chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Optic nerve injury, Visual impairment
Clinical narrative: Completely lost vision in left eye; Optic nerve had been attacked; Could not see out of left eye; Right eye is tired; Difficulty with balance; Intentional dose omission; Headache; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS (Completely lost vision in left eye), OPTIC NERVE INJURY (Optic nerve had been attacked) and VISUAL IMPAIRMENT (Could not see out of left eye) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00921A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced OPTIC NERVE INJURY (Optic nerve had been attacked) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (Could not see out of left eye) (seriousness criterion hospitalization). On 14-Jul-2021, the patient experienced BLINDNESS (Completely lost vision in left eye) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ASTHENOPIA (Right eye is tired), BALANCE DISORDER (Difficulty with balance), INTENTIONAL DOSE OMISSION (Intentional dose omission) and HEADACHE (Headache). The patient was hospitalized from 15-Jul-2021 to 17-Jul-2021 due to BLINDNESS, OPTIC NERVE INJURY and VISUAL IMPAIRMENT. At the time of the report, BLINDNESS (Completely lost vision in left eye) and VISUAL IMPAIRMENT (Could not see out of left eye) had not resolved, OPTIC NERVE INJURY (Optic nerve had been attacked), ASTHENOPIA (Right eye is tired), BALANCE DISORDER (Difficulty with balance) and HEADACHE (Headache) outcome was unknown and INTENTIONAL DOSE OMISSION (Intentional dose omission) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient saw both ophthalmologist and the neuro-ophthalmologist and was told that, her optic nerve had been attacked. She never had eye problems. Her vision in her right eye was 20/20.  The patient received intravenous steroids 1060 mg each day when she was hospitalized on 15-Jul-2021. She is taking 60 mg of oral steroids after she was released from the hospital on 18-Jul-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: It was reported that, the patient was hospitalized from 15-Jul-2021 to 17 Jul-2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue, Thrombosis
Clinical narrative: Diagnosed with Blood clots; Never received the second dose; Hospitalized for one day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Diagnosed with Blood clots) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced THROMBOSIS (Diagnosed with Blood clots) (seriousness criteria hospitalization and medically significant) and HOSPITALISATION (Hospitalized for one day). On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received the second dose). The patient was hospitalized for 1 day due to THROMBOSIS. At the time of the report, THROMBOSIS (Diagnosed with Blood clots) and HOSPITALISATION (Hospitalized for one day) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he was currently taking Blood thinners.   No concomitant medications were provided by the reporter.   This 53 year-old consumer called on 19Jul2021 to report that he received the first dose of Moderna COVID-19 vaccine on 29Mar2021 (Lot#006B21A). On 14Apr2021 patient   was diagnosed with Blood clots and was hospitalized for one day. He mentioned that he never received the second dose . Patient is currently taking Blood thinners.  No Lab data was provided by the reporter.  This report refers to a case of product dose omission for mRNA-1273 (lot # 006B21A) with associated AE reported of thrombosis. Based on the current available information and temporal association between the use of the product and the start date of the event thrombosi, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: This report refers to a case of product dose omission for mRNA-1273 (lot # 006B21A) with associated AE reported of thrombosis. Based on the current available information and temporal association between the use of the product and the start date of the event thrombosi, a causal relationship cannot be excluded. Further information has been requested
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Inappropriate schedule of product administration, Myocarditis
Clinical narrative: Myocarditis; chest pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a and 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (chest pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, MYOCARDITIS (Myocarditis) and CHEST PAIN (chest pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot#022c21A with AEs of Myocarditis and chest pain. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot#022c21A with AEs of Myocarditis and chest pain. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: his wife ended up in a hospital for 9 days, she had her gallbladder removed; This spontaneous case was reported by a consumer and describes the occurrence of GALLBLADDER DISORDER (his wife ended up in a hospital for 9 days, she had her gallbladder removed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gallbladder removal on 15-May-2021.   On 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced GALLBLADDER DISORDER (his wife ended up in a hospital for 9 days, she had her gallbladder removed) (seriousness criterion hospitalization). The patient was hospitalized for 9 days due to GALLBLADDER DISORDER. The patient was treated with Surgery for Gallbladder disorder. On 24-May-2021, GALLBLADDER DISORDER (his wife ended up in a hospital for 9 days, she had her gallbladder removed) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Patient received the Moderna vaccine, the 2nd dose on 09 May 2021, 6 days later she ended up in a hospital for 9 days, she had her gallbladder removed.  Although a temporal association exist, there s still limited information to assess the causal association between the reported event and the administration of mRNA-1273.  Critical details such as the patient's medical history. concomitant medication, clinical presentation and hospitalization details including investigations is lacking.  Additional information has been requested.; Sender's Comments: Although a temporal association exist, there s still limited information to assess the causal association between the reported event and the administration of mRNA-1273.  Critical details such as the patient's medical history. concomitant medication, clinical presentation and hospitalization details including investigations is lacking.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Patient was diagnosed with Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Patient was diagnosed with Blood clots) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Patient was diagnosed with Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Patient was diagnosed with Blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided. No treatment information was provided. The reporter called on 19-Jul-2021 to report that his 26-year-old daughter received her first dose of the Moderna COVID-19 vaccine (no date or lot number was provided). The patient was later diagnosed with blood clots. The reporter did not provide any additional information.   Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Myocardial infarction
