chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Somnolence, Vaccination complication
Clinical narrative: On 7/31/21 around 8pm that evening, I had a spontaneous bloody nose. The worst one I have ever had in my life. It took a whole roll of toilet paper to shove in my nose, apply pressure and stop the bleed. It was bleeding so bad, I couldn't keep up with the flow and thus got blood all over my new leather chair. When it was done after about 45 minutes, it looked like a murder scene that I had to clean up.  On 8/3/21 around 8am, I woke up in the morning with an extremely painful back spasm. I immediately laid on a heating/massaging pad and took 2 Advil for 3 hours. When I tried to move the pain was still there. I took more Advil and continued the heating/massage pad. I fell asleep until 4pm. My back was still in tremendous pain. It was my my lower back, just to the left of my spine. At this time, I took 250mg of Soma and rested more on the heating/massage pad. Around 8pm, I tried to get up and walk a little. the Soma (muscle relaxant worked on the paid about 50% bringing the pain level down from a 9 to about a 6. I took another Soma and got back on the heating/massage pad. Around 10pm, I took another 250mg Soma as my back was still spasming and still in pain.  Needless to say, I couldn't go to work today, it was too painful to move. I was unable to eat because the pain was too much. I was able to drink a small amount of cold water. I have never had any back pain, problems or spasms in my entire life. This pain was highly unusual and very scary. I have determined by talking with other health care professionals that my nose bleed and back spasms were directly related to the 1st dose of the Covid vaccine, Moderna that was administered on 7.30.21.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Shaking fever sweats chills bad headache. 26 weeks pregnant due date 11/12/21
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking fever sweats chills bad headache. 26 weeks pregnant due date 11/12/21
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort, Headache, Pain
Clinical narrative: Headaches; General body ache; Sensation of pressure in the head; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 06May2021 at 08:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included clarithromycin (CLARITIN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01G2) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 22:00 the patient experienced headaches, general body ache, sensation of pressure in the head and weakness. Therapeutic measures were taken as a result of the events headaches, general body ache, sensation of pressure in the head and weakness included treatment with tylenol MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events headaches, general body ache, sensation of pressure in the head and weakness was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Macular scar, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Raised itchy, rash first noticed in the right pectoral region extending from the sub clavicular area to the upper medial shoulder.; Raised itchy, rash first noticed in the right pectoral region extending from the sub clavicular area to the upper medial shoulder.; Rash was characterized by several (1-3) erythematous, macular lesions with progression to flat dark flesh colored scars over the next week or so.; Rash was characterized by several (1-3) erythematous, macular lesions with progression to flat dark flesh colored scars over the next week or so.; This is a spontaneous report from a contactable healthcare professional, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 20Apr2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 30Mar2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 06:00, the patient developed raised itchy rash which was first noticed in the right pectoral region extending from the sub clavicular area to the upper medial shoulder. Rash developed within 12 hours from injection, at a distance from the injection site (Deltoid). Rash was characterized by several (1-3) erythematous, macular lesions with progression to flat dark flesh colored "scars" over the next week or so. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events raised rash, itchy rash, rash erythematous and macular scar were recovered with sequelae on an unknown date in May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No PQC or additional AEs reported.; Caller reported expired dose of PNEUMOVAX 23 was administered.; This spontaneous report has been received from a registered nurse and refers to patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 15-JUL-2021, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliters (mL), administered intramuscularly (IM) (dose number, vaccination scheme frequency, and anatomical site of administration were not provided; lot number S029916, has been verified to be a valid lot number, with an expiration date reported and verified as 12-JUN-2021) as prophylaxis (expired product administered). No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE was reported; The patient received the third dose inadvertently on 6/18/2021.; This spontaneous report was received from a nurse referring to a 15 years old male patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 31-JUL-2017, the patient was vaccinated with the initial dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter; strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. 25-JUL-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter; strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.          On 18-JUN-2021, the patient was vaccinated inadvertently with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter; strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (incorrect dose administered). Agent entered quantity filed as 1 for the additional dose only. No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No other AE; MMRll did experience a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      Between 29-JUN-2021 and 30-JUN-2021, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number S039310, expiration date 04-DEC-2021 had a temperature excursion of 72 degrees Farhrenheit (°F) for 17 hours and 15 minutes, and was administered on 06-JUL-2021 (dosage regimen and route of administration were not reported) for prophylaxis (Product storage error). No adverse events were reported.; Sender's Comments:  US-009507513-2107USA007742:
Age: 0.58
