chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: Extreme muscular myalgia- body aches so severe my daughter could not get out of bed for one full day. This is quite unusual for my child so I felt important to report this. While this happened four months ago, I reflected back on this year and felt it was important to report. I am a supporter of vaccines, but this reaction was so severe, I cannot imagine she will get the booster vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This 4 year old child had a 12"length x 5"width red, painful, hot swollen lump on his left side thigh. It was hard to the touch and it was getting progressively larger. A 10 day antibiotic, amoxicillin, regiment was given to prevent any infection on site.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: This 4 year old child had a 12"length x 5"width red, painful, hot swollen lump on his left side thigh. It was hard to the touch and it was getting progressively larger. A 10 day antibiotic, amoxicillin, regiment was given to prevent any infection on site.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a registered medical assistant and refers to an unspecified group of unspecified patients. Their medical history, concurrent conditions and concomitant drugs were not provided. From 23-NOV-2018, the patients were vaccinated with improperly stored doses of VARIVAX lot# R011809, expiration date 23-APR-2020 (exact dose, route and site of administration were not reported) or improperly stored doses of PROQUAD recombinant human albumin (rHA), lot# R012417, expiration date 28-OCT-2019 (exact dose, route and site of administration were not reported) diluted in properly stored sterile diluent for prophylaxis. The administered doses of vaccines were stored in 11 Fahrenheit degrees for 45 minutes. Digital Data Logger was involved in capturing temperature excursion. No previous temperature excursion occurred. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Arterial injury, Carotid artery thrombosis, Cerebrovascular accident
Clinical narrative: Information has been received on 27-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 15-NOV-2014, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered a "brain attack" and became aphasic. He was diagnosed with a left carotid thrombus and cervical internal carotid artery which was either severe stenosis or near occlusion and a stroke with NIH score of a 4. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, 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 ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. Left carotid thrombus, cervical internal carotid artery which was either severe stenosis or near occlusion, cervical internal carotid artery which was either severe stenosis or near occlusion and a stroke with NIH score of a 4 were considered to be disabling. Upon internal review, left carotid thrombus, cervical internal carotid artery which was either severe stenosis or near occlusion, cervical internal carotid artery which was either severe stenosis or near occlusion and a stroke with NIH score of a 4 were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: FLUX, MMR
Symptoms: Crying, Irritability, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2013US116901). This spontaneous report was received from a health care professional referring to a 1-year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 25-JAN-2013, the patient was vaccinated with M-M-R II, 1 dosage form (dosage, strength, lot number, expiration date were not reported) and also with influenza virus vaccine (unspecified) 1 dosage form, both therapies indicated for immunisation. On 25-JAN-2013, the patient experienced fever of 102.4 (units not provided). On 02-APR-2013, the patient experienced a viral rash covering her entire body. On an unknown date, the patient was very irritable, crying, with sleep disorder, runny nose; the patient was a one-year old patient that received influenza therapy. The outcome of crying, viral rash, irritability, sleep disorder, rhinorrhoea and pyrexia was reported as resolved. The causality between the events fever, irritable, crying, sleep disorder, and runny nose with the therapies M-M-R II and influenza virus vaccine was unknown and the causality between the event viral rash and the therapy influenza virus vaccine (unspecified) was reported related. And for the therapy M-M-R II was unknown. The agency considered the all the events to be serious for the following reason: medically significant. Sender's Comments: 483880.
Sex: F
Vaccine: FLUX, MMR
Symptoms: Sleep disorder, Viral rash
Clinical narrative: Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2013US116901). This spontaneous report was received from a health care professional referring to a 1-year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 25-JAN-2013, the patient was vaccinated with M-M-R II, 1 dosage form (dosage, strength, lot number, expiration date were not reported) and also with influenza virus vaccine (unspecified) 1 dosage form, both therapies indicated for immunisation. On 25-JAN-2013, the patient experienced fever of 102.4 (units not provided). On 02-APR-2013, the patient experienced a viral rash covering her entire body. On an unknown date, the patient was very irritable, crying, with sleep disorder, runny nose; the patient was a one-year old patient that received influenza therapy. The outcome of crying, viral rash, irritability, sleep disorder, rhinorrhoea and pyrexia was reported as resolved. The causality between the events fever, irritable, crying, sleep disorder, and runny nose with the therapies M-M-R II and influenza virus vaccine was unknown and the causality between the event viral rash and the therapy influenza virus vaccine (unspecified) was reported related. And for the therapy M-M-R II was unknown. The agency considered the all the events to be serious for the following reason: medically significant. Sender's Comments: 483880.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: Shortly after getting the GARDASIL shot patient c/o arm pain dizziness and sweating. Dr. checked him. He remained in the office for 30 min to be monitored. Then he went home.
