chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Lip swelling, Musculoskeletal pain, Nausea
Clinical narrative: Extreme nausea, dizziness, chills, fever and pain in shoulder as well as pain in other areas of body.  Swollen face and lips are extremely swollen
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling face
Clinical narrative: Extreme nausea, dizziness, chills, fever and pain in shoulder as well as pain in other areas of body.  Swollen face and lips are extremely swollen
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site mass, Injection site pain, Injection site paraesthesia
Clinical narrative: RASH STARTED EVE OF SHOT ABOUT 1 AND 1/2 TO 2 INCH FROM INJECTION SITE. ITCHY, SWOLLEN, LUMP IN THAT AREA FOR DAYS AND HAS DIMINISHED AND RETURNED HERE AND THERE.  AS OF TODAY, IT'S A DIME SIZED RASH AND INCREASING IN ITCHINESS. STILL SORE TODAY AS WELL.  NOT CERTAIN WHICH DAY THE NEXT REACTION STARTED, BUT REPORTS NUMBNESS/TINGLING/FALLING ASLEEP FEELING FROM SHOULDERS TO PALMS OF HANDS OF BOTH ARMS, THIS IS BECOMING MORE FREQUENT AND CONSTANT.  ADVISED PATIENT TO TRY BENADRYL AND HYDROCORTISONE FOR RASH/ITCHING, AND TO CONTACT PCP REGARDING THE NUMBNESS.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Paraesthesia
Clinical narrative: RASH STARTED EVE OF SHOT ABOUT 1 AND 1/2 TO 2 INCH FROM INJECTION SITE. ITCHY, SWOLLEN, LUMP IN THAT AREA FOR DAYS AND HAS DIMINISHED AND RETURNED HERE AND THERE.  AS OF TODAY, IT'S A DIME SIZED RASH AND INCREASING IN ITCHINESS. STILL SORE TODAY AS WELL.  NOT CERTAIN WHICH DAY THE NEXT REACTION STARTED, BUT REPORTS NUMBNESS/TINGLING/FALLING ASLEEP FEELING FROM SHOULDERS TO PALMS OF HANDS OF BOTH ARMS, THIS IS BECOMING MORE FREQUENT AND CONSTANT.  ADVISED PATIENT TO TRY BENADRYL AND HYDROCORTISONE FOR RASH/ITCHING, AND TO CONTACT PCP REGARDING THE NUMBNESS.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse drug reaction, Injection site bruising, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: PATIENT HAD A BRUISE ON LEFT ARM AT INJECTION SITE MAINLY BECAUSE TAKING ASPIRIN. ALSO, HAD A RED RASH THAT WAS VISIBLE FROM BRUISE TO ELBOW. WAS HOT TO TOUCH ON 6/18, BUT WAS BETTER TODAY 6/19. THEY PUT ICE AND BENADRYL CREAM ON IT.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site bruising, Injection site pain
Clinical narrative: According to the patient, the administering pharmacist gave the first vaccination of the series SUBCUTANEOUS instead of INTRAMUSCULARLY.  Patient came for 2nd dose (3 months after incident) and made this known to the pharmacy staff. She complained of serious bruising and pain around the injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Eye irritation, Hyperhidrosis, Malaise
Clinical narrative: Very sick, high fever, eyes were dark red burning, body in serious pain for 2 weeks.  Pain in back and stomach.  Sweats very bad, in bed for 2 weeks
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Very sick, high fever, eyes were dark red burning, body in serious pain for 2 weeks.  Pain in back and stomach.  Sweats very bad, in bed for 2 weeks
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash around pectoral about 2 days after vaccination on the same side as the vaccination. The vaccine was a Tdap booster, but I'm unsure as to which brand. Previously I received Adacel, but this was my first visit to a new primary care provider
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: Rash, Urticaria Pruritus & URTICARIA; RASH; SWELLING OF ARM
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injected limb mobility decreased, Injection site inflammation, Injection site pain, Insomnia
Clinical narrative: Three hours after vaccination, patient experienced discomfort (shoulder and arm felt on fire) felt like the shoulder was dislocated. patient almost went to urgent care. Patient could not sleep or find comfortable position. This pain continued at the same intensity for a couple more days, then she called Pharmacy and RPh on duty recommended she take ibuprofen, patient complied but this treatment did not alleviate pain. She went to her PCP that Friday because pain was intolerable, MD found inflammation in upper arm, and said MD said vaccine had been injected into patient's joint, instead of Deltoid muscle. MD recommended patient continue using ibuprofen. Pain in upper arm and shoulder continues to this day 6/19/19, and can only lift arm up halfway, cannot rotate arm yet.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal discomfort, Product administered at inappropriate site
Clinical narrative: Three hours after vaccination, patient experienced discomfort (shoulder and arm felt on fire) felt like the shoulder was dislocated. patient almost went to urgent care. Patient could not sleep or find comfortable position. This pain continued at the same intensity for a couple more days, then she called Pharmacy and RPh on duty recommended she take ibuprofen, patient complied but this treatment did not alleviate pain. She went to her PCP that Friday because pain was intolerable, MD found inflammation in upper arm, and said MD said vaccine had been injected into patient's joint, instead of Deltoid muscle. MD recommended patient continue using ibuprofen. Pain in upper arm and shoulder continues to this day 6/19/19, and can only lift arm up halfway, cannot rotate arm yet.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Nodule, Pain, Tenderness
