chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: excessive mucus; feeling feverish; little difficulty breathing; she woke up with excessive coughing; she has experienced nasal & chest congestion; she has experienced nasal & chest congestion; loss of appetite; headache; muscle aches and fatigue; muscle aches and fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 30Apr2021 (at the age of 43-years-old) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 via an unspecified route of administration on unknown date for covid-19 immunization. On 30Apr2021, after the second vaccine the same day caller experienced muscle aches and fatigue that lasted for about 3 days. She took Tylenol Extra Strength that seemed to help. Within the last week on an unspecified date in May 2021, she had experienced nasal & chest congestion, loss of appetite, and headache. Yesterday, 30May2021 she woke up with excessive coughing. She took cough drop & increased her fluid intake. Caller reports waking up today with congestion worse. Also patient experienced excessive mucus, feeling feverish & a little difficulty breathing on 30May2021. Around 9 am she took some Tussin for mucous & congestion relief. The caller reports the medication seems to be helping some. Therapeutic measures were taken as a result of muscle aches and fatigue, she woke up with excessive coughing and excessive mucus. The outcome of event muscle aches and fatigue was recovered on 03May2021. The outcome of the rest events was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: experiencing nosebleed; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiry dates were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient reported that she experienced nosebleed and wanted to know if this was a normal side effect. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: We keep smelling/tasting this funk; We keep smelling/tasting this funk; This is a spontaneous report received from a contactable consumer via a medical information team. A patient of unknown age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. Patient medical history and concomitant medications were not reported. After vaccination, the patient experienced keep smelling/tasting this funk, or something rotten patient can't really explain on an unspecified date. Patient smell it randomly could be a bagel or egg or myself. The outcome of events was recovering.   Follow-up attempts are needed; information about lot/batch number requested.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: We keep smelling/tasting this funk; We keep smelling/tasting this funk; This is a spontaneous report from a contactable consumer. This consumer reporting same events under the same suspect product for four patients. This is 3 of 4 reports. 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 on an unspecified date as unknown, single for COVID-19 immunization. Medical history included, 4 of us had COVID-19 and lost our taste and smell. The concomitant medication was not reported. The patient reported, was lucky to have received both doses of the Pfizer vaccine. However, they have a lingering side effect they can not find more information about. They keep smelling/tasting this funk, or something rotten can't really explain. Smell it randomly could be a bagel or egg or self. For the other girls, it's the same thing that has this smell/taste i.e. every time they drink tea or eat onions keep smelling/tasting this funk. The outcome of events was unknown.   Information about batch/Lot number has been requested.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Diarrhoea, Illness, Impaired driving ability
Clinical narrative: sick; throw up; Diarrhea; pain; can't walk; can't drive my car anymore; back hurts; arm hurts/finger hurts; shoulder hurts; can't do anything; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of unspecified gender received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/lot number: ER8732) via unspecified route of administration on 26May2021 as 2nd dose single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation. On May2021 after the second dose of vaccination the patient reported that he was sick, and had throw up, diarrhea and everything that came out was black (not clear) and mentioned that was never before in his life, also reported pain, he can't walk and he can't drive car anymore his back hurts, arm hurts, shoulder hurts, finger hurts and can't do anything . The patient reported concern that I am 60 years old, I live on myself, I don't have nobody to help me. I don't know what I have to do and stated he is in pain since he got the second shot. The outcome of the events were reported as unknown.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Vomiting, Walking disability
Clinical narrative: sick; throw up; Diarrhea; pain; can't walk; can't drive my car anymore; back hurts; arm hurts/finger hurts; shoulder hurts; can't do anything; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of unspecified gender received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/lot number: ER8732) via unspecified route of administration on 26May2021 as 2nd dose single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation. On May2021 after the second dose of vaccination the patient reported that he was sick, and had throw up, diarrhea and everything that came out was black (not clear) and mentioned that was never before in his life, also reported pain, he can't walk and he can't drive car anymore his back hurts, arm hurts, shoulder hurts, finger hurts and can't do anything . The patient reported concern that I am 60 years old, I live on myself, I don't have nobody to help me. I don't know what I have to do and stated he is in pain since he got the second shot. The