chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: Terrible pain and swelling in the injection site; my arm pains, my arm at the injection site is so sore; Terrible pain and swelling in the injection site; my arm pains, my arm at the injection site is so sore; I was not feeling good; I couldn't eat and I was just so cold; Fever / temperature was about 100; I have got chills right now and my body is shaking; Nauseous; couldn't eat; body is shaking; sick; This is a spontaneous report from a contactable consumer. This consumer received the first dose of BNT162B2 (COVID Vaccine, lot number: EL3249), via an unspecified route of administration on an unspecified date in right arm at single dose for COVID-19 immunisation. Medical history included Covid from first week of Mar2020. The concomitant medications were not reported. The consumer previously got flu shots and shingles shot for immunization. The consumer got injected and then sometime in the middle of the night 2 or 3 clock, the consumer had terrible pain and swelling in the injection site so the consumer didn't pay attention to it, so the consumer went out and around 3 o'clock, the consumer was not feeling good, the consumer was feeling low but the consumer was like he/she will go out for and do things and all, so the consumer went to the lunch with a friend and he/she couldn't eat and was just so cold and then came home and the consumer take temperature. Normally my is 97 its never 98 and temperature was about 100, the consumer have got a fever and have got chills and body is shaking. The consumer had Covid in first week of Mar2020 until got the Covid test by the time Apr2020. The consumer already gone through but this is how the symptoms started, the consumer don't want to get it again. The consumer have got flu shots and shingles shot and stuff but nothing like this so sick, the consumer was nauseous, have a fever, have chills, arm pains, arm at the injection site is so sore and it's swollen, whole body is shaking. The consumer need to go to bed, whole body is just shaking terribly. The consumer will wait through the morning if not, he/she will go to the ER, was not going to get sick like he/she get in March, the consumer won't survive if I get sick again. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Terrible pain and swelling in the injection site; my arm pains, my arm at the injection site is so sore; Terrible pain and swelling in the injection site; my arm pains, my arm at the injection site is so sore; I was not feeling good; I couldn't eat and I was just so cold; Fever / temperature was about 100; I have got chills right now and my body is shaking; Nauseous; couldn't eat; body is shaking; sick; This is a spontaneous report from a contactable consumer. This consumer received the first dose of BNT162B2 (COVID Vaccine, lot number: EL3249), via an unspecified route of administration on an unspecified date in right arm at single dose for COVID-19 immunisation. Medical history included Covid from first week of Mar2020. The concomitant medications were not reported. The consumer previously got flu shots and shingles shot for immunization. The consumer got injected and then sometime in the middle of the night 2 or 3 clock, the consumer had terrible pain and swelling in the injection site so the consumer didn't pay attention to it, so the consumer went out and around 3 o'clock, the consumer was not feeling good, the consumer was feeling low but the consumer was like he/she will go out for and do things and all, so the consumer went to the lunch with a friend and he/she couldn't eat and was just so cold and then came home and the consumer take temperature. Normally my is 97 its never 98 and temperature was about 100, the consumer have got a fever and have got chills and body is shaking. The consumer had Covid in first week of Mar2020 until got the Covid test by the time Apr2020. The consumer already gone through but this is how the symptoms started, the consumer don't want to get it again. The consumer have got flu shots and shingles shot and stuff but nothing like this so sick, the consumer was nauseous, have a fever, have chills, arm pains, arm at the injection site is so sore and it's swollen, whole body is shaking. The consumer need to go to bed, whole body is just shaking terribly. The consumer will wait through the morning if not, he/she will go to the ER, was not going to get sick like he/she get in March, the consumer won't survive if I get sick again. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient).   This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247), via an unspecified route of administration at single dose on 19Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on 21Jan2021 with outcome of unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: He got the first dose on 06Jan then 12Jan he tested positive; He got the first dose on 06Jan then 12Jan he tested positive; This is a spontaneous report from a Pfizer sponsored program, via a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN, lot number: EK9231), on 06Jan2021 at single dose for covid-19 immunization. Medical history included idiopathic pulmonary fibrosis. Concomitant medication included nintedanib esilate (OFEV). patient got the first dose on 06Jan then 12Jan he tested positive and then he already scheduled for booster shot on 27Jan and he is asking if he can take that also because according to his doctor, other doctor said do not take it, the other doctor says take it. No investigation assessment. outcome of the events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Chills; fever of a 102; I threw up; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3247), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history included COVID. The patient's concomitant medications were none. After vaccination, the patient had terrible side effects, she thought she had COVID again. She had chills, fever of a 102 and she threw up that lasted a day. Her test was on the 17Jan2021 (also reported as 17Nov2021). Will that be anything that interfere with the shot? The patient received paracetamol (TYLENOL) for treatment. The outcome of event 'threw up' was recovered in Jan2021; of rest events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Nodule
