chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse effect; inadvertently administered a dose of Pneumovax 23 instead of second dose of Prevnar 13; This spontaneous report was received from a pharmacist referred to a 5-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 23-NOV-2019, the patient was inadvertently vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), for prophylaxis (route, lot # and expiry date were not reported) instead of administering the second dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (co-suspect product) (dose, route, lot # and expiry date were not reported) (wrong product administered). There were no adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms.; on 12/8/2019 an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a pharmacist (also reported as nurse) referring to a patient of unknown age and gender.  Concomitant therapies included sterile diluent.  Information about pertinent medical history, drug reactions or allergies was not provided.           On 08-DEC-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S022758, expiration date 22-JUL-2021, dosage detail and strength was not provided) subcutaneously for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion of 23 degrees Fahrenheit (F) for 14 hours. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect.; the patient ws inadvertently administered a dose of VARIVAX on 12/4/2019, that had been improperly stored.; This spontaneous report was received from an immunization coordinator referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent.  Information about pertinent medical history, drug reactions or allergies was not provided.     On 04-DEC-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S020464, expiration date 02-JUL-2021, dosage detail, route and strength was not provided) for prophylaxis.  The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion of -2.1 degrees Celsius (C) for 4 hours 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not experience any symptoms. NO Additional adverse effect reported.; 19 year old patient was administered a dose of pediatric VAQTA; 19 year old patient was administered a dose of pediatric VAQTA; This spontaneous report was received from a nurse referring to a 19 years old patient. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.      On 25-NOV-2019, the patient was vaccinated with a dose of pediatric hepatitis a vaccine, inactivated (VAQTA) (lot # S002506, expiration date 04-APR-2020; dose and route were not provided) intramuscular for prophylaxis (incorrect dose administered and product administered to patient of inappropriate age). Patient did not experience any symptoms. No additional adverse effect reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms were reported; received the third dose in the GARDASIL-9 series three days early; This spontaneous report as received from a consumer referring to her son of unknown age.  The patient's pertinent medical history, concomitant medications, concurrent condition and drug reactions/allergies were not reported. On 07-DEC-2019 (three days early), the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis (inappropriate schedule of product administration).  No additional adverse symptoms were reported. No product quality complaint (PQC) was reported. No other information was available.
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: severe pain at the injection site; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.       On an unknown date the patient experienced injection site pain.    The outcome of injection site pain is unknown.        This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA006344: US-009507513-1912USA006286:
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: severe pain at the injection site; This spontaneous report was received from a medical assistant via company representative refers to an elderly patient of unknown age. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, lot#, expiry date, route of administration and anatomical locations were unknown) for prophylaxis. On an unknown date, the patient experienced severe pain at the injection site (injection site pain). The outcome of injection site pain was unknown. The reporter's causality was not reported. No product quality complaint (PQC) reported for this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA006344: US-009507513-1912USA006268: US-009507513-1911USA006344:
Sex: U
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Rash
Clinical narrative: rash on the torso; canker sores; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received Shingrix. On 5th December 2019, 3 days after receiving Shingrix, the patient experienced rash. In December 2019, the patient experienced aphthous stomatitis. On an unknown date, the outcome of the rash and aphthous stomatitis were unknown.   It was unknown if the reporter considered the rash and aphthous stomatitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that on monday bofore the day of reporting, the patient received Shingrix vaccine and in the morning after got out of shower on the day of reporting experienced rash. The patient reported that, at the time of reporting the rash was not itchy and painful. The patient asked, if it was common to develop a rash on the torso or canker sores after receiving the shot. Less than a week after vaccination, the patient experienced aphthous stomatitis. The patient reported that, would call to the physician if the symptoms worsen and did not care to give out that in formation online.
