chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersensitivity, Illness, Product dose omission issue
Clinical narrative: Heart rhythm went berserk, my heart was just pounding and it was even slamming into my back; there is not one incidence of anything with my heart until I took this shot; my heart speed is up; I did not take the second shot; I am extremely sensitive\I had severe reaction; I was too sick; \This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: Unknown, Expiration date: Unknown, Age at vaccination: 70-year-old) via an unspecified route of administration in left arm on 12Mar2021 11:00 as dose 1, single for COVID-19 immunization. Medical history included menopause. Concomitant medications included Estrogen and Progesterone. On an unspecified date patient stated, heart rhythm went berserk, heart was just pounding and it was even slamming into my back; there was not one incidence of anything with my heart until patient took this shot; heart speed is up, patient was extremely sensitive and had severe reaction, sickness and did not take second shot. Patient had the first shot of the Pfizer Vaccine on 12March, it was like 6 weeks ago it was on Friday morning about 11 'O' clock, then Sunday morning within 36 hours took that shot my heart rhythm went berserk, heart was just pounding and it was even slamming into my back. Patient was needed to find out what was that. Patient did not take the second shot because didn't know what would happen to me, I went to the ER twice in one week. The first week I have been on a holter monitor the heart monitor for 14 days, Patient was on a beta blocker too twice a day to slow my heart beat down, had EKG in first saw the cardiologist. Patient didn't have any immediate allergic reactions or anything, but it was like within 36 hours and I am 70 year old and I have never had a heart issue in my life. Sunday morning at 4, 5 'O' clock in the morning it was early in the morning I woke up like that my heart was pounding, wanted to calm down. The only thing that happened to me is that my heart speed is up. Patient stated, "she was taking beta blockers that's supposed to slow your heart down, that's what cardiologist gave me." Lab test included blood work. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Electromyogram, Feeling abnormal, Limb discomfort, Magnetic resonance imaging
Clinical narrative: Tingling in extremities; Feeling of heaviness in limbs; Weakness and cramping throughout body; Brain fog; Weakness and cramping throughout body; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant 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 an unknown date in 2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) for an unspecified indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1383) via an unspecified route of administration in the left arm on 14Jan2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced tingling in extremities, feeling of heaviness in limbs, weakness and cramping throughout body and brain fog. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures, which included Electromyography (EMG), Magnetic resonance imaging (MRI) and the results were unknown. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included lab tests and referred to vascular. The clinical outcome of event tingling in extremities, feeling of heaviness in limbs, weakness and cramping throughout body and brain fog were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: Tingling in extremities; Feeling of heaviness in limbs; Weakness and cramping throughout body; Brain fog; Weakness and cramping throughout body; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant 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 an unknown date in 2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) for an unspecified indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1383) via an unspecified route of administration in the left arm on 14Jan2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced tingling in extremities, feeling of heaviness in limbs, weakness and cramping throughout body and brain fog. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures, which included Electromyography (EMG), Magnetic resonance imaging (MRI) and the results were unknown. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included lab tests and referred to vascular. The clinical outcome of event tingling in extremities, feeling of heaviness in limbs, weakness and cramping throughout body and brain fog were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri mass, Ear pain, Heavy menstrual bleeding, Pain, Vaginal haemorrhage
Clinical narrative: I had blurred vision the first day; ear aches; body aches; have not stopped bleeding; had lots of blood clots; I've been menstrating for 2 weeks straight, a week extra; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730, Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:00 (age at vaccination was 46 years) as dose 1, single and dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: EW0162) as dose 1, single for Covid-19 immunization. Medical history included Alpha thalassemia minor carrier, Anxiety /depression, ongoing Menorrhagia, Known allergies: Penicillin allergy. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); bupropion hcl (BUPROPION HCL); one a day allergy; naphazoline hydrochloride (ALLERGY [NAPHAZOLINE HYDROCHLORIDE]); calcium carbonate, colecalciferol (CALCIU D3). Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for Covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 16:00 the patient reported blurred vision the first day, ear aches, body aches, have not stopped bleeding, had lots of blood clots, she has been menstruating for 2 weeks straight, a week extra. She do have menorrhagia but this is not usual for me to have so many clots and bleeding that has not lightened. so she had been menstruating for 2 weeks straight, a week extra. Patient did not receive any treatment for occurred event. The outcome of events was not resolved.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: I had blurred vision the first day; ear aches; body aches; have not stopped bleeding; had lots of blood clots; I've been menstrating for 2 weeks straight, a week extra; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730, Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:00 (age at vaccination was 46 years) as dose 1, single and dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: EW0162) as dose 1, single for Covid-19 immunization. Medical history included Alpha thalassemia minor carrier, Anxiety /depression, ongoing Menorrhagia, Known allergies: Penicillin allergy. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); bupropion hcl (BUPROPION HCL); one a day allergy; naphazoline hydrochloride (ALLERGY [NAPHAZOLINE HYDROCHLORIDE]); calcium carbonate, colecalciferol (CALCIU D3). Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for Covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 16:00 the patient reported blurred vision the first day, ear aches, body aches, have not stopped bleeding, had lots of blood clots, she has been menstruating for 2 weeks straight, a week extra. She do have menorrhagia but this is not usual for me to have so many clots and bleeding that has not lightened. so she had been menstruating for 2 weeks straight, a week extra. Patient did not receive any treatment for occurred event. The outcome of events was not resolved.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: vaccination occurred 5-6 Drops of blood from the infection site; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer from BioNTech (manufacturer control number:46597), license party for (Comirnaty). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: EW0153) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vaccination occurred 5-6 drops of blood from the infection site on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a program. A contactable female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that there was a call from a caller who has already received her first dose of the vaccine and wanted to be scheduled for second dose. Caller stated that she is also experiencing fever and wanted to know if she will go through that with the second dose. The outcome of the event was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Pyrexia
Clinical narrative: I have had moderate to severe diarrhea; low grade fever; low energy; This is a spontaneous report from a contactable other hcp (patient). A 55-years-old non-pregnant 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 22Apr2021 14:15 (at the age of 55 years), (Batch/Lot Number: EW0171) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included High blood pressure, covid-19 from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid (VITAMINS C), vitamin d nos, zinc, levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO) and pitavastatin calcium (LIVALO) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 19:00, the patient experienced moderate to severe diarrhea that began about 5 hours after receiving the vaccine. She also had a low-grade fever in the evenings and low energy. The events resulted in the visit to Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: low grade on an unspecified date. If the patient received any treatment for the adverse events was unknown. The clinical outcome of the events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Off label use, Product use issue, Suppressed lactation
Clinical narrative: had to start supplementing formula bc milk production dropped drastically; Exposure via Breast feeding; Exposure via Breast feeding; had menthol taste/feeling in mouth/throat; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection and lot number: ER8727) via an unspecified route of administration, administered in arm right on 19Mar2021 08:15 (age at vaccination: 36-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma. Concomitant medications included loratadine (CLARITINE), received within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took dilaudid and had known allergies: Dilaudid. The vaccine exposure via Breast feeding on 19Mar2021 08:15. The patient experienced had menthol taste/feeling in mouth/throat on 19Mar2021. The patient had to start supplementing formula bc milk production dropped drastically on 21Mar2021. The patient was not received treatment for the events of had menthol taste/feeling in mouth/throat and had to start supplementing formula bc milk production dropped drastically. The outcome for the event of had menthol taste/feeling in mouth/throat was recovered on 20Mar2021 and other event of Lactation decreased was recovering.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: has a high temperature; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced high temperature, running a temperature of 103.3. Consumer stated that patient wasn't able to get treatment recommendations for fever from the company that manufactures the vaccine. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Rash erythematous
