chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Pyrexia, Varicella post vaccine
Clinical narrative: Pt developed Varicella (Chickenpox) after receiving the vaccine, pt developed fever 102 and and rash first appeared on Right leg.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: PT STATES ARM PIT SWELLING AND TENDER 1 DAY AFTER SHOT. RESOLVED COMPLETELY BY DAY 7.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Nausea, Pain in extremity, Visual impairment
Clinical narrative: Received 2 TRUMENBA at 12:02 PM. Had light breakfast at 10:40 AM - only ate 1/2 apple. Drove self home - ate lunch at restaurant afterwards. Felt dizzy at 3:45 PM. No syncope. Saw spots in front of eyes, nauseated. Took 1 ADVIL for sore arm and rested in bed. Feeling better 30 mins. later. 8/8/18 - called patient - no further complaints.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient's mom called and said that the patient has had a reaction to the vaccine that was given in the right leg 2 days ago at visit. Patient's mom describes it as red and warm, bigger than a golf ball but smaller than tennis ball. Looked up vaccine and it was the varicella. Spoke with Dr. about this and she said that it seems as a site reaction. Patient can try TYLENOL and cool compresses. Advised mom to circle the redden area so we can track if the redness gets bigger or smaller. Also advise mom to watch for any systemic reactions and if any are noted to bring patient in.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bone pain, Burning sensation, Diarrhoea, Headache
Clinical narrative: About 9 am the day after the vaccine I noticed some joint soreness. By 3 o clock PM that day I had to leave work early because of intense joint pain. I came home and had a fever, diarrhea, joint pain, a headache and bone pain. My tibia, fibula, sacrum, ileum, and ishium were on fire. I decided to take some over the counter anti inflammatory medication and some benadry. I slept one hour at a time all night due to excessive sweating and pain, but felt significantly better the next day.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Insomnia, Pyrexia
Clinical narrative: About 9 am the day after the vaccine I noticed some joint soreness. By 3 o clock PM that day I had to leave work early because of intense joint pain. I came home and had a fever, diarrhea, joint pain, a headache and bone pain. My tibia, fibula, sacrum, ileum, and ishium were on fire. I decided to take some over the counter anti inflammatory medication and some benadry. I slept one hour at a time all night due to excessive sweating and pain, but felt significantly better the next day.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Seizure, time course: 2-3 minutes in duration.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Pain
Clinical narrative: Patient reporting pain at the injection site, radiating down her left elbow and up the shoulder. Patient described the shoulder pain as soreness.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Muscle aches, extreme tiredness, nausea with vomit, headache, profuse perspiration, elevated temperature continuing as of this writing on 8/3/2018. No reaction to first dose two months earlier.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Muscle aches, extreme tiredness, nausea with vomit, headache, profuse perspiration, elevated temperature continuing as of this writing on 8/3/2018. No reaction to first dose two months earlier.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Arthralgia, Extra dose administered, Joint swelling
Clinical narrative: Grandmother called the clinic 8/2/2018 in the afternoon stating that her daughter brought the child to the clinic for vaccines and physical on 7/31/2018. She stated that she gave her daughter the wrong vaccine record. The record that was brought to the clinic did not have the last set of vaccines on it. She stated that the child had already had the vaccines done 2-3 months earlier.  Grandmother stated that the child was complaining that her hip was hurting and there was some swelling in her left knee. Instructed to take the child to see MD for evaluation.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood lactic acid, Cellulitis, Differential white blood cell count, Full blood count, Injection site pain
Clinical narrative: Given GARDASIL 9 and MENACTRA at WCC 6/27/18. GARDASIL 9 given in the right deltoid and MENACTRA given in the left deltoid. Injection site of the GARDASIL 9 very painful at the time of the injection - more painful than the left arm. Arm continued to be painful x 1 week. On 7/8/18 she woke up with a very swollen right arm and went to the Emergency room and was diagnosed with phlebitis and cellulitis of the right arm. Prescribed ibuprofen 600mg QID and cephalexin 500mg QID.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pain in extremity, Peripheral swelling, Phlebitis, Ultrasound Doppler
