chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemoptysis, Myalgia, Oropharyngeal pain, Productive cough
Clinical narrative: Sore throat; Cough with phlegm with a bit of blood; Cough with phlegm with a bit of blood; Pain at the top of her right lung it is a strange pain; Body ache; Feeling very tired; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Cough with phlegm with a bit of blood), HAEMOPTYSIS (Cough with phlegm with a bit of blood), PULMONARY PAIN (Pain at the top of her right lung it is a strange pain) and MYALGIA (Body ache) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052B22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no allergies to (medications, food and other products).  The patient's past medical history included COVID-19 in July 2022.    On 23-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Nov-2022, the patient experienced MYALGIA (Body ache) and FATIGUE (Feeling very tired). On 29-Nov-2022, the patient experienced PRODUCTIVE COUGH (Cough with phlegm with a bit of blood), HAEMOPTYSIS (Cough with phlegm with a bit of blood) and PULMONARY PAIN (Pain at the top of her right lung it is a strange pain). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Cough with phlegm with a bit of blood), HAEMOPTYSIS (Cough with phlegm with a bit of blood), PULMONARY PAIN (Pain at the top of her right lung it is a strange pain), MYALGIA (Body ache) and FATIGUE (Feeling very tired) outcome was unknown.            No concomitant products reported.  Patient administered 1st dose of Moderna on 29-Mar-2021 with lot Number: 018B21A,  and 2nd dose on 26-Apr-2021 with lot Number: ER9731 of unknown manufacturer,  1st Booster dose of Moderna on 12-Jan-2022 with lot number: 0-2H221B   She stated she also had pain at the top of her right lung it was a strange pain. She would like to know if these symptoms were normal side effects of the vaccine.   This case was linked to MOD-2022-679867 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: Sore throat; Cough with phlegm with a bit of blood; Cough with phlegm with a bit of blood; Pain at the top of her right lung it is a strange pain; Body ache; Feeling very tired; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Cough with phlegm with a bit of blood), HAEMOPTYSIS (Cough with phlegm with a bit of blood), PULMONARY PAIN (Pain at the top of her right lung it is a strange pain) and MYALGIA (Body ache) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052B22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no allergies to (medications, food and other products).  The patient's past medical history included COVID-19 in July 2022.    On 23-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Nov-2022, the patient experienced MYALGIA (Body ache) and FATIGUE (Feeling very tired). On 29-Nov-2022, the patient experienced PRODUCTIVE COUGH (Cough with phlegm with a bit of blood), HAEMOPTYSIS (Cough with phlegm with a bit of blood) and PULMONARY PAIN (Pain at the top of her right lung it is a strange pain). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Cough with phlegm with a bit of blood), HAEMOPTYSIS (Cough with phlegm with a bit of blood), PULMONARY PAIN (Pain at the top of her right lung it is a strange pain), MYALGIA (Body ache) and FATIGUE (Feeling very tired) outcome was unknown.            No concomitant products reported.  Patient administered 1st dose of Moderna on 29-Mar-2021 with lot Number: 018B21A,  and 2nd dose on 26-Apr-2021 with lot Number: ER9731 of unknown manufacturer,  1st Booster dose of Moderna on 12-Jan-2022 with lot number: 0-2H221B   She stated she also had pain at the top of her right lung it was a strange pain. She would like to know if these symptoms were normal side effects of the vaccine.   This case was linked to MOD-2022-679867 (Patient Link).
Age: 5.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: 5 year old receiving an ADACEL vaccine on 11Nov2022 instead of DAPTACEL with no reported adverse event; Initial information received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 5 years old male patient who had an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine on 11nov2022 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 11-NOV-2022 the patient developed a non-serious event of 5 year old receiving an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine (batch number: U7624AA and expiry date: unknown, route, administration site, formulation was unknown for Immunization) on 11nov2022 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]with no reported adverse event (wrong product administered) (latency: same day).   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  Outcome: 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: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: quadracel dose given at 8 years old and 9 months with no reported adverse event; Initial information was received on 28-Nov-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 8 years old female patient who had quadracel dose given at 8 years old and 9 months with no reported adverse event after receiving vaccine diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), rubella vaccine LIVE (WISTAR RA 27/3), VARICELLA zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection at dose of 0.5 ml frequency: total (lot C5970AA and expiry date: 02-Feb-2024) via intramuscular route in the left thigh for Immunization (Immunisation).  On an unknown date the patient had a non-serious event of quadracel dose given at 8 years old and 9 months with no reported adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken: not applicable.  Outcome: 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Did not get any reaction until 2 weeks later..now I live with tinittis....
