chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Skin discolouration, Swelling, Tenderness
Clinical narrative: olecranon bursitis in her left elbow; swelling; Elbow was "purple and green" and resulted in "puckering" of the forearm skin.; Elbow was still a little tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 (Lot number: EW0126) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURSITIS (non-serious) with onset Apr2021, outcome "recovered with sequelae", described as "olecranon bursitis in her left elbow"; SWELLING (non-serious) with onset Apr2021, outcome "recovered with sequelae", described as "swelling"; SKIN DISCOLOURATION (non-serious) with onset Apr2021, outcome "recovered with sequelae", described as "Elbow was "purple and green" and resulted in "puckering" of the forearm skin."; TENDERNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "Elbow was still a little tender". The events "olecranon bursitis in her left elbow", "swelling", "elbow was "purple and green" and resulted in "puckering" of the forearm skin." and "elbow was still a little tender" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of bursitis, swelling, skin discolouration, tenderness.  Additional information: Treatment received was unknown. Hospitalization prolonged it was reported as no. Prior to vaccination the patient diagnosed with COVID-19 was unknown. Since the vaccination the patient tested for COVID-19 was unknown. Patient also received bnt162b2, administered intramuscular administration date 18May2021 (Lot number: EW0183 Expiry date: Unknown) as dose 2, single for covid-19 immunisation. Reporter met a woman at a party on 06Nov2021. who said that she experienced olecranon bursitis in her left elbow shortly after receiving the first dose of the Pfizer vaccine in the left arm. She said that she had bumped the elbow on a doorknob shortly before getting the first dose, but that the swelling didn't occur until after the shot on 14Apr2021. She said she had consulted a rheumatologist about the bursitis and possible auto-immune disorders but was not diagnosed with any such disorder.  . No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: Abnormal heavy menstrual flow.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 12:00 (Lot number: FC3183) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gluten" (unspecified if ongoing). Concomitant medication(s) included: TDAP; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0121, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Aug2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 03Nov2021, outcome "unknown", described as "Abnormal heavy menstrual flow.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient reported other vaccine in four weeks. The other vaccine 4 weeks product like TDAP. Other medications in two weeks were Daily vitamins and Zyrtec. Prior to vaccination, was the patient diagnosed with COVID-19 was as No. Since the vaccination, has the patient been tested for COVID-19 was as Yes  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Lymphadenitis, Migraine, Nausea, Pain
Clinical narrative: fever; nausea; migraine; all body rash; lymph node swelling; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Aug2021 17:30 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: MIGRAINE (non-serious) with onset 30Aug2021 17:45, outcome "recovered" (2021), described as "migraine"; NAUSEA (non-serious) with onset 31Aug2021 08:30, outcome "recovered" (2021), described as "nausea"; PYREXIA (non-serious) with onset 31Aug2021 10:00, outcome "recovered" (2021), described as "fever"; RASH (non-serious) with onset 2021, outcome "unknown", described as "all body rash"; LYMPHADENITIS (non-serious) with onset 2021, outcome "unknown", described as "lymph node swelling"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, nausea, pyrexia.  Additional information: Prior vaccination within 4 weeks reported as None. Patient underwent lab test procedures which included: On 19Aug2021 COVID-19 Positive.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: fever; nausea; migraine; all body rash; lymph node swelling; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Aug2021 17:30 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: MIGRAINE (non-serious) with onset 30Aug2021 17:45, outcome "recovered" (2021), described as "migraine"; NAUSEA (non-serious) with onset 31Aug2021 08:30, outcome "recovered" (2021), described as "nausea"; PYREXIA (non-serious) with onset 31Aug2021 10:00, outcome "recovered" (2021), described as "fever"; RASH (non-serious) with onset 2021, outcome "unknown", described as "all body rash"; LYMPHADENITIS (non-serious) with onset 2021, outcome "unknown", described as "lymph node swelling"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, nausea, pyrexia.  Additional information: Prior vaccination within 4 weeks reported as None. Patient underwent lab test procedures which included: On 19Aug2021 COVID-19 Positive.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: Dose 2 vaccine is administered outside the range19 - 42 days after the first dose; Having chest pains; sudden rapid heart rate; shortness of breath; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Sep2021 (Batch/Lot number: unknown) as dose 1, single and administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Family history included: "Major family history on both sides of severe heart issues" (unspecified if ongoing); "strokes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cefaclor, reaction(s): "Known allergies: Cefaclor". The following information was reported: CHEST PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Having chest pains"; HEART RATE INCREASED (non-serious) with onset 10Sep2021, outcome "not recovered", described as "sudden rapid heart rate"; DYSPNOEA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "shortness of breath"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Oct2021, outcome "unknown", described as "Dose 2 vaccine is administered outside the range19 - 42 days after the first dose". The events "having chest pains", "sudden rapid heart rate" and "shortness of breath" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chest pain, heart rate increased, dyspnoea.  