chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: First and Second dose: sore arm; She's not sleeping well at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 07:00 (Lot number: EL9269) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sleeping trouble" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "First and Second dose: sore arm"; INSOMNIA (non-serious), outcome "not recovered", described as "She's not sleeping well at all". The events "first and second dose: sore arm" and "she's not sleeping well at all" were evaluated at the physician office visit.  Additional information:  No other vaccines administered on same date with the Pfizer vaccine considered as suspect. No Emergency Room and Physician Office routine visit with HCP. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations with no Relevant Tests. Patient had to put ice on her arm to help as she had to work and she's sure working didn't help her arm. Patient thinks her arm was sore for about 3 days after both Covid 19 vaccines.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test
Clinical narrative: Dizziness; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 15:00 (Lot number: EN6207) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "rheumatoid disease" (unspecified if ongoing); "vitaligo" (unspecified if ongoing), notes: too many to fit here; "Known allergies: Yes" (unspecified if ongoing), notes: allergic to many, many things. Concomitant medication(s) included: ACETAMINOPHEN; COENZYME Q10 [UBIDECARENONE]; CALCIUM. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, nausea.  Additional information: No Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Pain in extremity, Weight
Clinical narrative: Dizzy; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: ER8730) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetic. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 07Apr2021, outcome "unknown", described as "Dizzy"; PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter reported that, the patient was dizzy and had a sore arm.  Reporter suggested patient to take one Tylenol. No further details provided about whether her husband took a Tylenol or not. Reported stated that, the patient was diabetic, which he was under control. The reporter stated the patient had a medication prescribed to him for his diabetes, but no new medicines. The reporter stated that the patient hardly takes the diabetic medication as it was controlled with diet, his blood sugar was under 100. Reporter stated patient blood sugar did not go up when he got the vaccine, like they know other diabetics that did. Reporter stated that the patient blood sugar goes maybe up to 125 if he eats a cookie once in a while, but he stays away from those things. Reporter stated that his sugar stayed low, like 90, when he got home. Reporter stated that one friend of theirs, his sugar skyrocketed, and he takes insulin. Reporter stated patient takes a pill if his blood sugar was higher than 130, which it hasn't been in a while. Reporter stated that their friend's blood sugar rose to 480 something, reporter was scared when patient got his vaccine  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Insomnia, Pain in extremity
Clinical narrative: Second dose: trouble sleeping multiplied; First and Second dose: sore arm; Second dose: affecting everything, she is tired, tired, tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 (Lot number: EN6198) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: EL9269, left arm, Time 07:00), administration date: 12Feb2021, when the patient was 69 years old, for Covid 19 immunisation, reaction(s): "sore arm". The following information was reported: INSOMNIA (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: trouble sleeping multiplied"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "First and Second dose: sore arm"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: affecting everything, she is tired, tired, tired". The events "second dose: trouble sleeping multiplied", "first and second dose: sore arm" and "second dose: affecting everything, she is tired, tired, tired" were evaluated at the physician office visit.  Additional information: She used to be able to sleep 5-7 hours a night. She was having trouble going to sleep and staying asleep. She has been waking up every couple of hours, then she would go to sleep for an hour and wake up again. She was not sleeping well at all. 2nd dose was administered between 15:00-16:00. No other vaccine was administered on the same day and prior 4 weeks with the Covid vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Sleep disorder
Clinical narrative: Second dose: trouble sleeping multiplied; First and Second dose: sore arm; Second dose: affecting everything, she is tired, tired, tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 (Lot number: EN6198) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: EL9269, left arm, Time 07:00), administration date: 12Feb2021, when the patient was 69 years old, for Covid 19 immunisation, reaction(s): "sore arm". The following information was reported: INSOMNIA (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: trouble sleeping multiplied"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "First and Second dose: sore arm"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: affecting everything, she is tired, tired, tired". The events "second dose: trouble sleeping multiplied", "first and second dose: sore arm" and "second dose: affecting everything, she is tired, tired, tired" were evaluated at the physician office visit.  Additional information: She used to be able to sleep 5-7 hours a night. She was having trouble going to sleep and staying asleep. She has been waking up every couple of hours, then she would go to sleep for an hour and wake up again. She was not sleeping well at all. 2nd dose was administered between 15:00-16:00. No other vaccine was administered on the same day and prior 4 weeks with the Covid vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: Little knot about an inch above collar bone; the knot was a little bit sore yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:00 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: Verbatim: Blood pressure, Diagnosed 4 years ago. Concomitant medication(s) included: TRIAMTERENE & HCTZ taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose number - 01, Anatomical location: Left arm, Lot number: EV6205, Route: Injection), administration date: 17Mar2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: NODULE (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Little knot about an inch above collar bone"; NODULE (non-serious) with onset 08Apr2021, outcome "recovered", described as "the knot was a little bit sore yesterday".  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anger, Anxiety, Emotional disorder, Fear
