chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Head was hurting; Temperature was 101.4; This is a spontaneous report from a contactable consumer. A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0185) via an unspecified route of administration, administered in right arm on 04Jun2021 (age at vaccination: 15 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any prior vaccinations. On 05Jun2021, the patient experienced head was hurting, and temperature was 101.4. The patient was given paracetamol (TYLENOL) 500mg (1 pill) for headache. Reporter stated just gave him the pill a minute ago before calling, so it was not going to work that fast. It was reported that, the patient was scheduled in 26th for the second shot. Therapeutic measures were taken as a result of adverse events. The outcome of the events was not recovered.   Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Had a cold after first vaccine/ Reports a cold and took antibiotics, after the first vaccine; This is spontaneous report from contactable consumer (mother) reported for her daughter via medical information team.  A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Consumer stated that her daughter has a cold, later reclarified as a common cold and had tested negative, later reclarified as tested negative for Covid. Consumer said that her daughter's doctor had started her on an antibiotic and last dose was finished today (on reported date). Consumer stated that she was also due for her second dose of vaccine today (on reported date) and wants to know whether it is alright for her to get the second vaccine. Consumer was with her daughter, was waiting to be called, to get the vaccine and clarified that her daughter's antibiotic was a Z-Pak. Consumer stated that her daughter did not get a cold until weeks after the first vaccine. Patient underwent lab test included SARS-CoV-2 test with result: Negative on an unknown date. The event was considered as non-serious by the reporter. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood thyroid stimulating hormone, Mobility decreased, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Right on 13 May 2021 (at the age of 41-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing blood pressure high and diabetes, asthma and vertigo from an unknown date and unknown if ongoing. Concomitant medication included amlodipine taken for blood pressure high from an unspecified start date and ongoing; metformin taken for diabetes from an unspecified start date and ongoing; atenolol taken for an unspecified indication, start and stop date were not reported; olmesartan taken for blood pressure, start and stop date were not reported; cinnarizine taken for vertigo, start and stop date were not reported; diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to Covid vaccine. Facility where the COVID-19 vaccine was administered was Hospital. Patient stated, first time she didn't take anything she just took TYLENOL but her arm swell up the same day on 13May2021 and she couldn't move my arm for 2 days, it was stiff she couldn't move my hand. she put some heating pad and ice pad like stuff on it and about on the third day it started to get better but then 2 days after that she woke up swollen and she couldn't move on an unspecified date in May 2021. This was freaking me out. Under my arm and all the way down she don't think it should swell up like that and it is on whole body on an unspecified date in May 2021. Patient stated, she took TYLENOL for relief joint discomfort and inflammation on an unspecified date in 2021. The patient underwent lab tests and procedures which included TSH test: unknown results on 22Apr2021. There was investigation assessment reported. Therapeutic measures were taken as a result swollen arm, mobility decreased, limbs stiffness, joint discomfort and inflammation. The outcome of events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Right on 13 May 2021 (at the age of 41-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing blood pressure high and diabetes, asthma and vertigo from an unknown date and unknown if ongoing. Concomitant medication included amlodipine taken for blood pressure high from an unspecified start date and ongoing; metformin taken for diabetes from an unspecified start date and ongoing; atenolol taken for an unspecified indication, start and stop date were not reported; olmesartan taken for blood pressure, start and stop date were not reported; cinnarizine taken for vertigo, start and stop date were not reported; diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to Covid vaccine. Facility where the COVID-19 vaccine was administered was Hospital. Patient stated, first time she didn't take anything she just took TYLENOL but her arm swell up the same day on 13May2021 and she couldn't move my arm for 2 days, it was stiff she couldn't move my hand. she put some heating pad and ice pad like stuff on it and about on the third day it started to get better but then 2 days after that she woke up swollen and she couldn't move on an unspecified date in May 2021. This was freaking me out. Under my arm and all the way down she don't think it should swell up like that and it is on whole body on an unspecified date in May 2021. Patient stated, she took TYLENOL for relief joint discomfort and inflammation on an unspecified date in 2021. The patient underwent lab tests and procedures which included TSH test: unknown results on 22Apr2021. There was investigation assessment reported. Therapeutic measures were taken as a result swollen arm, mobility decreased, limbs stiffness, joint discomfort and inflammation. The outcome of events was unknown.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest pain, Pyrexia, Sinus congestion
