chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Discomfort, Nausea, Pruritus
Clinical narrative: cold sweat; fever; nausea; chills; low energy; pruritus; skin lesion; This case was reported by a consumer via call center representative and described the occurrence of cold sweat in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion. On an unknown date, the outcome of the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her brother in law. The age at vaccination was not reported. The patient received Shingrix and had symptoms that included cold Sweats, chills, fever, nausea, low energy, lesion, itching and skin lesion. This case linked with US2020147973, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147973:same reporter
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: cold sweat; fever; nausea; chills; low energy; pruritus; skin lesion; This case was reported by a consumer via call center representative and described the occurrence of cold sweat in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion. On an unknown date, the outcome of the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her brother in law. The age at vaccination was not reported. The patient received Shingrix and had symptoms that included cold Sweats, chills, fever, nausea, low energy, lesion, itching and skin lesion. This case linked with US2020147973, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147973:same reporter
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, Pustule
Clinical narrative: cold sweat; fever; nausea; chills; low energy; pruritus; skin lesion; This case was reported by a consumer via call center representative and described the occurrence of cold sweat in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion. On an unknown date, the outcome of the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her brother in law. The age at vaccination was not reported. The patient received Shingrix and had symptoms that included cold Sweats, chills, fever, nausea, low energy, lesion, itching and skin lesion. This case linked with US2020147973, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147973:same reporter
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: cold sweat; fever; nausea; chills; low energy; pruritus; skin lesion; This case was reported by a consumer via call center representative and described the occurrence of cold sweat in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion. On an unknown date, the outcome of the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her brother in law. The age at vaccination was not reported. The patient received Shingrix and had symptoms that included cold Sweats, chills, fever, nausea, low energy, lesion, itching and skin lesion. This case linked with US2020147973, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147973:same reporter
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Cold sweat, Nausea, Pruritus
Clinical narrative: cold sweat; fever; nausea; chills; low energy; pruritus; skin lesion; This case was reported by a consumer via call center representative and described the occurrence of cold sweat in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion. On an unknown date, the outcome of the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her brother in law. The age at vaccination was not reported. The patient received Shingrix and had symptoms that included cold Sweats, chills, fever, nausea, low energy, lesion, itching and skin lesion. This case linked with US2020147973, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147973:same reporter
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Skin lesion
Clinical narrative: cold sweat; fever; nausea; chills; low energy; pruritus; skin lesion; This case was reported by a consumer via call center representative and described the occurrence of cold sweat in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion. On an unknown date, the outcome of the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the cold sweat, fever, nausea, chills, energy decreased, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her brother in law. The age at vaccination was not reported. The patient received Shingrix and had symptoms that included cold Sweats, chills, fever, nausea, low energy, lesion, itching and skin lesion. This case linked with US2020147973, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147973:same reporter
Age: 12.0
Sex: M
Vaccine: HEPA, HEPA, TDAP
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site pain, Syncope
Clinical narrative: 8/4/20 1022 Client received TDAP and Hep A vaccines without complication. No adverse effect noted. 8/4/20 1059 Client's mother called to notify RN that client blanked out, became sweaty, and vomited. Client's mother stated she was on her way to the ER at the time.  8/5/20 0955 Called client's mother for follow up. She states the client is resting well with no complaints at this time. She states that he received motrin in the ER as well as Ice packs for his arm.
Age: 12.0
Sex: M
Vaccine: HEPA, HEPA, TDAP
Symptoms: Vomiting
Clinical narrative: 8/4/20 1022 Client received TDAP and Hep A vaccines without complication. No adverse effect noted. 8/4/20 1059 Client's mother called to notify RN that client blanked out, became sweaty, and vomited. Client's mother stated she was on her way to the ER at the time.  8/5/20 0955 Called client's mother for follow up. She states the client is resting well with no complaints at this time. She states that he received motrin in the ER as well as Ice packs for his arm.