Sex: M
Vaccine: TDAP
Symptoms: Mitochondrial cytopathy, Seizure
Clinical narrative: Diagnosed with acquired mitochondrial phosphorylation; Seizure; This case was reported by a consumer via interactive digital media and described the occurrence of mitochondrial cytopathy in a male patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced mitochondrial cytopathy (serious criteria GSK medically significant) and seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the mitochondrial cytopathy and seizure were unknown.   It was unknown if the reporter considered the mitochondrial cytopathy and seizure to be related to dTpa vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's wife. The reporter trying to informed how the DTP vaccine injured every member of her family. The patient experienced seizures right after one he received at work and later was diagnosed with acquired mitochondrial phosphorylation. The follow up was not required. This is 1 of the 4 linked cases reported by the same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Autoimmune thyroid disorder
Clinical narrative: Early auto immune thyroid; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune thyroid disorder in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced autoimmune thyroid disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune thyroid disorder was unknown.   It was unknown if the reporter considered the autoimmune thyroid disorder to be related to dTpa vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient trying to informed how the DTP vaccine injured every member of her family. The patient experienced early auto immune thyroid. The follow up was not required. This is 1 of the 4 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: Hearing loss; This case was reported by a non-health professional and described the occurrence of hearing loss unilateral in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced hearing loss unilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss unilateral was unknown.   It was unknown if the reporter considered the hearing loss unilateral to be related to Shingrix.  Aditional information was received as follows: The age at vccination was not reported. The patient received Shingrix and experienced hearing loss to his right ear post immunization.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Rash
Clinical narrative: Rash; Pain on the lower side of the belly; This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In November 2019, less than 4 months after receiving Shingrix, the patient experienced rash and lower abdominal pain. On an unknown date, the outcome of the rash and lower abdominal pain were unknown.   It was unknown if the reporter considered the rash and lower abdominal pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not provided but the patient could be 79 to 80 years. About a week before the time of reporting, the patient broke out with rash and pain on the lower left side of the belly.  The patient had gone to see his physician the day before reporting and had been prescribed medication for it. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: injection site swelling; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd August 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, fever and chills. On 25th August 2019, the outcome of the fever and chills were recovered/resolved. On 5th September 2019, the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix on her right arm. The patient developed injection site swelling that lasted 2 weeks then resolved. she also developed fever and chills and those lasted for three days then resolved. The consumer did not have vaccine information for this adverse event. She stated that she received the vaccine at Pharmacy, but wanted the health care professional to follow up to be her physician. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness; swollen; tender; warm area; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 4th December 2019, 2 days after receiving Shingrix, the patient experienced erythema, swelling, tenderness and skin warm. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the swelling, tenderness and skin warm were unknown.   It was unknown if the reporter considered the erythema, swelling, tenderness and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient stated that, after vaccination with dose of Shingrix, had red, swollen, tender, warm  area 2 to 3 inches belowthe injection site. The patient received vaccine at reported pharmacy. The patient consented to follow up with health care professional.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Rash; Bumps; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) (batch number EG55L, expiry date 7th December 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 5H39T, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Shingrix and Fluarix Quadrivalent 2019-2020 season. On an unknown date, couple of days after receiving Shingrix and Fluarix Quadrivalent 2019-2020 season, the patient experienced rash, swelling and pruritus. On an unknown date, the outcome of the rash, swelling and pruritus were recovered/resolved.   It was unknown if the reporter considered the rash, swelling and pruritus to be related to Shingrix and Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix was updated as EG55L from  E655L as per sale's data sheet. On 4th December 2019, the pharmacist called regarding the patient received Shingrix and Fluarix vaccine on the same day, and few days after experienced rash, bumps and itching . The reporter stated that, symptoms took a week to go away. The reporter mentioned that the patient did not know if there were shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Arm soreness at the injection site; Fever of 100.5; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 47XJ3, expiry date 30th April 2020) for prophylaxis.   On 3rd December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd December 2019, 12 hrs after receiving Shingrix, the patient experienced injection site pain, fever and shivering. Rechallenge with Shingrix was positive. On 4th December 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the injection site pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever and shivering to be related to Shingrix.  Additional details were provided as follows: The patient reported that after vaccination had arm soreness at the injection site, fever 100.5 and shivering. The patient stated that, at the time of reporting, the shivering has resolved, but other symptoms were on going. The reporter did not consent to follow up. This case was 1 of 3 linked cases.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Immediate post-injection reaction