Clinical narrative: Heart attack; Irregular heartbeat; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat). The patient was hospitalized on 24-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and HEART RATE IRREGULAR (Irregular heartbeat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Beta blocker (unspecified) and statin (unspecified) for an unknown indication. Treatment included few stents inserted for the heart attack.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart Attack after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack after vaccination) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack after vaccination) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.  Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: has a headache; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 19May2021, this case now contains all required information to be considered valid.  This is a spontaneous report a contactable consumer (patient) from a Pfizer- sponsored program.  A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date to an unspecified date, at 100 mg (frequency unknown) for breast cancer female (C50.211) . The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date after covid-19 shot.  The action taken in response to the events for palbociclib was unknown. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is an initial spontaneous report from a contactable reporter (Physician). This contactable reporter reported for a 44-year-old male patient that:  A 44-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Mar2021 (at the age of 44-year-old) as dose 1 single for covid-19 immunisation. Medical history included neoplasm of left kidney from 2007 to an unknown date. Patient had no known allergies. It was unknown that prior to vaccination, patient diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient was not received any other vaccine four weeks prior vaccination and it was unknown that patient receive any medication two weeks prior vaccination. The patient experienced nausea on 15Mar2021. It was unknown that since the vaccination, patient been tested for COVID-19. Adverse Event resulted to visit Doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The outcome of the event was reported as not recovered.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blepharitis, Condition aggravated, Eyelids pruritus, Swelling of eyelid
Clinical narrative: eyelids are swollen and itchy; eyelids are swollen and itchy; gotten gradually worse the past couple of months; eyelids are swollen and itchy; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for male patient that:  A 51(unit: unknown) male patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. Caller asked about treatment for long term side effects associated with the Pfizer covid 19 vaccine. On unspecified date patient experienced that his side effect has lasted longer than 6 months and has gotten gradually worse the past couple of months. His eye lids are swollen and itchy, noting the eye lids are fully swollen 24 hours a day and very itchy. Caller stated he has tried everything. The outcome of the events was unknown.   Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Her blood sugar went high to over 300; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number not reported), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. The patient's medical history included type 1 diabetic. The patient's concomitant medications were not reported. On 09Feb2021, the patient's blood sugar went high to over 300 last night after receiving the vaccine and it has never happened before. Is there something in the shot that raises my blood sugar. The patient has been continuing to take her insulin, but it was not going down. Caller asking there to have been any reports of this. Information responded that all agents were busy when attempting warm transfer (13 callers ahead) and caller did not want to hold, thus, AE transmitted. Caller was ok with someone calling her if additional information was required. Consumer was unwilling to further answer the questions. Hence, Limited information was available over the call. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram pelvis, Fall, Pain, Presyncope
Clinical narrative: Vertigo; she fell; On first day she was about to faint, second day she was about to faint again; Pain went away; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers from a Pfizer-sponsored program. A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 22Jan2021 (at the age of 96-years-old) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, on the first day, the patient was about to faint and on the second day, she was about to faint again; then on 26Jan2021, the patient fell. On 29Jan2021, they took the patient to an urgent care. CT of lumbar spine and pelvis performed on 04Feb2021 and thoracic spine and upper middle back scan performed on 10Feb2021 showed that nothing was broken. Therapeutic measures were taken as a result of the events. The patient had to have a caregiver because of her fall. Her second dose was due on 24Feb2021 and the reporter wanted to know if the patient should get it despite her current situation. On 13Mar2021, the patient started feeling better and the pain, which started from an unspecified date in 2021, went away. The event fall required emergency room visit but did not require hospital admission. The last week of Jun2021, the patient started having vertigo. The outcome of the event vertigo was unknown, recovered on 13Mar2021 for pain, and recovered on an unspecified date in 2021 for all other events.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Scan, Vertigo