outcome of the events were reported as unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I have a UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of unspecified age received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0173) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had a urinary tract infection on an unspecified date. Therapeutic measures were taken as a result of urinary tract infection and included treatment with sulfamethoxazole, trimethoprim (BACTRIM). The outcome of the event was unknown. The patient was scheduled to take the second dose on 01Jun2021 (tomorrow) however she was currently having urinary tract infection. The patient wanted to know if it is okay to have second dose on 01Jun2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Muscle weakness for couple months; This is a spontaneous report from a non-contactable consumer (for self) reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle weakness for couple months. The consumer asked to provide any resources for assistance or what the process here, like do you have any information on, how to deal with that and helps with any treatment and asked for the medical department. The seriousness criteria of the event was reported as non-serious by the reporter. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Nausea, Pain in extremity
Clinical narrative: nausea; fatigue; soreness in abdomen and left arm; soreness in abdomen and left arm; This is a spontaneous report from a non-contactable consumer or other non hcp. A 24-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 13May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 13May2021 the patient experienced nausea, fatigue, soreness in abdomen and left arm. The outcome of the events was resolved on an unknown date.  No follow-up attempt are possible. information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Heart rate, Heart rate increased, Migraine
Clinical narrative: I got small red rash; not normal, hyper; I had tightness in my chest and heart; felt like a fast heart beat which is like upper range of normal which is 86 or something per minute; Light sensitivity to eye; Pain in sinuses; Migraine headache; right eye was getting the ocular migraine; made me to go to the bathroom right away number 2 for an hour; Felt like I don't know how to describe it but the body was 'amtuck' I did like I felt like 'amtuck'; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown) via an unspecified route of administration on 25May2021 as unknown single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 25May2021 on the same day soon after receiving vaccine patient got small red rash that went away after 30 minutes and it also made to go to the bathroom right away number 2 for an hour. Later next three hours, patient felt like did not knew how to describe it but the body was 'amtuck' and patient did like felt like 'amtuck' and was not normal, hyper, and then had tightness in chest and heart. For three hours patient felt like a fast heartbeat which was like upper range of normal which was 86 or something per minute which that went back to normal which was like 60 for patient. After the three hours, patient got light sensitivity to both eyes, pain in sinuses and the right eye was getting the ocular migraine so it was going in and out of vision and was also getting a migraine headache. Patient enquired if that was a normal reaction. On 25May2021 the patient underwent lab tests and procedures which included heart rate which showed result as 86 and heart rate which went back to normal which was like 60. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ophthalmic migraine, Photophobia, Pollakiuria, Psychomotor hyperactivity, Rash erythematous
Clinical narrative: I got small red rash; not normal, hyper; I had tightness in my chest and heart; felt like a fast heart beat which is like upper range of normal which is 86 or something per minute; Light sensitivity to eye; Pain in sinuses; Migraine headache; right eye was getting the ocular migraine; made me to go to the bathroom right away number 2 for an hour; Felt like I don't know how to describe it but the body was 'amtuck' I did like I felt like 'amtuck'; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown) via an unspecified route of administration on 25May2021 as unknown single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 25May2021 on the same day soon after receiving vaccine patient got small red rash that went away after 30 minutes and it also made to go to the bathroom right away number 2 for an hour. Later next three hours, patient felt like did not knew how to describe it but the body was 'amtuck' and patient did like felt like 'amtuck' and was not normal, hyper, and then had tightness in chest and heart. For three hours patient felt like a fast heartbeat which was like upper range of normal which was 86 or something per minute which that went back to normal which was like 60 for patient. After the three hours, patient got light sensitivity to both eyes, pain in sinuses and the right eye was getting the ocular migraine so it was going in and out of vision and was also getting a migraine headache. Patient enquired if that was a normal reaction. On 25May2021 the patient underwent lab tests and procedures which included heart rate which showed result as 86 and heart rate which went back to normal which was like 60. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: I got small red rash; not normal, hyper; I had tightness in my chest and heart; felt like a fast heart beat which is like upper range of normal which is 86 or something per minute; Light sensitivity to eye; Pain in sinuses; Migraine headache; right eye was getting the ocular migraine; made me to go to the bathroom right away number 2 for an hour; Felt like I don't know how to describe it but the body was 'amtuck' I did like I felt like 'amtuck'; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown) via an unspecified route of administration on 25May2021 as unknown single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 25May2021 on the same day soon after receiving vaccine patient got small red rash that went away after 30 minutes and it also made to go to the bathroom right away number 2 for an hour. Later next three hours, patient felt like did not knew how to describe it but the body was 'amtuck' and patient did like felt like 'amtuck' and was not normal, hyper, and then had tightness in chest and heart. For three hours patient felt like a fast heartbeat which was like upper range of normal which was 86 or something per minute which that went back to normal which was like 60 for patient. After the three hours, patient got light sensitivity to both eyes, pain in sinuses and the right eye was getting the ocular migraine so it was going in and out of vision and was also getting a migraine headache. Patient enquired if that was a normal reaction. On 25May2021 the patient underwent lab tests and procedures which included heart rate which showed result as 86 and heart rate which went back to normal which was like 60. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Feeling extremely tired; little bit nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2, (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on 29May2021 as 1st dose, single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling extremely tired, little bit nauseous on May2021. The patient enquired, how long this would last. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer other non HCP (patient) received via Pfizer-sponsored program. A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179) via an unspecified route of administration in arm left on 30May2021 (at the age of 14-year-old) as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. It was reported that, whether patient could take a Tylenol. It was reported that, she needed to take a Tylenol and she mentioned that she was currently experiencing a headache, just a little headache. Patient was informed and provided the number of the Pfizer Medical Information Department. It was reported that, patient scheduled date of 2nd vaccination was on 01Jul2021, so they were actually going for June, so they scheduled it right when they would get back. she did not see expiration date of the vaccine, all she could see was the date given and date. Reported that, someone called her and tell her to take Tylenol. Treatment was not taken for event. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pyrexia
Clinical narrative: Migraines; A slight fever; Severe fatigue; This is a spontaneous report from a contactable consumer (patient's parent) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in May2021 as 1st dose, single dose for covid-19 immunization. Medical history included a few immunity issues (currently being treated). Concomitant medications were not reported. It was reported that the patient had first vaccine last week, which left her with migraines, a slight fever with severe fatigue on an unspecified date in May2021. The reported also concerned that the second would be more harsh. The outcome of the events was unknown.  information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Bedridden
Clinical narrative: side effects; she had health problems and she was almost bed ridden; This is a spontaneous report from a contactable consumer. A female patient (one girl) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that for the patient, that it took her 5 to 7 days for the side effects but she got wiped out but she had health problems and she was almost bed ridden. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Feverish; Aches in muscles and joints; Aches in muscles and joints; Fatigue; This is a spontaneous report from a non-contactable consumer (Patient). A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25May2021, as single dose for COVID-19 immunization at hospital. The patient medical history was not reported. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0167 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 04May2021, as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 26May2021, the patient experienced feverish, aches in muscles and joints and fatigue. The events were reported as non-serious. The patient did not receive any treatment in response to adverse events. The outcome of the events was reported as resolved on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: When I walk it hurts; shoulders are in so much pain; This is a spontaneous report from a contactable consumer (patient). This report was not related to a study or programme. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date (on Friday), as single dose for covid-19 immunisation. Medical history included Pain in joint, which the patient does have normally and auto immune condition. The patient concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown) for covid-19 immunisation. On an unspecified date, after got up in the morning the patient felt it hurts when walk and the shoulders were in so much pain. Clinical course reported as, I got my second injection on Friday and I normally do have pain in my joint, I mean I do have auto immune condition but I got up this morning and I felt like I can hardly (Incomplete sentence), when I walk it hurts, my shoulders are in so much pain. All the events were reported as non-serious. The outcome of the events was unknown.   Information on the lot/batch number has been requested