Age: 12.0
Sex: M
Vaccine: HEPA, HEPA, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Vomiting
Clinical narrative: 8/4/20 1022 Client received TDAP and Hep A vaccines without complication. No adverse effect noted. 8/4/20 1059 Client's mother called to notify RN that client blanked out, became sweaty, and vomited. Client's mother stated she was on her way to the ER at the time.  8/5/20 0955 Called client's mother for follow up. She states the client is resting well with no complaints at this time. She states that he received motrin in the ER as well as Ice packs for his arm.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache started 8 hours after injection. Body aches all over starting at 5am. Fever of 104.1 at 5:30am.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Feeling hot, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Got the Tdap because I am pregnant, due date is October 27th 2020. Pregnancy has been smooth sailing so far, no abnormalities in myself or the baby.   As soon as I got the shot (11:30am) in my upper arm the injection site stung. After about half an hour it became sore and as the day progressed it became very tender to the touch and I could not lift my arm past shoulder height. Once I got home from work around 1am and tried to go to sleep I was nauseous which I haven?t been durning the pregnancy for several months now. I felt achy all over not just at the injection site and very hot. I do not have a thermometer on hand to take my temperature but I felt like I was burning up. It made it extremely difficult to sleep and I am still achy all over (7am) though I don?t feel as hot anymore.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Got the Tdap because I am pregnant, due date is October 27th 2020. Pregnancy has been smooth sailing so far, no abnormalities in myself or the baby.   As soon as I got the shot (11:30am) in my upper arm the injection site stung. After about half an hour it became sore and as the day progressed it became very tender to the touch and I could not lift my arm past shoulder height. Once I got home from work around 1am and tried to go to sleep I was nauseous which I haven?t been durning the pregnancy for several months now. I felt achy all over not just at the injection site and very hot. I do not have a thermometer on hand to take my temperature but I felt like I was burning up. It made it extremely difficult to sleep and I am still achy all over (7am) though I don?t feel as hot anymore.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Insomnia, Rhinorrhoea, Vomiting projectile
Clinical narrative: Having troubles sleeping, projectile vomiting at 5 am 8/7, runny nose.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product supply issue
Clinical narrative: One of them mentioned that their PCP only gave their children one shot of GARDASIL 9 and did not give the second dose. The PCP indicated that the vaccine was out of stock. They eventually went to a pharmacy to get their child the second dose; One of them mentioned that their PCP only gave their children one shot of GARDASIL 9 and did not give the second dose. The PCP indicated that the vaccine was out of stock. They eventually went to a pharmacy to get their child the second dose; PCP indicated that the vaccine was out of stock; No additional adverse effects reported; This spontaneous report was received from consumers via company representative, referring to a child of unknown age and gender (also reported as "children" and "unspecified patients": conflicting information). The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (route of administration, anatomical location, lot number and expiration dates were not reported).  On an unknown date, the reporters took the patient at a subsequent visit, however did not received the second dose, as the vaccine was not available because it was out of stock (product availability issue). It was reported that eventually they went to a pharmacy to get the second dose (circumstance or information capable of leading to medication error and inappropriate schedule of product administration). No additional adverse effects reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not specified). On an unknown date, the patient was treated by an unspecified provider for the following injury resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. He claimed damages as result of injury to himself, loss of consortium, loss of services and economic losses. The outcome of herpes zoster was not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Pyrexia, Rash vesicular
