chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exercise electrocardiogram, Gait disturbance, Pulmonary function test, SARS-CoV-2 test
Clinical narrative: can't walk very far; Gasping for breath going up the stairs/couldn't catch breath/desperate breathing went away/she still had shortness of breath; Thought she was dying because she couldn't catch breath which was very frightening; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Gasping for breath going up the stairs/couldn't catch breath/desperate breathing went away/she still had shortness of breath), FEELING ABNORMAL (Thought she was dying because she couldn't catch breath which was very frightening) and GAIT DISTURBANCE (can't walk very far) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not had any allergies. Patient did not had any medical history. The patient did not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced DYSPNOEA (Gasping for breath going up the stairs/couldn't catch breath/desperate breathing went away/she still had shortness of breath) and FEELING ABNORMAL (Thought she was dying because she couldn't catch breath which was very frightening). On an unknown date, the patient experienced GAIT DISTURBANCE (can't walk very far). At the time of the report, DYSPNOEA (Gasping for breath going up the stairs/couldn't catch breath/desperate breathing went away/she still had shortness of breath) had not resolved and FEELING ABNORMAL (Thought she was dying because she couldn't catch breath which was very frightening) and GAIT DISTURBANCE (can't walk very far) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was reported.  On 22-Jan-2021, the patient took the first shot which was on Friday. On 25-Jan-2021, Monday morning, patient was gasping for breath going up the stairs. Patient thought she was dying because she couldn't catch breath. That was very frightening. Patient was gasping (making gasping sounds). That desperate breathing went away. It did not happen after the second dose or the first booster, but patient still had shortness of breath. Patient can't walk very far. There were times when patient can't get a deep breath.  The adverse event caused patient to seek many office visits. The patient did not experience a similar event in the past and symptoms reported as worsened.  No treatment medications was reported.   This case was linked to MOD-2022-642868 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Gait inability
Clinical narrative: unable to walk again; he's been in bed; 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 male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: BEDRIDDEN (non-serious) with onset 2021, outcome "unknown", described as "he's been in bed"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "unable to walk again".  Additional information: The patient stated I was screwed up with your vaccine. It took 10 years of my life. It was miserable. Some days were better than others, but i did not lived a livable life. I just wanted to let Pfizer know I'll never take another of your shots. I'll pass away knowing Pfizer caused this. The reporter assessed the events as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Cellulitis, Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 4 CM Red Circle around injection site, Red, hot and swollen; Painful to move arm; 4 CM Red Circle around injection site, Red, hot and swollen; 4 CM Red Circle around injection site, Red, hot and swollen; This spontaneous case retrieved on 18-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1768139-1), reported by other healthcare professional and concerned a 37-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient had no allergies.  On 06-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 308520.  On 07-Oct-2021, one day after receiving Flucelvax Quadrivalent vaccine, the patient experienced four cm red circle around injection site, red, hot and swollen. The patient stated it was painful to move arm.  At the time of the initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.   This case was assessed as non-serious.  Company comment: A 37-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. One day after vaccination the patient developed vaccination site erythema, warmth and swelling, as well as pain in extremity. Information regarding the related diagnostic findings was not provided. The reported events meet level 2 of diagnostic certainty for Brighton Collaboration criteria for cellulitis.; Sender's Comments: A 37-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. One day after vaccination the patient developed vaccination site erythema, warmth and swelling, as well as pain in extremity. Information regarding the related diagnostic findings was not provided. The reported events meet level 2 of diagnostic certainty for Brighton Collaboration criteria for cellulitis.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dental dysaesthesia, Hypoacusis
Clinical narrative: still experiencing the waxiness and grittiness on teeth and it's progressively gotten worse; still experiencing the waxiness and grittiness on teeth and it's progressively gotten worse; lost the hearing in right ear; This spontaneous case was reported by a patient and describes the occurrence of DENTAL DYSAESTHESIA (still experiencing the waxiness and grittiness on teeth and it's progressively gotten worse), CONDITION AGGRAVATED (still experiencing the waxiness and grittiness on teeth and it's progressively gotten worse) and HYPOACUSIS (lost the hearing in right ear) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A and 013m204) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced DENTAL DYSAESTHESIA (still experiencing the waxiness and grittiness on teeth and it's progressively gotten worse), CONDITION AGGRAVATED (still experiencing the waxiness and grittiness on teeth and it's progressively gotten worse) and HYPOACUSIS (lost the hearing in right ear). At the time of the report, DENTAL DYSAESTHESIA (still experiencing the waxiness and grittiness on teeth and it's progressively gotten worse), CONDITION AGGRAVATED (still experiencing the waxiness and grittiness on teeth and it's progressively gotten worse) and HYPOACUSIS (lost the hearing in right ear) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not reported.