Additional information: The patient received vaccination at facility of Military base. 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. The patient reported of having chest pains mixed with sudden rapid heart rate and shortness of breath. He had spoken and confirmed with 20 military co-workers who were having the same issue. This condition was not getting better rather it's getting worse. They all were currently being tested for any conditions, damage, and allergies. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: herpes outbreak; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 06Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "herpes", start date: 2018, stop date: 2018, notes: his wife contracted "herpes" in 2018. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "herpes outbreak".  Additional information: The caller states that he is embarrassed about this but since getting the 2nd dose of the Pfizer COVID 19 Vaccine him nor his wife have had a herpes outbreak. They received their 2nd dose of the vaccine 06Jun2021. The caller states that he generally has 3 outbreaks a year and she gets outbreaks about 2 times a month. The both of them have since had zero outbreaks. Caller wanted to know if we have seen this correlation before or if they have gotten "lucky." He would like to report this possible positive event to Pfizer, however declines warm transfer at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101547176 Same Reporter/Drug/AE, Different Patient
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: shortness of breath; chest pain; nausea; fatigue; arm pain at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 13 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 10:00 (Lot number: FF8841) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizure" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE; STRATTERA; HYDROXYZINE; HYDROXYZINE HCL (ongoing); DIVALPROEX SODIUM (ongoing); SINGULAIR (ongoing); ATOMOXETINE HCL (ongoing). Past drug history included: Amoxicillin, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: FF8841, via intramuscular route of administration), administration date: 16Oct2021, when the patient was 13 years old, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 08Nov2021, outcome "recovering", described as "shortness of breath"; CHEST PAIN (non-serious) with onset 08Nov2021, outcome "recovering", described as "chest pain"; NAUSEA (non-serious) with onset 08Nov2021, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 08Nov2021, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 08Nov2021, outcome "recovering", described as "arm pain at injection site". The events "shortness of breath", "chest pain", "nausea", "fatigue" and "arm pain at injection site" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, nausea, fatigue, vaccination site pain.  Additional information: The patient was not received other vaccine in four weeks. The patient received other medication in two weeks were DEPAKOTE, STRATTERA, HYDROXYZINE. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The vaccine was administered at pharmacy or drug store. The vaccine was not administered at private facility. The patient underwent lab test and procedure on 08Nov2021 which includes red blood cell sedimentation rate (sed rate): 0 (Normal), C-reactive protein (CRP): unknown result, Troponin T: less than 7 (Normal), Electrocardiogram (EKG): Normal. The reporter stated that the event was related to the BNT162B2. The reporter stated, the patient normally sees doctor. The reporter stated, the patient mother wanted him to continue to see doctor for any further follow up.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Red blood cell sedimentation rate, Troponin T, Vaccination site pain
Clinical narrative: shortness of breath; chest pain; nausea; fatigue; arm pain at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 13 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 10:00 (Lot number: FF8841) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizure" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE; STRATTERA; HYDROXYZINE; HYDROXYZINE HCL (ongoing); DIVALPROEX SODIUM (ongoing); SINGULAIR (ongoing); ATOMOXETINE HCL (ongoing). Past drug history included: Amoxicillin, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: FF8841, via intramuscular route of administration), administration date: 16Oct2021, when the patient was 13 years old, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 08Nov2021, outcome "recovering", described as "shortness of breath"; CHEST PAIN (non-serious) with onset 08Nov2021, outcome "recovering", described as "chest pain"; NAUSEA (non-serious) with onset 08Nov2021, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 08Nov2021, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 08Nov2021, outcome "recovering", described as "arm pain at injection site". The events "shortness of breath", "chest pain", "nausea", "fatigue" and "arm pain at injection site" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, nausea, fatigue, vaccination site pain.  Additional information: The patient was not received other vaccine in four weeks. The patient received other medication in two weeks were DEPAKOTE, STRATTERA, HYDROXYZINE. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The vaccine was administered at pharmacy or drug store. The vaccine was not administered at private facility. The patient underwent lab test and procedure on 08Nov2021 which includes red blood cell sedimentation rate (sed rate): 0 (Normal), C-reactive protein (CRP): unknown result, Troponin T: less than 7 (Normal), Electrocardiogram (EKG): Normal. The reporter stated that the event was related to the BNT162B2. The reporter stated, the patient normally sees doctor. The reporter stated, the patient mother wanted him to continue to see doctor for any further follow up.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Vaccination site pain
