chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Asthenia, Chills, Dizziness, Sensation of foreign body
Clinical narrative: Big pimples on right side cheeks/Pimples on end of tongue; Lump in right side of throat; Chills; Weak; Dizziness; This is a spontaneous report received from a contactable consumer (Patient). A 55-year-old female patient received second dose of BNT162B2(PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 18May2021 (at the age of 55 years) (Batch/Lot Number: EW0176) as second dose, single dose for covid-19 immunisation. Medical history included ongoing asthma Diagnosed about 2 years ago. The patient's concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Lot Number: EW0162) received on 23Apr2021 (at the age of 55 years). Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient denied any family medical History Relevant to adverse event. On an unspecified date in May2021, the patient experienced big pimples on right side cheeks/pimples on end of tongue, lump in right side of throat, chills, weak and dizziness. She stated that she had the Covid Pfizer Vaccine, second dose, on 18May2021. She then travelled on 24May2021. She was having side effects and wanted to report them. She was currently out of the country. Stated that the symptoms started after the second dose of the vaccine; but before she travelled out of the country. She developed big pimples on the right side of her cheeks. then a lump in the right side of her throat. She thought these were going away, so she went ahead and travelled. She stated now they've gotten bigger. She also had pimples on the end of her tongue. States she also experienced chills, being weak, and dizziness but that was okay now. Now everyday she noticed something new. She would like to know if she should continue this way if symptoms persist. Should she go back and receive treatment, or she should wait. She called her healthcare provider, but she isn't working on Fridays. She denied any medications, labs, testing, or treatments relevant to events. She was not visited to either emergency room or physician's office. Relevant teste was reported as none. The outcome of event Big pimples on right side cheeks/Pimples on end of tongue was unknown, Lump in right side of throat was worsened and not recovered and chills, weakness and dizziness were recovered on an unspecified date in May2021.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Headache, Joint range of motion decreased, Malaise
Clinical narrative: has been really shaky; has a headache; hasn't felt good; when she went to sleep she woke up 2 hours later; couldn't move her arm; cold chills; she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure; she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure; sharp pain throughout her arm; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 27May2021 (at the age of 20-years) as 1st dose, single dose in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient side effects are that she has been really shaky, she has a headache, she hasn't felt good since yesterday, 27May2021, and she went to sleep yesterday, 27May2021, and woke up 2 hours later and couldn't move her arm at all and every time she did move it, it was shooting sharp pain throughout her arm, she has cold chills and she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure. Clarified vaccine to the Pfizer COVID vaccine 1st dose. Reporter seriousness was Unspecified. She says they are all continuing to today except for she doesn't have the fever anymore and her arm is not shooting pain. But she does still have headache and cold chills every now and then and she's shaky. The outcome of the events Sleep disorder; Joint range of motion decreased; Fever; Burning sensation, Pain in arm was recovered in 2021. and rest of the events was not recovered.  Information on the lot/batch number has been requested
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: has been really shaky; has a headache; hasn't felt good; when she went to sleep she woke up 2 hours later; couldn't move her arm; cold chills; she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure; she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure; sharp pain throughout her arm; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 27May2021 (at the age of 20-years) as 1st dose, single dose in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient side effects are that she has been really shaky, she has a headache, she hasn't felt good since yesterday, 27May2021, and she went to sleep yesterday, 27May2021, and woke up 2 hours later and couldn't move her arm at all and every time she did move it, it was shooting sharp pain throughout her arm, she has cold chills and she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure. Clarified vaccine to the Pfizer COVID vaccine 1st dose. Reporter seriousness was Unspecified. She says they are all continuing to today except for she doesn't have the fever anymore and her arm is not shooting pain. But she does still have headache and cold chills every now and then and she's shaky. The outcome of the events Sleep disorder; Joint range of motion decreased; Fever; Burning sensation, Pain in arm was recovered in 2021. and rest of the events was not recovered.  Information on the lot/batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I was looking a little drowsy or whatever and they refuse to give me my second shot; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number and Expiration: Unknown), via an unspecified route of administration on unspecified date as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient reported that on an unknown date, went to get shot yesterday at the place where patient got it in and they refused. Patient was looking a little drowsy or whatever and they refuse to give the second shot. So, patient tried to figure out how would get the second shot. Patient informed that missed second shot of COVID-19 vaccine. Patient was informed about Pfizer Medical Information and provided the number and informed about the timings as 8 AM to 8 PM from Monday to Friday and 9 AM to 3 PM Saturday and Sunday as per EST. Limited information was available over the call. Reporter did not specify about seriousness. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Maternal exposure timing unspecified