Age: 1.58
Sex: F
Vaccine: DTAP, PNC
Symptoms: Erythema, Induration, Mass, Pain, Skin warm
Clinical narrative: This 1 year old 7 month girl exhibited a red, pain, hot, swollen about the size of a quarter, hard to the touch, lump. No antibiotic regimen was given to her at that time.
Age: 1.58
Sex: F
Vaccine: DTAP, PNC
Symptoms: Swelling
Clinical narrative: This 1 year old 7 month girl exhibited a red, pain, hot, swollen about the size of a quarter, hard to the touch, lump. No antibiotic regimen was given to her at that time.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Muscle twitching, Tremor
Clinical narrative: Elevated temperature; uncontrolled  muscle twitching in upper body. Involuntary shaking.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Disturbance in attention, Fatigue, Gait disturbance, Hypoaesthesia, Muscular weakness
Clinical narrative: Numbness/tingling (whole body/lasting longest in hands/feet); drop foot; muscle weakness; fatigue; trouble concentrating; trouble walking. Symptoms improving but still some numbness/tingling in hands/feet.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia, Peroneal nerve palsy
Clinical narrative: Numbness/tingling (whole body/lasting longest in hands/feet); drop foot; muscle weakness; fatigue; trouble concentrating; trouble walking. Symptoms improving but still some numbness/tingling in hands/feet.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Cough, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right leg swelling and redness and pain which progressed from Tuesday injection time seen on Thursday evening. Seen by provider Thursday evening. Diff dx local reaction vs. cellulitis. KEFLEX liquid with BENADRYL, TYLENOL for cough f/u appt. 12/24/2018.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction
Clinical narrative: Right leg swelling and redness and pain which progressed from Tuesday injection time seen on Thursday evening. Seen by provider Thursday evening. Diff dx local reaction vs. cellulitis. KEFLEX liquid with BENADRYL, TYLENOL for cough f/u appt. 12/24/2018.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Bursa inflammation reported, told patient to ice, treat with otc nsaid, and light exercise  to joint.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma
Clinical narrative: This spontaneous report was received from a physician via company representative regarding multiple female patients of unknown age. The patient's medical history, concurrent condition and concomitant medications were unknown. On an unknown dates, the patients were vaccinated with GARDASIL (strength, dose, frequency, route, lot # and expiry date were not provided) for prophylaxis. According to the cancer statistics review in 1975-2015, the standard incidence of invasive cervical cancer had decreased by 33% between 1989 and 2007 (from 10'7 to 667) before GARDASIL was commercialized but since the vaccination left to decrease (+0.1) in which vaccination coverage was lower than in the previous ones (around 60%), the same discrepancy was observed by age groups, although of lesser magnitude: women over 50 years of age- those not vaccinated. They benefited from a 5% decrease in risk (from 10'37 in 2007 to 9.87 in 2015) while the youngest, which group the vaccinated women saw their risk was increased by 4% (from 5'24 in 2007 to 5'47 in 2015). The physician stated that, the vaccines against HPV virus could produce cancer. The outcome of cervix carcinoma was unknown. The causality assessment for the cervix carcinoma was related with GARDASIL. Upon internal review, the event "cervix carcinoma" was determined to be medically significant.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Eye irritation, Occupational exposure to product, Ocular hyperaemia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of burning in eyes in a 56-year-old female nurse who intended to vaccinate with SHINGRIX (batch number AC5GX, expiry date 8th March 2021) for prophylaxis. On 23rd October 2018, the patient received SHINGRIX. On 23rd October 2018, unknown after receiving SHINGRIX, the patient experienced inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional stated that an employee inadvertently got SHINGRIX in their eye while re-constituting the SHINGRIX vaccine, which led to inadvertent exposure to vaccine and exposure via eye contact. No further information provided by healthcare professional. Follow up information received from nurse (patient) on 21st December 2018: The reporter details were updated. The patient's demographic details were updated. The reporter added the diluent to powder. Some of the liquid went into the vial. The reporter tried to inject the liquid back into the vial. As reporter did, she guess the needle slipped out the SHINGRIX and sprayed in her eyes. Less than a year, after inadvertent exposure to SHINGRIX, the patient's eyes burned and turned red. The VAERS details were updated.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of numbness of upper extremities in a 11-year-old male patient who received BOOSTRIX (batch number U5979AA ?, expiry date unknown) for prophylaxis. On 18th December 2018, the patient received BOOSTRIX. On 18th December 2018, less than a day after receiving BOOSTRIX, the patient experienced numbness of upper extremities (serious criteria hospitalization), rash (serious criteria hospitalization), pain in arm (serious criteria hospitalization), swelling arm (serious criteria hospitalization) and tingling of extremity (serious criteria hospitalization). On an unknown date, the outcome of the numbness of upper extremities, rash, pain in arm, swelling arm and tingling of extremity were unknown. It was unknown if the reporter considered the numbness of upper extremities, rash, pain in arm, swelling arm and tingling of extremity to be related to BOOSTRIX. Additional details were provided as follows: The patient had a rash and pain of the left arm. His left arm was swollen, numb and tingling in his arm. On the same day of vaccination in the evening, the patient went into the emergency room.