chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest X-ray normal, Myalgia, Pyrexia
Clinical narrative: On 05/07/209, Patient presented to Primary Care and received vaccination for shingles with Shingrix. The next day the Patient reported to the ED with complaints of fever of 100.8 at home, myalgia of the shoulder, and joint pain. No treatment was administered and CXR was negative for acute concerns.
Sex: M
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: It's been close to a month since I was injected with Prevnar 13, and I have been in pain since that day! Most troubling is the limited range of motion without pain, in the arm that was injected. Sharp pain is also experienced when moving my arm or at rest.
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Dysarthria, Electrocardiogram normal, Eyelid ptosis, Facial paralysis
Clinical narrative: I had the second dose .shingrix vaccine on October 21st. Within 12 hours, i felt ill, flu- like symptoms which lasted app 24 hrs. On December 1st, I experienced R cranial nerve pain and within 36 hrs I presented to an acute care hospital ER with a dx of r/o stroke - having symptoms of numbness around mouth, slurred speech, drooping R side mouth and severe drooping R eye, I am an otherwise healthy, active senior citizen with no hx of Bell's Palsy or other related dx.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Influenza like illness, Laboratory test normal, Malaise, Neuralgia
Clinical narrative: I had the second dose .shingrix vaccine on October 21st. Within 12 hours, i felt ill, flu- like symptoms which lasted app 24 hrs. On December 1st, I experienced R cranial nerve pain and within 36 hrs I presented to an acute care hospital ER with a dx of r/o stroke - having symptoms of numbness around mouth, slurred speech, drooping R side mouth and severe drooping R eye, I am an otherwise healthy, active senior citizen with no hx of Bell's Palsy or other related dx.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Audiogram abnormal, Deafness unilateral
Clinical narrative: Profound unilateral hearing loss pursuant to flu shot Second shot 11/07/19 resulted in further hearing loss in already affected ear 20 days later  Most recent repeat test 11/27/19 revealed further damage
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood count normal, Diarrhoea haemorrhagic, Occult blood positive
Clinical narrative: Acute on set of grossly bloody diarrhea. Breast feeding only. No change in infant's or Mom's diet.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient called today to report that she continues to have left arm/shoulder pain since her Prevnar vaccine in September. The pain started the day after administration. Tylenol improves the pain temporarily.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Influenza like illness, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Initial reaction was pain in the arm near the area of vaccination.  By the next day the pain was worse, I also started feeling flu like symptoms, body aches & fever By the second day I developed a rash that extended down to elbow. It was hot! Started antibiotics at this time.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Skin warm
Clinical narrative: Initial reaction was pain in the arm near the area of vaccination.  By the next day the pain was worse, I also started feeling flu like symptoms, body aches & fever By the second day I developed a rash that extended down to elbow. It was hot! Started antibiotics at this time.
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Dizziness, Tremor
Clinical narrative: DIARHEA DIZZINESS-FELL 5 TIMES CHILLS SHAKING DIDNT GET MEDICAL HELP
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever, aches, nausea SX's.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Death
Clinical narrative: PATIENT HAS PASSED AWAY
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Injection site erythema, Injection site pain, Post herpetic neuralgia
Clinical narrative: History of prior acute shingles two ears ago with post herpetic neuralgia She then had first Zoster vaccine every with Shingrix 11/6. After this she had sore red dot at Shingrix administration site. Then a week or so after, her chronic post herpetic neuralgia pain was much worse like she was having acute shingles again. She states one small fluid filled vesicle appeared in the anterior part of this dermatome. Over several weeks her post herpetic neuralgia pain returned to baseline.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: I had the second dose of the shingles vaccine almost a month ago and my arm is still in pain. It still feels like I've been punched very hard. I have difficulty sleeping because of the pain. I have no problem moving it but there's a constant ache. After second shot. First shot had arm pain for 3 to 5 days.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site swelling, Pain, Swelling
Clinical narrative: swelling at the injection site area; This spontaneous report was received from a registered nurse and refers to a 16-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 14-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621934, expiration date 29-JAN-2022, intramuscularly and with meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot # and expiration date were unknown) both for prophylaxis. The nurse stated that the vaccines were administered in the same arm, about one inch apart from each other. On 22-NOV-2019, the patient developed swelling at the injection site area. The patient received ibuprofen, cetirizine hydrochloride (ZYRTEC) and diphenhydramine hydrochloride (BENADRYL) as the treatment. The outcome of injection site swelling was reported as not recovered/not resolved. The causality assessment between the vent and suspect therapy was not provided.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: swelling at the injection site area; This spontaneous report was received from a registered nurse and refers to a 16-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 14-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621934, expiration date 29-JAN-2022, intramuscularly and with meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot # and expiration date were unknown) both for prophylaxis. The nurse stated that the vaccines were administered in the same arm, about one inch apart from each other. On 22-NOV-2019, the patient developed swelling at the injection site area. The patient received ibuprofen, cetirizine hydrochloride (ZYRTEC) and diphenhydramine hydrochloride (BENADRYL) as the treatment. The outcome of injection site swelling was reported as not recovered/not resolved. The causality assessment between the vent and suspect therapy was not provided.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, HPVX, MNQ, HPV9, MNQ
