chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: she had a fast heartbeat; can taste the medication in her mouth; her whole face became swollen, including her eyes.; her whole face became swollen, including her eyes.; also said she had hives all over her face and across her eyes; Shorter breath; high rash; Itching; Bad muscle pain; Weakness and Sleepiness.; Weakness and Sleepiness.; her face was red; tiredness; shoulder and arm pain; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EW0171, Expiration date: Unknown), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. Medical history included she has a brain tumor and iodine reaction to the contrast when they do the MRI ever since (was allergic to the radiocontrast dye), high blood pressure, gall bladder removed, both knees replaced, sinus surgery, hysterectomy, cataract surgery and tonsil removed. Concomitant medications included levothyroxine, hydrocortisone, metoprolol, Vitamin D and magnesium. On an unknown date, patient experienced non-severe reaction to the Covid-19. When she first took the only one shot and they asked her to stick with 15 minute and she did that and a few minutes after she sat there may be about five minutes, she could taste them and can taste the medication in her mouth and asked if she supposed to be tasting the medication, they said nobody has ever said that now. She also said she felt as if her body was going through a change. She was given water which helped make her feel better. Then 4 or 5 days after, her whole face became swollen, including her eyes. She had a high rash, her face was red you know, itching oh bad. She also said she had hives all over her face and across her eyes. She also had the usual side effects, such as tiredness, weakness and sleepiness, bad muscle pain, shoulder and arm pain for a week. She had that contrast reaction and everything she said what kind of medications, she takes, she always has some type of reaction to it. That is why she was not sure if should take the mediation means take the vaccine so anyway, she took it and had that shorter breath, fast heartbeat. Patient do not want to take the second one and get more severe again because her face will get her eyes closed up. Therapeutic measures taken as a result of face was red and was itching so bad, she took Benadryl and Calamine lotion which helped with the swelling of her face. However, the itchiness and redness were still there. The patient underwent lab test and procedure which included blood work and magnetic resonance imaging (MRI). The clinical outcome of the whole face became swollen was recovering, itching and face was red were still there (not recovered) and for rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema, Eye swelling, Fatigue, Heart rate increased
Clinical narrative: she had a fast heartbeat; can taste the medication in her mouth; her whole face became swollen, including her eyes.; her whole face became swollen, including her eyes.; also said she had hives all over her face and across her eyes; Shorter breath; high rash; Itching; Bad muscle pain; Weakness and Sleepiness.; Weakness and Sleepiness.; her face was red; tiredness; shoulder and arm pain; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EW0171, Expiration date: Unknown), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. Medical history included she has a brain tumor and iodine reaction to the contrast when they do the MRI ever since (was allergic to the radiocontrast dye), high blood pressure, gall bladder removed, both knees replaced, sinus surgery, hysterectomy, cataract surgery and tonsil removed. Concomitant medications included levothyroxine, hydrocortisone, metoprolol, Vitamin D and magnesium. On an unknown date, patient experienced non-severe reaction to the Covid-19. When she first took the only one shot and they asked her to stick with 15 minute and she did that and a few minutes after she sat there may be about five minutes, she could taste them and can taste the medication in her mouth and asked if she supposed to be tasting the medication, they said nobody has ever said that now. She also said she felt as if her body was going through a change. She was given water which helped make her feel better. Then 4 or 5 days after, her whole face became swollen, including her eyes. She had a high rash, her face was red you know, itching oh bad. She also said she had hives all over her face and across her eyes. She also had the usual side effects, such as tiredness, weakness and sleepiness, bad muscle pain, shoulder and arm pain for a week. She had that contrast reaction and everything she said what kind of medications, she takes, she always has some type of reaction to it. That is why she was not sure if should take the mediation means take the vaccine so anyway, she took it and had that shorter breath, fast heartbeat. Patient do not want to take the second one and get more severe again because her face will get her eyes closed up. Therapeutic measures taken as a result of face was red and was itching so bad, she took Benadryl and Calamine lotion which helped with the swelling of her face. However, the itchiness and redness were still there. The patient underwent lab test and procedure which included blood work and magnetic resonance imaging (MRI). The clinical outcome of the whole face became swollen was recovering, itching and face was red were still there (not recovered) and for rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Product taste abnormal, Pruritus, Swelling face, Urticaria
