chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 44-year) on 26Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jul2021 the patient experienced diarrhea, soreness of arms, swelling of underarm (arm where she got injected) that has a knot and feels warm, swollen lymph nodes. It was reported that the patient reported diarrhea, soreness of the arm, swelling under the arm that was injected after receiving her first dose of the Pfizer COVID-19 vaccine. The caller clarified that there was a knot under the arm that feels warm and said that it was a swollen lymph node. The caller also reported that her son also experienced swollen lymph nodes after he received the vaccine same day as her and the patient asked if swollen lymph node was one of the side effects of Pfizer COVID-19 vaccine. The clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Rash, Vaccination site swelling
Clinical narrative: Feverish feeling; Rash on my face, chest; Severe swollen on my Lymph node underneath my armpit on my arms on the vaccine site; Severe swollen on my Lymph node underneath my armpit on my arms on the vaccine site; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 26Jul2021 (Lot Number: FA7484) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (LOT number: EW0196) on 21Jun2021 and patient was fine with the first dose. It was reported that patient was just had a question for his/her second dose. Patient was fine with the first dose but for a second dose which he/she received yesterday (before reporting date). On Jul2021 patient experienced the Feverish feeling, patient woke up and patient got rash on his/her face, chest and patient got severe swollen on Lymph node underneath his/her armpit on arms on the vaccine site. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, unknown lot number), dose 2 via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection) on an unknown date as single dose for covid-19 immunisation. Patient received the two doses of the Pfizer´s COVID-19 vaccine, he was not sure but believes that it could have been two months ago on an unknown date in 2021. He was an immunocompromised patient and presented no antibodies after receiving the second dose of the Pfizer's COVID-19 vaccine. When he received the second dose of the vaccine he had mild flu like symptoms. He also wanted to know if a low level of antibodies could indicate that he requires a third "booster" dose. He was advised to get revaccinated by his physician. Patient underwent lab test which included antibody test on an unknown date in 2021 and which showed no antibodies. The outcome of the events was unknown.  The lot number for the vaccine bnt162b2 was not provided and has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate, Heart rate increased, Lung disorder
Clinical narrative: lung issues; heart issues; random heart rate spike; This is a spontaneous report from a non-contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in left arm on an unspecified date in May2021 as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. It was unknown if the patient received any concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced lung issues, heart issues and random heart rate spike on an unspecified date in May2021. It was reported that the patient feels iffy about the vaccine. Patient was hospitalized 2 times due to reaction to vaccine. She also stated the vaccine gave her heart and lung issues but they're finally going down some but still having random heart rate spike. Since the vaccination, patient has not been tested for COVID-19 and it was unknown if any treatment was received for the event. Outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia
Clinical narrative: The area where received the 2nd vaccination had no feeling; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the right arm on 27Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 08:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021, the area where the patient received the second vaccination had no feeling. She could not feel her skin to the touch but she had muscular feeling. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event. The patient contacted her physician who advised her to contact Pfizer as reported. The clinical outcome of the event the area where received the second vaccination had no feeling was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Ear disorder, Eye disorder, Eye swelling
Clinical narrative: ill feelings; Still ill feeling; Down feeling; Tiredness; Sore throat once in a while; Nausea; I am unwell; Woke up and my right ear I could hear my heartbeat; I could hear my heartbeat I mean really, really loud that it kind of woke me up;; Chills; Eye was kind of swollen; in the right eye I had, all red, the white was red; in the right eye I had, all red, the white was red for somehow the middle thing pop; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a 2nd of 2 reports. This consumer reported for a female patient that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWO80), dose 1 via an unspecified route of administration on 28Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ill feelings; still ill feeling, down feeling, tiredness, sore throat once in a while, nausea, unwell, woke up and right ear could hear, could hear heartbeat i mean really, really loud that it kind of woke me up, chills, eye was kind of swollen, in the right eye i had, all red, the white was red, in the right eye i had, all red, the white was red for somehow the middle thing pop, some were just annoying; not really bad off, it is just annoying, the way i feel just not myself (irritability, and feeling abnormal) on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100962492 same product and event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Irritability, Malaise, Nausea
