chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Rash papular, Rash vesicular, SARS-CoV-2 test
Clinical narrative: The center of the rash patches began blistering in the centers; Left arm had large blotches; The rash was red with raised patches about 1 1/2 inches across; The rash was red with raised patches about 1 1/2 inches across; Intense Rash (hive like) on left arm; Extremely sore left shoulder; Stiff neck; Her left forearm was still sore and weakened; Her left forearm was still sore and weakened; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0162, expiry date: unknown) via an unspecified route of administration, administered in left arm on 10Apr2021 08:35 (age at vaccination 62-years-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient has no known allergies. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via an unspecified route of administration, left arm on 20Mar2021 09:30 AM (age at vaccination 62-years-old and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. On 09May2021 05:00 PM, the patient experienced intense rash (hive like) on left arm, extremely sore left shoulder, stiff neck. The patient experienced stiff neck and extremely sore left shoulder started on 09May2021 5 PM. By 14May2021, her left arm hand had large blotches. The rash was red with raised patches about 1 1/2 inches across. On 15May2021, the centre of the rash patches began blistering in the centres. Rash disappeared within a couple weeks. Her left forearm was still sore and weakened on an unknown date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination and since the day of vaccination, she has not tested for COVID-19. The patient had COVID test on 07Nov2020 and the result was negative. The patient visited clinic for consulting Doctor/other healthcare professional. The patient received treatment for the events experienced intense rash (hive like) on left arm, extremely sore left shoulder, stiff neck and had alignment to reduce neck pain. The patient had chiropractic treatment for the events. The outcome of the event rash on left arm was recovered on an unknown date in May2021, shoulder soreness, left forearm was still sore and weakened and stiff neck was not recovered, outcome of other events was unknown. These events were reported as non-serious.  Follow-up attempts are completed. No further information was expected
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; Fever of 100.7; Left Arm Pain where I can't move my arm/Excruciating pain in my Left Arm; Headache; This is a spontaneous report from a contactable 47-year-old female consumer (patient) reported for herself. A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0167) via an unspecified route of administration, administered in Left arm on 30Apr2021 at 01:15 (at the age of 47-year-old) as a single dose for COVID-19 immunization. Medical history included Lupus, Chronic Fatigue, Arthritis and have known allergies to Iodine, Shellfish and Opiods. Concomitant medications included Hydroxychloroquine, Azathioprine (IMURAN) and NSAIDs. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17May2021 at 03:45, patient experienced fever of 100.7, left arm pain where patient was not able to move her arm/excruciating pain in left arm 18 days after first vaccination, headache, and fatigue. Patient underwent lab test and procedures which included fever-100.7 on 17May2021. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: General joint Achiness; This is a spontaneous report received from a contactable male consumer (patient). A 58-year-old male patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 58 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated he had general joint achiness after COVID-19 vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (16Jul2021): 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 completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes came out the whole body within the next day after the second dose of vaccine.; This is a spontaneous report from a contactable consumer (patient).A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0164) via an unspecified route of administration, administered in left arm on 24Apr2021 at 13:15 (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported.  There were no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date (at the age of 60-year-old) as dose 1, single, for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Apr2021 at 12:00, within the next day after the second dose of vaccine the patient experienced rashes came out the whole body.  The event resulted in doctor or other healthcare professional office/clinic visit. The patient was not received any treatment of event. Outcome of the event was not resolved.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: He has an existing painful shoulder; This is a spontaneous report received from a sponsored program from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on 18May2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The medical history reported is painful shoulder. Concomitant medications were not reported. The patient experienced he has an existing painful shoulder on an unspecified date. It was reported that, got the first dose of the Pfizer vaccine on 27Apr2021 and the second dose was given today 18May2021 (correct dosing schedule). Patient was asking if he can take Tylenol now or should he wait before taking it to avoid contamination of the vaccine. Patient said he has an existing painful shoulder that's why he wants to take Tylenol. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity, Rash, SARS-CoV-2 test negative
