chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Vaccination site erythema, Vaccination site pain
Clinical narrative: received a higher than recommended dose of the purple cap formulation; Redness of the area and usual pain from the injection; Redness of the area and usual pain from the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 12 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 19Nov2021 15:22 (Lot number: EW0182) at the age of 12 years as dose 1, 0.5 ml single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 19Nov2021, outcome "unknown", described as "received a higher than recommended dose of the purple cap formulation"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Redness of the area and usual pain from the injection". Therapeutic measures were not taken as a result of overdose, vaccination site pain, vaccination site erythema.  Reporter reports two patients received a higher than recommended dose of the purple cap formulation. A 12 y/o male and a 14 y/o female both received 0.5 ml dose instead of 0.3 ml dose. It was their first Comirnaty dose and it occurred on 19Nov2021.She wants to know what to do about the second dose. Transferring agent stated, "She is calling regarding Comirnaty Vaccine, she states that 2 patients, a 12-year-old male (consumer) and 14-year-old female they both were given a higher than recommended dose of the adult formulation of the Comirnaty Vaccine, so the purple cap vial. They were given 0.5 ml instead of recommended 0.3 ml dose. That happen on 19Nov2021 and she was calling into Medical Information to inquiry about, what to do about the second dose. Vaccine LOT#EW0182. When probed for vaccine Expiration date, Nurse stated, "Nov2021, that are expiration date as far as when it was taken out of the cold and put into refrigerator because of the 30 days that's not the listed expiration date, that our expiration date. When probed to confirm if patients experienced any adverse event, Nurse stated, "No, just a generalized redness of the area and usual pain from the injection were the only complain." When probed for any treatment, Nurse stated, "The provider spoke with them, there was no treatment."  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101652350 same reporter/drug/AE, different patient
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Blister, Computerised tomogram, Fatigue, Pain
Clinical narrative: she had tiny little blisters on the inside of her elbow; soreness; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Mar2021 (Lot number: EN6207) at the age of 52 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: BLISTER (non-serious) with onset Mar2021, outcome "unknown", described as "she had tiny little blisters on the inside of her elbow"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "soreness"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue". The events "she had tiny little blisters on the inside of her elbow", "soreness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blister, pain, fatigue.  Additional Information: It was stated that patient had tiny little blisters on the inside of her elbow at first after her 1st shot of the Pfizer Covid vaccine . Caller stated that the blisters began after she had the first dose of the vaccine in Mar and thinks her dose was on 25Mar or 26Mar2021; states she was thinking by the first week in Apr which was the last time she went off the medication and tried all through the summer to go off of different things and started with steroids and got off those after a month or two and everything came back like the soreness and fatigue and she noticed it started taking a long time to come back and she is getting less of it. Caller stated she can't remember the date of her 1st dose of the Pfizer COVID Vaccine then clarified it was on 19Mar2021. There was no prior Vaccinations (within 4 weeks):  She did knew that her dad had a reaction and it also may be genetic or not but her dad had the reaction that was different but it was a reaction to the Pfizer Covid vaccine also given at the same place as the caller had her vaccine administered.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Positron emission tomogram
Clinical narrative: she had tiny little blisters on the inside of her elbow; soreness; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Mar2021 (Lot number: EN6207) at the age of 52 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: BLISTER (non-serious) with onset Mar2021, outcome "unknown", described as "she had tiny little blisters on the inside of her elbow"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "soreness"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue". The events "she had tiny little blisters on the inside of her elbow", "soreness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blister, pain, fatigue.  Additional Information: It was stated that patient had tiny little blisters on the inside of her elbow at first after her 1st shot of the Pfizer Covid vaccine . Caller stated that the blisters began after she had the first dose of the vaccine in Mar and thinks her dose was on 25Mar or 26Mar2021; states she was thinking by the first week in Apr which was the last time she went off the medication and tried all through the summer to go off of different things and started with steroids and got off those after a month or two and everything came back like the soreness and fatigue and she noticed it started taking a long time to come back and she is getting less of it. Caller stated she can't remember the date of her 1st dose of the Pfizer COVID Vaccine then clarified it was on 19Mar2021. There was no prior Vaccinations (within 4 weeks):  She did knew that her dad had a reaction and it also may be genetic or not but her dad had the reaction that was different but it was a reaction to the Pfizer Covid vaccine also given at the same place as the caller had her vaccine administered.