Clinical narrative: Woke up with chest pain; He said his upper back was aching; temperature of 100 degree; Sinus pain; Sinus pain and Congestion; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine; Solution for injection; Batch/Lot Number: EW0185) intramuscular, administered in Arm Right on 04Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot Number: EW0182) on right upper arm on 14May2021 for covid-19 immunisation. The patient reported, had his 2nd vaccine on Friday 2 days ago yesterday he just had congestion, today on 06Jun2021, he woke up with chest pain and he said his upper back was aching and he has chest pain. He is also having temperature of 100 degree, so Tylenol was given. Sinus congestion and pain was yesterday on 05Jun2021. He does not have congestion today. Yesterday for sinus pain and congestion, the patient was given Sudafed 1 tablet. It is an over-the-counter medicine, 30 milligrams 1 tablet. A history of sinus was reported for about everybody in his family got sinus one time in life. The outcome for the events sinus congestion and pain was recovered on 06Jun2021. Outcome for the events chest pain, upper back was aching and having temperature of 100 degree was unknown.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Woke up with chest pain; He said his upper back was aching; temperature of 100 degree; Sinus pain; Sinus pain and Congestion; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine; Solution for injection; Batch/Lot Number: EW0185) intramuscular, administered in Arm Right on 04Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot Number: EW0182) on right upper arm on 14May2021 for covid-19 immunisation. The patient reported, had his 2nd vaccine on Friday 2 days ago yesterday he just had congestion, today on 06Jun2021, he woke up with chest pain and he said his upper back was aching and he has chest pain. He is also having temperature of 100 degree, so Tylenol was given. Sinus congestion and pain was yesterday on 05Jun2021. He does not have congestion today. Yesterday for sinus pain and congestion, the patient was given Sudafed 1 tablet. It is an over-the-counter medicine, 30 milligrams 1 tablet. A history of sinus was reported for about everybody in his family got sinus one time in life. The outcome for the events sinus congestion and pain was recovered on 06Jun2021. Outcome for the events chest pain, upper back was aching and having temperature of 100 degree was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: I feel very bad; all my body hurts; Fever; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (Pfizer COVID 19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient got COVID shot yesterday (05Jun2021), but today (06Jun2021), the patient felt very bad and stated that, "all my body hurts and I have a fever". The outcome of events was reported as unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: experienced anaphylaxis after receiving the second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, patient received first dose PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unknown date, the patient reported that as someone who experienced anaphylaxis after receiving the second dose of your COVID vaccine, she was wondering whether Pfizer was attempting to modify future RNA vaccines, in particular the booster, so that they were less likely to cause allergic reactions. She hoped she will not need to forego the benefits of this wonderful new technology in the future and said thank you very much. The outcome for was unknown.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash macular
Clinical narrative: I got some red, blotchiness in different pars of my left forearm and left hand; They are anywhere quarter by quarter squares to pinpoint sized red dots; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration Mar2021 at 1st dose, single dose for COVID-19 immunization and second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 01Apr2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he experienced some red, blotchiness in different parts of his left forearm and left hand and they are anywhere quarter by quarter squares to pinpoint sized red dots on an unspecified date. The patient stated that when he went to doctor he said it is from burst capillaries. But he didn't know what the cause of it was. The only thing they were coming up with is that is the arm he got the vaccine in. He had received both doses. Second dose was April 1st and the first dose was 3 weeks before that. The patient was still experiencing it. Some have faded away. But more have showed up. He noticed it about 2 1/2 weeks after his vaccine. His doctor kept him on prednisolone treatment. Therapeutic measures were taken as a result of event which included prednisone and that helped stop it a little bit and was concerning because if this is reaction he may be hard pressed to get a booster. The patient stated "I don't like what's going on because I don't know what's going on. If the CDC says I should get one every year, I wouldn't want to get a Pfizer because I don't know if that's what caused that. This is a little un-nerving because I was all in favor of these vaccines, but now I don't know. Is the reaction on my left arm connected to the vaccine?". The outcome of the events was reported as resolving.  Information about batch no/lot no has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Throat tightness
Clinical narrative: Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 28Feb2021 18:00 as single dose for COVID-19 immunization. Medical history included reaction to flu shot many years ago and known allergies from clams. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); lisinopril; amitriptyline hydrochloride (AMITRIPTYLIN); rosuvastatin. No COVID prior to vaccination. The patient had not been tested for COVID post vaccination. On 28Feb2021 18:15, the patient experienced within 20 minutes my throat felt tight and he had trouble swallowing, his voice sounded froggy. The patient visited the emergency room/department or urgent care for the events. Treatment medications included Epipen, Benadryl and steroids. Outcome of the events were reported as recovered with sequel.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haematoma
