chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Saturday felt sluggish still had chills and then felt hot and sweaty.; Saturday felt sluggish; then felt hot; Body aches; Headache; Chills; Could not left arm, it was very painful; Fever; Didn't really sleep; Trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, Patient was 60-year-old and not pregnant at the time of vaccination) via an unspecified route of administration on 20May2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included hydrochlorothiazide, lisinopril, (MANUFACTURER UNKNOWN) and vitamin D NOS (VITAMIN D); both for unknown indications and since unknown dates. 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 21May2021 Friday at 02:30, the patient woke up with headache, body aches, chills, could not lift arm, as it was very painful. The patient reported that a fever broke at around noon that day and had a little trouble breathing. The patient laid in bed all day till the following day and experienced chills a second time, didn't really sleep, and just laid in bed. On Saturday, 22May2021, the patient felt sluggish still had chills and then felt hot, sweaty and her breathing was still affected. On Sunday, 23May2021, the patient felt better with a little bit of activity, but still felt winded. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events trouble breathing, fever, didn't really sleep, body aches, headache, chills, could not lift arm, sweaty, then felt hot and felt sluggish were resolving at the time of this report.  Information on lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Pyrexia, Sluggishness
Clinical narrative: Saturday felt sluggish still had chills and then felt hot and sweaty.; Saturday felt sluggish; then felt hot; Body aches; Headache; Chills; Could not left arm, it was very painful; Fever; Didn't really sleep; Trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, Patient was 60-year-old and not pregnant at the time of vaccination) via an unspecified route of administration on 20May2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included hydrochlorothiazide, lisinopril, (MANUFACTURER UNKNOWN) and vitamin D NOS (VITAMIN D); both for unknown indications and since unknown dates. 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 21May2021 Friday at 02:30, the patient woke up with headache, body aches, chills, could not lift arm, as it was very painful. The patient reported that a fever broke at around noon that day and had a little trouble breathing. The patient laid in bed all day till the following day and experienced chills a second time, didn't really sleep, and just laid in bed. On Saturday, 22May2021, the patient felt sluggish still had chills and then felt hot, sweaty and her breathing was still affected. On Sunday, 23May2021, the patient felt better with a little bit of activity, but still felt winded. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events trouble breathing, fever, didn't really sleep, body aches, headache, chills, could not lift arm, sweaty, then felt hot and felt sluggish were resolving at the time of this report.  Information on lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Nasal congestion, Oropharyngeal pain, Throat tightness
Clinical narrative: Extreme pain at injection site; Large red itch welt 18 hours later; Large red itch welt 18 hours later; Fatigue; Stuffy nose; Blurry eyes; Tightness throat; Hoarseness; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 38-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 left arm on 26May2021 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. Medical history included migraine and polycystic ovarian syndrome (PCOS). The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 05:00, the patient experienced extreme pain at injection site, large red itch welt 18 hours later, fatigue, stuffy nose, blurry eyes, tightness/hoarseness/sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme pain at injection site, large red itch welt 18 hours later, fatigue, stuffy nose, blurry eyes, tightness/hoarseness/sore throat was not recovered at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain, Vaccination site pruritus, Vision blurred
Clinical narrative: Extreme pain at injection site; Large red itch welt 18 hours later; Large red itch welt 18 hours later; Fatigue; Stuffy nose; Blurry eyes; Tightness throat; Hoarseness; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 38-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 left arm on 26May2021 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. Medical history included migraine and polycystic ovarian syndrome (PCOS). The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 05:00, the patient experienced extreme pain at injection site, large red itch welt 18 hours later, fatigue, stuffy nose, blurry eyes, tightness/hoarseness/sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme pain at injection site, large red itch welt 18 hours later, fatigue, stuffy nose, blurry eyes, tightness/hoarseness/sore throat was not recovered at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle injury, Muscle strain, Neck pain, Pain in extremity