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of numbness of upper extremities in a 11-year-old male patient who received BOOSTRIX (batch number U5979AA ?, expiry date unknown) for prophylaxis. On 18th December 2018, the patient received BOOSTRIX. On 18th December 2018, less than a day after receiving BOOSTRIX, the patient experienced numbness of upper extremities (serious criteria hospitalization), rash (serious criteria hospitalization), pain in arm (serious criteria hospitalization), swelling arm (serious criteria hospitalization) and tingling of extremity (serious criteria hospitalization). On an unknown date, the outcome of the numbness of upper extremities, rash, pain in arm, swelling arm and tingling of extremity were unknown. It was unknown if the reporter considered the numbness of upper extremities, rash, pain in arm, swelling arm and tingling of extremity to be related to BOOSTRIX. Additional details were provided as follows: The patient had a rash and pain of the left arm. His left arm was swollen, numb and tingling in his arm. On the same day of vaccination in the evening, the patient went into the emergency room.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pruritus, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (itching, tiredness and muscle ache after receiving 1st dose on 20th October  2018, see case US2018231048.). On 20th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 21st December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, pruritus, tiredness and muscle pain. The patient was treated with ibuprofen (Advil). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, pruritus, tiredness and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the headache, pruritus, tiredness and muscle pain to be related to SHINGRIX. Additional information was provided as follows: The patient received the second dose of SHINGRIX vaccine and experienced headache, itching, tiredness and muscle ache. She took Advil today morning. Did not consent to follow up. No further details were provided. This case linked with US2018231048, by same reporter for the same patient.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 8-year-old female patient who received KINRIX (batch number T7E4A, expiry date 2nd June 2020) for prophylaxis. On 6th November 2018, the patient received KINRIX. On 6th November 2018, unknown after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The vaccine administration facility was the same as that of primary reporter. The patient inadvertently received KINRIX at an age of 8 year, which led to inappropriate age at vaccine administered. The healthcare professional consented to follow up. Follow up information received from other health professional on 21st December 2018: This case US2018203449 was identified as duplicate of case US2018230982. The case US2018230982 will be deleted and all the future correspondence will be added in the present case which stands as case of record for this patient. The duplicate case contained the following additional information: The patient received KINRIX vaccine on an unknown arm. Less than a year after receiving KINRIX, the patient experienced injection site redness. However, the reporter was unsure if it was in the arm vaccinated with KINRIX. It was unknown if the reporter considered the injection site redness to be related to KINRIX. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of blistery rash in a 60-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2022) for prophylaxis. On 12th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was unknown. It was unknown if the reporter considered the blistery rash to be related to SHINGRIX. Additional details were provided as follows: The batch number of SHINGRIX was reported as D249J, which was corrected to D294J as per sales data sheet. The patient experienced shingles like blisters. The healthcare professional (HCP) did not have too much details as the patient had not been seen by the HCP till the time of reporting, per HCP patient would be seen later. The healthcare professional consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Feeling abnormal, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 17th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, mass, injection site warmth and injection site itching. On 18th December 2018, the patient experienced feeling bad. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, mass, injection site warmth and injection site itching were unknown and the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, feeling bad, injection site erythema, mass, injection site warmth and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The next day after vaccination, the patient felt really bad and this had resolved. The patient had arm swelling from injection site down to her elbow, redness around injection site about the size of a softball, two knots in her arm each about 1 inch in size, the injection site was warm to the touch and felt itchy. The reporter gave consent to follow up. This case has been linked with case US2018231003, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Nodule
