chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Enterovirus test, Epstein-Barr virus test, Fibrin D dimer, Full blood count
Clinical narrative: Admitted to Hospital on 6/15/2023 for acute idiopathic pericarditis and pericardial effusion
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: HIV antibody, HIV antigen, Hepatitis C antibody, Influenza A virus test, Influenza B virus test
Clinical narrative: Admitted to Hospital on 6/15/2023 for acute idiopathic pericarditis and pericardial effusion
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: International normalised ratio, Laboratory test, Legionella test, Metabolic function test, N-terminal prohormone brain natriuretic peptide
Clinical narrative: Admitted to Hospital on 6/15/2023 for acute idiopathic pericarditis and pericardial effusion
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pericardial effusion, Pericarditis, Procalcitonin, Red blood cell sedimentation rate, Respiratory pathogen panel
Clinical narrative: Admitted to Hospital on 6/15/2023 for acute idiopathic pericarditis and pericardial effusion
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Reticulocyte count, SARS-CoV-2 test, Scan with contrast, Serum ferritin, Thyroxine free
Clinical narrative: Admitted to Hospital on 6/15/2023 for acute idiopathic pericarditis and pericardial effusion
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Troponin I, Urine analysis
Clinical narrative: Admitted to Hospital on 6/15/2023 for acute idiopathic pericarditis and pericardial effusion
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoglycaemia, Obstructive sleep apnoea syndrome, Type 2 diabetes mellitus
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/19/2023 DM 2 W HYPOGLYCEMIA
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery disease, Pulmonary embolism
Clinical narrative: I26.92 SADDLE PULMONARY EMBOLISM 3/31/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt light headedness and slightly fainted after 15 minutes receiving vaccine
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Aortic aneurysm
Clinical narrative: ACUTE NON ST ELEVATION MI 4/7/2023 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 4/7/2023 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: MMR and separate varicella vaccinations were the appropriate ordered vaccinations for the patient at 12 mo of age.  Nurse accidentally drew up MMRV vaccination and also gave the separate varicella vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Gestational diabetes, Hypersensitivity
Clinical narrative: T78.3XXD ANGIOEDEMA, SUBSEQ 3/2/2023 GESTATIONAL DM, DIET CONTROLLED T78.40XA ALLERGIC REACTION, INIT 2/28/2023 GESTATIONAL DM, DIET CONTROLLED
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse effects
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Asthma
Clinical narrative: ACUTE NON ST ELEVATION MI 3/24/2023 ASTHMA, UNSPECIFIED
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Balance disorder, Dizziness, Headache, Laboratory test
Clinical narrative: lymphodema, swelling, pain, arthralgia, headaches, dizziness, stiffness, tenderness, neck pain, balance disorder, right side of body issues
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Lymphoedema, Magnetic resonance imaging, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: lymphodema, swelling, pain, arthralgia, headaches, dizziness, stiffness, tenderness, neck pain, balance disorder, right side of body issues
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Swelling, Tenderness
Clinical narrative: lymphodema, swelling, pain, arthralgia, headaches, dizziness, stiffness, tenderness, neck pain, balance disorder, right side of body issues
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side effects reported.; Patient inadvertently received a third dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.  On 16-JUN-2023, the patient was inadvertently vaccinated with his third dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, at a dose of 0.5 milliliter, intramuscularly as regular immunisation (extra dose administered) (anatomical location, lot # and expiration date were not reported). The vaccine was reconstituted with a sterile diluent. The patient also received first doses of a vaccine, inactivated(VAQTA) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) at the appointment.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administration of VARIVAX that experienced a temperature excursion; This spontaneous report was received from a office manager referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # W025274, expiration date 10-AUG-2024 at  0.5 milliliter once for prophylaxis (route was not reported) that experienced a temperature excursion. Confirmed with reporter that no symptomatic adverse effects were reported. The temperature was -13.2 Celsius degrees. The time frame was 0 hours 58 minutes 0 seconds (total)  and there was a previous temperature excursion. The call was not because of a "data logger".
