chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: itchy rash and hives; Rash started morning of 5/15, within 24 hours covered whole body from scalp to feet; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 29-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 11May2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant were not reported. On 15 may2021 the patient had experienced rash started morning of 5/15, within 24 hours covered whole body from scalp to feet and on an unspecified date patient had experienced itchy rash and hives. Therapeutic measures were taken for the AE rash started morning of 5/15 and treatment included with antihistamine to stop rash. The clinical outcome of the events rash started morning of 5/15, within 24 hours covered whole body from scalp to feet was recovered on May2021, and outcome of the event itchy rash and hives were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.   Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bradyphrenia, Nausea, Pruritus, Skin irritation
Clinical narrative: Slight nausea; Under the skin irritation; under the skin itchiness; Just feeling sluggish now; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received bnt162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203; Expiration date: 26Feb2021), via an unspecified route of administration, in right arm on an unspecified date as DOSE 2, SINGLE for covid-19 immunization (age at vac-cination:72-year-old). The patient medical history and concomitant medication were not reported. The patient did not take any other products other than bnt162B2 vaccine. Previously the patient received first dose of bnt162B2 (BNT162B2, solution for injection, Batch/Lot number: EM9809; Expiration date: 05Feb2021) via an unspecified route of ad-ministration, in right arm on 05Feb2021 at 13:30, as DOSE 1, single for COVID-19 immunization. A couple of days after the second shot, on an unspecified date the patient had slight nausea but only lasted a couple of days. There was no vomiting with second shot like there was with first one. The patient also experienced under the skin itchiness, Under the skin irritation and was Just feeling sluggish now. The patient did not receive any treatment for the event Under the skin irritation. Treatment details for the event's slight nausea and just feeling sluggish was not provided. The outcome of the event slight nausea and under the skin irritation was recovered and the outcome of the event Just feeling sluggish and experienced under the skin itchiness was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal discomfort, Oropharyngeal pain, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: experiencing a bad sore and swollen throat; experiencing a bad sore and swollen throat; general feeling of sickness; My throat does not seem to be as bad today as it has been but I still feel lousy; This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable male consumer (patient) reported for himself that:  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced experiencing a bad sore and swollen throat, general feeling of sickness, and throat does not seem to be as bad, as it has been but still felled lousy on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test and streptococcus test Both the tests were Negative. At the time of reporting, the outcome of the events were 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.
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: experiencing a bad sore and swollen throat; experiencing a bad sore and swollen throat; general feeling of sickness; My throat does not seem to be as bad today as it has been but I still feel lousy; This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable male consumer (patient) reported for himself that:  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced experiencing a bad sore and swollen throat, general feeling of sickness, and throat does not seem to be as bad, as it has been but still felled lousy on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test and streptococcus test Both the tests were Negative. At the time of reporting, the outcome of the events were 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Rash pruritic
Clinical narrative: itchy blotchy rash; itchy elbows/my back was itching; elbows were dry; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0165, expiration date was not reported), via an unspecified route of administration, administered in right arm on 04May2021 10:30 (at the age of 39-years-old) as dose 1, single for covid-19 immunization. The patient medical history included known allergies to bactrim, yogurt only. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications 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. It was reported that last wednesday on 12May2021 patient started with itchy elbows. She put lotion on thinking my elbows were dry but she would wake up itching. Shortly after her back was itching. As of yesterday 17May she noticed around 3:30pm a red blotchy rash on birth arms. As the day/night went on it spread to my stomach. When she woke up she was covered from head (in my scalp) to toe with this itchy blotchy rash. She went to urgent care at 10:30 this morning 18May. They gave her liquid prednisone and a prescription to take for a week. The only thing she have done differently was get the Pfizer vaccine exactly two weeks ago from today Tuesday. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room visit. Therapeutic measures were taken as a result of itchy elbows/my back was itching, elbows were dry, itchy blotchy rash. Prednisone was received as treatment for the adverse events. device timestamp 18May2021. The reporter assessed the seriousness as non-serious as events did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling, Swelling