Clinical narrative: pain on right leg, pain on right arm.; Right Ankle swollen; rash through body; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 55-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 10Feb2021 (at the age of 55-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history was not reported. Known allergies were reported as no. Concomitant medication included methimazole (METHIMAZOLE). Patient previously received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9809) via an unspecified route of administration on an unspecified date (at the age of 55-years-old) in right arm as dose 1, single for COVID-19 immunization and no reaction reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior to vaccination. On 14Feb2021 at 13:00, the patient experienced pain on right leg, pain on right arm, right ankle swollen, rash through body. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 08Mar2021. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: I have had fatigue and ongoing joint pain ever since the second vaccine.; I have had fatigue and ongoing joint pain ever since the second vaccine.; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 16:30 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 43 years). The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 17:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced in May2021 i have had fatigue and ongoing joint pain ever since the second vaccine. It's going on a month now. Therapeutic measures were taken as a result for all the events included with Physical therapy and NSAIDS. The patient visited doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were not recovered.  Information about batch/lot number has been requested  Follow-up (19Jul2021): 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 completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Dizziness, Hypersensitivity
Clinical narrative: had allergies before the shot and now they are getting worse; chills; they are getting worse; felt dizzy; This is a spontaneous report from a contactable consumer. A 71-year-old female patient reported for herself that received (pfizer-biontech covid-19 vaccine, Formulation: Solution for injection, Batch/Lot Number was EW0168, Expiration Date: Unknown), dose 2 Single on Friday, via an unspecified route of administration, on 14May2021(age at vaccination 71 years old) for covid-19 immunisation. Historical vaccine included dose1 (pfizer-biontech covid-19 vaccine, formulation: Solution for injection, Batch/Lot Number: EW0164 ; Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration on 07Apr2021 for covid-19 immunisation.Medical history included asthma which was going on, sore throat , swelling under her glands in her throat, her ear hurt, itchy eyes from her allergies. Concomitant medication included Singulair every day and Prednisone.On an unknow date, it was reported that  first dose was given 07Apr2021, with lot number EW0164, and the second dose was given 14May2021, with lot number EW0168. The first vaccine she didn't have allergy issues yet. Her allergies weren't acting up. The second shot gave her the same symptoms as the first. They did tell her not to take allergy medicine like Claritin or anything before the vaccine.On 14May2021, she received her second dose of the vaccine last Friday.She said that she had allergies before the shot, and now they are getting worse.She has asthma and she takes Singulair every day.She mentioned that she felt dizzy for a couple of days after the second shot, and she had chills.The caller clarified the details provided by the transferring agent.She had chills dizziness after the first shot too.The second shot did the same, but now she has allergies going on.She started to have allergies before the second shot.She just has her normal allergies going on.She called to ask if she could take prednisone. The previous agent said it would be up to her doctor.The pharmacy said not to that it might affect her immune system.She had the same symptoms after the first and second vaccine.She reported the first she thinks because she called to ask if dizziness was a part of it. She would get up and things would spin.That lasted a couple of days both times. She just had her normal allergies going on. Patient knows the allergies are not from the vaccine. She has allergies every year at this time, and she relates that to her asthma. She told the pharmacy before her second shot that her allergies were acting up.She was told not to take prednisone until 2 weeks out from the vaccine so it doesn't affect her immune system. The  outcome of all events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: experiencing extreme shoulder blade pain that has been preventing her from moving her shoulder; This is a spontaneous report received from a contactable consumer. This 21-years female consumer (patient) reported for herself. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date (Monday) as a single dose for covid-19 immunization. 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 an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. By the middle of the day on Tuesday, she has been experiencing extreme shoulder blade pain that has been preventing her from moving her shoulder. She has been taking tylenol but it has not been working. Outcome of the event was unknown Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Freezing phenomenon, Mobility decreased, Muscle disorder, Pain