Clinical narrative: ill feelings; Still ill feeling; Down feeling; Tiredness; Sore throat once in a while; Nausea; I am unwell; Woke up and my right ear I could hear my heartbeat; I could hear my heartbeat I mean really, really loud that it kind of woke me up;; Chills; Eye was kind of swollen; in the right eye I had, all red, the white was red; in the right eye I had, all red, the white was red for somehow the middle thing pop; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a 2nd of 2 reports. This consumer reported for a female patient that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWO80), dose 1 via an unspecified route of administration on 28Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ill feelings; still ill feeling, down feeling, tiredness, sore throat once in a while, nausea, unwell, woke up and right ear could hear, could hear heartbeat i mean really, really loud that it kind of woke me up, chills, eye was kind of swollen, in the right eye i had, all red, the white was red, in the right eye i had, all red, the white was red for somehow the middle thing pop, some were just annoying; not really bad off, it is just annoying, the way i feel just not myself (irritability, and feeling abnormal) on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100962492 same product and event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Palpitations
Clinical narrative: ill feelings; Still ill feeling; Down feeling; Tiredness; Sore throat once in a while; Nausea; I am unwell; Woke up and my right ear I could hear my heartbeat; I could hear my heartbeat I mean really, really loud that it kind of woke me up;; Chills; Eye was kind of swollen; in the right eye I had, all red, the white was red; in the right eye I had, all red, the white was red for somehow the middle thing pop; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a 2nd of 2 reports. This consumer reported for a female patient that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWO80), dose 1 via an unspecified route of administration on 28Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ill feelings; still ill feeling, down feeling, tiredness, sore throat once in a while, nausea, unwell, woke up and right ear could hear, could hear heartbeat i mean really, really loud that it kind of woke me up, chills, eye was kind of swollen, in the right eye i had, all red, the white was red, in the right eye i had, all red, the white was red for somehow the middle thing pop, some were just annoying; not really bad off, it is just annoying, the way i feel just not myself (irritability, and feeling abnormal) on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100962492 same product and event, different patients
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Visual impairment
Clinical narrative: rainbow vision going across her eye; looked one way and saw like rainbow, kind of halos/I had rainbow vision, floating in front of my eyes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection,Batch/Lot Number: EW0217; Expiration Date: 30Sep2021), via intramuscular, administered in left arm on 27Jul2021 14:00 (at age of 51-year-old) as dose 1, 0.3 ml single for covid-19 immunization. Medical history included respiratory illnesses in the past, pneumonia and bronchitis, this was a couple of years ago, and recovered completely. The patient previously had an allergic to Erythromycin, allergic reaction as a baby and never took it again.Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. No AE(s) following prior vaccinations.Other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none.The patient's concomitant medications were not reported she took vitamins, but no medicine. On 28Jul2021, 11:15 next day after receiving the vaccine the patient experienced rainbow vision going across her eye; looked one way and saw-like rainbow, kind of halos/patient had rainbow vision, floating in front of her eyes, but it was impeding her vision. The patient confirmed this rainbow vision was not ongoing and persisting at this time.She was driving home today and all of a sudden, her vision got a little weird.It just happened that one time. The caller wants to know if that is a side effect. The patient did not visit emergency room or physician's office. The patient underwent lab tests and procedures which included blood test: everything was fine on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood glucose, Blood glucose increased, Depression
Clinical narrative: RA flare; mental fogginess; extreme fatigue; increased blood sugars; joint pains; increased depression; generalized weakness; the worst migraine in over 25 years; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Jul2021 10:30 (Lot Number: EW0179; at the age of 49-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), hypothyroidism, allergies, and migraine. Concomitant medications were not specified. The patient previously took etanercept (ENBREL) and ibuprofen (MOTRIN) for migraine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 14Jul2021, the patient experienced RA flare, extreme fatigue, increased blood sugars, joint pains, increased depression, mental fogginess, generalized weakness, and the worst migraine in over 25 years. It was reported that patient have not had a migraine in 20 years that was untreatable with Motrin (for clarification) and thought this was after not having Enbrel for weeks prior to COVID vaccination. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mental impairment, Migraine, Rheumatoid arthritis