Clinical narrative: his left arm pit was swollen as well as his left chest; his left arm pit was swollen as well as his left chest; side of his chest became very swollen. It was numb.; This is a spontaneous report from contactable consumer (patient). A 16-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 12May2021 at 15:45 (at the age of 16-years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received his first dose of the Pfizer COVID-19 vaccine on 12May2021 and the next day on Saturday 13May2021 noticed his left arm pit was swollen as well as his left chest, he states that was the side he received the dose. Yesterday he started noticing improvement. It was after his first dose that he developed a very swollen arm pit, and the side of his chest became very swollen. It was numb. The afternoon the next day he noticed the swelling for the first time, but he thinks he had it that morning. He was playing basketball, and he remembers his armpit was swollen, and it was fat and jiggly. It started to improve some as of yesterday. He had not gone to the physician or ER. The outcome of the events was recovering.  Information on lot/batch number was available. Additional information has been requested,  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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Vaccination site discolouration, Vaccination site erythema, Vaccination site swelling
Clinical narrative: had redness and swelling in the area where he got the injection; had redness and swelling in the area where he got the injection; bruise; still has that discoloration in the area; This is a spontaneous report from a contactable consumer. This male patient (consumer) reported for himself. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 08Apr2021 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Within 24 hours, the patient had redness and swelling in the area where he got the injection and it still ongoing and now he had a bruise in that area. He still had that discoloration in the area. Still had a bruise 6 weeks later. Doesn't think he should get 2nd injection. Outcome of the event was not recovered. Follow-up attempts are needed; information about lot/batch number requested. Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Confusional state, Dyspnoea, Fatigue
Clinical narrative: drowsiness; chills; body aches; burning sensation of the skin; shortness of breath; extreme fatigue; anxiety; confusion; This is a spontaneous report from a contactable consumer. A 41-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Left on 14May2021 09:30 as dose 2, single for covid-19 immunisation (at the age of 41 years). Medical history included covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. Not known allergies. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On 14May2021 20:00 patient experienced drowsiness, chills, body aches, burning sensation of the skin. Days 2 through 4 - shortness of breath, extreme fatigue, anxiety and confusion. The treatment was not received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Skin burning sensation, Somnolence
Clinical narrative: drowsiness; chills; body aches; burning sensation of the skin; shortness of breath; extreme fatigue; anxiety; confusion; This is a spontaneous report from a contactable consumer. A 41-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Left on 14May2021 09:30 as dose 2, single for covid-19 immunisation (at the age of 41 years). Medical history included covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. Not known allergies. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On 14May2021 20:00 patient experienced drowsiness, chills, body aches, burning sensation of the skin. Days 2 through 4 - shortness of breath, extreme fatigue, anxiety and confusion. The treatment was not received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site mass
Clinical narrative: had like a ball form on left shoulder and it's hurting her, where she got the vaccine; it's hurting; This is a spontaneous report received from contactable consumer or other non-health professional reported for patient (sister-in-law).  A 26-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via an unknown route of administration in arm left (reported as left shoulder) on 14May2021 11AM (at the age of 26-years-old) as dose 1, single for covid-19 immunization. Medical history included ongoing thyroid. Concomitant medication included ongoing levothyroxine sodium [EUTIROX] Started taking two years ago for thyroid from unknown start and stop date. Family Medical History Relevant to AE reported as it was her aunt, she had the same thing, she got the Pfizer COVID vaccine one, and a ball formed on her shoulder, in the same spot where the patient had hers, but her aunt AE went down. No History of all previous immunization with the Pfizer vaccine considered as suspect and No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations taken within 4 weeks. No Adverse events reported following prior vaccinations. On 15May2021, patient reported to have had like a ball form on left shoulder and it was hurting her, where she got the vaccine, and it was growing more. It was hurting her more when she touches or if she accidentally touches it and she noticed at night, around 11 or 12 after the day of first dose of the Pfizer vaccine. AE did not require a visit to Emergency Room and Physician Office. Patient was not hospitalized. Investigation Assessment was reported as no. Reporter wanted to know is the second dose safe for her sister-in-law, which was scheduled on 04Jun2021. Relevant Tests were reported as no. Patient took Tylenol pills as therapeutic measures for the reported events, and it helped a little bit. Patient reported still she has it. Outcome of the events was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Urticaria
