chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Parosmia
Clinical narrative: she developed a chemical smell and taste; she developed a chemical smell and taste; can't taste her food, and everything smells the same; This is a spontaneous report from a contactable consumer or healthcare professional Nurse (patient). A 63-years-old female patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, lot number: EW0150, expiry date: unspecified date in Jul2021) via unknown route of administration in left arm on 05Apr2021 at 16:30 (at the age of 62 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication were reported. She stated that she quit taking any other medications to try and rule them out, and she had not yet restarted those other mediations, so she was sure that this event had to be from the vaccine. It was reported that a couple of days after her 1st dose, she developed a chemical smell and taste. She stated that she cannot taste her food, and everything tastes the same on an unspecified date in Apr2021. She said this reaction was still ongoing. Like her bowel movements smell the same as her coffee, same as toothpaste and food. She was wondering how long this would last and if other people have had this side effect. It was reported that if this was a known side effect, then it should be listed on the list of side effects, because it was not on the papers she was given. It was reported that the reporter wanted to know if this was a known side effect of the vaccine, and how long it lasts. She said she had heard of it happening to other people. she got it because of the pressure that she would have to have it in order to travel places, and because she has friends who were concerned to not be around anyone who did not have the vaccine. It was stated that she was frustrated about it because she had not planned for this to occur, it was not life threatening in any way, but if she was going to have this for the rest of her life, she wanted to know it now and said she may need to get herself a tongue and nose transplant. The patient had no other vaccines on the same day as the suspect product and did not receive other vaccines Prior Vaccinations (within 4 weeks). The patient did not visit Emergency Room or physician office due to events. It was reported that the event can't taste her food, and everything smells was related to product. The outcome of the event can't taste her food, and everything smells the same was not recovered and other was unknown.  Follow up attempts were completed. No further information was expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chest discomfort, Dizziness, Muscular weakness
Clinical narrative: She was so dizzy; pain in her shoulder started; then it went under her arm, a throbbing pain; Then, it shot down to her calf, its weird; Her muscles just ache; she had no strength in her wrist; After the first shot she had a bruise on her arm for week after she got it; Around the second day she experienced head spinning; chest tightness; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 54 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:00 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hepatitis from an unknown date and unknown if ongoing, Arthritis, Degenerative Joint Disease. The patient's concomitant medications were not reported. The patient experienced around the second day she experienced head spinning causing vertigo on 15Apr2021 with outcome of unknown, chest tightness causing chest discomfort on 15Apr2021 with outcome of unknown, she was dizzy on an unspecified date with outcome of unknown , pain in her shoulder started causing arthralgia on an unspecified date with outcome of recovered , then it went under her arm, a throbbing pain causing axillary pain on an unspecified date with outcome of recovered , then, it shot down to her calf, its weird causing pain in extremity on an unspecified date with outcome of recovered, her muscles just ache causing myalgia on an unspecified date with outcome of recovered , she had no strength in her wrist causing muscular weakness on an unspecified date with outcome of recovered, after the first shot she had a bruise on her arm for week after she got it causing vaccination site bruising on an unspecified date with outcome of recovered. Therapeutic measures were taken as a result of , her muscles just ache, Ointment Capsaicin Deep Penetrating, Odour Free for Arthritis Pain Relief. They gave her Naproxen but, she never took it,  Follow-up(11May2021):This is a follow-up spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: Additional information regarding medical history, adverse events and therapeutic measures taken were added.    No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site bruising, Vertigo