Clinical narrative: Got the second dose and she was pregnant; Feeling tired; Headache; Chest pain; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on 28May2021(Pregnant) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection) on an unknown date for covid-19 immunization. Reporter reported for the side effect of his wife (consumer). It was reported that, She got the second dose yesterday and she was pregnant, she felt well yesterday last night after she got the vaccine. On 29May2021, she was kind of feeling tired, had headache but she felt like chest pain. Also reported that If she needed to go to the hospital or wait because she was feeling better now. The outcome of the events headache, feeling tired and chest pain was reported as recovering and for got the second dose and she was pregnant was unknown.  Information on Lot/Batch number has been requested.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Illness, Weight, Weight decreased
Clinical narrative: been sick/she is kind of halfway sick; been sick; lost a bunch of weight; already had three of her shots; This is a spontaneous report from a contactable consumer (Patient). A 94-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced seriousness for been sick, lost a bunch of weight and already had three of her shots, she is kind of halfway sick, she confirms she didn't have any experience to report. Patient states she is calling because they didn't give her a card. When probed for telephone number, the caller explains she doesn't have but one number, and she is kind of halfway sick. Patient already had three of her shots at (#) She doesn't know what happened but she doesn't have a card. She clarifies she took three shots already. She was looking through her purse and she doesn't have a card for that, but she has already had three shots already. She confirms she didn't have any experience to report. they said she already had two shots already, but she still couldn't understand that the last one she had was taken at #,that's the hospital where she goes. Reporter clarifies she doesn't know if she got the Pfizer COVID-19 vaccine. Patient thought everybody was getting one. Patient clarifies # is her regular hospital. She went there the first time, and she went there the second time, and the last time she went, she thought that was it. She kept seeing in the papers that they might give her another shot later. She didn't pay that much attention, but after she left one hospital, she didn't know where to go for another one. She clarifies it was in some papers that gave her and she didn't look at it. It was her fault. The first time, she went back to the hospital, and the last time was at hospital. She will be sure she look good next time. It was her fault. She is not able to provide an NDC/Lot/Expiry date. She mentions she might get her granddaughter to call. Her granddaughter lives in #. The patient thought she wouldn't take the Covid-19 shot, but her granddaughter told her to take it. Her granddaughter took her shot at the same the caller did, the same date. She said when she went to get her shot, the hospital staff asked her if she was coming to get her shot. After she got the shot, the staff told her she was through, and that was her last shot. She was born in that section of the hospital where she got her shot. Patient will contact her granddaughter in #and tell her what happened about her getting sent a card. She was reading in the paper, or book, that she was supposed to get another shot, but the caller doesn't know. She really doesn't want another shot, she's too old. She did good. Patient underwent lab test and procedures included weight. The outcome of events was unknown.  Information about batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm is getting sore; the arm where the shot was given was swollen and red; the arm where the shot was given was swollen and red; started feeling little warm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number, UPC number and Expiration date were Unknown), via an unspecified route of administration on 28May2021 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included deafness (deaf, hard of hearing) from an unknown date. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date for covid-19 immunisation. It was reported that, the patient got the vaccination yesterday the second one, and felt fine but today on 29May2021, well all throughout the night the patient experienced arms were getting sore, that morning by time went to the store and got back home started feeling little warm and the arm where the shot was given was swollen and red. The Interpreter also asked, what can be done and if the patient can take Tylenol for that? Reporter seriousness for Arm is getting sore; started feeling little warm and the arm where the shot was given was swollen and red was Unspecified. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unknown date in May2021, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in May2021, after taking the vaccine, the patient experienced irregular heartbeat and went to clinic. It was reported that the doctors had not fully determined the cause but because he had his first COVID-19 shot last week, who said it was possibly due to that. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain level was higher then normal; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program. A female patient of an unspecified age received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date in May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had her 1st dose of the Pfizer vaccine 2 weeks ago (May2021). She said her pain level was higher than normal on the first day after vaccine and by the third day it was almost back to normal. Now (May2021) she had her second dose and her doctor wants too put her on immunosuppressant. Outcome of the event was recovered in May 2021. Information about batch/lot number has been requested.
