chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling; redness; Initial information was received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 years old male patient who experienced swelling and redness while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Nov-2022, the patient received a dose 4 of suspect standard diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection once (lot C5969AD, expiry date - 17-Feb-2024) via unknown route at arm not otherwise specified for Immunization.  On an unknown date the patient developed non-serious event of swelling (vaccination site swelling), redness (vaccination site erythema) (unknown latency) following the administration of vaccine.  It was reported He has had swelling and redness on a large portion of his arm. he had no other vaccines that day. He has had no nausea or vomiting.   Action taken was not applicable.  The patient was treated with diphenhydramine hydrochloride (Benadryl [diphenhydramine hydrochloride]) for Vaccination site swelling and Vaccination site erythema.  At time of reporting, the outcome was Unknown for the events.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an ActHIB vaccine that was later noted to have expired on 10/15/2022 with no reported adverse event; Initial information was received on 10-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves 15 months old female patient who was administered by an HAEMOPHILUS TYPE B (HIB) VACCINE (prp/t) vaccine [Act-Hib] vaccine that was later noted to have expired on 10/15/2022 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  Concomitant medications included influenza vaccine inact split 4v (Fluzone quadrivalent) for prophylactic vaccination (Immunisation); pneumococcal vaccine conj 7v (crm197) (Prevnar) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Dtap) for unknown indication.   On 10-Nov-2022, the patient was administered by 0.5 ml dose 4 of suspect HAEMOPHILUS TYPE B (HIB) (prp/t) vaccine (formulation: unknown, strength: standard, lot number: UJ583ABB, expiry date 15-Oct-2022) via intramuscular route in the right arm for Immunisation that was later noted to have expired (expired product administered) with no reported adverse event (latency: same day).  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: 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.
Sex: U
Vaccine: MNQ
Symptoms: Product dose omission issue
Clinical narrative: Pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event; Initial information was received on 14-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to cases 2022SA471962 and 2022SA473333.  This case involves Child with unknown gender patient and reporter reported that office states that 3 scheduled vaccines were prepared for a patient, but the parent refused 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 vaccine Meningococcal A-C-Y-W135 (T CONJ) (with unknown strength, dose, lot number and expiration date) for Prophylactic vaccination was scheduled and prepared for a patient, but the parent refused with no reported adverse event (product dose omission issue) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  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 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: 12.0
Sex: M
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administration Influenza Quadrivalent Recombinant Vaccine [Flublok] vaccine at inappropriate age.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Nov-2022, the patient received a dose of 0.5 ml dose 1 of suspect Influenza Quadrivalent Recombinant Vaccine (lot UJ888AA) via intramuscular route in the right deltoid (formulation, expiry date, strength was unknown) for immunization that was administration at inappropriate age with no reported adverse event.  Action taken 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: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received the FLUZONE QIV NP vaccine 3 weeks apart instead of 4 weeks apart, with no reported adverse event; Initial information received  on 14-Nov-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 months old female patient who received the influenza quadrival A-B [Fluzone Quadrivalent] vaccine 3 weeks apart instead of 4 weeks apart, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  On 10-Nov-2022, the patient received dose 2 of suspect influenza quadrival A-B Vaccine suspension for injection with unknown strength (lot: UT7695MA, expiry date: 30-Jun-2023) via intramuscular route in the right vastus lateralis for Immunization, 3 weeks apart instead of 4 weeks apart with no reported adverse event (inappropriate schedule of product administration).  Action taken 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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired dose of ACTHIB was administered to a patient, with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who experienced an expired dose of acthib was administered to a patient, with no reported adverse event while receiving vaccine hib (prp/t) vaccine (Act-Hib).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197).  On 04-Nov-2022, the patient received a dose 4 of suspect hib (prp/t) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml with lot UJ594AAA and expiry date 26-Oct-2022 via intramuscular route in the right thigh for Immunization.  On 04-Nov-2022 (latency: same day) the patient developed a non-serious an expired dose of acthib was administered to a patient, with no reported adverse event (expired product administered) following the administration of hib (prp/t) 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: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of fluzone QIV with no reported adverse event; Initial information was received  on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 57 years old male patient received an expired dose of fluzone qiv with no reported adverse event after receiving influenza quadrival a-b multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Oct-2022, the patient received a dose of 0.5 ml suspect influenza quadrival a-b multidose vaccine preserved (suspection for injection) (Frequency: once) (lot number: UT7316NA,Expiration date:30-Jun-2022)(strength: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) .  