Clinical narrative: developed 'bumps' that are big like mosquito bites; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left arm really swollen; left arm really swollen and irritated; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0182), via an unspecified route of administration in Arm Right on 03Jun2021 (age at vaccination 44years old) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus diagnosed from 20 years ago. The patient's concomitant medications were not reported. She received her first dose of the Pfizer Biontech Covid 19 vaccine on 03Jun2021 in right arm/shoulder. On 05Jun2021, she started have problems with opposite side; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection) and then she noticed the 'bumps'. Not only bumps but also itching and left arm really swollen and irritated. So to clarify, on the left side, she has 8 bumps on arm and elbow and one on her index finger. On her right side, she has one bump on right index finger and one on right arm (that was just noticed today). The area is Irritated, and she has tried cortisone, alcohol, hair dryer, but nothing is working. She took Benadryl last night and it helped her to get some sleep. The bumps are getting worse; they are not as swollen today, compared to yesterday. This was about mid-night on 05Jun2021. she has these little bumps, some are really big bumps, kind of like mosquito bites. there is no bite puncture, the bumps are hard and itchy. It is the same reaction she gets to a mosquito bite. she knows everybody is different. The bumps are hard and risen and hot to the touch and just itchy. her whole arm where the bumps are just itches. the bumps are on both hands, especially worse is on the left hand. The outcome of the events was unknown. Therapeutic measures were taken as a result of developed 'bumps' that are big like mosquito bites, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left arm really swollen, left arm really swollen and irritated.  Follow-up (07Jun2021): This is a follow-up spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported that: Report Type, HCP postal address, Dates for Reading through side effects and is getting, has like these bumps, Suspect product information, Other Products, Patient History.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Adverse event, Constipation, Diarrhoea, Headache
Clinical narrative: My arm is itchy (started after the 2nd dose a week later).; For my 2nd dose I had every single side effect listed; Constipation; For my period this was amazing. First time every I had zero cramps; Instead of cramps I got headache which normally doesn't happen for me; my period was affected.; bloating; diarrhea; Nausea; This is a spontaneous report from a non-contactable consumer (patient) via company representative. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), 2nd dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included eczema, other period symptoms bloating, diarrhea and nausea, birth control and cramps (when the patient was on birth control). The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, the patient experienced "My arm is itchy (started after the 2nd dose a week later)" and "my period was affected". She mentioned that "for my 2nd dose I had every single side effect listed", even constipation (which was not on the list). Her arm was still itchy and she was definitely worried. She don't need that on her arm since she already deals with eczema. She further stated that "for my period this vaccine was amazing, first time every I had zero cramps" and that happened only when she was on birth control in the past. All her other period symptoms were there which included bloating, diarrhea and nausea. "Instead of cramps I got headache which normally doesn't happen for me". She did not report this to her health care professional. The outcome of the event pruritus was not resolved and was unknown for rest all other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Nausea, Pruritus, Therapeutic response unexpected
Clinical narrative: My arm is itchy (started after the 2nd dose a week later).; For my 2nd dose I had every single side effect listed; Constipation; For my period this was amazing. First time every I had zero cramps; Instead of cramps I got headache which normally doesn't happen for me; my period was affected.; bloating; diarrhea; Nausea; This is a spontaneous report from a non-contactable consumer (patient) via company representative. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), 2nd dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included eczema, other period symptoms bloating, diarrhea and nausea, birth control and cramps (when the patient was on birth control). The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, the patient experienced "My arm is itchy (started after the 2nd dose a week later)" and "my period was affected". She mentioned that "for my 2nd dose I had every single side effect listed", even constipation (which was not on the list). Her arm was still itchy and she was definitely worried. She don't need that on her arm since she already deals with eczema. She further stated that "for my period this vaccine was amazing, first time every I had zero cramps" and that happened only when she was on birth control in the past. All her other period symptoms were there which included bloating, diarrhea and nausea. "Instead of cramps I got headache which normally doesn't happen for me". She did not report