Clinical narrative: She was so dizzy; pain in her shoulder started; then it went under her arm, a throbbing pain; Then, it shot down to her calf, its weird; Her muscles just ache; she had no strength in her wrist; After the first shot she had a bruise on her arm for week after she got it; Around the second day she experienced head spinning; chest tightness; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 54 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:00 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hepatitis from an unknown date and unknown if ongoing, Arthritis, Degenerative Joint Disease. The patient's concomitant medications were not reported. The patient experienced around the second day she experienced head spinning causing vertigo on 15Apr2021 with outcome of unknown, chest tightness causing chest discomfort on 15Apr2021 with outcome of unknown, she was dizzy on an unspecified date with outcome of unknown , pain in her shoulder started causing arthralgia on an unspecified date with outcome of recovered , then it went under her arm, a throbbing pain causing axillary pain on an unspecified date with outcome of recovered , then, it shot down to her calf, its weird causing pain in extremity on an unspecified date with outcome of recovered, her muscles just ache causing myalgia on an unspecified date with outcome of recovered , she had no strength in her wrist causing muscular weakness on an unspecified date with outcome of recovered, after the first shot she had a bruise on her arm for week after she got it causing vaccination site bruising on an unspecified date with outcome of recovered. Therapeutic measures were taken as a result of , her muscles just ache, Ointment Capsaicin Deep Penetrating, Odour Free for Arthritis Pain Relief. They gave her Naproxen but, she never took it,  Follow-up(11May2021):This is a follow-up spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: Additional information regarding medical history, adverse events and therapeutic measures taken were added.    No follow-up attempts are needed. No further information is expected.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Incomplete course of vaccination, Lethargy, Pyrexia
Clinical narrative: high fever; lethargic; did not receive 4th dose of Prevnar vaccine; This is a spontaneous report from a contactable nurse. An infant male patient received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at age 6-month-old) as dose number 3, single for immunization. The patient's medical history and concomitant medications were not reported. After third dose of Prevnar vaccine, patient ran a high fever of 105F and was lethargic for 5 days and ultimately did not receive 4th dose of Prevnar vaccine. He has had no other issue with vaccines. Outcome of the events was unknown.  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: Headache, Nausea, Pain in extremity, Vaccination site mass
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 26-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 27, via an unspecified route of administration, in left arm, on Apr 27, 2021, 08:15, single dose, for COVID-19 immunization. The patient's medical history not reported. Concomitant medications included Nexplanon and testosterone. The patient previously took sesame oil and experienced drug hypersensitivity. Reportedly, patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination, nor  tested post vaccination. On May 1, 2021, at 12:00 (patient reported 10 days post vaccine), she still has a lump at vaccination site, arm soreness, headaches almost every day and nausea. The patient did not receive any treatment for the events. At the time of report, the outcome: not recovered from the events. No follow-up attempts possible. Information about batch/lot cannot be obtained. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip discolouration, Lip dry, Oral discomfort, Paraesthesia oral
Clinical narrative: her lips became dry and the corner is a little dry.; She states her lip is also discolored, being a little darker than usual.; some tingling and a little burning; some tingling and a little burning; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported for that a 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot Number: EW0161), via an unspecified route of administration in left arm on 06May2021 at 11:00 (at the age of 67 years old) as dose 1, single for covid-19 immunisation; levetiracetam (KEPPRA), oral from Oct2020 (Batch/Lot number was not reported) and ongoing, at 500 mg, 2x/day, 1 tablet twice a day by mouth for seizure. Medical history included seizure from Oct2020 and ongoing, multiple sclerosis from 1998 and ongoing. The patient's concomitant medications were not reported. The patient previously took keppra for seizure. The patient not had history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not administer additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks. She received first dose of the Pfizer BioNTech Covid 19 vaccine last Thursday. Late Saturday afternoon, on 08May2021her lips became dry and the corner was a little dry. They are also having some tingling and a little burning, and still ongoing today. She stated her lip was also discolored, being a little darker than usual. In the corner of her mouth, she thinks she may be developing a cold sore, but she gets those once or twice a year. She also has been on Keppra since October, and she got dry hands from the Keppra. Her second dose was scheduled for 27May2021. He stated late Saturday night the patient started having dryness and itchiness on her neck and she wonders what the problem with this was. She clarified it was not the neck. Stated she has dryness on her lips and a little darkness in the corner of her bottom lip. Therapeutic measures were taken as a result of her lips became dry and the corner was little dry, she states her lip was also discolored, being a little darker than usual with lubricating with vaseline Lip Therapy Tube. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not visit emergency room or physician office. The action taken in response to the events for KEPPRA was unknown. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Ear swelling, Erythema, Feeling hot
