chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Mom states that she dressed child the morning following vaccine administration (7/19/17) and child stated that his right arm was hurting but mom did not look at it. Later that same day as she was undressing child, she looked at arm and noticed that it was red, warm to touch and swollen. Child had temp of 100 F. Mom gave child BENADRYL and TYLENOL. Mom brought child to clinic today, 7/20/17, with complaints of continued redness, whelps and pain to upper right arm. Child was given topical BENADRYL and liquid CLARITIN to take at home. Mom instructed to follow up at ER or clinic if child has any breathing issues or reaction worsens/increases in size.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information was received on 05-JUL-2017 from a pharmacist via a company representative who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The pharmacist reported that the patient received a dose of ZOSTAVAX (lot and expiration not reported) on an unknown date "about a month ago" and developed a rash "from the injection site down the length of the arm". The patient was advised by the pharmacist to see their primary care physician. The patient has not provided any follow-up information to the pharmacist on the status of the event. No other information is available. Additional information is not expected. No further information to report.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information was received on 14-JUL-2017 from a pharmacist who reported that a 60 year old female patient was administered reconstituted ZOSTAVAX (lot# M038863, expiration 12-DEC-2017) to prevent shingles with diluent (unknown lot#/expiration) on an unspecified date and experienced "pain and redness the size of a 50 cent piece at the injection site" (onset not reported). Concomitant medication included methotrexate. Outcome of events was not reported. No treatment provided. No additional information. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 13-JUL-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-JUL-2017 the patient was administered a dose of VARIVAX lot # M048200 (also reported as M0048200), expiration 07-DEC-2018 subcutaneous for prophylaxis which was improperly stored. Concomitant therapies included properly stored sterile diluent (lot number and expiration unknown) which was used to reconstitute the vaccine. No adverse effects were reported. The vaccine was stored at -11 degrees Celsius for 13 full days (dates not reported.) There was no previous temperature excursion. The call was made due to a data logger. No additional information was available. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 05-JUL-2017 from a physician who was reporting on a female patient who was 8 weeks of age. No medical history or concomitant medication were reported. The physician reported that on 05-JUL-2017, the 8 week old patient received a dose of VAQTA (lot # M036459, expiration 18-JUN-2018) (dose, site and route not reported). No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 26-JUN-2017, the patient was vaccinated with one expired dose of VAQTA 25/0.5, with lot # M009377 and expiration date on 17-JUN-2017 (route of administration was not provided) for prophylaxis. It was reported, that the patient did not experience any adverse events and that no product quality issue was involved. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Eye irritation
Clinical narrative: The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 12Jul2017, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's mother). A male patient of an unspecified age, race and ethnicity received the third dose of TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history was unknown. The patient was on a prednisone eye drop concomitantly. On an unspecified date, the patient experienced eye irritation. Patient's mother said it's just under his left eye lid, the eye itself was not red, just a little irritation was noted. Clinical outcome of the event was unknown at time of this report.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site scab, Wound
Clinical narrative: 31 weeks 4 days at time of vaccination & adverse event; EDD 9/5/17. Pt c/o localized erythema and pruritus around site of injection. Pt did not call provider. Pt took BENADRYL on her own and found decrease in symptoms. Topical hydrocortisone provided no relief. Small healing wound/scab at site of injection where pt states that she "scratched".