Clinical narrative: Anaphylaxis; This case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 2DB5X, expiry date 30th June 2020) for prophylaxis.   On 11th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 11th October 2019, immediately after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced anaphylaxis (serious criteria GSK medically significant). The patient was treated with epinephrine, steroids nos (Steroids) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis was recovered/resolved.   It was unknown if the reporter considered the anaphylaxis to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows:  This case was reported by the medical assistant. The patient received Fluarix Quadrivalent 2019-2020 season vaccine in an unknown arm. The patient went to the emergency room, where he was treated with Epinephrine, IV steroids, and Benadryl.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic kidney disease, Dialysis
Clinical narrative: Unsure if patient had CKD prior to receiving Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of chronic kidney disease in a elderly female patient who received Herpes zoster (Shingrix) (batch number 477Z7, expiry date 7th December 2021) 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 chronic kidney disease (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the chronic kidney disease was unknown.   It was unknown if the reporter considered the chronic kidney disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. It was reported that the patient started dialysis after 1st dose of Shingrix, and the patient was in the hospital for unknown reason.  He was unsure if patient had chronic kidney disease (CKD) prior to receiving Shingrix. The batch number of Shingrix was reported as 47727, but it was changed to 477Z7 as per sales data sheet. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle twitching
Clinical narrative: muscle fiber twitching; This case was reported by a consumer via call center representative and described the occurrence of muscle twitching in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th November 2019, 21 days after receiving Shingrix, the patient experienced muscle twitching. On an unknown date, the outcome of the muscle twitching was not recovered/not resolved.   It was unknown if the reporter considered the muscle twitching to be related to Shingrix.  Additional details were reported as follows: The patient planned to follow-up with a neurologist. Reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in 31st January 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The patient received 1st dose in 31st January, till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. Reporter consented to follow up. This case was considered as medication error without harm.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Autoimmune disorder, Lyme disease, Pain
Clinical narrative: full auto immune disease; Lyme's disease; lot of aches and pains; Initial information received on 24-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 63 years old female patient (going to be 65 in January and reaction was to last year flu vaccine) who experienced full auto immune disease (autoimmune disorder) and lyme's disease (lyme's disease), while she received vaccines VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and INFLUENZA VACCINE (INFLUENZA VACCINE).  The patient medical history, concomitant therapy, medical treatment(s), and family history were not provided.  Patient has had autoimmune reaction to influenza vaccine administered prior to last year as well.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient received a dose  dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route.  On an unknown date, The patient developed a serious full auto immune disease (autoimmune disorder) and lyme's disease (lyme disease) with lot of aches and pains (pain) Unknown latency following the administration of INFLUENZA VACCINE and SHINGRIX. These events were assessed as medically significant.  No lab test reported.  Final diagnosis was lyme's disease and full auto immune disease.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  Information on the batch number was requested.; Sender's Comments: Patient experienced unspecified autoimmune disorder and Lyme's disease after vaccination. Time to onset is compatible with the role of the vaccine. However, further information including patient's concomitant medications, laboratory investigations excluding other etiology would be needed to fully assess this case. Lyme's disease is an infectious disease and cannot be causally associated with the vaccine; it can be a confounding factor for the occurrence of autoimmune disorder as well. Based on available information the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX, PNC13, PPV, VARZOS
Symptoms: Decreased immune responsiveness
Clinical narrative: Diagnosis of decreased immune system; This case was reported by a pharmacist via other manufacturer and described the occurrence of decreased immune responsiveness in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOVAX) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Shingrix, PREVNAR 13 and PNEUMOVAX. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix, the patient experienced decreased immune responsiveness. On an unknown date, the outcome of the decreased immune responsiveness was unknown.   It was unknown if the reporter considered the decreased immune responsiveness to be related to Influenza vaccine Quadrivalent unspecified season and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient received Flu, Shingrix and Prevnar 13, Pneumovax vaccine at one time and went to the hospital with a diagnosis of decreased immune system. The reporter consented to follow up.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Arthralgia, Arthritis, Candida infection, Condition aggravated
Clinical narrative: Lupus flare; Rash / Rash itches as it fades; Arthritis aches; Headaches; Interfered with my sleep; Skins continued to itch; This case was reported by a consumer via call center representative and described the occurrence of sle flare in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nonspecific reaction (received 1st dose on 28th August 2019). Concurrent medical conditions included systemic lupus erythematosus (from many years and had to be very patient to get back to normal).   On 30th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced sle flare (serious criteria GSK medically significant), itchy rash, pruritus, arthritis, headache and sleeplessness. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the sle flare, itchy rash, arthritis, headache and sleeplessness were recovering/resolving and the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the sle flare, itchy rash, pruritus, arthritis, headache and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient had 2nd injection and had severe reaction that caused Lupus flare rash, arthritis aches, headaches beginning the next day, the rah itched as it faded and the skin continued to itch for 4 o 5 weeks afterwards which interfered with sleep. The patient had already informed about the lupus but was told that it did not mattered, which was after the patient checked it out with the person who gave injection and told that there were no reported side effects from the injections. The patient used cortisone cream n on the reaction which caused her thrush. The patient received additional medicines for that it went on and on. The side effects were not completely resolved
