb2021 at 06:00 PM, the patient experienced headache, arm pain, fever and worst part was the swollen lymph glands. The patient had visible swollen under arm into breast and down side of her arm, almost looks like a half a baseball sticking out of her arm. The patient saw doctor on 22Feb2021 and received treatment. The outcome of the events was resolving.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; First dose on 02Feb2021, second dose on 19Feb2021; This is a spontaneous report from a contactable healthcare professional reported for herself. This 48-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El9262) on 19Feb2021 at 08:45 AM single dose at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin, sulfa and Pre diabetic. Historical vaccine was 1st dose of BNT162B2 (lot number El3247) for COVID-19 immunisation on 02Feb2021 at 08:00 AM at left arm. Concomitant drugs included semaglutide (OZEMPIC), pravastatin sodium (PRAVASTINE), metformin and losartan potassium (LOSARTIN). On 19Feb2021 at 06:00 PM, the patient experienced headache, arm pain, fever and worst part was the swollen lymph glands. The patient had visible swollen under arm into breast and down side of her arm, almost looks like a half a baseball sticking out of her arm. The patient saw doctor on 22Feb2021 and received treatment. The outcome of the events was resolving.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Nausea; Pain at the injection site; sore muscles in the upper back and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). This 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) via unspecified route of administration in the left arm on 18Feb2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EL3247) in the left arm on 28Jan2021 at 09:30 (at the age of 39-years-old) for COVID-19 immunisation. On 18Feb2021 at 22:00 the patient experienced nausea, pain at the injection site, sore muscle in the upper back and shoulders, and tiredness. The events were reported as non-serious and did not require hospitalization. No treatment was received for the adverse events. The clinical outcomes of nausea, pain at the injection site, sore muscles in the upper back and shoulders, and tiredness were recovered in Feb2021. It was also reported that since vaccination the patient was not tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Sick stomach; headache; bruised injection spot and swollen; bruised injection spot and swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EN6198) via an unspecified route of administration, administered in arm left on 13Feb2021 14:15 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Patient is not pregnant. Concomitant medications included Fluoxetine, Estrodial, calcium carbonate/colecalciferol (VITAMIN D 2000), magnesium sulfate, fish oil. The patient experienced sick stomach, headache, bruised injection spot and swollen on 13Feb2021 15:45. No treatment received. There is no other vaccine received in four weeks. The patient did not have COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovering.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: couldn't feel her legs; uncomfortable walking; fever of 102; Exhausted; Sick to my stomach; Sore throat; Headache; major brain fog; having a lot of trouble talking; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9266/expiration date: not provided), via an unspecified route of administration, on an unknown date on "Thursday", as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included high blood pressure, diabetes mellitus and the patient had COVID in Nov202. Concomitant medication included paracetamol (TYLENOL) and high blood pressure medicine. On an unknown date, the patient reported that she had a really bad reaction on "Friday morning". She woke up and couldn't feel her legs really and was uncomfortable walking. She had a fever of 102. Additionally, the patient reported that she was exhausted, sick to her stomach, had a sore throat, headache, had major brain fog, and was having a lot of trouble talking. The patient reported that she was a little nervous about getting my second shot. She was going to get it, but was very concerned now that she had this reaction. No treatment was given for the events. Relevant lab tests included: an antibody test done, on an unknown date, the week prior to receiving the vaccine with results not provided. The outcome of the events couldn't feel her legs, uncomfortable walking, fever, exhausted, sick to her stomach, sore throat, headache, brain fog and trouble talking was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: couldn't feel her legs; uncomfortable walking; fever of 102; Exhausted; Sick to my stomach; Sore throat; Headache; major brain fog; having a lot of trouble talking; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9266/expiration date: not provided), via an unspecified route of administration, on an unknown date on "Thursday", as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included high blood pressure, diabetes mellitus and the patient had COVID in Nov202. Concomitant medication included paracetamol (TYLENOL) and high blood pressure medicine. On an unknown date, the patient reported that she had a really bad reaction on "Friday morning". She woke up and couldn't feel her legs really and was uncomfortable walking. She had a fever of 102. Additionally, the patient reported that she was exhausted, sick to her stomach, had a sore throat, headache, had major brain fog, and was having a lot of trouble talking. The patient reported that she was a little nervous