On 12-Oct-2022 the patient received an expired dose of fluzone qiv with no reported adverse event (expired product administered) (latency: same day) following the administration of influenza quadrival a-b multidose vaccine preserved.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event patient received an expired dose of fluzone qiv with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired FLUZONE QIV NP with no reported adverse event; Initial information was received on 14-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves 38 years old female patient who received an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s)and family history were not provided.   On 14-Nov-2022, the patient received an expired 0.5 mL dose, a standard strength of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7384KA, expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunisation with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event patient received an expired fluzone qiv np with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: DTaP-IPV component of PENTACEL given without the ACTHIB component, with no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient reporter stated dtap-ipv component of pentacel given without the acthib component, with no reported adverse event. (diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine) [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Nov-2022, the patient received 2 dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml Total with standard strength (form, strength,  expiry date: unknown) via intramuscular route in unknown administration site for Immunization.   On 10-Nov-2022 the patient was given dtap-ipv component of pentacel given without the acthib component, with no reported adverse event (product preparation error) (latency: same day).  Action taken was not applicable.  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: 64.0
Sex: F
Vaccine: FLUX
Symptoms: COVID-19, Cerebral disorder, Crying, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Very congested; Positive for COVID; Runny nose; Brain cold; Crying eyes; Sore throat; This spontaneous case was received on 02-Nov-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-05326) and concerned a 64-years-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 27-Oct-2022, the patient was vaccinated with Influenza vaccine (brand not specified; dose, route of administration, anatomical location: not reported) for prevention of influenza disease.  On 29-Oct-2022, two days after receiving influenza vaccine, the patient experienced sore throat.   On 30-Oct-2022, the patient experienced runny nose, crying eyes and what patient called brain cold.   On 01-Nov-2022, the patient took a Covid-19 test and the result was positive.   On 03-Nov-2022, the patient felt very congested, and her eyes and nose were still runny.  The outcome of the events was unknown.   The reporter did not provide a causality assessment. The patient was thinking were these side effects related to the flu vaccine and that her covid test contradicted the result.  Company comment: A 64-years-old, female patient was vaccinated with influenza vaccine. Two days after vaccination, the patient experienced sore throat. Following day, the patient experienced runny nose, crying eyes and brain coldness. The patient also felt very congested. The patient took a Covid-19 test and the result was positive. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as not related for the event Covid-19, due to biological implausibility. Although, causality for the remaining events is confounded with the reported Covid-19, cannot be completely excluded and is assessed as possibly related, with the currently available information and plausible temporal relationship.; Reporter's Comments: The patient was thinking were these side effects related to the flu vaccine and that her covid test contradicted the result.; Sender's Comments: A 64-years-old, female patient was vaccinated with influenza vaccine. Two days after vaccination, the patient experienced sore throat. Following day, the patient experienced runny nose, crying eyes and brain coldness. The patient also felt very congested. The patient took a Covid-19 test and the result was positive. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as not related for the event Covid-19, due to biological implausibility. Although, causality for the remaining events is confounded with the reported Covid-19, cannot be completely excluded and is assessed as possibly related, with the currently available information and plausible temporal relationship.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Very congested; Positive for COVID; Runny nose; Brain cold; Crying eyes; Sore throat; This spontaneous case was received on 02-Nov-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-05326) and concerned a 64-years-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 27-Oct-2022, the patient was vaccinated with Influenza vaccine (brand not specified; dose, route of administration, anatomical location: not reported) for prevention of influenza disease.  On 29-Oct-2022, two days after receiving influenza vaccine, the patient experienced sore throat.   On 30-Oct-2022, the patient experienced runny nose, crying eyes and what patient called brain cold.   On 01-Nov-2022, the patient took a Covid-19 test and the result was positive.   