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 17th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, mass, injection site warmth and injection site itching. On 18th December 2018, the patient experienced feeling bad. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, mass, injection site warmth and injection site itching were unknown and the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, feeling bad, injection site erythema, mass, injection site warmth and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The next day after vaccination, the patient felt really bad and this had resolved. The patient had arm swelling from injection site down to her elbow, redness around injection site about the size of a softball, two knots in her arm each about 1 inch in size, the injection site was warm to the touch and felt itchy. The reporter gave consent to follow up. This case has been linked with case US2018231003, reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 76-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 17th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 18th December 2018, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the feeling bad and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was patient's wife. The next day after vaccination, the patient felt bad and this had resolved. The patient was experience sore arm till the time of reporting. The reporter gave consent to follow up. This case has been linked with case US2018231001, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and 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 pain, influenza-like symptoms and drug dose administration interval too long. On an unknown date, the outcome of the pain and influenza-like symptoms were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician for himself. The age at vaccination was not reported. The batch number and expiry date were not reported. After receiving 1st dose of SHINGRIX, the patient experienced severe pain for 1 week along with flu like symptoms. The patient was late for the 2nd dose of SHINGRIX, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site soreness after 1st dose of SHINGRIX. The reporter did not consent for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain. On 21st December 2018, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, his wife experienced soreness after her second dose of SHINGRIX, but it went away in a couple of days and was not extreme. No further details were provided.
Sex: U
Vaccine: FLU4, HEPA, PPV, TDAP
Symptoms: Abscess, Culture, Furuncle, Product storage error, Secretion discharge
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of abscess in a patient who received HAVRIX for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis, PNEUMOCOCCAL VACCINE for prophylaxis and FLUZONE for prophylaxis. On an unknown date, the patient received HAVRIX at an unknown dose, dTpa vaccine, PNEUMOCOCCAL VACCINE at an unknown dose and FLUZONE at an unknown dose. On an unknown date, unknown after receiving HAVRIX and dTpa vaccine, the patient experienced abscess, boil, fluid discharge and incorrect product storage. On an unknown date, the outcome of the abscess, boil, fluid discharge and incorrect product storage were unknown. It was unknown if the reporter considered the abscess, boil and fluid discharge to be related to HAVRIX and dTpa vaccine. Additional details were reported as follows: The reporter was worked for the public health. The age at the vaccination was not reported. About 66 to 68 patients, received HAVRIX (healthcare professional believed that it was HAVRIX but still figuring it out), FLUZONE, Tdap, and Pneumococcal vaccine. The all patients experienced severe abscesses and boils that were draining. The reporter believed that, it was due to the injection practices of the clinic that was vaccinating. They were waiting on cultures and this was still under investigation. The clinic also was not monitored the temperatures for the vaccines so the healthcare professional did not even know if the vaccines were viable, which led to possible incorrect product storage. The reporter was still investigating this. The reporter had consented to follow. The reporter was okay with follow-up from safety.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 20th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, pruritus, tiredness and muscle pain. The patient was treated with ADVIL. On an unknown date, the outcome of the pain, pruritus, tiredness and muscle pain were recovered/resolved. It was unknown if the reporter considered the pain, pruritus, tiredness and muscle pain to be related to SHINGRIX. Additional information was provided as follows: The patient received first dose of SHINGRIX and experienced pain, itching, tiredness and muscle ache. She took ADVIL and she recovered within one day. The reporter did not consent to follow up. No further details were provided. For tolerance with 2nd dose of SHINGRIX, refer linked case US2018GSK233751.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient who was consumer friend got sick after getting a SHINGRIX shot. The reporter hung up before further information could be obtained.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 20th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was not recovered/not resolved. It was unknown if the reporter considered the blurred vision to be related to SHINGRIX. Additional information received as follows: The patient was experiencing blurry vision in the lower field of vision in his right eye. The patient had seen his ophthalmologist for examination and no evidence of shingles at this time. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Irritability, Rash macular
Clinical narrative: Patient was extremely irritable, developed a flat blotchy rash around injection site.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: After vaccination, 8 days of punctate erythematous lesion at injection site. Beginning on day 8, localized varicella rash at the injection site that was warm and indurated.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: After vaccination, 8 days of punctate erythematous lesion at injection site. Beginning on day 8, localized varicella rash at the injection site that was warm and indurated.
