chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Muscle twitching, Rash erythematous
Clinical narrative: Patient's grandmother contacted facility via phone call on 3/19/19 to inform of unusual symptoms which occurred approximately 5 minutes after patient received vaccinations on 3/12/19. She stated that the patient was sitting in his car seat when she noticed a reddened rash on his left cheek 1.5 inches in diameter. He then had 3 consecutive twitching episodes, lasting approximately 1 minute each. Patient was alert and oriented after the twitching episodes ended, and ate and drank appropriately. Red rash on left cheek disappeared after twitching episodes ended. Grandmother stated patient has had no further issues since then, and will make a follow-up appointment with the patient's pediatrician for further evaluation.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Injection site reaction, Polymerase chain reaction, Viral test
Clinical narrative: Herpes zoster L leg 7 months after vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pharmacist attempted to adminsiter vaccine in left arm, at the top of the shoulder, not in the thickest part of the deltoid, but syringe failed and vaccine spilled to the floor. The pharmacist adminstered a new dose in right arm, at the top of the shoulder, not in the thickest part of the deltoid. Patient came back to pharmacy next morning stating inability to sleep the night prior due to pain shooting down from both shoulders. She tried taking ibuprofen and found no relief and continues to have limited range of motion. Primary care provider Dr aware of incident and asking patient to be seen for evaluation.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Hypoaesthesia, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Patient reports two days after vaccination noticed persistent left arm/shoulder pain. Patient denies reporting shoulder pain to employee health or provider. Patient reports discomfort did not go away and approximately in January had decreased range of motion to the left arm from the shoulder area with numbness/tingling in fingers. Patient denies seeking medical attention. Patient reports today March 20, 2019 decreased ROM to left arm/shoulder and at times numbness and tingling in the left hand fingers. March 20, 2019 when patient followed up with Employee Health regarding potential adverse reaction declined further follow up and care. PA for employee health notified.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports two days after vaccination noticed persistent left arm/shoulder pain. Patient denies reporting shoulder pain to employee health or provider. Patient reports discomfort did not go away and approximately in January had decreased range of motion to the left arm from the shoulder area with numbness/tingling in fingers. Patient denies seeking medical attention. Patient reports today March 20, 2019 decreased ROM to left arm/shoulder and at times numbness and tingling in the left hand fingers. March 20, 2019 when patient followed up with Employee Health regarding potential adverse reaction declined further follow up and care. PA for employee health notified.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pruritus
Clinical narrative: CLIENT STATES SHE HAD REDNESS AND ITCHING THE NEXT DAY FOLLOWING THE VACCINE. STATES SHE APPLIED BENADRYL CREAM AND TOOK IBUPROFEN.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nuclear magnetic resonance imaging, Peripheral swelling
Clinical narrative: Swelling of upper left limb, redness. Patient  was sent for MRI to rule out cellulitis /possible abscess.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Ecchymosis, Lymphadenopathy, Tenderness
Clinical narrative: Onset of severe axillary pain (injection site left deltoid) the night following administration. Over the next 3 days, there was ecchymosis, swelling, and tenderness of the left axilla extending to the left breast. These symptoms subsequently resolved.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Cold sweat, Ear discomfort, Feeling abnormal, Hyperhidrosis
Clinical narrative: Minor arm pain, stomach pain, ears feeling full, throat feeling scratchy, neck pain, pink rash on neck, arms, trunk, inner thighs, feeling clammy, hot and cold sweats, foggy feeling in head.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Rash, Throat irritation
Clinical narrative: Minor arm pain, stomach pain, ears feeling full, throat feeling scratchy, neck pain, pink rash on neck, arms, trunk, inner thighs, feeling clammy, hot and cold sweats, foggy feeling in head.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Hypokinesia, Pain, Swelling