Sex: F
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 or other non hcp (patient). A female patient of an unspecified age 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 2nd dose, 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. Historical vaccine included 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 1st dose, single dose for covid-19 immunization. The patient reported, was lucky to have received both doses of the Pfizer vaccine. However, they had 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 on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Myalgia, Nausea, Nervousness
Clinical narrative: Muscle pain; Chills; Nausea; Difficulty in breathing; She was very scared; This is a spontaneous report received from a non-contactable consumer (patient friend). A female patient of unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 31May2021 (Batch number/Lot Number: UNKNOWN) as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported the patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter stated, patient just got second vaccine (Unspecified Vaccine) and she did not feel anything horrible or bad at the first one, now after the second one she was having some side effects on 31May2021, like muscle pain, chills, nausea and difficulty in breathing. Patient does not wanted to go to ER. She was very scared. Reporter told her to take a pill of Allegra. Seriousness of the events was not reported. The outcome of all the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: after the shot my smell and taste went away and I still haven't get it back; after the shot my smell and taste went away and I still haven't get it back; This is a spontaneous report from a contactable 28-year-old male consumer reported for himself. A 28-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route, in right arm on 04Mar2021 (at the age of 28-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.Prior to vaccination before 4 week, patient had never tested positive for covid .On 04Mar2021,hour after the vaccination, the patient smell and taste went away and still haven't got it back. The patient does not remember  time of vaccination.No treatment was given. The patient asked about anything he can do to get smell and taste back. He also stated that his second dose is scheduled after 3 weeks. The outcome of the event was not recovered.  Information on the lot/batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Fatigue, Nausea, Pruritus
Clinical narrative: Nausea; Had no appetite; Little bit tired; little red welt; Started developing little red welt or greyish circular spot on my neck and on the back of my calf on my right leg; it was very itchy and red and grey; it was very itchy and red and grey; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 07May2021 as a single dose and covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea, had no appetite, little bit tired, little red welt, started developing little red welt or greyish circular spot on patient neck and on the back of patient calf on patient right leg, it was very itchy and red and grey. Patient called to doctor and he said it was a local reaction. And so it was very itchy and red and grey. And so patient put Calamine (further clarification unknown) on it but nobody was telling what more to do, it feels weird 3 weeks later.   The outcome for all the events was unknown.  No further information available over the call as the consumer hung up the call abruptly. Hence limited information available over the call.  Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Nausea; Had no appetite; Little bit tired; little red welt; Started developing little red welt or greyish circular spot on my neck and on the back of my calf on my right leg; it was very itchy and red and grey; it was very itchy and red and grey; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 07May2021 as a single dose and covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea, had no appetite, little bit tired, little red welt, started developing little red welt or greyish circular spot on patient neck and on the back of patient calf on patient right leg, it was very itchy and red and grey. Patient called to doctor and he said it was a local reaction. And so it was very itchy and red and grey. And so patient put Calamine (further clarification unknown) on it but nobody was telling what more to do, it feels weird 3 weeks later.   The outcome for all the events was unknown.  No further information available over the call as the consumer hung up the call abruptly. Hence limited information available over the call.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of relaxation
Clinical narrative: Its peaceful; This is a spontaneous report from a contactable consumer. A 31-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 29May2021 17:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history were not reported. The patient's concomitant medications were not reported. No known allergies reported. On 29May2021 17:00, the patient experienced its peaceful. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No COVID tested post vaccination. The outcome of event was recovered.   Information about Lot/batch number has been requested