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; Received GARDASIL 9 in alternate dosing schedule; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant medications were not reported.   On 18-JAN-2021 and 30-JUL-2021, the patient was vaccinated with the first and second doses, respectively, of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, as prophylaxis (routes of administration and injection anatomical locations were not reported). On 20-MAY-2023, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, as prophylaxis (route of administration and injection anatomical location were not reported) (lot numbers 1687290, T028583, W001498 [the specific dates of administration of each were unknown] were verified to be valid, expiration dates reported and confirmed as 06-SEP-2022, 04-MAR-2023, and 15-SEP-2024, respectively). It was stated that the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in alternate dosing schedule (Inappropriate schedule of product administration). No additional adverse events or product quality complaints were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; HCP reported that a patient was administered an improperly stored vaccine; This spontaneous report was received from Other Health Professional 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-JUL-2023 (conflicting information, year of administration reported as 2024), the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)(Product storage error) injection (lot #W015900, has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with an expiration date of 20-OCT-2023), administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event was reported.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; GARDASIL 9 that were improperly stored and inadvertently administered; This spontaneous report was received from a nurse and refers to a 13-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JUN-2023, the patient was vaccinated with improperly stored (Product storage error) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, formulation, lot #, expiration date, site and route of administration were not provided) for prophylaxis. Temperature excursion details: above 47 degrees Fahrenheit (48.6 degrees Fahrenheit) for 16 hours 30 minutes; below 36 degrees Fahrenheit (28.0 degrees Fahrenheit) for 22 hours; cumulative: 38 hours 30 minutes; no previous temperature excursion. No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA008888:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; HCP calling to report an AE regarding VARIVAX. HCP calling to report that a patient was administered a improperly stored vaccine. Permission to contact HCP was provided. Case 02428709 filed. AE cases 02428861, 02428862, 02428865, 02428779, 024288; This spontaneous report was received from an other health care professional refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-JUN-2023, the patient was vaccinated with dose of improper storage varicella virus vaccine live (oka/merck)(VARIVAX) lot #W031810, expiration date: 05-OCT-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.     Administered dose of vaccine experienced the temperature excursion (product storage error). There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Inbound call from CMA who reports improperly stored MMR II was administered to 2 patients.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT).   On 15-JUL-2023,  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHa) (M-M-R II) underwent temperature excursion for 30 hours in above 14 degree Celsius (9C) (Product storage error). On 17-JUL-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHa) (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: huge welt on her arm that is hot and itchy; This spontaneous report was received from Consumer and refers to a 19-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-JUL-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 14-JUL-2023, the patient experienced huge welt on her arm that is hot and itchy. No treatment was given for huge welt on her arm that is hot and itchy. No additional details were given. At the time of reporting, the patient had not recovered from the event of huge welt on her arm that is hot and itchy. The action taken with VARIVAX regarding huge welt on her arm that is hot and itchy was reported as Not Applicable.   The causal relationship between huge welt on her arm that is hot and itchy and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: First Dose of Heplisav-B 4 Weeks Ago, 2nd Dose Engerix; Initial Report Received on 09-May-2023  A pharmacist reported that a 20-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.   Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On 07-Apr-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941055; expiration date 29-Nov-2024, NDC # 43528-003-05) in the left arm.   On 08-May-2023, 32 days after having been vaccinated with HEPLISAV-B, the patient was given Engerix B (no details available) in the left arm as the second dose. No adverse reactions were reported by the patient.  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: U
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Exposure during pregnancy
Clinical narrative: Elevated ALT Levels; Pregnancy; Initial Report Received on 10-May-2023  A pregnant female patient (age, race, and ethnicity not provided), spontaneously reported to the HEPLISAV-B pregnancy registry that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 30-weeks pregnant and developed elevated ALT levels.  No relevant medical history or concomitant medications were reported.   The last menstrual period date, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  On an unspecified date, when the patient was 30-weeks pregnant, she received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported) from her health care provider (HCP). The patient stated that the HCP did not read the package insert, which advised that this vaccine was not recommended in pregnancy. At the time of reporting, the patient was 35-weeks pregnant, and her ALT levels were elevated.  The patient was offered the option to enroll in the pregnancy registry, which she declined.   No contact information or 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: Exposure during pregnancy