Clinical narrative: she had a fast heartbeat; can taste the medication in her mouth; her whole face became swollen, including her eyes.; her whole face became swollen, including her eyes.; also said she had hives all over her face and across her eyes; Shorter breath; high rash; Itching; Bad muscle pain; Weakness and Sleepiness.; Weakness and Sleepiness.; her face was red; tiredness; shoulder and arm pain; This is a spontaneous report from a contactable other HCP (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EW0171, Expiration date: Unknown), via an unspecified route on an unknown date, as a single dose for covid-19 immunization. Medical history included she has a brain tumor and iodine reaction to the contrast when they do the MRI ever since (was allergic to the radiocontrast dye), high blood pressure, gall bladder removed, both knees replaced, sinus surgery, hysterectomy, cataract surgery and tonsil removed. Concomitant medications included levothyroxine, hydrocortisone, metoprolol, Vitamin D and magnesium. On an unknown date, patient experienced non-severe reaction to the Covid-19. When she first took the only one shot and they asked her to stick with 15 minute and she did that and a few minutes after she sat there may be about five minutes, she could taste them and can taste the medication in her mouth and asked if she supposed to be tasting the medication, they said nobody has ever said that now. She also said she felt as if her body was going through a change. She was given water which helped make her feel better. Then 4 or 5 days after, her whole face became swollen, including her eyes. She had a high rash, her face was red you know, itching oh bad. She also said she had hives all over her face and across her eyes. She also had the usual side effects, such as tiredness, weakness and sleepiness, bad muscle pain, shoulder and arm pain for a week. She had that contrast reaction and everything she said what kind of medications, she takes, she always has some type of reaction to it. That is why she was not sure if should take the mediation means take the vaccine so anyway, she took it and had that shorter breath, fast heartbeat. Patient do not want to take the second one and get more severe again because her face will get her eyes closed up. Therapeutic measures taken as a result of face was red and was itching so bad, she took Benadryl and Calamine lotion which helped with the swelling of her face. However, the itchiness and redness were still there. The patient underwent lab test and procedure which included blood work and magnetic resonance imaging (MRI). The clinical outcome of the whole face became swollen was recovering, itching and face was red were still there (not recovered) and for rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Feeling abnormal, Heart rate
Clinical narrative: brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bring down 210 over 109.; immediately ringing in ears; Facial stiffness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm (reported as left shoulder) on 29Mar2021 09:30 (Batch/Lot Number: ER8730) (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient had no relevant medical history and no known allergies. There were no concomitant medications. On 30Mar2021, the patient experienced spike in blood pressure, immediately ringing in ears, and facial stiffness. On 31Mar2021, the patient experienced brain fog and tiredness. It was further reported that after tracking O2, blood pressure, heart rate and exercise for one and half years with all being under normal, the patient almost immediately had ringing in ear, facial stiffness, high very high blood pressure, needed treatment to bring down 210 over 109 (blood pressure medicine). The events spike in blood pressure, had ringing in ear, and facial stiffness were considered as serious important medical event. The events spike in blood pressure, brain fog and tiredness resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: normal in 2020, blood pressure measurement: needed treatment to bring down 210 over 109 in 2021, heart rate: normal in 2020, oxygen saturation: normal in 2020, and physical examination: good (released for sports) on 30Sep2020. Therapeutic measures were taken as a result of all events. The patient received the second dose of bnt162b2 administered in left shoulder on 19Apr2021 09:30 (Batch/Lot number: EW0153). The patient was recovering from spike in blood pressure, immediately ringing in ears, and facial stiffness while outcome of brain fog and tiredness was not yet recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Oxygen saturation, Physical examination, Tinnitus
Clinical narrative: brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bring down 210 over 109.; immediately ringing in ears; Facial stiffness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm (reported as left shoulder) on 29Mar2021 09:30 (Batch/Lot Number: ER8730) (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient had no relevant medical history and no known allergies. There were no concomitant medications. On 30Mar2021, the patient experienced spike in blood pressure, immediately ringing in ears, and facial stiffness. On 31Mar2021, the patient experienced brain fog and tiredness. It was further reported that after tracking O2, blood pressure, heart rate and exercise for one and half years with all being under normal, the patient almost immediately had ringing in ear, facial stiffness, high very high blood pressure, needed treatment to bring down 210 over 109 (blood pressure medicine). The events spike in blood pressure, had ringing in ear, and facial stiffness were considered as serious important medical event. The events spike in blood pressure, brain fog and tiredness resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: normal in 2020, blood pressure measurement: needed treatment to bring down 210 over 109 in 2021, heart rate: normal in 2020, oxygen saturation: normal in 2020, and physical examination: good (released for sports) on 30Sep2020. Therapeutic measures were taken as a result of all events. The patient received the second dose of bnt162b2 administered in left shoulder on 19Apr2021 09:30 (Batch/Lot number: EW0153). The patient was recovering from spike in blood pressure, immediately ringing in ears, and facial stiffness while outcome of brain fog and tiredness was not yet recovered.