Clinical narrative: Given GARDASIL 9 and MENACTRA at WCC 6/27/18. GARDASIL 9 given in the right deltoid and MENACTRA given in the left deltoid. Injection site of the GARDASIL 9 very painful at the time of the injection - more painful than the left arm. Arm continued to be painful x 1 week. On 7/8/18 she woke up with a very swollen right arm and went to the Emergency room and was diagnosed with phlebitis and cellulitis of the right arm. Prescribed ibuprofen 600mg QID and cephalexin 500mg QID.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Headache, body ache, perspiration, tiredness, nausea, vomit, continuing to 8/3/2018.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Headache, body ache, perspiration, tiredness, nausea, vomit, continuing to 8/3/2018.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling, tenderness at L deltoid 5 inches x 4.75 inches in diameter. Rx KEFLEX.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Day 2, redness at shot site, shoulder muscles pain, weak and tired, headache, shivering, day 3, redness and very sore at shot site, rash on arms chest, stomach, back and legs, very tired, small headache, day 4, sore at shot site and still have rash, day 5, rash better but still evident, arm still sore but better.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Rash
Clinical narrative: Day 2, redness at shot site, shoulder muscles pain, weak and tired, headache, shivering, day 3, redness and very sore at shot site, rash on arms chest, stomach, back and legs, very tired, small headache, day 4, sore at shot site and still have rash, day 5, rash better but still evident, arm still sore but better.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Injection site soreness and redness, fatigue, extreme muscle aches (painful to even walk), shortness of breath, headache, teeth sensitivity. Fairly similar reaction to dose #1, except not the teeth sensitivity. I am unable to enter the Vaccine info above. SHINGRIX Vial Kit NDC: 58160-0823011.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Sensitivity of teeth
Clinical narrative: Injection site soreness and redness, fatigue, extreme muscle aches (painful to even walk), shortness of breath, headache, teeth sensitivity. Fairly similar reaction to dose #1, except not the teeth sensitivity. I am unable to enter the Vaccine info above. SHINGRIX Vial Kit NDC: 58160-0823011.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Day after(08/01/2018) soreness, red, andswelling at injection site. Tired, a little sick on my stomach and achy. 8/3/2018- light rash on sides and backs of my arms. Doesn't itch and is not red.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Day after(08/01/2018) soreness, red, andswelling at injection site. Tired, a little sick on my stomach and achy. 8/3/2018- light rash on sides and backs of my arms. Doesn't itch and is not red.
Age: 40.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient felt dizzy and threw up once. I put a cold, wet paper towel on the back of her neck as she had her head down. I also gave her some cold water. Later, she called me to see which vaccination it was that caused the reaction and I told her since she received them both, I wasn't sure. I asked her if she had eaten today and she said she had not at the time of the shots.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: 7/27 - Patient called to complain of arm soreness and concerns regarding pharmacist that gave injection. 7/28 - Patient was seen in acute care because her arm was getting worse. It was red, warm, and tende to palpitation. Patient was diagnosised with cellulitis and given an antibiotic.
Sex: U
Vaccine: VARCEL
Symptoms: Death, Varicella post vaccine
Clinical narrative: This literature marketed report has been received from the authors of the published article, and refers to an adult patient with a chronic autoimmune disease. The authors obtained data on varicella deaths for 2012-2016 using the Mortality Multiple Cause of Death public use records from the Center. A death from varicella was defined as one for which varicella diagnosis was listed on the death certificate. On an unknown date, the patient was vaccinated with a 1 dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) injection (exact dose, vaccination site, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died and varicella was listed as the underlying cause. The patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) within 1 month prior to death. Varicella-zoster virus (VZV) specimens were unavailable for laboratory testing. It was unknown if an autopsy was performed. The authors considered varicella post vaccine to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). This is one of several reports derived from the same literature article (linked with MARRS # 1808USA000251 and 1402USA010964). Sender's Comments: US-009507513-1402USA010964: US-009507513-1808USA000251: Reported Cause(s) of Death: varicella listed as the underlying cause of death.