Clinical narrative: Redness, swelling, pain, limited movement.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Dyspnoea, Headache, Injection site pain
Clinical narrative: I feel severe pain at inject site. Really bad headache. Dizziness. Difficulty of breathing.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Blister, Headache, Injection site pain, Macule
Clinical narrative: The patient is a 32 yo female with a history of lupus & autoimmune hepatitis on immunosuppression with IMURAN & prednisone presents to office per referral from call center due to a new onset dermatitis to her Right arm two days after receipt of SHINGRIX #1, also in her right arm. She reports receipt of SHINGRIX vaccine #1 (SKB 7L355) on 8 MAR 2019 without immediate adverse event other than injection pain. She denied urticaria, pruritus, oral face throat or tongue swelling, dyspnea or CP. The next day (day 1) she noted sharp needle like poking stinging pain to her right arm. She states on day 2 she noted development of painful vesicular lesions with confluent macules to her Right anterior arm, including palm. More lesions appeared Monday (day 3). On Tuesday (day 4) she noted lesions to her upper back and today on Wednesday (day 5) to her upper chest. The chest and back lesions were pruritic. Pain was significant at 8/10 and disturbed sleep. She experienced systemic symptoms of fever and headache on Saturday and Sunday, but those resolved. She denies myalgias, arthralgias, nausea, emesis, and diarrhea, CP or SOB. She self treated with ibuprofen OTC & x1 TYLENOL OTC dose, but due to her hepatic and renal hx she is to minimize or avoid these drugs.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymerase chain reaction, Pruritus, Pyrexia, Sleep disorder
Clinical narrative: The patient is a 32 yo female with a history of lupus & autoimmune hepatitis on immunosuppression with IMURAN & prednisone presents to office per referral from call center due to a new onset dermatitis to her Right arm two days after receipt of SHINGRIX #1, also in her right arm. She reports receipt of SHINGRIX vaccine #1 (SKB 7L355) on 8 MAR 2019 without immediate adverse event other than injection pain. She denied urticaria, pruritus, oral face throat or tongue swelling, dyspnea or CP. The next day (day 1) she noted sharp needle like poking stinging pain to her right arm. She states on day 2 she noted development of painful vesicular lesions with confluent macules to her Right anterior arm, including palm. More lesions appeared Monday (day 3). On Tuesday (day 4) she noted lesions to her upper back and today on Wednesday (day 5) to her upper chest. The chest and back lesions were pruritic. Pain was significant at 8/10 and disturbed sleep. She experienced systemic symptoms of fever and headache on Saturday and Sunday, but those resolved. She denies myalgias, arthralgias, nausea, emesis, and diarrhea, CP or SOB. She self treated with ibuprofen OTC & x1 TYLENOL OTC dose, but due to her hepatic and renal hx she is to minimize or avoid these drugs.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Pallor, Syncope
Clinical narrative: Pale and syncope with vaccine administration.
Age: 29.0
Sex: F
Vaccine: HEP, TD
Symptoms: Altered state of consciousness, Asthenia, Cluster headache, Dysgraphia, Electrocardiogram
Clinical narrative: First episode of symptoms included nausea, vomiting, weight loss, fever, headaches, falling, weakness, fatigue, altered level of consciousness and difficulty speaking, writing and walking, etc. Symptoms would wax and wane. Treatment included ORAP for difficulty speaking - "Tourette syndrome" and Verapamil for cluster headache.
Age: 29.0
Sex: F
Vaccine: HEP, TD
Symptoms: Electroencephalogram, Fall, Fatigue, Gait disturbance, Headache
Clinical narrative: First episode of symptoms included nausea, vomiting, weight loss, fever, headaches, falling, weakness, fatigue, altered level of consciousness and difficulty speaking, writing and walking, etc. Symptoms would wax and wane. Treatment included ORAP for difficulty speaking - "Tourette syndrome" and Verapamil for cluster headache.
Age: 29.0
Sex: F
Vaccine: HEP, TD
Symptoms: Imaging procedure, Laboratory test, Nausea, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: First episode of symptoms included nausea, vomiting, weight loss, fever, headaches, falling, weakness, fatigue, altered level of consciousness and difficulty speaking, writing and walking, etc. Symptoms would wax and wane. Treatment included ORAP for difficulty speaking - "Tourette syndrome" and Verapamil for cluster headache.