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Oral pain
Clinical narrative: Ulcers in her mouth; Mouth is extremely sore; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 14May2021 13:00 (at the age of 51-years-old) as dose 1, single for covid-19 immunisation. Medical history included Allergies: penicillin, Metastatic breast cancer from 2017 and ongoing, ongoing Immune compromised, Surgeries: double mastectomy for the metastatic breast cancer from Dec2016 to an unknown date and anxiety. Concomitant medications included adriamycin [doxorubicin] taken for breast cancer metastatic from an unspecified start date and ongoing; alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.On 15May2021 the patient experienced ulcers in her mouth and mouth is extremely sore. The patient reported ulcers in her mouth and asked if these are common and can she receive the second dose. She had seen her doctor and was prescribed Magic Mouth wash. The patient stated that she had a side effect after the first dose of the vaccine. Should she get the second dose. The patient was told that she should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. She reported tha she just received the vaccine this past Friday, 14May2021 at 1:00 pm and had ulcers on both sides of her mouth and theres a lot of them. The inside started to get sore Saturday evening then Sunday they were there and Monday and today they have gotten bigger over the course of the past several days. She says the ulcers started in the evening. The patient was undergoing chemotherapy. She called her doctor to tell him what was happening and was prescribed a mouthwash called Magic Mouthwash. She does not know the dosage of the Magic Mouthwash. She called her dentist too because it was in the mouth and sent him pictures of the inside of her mouth but he did not call anything in because she is on chemotherapy and he did not want anything to interact with the chemotherapy. The caller says her niece had the same experience but did not report it, her sister-in-law said her lips were really dry too and she did not correlate it to the vaccine. She stated that her own mouth is extremely sore. This is a clone master case, report 1 of 3. Therapeutic measures were taken as a result of ulcers in her mouth and mouth is extremely sore. The outcome of the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm and head ache; Arm and head ache; This is a spontaneous report from a contactable consumer (patient). A 27-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in left arm on 17May2021 (at the age of 27 years) as dose 2, single for COVID-19 immunisation. Medical history included pulmonary oedema. The patient's concomitant medications included birth control pills taken two weeks prior to vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown) via an unspecified route of administration on 26Apr2021 as dose 1, single for COVID-19 immunisation. Patient had no other vaccine in four weeks and had no covid prior vaccination. On 18May2021, the patient experienced arm and headache. Patient had no covid tested post vaccination. The clinical outcome of the events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Poor quality product administered, Product preparation error
Clinical narrative: the vaccine administered was diluted with sterile water instead of sodium chloride; the vaccine administered was diluted with sterile water instead of sodium chloride; head hurts; This is a spontaneous report from a Pfizer sponsored program Call Center via medical information team. A contactable consumer (patient) reported that a 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182, NDC number: 59267-1000-01), via an unknown route of administration on right arm on 16May2021 at 02.45 PM (at the age of 54-year-old) as single dose for COVID-19 immunization. Medical history included asthma, atrial fibrillation, ongoing anxiety, obstructive sleep apnea, fibromyalgia, thyroid condition, migraine, allergy to shellfish (causes anaphylaxis), bone spurs and plantar fasciitis in her feet. Concomitant medications included blood thinner, cardiac medicine, inhaler, anxiety medicine, arthritic medication on her joints (all unspecified). Historical Vaccine included influenza vaccine (FLU) for immunisation and she got hives after receiving a flu shot. This happened a long time ago when the flu vaccine first came out. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last Sunday, 16May2021 at 2:45. She received a call on 19May2021 at 1pm (today as reported) from Pharmacy stating that the vaccine administered was diluted with sterile water instead of sodium chloride, and was advised to re-receive the first dose. She wanted to verify if they she get overdosed. Also her head hurts on 16May2021. She asked if it was okay to receive another first dose. She has anxiety and was very overwhelmed that this happens. The outcome of event head hurts was unknown.  follow-up attempts are possible. further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021571366 same drug/AE, different patient