Clinical narrative: experienced shortness of breath; States his left arm at the injection site also hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer-sponsored program.  A 49-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 25Sep2021 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "experienced shortness of breath"; VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "States his left arm at the injection site also hurts". The event "experienced shortness of breath" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated his left arm at the injection site also hurts and he felt that for a couple of weeks and he thinks at this point that is resolved. Stated he did go to the doctor's office for this and they did do a breathalyzer or EKG or ECG and based on that it was fine and mostly they did it for the symptom of the shortness of breath which is why he was trying to find out the reason and they were not able to find any conclusion. States he had not started any new medications within 2 weeks prior to the reported event and stated he had just been on his regular medications; no further details provided by the caller. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. There were no additional vaccines administered on same date of the Pfizer suspect. The patient stated the shortness of breath started about 3 to 4 days later after getting the 1st dose of the vaccine and stated it was not ongoing but lasted several weeks and he started being able to take a full breath on Monday and he was not a HCP so was not able to say but he was able to take a breath and the shortness of breath used to happen when he was laying down in bed. There were no prior vaccinations, within 4 weeks of vaccination. Family Medical History Relevant to AE(s) was reported as none.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Urticaria
Clinical narrative: inflammation; hives head to toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 12-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "recovered", described as "inflammation"; URTICARIA (non-serious), outcome "recovered", described as "hives head to toe". Additional information Reporter stated, looks like it was FE3592. (Further clarification unknown hence, not captured in tab). Expiry Date of COVID-19 Vaccine: Unknown. Reaction/event as reported by primary source: My son had an adverse reaction to the COVID vaccine. He had inflammation and hives head to toe for about 4 days. Reporter stated, my son had an adverse reaction to the COVID vaccine, and I was looking at the website, so I looked that he should not receive the second dose, but I just wanted to confirm now with someone. Reporter was unwilling to complete the report, further probing could not be done. Hence, limited information was available over the call.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on neck, chest, abdomen, arms, and thighs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Nov2021 14:38 (Lot number: FK5127) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 10Nov2021 16:00, outcome "recovered", described as "Hives on neck, chest, abdomen, arms, and thighs". Therapeutic measures were taken as a result of urticaria.  Additional information: If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: None. Other medical history: None. Family Medical History: Father has hx of Fever / vomiting from childhood vaccines and had adjusted dose schedule. Relevant Tests: None. Specific Relevant Tests: None. Treatment Details: Benadryl/Cloritin. (Withheld) developed hives from neck to knees starting approximately 2 hours after administration. Patient received alternating doses of 25mg Benadryl and 10 mg Cloritin g/2 hours for approximately 3-4 days after then hives/itch no other sequalae.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Difficulty breathing; elevated heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 10Nov2021, outcome "unknown", described as "Difficulty breathing"; HEART RATE INCREASED (non-serious) with onset 10Nov2021, outcome "unknown", described as "elevated heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, heart rate increased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Vaccination site pain
Clinical narrative: fever; joint pains on his knees, arms, shoulders, and hips/joint pain in ankles, shoulders, hips, and elbows; pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 25Aug2021 (Lot number: FC3183) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Controlled hypertension" (ongoing), notes: Diagnosed with around 1998, 1999 or 2000, caller can't remember.; "Stent" (unspecified if ongoing), notes: heart patient that has 5 stents. The stents were placed in the years 2001, 2002 and 2018.; "anti-cholesterol medicine to keep cholesterol down" (unspecified if ongoing). Concomitant medication(s) included: REPATHA taken for blood cholesterol decreased (ongoing); PLAVIX taken for stent placement (ongoing). Vaccination history included: Bnt162b2 (First dose: 26Jan2021 , lot: EL9263, Route of administration: Right arm), administration date: 26Jan2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Second dose: 16Feb2021, lot: EL9267, Route of administration: Left arm), administration date: 16Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "pain at the injection site"; PYREXIA (non-serious), outcome "recovered" (2021), described as "fever"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "joint pains on his knees, arms, shoulders, and hips/joint pain in ankles, shoulders, hips, and elbows". Additional information: The joint pain came up a couple of weeks ago and its not from physical exercise or anything, has had a lot of joint pain which is abnormal for him.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Skin rash like hives; felt very itchy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 05Nov2021 16:30 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 09Nov2021 01:00, outcome "not recovered", described as "Skin rash like hives"; PRURITUS (non-serious) with onset 09Nov2021 01:00, outcome "not recovered", described as "felt very itchy". The events "skin rash like hives" and "felt very itchy" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, pruritus.  Additional information: Is pregnant: No. Adverse event: Skin rash like hives suddenly happened on the back in the middle night of day 3 post immunization. On the following days of day 4/5/6/7skin rash like hives happened again after warm shower. The kid felt very itchy. He never has allergy history or hives before. Today is day 7 post immunization. Will keep monitoring on it. Adverse events start date: 09Nov2021. Adverse events start time 01:00. AE resulted in: Doctor or other healthcare professional office/clinic visit. If treatment ae: Yes. If patient recovered: Not recovered. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Other medical history: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Dyspnoea, Fatigue, Myalgia
