chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: Meningitis; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) was referring to a male adult patient (age: 60-64). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported  On an unknown date, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.  On an unknown date in 2017, the patient experienced Streptococcus pneumoniae meningitis. On an unknown date in 2017, Streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event Streptococcus pneumoniae meningitis was not known.  The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of Streptococcus pneumoniae meningitis was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been received from National Notifiable Diseases Surveillance System (NNDSS), regarding to a female patient with age reported as 70-74 years.  The patient's pertinent concurrent conditions, medical history, past drug reactions or allergies, and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection (strength, exact dose, route and site of administration, lot number, and expiration date were not provided), for prophylaxis.   On an unknown date in 2017, streptococcus pneumoniae serotyping was not available. On the same date, the patient developed pneumococcal bacteraemia (pneumococcal bacteraemia).   At the time of reporting, the outcome of the event was unknown.   The causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.                                                                                      Upon internal review, the event pneumococcal bacteraemia was considered as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been received from National Notifiable Diseases Surveillance System (NNDSS), regarding to a female patient with age reported as 75-79 years.  The patient's pertinent concurrent conditions, medical history, past drug reactions or allergies, and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection (strength, exact dose, route and site of administration, lot number, and expiration date were not provided), for prophylaxis.   On an unknown date in 2017, streptococcus pneumoniae serotyping was not available. On the same date, the patient developed Streptococcus pneumoniae pneumonia (pneumonia pneumococcal).   At the time of reporting, the outcome of the event was unknown.   The causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.                                                                                      Upon internal review, the event pneumococcal bacteraemia was considered as medically significant.
Age: 0.17
Sex: U
Vaccine: MMRV, PNC, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effects were reported; was inadvertently administered PROQUAD instead of ROTATEQ; that a 2 month old infant was inadvertently administered PROQUAD instead of ROTATEQ; This spontaneous report was received from a physician and refers to a 9-week-old (also reported as 2-month-old infant) patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JAN-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, 0.5 milliliter, valid lot #X012609, expiration date: 29-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) instead of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (Wrong product administered) (Product administered to patient of inappropriate age). Healthcare provider (HCP) reported that the nurse confused the vaccine schedules. On the same date, the patient also received diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and pneumococcal vaccine conj 7v (crm197) (PREVNAR), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided). No adverse effects were reported.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; MMRII was administered on 1/9/2024 but expired 1/7/2024; This spontaneous report was received from a registered nurse, referring to a 33-year-old male patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 09-JAN-2024, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot #X004343, expiration date: 07-JAN-2024 (strength, and route of administration were not provided), 0.5 milliliter, once administered as prophylaxis (expired product administered); and with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, lot # W030846, expiration date: 12-MAR-2025 (strength, and route of administration were not provided), 0.7 milliliter, once administered as prophylaxis. There was no history of temperature excursions. It was confirmed that there were no side effects. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; single dose of GARDASIL 9 that was in a not supported TE was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-JAN-2024, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (once, 0.5 milliliter, lot #W028573 was valid for formulation pre-filled syringe, expiration date: 06-JAN-2025) or  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (once, 0.5 milliliter, lot #X014788 was valid for formulation pre-filled syringe, expiration date: 07-MAR-2025) (route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Temperature excursion of -13.21 degrees Celsius (C) for 6 minutes and 44 seconds was reported. Previous temperature excursions of 8.08 C for 14 minutes and 15 seconds and 8.07 C for 29 minutes were reported. No further adverse event (AE) details available (No adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX that experienced TE was administered to a patient; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 02-NOV-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #X017489, expiration date: 25-JUN-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Excursion began on 11-OCT-2023. Temperature excursion of -10 degrees Celsius (C) to 8 C (5.2C) for 528 hours was reported. No additional adverse event (AE) reported (No adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; PEDVAX HIB that was in a not supported TE was administered to a patient; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-JAN-2024, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (once, 0.5 milliliter, lot #X003656, expiration date: 06-NOV-2025, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Temperature excursion of -13.21 degrees Celsius (C) for 6 minutes and 44 seconds was reported. Previous temperature excursions: 8.07 C for 29 minutes and 8.08 C for 14 minutes and 15 seconds. No further adverse event (AE) details available (No adverse event). No product quality complaint (PQC).