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Approximately 8 hours after the vaccine was administered, I began to experience, fatigue, joint pain/soreness, slight fever, chills, headache, slight dizziness and mild shortness of breath. I have experienced similar symptoms after receiving previous doses. Based on this previous experience, I expect the symptoms to alleviate by vaccination time + 24 hours.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Pyrexia
Clinical narrative: Approximately 8 hours after the vaccine was administered, I began to experience, fatigue, joint pain/soreness, slight fever, chills, headache, slight dizziness and mild shortness of breath. I have experienced similar symptoms after receiving previous doses. Based on this previous experience, I expect the symptoms to alleviate by vaccination time + 24 hours.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pediatric dose was given to adults mistakenly; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender 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 INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly).    Concomitant medication not reported.  051B22A was kept in the freezer upon receipt of shipment on 1 Aug 2022 and individual vials were put in the refrigerator on the day of use. Pediatric dose was given to adults mistakenly and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.    Treatment medication not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This case was reported by a consumer via call center representative and described the occurrence of runny nose in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced runny nose. On an unknown date, the outcome of the runny nose was not recovered/not resolved.   It was unknown if the reporter considered the runny nose to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-Nov-2022. Reporter's Comment:  The reporter stated that her husband received the Shingrix shot recently and now the husband had a runny nose.  No other information reported to the agent by the reporter. The reporter declined for GlaxoSmithKline to store any contact information and declined to answer any more questions for the safety report. The reporter did not give consent to follow-up.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received  pediatric dose of Havrix; Adult received  pediatric dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 44-year-old female patient who received HAV (Havrix 720) (batch number T57F3, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2022, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   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: 22-NOV-2022. Reporter's Comment: The pharmacist reported that an adult patient received a pediatric dose of Havrix.  The reporter gave consent to follow up. Additional Supportive Information: The adult patient received a pediatric dose of Havrix, which led to adult use of a child product and underdose.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: weakness; Pain in the upper arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ASTHENIA (weakness) and PAIN IN EXTREMITY (Pain in the upper arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A, 031A21A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Golfer's elbow (he started with this issue before the pandemic, 3 years ago) in 2019. Concurrent medical conditions included Diabetes (1 year ago, Recent change in status such as improvement or worsening: no) since 2021, Blood pressure high (more than 10 years ago,Recent change in status such as improvement or worsening: no), High cholesterol (more than 10 years ago,Recent change in status such as improvement or worsening: no), Reaction to monosodium glutamate, Drug allergy (allergy to tramadol) and Drug allergy (allergy to chlorthalidone).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced ASTHENIA (weakness) and PAIN IN EXTREMITY (Pain in the upper arm). On 22-Nov-2021, ASTHENIA (weakness) and PAIN IN EXTREMITY (Pain in the upper arm) had resolved.            No concomitant products reported.  It was reported that patient did not experienced any adverse events after primary series, and only experienced pain in the upper arm and weakness during about 3 days after 1st booster, but no treatment was given. Patient was not able to take the 2nd regular booster at the right time since patient had elbow surgeries due to golfer's elbow. Patient was under a lot of medications but caller did not know names, she just know medications were for diabetes, high blood pressure and high cholesterol. Patient had no COVID positive test or diagnosis. Patient did not had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient visited a doctor. The patient did not experienced a similar event in the past.  No treatment products reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: patient broke out with body rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (patient broke out with body rashes) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (patient broke out with body rashes). At the time of the report, RASH (patient broke out with body rashes) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that, the patient broke out with body rashes that lasted for over a year.   No treatment medications were reported.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Joints ache/more soreness with weather change; Arm sore with fourth Moderna covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore with fourth Moderna covid 19 vaccine) and ARTHRALGIA (Joints ache/more soreness with weather change) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe Chronic Plaque Psoriasis).   