Clinical narrative: 6/10/209, 1130 hrs. Clinic evaluation by NP re: "palpable node, left clavicle region within 1 week of receiving vaccination. No other signs or symptoms inflammation, redness noted at injection site on left deltoid. Pt reports pain when raising left arm and shoulder, tender when palpating nodes. No report of fever, body aches or change in appetite. Small, palpable node left supraclavicular region approx. 1.5cm possible reaction to vaccine. Referral to primary care physician for further evaluation. Return to clinic in 1 week for follow-up.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Exfoliative rash, Peripheral swelling, Rash generalised, Rash pruritic
Clinical narrative: developed a rash in my hairline and spread all over my body; itchy rash; This rash is painful especially when exposed to heat; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced generalized rash, itchy rash and painful rash. On an unknown date, the outcome of the generalized rash, itchy rash and painful rash were unknown.   It was unknown if the reporter considered the generalized rash, itchy rash and painful rash to be related to Shingrix.  Additional details were provided 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 expereinced hairline rash which spread to whole body, the rash was itchy after receiving Shingrix vaccine. The rash was painful when exposed to heat.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Exfoliative rash, Hypersensitivity, Pruritus, Rash generalised
Clinical narrative: developed a rash in my hairline and spread all over my body; itchy rash; This rash is painful especially when exposed to heat; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced generalized rash, itchy rash and painful rash. On an unknown date, the outcome of the generalized rash, itchy rash and painful rash were unknown.   It was unknown if the reporter considered the generalized rash, itchy rash and painful rash to be related to Shingrix.  Additional details were provided 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 expereinced hairline rash which spread to whole body, the rash was itchy after receiving Shingrix vaccine. The rash was painful when exposed to heat.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash generalised, Rash pruritic, Temperature intolerance
Clinical narrative: developed a rash in my hairline and spread all over my body; itchy rash; This rash is painful especially when exposed to heat; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced generalized rash, itchy rash and painful rash. On an unknown date, the outcome of the generalized rash, itchy rash and painful rash were unknown.   It was unknown if the reporter considered the generalized rash, itchy rash and painful rash to be related to Shingrix.  Additional details were provided 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 expereinced hairline rash which spread to whole body, the rash was itchy after receiving Shingrix vaccine. The rash was painful when exposed to heat.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Headache, Injection site pain, Injection site warmth, Tremor
Clinical narrative: Pregnant went in for doctors appt  Doctor coerced me into taking dtap after I said no because in 2017 I got sick from dtap while pregnant with second child. Now pregnant with third child she had me get the shot next day was so sick throwing up could not keep anything down headaches and shakes lasting until 2 days later. Injection site was hurting and warm to touch. Called doctor tried to dismiss as stomach bug that is when I became educated about vaccine reactions and why to do.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Pregnant went in for doctors appt  Doctor coerced me into taking dtap after I said no because in 2017 I got sick from dtap while pregnant with second child. Now pregnant with third child she had me get the shot next day was so sick throwing up could not keep anything down headaches and shakes lasting until 2 days later. Injection site was hurting and warm to touch. Called doctor tried to dismiss as stomach bug that is when I became educated about vaccine reactions and why to do.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site reaction, Local reaction, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Patient developed localized reaction to left thigh that radiated towards left inner thigh (red, macular, papular rash).  No pain or itchiness reported.  No other symptoms were reported.  Patient had also developed fevers that ranged between 101-103.6, which was relieved by Tylenol and Motrin.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Epicondylitis, Headache, Hypoaesthesia, Muscle tightness
Clinical narrative: HEADACHE, CHILLS, MUSCLE PAIN, QUARTER SIZED RED AREA HOT TO THE TOUCH, NUMBNESS OF ALL 10 FINGERS, UPPER NECK AND BACK TENSION.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Skin warm
