chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea
Clinical narrative: Caller also stated when her daughter received the vaccine, her daughter's left leg went numb; Nauseous; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient mother) reported for her daughter (patient). This is report 2 of 2. This report is in regard to the reporter's daughter.  A female patient of an unspecified age received bnt162b2 (Pfizer COVID vaccine, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller stated that when her daughter received the vaccine, her daughter's left leg went numb. Caller also stated when her daughter received the vaccine, her daughters left leg went numb. Caller states after her daughter got the second dose, she was nauseous. Caller has heard of that before but has not heard of anybody's left leg going numb. Also stating that was her daughter's business. The outcome of events was unknown.  Information about batch/ lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN6201) via an unspecified route of administration, administered in Arm Right on 25Apr2021 11:30 (at the age of 51-years-old) as single dose for covid-19 immunization. Medical history included hypertension from an unspecified date and ongoing. She doesn't know when the blood pressure started, around 2018 to 2019. She had the Afib maybe 2 years ago, so 2019. AFib (atrial fibrillation) from an unknown date in 2019 to an unknown date. She has high blood pressure. She is extremely young to have this, but she had been in the hospital once for Afib which typically happens to people that are older, unhealthy, overweight, and in their 70s or 80s. When she was in the hospital everyone said she didn't belong there. It is rare to be young and have it to the extent she did. She has an underlying condition that is very critical for her. God forbid she catches Covid. The patient's concomitant medications were not reported. It was reported that the patient arm was sore on 26Apr2021. She was expecting her arm to be sore. Everyone said when they got the shot it will feel sore. For her it felt like when she works out too hard and hasn't worked out and is just sore. It was nothing alarming to her. After her first shot she was sore by late afternoon or evening the next day. She had the first dose on 25Apr2021. She had all those tests done recently prior to the Covid shot she would say in December 2020. She had a lot of workups done bloodwork-wise and everything else. The outcome of the event was unknown.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: first dose: upper right arm muscle was very sore; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FW0171, Expiration date was not reported), dose 1 intramuscularly, administered in upper right arm muscle on 29Apr2021 (age at vaccination 61 years) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced first dose: upper right arm muscle was very sore on 06May2021. He was unable to get second dose as scheduled today on 20May2021. Reporter stated, when he got the shot, he was fine except for his arm, right arm. they gave it to him in his upper right arm muscle and it was very sore for a week. his wife got the same shot on the same day right after him and she had no symptoms whatsoever. Caller asking does he have a time frame, today is two weeks, that he had the first shot. It was also reported that caller confirms he received his first dose of the Pfizer Covid vaccine on 06May2021 at 1555 and it began hurting later that afternoon towards the evening. Caller states he has an appointment today at 1555. Caller states he's going to try to call and try to get it for Sunday, he just needs to know if that's going to change the potency of the shot. The outcome of upper right arm muscle was very sore was recovered on 13May2021, missed dose outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient's husband). This is report 2 of 2. The report is cross referenced to report ID: NMW0TC2Y. This is report 2 of 2. This re-port is in regard to the caller's wife. A female patient (reporter's wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. It was re-ported, Caller was reporting on behalf of himself in regard to his experience with the COVID vaccine when he stated his wife also received the COVID vaccine and had no reaction at all other than her arm being sore. The clinical outcome for event was unknown.   No further details were provided or obtained. Information on the Lot/Batch number has been re-quested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Panic reaction