Sex: M
Vaccine: UNK, COVID19
Symptoms: Anti-thyroid antibody positive, Arthralgia, Back pain, Chest pain, Electromyogram normal
Clinical narrative: polymyalgia rheumatica; muscle fasciculations; upper arm weakness; pain; tested positive for ANA and thyroid peroxidase; tested positive for ANA and thyroid peroxidase; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1, Event onset date: 00-Jul-2021, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "infection"; Comirnaty (Dose: 1, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "brain fog", "headache", "sore throat"; Comirnaty (Dose: 1, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "drug ineffective", "feeling abnormal", "headache", "oropharyngeal pain", "suspected covid-19". The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "unknown", described as "muscle fasciculations"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "upper arm weakness"; PAIN (non-serious), outcome "unknown"; ANTI-THYROID ANTIBODY POSITIVE (non-serious), ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown" and all described as "tested positive for ANA and thyroid peroxidase". The events "polymyalgia rheumatica", "muscle fasciculations", "upper arm weakness", "pain" and "tested positive for ana and thyroid peroxidase" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase; Anti-thyroid antibody positive: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase. Therapeutic measures were taken as a result of polymyalgia rheumatica, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: UNK, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle contractions involuntary, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: polymyalgia rheumatica; muscle fasciculations; upper arm weakness; pain; tested positive for ANA and thyroid peroxidase; tested positive for ANA and thyroid peroxidase; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1, Event onset date: 00-Jul-2021, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "infection"; Comirnaty (Dose: 1, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "brain fog", "headache", "sore throat"; Comirnaty (Dose: 1, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "drug ineffective", "feeling abnormal", "headache", "oropharyngeal pain", "suspected covid-19". The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "unknown", described as "muscle fasciculations"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "upper arm weakness"; PAIN (non-serious), outcome "unknown"; ANTI-THYROID ANTIBODY POSITIVE (non-serious), ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown" and all described as "tested positive for ANA and thyroid peroxidase". The events "polymyalgia rheumatica", "muscle fasciculations", "upper arm weakness", "pain" and "tested positive for ana and thyroid peroxidase" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase; Anti-thyroid antibody positive: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase. Therapeutic measures were taken as a result of polymyalgia rheumatica, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: UNK, COVID19
Symptoms: Myalgia, Myocarditis, Pericarditis, Red blood cell sedimentation rate increased
Clinical narrative: polymyalgia rheumatica; muscle fasciculations; upper arm weakness; pain; tested positive for ANA and thyroid peroxidase; tested positive for ANA and thyroid peroxidase; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1, Event onset date: 00-Jul-2021, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "infection"; Comirnaty (Dose: 1, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "brain fog", "headache", "sore throat"; Comirnaty (Dose: 1, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "drug ineffective", "feeling abnormal", "headache", "oropharyngeal pain", "suspected covid-19". The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "unknown", described as "muscle fasciculations"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "upper arm weakness"; PAIN (non-serious), outcome "unknown"; ANTI-THYROID ANTIBODY POSITIVE (non-serious), ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown" and all described as "tested positive for ANA and thyroid peroxidase". The events "polymyalgia rheumatica", "muscle fasciculations", "upper arm weakness", "pain" and "tested positive for ana and thyroid peroxidase" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase; Anti-thyroid antibody positive: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase. Therapeutic measures were taken as a result of polymyalgia rheumatica, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: UNK, COVID19