Age: 29.0
Sex: F
Vaccine: HEP, TD
Symptoms: Speech disorder, Tourette's disorder, Vomiting, Weight decreased
Clinical narrative: First episode of symptoms included nausea, vomiting, weight loss, fever, headaches, falling, weakness, fatigue, altered level of consciousness and difficulty speaking, writing and walking, etc. Symptoms would wax and wane. Treatment included ORAP for difficulty speaking - "Tourette syndrome" and Verapamil for cluster headache.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Fever to touch 3/14 in the evening left thigh with redness, slight edema and warm to touch when awoke this AM. Fever also.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis from vaccine #1 of the shingles vaccine. Treated with antibiotics in emergency room. Given prescription for antibiotics.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hypoaesthesia
Clinical narrative: Patient experienced feeling of chill at 3/17/2019 around 9pm. On 3/18 morning, patient feels tired. In the evening of 3/18, patient feels shiver and numbness in the left hand and fingers. The numbness on the left hand continues to the morning of 3/19/19. Patient will be seeing her doctor, Dr. about these symptoms around 11:30pm on 3/19/2019.
Sex: U
Vaccine: MMR
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. On 05-MAR-2019, the patient would receive a dose of M-M-R II (lot # R015162 and expiration date 29-MAY-2020), administered subcutaneous for prophylaxis (dose and anatomical location were not reported). Other suspect therapies included MERCK STERILE DILUENT (lot # M044952 and expiration date 01-JUL-2019) (dose, frequency, and route of administration were not reported) for an unknown indication.  On that same day (05-MAR-2019), the pharmacist reported that during administration of the dose of M-M-R II some vaccine squirted back out of the injection site, resulting in topical exposure on the patient's arm (exposure via skin contact) and a possible partial dose (incorrect dose administered). No adverse effect reported. No additional information provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 12-MAR-2019, the patient was vaccinated with M-M-R II (strength and dose were not reported; lot # N020926 and expiration date 01-AUG-2019) which was reconstituted with sterile diluent intramuscularly rather than subcutaneously for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Dermatitis, Erythema multiforme, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration at single dose in the arm on an unspecified date for immunisation, influenza vaccine, via an unspecified route of administration in the arm on an unspecified date for immunisation, terbinafine, via an unspecified route of administration on an unspecified date for toe nail fungus. Medical history none. There were no concomitant medications. The patient stated as follows: "I had ended up being erythema multiforme I still have some results of that", on an unspecified date. She also developed rash, itching, dermatitis on an unspecified date. Therapeutic measures were taken as a result of itching and dermatitis included a cream and Prednisone. The outcome of the events was unknown. The information on the lot number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Burning sensation, Influenza like illness, Pain
Clinical narrative: This is a spontaneous report from a physician received via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that arm on fire and flu like symptoms, body aches for 2-3 days. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: Nausea, dizziness, sore/painful injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site reaction, Lipoma
Clinical narrative: Patient had lipoma at injection site in right deltoid with diagnosis of cellulitis spreading down to the right hand. Patient was treated with cephalexin, prednisone, hydroxyzine and famotidine. The swelling is clearing up with the medications.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Concussion, Influenza like illness, Loss of consciousness, Nystagmus, Syncope
Clinical narrative: Flu like symptoms began Saturday evening. Sunday morning he woke up and his wife heard him hit the bathroom floor. He passed out for 60-90 seconds. She called ambulance and he was taken to Medical Center. His doctor there decided he had a syncopal episode which caused a concussion. He reported still having vertigo and nystagmus Monday and Tuesday morning. He went back to work for the first time on Wednesday.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Flu like symptoms began Saturday evening. Sunday morning he woke up and his wife heard him hit the bathroom floor. He passed out for 60-90 seconds. She called ambulance and he was taken to Medical Center. His doctor there decided he had a syncopal episode which caused a concussion. He reported still having vertigo and nystagmus Monday and Tuesday morning. He went back to work for the first time on Wednesday.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Arm pain at injection site, dizziness, weakness, nausea, fever, rapid pulse, tightness of chest and tightness of breathing. Treatment went home to rest, TYLENOL, took inhaler (VENTOLIN). Symptoms lasted over 3 days, and continued to not feel well for a couple of weeks. (Had adverse reaction with prior flu vax, but thought it was coincidental and not sure if caused by the injection. This time proved it was for sure the vaccination. )
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: Arm pain at injection site, dizziness, weakness, nausea, fever, rapid pulse, tightness of chest and tightness of breathing. Treatment went home to rest, TYLENOL, took inhaler (VENTOLIN). Symptoms lasted over 3 days, and continued to not feel well for a couple of weeks. (Had adverse reaction with prior flu vax, but thought it was coincidental and not sure if caused by the injection. This time proved it was for sure the vaccination. )
