chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: she fell/ended up on the floor; cold sweat; shakes were a little bit better/hard shakes; couldn't get warm; chills; fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-year-old female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiration date: unknown) as single dose, administered in Arm Right on 05Mar2021 13:00 (at the age of 70-year-old), as dose 1, single for covid-19 immunisation. The Medical history and concomitant medications were not reported. No family history reported. No prior Vaccinations (within 4 weeks). On 22Mar2021 patient experienced chills, fever, shakes were a little bit better/hard shakes, couldn't get warm and on 23Mar2021 she fell/ended up on the floor, cold sweat. It was reported that scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 Vaccine today, 25Mar2021. Last Monday, 22Mar2021, Caller reported to have had chills, fever (all day until night) Caller had 2 blankets on, and heaters. Caller also mentioned that she fell, and that yesterday, the shakes were a little bit better but she also had a high fever. Reports on Monday she had hard shakes, could not get warm; this went on for several hours then at midnight it went the opposite and she broke out with a cold sweat. Her temperature was 101.2. Adds on Tuesday, late afternoon the same thing happened, she had hard shakes with chills and her temperature was 101.4; then she went to the bathroom and she does not know what happened next but she ended up on the floor. Adds then Wednesday the chills and shakes were less but she still had a 102. Fever. Now she is asking for a should she get the next shot or can she wait. Clarifies she had the first dose of the Pfizer COVID 19 vaccine on 05Mar2021 at 1300 pm in the right arm. She is scheduled for the second dose today on 25Mar2021 but she does not think she can make it. Patient did not visited Emergency Room or Physician Office. The patient underwent lab tests and procedures which included body temperature: 101.2 on an unspecified date and body temperature wass101.4 on 23Mar2021 , body temperature: 102 on 24Mar2021. The outcome of event recovering for hard shakes, Chills and Fever, cold sweat was not Recovered, she fell/ended up on the floor was Recovered on 23Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Parosmia, Rash
Clinical narrative: right ear ache; overactive smell; severe rash on trunk and top of her legs and arms; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had severe side effects from the first dose of Pfizer's COVID vaccine with a severe rash on trunk and top of her legs and arms. She also had a right ear ache and had an overactive smell. Her rash was coming from the inside out. The patient stated that she didn't itch it and it was small and not as red as it used to be. The patient wanted to know the efficacy percentage after one dose of Pfizer's COVID vaccine and if right ear ache or overactive smell had been reported after receiving a dose of Pfizer's COVID vaccine. The patient wanted to know what would happen if there is a booster dose and she is not able to get the second shot due to her severe side effects. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rash papular
Clinical narrative: Slight rash upper arms and upper chest and back/ rash on her shoulders, upper chest and upper back/ Rash with little bumps; She had a little bit of a fever.; This is a spontaneous report from a contactable consumer or other non-health care professional(patient). A 52-years-old non pregnant female patient received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER2613, Expiration date: unknown) administered in Arm Right as dose 2, single on 23Mar2021 14:00 (Age at vaccination: 52-Year-old) for covid-19 immunization. The medical history included High blood pressure, Known allergies Penicillin. Concomitant medication included lisinopril. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (lot number EN6200) dose 1, single, in right arm 02Mar2021, 12:00 PM, for covid-19 immunization. On 24Mar2021 at 02:30PM the patient experienced rash on her shoulders, upper chest and upper back. Stated it was nothing major and she had a little bit of a fever. Adds she had noticed in the past when she gets a fever, she gets a rash with little bumps and that was what she had this time too. Her temperature was 100. The patient underwent lab tests and procedures which included body temperature: 100 on Mar2021. The outcome of event She had a little bit of a fever was unknown whereas another event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Culture urine, Lymph node pain, Swelling