Symptoms: Anti-thyroid antibody positive, Antinuclear antibody, Antinuclear antibody positive, Muscle contractions involuntary, Muscular weakness
Clinical narrative: polymyalgia rheumatica; muscle fasciculations; upper arm weakness; pain; tested positive for ANA and thyroid peroxidase; tested positive for ANA and thyroid peroxidase; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1, Event onset date: 00-Jul-2021, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "infection"; Comirnaty (Dose: 1, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "brain fog", "headache", "sore throat"; Comirnaty (Dose: 1, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "drug ineffective", "feeling abnormal", "headache", "oropharyngeal pain", "suspected covid-19". The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "unknown", described as "muscle fasciculations"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "upper arm weakness"; PAIN (non-serious), outcome "unknown"; ANTI-THYROID ANTIBODY POSITIVE (non-serious), ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown" and all described as "tested positive for ANA and thyroid peroxidase". The events "polymyalgia rheumatica", "muscle fasciculations", "upper arm weakness", "pain" and "tested positive for ana and thyroid peroxidase" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase; Anti-thyroid antibody positive: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase. Therapeutic measures were taken as a result of polymyalgia rheumatica, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain, Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; muscle fasciculations; upper arm weakness; pain; tested positive for ANA and thyroid peroxidase; tested positive for ANA and thyroid peroxidase; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1, Event onset date: 00-Jul-2021, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "infection"; Comirnaty (Dose: 1, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "brain fog", "headache", "sore throat"; Comirnaty (Dose: 1, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Not recovered), administration date: Mar2021, for COVID-19 immunization, reaction(s): "cough"; Comirnaty (Dose: 2, Outcome of event: Recovering), administration date: Mar2021, for COVID-19 immunization, reaction(s): "drug ineffective", "feeling abnormal", "headache", "oropharyngeal pain", "suspected covid-19". The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "unknown", described as "muscle fasciculations"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "upper arm weakness"; PAIN (non-serious), outcome "unknown"; ANTI-THYROID ANTIBODY POSITIVE (non-serious), ANTINUCLEAR ANTIBODY POSITIVE (non-serious), outcome "unknown" and all described as "tested positive for ANA and thyroid peroxidase". The events "polymyalgia rheumatica", "muscle fasciculations", "upper arm weakness", "pain" and "tested positive for ana and thyroid peroxidase" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase; Anti-thyroid antibody positive: Positive, notes: He was seen by a neurologist and tested positive for ANA and thyroid peroxidase. Therapeutic measures were taken as a result of polymyalgia rheumatica, pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: short-term fatigue symptoms; Pfizer Biontech COVID 19 vaccine orange cap to a 3 and a half year old patient, instead of administering a Maroon Cap dose; Pfizer Biontech COVID 19 vaccine orange cap to a 3 and a half year old patient, instead of administering a Maroon Cap dose; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 11:00 as dose 1, (orange cap) 0.2 ml single (Lot number: FK5618) at the age of 3 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 13Jul2022 at 11:00, outcome "unknown" and all described as "Pfizer Biontech COVID 