Sex: U
Vaccine: VARCEL
Symptoms: Death, Varicella post vaccine
Clinical narrative: This literature marketed report has been received from the authors of the published article, titled as stated above and refers to an adult patient with a chronic renal failure on immunosuppressive treatment. The authors obtained data on varicella deaths for 2012-2016 using the Mortality Multiple Cause of Death public use records from the Center for Health Statistics. A death from varicella was defined as one for which varicella diagnosis was listed on the death certificate. On an unknown date, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (exact dose, site of administration, route of administration, lot# and expiration date were not provided). On an unknown date, the patient died and varicella was listed as the underlying cause. The patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) within 1 month prior to death. The patient was confirmed to have vaccine-strain varicella-zoster virus (VZV). It was unknown if an autopsy was performed. The authors considered varicella post vaccine to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports derived from the same literature article (linked with MARRS # 1807USA012959 and 1402USA010964). Sender's Comments: US-009507513-1402USA010964: US-009507513-1807USA012959. Reported Cause(s) of Death: varicella listed as the underlying cause of death.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age. On 07-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N026686, expiry date: 30-MAR-2019) (route: oral). The vaccine was exposed to a temperature of 47 F to 77 F at a time frame of 8 hours, 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1808USA001697: US-009507513-1808USA001701.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age. On 18-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N026686, expiry date: 30-MAR-2019) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 47 F to 77 F at a time frame of 8 hours, 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1808USA001326: US-009507513-1808USA001701.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Nausea, Vomiting
Clinical narrative: Patient got the chills and was nauseous several hours after receiving the vaccination. Patient reported vomiting and feeling very weak that evening but felt better the following day.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Lethargy, Pyrexia
Clinical narrative: Fever, headache, chill, lethargic and rash around area where injected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Chills, Differential white blood cell count, Dizziness, Full blood count
Clinical narrative: Severe right arm pain especially at injection site, dizzy, nausea, vomiting, fever, severe headache, chills, shaking, photophobia, phonophobia, neck pain, low back pain.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site pain, Metabolic function test, Nausea, Neck pain
Clinical narrative: Severe right arm pain especially at injection site, dizzy, nausea, vomiting, fever, severe headache, chills, shaking, photophobia, phonophobia, neck pain, low back pain.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Phonophobia, Photophobia, Pyrexia, Tremor
Clinical narrative: Severe right arm pain especially at injection site, dizzy, nausea, vomiting, fever, severe headache, chills, shaking, photophobia, phonophobia, neck pain, low back pain.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urine analysis, Vomiting
Clinical narrative: Severe right arm pain especially at injection site, dizzy, nausea, vomiting, fever, severe headache, chills, shaking, photophobia, phonophobia, neck pain, low back pain.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Per mother, slight rash and swelling began a few hours after vaccination. Next day, left upper arm was swollen, red, and itchy. Patient was taken to ER and diagnosed with allergic reaction to  vaccination. Instructed to follow up with PCP. Pt seen in office 8/3/18 and confirmed diagnosis of allergic reaction by MD. Prescribed following medications: triamcinolone acetonide 0.1 % topical cream Benadryl Allergy 12.5 mg/5 mL oral liquid prednisolone 15 mg/5 mL oral solution.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Swelling, Vaccination complication
Clinical narrative: Per mother, slight rash and swelling began a few hours after vaccination. Next day, left upper arm was swollen, red, and itchy. Patient was taken to ER and diagnosed with allergic reaction to  vaccination. Instructed to follow up with PCP. Pt seen in office 8/3/18 and confirmed diagnosis of allergic reaction by MD. Prescribed following medications: triamcinolone acetonide 0.1 % topical cream Benadryl Allergy 12.5 mg/5 mL oral liquid prednisolone 15 mg/5 mL oral solution.