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: ER8731) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, LOT-ER8735), administration date: 01Apr2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm".  Additional information: It was reported that she received her booster on Friday 19Nov2021 in her right arm and now has a bruise that is slightly above the injection site and a red spot that is getting worse and itches below the injection site that is painful and itchy and asks if this is normal,  asks what to put on it some kind of cream, states she had no problem with the first dose and with the second she was kind of tired and had a sore arm and is sure this time the bruise is from her hitting the vein. Caller asks how long will this last. Question about the booster, caller states she got the booster on Friday 19Nov2021, has a bruise right about injection site which she is not comfortable about, states there is a red spot underneath the injection site which is getting bigger, it is painful and itchy, states it is about 5 inches by 1 inch and is just getting bigger, wants to know if this is normal. Follow-up attempts are completed. No further information is expected.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Glycosylated haemoglobin abnormal
Clinical narrative: Her A1C was 7.2 from Jul or Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EN6201) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: she has been a diabetic for about 20 years. It isn't great or well controlled.; "asthma" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE] taken for asthma. Past drug history included: Factin, reaction(s): "Allergy: Factin", notes: She is not sure if there would be something in there, but with those reactions she had a physical form and a big break out. That was 10 to 15 years ago.; Boniva, reaction(s): "muscle aches", notes: Caller states she had a reaction to the Boniva over 20 years ago; Boniva for she couldn't even walk without holding on to stuff throughout the house; Boniva for she had a fine rash on both arms. Vaccination history included: Bnt162b2 (Dose 1, lot: EL9261, Right Arm), administration date: 22Jan2021, when the patient was 69 years old, for Covid-19 Immunization. The following information was reported: GLYCOSYLATED HAEMOGLOBIN ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Her A1C was 7.2 from Jul or Aug2021". Relevant laboratory tests and procedures included Glycosylated haemoglobin (2021): 7.2.  Additional information: Patient said that about her height she has shrunk an inch. Caller clarified that she shrunk prior to the vaccines. She has been shrinking for years due to age. Caller clarified that she was on Flonase and she was changed to something different, like Nasonex. Caller states she is not sure of the first letter but provides EN6201. It is handwritten on the card. Vaccination facility type was pharmacy.  No prior vaccinations (within 4 weeks) were done. No adverse event prior to vaccination. She is allergic to Factin and Boniva. She is not sure if there would be something in there, but with those reactions she had a physical form and a big break out. That was 10 to 15 years ago.   No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Vaccination site erythema, Vaccination site pain
Clinical narrative: received a higher than recommended dose of the purple cap formulation; Redness of the area and usual pain from the injection; Redness of the area and usual pain from the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 14 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 19Nov2021 15:20 (Lot number: EW0182) at the age of 14 years as dose 1, 0.5 ml, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "received a higher than recommended dose of the purple cap formulation"; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE PAIN (non-serious), outcome "unknown" and all described as "Redness of the area and usual pain from the injection". Therapeutic measures were not taken as a result of overdose, injection site erythema, injection site pain.  Additional information: Caller reported two patients received a higher than recommended dose of the purple cap formulation. A 12-year-old male and a 14-year-old female both received 0.5 ml dose instead of 0.3 ml dose. It was their first Comirnaty dose and it occurred on 19Nov2021.She wants to know what to do about the second dose. Vaccine LOT#EW0182. When probed for vaccine Expiration date, Nurse stated, "Nov2021, that are expiration date as far as when it was taken out of the cold and put into refrigerator because of the 30 days that's not the listed expiration date, that our expiration date. When probed to confirm if patients experienced any adverse event, Nurse stated, "No, just a generalized redness of the area and usual pain from the injection were the only complain." When probed for any treatment, Nurse stated, "The provider spoke with them, there was no treatment." The patient was administered Dose 2 of Pfizer Vaccine on 10Dec2021 at 15:48 on the Left Deltoid Intramuscularly. Batch/Lot number was reported FH8028. Vaccination Facility Type was Doctor's Office/Urgent Care. No concomitant drugs, Medical history, Relevant tests or specific tests reported.   No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101647432 same reporter/drug/AE, different patient