Clinical narrative: She was kind of panicky, she ended up not being able to breathe too well; She was kind of panicky, she ended up not being able to breathe too well; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer reported for a unknown female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. An contactable consumer (who was caller as well) stated that on an unspecified date the time she got done standing in line, the girl in front of them had a problem, she doesn't know what it was. Caller states everybody seemed fine that went ahead of her, but she doesn't know if she was kind of panicky, she ended up not being able to breathe too well, she had to have water and kind of had to sit in the chair and relax and of course the patient was there when she left. Caller states she guesses she's doing better now, but she doesn't know if it was panicky, or she reacted to the vaccine. Caller confirms the pharmacy was giving out Pfizer Covid vaccines. Caller declines to complete a report for the girl who was in front of her receiving the Pfizer Covid vaccine, stating she doesn't know her situation at all, she doesn't know what happened whether it was because of the vaccine or whether she got panicky, she has no idea. Caller states the pharmacist would know more than her, she just knows she was given an orange juice and water and she was sipping on them and she seemed to be better. The outcome of events was unknown.    Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A little tired for a day; This is a spontaneous report from a contactable consumer (patient himself).   A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization.  The patient'' medical history and concomitant medications were not reported.  The patient experienced a little tired for a day on an unspecified date. We are interested in our daughter, age 10, to participate in the vaccine trials done at (with held). She had expressed a strong willingness, and desire, to be vaccinated. She was typical, in excellent health, no exclusions listed in the study. the reporter had a couple questions of clarity about the study. Is the blood draw a typical arm draw or is it something simpler or more complex? Also, in this trial, and generally, participants who get the placebo are offered the effective shot at the end of the trial. the consumer stated that there was a 6 month blood draw, and also the study runs through 2022 and 2023. But there was some anecdotal reports that this shot would be offered for emergency use sometime in September. Part of our desire was to offer a chance for his daughter to get vaccinated as soon as possible. Ithe consumer stated that there was a possibility that she receives a placebo, and Im okay with that. Would there be any issue with her getting an effective shot in September from our doctor if she was currently in the study? Essentially, she could possibly get her shots this summer, or whenever the test was being run, and be potentially vaccinated in August or early September. But if she gets the placebo, could she get the regular shot or would she have to wait until the end of the test trial?. the consumer stated that his wife and he both got the shot. She had no ill effects, and he felt a little tired for a day. But its so worth it to feel better protected. Knowing that his daughter would soon be protected brings a great amount of closure to our concerns and worries over the past year. Even if we dont get to participate in the trial, he wanted  to say thanks. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Little soreness; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a patient (reporter's husband) that: A 45-years-old male patient second dose of received bnt162b2 (Solution injection; Batch/Lot number was unknown), via an unspecified route of administration on 11May2021 (at the age of 45-year-old) dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Solution injection; Batch/Lot number was unknown), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unknown date in May2021, the patient experienced little soreness after one or two days and was totally fine. Therapeutic measures were not taken due to the event. The clinical outcome of the event was recovered on an unknown date in May2021.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580004 same drug/reporter , different patient /event
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Has rashes on his feet; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported for himself that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included fish oil; vitamin d nos; potassium; ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50) all are taken for an unspecified indication, start and stop date were not reported. It was reported that Caller had the first dose of the Pfizer Covid19 vaccine on 18May. Caller is taking regular vitamins before taking the first dose of the vaccine like (fish oil, Vitamin D, potassium, Centrum Silver) he also has rashes on his feet, and he put ointment as well. However, he stopped taking vitamins and he wants to know if he can take his regular vitamins. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Somnolence
