chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Product administered at inappropriate site, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: EW0164) at the age of 52 years intramuscular, in right thigh for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Crab, Lobster, sand fleas" (unspecified if ongoing), notes: Known allergies: Crab, Lobster, sand fleas; "smoker/former smoker: No" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number EL0140, route of administration: Intramuscular, Anatomical location: Right leg thigh), administration date: 23Dec2020, when the patient was 52-year-old, for COVID-19 immunisation, reaction(s): "Vaccine administered at inappropriate site"; BNT162b2 (DOSE 2, SINGLE, lot number EL1283, route of administration: Intramuscular, Anatomical location: Right leg thigh), administration date: 09Jan2021, when the patient was 52-year-old, for COVID-19 immunisation, reaction(s): "Vaccine administered at inappropriate site", "Inappropriate schedule of vaccine administered". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 30Sep2021, outcome "unknown", described as "Location of injection: Leg Right thigh"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "HA"; FATIGUE (non-serious) with onset 2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not receive any other medications within 2 weeks of vaccination. This report was assessed as non serious. The patient received vaccination on the right leg thigh. The patient experienced fatigue and headache during the COVID-19 illness. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Follow-up (09Aug2022): This is a spontaneous follow-up report received from same contactable Nurse. This Nurse reported in response to HCP letter sent in cross reference case that included: New information: reporter information (contact information), patient contact information and age, historical vaccine details, lab data, vaccination details (start date, stop date, lot number, route of administration, anatomical location), concomitant drug, event details (additional event headache and fatigue, start date) and additional information was updated.
Sex: M
Vaccine: PNC13
Symptoms: Antibody test abnormal, Serology test
Clinical narrative: serology testing showing that he was low immunity on all of the pneumococcal strains; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 9-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "serology testing showing that he was low immunity on all of the pneumococcal strains". Relevant laboratory tests and procedures are available in the appropriate section. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown (booster), 0.2 ml 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: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), outcome "unknown" and all described as "a dose of orange cap formulation being provided to 1 patient without dilution. 0.2 ml volume provided resulting in a dose higher than intended". Additional information: The reporter classified the event as non-serious. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID: (Unknown). 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) and all described as "product was stored in the refrigerator one day beyond the before use date (10 week period). Two shots of these vials were administered". Additional information: The reporter clarified that patient was a Pharmacist, provided only as unknown type of Healthcare professional by inbound transfer agent. The reporter clarified that they had administered a couple of Pfizer Covid-19 Vaccine, gray cap formulation, to patients that were past the beyond use date. The reporter did not confirm the number of patients, however, it was more than one patient. She wanted to know if the vaccines were still viable or not. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Follow-up (09Aug2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Additional information: Query: Dear colleagues, Morning: Regarding case Report Number #, AER number 202201045242 & 202201046437, in initial source, the reporter stated "two shots" were given, and in follow-up source, narrative stated only one patient received "a couple of" shots. Could you please confirm if only one patient received the shots? Thanks so much. Please see below screenshots and source document for your information. Additional Context: Warm transfer from (Name withheld) with a caller on the line who is an unknown type of Healthcare professional. She has Pfizer Covid-19 Vaccine, gray cap administered a couple of vaccines to a patient that is beyond use date. She wanted to know if vaccines are still viable or not. Caller clarified that she is a Pharmacist, provided only as unknown type of Healthcare professional by inbound transfer agent. Caller clarified that they have administered a couple of Pfizer Covid-19 Vaccine, gray cap formulation, to patients that were past the beyond use date. She wanted to know if the vaccines are still viable or not. Response: Good Morning, After reviewing call recording, transfer agent provided that they administered a couple of Covid 19 vaccines to a patient. This was documented as provided. Caller confirmed that they have administered a couple of Covid 19 vaccines to patients. Caller declined to complete a report for the patients. Caller did not confirm the number of patients, however, it was more than one patient. Kind Regards, (Name withheld); Sender's Comments: Linked Report(s): US-PFIZER INC-202201045242 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had a rashes on her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 0.3 ml single (Lot number: 301308A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu (Caller stated she was able to get a flu, pneumonia, shingles shot); Pneumonia (Caller stated she was able to get a flu, pneumonia, shingles shot); Shingles (Caller stated she was able to get a flu, pneumonia, shingles shot). The following information was reported: RASH (non-serious), outcome "unknown", described as "had a rashes on her neck".  