Clinical narrative: Red rash across chest; The left side of neck hurt and it still does 6 days later; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control and phentermine, both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient went back to work after shot and experienced a red rash across chest. Later that evening, the patient experienced left side of her neck hurt and it still persisted 6 days later. This concerned the patient as it didn't hurt prior to the shot. The patient's neck had always been fine until the time of report. The patient stated that the rash went away. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red rash across chest was recovered on an unknown date in Apr2021. While that of the event neck hurt was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ecchymosis, SARS-CoV-2 test
Clinical narrative: Unexplainable ecchymosis on bilateral lower extremities; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram (MANUFACTURER UNKNOWN) and colecalciferol (vitamin D3) (MANUFACTURER UNKNOWN), all from unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 20Mar2021, the patient experienced unexplainable ecchymosis on bilateral lower extremities. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 27Jan2021, the patient underwent SARS-CoV2-PCR test and the result was negative. The clinical outcome of the event unexplainable ecchymosis on bilateral lower extremities was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Feeding disorder, Nausea
Clinical narrative: stated that he was not eating; has no sense of smell; has no sense of taste; drainage from his sinuses was out of control; Nauseated; throwing up; cough; has lost close to 20 pounds; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6204; Expiration Date: 21Jul2021) via an unspecified route of administration in Arm Left on 05Mar2021 08:45 as single dose for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing He had shingles three years ago. The patient's concomitant medications were not reported. The patient experienced stated that he was not eating on an unspecified date, has lost close to 20 pounds on 05Mar2021 06:30, has no sense of smell, has no sense of taste on 15Mar2021 06:30, drainage from his sinuses was out of control, nauseated, throwing up, cough on 15Mar2021. Clinical course was reported as he started not eating 06 Mar or 07Mar. he could not smell so he could not eat. he has had so much drainage from his sinuses in past six weeks that he is getting nauseated and throwing everything up. Clarified had a reduced sense of smell in past three years since shingles but now has no sense of smell. he had drainage since shingles but that it has gotten out of control since the vaccine. he would cough so violently and then be in the bathroom throwing up. The clinical outcome of the event lost close to 20 pounds was unknown other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus disorder, Vomiting, Weight decreased
Clinical narrative: stated that he was not eating; has no sense of smell; has no sense of taste; drainage from his sinuses was out of control; Nauseated; throwing up; cough; has lost close to 20 pounds; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6204; Expiration Date: 21Jul2021) via an unspecified route of administration in Arm Left on 05Mar2021 08:45 as single dose for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing He had shingles three years ago. The patient's concomitant medications were not reported. The patient experienced stated that he was not eating on an unspecified date, has lost close to 20 pounds on 05Mar2021 06:30, has no sense of smell, has no sense of taste on 15Mar2021 06:30, drainage from his sinuses was out of control, nauseated, throwing up, cough on 15Mar2021. Clinical course was reported as he started not eating 06 Mar or 07Mar. he could not smell so he could not eat. he has had so much drainage from his sinuses in past six weeks that he is getting nauseated and throwing everything up. Clarified had a reduced sense of smell in past three years since shingles but now has no sense of smell. he had drainage since shingles but that it has gotten out of control since the vaccine. he would cough so violently and then be in the bathroom throwing up. The clinical outcome of the event lost close to 20 pounds was unknown other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in their limbs after receiving the first Covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported for a friend. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified the patient experienced numbness in their limbs after receiving the first covid 19 vaccine. This report is in reference to the patient that the reporter's friend mentioned in the first report. When the reporter was speaking of her own experience with the Covid 19 vaccine, she mentioned a patient that had a similar experience. One of the reporter's friends is a primary care doctor and the doctor saw the same type of reaction that the reporter had, in another patient. The reporter's friend who is a doctor mentioned someone that had numbness in their limbs after receiving the first Covid 19 vaccine. When this person had the second Covid 19 vaccine they had more numbness in their body and now they are hospitalized in hospital. That person is having a bad reaction. When probing for information regarding the other patient that experienced numbness after receiving the Covid 19 vaccine who is now hospitalized, the reporter reports she does not know anything about that person. Outcome of the event was unknown.  No further information is provided or obtained.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Pyrexia
