chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna / Dose Number: 3:Pfizer / Dose Number: 2:Pfizer / Dose Number 1:Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6203) and on 20Nov2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 78 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 056A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Lipotor, reaction(s): "Known allergies: Lipotor". It was reported that paxlovid was received as COVID 19 Treatment from 15Oct2022 to 19Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Post Paxlovid re-occurance of Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Outcome of COVID 19 was not recovered, outcome of other event was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19, treatment received; COVID 19, treatment received; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jun2022 at 13:00 as dose number unknown, single (Lot number: F54991) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing); "Cervical spinal stenosis" (unspecified if ongoing), notes: Cervical spinal surgeries. The patient's concomitant medications were not reported. Past drug history included: Avelox, reaction(s): "Drug hypersensitivity"; Clindamycin, reaction(s): "Drug hypersensitivity"; Cipro, reaction(s): "Drug hypersensitivity". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19, treatment received". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19 received; (14Oct2022) Negative; (16Oct2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. The patient was treated with PF-07321332, ritonavir (PAXLOVID), from 07Oct2022 to 12Oct2022.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Soreness at the injection site; Felt nauseous; Very lightheaded and needed help to lie down; Had the chills for several hours; Slept and woke up sweating; Feeling hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 10:00 as dose 3 (booster), single (Lot number: GJ3277) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LOSARTAN; ATORVASTATIN; HCL PLUS. Vaccination history included: covid19 vaccine (Dose 2, Lot number: FM7553, Time of administration: 01:00 PM, vaccine location: Left arm), administration date: 21May2022, when the patient was 64-year-old, for COVID-19 immunization; covid19 vaccine (Dose 1, Lot number: 1855194, Time of administration: 09:30 PM, vaccine location: Left arm), administration date: 11Nov2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: FEELING HOT (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022); NAUSEA (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Felt nauseous"; CHILLS (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Had the chills for several hours"; HYPERHIDROSIS (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Slept and woke up sweating"; VACCINATION SITE PAIN (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Soreness at the injection site"; DIZZINESS (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Very lightheaded and needed help to lie down". Therapeutic measures were not taken as a result of vaccination site pain, nausea, dizziness, chills, hyperhidrosis, feeling hot.  Additional information: Facility type vaccine was Pharmacy or Drug Store. Patient had no known allergy. Patient had no other vaccine in four weeks. Adverse events were reported as soreness at the injection site, then about 8 hours later felt nauseous, very lightheaded and needed help to lie down. Had the chills for several hours. Slept and woke up sweating and feeling hot. All symptoms had disappeared by the following morning and after about 24 hours.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; Felt nauseous; Very lightheaded and needed help to lie down; Had the chills for several hours; Slept and woke up sweating; Feeling hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 10:00 as dose 3 (booster), single (Lot number: GJ3277) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LOSARTAN; ATORVASTATIN; HCL PLUS. Vaccination history included: covid19 vaccine (Dose 2, Lot number: FM7553, Time of administration: 01:00 PM, vaccine location: Left arm), administration date: 21May2022, when the patient was 64-year-old, for COVID-19 immunization; covid19 vaccine (Dose 1, Lot number: 1855194, Time of administration: 09:30 PM, vaccine location: Left arm), administration date: 11Nov2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: FEELING HOT (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022); NAUSEA (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Felt nauseous"; CHILLS (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Had the chills for several hours"; HYPERHIDROSIS (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Slept and woke up sweating"; VACCINATION SITE PAIN (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Soreness at the injection site"; DIZZINESS (non-serious) with onset 21Oct2022 at 18:00, outcome "recovered" (22Oct2022), described as "Very lightheaded and needed help to lie down". Therapeutic measures were not taken as a result of vaccination site pain, nausea, dizziness, chills, hyperhidrosis, feeling hot.  Additional information: Facility type vaccine was Pharmacy or Drug Store. Patient had no known allergy. Patient had no other vaccine in four weeks. Adverse events were reported as soreness at the injection site, then about 8 hours later felt nauseous, very lightheaded and needed help to lie down. Had the chills for several hours. Slept and woke up sweating and feeling hot. All symptoms had disappeared by the following morning and after about 24 hours.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness
Clinical narrative: She is experiencing dizziness/She feels dizzy/She also feels lightheadedness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 86 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pinched nerve" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. Vaccination history included: BNT162b2 (Dose 1, Batch/Lot number: unknown), administration date: 11Mar2021, when the patient was 85-year-old, for COVID-19 immunization, reaction(s): "No adverse event"; BNT162b2 (Dose 2, Batch/Lot number: unknown), administration date: 30Mar2021, when the patient was 85-year-old, for COVID-19 immunization, reaction(s): "No adverse event"; BNT162b2 (Dose 3, Batch/Lot number: unknown), administration date: 12Nov2021, when the patient was 85-year-old, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: DIZZINESS (non-serious) with onset 26Oct2022, outcome "not recovered", described as "She is experiencing dizziness/She feels dizzy/She also feels lightheadedness". Therapeutic measures were not taken as a result of dizziness.  Additional information: The patient did not have any family medical history relevant to adverse event. The vaccination facility type where the vaccine was administered was Pharmacy/Drug Store. The vaccine was not administered at facility. No additional vaccines were administered on same date of the Pfizer suspect. The patient received Flu shot within four weeks prior to the first administration date of the suspect vaccine. The caller stated that he was calling about the newest Booster Shot the one with several things it covers, verified Pfizer COVID-19 Bivalent dose. The patient received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (gray cap), yesterday. The caller stated that the patient, a day later that morning, had dizziness when she stood up, but no swelling or redness or anything like that. She didn't have any symptoms yesterday, but today, she was experiencing dizziness. When she got up, or walked, or turned her head quickly, she felt dizzy. She also felt lightheadedness. The caller explained that it was when she got up and walked or when she tried to walk fast or turned her head suddenly. They were aware of this side effect from vaccination, and they also thought the symptoms were caused by a pinched nerve she had. However, caller wanted to know if they had more information on this symptom from vaccination. The adverse event did not require a visit to Emergency Room or Physician Office. No investigations or relevant tests were done. The case was assessed as non-serious.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell(s) palsy on right side of my face.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 12:00 as dose 2, single (Lot number: FH8027) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FF2593, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 28Oct2021, when the patient was 30-year-old, for Covid-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 03Mar2022 at 14:00, outcome "recovering", described as "Bell(s) palsy on right side of my face.". The event "bell(s) palsy on right side of my face." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy.  Clinical course: Patient did not have any known allergies. Patient did not receive any other vaccine in four weeks and not received other medications in two weeks. Patient did not had covid prior vaccination and not tested covid post vaccination. Received treatment for AE with Steroids and Viral medicine.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported serious event Bell's Palsy and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 25Oct2022 tested positive for COVID-19 via a rapid test; On 25Oct2022 tested positive for COVID-19 via a rapid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 39 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Oct2022, outcome "recovering" and all described as "On 25Oct2022 tested positive for COVID-19 via a rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Diarrhoea, Interchange of vaccine products, Vomiting
Clinical narrative: diarrhea; vomiting; dose 1: 04MAR2021, Moderna; dose 2: 08APR2021, Moderna; dose 3: 31OCT2021, Moderna; dose 4: 06MAY2022, Moderna; dose 5: yesterday (25Oct2022), Pfizer Covid 19 Vaccine Bivalent; don't have a lot of appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 10:30 as dose 5 (booster), single (Lot number: GH9697) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 vaccine moderna (Dose: 01, Lot number: unknown), administration date: 04Mar2021, when the patient was 70-year-old, for COVID-19 immunization; coviD-19 vaccine moderna (Dose: 02, Lot number: unknown), administration date: 08Apr2021, when the patient was 70-year-old, for COVID-19 immunization; coviD-19 vaccine moderna (Dose: 03, Lot number: unknown), administration date: 31Oct2021, when the patient was 71-year-old, for COVID-19 immunization; coviD-19 vaccine moderna (Dose: 04, Lot number: unknown), administration date: 06May2022, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset 25Oct2022, outcome "unknown", described as "don't have a lot of appetite"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Oct2022 at 10:30, outcome "unknown", described as "dose 1: 04MAR2021, Moderna; dose 2: 08APR2021, Moderna; dose 3: 31OCT2021, Moderna; dose 4: 06MAY2022, Moderna; dose 5: yesterday (25Oct2022), Pfizer Covid 19 Vaccine Bivalent"; DIARRHOEA (non-serious) with onset 25Oct2022 at 22:30, outcome "recovered" (26Oct2022), described as "diarrhea"; VOMITING (non-serious) with onset 25Oct2022 at 22:30, outcome "recovered" (26Oct2022). Therapeutic measures were taken as a result of diarrhoea, vomiting.  Additional information: Caller stated the she received the shot at 10:30 a.m. and about 12 hours later she had diarrhea that lasted about 2-4 hours and a couple hours after that started she vomited her entire evening meal. Caller stated she did not have a reaction to her previous vaccines, but the others were Moderna. Treatment: Drank soda and put a pillow on her belly. The patient did not received any prior vaccinations within 4 weeks.
