chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Fungal skin infection, Herpes zoster
Clinical narrative: Very dizzy; Very tired; Lost his appetite; Sleeps al the time; Barely gets to work; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; Feels like the Flu; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; This is a spontaneous report from a contactable consumer. A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 13Apr2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date (at the age of 71-years-old) for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced very dizzy, very tired, lost his appetite, sleeps al the time, barely gets to work, developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi, feels like the flu. Caller would like to know if this has been reported and if so, how long after the vaccine was this observed. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Influenza like illness, Somnolence, Vaccination site rash
Clinical narrative: Very dizzy; Very tired; Lost his appetite; Sleeps al the time; Barely gets to work; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; Feels like the Flu; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; This is a spontaneous report from a contactable consumer. A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 13Apr2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date (at the age of 71-years-old) for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced very dizzy, very tired, lost his appetite, sleeps al the time, barely gets to work, developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi, feels like the flu. Caller would like to know if this has been reported and if so, how long after the vaccine was this observed. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fatigue, Headache
Clinical narrative: Feels dizzy and worsened; Having extreme pain in her head, which is pounding really bad and worsened; Feels really, really tired and worsened; Can't stand up; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 09Jun2021 (age at vaccination 13 years), (Batch/Lot number: Unknown, Expiry Date: Unknown, as reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no prior vaccinations within four weeks. The patient previously took bnt162b2 dose 1 for covid-19 immunization. Father stated that his 13-year-old daughter received her 2nd dose of the Pfizer COVID 19 Vaccine yesterday (09Jun2021). Since this morning (10Jun2021), patient had extreme pain in her head, which was pounding really bad and worsened, very tired, as well as dizziness, she could not stand up. He did not know what to do. Everything started at the same time this morning (10Jun2021) and had all been progressing and had gotten worse. Him and his wife were both at work. Was asking if they should call the hospital. Was advised to contact their primary care provider for medical advice. She had virtual school and was able to do that. No treatment received for the adverse events. The clinical outcome of the events was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oxygen saturation, Secretion discharge
Clinical narrative: extreme mucous production; uncontrollable cough; This is a spontaneous report from a contactable nurse. An adult male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) intramuscular, administered in Arm Right on 09Apr2021 (Lot Number: ER8733) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had COVID prior to the vaccination. Patient has no known allergies. It was unknown if patient had any other vaccine in four weeks. It was unknown if patient had any other medications in two weeks. The patient took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 09Apr2021, 20-30 min post vaccine, patient developed an extreme mucous production and uncontrollable cough; O2 sat 98% percentage. MD (Medical doctor) administered diphenhydramine (BENADRYL) and dexamethasone (DECADRON). EMS (Emergency medical services) called to transport patient to ED (emergency department). Patient was discharged home after ED visit; no issues reported from patient after follow-up call from MD. It was unknown if patient got COVID tested post vaccination. The outcome of the events was recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported event "extreme mucous production and uncontrollable cough" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: I got sick; feel more discomfort you feel like 3-4 days not feeling well; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included estrogens conjugated (PREMARIN) taken for vulvovaginal dryness, start and stop date were not reported (Patient reported as, "the vaginal dryness that I had it helps a lot. It helps the woman to have that environment again, like the mucous with the necessary hydration with the necessary fluids that the vaginal are is suppose to secrete but with the coming of age, menopause it changes but that cream was really good. Patient also shared "it helps the vaginal area to secrete fluids again its like the PH and balance of the liquids was soothing it helps renew the secretions in that area"). The patient experienced as, i got sick, feel more discomfort you feel like 3-4 days not feeling well on an unspecified date. Patient had the Covid Pfizer. Reported as, patient got sick the second time or patient got kind of like, people get like first few days they get discomfort and than they feel ok But the second shot you feel more discomfort you feel like 3-4 days not feeling well. Outcome of all the events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: 2 patients (16 year old female and 12 year old male) were accidentally given the second dose of the vaccine on 04JUN2021, 15 days after the first dose.; swollen lymph node in her armpit; This is a spontaneous report from a contactable pharmacist. A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 04Jun2021 as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04jun2021, 15 days after the first dose the patient experienced 2 patients (16 year old female and 12 year old male) were accidentally given the second dose of the vaccine, on 04Jun2021 with outcome of unknown, swollen lymph node in her armpit. The with outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Vomiting