On 03-Nov-2022, the patient felt very congested, and her eyes and nose were still runny.  The outcome of the events was unknown.   The reporter did not provide a causality assessment. The patient was thinking were these side effects related to the flu vaccine and that her covid test contradicted the result.  Company comment: A 64-years-old, female patient was vaccinated with influenza vaccine. Two days after vaccination, the patient experienced sore throat. Following day, the patient experienced runny nose, crying eyes and brain coldness. The patient also felt very congested. The patient took a Covid-19 test and the result was positive. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as not related for the event Covid-19, due to biological implausibility. Although, causality for the remaining events is confounded with the reported Covid-19, cannot be completely excluded and is assessed as possibly related, with the currently available information and plausible temporal relationship.; Reporter's Comments: The patient was thinking were these side effects related to the flu vaccine and that her covid test contradicted the result.; Sender's Comments: A 64-years-old, female patient was vaccinated with influenza vaccine. Two days after vaccination, the patient experienced sore throat. Following day, the patient experienced runny nose, crying eyes and brain coldness. The patient also felt very congested. The patient took a Covid-19 test and the result was positive. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as not related for the event Covid-19, due to biological implausibility. Although, causality for the remaining events is confounded with the reported Covid-19, cannot be completely excluded and is assessed as possibly related, with the currently available information and plausible temporal relationship.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Feeling abnormal, Malaise, Nasal congestion
Clinical narrative: Feels like I have a cold; Feel run down; Nasal congestion; Feel very tired; Sore throat; Wasn't feeling well; This spontaneous case was received on 02-Nov-2022 from other non-health professional (consumer) via Med Communications (reference number: SEQW22-05313) and concerned a 62-year-old female patient.  The patient's medical history was not reported. The patient's concomitant medications included lisinopril and hydrochlorothiazide (reported as HCT), both used for unreported indication. The patient stated that she was healthy person.  On 28-Oct-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration and anatomical location: not reported) as active immunization for the prevention of influenza disease. The batch number was not reported.  On 31-Oct-2022, three days after receiving influenza vaccine, the patient felt unwell and was very tired, also developed nasal congestion, felt run down and developed sore throat. The patient also reported she felt like she had a cold. The patient took her temperature and said she didn't have a fever.  At the time of initial reporting, on 02-Nov-2022, the patient had not recovered from the events.  The reporter assessed events as related to influenza vaccine. As it was reported this was the first-time reporter ever had a reaction to o flu shot.  The case was assessed as non-serious.  Company comment: A 62-year-old patient experienced nasopharyngitis, asthenia, nasal congestion, fatigue, oropharyngeal pain, and malaise three days after receiving the suspect product influenza vaccine. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Reporter's Comments: As it was reported this was the first-time reporter ever had a reaction to o flu shot.; Sender's Comments: A 62-year-old patient experienced nasopharyngitis, asthenia, nasal congestion, fatigue, oropharyngeal pain, and malaise three days after receiving the suspect product influenza vaccine. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Feels like I have a cold; Feel run down; Nasal congestion; Feel very tired; Sore throat; Wasn't feeling well; This spontaneous case was received on 02-Nov-2022 from other non-health professional (consumer) via Med Communications (reference number: SEQW22-05313) and concerned a 62-year-old female patient.  The patient's medical history was not reported. The patient's concomitant medications included lisinopril and hydrochlorothiazide (reported as HCT), both used for unreported indication. The patient stated that she was healthy person.  On 28-Oct-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration and anatomical location: not reported) as active immunization for the prevention of influenza disease. The batch number was not reported.  On 31-Oct-2022, three days after receiving influenza vaccine, the patient felt unwell and was very tired, also developed nasal congestion, felt run down and developed sore throat. The patient also reported she felt like she had a cold. The patient took her temperature and said she didn't have a fever.  At the time of initial reporting, on 02-Nov-2022, the patient had not recovered from the events.  The reporter assessed events as related to influenza vaccine. As it was reported this was the first-time reporter ever had a reaction to o flu shot.  The case was assessed as non-serious.  Company comment: A 62-year-old patient experienced nasopharyngitis, asthenia, nasal congestion, fatigue, oropharyngeal pain, and malaise three days after receiving the suspect product influenza vaccine. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Reporter's Comments: As it was reported this was the first-time reporter ever had a reaction to o flu shot.; Sender's Comments: A 62-year-old patient experienced nasopharyngitis, asthenia, nasal congestion, fatigue, oropharyngeal pain, and malaise three days after receiving the suspect product influenza vaccine. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental overdose, No adverse event, Syringe issue