In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2022, the patient experienced VACCINATION SITE PAIN (Arm sore with fourth Moderna covid 19 vaccine). On an unknown date, the patient experienced ARTHRALGIA (Joints ache/more soreness with weather change). In 2022, VACCINATION SITE PAIN (Arm sore with fourth Moderna covid 19 vaccine) had resolved. At the time of the report, ARTHRALGIA (Joints ache/more soreness with weather change) had not resolved.            Concomitant medications were not reported. Patient received Dose 1 and Dose 2 of vaccine on unspecified dates (Intramuscular). Patient received Dose 3/booster of Moderna COVID-19 vaccine on 2022 (Intramuscular). It was unknown if patient was enrolled in covid-19-vaccine trial. The reporter's causality for the event(s) of arm sore with fourth Moderna COVID-19 vaccine and joints ache/more soreness with weather change with Adalimumab Solution for Injection was No Reasonable Possibility                       No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Sick with Covid) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Sick with Covid). At the time of the report, COVID-19 (Sick with Covid) had not resolved.            Concomitant medication list was not provided. It was reported that the patient had completed the four Moderna COVID-19 vaccines that were available to the patient. Patient was on day 4 of being sick with COVID-19. Patient hardly ever got sick. Patient thought that it would be beneficial to have a local medical faculty draw a blood sample, figure out which variant had got the patient down and fix the vaccines, so it does not happen to others. Treatment information was not provided.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Cough, Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: coughing; sneezing; runny nose; Throat scratchy too; Initial information was received on 26-Nov-2022 regarding an unsolicited valid non-serious case received from a patient.  This case involves a patient with unknown gender who had coughing, sneezing, runny nose and throat scratchy too after being vaccinated with Moderna COVID-19 vaccine and Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) and Moderna COVID-19 vaccine (not produced) (with unknown strength, dose, route, administration site, lot number and expiration date) for Prophylactic vaccination.  On an unknown date the patient had coughing (cough), sneezing, runny nose (rhinorrhoea) and throat scratchy too (throat irritation) (unknown latency) Crazy no fever thou following the administration of Influenza vaccine and Moderna COVID-19 vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported for all the events.   Outcome: Unknown for all the events.; Sender's Comments:
Sex: U
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: nurses at their office may have given a YF-Vax to a patient that was reconstituted with sterile water, not sodium chloride as is directed with no reported adverse event; Initial information received on 29-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics and it was reported that nurses at their office may have given a yf-vax(YELLOW FEVER VACCINE - ) to a patient that was reconstituted with sterile water, not sodium chloride as is directed with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect YELLOW FEVER VACCINE - (formulation, strength: unknown) lot UJ683AA, expiration date:15-Sep-2023 via unknown route in unknown administration site as Immunization.  On an unknown date the nurses at their office may have given a Yf-vax to a patient that was reconstituted with sterile water, not sodium chloride as is directed with no reported adverse event (product preparation error) (unknown latency) following the administration of YELLOW FEVER VACCINE -.  It was unknown to the reporter if a dose of Yf-Vax was given with the incorrect diluent; that at this time all was known was that there was an extra remaining diluent and no Yf-Vax; that the reason for the extra diluent was thought to be due to an incorrect diluent was used with the vaccine; that further research needs to be done.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (nurses at their office may have given a YF-Vax to a patient that was reconstituted with sterile water, not sodium chloride as is directed with no reported adverse event).  At time of reporting, the outcome was Unknown for the 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: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was administered with the product PENTACEL but with sterile diluent with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 months old male patient who was administered with the product Pentacel (DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE) but with sterile diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Nov-2022, the patient received a one dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot UJ680ABA, expiration date: 16-Sep-2023 via intramuscular route in the right thigh as Immunization.  On 30-Nov-2022 the patient was administered with the product pentacel but with sterile diluent with no reported adverse event (product preparation error) (same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Caller was asking some guidance with regards to Pentacel that was administered to a patient separately. The lyophilized portion was diluted with a different diluent instead of the diluent supplied with the vaccine thus wanted to know if that would count as a valid dose.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was administered with the product Pentacel but with sterile diluent with no reported adverse event).  At time of reporting, the outcome was Unknown for the 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 guidelines. 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: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: pt states her arm swelled from the elbow to her shoulder on her left side lasted about 6 days
