chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site swelling; puffy/there is not a big lump there; Injection site redness; Injection site itching; Some muscle pain/muscle ache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-year-old female patient received a second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration dates were not reported), via intramuscular route of administration in left arm on 28Jan2021 10:45, as single dose for prevent covid/COVID-19 immunisation. The patient's medical history was not reported. Patient took unspecified concomitant medications (She was taking a lot of mediations, it is too long of a list to go into). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an intramuscular route of administration in left arm, on 07Jan2021 around 11:30-11:45 am, for COVID-19 immunisation and on an unknown date, the patient received tetanus shot and experienced ache. It was reported that, she got the second dose of the COVID vaccine last Thursday (28Jan2021). On 28Jan2021, patient had muscle pain/muscle ache. Patient had injection site swelling, injection site redness and injection site itching on 29Jan2021. Reported it kind of looks like a circle and it seems like according to paperwork that it was not an usual reaction or side effect. She wanted to make sure that these are reported reactions to the vaccine. Clarified swelling as it was puffy and there was not a big lump there. Stated that the muscle ache was like an ache when you get a tetanus shot and It was a little worse. She did not think about it till today. She has an aide that comes once a week and was advised to bring it to the attention of the doctor. She still had some muscle pain as of 02Feb2021. Seriousness of the events was reported as non serious. The outcome of the all the events was reported as worsened/not recovered (at the time of the report).  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19; This is a spontaneous report from a non-contactable consumer received via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient was tested positive for covid 19. It was reported that she tested positive for Covid 19 one week after first dose and she is due for the second dose of the vaccine next week. The patient underwent lab tests and procedures which included sars-cov-2 test with positive results on an unknown date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Feb2021 as SINGLE DOSE for covid-19 immunization.  Medical history and concomitant medications were not reported. On an unspecified date, patient experienced hip pain. It was reported that, she had her first dose of Pfizer's COVID vaccine today on 02Feb2021, upon follow-up (02Feb2021) reported that she hasn't experienced any side effects but wants to know if she can take Cortisone for hip pain. She will have the second dose on 23Feb2021. Upon follow-up (05Feb2021), her doctor reported her as she "needs a new hip." Patient was scheduled for surgery on 25Feb2021, and patient would like to know if it is going to effect the vaccine for her to have surgery so soon after receiving the second dose of the Pfizer COVID-19 vaccine. It was reported that, patient is scheduled to have hip surgery after receiving both doses of the Pfizer COVID-19 vaccine. The outcome for the event was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Body temperature, Body temperature abnormal, Fatigue
Clinical narrative: Arm soreness; Fatigue; Throbbing headache; Rib and upper back pain; Rib and upper back pain; Axilla pain; Rapid pulse; Temp; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE ;solution for injection; Lot Number: EN53185/21) via intramuscular to right arm on 29Jan2021 at 11:00 as single dose for COVID-19 immunisation. Medical history included hypertension, gastrooesophageal reflux disease, anxiety, thrombosis, COVID-19. The patient had Covid prior vaccination. Concomitant medications included labetalol, NORVASC, ELIQUIS, OMEPRAZOLE, ZOLOFT, VIT D and VIT C. The patient experienced Arm soreness, temp, fatigue, throbbing headache, rib and upper back pain, axilla pain, rapid pulse on 29Jan2021 at 20:00. The patient underwent lab tests and procedures which included body temperature with unknown result heart rate with rapid result, viral test with negative on 01Feb2021. Therapeutic measures were taken for the events with Tylenol. The outcome of the events was recovering.  Follow-up activities have been completed and no further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Arm soreness; Fatigue; Throbbing headache; Rib and upper back pain; Rib and upper back pain; Axilla pain; Rapid pulse; Temp; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE ;solution for injection; Lot Number: EN53185/21) via intramuscular to right arm on 29Jan2021 at 11:00 as single dose for COVID-19 immunisation. Medical history included hypertension, gastrooesophageal reflux disease, anxiety, thrombosis, COVID-19. The patient had Covid prior vaccination. Concomitant medications included labetalol, NORVASC, ELIQUIS, OMEPRAZOLE, ZOLOFT, VIT D and VIT C. The patient experienced Arm soreness, temp, fatigue, throbbing headache, rib and upper back pain, axilla pain, rapid pulse on 29Jan2021 at 20:00. The patient underwent lab tests and procedures which included body temperature with unknown result heart rate with rapid result, viral test with negative on 01Feb2021. Therapeutic measures were taken for the events with Tylenol. The outcome of the events was recovering.  