Clinical narrative: titres were drawn on an unknown date, producing an IgG reading of 114. IgM antibodies were not asses due to lab oversight/ titres drawn; second VARIVAX dose recommended but not administered at patient's request/ varicella titres/ Negative titers; patient received a dose of VARIVAX on 7/1/2020. On 7/14/2020, the patient developed "less than 12 varicella-like lesions" on her skin, and developed a low grade fever.; developed a low grade fever; This spontaneous report as received from a nurse practitioner, who refers to a female patient of unknown age. The patient had no pertinent medical history, no drug reactions/allergies and she did not administer any concomitant medication. On 01-JUL-2020 the patient was received first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneously, for vaccination (strength, dose, frequency, indication, lot # and expiry date were not reported). Other suspect therapies included sterile diluent (STERILE DILUENT) 0.5 ml (no further details provided). On 14-JUL-2020, the patient developed "less than 12 varicella-like lesions" on her skin and a low grade fever. On an unknown date, titres were drawn and results showed immunoglobulin G (IgG) was 114 (units not provided) and immunoglobulin M (IgM) antibodies were not assessed due to lab oversight. The second dose of varicella virus vaccine live (oka/merck) (VARIVAX) was recommended, but was not administered at patient's request. No product quality complaint (PQC) involved. Varicella Zoster Virus (VZV) packet due to Program was sent per request. The outcome of the events was reported as not recovered. The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) was not applicable. The causality assessment between the suspect therapy and all events was not provided.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: the patient reported significant pain, swelling, redness, and itching around the injection site; the patient reported significant pain, swelling, redness, and itching around the injection site; the patient reported significant pain, swelling, redness, and itching around the injection site; the patient reported significant pain, swelling, redness, and itching around the injection site; This spontaneous report as received from a pharmacist refers to a 79 year old male patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medial history.   On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 30-JUL-2020, the patient experienced significant pain, swelling, redness, and itching around the injection site (injection site swelling, injection site pruritus, injection site erythema and injection site pain). It was unknown by the reporter if the patient received any treatment for the adverse events  The outcome of the events and the causal relationship between the events and vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  This is one of three cases from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2008USA001325: US-009507513-2008USA001498:
Age: 70.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired VAQTA that was administered; This spontaneous report has been received from an office manager concerning a 70 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.   On 03-AUG-2020, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) with lot # S007265 and expiration date 07-JUL-2020, for prophylaxis ((dose, dose number, route of administration and anatomical location were not provided). No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Caller reported administered MMR II that was improperly stored in the freezer.; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 31-JUL-20, the physician reported that, on an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number S020161 which has been verified to be valid, expiration date reported and validated as 30-JUN-2021) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis. The administered dose of the vaccine was stored at a temperature of -10 degrees Fahrenheit (F). There was a previous temperature excursion of below 36 F (10 F), during a time frame of 50 minutes, as recorded by a digital data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001787: US-009507513-2008USA002399:
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored medication given to patient; Information has been received from a health care professional (also reported as the "office manager"), referring to a 12 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-AUG-2020, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T005401, expiration date on 12-AUG-2021, subcutaneously for prophylaxis.      The vaccine had one temperature excursion of 2 hours with 7.9 Celsius (C). It was confirmed that a digital data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: caller reported administered MMR II that was improperly stored in the freezer; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 22-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S020161, expiration date: 30-JUN-2021) as prophylaxis (product storage error).  The vaccine experienced a temperature excursion of 10 degrees Fahrenheit (F). There was a previous temperature excursion below 36F (10F) for 50 minutes, as recorded by a data logger.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Incorrect product storage; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 29-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T007395 and expiration date 29-AUG-2021 for prophylaxis (dose, frequency, and route of administration were not reported). It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX) also presented temperature excursions but there was no information about the doses being administered to the patient.  