Clinical narrative: Abdomen pain; Headache; Tiredness; Drowsy; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 13 year old non pregnant female patient received the first dose of bnt162b2 (BNT162B2) intramuscular on 22May2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if was the patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced abdomen pain, headache, tiredness and drowsiness on 22May2021 few hours after vaccine shot. The patient did not receive any treatment for the events. The clinical outcome for the events was recovered.  Upon Follow-up (24May2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: that the adverse events were not directly reported by them.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: Rapid pulse/High heart rate -137; Nausea/Severe Nausea; Hives; Fatigue; Palpitations; Chills; Sweating; Fever; Severe joint pain; Dizziness; Headache; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE; Lot Number: EWO167; Expiration Date: 31Aug2021), intramuscular, in right arm on 17May2021 15:45 (at the age of 54-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing conditions of juvenile idiopathic arthritis from 1969, Raynauds from 1966, Hypertension from 1991, Scleroderma from 1990, Sjogren from 1975, Gallbladder disease from 1994, Graves disease from 1996, Chronic tachycardia from 1993, Congestive heart failure from 2013, Type 1 Diabetes from 2013, neuropathy - 3 kins from 2013-2014, Chronic Infections from 2013 and psoriatic Arthritis. Concomitant medications included ursodiol and ursodeoxycholic acid (ACTIGALL) taken for gallbladder disorder from 1992 and ongoing, diltiazem (CARDIZEM) taken for hypertension from 1991 and ongoing; ciprofloxacin hydrochloride (CIPRO) taken for infection, metronidazole (FLAGYL) taken for infection, tedizolid phosphate (SIVEXTRO), propylthiouracil (PTU) taken for graves disease, spironolactone taken for cardiac failure congestive and metoprolol taken for tachycardia. The patient had unspecified allergies. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient was administered second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; LOT number EW0181), intramuscular in right arm on 20Jun2021 for COVID-19 immunization. The patient experienced hives on 17May2021 14:40, rapid pulse/high heart rate -137 on 17May2021 15:55, nausea/severe nausea on 17May2021 15:50 and palpitations, chills, sweating, fever, severe joint pain, dizziness, bad headache and fatigue on on 17May2021. Therapeutic measures were taken as a result of rapid pulse/high heart rate -137 and nausea/severe nausea. The events high heart rate and hives resulted call to physician. The outcome of the event rapid pulse/high heart rate was recovered on 20May2021. The outcome of the event hives was recovered on 22May2017. The outcome of event severe nausea was recovered on 19May2021. The outcome of event palpitations, chills, sweating, fever, severe joint pain, dizziness, bad headache and fatigue was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: Rapid pulse/High heart rate -137; Nausea/Severe Nausea; Hives; Fatigue; Palpitations; Chills; Sweating; Fever; Severe joint pain; Dizziness; Headache; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE; Lot Number: EWO167; Expiration Date: 31Aug2021), intramuscular, in right arm on 17May2021 15:45 (at the age of 54-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing conditions of juvenile idiopathic arthritis from 1969, Raynauds from 1966, Hypertension from 1991, Scleroderma from 1990, Sjogren from 1975, Gallbladder disease from 1994, Graves disease from 1996, Chronic tachycardia from 1993, Congestive heart failure from 2013, Type 1 Diabetes from 2013, neuropathy - 3 kins from 2013-2014, Chronic Infections from 2013 and psoriatic Arthritis. Concomitant medications included ursodiol and ursodeoxycholic acid (ACTIGALL) taken for gallbladder disorder from 1992 and ongoing, diltiazem (CARDIZEM) taken for hypertension from 1991 and ongoing; ciprofloxacin hydrochloride (CIPRO) taken for infection, metronidazole (FLAGYL) taken for infection, tedizolid phosphate (SIVEXTRO), propylthiouracil (PTU) taken for graves disease, spironolactone taken for cardiac failure congestive and metoprolol taken for tachycardia. The patient had unspecified allergies. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient was administered second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; LOT number EW0181), intramuscular in right arm on 20Jun2021 for COVID-19 immunization. The patient experienced hives on 17May2021 14:40, rapid pulse/high heart rate -137 on 17May2021 15:55, nausea/severe nausea on 17May2021 15:50 and palpitations, chills, sweating, fever, severe joint pain, dizziness, bad headache and fatigue on on 17May2021. Therapeutic measures were taken as a result of rapid pulse/high heart rate -137 and nausea/severe nausea. The events high heart rate and hives resulted call to physician. The outcome of the event rapid pulse/high heart rate was recovered on 20May2021. The outcome of the event hives was recovered on 22May2017. The outcome of event severe nausea was recovered on 19May2021. The outcome of event palpitations, chills, sweating, fever, severe joint pain, dizziness, bad headache and fatigue was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Urticaria