Clinical narrative: Lymph node pain; swelling; chest painful; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200, Expiration date was not reported), via intramuscular on 18Feb2021 at 11:20 AM as a dose 2, single for COVID-19 immunization. The family medical history relevant to AE(s) included cancer, lungs than entire body, father passed away: cancer, lungs than entire body and heart stents, mother: heart stents. The patient's medical history included blood pressure and cholesterol. The patient's concomitant medications included amlodipine, taken for blood pressure and simvastatin (ZOCOR), taken for cholesterol. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982, Expiration date was not reported), via intramuscular on 28Jan2021 at 11:15 AM as a dose 1, single for COVID-19 immunization. On 22Feb2021, the patient experienced lymph node pain, swelling and chest painful. The adverse events resulted in physician office visit. On 24Feb2021, the patient was better. Treatment was not received for the events. The patient underwent lab tests and procedures which included blood work: results not provided on 04Jan2021 and urine culture: results not provided on 05Jan2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Feeling hot, Headache
Clinical narrative: generalized pain; pain in the joints; headache; pain in the injection site; dizzy; cloudy mind; warm sensation.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received first 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 24Mar2021 as dose 1, single for COVID-19 immunization. Medical history included allergic reactions to medications. The patient concomitant medications were not reported. On 24Mar2021, immediately after vaccination patient felt dizzy with a cloudy mind and a generalized warm sensation. Patient also felt generalized pain, pain in the joints, headache and pain in the injection site since the administration of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: generalized pain; pain in the joints; headache; pain in the injection site; dizzy; cloudy mind; warm sensation.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received first 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 24Mar2021 as dose 1, single for COVID-19 immunization. Medical history included allergic reactions to medications. The patient concomitant medications were not reported. On 24Mar2021, immediately after vaccination patient felt dizzy with a cloudy mind and a generalized warm sensation. Patient also felt generalized pain, pain in the joints, headache and pain in the injection site since the administration of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity, Walking disability
Clinical narrative: a lot of pain on her left thigh and on her hip on the same side; a lot of pain on her left thigh and on her hip on the same side; she can not walk and can not cross her legs; she can not walk and can not cross her legs; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a lot of pain on her left thigh and on her hip on the same side. She wanted to know of that was a normal reaction after the vaccination, the pain was so strong that she cannot walk and cannot cross her legs. She also wanted to know if the duration of these side effects was known. The seriousness of the events was reported as non-serious. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: throat swelling; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported),via an unspecified route of administration on 22Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported),via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. On 22Mar2021 the patient experienced throat swelling. The patient had difficulty swallowing and throat swelling after 1st dose, but only had throat swelling after 2nd dose. The patient says throat swelling was not visually verified by health care practitioner. The patient said she was monitored at vaccination site both times by health care practitioner and throat swelling resolved on its own within 30 minutes without need for intervention. The patient would like to confirm if it is okay to take the 2nd dose vaccine today. The patient is asking about taking the vaccine for more than 3 weeks and creating adverse event form since the patient 2nd dose schedule is more than 21 days and experienced side effects. The outcome of the events was recovered.  Follow-up (25Mar2021): This follow up report contains no new safety information.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: have problems with knees; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection in pre-filled syringe, Batch/lot number: Unknown), via an unspecified route of administration on 12Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22Mar2021 patient experienced had problems with knees. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dry throat, Feeling abnormal
Clinical narrative: little abnormal; coughed; hip pain; dry throat; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 15Mar2021 as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced a little abnormal on 21Mar2021. He said he coughed a little, he had hip pain and dry throat on an unspecified date in Mar2021. Therapeutic measures were taken as a result of hip pain with meloxicam. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Investigation
