chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Oropharyngeal pain, Pain in extremity, Walking disability
Clinical narrative: could not walk; my legs started to hurt; my knees to the back top of my calf's that was horrible pain; slight sore throat; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration on 08Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included guillain-barre syndrome from an unknown date and unknown if ongoing, Epstein Barr viraemia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced could not walk on 11Mar2021, slight sore throat on Mar2021, my legs started to hurt on 11Mar2021, my knees to the back top of my calf's that was horrible pain on 11Mar2021. Limited information was provided by the caller. Therapeutic measures were taken as a result of could not walk, my legs started to hurt, my knees to the back top of my calf's that was horrible pain was pain medication. The outcome of the events oropharyngeal pain walking disability, pain in extremity, arthralgia was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Oropharyngeal pain
Clinical narrative: Tightness in chest; Sore throat; Fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp. A 27-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Mar2021 16:45 (age at vaccination: 27-Years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient didn't had COVID-19 prior to vaccination. Patient didn't other vaccines within 4 weeks prior to vaccination, patient had received other medication was Daily multivitamin within 2weeks of vaccination. The patient medical history and concomitant medications were not reported. On 13Mar2021 18:00 the patient experienced tightness in chest, sore throat, fatigue. No therapeutic measures were taken for the events. Patient was not tested with COVID-19 to post vaccination. The outcome of the events chest discomfort, oropharyngeal pain, fatigue was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Restlessness
Clinical narrative: I started getting a cough; I have been restless at sleeping at night when I lay down it's hard to breathe; I have been restless at sleeping at night when I lay down it's hard to breathe; This is a spontaneous report from a contactable consumer. A consumer (patient) of unknown age and gender reported that he/she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6204) via an unspecified route of administration on 08Mar2021 at 11:40 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Mar2021 the patient started getting side effects, he/she started getting cough and had been restless at sleeping at night when he/she layed down it was hard to breathe and in the daytime it felt fine. Patient would like to know do you have any idea and how long these symptoms would last. The event outcome was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Hypoaesthesia, Migraine
Clinical narrative: numbness/tingling in arms and legs; migraine; fever; chills; Extreme fatigue; SOB; numbness/tingling in arms and legs; This is a spontaneous report from a contactable other hcp. A 28-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 intramuscular, administered in the left arm on 28Jan2021 18:30 (at the age of 28 years old) dose 1, single for COVID-19 immunisation at public health clinic/veterans. Patient was not pregnant at the time of vaccination. The patient's medical history included anxiety, and migraine. Patient had no known allergies. Concomitant medications included bupropion. 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. On 18Feb2021 at 12:00, the patient experienced extreme fatigue, SOB, numbness/tingling in arms and legs, migraine, fever, chills. No treatment was given. The clinical outcome of the events was reported as recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: numbness/tingling in arms and legs; migraine; fever; chills; Extreme fatigue; SOB; numbness/tingling in arms and legs; This is a spontaneous report from a contactable other hcp. A 28-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 intramuscular, administered in the left arm on 28Jan2021 18:30 (at the age of 28 years old) dose 1, single for COVID-19 immunisation at public health clinic/veterans. Patient was not pregnant at the time of vaccination. The patient's medical history included anxiety, and migraine. Patient had no known allergies. Concomitant medications included bupropion. 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. On 18Feb2021 at 12:00, the patient experienced extreme fatigue, SOB, numbness/tingling in arms and legs, migraine, fever, chills. No treatment was given. The clinical outcome of the events was reported as recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EN6200 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Feb2021 at 14:45 (Age at vaccination was 74 years) as dose 2, single for covid-19 immunization. Medical history included knee arthroplasty on an unknown date. The patient was allergic to IV iodine. There were no concomitant medications. The patient did not have COVID-19 prior to vaccination. The patient did not take other vaccine within four weeks and other medication within two weeks. The patient also took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL8982 and expiration date was not reported) via an unspecified route of administration, administered in right arm on 26Jan2021 at 14:45 (Age at vaccination was 74 years) as dose 1, single for covid-19 immunization. On 16Feb2021 at 20:00 the patient experienced terrible joint pain and patient stated that 6 hours after 2nd vaccination I could hardly walk as knees giving way. The patient did not tested COVID post vaccination. Adverse event resulted in doctor or other healthcare professional office. Physical therapy was taken as therapeutic measures for the events. The outcome of both the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Joint swelling