Clinical narrative: Fever; body aches; pain that goes up her neck and behind her head; pain that goes up her neck and behind her head; This is a spontaneous report received from a contactable consumer (patient herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0151; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:00 (at age of 64-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing hypertension; high blood pressure and blood cholesterol increased; high cholesterol, she was diagnosed last year. She has been taking pills for it since last year and ongoing thyroiditis. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as no. Patient's medical history (including any illness at time of vaccination) was reported as no. Family medical history relevant to AE(s) was reported as no. Other products was reported as unknown. It was reported that on 07Apr2021 caller stated she had a fever; the next day after the vaccine, at 2 o'clock, she started feeling body aches, and thought she had a fever, too. She still felt a little pain in her neck- it was not much, but she can still feel it. She clarified the pain went up her neck and behind her head, and it was still there a little bit but she was taking Ibuprofen. Caller confirmed she did not have the Ibuprofen with her at the time of the call to provide product information, but stated it was 600 mg. She clarified the fever and body aches stopped after she took Ibuprofen and she also took a Tylenol then, too. The adverse event did not require visit to emergency room or physician office visit. Caller was calling about the COVID-19 Vaccine. Caller stated that she was supposed to have her second vaccine on 27Apr2021 but she thought it was yesterday, 28Apr2021. She stated that she missed her appointment and she needed to make another second appointment. Caller stated that she got the vaccine. She stated she called her doctor and they said that they have no vaccines at clinic to give out. The outcome of fever and body aches was resolved on 07Apr2021 while not recovered for other events.  No further details were provided or obtained.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Fatigue, Vision blurred
Clinical narrative: Tiredness; fatigue; right eye itches/burning sensation; right eye itches/burning sensation,; right eye slightly blurred; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 26Apr2021 at 14:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ALLERGY RELIEF) for unspecified indication from unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the right arm on 05Apr2021 at 14:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 06:00, the patient experienced tiredness, fatigue, right eye itched/burning sensation and right eye slightly blurred. No therapeutic measures were taken as a result of these events. These events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events tiredness, fatigue, itchy eyes, burning sensation on eye and right eye slightly blurred was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Grade 1 Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VIT D3), lysine (MANUFACTURER UNKNOWN), ascorbic acid; calcium carbonate; calcium pantothenate; calcium phosphate; chromium; cyanocobalamin; folic acid; magnesium carbonate; magnesium hydroxide; manganese gluconate; nicotinic acid; potassium bicarbonate; potassium carbonate; potassium phosphate dibasic;, pyridoxine hydrochloride; quercetin; riboflavin sodium phosphate; sodium bicarbonate; sodium phosphate; thiamine hydrochloride; thioctic acid; zinc ascorbate (EMERGEN C), cetirizine hydrochloride (ZYRTEC) and unspecified "MultiVit" ; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Apr2021, the patient experienced grade 1 fatigue which lasted for 24 hours and was relieved by rest, started the day after the second dose was received. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event grade 1 fatigue was resolved on 25Apr2021 after a duration of 24 hours.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Throat irritation, Tongue pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 40, via an unspecified route of administration, left arm, on Apr 7, 2021, at 09:30, single dose, for COVID-19 immunisation. The patient has no reported medical history. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Vitamin K2 (menaquinone), Vitamin D3 (cholecalciferol), Vitamin B12 (cyanocobalamin), magnesium and multivitamin. On Apr 7, 2021, at 10:15 (30 minutes after vaccination), patient's throat became itchy, the bottom of her tongue and back began to tingle and itch really bad. No therapeutic measures taken as a result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of the events throat became itchy, the bottom of her tongue and back began to tingle and itch really bad: unknown (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EW0176) via intramuscular route of administration in the left arm on 29Apr2021 at 14:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and hypertension. The patient was allergic to fish (walleye). Concomitant medications included ZOLOFT, Omeprazole, Lisinopril-Hydrochlorothiazide, and Atorvastatin, all for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 05:00, the patient experienced moderate pain at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain at injection site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Muscle tightness, Myalgia