Clinical narrative: RA flare; mental fogginess; extreme fatigue; increased blood sugars; joint pains; increased depression; generalized weakness; the worst migraine in over 25 years; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Jul2021 10:30 (Lot Number: EW0179; at the age of 49-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), hypothyroidism, allergies, and migraine. Concomitant medications were not specified. The patient previously took etanercept (ENBREL) and ibuprofen (MOTRIN) for migraine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 14Jul2021, the patient experienced RA flare, extreme fatigue, increased blood sugars, joint pains, increased depression, mental fogginess, generalized weakness, and the worst migraine in over 25 years. It was reported that patient have not had a migraine in 20 years that was untreatable with Motrin (for clarification) and thought this was after not having Enbrel for weeks prior to COVID vaccination. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Nausea, Vertigo
Clinical narrative: Metallic taste immediately following injection that lasted about 24 hours; Headache and nausea with vertigo; Headache and nausea with vertigo; Headache and nausea with vertigo; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 27Jul2021 at 15:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic Epstein-Barr virus infection, osteonecrosis, hyperacusis, supraventricular tachycardia and allergy to latex, contrast dye, PCN, Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 25Jun2021 at 17:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation and took cefalexin (KEFLEX) on an unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jul2021 at 15:30, immediately following injection, the patient experienced metallic taste lasted about 24 hours, headache and nausea with vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metallic taste immediately following injection was resolved on 28Jul2021 and of the headache and nausea with vertigo was not resolved at the time of this report.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on left side of neck and under left arm. Under left arm is still swollen as of 28Jul2021; This is a spontaneous report from a contactable consumer (patient). This consumer reported different events for different vaccine doses for the same patient. This is one of the two reports.   A 25-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 26Mar2021 (Batch/Lot Number: EP7534) single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Apr2021, the patient experienced swollen lymph nodes on the left side of neck and under the left arm. The patient received the second dose of BNT162B2 on 05Jul2021 (Lot number: EN6206). Lymph node under the left arm was still swollen as of 28Jul2021. The patient did not receive treatment for the event but required a doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior to the vaccination and was not COVID tested post vaccination. Outcome of the event was not recovered. The event was reported as serious disabling, incapacitating.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Feeling abnormal, Feeling cold
Clinical narrative: Body is weak/ feeling weak in her body; dizziness/ keeps being dizzy; Left arm joint pain (injection arm).; Left jaw bone pain; Two fingers in right hand asleep; Feels like she has a cold, nose feels wet; Not walking fast, doesn't want to fall. State that this is weird because she feels like her body is weak.; Left arm joint pain (injection arm); This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0196, Expiration date: was not reported) via an unspecified route of administration (age at vaccination 62-year) in Right Arm on 20Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took septra and experienced drug hypersensitivity (Caller mentions she is allergic to Septra, like Bactrim). Patient previously received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0181, Expiration date: was not reported) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 29Jun2021 as dose 1, single for COVID-19 immunization and experienced her left-hand fingers went to sleep for about 7-8 hours. Prior Vaccinations (within 4 weeks) / list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. On 20Jul2021 the patient experienced dizziness/ keeps being dizzy; in Jul2021 the patient experienced left arm joint pain, body is weak/ feeling weak in her body, left jaw bone pain, two fingers in right hand asleep, feels like she has a cold, nose feels wet, Caller mentions that she is not walking fast, doesn't want to fall. state that this is weird because she feels like her body is weak, left arm joint pain. AE does not require to visit Emergency Room/Physician Office. Caller states that she has a question; Says that she had the vaccine on 20Jul2021 and keeps being dizzy, today she woke up and her body is weak, asks if this is normal after the vaccine, what she can do possibly about it. She states she is trying to call her primary care but is having difficulty getting through; States that her husband has called health insurance company for her also. Caller denies any medications, medical conditions, labs, testing or treatments relevant to report. The seriousness of the events was reported as non-serious. The clinical outcome of dizziness/ keeps being dizzy was recovering, while the outcome of all other events was unknown.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Pain in jaw