Clinical narrative: HEADACHE, CHILLS, MUSCLE PAIN, QUARTER SIZED RED AREA HOT TO THE TOUCH, NUMBNESS OF ALL 10 FINGERS, UPPER NECK AND BACK TENSION.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; 1 dose o improperly stored PROQUAD as administered; This spontaneous report was received from a nurse referring to a 4 years old female patient. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. Concomitant therapies included sterile diluent.  On 17-MAY-2019, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was mistakenly put in the refrigerator after it arrived. On 28-MAY-2019 the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) therapy type rHA(dose, frequency and route were not reported, lot # was S002924, expiration date was 28-JUL-2020) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no previous temperature excursion. The temperature and time frame was from 15 Fahrenheit (F) to 46 F for 14 days (or 336 hours). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Incorrect product storage; This spontaneous report has been received from a medical assistant and it refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical or concomitant drugs were not reported.  The medical assistant reported that on 10-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Injection, lot # S002493, expiration date 23-JUL-2020, for prophylaxis (strength, dose number, dose and route not reported), which was exposed to a temperature range of 15 F to 46 F (36F) for 8 hours. No adverse effects were reported.  This call was made because of a digital data logger.
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test abnormal
Clinical narrative: The patient asked if receiving GARDASIL 9 could cause a test-positive for an STD; This spontaneous report was received from a female consumer of unknown age regarding herself. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  In May 2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDSAIL 9) for prophylaxis, (strength, dosage, frequency, route of administration, lot number and expiration date were not reported).  On unspecified date, the patient asked if receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) could cause a test positive for an sexually transmitted diseases (STD) (Sexually transmitted disease). Also, in may 2019, STD test was performed. She also received sought medical attention.   The outcome of the event was not provided. The causal relationship between the event and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; expired dose of VARIVAX was administered to a patient; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 14-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous (dosage schedule and anatomical location were not reported), lot # N017394 with expiration date on 07-JUN-2019, indicated for prophylaxis (expired product administered). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: The patient received third dose in Gardasil 9 immunization series and reported the vaccination to be "painful going in and coming out compared to other vaccinations."; This spontaneous report was received from a pharmacist and refers to a 38 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 14-FEB-2019, the patient was vaccinated with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular for HPV prevention (dose, lot number and expiration date were not reported). It was reported that, the vaccination was painful going in and coming out compared to other vaccinations (vaccination site pain). The prior doses, dates and lot # in series were unknown. The patient did not receive treatment for the adverse event. The outcome of vaccination site pain was reported as recovered. The causal relationship between the event and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-1906USA006867:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; An expired dose of Vaqta was administered to the patient; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender.   There was no information about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history provided.  On 17-JUN-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 50 (units not provided), lot # R013859, expiration date reported as 14-JUN-2019 (expired product administered) intramuscularly, for prophylaxis (strength, not reported).  No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: the vaccination to be painful going in and coming out compared to other vaccinations; This spontaneous report was received from a pharmacist via a company representative concerning a 31 years old female patient of an unknown race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were unknown by reporter.  On 14-JUN-2019, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular (frequency, lot number and expiration date were not reported) for human papillomavirus prevention (HPV prevention).  On the same date, the patient stated that the vaccination was painful going in and coming out (vaccination site pain) compared to other vaccinations. Prior doses in series were unknown. No medical attention was sought, and no treatment was given for the adverse event. The outcome of vaccination site pain was reported as recovered.  The relatedness between the event occurrence and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administration was not reported.  This is on of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA006827:
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site pain