Clinical narrative: Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EW0176) via intramuscular route of administration in the left arm on 29Apr2021 at 14:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and hypertension. The patient was allergic to fish (walleye). Concomitant medications included ZOLOFT, Omeprazole, Lisinopril-Hydrochlorothiazide, and Atorvastatin, all for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 05:00, the patient experienced moderate pain at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain at injection site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Chills; Headache; Body aches; Nausea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 11:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 22:00, the patient experienced fever, chills, headache, body aches, nausea and vomiting. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, headache, body aches, nausea and vomiting were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Chills; Headache; Body aches; Nausea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 11:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 22:00, the patient experienced fever, chills, headache, body aches, nausea and vomiting. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, headache, body aches, nausea and vomiting were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: She is now experiencing a fever of 99.5 degrees; sneezing, nose is running, she feels like she has head colds; sneezing, nose is running, she feels like she has head colds; sneezing, nose is running, she feels like she has head colds; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (BNT162B2 Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient was experiencing a fever of 99.5 degrees, sneezing, nose is running, she feels like she has head colds, but she never had colds for years. The patient underwent lab tests and procedures which included pyrexia: 99.5 degree. No unaddressed medical questions referred or forwarded to Medical Information. The outcome for all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in L arm post Covid vaccine injection; tingling in L arm post Covid vaccine injection; This is a spontaneous report from a contactable other hcp (Nurse) (patient). This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history included numbness and tingling due to spinal cord compression. Concomitant medications were not reported. On an unspecified date the patient experienced numbness and tingling in L arm post covid vaccine injection. Description of Event: Numbness and tingling in L arm post Covid vaccine injection. Hx of numbness and tingling due to spinal cord compression. Event took place after use of product. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Within 24 hrs of vaccine swelling in arm pit which increased in size and sensitivity over the course of 2 days, approximate size of a lemon. Swelling and sensitivity then decreased over a course of 2 days; Within 24 hrs of vaccine swelling in arm pit which increased in size and sensitivity over the course of 2 days, approximate size of a lemon. Swelling and sensitivity then decreased over a course of 2 days; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Other medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GP6955 6121) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 02:00, within 24 hours of vaccine, the patient experienced swelling in arm pit which increased in size and sensitivity over the course of two days, approximate size of a lemon. Swelling and sensitivity then decreased over a course of two days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events within 24 hours of vaccine, experienced swelling in arm pit which increased in size and sensitivity over the course of two days, approximate size of a lemon; swelling and sensitivity then decreased over a course of two days was resolved on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chest discomfort, Confusional state, Diarrhoea
Clinical narrative: 5+ days of chest tightness; Low heart rate (47-51 BPM); Fatigue/Exhaustion; Headache; Nausea; Vomiting; Fibromayalgia symptoms; Diarrhea; Cold feet/hands; Muscle shaking; Confusion; Abdomen discomfort; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: EW0161) via an unspecified route of administration, administered in Arm Left on 23Apr2021 19:15 at the age of (26-years-old) as a dose 2, single for covid-19 immunization. Medical history included sjogren's syndrome, Hashimoto's, fibromyalgia, asthma, endometriosis, Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Concomitant medication included hydroxychloroquine taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient did not diagnose with covid-19. Since the vaccination patient was not diagnosed with covid-19. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: ER8730) via an unspecified route of administration, administered on an unspecified date in mar2021 at 07:00 PM as a single dose for covid-19 immunisation. It was reported that on 24Apr2021 13:00 the patient experienced 5+ days of chest tightness, low heart rate (47-51 BPM), fatigue/exhaustion, headache, nausea, vomiting, Fibromyalgia symptoms, diarrhoea, cold feet/hands, muscle shaking, confusion, abdomen discomfort & joint pain. On 24Apr2021 the patient underwent lab tests and procedures which included heart rate which includes low heart rate (47-51 bpm), on 27Apr2021 Nasal Swab test: negative, PCR test: negative, Rapid Test: Negative Nasal Swab. On 29Apr2021 COVID-19 BY NAAT PCR, TMA: negative. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.