Clinical narrative: Body is weak/ feeling weak in her body; dizziness/ keeps being dizzy; Left arm joint pain (injection arm).; Left jaw bone pain; Two fingers in right hand asleep; Feels like she has a cold, nose feels wet; Not walking fast, doesn't want to fall. State that this is weird because she feels like her body is weak.; Left arm joint pain (injection arm); This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0196, Expiration date: was not reported) via an unspecified route of administration (age at vaccination 62-year) in Right Arm on 20Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took septra and experienced drug hypersensitivity (Caller mentions she is allergic to Septra, like Bactrim). Patient previously received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0181, Expiration date: was not reported) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 29Jun2021 as dose 1, single for COVID-19 immunization and experienced her left-hand fingers went to sleep for about 7-8 hours. Prior Vaccinations (within 4 weeks) / list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. On 20Jul2021 the patient experienced dizziness/ keeps being dizzy; in Jul2021 the patient experienced left arm joint pain, body is weak/ feeling weak in her body, left jaw bone pain, two fingers in right hand asleep, feels like she has a cold, nose feels wet, Caller mentions that she is not walking fast, doesn't want to fall. state that this is weird because she feels like her body is weak, left arm joint pain. AE does not require to visit Emergency Room/Physician Office. Caller states that she has a question; Says that she had the vaccine on 20Jul2021 and keeps being dizzy, today she woke up and her body is weak, asks if this is normal after the vaccine, what she can do possibly about it. She states she is trying to call her primary care but is having difficulty getting through; States that her husband has called health insurance company for her also. Caller denies any medications, medical conditions, labs, testing or treatments relevant to report. The seriousness of the events was reported as non-serious. The clinical outcome of dizziness/ keeps being dizzy was recovering, while the outcome of all other events was unknown.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report. A contactable female consumer (patient) reported for herself of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot Number: not reported), dose 1 via unspecified route on 22Jul2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient that had the on 22Jul2021 who experienced sore arm in 2021 and wanted to know if it was safe to go to a funeral after receiving the first dose. The outcome of event was unknown.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Humming in ears; This is a spontaneous report from a contactable nurse. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an intramuscular route of administration on 27Apr2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia, hypocalcemia, vitamin d deficiency, penicillin allergy, peanut allergy, shellfish allergy, reaction to sulfites and food allergy (chocolate and eggplant allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ubidecarenone (COENZYME Q10), vitamin b12 nos (VITAMIN B12), methylsulfonylmethane (MSM), fish oil/vitamin e nos (OMEGA 3), probiotics nos (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and vitamin k nos (VITAMIN K) all from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151), via an intramuscular route of administration on 06Apr2021, as a single dose for COVID-19 immunisation. The patient previously took sulfur (MANUFACTURER UNKNOWN), estrogen nos (MANUFACTURER UNKNOWN) and progesterone(MANUFACTURER UNKNOWN) and experienced allergy with all. On 11May2021, the patient experienced humming in ears. Therapeutic measures as a result of the event included treatment with flonase nasal spray and ASA 81mg. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event humming in ears was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: son experienced swollen lymph nodes. Got the vaccine same day as her; This is a spontaneous report from a contactable consumer (parent). This consumer reported for a male patient that, a male patient of 44 years old received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), dose 1 via an unspecified route of administration on 26Jul2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes. got the vaccine same day as her on Jul2021. The patient got her first dose of the Pfizer covid 19 vaccine last 26Jul2021, experienced diarrhea, soreness of arms, swelling of underarm (arm where she got injected) that has a knot and feels warm. Reported also that her son experienced swollen lymph nodes. Got the vaccine same day as her Asking if swollen lymph node was one of the side effects of our vaccine. Asked what they can do to ease the pain and swelling. Outcome of the event was unknown.  Information about lot/ Batch number has been requested.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in Hives two days later on face, hands and arms; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 24Jul2021 at 12:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Jul2021, two days after the vaccine, the patient broke out in hives on face, hands and arms. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event hives on face, hands and arms was recovering at the time of this report.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Paraesthesia, Pruritus