Clinical narrative: The patient was diagnosed with "an allergic reaction" to the vaccine or a component of it; The patient complained of "pain, tenderness, soreness at the injection site" the following day; This spontaneous report has been received from a pharmacist via company representative, concerning a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and an unspecified allergy medication.  Approximately on an unknown date in June 2019 (reported as "last week"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R025297 (dose, frequency, route, anatomical location and expiration date were not provided) for prophylaxis.    Approximately on an unknown date in June 2019 (reported as "the following day"), the patient experienced pain, soreness, tenderness at the injection site (injection site pain). The reporter directed patient to her primary physician and the patient was diagnosed with an allergic reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) or a component of it (allergy to vaccine). The patient was treated with prednisone.  The outcome of allergy to vaccine and injection site pain was reported as resolved. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal relationship between injection site pain and the therapy was not assessed.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; On 6/18/2019 a patient was administered an expired VAQTA; This spontaneous report was received from a nurse  refers to a 11 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 18-JUN-2019  date the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) lot # R009799 has been verified to be a valid lot number forhepatitis a vaccine, inactivated, expiration date reported as 02-JUN-2019, but upon internal validation established as 02-JUN-2019, for prophylaxis.         No adverse effects were reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; the third dose of ROTATEQ was administered to a 6-month old patient; This third dose was inadvertently administered after ROTATEQ dose was expired; This spontaneous report was received from a registered nurse referring to a 6-month-old patient of unknown gender. the patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 17-JUN-2019, the patient was inadvertently administered with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R002059 (expiration date: 03-JUN-2019) third dose, orally, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Product administered at inappropriate site
Clinical narrative: Unspecified number of doses of MMRII were improperly administered subcutaneously "in the outer aspect of leg" to unspecified children younger than 12 months of age at unknown times; This spontaneous report was received from a nurse and refers to a unspecified children younger than 12 months old. No information was provided regarding the patient's concurrent condition, concomitant medication, pertinent medical history and drug reactions/allergies.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) by subcutaneous in the outer aspect of leg (Vaccine administered at inappropriate site), for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported).   The nurse stated, she was not feel comfortable to provided any information.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product use in unapproved indication
Clinical narrative: Used for Warts on her fingers; No adverse effects; This spontaneous report as received from a pharmacist refers to a female patient of unknown age with skin papilloma.    On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for skin papilloma.       On an unknown date the patient experienced product use in unapproved indication and no adverse event.    The outcome of product use in unapproved indication and no adverse event is unknown.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Injection site discharge, Injection site pain, Purulent discharge
Clinical narrative: 3 bumps that looked like blisters about an inch away from vaccination site; Spontaneous report received on 20Apr2019 from a consumer via a medical inquiry.  A 24 year old male reported that he experienced injection site pain, injection site discharge and blisters following immunization with ACAM2000 (smallpox vaccine).  About 10 days ago, he stated that after receiving the vaccine, the area was sensitive. The male reported that he eventually developed some pus and drainage at the site but that he did not develop a hard scab.  He also stated that the vaccination site was not healed and that when he changed his bandage, he noticed 3 bumps that looked like blisters about an inch away from the vaccination site. The patient questioned as to what he should do about the blisters and was informed to contact his doctor for more information. The outcome at the time of report was ongoing.  The patient's medical history included that he received the BioThrax (anthrax vaccine adsorbed) vaccination 1 month prior to the ACAM2000 vaccination, but no other vaccines the day he received ACAM2000.  Allergies included a penicillin allergy.  Concomitant medications included Valtrex 1g.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Skin ulcer
Clinical narrative: Itchy sores that popped up on his arms and torso; Spontaneous report received on 02MAY2019.   A 29 years old male patient experienced itchy sores on his arms and torso following the administration of ACAM2000( smallpox (vaccinia) vaccine live).   Two days ago (30APR2019) the subject received smallpox vaccine (lot, dose and route unknown).  Patient stated that he had smallpox vaccine 2 days ago and he was keeping the area covered. Patient reported that in the morning (02MAY2019) he developed some itchy sores that popped up on his arms and torso. He enquired if that could be from the vaccine or anything else was going on? Outcome at the time of report was unknown.  Patient's medical history and allergies was not reported.  Concurrent medical conditions and Concomitant medication was not reported.  Company Comment: The information provided is not enough to properly assess this case. The Company considers that the itchy rash is not assessable and possible autoinoculation unlikely. Normally, papule formation at the vaccination site occurs at the third day and it would have been unlikely to have contamination at the same day of vaccination. Ideally, more information is needed.