Additional information: It was reported that, the reporter confirmed, her rashes didn't happen right away and didn't notice it the next day. She had no primary care physician and don't take any medication. She tried today and get her booster her pharmacist seemed very reluctant to administer the vaccine and advised to call Pfizer. She never had an allergy to anything and had no primary care physician/allergist. She was able to get a flu, pneumonia, shingles shot and never had a reaction until she took the Covid-vaccine. The reporter was seeking recommendation on what to do going forward. The reporter stated she and her husband were doing the best they could to be healthy. She exercises and walks 2 miles everyday and she was as healthy as she could be. She already got first and second Pfizer COVID-19 vaccine. She didn't actually notice after getting the first shot of the vaccine she had a rashes on her neck she already. She also got the booster shot, the first one and the same thing happened to her. When she got the first shot she did know anything happened. With the second shot, the next day, she had a light pink rash on the neck. Went to patient first, got steroids and it went away in couple days. With the first booster dose, she literally forgot about the previous rash, she went and got the booster dose and the rash came back. It was deeper pink and more widespread. Went to patient first, got steroids again and it went away in couple days.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in his feet; This is a spontaneous report received from contactable reporter (consumer) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 27Jul2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 69 years for COVID-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: He has little things he is allergic to but nothing major.; "Diabetic" (unspecified if ongoing), notes: He also has diabetic strips that he uses for his meter.; "Amyloidosis in the heart" (unspecified if ongoing). Concomitant medications included: VYNDAMAX oral taken for cardiac amyloidosis, start date: Jul2022; HYDROCODONE; GABAPENTIN; LEVOTHYROXINE; AMLODIPINE; METOPROLOL SUCCINATE; IBUPROFEN; PANTOPRAZOLE; METFORMIN; ASPIRIN [ACETYLSALICYLIC ACID] oral; ATORVASTATIN; ALLOPURINOL oral; FOLIC ACID; THIAMINE; VITAMIN B12 [VITAMIN B12 NOS]; MULTIVITAMINS. Vaccination history included: BNT162b2 (lot number: EL9266, as dose 1, single), administration date: 24Feb2021, when the patient was 67-year-old, for COVID-19 immunisation; BNT162b2 (lot number: FN6199, as dose 2, single), administration date: 17Mar2021, when the patient was 67-year-old, for COVID-19 immunisation; BNT162b2 (lot number: FD0809, as dose 3 (booster), single), administration date: 02Dec2021, when the patient was 68-year-old, for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "not recovered", described as "Swelling in his feet". Additional information: The patient experienced swelling in his feet. He received the second booster of the COVID-19 vaccine on 27Jul2022 and noticed that the swelling started after he received the shot. He wanted to know if swollen feet are a reported side effect after receiving the COVID-19 vaccine. Overnight, the swelling goes away, but then during the day, it seems to come back. It started either the end of Jul2022 or beginning of Aug2022. The swelling was in both feet, and it's about the same as when it first started. There was no redness or warm temperature with the swelling. At the time of reporting, his feet were starting to swell, but it was good this morning.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthma; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID: (159558).  A 5-year-old male patient received BNT162b2 (COMIRNATY), on 19Jul2022 as dose 1, single (Lot number: FT9142, Expiration Date: 31Dec2022) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ASTHMA (non-serious), outcome "unknown".  Additional information: Caller clarifies that the patient received a dose of the Pfizer Covid vaccine with the maroon cap 21 days ago on 19Jul2022. At the time of his first dose, the patient was 4 years old. NDC unknown. Caller states the patient appears to a have asthma according to medication profile at pharmacy but it is not confirmed. Patient has not yet received the second dose,
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Chills, Echocardiogram, Investigation
Clinical narrative: several severe morning charley horses; some lower leg cramping; had heart palpitations followed by a low fever; chills; body aches; upset digestive tract; had heart palpitations followed by a low fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 at 14:20 as dose 2, single (Lot number: ER8737) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Right or Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN6208), administration date: 12Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "several severe morning charley horses", "some lower leg cramping". The following information was reported: PAIN (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021), described as "body aches"; CHILLS (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021); PALPITATIONS (non-serious) with onset Jul2021, outcome "unknown", PYREXIA (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021) and all described as "had heart palpitations followed by a low fever"; ABDOMINAL DISCOMFORT (non-serious) with onset Jul2021, outcome "unknown", described as "upset digestive tract"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "several severe morning charley horses"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "some lower leg cramping". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After her Pfizer vaccines in Mar2021 and Apr2021, patient occasionally experienced several severe morning charley horses, and some lower leg cramping. In Jul2021, patient had heart palpitations followed by a low fever, chills, body aches, and upset digestive tract. She had an Echocardiogram on 11Aug2021 that was normal. The palpitations subsided. On 19Nov2021, a cardiologist said my heart was normal, with only minor heart palpitations that didn't require medication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, Musculoskeletal stiffness, Pain, Palpitations