Clinical narrative: she broke out in hives from head to toe; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunization (age at vaccination 86 years) and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: SH6198) via an unspecified route of administration, administered on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced she broke out in hives from head to toe. Caller stated that 11 days after she got the first shot she broke out it hives head to foot. Caller who reports that 11 days after her first dose of the Pfizer COVID 19 vaccine she broke out in hives from head to toe. She reports, I have been on two rounds of steroids and I have had my second dose and I still have the hives. The steroid faded the hives somewhat but once I finished the steroid the hives came right back. The vaccine contains PEG and we think that is what caused the reaction. I have been in contact with the CDC and they told me to contact Pfizer. No one has any recommendations for me. patients allergist told her that she would have to have a monthly injection at the hospital of a medication called Zolair but we looked that up and it has many side effects as well. She had the second Pfizer vaccine and said that she has been on 2 rounds of steroids and they made the hives fade and took the itch away, but as soon as she stopped they came right back. Caller clarified that the steroids made the hives disappear. On an unspecified date the patient underwent lab tests and procedures which included blood test: normal, Blood work is not showing anything. Therapeutic measures were taken as a result of she broke out in hives from head to toe. The outcome of the event was reported as not recovered.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had a bad allergic reaction; This is a spontaneous report from a Pfizer from a contactable female consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 26Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a bad allergic reaction. Her Doctor already told her she should not but she does not know what to do and mentioned she is stuck in a state where she will have to keep on wearing a mask because she was not fully vaccinated. The 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.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: red welts on her arm/weird rash with welts that looked like drip marks; broke out in weird rash/weird rash with welts that looked like drip marks; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced red welts on her arm/weird rash with welts that looked like drip marks and broke out in weird rash/weird rash with welts that looked like drip marks on an unspecified date. It was reported that about to get the 2nd dose of the Pfizer covid vaccine. After the first dose she broke out in weird rash, red welts on her arm. She told the pharmacist that and they told her to call Pfizer. broke out into weird rash with welts that looked like drip marks. She had side effects with the first one. She broke out into a weird rash, with bright red giant welts that looked like drip marks. They looked like drip marks and were on the same arm as the vaccine was given. The outcome of the events was unknown.   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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: Moderate joint pain; muscle pain; tiredness; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0179 and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 07May2021 as dose 1, single (at the age of 38-years-old) for COVID-19 immunization. Medical history included inflammation, obesity, pollen allergy and COVID-19 (prior to vaccination) from unknown date to unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. Concomitant medications included paracetamol (Tylenol) and Zurtec. On 11May2021, patient had moderate joint pain, muscle pain and tiredness, included big toe, thumbs, underarm, neck and pelvic/leg area. Patient received no treatment for the events. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site lymphadenopathy
Clinical narrative: Swollen lyphnodes under injection site arm; I had a 103 degree fever from Friday midnight until Tuesday 4am.; This is a spontaneous report from a contactable consumer (Patient).  A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0177 and expiry date was not reported), via an unspecified route of administration on 14May2021 at 10: 15 AM (Age at vaccination: 32-year-old) on left arm as dose 1, single for covid 19 immunization.  Medical history included: The patient previously received Monoclonal Antibodies on 11Feb2021 due to a positive COVID diagnosis. The patient had allergies to tetanus shot. The patient did not get tested positive for covid 19 post vaccination. The patient Neither received any other vaccines with in four weeks nor received any other medications in two weeks of covid vaccine. Concomitant medications were not reported. On 14May2021 at 11: 45 pm (midnight), the patient had fever of 103 degrees (from Friday until Tuesday at 4 AM). The patient had swollen lymph nodes on the injection site arm. Therefore, the patient visited doctor/other healthcare professionals office/clinic. The patient was treated with Tylenol, advil, and elective IV fluids. Outcome of event swollen lymph nodes on the injection site arm was recovered on unspecified date in 2021 and fever was recovered on unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: Sleepiness; Fatigue; Body aches; Low grade fever; This is a spontaneous report received from a contactable consumer or other non-health care professional reported for himself.  