Clinical narrative: trembling uncontrollably; freezing; felt like every muscle in my body had seized; I couldn't move; 103.5°fever / I'm still running a 101°fever; tremendous amount of pain; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 28-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, in Arm Right on 18May2021 at 15:00 (at the age of 28-year-old), as dose 2, single for COVID-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 27Apr2021 at 15:00 (at the age of 28-year-old), in Arm Right, as dose 1, single for COVID-19 immunization. Patients did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as not applicable. Patient had not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. Covid prior to the vaccination reported as no. patient had no known allergies. On 19May2021 05:00, patient experienced trembling uncontrollably and freezing. Patient felt like every muscle in my body had seized and she couldn't move. Patient was running a 103.5-degree fever. patient was still running a 101degree fever and patient body, while now able to move. Patient had tremendous amount of pain. The patient underwent lab tests and procedures which included on 19May2021 body temperature: 103.5 fahrenheit, I was running a 103.5 degree fever, body temperature: 101 fahrenheit on 19May2021 It is now 5:30pm, I'm still running a 101 degree fever. Patient did not received any treatment as a result of AE. The clinical outcome of the events was unknown.  Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: trembling uncontrollably; freezing; felt like every muscle in my body had seized; I couldn't move; 103.5°fever / I'm still running a 101°fever; tremendous amount of pain; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 28-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, in Arm Right on 18May2021 at 15:00 (at the age of 28-year-old), as dose 2, single for COVID-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 27Apr2021 at 15:00 (at the age of 28-year-old), in Arm Right, as dose 1, single for COVID-19 immunization. Patients did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as not applicable. Patient had not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. Covid prior to the vaccination reported as no. patient had no known allergies. On 19May2021 05:00, patient experienced trembling uncontrollably and freezing. Patient felt like every muscle in my body had seized and she couldn't move. Patient was running a 103.5-degree fever. patient was still running a 101degree fever and patient body, while now able to move. Patient had tremendous amount of pain. The patient underwent lab tests and procedures which included on 19May2021 body temperature: 103.5 fahrenheit, I was running a 103.5 degree fever, body temperature: 101 fahrenheit on 19May2021 It is now 5:30pm, I'm still running a 101 degree fever. Patient did not received any treatment as a result of AE. The clinical outcome of the events was unknown.  Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: rash on the buttocks, had a burning sensation; rash on the buttocks, had a burning sensation; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via sponsored program. A 64-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: unknown) via an unspecified route of administration on 28Mar2021 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: unknown) via an unspecified route of administration on 18Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Apr2021, the patient experienced rash on the buttocks, had a burning sensation. Patient received both doses and he stated that he thinks he was experiencing a side effect. He also wanted to talk to someone about the vaccine side effects. Therapeutic measures were taken as a result of the event, patient sought consultation and was given medications. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Constipation, Headache, Illness, Nausea, Pain
Clinical narrative: severe fever; body aches; nausea; head aches; constipation; vomits; has been sick; This is a spontaneous report from a contactable consumer or other non hcp reporting for a patient (wife).  A 36-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151, expiry date: unknown) via an unspecified route of administration on 06May2021 (at the age of 36-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, after vaccination on 06May2021, reporter stated that his wife experienced severe fever, body aches, nausea, headaches, and some constipation to the point that she doesn't eat or drink, and if she does she vomits. Reporter stated that his wife was currently in contact with their physician, but asked if these were possible side effects of the vaccine. Patient stated she got the vaccine on 06May2021 since then she has been sick and has had all the symptoms such as nausea, fever, body aches, headache, not able to eat food and as soon as she eat she vomits, and constipation. Patient stated she needed to report this and ask what she should she do. Patient stated she was in contact with the physician and talking to them. Reporter stated his wife the last couple of weeks had not been able to eat anything or drink anything. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: severe fever; body aches; nausea; head aches; constipation; vomits; has been sick; This is a spontaneous report from a contactable consumer or other non hcp reporting for a patient (wife).  A 36-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151, expiry date: unknown) via an unspecified route of administration on 06May2021 (at the age of 36-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, after vaccination on 06May2021, reporter stated that his wife experienced severe fever, body aches, nausea, headaches, and some constipation to the point that she doesn't eat or drink, and if she does she vomits. Reporter stated that his wife was currently in contact with their physician, but asked if these were possible side effects of the vaccine. Patient stated she got the vaccine on 06May2021 since then she has been sick and has had all the symptoms such as nausea, fever, body aches, headache, not able to eat food and as soon as she eat she vomits, and constipation. Patient stated she needed to report this and ask what she should she do. Patient stated she was in contact with the physician and talking to them. Reporter stated his wife the last couple of weeks had not been able to eat anything or drink anything. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Swelling face, Vomiting