Clinical narrative: Dizziness; Hunched over; Vomiting; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 09Jun2021 at 01:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient had been tested for COVID-19 since the vaccination. On 09Jun2021 at 01:00, the patient experienced dizziness, hunching over, vomiting and refused medical transport. Therapeutic measures were taken as a result of events and included treatment with first aid and vitals (unspecified). The clinical outcome of the events dizziness, hunched over and vomiting were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: excessive menstrual bleeding; This is a spontaneous report from a contactable physician. A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA 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. It was unknown if the patient had other vaccine in four weeks. It was unknown if the patient had covid prior vaccination and covid tested post vaccination. The patient experienced excessive menstrual bleeding since an unspecified date. Outcome of the event was unknown.  Lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose 6 hours after receiving vaccine; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the arm right on 10Jun2021 at 10:15(at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety from unknown date and unknown if ongoing. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) on unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0185) via an unspecified route of administration in the right arm on 20May2021 at 20:00 (at the age of 12-years-old) as a single dose for Covid-19 immunisation. 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. On 10Jun2021 at 16:00, 6 hours after receiving vaccination, the patient experienced bloody nose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event Bloody nose was recovered on 10Jun2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vertigo, Vomiting
Clinical narrative: Bad vertigo; Diarrhea; Vomiting; Chill; This is a follow-up spontaneous report from a contactable consumer (the patient). A 51-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiration date was not reported), dose 2 via an unspecified route of administration in the left arm, on 20May2021 at 08:15 (at the age of 51-year-old), as single dose for COVID-19 immunization. The patient's medical history included ongoing known allergies hive and itch from Sun light, seafood sometimes, allergies to morphine. Other medical history Fibroids. Side effects from Shingrix, Augmentin, Macrobid, Iron supplement and Vitamin B. List of other medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN-C), ergocalciferol (VIT D), tocopherol (VITAMIN E), fish oil and probiotic from an unknown date for an unknown indication. The patient's historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiration date were not reported), dose 1 via an unspecified route of administration, in the left arm, on 29Apr2021 (at the age of 51-year-old) as single dose for COVID-19 immunization. Adverse event four days after getting the 2nd dose of Pfizer vaccine on 20May2021, patient got bad vertigo, diarrhea, vomiting, and chill in the early morning on 24May2021 at 04:15. It lasted about 3 to 4 hours and then patient had been fine since that event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any treatment for events. Facility where the most recent COVID-19 vaccine was administered is reported as Other. Outcome of the events was recovered on 24May2021.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia, Vomiting
Clinical narrative: My son is vomiting non stop and fever; My son is vomiting non stop and fever; Dose 1: 26May2021; Dose 2: 09Jun2021; This is a spontaneous report from a contactable consumer (Patient parent). A male patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 09Jun2021 at 14:00 as dose 2, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included Celiac. Patient had known allergies Celiac disease. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The 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. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in Left arm on 26May2021 at 15:00 for COVID-19 immunisation. On 10Jun2021 at 12:00, reporter son (Patient) experienced vomiting nonstop, fever and Inappropriate schedule of vaccine administered. AE did not result in physician office and emergency room. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm sore; This is a spontaneous report from a contactable consumer (Patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left arm sore. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Skin discomfort