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No other information provided; Pediatric patient was inadvertently given PUENMOA VX 23 the patient was 7 months of age; This spontaneous report was received from a medical assistant, referring to a 7-month-old pediatric patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 23-JUL-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration were not provided) for prophylaxis (product administered to patient of inappropriate age). No other information provided.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: "extreme pain", itching, and warmth in the arm that she received the vaccination; warmth in the arm that she received the vaccination.; "extreme pain", itching, and warmth in the arm that she received the vaccination; Fatigue; This spontaneous report as received from a medical assistant and refers to a 60-year-old non-pregnant female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. She was allergic to metoclopramide and non-steroidal anti-inflammatory drugs (NSAIDs).   On 21-JUL-2021 in the morning, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T036820 was confirmed to be valid, expiration date 01-JUL-2022, 0.5 milliliter, intramuscularly (anatomical location was not reported) as routine immunization.    On the same date, in the evening, the patient experienced extreme pain, itching, and warmth in the arm that she received the vaccination. The patient stated that "intense pain and warmness" continued into the next day, 22-JUL-2021. She also reached out to her health care practitioner (HCP) for guidance (sought medical attention), but the reporter was unsure if any treatment was provided to the patient. The events were not cancer and the patient did not overdose. The outcome of the events was unknown.  The causality assessment between the events and the suspect vaccine was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T036820; expirationdate: 01-JUL-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No symptoms reported; expired dose of M-M-R II was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 26-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, intramuscular, lot number S020962, expiration date 07-JUL-2021, for prophylaxis. No adverse events of symptoms were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no additional AE reported; dose of MMR II expired on 22-JUL-2021 was administered on 23-JUL-2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 23-JUL-2021, the patient was vaccinated with an expired dose of recombinant Human albumin (rHA) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml, lot # S022753, expiration date 22-JUL-2021 (route of administration was not provided) for prophylaxis. The vaccine never had a temperature excursion. No additional AE was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: The patient suffered herpes zoster; The patient suffered post herpetic neuralgia; Information has been received from a lawyer, the patient and the patient's spouse and refers to patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After received zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered herpes zoster and post herpetic neuralgia. As a result of these symptoms, Plaintiff was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine Plaintiff's symptoms have resulted in physical limitations not presented prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the patient had not recovered from the events. Herpes zoster and post herpetic neuralgia were considered to be related to zoster vaccine live (ZOSTAVAX). Herpes zoster and post herpetic neuralgia were considered to be Disability events.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; incorrect product storage; This spontaneous report was received from an officer manager concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 22-JUL-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379, expiration date 31-MAY-2022) at a dose of 0.5 milliliter for prophylaxis (strength, route, anatomical site and vaccination schedule were not provided), which ha a temperature excursion of 46.8°F for 9 hours which was detected by a data logger. The vaccine had no previous temperature excursion and no adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Contusion, Discomfort, Injection site discolouration, Injection site pain
Clinical narrative: bruising; discomfort; Darkening of skin around injection area; tenderness in shoulder; tenderness at injection site; This spontaneous report was received from a consumer referring to him/herself, a 51-year-old patient of unknown genre with hiv infection. The patient's medical history was not provided and had no drug allergies and concomitant medications.  On 20-JUL-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), at a dose of 0.5 milliliter, intramuscular for pneumococcal disease prophylaxis (strength, anatomical site, vaccination schedule, lot# and expiration date were not provided).  On the same date, the patient experienced bruising (contusion), discomfort, darkening of skin around injection area (vaccination site discolouration) and tenderness in shoulder and injection site (arthralgia and vaccination site pain). No treatment was given for the reported events.  The reporter stated that he/she recovered from discomfort, vaccination site pain and arthralgia on 22-JUL-2021 (reported as within two days); in addition, It was reported that skin around injection site continues to remain dark (contusion and vaccination site discolouration) which was reported as recovering.  The causality assessment between the occurrence of the events and the suspect vaccine administration was not provided.  The reporter considered that the reported events were not life threatening or disabling.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Seizure
Clinical narrative: seizure; fever; her daughter may have known allergies to that could be present to the administered vaccine; This spontaneous report was received from a consumer who was also the patient's mother, concerning a currently 16-year-old female patient. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  In approximately 2005 reported as "when the patient was 12-months old", she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), prophylaxis. Ten days post-vaccination of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), the patient experienced multiple seizure. In addition, she developed a fever (pyrexia) that did not resolve immediately. The reporter further stated that her daughter might have a known allergy that could be present to the administered vaccine (allergy to vaccine).   At the time of the report, the patient had recovered from pyrexia. However, the outcome of seizure and allergy to vaccine was unknown.     The causal relationship between the event of allergy to vaccine and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was related. No causality assessment was provided regarding the other events and the suspect vaccine.    Upon internal review, the event of seizure was determined to be medically significant.