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: Systemic: nausea and flush-Mild, Systemic: Vomiting-Medium, Additional Details: patient looked whitish/pale in the face, requested pt to stay a few more minutes, gave him water, he then vomitted a moderate amount, after resting and vomitting, patient stated he felt better. called on 11/28/2022 as a follow up for patient. left message.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired one day before given. Manufacuter date 12/1/21
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow abnormal, Blood test, Crohn's disease, Death, Neoplasm malignant
Clinical narrative: Received Covid 19 vaccine 2021, diagnosed in April 2021 with crohn dz, put on April 2021 Humira every other week, October 2021 for blood work - Humira not working, then started having bleeding from rectum, switched to stelara, three doses later may 11, 2022 hospitalized had to get emergency blood transfusion, bone marrow biopsy May 16, 2022 indicated cancer, placed in hospice may 18, 2022, passed June 18, 2022
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Rectal haemorrhage, Therapy non-responder, Transfusion
Clinical narrative: Received Covid 19 vaccine 2021, diagnosed in April 2021 with crohn dz, put on April 2021 Humira every other week, October 2021 for blood work - Humira not working, then started having bleeding from rectum, switched to stelara, three doses later may 11, 2022 hospitalized had to get emergency blood transfusion, bone marrow biopsy May 16, 2022 indicated cancer, placed in hospice may 18, 2022, passed June 18, 2022
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Autoimmune disorder, Pruritus, Urticaria
Clinical narrative: Patient received the Shingrix vaccine on 08/26/2021, and within two weeks, she was covered with hives and had severe pruritus. The reaction began in her legs and gradually went up her body. she now has to receive monthly injections of omalizumab (Xolair, 150 mg in each arm), an anti-lgE biologic, to control the hives and angioedema that have kept recurring since the original reaction. She states her allergist told her she has developed an autoimmune condition and may need to receive indefinite treatment.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dental restoration failure, Malaise, Mechanical ventilation, Throat tightness, Tooth disorder
Clinical narrative: After each shingrix vaccine, first and second, I got sick. Three weeks after the second shot, my throat closed on me and I was in hospital on ventilator. After each shot I lost a cap on a tooth.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse food reaction, Feeling abnormal, Histamine level increased, Medical diet, Nasal oedema
Clinical narrative: I received the first Covid-19 Vaccine on 11/19/2021. I experienced the excepted side effects of running a fever and feeling bad for a couple of days. In addition to those side effects, I also experienced scalp itching that progressed to full blown hives after eating, that I have been dealing with for the last year. I experience facial, neck, and nasal passage swelling in addition to the hives if I eat wheat, eggs, dairy, and nuts. If I don't eat, I don't have this reaction. If I eat, I react in this way. I have never had food allergies nor have I ever had to limit my food choices. I have now been placed on a low histamine diet to try to decrease the amount of histamine in my system to reduce the reaction. I have lost 25 pound so far and can't afford to lose any more.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Swelling, Swelling face, Urticaria
Clinical narrative: I received the first Covid-19 Vaccine on 11/19/2021. I experienced the excepted side effects of running a fever and feeling bad for a couple of days. In addition to those side effects, I also experienced scalp itching that progressed to full blown hives after eating, that I have been dealing with for the last year. I experience facial, neck, and nasal passage swelling in addition to the hives if I eat wheat, eggs, dairy, and nuts. If I don't eat, I don't have this reaction. If I eat, I react in this way. I have never had food allergies nor have I ever had to limit my food choices. I have now been placed on a low histamine diet to try to decrease the amount of histamine in my system to reduce the reaction. I have lost 25 pound so far and can't afford to lose any more.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: I received the first Covid-19 Vaccine on 11/19/2021. I experienced the excepted side effects of running a fever and feeling bad for a couple of days. In addition to those side effects, I also experienced scalp itching that progressed to full blown hives after eating, that I have been dealing with for the last year. I experience facial, neck, and nasal passage swelling in addition to the hives if I eat wheat, eggs, dairy, and nuts. If I don't eat, I don't have this reaction. If I eat, I react in this way. I have never had food allergies nor have I ever had to limit my food choices. I have now been placed on a low histamine diet to try to decrease the amount of histamine in my system to reduce the reaction. I have lost 25 pound so far and can't afford to lose any more.