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: Arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm.; Arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm.; Have a knot about size of ping pong ball; Had flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 15:45 (Batch/Lot Number: EWOI86) as single dose for COVID-19 immunisation. Medical history included High blood pressure, high cholesterol, arthritis, nerve damage. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included benazepril (BENAZEPRIL) at 5mg; rosuvastatin (ROSUVASTATIN) at 5mg; mometasone furoate (NASONEX); gabap (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously took vioxx, atorvastatin (LIPITOR) and chlorhexidine diacetate and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 25May2021, 16.00, arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm. Have a knot about size of ping pong ball. Had flu like symptoms. The patient used Cold compresses, Tylenol to treat the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the armpit of the arm that had the shot; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A female patient of an unspecified age 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 immunisation. The patient medical history and concomitant medications were not reported. It was not known if the patient was pregnant at time of vaccination. The patient experienced pain in the armpit of the arm that had the shot on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: when he got his vaccine he got very ill from both shots; This is a spontaneous report from a contactable consumer (patients mother) reporting for A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose, dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunization. The patient's medical history included Reporter stated that son (patient) had Covid, his wife and his son. He was very, very bad but he was quarantined and in the house, that had been a while back. and concomitant medications were not reported. On an unspecified date, the patient was very ill from both shots. When he got his vaccine he got very ill from both shots. The outcome of event was unknown. Patient relevant information added to the narrative and rest of the information was in cross linked case for the respective patient. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Fever; Headache; Body aches; Dizziness; got the shot my arm is very sore there is a lump there its red its hot; got the shot my arm is very sore there is a lump there its red its hot; got the shot my arm is very sore there is a lump there its red its hot; got the shot my arm is very sore there is a lump there its red its hot; I'm not feeling good; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender 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 on 27May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the shot, the first shot (unspecified shot) of the vaccine on Thursday (27May2021) and they said that patient had symptoms afterwards, first when he/she got it on Thursday, it was Thursday he/she do not know around may be 6'o clock or 7 somewhere around the very next day (28May2021), patient had started getting symptoms like fever, body aches, headache, dizziness. On an unspecified date of May2021, patient arm where he/she got the shot his/her arm was very sore there was a lump there its red its hot and was not feeling good. Patient stated that he/she was not going to start doing the survey when he/she was not feeling good. Patient still had a fever, arm where patient got the shot his/her arm was very sore there was a lump there it was red and its hot. Patient still had it and today was Monday, patient asked was that normal. The outcome of was not feeling good was unknown and not recovered for rest of the events.  Information about batch/ lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever; Headache; Body aches; Dizziness; got the shot my arm is very sore there is a lump there its red its hot; got the shot my arm is very sore there is a lump there its red its hot; got the shot my arm is very sore there is a lump there its red its hot; got the shot my arm is very sore there is a lump there its red its hot; I'm not feeling good; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender 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 on 27May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the shot, the first shot (unspecified shot) of the vaccine on Thursday (27May2021) and they said that patient had symptoms afterwards, first when he/she got it on Thursday, it was Thursday he/she do not know around may be 6'o clock or 7 somewhere around the very next day (28May2021), patient had started getting symptoms like fever, body aches, headache, dizziness. On an unspecified date of May2021, patient arm where he/she got the shot his/her arm was very sore there was a lump there its red its hot and was not feeling good. Patient stated that he/she was not going to start doing the survey when he/she was not feeling good. Patient still had a fever, arm where patient got the shot his/her arm was very sore there was a lump there it was red and its hot. Patient still had it and today was Monday, patient asked was that normal. The outcome of was not feeling good was unknown and not recovered for rest of the events.  Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram neck, Dizziness, Headache, Magnetic resonance imaging
Clinical narrative: right thumb twitching; tremors; moderate to extreme dizziness; episodic blurry vision; regular headaches/ mild to moderate headaches; nausea w/o vomiting; nausea w/o vomiting; This is a spontaneous report from a contactable Physician (patient).   A 49-years-old female patient (non-pregnant) received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as, Second dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: ER8732, Expiration date) via an unspecified route of administration in left arm on 03Feb2021 at 4:00 as, first dose single dose for COVID-19 immunization and experienced episodic dizziness, alcohol intolerance and mild caffeine intolerance on Feb2021. 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 an unspecified date after patient experienced regular headaches and then 5 weeks after right thumb twitching, tremors, moderate to extreme dizziness, mild to moderate headaches, episodic blurry vision, nausea, vomiting and so extreme on 25May21. patient went to the emergency room or department or urgent care. The patient underwent lab tests and procedures which included blood test: MRI of two regions including vasculature and CT scan of neck along with blood work. Symptoms better upon rising and worsen as the day goes on. Extreme with very small amount of alcohol or caffeine. Therapeutic measures were taken as a result of the events included aspirin per day. The outcome of events was not recovered.  Follow-up attempts needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Nausea, Tremor, Vision blurred, Vomiting