about getting my second shot. She was going to get it, but was very concerned now that she had this reaction. No treatment was given for the events. Relevant lab tests included: an antibody test done, on an unknown date, the week prior to receiving the vaccine with results not provided. The outcome of the events couldn't feel her legs, uncomfortable walking, fever, exhausted, sick to her stomach, sore throat, headache, brain fog and trouble talking was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: couldn't feel her legs; uncomfortable walking; fever of 102; Exhausted; Sick to my stomach; Sore throat; Headache; major brain fog; having a lot of trouble talking; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9266/expiration date: not provided), via an unspecified route of administration, on an unknown date on "Thursday", as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included high blood pressure, diabetes mellitus and the patient had COVID in Nov202. Concomitant medication included paracetamol (TYLENOL) and high blood pressure medicine. On an unknown date, the patient reported that she had a really bad reaction on "Friday morning". She woke up and couldn't feel her legs really and was uncomfortable walking. She had a fever of 102. Additionally, the patient reported that she was exhausted, sick to her stomach, had a sore throat, headache, had major brain fog, and was having a lot of trouble talking. The patient reported that she was a little nervous about getting my second shot. She was going to get it, but was very concerned now that she had this reaction. No treatment was given for the events. Relevant lab tests included: an antibody test done, on an unknown date, the week prior to receiving the vaccine with results not provided. The outcome of the events couldn't feel her legs, uncomfortable walking, fever, exhausted, sick to her stomach, sore throat, headache, brain fog and trouble talking was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hot flush
Clinical narrative: Hot/cold flushes; Hot/cold flushes; This is a spontaneous report from a contactable consumer (patient) from a . A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced hot/cold flushes after having the 1st dose. The patient took Tylenol after the first dose. The patient received treatment for events. The outcome of events was unknown.  Information about lot/ batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Facial pain, Pruritus, Swelling face, Temporomandibular joint syndrome
Clinical narrative: Sore besides my eyebrows; Jaw joints hurts; Swollen red forehead; Swollen red forehead; Itchy; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL8982) on 18Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included diabetes type 2. Concomitant medications were not reported. Historical vaccine included COVID-19 VACCINE. Patient experienced swollen red forehead and itchy on 19Feb2021, sore besides eyebrows and jaw joints hurts on 20Feb2021. Investigation Assessment was no. Patient reported that she has come up with some peculiar reactions to the Covid thing. She has developed swollen red forehead and that is itchy and it looks like a dog bone across of her forehead. She had second shot on Thursday evening at about 5:30. So, this developed the next afternoon, Friday afternoon, during the afternoon it became a little swollen and a little itchy and then last evening so this is another day later she was sore beside eyebrows and her jaw joints hurt. No treatment was received. The outcome of the events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis has gotten worse; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 09Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing; lymphocytic colitis from an unknown date and unknown if ongoing; and psoriasis for about 45 years from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID. The patient had no known allergies. Concomitant medications included lisinopril, furosemide (LASIX), amlodipine, atorvastatin (LIPITOR), and metoprolol, all from unknown dates for unknown indications. The patient had not received other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (lot number EL1283) in the left arm on 19Jan2021 at 14:15 (at the age of 68-years-old) for COVID-19 immunisation and experienced excruciating left arm pain at the injection site and her psoriasis appeared to be getting better. The patient reported that she had psoriasis for about 45 years and after her second injection her psoriasis had gotten worse on 17Feb2021. No treatment was received for the event. The clinical outcome of psoriasis had gotten worse was not recovered. It was also reported the patient had not been COVID-tested since vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Off label use, Vaccination site pain