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate
Clinical narrative: Very high heart rate over 120 for 8 hours; Fever.; Chills; Sore muscles; Headache; Dizzy; Very high heart rate over 120 for 8 hours.  Fever, chills, sore muscles, headache, dizzy, and tired.; This is a spontaneous report from a contactable consumer (patient). A 16-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left (at the age of 16 years old) on 12May2021 at 18:30 (Batch/Lot Number: EW0186) as DOSE 2, SINGLE for covid-19 immunization. Also reported 'Device Date:19May2021' no additional details provided. Facility where the most recent COVID-19 vaccine was administered was health facility. No other vaccines were given within 4 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Medical history included attention deficit hyperactivity disorder. Concomitant medication(s) included methylphenidate hydrochloride (CONCERTA) 54mg. Historical Vaccine includes BNT162B2 Dose 1 (at the age of 16 years old) on  21Apr2021 at 18:30 Batch/lot number ER8736, Left arm Covid-19 immunization and not events were reported. The patient previously took amoxicillin and experienced drug hypersensitivity. On 13May2021 at 02:00 The patient experienced Very high heart rate over 120 for 8 hours, Fever, chills, sore muscles, headache, dizzy, and tired. The event Very high heart rate over 120 for 8 hours was considered medically significant. The patient underwent lab tests and procedures which included heart rate: high on 13May2021 (Very high heart rate over 120 for 8 hours). No Treatment was given and No hospitalization was involved. The clinical outcome of the events was recovered May2021.   Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tachycardia
Clinical narrative: Very high heart rate over 120 for 8 hours; Fever.; Chills; Sore muscles; Headache; Dizzy; Very high heart rate over 120 for 8 hours.  Fever, chills, sore muscles, headache, dizzy, and tired.; This is a spontaneous report from a contactable consumer (patient). A 16-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left (at the age of 16 years old) on 12May2021 at 18:30 (Batch/Lot Number: EW0186) as DOSE 2, SINGLE for covid-19 immunization. Also reported 'Device Date:19May2021' no additional details provided. Facility where the most recent COVID-19 vaccine was administered was health facility. No other vaccines were given within 4 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Medical history included attention deficit hyperactivity disorder. Concomitant medication(s) included methylphenidate hydrochloride (CONCERTA) 54mg. Historical Vaccine includes BNT162B2 Dose 1 (at the age of 16 years old) on  21Apr2021 at 18:30 Batch/lot number ER8736, Left arm Covid-19 immunization and not events were reported. The patient previously took amoxicillin and experienced drug hypersensitivity. On 13May2021 at 02:00 The patient experienced Very high heart rate over 120 for 8 hours, Fever, chills, sore muscles, headache, dizzy, and tired. The event Very high heart rate over 120 for 8 hours was considered medically significant. The patient underwent lab tests and procedures which included heart rate: high on 13May2021 (Very high heart rate over 120 for 8 hours). No Treatment was given and No hospitalization was involved. The clinical outcome of the events was recovered May2021.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Malaise, Pyrexia
Clinical narrative: all of them in their family got the Pfizer vaccine and just didn't feel well for a day but was fine the day after; Arms hurt; had a low grade fever that evening, 99.2F to 99.4F; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Caller was calling for her 14-year-old daughter who received her 1st dose of the Pfizer COVID vaccine on Friday, last week at 16:15. She had come down with a 99.2F to 99.4F fever since then and had been going on. She mentioned that she was also tired, has flushed cheeks, and just feels like crap since then. This morning, her temperature was 99.4F. She mentioned that today was the 5th day that it had been going on. She mentioned that all of them in their family got the Pfizer vaccine and just didn't feel well for a day but was fine the day after. She was asking if lingering fevers that go away was a side effect specifically for adolescents. During call reporting on her daughter, caller also mentioned she, herself, got the COVID Pfizer vaccine, arms hurt and had a low-grade fever that evening. The next day it was gone. It was like one day. The patient underwent lab-test included fever 99.2F to 99.4F low grade fever. The clinical outcome of the events, all of them in their family got the Pfizer vaccine and just did not feel well for a day but was fine the day after, Arms hurt, had a low-grade fever that evening 99.2F to 99.4F was resolved in 2021 and outcome of all other events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia, Paraesthesia
