chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; broke out with a rash around surgical area, ears and head itch/the rash is "raised, red, super itchy"; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727; Expiration Date: 30Jul2021), via an unspecified route of administration in the right shoulder on 18Mar2021 10:00 (age at vaccination: 68 years) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. The patient's medical history included lateral lumbar interbody fusion from 10Feb2021 to an unknown date. The patient had surgery 5 weeks before. There were no concomitant medications. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. On 18Ma2021, the patient broke out with a rash around surgical area, ears and head itch/the rash was raised, red, super itchy. The rash was only around her surgical site. The rash was really bumpy and dense. It was mostly around her surgical site on her abdomen. The reporter was thinking that she shouldn't get the second dose because of this. The adverse events did not require a visit to emergency room. The patient has been calling her surgeon. The patient did not have any prior vaccinations in four weeks nor was tested post vaccination. The outcome of the events was not recovered. There was no product quality complaint (PQC) present.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: it is aching into her shoulder, shoulder blade and in the front; my arm started hurting/aching at injection site,; arm sore; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 15Mar2021 13:15 (Batch/Lot number was not reported: Expiry date: unknown) as dose 1, single for covid-19 immunisation (at the age 71-years-old). The patient medical history and concomitant medications were not reported. The patient doesn't have family history. No relevant tests were conducted. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. On 15Mar2021, the patient experienced headache for a day then it was gone. On 22Mar2021, the patient experienced arm sore then last night it was really painful; and today it is aching into her shoulder, shoulder blade and in the front and she also reported yesterday on 23Mar2021, her arm started hurting/aching at injection site, going up into her shoulder. Reporter said and enquired for information about this and some information says a delayed onset can happen. The outcome of the event headache was recovered; arm sore was not recovered and for the remaining events it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma; This is a spontaneous report from a contactable consumer (patient). A 60-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration, in the left arm on an unspecified date in Mar2021 at 09:00 AM (age at the time of vaccination was 60-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma and diabetes from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Patient had no known allergies. Patient had no allergies to medications, food, or other products. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had received other medications (unspecified) within 2 weeks of vaccination. On 10Mar2021 at 09:15 AM, patient experienced asthma. Therapeutic measures were taken as a result of the event and treatment included albuterol. Reporter considered the event as non-serious. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Electrocardiogram, Muscle tightness, Myocardial necrosis marker
Clinical narrative: Tightness in chest; Tightness in neck area; Light headed; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:30 (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. Medical history included musculoskeletal disorder and known allergies with Pineapple or citrus fruits from an unknown date and unknown if ongoing. Concomitant medication(s) included cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and diclofenac (DICLOFENAC) received within 2 weeks of vaccination taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 10:30 the patient experienced tightness in chest and neck area, Lightheaded and blurry vision. The patient underwent lab tests and procedures which included electrocardiogram with unknown and myocardial necrosis marker with unknown results on an unspecified date. Therapeutic measures were taken as a result of all events. The adverse events resulted in emergency room visit. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Tightness in chest; Tightness in neck area; Light headed; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:30 (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. Medical history included musculoskeletal disorder and known allergies with Pineapple or citrus fruits from an unknown date and unknown if ongoing. Concomitant medication(s) included cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and diclofenac (DICLOFENAC) received within 2 weeks of vaccination taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 10:30 the patient experienced tightness in chest and neck area, Lightheaded and blurry vision. The patient underwent lab tests and procedures which included electrocardiogram with unknown and myocardial necrosis marker with unknown results on an unspecified date. Therapeutic measures were taken as a result of all events. The adverse events resulted in emergency room visit. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza, Pain, Pain in extremity