Clinical narrative: anaphylactic shock; severe itching; tingling in my extremities; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 07:45 (at the age of 80years) as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included known allergies: fish, seafood; No chronic health conditions. There were no concomitant medications.  The patient previously took Medrol, Cephalosporins, Naprosin, Celebrex, and class c cortisones (neomycin sulfate) and experienced allergy. The patient did not have Covid-19 prior to vaccination. On 14Jul2021 20:00, the patient experienced eight episodes of severe itching and tingling in her extremities over 6 days. Upon each onset she took 50 mg of Benadryl. Within a half hour she was better, but she was afraid as she gets anaphylactic shock. The patient was not tested for Covid-19 post vaccination. The outcome of events as recovering.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Pruritus
Clinical narrative: anaphylactic shock; severe itching; tingling in my extremities; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 07:45 (at the age of 80years) as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included known allergies: fish, seafood; No chronic health conditions. There were no concomitant medications.  The patient previously took Medrol, Cephalosporins, Naprosin, Celebrex, and class c cortisones (neomycin sulfate) and experienced allergy. The patient did not have Covid-19 prior to vaccination. On 14Jul2021 20:00, the patient experienced eight episodes of severe itching and tingling in her extremities over 6 days. Upon each onset she took 50 mg of Benadryl. Within a half hour she was better, but she was afraid as she gets anaphylactic shock. The patient was not tested for Covid-19 post vaccination. The outcome of events as recovering.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Throat tightness, Tryptase
Clinical narrative: anaphylactic shock; severe itching; tingling in my extremities; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 07:45 (at the age of 80years) as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included known allergies: fish, seafood; No chronic health conditions. There were no concomitant medications.  The patient previously took Medrol, Cephalosporins, Naprosin, Celebrex, and class c cortisones (neomycin sulfate) and experienced allergy. The patient did not have Covid-19 prior to vaccination. On 14Jul2021 20:00, the patient experienced eight episodes of severe itching and tingling in her extremities over 6 days. Upon each onset she took 50 mg of Benadryl. Within a half hour she was better, but she was afraid as she gets anaphylactic shock. The patient was not tested for Covid-19 post vaccination. The outcome of events as recovering.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Headache, Hypoaesthesia, Migraine
Clinical narrative: Headache; Numbness in the face; Migraine after he had 1st Pfizer dose/migraine was returning; Migraine after he had 1st Pfizer dose/migraine was returning; This is a spontaneous report from a contactable nurse (patient's parent). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0177), via an unspecified route of administration on 10Jun2021 (at the age of 19 years old) as dose 1, single for COVID-19 immunization. Medical history included migraine (but he was fine for like the last 2 years), diabetes, and food and drug allergy (not further specified). Concomitant medications were not reported. The reporter stated that the patient got his migraine on an unspecified date in Jun2021 after he had 1st COVID vaccine on 10Jun2021, the next day, 11Jun2021, he started having headache and continued on to the point that they ended up scheduling the Doctor's appointment. He was having anywhere from 2-7 migraines a day and they had the Doctor appointment and the Doctor started treatment on him. His migraine was so bad that he had numbness in his face and required an emergency room (ER) visit for that. The reporter thought that the Pfizer vaccine may have somehow contributed to the side-effects his migraine was returning. It was reported that the headache became different instead, he used to have migraine like once in a while, they go away and they were treatable, now they are coming in clusters and Tylenol, Ibuprofen even the prescribed medication the Doctor had given him which was Topamac was not helping and reached to severe enough level that he was actually having numbness in his face. The reporter said that after getting that Pfizer vaccine, the patient started getting severe migraines every day. They were bringing him to a point of tears. Nothing he had experienced before was like this. The outcome of the event "migraine was returning" was not recovered, and for other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain
Clinical narrative: Headache; low grade fever; chills; body aches; joint pain; It feels like she had Covid all over again; This is a spontaneous report received from a contactable (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 25Jul2021 as dose 1, single for covid-19 immunisation. The patients medical history included patient had Covid in October and was sick for a long time, but then got well. The patient's concomitant medications were not reported. The patient got her fist dose of the Pfizer BioNTech Covid-19 vaccine on Sunday, 25Jul2021 and on Jul2021, the patient experienced it feels like she had Covid all over again. Her symptoms included low grade fever, chills, body aches, joint pain, and headache. Patient was asking if it was normal to have it (side effects) this long and was it something she should be concerned with,How long will that last? Seriousness reported as no. The patient underwent lab tests and procedures which included positive sars-cov-2 test on Oct 2020. The outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Headache; low grade fever; chills; body aches; joint pain; It feels like she had Covid all over again; This is a spontaneous report received from a contactable (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 25Jul2021 as dose 1, single for covid-19 immunisation. The patients medical history included patient had Covid in October and was sick for a long time, but then got well. The patient's concomitant medications were not reported. The patient got her fist dose of the Pfizer BioNTech Covid-19 vaccine on Sunday, 25Jul2021 and on Jul2021, the patient experienced it feels like she had Covid all over again. Her symptoms included low grade fever, chills, body aches, joint pain, and headache. Patient was asking if it was normal to have it (side effects) this long and was it something she should be concerned with,How long will that last? Seriousness reported as no. The patient underwent lab tests and procedures which included positive sars-cov-2 test on Oct 2020. The outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Hypoaesthesia, Illness, Paraesthesia
Clinical narrative: the caller noticed her thumb and pinky fingers felt tingly and numb; she felt tingling in her fingers/it is still in her thumb and is still tingling; ear infection; super sick; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 56-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in arm on an unspecified date in May2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. No reactions were reported with the first dose. Patient had the second covid shot she has a question about a experience she had been having. It was reported that on an unspecified date in May2021 after administration of second dose on the way home from receiving the vaccine in her arm, her upper arm, the patient noticed her thumb and pinky fingers felt tingly/tingling and numb, so she just shook it out. That night she reported she felt like she slept on that arm and thought it fell asleep. She would like to know if it was possible they hit a nerve and would like information on the tingling. She further stated that she was super sick with an ear infection and forgot about the numbness/tingling. She said that she was very skinny. She said that she had been dealing with medical issues currently, and put the tingling on the back burner, but realized this week it was still in her thumb and was still tingling. She said that she had a lot of flu shots in the past but has never had the tingling. Now 3 months later she was recovering at home and noticed that her thumb was still numb and tingling sometimes but not in pain. She was very petite and wondered if the vaccination provider administered the vaccine in a nerve to cause this side effect. It was very concerning. The outcome of the events was recovering.  The lot number for the vaccine, [Pfizer/BioNTech Covid-19 Vaccine], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over body; This is a spontaneous report from a contactable Other Health Professional. A 4-decade old female patient received first dose of 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 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient complained of hives all over body after 3 days later on an unspecified date. Rash disappeared a few days later. The clinical outcome of the event was recovered on an unknown date.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Rash
Clinical narrative: He experienced right leg rash; Mild headache; Body aches; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date in 2021 as dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient mentioned that he had taken the shot 3 weeks ago and he was about to get his second dose but he experienced right leg rash and mild headache and body aches in 2021. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Muscle spasms, Musculoskeletal stiffness, Torticollis, Tremor
Clinical narrative: torticollis/ cervical dystonia; tremors; muscles spasms; stiff neck; This is a spontaneous report from a contactable consumer(patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot Number: ER2613) (at age 42-years-old) as dose 2, single for covid-19 immunisation.  The first dose was received on 04Mar2021 09:00(lot number: EN6205) (at age 42-years-old) on the left arm.  Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium taken for an unspecified indication, start and stop date were not reported. Patient started having neck issues, tremors and muscles spasms about 2-3 weeks after the second dose. She was experiencing stiff neck, and torticollis and as progressed it got worse she ended up in the ER and a CAT scan. She was referred to a neurologist that diagnosed with cervical dystonia for which patient had been under care. Patient did not had any previous medical issues prior to the Covid-19 Vaccine. Events started on 13Apr2021 13:00 and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Botex injection medication and physical therapy was given as treatment for the events. Outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.