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Yesterday during the vaccination, the patient mentioned her she felt the vaccine being administered and it hurt. The administrator was kneeling next to the seated patient and administered per protocol. The patient called the pharmacy this morning to let the pharmacist know that she experienced fever/chills and soreness in her arm last night. She said she took 2 TYLENOL twice within a 12-hour period, which seemed to help at first. Upon calling this morning, the administrator asked if the patient was sick (even though the patient stated on her vaccine form that she wasn't), and the patient mentioned she had a UTI the week prior and was on antibiotics for this, but the treatment was completed prior to receiving the vaccine. The administrator told the patient to continue to use TYLENOL for fever/chills/soreness and to ice the area while she waits to be seen from the doctor. The pharmacy left a message for the patient's PCP to make him aware of the situation, and the patient was following up with the doctor as well.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong drug administered
Clinical narrative: Patient presented to OV with siblings. Had all vaccines separated and on metal trays for all 3 patients.  Verified name and dob. Then accidentally pulled a TRUMENBA from the older siblings tray and administered to the 11 year old.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Headache, Myalgia, Nausea
Clinical narrative: Pain everywhere for 24 hours (all joints and muscles, including cheeks, muscles in feet, forearms, pretty much everywhere), headache, nausea. Pain started in about 12 hours after shot and continued for 24 hours. Gastrointestinal upset lasted for about a week.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain everywhere for 24 hours (all joints and muscles, including cheeks, muscles in feet, forearms, pretty much everywhere), headache, nausea. Pain started in about 12 hours after shot and continued for 24 hours. Gastrointestinal upset lasted for about a week.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Delirium, Loss of consciousness, Syncope, Tremor
Clinical narrative: Patient came to clinic for MENACTRA vaccine for college and his mother also wanted him to have his first GARDASIL 9 shot. Patient was informed the purpose of both vaccines and possible side effects. Patient was given 0.5 ml of GARDASIL 9 in his right deltoid muscle and then MENACTRA 0.5 ml into his left deltoid muscle. After removing the MENACTRA needle from the patient's left arm, patient fainted into my arms and I called mother into the exam room to call 911. Patient was brought down to the floor and was noted to have tremors in his upper extremities and then pinched my upper arms; patient was noted to have loss of conscious and delirious behavior for about 1 minute. Patient woke up and requested water to drink. Patient also stated he did not eat anything prior to coming to the clinic, and stated he not does have a history of seizures or never had a reaction to getting a vaccine. A mini physical exam was conducted on the patient, which was within normal limits. EMS arrived at the clinic, and patient was safely escorted to the hospital with his mother.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 13-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 24-OCT-2016, the patient received his second dose with GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported). On 06-JUL-2018, the patient received the third dose with GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 55-year-old female patient received PREVNAR 13 via an unspecified route of administration on 25Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that the injection site area was still very red, with big circle area around it and hardened in the middle, hot to touch and tender. It was stated that the patient did not have a fever but had a local reaction and felt "kinda icky" and still not 100% self. The reporter wanted to know if this was common as it had been 7 days since the injection. The outcome of the events injection site area was still very red, with big circle area around it and hardened in the middle, hot to touch and tender was not recovered, while outcome of the event felt "kinda icky" and still not 100% self was unknown. Information on batch and lot numbers has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 55-year-old female patient received PREVNAR 13 via an unspecified route of administration on 25Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that the injection site area was still very red, with big circle area around it and hardened in the middle, hot to touch and tender. It was stated that the patient did not have a fever but had a local reaction and felt "kinda icky" and still not 100% self. The reporter wanted to know if this was common as it had been 7 days since the injection. The outcome of the events injection site area was still very red, with big circle area around it and hardened in the middle, hot to touch and tender was not recovered, while outcome of the event felt "kinda icky" and still not 100% self was unknown. Information on batch and lot numbers has been requested.