Symptoms: Injection site swelling
Clinical narrative: swelling at the injection site area; This spontaneous report was received from a registered nurse and refers to a 16-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 14-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621934, expiration date 29-JAN-2022, intramuscularly and with meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot # and expiration date were unknown) both for prophylaxis. The nurse stated that the vaccines were administered in the same arm, about one inch apart from each other. On 22-NOV-2019, the patient developed swelling at the injection site area. The patient received ibuprofen, cetirizine hydrochloride (ZYRTEC) and diphenhydramine hydrochloride (BENADRYL) as the treatment. The outcome of injection site swelling was reported as not recovered/not resolved. The causality assessment between the vent and suspect therapy was not provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Rash, Rash pruritic
Clinical narrative: Vaccination failure; got shingles; mild symptoms; Pain worsened; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. In July 2019, the patient received the 2nd dose of Shingrix. In November 2019, between 9 and 11 months after receiving Shingrix, between 3 and 5 months after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, general discomfort and pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, general discomfort and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the general discomfort and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provide. The patient was given Valrex 7 days with mild symptoms and after 7 days symtoms of pain worsened. The patient was on gabapentin, but still at the time of reporting was not symptom free .  The patient didn't knew if keeping records how effective vaccine was.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Vaccination failure; got shingles; mild symptoms; Pain worsened; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. In July 2019, the patient received the 2nd dose of Shingrix. In November 2019, between 9 and 11 months after receiving Shingrix, between 3 and 5 months after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, general discomfort and pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, general discomfort and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the general discomfort and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provide. The patient was given Valrex 7 days with mild symptoms and after 7 days symtoms of pain worsened. The patient was on gabapentin, but still at the time of reporting was not symptom free .  The patient didn't knew if keeping records how effective vaccine was.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Injection site urticaria, Malaise, Myalgia
Clinical narrative: Pt had severe onset of symptoms within 12 hours of vaccination. Symptoms of myalgia, malaise, joint pain, cough, sore throat, fever of 103', hives at the injection site, and an eruption of her cold sores in mouth and nose that were unresponsive to valacyclovir. These last for 24hrs and then were resolving. Three days later they returned at the same intensity as originally, they resolved after another 24hrs. The cough continued and was still active to date 12/18/19.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Pt had severe onset of symptoms within 12 hours of vaccination. Symptoms of myalgia, malaise, joint pain, cough, sore throat, fever of 103', hives at the injection site, and an eruption of her cold sores in mouth and nose that were unresponsive to valacyclovir. These last for 24hrs and then were resolving. Three days later they returned at the same intensity as originally, they resolved after another 24hrs. The cough continued and was still active to date 12/18/19.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported. Patient is not experiencing any symptoms.; an unspecified 19 year old patient received a second dose ofGARDASIL9 outside the recommended dosing schedule per the PI. Patient received her first dose of GARDASIL9 on 6/25/2019 and second dose on 7/22/2019.; Information has been received from a nurse via the company representative referring to a 19 years old female patient. The patient's medical history, concurrent condition and concomitant medications were not provided.      On 25-JUN-2019, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis. On 22-JUL-2019, the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis outside the recommended dosing schedule per the prescribing information (PI) (inappropriate schedule of product administration). No additional adverse effects was reported. Patient was not experiencing any symptoms.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient experienced no symptoms.; an expired dose of VAQTA was administered to a patient on 12/2/2019.; This spontaneous report has been received from a nurse refers to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 02-DEC-2019, the patient was vaccinated with a dose of expired hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unknown unit)(lot #: R034339, expiration date: 23-NOV-2019; strength, frequency and dose details were unknown) intramuscularly for prophylaxis (expired product administered). The patient experienced no symptoms.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse events; Administered one month after Prevnar 13; This spontaneous report was received from a registered nurse referring to a patient of an unknown age and gender. Information on the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. Historical drugs included PREVNAR 13 on 21-NOV-2018. On 21-DEC-2018 (reported as one month after receiving PREVNAR 13), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R011632, Expiry date: 02-FEB-2020 (dose, route and anatomical location were not reported) for prophylaxis (Inappropriate schedule of product administration). No adverse events reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse evnts; patient received expired dose of VAQTA; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 13-DEC-2019, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) (strength, dose, route of administration and anatomical location were unknown) with lot # R025518 and expiration date 15-NOV-2019 for prophylaxis (expired product administered). There were no known adverse events. There was no product quality complaint associated with the case.