Clinical narrative: Muscles in upper left arm feels strained/injured Unable to lift anything above 5 lbs without pain; Soreness in upper left arm surrounding the injection site 2 hours after the first shot; Soreness moved around various parts of that arm. Soreness became an aching pain.; Aching pain moved to upper shoulder/base of neck; Aching pain moved to upper shoulder/base of neck; Muscles in upper left arm feels strained/injured Unable to lift anything above 5 lbs without pain; This is a spontaneous from a contactable consumer (patient). A 29-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, in the left arm on 01Apr2021 (at the age of 29-years-old) as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration, in the left arm on 29Apr2021 as dose 2, single both for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced soreness in upper left arm surrounding the injection site 2 hours after the first shot. Soreness moved around various parts of that arm. Soreness became an aching pain. Aching pain moved to upper shoulder/base of neck. Muscles in upper left arm feels strained/injured. Unable to lift anything above 5 lbs without pain. Seriousness criteria reported as no. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscles in upper left arm feels strained/injured Unable to lift anything above 5 lbs without pain; Soreness in upper left arm surrounding the injection site 2 hours after the first shot; Soreness moved around various parts of that arm. Soreness became an aching pain.; Aching pain moved to upper shoulder/base of neck; Aching pain moved to upper shoulder/base of neck; Muscles in upper left arm feels strained/injured Unable to lift anything above 5 lbs without pain; This is a spontaneous from a contactable consumer (patient). A 29-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, in the left arm on 01Apr2021 (at the age of 29-years-old) as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration, in the left arm on 29Apr2021 as dose 2, single both for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced soreness in upper left arm surrounding the injection site 2 hours after the first shot. Soreness moved around various parts of that arm. Soreness became an aching pain. Aching pain moved to upper shoulder/base of neck. Muscles in upper left arm feels strained/injured. Unable to lift anything above 5 lbs without pain. Seriousness criteria reported as no. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Lymph node pain, Pain in extremity
Clinical narrative: Brain fog/A disconnect with my arms and legs; Arm pain; Horrible joint/lymph gland pain; Horrible joint/lymph gland pain; Feeling of small needles poking me in the head; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170), via an unspecified route of administration in right arm on 29Apr2021 at 13:15 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypoglycemia from an unknown date and unknown if ongoing, splenic hemangiomas from an unknown date and unknown if ongoing, peanuts bother me from an unknown date and unknown if ongoing, hypersensitive to meds from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; Oil of oreganol taken for an unspecified indication, start and stop date were not reported. 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 an unknown date, after first vaccination, the patient experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with my arms and legs and fatigue. This lasted about 4 days. The seriousness of the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Brain fog/A disconnect with my arms and legs; Arm pain; Horrible joint/lymph gland pain; Horrible joint/lymph gland pain; Feeling of small needles poking me in the head; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170), via an unspecified route of administration in right arm on 29Apr2021 at 13:15 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypoglycemia from an unknown date and unknown if ongoing, splenic hemangiomas from an unknown date and unknown if ongoing, peanuts bother me from an unknown date and unknown if ongoing, hypersensitive to meds from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; Oil of oreganol taken for an unspecified indication, start and stop date were not reported. 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 an unknown date, after first vaccination, the patient experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with my arms and legs and fatigue. This lasted about 4 days. The seriousness of the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Dizziness; This is a spontaneous report from a contactable consumer. A 15-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), intramuscularly administered in right arm on 05Jun2021 at 11:15 (at the age of 15 years old) as dose 2, single for COVID-19 immunisation. No medical history was reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Lot Number: unknown), intramuscularly administered in the right arm on 15May2021 at 11:15 (at the age of 15-years-old) as dose 1, single dose for COVID-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and did not receive any other medications within 2 weeks prior to the vaccination. On 06Jun2021 at 00:00, about 18 hours after vaccination (as reported, possible discrepant), the patient experienced body aches, fever and dizziness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events, body aches, fever and dizziness which included treatment with paracetamol (TYLENOL) and ibuprofen (ADVIL). Outcome of all events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Headache