Clinical narrative: her husband may have had some aggravation agitation and irritation; her husband may have had some aggravation agitation and irritation; he had soreness around the injection sight; angered; upset; Frightened; he was worried about getting sleep for work; he was worried about getting sleep for work; soreness/mildly sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:00 (Lot number: EW0150) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGITATION (non-serious), IRRITABILITY (non-serious), outcome "unknown" and all described as "her husband may have had some aggravation agitation and irritation"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "he had soreness around the injection sight"; ANGER (non-serious), outcome "unknown", described as "angered"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "upset"; FEAR (non-serious), outcome "unknown", described as "Frightened"; ANXIETY (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "he was worried about getting sleep for work"; PAIN (non-serious), outcome "unknown", described as "soreness/mildly sore".  Additional information: Reporter states they got the first vaccine, both her and her husband at 9 am Wednesday, she confirms 07Apr2021. She states her husband may have had some aggravation agitation and irritation that maybe related because he received the same vaccination. She does not know if his was physical but he had soreness around the injection sight. Could have been experiencing something similar and was angered, upset, and frightened and didn't mention it. She does not really know. She states that she isn't really sure about the aggravation and irritation, but that it began when they were having to go to the hospital because of her symptoms and he was worried about getting sleep for work the next day. It was around 12:30 AM that night after the injection was given at 9 that day. The soreness began the same day, she does not think it is still going on he has not complained about it. It may be mildly sore.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Irritability, Pain, Vaccination site pain
Clinical narrative: her husband may have had some aggravation agitation and irritation; her husband may have had some aggravation agitation and irritation; he had soreness around the injection sight; angered; upset; Frightened; he was worried about getting sleep for work; he was worried about getting sleep for work; soreness/mildly sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:00 (Lot number: EW0150) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGITATION (non-serious), IRRITABILITY (non-serious), outcome "unknown" and all described as "her husband may have had some aggravation agitation and irritation"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "he had soreness around the injection sight"; ANGER (non-serious), outcome "unknown", described as "angered"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "upset"; FEAR (non-serious), outcome "unknown", described as "Frightened"; ANXIETY (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "he was worried about getting sleep for work"; PAIN (non-serious), outcome "unknown", described as "soreness/mildly sore".  Additional information: Reporter states they got the first vaccine, both her and her husband at 9 am Wednesday, she confirms 07Apr2021. She states her husband may have had some aggravation agitation and irritation that maybe related because he received the same vaccination. She does not know if his was physical but he had soreness around the injection sight. Could have been experiencing something similar and was angered, upset, and frightened and didn't mention it. She does not really know. She states that she isn't really sure about the aggravation and irritation, but that it began when they were having to go to the hospital because of her symptoms and he was worried about getting sleep for work the next day. It was around 12:30 AM that night after the injection was given at 9 that day. The soreness began the same day, she does not think it is still going on he has not complained about it. It may be mildly sore.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and pain at the injection sites; pain at the injection sites; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "swelling and pain at the injection sites"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at the injection sites". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pain.  Additional information: Physician reported patient started to experience swelling and pain at the injection sites days after patient received their 2nd dose of the Covid 19 Pfizer vaccine. The patient was injected approx. 10 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLBELLA with Lidocaine and 11 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLITE. Treated with Telfast and betacorten steroidal ointment. Symptoms resolved. This record captures events relating to the second injection with Juvederm VOLUMA with Lidocaine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: After patient received his vaccine, he had chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Covid 19", start date: Nov2020 (unspecified if ongoing), notes: mild; "Lost sense of taste and smell " (unspecified if ongoing); "Lost sense of taste and smell " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "After patient received his vaccine, he had chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nodule, SARS-CoV-2 test