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer called and report that ROTATEQ involved in a temperature excursion was administered to a patient after the excursion. Caller stated no patient symptoms have been reported. Caller also provided patient information for other patients that rece; This spontaneous report was received from a physician concerning a patient of unknown age, gender and race. The patient's concurrent conditions, medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 15-JAN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid 1 dose, lot number W036253, expiration date 17-MAY-2024 as prophylaxis (strength, exact dose, route of administration, scheme vaccine frequency not reported), which had a temperature excursion (product storage error) reported as follows: temperature 61.2 F for 7 hours, 45 minutes, 0 seconds. No previous temperature excursions were reported, nor patient's symptoms or additional adverse event.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer called and report that MMR II involved in a temperature excursion was administered to a patient after the excursion. Caller stated no patient symptoms have been reported. Caller also provided patient information for other patients that recei; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 15-JAN-2024, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # X012616, expiration date: 02-MAY-2025, therapy type stablished as rHA (strength, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 61.2 Fahrenheit (F) for 7 hours and 45 minutes (product storage error). It was reported that the patient did not report any symptom. No previous temperature excursions were reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2401USA009432: US-009507513- 2401USA008381: US-009507513- 2401USA009485: US-009507513- 2401USA008754:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP reports no symptoms or side effects for the patient; on 1/12/2024 an expired dose of MMR II was administered to a patient. HCP reports that the product has not been through any prior TEs. HCP reports no symptoms or side effects for the patient. HCP gives permission to contact.; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 12-JAN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection,  dose : 0.5 milliliter, lot # W019428, expiration date was not reported, but upon internal validation established as 07-JAN-2024, for prophylaxis (dose number, anatomical site of administration and route of administration were not reported).         The reporter mentioned that that the product had not been through any prior temperature excursions (TEs). The registered did not report symptoms or side effects for the patient.
Sex: U
Vaccine: PNC13, PNC15
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Medical assistant called to report the following AE for VAXNEUVANCE: Medical assistant states VAXNEUVANCE was inadvertently administered on 03/27/2023 in addition to Prevnar 13 which was also administered to patient on 03/27/2023.  Caller reports no; Medical assistant called to report the following AE for VAXNEUVANCE: Medical assistant states VAXNEUVANCE was inadvertently administered on 03/27/2023 in addition to Prevnar 13 which was also administered to patient on 03/27/2023.  Caller reports no; Spontaneous information has been received from a physician assistant regarding a patient of unknown age or gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not provided.   On 27-MAR-2023, the patient was inadvertently vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) for prophylaxis, with valid lot # W027250, expiration date on 09-JUL-2024 (dose, route and anatomical place was not provided). On the same date, the patient received in addition a dose of pneumococcal vaccine conj 13V (CRM197) (PREVNAR) (inappropriate schedule of vaccine administered). No side effects or symptoms reported by the patient.
Age: 1.25
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; inadvertent administration of GARDASIL 9 to a 15-month-old patient on 17JAN2024.; This spontaneous report was received from a medical assistant referring to a 15-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 17-JAN-2024, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5ml/once, strength, route of administration, lot#, and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Fatigue, Injection site pain, Pregnancy, Pregnancy test positive
Clinical narrative: Pain around the injection site; Tiredness; My Sister Had the Vaccine And Just Found Out She is Pregnant; Initial report received on 20-Nov-2023  A consumer reported that her sister, a 28-year-old pregnant female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced pain around the injection site and tiredness.  No medical history, allergies, or concomitant medications at the time of vaccination were reported.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported. Gestational age was unknown.  On 10-Nov-2023, the patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site were unknown).   On an unspecified date, the patient had side effects after the HEPLISAV-B injection such as pain around the injection site and tiredness.  On 20-Nov-2023, the patient discovered she was pregnant, as confirmed by three home pregnancy tests. The patient will follow up with her physician for blood test confirmation and evaluation.   No additional information was provided.  Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient Received a 2nd Dose a Week Too Soon; Initial report received on 05-Dec-2023  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization one week too soon.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On 07-Nov-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).  On 28-Nov-2023, 22 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (no details provided), which was one week too soon.   No additional information was available or provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received a Dose Of Heplisav-B On 06DEC2023 That Expired On 14SEP2023; Initial report received on 06-Dec-2023  A nurse reported that a 76-year-old female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history at the time of vaccination included allergies to penicillin. Concomitant mediations at the time of vaccination were not reported.   On 06-Dec-2023, the patient received the first dose of HEPLISAV-B (Lot # 937780, expiration date 14-Sep-2023, and NDC # 43528-003-05; route not reported) in the left deltoid. The HEPLISAV-B dose was expired. No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: RVX