Follow-up activities have been completed and no further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: Arm soreness; Fatigue; Throbbing headache; Rib and upper back pain; Rib and upper back pain; Axilla pain; Rapid pulse; Temp; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE ;solution for injection; Lot Number: EN53185/21) via intramuscular to right arm on 29Jan2021 at 11:00 as single dose for COVID-19 immunisation. Medical history included hypertension, gastrooesophageal reflux disease, anxiety, thrombosis, COVID-19. The patient had Covid prior vaccination. Concomitant medications included labetalol, NORVASC, ELIQUIS, OMEPRAZOLE, ZOLOFT, VIT D and VIT C. The patient experienced Arm soreness, temp, fatigue, throbbing headache, rib and upper back pain, axilla pain, rapid pulse on 29Jan2021 at 20:00. The patient underwent lab tests and procedures which included body temperature with unknown result heart rate with rapid result, viral test with negative on 01Feb2021. Therapeutic measures were taken for the events with Tylenol. The outcome of the events was recovering.  Follow-up activities have been completed and no further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with covid; This is a spontaneous report from contactable consumer (patient reported herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 21Jan2021 in series via injection at single dose to her left arm for COVID prevention. The patient's medical history and concomitant medications were not reported. Caller stated she received the first dose of the Pfizer Covid 19 vaccine on 21Jan2021 and has been diagnosed with Covid. Caller stated her second dose on 11Feb2021 and wanted to know if she could get the second dose. Caller hung up on the agent before the offer to be transferred to unit could be made. Caller stated she was very disappointed in the information that Pfizer could give about getting the vaccine after a diagnosis of Covid. AE noted. It was reported that on 01Feb2021, just came down with a mild case of COVID. Caller reported that the lot number was not written on her vaccine card. Caller stated she was due for her second dose on 11Feb2021, and she is wondering if she still needs to get the second dose of the product. Caller reported that her primary care physician was not aware of her current situation but provided consent for follow up anyway. Caller was tested for COVID on Monday 01Feb2021, and it was a 48hour test. Caller got results that morning that were positive for COVID. Caller had no other vaccines on the same day as the COVID vaccine. Caller stated that her husband had COVID, and she decided to get tested. Caller confirmed that her husband had not yet had the COVID vaccine, he had not had it because he had been sick. On 01Feb2021, COVID-19 48hour test showed positive. Outcome of the event was unknown. No more information available. No PQC Present.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID-19; This is a spontaneous report from a contactable Pharmacist reported for an unspecified age and gender of patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was  diagnosed with COVID-19. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: He is now having coughs and flem; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for male patient (reporter's father) of an unspecified age received BNT162B2(BNT1PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date at single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient was now having coughs and flem on an unspecified date with outcome of unknown.  Information about Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Injury, Myalgia, Pyrexia
Clinical narrative: Muscle pain on the first day; low grade fever of up to 101.5F; "traumatic" side effects; This is a spontaneous report from a contactable Consumer (patient) via Medical information Team. A (Age: 70; Unit: Unknown) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on Jan2021 as a SINGLE DOSE for covid-19 immunisation. Medical history included COVID-19. The patient's concomitant medications were not reported. The patient experienced Muscle pain on the first day (non-serious) on Jan2021, low grade fever of up to 101.5F (non-serious) on Jan2021 and "traumatic" side effects on Jan2021. Call is asking for guidance because he received the 1st dose 2 weeks ago and is experiencing "traumatic" side effects such as Muscle pain on the first day and 2 full days of substantial low grade fever of up to 101.5F. He mentioned that he had "a moderate take of" COVID before and the fever he experienced was almost the same with it being a fever for 2 weeks on and off. The muscle pain was much less than what he experienced with COVID. He is asking if it will be okay for him to take the 2nd dose given the side effects that he experienced and the fact that he had Covid before and might have developed antibodies already. I've heard that the side effects of the 2nd dose would be more egregious than the 1st. Do you have data on that? That's very helpful, you've been great. The patient underwent lab tests and procedures which included Fever: 101.5 F (low grade) on an unspecified date in Jan2021. For events, outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Nasopharyngitis