Clinical narrative: Rapid pulse/High heart rate -137; Nausea/Severe Nausea; Hives; Fatigue; Palpitations; Chills; Sweating; Fever; Severe joint pain; Dizziness; Headache; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE; Lot Number: EWO167; Expiration Date: 31Aug2021), intramuscular, in right arm on 17May2021 15:45 (at the age of 54-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing conditions of juvenile idiopathic arthritis from 1969, Raynauds from 1966, Hypertension from 1991, Scleroderma from 1990, Sjogren from 1975, Gallbladder disease from 1994, Graves disease from 1996, Chronic tachycardia from 1993, Congestive heart failure from 2013, Type 1 Diabetes from 2013, neuropathy - 3 kins from 2013-2014, Chronic Infections from 2013 and psoriatic Arthritis. Concomitant medications included ursodiol and ursodeoxycholic acid (ACTIGALL) taken for gallbladder disorder from 1992 and ongoing, diltiazem (CARDIZEM) taken for hypertension from 1991 and ongoing; ciprofloxacin hydrochloride (CIPRO) taken for infection, metronidazole (FLAGYL) taken for infection, tedizolid phosphate (SIVEXTRO), propylthiouracil (PTU) taken for graves disease, spironolactone taken for cardiac failure congestive and metoprolol taken for tachycardia. The patient had unspecified allergies. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient was administered second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; LOT number EW0181), intramuscular in right arm on 20Jun2021 for COVID-19 immunization. The patient experienced hives on 17May2021 14:40, rapid pulse/high heart rate -137 on 17May2021 15:55, nausea/severe nausea on 17May2021 15:50 and palpitations, chills, sweating, fever, severe joint pain, dizziness, bad headache and fatigue on on 17May2021. Therapeutic measures were taken as a result of rapid pulse/high heart rate -137 and nausea/severe nausea. The events high heart rate and hives resulted call to physician. The outcome of the event rapid pulse/high heart rate was recovered on 20May2021. The outcome of the event hives was recovered on 22May2017. The outcome of event severe nausea was recovered on 19May2021. The outcome of event palpitations, chills, sweating, fever, severe joint pain, dizziness, bad headache and fatigue was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Vaccination site pain
Clinical narrative: She was experiencing severe muscle aches; Injection site soreness; After her second dose she is not feeling well; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. This is one of two reports. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0182; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 10May2021 (at the age of 67-years-old) as dose 2, single for covid-19 immunization. Medical history included bad hip and knee. There were no concomitant medications. The patient previously took first dose of historical vaccine bnt162b2 (Lot number: EW0161) via unspecified route in right arm on 19Apr2021 (at the age of 67-years-old) for covid-19 immunization and experienced injection site soreness. NDC number and expiry date was unknown and COVID vaccine stated as dosage previously discontinued or treatment completed. The patient experienced she was experiencing severe muscle aches, injection site soreness on 11May2021, after her second dose she was not feeling well on unspecified date in May2021. She had her first dose of the COVID vaccine 19Apr2021, and second dose on 10May2021. After her second dose she was not feeling well. She was experiencing severe muscle aches. This was happening earlier. The muscle aches started on the 11th and 12th. She was still sore. Patient did not have a prescribing doctor. She has a bad hip and knee that was probably not helping. The bad hip and knee started before the vaccine. She had no problems except injection site soreness with the first one. But she had that with every vaccine. She got both doses in her right arm. Investigation assessment included none. Clinical outcome of severe muscle aches was resolving and outcome of other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up(22Jul2021): Follow-up attempts have been completed and no further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Lethargy, Loss of personal independence in daily activities, Somnolence
Clinical narrative: Trouble at work and thought he was high on drugs; Began acting strange/acting goofy; acting like he was drunk; Glazed over and falling asleep randomly/friday night falling asleep in the car; Lethargy; This is a spontaneous report from a contactable consumer (patient mother). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 intramuscular, administered in Arm Left on 14May2021 13:55 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included attention deficit hyperactivity disorder from 2010 and ongoing Her son would have behavioral ticks associated with his ADHD. The patient's concomitant medications were not reported. Historical Vaccine includes BNT162B2 1st dose at right arm for COVID-19 immunisation. On 14May2021 the patient States her son received the second dose, and afterwards had lethargy as everyone else seemed to have after their second dose, on15May2021 but he began acting strange acting goofy, acting like drunk. States it took a while for her to put two and two together. He has ADHD and his demeanor for 24-36 hours was very goofy and he was acting like he was drunk. On 14may2021 States he was giggling a lot and glazed over and falling asleep randomly. On 16may2021 States he was then having trouble at work and they thought he may have been high on drugs and they ended up questioning him. States after it subsided after a couple days, they thought it had to do with his second dose. States with his ADHD he has less ability to control his emotion when he is in stressful situations or over tired. Added this was much more pronounced. Outcome of the events lethargy abnormal behaviour was recovering, somnolence, acting like drunk was recovered on 16May2021, loss of personal independence in daily activities was recovered on 17May2021.    Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Decreased appetite, Diarrhoea, Dysgeusia