Clinical narrative: Vertigo; she fell; On first day she was about to faint, second day she was about to faint again; Pain went away; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers from a Pfizer-sponsored program. A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 22Jan2021 (at the age of 96-years-old) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, on the first day, the patient was about to faint and on the second day, she was about to faint again; then on 26Jan2021, the patient fell. On 29Jan2021, they took the patient to an urgent care. CT of lumbar spine and pelvis performed on 04Feb2021 and thoracic spine and upper middle back scan performed on 10Feb2021 showed that nothing was broken. Therapeutic measures were taken as a result of the events. The patient had to have a caregiver because of her fall. Her second dose was due on 24Feb2021 and the reporter wanted to know if the patient should get it despite her current situation. On 13Mar2021, the patient started feeling better and the pain, which started from an unspecified date in 2021, went away. The event fall required emergency room visit but did not require hospital admission. The last week of Jun2021, the patient started having vertigo. The outcome of the event vertigo was unknown, recovered on 13Mar2021 for pain, and recovered on an unspecified date in 2021 for all other events.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperaesthesia teeth, Nausea, Pain in jaw, Tooth abscess
Clinical narrative: severe headache; nausea; pain in the upper jaw/teeth; pain in the upper jaw/teeth; almost like abscess tooth or something; became very, very sensitive; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable male consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that after his first dose, the patient experienced severe headache, nausea and pain in the upper jaw/teeth on an unspecified date. The patient also stated that he had Pneumonia shot a long time ago. Patient stated that he experienced real bad headache. Nausea with the first one because he did not eat for several hours. Teeth was sort of hurting bad, almost like abscess tooth or something, became very, very sensitive so as he could not drink anything. He stated did not have severe nausea but had severe headache. Headaches are not as bad but teeth are still real bad, can hardly drink anything cool and not anything hot. The patient reports the things that were happening with me because they said they wanted to let them know. I have had both injections now. I have had the same problem with first one, but I wasn't positive, you know, it was just the injection which now I am. The problems are real bad headache, I had nausea with the first one because I didn't eat for several hours later which I did not do this time when I ate right away, I didn't have severe nausea, but I've had severe headache all that day, still some present today of it. By, I would say 8 o' clock, I don't know exactly what time, but my teeth were sort of hurting bad almost like you would have like abscess tooth or something and they became very, very sensitive so as I couldn't drink anything. But only the upper jaw teeth, both sides, but only in the upper jaw, nothing on the bottom and the head hurt. And the headaches are not as bad now, but these teeth are still really bad. And I can hardly drink anything cool and on the other side not anything hot. And what I wanted to ask is there anything that we can do about. The outcome of headache was recovering, for nausea, pain in the upper jaw/teeth outcome was unknown, pain in the upper jaw/teeth(toothache), almost like abscess tooth or something and became very, very sensitive was not recovered  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: severe headache; nausea; pain in the upper jaw/teeth; pain in the upper jaw/teeth; almost like abscess tooth or something; became very, very sensitive; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable male consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that after his first dose, the patient experienced severe headache, nausea and pain in the upper jaw/teeth on an unspecified date. The patient also stated that he had Pneumonia shot a long time ago. Patient stated that he experienced real bad headache. Nausea with the first one because he did not eat for several hours. Teeth was sort of hurting bad, almost like abscess tooth or something, became very, very sensitive so as he could not drink anything. He stated did not have severe nausea but had severe headache. Headaches are not as bad but teeth are still real bad, can hardly drink anything cool and not anything hot. The patient reports the things that were happening with me because they said they wanted to let them know. I have had both injections now. I have had the same problem with first one, but I wasn't positive, you know, it was just the injection which now I am. The problems are real bad headache, I had nausea with the first one because I didn't eat for several hours later which I did not do this time when I ate right away, I didn't have severe nausea, but I've had severe headache all that day, still some present today of it. By, I would say 8 o' clock, I don't know exactly what time, but my teeth were sort of hurting bad almost like you would have like abscess tooth or something and they became very, very sensitive so as I couldn't drink anything. But only the upper jaw teeth, both sides, but only in the upper jaw, nothing on the bottom and the head hurt. And the headaches are not as bad now, but these teeth are still really bad. And I can hardly drink anything cool and on the other side not anything hot. And what I wanted to ask is there anything that we can do about. The outcome of headache was recovering, for nausea, pain in the upper jaw/teeth outcome was unknown, pain in the upper jaw/teeth(toothache), almost like abscess tooth or something and became very, very sensitive was not recovered  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report from a non contactable consumer (patient's spouse). A female patient of unknown age, received the final dose (reported as final dose) of Covid-19 vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. Cosuspect drug was eletriptan HBr (RELPAX) 40mg (NDC 0049-2340-45), frequency unknown  for unknown indication. The consumer wanted to know if there is a correlation between Relpax and a Covid-19 vaccine because after the final dose of vaccine, she she started experiencing migraine in the morning of 12Mar2021. Action taken with suspect drugs was unknown. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Sensitive skin, Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: with the second round, she couldn't tell she had a shot unless she pushed on it, like she got a bruise; Soreness around the injection site with very little swelling- like a mosquito bite,; she had a small bumps and it was sensitive to the touch; Very little bit of heaviness when lifting arm; Soreness around the injection site with very little swelling- like a mosquito bite,; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's historic vaccine included bnt162b2 (BNT162B2, solution for injection), dose 1 on an unspecified date as single dose for covid-19 immunization. she experienced soreness around the injection site with very little swelling- like a mosquito bite, she had a small bumps and it was sensitive to the touch and little bit of heaviness when lifting arm. On an unspecified date, patient couldn't tell she had a shot unless she pushed on it, like she got a bruise. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Paraesthesia oral, Seizure, Vertigo
Clinical narrative: Tingling sensation on their lips and tongues; head and room  spinning; seizure; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205) via an unspecified route of administration, on 06Mar2021 (at the age of 76 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included allergy to many antibiotics wherein the patient got hives or intense vomiting, and an ongoing high blood pressure. Concomitant medication included an unknown high blood pressure medication. The healthcare professional also said for her to stop taking it because of that sensation she had on her lips and tongue. On 06Mar2021, immediately after the vaccination, it was reported that the patient experienced tongue and lips were tingling. The nurse had the patient stayed for 30 minutes longer until sensation disappeared. The patient was admitted to the hospital and did not receive any treatment for the event. 7 hours later, the patient experienced that her head and room was spinning so intensely she couldn't function or open her eyes. The patient's husband wanted to take her to the hospital, but due to COVID, the patient was afraid to go. The spinning lasted for 7 hours. The patient did go to a neurologist to be sure that she didn't have a tumor, the doctor said that she was fortunate that she didn't have a stroke. The patient had an MRI brain scan to be sure she didn't have any prior issues that may have caused that seizures. She never experienced the dizziness and intense length of time. The outcome of the event "tingling sensation on their lips and tongues" was recovered on 06May2021, vertigo was recovered on unspecified date in Mar2021, while for the remaining event was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: uterine/menstrual type cramping from below my belly button down to my anus; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Not reported), via an unspecified route of administration, administered in Arm Right on 11Mar2021 as single dose (at age of 45-years old) for COVID-19 immunization. The patient concomitant medications were not reported. The patient did not have any known allergies and other medical history. Previously, the patient received first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that about 1 PM today (11Mar2021), she began having uterine/menstrual type cramping from below her belly button down to her anus. Worst cramping she had in a long. No treatment was received for the reported event. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Pruritus, Rash
Clinical narrative: rash is on his chest, head, arms and hand.; itching; can't sleep at night; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer-sponsored program. A 70-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date for covid-19 immunisation. On an unspecified date, the patient experienced rash is on his chest, head, arms and hand; itching and can't sleep at night. The patient underwent lab tests and procedures which included Bloodwork: unknown results on 16Mar2021. Therapeutic measures were taken as a result of rash is on his chest, head, arms and hand, itching was Triamcinolone acetonide a lotion for his body and Fluocinolone acetonide an oil for his head and after 1 week and Allegra and other creams were prescribed by dermatologist still itching horribly lasted up to 3 weeks. He asked if his experience have been reported as a side effect to the vaccine. The outcome of the events rash, pruritus was not resolved, and for the event insomnia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Influenza like illness, Myalgia, Pain
Clinical narrative: I had flu-like symptoms after the first shot; Achiness; chills; sore muscles; difficulty breathing; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received the first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 at 12:15pm (at the age of 65-years-old) as a single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, on an unspecified date in Mar2020 patient had affected with covid-19 and unknown if ongoing. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Albuterol Sulfate which was prescribed in last year. The patient reported that on 20Mar2021 at 01:00 AM he had flu-like symptoms after the first shot, the patient had achiness, chills, sore muscles and difficulty breathing and those subsided within 24 hours. The patient received second dose of vaccine on 19Mar2021 at 12:15 PM (Batch/Lot: EN6207). The patient was recovering from the events.  No follow-up attempts are needed. No Further information is expected. .