On an unknown date, the mentioned vaccines had a temperature excursion on 6.8F during 7 hours. Previous temperature excursions were reported. Digital data logger was involved.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: RECOMBN AX Hb that was improperly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 27-JUL-2020, the patient was vaccinated with an onetime dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), thimerosal free, lot number R034547 with expiration date 06-JUN-2021 (dose, route and anatomical location were not reported) which was improperly stored, for prophylaxis. The vaccine was exposed to 11.8 Celsius degrees (C) for 48 minutes. There was no previous temperature excursion, digital data logger was filled.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: shoulder pain; stiff neck; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received the 2nd dose of Shingrix. On 1st August 2020, 1 days after receiving Shingrix, the patient experienced shoulder pain and stiff neck. On an unknown date, the outcome of the shoulder pain and stiff neck were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. It was reported the patient experienced achy right shoulder and stiff neck, after the patient received second part of shingles vaccine In left arm late yesterday.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Inflammatory marker increased
Clinical narrative: Polymyalgia rheumatica; severe myalgias/hip/shoulder girdle myalgias; morning stiffness; thigh pain/hamstring pain; Fatigue; joint pain; Joint swelling; decreased range of motion left and Right shoulder, to the right and left hip and to the Lumbar back; joint stiffness; Shoulders feel stiff; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). On an unknown date, the outcome of the polymyalgia rheumatica was unknown.   It was unknown if the reporter considered the polymyalgia rheumatica to be related to Shingrix.  The initial information received on 29 July 2020 via medical records (The case is medically confirmed). As per the records, He had a history of vertigo and tinnitus, seasonal allergies. As per the previous records on 01 October 2012, he had Zoster Vaccine (2 of 3- SHINGRIX) planned on 26 November 2012 and completed on 01 October 2012. On 13 October 2015, he had Influenza Vaccine. As per record on 25 September 2018, he had flu shot and later he got varicella-zoster, (SHINGRIX) 50 mcg/0.5 ml vaccine Inject 0.5 ml inject into the muscle one time for 1 dose. A week or so later he was very fatigued and feeling poorly. He had morning stiffness worse lately better later in the day slight headache worse with allergies, he had occasional nausea and positive rheumatoid factor. On 30 September 2019, he had Shingrix shot, since, Shingrix shot (3 weeks and 2 days) he had severe myalgias and rare slight headache. As per the records, he exhibits Joint range of motion decreased in left and Right shoulder, to the right and left hip and to the lumbar back. He also had tenderness in Right and left hip and to the left knee. As per records dated 19 December 2019, he presents for evaluation of acute onset hip/shoulder girdle myalgias started abruptly after Shingrix vaccine in September, found to have elevated inflammatory markers and RF 41. He was receiving prednisone 20 mg once daily for polymyalgia rheumatica. He also had joint stiffness and shoulder stiffness.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Joint stiffness, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Polymyalgia rheumatica; severe myalgias/hip/shoulder girdle myalgias; morning stiffness; thigh pain/hamstring pain; Fatigue; joint pain; Joint swelling; decreased range of motion left and Right shoulder, to the right and left hip and to the Lumbar back; joint stiffness; Shoulders feel stiff; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). On an unknown date, the outcome of the polymyalgia rheumatica was unknown.   It was unknown if the reporter considered the polymyalgia rheumatica to be related to Shingrix.  The initial information received on 29 July 2020 via medical records (The case is medically confirmed). As per the records, He had a history of vertigo and tinnitus, seasonal allergies. As per the previous records on 01 October 2012, he had Zoster Vaccine (2 of 3- SHINGRIX) planned on 26 November 2012 and completed on 01 October 2012. On 13 October 2015, he had Influenza Vaccine. As per record on 25 September 2018, he had flu shot and later he got varicella-zoster, (SHINGRIX) 50 mcg/0.5 ml vaccine Inject 0.5 ml inject into the muscle one time for 1 dose. A week or so later he was very fatigued and feeling poorly. He had morning stiffness worse lately better later in the day slight headache worse with allergies, he had occasional nausea and positive rheumatoid factor. On 30 September 2019, he had Shingrix shot, since, Shingrix shot (3 weeks and 2 days) he had severe myalgias and rare slight headache. As per the records, he exhibits Joint range of motion decreased in left and Right shoulder, to the right and left hip and to the lumbar back. He also had tenderness in Right and left hip and to the left knee. As per records dated 19 December 2019, he presents for evaluation of acute onset hip/shoulder girdle myalgias started abruptly after Shingrix vaccine in September, found to have elevated inflammatory markers and RF 41. He was receiving prednisone 20 mg once daily for polymyalgia rheumatica. He also had joint stiffness and shoulder stiffness.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica, Rheumatoid factor positive