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Erythema, Pain of skin, Skin warm
Clinical narrative: Pt was vaccinated 7/18/2017. Pt presents to clinic with left upper extremity reddened area. Warm to touch. Tenderness upon touch. Pt was evaluated at Urgent Care, dx with Cellulitis and was prescribed antibiotics and was advised to follow-up with PCM in 48 hours.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Erythema, Injection site swelling, Pain in extremity, Tenderness
Clinical narrative: Pt was vaccinated 7/18/2017. Pt presents to clinic with left upper extremity reddened area. Warm to touch. Tenderness upon touch. Pt was evaluated at Urgent Care, dx with Cellulitis and was prescribed antibiotics and was advised to follow-up with PCM in 48 hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Oedema, Skin warm, Tenderness
Clinical narrative: Right thigh warmth, erythema, mild tenderness, mild edema.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large, red, swollen area on left deltoid and fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Swelling
Clinical narrative: Given Dtap and Varicella in right upper arm on 7/18/17 followed by local erythema and induration over a 4-5 cm area of upper arm. No Systemic fever. Reaction seems to be subsiding with less redness and puffiness. Also has had diarrhea for 1-2 days.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Endotracheal intubation, Guillain-Barre syndrome, Immobile, Intensive care
Clinical narrative: Guillain-Barre syndrome, started 2/14/17 with back pain, progressed to hospital admission and rehabilitation stay. Was in hospital for several weeks, admitted to ICU, intubated. Developed pulmonary embolus due to immobility. Initially walking with walker, neuropathic pain. Improving walking, still with pain, though improving. Tracheostomy site healed.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Neuralgia, Pulmonary embolism, Rehabilitation therapy, Tracheostomy
Clinical narrative: Guillain-Barre syndrome, started 2/14/17 with back pain, progressed to hospital admission and rehabilitation stay. Was in hospital for several weeks, admitted to ICU, intubated. Developed pulmonary embolus due to immobility. Initially walking with walker, neuropathic pain. Improving walking, still with pain, though improving. Tracheostomy site healed.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Walking aid user
Clinical narrative: Guillain-Barre syndrome, started 2/14/17 with back pain, progressed to hospital admission and rehabilitation stay. Was in hospital for several weeks, admitted to ICU, intubated. Developed pulmonary embolus due to immobility. Initially walking with walker, neuropathic pain. Improving walking, still with pain, though improving. Tracheostomy site healed.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The patient came in to get a PNEUMOVAX 23 vaccine it was administered 7/19 and the patient came back that night and said her arm was swollen and red. The pharmacist said to contact md in the morning. The patient made an appt with the md on 7/20 and she was prescribed cephalexin for the infection on 7/20.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: Site of injection had swelling, was sore (hurt to move arm), and had a large red rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Patient presented to pharmacy 4 days after receiving ZOSTAVAX immunization with complaint of warmth. Upon exam, the injection site looked rather red and felt warm to the touch. Discovering pharmacist immediately contacted PCP and informed them of the reaction. PCP stated to take TYLENOL, monitor the site/keep it clean and come in if symptoms do not appear to resolve. Patient was advised by pharmacist accordingly.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Altered state of consciousness, Dizziness, Malaise, Pain in extremity, Pallor
Clinical narrative: Patient was given Tdap BOOSTRIX at 6:20pm along with another friend (patient's friend also received the same shot). They both left after receiving shots (at that moment, they both were normal). At 6:30pm, his friend came back saying patient was not feeling well. I went out to check on patient and found patient with head down on a chair. Patient was still conscious and was able to speak. His face looked pale as if his sugar was very low. He said he felt dizzy and just wanted to pass out. He just sat down and put his head down. I gave patient some Pepsi and water. Patient drank the Pepsi and the water. Throughout the whole time, patient was still able to speak and look up. Patient never passed out. Patient stated he received Tdap shot when he was 12 and he fainted back then. After about 5 minutes, patient threw up some water and he said he immediately felt better. I suspected that Tdap shot brought patient's sugar down which caused him to feel dizzy. I kept patient for another 10 minutes and he felt much better. He was able to speak and walk normally. So patient was back to normal after 15 minutes. I said I would call and check up on him the next and patient agreed. I just spoke to patient today (7/20) and patient stated he felt way better. He stated he should be back to normal at least 90%. Patient stated he felt some soreness in the injecting arm which was normal. Besides that, patient said he felt all good. So after checking on patient today, I found patient to be all normal again.