Clinical narrative: Chills; tiredness; headache; feeling unwell; swelling & pain in right wrist; swelling & pain in right wrist; This is a spontaneous report from a contactable consumer(patient). A 78-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 06Mar2021 at 10:15 AM (age at vaccination: 78-years-old), as dose 2, single for COVID-19 immunization. The patient's medical history included arthritis. Concomitant medications included atorvastatin. The patient was allergic to morphine, codeine and darvacet. The patient did not receive any vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 08Mar2021, at 7:00 PM, the patient experienced chills, tiredness, headache, feeling unwell, swelling & pain in right wrist. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Chills; tiredness; headache; feeling unwell; swelling & pain in right wrist; swelling & pain in right wrist; This is a spontaneous report from a contactable consumer(patient). A 78-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 06Mar2021 at 10:15 AM (age at vaccination: 78-years-old), as dose 2, single for COVID-19 immunization. The patient's medical history included arthritis. Concomitant medications included atorvastatin. The patient was allergic to morphine, codeine and darvacet. The patient did not receive any vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 08Mar2021, at 7:00 PM, the patient experienced chills, tiredness, headache, feeling unwell, swelling & pain in right wrist. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Chills; injection site pain/ache; fever; generally feeling unwell; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 12Mar2021 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 55 years). The patient medical history included hypothyroidism. Concomitant medications included Cetirizine hydrochloride (ZYRTEC (CETIRIZINE HYDROCHLORIDE)) and Levothyroxine. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 18Feb2021 10:15 as dose 1, single for COVID-19 immunization (Age at Vaccination was 55 years). It was stated that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID vaccine. The other medications in two weeks include Zyrtec, Levothyroxine. She was not diagnosed with COVID-19 prior to vaccination, not been tested for COVID-19 since the vaccination and no known allergies. On 12Mar2021 21:15, the patient experienced chills, injection site pain/ache, fever, generally feeling unwell. No therapeutic measures were taken as a result of events. The outcome of events was recovering.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: 100 Degree Fever; Headache; This is a spontaneous report from a contactable consumer (patient himself). A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 12Mar2021 09:00 (at the age of 63-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included blood pressure increased, gout, cardiac disorder, hernia and COVID-19 from an unknown date and unknown if ongoing. Patient had not any known allergies. Other medications (concomitant medications) in two weeks was reported as yes (drugs not specified). The patient experienced 100 degree fever and headache on 12Mar2021 23:00. Patient did not receive any treatment for adverse event. The outcome of both the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain; redness; swelling to over 2in still after 60 hours; This is a spontaneous report from a contactable consumer (patient) via regulatory authority.   A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:00 (lot number: EN6206; expiry date: unknown) at the age of 31-years-old, as dose 1, single, for Covid-19 immunisation. Medical history included Covid. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid-19 prior vaccination. On 10Mar2021, at 15:00, the patient experienced pain, redness, swelling to over 2 in still after 60 hours. The patient did not receive treatment for the events. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Influenza, Myalgia
Clinical narrative: Bad joint; muscle pain; there was some discomfort; a miserable case of the flu; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient herself). A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot Number: EN6207 Expiration date: Unknown) via an unspecified route of administration, in Left arm on 11Mar2021 11:15 AM (at the age of 76-year-old) as dose 1, single for covid-19 immunization. Patients medical history included diabetes mellitus and covid-19 (prior vaccination) from an unknown date and unknown if ongoing. Patient does not have any known allergy and she was not tested for covid-19 post vaccination. If patient received other vaccine in four weeks was unknown and received any other medications in two weeks was unspecified (Too many for this space). On 12Mar2021 12.00 AM patient experienced Bad joint and muscle pain, Like a miserable case of the flu without the sour stomach. It was like this the day after the shot, On the next day, there was some discomfort, but not like the day after. Patient did not receive any treatment. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Nasal discomfort