Clinical narrative: male at day 12 PV unilateral dermatoma L flank and altered skin sensation.; This is a spontaneous report from contactable physician. This contactable physician reported that, a 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included varicella from an unknown date and unknown if ongoing reported as, HX of chickenpox at age 8, that was treated with valacyclovir and Gapapentin. Was PCR postive. The patient's concomitant medications were not reported. It was reported that the male at day 12 PV unilateral dermatoma, l flank and altered skin sensation, on an unspecified date. Event took place after use of product. The patient underwent lab tests and procedures which included polymerase chain reaction that was pcr on an unspecified date. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Vision blurred
Clinical narrative: Dizziness; Blurry vision; Nausea; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Jun2021 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and polycystic ovary syndrome (PCOS). The patient had no known allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN); both from unknown date for unknown indication. 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 COVID vaccine. On 10Jun2021 at 13:45, the patient experienced dizziness with blurry vision, nausea, and chills burst within 1 hour after first dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events dizziness, blurry vision, nausea and chills was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: Slight chill on his shoulder; This is a spontaneous report from a contactable consumer or other non-professional healthcare professional (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), via an unspecified route of administration on 19Mar2021 as concentrated, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller called to report adverse event for his friend with the Pfizer COVID Vaccine. The caller stated that, he had the Pfizer injection and nothing happened to him, it was great. The caller ran a triage for a while in a rehab hospital in a correctional facility. Rehab clients would come in and he would take their temperature, vitals, do intake and get them ready for rehab. He was not a nurse, doctor or pharmacist. For himself the only adverse effect was a slight chill on his shoulder for 4 to 5 hours on an unspecified date in Mar2021. He received it on 19Mar2021 and it could have been the weather. It doesn't matter. The caller declined to do a report for himself about his experience with the Pfizer COVID vaccine. The outcome of the event was recovered on an unspecified date in Mar2021.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Heart palpitations; Hard time breathing; This is a spontaneous report from a Pfizer sponsored program report received from a contactable consumer or other non-health care professional. A 66-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number EW0150), via an unspecified route of administration in the arm right on 05Apr2021 at a 11:30 (at the age of 66-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history included ongoing cholesterol (Verbatim: Cholesterol). Concomitant medications were not reported. On an unspecified date, the patient experienced heart palpitations, congestion and hard time breathing. The patient stated that he was congested and never had this before and it was hard to breathe. He said he worked out and ran. All the events were non-serious. The outcome of all the events was not recovered.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Extreme nausea,; Diarrhoea; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Jun2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Jun2021 the patient experienced extreme nausea, diarrhoea and vomiting. The clinical outcome of the events extreme nausea, diarrhoea and nausea were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Libido disorder
Clinical narrative: I have been experiencing sexual arousal (think puberty) for a few hours; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 36-year) on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication includes Bunch of vitamins the patient received within 2 weeks of vaccination. Historical vaccine includes first dose of BNT162B2 in left arm administered on 20May2021 at 07:00 PM for COVID-19 immunization; the noticed light tingling in his head - super weird after the first dose. No allergies were reported. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received no other medications in four weeks. On an unspecified date in 2021 the patient experienced sexual arousal (think puberty) for a few hours. It was reported by the patient that "Nothing terrible, but within seconds to a few minutes after getting the first dose he noticed light tingling in his head - super weird. Also, the first 4-6 hours after the first and now second shot he has been experiencing sexual arousal (think puberty) for a few hours. Not a big deal, but interesting and he thought this info may be valuable." No treatment was received for the adverse event by the patient. The clinical outcome of the event 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 have been completed and no further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Paraesthesia
Clinical narrative: Light tingling in my head - super weird; Light tingling in my head - super weird; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration in left arm on 20May2021 at 07:00 PM (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. No known allergies. the patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient received Bunch of vitamins within 2 weeks of vaccination. Nothing terrible, but within seconds to a few minutes after getting the first dose on 20May2021 at 07:00 PM, I noticed light tingling in my head - super weird. Not a big deal, but interesting and I thought this info may be valuable. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The report was non serious. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lump felt in arm pit days after receiving first dose; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0182) via an unspecified route of administration in the left arm on 21May2021 at 16:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient experienced lump felt in arm pit days after receiving first dose. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lump felt in arm pit was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lymphadenopathy, Vision blurred