Clinical narrative: Facial Numbness Left Side; Tingling on left part of forehead; She is very anxious to have her question addressed by USMI; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW1077), via an unspecified route of administration on 19May2021 11:15 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypochondriac (she is probably being a hypochondriac). The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COVID VACCINE, Lot number: EW0179) on 29Apr2021 for COVID-19 immunization. Patient got the second dose today at 11:15 and was fine as she was driving off. Then she noticed that the left part of her forehead was slightly tingling. Caller states that she went to scratch it and it is not totally numb; bus she is having facial numbness on the left side on 19May2021. Patient states she then searched it and something on the internet told her she would be paralyzed for life. Wants to know if that is true? Patient was very anxious to have her question addressed by contactable consumer on 19May2021. The more questions the call handler asks the more anxious the caller seems to become. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: First dose: A little tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613, Expiry date: unknown, Age at vaccination 64 years), dose 1 via an unspecified route of administration, on 25Mar2021 on left arm as dose 1, single for covid-19 immunization. Medical history included blood pressure measurement and history of smoking (he doesn't smoke any more). Concomitant medication(s) included lisinopril for 3-4 years taken for blood pressure measurement; vitamin c [ascorbic acid] (he has been taking vitamins his whole life); vitamin d nos and Multivitamins. The patient reported, that he received both doses of the Pfizer Covid-19 vaccine, the first on 25Mar2021 and the second on 15Apr2021. He reported that if a quarter will be kept, the US currency, wherever you had the Pfizer Covid-19 vaccine and it'll stick right there on his arm in the shoulder area around 14:00 on 19May2021. He placed a dime, nickel, penny, quarter, and even a key off of his key ring onto the Covid-19 vaccine injection site and all of the objects stuck. He reported that the metal objects would fall off if. He tried on any other location on his body. He had a concern and inquired what would be in the Covid-19 vaccine that would cause US currency and a key to stick to him. A magnet doesn't stick to currency so it can't be magnetism that is causing the currency and key to stick to the vaccine injection site. It stick to arm where the Covid-19 vaccine was injected. He began feeling a little tired around 2:00 PM on 25Mar2021 and by the next day he was fine. He received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158, Expiry date: unknown), dose 2 via an unspecified route of administration, on 15Apr2021 10:30 on left arm as dose 2, single for covid-19 immunization at Physician office. Prior Vaccinations (within 4 weeks) was None. The outcome of event was recovered on 25Mar2021.  Follow up needed, further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: My immune system was compromised; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation Solution for injection) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced "my immune system was compromised on an unspecified date. "Patient added, "I had an adverse reaction to the first one on April and the violent one where I thought I am going to die was on the second one" so, the patient's doctor told the patient to report it and that patient have a severe reaction to both doses and advised the patient to not have the booster shot since it will exhaust him/her. The reporter also stated, "I went to my doctor, my doctor told me to call to let the CDC know what exactly side effects I have". The seriousness of the event was non-serious. The outcome of event was unknown.  Follow-up(27May2021): New information was received from a contactable consumer includes: Reporter stated that the seriousness criteria for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect was reported as no.   Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Hypersomnia
Clinical narrative: has terrible pressure on her spine.; inflammation of spine; Difficulty breathing, no throat closing; Coughing; Kidney pain; Tiredness; Muscle pain; Headache; injection site really, really sore; slept most of time; This is a spontaneous report from a contactable consumer. This consumer (patient friend) reported for a 25-year-old female patient that:  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0177 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm right on 19May2021 17:30 (age at vaccination was 25-year-old) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder/ for mental health, 30mg, 1 tablet by mouth twice daily, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior or the same day and no problems with the vaccines in past. On 19May2021, it was reported on behalf of his friend, who got the first Pfizer BionTech vaccine yesterday and since then has been having most of the symptoms read about but had one that was not heard of. Has had terrible pressure on the lower spine, it feels like she got an epidural. Clarifies most symptoms patient experienced as inflammation of the spine, difficulty breathing, but no throat closing, more coughing, kidney pain, tiredness, muscle pains, headache, and the inject site was really really sore. When she first got it she was kind of tired and slept most of the time afterwards and this morning the spine pressure/inflammation started getting worse and worse as time goes by. Everything has gotten worsened. The patient did not visit Emergency Room and Physician Office. The outcome of the events was not recovered.  Follow up needed, further information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Renal pain, Spinal pain, Spondylitis, Vaccination site pain