Clinical narrative: cold chills; fever; feel like I have flu symptoms; arm sore; feeling achy; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an un-Age: 71; Unit: Unknown received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 24Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling achy, arm sore on 24Mar2021, patient experienced cold chills on 25Mar2021 15:00, patient experienced fever, and feel like i have flu symptoms on 25Mar2021. Caller stated she was looking on the paperwork she received. She received the first dose of the Pfizer vaccine yesterday. his arm got sore last night and this morning for a while. she was feeling achy. Today at 3pm she had cold chills, some of the stuff there that's on the paperwork. Cold, achy joints. she started with a temperature at 99.3 then 100.3. The paperwork says if a fever goes over 100F or higher call Care/doctors. patient temperature is 100.3 it's already after 6pm here. she just wants to know it went over 100. she took Tylenol early this morning for his arm because it was sore and took ibuprofen. she feels like she have flu symptoms. Most people say it's the 2nd shot that they had reactions. she wasn't going to get the vaccine. Everything was so sketchy, one thing one day and something the next day.  she got covid in Oct, even though there was a lot of talk about not taking it. It's similar to how she was feeling now, but twice as worse. The patient underwent lab tests and procedures which included body temperature: 99.3 fahrenheit, body temperature: 100.3 fahrenheit, body temperature: goes over 100f fahrenheit on 25Mar2021. The outcome of events was unknown.   No follow-up attempts are possible. No information about lot/batch number cannot requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: cold chills; fever; feel like I have flu symptoms; arm sore; feeling achy; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an un-Age: 71; Unit: Unknown received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 24Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling achy, arm sore on 24Mar2021, patient experienced cold chills on 25Mar2021 15:00, patient experienced fever, and feel like i have flu symptoms on 25Mar2021. Caller stated she was looking on the paperwork she received. She received the first dose of the Pfizer vaccine yesterday. his arm got sore last night and this morning for a while. she was feeling achy. Today at 3pm she had cold chills, some of the stuff there that's on the paperwork. Cold, achy joints. she started with a temperature at 99.3 then 100.3. The paperwork says if a fever goes over 100F or higher call Care/doctors. patient temperature is 100.3 it's already after 6pm here. she just wants to know it went over 100. she took Tylenol early this morning for his arm because it was sore and took ibuprofen. she feels like she have flu symptoms. Most people say it's the 2nd shot that they had reactions. she wasn't going to get the vaccine. Everything was so sketchy, one thing one day and something the next day.  she got covid in Oct, even though there was a lot of talk about not taking it. It's similar to how she was feeling now, but twice as worse. The patient underwent lab tests and procedures which included body temperature: 99.3 fahrenheit, body temperature: 100.3 fahrenheit, body temperature: goes over 100f fahrenheit on 25Mar2021. The outcome of events was unknown.   No follow-up attempts are possible. No information about lot/batch number cannot requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Diarrhoea, Influenza like illness
Clinical narrative: 5 days after receiving vaccine I developed flu-like symptoms.; Minor diarrhea; upset stomach; chills; fever that got up to 100 at first then 101 later.; This is spontaneous report from a contactable other healthcare professional. This 41-year-old female other healthcare professional (patient) reported that: A 41-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown) via unknown route of administration on 19Mar2021 10:30 (at the age of 41 years old) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not have relevant medical history and concomitant medication. The patient did not have allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient did not receive any other medications within 2 weeks of vaccination. On 24Mar2021 14:30, the patient experienced 5 days after receiving vaccine patient developed flu-like symptoms, minor diarrhea, upset stomach, chills and fever that got up to 100 at first then 101 later. On 24Mar2021, the lab data included body temperature was fever that got up to 100 at first then 101 later and nasal swab test performed result was pending. Patient visited emergency room due to the events. No treatment was received for events. The patient did not have covid prior vaccination and tested for covid post vaccination. The outcome of the events was not recovered at the time of last observation.  