chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Vaccine brand: Pfizer / BioNTech/Product: COVID 19 Treatment; Vaccine brand: Pfizer / BioNTech/Product: 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 32-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL, start date: 17Apr2022, stop date: 20Apr2022. Vaccination history included: Covid-19 vaccine (Previous immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Vaccine brand: Pfizer / BioNTech/Product: COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Fatigue, Feeling abnormal, Mammogram, Near death experience
Clinical narrative: is she going to die/half dead; her whole body is falling apart; She is tired and venting; aches; She is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts; 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 70-year-old 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: NEAR DEATH EXPERIENCE (non-serious), outcome "unknown", described as "is she going to die/half dead"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "her whole body is falling apart"; FATIGUE (non-serious), outcome "unknown", described as "She is tired and venting"; PAIN (non-serious), outcome "unknown", described as "aches"; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "She is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts". The events "is she going to die/half dead", "her whole body is falling apart", "she is tired and venting", "aches" and "she is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts" required emergency room visit. The patient underwent the following laboratory tests and procedures: Mammogram: Unknown results, notes: Her breasts, are unbelievable, she had to get a mammograms. Therapeutic measures were taken as a result of 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: Pain
Clinical narrative: is she going to die/half dead; her whole body is falling apart; She is tired and venting; aches; She is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts; 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 70-year-old 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: NEAR DEATH EXPERIENCE (non-serious), outcome "unknown", described as "is she going to die/half dead"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "her whole body is falling apart"; FATIGUE (non-serious), outcome "unknown", described as "She is tired and venting"; PAIN (non-serious), outcome "unknown", described as "aches"; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "She is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts". The events "is she going to die/half dead", "her whole body is falling apart", "she is tired and venting", "aches" and "she is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts" required emergency room visit. The patient underwent the following laboratory tests and procedures: Mammogram: Unknown results, notes: Her breasts, are unbelievable, she had to get a mammograms. Therapeutic measures were taken as a result of pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Nasopharyngitis
Clinical narrative: Crohn's disease aggravated; Common cold; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4364187-00 (Agency).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), on 20May2021 as dose 2, single (Batch/Lot number: unknown) and on 20Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years, all intramuscular for covid-19 immunization; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Feb2022, outcome "unknown", described as "Common cold"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's disease aggravated". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.   Causality for BNT162B2: The reporter's assessment of the causal relationship of "crohn's disease aggravated" with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "common cold" related to BNT162b2 (reported as Possible).  Causality for adalimumab (HUMIRA): The reporter's causality for the event(s) of Crohn's disease flare up  with adalimumab (HUMIRA) was a reasonable possibility (also reported as Probable). The reporter's causality for the event(s) of mild cold with Humira (Adalimumab) was no reasonable possibility (also reported as Not related).  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 in the case report, a possible causal relationship between the reported event: "Common cold" and the suspect drug BNT162B2 cannot be completely excluded. As per the company assessment the reported event: "Crohn's disease aggravated" was assessed as Unelated to the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph nodes in underarm are swollen and painful; lymph nodes in underarm are swollen and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (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 (Dose 1; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "lymph nodes in underarm are swollen and painful".  Clinical course: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Vaccine brand: Pfizer / BioNTech/Product: COVID-19 treatment; Vaccine brand: Pfizer / BioNTech/Product: 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 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: NAPROXEN; BROM/PSE/DM. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Vaccine brand: Pfizer / BioNTech/Product: COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR 18Apr2022 now positive; PCR 18Apr2022 now positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318), on 27Feb2021 as dose 2, single (Lot number: EN6202) and on 03Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 01Dec2021, stop date: 01Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "unknown" and all described as "PCR 18Apr2022 now positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Inconclusive; (18Apr2022) Positive, notes: Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: PCR. other vaccine 4 weeks product includes Flu Sequiris. very mild ST 16Apr2022 and did Ag test 17Apr2022 inconclusive and PCR 18Apr2022 now positive. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and Since the vaccination, the patient been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result Positive; covid test result Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 09:45 as dose 1, single (Lot number: EN6203), on 24Mar2021 at 09:45 as dose 2, single (Lot number: EN6203) and on 02Dec2021 at 12:30 as dose 3 (booster), single (Lot number: FF8839) at the age of 45 years, all intramuscular for COVID-19 immunization. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022 at 16:00, outcome "recovering" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive, notes: COVID test type post vaccination=Nasal Swab,. Therapeutic measures were not taken as a result of vaccination failure, COVID-19. The facility type vaccine was workplace clinic. Patient did not have any other vaccines in four weeks and other medications in two weeks. The patient tested for COVID post vaccination. Patient did not experience COVID prior vaccination.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Pain
Clinical narrative: covid test result Positive; covid test result Positive; fever; HA; body aches; chills; cough; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 26-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 26-year-old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Apr2022, outcome "unknown", described as "HA"; PAIN (non-serious) with onset 18Apr2022, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 18Apr2022, outcome "unknown"; COUGH (non-serious) with onset 18Apr2022, outcome "unknown"; PYREXIA (non-serious) with onset 18Apr2022, outcome "unknown", described as "fever"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive, notes: Unknown HOME Ag,. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, headache, pain, chills, cough.  Clinical Course: Facility type vaccine: Workplace clinic If other vaccine in four weeks: Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result Positive; covid test result Positive; fever; HA; body aches; chills; cough; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 26-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 26-year-old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Apr2022, outcome "unknown", described as "HA"; PAIN (non-serious) with onset 18Apr2022, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 18Apr2022, outcome "unknown"; COUGH (non-serious) with onset 18Apr2022, outcome "unknown"; PYREXIA (non-serious) with onset 18Apr2022, outcome "unknown", described as "fever"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive, notes: Unknown HOME Ag,. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, headache, pain, chills, cough.  Clinical Course: Facility type vaccine: Workplace clinic If other vaccine in four weeks: Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia
Clinical narrative: severe shooting nerve pain; muscle pain around my neck area, upper back, shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: anxiety just around the, same time I got vaccine. No previous, health problems. Concomitant medication(s) included: BUPROPION; CITALOPRAM. Past drug history included: Azithromycine, reaction(s): "known allergies: Azithromycine", notes: known allergies: Azithromycine.The following information was reported: MYALGIA (disability) with onset 01Jun2021, outcome "recovered", described as "muscle pain around my neck area, upper back, shoulder"; NEURALGIA (disability) with onset 01Jun2021, outcome "recovered", described as "severe shooting nerve pain". The events "severe shooting nerve pain" and "muscle pain around my neck area, upper back, shoulder" required physician office visit. Therapeutic measures were taken as a result of neuralgia, myalgia.Clinical information: Ae treatment: Prednisone, Advil, physiotherapy for 5 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Inappropriate schedule of product administration, Pain, Swelling