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A female patient received TRUMENBA; (lot number and expiration date unknown) via unspecified route of administration in the arm on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. The reported stated that her daughter experienced pain in her arm after receiving a dose of meningococcal group B vaccine on unspecified date. The reporter needed to know the most common reactions in the administration site. Outcome of the event was unknown. Information on batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13; (lot/batch number and expiry date were unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. No concomitant medications, medical history, or relevant testing or investigations to report. The pharmacist stated that the area around the injection was more red than normal, there was more of a bump, and the top layer of skin peeled off like a sunburn. The outcome of the events was unknown. Information regarding lot/batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Abnormal behaviour, Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age (Age: 18, Unit: Unknown) received TRUMENBA, (lot number: S85201, expiration date: 32Dec2019) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was given meningococcal group b rlp2086 in the lab and fainted at check out. It was reported that the patient wasn't acting right at home and was brought back in. The outcome of fainted and wasn't acting right at home was unknown.
Age: 4.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old patient (gender not reported) who received a dose of MENACTRA lot U5839AA via unknown route in the left arm and ADACEL lot U5898AA via unknown route in the left arm on 20 Jul 2018 instead of fifth dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) lot number not reported via unknown route and a dose of PROQUAD lot number not reported via unknown route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered as patient received MENACTRA and ADACEL, however vaccinations were intended to be the 5th dose of DTaP and first dose of PROQUAD. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urticaria
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 73 years old female patient who experienced hives all over her body, while she received INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. The patient did not have an allergy to bird products. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer, lot number, expiry date and dose not reported via unknown route in unknown administration site four years ago. On an unknown date, the patient developed a non-serious hives all over her body (urticaria) with unknown latency following the administration of INFLUENZA VACCINE. Lab data was not provided. Final diagnosis was hives all over her body. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for hives all over her body. List of documents held by sender- none.
Age: 4.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 4 years old male patient who received IPOL and TDAP vaccine twice. The patients past medical history, concomitant medication and family history were not provided. On 25-Jul-2018, the patient received injection of suspect IPV (VERO) lot number, expiry date and dose not reported not reported via unknown route in left leg. On 27-Jul-2018 he also received injection of the same vaccine with an unknown batch number via unknown route in the right arm. On 25-Jul-2018, the patient received injection of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in left leg. On 27-Jul-2018 he also received injection of the same vaccine with an unknown batch number via unknown route in the right arm. It was an actual medication error due to extra dose administered. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA207851, 2018SA208860, and 2018SA208862 (same reporter). This case involves an infant patient (unknown gender, age reported as 12-9 days months old ) who was vaccinated with a 0.5 ml fourth single expired dose of vaccine ACT-HIB lot UI719AAA, (expiry date: 18-Oct-17), in the left thigh on 09-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; PREVNAR 13; and MMR VACCINE. It was a case of actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered. It was unknown whether patient experienced any adverse event to product. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid serious case received from a physician. This case involves male patient (age not reported) who experienced guillian-barre syndrome, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2017, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route. On an unspecifeid date, the patient developed a serious guillian-barre syndrome (guillain-barre syndrome) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event on 23-Oct-2017. Laboratory data was not provided. Final diagnosis was guillian-barre syndrome. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for guillian-barre syndrome. Documents held by sender: none.; Sender's Comments: This case concerns a patient who developed Guillain Barre Syndrome (GBS) post-vaccination with FLUZONE HD. The time to onset is not known. There is no information reported regarding use of Immunoglobulin Therapy. There is no information provided regarding patient's past medical history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies, particularly neurologic and infectious. There are multiple possible etiologies for this disease which need to be ruled out before a causal role of the vaccine can be assessed. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid serious case received from a office staff. This case involves an unknown age female patient who experienced Bell's palsy, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a serious Bell's palsy following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab data). Final diagnosis was Bell's palsy. Corrective treatment was not reported. The patient outcome is reported as Unknown for Bell's palsy. Sender's Comments: This case involves an unknown age patient who presented with Bell's palsy post vaccination with FLUZONE. Time to onset is unknown. Bell's palsy is expected post vaccination with FLUZONE. However, patient's medical history, medical condition at the time of vaccination and lab/radiological tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: HIBV, PNC13, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves 15 Month old patient who received 0.5 ml vaccination with ADACEL (frequency once, batch number, expiry date was not reported) intramuscularly in thigh on 30 July 2018 instead of pediatric dose. Concomitant medications included ACTHIB; and PREVNAR. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, MNQ, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 2 month old male patient who was vaccinated with 0.5 ml (batch number U6002AA, expiry date 11-SEP-2019 and site of administration were not reported) intramuscularly on an unspecified date instead of PREVNAR. Patient concurrently received PENTACEL for Immunisation for Immunisation; ENGERIX for Immunisation; and ROTATEQ for Immunisation. It was a case of actual medication error as Wrong vaccine administered. There are no reported reactions/symptoms. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old female patient who received a 0.5 mL dose of QUADRACEL lot C5248AA via intramuscular route in the left deltoid on 27-Jul-2018, after the dose of KINRIX administered in Dec-2017. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was reported that QUADRACEL had been inadvertently administered to a patient for the purpose of polio immunization after KINRIX had been administered in Dec-2017. She reported the intention had been for the patient to receive dose 5 in the series for polio immunization. She reported no other vaccines were administered concomitantly. 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. Documents held by sender: none.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old male patient who experienced excursion of opened polio 48.6 degrees f x 2 hours and 40 minutes, while he received vaccine IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPOL lot N1G41, expiry date- 28-Jul-2019 via intramuscular route in the left deltoid. It was a case of potential medication error due to incorrect product storage. (Other relevant tests included No lab data.) Final diagnosis was excursion of opened polio 48.6 degrees f x 2 hours and 40 minutes. An unknown corrective treatment was received. The patient outcome is reported as Not Applicable for excursion of opened polio 48.6 degrees f x 2 hours and 40 minutes.
Age: 5.0
Sex: U
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old patient who received GARDASIL instead of PENTACEL, while he/she received vaccines GARDASIL and PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient did not receive a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route but received a dose of suspect GARDASIL not produced by Sanofi Pasteur lot number not reported via unknown route. It was a case of potential medication error due to wrong vaccine administered. (Other relevant tests included No lab test). Final diagnosis was patient received GARDASIL instead of PENTACEL. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for patient received GARDASIL instead of PENTACEL. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child male patient who experienced dose of DAPTACEL was given to a patient one day past the expiration date, while he received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose dose of suspect DAPTACEL lot C5014AA, expiry date- 29-Jul-2018 via unknown route. It was a case of actual medication error due to expired vaccine used. (Other relevant tests included No lab data.) Final diagnosis was dose of DAPTACEL was given to a patient one day past the expiration date. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for dose of DAPTACEL was given to a patient one day past the expiration date. 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 and Module VI of the 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: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Fatigue, Loss of consciousness, Vomiting