Clinical narrative: No adverse event; Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose; Likely that the patient received a higher than normal bivalent vaccine dose; This spontaneous case was reported by a nurse and describes the occurrence of SYRINGE ISSUE (Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose), ACCIDENTAL OVERDOSE (Likely that the patient received a higher than normal bivalent vaccine dose) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient 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 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced SYRINGE ISSUE (Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose) and ACCIDENTAL OVERDOSE (Likely that the patient received a higher than normal bivalent vaccine dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose), ACCIDENTAL OVERDOSE (Likely that the patient received a higher than normal bivalent vaccine dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for SYRINGE ISSUE (Vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose) and ACCIDENTAL OVERDOSE (Likely that the patient received a higher than normal bivalent vaccine dose).    Concomitant medications were not reported.  Reporter reported about her son who received his first Moderna Covid-19 bivalent vaccine and not all of the vaccine went into the patients arm. Patient did not report any other adverse reactions however when the pharmacy technician gave patient the first dose the vaccine administrator said that the syringe malfunctioned and the patient did not get his entire dose.  However, the technician consulted with the Pharmacist and gave the patient a second dose. It was likely that the patient received a higher than normal bivalent vaccine dose.  Treatment medications were not reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. The patient's concurrent conditions or medical history was not provided.  On 18-OCT-2022 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # U029319, expiration date: 19-MAR-2023),0.5 milliliter, subcutaneous in the right vastus lateralis for prophylaxis. The same day the patient was also vaccinated with improperly stored diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) and influenza vaccine. Patient also received COVID 19 vaccine on 26-SEP-2022.  Administered dose of vaccine experienced the temperature excursion of 10.8 degrees Fahrenheit (F) for 18 hours 30 minutes. There was no previous temperature excursion.  There was no adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I am Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was asking how long the side effect would last. The patient received the shingles shot in morning the day before the reporting. The patient was sick till the day of reporting. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: I am nauseated; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nausea. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shingles shot. The patient was nauseated. The patient was asking how long the side effect would last. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever; pain / exceptionally sore; incredible headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, pain and headache. On an unknown date, the outcome of the fever, pain and headache were unknown.   It was unknown if the reporter considered the fever, pain and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-NOV-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had the 2nd dose of Shingles vaccie 1 day prior to the day of reporting.  The patient was realized everyone's different, fever, pain, incredible headache and exceptionally sore. However, he or she would do it again to avoid what happened to some of the previous posters. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea
Clinical narrative: HEART ISSUE; BREATHING ISSUES; This spontaneous report received from a parent via a company representative via social media concerned a 38 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin  not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin  not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart issue and breathing issues (Dose number in series 2). It was reported as "I know what you are saying my 38 year old son now has heart and breathing issues because of the shots too that he had to get for work or could not work there. He is still dealing with this and is still having chest pains and breathing issues." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breathing issues, and heart issue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Feeling abnormal
Clinical narrative: COMPLICATIONS WITH VACCINE; LIVING A NIGHTMARE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced complications with vaccine, and living a nightmare. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from living a nightmare, and the outcome of complications with vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221144199. This report was associated with product quality complaint: 90000260003.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: experienced side effects after taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (experienced side effects after taking the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 IMMUNISATION REACTION (experienced side effects after taking the vaccine). At the time of the report, IMMUNISATION REACTION (experienced side effects after taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: pain in leg-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient daughter called a few hours after getting vaccine and stated that he was experiencing severe leg pain. NO issues in the arm but the leg pain started right after vaccine he stated