Clinical narrative: she felt really cold (chills); she felt really cold (chills); she stated joint pain; not feeling well today; This is a spontaneous report from a contactable consumer (patient reported herself) via Pfizer Sales Representative. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER COVID 19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 28Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical Vaccine included BNT162B2 for Covid-19 immunization. It was reported that, "Pfizer Sales Representative had a scheduled call to discuss Pfizer Injectables updates today. The Pharmacy Buyer reported receiving her second dose of the Pfizer COVID 19 vaccine yesterday 28Jan2021. She reported not feeling well today (29Jan2021). She stated she felt really cold (chills) and believed she stated joint pain. She was going home sick for the day after our call today. Had no additional details. She received the vaccine via employer". Event took place after use of product. Outcome of the events was unknown.  Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: tired; itchy; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced after first 1st dose got tired and was itchy. Outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Ear infection, Fatigue, Infection
Clinical narrative: confused and tired; confused and tired; ear infection as well as an ongoing infection; ear infection as well as an ongoing infection; This is as spontaneous report received from a contactable consume. A patient of 101-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: Not reported) via unspecified route on 20Jan2021 at 12:00 PM, as a single dose in the right arm for COVID-19 immunization. Patient's medical history included conjunctive heart failure, can't walk, allergies, chronic infection in hip. The patient was not allergic to medications, food and other products. Concomitant medications included spirolactone, Asprin (acetylsalicylic acid), Ceflex (cefaclor), Lasik (furosemide) and Esclaminapin. The patient did not receive other vaccines in four weeks. The patient had not diagnosed with COVID-19 prior vaccination and was not tested since the vaccination. On 28Jan2021 at 04:45 PM, 7days after the vaccination, the patient experienced confusion and tired. The patient also had ear infection along with ongoing treatment which included Keflex. The patient visited to clinic due to events. Event of ear infection was not sure if it was caused by vaccine. Outcome of events was resolved with lasting effects.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea
Clinical narrative: nausea reported around 3am; This is a spontaneous report from a contactable other healthcare professional and contactable consumer.  A 47-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immuization; tofacitinib citrate (XELJANZ XR, strength: 11mg), oral from Jan2021 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. The patient's medical history include ulcerative colitis, heart attack 2018, blood clot. high cholesterol, heart -low ejection fraction. Concomitant medications were not reported. The patient experienced nausea reported around 3am.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: she contracted COVID 3 days after getting the 1st dose; This is a spontaneous report from a contactable consumer (Patient's mother) via Medical information Team. A female patient (daughter) of an unspecified age (Age: 27; Unit: Unknown) 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 SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she contracted covid 3 days after getting the 1st dose (non-serious) on an unspecified date. Patient's mother called to ask if her daughter can take the 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE since she contracted COVID 3 days after getting the 1st dose - She is now fully recovered and ready for the 2nd shot on 11Feb2021. The outcome was recovered on an unspecified date.  Information on the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from a contactable consumer (reporting for herself), via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date of Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date of Jan2021, patient had her first dose of the covid vaccine (a week ago), she wants to report their reaction series of vomiting on an unspecified date of Jan2021, 6 hours after receiving the first dose, 6x lasted 15 mins. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test, Somnolence