Age: 35.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Erythema, Fatigue, Skin abrasion, Skin warm
Clinical narrative: she reacted to the adhesive on the tape and developed blister; She had a little fatigue but she had that before; This spontaneous report was received on 09MAY2019 from a health professional. A 35-year-old female patient, developed a reaction distal to the injection site following the administration of ACAM2000.   On 26APR2019, the patient received ACAM2000 (lot# unknown) in her right upper arm. An occlusive dressing was placed on over the injection site. When the patient was seen on 07MAY2019, the patient was noted to have reacted to the adhesive on the tape and developed blisters. The blisters were healing and now looked like an abrasion. There were no subsequent blisters other than at the inoculation site. On the same date, distal to the vaccination site, the area was red, warm and swollen similar to cellulitis. The patient was not washing the area and had no fever, but experienced little fatigue which she had before. The patient stated that the redness spread within a couple of hours. According to the reporter, the outcome at the time of the report was that the redness was nearly gone and the reaction improved.   According to the reporter, the reaction was localized, not systemic and could either be from the tape of the ACAM2000.   Treatments included intramuscular(IM) Ancef and Oral Keflex to treat the possible cellulitis. Patient stated that the redness spread within a couple of hours and on follow up on 09MAY2019 redness had almost gone. Outcome at the time of report was Improved( Redness nearly gone).  Patient's medical history: None  Allergies included Hives with penicillin.  Concomitant medications: None  Company Comment:  The reaction describes a satellite lesion with possibly robust take that the Company considers possibly related to ACAM2000 and not to the tape. Satellite lesions is a common post vaccination complication and sometimes it is associated with erythema and edema similar to the reaction described by the reporter. Fatigue is not assessable and relationship to ACAM is not possible to determine as the patient had fatigue before.
Age: 35.0
Sex: F
Vaccine: SMALL
Symptoms: Swelling
Clinical narrative: she reacted to the adhesive on the tape and developed blister; She had a little fatigue but she had that before; This spontaneous report was received on 09MAY2019 from a health professional. A 35-year-old female patient, developed a reaction distal to the injection site following the administration of ACAM2000.   On 26APR2019, the patient received ACAM2000 (lot# unknown) in her right upper arm. An occlusive dressing was placed on over the injection site. When the patient was seen on 07MAY2019, the patient was noted to have reacted to the adhesive on the tape and developed blisters. The blisters were healing and now looked like an abrasion. There were no subsequent blisters other than at the inoculation site. On the same date, distal to the vaccination site, the area was red, warm and swollen similar to cellulitis. The patient was not washing the area and had no fever, but experienced little fatigue which she had before. The patient stated that the redness spread within a couple of hours. According to the reporter, the outcome at the time of the report was that the redness was nearly gone and the reaction improved.   According to the reporter, the reaction was localized, not systemic and could either be from the tape of the ACAM2000.   Treatments included intramuscular(IM) Ancef and Oral Keflex to treat the possible cellulitis. Patient stated that the redness spread within a couple of hours and on follow up on 09MAY2019 redness had almost gone. Outcome at the time of report was Improved( Redness nearly gone).  Patient's medical history: None  Allergies included Hives with penicillin.  Concomitant medications: None  Company Comment:  The reaction describes a satellite lesion with possibly robust take that the Company considers possibly related to ACAM2000 and not to the tape. Satellite lesions is a common post vaccination complication and sometimes it is associated with erythema and edema similar to the reaction described by the reporter. Fatigue is not assessable and relationship to ACAM is not possible to determine as the patient had fatigue before.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix. On 10th June 2019, 8 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced rash on thigh. The patient was asking if she need to see a physician.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: headache; muscle pain; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient 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 headache, muscle pain and shivering. On an unknown date, the outcome of the headache, muscle pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain and shivering to be related to Shingrix.  Additional details were provided 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 experienced muscle pain, headache and shivering after receiving a dose of Shingrix vaccine. The patient inquired how long does the side effects would last.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain, Asthenia, Chills, Decreased appetite