Clinical narrative: had breathing issues (difficulty breathing)/ Couldn't breathe; chest discomfort, pressure; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 between 09:00-09:30 (at the age of 60 years) as dose 1, single for COVID-19 immunization. The patient's medical history was none. The patients concomitant medications were not reported. Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations (within 4 weeks) were none. AEs following prior vaccinations were none. The patient experienced breathing issues (difficulty breathing)/ couldn't breathe and chest discomfort, pressure on 23Mar2021 about 5 mins after she got the injection. She said luckily there were paramedics there that helped her. Her symptoms lasted 3 or 4 minutes it resolved by itself, but she said it was pretty scary and she was concerned about taking the second dose of the vaccine. They checked her out everything was ok, she went to hospital, everything was ok. Event resulted in emergency room visit. The patient was not hospitalised. She stated they took some blood at the hospital, but she doesn't know the results. She had to get that from the hospital. The outcome of the event recovered on 23Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Insomnia, Pain, Swelling
Clinical narrative: underarm swelled; extreme fatigue; insomnia; body aches; joint pains; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 2 via an unspecified route of administration on 03Mar2021 as dose 2 single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunization on 09Feb2021. In Mar2021 the patient experienced underarm swelled, extreme fatigue, insomnia, body aches and joint pains. The patient stated that he already received both doses of the Pfizer Covid Vaccine and was experiencing long term side effects, he mentioned that his underarm swelled and that he's still experiencing extreme fatigue, insomnia, body aches and joint pains. He Wanted to know how long these will last and what was Pfizer doing about this. The patient stated that I can't believe that the FDA approved this. Also complained about Pfizer not saying that the side effects would last more than 24-48 hours. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: out of breath; This is a spontaneous report from a non-contactable consumer from a Pfizer Sponsored Program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date was not reported), via an unspecified route of administration on an unspecified date Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient was a little out of breath, said he was exercising on an unspecified date Mar2021, had 2nd dose of covid vaccine about 2 weeks ago and still having light symptoms from vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration
Clinical narrative: black and blue marks towards the pad of the finger/Her whole finger except for a little bit in the front is black and blue and moving to the next joint; formed a bruise on the pinky finger/her whole finger except for a little bit in the front is black and blue and moving to the next joint; This is a spontaneous report from a contactable nurse.  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 13:35 (Batch/Lot Number: EN6208) as dose 1, single (at the age of 64 years old) for COVID-19 immunisation.  Medical history included Left Hip Replacement from 23Feb2021 (she had a total hip replacement and she has been taking Aspirin 81mg twice a day), Breast Cancer with Lymph Node Removal; Right; she can't have anything in the right arm because she is a breast cancer survivor and had lymph nodes removed) and taken aspirin-started to prevent blood clots. Concomitant medications included acetylsalicylic acid (ASPIRIN 81) taken for anticoagulant/ started to prevent blood clots from 23Feb2021.  The patient experienced she had a strange reaction and she did not know if it is due to the Pfizer covid 19 vaccine. Last night (24Mar2021) at 8:30 pm she formed a bruise on the pinky finger on the side that she got the vaccine in. She had black and blue marks towards the pad of the finger. This morning, the purple went to the whole pad and throughout the day it has extended to the other side of her finger on the outside and moving down the inside of her finger below the nail, not underneath the fingernail, and across like it is trying to meet in the front. Stated that on the outside it has now covered the whole line, covering the entire pad and side of the finger and now on the top. Her whole finger except for a little bit in the front is black and blue and moving to the next joint. Patient wanted to know if this was due to the aspirin. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Blood pressure measurement, Hypertension
Clinical narrative: have asthma; high B/P; This is a spontaneous report from a contactable other HCP (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced high B/P and had asthma on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. The outcome of all the events was unknown.  No follow up attempts are possible. Information about lot or batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing
Clinical narrative: Redness or blush on left arm and hand up to elbow; Redness or blush on left arm and hand up to elbow; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of bnt162b2 (Pfizer COVID19 Vaccination, solution for injection, Batch/lot number: EN6207, Expiry date: 31Jul2021), via an unspecified route in the left arm on 21Mar2021 at 10:30 in the morning (age at vaccination: 83-year-old), as a single dose for covid-19 immunization. Medical history included AFib (atrial fibrillation) in 2018 ongoing, ongoing hypertension from long time ago and it has been 11 years since she smoked/ex-smoker ongoing. Patient has six medications she takes (not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 15:30, patient experienced redness or blush on left arm and hand up to elbow/ redness/pinkish was mostly on her hand and went up to wrist and a little up to the elbow. Today (22Mar2021) it is very slight but is still there. Adverse events did not result in emergency room or physician office visit. The clinical outcome of the events recovering/resolving.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: Lips are swollen; Itchy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Mar2021 the patient experienced lips are swollen, itchy. It was reported that, the patient administered the Pfizer-BioNTech COVID-19 Vaccine yesterday, 22Mar2021. They told her she can do her regular activities, so she went to work today; but her lips are swollen, and she was itchy. She did not know if this is an allergic reaction to the vaccine or what she should do regarding this event. The outcome of both the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Vaccination site pain, Weight
Clinical narrative: Slight pain on the site of injection; Lymph node might be little bit swollen and that's what I am experiencing right now; Lymph node under the arms where I got the vaccine, It was hurting; Feeling a like little feverish, I do not think I have a temperature; This is a spontaneous report from a contactable Consumer or other non-health professional (patient). A 51-years-old female patient received BNT162B2 (Batch/Lot Number: ER2613; Expiration Date: Jul2021, NDC number and UPC number were unknown), dose 1 via an unspecified route of administration, administered in Arm on 20Mar2021 (Age at vaccination 51 years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension Verbatim Blood pressure high from unknown start date and unknown start date. Concomitant medication(s) included amlodipine besilate (NORVASC) it's 5, omeprazole (OMEPRAZOLE) it's 40, cevimeline (CEVIMELINE) 30 mg start date and stop dates were not reported. The patient reported that I got the first COVID vaccine this past Saturday and I did not have really any feeling for anything on Saturday, but Sunday on 21Mar2021 the patient experienced slight pain on the site of injection (injection site pain) which was then cleared up but then I read on the sheet that I was given that, well the pain of the site, I do not have that pain anymore, lymph node might be little bit swollen and that's what I am experiencing right now; lymph node under the arms where i got the vaccine, it was hurting, the patient stated that I noticed that my lymph node under the arms where I got the vaccine, It was hurting, it's not hurting as much as it was, it seems like it starting to go down and I just feel, feeling a like little feverish, i do not think i have a temperature, But he was just calling to see you know like how long these symptoms should last 21Mar2021. The patient underwent lab tests and procedures which included weight: 199 lbs on I think I am at 199 (pounds). The outcome of the event slight pain on the site of injection and lymph node might be little bit swollen and that's what I am experiencing right now was recovering, while the outcome of the event feeling a like little feverish, I do not think I have a temperature was unknown  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: just got a little rash on my hand; 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 VACCINE, solution for injection; batch/lot number, NDC number, UPC number, expiry date was reported as unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first shot at job and experienced a side effect from the shot. Patient had little rash on hand. It was not all over the body. The patient was concerned and asked if it was going to go away. Consumer was informed about the role of Pfizer drug safety and Pfizer medical information. The patient might get the second shot. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Feeling abnormal
Clinical narrative: Start to getting 'twig' on the back of my throat; I thought like I had a full blow taste of flu; All the symptoms of the flu and what you guys got down on that paper for COVID symptoms, but I know I don't have COVID; Headache; Muscle pain; Chills; swelling at injection site; Nauseated; Coughing; Sore throat; I just didn't feel right; I had injection at the pain site; Sore arm; Aching joints/Joint pain; Tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) via an unspecified route of administration, administered in left arm on 11Mar2021 (Batch/Lot Number: EN6207) (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. Medical history included thyroid, macular degeneration and patient had a hearing problem from an unknown date and it is ongoing. Concomitant medication(s) included paracetamol (TYLENOL); levothyroxine sodium (L-THYROXINE [LEVOTHYROXINE SODIUM]); ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) taken for macular degeneration prescribed by eye doctor, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid prescribed by his family doctor because of his thyroid is out of way, start and stop date were not reported. The symptoms started on 11March2021. On 11Mar2021, the patient experienced sore arm and achy joints and he was tired, reporter stated he had injection at the pain site, he was tired, he had headache, did have muscle pain but he does not know, chills, joint pain, he had swelling at the injection site, it was times that he was nauseated, he just didn't feel right, he had cough, sore throat. 