Clinical narrative: continued intermittent headaches; Extreme fatigue; sleepiness; This is a spontaneous report from a contactable 58-year-old female Nurse reported for herself that:  Age at vaccination: 58  Pregnant at the time of vaccination?: No  Covid vaccine details:  Product=COVID 19, brand=Pfizer Lot number=GL9261 Lot unknown=False Administration date=29Jan2021 Administration time=12:00 PM Administrator route=Intramuscular Vaccine location=Left arm Dose number=2 Product=COVID19, brand=Pfizer Lot number=EK9321 Lot unknown=False Administration date=08Jan2021 Administration time=10:45 AM Administrator route=Intramuscular Vaccine location=Left arm Dose number=1  Facility where the most recent COVID-19 vaccine was administered:Nursing Home/Senior Living Facility Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No List of any other medications the patient received within 2 weeks of vaccination:Bupropion omeprazole atorvastatin duloxetine  Adverse event: Extreme fatigue, sleepiness and continued intermittent headaches Adverse event start date: 29Jan2021 Adverse event start time: 02:00 PM If patient recovered: Recovered with lasting effects Was treatment received for the adverse event?: No Serious: NO  Seriousness criteria-Results in death: NO Seriousness criteria-Life threatening: NO  Seriousness criteria-Caused/prolonged hospitalization: NO  Seriousness criteria-Disabling/Incapacitating: NO  Seriousness criteria-Congenital anomaly/birth defect: NO  Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:Yes Test Name: PCR mouth swab Covid test date=02Feb2021 Covid test result=Negative  Allergies to medications, food, or other products:Sulfa Other medical history: High cholesterol herniated cervical discs reflux  Vaccine Facility information available. Ethnicity information is available.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that the patient experienced pain in the arm after the 1st dose of vaccine. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This is a spontaneous report from a contactable consumer (Father). A 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date: Not provided) at a single dose via unspecified route on 20Jan2021 for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 28Jan2021 the patient tested positive for COVID-19. The reporter would like to know when the patient could receive the second dose. The reporter checked with treating physician regarding the same and contacted. Outcome of event was resolved.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dry eye, Nasopharyngitis, Pain in extremity, Paranasal sinus discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3302, Expiration date: unknown) via an unspecified route of administration in left arm on 26Jan2021 at 14:30 at single dose for COVID-19 Immunization. The patient medical history and family history were none. No prior vaccinations within 4 Weeks. Current condition included, hypochondriac. History Of All Previous Immunizations was Not provided. Additional Vaccines Administered On Same Date Of Pfizer Suspect was reported as no. Concomitant conditions were not reported.       On 27Jan2021 patient experienced sore arm, "more pronounced than normal flu shot" On 28Jan2021 patient experienced the events, "nose starting dripping/running", "eyes dry", "dry hacking cough". "sinuses swollen a little bit" the patient said that symptoms were similar to "cold symptoms" and still experiencing nasal drainage and "tickle in throat", "eyes dried out", Paranasal sinus discomfort. Nose dripping stopped after about a week and turned more into sinus pressure. Patient underwent lab test Swab COVID test on 01feb2021, results negative on 02Feb2021. No other testing since the COVID-19 Vaccine. His eyes are dried out and it feels like a cold that progresses into different stages. Arm soreness: lasted two day. More pronounced than flu shots he's received. Lasted through 28Jan2021. Tickle in throat with cough: Has a little tiny bit of irritation still. Not a constant cough. Is talking now and feels like he wants to cough, but doesn't. Nose is not dripping as much. Never been totally stopped up. Feels pressure underneath eyes. Adverse Events did not require Require A Visit To: no, it is just mild, but weird. Relevant Tests included Swab COVID test on 01Feb2021. Negative results came back on 02Feb2021. No other testing since the COVID-19 Vaccine. The patient did not received any treatment for these symptoms. Product Complaint was Yes. Not provided, if a sample of the product available to be returned. No information provided whether product Packaging sealed and intact. Outcome for all events were reported as unknown.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Sinus disorder, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3302, Expiration date: unknown) via an unspecified route of administration in left arm on 26Jan2021 at 14:30 at single dose for COVID-19 Immunization. The patient medical history and family history were none. No prior vaccinations within 4 Weeks. Current condition included, hypochondriac. History Of All Previous Immunizations was Not provided. Additional Vaccines Administered On Same Date Of Pfizer Suspect was reported as no. Concomitant conditions were not reported.       