Age: 67.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event reported. Patient received TWINRIX on 10/26/18, 12/26/18, 12/31/18.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Swelling
Clinical narrative: The site was immediately more painful than other injections (autoinjector). May have been too high and too anterior site on my L arm. Ever since, limited motion. I can not raise up the arm or cross the body without pain. Worse at night. Swelling gradually went away. This was my second SHINGRIX with 2 months in between. I had had a previous ZOSTAVAX 6-8 years prior, also.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Glossodynia, Headache, Oral discomfort
Clinical narrative: Within two hours of administration, burning sensation felt in roof of mouth, left side only. Within 12 hours, pain felt on left side of head from top of forehead along side of face down to halfway down throat, left side only, including but not limited to shots of pain in ear, back of tongue, jaw. Severe pain upon movement of tongue from side to side or extension. Pain continued for two weeks. Additionally, soreness at site of vaccination for approximately four days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Pain in jaw, Vaccination site pain
Clinical narrative: Within two hours of administration, burning sensation felt in roof of mouth, left side only. Within 12 hours, pain felt on left side of head from top of forehead along side of face down to halfway down throat, left side only, including but not limited to shots of pain in ear, back of tongue, jaw. Severe pain upon movement of tongue from side to side or extension. Pain continued for two weeks. Additionally, soreness at site of vaccination for approximately four days.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received SHINGRIX. In December 2018, 18 hrs after receiving SHINGRIX, the patient experienced chills, headache and general body pain. On an unknown date, the outcome of the chills, headache and general body pain were unknown. It was unknown if the reporter considered the chills, headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a SHINGRIX shot at 9:30 am, the day before the time of reporting and woke up at 3:30 am morning on the day of reporting with a pounding headache, chills, body aches. The patient asked about how long did the symptoms would last.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician and described the occurrence of rotator cuff tear in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of musculoskeletal pain (1st dose received in May 2018, refer case US2018195870). In November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rotator cuff tear, flu symptoms and shoulder pain. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the rotator cuff tear was unknown and the outcome of the flu symptoms and shoulder pain were recovered/resolved. It was unknown if the reporter considered the rotator cuff tear, flu symptoms and shoulder pain to be related to SHINGRIX. Additional information received as follows: This case was reported by the patient's husband. The batch number was not known. The patient experienced flu symptoms and pain in shoulder for 1 to 2 days. It was much less to correlate rotator cuff symptoms with 2nd dose of SHINGRIX than 1st dose of SHINGRIX. Lab Comments: In 2018, the patient underwent lab test Nuclear magnetic resonance imaging.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 19th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site lump, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site lump, injection site induration and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site lump, injection site induration and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: On the day of reporting, the patient went to the pharmacy with injection site redness, injection site hard lump and injection site warm to touch.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that an immune compromised patient received a 3 dose ENGERIX-B series and did not develop antibodies. The health care professional had no patient or vaccine information such as dose dates lot or expiry dates. Lab Comments: On unknown date, hepatitis B antibody test was performed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a 54-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 28th April 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX subcutaneously, which led to intramuscular formulation administered by other route. The patient had experienced an injection site reaction (unspecified).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site paraesthesia, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash, injection site warmth and injection site paresthesia. On an unknown date, the outcome of the injection site rash and injection site warmth were recovered/resolved and the outcome of the injection site paresthesia was not recovered/not resolved. It was unknown if the reporter considered the injection site rash, injection site warmth and injection site paresthesia to be related to SHINGRIX. Additional details were reported as follows: The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. The injection site was hot to touch and had pin and needles sensation as well. The patient planned to follow-up with her physician on an unknown date. The reporter had consented to follow up.