Clinical narrative: felt soreness in the area of the injection site; first dose of BNT162B2 on 01Feb2021/ second dose of BNT162B2 on 18Feb2021; first dose of BNT162B2 on 01Feb2021/ second dose of BNT162B2 on 18Feb2021; This is a spontaneous report from a contactable consumer. A 57-Years-Old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266), via an unspecified route of administration in left arm on 18Feb2021 at single dose for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications included atorvastatin calcium (LIPITOR). The patient previously received first dose of BNT162B2 on 01Feb2021 at the age of 57 years old for COVID-19 immunisation (lot number=EL9262, vaccine location=Left arm, dose number=1). The patient felt soreness in the area of the injection site on 20Feb2021. No treatment received for the event. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks. The outcome of the event felt soreness in the area of the injection site was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: felt soreness in the area of the injection site; first dose of BNT162B2 on 01Feb2021/ second dose of BNT162B2 on 18Feb2021; first dose of BNT162B2 on 01Feb2021/ second dose of BNT162B2 on 18Feb2021; This is a spontaneous report from a contactable consumer. A 57-Years-Old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266), via an unspecified route of administration in left arm on 18Feb2021 at single dose for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications included atorvastatin calcium (LIPITOR). The patient previously received first dose of BNT162B2 on 01Feb2021 at the age of 57 years old for COVID-19 immunisation (lot number=EL9262, vaccine location=Left arm, dose number=1). The patient felt soreness in the area of the injection site on 20Feb2021. No treatment received for the event. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks. The outcome of the event felt soreness in the area of the injection site was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Facial pain, Peripheral swelling
Clinical narrative: My right and left leg swelling up; Wondering; face is hurting on right side; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS), thyroid disorder. Concomitant medications included unspecified products. Patient experienced right and left leg swelling up; wondering; face is hurting on right side on an unspecified date. Patient went to "(city name)" (not clarified) the day prior for vaccination, took it about 5 o'clock and at the time of the report patient leg is swelling up the right and the left. And also patient face is hurting on the right side and patient have "MS" and patient was wondering what he/she should do. The outcome of the events was unknown.  Information about lot/Batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Rash got worse again a few days after second dose/ red and hot rash; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at left arm on 15Feb2021 (24-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications in two weeks. The patient did not received any other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at left arm on 25Jan2021 at 09:00 (24-year-old at time of vaccination) at single dose for COVID-19 immunization and experienced red and hot rash on the same arm (located in the crease of the elbow and about 5 inches in diameter) from 01Feb2021 at 08:00; received cortisone for the rash (it got better). Rash got worse again a few days after second dose in Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not test COVID post vaccination. Therapeutic measures were taken as a result of the event and included cortisone. The outcome of the event was recovering.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Syncope
Clinical narrative: fainted; severe headache; Chills; body aches; arm pain; This is a spontaneous report received from  from a contactable consumer (patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Mar2021 at 14:00 (Lot Number: EN6198) (at 34-year-old) at single dose in arm left for COVID-19 immunization. The patient's medical history was not reported. No allergy to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included testosterone cypionate, chorionic gonadotrophin (HCG), rosuvastatin, and tadalafil (CIALIS), all taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Feb2021 at 14:00 (Lot Number: EN6201) at single dose in arm left for COVID-19 immunization. He woke up in the middle of the night (4:00 am on 06Mar2021) after getting his second vaccine with severe headache, chills, body aches and arm pain. After getting up and using the bathroom, he went to take his temperature and fainted. The events were reported as non-serious, while resulted in emergency room/department or urgent care, treatment included intravenous (IV) fluids, paracetamol (TYLENOL). The outcomes of the events were resolved on an unspecified date in Mar2021.  Information on the expiration date of vaccine has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Developed ITP (Idiopathic Thrombocytopenia Pura); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date not reported), via an unspecified route of administration on an unspecified date (at age of 41 years old, no pregnant) at a single dose for COVID-19 immunization. The patient medical history was not reported. There was no COVID prior vaccination and no COVID tested post vaccination. The patient's concomitant medications were not reported. The patient developed ITP (Idiopathic Thrombocytopenia Pura) on 23Feb2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment received dexamethasone. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Developed ITP (Idiopathic Thrombocytopenia Pura); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date not reported), via an unspecified route of administration on an unspecified date (at age of 41 years old, no pregnant) at a single dose for COVID-19 immunization. The patient medical history was not reported. There was no COVID prior vaccination and no COVID tested post vaccination. The patient's concomitant medications were not reported. The patient developed ITP (Idiopathic Thrombocytopenia Pura) on 23Feb2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment received dexamethasone. The outcome of the event was unknown.  Information on the lot/batch number has been requested.