Clinical narrative: nodular reaction on injection site of the filler, but they are not visible but palpable; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Covid-19 a year ago with a positive PCR test", start date: 2020 (unspecified if ongoing). Concomitant medication(s) included: JUVEDERM VOLUMA. The following information was reported: NODULE (non-serious) with onset 2021, outcome "unknown", described as "nodular reaction on injection site of the filler, but they are not visible but palpable". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nodule.  Additional information: The patient was vaccinated for Covid-19 with the Pfizer vaccine 10 days ago (2021), since then the patient presents nodular reaction on injection site of the filler, but they are not visible but palpable. HCP has put patient on Corticosteroids. Volume of filler and injection site not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I have some tingling on the bottom of my feet and my toes of both feet.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "I have some tingling on the bottom of my feet and my toes of both feet.".  Additional Information: In about 2 days after the shot, patient had some tingling on the bottom of feet and toes of both feet and just wondered how long that last and also if the 2nd shot was going to make it worse. Patient enquired if more problems occur with this tingling that was already having.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain injection site; arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 09Jan2021 (Lot number: EK9231) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "3rd stage kidney disease" (unspecified if ongoing), notes: Verbatim: 3rd stage kidney disease; "stent in her heart" (unspecified if ongoing), notes: Verbatim: stent in her heart; "a fib" (unspecified if ongoing), notes: Verbatim: a fib; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: FLECAINIDE taken for cardiac fibrillation; PRAVASTATIN; AMLODIPINE; CARVEDILOL; ELIQUIS; FISH OIL; C-VITAMIN; VITAMIN D 2000; CINNAMON; CALCIUM; TYLENOL ACHES & STRAINS taken for pain. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Jan2021, outcome "not recovered", described as "Pain injection site"; PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "arm was sore". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient is calling about the Pfizer covid vaccine. The caller received the first dose on 09Jan2021 and her second dose on 30Jan2021. The patient went to pharmacy and was talking to her pharmacist about this event and the pharmacist told her she should call Pfizer and report it. After the caller received her first dose, the first night the caller's arm was really sore so she took a couple of Tylenol and the soreness never went away and now its down to her elbow. The patient took extra strength Tylenol, the Equate brand, and it helped with the pain but the pain didn't ever really go away. Lot 9FE3331A, expiration date Apr2021, it was not expired at the time of the caller taking it. Patient had taken second dose of vaccine on 30Jan2021 (lot no: EL9265). Patient had not received any prior vaccination within 4 weeks. Patient did not administer additional vaccines on same date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Migraine, Vomiting
Clinical narrative: chronic migraines; she cannot hear out of her right eye; states she is having a migraine that makes her want to throw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: She has had migraines since she was 30 years old, prior to vaccine. The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 09Apr2021, outcome "not recovered", described as "states she is having a migraine that makes her want to throw up"; MIGRAINE (non-serious), outcome "unknown", described as "chronic migraines"; EYE DISORDER (non-serious), outcome "unknown", described as "she cannot hear out of her right eye".  Additional information: The caller stated that she had an appointment scheduled for her second dose of the Pfizer COVID vaccine that day, stated she had chronic migraines and she was having one today that made her want to throw up and she was hoping to reschedule her second shot as soon as possible but cancel the one for that day. She stated that she cannot hear out of her right eye. She stated that migraines she has had since she was 30 years old, prior to vaccine, they were called chronic retractable, means it didn't respond, sometimes they made her throw up, sometimes they last 4 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021417529 (Pfizer).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:45 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation; multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Mar2021, outcome "recovered" (20Mar2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Gingivitis
Clinical narrative: developed an infection in his gums; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dental issue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GINGIVITIS (non-serious) with onset 2021, outcome "unknown", described as "developed an infection in his gums". Therapeutic measures were taken as a result of gingivitis.  Clinical Course: The patient was dealing with dental issues since before the vaccine. He developed an infection in his gums and was prescribed amoxicillin (took 2 pills of amoxicillin). He is due for his second Pfizer dose on 10Apr2021 and she wants to know if it is safe for him to get the vaccine while on this antibiotic. He needs a root canal and wondering if her husband can take the second dose tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: soreness at injection site; Left arm pain for a week; developed body aches which lasted for 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021417529 (Pfizer).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 11:45 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; IBUPROFEN. Vaccination history included: Bnt162b2 ({product=COVID, 19, brand=Pfizer, lot_unknown=False,, administration_date=19/03/2021,, administration_time=10:45 AM,, vaccine_location=Left arm,, dose_number=1}]), administration date: 19Mar2021. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered", described as "soreness at injection site"; PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovered", described as "Left arm pain for a week"; PAIN (non-serious) with onset 09Apr2021, outcome "recovered", described as "developed body aches which lasted for 24 hours". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, pain.  Additional information: No treatment received, no covid prior to vaccination, no covid tested post vaccination, no vaccines received within 4 prior to the covid vaccine, no allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Sluggishness, Tenderness, Vaccination site pain