No follow-up attempts were needed. No further information was expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: 5 days after receiving vaccine I developed flu-like symptoms.; Minor diarrhea; upset stomach; chills; fever that got up to 100 at first then 101 later.; This is spontaneous report from a contactable other healthcare professional. This 41-year-old female other healthcare professional (patient) reported that: A 41-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown) via unknown route of administration on 19Mar2021 10:30 (at the age of 41 years old) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not have relevant medical history and concomitant medication. The patient did not have allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient did not receive any other medications within 2 weeks of vaccination. On 24Mar2021 14:30, the patient experienced 5 days after receiving vaccine patient developed flu-like symptoms, minor diarrhea, upset stomach, chills and fever that got up to 100 at first then 101 later. On 24Mar2021, the lab data included body temperature was fever that got up to 100 at first then 101 later and nasal swab test performed result was pending. Patient visited emergency room due to the events. No treatment was received for events. The patient did not have covid prior vaccination and tested for covid post vaccination. The outcome of the events was not recovered at the time of last observation.  No follow-up attempts were needed. No further information was expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Itchy rashes all over my body; My entire tong felt thick and tingly; My entire tong felt thick and tingly; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; Nausea; Diarrhea; Throw-up once; Sweating; Shivering; Body ached all over; I woke-up feeling warm; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 (at the age of 37-year-old) as DOSE 2, SINGLE DOSE for covid-19 immunisation. Medical history included thyroid and asthma. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. List of any other medications the patient received within 2 weeks of vaccination was reported as yes. Patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Feb2021 09:15 (at the age of 37-year-old) as DOSE 1, SINGLE DOSE for covid-19 immunisation and experienced Itchy, Rashes all over my body, The back of my tong felt thick and tingly, Difficult to swallow, Wheezing, the site of injection was red, warm, itchy, and raised. On 18Mar2021 09:45, the patient experienced itchy rashes all over her body, her entire tong felt thick and tingly, the injection site was red, warm, itchy, and raised. That night, she woke up sweating and shivering and her body ached all over. She had diarrhea for two days and throw up once. She was still experiencing body pains, nausea, thick and tingly tong, and itchy rashes all over. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient received treatment for events as she was prescribed steroid pack and OTC Benadryl. The outcome of events diarrhea, vomiting was recovered and rest all other events was recovering.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia oral, Rash pruritic, Tongue disorder, Vaccination site erythema
Clinical narrative: Itchy rashes all over my body; My entire tong felt thick and tingly; My entire tong felt thick and tingly; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; Nausea; Diarrhea; Throw-up once; Sweating; Shivering; Body ached all over; I woke-up feeling warm; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 (at the age of 37-year-old) as DOSE 2, SINGLE DOSE for covid-19 immunisation. Medical history included thyroid and asthma. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. List of any other medications the patient received within 2 weeks of vaccination was reported as yes. Patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Feb2021 09:15 (at the age of 37-year-old) as DOSE 1, SINGLE DOSE for covid-19 immunisation and experienced Itchy, Rashes all over my body, The back of my tong felt thick and tingly, Difficult to swallow, Wheezing, the site of injection was red, warm, itchy, and raised. On 18Mar2021 09:45, the patient experienced itchy rashes all over her body, her entire tong felt thick and tingly, the injection site was red, warm, itchy, and raised. That night, she woke up sweating and shivering and her body ached all over. She had diarrhea for two days and throw up once. She was still experiencing body pains, nausea, thick and tingly tong, and itchy rashes all over. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient received treatment for events as she was prescribed steroid pack and OTC Benadryl. The outcome of events diarrhea, vomiting was recovered and rest all other events was recovering.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pruritus, Vaccination site warmth, Vomiting