19 vaccine orange cap to a 3 and a half year old patient, instead of administering a Maroon Cap dose"; FATIGUE (non-serious), outcome "unknown", described as "short-term fatigue symptoms". Additional information: It was reported that the patient age was 3 and a half years old. Registered nurse reported the inadvertent administration of a Pfizer Biontech COVID 19 vaccine orange cap to a 3 and a half year old patient, instead of administering a Maroon Cap dose (that was intended for a 5-12 year old in error). Nurse enquired what symptoms to look for and the child progression regarding the next vaccine. This was the patient's first dose. Nurse thought the vaccine coordinator said patient was 5 years old and he was under 5. Nurse mistakenly drew up the vaccine for a 5-12 year old as opposed to the one for 6 months to 5 years. No additional Vaccines Administered on Same Date of the Pfizer Suspect administered. It was also reported that NDC was very small. It was opened and diluted per instruction from Pfizer and 1 vaccine was drawn out. Reporter provided information to you regarding the reported adverse events with the use of the product. Reporter considered Pfizer product had a casual effect to the adverse event. Vaccination Facility Type was reported as Public Health Clinic/Facility. Vaccine Administered at private Facility was reported as No. Prior Vaccinations (within 4 weeks) was reported Unknown. Patient medical history, concomitant medications and relevant tests were reported as unknown. Administering nurse selected the incorrect vial Preparation. Lack of communication. Patient suffered short term fatigue symptoms.   Follow-up attempts are completed. No further information is expected.  Follow-up (12Sep2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported for a patient that:  Updated information included: Reporter information (middle name) updated. Dosage regimen slide (vaccine administered time) updated. New event (Fatigue) added.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Overdose, Product administered to patient of inappropriate age
Clinical narrative: short-term fatigue symptoms; Pfizer Biontech COVID 19 vaccine orange cap to a 3 and a half year old patient, instead of administering a Maroon Cap dose; Pfizer Biontech COVID 19 vaccine orange cap to a 3 and a half year old patient, instead of administering a Maroon Cap dose; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 11:00 as dose 1, (orange cap) 0.2 ml single (Lot number: FK5618) at the age of 3 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 13Jul2022 at 11:00, outcome "unknown" and all described as "Pfizer Biontech COVID 19 vaccine orange cap to a 3 and a half year old patient, instead of administering a Maroon Cap dose"; FATIGUE (non-serious), outcome "unknown", described as "short-term fatigue symptoms". Additional information: It was reported that the patient age was 3 and a half years old. Registered nurse reported the inadvertent administration of a Pfizer Biontech COVID 19 vaccine orange cap to a 3 and a half year old patient, instead of administering a Maroon Cap dose (that was intended for a 5-12 year old in error). Nurse enquired what symptoms to look for and the child progression regarding the next vaccine. This was the patient's first dose. Nurse thought the vaccine coordinator said patient was 5 years old and he was under 5. Nurse mistakenly drew up the vaccine for a 5-12 year old as opposed to the one for 6 months to 5 years. No additional Vaccines Administered on Same Date of the Pfizer Suspect administered. It was also reported that NDC was very small. It was opened and diluted per instruction from Pfizer and 1 vaccine was drawn out. Reporter provided information to you regarding the reported adverse events with the use of the product. Reporter considered Pfizer product had a casual effect to the adverse event. Vaccination Facility Type was reported as Public Health Clinic/Facility. Vaccine Administered at private Facility was reported as No. Prior Vaccinations (within 4 weeks) was reported Unknown. Patient medical history, concomitant medications and relevant tests were reported as unknown. Administering nurse selected the incorrect vial Preparation. Lack of communication. Patient suffered short term fatigue symptoms.   