3 days after injection, on 14Mar2021, he started to getting 'twig' on the back of his throat and by that night which was Sunday (on 14Mar2021) night he thought like he had a full blow taste of flu, that he have it till today but not quite as bad. All the symptoms of the flu but he knew he didn't have COVID. Patient was asked was it possible for him to had a reaction to that shot. Patient was due for his second shot on 02April2021 and enquired if he should get that shot. The outcome of the events tired, headache and cough was not recovered and for the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Oropharyngeal discomfort
Clinical narrative: Start to getting 'twig' on the back of my throat; I thought like I had a full blow taste of flu; All the symptoms of the flu and what you guys got down on that paper for COVID symptoms, but I know I don't have COVID; Headache; Muscle pain; Chills; swelling at injection site; Nauseated; Coughing; Sore throat; I just didn't feel right; I had injection at the pain site; Sore arm; Aching joints/Joint pain; Tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) via an unspecified route of administration, administered in left arm on 11Mar2021 (Batch/Lot Number: EN6207) (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. Medical history included thyroid, macular degeneration and patient had a hearing problem from an unknown date and it is ongoing. Concomitant medication(s) included paracetamol (TYLENOL); levothyroxine sodium (L-THYROXINE [LEVOTHYROXINE SODIUM]); ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) taken for macular degeneration prescribed by eye doctor, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid prescribed by his family doctor because of his thyroid is out of way, start and stop date were not reported. The symptoms started on 11March2021. On 11Mar2021, the patient experienced sore arm and achy joints and he was tired, reporter stated he had injection at the pain site, he was tired, he had headache, did have muscle pain but he does not know, chills, joint pain, he had swelling at the injection site, it was times that he was nauseated, he just didn't feel right, he had cough, sore throat. 3 days after injection, on 14Mar2021, he started to getting 'twig' on the back of his throat and by that night which was Sunday (on 14Mar2021) night he thought like he had a full blow taste of flu, that he have it till today but not quite as bad. All the symptoms of the flu but he knew he didn't have COVID. Patient was asked was it possible for him to had a reaction to that shot. Patient was due for his second shot on 02April2021 and enquired if he should get that shot. The outcome of the events tired, headache and cough was not recovered and for the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Vaccination site pain, Vaccination site swelling
Clinical narrative: Start to getting 'twig' on the back of my throat; I thought like I had a full blow taste of flu; All the symptoms of the flu and what you guys got down on that paper for COVID symptoms, but I know I don't have COVID; Headache; Muscle pain; Chills; swelling at injection site; Nauseated; Coughing; Sore throat; I just didn't feel right; I had injection at the pain site; Sore arm; Aching joints/Joint pain; Tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) via an unspecified route of administration, administered in left arm on 11Mar2021 (Batch/Lot Number: EN6207) (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. Medical history included thyroid, macular degeneration and patient had a hearing problem from an unknown date and it is ongoing. Concomitant medication(s) included paracetamol (TYLENOL); levothyroxine sodium (L-THYROXINE [LEVOTHYROXINE SODIUM]); ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) taken for macular degeneration prescribed by eye doctor, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid prescribed by his family doctor because of his thyroid is out of way, start and stop date were not reported. The symptoms started on 11March2021. On 11Mar2021, the patient experienced sore arm and achy joints and he was tired, reporter stated he had injection at the pain site, he was tired, he had headache, did have muscle pain but he does not know, chills, joint pain, he had swelling at the injection site, it was times that he was nauseated, he just didn't feel right, he had cough, sore throat. 3 days after injection, on 14Mar2021, he started to getting 'twig' on the back of his throat and by that night which was Sunday (on 14Mar2021) night he thought like he had a full blow taste of flu, that he have it till today but not quite as bad. All the symptoms of the flu but he knew he didn't have COVID. Patient was asked was it possible for him to had a reaction to that shot. Patient was due for his second shot on 02April2021 and enquired if he should get that shot. The outcome of the events tired, headache and cough was not recovered and for the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Pyrexia