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; sore arm; This is a spontaneous report received from a contactable reporter other HCP.  A 21 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Oct2021 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 30Oct2021, outcome "recovered" (2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 30Oct2021, outcome "recovered" (2021), described as "sore arm".   Additional information:-Vaccination facility type was Physician's office/Urgent care.Specific Relevant Test for thromboembolic events with thrombocytopenia was none.Comment and Narrative including that (Name) received his second dose of Pfizer on 30Oct2021.Today 15Nov2021 patient report no issues or concerns. He reports having a sore arm and headache for week after his vaccination 30Oct2021. He has no concerned or issues at this time & is considered fully vaccinated.the patient did not provide information to regarding the reported adverse event(s) with the use of the product   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Fear of injection, Inappropriate schedule of product administration, Lethargy
Clinical narrative: On 15Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 31Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech; Lack of energy; Needle Phobia; Fatigue; Lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4167016-00.  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 15Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "On 15Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 31Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Lack of energy"; FEAR OF INJECTION (non-serious) with onset 2021, outcome "unknown", described as "Needle Phobia"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; LETHARGY (non-serious) with onset 2021, outcome "unknown", described as "Lethargic". The action taken for adalimumab was unknown.   Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for suspected product Pfizer biontech covid-19 vaccine with events Loss of energy, Fear of needles, Fatigue, Lethargic is reported as Possible. The reporter's causality for the event(s) of pen misfire with humira (adalimumab) was a reasonable possibility and for event(s) of lack of energy, needle phobia, fatigue and lethargic was not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Gastrointestinal disorder, Inappropriate schedule of product administration, Malaise, Pain
Clinical narrative: Flared up in colon; On 14Aug2021,She received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 18 Oct 2021,She received 2nd dose COVID-19; Ill; Pain; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4162646-00.  A 54-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route: Intramuscular), administration date: 14Aug2021, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Oct2021, outcome "unknown", described as "On 14Aug2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 18 Oct 2021, she received 2nd dose COVID-19"; MALAISE (non-serious) with onset 18Oct2021, outcome "unknown", described as "Ill"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "Vomiting"; GASTROINTESTINAL DISORDER (non-serious) with onset 23Oct2021, outcome "recovered" (15Nov2021), described as "Flared up in colon". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for adalimumab was unknown.  Additional information: On unknown dates, the patient experienced pain, vomiting and Humira had to stop Working. On 18Oct2021, the patient experienced ill. On 23Oct2021, the Patient experienced flared up in colon. On 15Nov2021, the flared up in colon resolved. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. Causality for Humira (adalimumab): The reporter's causality for the event(s) of ill, pain, vomiting, Humira had to stop working and flared up in Colon was not provided. Causality for BNT162B2: The reporter's causality for the event(s) of ill, pain, vomiting, Colopathy-Gastrointestinal disorder was considered possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Flared up in colon; On 14Aug2021,She received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 18 Oct 2021,She received 2nd dose COVID-19; Ill; Pain; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4162646-00.  A 54-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route: Intramuscular), administration date: 14Aug2021, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Oct2021, outcome "unknown", described as "On 14Aug2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 18 Oct 2021, she received 2nd dose COVID-19"; MALAISE (non-serious) with onset 18Oct2021, outcome "unknown", described as "Ill"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "Vomiting"; GASTROINTESTINAL DISORDER (non-serious) with onset 23Oct2021, outcome "recovered" (15Nov2021), described as "Flared up in colon". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for adalimumab was unknown.  