Clinical narrative: several severe morning charley horses; some lower leg cramping; had heart palpitations followed by a low fever; chills; body aches; upset digestive tract; had heart palpitations followed by a low fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 at 14:20 as dose 2, single (Lot number: ER8737) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Right or Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN6208), administration date: 12Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "several severe morning charley horses", "some lower leg cramping". The following information was reported: PAIN (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021), described as "body aches"; CHILLS (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021); PALPITATIONS (non-serious) with onset Jul2021, outcome "unknown", PYREXIA (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021) and all described as "had heart palpitations followed by a low fever"; ABDOMINAL DISCOMFORT (non-serious) with onset Jul2021, outcome "unknown", described as "upset digestive tract"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "several severe morning charley horses"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "some lower leg cramping". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After her Pfizer vaccines in Mar2021 and Apr2021, patient occasionally experienced several severe morning charley horses, and some lower leg cramping. In Jul2021, patient had heart palpitations followed by a low fever, chills, body aches, and upset digestive tract. She had an Echocardiogram on 11Aug2021 that was normal. The palpitations subsided. On 19Nov2021, a cardiologist said my heart was normal, with only minor heart palpitations that didn't require medication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: several severe morning charley horses; some lower leg cramping; had heart palpitations followed by a low fever; chills; body aches; upset digestive tract; had heart palpitations followed by a low fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 at 14:20 as dose 2, single (Lot number: ER8737) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Right or Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN6208), administration date: 12Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "several severe morning charley horses", "some lower leg cramping". The following information was reported: PAIN (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021), described as "body aches"; CHILLS (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021); PALPITATIONS (non-serious) with onset Jul2021, outcome "unknown", PYREXIA (non-serious) with onset Jul2021, outcome "recovered" (07Jul2021) and all described as "had heart palpitations followed by a low fever"; ABDOMINAL DISCOMFORT (non-serious) with onset Jul2021, outcome "unknown", described as "upset digestive tract"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "several severe morning charley horses"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "some lower leg cramping". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After her Pfizer vaccines in Mar2021 and Apr2021, patient occasionally experienced several severe morning charley horses, and some lower leg cramping. In Jul2021, patient had heart palpitations followed by a low fever, chills, body aches, and upset digestive tract. She had an Echocardiogram on 11Aug2021 that was normal. The palpitations subsided. On 19Nov2021, a cardiologist said my heart was normal, with only minor heart palpitations that didn't require medication.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Apr2022) Positive, notes: three days after completing the course of Paxlovid my Covid symptoms returned and I tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: No known allergies reported for patient. Reporter stated that three days after completing the course of Paxlovid patient's Covid symptoms returned and was tested positive for Covid. 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: Arthralgia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Severe body aches; joing pain; shivering, couldn't get warm; arm pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2022 at 10:00 as dose 4 (booster), single (Lot number: FP7137) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac disease" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number=3, lot number: FE3590, administration time: 12:00 PM, Left arm), administration date: 28Oct2021, when the patient was 54-year-old, for Covid-19 immunization, reaction(s): "Severe body aches", "Joint pain", "Shivering", "Pain in arm", "Headache"; BNT162b2 (Dose 2, lot number: EL1284), administration date: 13Jan2021, when the patient was 53-year-old, for Covid-19 immunization, reaction(s): "Severe body aches", "Joint pain", "Shivering", "Pain in arm", "Headache"; BNT162b2 (Dose 1, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for Covid-19 immunization, reaction(s): "Severe body aches", "Joint pain", "Shivering", "Pain in arm", "Headache". The following information was reported: PAIN (non-serious) with onset 09Aug2022 at 20:00, outcome "recovering", described as "Severe body aches"; PAIN IN EXTREMITY (non-serious) with onset 09Aug2022 at 20:00, outcome "recovering", described as "arm pain"; ARTHRALGIA (non-serious) with onset 09Aug2022 at 20:00, outcome "recovering", described as "joing pain"; HEADACHE (non-serious) with onset 09Aug2022 at 20:00, outcome "recovering", described as "severe headache"; CHILLS (non-serious) with onset 09Aug2022 at 20:00, outcome "recovering", described as "shivering, couldn't get warm".