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Muscular weakness
Clinical narrative: arm pain at the injection site and into the elbow; arm weakness; arm pain at the injection site and into the elbow; This spontaneous report was received from a physician referring to a 90-year-old male patient. The patient was allergic to tetracycline. The patient had no concomitant medication and no pertinent medical history.  On an unknown date in MAY 2018 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, frequency, lot# and expiration date were not reported) intramuscularly for routine prevention.  On an unknown date in MAY 2018 the patient began experiencing arm pain at the injection site and into the elbow, and arm weakness after the administration of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).   The patient sought medical attention in the physician's office and received treatment methylprednisolone(MEDROL) pack for the events. There was no lab diagnostics/studies performed. The outcome of the events was reported as not recovered. The causality assessment was not provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported; 1 patient was administered a dose of improperly stored RECOMBIVAX (R006746, exp: 11/09/2020) on 11/20/2019.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, concomitant therapies and drug allergies was not provided.  On 20-NOV-2019, the patient administered a dose of improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot# R006746, expiration date 09-NOV-2020; dose, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion was below 36 Fahrenheit degree (33.7 Fahrenheit degree) for 4 hours and 23 minutes. There was no previously temperature excursion. There was a data logger involved. No adverse symptoms were reported.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: injection site pain; injection site swelling; injection site warmth; bumps with a little fluid; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 8th November 2019, the patient received Shingrix (intramuscular). On 9th November 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site warmth. In November 2019, the patient experienced raised rash. On an unknown date, the outcome of the raised rash, injection site pain, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the raised rash, injection site pain, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were received as follows: The patient after vaccination noticed a bump with a little fluid come up on his wrist. The patient had continued to have bumps come up, all consistent in appearance. The bumps were mostly on his arms, with some on his ankles and 1to 2 on his thigh. The patient also has pain, swelling and heat at the injection site that started the day after the vaccine. The patient planed to visit an urgent care clinic regarding the bumps on his body.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: injection site pain; injection site swelling; injection site warmth; bumps with a little fluid; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 8th November 2019, the patient received Shingrix (intramuscular). On 9th November 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site warmth. In November 2019, the patient experienced raised rash. On an unknown date, the outcome of the raised rash, injection site pain, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the raised rash, injection site pain, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were received as follows: The patient after vaccination noticed a bump with a little fluid come up on his wrist. The patient had continued to have bumps come up, all consistent in appearance. The bumps were mostly on his arms, with some on his ankles and 1to 2 on his thigh. The patient also has pain, swelling and heat at the injection site that started the day after the vaccine. The patient planed to visit an urgent care clinic regarding the bumps on his body.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip blister, Paraesthesia, Rash
Clinical narrative: JB experienced tingling in the head region, states that he had a rash and had a blister on his lip.; rash; had a blister on his lip.; This case was reported by a pharmacist via sales rep and described the occurrence of tingling in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced tingling, rash and lip blister. On an unknown date, the outcome of the tingling, rash and lip blister were unknown.   It was unknown if the reporter considered the tingling, rash and lip blister to be related to Shingrix.  Additional details were provided as follows: The patient experienced tingling in the head region, states that he had a rash and had a blister on his lip. The reporter agreed to follow up.