Clinical narrative: Rash allover her body, upper lip swollen, hands swollen and red, having a lot of itching; Rash allover her body; Upper lip swollen; Hands swollen and red, having a lot of itching; Hands swollen and red, having a lot of itching; Hands are swollen red and hot; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; Both ears are red and swollen and a lot itching; right shoulder, have a lot of pain and can hardly move it; right shoulder, have a lot of pain and can hardly move it; hives, redness and rash in left arm from where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW3344, Expiry date: unknown) (age at the time of vaccination was 58 years), administered in deltoid Left on 11May2021 at 10:00 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 11May2021 at 13:00, after the second dose, the patient started experiencing rash all over her body, upper lip swollen, hands swollen and red, having a lot of itching. The patient received the dose on her left shoulder, but her right shoulder have a lot pain and can hardly move it, and a big red hive, and itching too. The patient had hives, redness and rash in left arm where the patient took the shot and my upper lips were swollen. The patient had different form of lips, because they were so swollen. The patient lips become red, in the back of both legs got itching and hives. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Inflammation, Lip swelling, Mobility decreased, Peripheral swelling
Clinical narrative: Rash allover her body, upper lip swollen, hands swollen and red, having a lot of itching; Rash allover her body; Upper lip swollen; Hands swollen and red, having a lot of itching; Hands swollen and red, having a lot of itching; Hands are swollen red and hot; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; Both ears are red and swollen and a lot itching; right shoulder, have a lot of pain and can hardly move it; right shoulder, have a lot of pain and can hardly move it; hives, redness and rash in left arm from where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW3344, Expiry date: unknown) (age at the time of vaccination was 58 years), administered in deltoid Left on 11May2021 at 10:00 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 11May2021 at 13:00, after the second dose, the patient started experiencing rash all over her body, upper lip swollen, hands swollen and red, having a lot of itching. The patient received the dose on her left shoulder, but her right shoulder have a lot pain and can hardly move it, and a big red hive, and itching too. The patient had hives, redness and rash in left arm where the patient took the shot and my upper lips were swollen. The patient had different form of lips, because they were so swollen. The patient lips become red, in the back of both legs got itching and hives. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site rash
Clinical narrative: Rash allover her body, upper lip swollen, hands swollen and red, having a lot of itching; Rash allover her body; Upper lip swollen; Hands swollen and red, having a lot of itching; Hands swollen and red, having a lot of itching; Hands are swollen red and hot; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; She has blisters or hives on her body and everything is red and inflamed and itchy; Both ears are red and swollen and a lot itching; right shoulder, have a lot of pain and can hardly move it; right shoulder, have a lot of pain and can hardly move it; hives, redness and rash in left arm from where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW3344, Expiry date: unknown) (age at the time of vaccination was 58 years), administered in deltoid Left on 11May2021 at 10:00 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 11May2021 at 13:00, after the second dose, the patient started experiencing rash all over her body, upper lip swollen, hands swollen and red, having a lot of itching. The patient received the dose on her left shoulder, but her right shoulder have a lot pain and can hardly move it, and a big red hive, and itching too. The patient had hives, redness and rash in left arm where the patient took the shot and my upper lips were swollen. The patient had different form of lips, because they were so swollen. The patient lips become red, in the back of both legs got itching and hives. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Diarrhoea, Dizziness, Dyspepsia