Clinical narrative: right arm lymph nodes were swollen and sensitive; a little sluggish; soreness at the injection site; tenderness under the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 10Mar2021 11:00 (Lot number: EL9269) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "recovered" (12Mar2021), described as "soreness at the injection site"; TENDERNESS (non-serious) with onset 10Mar2021, outcome "recovered" (2021), described as "tenderness under the arm"; LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "right arm lymph nodes were swollen and sensitive"; SLUGGISHNESS (non-serious) with onset 10Mar2021, outcome "recovered" (15Mar2021), described as "a little sluggish".  Additional Information: Reporter stated that that back in early Dec2020, he believed that he had COVID virus. Reporter reported that he did not have a fever and that his core body temperature was 2 degrees lower than normal. During Dec2020, he had symptoms of headache, crazy chills and the last week and a half he had a cough. He tested negative 3 days into the symptoms in Dec2020. Reporter works for a company that has events and he might be traveling in the summer so he did not want to cause problems or catch COVID.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: injection site tenderness; fatigue; moderate headache for around 24 hours; Slight chills for a few hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sulfa drugs" (unspecified if ongoing), notes: Known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Apr2021 20:00, outcome "recovered" (04Apr2021), described as "injection site tenderness"; FATIGUE (non-serious) with onset 03Apr2021 20:00, outcome "recovered" (04Apr2021), described as "fatigue"; HEADACHE (non-serious) with onset 03Apr2021 20:00, outcome "recovered" (04Apr2021), described as "moderate headache for around 24 hours"; CHILLS (non-serious) with onset 03Apr2021 20:00, outcome "recovered" (03Apr2021), described as "Slight chills for a few hours". Therapeutic measures were taken as a result of vaccination site pain, headache. Therapeutic measures were not taken as a result of fatigue, chills.  Additional information: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: Unknown. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, the patient been tested for COVID-19: No. Took 400mg ibuprofen for the events Injection site tenderness and moderate headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lip disorder
Clinical narrative: patient developed nodules on the lips; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single. for covid-19 immunisation. Relevant medical history included: "injected in the lips with a non-Allergan dermal filler" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: LIP DISORDER (non-serious), outcome "not recovered", described as "patient developed nodules on the lips".  Additional information: Patient (who is also a health professional) reported being injected in the lips with a non-Allergan dermal filler. The patient received this COVID-19 vaccine two weeks later. A week later, the patient developed nodules on the lips. This was a Pfizer COVID-19 vaccine reaction. The event is ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Oedema peripheral, Sensory disturbance
Clinical narrative: not able to feel hot or cold sensation to the back of the LU thigh/he noticed the coldness of the toilet seat on the back of his R thigh, but could not feel anything to the back of his L thigh; numbness and some discomfort to the L foot, great toe; toes on L foot felt "fat"; numbness and some discomfort to the L foot, great toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 08:00 (Lot number: EN6201) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SENSORY DISTURBANCE (non-serious) with onset 24Feb2021 08:00, outcome "not recovered", described as "not able to feel hot or cold sensation to the back of the LU thigh/he noticed the coldness of the toilet seat on the back of his R thigh, but could not feel anything to the back of his L thigh"; HYPOAESTHESIA (non-serious), LIMB DISCOMFORT (non-serious) all with onset 24Feb2021 08:00, outcome "not recovered" and all described as "numbness and some discomfort to the L foot, great toe"; OEDEMA PERIPHERAL (non-serious) with onset 24Feb2021 08:00, outcome "not recovered", described as "toes on L foot felt "fat"". The events "not able to feel hot or cold sensation to the back of the lu thigh/he noticed the coldness of the toilet seat on the back of his r thigh, but could not feel anything to the back of his l thigh", "numbness and some discomfort to the l foot, great toe", "toes on l foot felt "fat"" and "numbness and some discomfort to the l foot, great toe" were evaluated at the physician office visit. Therapeutic measures were taken as a result of sensory disturbance, hypoaesthesia, oedema peripheral, limb discomfort.  Additional information: The patient reported that 24 hours after 1st Pfizer injection, patient was not able to feel hot or cold sensation to the back of the LU thigh and toes on L foot felt "fat," with numbness and some discomfort to the L foot, great toe. He stated when he woke the next morning (24Mar2021), he noticed the coldness of the toilet seat on the back of his R thigh, but could not feel anything to the back of his L thigh. He received treatment of medication for the neuropathy like symptoms. The patient received second dose of bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EP7534) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine, He received other medications within 2 weeks of the vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oral mucosal eruption, Vaccination site mass, Vaccination site rash, Vaccination site swelling