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Patient was given Tdap BOOSTRIX at 6:20pm along with another friend (patient's friend also received the same shot). They both left after receiving shots (at that moment, they both were normal). At 6:30pm, his friend came back saying patient was not feeling well. I went out to check on patient and found patient with head down on a chair. Patient was still conscious and was able to speak. His face looked pale as if his sugar was very low. He said he felt dizzy and just wanted to pass out. He just sat down and put his head down. I gave patient some Pepsi and water. Patient drank the Pepsi and the water. Throughout the whole time, patient was still able to speak and look up. Patient never passed out. Patient stated he received Tdap shot when he was 12 and he fainted back then. After about 5 minutes, patient threw up some water and he said he immediately felt better. I suspected that Tdap shot brought patient's sugar down which caused him to feel dizzy. I kept patient for another 10 minutes and he felt much better. He was able to speak and walk normally. So patient was back to normal after 15 minutes. I said I would call and check up on him the next and patient agreed. I just spoke to patient today (7/20) and patient stated he felt way better. He stated he should be back to normal at least 90%. Patient stated he felt some soreness in the injecting arm which was normal. Besides that, patient said he felt all good. So after checking on patient today, I found patient to be all normal again.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Rash papular
Clinical narrative: Patient noticed her arm had an adverse reaction 5 days after prevnar vaccine (vaccine given in left arm on 7/13/17). Reported her upper arm had a rash "the size of a dollar bill" on 7/18/17 that was not there the day before. The rash was hot to the touch, red and bumpy. According to the patient the size of the rash decreased significantly from 7/18 to 7/20 and is now about 3 inches diameter around injection site. She is comfortable monitoring it from home as it continues to improve. I advised her to call us or her doctor if she notices it worsening or if it doesn't improve. We will call and check on her tomorrow as well to make sure it is improving.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Blood cholesterol abnormal, Blood pressure increased, Blood triglycerides abnormal, Blood urine present, Full blood count abnormal
Clinical narrative: The day after above shots were given, patient's face swelled up. Over the next 4 months, his face swelled intermittently for no apparent reason. On July 7, his face and entire body swelled. He was heavier too. His weight went from 42lbs upto 48lbs over 6 days time. Dr saw him over the next 4-5 days and he went to the ER 2x to attempt to restore his kidney function. Patient's blood pressure and weight continued to rise and his urine revealed protein and blood. His other labs were abnormal too. Due to his elevated blood pressure and continued proteinuria, patient was admitted to Hospital. With a diagnosis of Nephrotic Syndrome. He was an inpatient there from July 13-16. His Blood pressure and swelling have resolved and his urine is free from protein as of today 7/20/17. He will require continued Dr visits with a Pediatric Nephrologist and 12 weeks of steroids and urine checks.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Metabolic function test abnormal, Nephrotic syndrome, Protein urine present, Proteinuria, Renal function test abnormal
Clinical narrative: The day after above shots were given, patient's face swelled up. Over the next 4 months, his face swelled intermittently for no apparent reason. On July 7, his face and entire body swelled. He was heavier too. His weight went from 42lbs upto 48lbs over 6 days time. Dr saw him over the next 4-5 days and he went to the ER 2x to attempt to restore his kidney function. Patient's blood pressure and weight continued to rise and his urine revealed protein and blood. His other labs were abnormal too. Due to his elevated blood pressure and continued proteinuria, patient was admitted to Hospital. With a diagnosis of Nephrotic Syndrome. He was an inpatient there from July 13-16. His Blood pressure and swelling have resolved and his urine is free from protein as of today 7/20/17. He will require continued Dr visits with a Pediatric Nephrologist and 12 weeks of steroids and urine checks.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Renal impairment, Swelling, Swelling face, Ultrasound kidney normal, Urine analysis abnormal
Clinical narrative: The day after above shots were given, patient's face swelled up. Over the next 4 months, his face swelled intermittently for no apparent reason. On July 7, his face and entire body swelled. He was heavier too. His weight went from 42lbs upto 48lbs over 6 days time. Dr saw him over the next 4-5 days and he went to the ER 2x to attempt to restore his kidney function. Patient's blood pressure and weight continued to rise and his urine revealed protein and blood. His other labs were abnormal too. Due to his elevated blood pressure and continued proteinuria, patient was admitted to Hospital. With a diagnosis of Nephrotic Syndrome. He was an inpatient there from July 13-16. His Blood pressure and swelling have resolved and his urine is free from protein as of today 7/20/17. He will require continued Dr visits with a Pediatric Nephrologist and 12 weeks of steroids and urine checks.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Weight increased