Clinical narrative: injection site pain; injection site swelling; redness at injection site; waking several hours; vomiting; participate in any meaningful activity for 2 full days / not quite up to my normal activities; anorexia; weakness; general fatigue / feeling very tired; nausea; bloting; abdominal pain; headache; muscle pain; chills; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. In June 2019, the patient experienced hypersomnia, headache, muscle pain, chills, nausea, bloating, abdominal pain, vomiting, activities of daily living impaired, anorexia, weakness and fatigue. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, hypersomnia, vomiting, activities of daily living impaired, anorexia, weakness and fatigue were unknown and the outcome of the headache, muscle pain, chills, nausea, bloating and abdominal pain were recovered/resolved.   The reporter considered the injection site pain, injection site swelling, injection site erythema, hypersomnia, headache, muscle pain, chills, nausea, bloating, abdominal pain, vomiting, activities of daily living impaired, anorexia, weakness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on an unknown deltoid. 3 to 4 hours after vaccination, the patient expereinced pain, swelling and redness at injection site. The patient had anticipated the events. The patient also took several hours more to wake up with severe headache, muscle pain, chills, nausea, bloating and abdominal pain. The patient also expereinced vomiting. The patient was tired, experienced anorexia, weakness and was not able to participate in any meaningful activity for 2 full days. The patient stated that she will not take 2nd dose and would would rather take chances of getting shingles rather than feel as bad as she have felt for the past 3-4 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: injection site pain; injection site swelling; redness at injection site; waking several hours; vomiting; participate in any meaningful activity for 2 full days / not quite up to my normal activities; anorexia; weakness; general fatigue / feeling very tired; nausea; bloting; abdominal pain; headache; muscle pain; chills; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. In June 2019, the patient experienced hypersomnia, headache, muscle pain, chills, nausea, bloating, abdominal pain, vomiting, activities of daily living impaired, anorexia, weakness and fatigue. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, hypersomnia, vomiting, activities of daily living impaired, anorexia, weakness and fatigue were unknown and the outcome of the headache, muscle pain, chills, nausea, bloating and abdominal pain were recovered/resolved.   The reporter considered the injection site pain, injection site swelling, injection site erythema, hypersomnia, headache, muscle pain, chills, nausea, bloating, abdominal pain, vomiting, activities of daily living impaired, anorexia, weakness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on an unknown deltoid. 3 to 4 hours after vaccination, the patient expereinced pain, swelling and redness at injection site. The patient had anticipated the events. The patient also took several hours more to wake up with severe headache, muscle pain, chills, nausea, bloating and abdominal pain. The patient also expereinced vomiting. The patient was tired, experienced anorexia, weakness and was not able to participate in any meaningful activity for 2 full days. The patient stated that she will not take 2nd dose and would would rather take chances of getting shingles rather than feel as bad as she have felt for the past 3-4 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Myalgia, Nausea, Vomiting
Clinical narrative: injection site pain; injection site swelling; redness at injection site; waking several hours; vomiting; participate in any meaningful activity for 2 full days / not quite up to my normal activities; anorexia; weakness; general fatigue / feeling very tired; nausea; bloting; abdominal pain; headache; muscle pain; chills; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. In June 2019, the patient experienced hypersomnia, headache, muscle pain, chills, nausea, bloating, abdominal pain, vomiting, activities of daily living impaired, anorexia, weakness and fatigue. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, hypersomnia, vomiting, activities of daily living impaired, anorexia, weakness and fatigue were unknown and the outcome of the headache, muscle pain, chills, nausea, bloating and abdominal pain were recovered/resolved.   The reporter considered the injection site pain, injection site swelling, injection site erythema, hypersomnia, headache, muscle pain, chills, nausea, bloating, abdominal pain, vomiting, activities of daily living impaired, anorexia, weakness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on an unknown deltoid. 3 to 4 hours after vaccination, the patient expereinced pain, swelling and redness at injection site. The patient had anticipated the events. The patient also took several hours more to wake up with severe headache, muscle pain, chills, nausea, bloating and abdominal pain. The patient also expereinced vomiting. The patient was tired, experienced anorexia, weakness and was not able to participate in any meaningful activity for 2 full days. The patient stated that she will not take 2nd dose and would would rather take chances of getting shingles rather than feel as bad as she have felt for the past 3-4 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Balance disorder, Dizziness, Fatigue, Impaired work ability