Clinical narrative: My neck got stiff on the right side; slight headache; dizziness; face turned red got very hot; face turned red got very hot; the right side of my face went numb; Facial flushing; vasodilation 15 min after administration; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 61-years-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: Fr8731), via intramuscular route of administration, administered in Arm Right on 01Jun2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, arthropod sting from an unknown date and unknown if ongoing known allergies Bee stings, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa, back pain from an unknown date and unknown if ongoing other medical history chronic back pain. Concomitant medications included cetirizine hydrochloride; asa (ASA). 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 01Jun2021 10:15, the patient experienced my neck got stiff on the right side, slight headache, dizziness, face turned red got very hot, face turned red got very hot, the right side of my face went numb, facial flushing, vasodilation 15 min after administration. The outcome of the evens was not recovered.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Vasodilation procedure
Clinical narrative: My neck got stiff on the right side; slight headache; dizziness; face turned red got very hot; face turned red got very hot; the right side of my face went numb; Facial flushing; vasodilation 15 min after administration; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 61-years-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: Fr8731), via intramuscular route of administration, administered in Arm Right on 01Jun2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, arthropod sting from an unknown date and unknown if ongoing known allergies Bee stings, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa, back pain from an unknown date and unknown if ongoing other medical history chronic back pain. Concomitant medications included cetirizine hydrochloride; asa (ASA). 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 01Jun2021 10:15, the patient experienced my neck got stiff on the right side, slight headache, dizziness, face turned red got very hot, face turned red got very hot, the right side of my face went numb, facial flushing, vasodilation 15 min after administration. The outcome of the evens was not recovered.  Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed
Clinical narrative: Altered me natural cycle; late period; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the left arm on 26May2021 at 12:00 (at the age of 24-years-old) as dose 2, single for COVID-19 immunisation at a pharmacy or drugstore. The patient has no relevant medical history and no concomitant medications. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. 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 26May2021, the patient experienced altered menstrual (reported as me natural) cycle and late period. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Have not gotten her monthly menstrual cycle; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 14May2021 at 16:00 (at the age of 32 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination and prior to vaccination the patient was not diagnosed with COVID-19.  The patient did not receive other vaccine in four weeks. On 14May2021, the patient reported that she have not gotten her monthly menstrual cycle. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the event. The patient underwent lab tests/ COVID test after vaccination which included nasal swab with a negative result on an unspecified date. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Menstrual cycle is more than a week late; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 21May2021 at 13:00 (at the age of 14-years-old) (Batch/Lot number was not reported) as dose1, single for COVID-19 immunisation. Medical history included MDD (major depressive disorder), SAD (seasonal affective disorder), and GERD (gastrooesophageal reflux disease). The patient was not pregnant at the time of the event. The patient has known allergies to amoxicillin, lamyctil, and adhesives. Concomitant medications included sertraline hydrochloride (ZOLOFT), dexmethylphenidate hydrochloride (FOCALIN), cyproheptadine, and trazodone. The patient did not receive other vaccine in four weeks. Zoloft, focalin, cyproheptadine, and trazodone were received in two weeks.  The patient did not have COVID-19 prior to vaccination and had not been tested for COVID-19 post-vaccination. On 02Jun2021, the patient experienced menstrual cycle is more than a week late. No treatment was received for the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: swelling in right armpit; tissue in right armpit seems to be hard and hurts to touch; This is a spontaneous report from a contactable consumer or other non-HCP reported about herself.    A 49-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration, administered in right arm as dose 2, single on 12Jun2021 (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included allergies with amoxicillin, vicodin drugs and with pollen extracts. Historical vaccine included first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EW0186), via an unspecified route of administration, administered in right arm as dose 1, single on 22May2021 09:15 AM (at the age of 49-year-old) for covid-19 immunisation. And the patient took another second dose of unspecified Pfizer vaccine (Lot number: EW0167) via unspecified route of administration, administered in right arm on 22May2021. Concomitant medications included labetalol, losartan and hydrochloorthiazide all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications labetalol, losartan and hydrochlorothiazide within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 13Jun2021, the next day after the second dose of vaccine patient experienced there was swelling and tissue in right armpit seemed to be hard and hurts to touch. At the time of this report, outcome of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash maculo-papular