Clinical narrative: Received Heplisav-B While Pregnant; Initial Report Received on 15-May-2023  A registered pharmacist reported that pregnant female patient (age, race, and ethnicity unknown) was given a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Medical history, allergies, and concomitant medications at the time of vaccination were not reported. The last menstrual period date estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  On 12-May-2023, the pregnant patient (gestation age unknown) received a dose of HEPLISAV-B vaccine (Lot # 941580, expiration date 06-Jan-2025, and NDC # 43528-003-05; route and injection site not 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: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion; Initial Report Received on 16-May-2023  A registered pharmacist reported that a 50-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the refrigerator had multiple power outages.  Medical history, allergies, and medications at the time of vaccination were not reported.   On 15-May-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941591, expiration date 31-Aug-2025, and NDC # 43528-003-05) intramuscularly in the left arm. The injection was given after the refrigerator had multiple power outages. No adverse side effects were reported.  No further 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: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Heplisav-B Administered to 5 month old; Initial Report Received on 17-May-2023  A registered pharmacist reported that a 5-month-old patient (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history, allergies, and medications at the time of vaccination were not reported.   On 17-May-2023, a 5-month-old patient received a dose of HEPLISAV-B vaccine (Lot # 939305, expiration date 29-Mar-2024, and NDC # 43528-003-05) intramuscularly in the leg (unknown if right or left) by a nurse. No adverse side effects were reported at the time of reporting.  No further 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: VARZOS
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Swelling arm; Diffuse redness surrounding the injection site; This non-serious case was reported by a other health professional and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 95252, expiry date 18-JUN-2024) for prophylaxis.   On 11-JUL-2023, the patient received Shingrix (intramuscular). On 12-JUL-2023, 1 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling arm). In JUL-2023, the patient experienced injection site erythema (Verbatim: Diffuse redness surrounding the injection site). The patient was treated with paracetamol (Apap) and benadryl (nos) (Benadryl). The outcome of the injection site erythema was not reported and the outcome of the swelling arm was not resolved.   It was unknown if the reporter considered the injection site erythema and swelling arm to be related to Shingrix.     It was unknown if the company considered the injection site erythema and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUL-2023 Patient was treated with APAP and Benadryl for swelling arm. On 13th July 2023, the outcome of event swelling arm was not reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Nausea; high fever 101f.; Pain throughout body; 48 year's old patient received shingles vaccine; This non-serious case was reported by a consumer and described the occurrence of nausea in a 48-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 3N743, expiry date 20-AUG-2024) for prophylaxis.   On 14-JUL-2023, the patient received Shingles vaccine. On 14-JUL-2023, less than a day after receiving Shingles vaccine, the patient experienced nausea (Verbatim: Nausea), fever (Verbatim: high fever 101f.), general body pain (Verbatim: Pain throughout body) and inappropriate age at vaccine administration (Verbatim: 48 year's old patient received shingles vaccine). The outcome of the nausea, fever and general body pain were not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the nausea, fever and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the nausea, fever and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 15-JUL-2023 The patient self-reported this case. The symptoms were not treated. On 15 July 2023 the outcome of events was reported as not recovered. The reporter consent to follow up by email. The patient received Shingles vaccine before recommended age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This shot hurts more than any vaccination ever; Arm is red; Arm is red and hit and swollen; Short burned going in; Arm is red and hit and swollen; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: This shot hurts more than any vaccination ever), erythema (Verbatim: Arm is red), swelling arm (Verbatim: Arm is red and hit and swollen), burning sensation (Verbatim: Short burned going in) and pain in arm (Verbatim: Arm is red and hit and swollen). The outcome of the pain, erythema, swelling arm, burning sensation and pain in arm were not reported.   It was unknown if the reporter considered the pain, erythema, swelling arm, burning sensation and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain, erythema, swelling arm, burning sensation and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 10-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she got second dose of Shingles vaccine, and the vaccine hurts the patient more than any vaccination ever. The reporter reported that the arm was red and hit and swollen, shot burned going in. The reporter said it was not fun, but it if he or she did not get this horrid thing judging from everyone's description. The follow-up could not be possible as the as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: A lot of fatigue; Three days of pain in the place of the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Three days of pain in the place of the vaccine) and fatigue (Verbatim: A lot of fatigue). The outcome of the injection site pain was resolved (duration 3 days) and the outcome of the fatigue was resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain and fatigue to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Jul-2023 This case was reported the patient via interactive digital media. The patient just got 2nd vaccine and had three days of pain at the injection site and lots of fatigue but it was over now (in recent time). And based on the experience, the patient stated it was worth getting the vaccine, supposedly it protects you for approximately 5 years. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: TTOX, VARZOS