Clinical narrative: severe fever; body aches; nausea; head aches; constipation; vomits; has been sick; This is a spontaneous report from a contactable consumer or other non hcp reporting for a patient (wife).  A 36-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151, expiry date: unknown) via an unspecified route of administration on 06May2021 (at the age of 36-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, after vaccination on 06May2021, reporter stated that his wife experienced severe fever, body aches, nausea, headaches, and some constipation to the point that she doesn't eat or drink, and if she does she vomits. Reporter stated that his wife was currently in contact with their physician, but asked if these were possible side effects of the vaccine. Patient stated she got the vaccine on 06May2021 since then she has been sick and has had all the symptoms such as nausea, fever, body aches, headache, not able to eat food and as soon as she eat she vomits, and constipation. Patient stated she needed to report this and ask what she should she do. Patient stated she was in contact with the physician and talking to them. Reporter stated his wife the last couple of weeks had not been able to eat anything or drink anything. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Contusion, Electrocardiogram
Clinical narrative: Big black bruise; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6207; Expiration Date: 21Jul2021), via intramuscular on 25Mar2021 in left arm as dose 2, single for covid-19 immunization. The patient's medical history was not reported, prior vaccinations and concomitant medication were reported as none. Historical vaccine included bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6198; Expiration Date: 21Jun2021), via intramuscular on 01Mar2021 in left arm as dose 1, single for covid-19 immunization and the patient experienced lightheaded, high blood pressure, left arm muscle weakness for a month, hands a little numb too. On 25Mar2021, the patient experienced big black bruise. The patient underwent lab tests and procedures which included blood pressure measurement: norm high on 01Mar2021, electrocardiogram: good (normal) on 01Mar2021. The outcome of event was recovered on 01Apr2021 in 1 week.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: second dose- had achy joints; This is a spontaneous report from a sponsored program. A contactable male consumer (patient) reported that: A 64-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on unknown date (at the age of 64-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on unknown date as dose 1, single for COVID-19 immunization. The patient experienced second dose- had achy joints. The outcome of the event was recovered on unspecified date.   Communication: Declined to complete a report at this time. Unable to obtain further details.  Follow up needed, further information was requested.  Follow-up (16Jul2021): 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 completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: arm pain in left shoulder blade; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date: unknown), via an unspecified route of administration, administered in left arm on 17May2021 (at the age of 21 years old) as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. The patient experienced arm pain in left shoulder blade (which was reported as worsened) on 18May2021. Patient had tried to treat the pain with Ice and Tylenol, but nothing was really getting rid of the pain. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Disturbance in attention, Feeding disorder, Pyrexia, Vomiting
Clinical narrative: keeps vomiting, She is unable to keep any food down; She still can't focus on anything; Fever; have not been able to eat; it almost seems like it is getting worse; This is a spontaneous report from a contactable Consumer (Mother). This Female consumer reporting for a 16-year-old daughter (Patient). A 16-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; Lot Number: EW0173), via an unspecified route of administration as dose 2, single on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation and had no side effects. Reporter Stated, Pfizer both for the first one she didn't have any side effect and that was Pfizer BioNTech and this one was like printed in green and it said Pfizer Covid 19 vaccine. Reporter Stated her daughter (patient) had the Pfizer vaccine (Covid 19 Vaccine) yesterday and she had like all the symptoms, and she kept on vomiting, and she was unable to keep any food down and so it's beyond 24 hours what it was been like noon and its now 8 O' clock at night on unspecified date. So, patient still cannot focus on anything, and she just keep on vomiting anything she eats. Reporter just don't understand symptoms like what it was going to alleviate or what should she expect. Reporter Stated no other medical conditions, but she was not able to eat, and it almost seems like it was getting worse she just had fever on unspecified date. Patient just tried taking Tylenol as treatment for side effect. Therapeutic measures were taken as a result of events with Tylenol. At the time of this report, the outcome of events was unknown.  Information about Lot/batch number was available. further information was expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anaemia