On 27Jan2021 patient experienced sore arm, "more pronounced than normal flu shot" On 28Jan2021 patient experienced the events, "nose starting dripping/running", "eyes dry", "dry hacking cough". "sinuses swollen a little bit" the patient said that symptoms were similar to "cold symptoms" and still experiencing nasal drainage and "tickle in throat", "eyes dried out", Paranasal sinus discomfort. Nose dripping stopped after about a week and turned more into sinus pressure. Patient underwent lab test Swab COVID test on 01feb2021, results negative on 02Feb2021. No other testing since the COVID-19 Vaccine. His eyes are dried out and it feels like a cold that progresses into different stages. Arm soreness: lasted two day. More pronounced than flu shots he's received. Lasted through 28Jan2021. Tickle in throat with cough: Has a little tiny bit of irritation still. Not a constant cough. Is talking now and feels like he wants to cough, but doesn't. Nose is not dripping as much. Never been totally stopped up. Feels pressure underneath eyes. Adverse Events did not require Require A Visit To: no, it is just mild, but weird. Relevant Tests included Swab COVID test on 01Feb2021. Negative results came back on 02Feb2021. No other testing since the COVID-19 Vaccine. The patient did not received any treatment for these symptoms. Product Complaint was Yes. Not provided, if a sample of the product available to be returned. No information provided whether product Packaging sealed and intact. Outcome for all events were reported as unknown.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Skin irritation
Clinical narrative: irritation; I experienced itching & redness on my right arm from the injection site; I experienced itching & redness on my right arm from the injection site; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL8982) unknown route at right arm on 28Jan2021 10:00 at single dose for covid-19 immunization. Medical history includes Allergies to Aspirin, penicillin.  The patient previously received first dose of bnt162b2 on 07Jan2021 10:00 at Right arm single for Covid-19 immunization (Lot number: EK5730). patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination incldes Daily Multi Vitamins. It was reported six days after my second Pfizer injection (03Feb2021 19:00) patient experienced itching & redness on right arm from the injection site & below in an area about 3" x 4". On days seven & eight the redness & itching are gradually reducing in color (pink) & irritation. There was no treatment received for the adverse events. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been not tested for COVID-19. The outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass
Clinical narrative: I have a large lump on the lower portion of my neck on the same side as my shot was administered; Most likely lymph node very swollen.; This is a spontaneous report from a contactable 52-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9264) via an unspecified route of administration from 02Feb2021 at 08:30 am to 02Feb2021 at 08:30 am at single dose on left arm for covid-19 immunization. Patient was 52 years old and not pregnant at the time of vaccination. Patient's medical history included allergies to medications, food, or other products; Cipro and Keflex (dates unspecified). Historical vaccine included (other vaccine 4 weeks details, Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; yes) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0142) via an unspecified route of administration from 12Jan2021 to 12Jan2021 at single dose on left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. Concomitant drugs (List of any other medications the patient received within 2 weeks of vaccination: No) were not reported. Patient reported that on 04Feb2021 at 04:00 pm 'I have a large lump on the lower portion of my neck on the same side as my shot was administered. It is about the size of two grapes. Most likely lymph node very swollen. Treatment received for the adverse event was reported as no. The reported events were considered as non-serious (serious; no, seriousness criteria-results in death; no, seriousness criteria-life threatening; no, seriousness criteria-caused/prolonged hospitalization; no, seriousness criteria -disabling /Incapacitating; no, seriousness criteria-congenital anomaly/birth defect; no). Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19 was reported as no. The outcome of events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Son is Health Care Worker who also received 1st dose of covid vaccine, had tested positive for covid after 1st dose.; Son is Health Care Worker who also received 1st dose of covid vaccine, had tested positive for covid after 1st dose.; This is a spontaneous report from a contactable consumer (parent) reported that a male patient (son) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The reporter stated that son is health care worker who also received first dose of covid vaccine, had tested positive for covid after first dose. The patient underwent lab tests and procedures which included covid: positive on an unspecified date. The outcome of the events was reported as unknown.   Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. Consumer mentioned currently taking antibiotics for her UTI on an unspecified date. Consumer wanted to know if it is okay for her to take the second dose while on antibiotics therapy. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Neck pain