this to her health care professional. The outcome of the event pruritus was not resolved and was unknown for rest all other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: side effects in my arm around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 41-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 08May2021 as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced still having side effects in his arm around the injection site. The outcome of the event was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness in the left arm; Soreness in the left arm; This is a spontaneous report received from a contactable consumer. A  female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EP7533, Pfizer NTEC), via an unspecified route of administration in Arm Left on 17May2021 at 10:00 (age at vaccination was 54) as 1st dose, single dose for covid-19 immunisation. Medical history included and concomitant medications were not reported. The patient previously took metoprolol 50mg twice a day has been taking this medication for about 5 years for hypertension. After 1st dose of the vaccine she has been experienced redness and soreness in her arm has been persisting since the day she got her first vaccine, on 17May2021. She was not allowed to get the 2nd dose today 07June2021 due to she still have redness and soreness in the left arm and asked to secure medical clearance in order for her to get the 2nd dose she was just waiting for her primary care doctor's response she wants to know what will happen if she was not able to get the 2nd dose on time she will be in Hawaii in 2 weeks time. Caller states that she was calling about the Covid 19 Vaccine. Stated they told her to call and report this. Caller states that she called her primary care provider. Said that she needs to get her vaccines because she was traveling soon and needs them for that. And patient said she tried to fill out the report online but had issues with the website not letting her press the enter button. Caller states she went to the emergency room this past Friday due to the pain in her left arm being worse that day. She was not admitted to the hospital. The outcome of the events was reported as not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm started to hurt; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 01Jun2021 as 1st dose,0.3 ml single dose for COVID-19 immunization. Medical history included lipoma from an unknown date and unknown if ongoing she has a lipoma in that arm since it doesn't bother her. The patient's concomitant medications were not reported. On an unspecified date the She thought of it later that day when her arm started to hurt and she rubbed it. So know she was not sure if the vaccine was injected into the muscle or her lipoma. She should like to know if she should get another shot or just oto continue with the series as planned. Response received as Read from PI LAB-# Revised: 19May2021. The outcome of even was unknown.  Information about batch/ lot number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: He said he had just started having muscle pain in his leg; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: ER8729; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 09Apr2021 (at the age of 36-years-old) 09:30 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient had no medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 19Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient had no prior vaccinations (within 4 weeks). No additional administered Vaccines. On 04Jun2021, the patient experienced muscle pain in leg. Patient stated that he wanted to know if this was still associated with the vaccine and heard of people who had side effects 1 week or just 24 hours after receiving the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if there had been reports of people having side effects almost 2 months after receiving the vaccine and had tried to find out if the side effect he was having from the Pfizer vaccine. He has a primary care doctor but declined to provide HCP information and he just put ice on it. Patient had not visited emergency room and physician office. The patient had no relevant tests. The outcome of event was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: received both covid vaccines and has fatigue; This is a spontaneous report from a sponsored program. A contactable Consumer reported. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose, dose 1 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received both COVID vaccines and had fatigue and wants to know if it was a side effect of vaccine. The outcome of event was unknown.  Follow up attempts needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Hypoaesthesia, Pain in extremity
Clinical narrative: numbness; Pain in the arm; Bloating; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unspecified) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she took her first shot of the vaccine and experienced a lot of side effects such as pain in the arm, numbness, and bloating on an unspecified date. The clinical outcome for the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat with a runny nose; Sore throat with a runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A female patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had sore throat with a runny nose and wanted to know if Tylenol can be taken or if it would interfere with the efficacy of the vaccine. She asked if she could take Tylenol or allergy pills for her symptoms, after the vaccine. The outcome for the events was reported as unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: sore for about a month and a half; shoulder is hurting really bad; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 80-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) as single dose on unspecified date for COVID-19 Immunization. The patient experienced sore for about a month and a half and shoulder was hurting really bad on an unspecified date. Caller (male, 80 years old) reported getting a second dose of PFIZER-BIONTECH COVID-19 VACCINE almost 3 months ago, stated, it was sore for about a month and a half, now hurting bad upon further clarification the shoulder was hurting bad. Looking for information about it. The outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood iron decreased, Blood test, Enzyme level test, Feeling cold