Clinical narrative: has terrible pressure on her spine.; inflammation of spine; Difficulty breathing, no throat closing; Coughing; Kidney pain; Tiredness; Muscle pain; Headache; injection site really, really sore; slept most of time; This is a spontaneous report from a contactable consumer. This consumer (patient friend) reported for a 25-year-old female patient that:  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0177 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm right on 19May2021 17:30 (age at vaccination was 25-year-old) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder/ for mental health, 30mg, 1 tablet by mouth twice daily, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior or the same day and no problems with the vaccines in past. On 19May2021, it was reported on behalf of his friend, who got the first Pfizer BionTech vaccine yesterday and since then has been having most of the symptoms read about but had one that was not heard of. Has had terrible pressure on the lower spine, it feels like she got an epidural. Clarifies most symptoms patient experienced as inflammation of the spine, difficulty breathing, but no throat closing, more coughing, kidney pain, tiredness, muscle pains, headache, and the inject site was really really sore. When she first got it she was kind of tired and slept most of the time afterwards and this morning the spine pressure/inflammation started getting worse and worse as time goes by. Everything has gotten worsened. The patient did not visit Emergency Room and Physician Office. The outcome of the events was not recovered.  Follow up needed, further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling abnormal, Mood altered, Pain in extremity
Clinical narrative: feeling a little bit off; she moves it is when it hurts, it's tender.; she doesn't know how to explain, its an odd feeling; getting a little bit panicky; lightheaded; arm tenderness; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186 and expiration date was not reported), first dose via intramuscular route of administration, administered in arm left on 19May2021 11:00 (at the age of 66 year old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19May2021 16:00 patient experienced arm tenderness. On 20May2021 the patient experienced lightheaded, feeling a little bit off and patient stated that she moves it is when it hurts, it's tender and she doesn't know how to explain, its an odd feeling, getting a little bit panicky. Patient enquired with the first shot, since she did not experience severe allergic reactions/side effect she should be ok with the second dose. The outcome of the events arm tenderness, feeling a little bit off, she moves it is when it hurts, its tender were not recovered. The outcome of other events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: feeling a little bit off; she moves it is when it hurts, it's tender.; she doesn't know how to explain, its an odd feeling; getting a little bit panicky; lightheaded; arm tenderness; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186 and expiration date was not reported), first dose via intramuscular route of administration, administered in arm left on 19May2021 11:00 (at the age of 66 year old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19May2021 16:00 patient experienced arm tenderness. On 20May2021 the patient experienced lightheaded, feeling a little bit off and patient stated that she moves it is when it hurts, it's tender and she doesn't know how to explain, its an odd feeling, getting a little bit panicky. Patient enquired with the first shot, since she did not experience severe allergic reactions/side effect she should be ok with the second dose. The outcome of the events arm tenderness, feeling a little bit off, she moves it is when it hurts, its tender were not recovered. The outcome of other events were unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in both hands, including all fingers. The right hand resolved 3-4 days after the dose, and had gradual improvement; numbness and tingling in both hands, including all fingers. The right hand resolved 3-4 days after the dose, and had gradual improvement; This is a spontaneous report from a contactable other healthcare professioal. A 33-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced numbness and tingling in both hands, including all fingers. the right hand resolved 3-4 days after the dose, and had gradual improvement. Question: Call transferred from Safety by NT ID: withheld, Reportum: withheld. Caller remote disconnected prior to transfer. Outbound Call Successful at 11:33 AM EST, 20MAY2021. No additional AE information obtained from the Caller. Documenting possible duplicate AE, e-transmitting report for review (33 years old, Female). Patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine (Caller does not have date on both doses). "A couple of hours" after the first dose, Caller reported that Patient experienced "numbness and tingling in both hands, including all fingers. The right hand resolved 3-4 days after the dose, and had gradual improvement." "Within 2 hours after the second dose", Patient experienced "recurrent, worsening, tingling in the left hand, palm & finger, and ended at the wrist." The numbness & tingling did not come back to the right hand. Caller asked if this is a possible side effect to the vaccine? Response: Caller disconnected prior to transfer from Safety, but had a successful Callback. Spoke from attached