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; patient over the age of 45 years of age was administered a dose of GARDASIL 9 approximately 1 month ago; This spontaneous report was received from a nurse prescribed and refers to a patient of unknown age (reported as over 45-year-old) and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date approximately in June 2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose, lot # 1659422, expiration date 04-SEP-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate age at vaccine administration). There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: HPV9
Symptoms: Pallor
Clinical narrative: became pale; This spontaneous report was received from a field employee on behalf of an office manager concerning a female patient of unknown age.    The concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly (dose, frequency, lot# and the expiration date were not reported) for immunisation.         Subsequently after received the vaccine, the patient became pale (pallor), sought medical attention and had to go to the emergency room. She would be schedule to follow up with a cardiologist.    The outcome of pallor was not provided. The relatedness between the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: The patient report that an expired dose of PNEOMUVAX 23 was administered; This spontaneous report has been received from a pharmacist concerning to a patient of unknown age.      The patient's concurrent conditions, medical history and concomitant medication were not reported.  On 30-JUL-2021 (also reported as "today"), the patient was vaccinated with first dose of an expired vaccine of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S027979 has been verified to be valid, expiration date 30-MAY-2021) (anatomical location was not reported) for prophylaxis. Moreover, the reporter stated that pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was properly stored up through administration, with no temperature excursiones. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S027979; expirationdate: 30-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Influenza like illness, Pain, Urticaria
Clinical narrative: Hives; fatigue; achiness; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of hives in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (received 1st dose on 21st May 2021 and experienced hives began on their feet, then spread to arms, legs, and stomach, refer case US2021161368).   On 25th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, 2 days after receiving Shingrix, the patient experienced hives, fatigue, pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the fatigue, pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the hives, fatigue, pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received second dose of Shingrix and experienced hives, fatigue, achiness, and flu-like symptoms. All symptoms were began approximately 2 days after receiving second dose. The patient reported that the fatigue, achiness, and flu-like symptoms were resolved within approximately 24 hours. The patient reported that the hives were ongoing. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021161368:same patient/reporter (1st dose)
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Hives; fatigue; achiness; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of hives in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (received 1st dose on 21st May 2021 and experienced hives began on their feet, then spread to arms, legs, and stomach, refer case US2021161368).   On 25th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, 2 days after receiving Shingrix, the patient experienced hives, fatigue, pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the fatigue, pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the hives, fatigue, pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received second dose of Shingrix and experienced hives, fatigue, achiness, and flu-like symptoms. All symptoms were began approximately 2 days after receiving second dose. The patient reported that the fatigue, achiness, and flu-like symptoms were resolved within approximately 24 hours. The patient reported that the hives were ongoing. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021161368:same patient/reporter (1st dose)
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I just got the second shot but the first was Oct 2019; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019).   On 28th July 2021, the patient received the 2nd dose of Shingrix. On 28th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient had reported for him/herself. The patient received 2nd dose of Shingrix later than the recommended schedule which led to lengthening of vaccination schedule. The patient asked if he/she needed 3rd dose.
Age: 15.0
Sex: M
Vaccine: MENB, MENB, MNQ
Symptoms: Asthenia, Chills, Headache, Meningitis, Musculoskeletal stiffness
Clinical narrative: septic meningitis /was in hospital from 6/6/21 -6/10/21; headaches; high Fever 102; chills; stiffness of right thumb; weakness.; suspected vaccination failure; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adolescent male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Manactra (Received on 13th July 2015).   On 11th November 2020, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th May 2020, the patient received Menveo. On 7th December 2019, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device and less than 2 years after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), fever (serious criteria hospitalization), chills (serious criteria hospitalization), stiff fingers (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, meningitis, fever, chills, stiff fingers and weakness were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, meningitis, headache, fever, chills, stiff fingers and weakness to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, 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 details were provided as follows: The reporter was an office manager. The patient received three vaccines of meningococcal vaccine such as 1st dose of Bexsero, Menveo and 2nd dose of Bexsero and Approximately one year after receiving meningococcal vaccines he experienced septic meningitis. The reporter stated that the patient also had headache, high fever about 102 degree F, chills, stiffness of right thumb and weakness. The patient was hospitalized from 6th June 2021 till 10th June 2021. The reporter stated that the headache lasted till day before reporting date. The reporter agreed to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming meningitis were unknown at the time of reporting.