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness from the first injection and that was all; This is a spontaneous report received from a contactable consumer. A 20-year-old male patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EW0176), via intramuscular route of administration in Arm Left 03May2021 at 16:00 (at the age of 20 years old) as 1st dose single, dose for covid-19 immunisation at school. Medical history included seasonal allergy. Family medical history included "his mom has Meniere's disease, it comes in rare spurts". Concomitant medication included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for seasonal allergy, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy. The patient experienced soreness from the first injection and that was all in May2021. The events assessed as non-serious. Outcome of the event were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Illness, Nasal congestion, Pain
Clinical narrative: sick; cough/coughing; body hurts/I have got to bad body ache/a lot of body pain; my nose is running; short of breath; nose is congested; This is a spontaneous report from a contactable consumer (Patient) or other non-Health Care Professional reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 18May2021 as 2nd dose single, for COIVD-19 immunization. Patients' historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on unspecified date as 1st dose single, for COIVD-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 29May2021 the patient experienced sick, cough/coughing, body hurts/I have got to bad body ache/a lot of body pain, my nose was running, short of breath, nose was congested (short of breath). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: sick; cough/coughing; body hurts/I have got to bad body ache/a lot of body pain; my nose is running; short of breath; nose is congested; This is a spontaneous report from a contactable consumer (Patient) or other non-Health Care Professional reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 18May2021 as 2nd dose single, for COIVD-19 immunization. Patients' historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on unspecified date as 1st dose single, for COIVD-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 29May2021 the patient experienced sick, cough/coughing, body hurts/I have got to bad body ache/a lot of body pain, my nose was running, short of breath, nose was congested (short of breath). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol intolerance, Dizziness, Drug intolerance
Clinical narrative: This is a spontaneous report from a contactable physician (patient). A 49-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in arm left on 03Feb2021 16:00 (at the age of 49-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies reported. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  The patient did not receive any vaccines within four weeks prior to the vaccination and did not receive any vaccines within two weeks prior to the vaccination. On Feb2021, after one shot, the patient had episodic dizziness, alcohol intolerance and mild caffeine intolerance. Adverse event does not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment for the event included aspirin per day. Outcome of event was not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Facial spasm, Investigation, Muscle twitching
Clinical narrative: I am suffering from facial spasm; Muscle underneath the eye keep pumping for couple of minutes; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732), via intramuscular route of administration in the left arm, on 29Mar2021 as a 2nd dose, single for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199), via unspecified route of administration in the left arm, on 08Mar2021 as a 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient underwent annual lab check up and the results were unspecified. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced facial spasm and her muscle underneath the eye was pumping for couple of minutes. It was reported that it was became more serious on 09May2021. The patient wanted to find out how many people got the same symptoms like her. The patient did not received any treatment. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Neck pain, Neuralgia, Vaccination site pain
Clinical narrative: I was unresponsive, he could not wake me up; Had pain in my neck on the same site of the shot; Had pain in my neck on the same site of the shot.; Nerve pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration, administered in left deltoid (left arm) on 17May2021 (at the age of 60-year-old, Batch/Lot Number: EW0177) as a single dose for Covid-19 immunization. Medical history included the patient had a child arrhythmia; she believed it was from 1996 but it pretty much controlled and prior to vaccine. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This report was not related to a study or programme. The patient stated that she had a concern because she took the first COVID vaccine on the 17May2021 and she was due to get the second one on the 07Jun2021 however she had some concern today. The patient stated that she had some changed episode of reactions on 17May2021, she started having pain, after she took the first one, on the same day, she had pain in her neck on the same site of the shot and had some effect of pain, a nerve pain and it had devastated to the back of her neck where she had her thick neck and she had to use warm pack on the back of my neck. It would be about 4'O clock in the morning which would be on the 18May2021 her husband was observing her because he is a nurse and he could not wake her up, he tried everything possible to wake her up and he attempted to perform cardiopulmonary resuscitation (CPR) on her, so she was concerned about putting herself again such