document, explained VRBPAC information, gave disclaimers, and referred Patient to HCP for further guidance. The patient is a 33 year old who developed numbness and tingling in both hands and all 10 digits. The patient's right hand resolved in 3 to 4 days after receiving the first Covid 19 vaccine. Her symptoms started within 2 hours after receiving the first Covid 19 vaccine. She did have gradual improvement. The patient received the second Covid 19 vaccine and within a couple hours the patient experienced recurrent worsening tingling in the left hand, palm, and fingers. The tingling ended at the wrist and did not go up into the arm. The tingling did not come back in the right hand. Is this a common report. She reports her practice will be doing testing but have not done any testing yet. The reporter does not have any details regarding the Covid 19 vaccine like the NDC/Lot/Expiry, or the dates the Covid 19 vaccine was administered. The outcome for the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity
Clinical narrative: Migraine; Sore arm on the left side the first shot; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on an unspecified date in Apr2021 14:00 (Batch/Lot Number: EW0158, Expiry date: unknown) as 0.3 ML single for covid-19 immunization. Medical history and past drugs reported as no. Concomitant medications included lisinopril, omeprazole, fluticasone propionate (FLONASE ALLERGY RELIEF) and loratadine taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 was mentioned as no. The patient received any other vaccines within 4 weeks prior to the COVID vaccine as no. After first shot in Apr2021, the patient had very bad migraine a mile sore arm on the left side resulted in doctor or other healthcare professional office/clinic visit. The unspecified medication was giving help some with the pain. The outcome of events was not recovered.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: blister; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 14May2021 08:30 (Batch/Lot Number: EW0168) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's Medical history and concomitant medications were not reported. On 15May2021 10:00 patient experienced blister. No treatment was provided for the event. The outcome for the event was recovered on an unknown date.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain was different than that and he wanted to know if it could be related to vaccine. He asked if having joint pain after is that a side effect. He was having terrible joint pain in his right knee. He mentioned it is more common on the left and was not worried about his left but more in his right foot. He used to have this, but this time is something different. He wasn't sure if the joint pain in the right foot was normal or abnormal. Therapeutic measure was taken as a result of joint pain with pain medication. The outcome of the event was unknown.  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity, Swelling
Clinical narrative: His arm is been soar and in pain; I'm in bed, I feel weak, I feel pain, swollen and I am feeling weak; I'm in bed, I feel weak, I feel pain, swollen and I am feeling weak; This is a spontaneous report from a contactable consumer. A 58-year-old male patient (reporter's dad) received bnt162b2 (formulation: solution for injection; manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown; lot number: unknown), via an unspecified route of administration on an unspecified date as unknown dose number, single for covid-19 immunisation. Medical history included ongoing diabetes from an unknown date. Concomitant medication included insulin aspart (NOVOLOG; injection) taken for diabetes, the patient had been taking it morning and afternoon. He takes the dose 28 to 26 unit in morning, afternoon he gets 66 unit start and stop date were not reported. Reporter reported that, on 19May2021, has been having side effects, he is weak right now. His arm is been soar and in pain from the covid vaccine. Patient reported ''I am in bed, I feel weak, I feel pain, swollen and I am feeling weak''. The patient did not take any therapeutic measure for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Fatigue, Nasopharyngitis, Pain
Clinical narrative: cold-like symptoms; sniffling; coughing; when she inhales her chest hurts a little bit; sneezing; body aches; tired; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cold-like symptoms, sniffling, coughing, sneezing, does not have a fever. She also added that even when she inhales her chest hurts a little bit, she has slight body aches and was tired. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20May2021. Patient was asking whether to get the 2nd dose while having cold-like symptoms as scheduled on 21May2021. Reporter seriousness for cold-like symptoms was unspecified. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Sneezing
Clinical narrative: cold-like symptoms; sniffling; coughing; when she inhales her chest hurts a little bit; sneezing; body aches; tired; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cold-like symptoms, sniffling, coughing, sneezing, does not have a fever. She also added that even when she inhales her chest hurts a little bit, she has slight body aches and was tired. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20May2021. Patient was asking whether to get the 2nd dose while having cold-like symptoms as scheduled on 21May2021. Reporter seriousness for cold-like symptoms was unspecified. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information is expected.