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a other health professional via sales rep and described the occurrence of fever in an unspecified number of patients who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On an unknown date, the patient received Fluarix at an unknown dose. On an unknown date, unknown after receiving Fluarix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Fluarix.  Additional case details were reported as follows: This case was reported by medical assistant. The age at vaccination was not reported. The reporter did not give consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurts like crazy; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient reported that the arm hurts like crazy.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Contusion, Insomnia, Pain, Pain in extremity
Clinical narrative: On the left side of my body I have developed rashes; fluid filled blisters; These blisters in turn would pop and turn into bruises; pain from the skin down to her bone; severe pain in her arm; This case was reported by a consumer and described the occurrence of rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, couple of days after receiving Shingrix, the patient experienced rash, blister, contusion, pain and pain in arm. On an unknown date, the outcome of the rash, blister, contusion, pain and pain in arm were unknown.   The reporter considered the rash, blister, contusion and pain to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Couple of days after vaccination with dose of Shingrix, the patient had rash on left side of the body as well as fluid filled blisters. These blisters in turn would pop and turn into bruises. The patient had severe pain from  the skin down to bone where the blisters were occurring. The blisters were all on the left side of body, arm, breast and stomach. The blisters on breast and stomach have started drying up and the pain is improving, but still having severe pain in arm. The pain has been preventing from sleeping. The patient went to emergency room  and was told having an adverse reaction to Shingrix. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccination complication
Clinical narrative: On the left side of my body I have developed rashes; fluid filled blisters; These blisters in turn would pop and turn into bruises; pain from the skin down to her bone; severe pain in her arm; This case was reported by a consumer and described the occurrence of rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, couple of days after receiving Shingrix, the patient experienced rash, blister, contusion, pain and pain in arm. On an unknown date, the outcome of the rash, blister, contusion, pain and pain in arm were unknown.   The reporter considered the rash, blister, contusion and pain to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Couple of days after vaccination with dose of Shingrix, the patient had rash on left side of the body as well as fluid filled blisters. These blisters in turn would pop and turn into bruises. The patient had severe pain from  the skin down to bone where the blisters were occurring. The blisters were all on the left side of body, arm, breast and stomach. The blisters on breast and stomach have started drying up and the pain is improving, but still having severe pain in arm. The pain has been preventing from sleeping. The patient went to emergency room  and was told having an adverse reaction to Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: felt uncomfortable for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of discomfort in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient felt uncomfortable for a couple of days after the first dose of Shingrix. The reporter did not consent to follow up. This case has been linked to cases US2019228120 and US2019228122 reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vacination failure; Potential episode of Shingles; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number K2ZY4, expiry date 13th April 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. The patient received both doses of Shingrix within the time frame. It was necessary to report a possible scenario of Shingles on a patient. The reporter wanted to know, If an episode of Shingles was confirmed for this patient, it was told to the health care provider to report it and provide further information if it was necessary. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: pain at injection site; fever; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 8th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, fever and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years. After vaccination with Shingrix, had injection site pain, nausea and fever. The reporter consented to follow up. This case has been linked with case US2019224047, reported by same reporter for same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Fever Blisters broke out on face; This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, had fever blisters which broke out on face, around bottom lips after vaccination with dose of Shingrix. The patient asked, if could take Valtrex. The reporter did not consented to follow up
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Pain
Clinical narrative: Headache; Body-ache; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced headache, general body pain and injection site erythema. On an unknown date, the outcome of the headache, general body pain and injection site erythema were unknown.   It was unknown if the reporter considered the headache, general body pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, after vaccination with dose of Shingrix, the patient had headache, body-ache and redness at injection site. The reporter did not consent to follow up. This case has been linked with case US2019224139 reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Induration, Injection site reaction, Miliaria, Rash erythematous, Rash pruritic
Clinical narrative: large red rash around injection site; The spot is hard; The spot is itchy; hot spots; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 -3 months ago).   On 8th December 2019, the patient received the 2nd dose of Shingrix. On 11th December 2019, 3 days after receiving Shingrix, the patient experienced red rash, induration, itchy rash and heat rash. On an unknown date, the outcome of the red rash, induration, itchy rash and heat rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash, induration, itchy rash and heat rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a large red rash, the spot was 4 by 4 inches around the injection site.  The spot was hot, hard and itchy.  The patient could not lay on it or put pressure on it.  The spot seems to be growing a bit.