Follow-up attempts are completed. No further information is expected.  Follow-up (12Sep2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported for a patient that:  Updated information included: Reporter information (middle name) updated. Dosage regimen slide (vaccine administered time) updated. New event (Fatigue) added.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Positive on 25Feb2022; Positive on 25Feb2022; 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 female patient received BNT162b2 (BNT162B2), on 25Mar2021 at 12:00 as dose 1, single (Lot number: ER8730), in arm, on 22Apr2021 at 14:30 as dose 2, single (Lot number: EW0171), in arm and on 12Nov2021 at 11:40 as dose 3 (booster), single (Lot number: FH8028) at the age of 54 years, in arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Feb2022, outcome "recovered" and all described as "Positive on 25Feb2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Feb2022) Negative, notes: Test: COVID Date: 22Feb2022 Result: NEG; (24Feb2022) Positive, notes: Test: COVID, Date: 24Feb2022 Result: POS; (25Feb2022) Positive, notes: confirmed positive on 25Feb2022. Lasted 13 days before testing negative on 09Mar2022; (03Mar2022) Positive, notes: Test: COVID Date: 03Mar2022 Result: POS; (08Mar2022) Negative, notes: Test: COVID Date: 08Mar2022 Result: NEG; (09Mar2022) Negative, notes: confirmed positive on 25Feb2022. Lasted 13 days before testing negative on 09Mar2022.  Clinical information: Patient had not taken any other medication within two weeks of vaccination. past medical history was reported as none.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Ear swelling, Hypoacusis
Clinical narrative: Positive on 25Feb2022; Positive on 25Feb2022; 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 female patient received BNT162b2 (BNT162B2), on 25Mar2021 at 12:00 as dose 1, single (Lot number: ER8730), in arm, on 22Apr2021 at 14:30 as dose 2, single (Lot number: EW0171), in arm and on 12Nov2021 at 11:40 as dose 3 (booster), single (Lot number: FH8028) at the age of 54 years, in arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Feb2022, outcome "recovered" and all described as "Positive on 25Feb2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Feb2022) Negative, notes: Test: COVID Date: 22Feb2022 Result: NEG; (24Feb2022) Positive, notes: Test: COVID, Date: 24Feb2022 Result: POS; (25Feb2022) Positive, notes: confirmed positive on 25Feb2022. Lasted 13 days before testing negative on 09Mar2022; (03Mar2022) Positive, notes: Test: COVID Date: 03Mar2022 Result: POS; (08Mar2022) Negative, notes: Test: COVID Date: 08Mar2022 Result: NEG; (09Mar2022) Negative, notes: confirmed positive on 25Feb2022. Lasted 13 days before testing negative on 09Mar2022.  Clinical information: Patient had not taken any other medication within two weeks of vaccination. past medical history was reported as none.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive on 25Feb2022; Positive on 25Feb2022; 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 female patient received BNT162b2 (BNT162B2), on 25Mar2021 at 12:00 as dose 1, single (Lot number: ER8730), in arm, on 22Apr2021 at 14:30 as dose 2, single (Lot number: EW0171), in arm and on 12Nov2021 at 11:40 as dose 3 (booster), single (Lot number: FH8028) at the age of 54 years, in arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Feb2022, outcome "recovered" and all described as "Positive on 25Feb2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Feb2022) Negative, notes: Test: COVID Date: 22Feb2022 Result: NEG; (24Feb2022) Positive, notes: Test: COVID, Date: 24Feb2022 Result: POS; (25Feb2022) Positive, notes: confirmed positive on 25Feb2022. Lasted 13 days before testing negative on 09Mar2022; (03Mar2022) Positive, notes: Test: COVID Date: 03Mar2022 Result: POS; (08Mar2022) Negative, notes: Test: COVID Date: 08Mar2022 Result: NEG; (09Mar2022) Negative, notes: confirmed positive on 25Feb2022. Lasted 13 days before testing negative on 09Mar2022.  Clinical information: Patient had not taken any other medication within two weeks of vaccination. past medical history was reported as none.