Clinical narrative: The day after above shots were given, patient's face swelled up. Over the next 4 months, his face swelled intermittently for no apparent reason. On July 7, his face and entire body swelled. He was heavier too. His weight went from 42lbs upto 48lbs over 6 days time. Dr saw him over the next 4-5 days and he went to the ER 2x to attempt to restore his kidney function. Patient's blood pressure and weight continued to rise and his urine revealed protein and blood. His other labs were abnormal too. Due to his elevated blood pressure and continued proteinuria, patient was admitted to Hospital. With a diagnosis of Nephrotic Syndrome. He was an inpatient there from July 13-16. His Blood pressure and swelling have resolved and his urine is free from protein as of today 7/20/17. He will require continued Dr visits with a Pediatric Nephrologist and 12 weeks of steroids and urine checks.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: On 7/17/17, patient was inadvertently given only the liquid portion of the MENVEO by a staff member, and did not receive the Group A portion of the vaccine. Patient returned on 7/20/17 to receive a full vaccine.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Influenza, Influenza like illness, Pain, Rash macular
Clinical narrative: Very strong flu like symptoms, aching all over body as if you had a bad case of flue. Worst by 7:00 pm. Took ibprophin and went to bed. OK next morning  about 10 hours later. Also red blotch on both sides of body from belt line to arm pit.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Oropharyngeal pain, Petechiae, Pyrexia, Streptococcus test
Clinical narrative: On 7/14/17 patient developed sore throat, fever, and arthralgias. Parent took patient to Hospital. Rapid strep testing was negative. Diagnosis viral pharyngitis. Bilateral 1 mm sized petticheal lesions to distal legs [on shins] developed same day after ER visit. All symptoms except lesions have resolved. Lesions have not spread or worsened.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Streptococcus test negative, Viral pharyngitis
Clinical narrative: On 7/14/17 patient developed sore throat, fever, and arthralgias. Parent took patient to Hospital. Rapid strep testing was negative. Diagnosis viral pharyngitis. Bilateral 1 mm sized petticheal lesions to distal legs [on shins] developed same day after ER visit. All symptoms except lesions have resolved. Lesions have not spread or worsened.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Fall, Loss of consciousness, Restlessness
Clinical narrative: Patient fell on the floor. Temporarily feeling weak, zoned out and uneasy for less than 5 minutes, no rash development.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: Vaccine was given around 1:30 pm on Friday. By 6 pm arm was starting to hurt. Woken at 2 am by nausea, arm pain and headache. The next 2 days had severe fatigue, headache, fever of 101, chills, nausea, body aches. Arm was hot and swollen but not red. Very painful to move, shooting, aching pain up into shoulder and neck, and all the way down to my hand. Took Tylenol - not sure if it helped. By Monday arm was still sore to the touch but most other symptoms (except fatigue) subsided. Tuesday the nausea, aches and headache returned and red, hot itchy blotches appeared on my arm. Weds went to doctor who prescribed prednisone 40 mg a day for 5 days. The blotches would go away a few hours after taking the prednisone , but come back by late afternoon. By Friday (7 days after vaccine) felt mostly better except for fatigue and itching arm. Itching completely gone 1 day after finishing prednisone.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Vaccine was given around 1:30 pm on Friday. By 6 pm arm was starting to hurt. Woken at 2 am by nausea, arm pain and headache. The next 2 days had severe fatigue, headache, fever of 101, chills, nausea, body aches. Arm was hot and swollen but not red. Very painful to move, shooting, aching pain up into shoulder and neck, and all the way down to my hand. Took Tylenol - not sure if it helped. By Monday arm was still sore to the touch but most other symptoms (except fatigue) subsided. Tuesday the nausea, aches and headache returned and red, hot itchy blotches appeared on my arm. Weds went to doctor who prescribed prednisone 40 mg a day for 5 days. The blotches would go away a few hours after taking the prednisone , but come back by late afternoon. By Friday (7 days after vaccine) felt mostly better except for fatigue and itching arm. Itching completely gone 1 day after finishing prednisone.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Pyrexia, Rash macular, Skin warm, Sleep disorder
Clinical narrative: Vaccine was given around 1:30 pm on Friday. By 6 pm arm was starting to hurt. Woken at 2 am by nausea, arm pain and headache. The next 2 days had severe fatigue, headache, fever of 101, chills, nausea, body aches. Arm was hot and swollen but not red. Very painful to move, shooting, aching pain up into shoulder and neck, and all the way down to my hand. Took Tylenol - not sure if it helped. By Monday arm was still sore to the touch but most other symptoms (except fatigue) subsided. Tuesday the nausea, aches and headache returned and red, hot itchy blotches appeared on my arm. Weds went to doctor who prescribed prednisone 40 mg a day for 5 days. The blotches would go away a few hours after taking the prednisone , but come back by late afternoon. By Friday (7 days after vaccine) felt mostly better except for fatigue and itching arm. Itching completely gone 1 day after finishing prednisone.