Clinical narrative: Discomfort on the right arm; fever; chill; This is a spontaneous report reported by a consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported, via an unspecified route of administration, on 16Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had first shot 16Mar and was scheduled to take second shot on 08Apr. On an unspecified date, the patient experienced discomfort on the right arm. She was also experiencing fever and chill. The patient wanted to know if she needed to take second shot. Outcome of the event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Swelling face
Clinical narrative: Pain in arm; Stiffness in arm; swollen fingers/ swollen hands; puffy face; This is a spontaneous report received from a contactable consumer (patient). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on 22Mar2021 at 15:20 (at the age of 79-years-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, on an unspecified date in 2021, the patient experienced pain in arm, stiffness in arm, swollen fingers, swollen hand, puffy face. The consumer stated that, yesterday, on 22Mar2021, she went to get the first dose of the Pfizer vaccine around 03:20pm and when she got home there was no problem. Stated that, she went to bed at 11pm and woke up at 02:30am with pain in her arm, it was stiff and swollen. Stated that, her hand was swollen, fingers were swollen and her face was a little puffy. Stated that, initially she had swelling in her arm but clarified that, she had pain in her arm and not swelling. Only her hand, fingers and face were swollen and puffy. Stated that, she was scared to take the second shot and enquired, whether that was a normal reaction. The swelling lasted for 4 hours and now it was normal. At 06:30 am, she was already normal. Stated that, the pain was no problem. The swelling scared her. This was on her left side. Stated that, everybody that she heard of had something. Stated that, she knows everyone had a reaction or small problem with stiffness. No other details were provided. Stated that, her son said maybe she should not take the second dose and to call and inquire about this. She asked whether the second dose was safe and if she can take it or not. Stated that, she asked whether that would be safe. Stated that, she can deal with the puffiness. Everybody had issues in their arms, it was like having Covid. Stated that, she only called to ask whether it was normal and safe to take. The outcome of the events for swollen fingers/ swollen hands was recovered on an unspecified date in 2021 while for the other events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.  No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: I broke with itchy rash all over my body; then another patch on my arm that actually black; I broke with itchy rash all over my body; then another patch on my arm that actually black; I had rash, red spot, or other rash all over my body; it's most severe on my right arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, on 26Feb2021 (age at vaccination was 68 years), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she like to report the side effect of Covid-19 vaccination. On an unspecified date, the patient broke with itchy rash all over my body, then another patch on her arm that actually black. When paraphrased the above concern, the patient stated that she had rash, red spot, or other rash all over my body and it's most severe on her right arm. Reportedly the patient was still little itchy. The patient received treatment with Lotrimin for events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: the very next day and I am still little itchy; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number: EN6198) via an unspecified route of administration on 20Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number: EN6198) via an unspecified route of administration on 26Feb2021 (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation and experienced itchy rash all over her body and then another patch on her arm that actually black, patient had rash, red spot, or other rash all over her body and it was most severe on her right arm. On 21Mar2021, after second shot, the very next day, patient was still little itchy, the patch on her right arm appears to be getting better, that was improving. Patient's husband had some Lotrimin [corrective treatment], patient put that on there and that helps it. The outcome of event was recovering.  No follow-up attempts are possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Influenza, Malaise, Rhinorrhoea