Symptoms: Arthralgia, Bone pain, Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Lot of bone pain my toes; Hand hurt/ Pain in finger; Bone came out a little from a joint of my finger; Struggle to raise my arms up; My toes fell asleep/still fall asleep; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bone pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 1st dose of TETANUS VACCINE. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced bone pain (Verbatim: Lot of bone pain my toes), pain in hand (Verbatim: Hand hurt/ Pain in finger), pain in joint involving hand (Verbatim: Bone came out a little from a joint of my finger), mobility decreased (Verbatim: Struggle to raise my arms up) and numbness in toes (Verbatim: My toes fell asleep/still fall asleep). The outcome of the bone pain, pain in hand and pain in joint involving hand were not reported and the outcome of the mobility decreased and numbness in toes were not resolved.   It was unknown if the reporter considered the bone pain, pain in hand, pain in joint involving hand, mobility decreased and numbness in toes to be related to Shingles vaccine.     It was unknown if the company considered the bone pain, pain in hand, pain in joint involving hand, mobility decreased and numbness in toes to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that young man asked him or her if he or she already got the tetanus vaccine and the reporter said no and asked about the shingles. The reporter told him if he or she had 1 and told reporter it was time to put the second one to good but reporter asked him q to put both to the same day. Reporter asked question that would he or she had side effects and he said no, nothing would happen, but at night of vaccination day reporter got a lot of bone pain in his or her toes fell asleep and reporter still fall asleep and that same day his or her hands hurt and it came out a little bone of a joint of his or her finger and since then reporter struggle to raise his or her arms up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Fatigue; Chills; Body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of covid-19 (received first dose about 2 years ago, refer case US2023098138).   On 16-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 17-JUL-2023, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue), chills (Verbatim: Chills) and general body pain (Verbatim: Body aches). The outcome of the fatigue, chills and general body pain were not resolved.   It was unknown if the reporter considered the fatigue, chills and general body pain to be related to Shingrix.     It was unknown if the company considered the fatigue, chills and general body pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023098138   Additional Information: GSK Receipt Date: 17-JUL-2023 The reporter was the patient.  The patient did not receive the second dose within six months because she did not know she needed a second dose and because she developed COVID. The patient received second dose of Shingrix, and she had chills, fatigue and body aches. Nothing else was reported. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023098138:Same reporter, different dose
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: CYW-135 vial and not the lyophilized vial; CYW-135 vial and not the lyophilized vial; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 20-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date MAR-2024) for prophylaxis.   On 06-JUN-2023, the patient received Menveo. On 06-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: CYW-135 vial and not the lyophilized vial) and inappropriate dose of vaccine administered (Verbatim: CYW-135 vial and not the lyophilized vial). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 18-Jul-2023 The reporter reported that the clinic would like information on how to proceed with the patient. The reporter consented to follow-up. The patient was given only the Men CYW-135 vial and not the lyophilized vial of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was asked to come back in one week instead of 1 month; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 18-JUL-2023, the patient received the 2nd dose of Bexsero. On 18-JUL-2023, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Patient was asked to come back in one week instead of 1 month). The outcome of the drug dose administration interval too short 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-Jul-2023 The patient was asked to come back in one week instead of 1 month and staff did not realized until after patient was vaccinated. The reporter did not consent to follow-up. The patient received 2nd dose of Bexsero earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: M
Vaccine: MENB
Symptoms: Fear, Gait disturbance, Head discomfort, Headache, Photosensitivity reaction
Clinical narrative: pressure in head causes pain; light sensitivity; pressure in head causes pain; issues walking; usual tactics at play here using fear; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced headache (Verbatim: pressure in head causes pain), photosensitivity (Verbatim: light sensitivity), head pressure (Verbatim: pressure in head causes pain), walking difficulty (Verbatim: issues walking) and fear (Verbatim: usual tactics at play here using fear). The outcome of the headache, photosensitivity, head pressure, walking difficulty and fear were not reported.   The reporter considered the headache, photosensitivity, head pressure, walking difficulty and fear to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the headache, photosensitivity, head pressure, walking difficulty and fear to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Jul-2023 The case was received from the patient's parent via interactive digital media. The reporter stated that ridiculous big pharma push.  The patient developed so many complications from this exact vax. The patient usual tactics at play using fear. This would be a huge unfollow from the reporter and please wake up and research what was exactly in the vaccines. Seriously, then, please look at the number of shots children these days receive and compare it to the autism, food allergy and cancer cases. The reporter bet that they would not be pushing this anymore or wait- might be for the right amount of money they will. The follow-up could not be possible as no contact details were available.