Clinical narrative: fatigue; missed work; Couldn't get out of bed; severe low back pain; light headed; altered mental status/ making mistakes; Wobbly legs/ bilateral leg weekness; Head feels funny; numbness/Numbness in the face; This case was reported by a nurse via call center representative and described the occurrence of weird feeling in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th March 2019, less than a day after receiving Shingrix, the patient experienced weird feeling, numbness generalized, lower extremities weakness of and mental status changes. On 20th March 2019, the patient experienced light headedness. On 21st March 2019, the patient experienced low back pain, bedridden and impaired work ability. On an unknown date, the patient experienced fatigue. The patient was treated with muscle relaxants (Muscle Relaxant). Shingrix was discontinued. On an unknown date, the outcome of the weird feeling, numbness generalized, low back pain, lower extremities weakness of, bedridden, light headedness, mental status changes, fatigue and impaired work ability were unknown.   It was unknown if the reporter considered the weird feeling, numbness generalized, low back pain, lower extremities weakness of, bedridden, light headedness, mental status changes, fatigue and impaired work ability to be related to Shingrix.  Additional details were provided as follows: Less than a year after vaccination, the patient experienced fatigue. After vaccination with Shingrix, the numbness persisted 1 day and then reoccurring. As the patient did not feel right in the head or Altered Mental Status, led to emergency room visit. The patient was not admitted in the hopital. On 22nd March 2019, the patient was diagnosed with alerted mental status and severe lower back pain. The patient prescribed with muscle relaxant, relaxer in the emergency room but back pain improved but not resolved. The patient reported symptoms intermittently over 6 weeks after vaccination. The nurse will provide the report with more details to safety when they receive correspondence in the mail. This was intentional medication error with associated adverse reaction.      Lab Comments: On 22nd March 2019, the patient was evaluated for alerted mental status and severe lower back pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: fatigue; missed work; Couldn't get out of bed; severe low back pain; light headed; altered mental status/ making mistakes; Wobbly legs/ bilateral leg weekness; Head feels funny; numbness/Numbness in the face; This case was reported by a nurse via call center representative and described the occurrence of weird feeling in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th March 2019, less than a day after receiving Shingrix, the patient experienced weird feeling, numbness generalized, lower extremities weakness of and mental status changes. On 20th March 2019, the patient experienced light headedness. On 21st March 2019, the patient experienced low back pain, bedridden and impaired work ability. On an unknown date, the patient experienced fatigue. The patient was treated with muscle relaxants (Muscle Relaxant). Shingrix was discontinued. On an unknown date, the outcome of the weird feeling, numbness generalized, low back pain, lower extremities weakness of, bedridden, light headedness, mental status changes, fatigue and impaired work ability were unknown.   It was unknown if the reporter considered the weird feeling, numbness generalized, low back pain, lower extremities weakness of, bedridden, light headedness, mental status changes, fatigue and impaired work ability to be related to Shingrix.  Additional details were provided as follows: Less than a year after vaccination, the patient experienced fatigue. After vaccination with Shingrix, the numbness persisted 1 day and then reoccurring. As the patient did not feel right in the head or Altered Mental Status, led to emergency room visit. The patient was not admitted in the hopital. On 22nd March 2019, the patient was diagnosed with alerted mental status and severe lower back pain. The patient prescribed with muscle relaxant, relaxer in the emergency room but back pain improved but not resolved. The patient reported symptoms intermittently over 6 weeks after vaccination. The nurse will provide the report with more details to safety when they receive correspondence in the mail. This was intentional medication error with associated adverse reaction.      Lab Comments: On 22nd March 2019, the patient was evaluated for alerted mental status and severe lower back pain.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; spot on neck; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a year after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In the beginning of April 2019, the patient received her 1st Shingrix vaccine. At the end of May 2019, she was diagnosed with shingles. It developed on her neck.   Shingles had healed but there was a spot. The reporter did not have further information regarding the event to provide.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pruritus, Urticaria
Clinical narrative: Hives; itchy; feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced hives, pruritus and feeling unwell. On an unknown date, the outcome of the hives, pruritus and feeling unwell were unknown.   It was unknown if the reporter considered the hives, pruritus and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient experienced big hive on his arm, which was itchy and felt sick. No additional details were provided.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Injection site swelling, Nausea
Clinical narrative: swelling; chills; nausea; aches; tiredness; stomach upset; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th June 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, chills, nausea, pain, tiredness and upset stomach. The patient was treated with ibuprofen (Advil). The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site swelling, chills, nausea, pain, tiredness and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, chills, nausea, pain, tiredness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm at doctor's office. On the same day night, the patient started to experience swelling on his left arm, chills, nausea, aches, tiredness, and stomach upset.  On 11th June 2019, the patient did take an Advil. The patient could not provide address and first name of the physician. There is a discrepancy in the reporting the outcome was reported in the structured field as not recovered/not resolved, but the outcome reported in the source document recovering/ resolving, however outcome is retain as per database fields. The reporter consented to follow up.