Sex: M
Vaccine: COVID19-2
Symptoms: Axillary pain, Back pain, Injection site pain, Swelling
Clinical narrative: Received my Pfizer bivalent booster vaccine on 10/16/22. Had the usual right deltoid soreness around the injection site for about 3-5 days, which was more severe than any of my other injections. About 2 days after the initial vaccination I had severe pain running along the backside of my right armpit and extending a few inches beyond down my back. The area was painful and more dense than the surrounding tissues. This pain and swelling resolved within 3-5 days of onset.
Sex: M
Vaccine: COVID19
Symptoms: Anti-IA2 antibody, Diabetic ketoacidosis, Glycosylated haemoglobin increased, Type 1 diabetes mellitus
Clinical narrative: My 3 year old son was hospitalized due to DKA and diagnosed as type 1 diabetes on 11/14/2022. He had 3 doses covid vaccines (COVID-19, mRNA, LNP-S, PF, 3 mcg/0.2 mL dose, tris-sucrose) on 08/11/2022, 09/01/2022, 10/27/2022.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness bilateral, Magnetic resonance imaging head, Tinnitus
Clinical narrative: started getting hissing sound in bilateral ears. Went to my ENT doctor & he diagnosed it as bilateral tinnitus. I took Lipoflavinoid with no relief. hearing loss, mixed bilateral. Hearing loss unspecified hearing loss; constant tinnitus; chroni micrvascular ischemic changes
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Pt was 7 yrs old- requiring the second dose of monovalent Pediatric Pfizer 0.2 mL with the 1.3 ml diluent for a dose of (10mcg), pt was incorrectly given monovalent pfizer for age group 6mths-<5 yrs formula with incorrect diluent of 1.3 ml (should be 2.2 ml diluent for this product) with a dose of 0.2mL. Pt did not experience any symptoms but was underdosed with the incorrect formula of pfizer for her age group.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 11/30/2022
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Inguinal hernia, Inguinal hernia repair, SARS-CoV-2 test positive
Clinical narrative: Death on 11/26/2022
Age: 5.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: On 10/10/22, pt. developed acute ITP with platelet count <2,000. She has been treated with IVIG x2 on 10/10/22 and 10/20/22 and high dose steroids started on 10/19/22 with recurrent thrombocytopenia after weaning steroids as of 12/2/22.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough event
Age: 6.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Anal rash, Bacterial infection, Diarrhoea, Rash, Rash papular
Clinical narrative: Rash on bottom, around anus, raised bumps outside of that, painful and itchy. Started on 11/20 with diarrhea, which resolved within 24 hours, but the rash remained and grew worse on 11/26. At-home cortisone cream wasn't helping, so a doctor visit occurred on 12/1. Doctor determined that it's a bacterial infection, and prescribed antibiotics and an antifungal cream. The rash (and especially the pain and itchy) has already started to improve (on 12/2).