Symptoms: Essential tremor, Tremor
Clinical narrative: exhibiting pretty severe tremor; 100.2 fever; Mild essential tremor; This non-serious case was reported by a consumer via call center representative and described the occurrence of tremor in a 78-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included urinary tract infection (recovering from UTI).   On 13-JAN-2024, the patient received RSV vaccine. On 13-JAN-2024, less than a day after receiving RSV vaccine, the patient experienced tremor (Verbatim: exhibiting pretty severe tremor), fever (Verbatim: 100.2 fever) and essential tremor (Verbatim: Mild essential tremor). The outcome of the tremor and fever were not resolved and the outcome of the essential tremor was not reported.   It was unknown if the reporter considered the tremor, fever and essential tremor to be related to RSV vaccine.     It was unknown if the company considered the tremor, fever and essential tremor to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 13-JAN-2024 The consumer reported that a 78 year old female recovered from UTI took RSV Vaccine about 4 hours ago.  The reported that the patient now exhibiting pretty severe tremor and 100.2 fever. The reported that she suffered from mild essential tremor to start with. The reporter asked is this a severe reaction requiring immediate medical care.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: had achy body and pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, reference case US2024007067).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: had achy body and pain). Rechallenge with Shingrix was positive. The outcome of the general body pain was resolved (duration 24 hrs).   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Linked case(s) involving the same patient: US2024007067   Additional Information: GSK Receipt Date: 16-JAN-2024. The patient self reported this case. The patient had achy body and pain after getting both doses of Shingrix that lasted 12-24 hours. The reporter refused to provide demographics and did not provide the time of the events.  The reporter did not recall enough regarding the events. The reporter did not consent to follow-up. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024007067:same patient / 1 st dose US-GSK-US2024007068:Same reporter US-GSK-US2024AMR009073:Same reporter US-GSK-US2024007067:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: During first dose of shingrix it was noticed that 2-3 drops of dose escaped from the base of the needle; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: During first dose of shingrix it was noticed that 2-3 drops of dose escaped from the base of the needle). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 13-JAN-2024 Reporter was the Other Health Professional. The reporter reported that during the first dose of shingrix it was noticed that 2-3 drops of dose escaped from the base of the needle while injecting. The reporter ask a questioned about can he/she take redose recommended? or just the typical 2 dose series per the norm? The reporter reported that the vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injected limb mobility decreased, Malaise, Pain in extremity
Clinical narrative: Hardly lift arm (of injected arm); the injected arm was very sore and tender; not able to get second one within six months; Did not feel good; This non-serious case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injected limb mobility decreased (Verbatim: Hardly lift arm (of injected arm)), pain in arm (Verbatim: the injected arm was very sore and tender), feeling unwell (Verbatim: Did not feel good) and incomplete course of vaccination (Verbatim: not able to get second one within six months). The outcome of the injected limb mobility decreased, pain in arm and incomplete course of vaccination were unknown and the outcome of the feeling unwell was resolved (duration 4 days).   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injected limb mobility decreased, pain in arm and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JAN-2024 The patient self-reported this case.  The patient received the first dose of Shingrix in the left arm and after that the injected arm was very sore and tender and the patient could hardly lift her arm.   The patient also stated that she did not feel good for 4 days. The patient had her first shot but was not able to get second one within six months because of having to fly out of the country for several times as her mum died.  She was not sure if she should take the second shot at this time. The reporter consented to the follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Inappropriate schedule of product administration, Nausea, Pain in extremity
Clinical narrative: arm pain/aching legs; received second dose on 21-Dec-2023 and received first dose in May 2023; low energy; tiredness; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of energy decreased in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in May 2023).   On 21-DEC-2023, the patient received the 2nd dose of Shingrix (left arm). In DEC-2023, 1 day after receiving Shingrix, the patient experienced energy decreased (Verbatim: low energy), tiredness (Verbatim: tiredness) and nausea (Verbatim: nausea). On 21-DEC-2023, the patient experienced pain in extremity (Verbatim: arm pain/aching legs) and drug dose administration interval too long (Verbatim: received second dose on 21-Dec-2023 and received first dose in May 2023). The outcome of the energy decreased, tiredness, nausea and pain in extremity were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the energy decreased, tiredness, nausea and pain in extremity to be related to Shingrix.     It was unknown if the company considered the energy decreased, tiredness, nausea and pain in extremity to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JAN-2024 The member of public reported that his wife (patient) received her second Shingrix dose and afterward (less than a day after received vaccine) she had arm pain that resolved after 2 days in Dec-2023.  