Clinical narrative: broke out in spots that are red and raised like pumped up on her belly; her skin is turning red; itch on the spots; This is a spontaneous report received from a contactable consumer (patient's husband). A 77-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number: EM9810; Expiration date were not reported), via an unspecified route of administration in the right arm on 11Feb2021 16:00 (at the age of 77-years-old) as dose 2, single for COVID-19 immunization at a clinic. Medical history included allergy to shellfish from an unknown date and unknown if ongoing. The patient has no concomitant medications. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3246) via an unspecified route of administration in the right arm on 21Jan2021 16:00 (at the age of 76 years-old) as dose 1, single for COVID-19 immunisation and experienced broke out in spots that are red and raised (that were like little bites, like welts that stay for two or three days and then they go down). No other vaccine was received by the patient in four weeks. On an unspecified date after the second dose, the patient broke out in spots that are red and raised like pumped up on her belly and her skin was turning red and itch on the spots. Events resulted in a physician (dermatologist) office visit. Treatment with a cream and rubbing alcohol were taken for the events.  The outcome of the events was not recovered. The reporter was querying if the events were normal and how long will the events last.  No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Varicella
Clinical narrative: Rash ( looks like chickenpox ) on both arms and especially hands on inside palms; Rash ( looks like chickenpox ) on both arms and especially hands on inside palms; This is a spontaneous report from a contactable consumer reported that :A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Jun2021 12:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization(Age at vaccination 14 years). The patient medical history was not reported. Concomitant medication(s) included amoxicillin, clavulanate potassium 875-125 mg taken for an unspecified 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. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient experienced rash (looks like chickenpox) on both arms and especially hands on inside palms on 15Jun2021 08:00. No treatment was reported. The event outcome was Not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Joint injury
Clinical narrative: I am experiencing bone and joint pain. The effects are concentrated in my knees.; I am experiencing bone and joint pain. The effects are concentrated in my knees.; I am experiencing bone and joint pain. The effects are concentrated in my knees.; This is a spontaneous report from a contactable consumer. This 48-year-old non-pregnant female consumer (patient) reported that she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: GW0183) via an unspecified route of administration on 14Jun2021 (at 48-year-old) on left arm as dose number unknown, single for COVID-19 immunization. The patient had no medical history and no allergies. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. It was mentioned that patient was not pregnant at the time of vaccination, she did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. On 14Jun2021 at 04:30 PM the patient experienced bone and joint pain. The effects are concentrated in her knees. No treatment was received for the events..The patient had not recovered. The device Date was 21Jun2021 Follow-up attempts were completed. No further information was expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Chest X-ray, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: Minor chest pains were felt; Shortness of breath; This is a spontaneous report from a from a contactable physician and from contactable consumer (patient reported for himself). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Left on 12Jun2021 at 10:30 am (Batch/Lot Number: EW0179) as dose 1, single for covid-19 immunization (at the age of 36-years-old). Medical history included ongoing slightly elevated high blood pressure and anxiety from an unknown date. Concomitant medication(s) included bisoprolol fumarate (BISOPROLOL FUMARATE, 5 mg) taken for slightly elevated high blood pressure from 29May2021 and ongoing. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies. It was reported by the patient that within hours of receiving first dose of vaccine on 12Jun2021 at 16:30 pm the minor chest pains were felt and these continued sporadically, about twice a day, for several days, along with occasional shortness of breath. One week after receiving the first dose, the chest pains became more frequent, five to six times a day. this increased frequency continues through the date this report was being filed 23Jun2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. After that the physician reported the laboratory test results and physician considered that the Pfizer product had a causal effect to the adverse event. Therapeutic measures were taken as a result of adverse events. The patient underwent lab tests and procedures which included TSH (blood thyroid stimulating hormone) which result showed units 2.8, normal on 26Jun2021, CXR (chest x-ray) which showed RBBB, normal in ER (emergency room) on 21Jun2021, Echo (echocardiogram) which was normal on 08Jul2021, EKG (electrocardiogram) had unknown results on an unspecified date in 2021 and showed NSR incomplete on 20Jun2021 in emergency room, Troponin level test (troponin) and X-ray which had unknown results on an unspecified date in 2021. The outcome of the events was unknown.   The Physician considered that the Pfizer product had a related causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Troponin, X-ray
Clinical narrative: Minor chest pains were felt; Shortness of breath; This is a spontaneous report from a from a contactable physician and from contactable consumer (patient reported for himself). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Left on 12Jun2021 at 10:30 am (Batch/Lot Number: EW0179) as dose 1, single for covid-19 immunization (at the age of 36-years-old). Medical history included ongoing slightly elevated high blood pressure and anxiety from an unknown date. Concomitant medication(s) included bisoprolol fumarate (BISOPROLOL FUMARATE, 5 mg) taken for slightly elevated high blood pressure from 29May2021 and ongoing. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies. It was reported by the patient that within hours of receiving first dose of vaccine on 12Jun2021 at 16:30 pm the minor chest pains were felt and these continued sporadically, about twice a day, for several days, along with occasional shortness of breath. One week after receiving the first dose, the chest pains became more frequent, five to six times a day. this increased frequency continues through the date this report was being filed 23Jun2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. After that the physician reported the laboratory test results and physician considered that the Pfizer product had a causal effect to the adverse event. Therapeutic measures were taken as a result of adverse events. The patient underwent lab tests and procedures which included TSH (blood thyroid stimulating hormone) which result showed units 2.8, normal on 26Jun2021, CXR (chest x-ray) which showed RBBB, normal in ER (emergency room) on 21Jun2021, Echo (echocardiogram) which was normal on 08Jul2021, EKG (electrocardiogram) had unknown results on an unspecified date in 2021 and showed NSR incomplete on 20Jun2021 in emergency room, Troponin level test (troponin) and X-ray which had unknown results on an unspecified date in 2021. The outcome of the events was unknown.   The Physician considered that the Pfizer product had a related causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills
Clinical narrative: felt like someone was sitting on her chest; the patient developed chills; stated she 'felt like someone was sitting on her chest' (PT Chest pain); This is a spontaneous report from a non-contactable pharmacist. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported, Age group: Adult 18-64 Years), dose 2 via an unspecified route of administration on Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on Jan2021 as dose 1, single for covid-19 immunisation. Prior to 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 Jan2021 the patient experienced Several hours after the 2nd dose of the covid-19 vaccine, felt like someone was sitting on her chest, the patient developed chills, stated she 'felt like someone was sitting on her chest' (PT: chest pain). The patient took acetaminophen for treatment. The events resolved by the next morning. The outcome of event was recovered on Jan2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Intraocular pressure increased
Clinical narrative: eye pressure is rising; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a 70 year old female patient started to receive exemestane (AROMASIN, Coated tablet, strength: 25 mg) via unknown route of administration from an unknown date at an unknown dose and frequency for Malignant neoplasm of unspecified site of right female breast and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unknown route of administration on an unknown date as dose number unknown, single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Patient stated her eye pressure was rising. Also, stated she had received the Pfizer Covid shot and is very happy so far. The action taken in response to the event with exemestane was unknown. The outcome of the event was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Fatigue, Rash erythematous, SARS-CoV-2 test, Somnolence