Clinical narrative: hot; chilled; liver enzymes were elevated; iron levels very low; stomach pain; irritation in her throat; This is a spontaneous report from a contactable consumer or other non HCP (patient herself). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25May2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received the first dose of Pfizer's COVID vaccine on 25May2021. She began to have some stomach pain the next day and irritation in her throat (on 26May2021). About a week later on (Wednesday) 02Jun2021, she had very bad stomach pain. She was hot, then very chilled, and she went to her doctor the next day and to the ER the day after. She had some blood work done and ultrasound, and the imaging came back normal. But her liver enzymes were elevated and iron levels very low. Only the tests and the pain indicated that something was wrong. She was asking has anything like this been reported before and was it safe for her to receive the 2nd covid vaccine. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hepatic enzyme abnormal, Throat irritation, Ultrasound scan
Clinical narrative: hot; chilled; liver enzymes were elevated; iron levels very low; stomach pain; irritation in her throat; This is a spontaneous report from a contactable consumer or other non HCP (patient herself). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25May2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received the first dose of Pfizer's COVID vaccine on 25May2021. She began to have some stomach pain the next day and irritation in her throat (on 26May2021). About a week later on (Wednesday) 02Jun2021, she had very bad stomach pain. She was hot, then very chilled, and she went to her doctor the next day and to the ER the day after. She had some blood work done and ultrasound, and the imaging came back normal. But her liver enzymes were elevated and iron levels very low. Only the tests and the pain indicated that something was wrong. She was asking has anything like this been reported before and was it safe for her to receive the 2nd covid vaccine. The outcome of the events was unknown.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pain, Paranasal sinus hypersecretion
Clinical narrative: I am having a very bad cough; My sinus are uncontrolled and running all over the place; the cough is so bad my left side is really hurting bad almost like I got fight  somebody had big time punch me; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0183 and Expiration date: unknown), dose 1 via intramuscular route, in left arm on 25May2021 at 08:15 as single dose for covid-19 immunisation. Medical history included High blood pressure and ongoing diabetes. The patient's concomitant medication included insulin. After first shot of vaccination, the patient experienced a very bad cough and sinus are uncontrolled and running all over the place, the cough was so bad that patient's left side was really hurting bad almost like got fight somebody and had big time punch. Patient had some lab work done about two three, three four weeks ago, don't know the test name. No treatment received other than, over the counter cough syrup (Robitussin). Outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: bumping on the day after; flared up and was red, bumpy and itchy; flared up and was red, bumpy and itchy; as hives that are covering her entire belly, under her breasts, on her arms and some spots on her legs and it is going to the sides of her abdomen under the armpits was mostly her upper body.; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 19May2021 as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient stated that she had the second dose of the Pfizer covid 19 vaccine on 19May2021. Patient stated that she started bumping on the day after (20May2021) then it flared up and was red, bumpy and itchy. Caller described it as hives that are covering her entire belly, under her breasts, on her arms and some spots on her legs. Caller stated it is going to the sides of her abdomen under the armpits Patient stated it was mostly her upper body. Patient sated it did not cover her face. Patient stated she called out of work on 27May2021, 28May2021 and 30May2021 because the benadryl made her sleep Caller stated she had been taking benadryl and using eucerin since 20May2021. Caller stated this is helping some. Patient stated yesterday it flared up again. Patient stated she took two benadryl last night so she could sleep. Patient wanted to know when it should clear up. Patient wanted to report AE.  The outcome of the events was unknown.   