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I had flu-like symptoms after the first shot; Achiness; chills; sore muscles; difficulty breathing; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received the first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 at 12:15pm (at the age of 65-years-old) as a single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, on an unspecified date in Mar2020 patient had affected with covid-19 and unknown if ongoing. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Albuterol Sulfate which was prescribed in last year. The patient reported that on 20Mar2021 at 01:00 AM he had flu-like symptoms after the first shot, the patient had achiness, chills, sore muscles and difficulty breathing and those subsided within 24 hours. The patient received second dose of vaccine on 19Mar2021 at 12:15 PM (Batch/Lot: EN6207). The patient was recovering from the events.  No follow-up attempts are needed. No Further information is expected. .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I had pretty intense joint pain about 4-5 hours after the shot. It was primarily in my right shoulder, elbow, wrist, and fingers.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533) via unspecified route of administration in the right arm on 26Mar2021 at 14:45 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included inflammatory bowel disease (Crohn's). Concomitant medications included mesalazine (APRISO), women's multi-vitamin and ashwagandha (KSM-66); all from an unknown date for unknown indications. 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 had not tested for COVID-19. On 26Mar2021 at 18:30, the patient experienced pretty intense joint pain after 4-5 hours after the shot which was primarily in the right shoulder, elbow, wrist and fingers. The pain lasted most of the night but subsided the following morning. The patient did not receive treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pain in joint involving hand was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated coding of history: IBD (Crohn's), Deleted concomitant drug Multivitamin and Concomitant therapy selected as yes.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in arm left on 26Mar2021 at 14:15 (at the age of 48-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient did not take any concomitant medications. The patient had no known allergies to medications, food or other products. Historical vaccine included tetanus (TETANUS VACCINE, Lot number: 5), via an unspecified route of administration on 17Feb2021 as a fifth dose for immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 15:00, the patient experienced headache and nausea. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events for headache and nausea was not recovered.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccine facility information was added. Concomitant therapy was left as blank since case contain concomitant medication. TETANUS VACCINE was removed from concomitant drug and updated as Historical vaccine as it was administration outside the 4 week interval.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Pharyngeal swelling, SARS-CoV-2 test, Swollen tongue
Clinical narrative: Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 11:00 (at 52 years old, not pregnant) Batch/Lot Number: EN6204) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High blood pressure, High lipids, KNown allergies:penicillin, all from an unknown date. No concomitant medications. On 05Mar2021, patient experienced swollen and closing throat, swollen and numbed lips and tongue. Treatment for events was Benadryl. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 test: negative on 21Mar2021. Facility type vaccine: available. No other vaccine in four weeks. The outcome of the events was Resolved with Sequel.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; Swollen and closing Throat, Swollen And Numbed Lips And Tongue.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 11:00 (at 52 years old, not pregnant) Batch/Lot Number: EN6204) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High blood pressure, High lipids, KNown allergies:penicillin, all from an unknown date. No concomitant medications. On 05Mar2021, patient experienced swollen and closing throat, swollen and numbed lips and tongue. Treatment for events was Benadryl. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 test: negative on 21Mar2021. Facility type vaccine: available. No other vaccine in four weeks. The outcome of the events was Resolved with Sequel.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash on stomach and chest.; Seems like hives; This is a spontaneous report received from a non-contactable consumer (patient reported for herself). A 36-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), as a single dose via an unspecified route of administration on left arm on 26Feb2021 at 14:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. The patient was non- pregnant at the time of vaccination. Medical history included uveitis, had chronic urticaria a decade ago but have been asymptomatic for years. The patient reported allergy to NSAIDS. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), as a single dose via an unspecified route of administration on right arm on 26Mar2021 at 14:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Concomitant medications included Desogestrel, ethinylestradiol (KARIVA), netarsudil mesylate (RHOPRESSA), brimonidine tartrate; brinzolamide (SIMBRINZA), cetirizine hydrochloride (ZYRTEC) and mometasone furoate (FLONASE), all taken for an unspecified indication, start and stop dates were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Mar2021 at 10:00, the patient experienced rash on stomach and chest, does not itch, seems like hives. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome for the event rash and hives was not resolved.   No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment (11Jul2021): This follow-up report is being submitted to amend previously reported information: Patient country added in patient tab. Dose 1 was ticked as primary regimen, stop date of dose 1 updated as 26-FEB-2021 14:00. Vaccine Facility Information added. Concomitant drug Zyrtec, Flonase were coded via WHODrug.