Age: 64.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Mild itching all over; Unable to sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 02May2022 at 08:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 64 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 01Nov2020; VITAFUSION WOMEN'S; LEVOTHYROXINE; ACETAMINOPHEN; HYALURONIC ACID; ZAFIRLUKAST; PANTOPRAZOLE; FLAXSEED; FISH OIL; SUPER B COMPLEX WITH C; ZINC; ARNUITY ELLIPTA; GABAPENTIN; VIACTIV [CALCIUM]; OXYBUTYNIN; SLOW RELEASE IRON. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: EN6205; Route of Administration: Intramuscular; Anatomical site: Left Arm; Time of vaccination: 14:00), administration date: 13Mar2021, when the patient was 64-year-old, for COVID-19 immunisation; BNT162b2 (Dose 2, SINGLE; lot number: EP7534; Route of Administration: Intramuscular; Anatomical site: Left Arm; Time of vaccination: 14:00), administration date: 03Apr2021, when the patient was 64-year-old, for COVID-19 immunisation; BNT162b2 (Dose 3, SINGLE; lot number: FF2J90; Route of Administration: Intramuscular; Anatomical site: Left Arm; Time of vaccination: 14:00), administration date: 13Oct2021, when the patient was 64-year-old, for COVID-19 immunisation. The following information was reported: PRURITUS (non-serious) with onset 24Jul2022 at 22:00, outcome "not recovered", described as "Mild itching all over"; INSOMNIA (non-serious) with onset 24Jul2022 at 22:00, outcome "not recovered", described as "Unable to sleep at night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, insomnia.  Additional information: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment Include prescribed medicines, store bought medicines, dietary supplements and herbal remedies. patient received a Covid-19 Vaccine.  The following information was reported: PRURITUS (non-serious) with onset 24Jul2022 at 22:00, outcome "not recovered", described as "Mild itching all over"; INSOMNIA (non-serious) with onset 24Jul2022 at 22:00, outcome "not recovered", described as "Unable to sleep at night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, insomnia.  Follow-up (12Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Pruritus, SARS-CoV-2 test
Clinical narrative: Mild itching all over; Unable to sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 02May2022 at 08:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 64 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 01Nov2020; VITAFUSION WOMEN'S; LEVOTHYROXINE; ACETAMINOPHEN; HYALURONIC ACID; ZAFIRLUKAST; PANTOPRAZOLE; FLAXSEED; FISH OIL; SUPER B COMPLEX WITH C; ZINC; ARNUITY ELLIPTA; GABAPENTIN; VIACTIV [CALCIUM]; OXYBUTYNIN; SLOW RELEASE IRON. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: EN6205; Route of Administration: Intramuscular; Anatomical site: Left Arm; Time of vaccination: 14:00), administration date: 13Mar2021, when the patient was 64-year-old, for COVID-19 immunisation; BNT162b2 (Dose 2, SINGLE; lot number: EP7534; Route of Administration: Intramuscular; Anatomical site: Left Arm; Time of vaccination: 14:00), administration date: 03Apr2021, when the patient was 64-year-old, for COVID-19 immunisation; BNT162b2 (Dose 3, SINGLE; lot number: FF2J90; Route of Administration: Intramuscular; Anatomical site: Left Arm; Time of vaccination: 14:00), administration date: 13Oct2021, when the patient was 64-year-old, for COVID-19 immunisation. The following information was reported: PRURITUS (non-serious) with onset 24Jul2022 at 22:00, outcome "not recovered", described as "Mild itching all over"; INSOMNIA (non-serious) with onset 24Jul2022 at 22:00, outcome "not recovered", described as "Unable to sleep at night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, insomnia.  Additional information: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment Include prescribed medicines, store bought medicines, dietary supplements and herbal remedies. patient received a Covid-19 Vaccine.  The following information was reported: PRURITUS (non-serious) with onset 24Jul2022 at 22:00, outcome "not recovered", described as "Mild itching all over"; INSOMNIA (non-serious) with onset 24Jul2022 at 22:00, outcome "not recovered", described as "Unable to sleep at night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, insomnia.  Follow-up (12Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Wrong product administered
Clinical narrative: 31 year old patient, who is pregnant, was inadvertently administered GARDASIL 9 yesterday; HCP states the patient has not experienced any side effects; Pt was given wrong vaccine; This spontaneous report has been received from a physician concerning a 31-year-old pregnant female patient. Her concurrent conditions, medical history, drug reactions/allergies. The patient's concomitant medications included prenatal vitamins.   On 16-AUG-2022, the patient was wrongly vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly (IM), administered as prophylaxis, lot number 178018 was an invalid lot number for of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Lot number 178018 does not match any Company product as confirmed by Lot Verification Team, with expiration date 02-DEC-2023 (dose frequency was not reported) (Exposure during pregnancy) (Wrong product administered).  No additional adverse event was reported (No adverse event).   At the time of reporting, the outcome of pregnancy was pending.