Clinical narrative: Polymyalgia rheumatica; severe myalgias/hip/shoulder girdle myalgias; morning stiffness; thigh pain/hamstring pain; Fatigue; joint pain; Joint swelling; decreased range of motion left and Right shoulder, to the right and left hip and to the Lumbar back; joint stiffness; Shoulders feel stiff; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). On an unknown date, the outcome of the polymyalgia rheumatica was unknown.   It was unknown if the reporter considered the polymyalgia rheumatica to be related to Shingrix.  The initial information received on 29 July 2020 via medical records (The case is medically confirmed). As per the records, He had a history of vertigo and tinnitus, seasonal allergies. As per the previous records on 01 October 2012, he had Zoster Vaccine (2 of 3- SHINGRIX) planned on 26 November 2012 and completed on 01 October 2012. On 13 October 2015, he had Influenza Vaccine. As per record on 25 September 2018, he had flu shot and later he got varicella-zoster, (SHINGRIX) 50 mcg/0.5 ml vaccine Inject 0.5 ml inject into the muscle one time for 1 dose. A week or so later he was very fatigued and feeling poorly. He had morning stiffness worse lately better later in the day slight headache worse with allergies, he had occasional nausea and positive rheumatoid factor. On 30 September 2019, he had Shingrix shot, since, Shingrix shot (3 weeks and 2 days) he had severe myalgias and rare slight headache. As per the records, he exhibits Joint range of motion decreased in left and Right shoulder, to the right and left hip and to the lumbar back. He also had tenderness in Right and left hip and to the left knee. As per records dated 19 December 2019, he presents for evaluation of acute onset hip/shoulder girdle myalgias started abruptly after Shingrix vaccine in September, found to have elevated inflammatory markers and RF 41. He was receiving prednisone 20 mg once daily for polymyalgia rheumatica. He also had joint stiffness and shoulder stiffness.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chemotherapy, Incomplete course of vaccination, Neoplasm malignant
Clinical narrative: cancer; first dose over a year ago; This case was reported by a other health professional via call center representative and described the occurrence of cancer in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and incomplete course of vaccination. The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the cancer and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose over a year before reporting. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient diagnosed with cancer (not specified) and undergoing chemotherapy. No more information could be gathered since reporter made emphasis on only wanting opinions or answers on their questions. Reporter's question was regarding safety of a second dose of Shingrix to the patient, considering chemotherapy, viability of the second dose after the longer period of validity for second dose and if it was possible and efficient to only administer one dose of Shingrix. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was given an expired dose of Menactra vaccine, No AE; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (Office staffer)  This case involves an 18 years old male patient who was given an expired 0.5mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6208AB, expiry date: 08-Jul-2020) via intramuscular route in the right deltoid for prophylactic vaccination on an unknown date (mentioned as today).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  They had standing orders so no physician specifically ordered the vaccine.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: COVID-19, Cough, Headache, Nausea
Clinical narrative: symptoms of COVID; cough; nausea; headaches; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a nurse manager.  This case involves three female patients of an unknown age who were having symptoms of COVID (Suspected COVID-19), cough, nausea and headache, while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.  On 23-Jul-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot R1C711M, expiry date 30-Apr-2021) via an unknown route and administration site for prophylactic vaccination.  On an unknown date in Jul-2020, patient was having symptoms of COVID (Suspected COVID-19), cough, nausea and headache (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported that the, the patients were due for second dose tomorrow, but they were having symptoms of COVID and were going to get tested.  Details of laboratory data were not reported.  Final diagnosis was Suspected COVID-19, headaches, nausea and having a cough.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events at the time of reporting.