Sex: F
Vaccine: COVID19-2
Symptoms: Discomfort, Overdose, Pain, Product administered to patient of inappropriate age
Clinical narrative: uncomfortable; she feels really achy; 5 year old female and 10 year old male, who were accidently administered the adult gray cap bivalent formulation; 5 year old female and 10 year old male, who were accidently administered the adult gray cap bivalent formulation; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 07Nov2021, for COVID-19 immunization; BNT162b2 (Dose 2, Single), administration date: 04Dec2021, for COVID-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable"; PAIN (non-serious), outcome "unknown", described as "she feels really achy"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "5 year old female and 10 year old male, who were accidently administered the adult gray cap bivalent formulation".  Additional information: Reported as, Pediatrician stated that two patients 5-year-old female and 10-year-old male, who were accidently administered the adult gray cap bivalent formulation of the Pfizer BioNTech COVID-19 vaccine at their local withheld instead of getting the pediatric 5-11 bivalent orange cap booster. They received their primary series of the monovalent orange formulation on 07Nov2021 and 04Dec2021. He was not worried so much about repercussions of the vaccines, he was more concerned as to whether or not this will affect the series going forward. Physician stated that five year old was getting her butt kicked, that she feels really achy and uncomfortable as reported by her mother. No fever, no headache, no respiratory distress, no chest pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Weight, Weight decreased, White blood cell count, White blood cell count decreased
Clinical narrative: white blood cells have been very low; lose weight; pain on the left wrist side; 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 64-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "deaf" (unspecified if ongoing), notes: Caller is deaf/hard of hearing; "hard of hearing" (unspecified if ongoing), notes: Caller is deaf/hard of hearing. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "white blood cells have been very low"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lose weight"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain on the left wrist side". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller is deaf/hard of hearing, calling using relay application, operator #(number withheld), #(number withheld), #(number withheld). "I wonder if it can cause to have white blood cells to go down because my white blood cells have been very low." "I wonder if my Pfizer shot vaccine caused my white blood cells to go down." Caller is not sure if Pfizer vaccine shot had caused her to lose weight, pain on the left wrist side, low white blood cells etc. Caller's doctor is helping her to find out what may have caused these side effects. "I'm calling because I am not sure if it is true that Pfizer has been recalled?" Caller had Pfizer shot in Jul and Aug2021. Should she be worried? Caller saw about recall for Pfizer. Caller is not sure which Pfizer product has been recalled, if it is the tablet or shot that has been recalled. Caller confirmed she is calling for the Pfizer Covid-19 vaccine but unable verify which presentation. Caller provided lot number EWOR N0107 from her vaccination card with the following dates. 03Aug2021, 24Aug2021. Caller stated that she doesn't understand how the vaccine works in the body.  Caller hoped it would not harm the white blood cells.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Haematocrit, Haematocrit increased, Haemoglobin, Haemoglobin increased
Clinical narrative: Red blood cells, hematocrit, and hemoglobin were off the charts high; Red blood cells, hematocrit, and hemoglobin were off the charts high; Red blood cells, hematocrit, and hemoglobin were off the charts high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), 0.3 ml single (Lot number: FH8020, Expiration Date: 31Jan2022) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, LOT: EL9266, EXPIRY: 30May2021, Dose: 0.3 mL), administration date: 21Feb2021, when the patient was 62-year-old, for COVID-19 immunization; Bnt162b2 (DOSE 2, LOT: EN6206, EXPIRY: 30Jun2021, Dose: 0.3 mL), administration date: Mar2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: RED BLOOD CELL COUNT INCREASED (non-serious), HAEMATOCRIT INCREASED (non-serious), HAEMOGLOBIN INCREASED (non-serious) all with onset Jun2022, outcome "recovered" (17Oct2022) and all described as "Red blood cells, hematocrit, and hemoglobin were off the charts high". The events "red blood cells, hematocrit, and hemoglobin were off the charts high" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: After having the COVID-19 vaccine and then the COVID-19 vaccine booster she had her annual physical where she had a blood test. Test indicated her red blood cells, hematocrit, and hemoglobin were off the charts high. She felt fine, wouldn't have gone to the doctor to even know about this if it wasn't for her annual physical. Saw two different hematologists. First one said "not this not that, doesn't know what caused it". Went for second opinion and second hematologist didn't know what could be causing it either. Tested for blood cancer, polycythemia vera, and didn't have the mutated genes. Just bizarre. Hadn't discussed with her primary care physician but she was not anxious to get another booster. Had a polycythemia vera blood test to see if she had blood cancer. Had no other test results to provide at this time.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count, Red blood cell count increased
Clinical narrative: Red blood cells, hematocrit, and hemoglobin were off the charts high; Red blood cells, hematocrit, and hemoglobin were off the charts high; Red blood cells, hematocrit, and hemoglobin were off the charts high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), 0.3 ml single (Lot number: FH8020, Expiration Date: 31Jan2022) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, LOT: EL9266, EXPIRY: 30May2021, Dose: 0.3 mL), administration date: 21Feb2021, when the patient was 62-year-old, for COVID-19 immunization; Bnt162b2 (DOSE 2, LOT: EN6206, EXPIRY: 30Jun2021, Dose: 0.3 mL), administration date: Mar2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: RED BLOOD CELL COUNT INCREASED (non-serious), HAEMATOCRIT INCREASED (non-serious), HAEMOGLOBIN INCREASED (non-serious) all with onset Jun2022, outcome "recovered" (17Oct2022) and all described as "Red blood cells, hematocrit, and hemoglobin were off the charts high". The events "red blood cells, hematocrit, and hemoglobin were off the charts high" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: After having the COVID-19 vaccine and then the COVID-19 vaccine booster she had her annual physical where she had a blood test. Test indicated her red blood cells, hematocrit, and hemoglobin were off the charts high. She felt fine, wouldn't have gone to the doctor to even know about this if it wasn't for her annual physical. Saw two different hematologists. First one said "not this not that, doesn't know what caused it". Went for second opinion and second hematologist didn't know what could be causing it either. Tested for blood cancer, polycythemia vera, and didn't have the mutated genes. Just bizarre. Hadn't discussed with her primary care physician but she was not anxious to get another booster. Had a polycythemia vera blood test to see if she had blood cancer. Had no other test results to provide at this time.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 08:00 as dose 1, single, in left arm, on 26Apr2021 at 08:00 as dose 2, single, in left arm and on 03Jan2022 at 08:00 as dose 3 (booster), single at the age of 38 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ARMODAFINIL, start date: 05Aug2015; LAMOTRIGINE, start date: 17Sep2021; PROZAC, start date: 07Feb2006; WELLBUTRIN, start date: 06Feb2006.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient had no known allergies and other medical history of Asthma.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as no. Patient received Paxlovid treatment from 21Sep2022 to 25Sep2022 for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in right arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Oct2022, outcome "unknown", COVID-19 (medically significant) with onset Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: after 2 negative tests; (23Oct2022) Positive, notes: I took a positive test Sunday 23Oct and Tuesday 25Oct; (25Oct2022) Positive, notes: I took a positive test Sunday 23Oct and Tuesday 25Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: patient did not take other medications in 2 weeks. No known allergies and no medical history. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; 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), on 28Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 31Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Copd" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). No known Allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 01Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: EVAMIST, start date: 01Sep2014, stop date: 26Oct2022. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient received PAXLOVID for treatment of COVID-19 from 16Oct2022 to 21Oct2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasopharyngeal swab