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Severe body aches; joing pain; shivering, couldn't get warm; arm pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Celiac disease" (unspecified if ongoing), notes: Other medical history: Celiac disease; "Known allergies: Gluten Free" (unspecified if ongoing), notes: Known allergies: Gluten Free. There were no concomitant medications. The following information was reported: PAIN (non-serious), outcome "recovering", described as "Severe body aches"; ARTHRALGIA (non-serious), outcome "recovering", described as "joing pain"; CHILLS (non-serious), outcome "recovering", described as "shivering, couldn't get warm"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm pain"; HEADACHE (non-serious), outcome "recovering", described as "severe headache".
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Severe body aches; joing pain; shivering, couldn't get warm; arm pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 2, single (Lot number: EL1284) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Celiac disease" (unspecified if ongoing); "Known allergies: Gluten Free" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Vaccine administration date: 23Dec2020, Batch/Lot No: EJ1685, Verbatim: Severe body aches), administration date: 23Dec2020, when the patient was 53-year-old, for Covid-19 immunization, reaction(s): "Severe body aches", "joing pain", "shivering, couldn't get warm", "arm pain", "severe headache". The following information was reported: PAIN (non-serious), outcome "recovering", described as "Severe body aches"; ARTHRALGIA (non-serious), outcome "recovering", described as "joing pain"; CHILLS (non-serious), outcome "recovering", described as "shivering, couldn't get warm"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm pain"; HEADACHE (non-serious), outcome "recovering", described as "severe headache".  Additional information: The patient had Comirnaty dose 4 Lot number: FP7137 on 09Aug2022 10:00 on left arm. The patient had Comirnaty dose 3 Lot number: FE3590 on 28Oct2021 12:00 on left arm. The patient did not receive any other vaccine in four weeks. The patient did not have any other medications in 2 weeks. The patient did not have covid prior vaccination. The patient did not test for covid post vaccination. The patient reacted to both Covid19 vaccine shots plus 2 boosters. Severe body aches and joint pain, shivering, couldn't get warm, arm pain, severe headache.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Severe body aches; joing pain; shivering, couldn't get warm; arm pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac disease" (unspecified if ongoing), notes: Other medical history: Celiac disease; "Known allergies: Gluten Free" (unspecified if ongoing), notes: Known allergies: Gluten Free. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Single, lot number: EL1284), administration date: 13Jan2021, when the patient was 53-year-old, for Covid-19 Immunization, reaction(s): "Severe body aches", "joing pain", "shivering, couldn't get warm", "arm pain", "severe headache"; BNT162b2 (Dose 1, Single, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Severe body aches"; BNT162b2 (Dose 1, Single, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for Covid-19 Immunization, reaction(s): "joing pain"; BNT162b2 (Dose 1, Single, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for COVID-19 Immunization, reaction(s): "shivering, couldn't get warm"; BNT162b2 (Dose 1, Single, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for covid-19 immunization, reaction(s): "arm pain", "severe headache". The following information was reported: PAIN (non-serious), outcome "recovering", described as "Severe body aches"; ARTHRALGIA (non-serious), outcome "recovering", described as "joing pain"; CHILLS (non-serious), outcome "recovering", described as "shivering, couldn't get warm"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm pain"; HEADACHE (non-serious), outcome "recovering", described as "severe headache".  Additional information: The patient did not receive other vaccine in four weeks and any other medications in two weeks. Patient reacted to both Covid 19 vaccine shots plus 2 boosters. Severe body aches and joint pain, shivering, couldn't get warm, arm pain, severe headache. Patient did not have covid prior to vaccination and not covid tested post vaccination.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 4-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2022 at 16:00 as dose 1, single (Lot number: FL2757) at the age of 4 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 27May2022 (unspecified if ongoing), notes: patient tested positive for COVID-19 on 27May2022. The patient's illness at vaccination included: "nasal congestion" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 09Aug2022 at 07:00, outcome "recovered" (09Aug2022 at 08:00). Therapeutic measures were not taken as a result of cough. The reporter considered "cough" not related to BNT162b2. Additional information: the patient had no known allergies. Vaccine (dose 1) was received at 4 pm on 08Aug2022. On morning of 09Aug (7 am), patient awoke with an occasional cough, resolving within 1 hour. Patient had nasal congestion the day prior; reporter (patient's mother) expects the cough was unrelated to vaccine (related to congestion from daycare exposure).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Rash pruritic, Urticaria, Weight