Clinical narrative: tightness in chest; Diarrhea; light headedness; total exhaustion; weird heart palpations; heartburn; sleeping all the time; worse with movement and exertion; This is a spontaneous report from a contactable consumer (Patient) reported for herself that:  A 61-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172) via an unspecified route of administration, on 04May2021 (At the age of 61 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pericarditis, when she was 19 years old, cardiac disorder, dyspepsia and anaphylactic shock from an unknown date and unknown if ongoing. Concomitant medications included Ipratropium bromide taken for an unspecified indication from 22Apr2021 to an unspecified stop date; Fluticasone propionate taken for nasal drip issues, Mylanta for indigestion, Omeprazole was taken for unspecified indication, hydrochlorothiazide, lisinopril was taken for blood pressure measurement, start and stop date were not reported. On an unspecified date in May2021, the patient had experienced weird heart palpations, worse with movement and exertion, sleeping all the time and heartburn. On 04May2021, the patient had experienced total exhaustion and lightheaded. On 07May2021, the patient had experienced diarrhea. On8 May 2021, the patient had experienced tightness in chest. I am more concerned with the chest tightness because of my history of heart problems and lab test I have been checking my blood pressure and its been within the normal range I just don't know if I should go to the ER. On 09May2021, the event diarrhea was recovered. At the time of reporting, the events weird heart palpation, tightness in chest, light headedness and total exhaustion was not recovered whereas the events worse with movement and exertion, sleeping all the time and heartburn were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Movement disorder, Palpitations
Clinical narrative: tightness in chest; Diarrhea; light headedness; total exhaustion; weird heart palpations; heartburn; sleeping all the time; worse with movement and exertion; This is a spontaneous report from a contactable consumer (Patient) reported for herself that:  A 61-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172) via an unspecified route of administration, on 04May2021 (At the age of 61 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pericarditis, when she was 19 years old, cardiac disorder, dyspepsia and anaphylactic shock from an unknown date and unknown if ongoing. Concomitant medications included Ipratropium bromide taken for an unspecified indication from 22Apr2021 to an unspecified stop date; Fluticasone propionate taken for nasal drip issues, Mylanta for indigestion, Omeprazole was taken for unspecified indication, hydrochlorothiazide, lisinopril was taken for blood pressure measurement, start and stop date were not reported. On an unspecified date in May2021, the patient had experienced weird heart palpations, worse with movement and exertion, sleeping all the time and heartburn. On 04May2021, the patient had experienced total exhaustion and lightheaded. On 07May2021, the patient had experienced diarrhea. On8 May 2021, the patient had experienced tightness in chest. I am more concerned with the chest tightness because of my history of heart problems and lab test I have been checking my blood pressure and its been within the normal range I just don't know if I should go to the ER. On 09May2021, the event diarrhea was recovered. At the time of reporting, the events weird heart palpation, tightness in chest, light headedness and total exhaustion was not recovered whereas the events worse with movement and exertion, sleeping all the time and heartburn were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Balance disorder, Feeling abnormal, Gait inability
Clinical narrative: trouble speaking; with the balance which he fell on the flour,; muscle ache; severe headache/Caller reports an extremely strong headaches.; he took some medication to help him sleep at night; Weakness; Equilibrium is way off; Back hurts; below 98.6 degrees, after the first vaccine; Felt extremely horrible; Could not hardly walk; This is a spontaneous report from a contactable consumer or other Non-Health Care Professional.     A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced trouble speaking, the issue with the balance which he fell on the flour, muscle ache and severe headache which he took some medication to help him sleep at night, Weakness, Equilibrium is way off, Could hardly get out of bed, and fell out of bed and couldn't get up, Could hardly get out of bed, and fell out of bed and couldn't get up, Back hurts, his temperature went up 1.2 degrees and down 1.2 degrees, below 98.6 degrees. Caller is afraid to take the second dose schedule because he might have severe side effects. Second dose schedule will be on 13May2021. At the time of reporting, the outcome of the events were unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Myalgia, Pyrexia, Speech disorder