Additional information: On unknown dates, the patient experienced pain, vomiting and Humira had to stop Working. On 18Oct2021, the patient experienced ill. On 23Oct2021, the Patient experienced flared up in colon. On 15Nov2021, the flared up in colon resolved. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. Causality for Humira (adalimumab): The reporter's causality for the event(s) of ill, pain, vomiting, Humira had to stop working and flared up in Colon was not provided. Causality for BNT162B2: The reporter's causality for the event(s) of ill, pain, vomiting, Colopathy-Gastrointestinal disorder was considered possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: pressure rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Nov2021 00:15 (Lot number: FK5127) at the age of 34 years as dose 1, single for covid-19 immunisation at pharmacy or drug store. Relevant medical history included: "Environmental allergies" (unspecified if ongoing), notes: Environmental allergies; "ADHD" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: Known allergies:Amoxicillin. Vaccination history included: Flu vaccine (Location: Right shoulder), administration date: 09Oct2021. The following information was reported: RASH (non-serious) with onset 11Nov2021 17:00, outcome "not recovered", described as "pressure rashes". The event "pressure rashes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Started having pressure rashes that haven't resolved. Unsure if related to vaccine, methylphenidate, or an autoimmune disorder we weren't previously aware of (waiting to see an allergist). We just want to provide information in case it is an adverse reaction not discovered during testing. Ae treatment:5 days of Prednisone, Zyrtec, and Benadryl.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Sore at injection site and down left arm into top of left hand; Sore at injection site and down left arm into top of left hand/some pain in left leg and top of foot also; fatigue; nauseous; Sore at injection site and down left arm into top of left hand/some pain in left leg and top of foot also; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 01:00 (Lot number: FH8028) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "Allergy"; Dairy sensitivities for Allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left), administration date: 16Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 23Feb2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 18:00, outcome "recovering", described as "Sore at injection site and down left arm into top of left hand"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 23Nov2021 18:00, outcome "recovering" and all described as "Sore at injection site and down left arm into top of left hand/some pain in left leg and top of foot also"; FATIGUE (non-serious) with onset 23Nov2021 18:00, outcome "recovering", described as "fatigue"; NAUSEA (non-serious) with onset 23Nov2021 18:00, outcome "recovering", described as "nauseous". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, fatigue, nausea, pain in extremity.  Additional information: Patient had not Covid prior vaccination and not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Sore at injection site and down left arm into top of left hand; Sore at injection site and down left arm into top of left hand/some pain in left leg and top of foot also; fatigue; nauseous; Sore at injection site and down left arm into top of left hand/some pain in left leg and top of foot also; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 01:00 (Lot number: FH8028) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "Allergy"; Dairy sensitivities for Allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left), administration date: 16Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 23Feb2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 18:00, outcome "recovering", described as "Sore at injection site and down left arm into top of left hand"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 23Nov2021 18:00, outcome "recovering" and all described as "Sore at injection site and down left arm into top of left hand/some pain in left leg and top of foot also"; FATIGUE (non-serious) with onset 23Nov2021 18:00, outcome "recovering", described as "fatigue"; NAUSEA (non-serious) with onset 23Nov2021 18:00, outcome "recovering", described as "nauseous". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, fatigue, nausea, pain in extremity.  Additional information: Patient had not Covid prior vaccination and not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 20Mar2021 10:30 (Lot number: 1111-20-ER8731) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing); "High cholestrol" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); ROSUVASTATIN taken for blood cholesterol increased (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination facility Type: doctor's office/urgent car. Vaccine administered at military facility: no  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I felt a bit worse after the second shot, but still not too bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 14:00 (Batch/Lot number: unknown) at the age of 20 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; BENADRYL. Vaccination history included: Bnt162b2 (dose number-1, lot unknown-True,, lot unknown reason-Unable to locate or read the details,, administration date-19Jan2021,, administration time-02:00 PM,, vaccine location-Left arm), administration date: 19Jan2021, when the patient was 20 years old, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "I felt a bit worse after the second shot, but still not too bad". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: The patient receive any other medications within 2 weeks of vaccination includes Ibuprofen, Benadryl . The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient had no allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Feb2021 09:00 (Lot number: EN66201) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing); LISINOPRIL taken for blood pressure increased (ongoing); TOPROL XL taken for tachycardia (ongoing); CRESTOR taken for blood cholesterol increased (ongoing); GABAPENTIN taken for restless legs syndrome (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (15Nov2021), described as "sore arm".  Additional information: Had arm soreness for 17 days.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Diarrhoea, Headache, Hyperhidrosis, Muscle spasms
Clinical narrative: muscle cramping legs; sore arm; vomiting; diarrhea; weakness; headache; Profusely sweating; Other vaccine same date vaccine date 24Nov2021; Other vaccine same date vaccine date 24Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Nov2021 12:30 (Lot number: FF2587) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; DULOXETINE HCL. Past drug history included: Liquid codeine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (dose number=2, lot number=EN6202, lot unknown=False,, administrator route=Intramuscular, vaccine location=Left arm, administration time=14:00), administration date: 11Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (dose number=1, lot number= EN6201, lot unknown=False,, administrator route=Intramuscular, vaccine location=Left arm, administration time=14:00), administration date: 12Feb2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 24Nov2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 24Nov2021"; MUSCLE SPASMS (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "muscle cramping legs"; PAIN IN EXTREMITY (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "sore arm"; VOMITING (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "vomiting"; DIARRHOEA (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "diarrhea"; ASTHENIA (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "weakness"; HEADACHE (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "headache"; HYPERHIDROSIS (non-serious) with onset 25Nov2021, outcome "recovering", described as "Profusely sweating". Therapeutic measures were not taken as a result of muscle spasms, pain in extremity, vomiting, diarrhoea, asthenia, headache.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Pain in extremity, Product use issue, Vomiting
Clinical narrative: muscle cramping legs; sore arm; vomiting; diarrhea; weakness; headache; Profusely sweating; Other vaccine same date vaccine date 24Nov2021; Other vaccine same date vaccine date 24Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Nov2021 12:30 (Lot number: FF2587) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; DULOXETINE HCL. Past drug history included: Liquid codeine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (dose number=2, lot number=EN6202, lot unknown=False,, administrator route=Intramuscular, vaccine location=Left arm, administration time=14:00), administration date: 11Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (dose number=1, lot number= EN6201, lot unknown=False,, administrator route=Intramuscular, vaccine location=Left arm, administration time=14:00), administration date: 12Feb2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 24Nov2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 24Nov2021"; MUSCLE SPASMS (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "muscle cramping legs"; PAIN IN EXTREMITY (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "sore arm"; VOMITING (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "vomiting"; DIARRHOEA (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "diarrhea"; ASTHENIA (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "weakness"; HEADACHE (non-serious) with onset 25Nov2021 00:15, outcome "recovering", described as "headache"; HYPERHIDROSIS (non-serious) with onset 25Nov2021, outcome "recovering", described as "Profusely sweating". Therapeutic measures were not taken as a result of muscle spasms, pain in extremity, vomiting, diarrhoea, asthenia, headache.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal discomfort, Vulvovaginal pain
Clinical narrative: Vaginal pain. Feels pressure and painful like I have my period but I do not; Vaginal pain. Feels pressure and painful like I have my period but I do not; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 19:00 (Lot number: FIT8020) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "TBI frontal lobe diffused axonal injury" (unspecified if ongoing); "left kidney removed due to car accident", start date: 2011 (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 01Nov2021; ZOLOFT; ADDERALL; VRAYLAR; WELLBUTRIN. Vaccination history included: Bnt162b2 (DOSE NUMBER-1, Prev dose lot number=F51620, Prev dose number=1,, Prev dose vaccine location=Left arm), administration date: 01Nov2021, when the patient was 33 years old, for COVID-19 IMMUNIZATION. The following information was reported: VULVOVAGINAL PAIN (non-serious), VULVOVAGINAL DISCOMFORT (non-serious) all with onset 25Nov2021 01:00, outcome "recovering" and all described as "Vaginal pain. Feels pressure and painful like I have my period but I do not". Therapeutic measures were not taken as a result of vulvovaginal pain, vulvovaginal discomfort.  Additional information: No known allergies. Patient received other vaccines with in four weeks. Patient not had covid prior vaccination. Patient had not tested covid post vaccination. She got her period on time after the1st vaccine but also had the same symptoms after receiving the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Vulvovaginal discomfort, Vulvovaginal pain