Clinical narrative: My appetite is messed, not good; I am never gonna have appetite.; taste is sweet; throwing up; Diarrhea; A bad taste in my mouth; Headache; Chills; I get hot for a while then I get down cold.; that night my blood sugar was high; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included hypertension (Verbatim: Hypertension) and Blood sugar was high (Verbatim: Blood sugar was high) The patient's concomitant medications were not reported. The patient experienced her appetite is messed, not good; she never gonna have appetite, taste is sweet, throwing up, diarrhea, a bad taste in her mouth, headache, chills, she get hot for a while then she get down cold and that night my blood sugar was high on an unspecified date. Patient reported that she received a treatment. The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Taste disorder, Vomiting
Clinical narrative: My appetite is messed, not good; I am never gonna have appetite.; taste is sweet; throwing up; Diarrhea; A bad taste in my mouth; Headache; Chills; I get hot for a while then I get down cold.; that night my blood sugar was high; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included hypertension (Verbatim: Hypertension) and Blood sugar was high (Verbatim: Blood sugar was high) The patient's concomitant medications were not reported. The patient experienced her appetite is messed, not good; she never gonna have appetite, taste is sweet, throwing up, diarrhea, a bad taste in her mouth, headache, chills, she get hot for a while then she get down cold and that night my blood sugar was high on an unspecified date. Patient reported that she received a treatment. The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Full blood count, Headache, Migraine
Clinical narrative: Migraine; Dizziness; Headache; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm Right on 14May2021 (at the age of 52-year-old) as dose 1, single for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, allergy to artificial sugars. Concomitant medications included celecoxib (CELEXA) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. On 16May2021, the patient experienced migraine, dizziness, headache. Patient was not informed about the vaccine containing artificial sugars and she mentioned that she is allergic to all types of artificial sugars. When asked for side effects, consumer stated, "Yes, I get migraines from the artificial sugars and I have been suffering from the migraine since I got the shot along with the dizziness but I don't know it's just a typical side effect of the shot but yeah I have been getting migraine". Consumer stated, "It's probably, I would say may be 16May, I don't think I got the headache right away but on 16 definitely it went really bad." The patient underwent lab tests and procedures which included full blood count: unknown date. Therapeutic measures were taken as a result of events included maxalt. The outcome of the events were unknown.   Information on Lot/Batch number was available. Additional information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Blister, Feeling abnormal, Rash, Rash macular
Clinical narrative: am all broke out; Very bad rash, terrible rash; They are big, like couple of big blotches are there almost like may be they were blisters or something; Very bad rash, terrible rash; They are big, like couple of big blotches are there almost like may be they were blisters or something; Very bad rash, terrible rash; They are big, like couple of big blotches are there almost like may be they were blisters or something; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 20May2021 as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2, (Lot number: EW0167) for Covid-19 immunization. On an unspecified date in May2021, patient experienced very bad rash, terrible rash; they were big, like couple of big blotches are there almost like maybe they were blisters or something. Patient was asking that those were side effects because patient had not been out, have not been anywhere, have not touched anything, have been worked off, so patient did not touch no bushes or anything. Patient reported, on 21May2021, Because I got my second shot yesterday the Pfizer and I am all broke out (further clarification unknown) today and somebody told me that this is one of the side effects. The outcome of event was unknown.  Additional Information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: Arm was swollen; Arm can't move; This is a spontaneous report from a contactable consumer or other non health care professional (patient).  