Clinical narrative: 3 red bumps around my mouth; it is an acne break out; feeling extremely fatigued and slept most of the day; feeling extremely fatigued and slept most of the day; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0181), via an unspecified route of administration, on 25Jun2021 at 05:45 PM (at the age of 36-year-old), as dose 1, single for COVID-19 immunization. Patient's medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Patient's had allergies to red and purple tattoo ink. Concomitant medications included lynestrenol taken for an unspecified indication, start and stop date were not reported. On 27Jun2021 (day 3) the patient experienced feeling extremely fatigued and slept most of the day, on 02Jul2021 (day 8) 3 red bumps around my mouth, On day 13 the red bumps spread all over my face, it is an acne. On 16Jun2021 the patient underwent lab tests and procedures which included sars-cov-2 test and the result was negative. Patient was received Antihistimine and topical ointment treatment. Outcome of all events were not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: was supposed to get her period around the same day as her 2nd vaccine (17Jun2021) it is now 12Jul2021 and she has still not gotten it; This is a spontaneous report from a contactable consumer, the patient. A 14-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0185), via an unspecified route of administration in the arm left on 17Jun2021 17:00 as dose 2, single (at the age of 14-years old) for covid-19 immunization. Medical history included ongoing asthma and allergies to penicillin family. Concomitant medications included montelukast sodium (SINGULAIR), beclometasone dipropionate (QVAR), clarithromycin (CLARITIN), allergy nasal spray and vit. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0185), via an unspecified route of administration in the arm left on 27May2021 17:15 as dose 1, single (at the age of 14-years old) for covid-19 immunization. On 18Jun2021, the patient was supposed to get her period around the same day as her 2nd vaccine (17Jun2021) it was now 12Jul2021 and she had still not gotten it. The patient visited the doctor or other healthcare professional office/clinic for the events. The patient did not receive any treatment for the events. The patient did not receive any other vaccine in four weeks. The patient had not covid prior to the vaccination and the patient had not tested for covid post vaccination. The outcome of the event was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding after first dose; This is a spontaneous report from a non-contactable consumer or other non hcp. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration, administered in Arm Left on 01May2021 13:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing Other medical history: Thyroid. Concomitant medications included modafinil (MODAFINIL) duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took indomethacin [indometacin] and experienced drug hypersensitivity, zoloft and experienced drug hypersensitivity. On 04May2021, the patient experienced vaginal bleeding after first dose. Outcome of events was recovered on unspecified date of 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: mild tingling in both of his arms and hands; mild numbness; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 17Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included calcitriol (VITAMIN D) for 8 months, fish oil been taking for many years, zinc been taking it for 8months, multivitamin been taking for 8 months all ongoing. On 17Jun2021 He experienced mild numbness and tingling in arms and hands (both started 5hrs after vaccination) and the symptoms were gone in 48 hours. Outcome of recovered events was recovered on 19Jun2021.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, HIV test, Pyrexia, Weight
Clinical narrative: nightly fevers up to 102F; This is a spontaneous report from a contactable pharmacist. A 28-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Jul2021 (age at vaccination: 28 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history included HIV infection from an unknown date and unknown if ongoing He has a new diagnosis of HIV 25 days ago, and 7 days ago is when he got the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced nightly fevers up to 102f on 08Jul2021. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on  degrees Fahrenheit, HIV test: HIV diagnosis on 25 days ago, weight: 220 lbs on 2020 lbs Last year, on 2020, patient was 220 lbs. Therapeutic measures were taken as a result of nightly fevers up to 102f was Tylenol. The outcome of the event pyrexia was not recovered.  Information about lot/batch has been requested.  No follow-up attempts are needed. No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient received PENTACEL but did not get the ACT-HIB portion/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via  Medical Information (Reference number- 00736108).  This case involves a 3-month-old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] but did not get the ACT-HIB portion (product preparation issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 04-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (suspension, lot number: UJ465AAA and expiry date: 21-Mar-2021) via an intramuscular route in the right lateral thigh for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  It was reported "caller is wanting to know what to do."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.