Clinical narrative: The caller refers having, since the primary series administration, an itchy rash all over her legs, arms and body. "It is like getting hives"; The caller refers having, since the primary series administration, an itchy rash all over her legs, arms and body. "It is like getting hives"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Lot number: EN6201) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies to Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN (ongoing); BYSTOLIC (ongoing); ZOCOR; CETIRIZINE taken for hypersensitivity (ongoing); FLUTICASONE nasal (ongoing); IPRATROPIUM BROMIDE nasal (ongoing); OMEPRAZOLE (ongoing); LORAZEPAM (ongoing); DILTIAZEM (ongoing). Past drug history included: Clonidine, reaction(s): "Allergies to Clonidine". Vaccination history included: BNT162b2 (First dose, Lot: EL9269, NDC/Expiry: Unknown, not on the CDC vaccine record card., Dose: Unknown strength/formulation/dose injection to left arm), administration date: 06Feb2021, when the patient was 82-year-old, for COVID-19 immunization, reaction(s): "Covid-19", "Itchy". The following information was reported: RASH PRURITIC (non-serious), URTICARIA (non-serious), outcome "not recovered" and all described as "The caller refers having, since the primary series administration, an itchy rash all over her legs, arms and body. "It is like getting hives"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash pruritic, urticaria.  Additional information: The patient reported her doctor gave her antibiotic but it wouldn't go away.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller confirmed that she tested positive for COVID-19 yesterday; Caller confirmed that she tested positive for COVID-19 yesterday; 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 68-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "unknown" and all described as "Caller confirmed that she tested positive for COVID-19 yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) Positive.  Clinical information: Caller asked about Paxlovid. Caller confirmed she has not started it yet, and is concerned if there is any recommendation or contraindication for those with a history "C Diff" [Clostridioides difficile infection]? Caller confirmed she can't get just any antibiotic and that she sees diarrhea as a possible side effect. Caller confirmed that she tested positive for COVID-19 yesterday, and that she got both the Pfizer-BioNTech COVID-19 Vaccine and boosters. Caller also added that she is has "underlying issues with health" and was also prescribed Paxlovid yesterday. Caller also reported that her daughter had a terrible bitter metal taste that won't go away and made her throw up; "the side effects are scary". Caller mentioned, she expected to be transferred to someone who knows the product and the benefits, as you are the ones who made the product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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) from product quality group. The reporter is the patient.  A 54-year-old patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: EP7534), in right arm, in Apr2021 as dose 2, single (Lot number: ER8735), in right arm and on 20Nov2021 as dose 3 (booster), single (Lot number: Fj1670) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "MVP" (unspecified if ongoing), notes: MVP; "Recent tachycardia" (unspecified if ongoing), notes: Recent tachycardia; "medullary sponge kidney" (unspecified if ongoing); "gerds" (unspecified if ongoing), notes: gerds; "known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment start date=30Jul2022, stop date=04Aug2022. No other medications/products within 2 weeks of starting COVID-19 treatment. Five days after stopping Paxlovid, symptoms rebounded on 09Aug2022 at 19:30 (fever, congestion, sore throat, increasing resting heart rate, runny nose). Device date was reported as 10Aug2022.