Clinical narrative: I am losing my taste; anemic; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on 19Mar2021 (at the age of 54-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported) via an unspecified route of administration on 26Feb2021 (at the age of 54-year-old) as dose 1, single for covid-19 immunization. The patient medical history included hypertension (high blood pressure), blood cholesterol (cholesterol), diabetes mellitus (diabetes), lupus-like syndrome (Lupus) and neoplasm malignant (cancer). The patient concomitant medication included metformin, doxepin, eicosapentaenoic acid ethyl ester (VASCEPA), clonazepam, bisoprolol fumarate, losartan, atorvastatin, potassium, hydrocodone, hydroxychloroquine, famotidine, calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, furosemide. On an unspecified date in 2021, the patient experienced she am losing taste and anaemic. The patient stated, the patient had first vaccine on 26Feb2021 and second vaccine on 19Mar2021 and in a week and half ago, the patient does not know why but lost taste. Was that normal. The patient stated she took Pentosan that is for diabetes. The patient stated, she took it, but she does not know it was for one of her doctors because she was anaemic and he wants some lab. She spoke with him on Monday (unspecified date) and he said the patient was fine. The outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling; Redness; Pain; This is a spontaneous report based on the information received by Pfizer . (LRN: LRN4318153)  A contactable healthcare professional reported that a 40-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphteria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. Medical history included (lower) leg localized swelling, ongoing asthma with acute exacerbation (also reported as severe persistent asthma, uncomplicated), blurry vision, carbuncle chest wall, cervicalgia, depression, possible diffuse nontoxic goiter, esophageal reflux, hepatic disorder, allergic rhinitis, vaginal discharge, lumbar strain, menorrhagia, open wound of the hand, telangiectasia, hereditary hemorrhagic and "last blood transfus". Concomitant medications were not reported. On an unknown date, the patient experienced swelling, redness and pain. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Movement disorder
Clinical narrative: I woke this morning and couldn't get out of bed.; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 07May2021 (at the age of: 68-years-old) as dose 2, single for covid-19 immunisation and also received pregabalin (LYRICA, Lot Number: UNKNOWN), via unspecified route of administration, start and stop date, not reported for an unspecified indication. Medical history included bleeding problems from an unknown date and unknown if ongoing. She has done Flonase and Rhinocort clinical trials in the past. About 5 years ago she woke up with a nosebleed and the doctor said there was nothing they could do. They had to go up through my groin to stop it. Concomitant medication(s) included losartan potassium (COZAAR) and tramadol (TRAMADOL) taken for an unspecified indication, start and stop date were not reported. The patient was allergic to tetanus, naproxen, hydrocodone, Niaspan, Tylenol, HCTZ, morphine, Toprol and Flexidine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 16Apr2021 (at the age of: 68-years-old) as dose 1, single for covid-19 immunisation it was reported that after receiving second dose she woke up the morning and could not get out of bed on an unspecified date. she was prescribed Lyrica because she had a history of bleeding problems, so she scared to take Lyrica. Outcome of the events was unknown.  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 completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Folliculitis, Pruritus, Rash, Urticaria
Clinical narrative: noticed in her scalp, little raised bumps; welts breaking out on her neck/welts went down to the area between her breasts; rash is still present and it itches now sometimes; rash is still present and it itches now sometimes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm left, on 12May2021 (age at vaccination: 63 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes sick with flu like symptoms and ongoing diabetes. The patient concomitant medications were not reported. It was reported that in the past she travelled to Africa and received many vaccines that the CDC recommended. One of them made her sick with flu like symptoms. It was reported that the patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm left, on an unspecified date, as a dose 1, single for COVID-19 immunization. On 14May2021, two days later she started to notice in her scalp, little raised bumps. They didn't itch but she noticed them. On her neck area, might be a rash but looks like welts breaking out on her neck and down into the area between her breasts. The patient queried if this was a side effect. The patient stated that nothing new has changed as far as her routines or her medications. The rash was still present, and it itches now sometimes. Reportedly the patient showed it to the pharmacist, and he told her to take Benadryl and Hydrocortisone. She's been doing that since last Thursday. Relevant Tests was None. The patient did not Emergency Room and Physician Office. Outcome of the event was not recovered.  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 completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Severe inflammation in my neck, spine, shoulders, elbow, wrist, fingers, knees, ankles.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 33-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: Ew0161, Expiry date : not reported), via an unspecified route of administration, in the Arm Right on 23Apr2021 15:00 (at the age of 33-years) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included ankylosing spondylitis. Patient previously took Vancomyosin, Rocephen and experienced allergy and latex allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccine, the patient was not diagnosed to COVID-19, since the vaccination the patient has not been tested for COVID-19. Concomitant medication(s) included diazepam (VALIUM), naproxen taken for an unspecified indication, start and stop date were not reported.  The patient previously took vancomycin, rocephin [ceftriaxone] and experienced allergy. The patient has received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: Ew0177, Expiry date : not reported), via an unspecified route of administration, in the Arm Right on 14May2021 16:00 as DOSE 2, SINGLE for covid-19 immunisation.  Facility type vaccine was workplace Pharmacy or drug store. On 24Apr2021 09:00, the patient experienced severe inflammation in his neck, spine, shoulders, elbow, wrist, fingers, knees, ankles. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe inflammation in my neck, spine, shoulders, elbow, wrist, fingers, knees, ankles (prednisone). The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Vaccination site pain