Clinical narrative: swelling, lumps, bumps, and rash at injection sites and around mouth; swelling, lumps, bumps, and rash at injection sites and around mouth; swelling, lumps, bumps, and rash at injection sites and around mouth; swelling, lumps, bumps, and rash at injection sites and around mouth; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Juvéderm volbella xc, notes: injected in the nasolabial folds and vermillion border with x1 syringe. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE RASH (non-serious), ORAL MUCOSAL ERUPTION (non-serious), outcome "unknown" and all described as "swelling, lumps, bumps, and rash at injection sites and around mouth".  Additional information: Healthcare professional reported that a patient was injected in the nasolabial folds and vermillion border with x1 syringe of JUVÉDERM VOLBELLA® XC. Approximately five months later the patient noticed "swelling, lumps, bumps, and rash at injection sites and around mouth." HCP reported the patient received 1st injection of COVID (Pfizer) vaccine four months after injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Facial discomfort
Clinical narrative: Patient symptoms "on the chin, lips, left side of face near the eye and right cheek bone underneath the right eye."; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Juvederm voluma ® xc. The following information was reported: FACIAL DISCOMFORT (non-serious), outcome "not recovered", described as "Patient symptoms "on the chin, lips, left side of face near the eye and right cheek bone underneath the right eye."".  Additional information: Patient reported that they were injected in the cheeks with one syringe of JUVEDERM VOLUMA ® XC. About a year and a half later patient was injected in the lips with one syringe of JUVEDERM VOLBELLA ® XC. About five months later patient reported experiencing "delayed on set nodules." About a month later patient received the first Pfizer COVID Vaccine dose and the second dose the following month. Patient symptoms "on the chin, lips, left side of face near the eye and right cheek bone underneath the right eye." Symptoms are ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: Left arm lymphadenopathy; 48 hours swelling visual; Pain with movement; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 16 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, ), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Left arm lymphadenopathy"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "48 hours swelling visual"; PAIN (non-serious), outcome "unknown", described as "Pain with movement".  Additional information:No concomitant meds or vaccines were reported. No underlying conditions. No similar reaction with past vaccines noted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: "I went from a little pain in my hand"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as ""I went from a little pain in my hand"".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: 2nd shot (he got on the 10th) he felt the shot this time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 94 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), when the patient was 94 years old, for Covid-19 immunisation. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown", described as "2nd shot (he got on the 10th) he felt the shot this time".  Additional information: Clinical course reported as Patient (age 94) also received the Pfizer vaccine. He did not have any side effects and he didn't even feel the needle and 2nd shot (he got on the 10th) he felt the shot this time. So far so good. He was feeling great.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was a little sore where the needle went in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 28Jan2021, for COVID-19 immunisation, reaction(s): "shot was not administered correctly". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "arm was a little sore where the needle went in".  Additional information: Patient stated he had no other side effects other than his arm was a little sore where the needle went in. He wanted to know if it was safe if he receives a third dose of the vaccine because he thinks the first one does not count, so it would be like getting 2 doses.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches". The patient experienced body aches second day after the 2nd dose of the COVID vaccine.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Nausea
Clinical narrative: headache; sick; nausea; she was feeling terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sick" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; ILLNESS (non-serious), outcome "unknown", described as "sick"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she was feeling terrible". Therapeutic measures were taken as a result of headache, illness, nausea, feeling abnormal.  Additional information: She was already sick when she took the Pfizer Covid-19 vaccine first dose on 09Apr2021. The 2nd dose was 3 weeks later and didn't provide the exact 2nd dose schedule. She took some Tylenol and had been feeling better now. He would like to consult if it was ok to take medication such as Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single; Lot number :unknown), administration date: 11Mar2021, when the patient was 64 years old, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 12Apr2021 19:30, outcome "not recovered", described as "dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Started experiencing extreme dizziness last night. 11 Days after the second shot. Did not think it was related until other's at wok experienced something similar. Reporting as this seems to only be reported in forums. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Did not had known allergies, allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.