A 58-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm Right on 19May2021 (age at vaccination: 58-years-old) as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. The patient got the vaccine on Wednesday, 19May2021, then after she got that shot she came home, her arm was swollen she could go to work since Wednesday and Thursday her arm could not move, so she called off at work. Patient did not receive any treatment for the events. The outcome for the events was unknown.   Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node issue where armpit swelled up to 3 times, the normal size; This is a spontaneous report from a contactable consumer (friend of patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lymph node issue where armpit swelled up to 3 times, the normal size on an unspecified date. Caller stated her symptoms went away after 3 days. Reporter seriousness for Lymph node issue where armpit swelled up to 3 times the normal size was unspecified. The outcome of event was unknown.  Follow-up activities closed. Batch/lot number not available.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Lip pruritus, Lip swelling, SARS-CoV-2 test
Clinical narrative: swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy.  top lip was more swollen than the bottom.; swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy.  top lip was more swollen than the bottom.; some small bumps around the outer border of lip tissue; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration in arm left on 30Apr2021 at 15:00 (at the age of 17-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications received within 2 weeks of vaccination included bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), taken for an unspecified indication and multivitamin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0153), via an unspecified route of administration in arm left on 08Apr2021 at 10:45 AM (at the age of 17-year-old) as a dose 1, single for COVID-19 immunisation. It was reported that, the patient was not pregnant at time of vaccination. 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. Since the vaccination, has the patient been tested for COVID-19 was reported as yes, (COVID test type post vaccination was nasal swab). On 08May2021, the patient experienced swollen, itchy lips, some small bumps around the outer border of lip tissue, bumps were also itchy, top lip was more swollen than the bottom. Treatment received for the events was reported as yes, self-administered over the counter antihistamine. The device date was on 23May2021. The patient underwent lab tests and procedures which included nasal swab, resulted as negative on 19Apr2021, nasal swab, resulted as negative on 26Apr2021, nasal swab, resulted as negative on 03May2021, nasal swab, resulted as negative on 10May2021 and nasal swab, resulted as negative on 17May2021. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I have pretty large amount of pain kind of in that area.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. No investigation assessment. The patient stated he had the first dose of the Pfizer vaccine and had pretty large amount of pain kind of in that area. He asked that how much pain is typical after the injection. He stated he just tried to call regular doctor office. He wanted to make sure if he had to do something that night normal and wanted to talk to somebody to double check. He stated he was sure everything will be fine, it was not, it just lot of specific pain in that area and it was more like just wanted to talk to somebody was that normal. He do not wanted to make a big thing out of this. He stated probably two tylenol and kind of slept it off. He did not thought it was not a big deal, but he would probably take it. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Malaise
Clinical narrative: Feeling sick and I think I having a bad reaction to it; Feeling sick and I think I having a bad reaction to it; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 69-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0177, Expiration date: Unknown), via an unspecified route of administration, in left arm on 19May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had experienced feeling sick and thought that having a bad reaction to it on 19May2021. The patient received treatment as Norco medication but that was it, 7.5mg. The outcome of the events was unknown.  Additional information is requested.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Discharge, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Cold; Fever of about a 100 degree; Discharge that begin to happen that night; This is a spontaneous report from a contactable consumer (patient). A 39-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 11:30 (at the age of 39-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 19May2021, beginning Wednesday afternoon, the patient experienced sore throat, more or less had cold, fever of about a 100 degree, discharge that begin to happen that night. The patient would prefer just to report because the patient was sick right now and I don't feel like having to repeat. The patient did not receive any treatment. Outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea, Feeling hot, Limb injury, Muscle disorder