Clinical narrative: Blurred vision; dizziness; Swollen lymph node in left underarm; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0177) via an unspecified route of administration in the left arm on 08Jun2021 at 16:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and penicillin allergy. The patient received other medications within two weeks of vaccination, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0183) via an unspecified route of administration in the left arm on 18May2021 at 16:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. 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. On 09Jun2021 at 14:15, the patient experienced blurred vision, dizziness, swollen lymph node in left underarm. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events blurred vision, dizziness, swollen lymph node in left underarm was recovered on an unspecified in Jun2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Myalgia, Pain
Clinical narrative: sore arm; muscle soreness, like an ache "on and off" and then it went away; had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; picking things up and dropping things; having a tingling feeling off and on but that went away; some weakness to her hand on the side of her injection; tired; Pain at the injection site; feel discomfort at the injection site; This is a spontaneous report from a contactable consumer (patient).  This is the first case out of the 2 cases. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm, muscle soreness, like an ache "on and off" and then it went away, had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group, picking things up and dropping things, having a tingling feeling off and on but that went away, some weakness to her hand on the side of her injection, tired and feel discomfort at the injection site. Reporter was asking "Is this something that happens to other people?" Reporter reported that she received her second dose of the Covid vaccine on Apr18 and from the time she got the injection she started having a sore arm. Reporter reported having muscle soreness, like an ache "on and off" and then it went away. Reporter reported that 2 weeks ago the soreness started to come back, same place, same muscle, same ache. She had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group. The first vaccine dose was not painful, but the second shot was more painful and may have been given with a larger needle. She went on to report that "she had 5,6,7 days where I was picking things up and dropping things" and reported having a tingling feeling off and on but that went away. Reporter also reported having some weakness to her hand on the side of her injection. Patient had Soreness to her arm, tiredness and pain at the injection site. There was no product complaint reported. The clinical outcome of all the events were unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687675 same patient/drug/similar event, different patient;US-PFIZER INC-2021687677 same patient/drug/similar event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site discomfort, Vaccination site pain
Clinical narrative: sore arm; muscle soreness, like an ache "on and off" and then it went away; had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; picking things up and dropping things; having a tingling feeling off and on but that went away; some weakness to her hand on the side of her injection; tired; Pain at the injection site; feel discomfort at the injection site; This is a spontaneous report from a contactable consumer (patient).  This is the first case out of the 2 cases. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm, muscle soreness, like an ache "on and off" and then it went away, had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group, picking things up and dropping things, having a tingling feeling off and on but that went away, some weakness to her hand on the side of her injection, tired and feel discomfort at the injection site. Reporter was asking "Is this something that happens to other people?" Reporter reported that she received her second dose of the Covid vaccine on Apr18 and from the time she got the injection she started having a sore arm. Reporter reported having muscle soreness, like an ache "on and off" and then it went away. Reporter reported that 2 weeks ago the soreness started to come back, same place, same muscle, same ache. She had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group. The first vaccine dose was not painful, but the second shot was more painful and may have been given with a larger needle. She went on to report that "she had 5,6,7 days where I was picking things up and dropping things" and reported having a tingling feeling off and on but that went away. Reporter also reported having some weakness to her hand on the side of her injection. Patient had Soreness to her arm, tiredness and pain at the injection site. There was no product complaint reported. The clinical outcome of all the events were unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687675 same patient/drug/similar event, different patient;US-PFIZER INC-2021687677 same patient/drug/similar event, different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Cansancio; dolor de cuerpo intenso; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 20May2021 at 14:30(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jun2021 at 02:30 the patient experienced fatigue, abdominal pain intense and full-bodied. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of both the events fatigue, abdominal pain intense and full-bodied was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: Extreme fatigue; flu-like symptoms; swollen arm pit (left); painful arm pit (left); headache; low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 07Jun2021 at 17:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 17May2021 at 17:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021 at 11:00, the patient had extreme fatigue, swollen and painful arm pit (left) flu-like symptoms, headache, low grade fever. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, swollen and painful arm pit (left) flu-like symptoms, headache, low grade fever was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Extreme fatigue; flu-like symptoms; swollen arm pit (left); painful arm pit (left); headache; low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 07Jun2021 at 17:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 17May2021 at 17:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021 at 11:00, the patient had extreme fatigue, swollen and painful arm pit (left) flu-like symptoms, headache, low grade fever. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, swollen and painful arm pit (left) flu-like symptoms, headache, low grade fever was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pleurisy
Clinical narrative: PLEURISY.TWO WEEKS AFTER THE 1ST SHOT, I WAS GETTING IN MY CAR AND HAD A SUDDEN SHARP PAIN IN MY CHEST THAT HURT SO BAD I COULD BARELY MOVE MY SHOULDERS AND ARMS AND HAD A HARD TIME BREATHING.  IT DI; PLEURISY.TWO WEEKS AFTER THE 1ST SHOT, I WAS GETTING IN MY CAR AND HAD A SUDDEN SHARP PAIN IN MY CHEST THAT HURT SO BAD I COULD BARELY MOVE MY SHOULDERS AND ARMS AND HAD A HARD TIME BREATHING.  IT DI; PLEURISY.TWO WEEKS AFTER THE 1ST SHOT, I WAS GETTING IN MY CAR AND HAD A SUDDEN SHARP PAIN IN MY CHEST THAT HURT SO BAD I COULD BARELY MOVE MY SHOULDERS AND ARMS AND HAD A HARD TIME BREATHING.  IT DI; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW017, Expiration date: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 17:00 (at the age of 21-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included wheezing, food allergy NUTS, POLLEN, PET DANDER, SHELLFISH, seasonal allergy, allergy to animal, food allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On 10Jun2021 04:30, the patient had experienced pleurisy. Two weeks after the 1st shot, patient was getting in my car and had a sudden sharp pain in her chest that hurt so bad patient could barely move her shoulders and arms and had a hard time breathing. It dissipated a bit after 20 minutes, but when patient slept, patient turned in my sleep and again the sharp pain hit again and patient could not sleep. patient tried to get comfortable and slept the rest of the night. patient have not seen a medical professional yet because a close family friend had the exact same reaction 2 weeks after her moderna vaccine and walked me through it. She had gone to urgent care and they told her it was pleurisy, which lasted a few days for her. Hopefully it did not get more severe. Outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mouth swelling, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: swollen mouth; swollen glands; sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 07Jun2021 at 08:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included milk allergy (Dairy allergy), gluten intolerance (Wheat allergy). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 09Jun2021 at 22:00, the patient experienced swollen glands, sore throat and swollen mouth. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. On 10Jun2021, the patient underwent COVID-19 virus test (Nasal swab) and the result was negative. The clinical outcome of the events swollen glands, sore throat and swollen mouth was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Limb discomfort
Clinical narrative: Thigh numbness, 17 days after 2nd dose; Arm heaviness; Lower back pain on and off,; hip soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date the patient experienced thigh numbness. On an unknown date 17 days after 2nd dose vaccination, the patient experienced arm heaviness, lower back pain on and off and hip soreness. The clinical outcome of the events thigh numbness, arm heaviness, lower back pain on and off and hip soreness was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 40-year-old) as a single dose for COVID-19 immunization.  Medical history included COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) for unknown indication from unspecified date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was 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. On 04Jun2021 at 16:30, the patient experienced shingles. The event resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the event and included treatment with medication. The clinical outcome of the event shingles was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: Stabbing pain in lungs; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Jun2021, at 22:00 the patient experienced stabbing pain in lungs. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the event stabbing pain in lungs was not resolved at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.