Clinical narrative: right thumb twitching; tremors; moderate to extreme dizziness; episodic blurry vision; regular headaches/ mild to moderate headaches; nausea w/o vomiting; nausea w/o vomiting; This is a spontaneous report from a contactable Physician (patient).   A 49-years-old female patient (non-pregnant) received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as, Second dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: ER8732, Expiration date) via an unspecified route of administration in left arm on 03Feb2021 at 4:00 as, first dose single dose for COVID-19 immunization and experienced episodic dizziness, alcohol intolerance and mild caffeine intolerance on Feb2021. 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 an unspecified date after patient experienced regular headaches and then 5 weeks after right thumb twitching, tremors, moderate to extreme dizziness, mild to moderate headaches, episodic blurry vision, nausea, vomiting and so extreme on 25May21. patient went to the emergency room or department or urgent care. The patient underwent lab tests and procedures which included blood test: MRI of two regions including vasculature and CT scan of neck along with blood work. Symptoms better upon rising and worsen as the day goes on. Extreme with very small amount of alcohol or caffeine. Therapeutic measures were taken as a result of the events included aspirin per day. The outcome of events was not recovered.  Follow-up attempts needed. Further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: is experiencing a rash after getting the second dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 64-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration in right arm on 22May2021 12:00 as 2nd dose, single dose (at the age of 64-years-old) for COVID-19 immunization. Vaccine was not administered at military facility. Patient did not receive any prior vaccinations within 4 weeks. Patient medical history included blood pressure, diabetes, anxiety all of which were ongoing. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EH0150) via an unspecified route of administration in right arm on 01May2021 12:00 as 1st dose, single dose for COVID-19 immunization. On 22May2021, patient was experiencing a rash after getting the second dose of the Pfizer COVID-19 vaccine. She is trying to see if it could be a reaction to the vaccine and what she should do for the rash. Rash was reported as worsened. Patient states she started noticing it in the evening on 22May2021 then she really started to notice it more that 24May2021, like where it was getting kind of bad and stuff. Patient states she received the vaccine on the 22May2021 and so right now she was experiencing a rash and so she was trying to see if the rash was part of could be a symptom of an outbreak or adverse reaction to it. She states because on her arm, it started on her right arm, where she did have the vaccine at, and now it was on her chest and on her neck and everything. She states so she was trying to see if it was related. The adverse events did not result in emergency room or physician office visit. The treatment for the adverse event included use of Hydrocortisone cream by the patient. The outcome of the event was not recovered.   Follow-up attempts are possible, additional information has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Vaccination site pain
Clinical narrative: pain in the arm is getting worse every week, throbbing pain 0 to 8 number in the arm.; pain at the injection site; This is a spontaneous report received from a contactable consumer (Patient).  A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left in Mid-afternoon on 30Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single dose for covid-19 immunisation.  The patient medical history was reported as none. Concomitant medication was not reported. Patient family Medical History Relevant to AE was reported as none. Patient historic vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization on 31Mar2021. Adverse event following prior vaccination was reported as none. Patient did not receive any other vaccine within 4 weeks prior to the first administration date of the Pfizer vaccine. On 30Apr2021, had a little bit of pain, normal, where the shot was. From that time, about 1-2 times per week he had pain in that left arm. Pain had been progressively constant on 0-8 pain scale for the site where the shot was put in his arm. He called the CDC, just came from his doctor's office. He was following CDC protocols implemented on this. He had to get bloodwork-clarified he had bloodwork drawn today; doctor wanted him to get an ultrasound done on his arm and start steroids as prescribed. As soon as he got the shot, he felt some...what he thinks was an indication of he got a shot-his body protecting itself from foreign body. About a week later he started to develop more pain in that area and then it progressively got worse, throbbing. He just had an appointment with his doctor's PA at 08:30 this morning on 01Jun2021. He just had bloodwork drawn but had no information for that or any other relevant testing/investigations done to provide for report. He received second dose of Covid-19 Vaccine, which he verified as being Pfizer-BioNTech product from CDC vaccine record card, on 30Apr2021. He reported pain starting that day and progressively worsening. He asked how long this side effect is going to take, who is going to pay for this process because supposedly he has to pay for this; but this is basically a clinical trial and when in a clinical trial the company pays for this, right? He also mentioned that his first dose of Covid-19 Vaccine was on 31Mar2021, and second dose of Covid-19 Vaccine was on 30Apr2021; so, second dose administered 30 days after first dose. He reported that kept him within the 6-week window. The outcome wof the events was not recovered.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection; This is spontaneous report received from a contactable consumer (parent). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: RN6202; Expiration Date: 30Jun2021), via an unspecified route of administration on 28Feb2021 at a single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. Parent of the patient stated that the patient received first dose of the Pfizer BioNTech covid vaccine on 28Feb2021 (lot number: RN6202 expiry date 30Jun2021) when she was 16 and she's 17 now. Patient had an infection on an unspecified date in 2021 and was taking 5 days of prednisone. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Paranasal sinus discomfort