Clinical narrative: Itchy rashes all over my body; My entire tong felt thick and tingly; My entire tong felt thick and tingly; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; The injection site was red, warm, itchy and raised; Nausea; Diarrhea; Throw-up once; Sweating; Shivering; Body ached all over; I woke-up feeling warm; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:15 (at the age of 37-year-old) as DOSE 2, SINGLE DOSE for covid-19 immunisation. Medical history included thyroid and asthma. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. List of any other medications the patient received within 2 weeks of vaccination was reported as yes. Patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Feb2021 09:15 (at the age of 37-year-old) as DOSE 1, SINGLE DOSE for covid-19 immunisation and experienced Itchy, Rashes all over my body, The back of my tong felt thick and tingly, Difficult to swallow, Wheezing, the site of injection was red, warm, itchy, and raised. On 18Mar2021 09:45, the patient experienced itchy rashes all over her body, her entire tong felt thick and tingly, the injection site was red, warm, itchy, and raised. That night, she woke up sweating and shivering and her body ached all over. She had diarrhea for two days and throw up once. She was still experiencing body pains, nausea, thick and tingly tong, and itchy rashes all over. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient received treatment for events as she was prescribed steroid pack and OTC Benadryl. The outcome of events diarrhea, vomiting was recovered and rest all other events was recovering.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Coordination abnormal, Decreased appetite, Diarrhoea
Clinical narrative: I had tremors for 2 hours constant shaking with no fever; joint and bone pain; joint and bone pain; headache; neck ache; diarrhea; no appetite; I felt crappy; my coordination is bad and mental capability is slow; my coordination is bad and mental capability is slow; vision was also blurred; have a stinging in my lung and i'm kind of short of breath; have a stinging in my lung and i'm kind of short of breath; started feeling ill; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 20Mar2021 09:00 (at the age of 66 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced uncomfortable and feeling sick. Patient stated "after I got my 1st dose, I had side effects, but they were not as extreme as the 2nd dose. After the 1st dose I mainly had 2 days of being uncomfortable and feeling sick, it was over in 2 days. I took my 2nd dose on Saturday 20Mar2021 AT 9 am and started feeling ill at 2pm, I had tremors for 2 hours constant shaking with no fever, I had joint and bone pain, all my long bones in arms and legs aching, headache, neck ache, diarrhea and no appetite, I felt crappy. This morning I took a shower and found that my coordination was bad and mental capability was slow and vision was also blurred, but I was getting better when moving about, I was better than before." Patient had spoken to her doctor. Patient added "I was concerned with my lungs; I had a stinging in my lung, and I was kind of short of breath". The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Malaise, Mental disorder
Clinical narrative: I had tremors for 2 hours constant shaking with no fever; joint and bone pain; joint and bone pain; headache; neck ache; diarrhea; no appetite; I felt crappy; my coordination is bad and mental capability is slow; my coordination is bad and mental capability is slow; vision was also blurred; have a stinging in my lung and i'm kind of short of breath; have a stinging in my lung and i'm kind of short of breath; started feeling ill; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 20Mar2021 09:00 (at the age of 66 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced uncomfortable and feeling sick. Patient stated "after I got my 1st dose, I had side effects, but they were not as extreme as the 2nd dose. After the 1st dose I mainly had 2 days of being uncomfortable and feeling sick, it was over in 2 days. I took my 2nd dose on Saturday 20Mar2021 AT 9 am and started feeling ill at 2pm, I had tremors for 2 hours constant shaking with no fever, I had joint and bone pain, all my long bones in arms and legs aching, headache, neck ache, diarrhea and no appetite, I felt crappy. This morning I took a shower and found that my coordination was bad and mental capability was slow and vision was also blurred, but I was getting better when moving about, I was better than before." Patient had spoken to her doctor. Patient added "I was concerned with my lungs; I had a stinging in my lung, and I was kind of short of breath". The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Tremor, Vision blurred