Clinical narrative: Feeling sick; Runny nose; Itchy eyes; feels like she has the flu; This is a spontaneous report from a non-contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Not reported; Expiration date: Not reported) via an unspecified route of administration, administered on 25Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Mar2021, the patient experienced feeling sick, runny nose, itchy eyes, feels like she has the flu. The patient is calling about the Pfizer covid vaccine. The patient got the first dose of the vaccination at (Facility name) in (name) on 25Feb2021. Today the patient is supposed to get the second shot but she woke up feeling sick, has a runny nose, itchy eyes and feels like she has the flu. This actually started yesterday. The patient wants to know if she should get her second dose of the vaccine at 2:00pm as scheduled. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the opposite side arm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a rash on the opposite side arm after receiving the COVID vaccine first dose on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: she had a 99.9 degree fever; she felt really cruddy today; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Formulation: solution for injection, Batch/Lot number: not reported and Expiry date: Unknown) via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Mar2021, the patient experienced she felt really cruddy today, and she had a 99.9 degree fever so she didn't feel really good. She said she was going to celebrate her grandson's second birthday on 26Feb2021. She said she read the pamphlets for the Pfizer COVID-19 Vaccine, but the pamphlets didn't say anything about if she would be contagious after getting the COVID-19 Vaccine. She said she didn't want to expose her 2-year-old grandson, if she was. On an unspecific date the patient underwent lab tests and procedures which included body temperature: 99.9-degree. The outcome of the events was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Feeling abnormal, Nausea
Clinical narrative: night sweats; nausea; body aches; chills; sleepiness; severe with slight fever; shakiness; brain fog; weakness; loss of weight; anxiety; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number -not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE (at 76-years age) for covid-19 immunisation. Medical history included celiacs, RA (rheumatoid arthritis), anemia, osteo-sarthritis, allergies all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), fluticasone (FLUTICASONE), lamotrigine (LAMOTRIGINE), leflunomide (LEFLUNOMIDE) all were taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number-unknown) via unspecified route of administration time in Left arm on 21Feb2021 at 06: 45 pm as DOSE 1, SINGLE for covid-19 immunization. The patient received vaccine at hospital. The patient not diagnosed with covid-19 prior to vaccination and did not tested post vaccination. The patient did not receive other vaccine in four weeks. The patient experienced night sweats, nausea, body aches, chills, sleepiness. for around 2 days after with lingering symptoms for a few days second shot, same reactions only more severe with slight fever and shakiness, have something like a brain fog, weakness, loss of weight, still experiencing symptoms but not as severe with anxiety and weakness on 23Feb2021 02:30 PM. The patient did not received treatment for all events. The outcome of all events was resolving.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pyrexia, Somnolence, Tremor
Clinical narrative: night sweats; nausea; body aches; chills; sleepiness; severe with slight fever; shakiness; brain fog; weakness; loss of weight; anxiety; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number -not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE (at 76-years age) for covid-19 immunisation. Medical history included celiacs, RA (rheumatoid arthritis), anemia, osteo-sarthritis, allergies all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), fluticasone (FLUTICASONE), lamotrigine (LAMOTRIGINE), leflunomide (LEFLUNOMIDE) all were taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number-unknown) via unspecified route of administration time in Left arm on 21Feb2021 at 06: 45 pm as DOSE 1, SINGLE for covid-19 immunization. The patient received vaccine at hospital. The patient not diagnosed with covid-19 prior to vaccination and did not tested post vaccination. The patient did not receive other vaccine in four weeks. The patient experienced night sweats, nausea, body aches, chills, sleepiness. for around 2 days after with lingering symptoms for a few days second shot, same reactions only more severe with slight fever and shakiness, have something like a brain fog, weakness, loss of weight, still experiencing symptoms but not as severe with anxiety and weakness on 23Feb2021 02:30 PM. The patient did not received treatment for all events. The outcome of all events was resolving.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.