Clinical narrative: Strange zit feeling in nasal cavity that moves around; feel the inflammation then moves to another spot ever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL7261) via an unspecified route of administration, administered in arm left on 08Feb2021 12:00 (at the age of 51-year-old) at dose 2, single for covid-19 immunisation. Medical history included babesiosis and known allergies: Asprin. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); lisinopril (LISINOPRIL); fish oil (FISH OIL); colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in arm left on 18Jan2021 17:00 (at the age of 51-year-old) at dose 1, single for covid-19 immunisation. On 15Feb2021 the patient experienced strange zit feeling in nasal cavity that moves around, feel the inflammation then moves to another spot ever since my second vaccination and continues to this day. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.  No follow-up attempts are possible; No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nasal oedema, Rash
Clinical narrative: Left side of face swollen, eyelid and nose; Left side of face swollen, eyelid and nose; Left side of face swollen, eyelid and nose; Under arm swollen knot; bad rash under arm; headaches; tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female non-pregnant patient received bnt162b2 (BNT162B2) formulation solution for injection, unknown (Lot Number: EN6202 expiry date was unknown) via an unspecified route of administration at arm left on 01Mar2021 15:00 as a single for covid-19 immunisation. The patient medical history and concomitant medication(s) included losartan, simvastatin, amlodipine. 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 vaccine within four weeks prior to the COVID vaccine. The patient experienced 05Mar2021 06:00 left side of face swollen, eyelid and nose. Under arm swollen knot, bad rash under arm, headaches, and tiredness. Outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: Left side of face swollen, eyelid and nose; Left side of face swollen, eyelid and nose; Left side of face swollen, eyelid and nose; Under arm swollen knot; bad rash under arm; headaches; tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female non-pregnant patient received bnt162b2 (BNT162B2) formulation solution for injection, unknown (Lot Number: EN6202 expiry date was unknown) via an unspecified route of administration at arm left on 01Mar2021 15:00 as a single for covid-19 immunisation. The patient medical history and concomitant medication(s) included losartan, simvastatin, amlodipine. 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 vaccine within four weeks prior to the COVID vaccine. The patient experienced 05Mar2021 06:00 left side of face swollen, eyelid and nose. Under arm swollen knot, bad rash under arm, headaches, and tiredness. Outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Have a low to medium grade fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 12Mar2021 at 10:00 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 12Mar2021 patient stated "had my Pfizer Vaccine (Covid-19 Vaccine) today in the morning and just want to know that is it normal to have a low to medium grade fever, patient had it around 10:00 AM. So, is it normal for me to have fever like at night, started feeling this around at 08:30 or 9:00 I guess." In response to further probing, consumer stated, "No, I am at the bed right now and I need to sleep." The patient underwent lab tests and procedures which included body temperature with result low to medium grade fever on 12Mar2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Extreme itching and rash of bilateral upper extremities starting on arm of injection; Extreme itching and rash of bilateral upper extremities starting on arm of injection; This is a spontaneous report from a non-contactable nurse (patient). A 24-year-old female patient (age at vaccination: 24 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL0142 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 07Jan2021, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 25Jan2021, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies: pineapple. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), methylphenidate hydrochloride (CONCERTA), buspirone, and birth control. Past drug included Dexamethasone (known allergies: Dexamethasone) and Bactrim (known allergies: Bactrim). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 11Jan2021, the patient experienced extreme itching and rash of bilateral upper extremities starting on arm of injection and then moving lower. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible; no further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Illness, Rash
Clinical narrative: I am too sick; Lips are numb; Excruciating headache; Have rash on parts of my body; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that patient was too sick, lips was numb, excruciating headache, had rash on parts of body. The clinical outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Lethargy, Pain, Pain in extremity