Age: 55.0
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Bedridden, Chills, Pyrexia
Clinical narrative: Upset stomach/ Cannot hold down liquids or any food; Fever; Shivering; she is in bed for 48-72 hours; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 77J90, expiry date 15-OCT-2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 3R4ST, expiry date 17-SEP-2022) for prophylaxis and ELASOMERAN (MODERNA COVID VACCINE) for prophylaxis.   On 03-MAY-2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18-FEB-2021, the patient received the 1st dose of Shingrix (intramuscular). On 15-JUN-2021, the patient received MODERNA COVID VACCINE. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced upset stomach (Verbatim: Upset stomach/ Cannot hold down liquids or any food), fever (Verbatim: Fever), shivering (Verbatim: Shivering) and bedridden (Verbatim: she is in bed for 48-72 hours). The outcome of the upset stomach, fever and shivering were not resolved and the outcome of the bedridden was resolved.   It was unknown if the reporter considered the upset stomach, fever, shivering and bedridden to be related to Shingrix and Shingrix.     It was unknown if the company considered the upset stomach, fever, shivering and bedridden to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 10-Jul-2023 The patient had her 1st and 2nd dose of Shingrix and ever since then, she had been having shivering, fever, upset stomach that was so bad she was in bed for 48 to 72 hours, and she could not hold down liquids or any foods. The patient was not able to provide when these adverse events started after receiving the Shingrix vaccines but reported that she used to have these side effects every 4 to 6 months, and now in recent time she was having these side effects every month. The patient also reported that she received her Moderna Covid vaccines on 15-JUN-2021. The pharmacist would call back if she could obtain other information. Neither the patient nor the pharmacy had the location of the administration available for either dose of Shingrix. It was unknown if the reporter considered the upset stomach, fever, shivering and bedridden to be related to Moderna Covid vaccines. The reporter consented to follow up with the pharmacy via pharmacist.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: An adolescent patient was inadvertently administered an 1 mL Adult Havrix dose in the Right deltoid; An adolescent patient was inadvertently administered an 1 mL Adult Havrix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 16-year-old female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 11-JUL-2023, the patient received Havrix adult (right deltoid) 1 ml. On 11-JUL-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: An adolescent patient was inadvertently administered an 1 mL Adult Havrix dose in the Right deltoid) and inappropriate age at vaccine administration (Verbatim: An adolescent patient was inadvertently administered an 1 mL Adult Havrix dose). The outcome of the accidental overdose and inappropriate age at vaccine administration 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: 12-JUL-2023 The reporter called to inquired that would they still required a second vaccine of Havrix and how to proceed with series. The reporter also asked that any reaction from getting the higher dose and what to look for. The reporter reported that an adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of 0.5 Ml dose, which lead to overdose and inappropriate age at vaccine administration. The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 06th January 2023) and Shingrix (2nd dose received on 08th April 2023).   On 10-JUL-2023, the patient received the 3rd dose of Shingrix. On 10-JUL-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received 3rd dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 10-JUL-2023 The pharmacist stated that a patient went to the pharmacy to receive a second dose of Shingrix after receiving first dose on 06th January 2023. Vaccination was completed on 10th July 2023. When pharmacist submitted information to the insure found that patient in fact received the second dose of Shingrix on 08th April 2023 in a different pharmacy.  Pharmacist contacted to confirm that.  Patient stated that she did not recall getting that second dose, resulting in getting an extra dose of Shingrix which led to extra dose administered. According to pharmacist the patient is doing fine, no side effects reported.  The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Inadvertently administered Bexsero instead of an unknown brand of hepatitis B vaccine; wrong age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Inadvertently administered Bexsero instead of an unknown brand of hepatitis B vaccine) and inappropriate age at vaccine administration (Verbatim: wrong age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 12-JUL-2023 The reporter reported that the patient was inadvertently administered Bexsero instead of an unknown brand of hepatitis B vaccine, which lead to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on her entire chest area and stomach; This non-serious case was reported by a physician via sales rep and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced rash (Verbatim: Rash on her entire chest area and stomach). The outcome of the rash was resolved (duration 45 days).   