Clinical narrative: headache; light headed; pain at the back of the neck; This is a spontaneous report from a Pfizer A Contactable female Consumer (patient) reported that. An unspecified age of female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/ Batch number: Unknown, Expiration date: Unknown) via unspecified route of administration on 28Jan2021, at SINGLE DOSE COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient experiences headache, lightheaded and pain at the back of the neck on unknown date. The outcome of event was unknown.  Information on the Batch/Lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: They got appointments for 4 weeks later; This case has been considered invalid as there is no indication that the patient experienced an event under suspect product BNT162B2.  This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263), via an unspecified route of administration on an unspecified date and time at single dose for covid-19 immunisation. Medical history included none. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 25Jan2021. Concomitant medications were not reported. The patient reported, they got their first shot on 25Jan2021. She heard the vaccine was supposed to be given 3 weeks later, but they got appointments for 4 weeks later. The seriousness was reported as non-serious. The outcome of the events unknown.  Information on the lot/batch number has been requested.  Amendment: This follow up is being submitted to amend the previous reported information which included: to make the case invalid as patient's schedule is within the 19-42 days range after the first dose (hence not an event).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive after the 1st dose last 13Jan2021; fatigued; This is a spontaneous report from Pfizer-sponsored program. A contactable Pharmacist reported that a 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176, expiry date: Mar2021), via an unspecified route of administration on left arm on 13Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The pharmacist reported, his team member has been tested positive after the 1st dose on 20Jan2021. The patient got the first dose on 13Jan in the afternoon between 05:00PM-06:00PM injected into her left arm. He says that the type of test given for COVID-19 positive test was unknown. He says that his team member has recovered, though she still feels fatigued. The patient received additional therapies for COVID-19 such as Remdesivir, Hydroxychloroquine/chloroquine, Azithromycin, Corticosteroids. The outcome of event COVID-19 virus test positive was recovered and for fatigue it was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: still sick; she was diagnosed with Covid-19; This is a spontaneous report from Pfizer-sponsored program Pfizer First Connect. A contactable female Other HCP (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she received the first dose of Covid 19 vaccine shot on 19Jan and 1 week later she was diagnosed with Covid-19. She has a schedule for the second dose next week and she stated that she is still sick, asking if she can take the second dose of vaccine. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The caller got the first dose and tested positive after 6 days; This is a spontaneous report from the Pfizer Sponsored Program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the first dose and tested positive after 6 days on an unspecified date and she is asking if she can still get the second dose. The patient underwent lab tests and procedures which included COVID-19 test on an unspecified date: positive. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that:  Is the Reporter a Healthcare Professional (HCP): No, Occupation/Specialty: Unknown Is the reporter the prescribing HCP: Name: Unknown Address: Unknown Occupation/Specialty: Unknown Is the reporter's contact information available to you or a sub-contracted party: Yes  Suspect Product(s): (provide Name / Indication/Dosage/Start and Stop date where possible) Pfizer Covid-19 Vaccine Start Date: 21Jan2021  Stop Date: Unknown  Verbatim and Event Description: Caller Concern: Caller said she got disconnected earlier while being transferred to PMI. Caller said her 2nd dose is scheduled 4 weeks (18Feb), she got her first dose on 21Jan. Caller said she knows that it should be in 3 weeks. Caller asked if it is okay.  Information on the lot/batch number has been requested.  Follow up (08Mar2021): This is a Follow up spontaneous report from a contactable Consumer. This Consumer reported in response to the Non-HCP letter sent that included:  Pfizer/BioNTech COVID-19 Vaccine Follow-up Questionnaire Patient Age at Time of Vaccination: 70 (Years)  Pfizer/BioNTech COVID-19 Vaccine Details: Dose: 1st Date/Time:  Date: 21Jan2021 Time: 2.00 PM Site and route of injection:  Anatomical Site of injection: Upper Left Arm Route of administration: Intramuscular Batch/Lot number: EL9263  Dose: 2nd Date/Time:  Date: 18Feb2021 Time: 1:00 pm Site and route of injection:  Anatomical Site of injection: Upper Left Arm Route of administration: Intramuscular Batch/Lot number: EL9267  Vaccination Facility Type: Other, please specify: (Address) Vaccination Administered at Military Facility: No Vaccination Facility address: USA  Prior vaccinations: None Concomitant drugs: None  Patient's medical history:  Illness/AE: MS Stop Date: ongoing Pertinent Details: None  Adverse events: Seriousness criteria:  Not Serious  Adverse events: Seriousness criteria:  Not Serious  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Hyperphagia, SARS-CoV-2 test