Clinical narrative: Fever; aches; chills; arm pain shoulder to wrist; general lethargy feeling of unwell; general lethargy feeling of unwell; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 11:15 (Batch/Lot Number: EL9263) as DOSE 1 SINGLE for covid-19 immunizations (Age at vaccination 53 years). Facility type vaccine: Health Clinic. The patient past Medical history included PVCs (Premature ventricular contractions) from an unknown date and unknown if ongoing and  covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes. Concomitant medication(s) included zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL XL SANDOZ) taken for an unspecified indication, start and stop date were not reported; fish oil (OMEGA 3 [FISH OIL]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took morphine and experienced drug hypersensitivity. 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 vaccine within 4 weeks prior to covid-19 vaccination. On 10Mar202116:00, the patient experienced fever, aches, chills, arm pain shoulder to wrist and general lethargy feeling of unwell. The event outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; aches; chills; arm pain shoulder to wrist; general lethargy feeling of unwell; general lethargy feeling of unwell; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 11:15 (Batch/Lot Number: EL9263) as DOSE 1 SINGLE for covid-19 immunizations (Age at vaccination 53 years). Facility type vaccine: Health Clinic. The patient past Medical history included PVCs (Premature ventricular contractions) from an unknown date and unknown if ongoing and  covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes. Concomitant medication(s) included zinc (ZINC) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL XL SANDOZ) taken for an unspecified indication, start and stop date were not reported; fish oil (OMEGA 3 [FISH OIL]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took morphine and experienced drug hypersensitivity. 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 vaccine within 4 weeks prior to covid-19 vaccination. On 10Mar202116:00, the patient experienced fever, aches, chills, arm pain shoulder to wrist and general lethargy feeling of unwell. The event outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia oral, Vomiting
Clinical narrative: Vomiting; feeling flush; lips tingling; This is a spontaneous report from a contactable other health care professional (patient reported for herself). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199) via an unspecified route of ad-ministration, in left arm on 12Mar2021 at 16:45 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included Hashimoto, known allergy to shell-fish, red Cedar, cat hair and seasonal allergies. The patient had received other medications in two weeks (not specified). The patient previously took tetracycline and had allergy. Patient had no COVID-19 prior to vaccination and had not been tested since the vaccination. On 12Mar2021 at 19:30 PM, the patient experienced vomiting, feeling flush and lips tingling. Patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Fatigue, Headache, Ligament pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 52-year) in left arm on 05Mar2021 at 02:45 PM as dose 1, single for COVID-19 immunization. Medical history included depression and anxiety, diabetes, high cholesterol, Known allergies to Zpack, and Milk, all from an unknown date and unknown if ongoing. Concomitant medications included metformin; lisinopril; sertraline hydrochloride; simvastatin; all taken for an unspecified indication, start and stop date were not reported. As reported facility type Vaccine was hospital. Patient received no other vaccine in four weeks. Patient had no COVID prior vaccination. The patient not tested COVID post vaccination. On 06Mar2021 at 05:00 PM the patient experienced slight fever, sore throat, muscle and ligament pain like arthritis, low back pain, fatigue, headache, ringing in ears, vertigo. Therapeutic measures were taken as a result of the adverse events, the patient was treated with Aleve, Tylenol, zantac. The clinical outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Tinnitus, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 52-year) in left arm on 05Mar2021 at 02:45 PM as dose 1, single for COVID-19 immunization. Medical history included depression and anxiety, diabetes, high cholesterol, Known allergies to Zpack, and Milk, all from an unknown date and unknown if ongoing. Concomitant medications included metformin; lisinopril; sertraline hydrochloride; simvastatin; all taken for an unspecified indication, start and stop date were not reported. As reported facility type Vaccine was hospital. Patient received no other vaccine in four weeks. Patient had no COVID prior vaccination. The patient not tested COVID post vaccination. On 06Mar2021 at 05:00 PM the patient experienced slight fever, sore throat, muscle and ligament pain like arthritis, low back pain, fatigue, headache, ringing in ears, vertigo. Therapeutic measures were taken as a result of the adverse events, the patient was treated with Aleve, Tylenol, zantac. The clinical outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vision blurred
Clinical narrative: Body aches; chills; fever; blurred vision; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 34-years-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm on 12Mar2021 14:15 (age at vaccination: 34-years) as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient had no known allergies. No other vaccines were given to patient in four weeks. On 13Mar2021 2:15 patient experienced body aches, chills, fever, blurred vision, fatigue. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment was given due to the adverse events. The outcome of events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Swelling face