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 5 minutes after the vaccine(s) Moderna and Flu were administered, patient began to experience sweating, chills, tinnitus, and nausea. Patient never lost consciousness and was talking the entire time. Blood pressure measured 110/40 bp.  Patient mother reported he experience this before the last time he had Moderna were he lost consciousness.  Patient recovered in about 10 minutes.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Nausea, Paraesthesia, Tinnitus, Visual impairment
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 5 minutes after the vaccine(s) Moderna and Flu were administered, patient began to experience sweating, chills, tinnitus, and nausea. Patient never lost consciousness and was talking the entire time. Blood pressure measured 110/40 bp.  Patient mother reported he experience this before the last time he had Moderna were he lost consciousness.  Patient recovered in about 10 minutes.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Breast pain, Hypoaesthesia, Injected limb mobility decreased, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient came into the phamracy on 11/18/22 to complain of immense pain, shoulder injury and bruising to her left arm. Patient says she has limited range of motion and cannot use her arm as freely with pain radiating to her left breast.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint injury, Joint range of motion decreased
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient came into the phamracy on 11/18/22 to complain of immense pain, shoulder injury and bruising to her left arm. Patient says she has limited range of motion and cannot use her arm as freely with pain radiating to her left breast.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Limb injury, Pain, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient came into the phamracy on 11/18/22 to complain of immense pain, shoulder injury and bruising to her left arm. Patient says she has limited range of motion and cannot use her arm as freely with pain radiating to her left breast.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: ?pt has had fainting with vaccinations in past, last covid was ok, she fainted within 5 min of shot today, was laid flat on ground wih feet elevated, when she felt better she had oj, bp normal- first responders came and evaluated, pt didnt watnt to go to hospital--was cleared to go home --pt was called at 7 pm-said obgyn said she didnt hit her head "hard". so she is ok.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Muscle spasms, Muscular weakness, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient did not experience any pain or discomfort on injection.  After dose was administered pt felt a muscle cramp under right arm pit. After 15 min she returned to report she was experience tinging, numbness and weakness in right arm/hand.  If it persisted she was going to follow up with healthcare provider.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID positive
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Fall, Generalised tonic-clonic seizure, Oral mucosal discolouration, Pyrexia
Clinical narrative: ON 11/16/22 - HAD FEVER, TONIC CLINIC SEIZURE, PURPLE DISCOLORIZATION OF THE MOUTH. FELL ON THE GROUND, NO HEAD INJURY. DURATION 2 MINUTES NO BOWL, NO URINARY INCONTINENCE
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Device leakage
Clinical narrative: When drawing up a dose of the Shingrix vaccine, there was a vial malfunction. The medication leaked around the stopper when trying to draw up the medication into the syringe.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: After getting my 2nd Moderna covid booster, I got a headache that has not gone away. Booster received 10/14/22. Headache started on 10/20/2022. Over the counter medication such as Tylenol and Advil have not helped. Doc prescribed medication has not helped either.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001673 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *29-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  Additional information received on 27-Jul-2022 from Bavarian Nordic included local BN case ID.  This case is linked with cases no. US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via Bavarian Nordic on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 29-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis (PrEP), which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product, but to human factor. The case is non-serious.; Sender's Comments: A 29-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis (PrEP), which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product, but to human factor. The case is non-serious.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram cerebral, Aphasia, Arteriogram carotid, Computerised tomogram head
Clinical narrative: expressive aphasia , hospitalization
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Pain, Pyrexia
Clinical narrative: low grade fever, body aches, cold sores
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Tinnitus both ears.  Continuing 24/7 since September after vaccination . Wakes me In night and prevents return to sleep for hours.  Using noise continuously, TV, radio.  MD appt 11/29/22 to assess this
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given the pediatric dose .25ml of COVID 19 bivalent vaccine, not the adult dose of .50ml
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given the pediatric dose .25ml of COVID 19 bivalent vaccine, not the adult dose of .50ml
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received an Influenza vaccination 9/27/2022. She did not require the dose given 11/21/2022. No adverse reaction.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was vaccinated with 12+ Pfizer bivalent instead of Pfizer bivalent, which is the correct one for this 10 year old.