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient was given an extra dose of Ipol by mistake along with Quadracel, no AE; Initial information received on 30-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-year-old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and IPV (VERO) [IPOL]. (PT: extra dose administered).  Past vaccination included a dose of Pediarix.  Medical history, medical treatment and family history were not provided.  Concomitant vaccination included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 29-Jul-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot P1F54M and expiry date: 07-Dec-2020) via an unknown route in the left thigh for prophylactic vaccination.  On 29-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5656AA and expiry date: 13-Aug-2021) via an unknown route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered. It was reported that she was given Pediarix and then plain polio, then Pediarix. Yesterday 29-Jul-2020 the patient came to their office and received Quadracel and also an Ipol dose. They gave the extra polio dose by mistake.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient had swollen arm and redness.  She went to clinic and they told her she had cellulitis
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: Although vaccinated twice for MMR, he never mounted mumps specific IgG; Literature report:.   This literature marketed report has been received from authors of the literature article entitled as stated above. Acute Otitis Media (AOM) was one of the most common reasons for antibiotic use in early childhood. The article explored the challenges when AOM fails traditional therapies and immunologic evaluation did not identify a commonly described immunodeficiency.  This report referred to an 18 months old male patient, who presented with 12 episodes of AOM and recurrent purulent otorrhea requiring intravenous antibiotics. Laboratory evaluation revealed a normal complete Blood Count (CBC), normal immunoglobulins (IgG 588 (unit unknown), IgA 76 (unit unknown), IgM 63 (unit unknown), IgE 12 (unit unknown)) and IgG subclasses. Lymphocyte subset panel was normal. Initial responses to diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) boosters were normal, however, there was rapid decline to tetanus and pneumococcal antibody titers.   On unknown dates, the patient was vaccinated with twice measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.     Although vaccinated twice for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), he never mounted mumps specific IgG (mumps antibody test negative). Mitogen response to phytohemagglutinin (PHA) was normal with decreased responses to concanavalin A (ConA) and pokeweed and no detectable tetanus nor candida responses. Further investigation revealed decreased non-class and class switched memory B-cells. The patient was recently vaccinated to Pneumococcal Vaccine, Polyvalent (23-valent) and at the present time has protective titers.  The outcome of mumps antibody test negative was unknown. The reporter considered mumps antibody test negative to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).     A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports obtained from the same literature (link # 2008USA002279).; Sender's Comments:  US-009507513-2008USA002279:
Sex: M
Vaccine: HIBV
Symptoms: Antibody test negative, Clostridium test negative, Vaccination failure
Clinical narrative: A sub optimal response to Haemophilus influenza Type B vaccine was noted;    This literature marketed report has been received from authors of the literature article entitled as stated above. Acute Otitis Media (AOM) was one of the most common reasons for antibiotic use in early childhood. The article explored the challenges when AOM fails traditional therapies and immunologic evaluation did not identify a commonly described immunodeficiency.  This report referred to an 18 months old male patient, who presented with 12 episodes of AOM and recurrent purulent otorrhea requiring intravenous antibiotics. Laboratory evaluation revealed a normal complete Blood Count (CBC), normal immunoglobulins (IgG 588 (unit unknown), IgA 76 (unit unknown), IgM 63 (unit unknown), IgE 12 (unit unknown)) and IgG subclasses. Lymphocyte subset panel was normal. Initial responses to diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) boosters were normal, however, there was rapid decline to tetanus and pneumococcal antibody titers.   On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.     On an unknown date, a sub optimal response to with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) was noted (vaccination failure). Mitogen response to phytohemagglutinin (PHA) was normal with decreased responses to concanavalin A (ConA) and pokeweed and no detectable tetanus nor candida responses. Further investigation revealed decreased non-class and class switched memory B-cells. The patient was recently vaccinated to Pneumococcal Vaccine, Polyvalent (23-valent) and at the present time has protective titers.  The outcome of vaccination failure was unknown. The reporter considered vaccination failure to be related to Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports obtained from the same literature (link # 2007USA011356).; Sender's Comments:  US-009507513-2007USA011356:
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 14-JUL-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered herpes zoster in his right axillary region with burning sensation and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the event herpes zoster to be disability.