Clinical narrative: I had tremors for 2 hours constant shaking with no fever; joint and bone pain; joint and bone pain; headache; neck ache; diarrhea; no appetite; I felt crappy; my coordination is bad and mental capability is slow; my coordination is bad and mental capability is slow; vision was also blurred; have a stinging in my lung and i'm kind of short of breath; have a stinging in my lung and i'm kind of short of breath; started feeling ill; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 20Mar2021 09:00 (at the age of 66 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced uncomfortable and feeling sick. Patient stated "after I got my 1st dose, I had side effects, but they were not as extreme as the 2nd dose. After the 1st dose I mainly had 2 days of being uncomfortable and feeling sick, it was over in 2 days. I took my 2nd dose on Saturday 20Mar2021 AT 9 am and started feeling ill at 2pm, I had tremors for 2 hours constant shaking with no fever, I had joint and bone pain, all my long bones in arms and legs aching, headache, neck ache, diarrhea and no appetite, I felt crappy. This morning I took a shower and found that my coordination was bad and mental capability was slow and vision was also blurred, but I was getting better when moving about, I was better than before." Patient had spoken to her doctor. Patient added "I was concerned with my lungs; I had a stinging in my lung, and I was kind of short of breath". The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 47-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration on 11Mar2021 at 16:30 (Batch/Lot Number: EN6207) as DOSE 2, SINGLE (at the age of 47-year-old) for covid-19 immunisation. Medical history included lupus, Mixed connective tissue disease, Auto immune disease, a reaction MRI contrast and Allergy to IV medications from an unknown date and unknown if ongoing. Reporter stated that she was allergic to all IV medications, It's not a certain drug class, the pharmacist told her that it seems like she was just allergic to a additive in the IV medications. Concomitant medications (other products) included prednisone (PREDNISONE) and diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 18Feb2021 at 16:30 (Batch/lot number: EN6200, Expiry Not Written) (at the age of 47-year-old) for covid-19 immunisation and experienced Hives, rash and welts. The patient experienced welts/hives, rash on 11Mar2021, reporter stated that within 30 minutes the patient got the hives, rash, welts, but it lasted about a day and a half, however she had took a lot more prednisone before the second dose. She has also Recovered completely form this. When querying to patient, it was stated this was all creepy and scary on an unspecified date. It was reported that the patient was given a high dose of prednisone to take before both Pfizer Covid vaccine doses because she has a history of allergic reaction. She experienced welts/hives within 10 minutes after each vaccine dose. The patient wants to know if there was any information on the efficacy of the vaccine for individuals who have received the vaccine while taking high dose steroids. The reporter stated that she feels the Pfizer website guidance on receiving the second dose after an allergic reaction was not clear. The physician recommended to take high dose prednisone and Benadryl prior to receiving the vaccine. It was reported that prior to the Second dose, she took a total of about 150mg. Then after receiving the second dose the following day she took 40mg in total, then 20mg the next day, and 20mg again the next day after, and then she was done, she didn't have as bad of a rash. It was reported that physician said its fine for the second dose, and to just pre-medicate again. She took more prednisone this time prior to the second dose, got the second dose, she had a rash again. Her physician was indicating that the efficacy of the vaccine was now maybe lower because she had the Prednisone. The patient does not recall if it was Prednisone tablets or capsules, it was little round circle. Therapeutic measures were taken as a result of welts/hives and rash. The outcome of event reported as recovered on unknown date of Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness around injection site; for the last 2-3 days she had itching at the COVID-19 Vaccine injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number EN6208, Expiry Date: Unknown) via an unspecified route of administration, administered in arm right on 16Mar2021, administered between 1:30PM-2:00PM (at the age of 41-year-old) as a dose 1, single for COVID-19 immunisation at pharmacy/drug store. The patient's medical history included multiple sclerosis from 2018 and unknown if was ongoing. The patient's concomitant medications were not reported. There were no other products. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. There were no prior vaccinations (within 4 weeks). On the day before reporting (on 24Mar2021), the patient realized she had redness at the place where she was injected with the COVID-19 Vaccine. She said that she now remembered that for the last 2-3 days, she had itching at the COVID-19 Vaccine injection site, as well. She said she had not done anything to the COVID-19 Vaccine injection site. Reported she had multiple sclerosis, and her doctor told her it was safe for her to get the COVID-19 Vaccine. Reported she had a virtual appointment with her doctor yesterday (24Mar2021) and forgot to mention the injection site itching and redness to her doctor at that time. On the day of reporting, the day was 9 from the first dose. It was like a circle around that area that is red. Reported she did not look for injection site redness since she got her COVID-19 Vaccine. She said she just happened to look in the mirror, and saw the COVID-19 Vaccine injection site was red. She clarified the injection site was itching, and she had not touched the injection site, but looked in the mirror, and saw the injection site was red. She stated that she got her COVID-19 Vaccine in her right arm because she was lefthanded. The patient with Multiple Sclerosis since 2018 who received the first dose of the Pfizer Covid-19 vaccine on 16Mar2021. She has noticed itching for the past 2-3 days and yesterday redness around injection site. Is this normal? Her doctor said it was ok to get the vaccine.  Today is day 9 from the first dose. It was like a circle around that area that is red. She asked, what should I do? asked if what she was experiencing was a normal reaction to the COVID-19 Vaccine. She did not visit emergency room or physician room. Relevant tests were none. The outcome of both the events were not resolved.  The follow-up attempts were made. Follow-up attempts had been completed and no further information was expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye swelling, Nasal oedema, Swelling face, Throat irritation
Clinical narrative: specific side effect swelling in the face, eyes and nose; specific side effect swelling in the face, eyes and nose; specific side effect swelling in the face, eyes and nose; itching in her throat; Cough; This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EP7533), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 16:15 (Age at vaccination: 24 years old), as DOSE 1, SINGLE for covid-19 immunisation . Medical history included food allergy, complex regional pain syndrome. Concomitant medication(s) included duloxetine (DULOXETINE) taken for complex regional pain syndrome from an unspecified start date and ongoing.  Prior Vaccinations within 4 weeks not any other vaccinations administered. On 25Mar2021, patient stated that she got first dose of the Pfizer Covid vaccine yesterday at 4:15 PM, states she woke up this morning, her face was swollen, her eyelids and in between bridge of nose specifically, states she has had a reaction like this before to environmental allergies, states she was allergic to tree nuts but not any medications. Stated her throat was kind of itchy and had a cough last night that has now resolved. She was breathing fine.  The outcome of the event cough was recovered and rest all event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; This is a spontaneous report from a contactable consumer or other non hcp.  A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:30 as (At the age of 49-years) dose 2, single for covid-19 immunisation. Medical history included hypertension, hypothyroidism from an unknown date and unknown if ongoing both Controlled with medication. List of any other medications the patient received within 2 weeks of vaccination include Lisinopril, hydrochlorthiazide, and levothyroxine sodium (SYNTHROID) all was taken for an unspecified indication, start and stop date were not reported. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. The patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 AM as (At the age of 49-years) dose 1, single for covid-19 immunisation. The patient experienced flu like symptoms, nausea, fever up to 101.7, achiness, vomiting (vomiting, influenza like illness, nausea, pyrexia, and pain) on 25Mar2021 05:00. Patient received treatment for the adverse event as promethazine 25 mg and ibuprofen 800 mg. The patient underwent lab tests and procedures which included body temperature: 101.7 on 25Mar2021 Up to 101.7. The events were assessed as Non serious by reporter. The outcome of events was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; Flu like symptoms, nausea, fever up to 101.7, achiness, vomiting; This is a spontaneous report from a contactable consumer or other non hcp.  A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:30 as (At the age of 49-years) dose 2, single for covid-19 immunisation. Medical history included hypertension, hypothyroidism from an unknown date and unknown if ongoing both Controlled with medication. List of any other medications the patient received within 2 weeks of vaccination include Lisinopril, hydrochlorthiazide, and levothyroxine sodium (SYNTHROID) all was taken for an unspecified indication, start and stop date were not reported. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. The patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 AM as (At the age of 49-years) dose 1, single for covid-19 immunisation. The patient experienced flu like symptoms, nausea, fever up to 101.7, achiness, vomiting (vomiting, influenza like illness, nausea, pyrexia, and pain) on 25Mar2021 05:00. Patient received treatment for the adverse event as promethazine 25 mg and ibuprofen 800 mg. The patient underwent lab tests and procedures which included body temperature: 101.7 on 25Mar2021 Up to 101.7. The events were assessed as Non serious by reporter. The outcome of events was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eye swelling, Rash, Rash erythematous, Swelling face