Age: 15.0
Sex: M
Vaccine: MENB, MENB, MNQ
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: septic meningitis /was in hospital from 6/6/21 -6/10/21; headaches; high Fever 102; chills; stiffness of right thumb; weakness.; suspected vaccination failure; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adolescent male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Manactra (Received on 13th July 2015).   On 11th November 2020, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th May 2020, the patient received Menveo. On 7th December 2019, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device and less than 2 years after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), fever (serious criteria hospitalization), chills (serious criteria hospitalization), stiff fingers (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, meningitis, fever, chills, stiff fingers and weakness were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, meningitis, headache, fever, chills, stiff fingers and weakness to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, 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 details were provided as follows: The reporter was an office manager. The patient received three vaccines of meningococcal vaccine such as 1st dose of Bexsero, Menveo and 2nd dose of Bexsero and Approximately one year after receiving meningococcal vaccines he experienced septic meningitis. The reporter stated that the patient also had headache, high fever about 102 degree F, chills, stiffness of right thumb and weakness. The patient was hospitalized from 6th June 2021 till 10th June 2021. The reporter stated that the headache lasted till day before reporting date. The reporter agreed to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming meningitis were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provide are as follows: The case was reported by patent herself. The age at vaccination not reported. The patient inadvertently received 3rd dose of Shingrix 1 month after receiving her 2nd dose, which led to extra dose administered. The reporter asked were there any adverse side effects or reactions to be concerned about. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: injections were more than six months apart; This case was reported by a consumer via SHINGRIX interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided are as follows: The case was reported by patient himself/ herself. The age at vaccination was not reported. The reporter reported that his/her Shingrix injections were more than six months apart, which led to drug dose administration interval too long. he reporter asked if that was okay. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got my shot/ got shingles\Suspected Vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The patient received shingles shot 3 years before reporting. The patient experienced shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Feeling abnormal, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Side effects of / her arm hurting; Side effects of how it didn't feel great; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (also experienced feeling bad after receiving 1st dose on an unknown date, refer case US2021163015).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received the second dose of Shingrix and experienced the side effects of how it did not feel great and her arm was hurting. The patient remembered completing the Shingrix series, but no record was found. The nurse inquired would it be harmful for the patient to redo the Shingrix series. No third dose was administered.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021163015:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 8 to 10 months ago and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 8 to 10 months ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable to this report. The pharmacist reported late second doses of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter had no information regarding the age or gender of the patient nor the exact date of the administration and expiration or lot number of the first dose. No further events were reported. The reporter consented to follow up. This case was linked to US2021AMR163652 and US2021163008, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163652:Same reporter US-GLAXOSMITHKLINE-US2021163008:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: high fever; chills; headache; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles about 8 years ago, lasted for few weeks or months). Previously administered products included Shingles vaccine (1st dose received on an unknown date). Concurrent medical conditions included pain (still had a pain in some area due to shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine and experienced high fever, chills and major headache.  All the events were lasted for 18 hours after receiving 2nd injection.  The patient reported that, this was the booster shot, he or she read 80 percent given had a reaction, it was still a lot better than getting it again. The follow-up would not possible as no contact details were available. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163744:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had to two shots year / One didn't end it, the next year I got shingles againg / that took care of them \ suspected vaccination failure; next year I got shingles againg / that took care of them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had two shingles shots year and one did not end it, the next year the patient got shingles again and that took care of them for good. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2021, the patient received Shingrix. On 30th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and patient experienced sore arm. The patient asked what he/she could take for pain. The patient was wondering if he/she could take ibuprofen or Tylenol after the shot at the day of reporting.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: mixed the powder component /with/ different diluent; mixed the powder component /with/ different diluent; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the clinic mixed the powder component of Menveo with a different diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.