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 07-SEP-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered severe visual impairment and vision loss. As a direct and proximate result the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Acute severe visual impairment and vision loss were considered disabling. Upon internal review, acute severe visual impairment and vision loss was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 9am 3days after receiving 2nd dose of SHINGRIX the patient get sick.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The caller reported a sore left arm injection site with dose of SHINGRIX. The reporter did not give consent to follow up. The caller refused medical doctor contact regarding this event.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 61-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. The patient's past medical history included shoulder operation. Concomitant products included SHINGRIX. On 20th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient reported that he received the first dose of SHINGRIX in June 2018 at Pharmacy. In October or November of 2018, he had a flu shot in the same left arm and he reported that he felt like someone was standing over him and beating him up on his arm in the muscle at the injection site. The patient reported that he had shoulder surgery a few years back in his right arm that's why he received both shots in his left arm. The patient received his 1st and 2nd dose of SHINGRIX at different pharmacy. He claims that last evening his arm was really bothering him. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in September 2018). On 3rd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In March 2019, less than a month after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported hives breakout of legs after receiving dose of SHINGRIX. The reporter did not give consent to follow up. The caller refused medical doctor contact regarding this event.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 69-year-old female patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 3rd March 2019, the patient received SHINGRIX (intramuscular). On 3rd March 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In March 2019, the patient experienced bruising of arm. On an unknown date, the outcome of the bruising of arm and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the bruising of arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her left arm. The pharmacist reported that due to the larger size of the patient, it was difficult for her to locate the deltoid muscle of the patient's arm and the vaccine might have been administered slightly outside of the deltoid region, which led to vaccine administered at inappropriate site. Less than a month after receiving vaccination, the patient complained of bruising on the side of her left arm. Onset date of bruising was not provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Lip blister, Lip discolouration, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 2nd dose of SHINGRIX. On 9th March 2019, 4 days after receiving SHINGRIX, the patient experienced lip discoloration, lip blister, scabbing and discharge. In March 2019, the patient experienced injection site erythema, pain and tiredness. The patient was treated with lysine. On an unknown date, the outcome of the injection site erythema, pain and tiredness were recovered/resolved and the outcome of the lip discoloration, lip blister, scabbing and discharge were not reported. It was unknown if the reporter considered the injection site erythema, pain, tiredness, lip discoloration, lip blister, scabbing and discharge to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient. Less than a week, after vaccination the patient experienced some pinkness around the injection site, achiness, and tiredness that went away after a couple of days. On 9th March 2019, the patient experienced a whitish, blistered area on her bottom lip on the left side. Watery stuff came out of it and it was scabby-looking. The patient tried crushing lysine tablets and putting it on her lip 2 or 3 times a daily in an effort to heal it. It did not appear to be helping much. This case has been linked with the case US2019044305, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Secretion discharge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 2nd dose of SHINGRIX. On 9th March 2019, 4 days after receiving SHINGRIX, the patient experienced lip discoloration, lip blister, scabbing and discharge. In March 2019, the patient experienced injection site erythema, pain and tiredness. The patient was treated with lysine. On an unknown date, the outcome of the injection site erythema, pain and tiredness were recovered/resolved and the outcome of the lip discoloration, lip blister, scabbing and discharge were not reported. It was unknown if the reporter considered the injection site erythema, pain, tiredness, lip discoloration, lip blister, scabbing and discharge to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient. Less than a week, after vaccination the patient experienced some pinkness around the injection site, achiness, and tiredness that went away after a couple of days. On 9th March 2019, the patient experienced a whitish, blistered area on her bottom lip on the left side. Watery stuff came out of it and it was scabby-looking. The patient tried crushing lysine tablets and putting it on her lip 2 or 3 times a daily in an effort to heal it. It did not appear to be helping much. This case has been linked with the case US2019044305, reported by same reporter.
Age: 19.0
Sex: F
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain
Clinical narrative: (L) sided abdominal pain.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, pain and tiredness. On an unknown date, the outcome of the injection site erythema, pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site erythema, pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of the patient. The patient experienced some pinkness around the injection site, achiness and tiredness that went away after a couple of days. This case has been linked with the case US2019044309, reported by same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple myeloma (diagnosed in December 2009). On 7th March 2019, the patient received the 1st dose of SHINGRIX. On 8th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On 9th March 2019, the patient experienced localized erythema and skin warm. On 11th March 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the localized erythema and skin warm were recovering/resolving. It was unknown if the reporter considered the pain in arm, localized erythema and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On the second day after receiving the vaccination, the patient's arm was very sore. She described that it was sore to the touch and noticeable with movement. On 9th March 2019 (Saturday), 2 days after receiving vaccination, the patient noticed a red area below the injection site. The area was red and slightly warm. It was located two inches below the injection site. On 10th March 2019 (Sunday), the red area got large and was larger on 11th March 2019. The red area was five inches long and three inches wide. On 11th March 2019, soreness was resolved. The patient did not consent to follow-up.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 47-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. The patient's past medical history included immunocompromised (had an unknown immunosuppressive disorder). On 4th December 2018, the patient received the 2nd dose of SHINGRIX. On 4th December 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. In March 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that approximately 3 months later the patient was complaining of an Injection site reaction, possibly a rash at injection site. The SHINGRIX was indicated for age of 50 years and above however, the patient of age 47 years received it, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: MEN
Symptoms: Meningococcal infection, Vaccination failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patients received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patients experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse called to report a local meningitis B outbreak that encouraged recipients of Meningococcal B vaccine to receive a third booster dose if more than 1 year had passed since the second dose of Meningococcal B vaccine was given. A letter regarding this outbreak was sent to the parents of the patients from their local school. BEXSERO was not explicitly mentioned by the nurse, only Meningococcal B vaccine. No booster doses were reported to have been administered, at the time of reporting. This case was considered as suspected vaccination failure cases as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac flutter, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart fluttering in a elderly female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 3 days after receiving SHINGRIX, the patient experienced heart fluttering (serious criteria GSK medically significant), injection site pain and influenza-like symptoms. On an unknown date, the outcome of the heart fluttering, injection site pain and influenza-like symptoms were recovered/resolved.  It was unknown if the reporter considered the heart fluttering, injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 68 or 69 years old. The patient received a dose of SHINGRIX in the afternoon on an unknown arm. Within 24 hours after vaccination, the patient experienced flu-like symptoms and mild soreness at the injection site. The flu-like symptoms lasted for approximately 48 hours but the patient did not know how long the mild soreness at the injection site lasted because it did not interfere with her normal daily activities. The heart fluttering lasted for approximately three hours. The patient went to her physician that same day but the physician could not find anything wrong with her. The reporter gave permission for her physician to be contacted. The reporter consented to follow up.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Loss of consciousness, Tremor, Visual impairment
Clinical narrative: Initial information received on 25-Feb-2019 regarding an unsolicited valid serious case received from a physician. This case involves a 18 years old male patient who experienced vision blackening, passed out for about 45 seconds and awoke, weak and shaking and trembling, while he received vaccine MENACTRA and TRUMENBA. The patient's past medical history included Syncope related to heat and dehydration. Medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA (lot number not reported) in the left arm. On an unknown date, the patient developed a serious passed out for about 45 seconds and awoke (loss of consciousness) and non-serious vision blackening (vision blurred) and weak (asthenia) and shaking and trembling (tremor) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Patient denied feeling lightheaded. He felt week, tried to get him to stand to get blood pressure, started shaking and trembling again, so laid him back down for about 20 or 30 minutes. This case was assessed as serious due to loss of consciousness. (Other relevant tests included No lab data.) Final diagnosis was shaking and trembling, weak, passed out for about 45 seconds and awoke and vision blackening. It was not reported if the patient received a corrective treatment. The patient was recovering from all the events. It was also reported some water(about 4 glasses) was given to patient. Was able to stand. Called mom about an hour they left and reported he was feeling better. List of document held by sender: none.; Sender's Comments: This case involves a 18 year old male patient who experienced loss of consciousness for 45 minutes, after vaccination with MENACTRA. He concomitantly received TRUMENBA. Time to onset is unknown. However the event is expected with the role of vaccine. The patient also had history of syncope with heat and dehydration. However, additional information regarding patient's condition at the time of vaccination, history of similar episode with past vaccinations and lab tests ruling out alternate etiologies are required for complete assessment of the case. Based on reported information the role of individual vaccine cannot be assessed.
Sex: M
Vaccine: RAB
Symptoms: Product dose omission
Clinical narrative: Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves male patient (age 21-22 years) who received 0.5 mL dose of vaccine IMOVAX RABIES lot N1K303M, expiry date- 28-Oct-2019 via unknown route in the right deltoid on 28-Feb-2019 but missed the second dose in series.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of potential medication error due to missed dose. He received his first immunization on 28-Feb-2019. His second in the series was due 7-Mar-2019, but he did not come in. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 63 years old male patient who accidentally received 0.5 mL suspect TUBERSOL via intramuscular route in left deltoid (lot - C5476AA, 16-Nov-2020) instead of 0.5 mL TENIVAC on 12-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Wrong product administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received on 13-Mar-2019 from a physician. No new information received. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, FLU4, HEP, MENB, PNC13, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 3 patients who experienced received vaccines TRUMENBA, PREVNAR 13, FLUZONE QUADRIVALENT and PENTACEL because there was a temperature excursion which reached 29 degrees Fahrenheit for 1 hour. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ061AAA via unknown route in the left thigh. On 21-Dec-2018, the patient received a  dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot X35262 via unknown route. On an unknown date, the patient received a  dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route. On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6315RA via unknown route in the left thigh. It was a case of actual medication error due to incorrect product storage. No adverse events have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient (age and gender unknown) who received an expired dose of vaccine MENACTRA. The patient's past medical history, concomitant medication and family history were not provided. On 13-Mar-2019, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA, expiry date: 11-Mar-2019, via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old female patient who just received the diluent of the PENTACEL (lot C5466AB, C5324AC and Exp. Date 05-Sep-2019) as a first dose via intramuscular route in the left thigh, on 08-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, PREVNAR 13 and ROTAVIRUS VACCINE for Immunisation. It was an actual medication error case due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: HIBV, HPV4, IPV, MMRV, MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case involves a 12 years (also reported as 13 years) old male patient who received a 0.5 mL dose of vaccine IPOL lot N1A45, expiry date: 05-Feb-2019 via intramuscular route in the right deltoid on 28-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was GARDASIL, MENACTRA, HIBERIX and PROQUAD. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2 months old patient who was administered with a dose of IPOL lot P1A432M (Expiry date 20-Apr-2020) via unknown route in the right thigh lot P1A432M Expiry date 20-Apr-2020) via unknown route in unknown administration site and PEDIARIX on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error case due extra dose administered. It was reported that patient got a single dose of IPOL and PEDIARIX. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.