Clinical narrative: Had swelling in lower neck area; Pain; 1st dose- May end/2nd dose - August end; Anxiety just around the same time I got vaccine; back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: anxiety just around the same time I got vaccine. Concomitant medication(s) included: BUPROPION; CITALOPRAM. Past drug history included: Azithromycin, reaction(s): "Known allergies: Azithromycin". Vaccination history included: Bnt162b2 (dose number: 1, product: Covid 19, brand: Pfizer, vaccine location: Left arm, had severe shooting nerve pain and muscle pain around my neck area, upper back, shoulder. Went to physiotherapist and took Pain killers. Resolved in 3-4 weeks), administration date: May2021, when the patient was 36 years old, for Covid-19 Immunization, reaction(s): "Muscle pain", "Nerve pain". The following information was reported: SWELLING (disability), outcome "recovering", described as "Had swelling in lower neck area"; PAIN (disability), outcome "recovering"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st dose- May end/2nd dose - August end"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety just around the same time I got vaccine"; BACK PAIN (non-serious), outcome "unknown". The events "had swelling in lower neck area", "pain", "1st dose- may end/2nd dose - august end" and "back pain" required physician office visit. Therapeutic measures were taken as a result of swelling, pain. Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. 1st dose- May end - I had severe shooting nerve pain and muscle pain around my neck area, upper back, shoulder. Went to physiotherapist and took Pain killers. Resolved in 3-4 weeks. 2nd dose - August end - similar symptoms but the pain intensity was 10 times more. Had swelling in lower neck area. Went to Physiotherapist and physician. Taking Advil did not help this time, so was given Prednisone medicine. Slowly recovered from the pain, had to take physiotherapy for few months as I also started getting back pain. I never had so many health issues in my life ever. I was a very healthy person, all this took a year from my life. I do have a very high tolerance for pain now that I think back given my condition after vaccine I should have hospitalized. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for 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: DTAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: medication error due to administering DAPTACEL twice in two consecutive days with no reported adverse event; Initial information received on 13-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who experienced medication error due to administering daptacel twice in two consecutive days with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 07-Apr-2022, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5774CA, C5829BA via intramuscular route in unknown administration site for Immunisation.  On 08-APR-2022 the patient developed a non-serious medication error due to administering daptacel twice in two consecutive days with no reported adverse event (vaccination error) 1 day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error due to administering DAPTACEL twice in two consecutive days with no reported adverse event).  At time of reporting, the outcome was Unknown for the event (medication error due to administering daptacel twice in two consecutive days with no reported adverse event.)    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 47 year old female patient who experienced medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].     The patient's past medical history, medical treatment(s)  and family history were not provided.    On 23-Mar-2022, the patient received dose of 0.5 ml total 1 day of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, strength: standard lot C5873AA expiry date: 30 -Jun-2023 via intramuscular route in the right deltoid for immunization.   On 23-Mar-2022 the patient developed a non-serious event of medication error due to administering dose post temperature excursion outside acceptable guidelines for excursion stability standard, with no reported adverse event (product administration error) (Latency: same day).  It was reported that low temperature was reached as negative 2.1 celsius from 07-Mar-2022 to 31-Mar-2022. Did it occur due to a human error was no. Does extended stability data cover the excursion: no and in case of negative advice: was the product used by/ administered to the patient was yes to 14 patients. Pregnancy was no. List of concomitant was no other vaccines.  Action taken was not applicable   Outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Headache, Injection site erythema
Clinical narrative: Client presented at vaccination site on 11/28/21. The client reported she received her first dose Pfizer COIVD vaccine on 11/07/21. Client reported within 15 mins she had redness on her left side of her face with hotness and numbness on her left arm where she had her injection. Client didn?t report to the EMT in the observation station. Client told she had the headache off and on for one whole week after and lightheadedness for two days and fatigue for one week. She told she took acetaminophen 500 mg with help for headache for three days straight. Client told she didn?t follow-up with her PCP. Client told she doesn?t have any chronic illnesses or taking any medications. Client told she has no known allergy. At 1112, PHN took client?s vitals: BP 112/71, HR 64, R 20, O2 Sat. 98%. Client is requesting second dose Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the second dose Pfizer COVID vaccine. Per the doctor, approval to proceed with the second dose Pfizer COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received the second dose Pfizer COVID vaccine, LOT#: FF8841 on 11/28/21 at 1145. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1215 unassisted and with a steady gait.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Joint injury