Clinical narrative: trouble speaking; with the balance which he fell on the flour,; muscle ache; severe headache/Caller reports an extremely strong headaches.; he took some medication to help him sleep at night; Weakness; Equilibrium is way off; Back hurts; below 98.6 degrees, after the first vaccine; Felt extremely horrible; Could not hardly walk; This is a spontaneous report from a contactable consumer or other Non-Health Care Professional.     A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced trouble speaking, the issue with the balance which he fell on the flour, muscle ache and severe headache which he took some medication to help him sleep at night, Weakness, Equilibrium is way off, Could hardly get out of bed, and fell out of bed and couldn't get up, Could hardly get out of bed, and fell out of bed and couldn't get up, Back hurts, his temperature went up 1.2 degrees and down 1.2 degrees, below 98.6 degrees. Caller is afraid to take the second dose schedule because he might have severe side effects. Second dose schedule will be on 13May2021. At the time of reporting, the outcome of the events were unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: reddish type of rash on the back and front of his body, the upper arms and a little on his neck/rash all on the front and sides of his body; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 74-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0183, Expiry date: Unknown) via an unspecified route of administration on 28Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10May2021 the patient experienced yesterday, he developed a reddish type of rash on the back and front of his body, the upper arms and a little on his neck/rash all on the front and sides of his body. The outcome of events was unknown.   Information about batch/Lot number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenitis, Pyrexia
Clinical narrative: high temperature (38C and more)/ fever symptoms; headache; strong fatigue; inflamed lymph nodes in the armpits; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0182), via an unspecified route of route of administration, administered at left arm on 08May2021 at 10:00 A.M (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: EW0189) via an unspecified route of administration, administrated at left arm on 17Apr2021 at 10:00 A.M (at the age of 36-year-old) as dose 1, single for covid-19 immunization. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam and tamsulosin hydrochloride (TAMSLUSIN); both from an unspecified date for an unspecified indication. On 08May2021 at 17:00, the patient had a high temperature (38C and more) and had it for two days/ fever symptoms, headache, a strong fatigue for two more days already and it did not pass yet and inflamed lymph nodes in the armpits. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstruation abnormally long after 1st dose of vaccination.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 15:00 (age at vaccination: 47 years) as dose 1 single for covid-19 immunisation. Patient's medical history included hypothyroidism.Patient did not receive any other vaccine in 4 weeks. Concomitant medication included varenicline tartrate (CHANTIX) taken for an unspecified indication, levothyroxine sodium (SYNTHROID) taken for an unspecified indication, ethinylestradiol, norgestimate (TRI LO MILI) taken for an unspecified indication. No known allergies were reported. Patient did not have Covid prior to vaccination. Patient was not tested COVID post vaccination. On 19Apr2021 at 03:00 pm, the patient experienced menstruation abnormally long after 1st dose of vaccination. Therapeutic measures change in birth control were taken as a result of menstruation abnormally long after 1st dose of vaccination. At the time of this report, the outcome of event was recovered on an unknown 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: Asthma, Blood test, Chest X-ray, Illness
Clinical narrative: sick; started having asthma at that time; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via Pfizer sponsored program. A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, Batch/Lot Number: EP6955; Expiration Date: Jun2021), via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:45 (at age of 52-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and ongoing chronic obstructive pulmonary disease. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Adverse events following prior vaccinations was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available)was reported as none. No additional administered vaccines if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported. Concomitant medication(s) included salbutamol (Ventoline [Salbutamol] taken for an unspecified indication from an unspecified start date and ongoing and Brio inhaler (Formulation, Batch/Lot Number and Expiration Date: not reported) only as needed. Clarified spelling of Brio inhaler, documented as provided. The patient experienced sick on an unspecified date and on 26Apr2021 03:00 patient experienced asthma. The patient was scheduled for second dose on 26Apr2021 and has missed her second dose as she was sick. The patient reported that she was in the hospital. She has a history of asthma and chronic obstructive pulmonary disease and she had to go to the hospital for a treatment. Clarified caller went to the emergency room and the caller confirmed she was not admitted to the hospital. The caller needs to know where she can go for her second dose Covid 19 vaccine. She's not sure if the facility where she received her first dose are still doing vaccines at that site. She reports she called the paramedics to take her to the hospital around 3:00AM on 26Apr2021. She started having asthma at that time and she received a treatment in the emergency room and within 45 minutes she was feeling better. She was discharged from the emergency department around 7:00AM-8:00AM on 26Apr2021. The patient underwent lab tests and procedures on 26Apr2021 which included blood test and chest x-ray, the results were