Clinical narrative: joints in the fingers have bumps on them; on each of the first joints on each of the fingers; Lots of joint stiffness and pain; Lots of joint stiffness and pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231), intramuscular in the left arm on an unspecified date in Jan2021 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. On an unspecified date in Jan2021, the patient experienced bumps on the joints in her fingers (on each of the first joints on each of the fingers), lots of joint stiffness and pain (in all the joints). The patient was treated with ibuprofen (ADVIL) for the events. The clinical outcome of bumps on the joints in her fingers (on each of the first joints on each of the fingers), lots of joint stiffness and pain (in all the joints) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site pruritus
Clinical narrative: My right arm not on injection site but right around injection site hard to touch, painful, itchy and it did not go away; My right arm not on injection site but right around injection site hard to touch, painful, itchy and it did not go away; My right arm not on injection site but right around injection site hard to touch, painful, itchy and it did not go away; This is a spontaneous report from a contactable consumer (patient).  This patient (demographics unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose on the right arm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient stated  'my right arm not on injection site but right around injection site hard to touch, painful, itchy and it did not go away'. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: painful feel in arm, around that shot, had the injection, start itchy start feel itchy/ he told that oh it's only 2-3 nights then go away, they were nothing; painful feel in arm, around that shot, had the injection, start itchy start feel itchy/ he told that oh it's only 2-3 nights then go away, they were nothing; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. It was reported that the painful feel in arm, around that shot, had the injection, start itchy start feel itchy. The consumer's neighbor, they also, her husband also had the injec (incomplete word), meant vaccine shot, the consumer asked her husband, he told that oh it's only 2-3 nights then go away, they were nothing. The outcome of the events was recovered.  Information about Lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: the painful feel in arm, around that shot, the injection, start itchy start feel itchy/ it's only 2-3 nights then went away, they were nothing/ another friend, she told the same way; the painful feel in arm, around that shot, the injection, start itchy start feel itchy/ it's only 2-3 nights then went away, they were nothing/ another friend, she told the same way; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friend) with unspecified age that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration at arm on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported another friend, she told the same way that the painful feel in arm, around that shot, the injection, start itchy start feel itchy/ it's only 2-3 nights then went away, they were nothing in Jan2021 with outcome of recovered in Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Exposure to SARS-CoV-2, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Slight sore throat; Slight fever; Slight headache/headache; I work, there were 2 women who work in my classroom. Who have tested positive for Covid.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL3247) on 20Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Patient got the vaccine on 20Jan2021 and had a headache during the day (on 20Jan2021). On 21Jan2021 had a slight sore throat; patient had a slight headache and a slight fever. Patient did not know if it was side effect or if it was Covid. Patient also stated that there were 2 women who work in patient's classroom, who have tested positive for Covid (Jan2021). Patient would like to know if she should get tested or if it was just normal side effect. Final outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; It continued to get worse over the next 24 hours; it continued to get worse after that it peak about 72 hours so enlarged in size; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date 31Mar2021), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Physician stated, "I just want to check actually because just before I waited should l be reporting an adverse reaction from the COVID vaccine. Should I be doing that online or over the phone? So I had the injection two weeks ago actually it was the day, I had it on 05Jan2021. So within 24 hours after I had the vaccine, I had an area of red, hot swollen indurated area that was far away an inch from the vaccine. It is not like within an inch the injection place and then it continued to get worse over the next 24 hours and then it continued to get worse after that it peak about 72 hours so enlarged in size so I would say the area of redness it was well I marked it. It was like about almost three inches by 3 inches.  So it continued to grow to that size like I said peak about 72 hours and very painful, very swollen, red, hot and indurated so hard so then it started to decrease from there. Still quite painful and finally I would say now two weeks after, the pain is gone and the redness is gone so it is now resolved." Clinical outcome of the events was recovered on Jan2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; had an area of red, hot swollen indurated area that was far away an inch from the vaccine/very painful, very swollen, red, hot and indurated so hard; It continued to get worse over the next 24 hours; it continued to get worse after that it peak about 72 hours so enlarged in size; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date 31Mar2021), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Physician stated, "I just want to check actually because just before I waited should l be reporting an adverse reaction from the COVID vaccine. Should I be doing that online or over the phone? So I had the injection two weeks ago actually it was the day, I had it on 05Jan2021. So within 24 hours after I had the vaccine, I had an area of red, hot swollen indurated area that was far away an inch from the vaccine. It is not like within an inch the injection place and then it continued to get worse over the next 24 hours and then it continued to get worse after that it peak about 72 hours so enlarged in size so I would say the area of redness it was well I marked it. It was like about almost three inches by 3 inches.  So it continued to grow to that size like I said peak about 72 hours and very painful, very swollen, red, hot and indurated so hard so then it started to decrease from there. Still quite painful and finally I would say now two weeks after, the pain is gone and the redness is gone so it is now resolved." Clinical outcome of the events was recovered on Jan2021.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Accident, Limb injury, Myalgia, Pain, Vaccination site pain