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Depressed mood, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt received shot at pharmacy, reported adr to store while picking up antibiotics for the treatment of swelling of arm and possible cellulitis. besides being unhappy about having to have a swollen arm, pt is ok.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: CUSTOMER STATED THAT SHE HAD  PAIN AT THE INJECTION SITE AFTER ADMINISTRATION, CONTINUED FOR MONTHS. ALSO STATED SHE CONSULTED WITH HER MD  3MOS AGO. SHE HAS LIMITED MOBILITY ON THE AFFECTED ARM DUE TO THE VACCINE
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache
Clinical narrative: Client presented at a vaccination site on 11/28/21. The client reported he received his first dose Pfizer COIVD vaccine on 11/07/21. He reported within 15 mins he had a very ?bad headache? for two weeks straight after. Client reported tiredness for one week and a feeling of ?diarrhea like sensation? for 1.5 weeks without having the diarrhea. Client told he did have dizziness and lightheadedness within the 15 minutes after the injection. Client told he didn?t report the symptoms to the EMT in the observation station. Client told he took Ibuprofen 800 mg with help for headache for two weeks straight. Client told he has hypertension and controlling with Lisinopril 10 mg daily. Client told he didn?t follow-up with his PCP. Client told he has no known allergy. At 1110, PHN took client?s vitals: BP 126/79, HR 52, R 18, O2 Sat. 99%. Client is requesting second dose Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the second dose Pfizer COVID vaccine. Per the doctor, approval to proceed with the second dose Pfizer COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received Pfizer COVID vaccine, LOT#: FF8841 on 11/28/21 at 1148 by vaccinating nurse. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1218 unassisted and with a steady gait.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose given; no adverse reaction reported by patient
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Tinnitus, Visual impairment
Clinical narrative: High pitched ringing in the right ear. Intermittent dizziness and vision changes. Ringing began within 12 hours of vaccination and has persisted for 3 weeks.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Urticaria
Clinical narrative: Five days after receiving the shot my daughter got hives. Which are still going as of today.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Oral herpes, Somnolence
Clinical narrative: Modest fever blister inside lower lip.  Still present after about 48 hours.  Extreme fatique from ordinary house work.  Had to stop working and try to sleep during the day.  Still present after about 24 hours.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Pain, Pain in extremity, Somnolence
Clinical narrative: sore/tender upper arm; achiness; tiredness- napped all day (missed work)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: sore/tender upper arm; achiness; tiredness- napped all day (missed work)
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Salivary hypersecretion, Tonsillar hypertrophy
Clinical narrative: My left tonsil swelled, increased salivation, trouble with breathing.  Pfizer
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Muscle aches, headache, stomach upset, diarrhea, complete fatigue, fever and chills.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches, headache, stomach upset, diarrhea, complete fatigue, fever and chills.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Heavy menstrual bleeding, Menstruation irregular, Thrombosis
Clinical narrative: I have been in peri-menopause since September 2021 with no period since Augusts 2021.    After my first 2 shots in December 2020  and January 2021 I did have irregularly heavy periods.  After I received the booster shot on 4/13 I got my period after no period for 7months.  I have had very heavy bleeding with clots and abdominal pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient does not speak the language well and her son was attempting to translate for her over the phone.  He said that her arm still has a lot of pain 5 days post vaccination.  I advised that she can ice the area as well as take OTC pain relief such as acetaminophen or ibuprofen.  He said she has done that and still has a lot of pain.  I advised that she should follow up with her physician if she continues to experience pain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Disorientation, Dizziness, Pyrexia, Somnolence
Clinical narrative: 101+ fever for 2 days, dizziness, sleepiness, disoriented, delirious at times, speech impairment.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: 101+ fever for 2 days, dizziness, sleepiness, disoriented, delirious at times, speech impairment.
Age: 52.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Pain, erythema, warmth, swelling at injection site in left arm just below where Shingrix was given measuring 30mm in diameter. Motrin 400mg TID taken. Generalized malaise and myalgias.