Clinical narrative: they both felt tired and after a day or two that went away; headache across the eyebrows that was progressively becoming worse; Sinus pressure; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 Immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9266, Expiration Date: 31May2021) on 04Feb2021 single dose for COVID-19 immunization. It was reported that he has developed a headache across the eyebrows that was progressively becoming worse in 2021. He thought it was spring-time allergies at first but never had them before. Patient felt tired in 2021 and after a day or two that went away. He thinks but he doesn't know since he has gotten the second COVID Vaccine, he has been getting headaches, usually in the morning and at night. It's like a sinus headache across his eyebrows. He has never had anything like this in his life. was it common to get a reaction to the vaccine like this? He started getting these headaches and sinus pressure a week or two weeks after getting the second shot in 2021. It was getting worse. Every day it gets worse and worse. Patient states worse time was in the morning when he get up around 7 a.m. and in the evening around 7 p.m. He does use a saline spray, which helps a little. The outcome of event felt tired was recovered in 2021, remaining events were not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen armpit; This is a spontaneous report from a contactable nurse (Patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 28May2021 at 13:15, as unknown, single dose in left arm for COVID-19 immunization at Workplace clinic. The patient's medical history included hypertension, diabetes, and COVID-19. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications in two weeks after vaccination included Glipizide and Hydrochlorothiazide (HCTZ). On 29May2021, the patient experienced swollen armpit. Treatment medication for the adverse event included ibuprofen. The patient had COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Retinal migraine
Clinical narrative: Ocular migraine; This is a spontaneous report received from a contactable female consumer (patient). A 4-decade-old (30s) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in unspecified location on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, few days after the vaccination, the patient experienced ocular migraine. The reporter assessed all events as non-serious. Caller wanted to know if ocular migraine was included among the commonly reported AEs, the caller also wanted to file a complaint due to lack of information on the reason why MRNAs were used instead of VLPs in making the Pfizer BioNTech Covid-19 Vaccine. Caller wanted to know why Pfizer did not use VLPs and used MRNAs instead for the Pfizer BioNTech Covid-19 Vaccine and how many days are allowed to get the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine from the first dose. The outcome of the event was unknown.  Information about Lot/Batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Nervousness, Poor quality product administered, Product temperature excursion issue
Clinical narrative: The third vaccination provider apparently got it right but he now has received 3 doses and only one of them was valid; unnerving; that shot of the vaccine was also invalid because the county said it was one day expired.; ended up shutting down because of temperature excursions; ended up shutting down because of temperature excursions; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A male patient of an unspecified age received 3 Pfizer Covid doses. The first dose on 07Apr2021, this was from the vaccination clinic that they ended up shutting down because of temperature excursions. That first dose he had was considered invalid and tossed out and they ended up closing on the 30Apr2021. As per the guidance from a Pfizer document that was online was that if you had a temperature issue and get a dose that was invalid to get the dose again immediately. However, as per the state recommendation, stated that to wait 3 weeks and then restart the regimen unless you have already had two and then only get a third dose. So, per the states recommendation, patient waited for 3 weeks to get his first dose again (a second dose). Patient received 2nd dose (revaccination of his first dose) on 28Apr2021, it was stated that shot of the vaccine was also invalid because the county said it was one day expired. So, two different providers got it wrong, and he said it was possibly for 3000-9000 doses (unable to verify the number he stated). He stated it was more than one agency and he thinks the staff even confiscated doses and was told to receive next shot in the series. Patient received the second dose (a third dose) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 20May2021 at a single dose for Covid-19 immunization. The third vaccination provider apparently got it right but he now had received 3 doses and only one of them was valid. Patient enquired whether like to know how to proceed and if he should receive a 4th Pfizer Covid vaccine in this situation. He stated it was unnerving to have 3 doses when you are supposed to have 2. The outcome of the events was unknown.  Information about lot/batch number has been requested.