About 1 to 2 days after the dose patient started experiencing aching legs, nausea, tiredness, and low energy. These symptoms were still ongoing intermittently.  The reporter also stated that the patient was on no medications.  The reporter did not have the lot number information. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. The reporter consented to follow-up.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix maladministration under age; 3 Dtaps doses and 3 IPV doses taking into account this last Kinrix shot; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included IPV (received 2 doses of IPV vaccine on unknown date) and Dtap (received 2 doses of Dtap vaccine on unknown date).   On 23-OCT-2023, the patient received Kinrix. On 23-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix maladministration under age) and inappropriate schedule of vaccine administered (Verbatim: 3 Dtaps doses and 3 IPV doses taking into account this last Kinrix shot). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 17-JAN-2024 The healthcare professional reported that a 1-year-old patient received Kinrix which led to inappropriate age at vaccine administration. The patient now had 3 Dtaps doses and 3 IPV doses taking into account this last Kinrix shot, which led to inappropriate schedule of vaccine administered.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: patient received a the ASO1B adjuvant of shingrix only inadvertently; patient received a the ASO1B adjuvant of shingrix only inadvertently; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JAN-2024, the patient received Shingrix. On 17-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received a the ASO1B adjuvant of shingrix only inadvertently) and inappropriate dose of vaccine administered (Verbatim: patient received a the ASO1B adjuvant of shingrix only inadvertently). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-JAN-2024 A nurse practitioner reported that a patient received the ASO1B adjuvant of shingrix only inadvertently, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix Reconstitution with a different diluent; patient received a dose of Shingrix that was reconstituted with a diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 4Z7K7, expiry date 16-AUG-2025) for prophylaxis.   On 15-JAN-2024, the patient received Shingrix. On 15-JAN-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix Reconstitution with a different diluent) and inappropriate dose of vaccine administered (Verbatim: patient received a dose of Shingrix that was reconstituted with a diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-JAN-2024 The reporter called to report that a patient received a dose of Shingrix that was reconstituted with a diluent other than the AS01B adjuvant suspension provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked question that if the patient had to be re-vaccinated. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: worse arm pain in the arm of administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD, expiry date 07-DEC-2024) for prophylaxis.   On 12-SEP-2023, the patient received Arexvy (unknown arm). On 12-SEP-2023, immediately after receiving Arexvy, the patient experienced pain in arm (Verbatim: worse arm pain in the arm of administration). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt date: 17-JAN-2024 A pharmacist reported that a patient received Arexvy on 12 September 2023 and ever since had progressively worse arm pain in the arm of administration.  She cannot sleep on that arm, the symptoms started almost immediately.  The reporter consented to follow up by email.
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Malaise
Clinical narrative: Patient feeling very unwell and ended in the hospital; This serious case was reported by a nurse via sales rep and described the occurrence of unwell in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Arexvy and Shingrix. On an unknown date, an unknown time after receiving Arexvy and Shingrix, the patient experienced unwell (Verbatim: Patient feeling very unwell and ended in the hospital) (serious criteria hospitalization). The outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Arexvy and Shingrix.     It was unknown if the company considered the unwell to be related to Arexvy and Shingrix.   Additional Information: GSK Receipt date: 17-JAN-2024 The patient was in her 90s. The reporter was nurse who visited the patient's house and administered Arexvy and Shingrix on same day and the following day, the patient's family called reporter to informed that the patient was feeling very unwell and ended in the hospital. This happened a few weeks ago from reporting day. No other information was provided. The reporter consented to follow-up.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received by error 2 Arexvy vaccine a month and a half apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3F729, expiry date 31-AUG-2026) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 17-JAN-2024, the patient received the 2nd dose of Arexvy. On 17-JAN-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received by error 2 Arexvy vaccine a month and a half apart). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 18-JAN-2024 The pharmacist reported that a patient received by error 2 Arexvy vaccine a month and a half apart, which led to extra dose administered. First dose of Arexvy was given on 01-DEC-2023. The reporter consented to follow up
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: an adult female patient accidentally received a dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 63-year-old female patient who received DTPa (Infanrix) for prophylaxis.   On 18-JAN-2024, the patient received Infanrix. On 18-JAN-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an adult female patient accidentally received a dose of Infanrix). The outcome of the inappropriate age at vaccine administration was 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: 18-JAN-2024 The medical assistant reported that an adult patient accidentally received a dose of Infanrix on the day of reporting, which led to an inappropriate age at vaccine administration. The lot number/expiry date was unknown at time of report. The reporter consented to follow up by email.