Age: 52.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Myalgia
Clinical narrative: Pain, erythema, warmth, swelling at injection site in left arm just below where Shingrix was given measuring 30mm in diameter. Motrin 400mg TID taken. Generalized malaise and myalgias.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Audiogram abnormal, Deafness unilateral, Ear discomfort, Magnetic resonance imaging head normal
Clinical narrative: 2 hours after vaccination experience some fullness in my right eustachian tube but hearing was normal. Next day I had mild buzzing in right ear but hearing was normal. Next day I had a profound deafness in right ear, sudden.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: 2 hours after vaccination experience some fullness in my right eustachian tube but hearing was normal. Next day I had mild buzzing in right ear but hearing was normal. Next day I had a profound deafness in right ear, sudden.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Overnight within 36 hours of receiving the Moderna booster I developed a full body painful and itchy red rash. It was mainly on the trunk of my body, front and back, spreading to my inner thighs, and up the side of my neck on the right side, where the injection was given. The rash is continuing nearly 72 hours after the injection. Treating with Benadryl 25 mg every 4 hours and applying topical Diphenhydramine HCL & Zinc Acetate.  Today the rash is subsiding. I have not needed to use the Epipen.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna vaccine at age 17. Moderna is only approved for ages 18 and older. Patient unclear about her age at time of vaccine with no ID.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna vaccine at age 17. Moderna is only approved for ages 18 and older. Patient was unclear about her age at time of vaccine with no ID.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna vaccine at age 17. Moderna is only approved for ages 18 and older. Patient was unclear about his age at time of vaccine with no ID.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Breast mass, Mammogram normal, Oligomenorrhoea, Skin disorder
Clinical narrative: 1. Since 2nd does of Vaccine, my monthly menstrual cycle has become longer.  It is now and has been 12 days long since 2nd dose of vaccine. 2. Since March of last year (2021), I have had skin issues that have required steroid creams and daily zyrtec dose. 3. I developed a dense mass of breast tissue in my left breast (non-cancerous).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound pelvis normal
Clinical narrative: 1. Since 2nd does of Vaccine, my monthly menstrual cycle has become longer.  It is now and has been 12 days long since 2nd dose of vaccine. 2. Since March of last year (2021), I have had skin issues that have required steroid creams and daily zyrtec dose. 3. I developed a dense mass of breast tissue in my left breast (non-cancerous).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Blood pressure abnormal, Chest pain, Condition aggravated, Costochondritis
Clinical narrative: Heart raced first day. As the days went on, my blood pressure became erratic, which sent me into an autonomic flare that I haven't come out of - almost a year later. In October 2021, I went to the ER: BP 149/133; HR: 59 and chest pain. No heart issues previous to shot. HR 145/100; no diagnosis other than costochondritis, which I never had.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: Heart raced first day. As the days went on, my blood pressure became erratic, which sent me into an autonomic flare that I haven't come out of - almost a year later. In October 2021, I went to the ER: BP 149/133; HR: 59 and chest pain. No heart issues previous to shot. HR 145/100; no diagnosis other than costochondritis, which I never had.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure increased, Confusional state, Coordination abnormal, Dysstasia
Clinical narrative: Seizures, very high temperature(103.9), prolonged elevated pulse rate (122+), loss of coordination, inability to stand, confusion, prolonged elevated blood pressure, prolonged elevated glucose readings.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Seizure
Clinical narrative: Seizures, very high temperature(103.9), prolonged elevated pulse rate (122+), loss of coordination, inability to stand, confusion, prolonged elevated blood pressure, prolonged elevated glucose readings.