Clinical narrative: feel like I get a little warm and it went away and then it came back and then; Mouth is dry; I feel my head was warm and my left arm was hurt; I feel my head was warm and my left arm was hurt; I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath.; muscles isn't right and then I have shortness of breath; short of breath; This is a spontaneous report from a contactable consumer/patient or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 and expiry date: unknown), dose 2 via an unspecified route of administration on 21May2021 at 09:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. Any other medication : Consumer stated, "Not yet. The patient was calling to see if its okay to use asthma machine because the patient was having like panic attack. The patient was taking a solution for asthma (Albuterol). The patient do take Proventil for inhaler and also have Flovent and also have machine. The patient experienced a panic attack I am not sure because my head was warm for couple of second then I was short of breath on 21May2021 (I put one second Pfizer shot today and it was 9'o clock in morning and few minutes ago I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath), muscles isn't right and then the patient had shortness of breath on an unknown date on May2021, feel like i get a little warm and it went away and then it came back and then, mouth is dry and i feel my head was warm and my left arm was hurt on an unspecified date. No treatment was received for the events I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath. Outcome of the events I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath, short of breath, muscles isn't right and then I have shortness of breath, Mouth is dry, I feel my head was warm and my left arm was hurt was unknown, feel like I get a little warm and it went away and then it came back and then was not recovered.  Follow-up (21May2021): This is a follow up-spontaneous report from a contactable consumer.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: feel like I get a little warm and it went away and then it came back and then; Mouth is dry; I feel my head was warm and my left arm was hurt; I feel my head was warm and my left arm was hurt; I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath.; muscles isn't right and then I have shortness of breath; short of breath; This is a spontaneous report from a contactable consumer/patient or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 and expiry date: unknown), dose 2 via an unspecified route of administration on 21May2021 at 09:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. Any other medication : Consumer stated, "Not yet. The patient was calling to see if its okay to use asthma machine because the patient was having like panic attack. The patient was taking a solution for asthma (Albuterol). The patient do take Proventil for inhaler and also have Flovent and also have machine. The patient experienced a panic attack I am not sure because my head was warm for couple of second then I was short of breath on 21May2021 (I put one second Pfizer shot today and it was 9'o clock in morning and few minutes ago I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath), muscles isn't right and then the patient had shortness of breath on an unknown date on May2021, feel like i get a little warm and it went away and then it came back and then, mouth is dry and i feel my head was warm and my left arm was hurt on an unspecified date. No treatment was received for the events I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath. Outcome of the events I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath, short of breath, muscles isn't right and then I have shortness of breath, Mouth is dry, I feel my head was warm and my left arm was hurt was unknown, feel like I get a little warm and it went away and then it came back and then was not recovered.  Follow-up (21May2021): This is a follow up-spontaneous report from a contactable consumer.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia
Clinical narrative: I am not diabetic but I do get hypoglycemic at times. A little bit after I got the first dose; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN6199, Expiry date: Unknown) via an unspecified route of administration on 06Mar2021 (age at vaccination: 55 years) as dose 1, single for COVID-19 immunisation. Medical history included menopause from an unknown date and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included fluoxetine (FLUOXETINE) 16mg total, a 10mg capsule and 6 mg liquid of the Fluoxetine taken for an unspecified indication, start and stop date were not reported; thyroid (ARMOUR THYROID) about 5mcg a day taken for thyroid disorder, start and stop date were not reported. On an unspecified date, the patient experienced, that she was not diabetic but she do get hypoglycemic at times, a little bit after she got the first dose.  The outcome of events was Unknown.  Follow-up attempts are needed. Further information is expected.