Clinical narrative: Feels very achy; Muscle pain; Had an accident; hurt shoulder; still having pain where I had the vaccine; This is a spontaneous report from a contactable consumer (patient). An 87-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer injection last Tuesday 12Jan2021, and the first day or so it was really okay but as the time has gone by it feels very achy. The patient was having some muscle pain. Other problem which patient reported that Pfizer have nothing to do was that patient had an accident and hurt shoulder. Both shoulders hurt now, other shoulder was not broken or anything, it just hurts and getting therapy for that. The patient asked if is it okay that patient was still having pain where the patient had the vaccine. Outcome of the events hurt shoulder and having pain where the patient had the vaccine was not recovered; for the other events was unknown.; Sender's Comments: The events "patient had an accident and hurt shoulder" are attributed to intercurrent conditions and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Body temperature, Dizziness, Fatigue
Clinical narrative: I felt very light headed like I could hardly think; Low grade fever; Fatigue; Body aches; Swelling lymph nodes; Joint ache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (it is reported lot number looks like: EL3249), via an unspecified route of administration on an unspecified date at single dose on left shoulder for covid-19 immunisation. Medical history included ongoing hypertension and ongoing asthma. Concomitant medications included hydrochlorothiazide, simvastatin and budesonide/ formoterol fumarate (SYMBICORT) for asthma. Initially and hour after the shot, patient felt very light-headed, like patient could hardly think.  And then, evening of the day, she had a low-grade fever but just didn't take anything because it wasn't that bad and then starting the next day patient had fatigue and body ache. Patient had to take paracetamol (TYLENOL) and Ibuprofen for 6 days every day in the evening and now.  Patient notice in the evening a lump over left collar bone where the swelling lymph nodes were and joint aches too. Treatment received for light-headed, a low-grade fever, fatigue and body ache. Couple months before, patient had blood test and it was normal. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: I felt very light headed like I could hardly think; Low grade fever; Fatigue; Body aches; Swelling lymph nodes; Joint ache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (it is reported lot number looks like: EL3249), via an unspecified route of administration on an unspecified date at single dose on left shoulder for covid-19 immunisation. Medical history included ongoing hypertension and ongoing asthma. Concomitant medications included hydrochlorothiazide, simvastatin and budesonide/ formoterol fumarate (SYMBICORT) for asthma. Initially and hour after the shot, patient felt very light-headed, like patient could hardly think.  And then, evening of the day, she had a low-grade fever but just didn't take anything because it wasn't that bad and then starting the next day patient had fatigue and body ache. Patient had to take paracetamol (TYLENOL) and Ibuprofen for 6 days every day in the evening and now.  Patient notice in the evening a lump over left collar bone where the swelling lymph nodes were and joint aches too. Treatment received for light-headed, a low-grade fever, fatigue and body ache. Couple months before, patient had blood test and it was normal. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chills and headache; Fever, chills and headache; Fever, chills and headache; This is a spontaneous report. A contactable consumer (patient) reported that a 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EKZ421 or EXZ421) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes, psoriasis. Concomitant medication included metformin for diabetes, secukinumab (COSENTYX) for psoriasis. The patient previously received the first dose of BNT162B2 (lot # EL1284) for COVID-19 immunization. The patient experienced fever, chills and headache in Jan2021. No treatment was received for the events. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (reporting for her mother). This consumer reported similar events for 2 patients. This is second of 2 reports.  A female patient (Age: 97, Units: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no side effects at all, just the sore arm. The patient was due for the second shot next Thursday. The reporter asked what the odds were of having side effects from the second shot. The clinical outcome of sore arm was unknown.   Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) same reporter, drug, event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Pfizer vaccine caused the death; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter claimed that Pfizer vaccine caused the death of the doctor (patient). No further details reported.  No follow-up attempts are possible. Information about lot and batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pfizer vaccine caused the death
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Headache, Pain in extremity, Swelling
Clinical narrative: Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was swollen into his left side of his neck; his left side of his face was swollen into his left side of his neck; Headache; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) on right arm, via an unspecified route of administration on 21Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) (home oxygen), heart disease, high blood pressure and diabetes. The patient's concomitant medications were not reported. The patient got the shot (vaccine) yesterday (21Jan2021) at 10:15 at the veteran administration. He got a headache right after that, just a slight headache. His arm was sore this morning (21Jan2021) and red and his left side of his face was swollen into his left side of his neck. The patient didn't receive any treatment for the problem and didn't visit any Physician Office/ Emergency Room. The outcome of events was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was swollen into his left side of his neck; his left side of his face was swollen into his left side of his neck; Headache; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) on right arm, via an unspecified route of administration on 21Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) (home oxygen), heart disease, high blood pressure and diabetes. The patient's concomitant medications were not reported. The patient got the shot (vaccine) yesterday (21Jan2021) at 10:15 at the veteran administration. He got a headache right after that, just a slight headache. His arm was sore this morning (21Jan2021) and red and his left side of his face was swollen into his left side of his neck. The patient didn't receive any treatment for the problem and didn't visit any Physician Office/ Emergency Room. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: fever 101.7; Sore throat; Headache; do not feel alright; This is a spontaneous report from a contactable consumer reported for self. This patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The patient experienced fever, sore throat, headache, do not feel alright in Jan2021. The patient had fever 101.7 and got a little bit of sore throat. The patient had got the headache. The patient wanted to make sure that all of this is normal. The patient worried about the fever more than anything. The patient did not feel alright and fever was going up. The outcome of the event fever was not resolved. The outcome of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: I feel metallic taste in my mouth; This is a spontaneous report from a contactable Consumer. This Consumer(patient) reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Jan2021 02:00 at SINGLE DOSE for covid-19 immunisation. The patient medical history  was not reported. There were no concomitant medications. Patient had a shot today the vaccine (Covid vaccine) that was at 2 O'clock and patient felt metallic taste in patient's mouth. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; This is a spontaneous report from a contactable consumer (patient). This 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# SL3247), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing thyroid. The patient's concomitant medications included thyroid (ARMOUR THYROID) for thyroid. Patient had a COVID 19 vaccine on 22Jan2021 and had couple of side effects with the numbness in the cheeks, lips and the tongue in Jan2021. No treatment received. Outcome of the events was unknown. No investigation assessment.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Feeling hot
Clinical narrative: Chills; It's kind of warm; I am really tired; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization , paracetamol (TYLENOL) , via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included diabetes. The patient's concomitant medications were not reported.  The patient experienced chills, it's kind of warm and she was really tired. It was reported that the patient had side effects that wasn't bad, she took some paracetamol and today she noticed she need to take a few more. Consumer stated that she was just curious to know, how long can side effects last. She was not in any pain or anything but the chills and it's kind of warm. And she was just wondering how long was that supposed to last. The patient was really tired. The start date of events was reported on 21Jan2021. Paracetamol was reported as co-suspect. The action taken in response to the event for paracetamol was unknown. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: received BNT162B2/ medical history included ongoing breast cancer; received BNT162B2/ medical history included ongoing breast cancer; sore arm; This is a spontaneous report from a contactable healthcare professional.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunisation.  The patient's medical history included ongoing breast cancer. Concomitant medications were not reported.  The patient previously took palbociclib (IBRANCE) in Oct2019, Sep2020, then in Dec2020 for breast cancer and experienced diarrhea, mouth sensitivity, lowered white blood, tired, hair loss, fluctuating blood sugars with insulin adjustment.   On an unspecified date in Jan2021, the patient experienced sore arm. The outcome of the event was unknown.  Information on Lot/Batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache and chills 6 to 8 hours after the second dose of the vaccine which lasted around 24 hours. It was mentioned that the event took place after use of product. The outcome of the event was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Impaired work ability, Malaise, Vaccine positive rechallenge
Clinical narrative: got sick; Initial information was received on 23-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/other nonprofessional.  This case involves 51-year-old patient (unknown gender) who got sick (illness), after vaccination with INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient got the flu shot three times, all three time the patient got sick and lost a week of work.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: had an awful reaction, was sick for a month; Initial information regarding this unsolicited valid non-serious case Health Authorities without narrative (level 2A), was received on 25-Jan-2021 from consumer/non-HCP (healthcare professional) via the health authority (under reference: US-SA-SAC20210130000197). The following narrative was based on the information retrieved from all other accessible data.  This case involves an adult patient of unknown gender who had an awful reaction, was sick for a month (Malaise), after received INFLUENZA VACCINE.  Medical history, past medical treatment, medical treatment(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dosage form of each suspect INFLUENZA VACCINE via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had an awful reaction, was sick for a month (Malaise), and same day following administration of INFLUENZA VACCINE.  Relevant lab data were not reported.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  Batch lot number was not provided.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient had one flu shot in 1978, was very sick afterwards; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who had one flu shot in 1978, was very sick afterwards (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date in 1978, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient had one flu shot in 1978, was very sick afterwards (illness) (latency: unknown) following the administration of suspect vaccine. Patient had not been sick with flu in over 50 years.