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: large red rash around injection site; The spot is hard; The spot is itchy; hot spots; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 -3 months ago).   On 8th December 2019, the patient received the 2nd dose of Shingrix. On 11th December 2019, 3 days after receiving Shingrix, the patient experienced red rash, induration, itchy rash and heat rash. On an unknown date, the outcome of the red rash, induration, itchy rash and heat rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash, induration, itchy rash and heat rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a large red rash, the spot was 4 by 4 inches around the injection site.  The spot was hot, hard and itchy.  The patient could not lay on it or put pressure on it.  The spot seems to be growing a bit.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: opthalmic zoster; This case was reported by a physician via sales rep and described the occurrence of ophthalmic zoster in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced ophthalmic zoster (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic zoster was recovered/resolved.   It was unknown if the reporter considered the ophthalmic zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was nor provided, The patient did not have any significant medical history for this patient. The patient was treated with Valtrex and the issue resolved without complications.   The patient was reluctant to get the second dose. There was discrepancy in the source document for the outcome of event ophthalmic zoster, as per xml sheet the outcome reported was recovered with sequel where as, as per argus the outcome reported was recovered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: he presented a case of shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week 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 details were received as follows: The age at vaccination was not reported. The patient within 4 days of the dose he presented a case of shingles. The patient gave permission to the GSK representative to report it but said he did not give permission to be contacted. The patient did not consent to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus
Clinical narrative: redness extending from the site down her arm; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 2B3P2, expiry date 10th May 2022) for prophylaxis.   On 14th December 2019, the patient received the 2nd dose of Shingrix. On 15th December 2019, 1 days after receiving Shingrix, the patient experienced injection site itching. On 16th December 2019, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities and injection site itching were unknown.   It was unknown if the reporter considered the erythema of extremities and injection site itching to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced itching at the site the following day and developed redness extending from the site down her arm.  The reporter consented to follow up. No further details were provided at the time of this call.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Tinnitus, Tremor
Clinical narrative: Woke up with  very strong shaking/vibrations  especially in upper body that I could not control. Was shortly able to get up.  Night lights in hallway and bathroom were extremely bright like someone had turned on the overhead lights (no one was home but me) and also heard loud chirping for a minute or more....I finally realized there was nothing actually making noise and that I was hearing the noise inside my head, but it was quite loud.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site pain
Clinical narrative: Flu like symptoms lasting approximately 6 hours followed by intense joint pain lasting 24 hours. Soreness at the injection site continues today 5 days after event.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Syncope
Clinical narrative: Vasovagal Syncope
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient was given the vaccination at 12 weeks gestation; provider was aware of pregnancy at time of vaccination. Error was not discovered/reported to administration until 12/18/19. Patient has had a normal/problem-free pregnancy so far and has not had any adverse events. Patient is being monitored by high-risk pregnancy facility due to her age and comorbid conditions that require she takes medications throughout pregnancy. The high-risk facility has been notified of the vaccine error.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, HEP, HIBV, HIBV, PNC13, PNC13, RV5, RV5
Symptoms: Anaphylactic reaction, Coma, Dyskinesia, Hypersensitivity, Loss of consciousness
Clinical narrative: Life threating allergic reaction of Anaphylaxis, full body jerking seizure lasting over an hour, loss of consciousness. Taken to ER, coma lasting one week.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, HEP, HEP, HIBV, HIBV, PNC13, PNC13, RV5, RV5
Symptoms: Seizure
Clinical narrative: Life threating allergic reaction of Anaphylaxis, full body jerking seizure lasting over an hour, loss of consciousness. Taken to ER, coma lasting one week.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Confusional state, Dizziness
Clinical narrative: Fever, headache,chills, body ache, dizziness, nausea, lightheartedness, confusion,difficulty breathing, GI distress and weakness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Fever, headache,chills, body ache, dizziness, nausea, lightheartedness, confusion,difficulty breathing, GI distress and weakness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever, headache,chills, body ache, dizziness, nausea, lightheartedness, confusion,difficulty breathing, GI distress and weakness.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Influenza like illness, Lip swelling, Pain, Pyrexia
Clinical narrative: on 12/17/19 I Obtained 2nd dose (shot) of Recombinant Zoster SHINGRIX at 0830am at Dr. First dose there was only achy feel and sort arm where shot was administered. Began feeling "flu-like" at 5pm. At 8pm I felt flu like, feverish, achy, stomach ache and minor swollen lips ( not visible but felt it ) . I took 2 Benedryl and went to sleep . At 0030am on 12/18/19 I felt worse and had a solid (not dots) rash on Neck, Inside Elbows, inside forearm, Torso, armpits, thighs. At 0700am I felt worse and rash continued and slightly itchy but not enough to scratch. Took 2 tablets of Benedryl To date 12/19 the rash continues but flu like symptoms have subsided. On 12/19 I did notify my physician Dr I do get similar reactions to NSIADS, Zinc, Penecillin
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: on 12/17/19 I Obtained 2nd dose (shot) of Recombinant Zoster SHINGRIX at 0830am at Dr. First dose there was only achy feel and sort arm where shot was administered. Began feeling "flu-like" at 5pm. At 8pm I felt flu like, feverish, achy, stomach ache and minor swollen lips ( not visible but felt it ) . I took 2 Benedryl and went to sleep . At 0030am on 12/18/19 I felt worse and had a solid (not dots) rash on Neck, Inside Elbows, inside forearm, Torso, armpits, thighs. At 0700am I felt worse and rash continued and slightly itchy but not enough to scratch. Took 2 tablets of Benedryl To date 12/19 the rash continues but flu like symptoms have subsided. On 12/19 I did notify my physician Dr I do get similar reactions to NSIADS, Zinc, Penecillin
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: on 12/17/19 I Obtained 2nd dose (shot) of Recombinant Zoster SHINGRIX at 0830am at Dr. First dose there was only achy feel and sort arm where shot was administered. Began feeling "flu-like" at 5pm. At 8pm I felt flu like, feverish, achy, stomach ache and minor swollen lips ( not visible but felt it ) . I took 2 Benedryl and went to sleep . At 0030am on 12/18/19 I felt worse and had a solid (not dots) rash on Neck, Inside Elbows, inside forearm, Torso, armpits, thighs. At 0700am I felt worse and rash continued and slightly itchy but not enough to scratch. Took 2 tablets of Benedryl To date 12/19 the rash continues but flu like symptoms have subsided. On 12/19 I did notify my physician Dr I do get similar reactions to NSIADS, Zinc, Penecillin
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Influenza like illness, Lip swelling, Pain, Pyrexia
Clinical narrative: Patient reported rash in the bilateral armpits, forearm, elbow, torso, neck, and upper thigh. As well as flu-like symptoms
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient reported rash in the bilateral armpits, forearm, elbow, torso, neck, and upper thigh. As well as flu-like symptoms
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: Patient reported rash in the bilateral armpits, forearm, elbow, torso, neck, and upper thigh. As well as flu-like symptoms
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A Hepatits B vaccine was ordered for this pt. however, the nurse inadvertently administered an influenza vaccine to the pt.  There was NO negative side effects reported.  This error was reported to poison control as well as the Immunization Branch who advised us to complete this form.  The mother has been made aware and reports no negative reactions.  Pt is doing well.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Patient reports redness, swelling, pain and heat of upper arm and shoulder starting the day of immunization and lessening over the next two days. Also reports body aches starting two days post injection and some throat itching. Some swelling, tenderness, and throat itching persist now, 3 days post injection.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Throat irritation
Clinical narrative: Patient reports redness, swelling, pain and heat of upper arm and shoulder starting the day of immunization and lessening over the next two days. Also reports body aches starting two days post injection and some throat itching. Some swelling, tenderness, and throat itching persist now, 3 days post injection.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional adverse events; a 2 month old patient was administered PNEUMOVAX 23 instead of PREVNAR 13; a 2 month old patient was administered PNEUMOVAX 23 instead of PREVNAR 13; This spontaneous report was received from a registered nurse and refers to a 2-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 19-NOV-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # S026366, expiration date 17-SEP-2020 (vaccination site and route of administration were not reported) for prophylaxis. The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). This was not a product confusion. No additional adverse events were reported.  The outcome was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: she inadvertently was given a GARDASIL 9 shot and she is 36 weeks pregnant; she was supposed to receive the Rhogam vaccine and got the gardasil 9; This spontaneous prospective pregnancy report refers to a 33-year-old female patient reporting on herself. The patient had no concomitant medications, she was allergic to penicillin and her medical history included penicillin treatment.  On 18-NOV-2019, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 shot (lot#, expiry date, anatomical location, route of administration were not reported) and she was 36 weeks pregnant. The patient was supposed to receive RHOGAM (unspecified) vaccine, and got hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) instead. The last menstrual period (LMP) was estimated as 11-MAR-2019. The estimated date of delivery (EDD) was 16-DEC-2019. At the time of the report the outcome of pregnancy was unknown.