Sex: U
Vaccine: COVID19
Symptoms: Visual acuity reduced, Visual acuity tests
Clinical narrative: My eyesight has dramatically declined from seeing scrip and sharply and praised and clearly over a distance of +/- 800 m; This spontaneous case was reported by a patient and describes the occurrence of VISUAL ACUITY REDUCED (My eyesight has dramatically declined from seeing scrip and sharply and praised and clearly over a distance of +/- 800 m) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 011F21A, 003A21A and 015M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Non-smoker and Vegetarian (Keep a vegetarian diet, with emphasis of vegetables and fruits.) since 1997.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISUAL ACUITY REDUCED (My eyesight has dramatically declined from seeing scrip and sharply and praised and clearly over a distance of +/- 800 m). At the time of the report, VISUAL ACUITY REDUCED (My eyesight has dramatically declined from seeing scrip and sharply and praised and clearly over a distance of +/- 800 m) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, Visual acuity tests: OD- Sphere  (-2.50) cyl (-1.75) axis (105) add (+2.25)  OS- Sphere (-1.00) cyl (-1.75) axis (060) add (+2.25). On 01-Mar-2022, Visual acuity tests: OD- Sphere  (-1.50) cyl (-1.75) axis (105) add (+1.00)  OS- Sphere (PL) cyl (-1.75) axis (060) add (+1.00).         No concomitant medications were reported. During that 34- month period patient eyesight has dramatically declined from seeing crisp and sharply  and precisely and clearly over a distance of +/-800m.It was reported that patient's eye doctors were baffled as well and it's not about the age. No one in the family neither the parents nor anyone of 7 siblings (patient was the 2nd youngest) experienced anything even remotely like what the patient experiencing with eyesight. Patient does not consume alcohol and not taking any other OTC medications other than eye drops. Patient was fit, healthy and strong, not had a covid. Patient rarely get ill, occasionally a sniffle. The decline in eyesight was frightening very much. The connection between the moderna Sars cov-2 vaccine can no longer be denied. Patient do not take any medicines other than eye drops.   This case was linked to MOD-2024-757612, MOD-2024-757604 (Patient Link).
Age: 69.0
Sex: U
Vaccine: COVID19-2
Symptoms: Visual acuity reduced
Clinical narrative: Patient eyesight had dramatically declined from seeing scrip and sharply and praised and clearly over a distance of +/- 800 m; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL ACUITY REDUCED (Patient eyesight had dramatically declined from seeing scrip and sharply and praised and clearly over a distance of +/- 800 m) in a 69-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-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 11-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VISUAL ACUITY REDUCED (Patient eyesight had dramatically declined from seeing scrip and sharply and praised and clearly over a distance of +/- 800 m). At the time of the report, VISUAL ACUITY REDUCED (Patient eyesight had dramatically declined from seeing scrip and sharply and praised and clearly over a distance of +/- 800 m) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was reported.  The patient received 1st dose of Moderna vaccine on 07-FEB-2021 and batch/lot number was 015M20A. The patient received 2nd dose of Moderna vaccine on 07-MAR-2021 and batch/lot number was 003A21A. The patient received other doses of Moderna vaccines on 05-NOV-2021, 13-APR-2022 and batch/lot number were 011F21A and 084J21A respectively. The patient received last dose of Moderna vaccine on 12-DEC-2023 and batch/lot number was 8059072l.  Patient did not smoke, alcohol and did not take any medications other than eye drops.  Patient had a vegetarian diet with emphasis on vegetable and frits since 1997.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-757612, US-MODERNATX, INC.-MOD-2024-757333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757612:2023-2024 dose US-MODERNATX, INC.-MOD-2024-757333:Monovalent dose
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid/had aching bones, congestion and coughing and couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid/had aching bones, congestion and coughing and couldn't sleep) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 4), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer, Pfizer and Pfizer.    On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for covid/had aching bones, congestion and coughing and couldn't sleep). At the time of the report, COVID-19 (tested positive for covid/had aching bones, congestion and coughing and couldn't sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant medication information was reported.  Patient took the Moderna vaccine on Sunday and got sick with it, had aching bones, congestion and coughing and could not sleep.  Patient had taken Pfizer vaccines previously but had no problem with them, but the patient knew people who did got really sick after taking them. Patient was prescribed Paxlovid and wanted to know if taking Paxlovid would prevent the Moderna vaccine from working or not.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild fever (100.4 to 101.2 °F); Joint pain and no interference with activity; Mild muscle pain and no interference with activity; Mild fatigue and no interference with activity; Mild injection site redness; Mild injection site swelling; Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In January 2024, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)), ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2024, Body temperature: 100.4 to 101.2 °F.         AutoCruitment Subject ID was reported.  RTI-HS Subject ID was reported.  Concomitant medication was not provided.  Patient experienced reported events anytime during the 2 days after COVID-19 vaccination, which occurred on Jan 13, 2024 and Jan 14, 2024. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-757659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757659:Same reporter