unknown. Therapeutic measures were taken as a result of started having asthma at that time (asthma). The outcome of the event sick was unknown and the outcome of the event asthma was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I had severe headache in back of my head; 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 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 14Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that three weeks ago on 14Apr2021 patient took the vaccine and then patient had severe headache in back of head, very severe headache, it goes and it comes right away on an unspecified date. Patient stated that had been taking Tylenol but it does not really work so patient started taking Aspirin. Patient don't want to report it, patient want to know what should do, is this normal, this is the headache. The patient received treatment as a result event. Outcome of the event was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain
Clinical narrative: shoulder and chest pain; shoulder and chest pain; pressure across his chest; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second 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 30Apr2021 at 16:20 (age at vaccination: 56 years), as dose 2, single dose for COVID-19 immunization. The patient's medical history included heart attack in Dec2017. Past drug included Imdur (60mg once per day by mouth), lisinopril (10mg once per day by mouth), Atorvastatin (40mg once per day by mouth), and Carvedilol (6.25mg and takes two per day of one in the morning and one in the evening). Concomitant medications included lisinopril, isosorbide mononitrate (IMDUR), atorvastatin calcium (ATORVASTATIN AL) and carvedilol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on 07Apr2021, as dose 1, single dose for COVID-19 immunization. The patient did not received any vaccine prior vaccinations (within 4 weeks). The patient experienced shoulder and chest pain 4-5 days after his second shot on an unspecified date. He just had the vaccine 2nd dose on 30Apr2021 and was telling his cardiologist how he was feeling and told him with activity and pushing his heart on the treadmill he did not feel any-thing but then he started putting the pieces together. He began having pressure across his chest and looked it up on the CDC and it said during the trials there were three heart attack type things reported and he wanted to find out if Pfizer had narrowed down that information to a particular medication or it happened almost right away after the vaccine or if it was a few weeks later; states he did not have the reported events prior to the Pfizer COVID vaccine and has worked very hard and lost 80 pounds and changed his diet and the pressure in his chest started about 4 days after the 2nd dose of the Pfizer COVID Vaccine. The patient stated he has not yet required treatment for the reported events. The adverse events did not require a visit to emergency room. There was a Product Complaint. Outcome of the events shoulder and chest pain was unknown and pressure across his chest was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Hives; itching/itching on injection site; Redness,Lump, itching on injection site a few days after vaccination; Redness,Lump, itching on injection site a few days after vaccination; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer (patient) reported that:  A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration in Arm Left on 13Apr2021 at 12:30 PM (age at the time of vaccination was 64 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient known allergies: fluconazole. The patient medical history includes high blood pressure, osteoporosis, arthritis, herniated disc. Concomitant medication was not reported. The patient receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 8727), via an unspecified route of administration in Arm Left on 23Mar2021 at 14:00 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced hives and itching half hour after vaccine. On 13Apr2021 13:00 patient experienced hives, itching/itching on injection site. On unspecified date in 2021 had redness and lump on injection site a few days after vaccination. Patient didn't received treatment for the events. The clinical outcome of the events was not recovered.   No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: sharp pain in the middle of her chest; feeling fatigue; sore throat; achiness in her arm and back; This is a spontaneous report from a contactable consumer reported for daughter (patient) that: A 27-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10May2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient 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 19Apr2021as DOSE 1, SINGLE for COVID-19 immunization.On an unspecified date the patient experienced sharp pain in the middle of her chest, feeling fatigue, sore throat and achiness in her arm and back. It was reported that Patient received her second dose of the Pfizer-BioNTech COVID-19 vaccine yesterday and experienced a sharp pain in the middle of her chest about 10 minutes ago. She asked her daughter to join the line and her daughter added she has been feeling fatigue, a sore throat, achiness in her arm and back. Her daughter also described the pain on her chest as shooting pain at