Information about the Lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint swelling, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: She reported having injection site swelling; the second shot hurt her; her arm was swore 2-3 days/arm a little sore after second shot; and was tired after; right hand swollen/Her index finger on the left hand is swollen back to the palm; right ankle swollen/swollen down to her wrist; thumb swollen and stiff; left index finger swollen/thumb swollen/her middle finger swelled; This is a spontaneous report from a contactable consumer or other non healthcare professional. An 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 30Apr2021 at 15:00 (Batch/Lot Number: ER8735) (at the age of 84 years) as 2nd dose, single dose for COVID-19 immunization. Medical history included arthritis, patient's mother had arthritis but she had it much younger than patient's age. Concomitant medication(s) included ubidecarenone (COQ 10) 100mg, once a day for health reasons and ongoing, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg, once a day for heart and ongoing, losartan (LOSARTAN) for cardiac disorder and ongoing (Had been taking over 10 years), carvedilol (CARVEDILOL) for cardiac disorder and ongoing (Had been taking over 10 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm 02Apr2021 (at the age of 84 years) as single dose for COVID-19 immunization. On 14May2021, patient experienced, left index finger swollen/thumb swollen/middle finger swelled. She went to the doctor on 14May2021, when she showed the doctor her finger they said it could possibly be arthritis. On an unspecified date, patient experienced injection site swelling, the second shot hurt her, her arm was sore 2-3 days/arm a little sore after second shot, was tired after, right hand swollen/her index finger on the left hand is swollen back to the palm, patient had to take her rings off, it hadn't gotten as bad as the index finger but it was swollen, it was not as stiff to bend as the index finger, it was hard to bend and was stiff when she got up right ankle swollen/ swollen down to her wrist, thumb swollen and stiff. She thought that the doctor said to take Tylenol as treatment, but she didn't care for Tylenol, so she didn't take anything. The outcome of the left index finger swollen/thumb swollen/middle finger swelled was not recovered while for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: She reported having injection site swelling; the second shot hurt her; her arm was swore 2-3 days/arm a little sore after second shot; and was tired after; right hand swollen/Her index finger on the left hand is swollen back to the palm; right ankle swollen/swollen down to her wrist; thumb swollen and stiff; left index finger swollen/thumb swollen/her middle finger swelled; This is a spontaneous report from a contactable consumer or other non healthcare professional. An 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 30Apr2021 at 15:00 (Batch/Lot Number: ER8735) (at the age of 84 years) as 2nd dose, single dose for COVID-19 immunization. Medical history included arthritis, patient's mother had arthritis but she had it much younger than patient's age. Concomitant medication(s) included ubidecarenone (COQ 10) 100mg, once a day for health reasons and ongoing, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg, once a day for heart and ongoing, losartan (LOSARTAN) for cardiac disorder and ongoing (Had been taking over 10 years), carvedilol (CARVEDILOL) for cardiac disorder and ongoing (Had been taking over 10 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm 02Apr2021 (at the age of 84 years) as single dose for COVID-19 immunization. On 14May2021, patient experienced, left index finger swollen/thumb swollen/middle finger swelled. She went to the doctor on 14May2021, when she showed the doctor her finger they said it could possibly be arthritis. On an unspecified date, patient experienced injection site swelling, the second shot hurt her, her arm was sore 2-3 days/arm a little sore after second shot, was tired after, right hand swollen/her index finger on the left hand is swollen back to the palm, patient had to take her rings off, it hadn't gotten as bad as the index finger but it was swollen, it was not as stiff to bend as the index finger, it was hard to bend and was stiff when she got up right ankle swollen/ swollen down to her wrist, thumb swollen and stiff. She thought that the doctor said to take Tylenol as treatment, but she didn't care for Tylenol, so she didn't take anything. The outcome of the left index finger swollen/thumb swollen/middle finger swelled was not recovered while for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient's wife) reported for husband. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 31May2021 as 2nd dose, single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 10May2021 as 1st dose, single dose for COVID-19 immunisation. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced diarrhea. Although reporter knew that diarrhea was a part of side effects of vaccine and she was wondering how long it can, how long he can experience this one. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Mobility decreased, Vaccination site atrophy, Vaccination site pain
Clinical narrative: Arm is locking up; Can't elevate past a certain degree; Lost mobility on the same arm where she got the vaccine.; Achiness and discomfort where she cant sleep on her arm; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via an unspecified route of administration on 04Feb2021, as 1st dose, single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included paracetamol (TYLENOL). On an unspecified date in Feb2021, the patient's arm was locking up, could not elevate past a certain degree, lost mobility on the same arm where she got the vaccine, achiness and discomfort where she can't sleep on her arm. Treatment medication included application of ice pack on the affected area. Physician suggested a physical therapy which patient did not agreed to perform. Patient did not receive second dose, which was reported as off-label timing. The clinical outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (Reporter's Grandson). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) for COVID-19 immunization.The patient experienced headache on an unspecified date after the last vaccination (might be after third day of vaccination). The outcome of event was unknown.  Information on the lot/batch number has been requested.