Clinical narrative: Extreme fatigue for 6 days; woke up with swollen face on left side; This is a spontaneous report from a contactable Consumer. This 56-Years-Old female Consumer (patient) reported. A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 14:30 (at the age of 56-years-old) as a single dose for covid-19 immunization. Medical history included arteriospasm coronary, asthma, congenital cystic kidney disease. Concomitant medication(s) in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR); fexofenadine hydrochloride (ALLEGRA); isosorbide; nifedipine. The patient had allergies with sulfa, penicillin. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Mar2021, the patient experienced extreme fatigue for 6 days, day number six woke up with swollen face on left side. Outcome of the event was not recovered, at the time of this report. No follow-up attempts are possible. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling of body temperature change, Hot flush, Insomnia
Clinical narrative: Immediate hot flashes after both shots; Chest pressure; palpitations and shortness of breath immediately after 2nd shot; palpitations and shortness of breath immediately after 2nd shot; extreme body aches; internal burning sensation while simultaneously freezing; uncontrolled shaking; throwing up; Pain was so bad; Fever; could not sleep; This is a spontaneous report from a non-contactable consumer (reported for herself). A 28-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 10Mar2021 (at the age of 28-years-old) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included ethinylestradiol, norgestimate (TRI-PREVIFEM) taken for oral contraception, start and stop date were not reported and fluticasone furoate (ARNUITY ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received amoxicillin and experienced drug hypersensitivity, azithromicin and experienced drug hypersensitivity, ceftin [ceftriaxone] and experienced drug hypersensitivity, sudafed [xylometazoline hydrochloride] and experienced palpitations, benzyol peroxide and flu vaccine preservative for immunization. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9266/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 08:15 AM (at the age of 28-years-old) as dose 1, single for covid-19 immunisation and experienced immediately painful as went into arm and hot flashes. On 10Mar2021 at 20:00, the patient experienced immediate hot flashes after both shots, chest pressure, palpitations and shortness of breath immediately after 2nd shot, extreme body aches, internal burning sensation while simultaneously freezing, uncontrolled shaking, throwing up, pain was so bad, fever and could not sleep. No treatment was given for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Pyrexia, Tremor
Clinical narrative: Immediate hot flashes after both shots; Chest pressure; palpitations and shortness of breath immediately after 2nd shot; palpitations and shortness of breath immediately after 2nd shot; extreme body aches; internal burning sensation while simultaneously freezing; uncontrolled shaking; throwing up; Pain was so bad; Fever; could not sleep; This is a spontaneous report from a non-contactable consumer (reported for herself). A 28-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 10Mar2021 (at the age of 28-years-old) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included ethinylestradiol, norgestimate (TRI-PREVIFEM) taken for oral contraception, start and stop date were not reported and fluticasone furoate (ARNUITY ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received amoxicillin and experienced drug hypersensitivity, azithromicin and experienced drug hypersensitivity, ceftin [ceftriaxone] and experienced drug hypersensitivity, sudafed [xylometazoline hydrochloride] and experienced palpitations, benzyol peroxide and flu vaccine preservative for immunization. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9266/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 08:15 AM (at the age of 28-years-old) as dose 1, single for covid-19 immunisation and experienced immediately painful as went into arm and hot flashes. On 10Mar2021 at 20:00, the patient experienced immediate hot flashes after both shots, chest pressure, palpitations and shortness of breath immediately after 2nd shot, extreme body aches, internal burning sensation while simultaneously freezing, uncontrolled shaking, throwing up, pain was so bad, fever and could not sleep. No treatment was given for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Immediate hot flashes after both shots; Chest pressure; palpitations and shortness of breath immediately after 2nd shot; palpitations and shortness of breath immediately after 2nd shot; extreme body aches; internal burning sensation while simultaneously freezing; uncontrolled shaking; throwing up; Pain was so bad; Fever; could not sleep; This is a spontaneous report from a non-contactable consumer (reported for herself). A 28-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 10Mar2021 (at the age of 28-years-old) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included ethinylestradiol, norgestimate (TRI-PREVIFEM) taken for oral contraception, start and stop date were not reported and fluticasone furoate (ARNUITY ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received amoxicillin and experienced drug hypersensitivity, azithromicin and experienced drug hypersensitivity, ceftin [ceftriaxone] and experienced drug hypersensitivity, sudafed [xylometazoline hydrochloride] and experienced palpitations, benzyol peroxide and flu vaccine preservative for immunization. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9266/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 08:15 AM (at the age of 28-years-old) as dose 1, single for covid-19 immunisation and experienced immediately painful as went into arm and hot flashes. On 10Mar2021 at 20:00, the patient experienced immediate hot flashes after both shots, chest pressure, palpitations and shortness of breath immediately after 2nd shot, extreme body aches, internal burning sensation while simultaneously freezing, uncontrolled shaking, throwing up, pain was so bad, fever and could not sleep. No treatment was given for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Productive cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration into left arm on 04Mar2021 17:00 (at the age of 50-years-old) as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, drug hypersensitivity (Penicillin) from an unknown date and unknown if ongoing, covid-19 (Prior to the vaccination) from an unknown date and unknown if ongoing. It was reported that she was not a pregnant at the time of vaccination. No other vaccine received within four weeks. It was reported received other medications in two weeks. The patient reported all common side effects for 4 days then on 09Mar2021 17:00, developed productive seal cough, fever, swollen lymph nodes, unbearable body aches in all parts of body- eyes, bottom of feet, hands now going on 7 days after first dose with little improvement. Therapeutic measures were not taken. The patient underwent lab tests and procedures which included sars-cov-2 test (saliva test): negative on 08Mar2021. The outcome of productive seal cough, fever, swollen lymph nodes, unbearable body aches in all parts of body - eyes, bottom of feet, hands was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site warmth
Clinical narrative: Started itching and I got a rash around it like circular rash one below it one above it and it feels warm to touch and it itches like crazy; Started itching and I got a rash around it like circular rash one below it one above it and it feels warm to touch and it itches like crazy; Hold my hand on the spot it felt warm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6205, and Expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 73-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included Osteoporosis. The concomitant medications for patient were not reported. It was reported that, on 24Feb (the patient did not know how long it was) she had a bone density test (result unknown). The patient reported that, she received the first COVID Vaccine on 04Mar2021, which was a week ago and (yesterday) on an unspecified date in Mar2021, she noticed she "started itching and I got a rash around it (Clarification unknown) like circular rash one below it one above it and it feels warm to touch and it itches like crazy". The patient stated, "I did not have a fever generally but when I hold my hand on the spot it felt warm" and she was wondering if that was something she needed to be concerned about. At the time of report, the patient was scheduled for second dose on 25Mar2021. No treatment was given for the events. The patient reported that, she had not done anything in response to events, she was just worried about it or something else was happening or maybe they should not get the second one she was not sure. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Heart rate increased, Lymphadenopathy, Nausea
Clinical narrative: Chills/ Severe shivers which lasted about 4 to 5 hours, uncontrollable shivers; Joint pain; Nauseous; I had some swollen lymph nodes; My heart beat was going pretty fast and that lasted for about 40 hours; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown and Expiration date was not reported), via an unspecified route of administration in arm right on 09Mar2021 (at the age of 73-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, the patient wanted to report some adverse effects from the COVID 19. Stated that, the first shot was no problem, the second shot, he thinks 10 hours after he got the shot, on an unspecified date in Mar2021, the patient got the chills and severe shivers which lasted about 4 to 5 hours, uncontrollable shivers, joint pain, nauseous, he had some swollen lymph nodes and his heart beat was going pretty fast and that lasted for about 40 hours. Stated that, the patient just wanted to let them know what kind of effects that he had in case someone else had the same thing. Stated that, the chills weren't bad but when he started shivering that was the worst part and that have lasted for about 4 hours constantly. The consumer stated that, he took Tylenol and that knocked it down. But after about 3 to 4 hours after when Tylenol went off and he started getting the chills again. So, he took second dose of Tylenol and that was it after that. So, he took 4 Tylenol over a 12 hour period. Stated that, the patient just wanted to let them know what happened to him. Stated that, his wife had no problem and other people he knew don't have no problem but for some reason he just got nailed. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included My heart beat was going pretty fast and that lasted for about 40 hours (heart rate), resulted as increased. The outcome of the events for joint pain, nauseous and I had some swollen lymph nodes was unknown while for the other events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible, information about batch/ lot number cannot be obtained.