Age: 6.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Rash pruritic
Clinical narrative: Rash on bottom, around anus, raised bumps outside of that, painful and itchy. Started on 11/20 with diarrhea, which resolved within 24 hours, but the rash remained and grew worse on 11/26. At-home cortisone cream wasn't helping, so a doctor visit occurred on 12/1. Doctor determined that it's a bacterial infection, and prescribed antibiotics and an antifungal cream. The rash (and especially the pain and itchy) has already started to improve (on 12/2).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Pfizer 4/20/21 EW0164, 8/26/21 EW0173, and boosted Moderna 12/3/21 024C21A.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Pfizer dose drawn up by RN - 0.2 cc from newly opened 5-11 Bivalent Pfizer vial. No diluent was mixed with vaccine, so child received 0.2 cc of undiluted vaccine. Patient's Mom informed of error and she is a Emergency RN and she immediately called Pediatrician Dr. PRIVATE. Dr. and Mom chatted within 10 - 15 minutes of the error. Dr. requested that Mom monitor patient closely and suggested Benadryl and Tylenol (per pkg. instructions) tonight. This RN also instructed Mom to push water tonight and tomorrow and Mom plans to push fluids, closely monitor and provide Benadryl and Tylenol as instructed
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Booster injection was given, but patient had not had  primary series completed
Age: 59.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Client was only given partial dose of MENVEO as the vaccine was mixed with sterile saline dilutant instead of conjugate. No adverse reaction occured.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chest pain, Chest tube insertion, Computerised tomogram thorax normal, Musculoskeletal chest pain
Clinical narrative: I was admitted to the hospital on 11/4/2022, for a collapsed lung and I had to stay there for 4 days. About 3 days before, I had slight chest pain, and my rib cage was hurting bad. They had to re-inflate my lung. I was diagnosed with Right Partial Spontaneous Pneumothorax. This normally occurs in smoker's and I haven't ever smoked.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumothorax spontaneous
Clinical narrative: I was admitted to the hospital on 11/4/2022, for a collapsed lung and I had to stay there for 4 days. About 3 days before, I had slight chest pain, and my rib cage was hurting bad. They had to re-inflate my lung. I was diagnosed with Right Partial Spontaneous Pneumothorax. This normally occurs in smoker's and I haven't ever smoked.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient has no symptoms related to the injection, the adverse event its a error on administration. Patient comes to the clinic for his 3rd dose (1rst booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine, the administered vaccine doesn't present any previous temperature excursion or any related problem.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MA administered Men B Bexsero to patient 11 years of age. No reactions reported to date.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: Heart Racing with High Blood Pressure
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Visibly swollen and tender lymph nodes in left arm pit.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Patient has no symptoms related to the injection, the adverse event its a error on administration. Patient comes to the clinic for his 3rd dose (1rst booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine, the administered vaccine doesn't present any previous temperature excursion or any related problems.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: None  Patient received Bivalent vaccine instead of primary series for 1st dose
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: the adverse event its a error on administration. Patient comes to the clinic for his 3rd dose (1rst booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine, the administered vaccine doesn't present any previous temperature excursion or any related problems.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Herpes zoster
Clinical narrative: Patient noted having a shingles infection lasting four weeks beginning four days after vaccination with prevnar 20
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Headache, Pain, SARS-CoV-2 test positive
Clinical narrative: I was positive for Covid 19 I was tired and had a headache; I had body aches that lasted couple of day.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Blood test normal, Chills, Electrocardiogram abnormal, Nausea
Clinical narrative: Next morning, after the vaccine, I had nausea and urinated very often, chills. I went to the ER locally; they took blood and urine for the tests. EKG was done. The urine test was normal, but it shows a urinary tack infection; they gave me medicine.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pollakiuria, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Next morning, after the vaccine, I had nausea and urinated very often, chills. I went to the ER locally; they took blood and urine for the tests. EKG was done. The urine test was normal, but it shows a urinary tack infection; they gave me medicine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Covid 19 vaccinated after 2 days of BUD