Clinical narrative: hurt at the site of the shot; bad headache; can't breath in when I have to blow my nose; This is a spontaneous report from a contactable consumer. A 60-years-old female non-pregnant patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EP7533, Expiry date: unknown) via an unspecified route of administration on 04May2021 11:00 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history includes high blood pressure ongoing, water retention, acid reflux, pain from accidents, thyroid, allergies, attention deficit caused by accident. Patient had known allergies: Don't known about medication but nose run after patient eat/when they mow the lawn. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), gabapentin (GABAPENTIN), ibuprofen (IBUPROFEN), pantoprazole (PANTOPRAZOLE) all taken for an unspecified indication, start and stop date were not reported and received within 2 weeks of vaccination. 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. On 10May2021 the patient art hurt at the site of the shot on second or forth day, it lasted for about a week. After about week I caught and had drink honey for it. Patient had to drink coffee or caffeine dabs for bad headache. Patient also have lisinopril and triamterene. Normal day patient have vitamin A,B,E and mineral zinc. Patient eat one egg in morning for vitamin Bs. Headache was really bad on the top of patient head and cant breath when she blow nose or get sinuses head ache from the things they clean paper nose tissue or tree product might give allergic sinus condition, but headache was really bad for about 1 or 2 weeks it comes back if patient don't drink caffeine. Still happens my arm stop hurting few days ago, but don't remember when they hurt yesterday or day before again. The clinical outcome of the event was recovering.   Follow-up (23Jun2021): Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Diarrhoea, Dyspnoea exertional, Fatigue
Clinical narrative: Shortness of breathe after slight physical activity; Persistent diarrhea; fatigue; Coughing/cough symptoms; chest pain; Pain; received DOSE 1 and DOSE 2 of bnt162B2 on same day; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received bnt162B2 (BNT162B2, solution for injection, Batch/Lot Number: ER8729), on 06Apr2021 07:30, via an unspecified route of administration in right arm, as DOSE 1, SINGLE for covid-19 immunization (age at vaccination: 48-year-old). The patient medical history included: continuing diabetes and psoriasis. The patient had no known allergies. Since the vaccination, the patient was not tested for COVID-19 and did not have COVID prior vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medication within two weeks of vaccination includes: Mucinex (1week) and Methyl prednisolone (1week). The patient also received dose 2 on same day bnt162B2 (BNT162B2, solution for injection, Batch/lot number: EW0170) was administered 06Apr2021 at 07:30 via an unspecified route of administration in right arm, for covid 19 immunization. Patient past drug history was reported was reported as none. On 08Apr2021 at 06:00 after two days of getting the vaccination, the patient started coughing and had chest pain. He had Difficulty breathing. Next day pain disappeared, how-ever chest pain and cough continued. On 29Apr2021, he had persistent diarrhea, had fatigue and still have chest pain and cough symptoms. He experienced shortness of breath after slight physical activity. The patient treatment included: Tylenol once for Difficulty breathing. The outcome of the events (Coughing/cough symptoms and chest pain, Persistent diarrhea, Fatigue, and Shortness of breath after slight physical activity) was not resolved. The outcome of the event Pain was resolved on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Shortness of breathe after slight physical activity; Persistent diarrhea; fatigue; Coughing/cough symptoms; chest pain; Pain; received DOSE 1 and DOSE 2 of bnt162B2 on same day; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received bnt162B2 (BNT162B2, solution for injection, Batch/Lot Number: ER8729), on 06Apr2021 07:30, via an unspecified route of administration in right arm, as DOSE 1, SINGLE for covid-19 immunization (age at vaccination: 48-year-old). The patient medical history included: continuing diabetes and psoriasis. The patient had no known allergies. Since the vaccination, the patient was not tested for COVID-19 and did not have COVID prior vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medication within two weeks of vaccination includes: Mucinex (1week) and Methyl prednisolone (1week). The patient also received dose 2 on same day bnt162B2 (BNT162B2, solution for injection, Batch/lot number: EW0170) was administered 06Apr2021 at 07:30 via an unspecified route of administration in right arm, for covid 19 immunization. Patient past drug history was reported was reported as none. On 08Apr2021 at 06:00 after two days of getting the vaccination, the patient started coughing and had chest pain. He had Difficulty breathing. Next day pain disappeared, how-ever chest pain and cough continued. On 29Apr2021, he had persistent diarrhea, had fatigue and still have chest pain and cough symptoms. He experienced shortness of breath after slight physical activity. The patient treatment included: Tylenol once for Difficulty breathing. The outcome of the events (Coughing/cough symptoms and chest pain, Persistent diarrhea, Fatigue, and Shortness of breath after slight physical activity) was not resolved. The outcome of the event Pain was resolved on an unspecified date.  Follow-up attempts completed. No further information expected.