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EN9581), in right arm, on 06Mar2021 as dose 2, single (Lot number: EN6200), in right arm, on 26Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing), notes: pre-diabetes; "High blood pressure" (unspecified if ongoing), notes: high blood pressure; "Heart palpitations" (unspecified if ongoing), notes: heart palpitations; "Hyperthyroidism" (unspecified if ongoing); "Known allergies: Kiwi" (unspecified if ongoing), notes: known allergies: Kiwi. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: Covid 19 Treatment (Paxlovid) was started at 31Jul2022 and stopped at 04Aug2022 with indication of Treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: had trouble breathing has not been the same since; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient 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: DYSPNOEA (non-serious), outcome "not recovered", described as "had trouble breathing has not been the same since".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-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 02Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19". Patient received paxlovid for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 79-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 at 10:15 as dose 1, single (Lot number: EL3249), in left arm, on 13Feb2021 at 11:15 as dose 2, single (Lot number: EL 926n), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "had a acending aorta", start date: 2014 (unspecified if ongoing); "Macula degeneration in both eyes." (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; DOXYCYCLINE; LEVOCETIRIZINE; IRBESARTAN; TEMAZEPAM; ALLOPURINOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Positive; (05Aug2022) negative; (07Aug2022) negative; (10Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment included PAXLOVID from 30Jul2022 to 04Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Patient received 3rd dose of COVID-19 vaccine in right leg; Vaccination site pain (right leg); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2022 at 16:30 as dose 3 (booster), single (Lot number: FL2757) at the age of 5 years intramuscular, in right leg for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: IRON. Vaccination history included: BNT162b2 (Prev dose lot number: FK5127,, Prev dose administrator route: Intramuscular, Prev dose dose number: 1), administration date: 09Nov2021, when the patient was 5-year-old, for COVID-19 immunization; BNT162b2 (Prev dose lot number: FK5127, Prev dose administrator route: Intramuscular, Prev dose dose number: 2), administration date: 02Dec2021, when the patient was 6-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 09Aug2022 at 20:00, outcome "recovered", described as "Patient received 3rd dose of COVID-19 vaccine in right leg"; VACCINATION SITE PAIN (non-serious) with onset 09Aug2022 at 20:00, outcome "recovered" (10Aug2022 at 19:30), described as "Vaccination site pain (right leg)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of product administered at inappropriate site, vaccination site pain.
Age: 59.0
Sex: F
Vaccine: 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8730), in right arm and on 18Apr2021 as dose 2, single (Lot number: EW0161) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Dec2021 as dose 3 (booster), single (Lot number: 070H21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ; METHOTREXATE; CLINDAMYCIN; DOXYCYCLINE. 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 underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment included PAXLOVID from 17May2022 to 22May2022.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Rash pruritic, SARS-CoV-2 test
Clinical narrative: The itchy rash got worse every time she had a vaccine; The itchy rash got worse every time she had a vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: PJ4989) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies to Penicillin" (unspecified if ongoing), notes: Allergies to Penicillin. The patient's concomitant medications were not reported. Past drug history included: Clonidine, reaction(s): "Allergies to Clonidine", notes: Allergies to Penicillin and Clonidine. Vaccination history included: BNT162b2 (First dose, Lot: EL9269), administration date: 06Feb2021, when the patient was 82-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Second dose:, Lot: EN6201), administration date: 01Mar2021, when the patient was 82-year-old, for Covid-19 immunization, reaction(s): "itchy rash all over her legs, arms and body", "COVID-19"; BNT162b2 (Third dose:, Lot: FE3590), administration date: 07Oct2021, when the patient was 83-year-old, for Covid-19 immunization, reaction(s): "itchy rash all over her legs, arms and body", "itchy rash gets worse", "COVID-19". The following information was reported: RASH PRURITIC (non-serious), outcome "not recovered", CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "The itchy rash got worse every time she had a vaccine".