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: the adverse event its a error on administration. Patient comes to the clinic for her 4th dose (2nd booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine (0.25 ml administered) , the administered vaccine doesn't present any previous temperature excursion or any related problems.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 2 days of BUD
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was inadvertently administered the Pfizer bivalent COVID-19 vaccine instead of the monovalent.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Pfizer Bivalent Booster for his first shot in the series.  Had not been vaccinated for COVID before 11.21.2022. Called CDC and they stated to have him come back in 3-8 weeks to recieve the Pfizer Monovalent and then 2 months to receive the bivalent COVIS second series vaccine.  Patient had no known adverse symptoms from getting the COVID booster.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 2 days of BUD
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was inadvertently administered the Pfizer monovalent COVID-19 vaccine instead of the bivalent.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: the adverse event its a error on administration. Patient comes to the clinic for her 4th dose (2nd booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine (0.25 ml administered), the administered vaccine doesn't present any previous temperature excursion or any related problems. We are waiting responses of the immunization system to see how proceed with the patient, if we need to revaccinate the patient(s) or what else we can do.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient given a COVID bivalent Booster that sat out over 24hours
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 2 days of BUD
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was inadvertently administered Pfizer bivalent COVID-19 vaccine that was beyond the best use date. Vial was left at room temperature for ~9hrs past the 12hr best use timeframe.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest discomfort, Chills, Cough
Clinical narrative: By 8pm my left arm and shoulder was in pain. By the next morning at 8am, my arm felt like it was trying to be ripped off my body. I was running a fever, had a halo migraine, body and joints felt like I had been in a severe accident with excruciating pain. Had to take Excedrin Migraine and 800mg of ibuprofen every 6 hours with very little relief. Also had chills and hot flashes. Then later that day I started having diarrhea and severe stomach pain. Whole body pain got worse over night and I couldn?t sleep. Today, after 3 hours of sleep, I woke with a migraine again, severe stomach cramping, heavy feeling in my chest and now have a cough. Body aches and pains have continued with barely any relief. Nothing is working for my migraine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gait disturbance, Hot flush, Insomnia, Migraine with aura
Clinical narrative: By 8pm my left arm and shoulder was in pain. By the next morning at 8am, my arm felt like it was trying to be ripped off my body. I was running a fever, had a halo migraine, body and joints felt like I had been in a severe accident with excruciating pain. Had to take Excedrin Migraine and 800mg of ibuprofen every 6 hours with very little relief. Also had chills and hot flashes. Then later that day I started having diarrhea and severe stomach pain. Whole body pain got worse over night and I couldn?t sleep. Today, after 3 hours of sleep, I woke with a migraine again, severe stomach cramping, heavy feeling in my chest and now have a cough. Body aches and pains have continued with barely any relief. Nothing is working for my migraine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sensory disturbance
Clinical narrative: By 8pm my left arm and shoulder was in pain. By the next morning at 8am, my arm felt like it was trying to be ripped off my body. I was running a fever, had a halo migraine, body and joints felt like I had been in a severe accident with excruciating pain. Had to take Excedrin Migraine and 800mg of ibuprofen every 6 hours with very little relief. Also had chills and hot flashes. Then later that day I started having diarrhea and severe stomach pain. Whole body pain got worse over night and I couldn?t sleep. Today, after 3 hours of sleep, I woke with a migraine again, severe stomach cramping, heavy feeling in my chest and now have a cough. Body aches and pains have continued with barely any relief. Nothing is working for my migraine.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Pyrexia, Respiratory tract congestion
Clinical narrative: She had a fever for about 5 days, loss of appetite, congestion, fatigue, and a cough that has been going on for about 9 days. She is still dealing with the cough at this time. All of the other symptoms are gone. No medications were prescribed. She was taking MUCINEX, and chewable ibuprofen.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: She had a fever for about 5 days, loss of appetite, congestion, fatigue, and a cough that has been going on for about 9 days. She is still dealing with the cough at this time. All of the other symptoms are gone. No medications were prescribed. She was taking MUCINEX, and chewable ibuprofen.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Injected limb mobility decreased
Clinical narrative: PATIENT REPORTS SHE HAD SURGERY IN OCTOBER TO RESOLVE MOBILITY ISSUES IN RIGHT ARM. SHE GOT A VACCINE ABOUT A MONTH LATER IN THAT ARM AND A RECENT DOCTOR VISIT SHOWED REDUCED MOBILITY IN THE RIGHT ARM AGAIN.