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth, firmness, itching to injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Approximately 12 hours after receiving both the ZOSTAVAX and the SHINGRIX vaccines I experienced chills, dizziness, headache, nausea, non -productive vomiting, fatigue, extreme weakness. Following the SHINGRIX vaccine my reaction was much more severe, actually blacking out, fainting on the floor and apparently losing bladder control noticed after becoming coherent again. Fortunately my partner was there to assist and care for me, but I just slept on the floor for 4 hours as it aggravated the symptoms when I attempted to move. He said I was completely limp and could not hold myself up. I finally was able to get back in bed and slept another 4 hours. Other than a headache, sore arm and some fatigue I feel it has resolved at this time, about 23 hours after receiving the vaccine. I am a healthy active adult, quite fit through running, swimming, biking, skiing etc so this reaction was surprising to me as I have never had any reaction to a vaccine. I did have difficulty with donating blood at one time but don't think thats related.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotonia, Incoherent, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: Approximately 12 hours after receiving both the ZOSTAVAX and the SHINGRIX vaccines I experienced chills, dizziness, headache, nausea, non -productive vomiting, fatigue, extreme weakness. Following the SHINGRIX vaccine my reaction was much more severe, actually blacking out, fainting on the floor and apparently losing bladder control noticed after becoming coherent again. Fortunately my partner was there to assist and care for me, but I just slept on the floor for 4 hours as it aggravated the symptoms when I attempted to move. He said I was completely limp and could not hold myself up. I finally was able to get back in bed and slept another 4 hours. Other than a headache, sore arm and some fatigue I feel it has resolved at this time, about 23 hours after receiving the vaccine. I am a healthy active adult, quite fit through running, swimming, biking, skiing etc so this reaction was surprising to me as I have never had any reaction to a vaccine. I did have difficulty with donating blood at one time but don't think thats related.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Urinary incontinence, Vomiting
Clinical narrative: Approximately 12 hours after receiving both the ZOSTAVAX and the SHINGRIX vaccines I experienced chills, dizziness, headache, nausea, non -productive vomiting, fatigue, extreme weakness. Following the SHINGRIX vaccine my reaction was much more severe, actually blacking out, fainting on the floor and apparently losing bladder control noticed after becoming coherent again. Fortunately my partner was there to assist and care for me, but I just slept on the floor for 4 hours as it aggravated the symptoms when I attempted to move. He said I was completely limp and could not hold myself up. I finally was able to get back in bed and slept another 4 hours. Other than a headache, sore arm and some fatigue I feel it has resolved at this time, about 23 hours after receiving the vaccine. I am a healthy active adult, quite fit through running, swimming, biking, skiing etc so this reaction was surprising to me as I have never had any reaction to a vaccine. I did have difficulty with donating blood at one time but don't think thats related.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, HEP, MMRV
Symptoms: Injection site vesicles, Rash generalised, Rash papular
Clinical narrative: Developed approx 3 vesicular lesions left arm 3 days after vaccination. Developed mild widespread papular rash that spread from days 5-12 after vaccination. Treating with supportive care.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Chest pain, Hypoaesthesia, Injection site pain, Lethargy
Clinical narrative: Body aches in late day/evening. Woke up around 3am the next morning with aches, felt slightly nauseous and almost passed out, aching increased especially across my chest and arms, some numbness in hands, stabbing pain in chest, left shoulder. Took two Advil, pain eased and I was able to go back to sleep. Two more days of aches and feeling lethargic, feeling better every day after that. Arm is still a little sore.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Body aches in late day/evening. Woke up around 3am the next morning with aches, felt slightly nauseous and almost passed out, aching increased especially across my chest and arms, some numbness in hands, stabbing pain in chest, left shoulder. Took two Advil, pain eased and I was able to go back to sleep. Two more days of aches and feeling lethargic, feeling better every day after that. Arm is still a little sore.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Woke in middle of night with aches and chills. Pain at injection site. Fever up to 100.7 Symptoms lasted for 20 hours.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 14 year old female patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 28-DEC-2018, the patient was inadvertently vaccinated with an adult dose of VAQTA as her first dose in the series, lot # R022983 with expiration date on 09-AUG-2019 for prophylaxis (route of administration was not reported). However, no adverse effects were reported.