A 66-year-old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8737), via an unspecified route of administration, in left arm on 07Apr2021 at 11:00 (at the age of 66-year-old) as dose 2, single for covid-19 immunization at doctor office/urgent care centre. Medical history included prostate cancer in 2020. Patient reported known allergies as no. Concomitant medications included dietary supplements; patient receive any other medications within two weeks of vaccination was reported as yes. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6204), via an unspecified route of administration, in left arm on 13Mar2021 at 13:00 (at the age of 66-year-old) as dose 1, single for covid-19 immunization at doctor office/urgent care centre. On 17May2021 at 10:00, 6 weeks post vaccination of second dose, patient experienced fatigue, body aches, low grade fever and sleepines. These events resulted in doctor or other healthcare professional office/clinic visit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient underwent lab tests and procedures which included body temperature resulted in low grade fever, on 17May2021. Therapeutic measures were reported as no. The outcome of the events which began 30 hours ago, was not recovered.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival pain, Muscle tightness, Oral pain, Swollen tongue
Clinical narrative: tongue swelling; jaw clenching; pain in nerves in mouth at times; gum sensitivity; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EWD151) via an unspecified route of administration, administered in arm right on 08Apr2021 (at the age of 28-years old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Patient medical history was reported as none. Patient had no known allergies. Concomitant medication included marijuana. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 08May2021, the patient experienced tongue swelling, jaw clenching, pain in nerves in mouth at times and gum sensitivity. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with steroids for the events. The outcome of the events was not recovered. The case was assessed as non serious.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: arm was sore; fever; chills; headache; lethargic; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Age at Vaccination 39-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arm was sore, fever, chills, headache and lethargic. It was reported that patient reported that he took COVID-19 vaccine. After that in the evening he had fever, chills, headache and was lethargic. The next day those symptoms resolved but arm was sore. The outcome of the event arm was sore was unknown. The outcome of the events was recovered on unspecified date.  Information about batch/Lot number has been requested.  Follow-up (28Jun2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient). A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left on 11May2021 14:00 (at the age of 34-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. No known allergies reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot Number: EN6198) on 20Apr2021 14:00 as dose 1, single at left arm for covid-19 immunization. No other vaccine four weeks. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. The patient experienced rash on 12May2021 08:00. Reporter assessed case as non-serious. No treatment received for the event. The outcome of event was not recovered.   Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Heart rate, Heart rate increased, Malaise
Clinical narrative: Fever; Bad headache; All over body aches; Malaise; Nausea; Rapid heartbeat; Shortness of breath when walking; This is a spontaneous report received from a contactable consumer or other non-health care professional reported for herself. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8736), via an unspecified route of administration, in right arm on 17MAY2021 at 14:45 (at the age of 56-year-old) as dose 1, single for covid-19 immunization at doctor's office/urgent care. Medical history included breast cancer 2016-2018, Covid-19 on 09Nov2020 and had Long-Haulers syndrome and was hesitant to get the vaccine, she finally consented; pneumonia on 30Dec2020, neuropathy, chronic pain, elevated blood pressure, degenerative disc disease. Known allergies was reported as penicillin, taxol. Patient received any other medications within two weeks of vaccination was reported as yes with concomitant medication included lisinopril, tamoxifen, pregabalin and venlafaxine ER. On 18May2021 at 05:00, after the first dose patient developed a fever, bad headache, all over body aches, malaise, nausea, rapid heartbeat, and shortness of breath when walking. She felt like she had COVID-19 again. Prior to the vaccination, the patient diagnosed with COVID-19 was reported as yes. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient underwent lab tests and procedures which included COVID-19 virus test resulted as positive, on an unspecified date; rapid heartbeat on 18May2021. Therapeutic measures were reported as no. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Bad headache; All over body aches; Malaise; Nausea; Rapid heartbeat; Shortness of breath when walking; This is a spontaneous report received from a contactable consumer or other non-health care professional reported for herself. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8736), via an unspecified route of administration, in right arm on 17MAY2021 at 14:45 (at the age of 56-year-old) as dose 1, single for covid-19 immunization at doctor's office/urgent care. Medical history included breast cancer 2016-2018, Covid-19 on 09Nov2020 and had Long-Haulers syndrome and was hesitant to get the vaccine, she finally consented; pneumonia on 30Dec2020, neuropathy, chronic pain, elevated blood pressure, degenerative disc disease. Known allergies was reported as penicillin, taxol. Patient received any other medications within two weeks of vaccination was reported as yes with concomitant medication included lisinopril, tamoxifen, pregabalin and venlafaxine ER. On 18May2021 at 05:00, after the first dose patient developed a fever, bad headache, all over body aches, malaise, nausea, rapid heartbeat, and shortness of breath when walking. She felt like she had COVID-19 again. Prior to the vaccination, the patient diagnosed with COVID-19 was reported as yes. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient underwent lab tests and procedures which included COVID-19 virus test resulted as positive, on an unspecified date; rapid heartbeat on 18May2021. Therapeutic measures were reported as no. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Developed severe itching and rash on the scalp, face and neck around 15:00; Developed severe itching and rash on the scalp, face and neck around 15:00; This is a spontaneous report from a contactable consumer (Patient).  A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in left arm on 18May2021 09:45 (at the age of 44-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medication was not reported. Patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. 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 27Apr2021 (at the age of 44-years-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced No reaction on previous exposure to Vaccine. Patient took Ibuprofen 400 mg x 2 around 12:30 to prevent any fever. On 18May2021 15:00 after the second dose of vaccination, the patient experienced developed severe itching and rash on the scalp, face and neck around 15:00. Patient never had any side effects from Ibuprofen, other vaccinations or any other drugs. The patient did not received treatment for the adverse events. The outcome of events was not recovered.  Follow-up attempts completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Tiredness; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 24-year-old (Non pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0182) via intramuscular route of administration, administered in left arm, on 08May2021 10:35 (at the age of 24 years), as dose 2, single for COVID-19 immunization. Medical history included fungal infection. Concomitant medications included TERBINAFINE HCL taken for fungal infection from 30Mar2021 and ongoing; desogestrel, ethinylestradiol (ISIBLOOM) taken for contraception from 07Apr2021 and ongoing. The patient had no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8731) via intramuscular route of administration, administered in left arm, on 17Apr2021 10:30 (at the age of 24 years), as dose 1, single for COVID-19 immunization, in 1-5 days the patient experienced unspecified events on 17Apr2021 14:00, the outcome of the event reported was recovered on unspecified date in 2021, the patient was not received treatment for the events. Prior vaccination, the patient was not infected from COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient was not received prior vaccination within 4 weeks. Within 24 hours on 08May2021 (onset time reported was 02:00 next day), the patient experienced fever, tiredness, muscle pain, chills. The patient was not received treatment for the events. The outcome of the events was recovered on unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Fall, Pain in extremity
Clinical narrative: Sore, reclarified as left arm after the first and second vaccine; Fell and had knee pain, after first vaccine; Fell and had knee pain, after first vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8729; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 11Apr2021 17:45 (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing glucose tolerance impaired; pre-diabetic, ongoing blood cholesterol increased; high cholesterol caller stated at about the same time as diagnosed with prediabetes. Concomitant medications included naproxen (NAPROXEN) taken for arthralgia from an unspecified start date to 10May2021; valaciclovir hydrochloride (VALACYCLOVIR HCL) taken for herpes zoster from 12May2021 and ongoing. Patient had not family medical history relevant to AE(s). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fell and had knee pain, after first vaccine on 19Apr2021. Later on patient experienced sore, reclarified as left arm after the first and second vaccine. AEs (fell and had knee pain, after first vaccine) resulted in physician office visit as caller had a video appointment with her doctor. AEs did not require emergency room. Therapeutic measures were taken as a result of fell and had knee pain, after first vaccine. Caller confirmed that the Motrin was effective for the knee pain. Caller stated that the Naproxen helped to lessen the knee pain. Caller stated she went to the Urgent Care, for the knee pain, and they gave her Naproxen. The patient underwent lab tests and procedures which included blood glucose: normal on an unspecified date. The outcome of all events was resolved on an unspecified date in 2021.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Heart rate, Heart rate increased, Hot flush, Nausea