Clinical narrative: muscle pains; Woke up with top of feet burning; shortness of breath; dizziness; fatigue; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Lot number: FF2587) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Surface eye drops" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Batch/Lot No: Ff2587, expiry date unknown, Location of injection: Arm Left, route of administration unknown), administration date: 21Oct2021, when the patient was 46 years old, for COVID-19 immunization.  The following information was reported: MYALGIA (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "muscle pains"; BURNING SENSATION (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "Woke up with top of feet burning"; DYSPNOEA (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "shortness of breath"; DIZZINESS (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "dizziness"; FATIGUE (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "sore arm". Therapeutic measures were not taken as a result of myalgia, burning sensation, dyspnoea, dizziness, fatigue, pain in extremity.  Additional information: 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 was not tested for COVID-19. Reportedly the patient was not tested for covid post vaccination. It was reported that the COVID-19 vaccine was administered to patient at doctor's office/urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: muscle pains; Woke up with top of feet burning; shortness of breath; dizziness; fatigue; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Lot number: FF2587) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Surface eye drops" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Batch/Lot No: Ff2587, expiry date unknown, Location of injection: Arm Left, route of administration unknown), administration date: 21Oct2021, when the patient was 46 years old, for COVID-19 immunization.  The following information was reported: MYALGIA (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "muscle pains"; BURNING SENSATION (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "Woke up with top of feet burning"; DYSPNOEA (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "shortness of breath"; DIZZINESS (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "dizziness"; FATIGUE (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "sore arm". Therapeutic measures were not taken as a result of myalgia, burning sensation, dyspnoea, dizziness, fatigue, pain in extremity.  Additional information: 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 was not tested for COVID-19. Reportedly the patient was not tested for covid post vaccination. It was reported that the COVID-19 vaccine was administered to patient at doctor's office/urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eye oedema, Eye swelling, Rash
Clinical narrative: Swelling and puffiness around both eyes - the skin in this area looked very red.; Swelling and puffiness around both eyes - the skin in this area looked very red.; Swelling and puffiness around both eyes - the skin in this area looked very red.; rash on the face; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: Flu shot ([{other vaccine 4 weeks product Flu Shot}), administration date: 15Oct2021, when the patient was 6 years old. The following information was reported: EYE SWELLING (non-serious), EYE OEDEMA (non-serious), ERYTHEMA (non-serious) all with onset 13Nov2021, outcome "recovering" and all described as "Swelling and puffiness around both eyes - the skin in this area looked very red."; RASH (non-serious) with onset 13Nov2021, outcome "recovering", described as "rash on the face". The events "swelling and puffiness around both eyes - the skin in this area looked very red.", "swelling and puffiness around both eyes - the skin in this area looked very red.", "swelling and puffiness around both eyes - the skin in this area looked very red." and "rash on the face" were evaluated at the physician office visit. Therapeutic measures were taken as a result of eye swelling, eye oedema, erythema, rash.  Additional information: No severe or life-threatening symptoms though. Treatment for adverse events included Benadryl. If covid prior vaccination and covid tested post vaccination reported as No.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Nasal congestion, Pain in extremity
Clinical narrative: Sore arm; Fatigue; Dizziness; I also got some coughing like some phlegm and some congestion; I also got some coughing like some phlegm and some congestion; some congestion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Fatigue"; DIZZINESS (non-serious) with onset Nov2021, outcome "unknown", described as "Dizziness"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I also got some coughing like some phlegm and some congestion"; NASAL CONGESTION (non-serious) with onset Nov2021, outcome "unknown", described as "some congestion".  Additional information: This is a spontaneous report from a non-contactable consumer. This non-contactable consumer (patient) reported for self that: patient mean that night patient had the sore arm and fatigue, some dizziness but patient also some congestion and patient was worried like they have given me a flu shot by mistake."  