first which lasted between 10-15 minutes and now it feels more like a tightness with sharp pain here and there. They asked if chest pain were reported as side effect from the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body aches; A low grade fever; And exhaustion,following her covid vaccination, she states the symptoms only lasted a day; This is a spontaneous report from a contactable consumer (herself) via Pfizer sponsored program. A 61-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; Tofacitinib citrate (XELJANZ), oral from Apr2020 (Batch/Lot number was not reported) to an unspecified date, at 5 mg, 2x/day for psoriatic arthropathy. No known allergies and medical history was reported. Concomitant medications included olmesartan medoxomil; rosuvastatin calcium (CRESTOR); omeprazole; vitamin d [vitamin d nos]; tramadol hcl and meloxicam (MOBIC) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient experienced in 2021 body aches, a low grade fever, and exhaustion, following her covid vaccination, she stated the symptoms only lasted a day on Feb/Mar 2021. No treatment measures were taken as result of events. The clinical outcome of the events were recovered in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Nasal congestion, Pruritus, Sneezing
Clinical narrative: eyes were a little bit swollen; it is a little itchy; congestion; being sneezing a lot; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO1TO), via an unspecified route of administration on 07May2021 (at the age of 35 years old) as a single dose for COVID-19 immunisation. The patient's medical history included Seasonal allergy, Prediabetes from an unknown date and unknown if ongoing. The patient's concomitant medication included Prempro (ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE) taken for hormones and start date and stop date was not reported. On an unspecified date of May-2021 the patient experienced eyes were a little bit swollen, Itchy, congestion, being sneezing a lot. The patient reported that her eye got too it was like its swollen but in two different parts like lid and then patient's upper eye lid and in the eye lid area and like patient was telling (name), patient did not know she got the vaccine on 07May it was a friday. So on Monday night patient noticed two swollen spots on eye. The patient was napping so she was not sure when that happened. Patient was washing face when Patient noticed swelling of the eye. The patient had tend to have seasonal allergy, it was just during spring and during fall time. So like the patient was telling (name) yesterday patient had Tylenol for my allergy but patient was calling to make sure she could take Zyrtec because this is something new the vaccine. The patient did not know if the patient could take over the counter medication so that's why patient called this number in the web page. The patient did not receive any treatment for events. The outcome of the events was unknown.  Follow-up(11May2021): This is a follow-up spontaneous report from a contactable consumer included Relevant medical history was added, Patient information updated, Product details were added and Concomitant drugs were added.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood test, Dizziness, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Sore arm; Little lightheaded; Tired; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; Got the Pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses).; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Patient). A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history included chronic lymphocytic leukaemia (he was diagnosed 14-15 months ago with CLL, He had a spleen that was measuring 22cm and was pushing his stomach out. He has moved from Stage 2 to Stage 0), dental disorder nos, orthopaedic, heart issues from an unknown date and unknown if ongoing. The concomitant medications included ibrutinib (IMBRUVICA) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Mar2021 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced sore arm, little lightheaded, tired and got the pfizer vaccines 1st dose-03/04/2021 and 2nd dose 03/24/2021 (less than 21 days in between doses). The patient asked that hopefully after the two initial doses and the booster I'm hoping to have some immunity. The patient also asked about data on patients with CLL or leukemia. He was confused, if there is a way to test for efficacy after the vaccine or not. On an unspecified date, the patient underwent lab tests and procedures which included blood immunoglobulin g: the first was an abigg, spike s (was a little arrow to the left less than 1), blood test: good (controlled by Imbruvica), investigation resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative), lymphocyte count resulted 50-60% lymphocytes, sars-cov-2 antibody test resulted negative (He had the immunity test to check if he gained immunity to the shots, like Corona IGG /Sars Covid 2 IGG spikes both came out negative and the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings), sars-cov-2 antibody test: the first was an abigg, spike s (the reading was a little arrow to the left less than 1) and white blood cell count resulted 16k. The outcome of the events was reported as unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.