an event taken place. The patient went to the emergency room. They took her to the emergency room however she got her name administered in 'first a clinic' and he was able to stabilize her. The patient went to the emergency room and when she got there it was like a concerning so when she got there, she was not seen by the doctor because she was feeling little better but the context person, and they did concern that some of the episode she had, she saw the effect after COVID vaccine, she was concerned because she was due for the second vaccine and this was the first episode which she had, and she was concerned whether not should, she take the second shot, she went on her and she reported. The patient could not get this anyone, all she got was the worst. They took her to late but whatever she never got a chance to speak with anyone in her life, you know she do consult with her doctor has followed her so she was concerned now that she would have a second shot, she did not know if she could really take it. When concern confirmed the patient stated that she did have adverse reactions to the Covid-19 shot. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypoacusis, Limb discomfort, Malaise
Clinical narrative: She felt really uncomfortable; she have pain in her knee and in her back; she have pain in her knee and in her back; arms are tender but it went really terrible; My hearing is not good; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (formulation: Solution for injection, Batch/Lot Number: EW0169, Expiration Date: May2021), via an unspecified route of administration on 21May2021 as 1st dose, single for covid-19 immunization. Medical history included arthritis from an unknown date and ongoing. Concomitant medication included ibuprofen (MOTRIN) taken for pain, start and stop date were not reported; naproxen sodium (ALEVE) taken for arthritis, start and stop date were not reported. On May2021, the patient felt really uncomfortable, she had pain in her knee and in her back, arms were tender but it went really terrible, her hearing was not good. She was advised to take Tylenol and she mentioned that she took Tylenol and she had two remaining and she wanted to know if she could take two remaining Tylenol until tomorrow. The patient asked whether she could take Tylenol that would have given her a little relief. Her arthritis was bothering her. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Lethargy
Clinical narrative: weakness; Fatigue; lethargy; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: Unknown) via an unspecified route of administration on unknown date as 2nd dose, single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. On unspecified date, the patient experienced fatigue, lethargy, weakness. The outcome of the events was resolved on 3 days after 2nd dose of vaccination.  Information on the lot/batch number; Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Feeling abnormal, Rash pruritic
Clinical narrative: Rash still after almost 2 weeks, spreading, very itchy.; Felt run down; Stomach issues; Anxiety; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) via an unspecified route of administration on 20May2021 at 10:30 in right arm as a single dose for COVID-19 immunization. Medical history was not reported. The patient previously took naproxen for allergies. The patient did not received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Concomitant medications included Alprazolam, Zoloft and Atenolol. On 21May2021, the patient experienced Rash still after almost 2 weeks, spreading, very itchy. Felt run down and having stomach issues and anxiety. The patient did not receive any treatment medication. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Lethargy, Nausea
Clinical narrative: Chills; mild nausea; lethargy; mild headache; difficulty sleeping; This is a spontaneous report from a contactable consumer or other non hcp. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection,Lot number and Expiry date:Unknown), dose 2 via an unspecified route of administration, administered in arm left on 31May2021 13:00 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization, (age at the time of vaccination was 37 years).Historical vaccination included, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 13:00 as 1st DOSE, SINGLE DOSE for COVID-19 immunization. No allergies were reported. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 31May2021 11:00, the patient experienced chills, mild nausea, lethargy, mild headache, difficulty sleeping. The events were assessed as non-serious. Outcome of the events were recovering at this point of time. Information on lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash, Tongue disorder
Clinical narrative: diarrhea about every 30 minutes; rash on legs; circles over tongue, looks shinny, looks like no taste buds there; This is a spontaneous report was received from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on 19May2021 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included COVID in Dec2020 and remembered had no taste then. The patient's concomitant medications were not reported. On 19May2021, the patient experienced diarrhoea about every 30 minutes since then and experienced a rash on legs, which was getting better. The patient also had circles over tongue, looks shiny, looks like no taste buds there, but did have taste. The patient was recovering from the event rash on legs and outcome of rest of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspepsia
Clinical narrative: indigestion type discomfort to her chest; indigestion type discomfort to her chest; This is a spontaneous case report received from a contactable consumer (patient's mother).   A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was the mother of patient and reported that the patient received the first dose of the Pfizer COVID vaccine and was now complaining of indigestion type discomfort to her chest on an unknown date which was received with Pepcid. The reporter stated that the patient did not have any history of indigestion problems. A review of the prescribing information for Pfizer COVID vaccine did not find information regarding indigestion/heartburn. As the prescribing information did not include all adverse reactions that have been reported or that might occur hence, the patient advised to consult with her doctor/healthcare provider about what she had experienced. Because her doctor/healthcare provider was most familiar with her medical condition clinical history how her treatment has been conducted and any relevant information to her specific case and her doctor/healthcare provider was in the best position to advise her about the appropriate action to take. Outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: After the second one i did have a mild flare up after holding it for a week; This is a spontaneous report from a contactable other hcp. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Pregnancy details were unknown at the time of vaccination. The patient medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ). The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on unspecified date at single dose for covid-19 immunization. Patient stated that occasionally she gets mild flare ups. Patient MD was aware. Patient had to stop Xeljanz for a week for each covid injection. After the second dose she did have a mild flare up. Treatment included Aleve otc (Over the Counter) which relieved her mild flare ups. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Blood cholesterol, Inappropriate schedule of product administration, Thyroid function test
Clinical narrative: Feels like she is losing her voice; my voice keeps trying to go away; Date of 1st dose of vaccination: 24 Mar 2021/received their second dose of the COVID-19 Vaccine on Friday May 28th; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (patient) reported for herself that A 52-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27May2021 13:30 (at the age of 52-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: ER8733 Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 24March 2021first dose single for covid-19 immunisation. Patient medical history included thyroid removed from Jan2012 to an unknown date Consumer stated, I have a thyroid problem, I got my thyroid removed; hypothyroidism Date of diagnosis of hypothyroidism: Consumer stated, It was sometimes in 2011 in September or October and it was removed in Jan of 2012.; Graves' disease and thyroiditis. Concomitant medication included levothyroxine taken for thyroid removed. patient states family medical history was not relevant to adverse event. Patient did not receive any other vaccines prior to the COVID vaccine. On an unspecified date patient experienced Feels like she is losing her voice; my voice keeps trying to go away was reported as worsened. Patient did not receive any medication. The patient underwent lab tests and procedures which included blood cholesterol and thyroid function test with unknown result on an unspecified date. Patient reported that she got a lot of lab test recently because she had been in the hospital. They did drug test, thyroid test they did my cholesterol. It was reported that event was persisting, it's worse than it was yesterday. patient states family medical history was not relevant to adverse event. The outcome of event feels like she is losing her voice; my voice keeps trying to go away was not recovered, while outcome of other event was unknown  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Fatigue; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.   A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history was not reported.Previously patient received BNT162b2 was taken as dose 1 for covid 19 immunization. Concomitant medications were not reported. It was reported that Caller was reporting feeling fatigued and feeling chills. Had just gotten the second dose a little under a month now and started to feel the chills and fatigue. He knows that it was a sign of his body fighting some kind of infection. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Does not feel very well; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183) via an unspecified route of administration, administered in left arm on 11May2021 10:45 AM as 1st dose, single for (receiving for COVID like everyone as reported) COVID-19 immunisation at Hospital. The patient medical history and concomitant medications were not reported. It was reported that patient stated she received her first dose on 11May2021 and was supposed to receive her second vaccine today. She stated there was no problems from the shot she just doesn't feel very well in 2021 and wanted to reschedule for another day this week. Patient stated the problem was with her not the shot. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient inadvertently administered expired Tenivac vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Agency (Reference number- 00610121) and transmitted to Sanofi on 20-May-2021.  This case involves a patient (unknown demographics) who received inadvertently administered expired vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number: U6265AA and expiry date: 19-Apr-2021 via unknown route at an unknown administration site) (expired product administered) on 18-May-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Reporter want to know what need to know and which actions to take for the affected donors  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.