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Diagnostic procedure, Facial paralysis
Clinical narrative: Patient has Bell's palsy. The right side of his face is affected. He was originally seen in the ER and is going to a neurologist at Hospital tomorrow (07/21/17). He was given prescriptions for prednisone and acyclovir at the ER.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Myalgia
Clinical narrative: Myalgia and erythema.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Within 5 minutes of receiving vaccines mom states she noticed child had developed hives on body primarily of face and upper trunk area. Immediately returned to office where child was given  6.25 mg  of Children's Diphenhydramine 12.5mg/5mL. Improvement in rash noted within 5 minutes of administration. No swelling of face or mucus membranes, vomiting, or dyspnea noted at any point. Child kept in office for greater than 30 minutes for evaluation for anaphylactic reaction.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: 24hrs after vaccines were administered, patient developed redness over the (R) and (L) deltoid. Patient presented on 7/20/2017 with (R) deltoid- 2in x 31/2in circular erythema and (L) deltoid-21/2in x 13/4in circular erythema.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, Oral administration complication, Regurgitation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a day after receiving ROTARIX, the patient experienced regurgitation of medication and accidental underdose. On an unknown date, the outcome of the regurgitation of medication and accidental underdose were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient regurgitated a dose of ROTARIX when given, which led to accidental underdose. The health care professional asked if replacement dose of ROTARIX should be given. No further information was provided.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Sharp pain in shoulder (left) when stretching arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Pt seen in our office 7/20/17 due to fever 101.2. Ax and (R) arm swelling at KINRIX immune site 5x3 cm red hard erythema. Dx with cellulitis. Given cephalexin PO TID x7 days.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dehydration, Dizziness, Feeling abnormal, Inadequate diet, Physical examination normal
Clinical narrative: Received call from Immunization Staff and spoke with patient and nurse. Patient advised she received TDaP booster on 7/11/2017 (last TDaP was 3/7/2007). She reported vaccine site was sore, but nothing unusual until this am. She awoke fine, but over the last few hours she felt dizzy and funny. Her eyes felt blurry, she cannot lay down or close eyes due to increased sensation of dizziness (head spinning), she advised most of sensation was to temple region of head. She feels like she has to move slowly but denies any fever, N/V, speech impairment, no paresthesia or muscle weakness/numbness, no neck pain or sinus/ear pain, no rash or lymphadenopathy. Nurse advised HR in 80's and normal with BP 118/80 and afebrile. Patient admits to not eating today so just ate before seeing immunization staff and drank some water. She reports a history of migraine headaches 2-3 times per week on TOPAMAX daily. This dizziness/head and visual sensation was not typical of her headaches but had location of symptoms was similar (has ocular migraines). Brief review of electronic medial record identified prior C/O dizziness since 2014. She has been evaluated by neurology several times since 2014. A note 10/5/2016 documented: "Patient states they (HA) occur on average two times a month. She has aura symptoms of visual floaters and tunnel vision and then within 30 minutes she feels bilateral frontal and occipital pressure and pressure behind her eyes which last for several hours to all day long even with abortive medications. Headaches are always associated with photophobia/phonophobia and sometimes nausea and vertigo. "She was diagnosed with migraine w/aura. 7/13 pt states is better but is seeing HCP for continued dizziness and funny feeling in her eyes. She did leave work yesterday and out of work today due to this reaction. HCP note: Dizziness and giddiness: Dizziness and light-headedness, was thought to have had an allergic reaction to TDaP vaccine. Unremarkable exam today, negative Dix Hall pike maneuver. After reviewing daily food intake and hydration status, likely patient was  dehydrated and has not been taking in enough calories on a daily basis. Additionally, has not been consistent with Vitamin D supplement that was prescribed to her for a vitamin D level of 20. Will repeat labs to R/O other cause: thyroid/hypoglycemia/vitamin D. Recommend pt have six small healthy meals vs 3 big meal to maintain daily nutrients level and prevent dehydration. Declined nutrition consult at this time. May F/U with PCM to review lab results. Pt ambulated without difficulty out of exam room, no dizziness or fainting observed.