Clinical narrative: She tested positive again two days ago; She tested positive again two days ago; more hunger; This is a spontaneous report from Pfizer. A female patient of an unspecified age (Age: 65; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on 14Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of the BNT162B2 on 14Jan2021 and then tested positive for covid on 25Jan2021. She tested positive again two days ago, but has no symptoms other than more hunger. She was scheduled to take the second dose of the vaccine tomorrow, however she was tested positive for Covid. She was under quarantine until Sunday or Monday. It was questioned that can she receive the vaccine as scheduled for today, did she have no symptoms/ such a mild case of covid because she already received the first dose of the vaccine. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive again two days ago; She tested positive again two days ago; more hunger; This is a spontaneous report from Pfizer. A female patient of an unspecified age (Age: 65; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on 14Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of the BNT162B2 on 14Jan2021 and then tested positive for covid on 25Jan2021. She tested positive again two days ago, but has no symptoms other than more hunger. She was scheduled to take the second dose of the vaccine tomorrow, however she was tested positive for Covid. She was under quarantine until Sunday or Monday. It was questioned that can she receive the vaccine as scheduled for today, did she have no symptoms/ such a mild case of covid because she already received the first dose of the vaccine. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Incorrect route of product administration
Clinical narrative: they are worried because of the subcutaneous injection done into her; they are worried because of the subcutaneous injection done into her; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a female patient (reporter's wife) received the 1st shot of our vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 on last sunday as single dose via her right arm for COVID-19 immunisation. The patient medical history was and concomitant medications were not reported. They are worried because of the subcutaneous injection done into her.  Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.  Follow-up (03Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation regarding the query related to patient initials. The response included:  Response: Delay Forwarding to Safety Site from Vcloud (CEP 2191). Report re-sent to correct previously reported information (Patient Initials).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received 1st dose of Covid vaccine last Tuesday and then tested positive for Covid on Friday; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 29Jan2021, the patient was tested Covid positive. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: redness and swelling at the injection site however this morning she woke up and it was itchy; redness and swelling at the injection site however this morning she woke up and it was itchy; redness and swelling at the injection site however this morning she woke up and it was itchy; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3249), NDC number, expiry date; unknown, Is COVID vaccine a Pfizer product; Yes, COVID vaccine manufacturer; unspecified via an unspecified route of administration from 01Feb2021 to 01Feb2021 at single dose on right arm (by injection once to right hand shoulder) for prevent from getting COVID. Identification of the country where the drug was obtained. Country of authorization/application;. Patient (weight; 60.78 kgs, height; 163 cm) was 76 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported (Other Products; No, Patient History; No). Caller received the vaccine on 01Feb2021 and experienced right away the redness and swelling at the injection site however this morning she woke up and it was itchy, as well as the redness and swelling. Caller had Pfizer shot two weeks ago, the COVID vaccine, everything was fine, but this morning, on 09Feb2021 her arm is itching, red, and swollen at the shot area, is that normal? Reporter email address declined. She stated it was itching really bad, she got her bath, and it looked red and swollen and was sore. Primary care doctor's address, phone number, and email address unknown. Vaccine card has the return shot date of 15Feb2021, the card doesn't have the date of the first shot. The outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm got very achy and my legs got achy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 26Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm got very achy and legs got achy on an unspecified date and took paracetamol (TYLENOL) as treatment. The patient was asking regarding taking paracetamol after the shot since when the patient got home, heard on the news that you were not supposed to take paracetamol or anything after having the shot. The patient was given some literature with a shot and read over and got the shot and it was not written in the literature. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.