Clinical narrative: Other vaccine same date vaccine date 01Nov2021; Vaginal pain. Feels pressure and painful like I have my period but I do not; Vaginal pain. Feels pressure and painful like I have my period but I do not; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 15:30 (Lot number: F51620) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bipolar type 2" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "TBI frontal lobe diffused axonal injury" (unspecified if ongoing); "left kidney removed due to car accident", start date: 2011 (unspecified if ongoing); "left kidney removed due to car accident", start date: 2011 (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ADDERALL; VRAYLAR; WELLBUTRIN; FLU taken for immunisation, administration date 01Nov2021. The following information was reported: VULVOVAGINAL PAIN (non-serious), VULVOVAGINAL DISCOMFORT (non-serious) all with onset Nov2021, outcome "recovering" and all described as "Vaginal pain. Feels pressure and painful like I have my period but I do not"; PRODUCT USE ISSUE (non-serious) with onset 01Nov2021, outcome "unknown", described as "Other vaccine same date vaccine date 01Nov2021". Therapeutic measures were not taken as a result of vulvovaginal pain, vulvovaginal discomfort, product use issue.  Additional information: No known allergies. Patient received  other vaccines with in four weeks. Patient not had covid prior vaccination. Patient had not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 10:30 (Lot number: Fk5618) at the age of 7 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 24Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 24Nov2021 12:00, outcome "recovered" (Nov2021), described as "Vomiting"; PYREXIA (non-serious) with onset 24Nov2021 12:00, outcome "recovered" (Nov2021), described as "fever". Therapeutic measures were taken as a result of vomiting, pyrexia.  Additional information: Patient was not tested covid post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: Bumps on torso as well- ro belly button, up shoulder, and on back. (High density around the injection site, far less as moving away); Bumps on torso as well- ro belly button, up shoulder, and on back. (High density around the injection site, far less as moving away); Rash; Itchy; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 14:00 (Lot number: Fk5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII. The following information was reported: VACCINATION SITE RASH (non-serious), RASH (non-serious), outcome "recovered" and all described as "Bumps on torso as well- ro belly button, up shoulder, and on back. (High density around the injection site, far less as moving away)"; RASH (non-serious) with onset 08Nov2021, outcome "recovered" (12Nov2021), described as "Rash"; PRURITUS (non-serious) with onset 08Nov2021, outcome "recovered" (12Nov2021), described as "Itchy". Therapeutic measures were taken as a result of vaccination site rash, rash, pruritus, rash.  Additional information: Patient received Flu vaccine with in four weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Insomnia, Movement disorder, Pain in extremity
Clinical narrative: very sore arm not move it or lift for 3 days.; very sore arm not move it or lift for 3 days.; Hurt so bad trouble sleeping; Hurt so bad trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:00 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Cefaclor, reaction(s): "known allergies: Cefaclor". The following information was reported: PAIN IN EXTREMITY (non-serious), MOVEMENT DISORDER (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "very sore arm not move it or lift for 3 days."; INSOMNIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "Hurt so bad trouble sleeping". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, movement disorder, insomnia, condition aggravated.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Disturbance in attention
Clinical narrative: Short term memory loss/ Unable to remember what I was doing more than 10x/day; loss of focus and concentration; 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 20Nov2021 (Lot number: FH8027) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 10Nov2021. Past drug history included: Codeine, reaction(s): "Codeine: Drug Allergy", notes: known allergies: None. The following information was reported: AMNESIA (non-serious) with onset 21Nov2021, outcome "not recovered", described as "Short term memory loss/ Unable to remember what I was doing more than 10x/day"; DISTURBANCE IN ATTENTION (non-serious) with onset 21Nov2021, outcome "not recovered", described as "loss of focus and concentration". Therapeutic measures were not taken as a result of amnesia, disturbance in attention.  No follow-up attempts are possible. No further information is expected.