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: Received call from Immunization Staff and spoke with patient and nurse. Patient advised she received TDaP booster on 7/11/2017 (last TDaP was 3/7/2007). She reported vaccine site was sore, but nothing unusual until this am. She awoke fine, but over the last few hours she felt dizzy and funny. Her eyes felt blurry, she cannot lay down or close eyes due to increased sensation of dizziness (head spinning), she advised most of sensation was to temple region of head. She feels like she has to move slowly but denies any fever, N/V, speech impairment, no paresthesia or muscle weakness/numbness, no neck pain or sinus/ear pain, no rash or lymphadenopathy. Nurse advised HR in 80's and normal with BP 118/80 and afebrile. Patient admits to not eating today so just ate before seeing immunization staff and drank some water. She reports a history of migraine headaches 2-3 times per week on TOPAMAX daily. This dizziness/head and visual sensation was not typical of her headaches but had location of symptoms was similar (has ocular migraines). Brief review of electronic medial record identified prior C/O dizziness since 2014. She has been evaluated by neurology several times since 2014. A note 10/5/2016 documented: "Patient states they (HA) occur on average two times a month. She has aura symptoms of visual floaters and tunnel vision and then within 30 minutes she feels bilateral frontal and occipital pressure and pressure behind her eyes which last for several hours to all day long even with abortive medications. Headaches are always associated with photophobia/phonophobia and sometimes nausea and vertigo. "She was diagnosed with migraine w/aura. 7/13 pt states is better but is seeing HCP for continued dizziness and funny feeling in her eyes. She did leave work yesterday and out of work today due to this reaction. HCP note: Dizziness and giddiness: Dizziness and light-headedness, was thought to have had an allergic reaction to TDaP vaccine. Unremarkable exam today, negative Dix Hall pike maneuver. After reviewing daily food intake and hydration status, likely patient was  dehydrated and has not been taking in enough calories on a daily basis. Additionally, has not been consistent with Vitamin D supplement that was prescribed to her for a vitamin D level of 20. Will repeat labs to R/O other cause: thyroid/hypoglycemia/vitamin D. Recommend pt have six small healthy meals vs 3 big meal to maintain daily nutrients level and prevent dehydration. Declined nutrition consult at this time. May F/U with PCM to review lab results. Pt ambulated without difficulty out of exam room, no dizziness or fainting observed.
Sex: F
Vaccine: RV1, RV1
Symptoms: Rotavirus test positive
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of virus stool test positive in a infant female patient who received ROTARIX lyophilized formulation (batch number YN47S, expiry date 9th November 2018). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, 17 days after receiving ROTARIX lyophilized formulation, the patient experienced virus stool test positive. On an unknown date, the outcome of the virus stool test positive was unknown. It was unknown if the reporter considered the virus stool test positive to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that 17 days after receiving ROTARIX it showed up positive in the stool for the patient. No additional information was provided.
Sex: F
Vaccine: RV1, RV1
Symptoms: Diarrhoea haemorrhagic, Rotavirus test positive
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of virus stool test positive in a infant female patient who received ROTARIX lyophilized formulation (batch number YN47S, expiry date 9th November 2018). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, 17 days after receiving ROTARIX lyophilized formulation, the patient experienced virus stool test positive. On an unknown date, the outcome of the virus stool test positive was unknown. It was unknown if the reporter considered the virus stool test positive to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that 17 days after receiving ROTARIX it showed up positive in the stool for the patient. No additional information was provided.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm redness swelling and pain.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Vaccine site red, hot and hot to touch no streaking or fever. C/O itch.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever post immunization to 101.7. Vomited x1.
