chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Aortic arteriosclerosis, Chronic obstructive pulmonary disease, Chronic spontaneous urticaria, Cryoglobulinaemia, Dermatitis
Clinical narrative: pneumonia; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; atherosclerosis of aorta; chronic obstructive pulmonary disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 27-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis. Patient also suffered and was diagnosed with pneumonia, atherosclerosis of aorta and chronic obstructive pulmonary disease.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of using zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  All events were considered to be disabling.  Upon internal review, cryoglobulinaemia and pneumonia were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Pneumonia, Rash, Rash vesicular, Swelling face
Clinical narrative: pneumonia; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; atherosclerosis of aorta; chronic obstructive pulmonary disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 27-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis. Patient also suffered and was diagnosed with pneumonia, atherosclerosis of aorta and chronic obstructive pulmonary disease.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of using zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  All events were considered to be disabling.  Upon internal review, cryoglobulinaemia and pneumonia were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Vasculitis
Clinical narrative: pneumonia; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis; atherosclerosis of aorta; chronic obstructive pulmonary disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 27-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered varicella type rash located throughout his body, facial swelling, difficulty swallowing and was diagnosed with autoimmune urticaria, dermatitis, cryoglobulinemia and vasculitis. Patient also suffered and was diagnosed with pneumonia, atherosclerosis of aorta and chronic obstructive pulmonary disease.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of using zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  All events were considered to be disabling.  Upon internal review, cryoglobulinaemia and pneumonia were considered to be medically significant.
Age: 1.0
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: No adverse event
Clinical narrative: The patient experienced no symptoms; a one year old patient was administered both VARIVAX (lot S015459, expiration 5/20/2021) and PROQUAD (lot S012467, expiration 10/20/2020) on the same day.; This spontaneous report has been received from a medical assistant, referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.  On 20-JAN-2020, the patient was vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S012467, expiration date 20-OCT-2020; strength, dose and frequency were unknown) subcutaneously for prophylaxis and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015459, expiration date 20-MAY-2021; strength, dose, frequency and route were unknown) for prophylaxis (overdose). Other suspect therapies included sterile diluent (STERILE DILUENT) (lot# was reported as R032612 and expiration date was reported as 22-JUL-2021, but upon internal validation established as non-valid; strength, dose, frequency and route were unknown). The patient experienced no symptoms (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling at injection site; redness at injection site; hot to the touch/It is also hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient still have redness and swelling at the injection site two days after receiving 1st dose. It was also hot to touch. The patient asked what could do to relieve the events.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain
Clinical narrative: 10 cm indurated area; erythematous area at right upper arm; pain 1 day post injection; This case was reported by a nurse via other manufacturer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix. On 27th June 2019, 1 days after receiving Shingrix, the patient experienced pain. On 28th June 2019, the patient experienced erythema. On an unknown date, the patient experienced induration. On an unknown date, the outcome of the pain, erythema and induration were unknown.   It was unknown if the reporter considered the pain, erythema and induration to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The nurse reported that she developed pain and erythematous at right upper arm and 10 cm indurated area after vaccination. No further information were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: tired; sleepy; This case was reported by a pharmacist via other manufacturer and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced tiredness and sleepiness. In January 2020, the outcome of the tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the tiredness and sleepiness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient was tired and sleepy after vaccination. No further information were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Achy for 48 hrs; This case was reported by a consumer via call center representative and described the occurrence of pain 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, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced pain after vaccination. The patient asked would any after effects occur 5 days after injection.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Pyrexia
Clinical narrative: dizzy; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020, the patient received Shingrix. On 14th February 2020, 1 days after receiving Shingrix, the patient experienced dizziness and low grade fever. On an unknown date, the outcome of the dizziness and low grade fever were unknown.   It was unknown if the reporter considered the dizziness and low grade fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received the vaccine and felt little dizzy and a low grade fever. The patient asked whether the events occurred are normal with the vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 101.4F; This case was reported by a nurse via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pneumonia. Previously administered products included Shingrix with an associated reaction of diarrhoea (received 1st dose on 26th October 2019, refer case US2020AMR027656).   On 9th February 2020, the patient received the 2nd dose of Shingrix. On 9th February 2020, 7 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The reporter stated that about 7 hours after receiving vaccine, the patient experienced a fever of 101.4F. The patient had another temperature elevation the next evening, then was afebrile on 11 February 2020 and had no recurrence of fever.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea which occurred the next day; This case was reported by a nurse via call center representative and described the occurrence of diarrhea in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix. On 27th October 2019, 1 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced diarrhea the next day after vaccination. The event resolved one to one and one half days later. For tolerance to 2nd dose, refer case US2020AMR027635.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: feel worse than 1st dose; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and feel worse. For tolerances of 2nd dose, refer case US2020AMR029036, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Vaccine positive rechallenge
Clinical narrative: feel worse than 1st dose; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (received 1st dose on unknown date, refer case US2020AMR029032).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and feel worse.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Lethargy, Malaise
Clinical narrative: 1st dose Shingrix in left arm 8/10/2019 / 2nd dose not administered yet; did not feel well (malaise); Lethargic; Headache; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 11th August 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise, lethargy and headache. On an unknown date, the patient experienced incomplete course of vaccination. On 12th August 2019, the outcome of the malaise, lethargy and headache were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the malaise, lethargy and headache to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose on left arm and did not feel well (malaise) the next day, was lethargic, and had a headache that lasted a day and was resolved the following da. Till the time of reporting the patient had not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; had recurrent Shingles outbreaks before Shingrix; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included varicella zoster virus vaccine, live, oka strain (Zostavax) for prophylaxis.   On 14th June 2019, the patient received Shingrix. On an unknown date, the patient started Zostavax at an unknown dose and frequency. On 14th June 2019, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and pain. On an unknown date, the outcome of the vaccination failure, herpes zoster and pain were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and pain to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient had recurrent Shingles outbreaks before Shingrix series and after complete series along with pain.  This case was considered as suspected vaccination failure, since the details regarding the, time to onset for event and laboratory confirmation for herpes zoster were not provided. The reporter did not consent to follow-up.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site warmth, Local reaction, Skin warm
Clinical narrative: Pt Right arm with pneumovax had localized reaction. warm raised red.  Pt Left arm warm and Red at injection site
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Pt Right arm with pneumovax had localized reaction. warm raised red.  Pt Left arm warm and Red at injection site
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Patient reported pain in shoulder area of left (administration) arm, fever of approximately 100 - 100.3 * F, and nausea. Fever and pain have persisted from 2/22/20 and continue as of today (2/24/20).
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: Left shoulder pain immediately after injection given and pain has persisted almost 1 month later. Shoulder pain (aching) with movement of arm. Treatment with rest, tylenol -- no improvement thus far
Sex: F
Vaccine: HPV9
Symptoms: Allergy test, Anxiety, Asthenia, Disturbance in attention, Dizziness
Clinical narrative: 3/3/2019 Onset - present  lightheaded & dizzy cold & tingling extreme heart palpitations poor concentration weakness tiredness difficult exercising gastrointestinal symptoms anxiety
Sex: F
Vaccine: HPV9
Symptoms: Exercise tolerance decreased, Fatigue, Feeling cold, Food allergy, Gastrointestinal disorder
Clinical narrative: 3/3/2019 Onset - present  lightheaded & dizzy cold & tingling extreme heart palpitations poor concentration weakness tiredness difficult exercising gastrointestinal symptoms anxiety
Sex: F
Vaccine: HPV9
Symptoms: Hypersensitivity, Hypertension, Oropharyngeal pain, Palpitations, Paraesthesia
Clinical narrative: 3/3/2019 Onset - present  lightheaded & dizzy cold & tingling extreme heart palpitations poor concentration weakness tiredness difficult exercising gastrointestinal symptoms anxiety
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Rhinorrhoea
Clinical narrative: 3/3/2019 Onset - present  lightheaded & dizzy cold & tingling extreme heart palpitations poor concentration weakness tiredness difficult exercising gastrointestinal symptoms anxiety
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye movement disorder, Loss of consciousness
Clinical narrative: Patient 4 years/old with hx of lumbar myeolominingocele, hrocephalus, s/p shunt, neurogenic bladder. Patient also with hx of brain surgery about a month ago due to shunt revision. Patient came for his annual well check (4 y/o), and received ProQuad and Quadracel vaccines. Reported allergies by mom were iodine and latex. Approximately 30 min after patient left the clinic, mother called to report that patient rolled his eyes up and passed out. She called 911, and was taken to ER for evaluation and management.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: PATIENT REPORTED LEFT ARM SORENESS, PAIN, AND MOBILITY PROBLEM THAT LASTED FOR ONE WEEK WITH FIRST DOSE OF SHINGRIX VACCINE
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Immediate onset pain at injection site and shoulder joint with progressive loss of mobility over the next 24-48hrs and worsening pain. Persisted despite home therapy for a month. Complete resolution of symptoms with left glenohumeral corticosteroid injection with recrudescence of pain about 10 weeks later without history of prior symptoms, trauma or mechanism of injury.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Loss of consciousness
Clinical narrative: I started feeling extremely weak, to the point I called my husband and told him it wasn't safe for me to drive the rest of the 10 minutes home.  Upon getting home, my husband had to help me to my bed where I passed out immediately and slept for several hours.  It took a few days to feel good again.  I felt like I was hanging onto life by a thread.  I am now too afraid to ever get a flu shot again nor do I want my kids getting a flu shot again.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; the patient was administered an improperly stored dose of MMR II; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 16-JAN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) 1 dose, lot # R030813, expiration date 24-OCT-2020 (dose number and route of administration were not provided) for prophylaxis. Sterile diluent used to reconstitute vaccine was properly stored.  The temperature excursion was above 47 degrees Fahrenheit (F) (74 F) for 13 hours. There were no previous excursions reported. The digital data logger was involved. No additional adverse events were reported.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Angioedema, Arthralgia, Chills, Depressed mood
Clinical narrative: developed angio edema; swelling in her face, lips; difficulty swallowing; weird feeling/feeling "down for the count"; feeling "down for the count"; Chills; fever; body aches; joint aches; muscle aches; diarrhea; upset stomach; started having injection site pain; started having injection site red /  red shoulder that extended to her elbow on the left side; This case was reported by a pharmacist via call center representative and described the occurrence of angioedema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles. Concurrent medical conditions included ra. Concomitant products included lisinopril.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 15 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, injection site erythema, facial swelling and swallowing difficult. The patient was treated with adalimumab (Humira) and methotrexate. On an unknown date, the outcome of the angioedema, feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, facial swelling and swallowing difficult were recovered/resolved and the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the angioedema, feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, injection site erythema, facial swelling and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about a half hour after experienced weird feeling that last 15 minutes and patient was fine. for the next 24 hours, then started feeling down for the count, chills, fever, body aches, muscle aches, joint aches, upset stomach, diarrhea that all lasted for 12 days.  The patient also experienced injection site pain and redness, and a red shoulder that extended to her elbow on the left side that started 24 hours after dose which was lasted for 9-10 days.  On an unknown date 15 days after dose patient developed angioedema, swelling in her face, lips. She states going to the Emergency room and being treated with prednisone and benadryl. After 16 days she had to go back to the Emergency room because she was having difficulty swallowing. She states her doctor things this may have been an allergic reaction to lisinopril and discontinued that medication. Reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dysphagia, Feeling abnormal, Injection site erythema, Injection site pain
Clinical narrative: developed angio edema; swelling in her face, lips; difficulty swallowing; weird feeling/feeling "down for the count"; feeling "down for the count"; Chills; fever; body aches; joint aches; muscle aches; diarrhea; upset stomach; started having injection site pain; started having injection site red /  red shoulder that extended to her elbow on the left side; This case was reported by a pharmacist via call center representative and described the occurrence of angioedema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles. Concurrent medical conditions included ra. Concomitant products included lisinopril.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 15 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, injection site erythema, facial swelling and swallowing difficult. The patient was treated with adalimumab (Humira) and methotrexate. On an unknown date, the outcome of the angioedema, feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, facial swelling and swallowing difficult were recovered/resolved and the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the angioedema, feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, injection site erythema, facial swelling and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about a half hour after experienced weird feeling that last 15 minutes and patient was fine. for the next 24 hours, then started feeling down for the count, chills, fever, body aches, muscle aches, joint aches, upset stomach, diarrhea that all lasted for 12 days.  The patient also experienced injection site pain and redness, and a red shoulder that extended to her elbow on the left side that started 24 hours after dose which was lasted for 9-10 days.  On an unknown date 15 days after dose patient developed angioedema, swelling in her face, lips. She states going to the Emergency room and being treated with prednisone and benadryl. After 16 days she had to go back to the Emergency room because she was having difficulty swallowing. She states her doctor things this may have been an allergic reaction to lisinopril and discontinued that medication. Reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Myalgia, Pain, Pyrexia, Swelling face
Clinical narrative: developed angio edema; swelling in her face, lips; difficulty swallowing; weird feeling/feeling "down for the count"; feeling "down for the count"; Chills; fever; body aches; joint aches; muscle aches; diarrhea; upset stomach; started having injection site pain; started having injection site red /  red shoulder that extended to her elbow on the left side; This case was reported by a pharmacist via call center representative and described the occurrence of angioedema in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles. Concurrent medical conditions included ra. Concomitant products included lisinopril.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 15 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, injection site erythema, facial swelling and swallowing difficult. The patient was treated with adalimumab (Humira) and methotrexate. On an unknown date, the outcome of the angioedema, feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, facial swelling and swallowing difficult were recovered/resolved and the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the angioedema, feeling abnormal, feeling down, chills, fever, general body pain, joint pain, muscle pain, diarrhea, upset stomach, injection site pain, injection site erythema, facial swelling and swallowing difficult to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about a half hour after experienced weird feeling that last 15 minutes and patient was fine. for the next 24 hours, then started feeling down for the count, chills, fever, body aches, muscle aches, joint aches, upset stomach, diarrhea that all lasted for 12 days.  The patient also experienced injection site pain and redness, and a red shoulder that extended to her elbow on the left side that started 24 hours after dose which was lasted for 9-10 days.  On an unknown date 15 days after dose patient developed angioedema, swelling in her face, lips. She states going to the Emergency room and being treated with prednisone and benadryl. After 16 days she had to go back to the Emergency room because she was having difficulty swallowing. She states her doctor things this may have been an allergic reaction to lisinopril and discontinued that medication. Reporter consented to follow up.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Herpes zoster
Clinical narrative: Shingles; I was very tired; Joint pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on 10Feb2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles at the same time on the second vaccine on 10Feb2020 (last week's Monday; so it has been 10 days). It was reported that patient was fine in the beginning. The patient became very tired. The patient goes out and does things but patient have to come back and rest because patient got tired and has joint pain. Patient was still very tired as of reporting time. Patient was asking if it was normal after so many days. Outcome of the event 'I was very tired' was not recovered while unknown for shingles and joint pain.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information regarding Batch/Lot number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test abnormal
Clinical narrative: Low antibody concentrations for multiple strains in the Prevnar 13; This is a spontaneous report from a contactable nurse via Pfizer sales representative.   A 16-year-old patient of an unspecified gender received four doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) all on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. It was reported the patient had low antibody concentrations for multiple strains in the pneumococcal 13-val conj vac (dipht crm197 protein).   Information on the lot/batch number has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 3 year old patient received a dose of an expired Daptacel vaccine on 14-FEB-2020 and the vaccine was expired on 07-FEB-2020/No AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA042252 (same reporter).  This case involves a three year old male patient who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 14-Feb-2020 , the patient received a 0.5ml booster dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5366 BA, expired date: 07-Feb-2020) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of report, 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.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 3 year old male patient  received an expired dose of Daptacel ,expiry date of 07-FEB-2020,No AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA042249 (same reporter).  This case involves a three year old male patient who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 14-Feb-2020, the patient received a 0.5 ml of booster dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5366 BA  and expiration date 07-FEB-2020) via an intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of report, 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.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a female patient received Adacel when she was 63 years of age, and again in 6 months at the age of 64, no AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case from a other health care professional (medical assistant).  This case involves a 64 years old female patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) when she was 63 years of age, and again after 6 months at the age of 64 (lot number and expiry date not reported)  via unknown route and in an unknown administration site for prophylactic vaccination on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided.   It was an actual medication error due to extra dose administered.  At the time of report, 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.  Information on batch number was requested.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old was given Quadracel (a delayed vaccine schedule), no AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who received a dose of 0.5 mL vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (5th dose for DTap and 4th for IPV) (lot number not reported) via an intramuscular route in the left thigh for prophylactic vaccination, on 31-Jan-2020.   Medical history, medical treatment, vaccination and family history were not provided.  No other vaccines were given.  It was a case of actual medication error due to Product administered to patient of inappropriate age.  The physician charted that the mom follows a delayed vaccine schedule, and that the physician discussed risks and benefits of following a delayed schedule. The patient is behind on vaccination for hepatitis A, hepatitis B, MMR, and varicella.  At the time of reporting, 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 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.  Information on the batch number was requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered only the DTaP-IPV portion of Pentacel to patient/No AE; Initial information was received on 14-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6 month old female patient who received only the DTaP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE; ROTAVIRUS VACCINE; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On an unknown date, the patient received third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ057AAA, expiry date - 07-Nov-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique. A medical assistant who administered only the DTaP-IPV portion of Pentacel.  At the time of report, 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.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered to patient / no AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a non-health professional.  This case involves a 4 years old male patient who was administered with expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number C5366BA Exp. Date 07-Feb-2020 via unknown route in unknown administration site, on 11-Feb-2020 for prophylactic vaccination.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used (Expired product administered).  At a time of reporting no adverse event reported. Reporter did not know which in the series this Daptacel dose was. Reporter stated that the patient had received concomitant vaccines, but declined to provide the names of the other vaccines. Reporter declined to provide any further information.  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.