Clinical narrative: Hot flashes; fever 102; nausea; Vein discoloration; aches; bone pain; tongue swelling; noticeable arm swelling/armpit swelling; itchiness (arm); elevated heart rate; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185, expiry date: unknown) via an unspecified route of administration, in right arm on 17May2021 05:30 PM (at the age of 36-year-old) as dose 2, single for covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0161, expiry date: unknown) via an unspecified route of administration, administered in right arm on 26Apr2021 05:30 PM (at the age of 36-year-old) as dose 1, single for covid-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patients medical history included known allergies with colligene, pork, gluten, penicillin and pituitary tumor, arthritis, polycystic ovarian syndrome (PCOS). Concomitant medications received within 2 weeks of vaccination included dulaglutide (TRULICITY), Metformin and Vitamins for an unspecified indication. She was not diagnosed with COVID-19 prior to vaccination and patient has not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Patient experienced hot flashes, fever 102, nausea, vein discoloration, aches, bone pain, tongue swelling, noticeable arm swelling, armpit swelling, itchiness (arm), and elevated heart rate, all on 18May2021 at 03:00 AM, she had not received any treatment for the events reported. Outcome of all events was not recovered.  Follow-up attempts completed. No further information is expected  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus, Pyrexia, Swollen tongue
Clinical narrative: Hot flashes; fever 102; nausea; Vein discoloration; aches; bone pain; tongue swelling; noticeable arm swelling/armpit swelling; itchiness (arm); elevated heart rate; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185, expiry date: unknown) via an unspecified route of administration, in right arm on 17May2021 05:30 PM (at the age of 36-year-old) as dose 2, single for covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0161, expiry date: unknown) via an unspecified route of administration, administered in right arm on 26Apr2021 05:30 PM (at the age of 36-year-old) as dose 1, single for covid-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patients medical history included known allergies with colligene, pork, gluten, penicillin and pituitary tumor, arthritis, polycystic ovarian syndrome (PCOS). Concomitant medications received within 2 weeks of vaccination included dulaglutide (TRULICITY), Metformin and Vitamins for an unspecified indication. She was not diagnosed with COVID-19 prior to vaccination and patient has not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Patient experienced hot flashes, fever 102, nausea, vein discoloration, aches, bone pain, tongue swelling, noticeable arm swelling, armpit swelling, itchiness (arm), and elevated heart rate, all on 18May2021 at 03:00 AM, she had not received any treatment for the events reported. Outcome of all events was not recovered.  Follow-up attempts completed. No further information is expected  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vein discolouration
Clinical narrative: Hot flashes; fever 102; nausea; Vein discoloration; aches; bone pain; tongue swelling; noticeable arm swelling/armpit swelling; itchiness (arm); elevated heart rate; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185, expiry date: unknown) via an unspecified route of administration, in right arm on 17May2021 05:30 PM (at the age of 36-year-old) as dose 2, single for covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0161, expiry date: unknown) via an unspecified route of administration, administered in right arm on 26Apr2021 05:30 PM (at the age of 36-year-old) as dose 1, single for covid-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patients medical history included known allergies with colligene, pork, gluten, penicillin and pituitary tumor, arthritis, polycystic ovarian syndrome (PCOS). Concomitant medications received within 2 weeks of vaccination included dulaglutide (TRULICITY), Metformin and Vitamins for an unspecified indication. She was not diagnosed with COVID-19 prior to vaccination and patient has not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Patient experienced hot flashes, fever 102, nausea, vein discoloration, aches, bone pain, tongue swelling, noticeable arm swelling, armpit swelling, itchiness (arm), and elevated heart rate, all on 18May2021 at 03:00 AM, she had not received any treatment for the events reported. Outcome of all events was not recovered.  Follow-up attempts completed. No further information is expected  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: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash. Started 4 days after 2nd shot. Still have rash as of today, 7th day after shot; This is a spontaneous report from a contactable consumer.   A 63-year-old-male consumer (patient) reported for himself. A 63-years-old male patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/lot number: EW0182) via unknown route of administration in right arm on 12May2021 at 9:30 (at the age of 63 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included Being treated for rectal cancer, allergy to Neosporin and Systemic sclerosis on 19Nov2020. Concomitant medication included loperamide hydrochloride (IMODIUM AD) for an unknown indication from an unknown date. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/lot number: ER8731) via unknown route of administration in left arm on 21Apr2021 at 09:45AM (at the age of 63 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16May2021, the patient experienced full body rash, started 4 days after 2nd shot. Still had rash as of today, 7th day after shot. the patient was not diagnosed with COVID-19, Prior to vaccination and not tested for COVID-19, Since the vaccination. The patient did not receive treatment for the event. At the time of this report the outcome of the event was not recovered.  No follow-up attempts were needed. No further information was expected.