Age: 1.67
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Vaccination site induration, Vaccination site nodule, Vaccination site pain
Clinical narrative: Child received 18m health check vaccines on 7/07/17. On 7/15/17, child presented with a small firm minimally tender less than 1 cm nodule noted on left thigh without erythema or induration. Took: MOTRIN.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Presyncope
Clinical narrative: Near fainting, black out, no loss of consciousness, right after injections. Conscious, recovered after 15 min.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: Lightheadness pt laid down then left the office.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: After administration pt reported feeling light headed. She sat down with head covered for 20 mins and felt fine after.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Concussion, Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Immediately following vaccines, patient developed syncope; striking her head on a windowsill in exam room. Patient evolved with concussion symptoms.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Pt. rec'd 12 mo. immunizations in office on 7/13/17. Mom C/D office 7/14/17 to report localized redness and edema to (LT) at 0900 AM 7/14. Pt. seen by PCP on 7/14. 1 1/2 cm red, circular patch around injection site. Plus induration. No rash/fever. Slightly warm to touch. Tx with TYLENOL/ibuprofen PRN. Monitor site for increase.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: Discoloration of injection site.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Patient received PNEUMOVAX w/no immediate complications. Returned home and was working on his garden (putting down decorative rocks), and noticed some pain in the left upper arm around 230pm. Thought this was muscle strain from his gardening work and decided to rest. Noted swelling to the upper arm around 530pm, pain increased over this time period. No prior vaccine reactions, received PREVNAR 13 vaccine 1/2017. No food allergies that he is aware of. Denies fever/chills. Some tingling in the digits on the left arm and difficulty with flexion and extension at the elbow due to pain. Per Urgent care clinic note, LUE: left upper arm tense with significant swelling from about 1.5-2 inches from acromion process extending distally through elbow. Area is mildly indurated, warm, and erythematous. Significantly tender to palpation. Hand grip strength is 5/5. Radial pulse is 2+. Hand is warm. Able to abduct and adduct digits of left hand without difficulty. Some difficulty making a fist D/T pain. Difficulty with flexion at elbow D/T pain. Likely infectious process rather than delayed hypersensitivity as he has received numerous vaccines in the past without issue. WBC WNL- Rx's PO clindamycin.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness, Vaccination site joint movement impairment, White blood cell count normal
Clinical narrative: Patient received PNEUMOVAX w/no immediate complications. Returned home and was working on his garden (putting down decorative rocks), and noticed some pain in the left upper arm around 230pm. Thought this was muscle strain from his gardening work and decided to rest. Noted swelling to the upper arm around 530pm, pain increased over this time period. No prior vaccine reactions, received PREVNAR 13 vaccine 1/2017. No food allergies that he is aware of. Denies fever/chills. Some tingling in the digits on the left arm and difficulty with flexion and extension at the elbow due to pain. Per Urgent care clinic note, LUE: left upper arm tense with significant swelling from about 1.5-2 inches from acromion process extending distally through elbow. Area is mildly indurated, warm, and erythematous. Significantly tender to palpation. Hand grip strength is 5/5. Radial pulse is 2+. Hand is warm. Able to abduct and adduct digits of left hand without difficulty. Some difficulty making a fist D/T pain. Difficulty with flexion at elbow D/T pain. Likely infectious process rather than delayed hypersensitivity as he has received numerous vaccines in the past without issue. WBC WNL- Rx's PO clindamycin.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Peripheral swelling, Skin warm
Clinical narrative: Next day upper arm was swollen, erythema medially, warm to touch, pt felt "warm". Improved today, mild swelling, erythema.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Loss of consciousness, Nausea, Paraesthesia, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of tingling of extremity in a 12-year-old male patient who received BOOSTRIX. Co-suspect products included MENVEO. On an unknown date, the patient received BOOSTRIX and MENVEO. On an unknown date, immediately after receiving BOOSTRIX and MENVEO, the patient experienced tingling of extremity, fainting and generalized rash. On an unknown date, the outcome of the tingling of extremity, fainting and generalized rash were recovering/resolving. It was unknown if the reporter considered the tingling of extremity, fainting and generalized rash to be related to BOOSTRIX and MENVEO. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported, after receiving both MENVEO and BOOSTRIX vaccines simultaneously, the patient experienced fainting and tingling in feet. After 48 hours, the patient experienced rash over entire body. 2 days after vaccination, the patient came to emergency room visit for fainting and tingling events. The doctor ordered for a computerized tomogram (CAT scan), blood work and was referred to neurology. The patient was recovering. No additional information was provided. It was reported that, the healthcare professional would call in with additional information.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Paraesthesia, Rash generalised, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of tingling of extremity in a 12-year-old male patient who received BOOSTRIX. Co-suspect products included MENVEO. On an unknown date, the patient received BOOSTRIX and MENVEO. On an unknown date, immediately after receiving BOOSTRIX and MENVEO, the patient experienced tingling of extremity, fainting and generalized rash. On an unknown date, the outcome of the tingling of extremity, fainting and generalized rash were recovering/resolving. It was unknown if the reporter considered the tingling of extremity, fainting and generalized rash to be related to BOOSTRIX and MENVEO. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported, after receiving both MENVEO and BOOSTRIX vaccines simultaneously, the patient experienced fainting and tingling in feet. After 48 hours, the patient experienced rash over entire body. 2 days after vaccination, the patient came to emergency room visit for fainting and tingling events. The doctor ordered for a computerized tomogram (CAT scan), blood work and was referred to neurology. The patient was recovering. No additional information was provided. It was reported that, the healthcare professional would call in with additional information.