Clinical narrative: Patient passed out within 5 minutes of vaccine administration. Patient became alert and oriented after 2-3 minutes of being unconscious. Once patient alert, he had emesis x 1. While patient was alert, he had complaints of abdominal pain and fatigue.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received telephone call from parent. Per report by parent on 8/2/18, patient had injection site swelling to right deltoid. Area was hard, red, and warm to touch. Swelling was about the size of the mother's hand (maybe 4"x4" or so). Parent said that the area on 7/31/18 was the size of a walnut after the injections by the time they arrived home. Patient notified parent of increased swelling on Wednesday night. Patient able to move arm. Patient was not complaining of pain, feels like a bruise. Patient complains of itching to site. Mother denies patient having any difficulty breathing, fever, hives, upset stomach. Mother states that patient has bad allergies (seasonal, pollen, dust). Mother applied ice to arm Wednesday night. Mother has not tried ibuprofen. Mother to try ibuprofen and call HD or doctor if area worsens.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Headache, Impaired work ability, Irritability
Clinical narrative: I received injection on Tuesday. Wednesday I awoke a bit dizzy, but made it through the day at work. Thursday I awoke a bit more dizzy and almost in sick, but proceeded to work. At 1 pm I was very dizzy and found that I was very easily irritable, which is not like me at all. I felt overwhelming anxiety and felt that I needed to be away from people immediately, so I told my boss "I have to go home, sorry" I made it home safe, at which point on Thursday night I had high fever. I pushed through the night, I took 3 ibuprofen for the headache that was rising. I got some sleep Thursday night and awoke Friday morning still dizzy but thankfully no fever, at which point I called the drs office that administered the shot and they referred me to contact you, please help. call.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: I received injection on Tuesday. Wednesday I awoke a bit dizzy, but made it through the day at work. Thursday I awoke a bit more dizzy and almost in sick, but proceeded to work. At 1 pm I was very dizzy and found that I was very easily irritable, which is not like me at all. I felt overwhelming anxiety and felt that I needed to be away from people immediately, so I told my boss "I have to go home, sorry" I made it home safe, at which point on Thursday night I had high fever. I pushed through the night, I took 3 ibuprofen for the headache that was rising. I got some sleep Thursday night and awoke Friday morning still dizzy but thankfully no fever, at which point I called the drs office that administered the shot and they referred me to contact you, please help. call.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Cough, Dyspnoea, Erythema, Immediate post-injection reaction
Clinical narrative: Patient was given Tdap at 2:50pm and complained of itching and burning sensation to right arm with erythema noted to right arm and hand immediately after the medication was given. Writer notified the provider who came in to assess patient. Patient was give BENADRYL 25mg by mouth at 3:05pm. At 3:08pm, patient complained of shortness of breath, throat itching, and a cough. At 3:10pm, the patient was give the Auto injector EPI-PEN 0.3mg IM in the left thigh. Within 3 minutes, patient stated the itching was resolving, no shortness of breath, and the erythema was resolving. Vital signs remained stable during event. After observation for approximately 1 hour, the patients symptoms resolved completely and left the center at 4pm.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Throat irritation
Clinical narrative: Patient was given Tdap at 2:50pm and complained of itching and burning sensation to right arm with erythema noted to right arm and hand immediately after the medication was given. Writer notified the provider who came in to assess patient. Patient was give BENADRYL 25mg by mouth at 3:05pm. At 3:08pm, patient complained of shortness of breath, throat itching, and a cough. At 3:10pm, the patient was give the Auto injector EPI-PEN 0.3mg IM in the left thigh. Within 3 minutes, patient stated the itching was resolving, no shortness of breath, and the erythema was resolving. Vital signs remained stable during event. After observation for approximately 1 hour, the patients symptoms resolved completely and left the center at 4pm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Flushing, Headache, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Day 1 - numb after injection at site. Day 2 - sore to touch/blotchy skin rash approxmiately 2 cm around site. Day 3/4 - diarrhea, fever 99.7 degrees F, flushing. Day 5/6 - swollen hands/feet/some joints, headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Joint swelling, Peripheral swelling, Pyrexia, Rash macular
Clinical narrative: Day 1 - numb after injection at site. Day 2 - sore to touch/blotchy skin rash approxmiately 2 cm around site. Day 3/4 - diarrhea, fever 99.7 degrees F, flushing. Day 5/6 - swollen hands/feet/some joints, headache.