Age: 83.0
Sex: M
Vaccine: COVID19, PNC20, VARZOS
Symptoms: Dementia, Fatigue, Gait disturbance
Clinical narrative: Patient feeling fatigued, unable to walk easily, patient also has dementia which could be causing the issue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Vomiting, extreme pain (headache, joint pain) fever, chills, lethargy, sweating and loss of appetite lasted 24 hours. Extreme fatigue lasted 48 hours.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, extreme pain (headache, joint pain) fever, chills, lethargy, sweating and loss of appetite lasted 24 hours. Extreme fatigue lasted 48 hours.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted. No anaphylactic reaction. Moved patient from chair to floor to lie on back.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: about 4 hours after shot pain in arm  developing. Overnight fever commenced. Took 2 double strength Tylenol starting 10 pm every  8 hours. Headache in morning and fever of 101.   Lot of coughing and chest pain.  During the day fever came down to 100. Took 1 Mobic for arm pain. No appetite. Next day fever gone, cough gone, headache gone but a rash appeared on my stomach going into the umbilicus. felt fragile otherwise OK,
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: about 4 hours after shot pain in arm  developing. Overnight fever commenced. Took 2 double strength Tylenol starting 10 pm every  8 hours. Headache in morning and fever of 101.   Lot of coughing and chest pain.  During the day fever came down to 100. Took 1 Mobic for arm pain. No appetite. Next day fever gone, cough gone, headache gone but a rash appeared on my stomach going into the umbilicus. felt fragile otherwise OK,
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient who is 11 years old came to receive his second dose of Pfizer on 4/22/22. Patient received a Pfizer dose that is for ages 12 and up instead of receiving the Pfizer for 5-11 years old. No adverse reactions reported during the observation time after being  vaccinated.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Paraesthesia
Clinical narrative: local pain followed by parethesias of left hand
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Dizziness, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Extreme fatigue, muscle cramping of my legs and arms, dizziness, my thinking was as if I had brain fog. Felt ill until taking B12, Zinc and Magnesium which helped a small amount.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Extreme fatigue, muscle cramping of my legs and arms, dizziness, my thinking was as if I had brain fog. Felt ill until taking B12, Zinc and Magnesium which helped a small amount.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I developed tinnitus about two weeks after getting the shot and it?s been 4 months now and there are no signs of it slowing down.  I have not had any hearing problems prior to getting the booster.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Limb mass, Magnetic resonance imaging abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: about three days aftr the vaccine I had a bmp forming on the right arm and it was starting to hurt.  It is still there and no one can tell me why or what is causing it.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Surgery, Tendon rupture, Ultrasound scan
Clinical narrative: about three days aftr the vaccine I had a bmp forming on the right arm and it was starting to hurt.  It is still there and no one can tell me why or what is causing it.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: patient called 4/23/22 stating that she had arm pain redness and swelling after getting her first shingrix dose. she did not indicate swelling of tongue/throat or increased trouble breathing from normal. she was told to take tylenol and use a cold compress to help with the symptoms and seem medical attention if she felt she needed to or increased trouble breathing  or swelling of tongue/throat
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Epistaxis, Malaise, Productive cough
Clinical narrative: Trouble breathing, bloody and phleme coming from nose, enormous chest pains in the center, chemical taste in my  throat,bumps break out. After 5 months still not well.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Taste disorder
Clinical narrative: Trouble breathing, bloody and phleme coming from nose, enormous chest pains in the center, chemical taste in my  throat,bumps break out. After 5 months still not well.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Tinnitus, Vertigo, Vomiting
Clinical narrative: Vertigo nausea  vomiting  Tinnitus  Dizziness
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: Significant flare up of rheumatoid arthritis after 2nd booster dose; almost 2 months after testing positive for Covid (early Feb)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site swelling, SARS-CoV-2 test negative
Clinical narrative: pt says area is inflammed. pt has flu like symptoms. tested negative. the injection site is still swollen. injection site and flu like symptoms have not improved. they started  the day after the immunization
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Two rash spots in armpit of left arm.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient given undiluted vaccine dose; no signs or symptoms known at this time.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache, body aches and fever.
Age: 49.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect route of product administration
Clinical narrative: Yellow Fever vaccine was given IM instead of SQ.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received an undiluted dose of the vaccine. No signs/symptoms known at this time.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Cough, Injection site swelling
Clinical narrative: Vomiting, cough, chest pain, fever, and swelling at injection site.