Clinical narrative: facial swelling; including his eyes which were "swollen shit." / Swollen eyes; Red rash on face/ had rash around both eyes; had a rash on his thighs; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number EN6200, NDC number, UPC number and expiry date: unknown) via an unspecified route of administration on 10Mar2021 at 11:00 (age at vaccination: 73-years-old) in right arm as dose 1, single for covid-19 immunisation. Medical history (including any illness at time of vaccination) included ongoing hypothyroidism, ongoing hypertension, ongoing blood cholesterol increased for years and ongoing eczema for 10-20 years. This report was not related to a study or programme. The patient is a veteran and received the covid 19 vaccine. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid-19. No adverse events following prior vaccinations. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. No additional administered vaccines and no other vaccines administered on same date with the Pfizer vaccine considered as suspect. It was reported that the patient was fine on 11Mar2021 but on 12Mar2021, his face blew up, clarified face swelled, had rash on thighs and around both eyes, eyes were swollen shut. The reporter had him take his blood pressure and that was fine and everything else was fine. He had red rash on face. This lasted for about 5 days. The reporter didn't know if that was one of the allergic reaction's symptoms or not, but he had swollen eyes and all red on face. He had swelling that lasted about 5 days but finally subsided. The events required visit to physician office. Patient was taking an antihistamine for swelling and swollen eyes. The doctor did mention to the nurse to tell patient to continue with antihistamine. The rash and swelling finally really went away on 18Mar2021 and he was fine. Patient had no problem in breathing, blood pressure was normal. She wanted to know if he should get the second dose. His MD instructed him to get the second dose but the covid line directed him to not get the second dose. Patient was due for second covid 19 vaccine on 30Mar2021. The reporter was afraid because she had heard that the second covid 19 vaccine might give him a reaction. He had a reaction with the first covid 19 vaccine. The reporter's concern was, should he go and get the second covid 19 vaccine. The reporter wonders if his immune system was affected. The patient underwent lab tests and procedures which included blood pressure measurement: normal (fine) on an unknown date in Mar2021. The outcome of all the events was resolved on 18Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support. A contactable consumer (patient) reported that a male patient of unspecified age received second dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 20Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient got the second dose of the Covid 19 vaccine yesterday (20Mar2021) and he was reporting adverse events like chills and fever he experienced today (21Mar2021). He asked what medication that he can take. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: Overnight started to feel minor chills; Joint aches; Tiredness; A bit of a temperature; Did not sleep well; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number EP-6955) via an unspecified route of administration, administered arm left on 24Mar2021 11:45 (age at the time of vaccination 58 years) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient's medical history included high blood pressure and cholesterol. List of any other medications the patient received within 2 weeks of vaccination included lisinopril, atorvastatin (LIPITOR), multivitamin, acetylsalicylic acid (ASPIRIN LOW), multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. He was not diagnosed with covid-19 prior vaccination. The patient experienced on 25Mar2021 at 4:00, overnight started to feel minor chills, joint aches and tiredness. He did not sleep well last night, woke up this morning with chills and a bit of a temperature. He was not received treatment received for the adverse event. Since the vaccination, the patient was not tested for COVID-19. The patient underwent lab test and procedure included body temperature: a bit of a temperature on 25Mar2021. Event took place after use of product. The outcome of chills, joint aches and tiredness was recovering and outcome for other events was unknown.  No follow-up attempts were needed. No further information was expected.