Age: 84.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an 84 year old male. The patient is allergic to sulfa drug. No information regarding concurrent condition was provided. The patient has taken antibiotics in the past. On 11-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M038216, expiry date: 31-JUL-2018 intramuscular (dose number and dose were not reported) for the prevention of pneumonia. Concomitant therapies included loratadine, pantoprazole, blood pressure medicine, and iron (unspecified). On 11-JUL-2017, a few hours after vaccination the patient began experiencing "swelling in the bicep area in the arm in which the injection was given". The outcome of the event was reported as not recovered. Causality assessment was unknown.
Age: 12.0
Sex: M
Vaccine: IPV, IPV
Symptoms: Fatigue, Pyrexia, Rash, Urticaria
Clinical narrative: Onset of fatigue and fever within 24 hours followed by urticaria extending to torso, limbs, face and buccal surfaces. Rash lasting 10 days.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site pain, Myalgia, Neck pain
Clinical narrative: Pain in my left, upper bicep, rotator muscles, neck, mid back.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Large area or erythema surrounding vaccination site, some pain.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, site of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced an outbreak of shingles on the thorax area a week after receiving ZOSTAVAX. The outcome of shingles was reported as recovered/resolved. Causality assessment was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 28-JUN-2017 from a registered nurse regarding a 21 year old male patient. Medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2017, the patient was inadvertently vaccinated with ZOSTAVAX 19400 PFU (lot # M035696, expiration date 07-NOV-2017) (dose, route, and site of administration not reported) reconstituted with sterile diluent (lot # M01218, expiration date 10-NOV-2017). The outcome of the event was not reported. No adverse effects were reported. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from an office manager via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 9 intramuscularly (strength, dose, anatomical location, lot number and expiration date were not provided), for prophylaxis.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Registered Pharmacist (R. Ph) concerning a 59 year old male patient. The patient's pertinent medical history and concurrent conditions were not reported. On 05-JUL-2017, the patient was vaccinated with a dose of PROQUAD (dose, frequency and route were not reported) (Lot # reported as N013268; expiration date 25-OCT-2018) for prophylaxis instead of M-M-R II. No adverse effects. There was no product quality complaint involved.
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Rash
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions /allergies were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot number and expiration date were not provided), dose and anatomical location were unknown subcutaneous injection as vaccine for shingles (prophylaxis). On an unknown date, three days after received a ZOSTAVAX injection, the patient experienced a rash on the side of the face that effected the her eyes. The outcome of rash was reported as not recovered/not resolved. The patient sought for medical attention. The reporter did not assess the causal relationship between the adverse event rash and the vaccination with ZOSTAVAX.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On unknown dates in 2015, reported as "two years ago", the patient received the first and second dose of GARDASIL 9 (strength, route of administration, Lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2017, reported as "presently", the patient was at the pharmacy to receive the third dose of the series of GARDASIL 9. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (DILUENT MRK). The patient's concurrent conditions and medical history were not reported. On 01-JUL-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M041086 with expiration date of 03-JAN-2018, for prophylaxis (route, anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit for 40 hours 16 minutes. Previous temperature excursion was reported as 15 to 46 degrees Fahrenheit for 60 hours (worst case). The call was not because of a "data logger". No further information was provided. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA007536: