chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about 2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a hospital for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was reported as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contact a persistent strain of herpes zoster accompanied by pain. On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient developed a painful rash. In response to these symptoms, the patient presented to a physician and was diagnosed with shingles and remained under their care. The outcome of the events were unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Epistaxis, Full blood count, Immune thrombocytopenic purpura, Penile haemorrhage
Clinical narrative: low platelet count; bruising; nose bleeds; bloody discharge from his penis; Thin skin; Immune thrombocytopenic purpura/ purpura lower extremity; This case was reported by a physician via call center representative and described the occurrence of platelet count low in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 28th July 2019, between 3 and 4 months after receiving Shingrix, the patient experienced contusion (serious criteria hospitalization), epistaxis (serious criteria hospitalization), penile hemorrhage (serious criteria hospitalization and GSK medically significant), skin thinness (serious criteria hospitalization) and immune thrombocytopenic purpura (serious criteria hospitalization and GSK medically significant). On 31st July 2019, the patient experienced platelet count low (serious criteria hospitalization). On an unknown date, the outcome of the platelet count low was not recovered/not resolved and the outcome of the contusion, epistaxis, penile hemorrhage, skin thinness and immune thrombocytopenic purpura were unknown.   The reporter considered the platelet count low, contusion, epistaxis, penile hemorrhage, skin thinness and immune thrombocytopenic purpura to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, however the patient could be 86 or 87 years old. The physician reported that a family member was admitted to the hospital yesterday after having seen a physician for 3 days history of unexplained bruising, nose bleeds and bloody discharge from his penis. The patient was diagnosed with Thin skin after having been seen by several physicians.  This physician reported that he noted lower extremity purpura and demanded a CBC. The results returned yesterday with a critical platelet value of 3000, so the patient received a phone call and was told to go straight to the Emergency room.  The reporter was trying to manage this all by phone with pictures, but states the family member was told by a physician at the hospital that these issues were caused by the Shingrix he received 4 months ago. The physician did not believed these issues to be related to the Shingrix and he was not aware if that was the first or second dose he had or any lot and expiration date information. The physician wanted to know if GSK was aware of any reports of ITP (idiopathic thrombocytopenic purpura) with Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count decreased, Skin atrophy
Clinical narrative: low platelet count; bruising; nose bleeds; bloody discharge from his penis; Thin skin; Immune thrombocytopenic purpura/ purpura lower extremity; This case was reported by a physician via call center representative and described the occurrence of platelet count low in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 28th July 2019, between 3 and 4 months after receiving Shingrix, the patient experienced contusion (serious criteria hospitalization), epistaxis (serious criteria hospitalization), penile hemorrhage (serious criteria hospitalization and GSK medically significant), skin thinness (serious criteria hospitalization) and immune thrombocytopenic purpura (serious criteria hospitalization and GSK medically significant). On 31st July 2019, the patient experienced platelet count low (serious criteria hospitalization). On an unknown date, the outcome of the platelet count low was not recovered/not resolved and the outcome of the contusion, epistaxis, penile hemorrhage, skin thinness and immune thrombocytopenic purpura were unknown.   The reporter considered the platelet count low, contusion, epistaxis, penile hemorrhage, skin thinness and immune thrombocytopenic purpura to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, however the patient could be 86 or 87 years old. The physician reported that a family member was admitted to the hospital yesterday after having seen a physician for 3 days history of unexplained bruising, nose bleeds and bloody discharge from his penis. The patient was diagnosed with Thin skin after having been seen by several physicians.  This physician reported that he noted lower extremity purpura and demanded a CBC. The results returned yesterday with a critical platelet value of 3000, so the patient received a phone call and was told to go straight to the Emergency room.  The reporter was trying to manage this all by phone with pictures, but states the family member was told by a physician at the hospital that these issues were caused by the Shingrix he received 4 months ago. The physician did not believed these issues to be related to the Shingrix and he was not aware if that was the first or second dose he had or any lot and expiration date information. The physician wanted to know if GSK was aware of any reports of ITP (idiopathic thrombocytopenic purpura) with Shingrix. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Chills, Headache, Injection site pain
Clinical narrative: Initial pain at the site of injection. About 12hrs later, fever, chills, headache, nausea, pain under the arm. Overall feeling of have been hit by a semi. Joints aching, hard to clench a fist of the left hand.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Nausea, Pain, Pyrexia
Clinical narrative: Initial pain at the site of injection. About 12hrs later, fever, chills, headache, nausea, pain under the arm. Overall feeling of have been hit by a semi. Joints aching, hard to clench a fist of the left hand.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Syncope
Clinical narrative: after administering vaccine to right arm the patient fainted, when the patient came to both her and her husband said it was a usual occurance and that she has been prohibitted to give blood beacause her fainting happened too regularly. patient was siiting in a chair while giving the vaccine so there was no other harm/injury from the fainting episode. we gave a glass of water as well because she said she was dehydrated.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Very achy,  headache
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Leukocytosis, Nausea, Neck pain
Clinical narrative: Fever began the evening after the injection.  The day after injection, patient reported to PCP with rash, nausea, neck pain, chills, fever and headache.  PCP said patient had leukocytosis in urine for the past week, patient did not disclose this to pharmacy prior to injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, White blood cells urine positive
Clinical narrative: Fever began the evening after the injection.  The day after injection, patient reported to PCP with rash, nausea, neck pain, chills, fever and headache.  PCP said patient had leukocytosis in urine for the past week, patient did not disclose this to pharmacy prior to injection.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: PT HAD SOME REDNESS IN LARGE AREA BELOW INJECTION, DID NOT SHOW UP TIL RECENTLY, WAS JUST SORE BEFORE. NO LONGER SORE PER PT
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient reports that she has experienced a decrease in range of motion and pain with her right should since receiving the Shingrix vaccine in the left shoulder.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Patient developed a rash on her chest and face within 5 minutes of completing vaccines. Rash spread throughout chest and slightly onto legs. Not on arms. Rash became more erythematous. Pt was stable, breathing comfortably. O2 sat 98%, HR 129, Temp 97.7.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site swelling, Pain, Pruritus
Clinical narrative: # Hep A site swollen,  Hep a given 6 days ago -- notes swelling, mild pain only, ess FROM of extremity -- no fever, systemic sxs, N/V. -- Some itching, but not very much. -- Overall it is persisting -- since yesterday maybe a little bit bigger. -- no prior reaction to vaccines
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Blood test, Fibromyalgia, Imaging procedure, Joint stiffness
Clinical narrative: within <24 hours of injection, patient began to experience aches in major joints with minor swelling, localized fever to the joints, stiffness, and difficulty with movement. the pain, swelling, and fever in joints continued over a period of months post injection, and lead to myalgia in the upper back, shoulders, arms, and legs. By May/June of 2010 patient was diagnosed with fibromyalgia by her primary care physician
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Joint swelling, Joint warmth, Mobility decreased, Myalgia
Clinical narrative: within <24 hours of injection, patient began to experience aches in major joints with minor swelling, localized fever to the joints, stiffness, and difficulty with movement. the pain, swelling, and fever in joints continued over a period of months post injection, and lead to myalgia in the upper back, shoulders, arms, and legs. By May/June of 2010 patient was diagnosed with fibromyalgia by her primary care physician
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Erythema
Clinical narrative: Patient called Pharmacy to report the adverse reaction on 8/3/19.  He reported a 5 to 6 inches long and about 2 inches wide of red spot.  He had no fever.  He feels a little weak but was fine after lunch.  He believed it is now getting a little better
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient experienced swelling, redness, pain in right arm. It looks like a bruise. Warm to the touch. Patient has had a doctor look at it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Peripheral swelling, Pruritus, Rash, Vaccination complication
Clinical narrative: Patient came to the pharmacy today 08/08/18 informing us that she had a adverse reaction from the  shingrix vaccine -rash, itchy,swollen arm,  lasted more that one week and left a large knot on her right arm
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: She said she was on the coach for 3 days with severe flu like symptoms. However she also said that her arm at the injection site was swollen and red for 10 days. She said she could move the arm fine. She also said the same thing happens when she gets stung by a bee or a mosquito bite.  She said that she is just really sensitive.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Whole upper arm was red and the injection site was bruised. It was warm to the touch. Patient said it was progressively getting worse since last week. I told her to ice it and have it looked at next door. She went to Dr. and had it checked out. Doctor said it was the beginning of cellulitis. She was prescribed Clindamycin every 8 hours for 5 days.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Dysphagia, Eating disorder, Herpes zoster, Malaise
Clinical narrative: Patient reports not feeling well (sore arm, general malaise) beginning day after the vaccination and worsening for two weeks until she developed "canker sore or ulcer-like blisters" on the right inside of her mouth and throat. Her tongue was also swollen (she claims to roughly twice normal size) on the right side and was bright red. She also complained of dysphagia and difficulty eating. She went into the clinic on 8/2/19 and was diagnosed with "Zoster with other complications" per diagnosis code and was prescribed Magic mouthwash 1:1:1 suspension to be used BID x7d and valacyclovir 1 gram TID x7d and seems to be feeling better when I spoke with her afternoon of 8/8/19.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Oropharyngeal blistering, Pain in extremity, Swollen tongue, Tongue erythema
Clinical narrative: Patient reports not feeling well (sore arm, general malaise) beginning day after the vaccination and worsening for two weeks until she developed "canker sore or ulcer-like blisters" on the right inside of her mouth and throat. Her tongue was also swollen (she claims to roughly twice normal size) on the right side and was bright red. She also complained of dysphagia and difficulty eating. She went into the clinic on 8/2/19 and was diagnosed with "Zoster with other complications" per diagnosis code and was prescribed Magic mouthwash 1:1:1 suspension to be used BID x7d and valacyclovir 1 gram TID x7d and seems to be feeling better when I spoke with her afternoon of 8/8/19.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dyspnoea, Feeling abnormal, Headache, Insomnia
Clinical narrative: By night, started to have pain on both legs--started from ankles going up like streams.  Patient rarely gets headaches, got headache, stomachaches, and labored breathing.   Patient could not sleep.  Got up the next day, felt awful but went about her day.  Patient went to bed and woke up feeling betterlike if had recovered completely. Patient went to yoga,   drank water and got a headache.  Patient has had an intermittent headache since then.   Patient called the doctor and waiting to hear back. Patient reports no problems after the first dose of vaccine.   Patient took no meds or did any treatment to feel better.  Arm hurt but heard everyone's does; now has slight pain on arm.   Patient notes that she only gets headache with flu.  Patient not at a 100% because of headache but functioning well otherwise.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: By night, started to have pain on both legs--started from ankles going up like streams.  Patient rarely gets headaches, got headache, stomachaches, and labored breathing.   Patient could not sleep.  Got up the next day, felt awful but went about her day.  Patient went to bed and woke up feeling betterlike if had recovered completely. Patient went to yoga,   drank water and got a headache.  Patient has had an intermittent headache since then.   Patient called the doctor and waiting to hear back. Patient reports no problems after the first dose of vaccine.   Patient took no meds or did any treatment to feel better.  Arm hurt but heard everyone's does; now has slight pain on arm.   Patient notes that she only gets headache with flu.  Patient not at a 100% because of headache but functioning well otherwise.
Age: 59.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Fatigue, Injection site pruritus, Pain
Clinical narrative: extreme tiredness the day after the 2d Shingrix shot that lasted 2 days, accompanied by mild body aches;  extreme itchiness at the vaccination site that started on the 4th day after the 2d shot and continues today, the 5th day after the 2d shot I do not know which of the hep A vaccines I received; I just picked one.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; vaccinated with one dose of improperly stored PROQUAD; This spontaneous report was received from a nurse referring to a 4-year-old child patient of unknown gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 25-JUL-2019, the patient was vaccinated with one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot/batch # R030803 and expiry date: 22-APR-2020 reconstituted with properly stored diluent for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (product storage error). No adverse effects were reported. The administered dose of vaccine experienced temperature excursion from 6ºF to 14ºF for a time frame of 24 hours. No previous temperature excursion occurred. The call was due to digital data logger. The outcome of the product storage error was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; Expired Proquad was Inadvertently administered; This spontaneous report was received from a health professional (Medical assistant) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 06-AUG-2019, the patient was inadvertently administered one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Therapy type: rHA, lot # R002936, Expiry date: 29-JUL-2019) for prophylaxis (expired product administered). No adverse effect was reported. No PQC was involved. The outcome of expired product administered and no adverse event was unknown.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: the cold; sore throat; fever; rash at the injection site; hard at the injection site; red at the injection site; This case was reported by a consumer via call center representative and described the occurrence of cold in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced cold, sore throat, fever, injection site rash, injection site induration and injection site erythema. On an unknown date, the outcome of the cold, sore throat, fever, injection site rash, injection site induration and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the cold, sore throat, fever, injection site rash, injection site induration and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Last Wednesday from the date of reporting, the patient received a dose of Shingrix. The patient experienced the cold, sore throat and fever.  The patient took medicine and it was better but she was having these symptoms at the time of this report.  The patient had rash where she got the shot, and It was growing below the site of injection. It grew 4 to 5 inches long and 3 inches wide. It all red and it did not itch. The patient visited her physician to made sure it was not shingles.  At the time of this report, the patient also had some hardness at the injection site. There is a discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: the cold; sore throat; fever; rash at the injection site; hard at the injection site; red at the injection site; This case was reported by a consumer via call center representative and described the occurrence of cold in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced cold, sore throat, fever, injection site rash, injection site induration and injection site erythema. On an unknown date, the outcome of the cold, sore throat, fever, injection site rash, injection site induration and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the cold, sore throat, fever, injection site rash, injection site induration and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Last Wednesday from the date of reporting, the patient received a dose of Shingrix. The patient experienced the cold, sore throat and fever.  The patient took medicine and it was better but she was having these symptoms at the time of this report.  The patient had rash where she got the shot, and It was growing below the site of injection. It grew 4 to 5 inches long and 3 inches wide. It all red and it did not itch. The patient visited her physician to made sure it was not shingles.  At the time of this report, the patient also had some hardness at the injection site. There is a discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Sex: M
Vaccine: DTAP, HPVX, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: severe Headache; fever; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA210296.  This case involves Child male patient who experienced severe headache and fever, while he received vaccines HPV VACCINE, DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PARACETAMOL (TYLENOL [PARACETAMOL]).  On 25-Jul-2019, the patient received a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6522AB (Expiry date 29-Jan-2021) via unknown route in the left deltoid.  On 25-Jul-2019, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On 25-Jul-2019, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious severe headache (headache) and fever (pyrexia) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HPV VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was fever and severe headache.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for severe headache and fever.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hypoglycaemia, Hypotension, Local reaction
Clinical narrative: hypoglycemia; hypotensive; dizziness; significant local reaction; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA210290 and 2019SA209569.  This case involves an unknown age female patient who experienced hypoglycemia, hypotensive, dizziness and significant local reaction, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PARACETAMOL (TYLENOL [PARACETAMOL]) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).  On an unknown date, the patient received a 0.5ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6522AB, expiry date: 29-Jan-2021 via unknown route in the right deltoid.  On an unknown date, the patient experienced a non-serious hypoglycemia (hypoglycemia), hypotensive (hypotension), dizziness and significant local reaction (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was significant local reaction, dizziness, hypotensive and hypoglycemia.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for the events.   List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: administered Menactra on 31Jul2019 in error; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15-month old female patient who was vaccinated with a second booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6152AA (expiry date: 19-Mar-2020) via unknown route in unknown administration site on 31-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to extra dose administered. It was reported that patient received second booster of Menactra after she received the it in a year prior.  It was not known whether the patient had any adverse event.  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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: 5 day expired Pentacel was administered to a patient; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who experienced 5 day expired pentacel was administered to a patient, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS B VACCINE RHBSAG (HEPA-B) for Immunisation.  On 01-Aug-2019, the patient received a dose  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5464AA via unknown route in the left thigh.  The patient developed a non-serious 5 day expired pentacel was administered to a patient (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was 5 day expired pentacel was administered to a patient.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Applicable for 5 day expired pentacel was administered to a patient.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: a 4 month old that received Acthib and Pentacel on the same day; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 4 month old patient who received 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] lot number was not reported via unknown route in the unknown, on the same day.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due extra dose administered.  It was unknown whether the patient had any adverse event.  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 the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Adacel which expired on 21JUL2019 and was given today, 02AUG2019 to an 11 year old female; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old female patient who received 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5729AA and Exp. Date 21-Jul-2019) via unknown route in unknown administration site, on 02-Aug-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 expired vaccine used.  It was reported that Adacel which expired on 21-Jul-2019 and was given today, 02-Aug-2019 to an 11 year old female.   It was unknown whether the patients 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.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Nausea, Peripheral swelling
Clinical narrative: nausea; the arm that the Trumenba was administered in was puffy; Headache; chills; Initial information regarding an unsolicited case was received from Pfizer (Non Licensed Partner) (MFR Control No: 2019332708) in the form of courtesy via physician via Pfizer Sales Representative and transmitted to Sanofi on 05-Aug-2019.   This case involves patient who experienced nausea, headache, chills and the arm that the Trumenba was administered in was puffy, while he/she received vaccines TRUMENBA and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Jul-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in the arm nos.  On 29-Jul-2019, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in the arm nos.  On 29-Jul-2019, the patient developed a non-serious nausea, headache, chills 6 hours following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA.  On 29-Jul-2019, the patient developed a non-serious the arm that the Trumenba was administered in was puffy (vaccination site swelling) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA.  (Other relevant tests included no lab data.)  Final diagnosis was the arm that the Trumenba was administered in was puffy, chills, headache and nausea.   It was not reported if the patient received a corrective treatment.  The patient was Not Recovered from headache and the arm that the Trumenba was administered in was puffy, the outcome of the other events was unknown.   On the next day on Tuesday, the patient came in with her siblings and was seeing the HCP and was still complaining that her arm was puffy and still had a headache.  Information on the batch number was requested.  Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV1
Symptoms: Abdominal X-ray, Bowel movement irregularity, Constipation, Irritability, Sleep disorder
Clinical narrative: Prior to vaccinations, patient had a normal bowel movement every other day. The day of his 2 month vaccinations he was fussier than usual but showed no signs of fever. Patient had a small bowel movement the following day, but did not have another until 4 days later, then again 7 days after that. His small bowel movement on 11/13 was the last one he would have for 32 days. At this time, patient was exclusively breastfed with no changes to his diet or mine as his source of breast milk. During the days following his vaccinations, and the 32 days without a bowel movement, patient was fussier than usual. He seemed to eat normally, but his sleep was very uncharacteristically disruptive. We made an appointment with his vaccinating pediatrician to discuss possible reasons why he was not having bowel movements, but the pediatrician simply said that it's common for breastfed babies to go a while between bowel movements. This did not seem common so we saw a new pediatrician at a different practice. This new pediatrician did a physical and said that it could be normal for a breastfed baby to go longer periods of time between bowel movements, but he wanted to make sure there was not another issue so he tried a glycerin suppository. Patient immediately pushed it out, along with a microscopic amount of stool. The pediatrician gave us a prescription for some kind of oral infant laxative to try. We gave patient the laxative 2-3 times, but it seemed to give him cramps and didn't produce any stool so we stopped. The next step the pediatrician recommended was an x-ray to see if there was actually any stool in patient's bowel to eliminate. After the x-ray, the pediatrician stated that he saw no stool, and recommended we take him to a pediatric gastroenterologist. This did not feel right to me, so I made patient an appointment with a chiropractor. On 12/14/18 patient has his first chiropractic adjustment, and had a regular bowel movement the following day. He saw the chiropractor every day for about a week, and his bowel movements became consistent again.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMRV, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was at appointment for 6 month well child visit.  given vaccines that were due: Pentacel, Prevnar, Rotvirus, and hEP b  Was also given vaccines due for his 12 month visit: Proquad and Hep A
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Body temperature increased, Vomiting
Clinical narrative: MOM STATES BABY VOMITED LAST NIGHT(08-07-19) WHILE SLEEPING AND THIS A.M (08-08-2019) ; THIS A.M (08-08-19) TEMP WAS ELEVATED TO 100.1, GAVE OTC TYLENOL , RECHECKED TEMP 20 MINS LATER AND TEMP WAS 100.3
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Discomfort, Fatigue, Injected limb mobility decreased
Clinical narrative: 1st 2 days, exhaustion 3rd day thru  day 36,  exessive left arm (injection site) pain at night, and cannot lift arm over head to remove garments, cannot play golf 3rd day thru 18 th day, extreme night time pain under left arm, down side of body, and shoulder pain 3rd day through  date of report (8/8/2019) left rotator cuff area pain in addition to arm pain, restricting many activities, lower back pain
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Injection site pain, Laboratory test normal, Loss of personal independence in daily activities, Pain
Clinical narrative: 1st 2 days, exhaustion 3rd day thru  day 36,  exessive left arm (injection site) pain at night, and cannot lift arm over head to remove garments, cannot play golf 3rd day thru 18 th day, extreme night time pain under left arm, down side of body, and shoulder pain 3rd day through  date of report (8/8/2019) left rotator cuff area pain in addition to arm pain, restricting many activities, lower back pain
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: syncope, mother witnessed event, after event, patient lied down for approximately 15 minutes, feet elevated, cool papertowel on forehead, ate some candy, patient recovered.  monitored blood pressure throughout.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray, Pyrexia
Clinical narrative: fever within several hours after receiving vaccine, temp of 101.3, pt was advised per his kidney dialysis dept to go to ER to have this addressed
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: abdominal pain, nausea, diarrhea,  vomiting for several hours which are not listed under the side effects!   Shame on the manufacturer!
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Fear, Feeling cold
Clinical narrative: abdominal pain, nausea, diarrhea,  vomiting for several hours which are not listed under the side effects!   Shame on the manufacturer!
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gastrointestinal sounds abnormal, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: abdominal pain, nausea, diarrhea,  vomiting for several hours which are not listed under the side effects!   Shame on the manufacturer!
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: patient received by retail pharmacy.  patient reported
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Blood test normal, Chills, Electrocardiogram normal, Headache, Respiration abnormal
Clinical narrative: couple hours   after vaccine administration patient reported headache, chills, and erratic breathing
Age: 51.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Basophil count decreased, Basophil percentage decreased, Dysgraphia, Eosinophil count decreased, Eosinophil percentage decreased
Clinical narrative: Pt c/o paresthesia in bilateral extremities about 2 wks after receiving vaccines. Pt also noticed being more "tongue tied" and difficulty writing and remembering letters. Pt has a hx of being "tongue-tied" 8 months prior and had a negative neuro and MRI. Pt has gone to the urgent care, pcp, and ED for a f/u on sx's. Pt has an apt with a neurologist next week.
Age: 51.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal
Clinical narrative: Pt c/o paresthesia in bilateral extremities about 2 wks after receiving vaccines. Pt also noticed being more "tongue tied" and difficulty writing and remembering letters. Pt has a hx of being "tongue-tied" 8 months prior and had a negative neuro and MRI. Pt has gone to the urgent care, pcp, and ED for a f/u on sx's. Pt has an apt with a neurologist next week.
Age: 51.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Memory impairment, Monocyte count increased
Clinical narrative: Pt c/o paresthesia in bilateral extremities about 2 wks after receiving vaccines. Pt also noticed being more "tongue tied" and difficulty writing and remembering letters. Pt has a hx of being "tongue-tied" 8 months prior and had a negative neuro and MRI. Pt has gone to the urgent care, pcp, and ED for a f/u on sx's. Pt has an apt with a neurologist next week.
Age: 51.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage increased, Paraesthesia, Platelet count normal
Clinical narrative: Pt c/o paresthesia in bilateral extremities about 2 wks after receiving vaccines. Pt also noticed being more "tongue tied" and difficulty writing and remembering letters. Pt has a hx of being "tongue-tied" 8 months prior and had a negative neuro and MRI. Pt has gone to the urgent care, pcp, and ED for a f/u on sx's. Pt has an apt with a neurologist next week.
Age: 51.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Red blood cell count normal, Red cell distribution width normal, Speech disorder, White blood cell count increased
Clinical narrative: Pt c/o paresthesia in bilateral extremities about 2 wks after receiving vaccines. Pt also noticed being more "tongue tied" and difficulty writing and remembering letters. Pt has a hx of being "tongue-tied" 8 months prior and had a negative neuro and MRI. Pt has gone to the urgent care, pcp, and ED for a f/u on sx's. Pt has an apt with a neurologist next week.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dizziness
Clinical narrative: Patient got the vaccines and was fine, parent and the patient went to check out and that is when the patient told mom she was feeling dizzy and light headed, patient was asked to have a seat and was given some juice, and the provider went  and talked a little bit with mom and found out that patient did have a heavy/hard workout and skipped lunch patient. After about 10-15 minutes patient was feeling better and was discharged from the office.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Altered state of consciousness, Malaise, Nausea, Pallor
Clinical narrative: Patient stated that she did not feel well after vaccine administration. Patient was advised to wait in waiting are for observation.  15mins post vaccination, mother advised patient was not feeling well, Patient was observed by staff to be pale, and patient advised staff that she feels like she wanted to pass out and throw up.  Patient was escorted to exam room, and was examined by Pediatrician. Patient was discharged by Physician without further incident with ER precaution.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient called the day after receiving the vaccination complaining of body aches, injection site had a bump, redness and was hurting. She also stated that she had a headache. We attempted to contact the patient on 8/8/19 to see if her symptoms had resolved but have not been able to reach her.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Pain, Post herpetic neuralgia
Clinical narrative: PATIENT STATED SHE WAS VERY TIRED WHERE SHOULD HAD TO KEEP GOING TO BED. SHE HAS A TERRIBLE HEADACHE AND DIARHHEA. SHE ALSO HAD SHINGLES ABOUT 8 YEARS AGO AND THIS VACCINATION REACTIVATED THE PAIN THAT SHE HAD WHEN SHE HAD THE SHINGLES. IT HAS BEEN 3 WEEKS AND THE SYMPTOMS HAVE STILL NOT GONE AWAY. SHE IS AFRAID TO GET SECOND VACCINATION AND WILL BE SPEAKING TO HER DOCTOR ABOUT THE ADVERSE REACTION SHE IS EXPERIENCING. SHE HAS PAIN ALL ALONG HER SIDE AND ACROSS HER BODY.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Hypoaesthesia, Muscle tightness, Musculoskeletal pain, Pain in extremity
Clinical narrative: The patient complained of pain/tightness in between his shoulder blades/upper back the following morning after receiving the Shingrix vaccine. He played golf that day for 3 days after. By the same afternoon (8/4/19) his left arm and side were sore. His middle two fingers were numb. His back was still sore. He went to the ER and they ran tests and a EKG to rule out heart issues. His diagnosis was 'muscular-skeletal.' On 8/5/19 to today (8/8/19), his inner elbow and middle 2 fingers are still numb. He will followup with his family Dr when he returns home.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: I gave the pt the shingrix shot-- She came back the enxt day with a raised raise at the site of injection
Age: 41.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Call received from patient today informing staff that after vaccinations received on Tuesday 8/6/19 , that she began to feel dizzy, and weak.  Contacted patient to follow up regarding concerns, patient stated " After I received the vaccines on Tuesday, in the evening around 10:00pm I began to feel really weak , head pounding and dizzy." "The dizziness was not that bad today, but I am still feeling weak." Patient denies any other complaints, advised if symptoms persist or worsen to go to nearest emergency room.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Diarrhoea, Ear infection, Ear pain, Gastrointestinal inflammation
Clinical narrative: Within a few hours of vaccine he was experiencing headache, earache, chills and flu like symptoms. He then had a fever and diarrhea. He missed school and also left early a couple days because of the diarrhea, chills, headache and pain at injection site. Put him on a BRAT diet until we noticed blood in his stool and salmon colored mucus along with a sleepless night on june 20th so we made an appointment for a doctor to make a house visit and discovered he has a ear infection along with the stomach problems. They gave him a 10 day antibiotic which only exacerbated the inflammation in his gut which caused an increase in the red stool and salmon colored mucus. He had 2 more visits and they are asking for a stool sample to see what is happening with his gut and may refer to a GI doctor if problem does not clear up. He still complains of on and off ear pain but the last visit on August 6th shows no infection but the pain still comes and goes.