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Pruritus, Rash pruritic, Systemic lupus erythematosus
Clinical narrative: Lupus flare; Rash / Rash itches as it fades; Arthritis aches; Headaches; Interfered with my sleep; Skins continued to itch; This case was reported by a consumer via call center representative and described the occurrence of sle flare in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nonspecific reaction (received 1st dose on 28th August 2019). Concurrent medical conditions included systemic lupus erythematosus (from many years and had to be very patient to get back to normal).   On 30th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced sle flare (serious criteria GSK medically significant), itchy rash, pruritus, arthritis, headache and sleeplessness. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the sle flare, itchy rash, arthritis, headache and sleeplessness were recovering/resolving and the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the sle flare, itchy rash, pruritus, arthritis, headache and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient had 2nd injection and had severe reaction that caused Lupus flare rash, arthritis aches, headaches beginning the next day, the rah itched as it faded and the skin continued to itch for 4 o 5 weeks afterwards which interfered with sleep. The patient had already informed about the lupus but was told that it did not mattered, which was after the patient checked it out with the person who gave injection and told that there were no reported side effects from the injections. The patient used cortisone cream n on the reaction which caused her thrush. The patient received additional medicines for that it went on and on. The side effects were not completely resolved
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and presented with shingles symptoms on approximately day 4 or 5.  The reporter asked what was the recommendation for the timing of his 2nd Shingrix dose.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: itchy rashes; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 16th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 1 week after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and about 1 week after getting the vaccine the patient developed itchy rashes on different areas of her body. She still has the rashes.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Red patches and swelling of left upper arm  Significant pain in left arm, collar bone and shoulder (unable to lift arm above head without severe pain) Tried Benadryl with no improvement Video visit w/ doctor (Online) on afternoon of 11/3/2019 Assessment by Dr.: Concern for possible cellulitis vs allergic reaction. Unclear which at this time. No symptoms suggestive of anaphylaxis. Will treat for possible infection with doxycycline and have her continue Benadryl 25mg 2X daily as needed.  Improvement after 2nd day of doxycycline. Symptoms cleared after 7 days.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Fall, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Started with weakness in legs, and by November 12 had severe balance problems and legs could not hold him. Went to the ER they sent him home, he fell at home. Had to have EMS come and take him to the hospital. From  hospital they sent him to different hospital because he wouldn't walk. The doctor there, Dr. sent him back to first hospital because he was getting weaker. First hospital sent him back to different hospital even though he could not walk or sit up and was loosing feeling in his hands. Was sent back to first hospital where was  than dignosed with Gilliam Barre Disease by the Neurologist Dr. at hospital. Was moved to Hospital for rehabilitation where Dr. attributed this diagnoses to the Flu Shot. He is still there for rehab.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Sensory loss, Spinal operation
Clinical narrative: Started with weakness in legs, and by November 12 had severe balance problems and legs could not hold him. Went to the ER they sent him home, he fell at home. Had to have EMS come and take him to the hospital. From  hospital they sent him to different hospital because he wouldn't walk. The doctor there, Dr. sent him back to first hospital because he was getting weaker. First hospital sent him back to different hospital even though he could not walk or sit up and was loosing feeling in his hands. Was sent back to first hospital where was  than dignosed with Gilliam Barre Disease by the Neurologist Dr. at hospital. Was moved to Hospital for rehabilitation where Dr. attributed this diagnoses to the Flu Shot. He is still there for rehab.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: PATIENT WAS SEEN IN THE OFFICE BY HER HEALTHCARE PROVIDER WHOM CALLED ME AND TOLD ME THAT SHE STARTED WITH A ITCHY WIDESPREAD RASH ON NECK, SCALP AND ARM PITS. THE RASH WAS STARTING TO COME DOWN HER ARMS AS WELL WHEN SEEN. SHE GOT THE RASH A COUPLE OF DAYS AFTER THE VACCINATION AND DID NOT REPORT IT UNTIL HER APPOINTMENT ON 12/12/19. THE DOCTOR WAS NOT CLEAR IF IT WAS VACCINE RELATED OR NOT SO WE ARE REPORTING.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Ileocolic Intussusception
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: severe swelling and redness from shoulder to elbow on left arm; pain. moved from injection site to interior aspect of left arm to elbow and slightly below over next 8 hours. fluid filled. applied ice. resolution began after 48 hours and is better but not completely resolved  by 12/13  10:30. Never had such a severe reaction to vaccines.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; first dose on 11/8/18, her second dose was on 2/7/2019 and her third dose was on 11/13/2019; This spontaneous report was received from a female patient of unknown age reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 08-NOV-2018, 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) (route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis. On 07-FEB-2019, she received the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis, and on 13-NOV-2019, the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis was administered (inappropriate schedule of product administration). No adverse effects were reported.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: No additional adverse effects reported; both of which were over the age of 12, were administered one dose of PROQUAD each; both of which were over the age of 12, were administered one dose of PROQUAD each; This spontaneous report has been received from a nurse, referring to a 16 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date in October 2019 (reported as last month), the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, route, lot# and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age and product use issue). No additional adverse effects reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA008978:
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via eye contact, Occupational exposure to product, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: the syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye; feeling that her left eye was swollen underneath the eyelid and a little red on the inside corner of the eye; The syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye; the syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye; the syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye; This spontaneous report was received from an unspecified person referring to a 26-year-old female patient (nurse). The patient's concurrent conditions, medical history, drug allergies/ reaction and concomitant medications were not reported. On 25-NOV-2019, the patient was getting ready to draw up measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, formulation, dose/frequency, route were not reported) lot # S012944, expiry date:28-APR-2019 for prophylaxis into the syringe. When the nurse began reconstituting the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with the sterile diluent the syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye (occupational exposure to product, exposure via eye contact and accidental exposure to product ). She washed the affected eye for about two minutes. On the same day, patient reported that her left eye was swollen underneath the eyelid and a little red on the inside of the eye (ocular hyperaemia and swelling of eyelid). The patient flushed her eye with water and sought medical attention from physician. The outcome of the events ocular hyperaemia, exposure via eye contact, accidental exposure to product, occupational exposure to product and swelling of eyelid was unknown. The causality of the events ocular hyperaemia and swelling of eyelid was unknown with respect to suspect therapy Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; a patient was administered an improperly stored dose of VARIVAX; Route of Administration: "intramuscular"; This spontaneous report was received from an administrator (also reported as healthcare business professional) referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent.  Information about pertinent medical history, drug reactions or allergies was not provided.      On 06-DEC-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S012036, expiration date 17-APR-2021, dosage detail and strength was not provided) intramuscularly for prophylaxis (product storage error, incorrect route of product administration). Administered doses of vaccine experienced temperature excursion of -10.6 degrees Celsius (C) for 24 minutes. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events; patient received PROQUAD today after received MMR II at age of 12 months old; This spontaneous report was received from a registered nurse referring to a child patient of unknown age and gender. The patient's historical vaccine included two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). Information regarding the patient's pertinent medical history and concomitant medications were not provided. On 10-DEC-2019 (reported as "today"), the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rha (PROQUAD) (extra dose administered) (strength, dose #, schedule and route of administration were not reported) lot # S027464 expiration date not reported, but upon internal validation established as 02-MAR-2021 for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients experience flu like symptoms after receiving Shingrix. The reporter stated that this was more common in 50-59 year olds and less frequent in those over 70 years of age. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain
Clinical narrative: developed intercostal pain 3 hours after receiving the shingles vaccine; This case was reported by a consumer via call center representative and described the occurrence of intercostal pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced intercostal pain. On an unknown date, the outcome of the intercostal pain was unknown.   It was unknown if the reporter considered the intercostal pain to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and after 3 hours developed intercostal pain.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: localized red and painful area about 1.5 inches in diameter; localized red and painful area about 1.5 inches in diameter; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced localized erythema and pain. On an unknown date, the outcome of the localized erythema and pain were unknown.   It was unknown if the reporter considered the localized erythema and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shringrix 36 hours before the time of reporting  The patient had localized red and painful area about 1.5 inches in diameter, about 1 inch below injection site. Injection site was clear.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Immediate post-injection reaction, Injury associated with device, Occupational exposure to product
Clinical narrative: she pricked her thumb with the needle; Inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of needle injury in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced needle injury, occupational exposure while administering product and exposure via skin contact. On an unknown date, the outcome of the needle injury, occupational exposure while administering product and exposure via skin contact were unknown.   It was unknown if the reporter considered the needle injury to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported she had an accident after reconstitution of Shingrix, she pricked her thumb with the needle. This led to occupational exposure while administering product and exposure via skin contact. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin ulcer, Wound secretion
Clinical narrative: shingles; oozing sores; sore; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles, wound secretion and skin ulcer. On an unknown date, the outcome of the shingles, wound secretion and skin ulcer were unknown.   It was unknown if the reporter considered the shingles, wound secretion and skin ulcer to be related to Shingrix.  Additional details were provided as follows:  This case was reported by the patient's friend. The age at vaccination was not reported. The reporter didn't know his exact age but said it was somewhere around 70s. Two to three days after vaccination, the patient got Shingles from the vaccine.  He had sores that were oozing.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: couple of bumps; This case was reported by a consumer via call center representative and described the occurrence of swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. Recently from the date of reporting, the patient received a dose of Shingrix and developed a couple of bumps afterwards. The reporter declined to provide any personal information for this case.  No other details are available, caller disconnected. The follow up consent was not granted. This case has been linked with case US2019222796, reported by same reporter.