Clinical narrative: Each time the lymph node under my armpit swelled up like a kiwi; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: tetracycline, reaction(s): "known allergies: Tetracycline". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Each time the lymph node under my armpit swelled up like a kiwi". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she got her flu shot 16Oct2022 in her left arm no problem. She had received 3 COVID shots 2 Pfizer 1 moderna. Each time the lymph node under her armpit swelled up like a kiwi. On 21Oct2022, she got the new COVID vaccine. Felt fine, not even a sore arm until 12 pm 22Oct2022. All of a sudden, she felt sore all over, chills and checked her temp 103.7. She took a shower and went to bed. She slept for 4 hours. When she woke up the lymph nodes under her arm, right breast and neck were all swollen and painful. Her husband called out doctor. She took Tylenol and Motrin and tandem for the next 48 hours. This was the most extreme reaction she had yet to have in getting any of the COVID shots or boosters. The swelling in the lymph nodes still persist but was improving. She no longer had a fever. She have never improved. She have never tested positive for COVID. If other vaccine in four weeks was yes, and If covid prior vaccination: No. If covid tested post vaccination was yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Jun2022 as dose 4 (booster), single (Lot number: 054A22A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (16Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. 3 days after completing the 5 day Paxlovid treatment, the patient had tested positive for covid-19 again. Her symptoms returned for another 5 days. These symptoms included fever, sorethroat, coughing, and congestion and sneezing.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shrimp" (unspecified if ongoing); "Known allergies: mildly strawberry/pineapple" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/ Covid -19 test positive; Treatment of COVID-19/ Covid -19 test positive; 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), on 05Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cervical" (unspecified if ongoing); "lumbar spondylitis" (unspecified if ongoing); "radiculopathy" (unspecified if ongoing). Concomitant medication(s) included: CORICIDIN [OXYMETAZOLINE HYDROCHLORIDE], start date: 11Oct2022, stop date: 17Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19/ Covid -19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (17Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization, reaction(s): "I was sick for days after horrible arm pain", "I was sick for days after horrible arm pain". The following information was reported: PAIN (non-serious), outcome "unknown".  Additional Information: I just watched what it made me feel it reminded me of the pain I had from the booster and the vaccine for COVID-19 that I received because I was sick for days after horrible arm pain.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective, Meningitis pneumococcal
Clinical narrative: pneumococcal meningitis; pneumococcal meningitis; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  An 8-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "chromosomal abnormality" (unspecified if ongoing); "health issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MENINGITIS PNEUMOCOCCAL (hospitalization), DRUG INEFFECTIVE (hospitalization), outcome "unknown" and all described as "pneumococcal meningitis". Patient had at least 3 doses of Prevnar 13. He was hospitalized for about a month, was home now, but on home antibiotics. Therapeutic measures were taken as a result of meningitis pneumococcal, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have not had a reaction to a mosquito bite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have not had a reaction to a mosquito bite".  Additional information: The patient just wanted to mention that ever since patient had Pfizer Covid vaccine, the patient had not had a reaction to a mosquito bite. The patient mentioned they normally love and get multiple welts that lasts days or weeks. The patient knows been bitten but have zero itchy welts! May be something worth looking into.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Chills; Hot flashes; Dizziness; Headache; Fatigue; Stomach pains; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; DIZZINESS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pains".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Hot flush
Clinical narrative: Chills; Hot flashes; Dizziness; Headache; Fatigue; Stomach pains; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; DIZZINESS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pains".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.