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUL-2023 The reporter reported that the patient came in office 2 week after receiving Shingrix vaccine. The reporter reported that rash went away in 45 days The reporter reported that after vaccination patient had a rash on her entire chest area and stomach. No other information was available. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: received only the adjuvant of shingrix; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number J2Y4L, expiry date 18-AUG-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant of shingrix) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-Jul-2023 A nurse reported that a patient received only the adjuvant of shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Accidental underdose
Clinical narrative: inadvertently administered only half dose of Kinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced accidental underdose (Verbatim: inadvertently administered only half dose of Kinrix). The outcome of the accidental underdose 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: 14-JUL-2023 The reporter reported that a patient over 4 years of age was inadvertently administered only half dose of Kinrix which led to accidental underdose. The pharmacist inquired that how to proceed with the Kinrix dose and series and if there was need to give the other half or a full dose. The reporter stated this would have been the patient's final dose of Polio. The reporter was unable to provide vaccine and patient details. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix in 2019 and a second dose in 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 529KK, expiry date 30-SEP-2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On 21-APR-2023, the patient received the 2nd dose of Shingrix. On 21-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in 2019 and a second dose in 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 17-JUL-2023 A healthcare professional reported that a patient received a first dose of Shingrix in 2019 and a second dose in 2023. They provided limited information about the vaccine, patient and event. They did consent to follow up, leaving a phone number which was documented in the adverse event case. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: patient "lost a little bit of balance" after receiving the first shingrix dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of loss of balance in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included parkinson's disease.   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 loss of balance (Verbatim: patient "lost a little bit of balance" after receiving the first shingrix dose). The outcome of the loss of balance was unknown.   It was unknown if the reporter considered the loss of balance to be related to Shingrix.     It was unknown if the company considered the loss of balance to be related to Shingrix.   Additional Information: GSK receipt date: 17-Jul-2023 Pharmacy technician reported that a patient lost a little bit of balance after receiving the 1st dose of Shingrix. No further information reported by the pharmacy technician to the agent. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: Loss of balance; This non-serious case was reported by a other health professional via call center representative and described the occurrence of loss of balance in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included parkinson's disease.   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 loss of balance (Verbatim: Loss of balance). The outcome of the loss of balance was not reported.   It was unknown if the reporter considered the loss of balance to be related to Shingrix.     It was unknown if the company considered the loss of balance to be related to Shingrix.   Additional Information: GSK receipt date: 17-JUL-2023 A pharmacy asked for information regarding the use of Shingrix in patients suffering from Parkinson´s disease. The Healthcare professional mentioned that after receiving the first dose of Shingrix a patient with Parkinson´s disease reported loss of balance. The Healthcare professional said that loss of balance could happen because of the normal progression of Parkinson's, but he wanted to verify if there was information regarding Shingrix in patients with Parkinson's disease. The Healthcare professional declined to share patient information since he said loss of balance could not be an adverse event but a normal symptom of the progression of Parkinson´s disease.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received only the Shingrix adjuvant; patient received only the Shingrix adjuvant; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number 934H5, expiry date 31-JUL-2024) for prophylaxis.   On 17-JUL-2023, the patient received Shingrix. On 17-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the Shingrix adjuvant) and inappropriate dose of vaccine administered (Verbatim: patient received only the Shingrix adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17 Jul 2023 A nurse reported that a patient received only the Shingrix adjuvant which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up by email.