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 31 year old patient, who is pregnant, was inadvertently administered GARDASIL 9 yesterday; HCP states the patient has not experienced any side effects; Pt was given wrong vaccine; This spontaneous report has been received from a physician concerning a 31-year-old pregnant female patient. Her concurrent conditions, medical history, drug reactions/allergies. The patient's concomitant medications included prenatal vitamins.   On 16-AUG-2022, the patient was wrongly vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly (IM), administered as prophylaxis, lot number 178018 was an invalid lot number for of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Lot number 178018 does not match any Company product as confirmed by Lot Verification Team, with expiration date 02-DEC-2023 (dose frequency was not reported) (Exposure during pregnancy) (Wrong product administered).  No additional adverse event was reported (No adverse event).   At the time of reporting, the outcome of pregnancy was pending.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: 31 year old patient, who is pregnant, was inadvertently administered GARDASIL 9 yesterday; HCP states the patient has not experienced any side effects; Pt was given wrong vaccine; This spontaneous report has been received from a physician concerning a 31-year-old pregnant female patient. Her concurrent conditions, medical history, drug reactions/allergies. The patient's concomitant medications included prenatal vitamins.   On 16-AUG-2022, the patient was wrongly vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly (IM), administered as prophylaxis, lot number 178018 was an invalid lot number for of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Lot number 178018 does not match any Company product as confirmed by Lot Verification Team, with expiration date 02-DEC-2023 (dose frequency was not reported) (Exposure during pregnancy) (Wrong product administered).  No additional adverse event was reported (No adverse event).   At the time of reporting, the outcome of pregnancy was pending.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bacterial test, Inflammation, Meningitis, Viral test
Clinical narrative: Developed meningitis within 1 week of receving COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) (seriousness criterion medically significant). At the time of the report, MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bacterial test: (Negative) Negative. On an unknown date, Lumbar puncture abnormal: showed active inflammation. On an unknown date, Viral test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment-This spontaneous case concerns a 4-year-old male child with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Meningitis that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. It was reported that patient developed meningitis within 1 week of receiving COVID vaccine. Lumbar tap done on an unknown date showed active inflammation with negative bacterial culture and viral screening. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 4-year-old male child with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Meningitis that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. It was reported that patient developed meningitis within 1 week of receiving COVID vaccine. Lumbar tap done on an unknown date showed active inflammation with negative bacterial culture and viral screening. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 3.0
Sex: M
Vaccine: UNK, DTAPHEPBIP
Symptoms: Diarrhoea, Laboratory test normal, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Facial swelling; Hives in legs, thighs, buttocks, and torso; Fever of 102.5; Rash in legs, thighs, buttocks and torso; Vomiting; Diarrhea; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 3-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 4th September 2022, 3 days after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced fever and rash. On 5th September 2022, the patient experienced facial swelling and hives. In September 2022, the patient experienced vomiting, diarrhea and lethargy. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy were recovered/resolved.   The reporter considered the vomiting, diarrhea, fever, rash, facial swelling, hives and lethargy to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: The reporter reported that the patient received Pediarix vaccine. The reporter stated that 12 hours after received Pediarix vaccine the patient experienced vomiting and 48 hours after received vaccine patient had diarrhea. The reporter reported after received vaccine on September 2022 Sunday patient also experienced a fever of 102.5 and a rash that covered the legs, thighs, buttocks and torso. On September 2022 Monday, patient was experienced facial swelling and the rash had turned into hives covered the same areas as the rash.  The reporter stated patient received Benadryl for the rash on Sunday, which seemed to resolve the hives. The hives reappeared later in the week, resulting in patient being taken to the emergency room (ER), where patient was given Prednisone on September 6 2022.  Reporter reported that the several tests were conducted on patient to rule out other possible causes of the reaction and everything came back clear. The reporter reported that the everything was coming back clear from the tests. The reporter believe the Pediarix is the likely cause of patient's symptoms. The reporter stated Prednisone resolved all symptoms.  The reporter does not known the patient previously Pediarix received or which dose patient was received. The reporter did consent to follow up.