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: a dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine with no AE; Initial information received on 26-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 month old female patient who administered dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstituting with the hib portion of the vaccine (Product preparation issue).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 21-Jan-2021, the patient received a 05mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ336AAA, Expiry date: 05-Jul-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (Product preparation issue) [latency: at the same time of vaccination].  It was reported that, caller reporting two patients were administered the vaccine but unsure of which patient was administered only the DTap-IPV portion of the vaccine. Caller with asked on when to re-vaccinate both patients.  At the time of report 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.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: patient missed his dose at 4-6 years/no AE; Initial information was received on 26-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient of 4-6 years who missed his dose (product dose omission issue) of IPV (VERO) [IPOL] (batch number and expiry date not reported) on an unknown date for prophylactic vaccination. They were trying to get him caught up for school.  At the time of report, patient was 17-year old and he was new to that practice and wanted to know if he can have a booster.   The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was a case of actual medication error due to missed dose.  At the time of report, no adverse event reported.  Result of assessment was not 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.  There will be no information available on batch number for this case.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired on 1/6/2021; This spontaneous report was received from an unspecified reporter referring to an 18-month-old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 07-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # T001419, expiration date was 06-JAN-2021, strength and route were not provided) 0.5 milliliter for prophylaxis which was expired on 06-JAN-2021 (expired product administered). No other adverse events were identified.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AEs.; expired vaccine given to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S021732 has been verified to be a valid lot number, albumin status has been verified as recombinant human albumin (rHA), expiration date reported as 10-JAN-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. On 01-FEB-2021, the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event was unknown. This agent confirmed there was no previous temperature excursion. Causality assessment was not provided.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that it made him or her sick.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: I am getting a shingles rash on my chest and back; I am getting a shingles rash on my chest and back; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 20 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix about 20 days before the date of reporting and now experiencing shingles rash on chest and back.  The reporter asked if this was normal. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: One large red itchy area below injection site; One large red itchy area below injection site; This case was reported by a consumer and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were unknown.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had one large red itchy area below injection site after Shingrix dose.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Nasopharyngitis, Rhinorrhoea
Clinical narrative: blowing nose; feeling cold; headcold; chills; This case was reported by a consumer and described the occurrence of head cold in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 1st dose of Shingrix. On 7th December 2020, 3 days after receiving Shingrix, the patient experienced runny nose and feeling cold. In December 2020, the patient experienced head cold and chills. On an unknown date, the outcome of the head cold, chills and runny nose were not recovered/not resolved and the outcome of the feeling cold was unknown.   It was unknown if the reporter considered the head cold, chills, runny nose and feeling cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the dose of Shingrix and developed a headcold and chills. Patient also reported that blowing nose a little in morning. The outside temperature was fairly warm but patient felt cold. Patient suspected if symptoms are from Shingrix vaccine or if a covid test was warranted. The reporter did not consent to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; hives; This case was reported by a pharmacist and described the occurrence of pruritus in a male patient who received Herpes zoster (Shingrix) (batch number 7434N, expiry date 24th April 2022) for prophylaxis.   On 4th September 2020, the patient received Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pruritus and hives. On an unknown date, the outcome of the pruritus and hives were recovered/resolved.   It was unknown if the reporter considered the pruritus and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was updated from 74342 to 7434N, as per sales data sheet. The patient experienced event and it could be on same day or a week after was not sure.  The patient did not had hives or itching any more. The reporter did not consent to follow up. The reporter did not want to prove further details and did not agree to follow up and was not happy providing details.  The reporter did not want to provide address and no further information provided.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Influenza like illness, Pyrexia
Clinical narrative: Fever; Flu like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 43-year-old female patient who received HBV (Engerix B) (batch number H2T35, expiry date 29th May 2022) for prophylaxis.   On 21st December 2020, the patient received the 1st dose of Engerix B. On 21st December 2020, less than a day after receiving Engerix B, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Engerix B.  Additional details were provided as follows: The patient received Engerix B and later went to the emergency room as she developed a fever of 102 degree F and had flu-like symptoms. No additional details as to duration of symptoms. The reporter consented to follow up.