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: Sore arm; Fatigue; Dizziness; I also got some coughing like some phlegm and some congestion; I also got some coughing like some phlegm and some congestion; some congestion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Fatigue"; DIZZINESS (non-serious) with onset Nov2021, outcome "unknown", described as "Dizziness"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I also got some coughing like some phlegm and some congestion"; NASAL CONGESTION (non-serious) with onset Nov2021, outcome "unknown", described as "some congestion".  Additional information: This is a spontaneous report from a non-contactable consumer. This non-contactable consumer (patient) reported for self that: patient mean that night patient had the sore arm and fatigue, some dizziness but patient also some congestion and patient was worried like they have given me a flu shot by mistake."  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose 24 hours post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).. This consumer reported for an 8-year-old male patient that:  A 8 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 11Nov2021 19:45 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known Allergy: Amoxicillin", notes: Known Allergy: Amoxicillin. The following information was reported: EPISTAXIS (non-serious) with onset 12Nov2021 19:45, outcome "recovered" (Nov2021), described as "Bloody nose 24 hours post vaccination". Therapeutic measures were not taken as a result of epistaxis.  Additional information: If other vaccine in four weeks: No.other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Vaccination site pain
Clinical narrative: Extreme low back pain; Extreme low back pain and worsening of joint inflammation; 3 episodes of recurrent injection site pain; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 (Lot number: EN6203) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, patient was diagnosed with COVID-19; "SI joint inflammation" (ongoing), notes: SI joint inflammation; "Low back arthritis" (ongoing), notes: Low back arthritis. There were no concomitant medications.  The following information was reported: BACK PAIN (non-serious) with onset 10Mar2021, outcome "recovered with sequelae" (2021), described as "Extreme low back pain"; ARTHRITIS (non-serious) with onset 10Mar2021, outcome "recovered with sequelae" (2021), described as "Extreme low back pain and worsening of joint inflammation"; VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "recovered with sequelae" (2021), described as "3 episodes of recurrent injection site pain". It was unknown if therapeutic measures were taken as a result of back pain, arthritis, vaccination site pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Difficulty breathing; headache; dizziness; feeling like going to far not; elevated blood glucose; overall body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 16:30 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PTSD" (unspecified if ongoing); "restless legs" (unspecified if ongoing); "CPAP" (unspecified if ongoing); "bipolar schizoeffective" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: covid prior vaccination reported as yes. Concomitant medication(s) included: INVEGA [PALIPERIDONE]; SEROQUEL; PRAMIPEXOLE. Vaccination history included: Bnt162b2 (Dose 2, single; Batch/Lot No: Unknown, Misplaced/discarded; in left arm; at 08:00 AM), administration date: 13Mar2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "Dose 1 09Jan2021; Dose 2 13Mar2021"; Bnt162b2 (Dose 1, single; Batch/Lot No: Unknown, Misplaced/discarded; in right arm; at 08:00 AM), administration date: 09Jan2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "Difficulty breathing"; HEADACHE (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "dizziness"; FEELING ABNORMAL (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "feeling like going to far not"; BLOOD GLUCOSE INCREASED (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "elevated blood glucose"; PAIN (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "overall body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, headache, dizziness, feeling abnormal, blood glucose increased, pain. Additional information: Known allergies was reported as yes. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as Invega, Seroquel pramipexole mipraxole magnesium v. Patient had covid test post vaccination was reported as nasal swab test with negative result on 08Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test
Clinical narrative: Difficulty breathing; headache; dizziness; feeling like going to far not; elevated blood glucose; overall body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 16:30 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PTSD" (unspecified if ongoing); "restless legs" (unspecified if ongoing); "CPAP" (unspecified if ongoing); "bipolar schizoeffective" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: covid prior vaccination reported as yes. Concomitant medication(s) included: INVEGA [PALIPERIDONE]; SEROQUEL; PRAMIPEXOLE. Vaccination history included: Bnt162b2 (Dose 2, single; Batch/Lot No: Unknown, Misplaced/discarded; in left arm; at 08:00 AM), administration date: 13Mar2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "Dose 1 09Jan2021; Dose 2 13Mar2021"; Bnt162b2 (Dose 1, single; Batch/Lot No: Unknown, Misplaced/discarded; in right arm; at 08:00 AM), administration date: 09Jan2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "Difficulty breathing"; HEADACHE (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "headache"; DIZZINESS (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "dizziness"; FEELING ABNORMAL (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "feeling like going to far not"; BLOOD GLUCOSE INCREASED (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "elevated blood glucose"; PAIN (non-serious) with onset 07Nov2021 12:00, outcome "recovering", described as "overall body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, headache, dizziness, feeling abnormal, blood glucose increased, pain. Additional information: Known allergies was reported as yes. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination reported as Invega, Seroquel pramipexole mipraxole magnesium v. Patient had covid test post vaccination was reported as nasal swab test with negative result on 08Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.