chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Nasopharyngitis, Pyrexia, Streptococcus test positive
Clinical narrative: This spontaneous report was received from a physician, concerning 12 year-old male patient. There were no concurrent conditions, medical history, drug reactions or allergies. His concomitant medications included CLARITIN. On 03-MAR-2017, the patient was intramuscularly vaccinated with the first dose of GARDASIL 9 (dose and frequency were not reported) lot # M031557 with expiration date of 07-APR-2019, for Human papillomavirus (HPV). On an unspecified date in 2017, after vaccination, he experienced high fever, was disoriented and hallucinating. It was not specified when symptoms resolved and no medical treatment was given per physician. On 05-MAY-2017, the patient was intramuscularly vaccinated with the second dose of GARDASIL 9 (dose and frequency were not reported) lot # M041990 with expiration date of 28-SEP-2019, for Human papillomavirus (HPV). On 08-MAY-2017, the patient went to the clinic and he was treated for an unspecified practitioner; the patient had a "rapid strep test" that was negative and also a throat culture was taken. The patient's mother gave him an unspecified dose of over the counter ADVIL which did not bring down a fever of 104°F. On the same date, he was taken to the hospital emergency room (ER) and treated by an unspecified physician. His laboratories (unspecified) were normal, a flu test was negative and a diagnosis of acute nasopharyngitis was given. Additionally, the patient also had a positive streptococcus culture come back from the clinic and Z-PACK was prescribed (unspecified dose). In summary, the patient was sick for 3-5 days after second dose of GARDASIL 9. At the time of the report, the patient was recovering from fever of 104°F, acute nasopharyngitis and positive streptococcus culture. The causality between the adverse events and GARDASIL 9 was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 12-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered dose of vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015680: US-009507513-1705USA015681: US-009507513-1705USA015682: US-009507513-1705USA015683:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medication was provided. On 30-MAY-2017, the patient was vaccinated with a dose of M-M-R II, lot # L015282 (dose and route of administration were not provided), which had expired on 30-APR-2017. The vaccine did not had had any temperature excursions prior to administration. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a health care professional via Pfizer referring to a currently 57 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot#, expiration date, dose, frequency and route were unknown) for prophylaxis. On an unknown date, the patient experienced swelling. The outcome of the event was unknown. The causality was not reported. On an unknown date, the patient was also developed dexamethasone sodium phosphate (DECADRON) anaphylaxis (captured in MARRS# 1706USA002026). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a consumer referring to his/her mother, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provide. On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot number and expiration date were unknown) for prophylaxis. The reporter was not sure which pneumococcal vaccine the patient received but the reporter would find out. On an unknown date, the patient was in hospital with cellulitis. The outcome of the event was unknown. The reporter considered the patient was in the hospital with cellulitis to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Upon internal review, cellulitis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis (incorrect product storage). The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003923: US-009507513-1706USA003924: US-009507513-1706USA003927: US-009507513-1706USA003926: US-009507513-1706USA003925.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M037248, expiry date 24-FEB-2019 and lot# M044032, expiry date 03-JUL-2019) intramuscular (strength, dosing details, anatomical location were unknown) for prophylaxis. The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003783.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M045206, expiry date 27-JUN-2019, via intramuscular route (strength, dosing details, anatomical location were unknown) for prophylaxis (incorrect product storage). The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA003783.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of GARDASIL, lot# M043731, expiry date 22-JUN-2019, via intramuscular route (strength, dosing details, anatomical location were unknown) for prophylaxis. The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003783.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of VAQTA (lot # M036459, expiry date 28-OCT-2017 and lot#M036459, expiry date 18-JAN-2018) intramuscularly (strength, dosing details, anatomical location were unknown) for prophylaxis. The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003783.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of ROTATEQ lot # M040268, expiry date 14-MAY-2018, orally (strength, dosing details, anatomical location were unknown) for prophylaxis. The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003783.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Diarrhoea, Eyelid oedema, Rash, Vomiting
Clinical narrative: Initial unsolicited report received from a nurse on 30-May-2017. This case involves six-month-old male patient, who was vaccinated with PENTACEL via intramuscular route (batch number: C5278AB, expiry date: 28-Aug-2017; dose, dose in series not reported) in right thigh and ROTATEQ via oral route (batch number: M039061, manufacturer: Merck; expiry date, dose, dose in series not reported) and PREVNAR 13 via intramuscular route (batch number: R41774, manufacturer: Pfizer; expiry date, dose, dose in series not reported) in left thigh and HEPATITIS B via intramuscular route (batch number: M042322, manufacturer: Merck; expiry date, dose, dose in series not reported) in left thigh on 26-May-2017. Patient had soy and milk allergy, Reflux, failure to thrive. No Illness at time of vaccination. Any other vaccinations within four weeks of vaccination was not reported. Patient's concomitant medications were not reported. On 27-May-2017, one day after the vaccination, the patient had a rash on left cheek and on abdomen, and patient's left eyelid was swollen and had a temp of 101 degree F, and some vomiting and diarrhea. Patient's other lab data and corrective treatment was not reported. Patient got recovered from the events' rash on abdomen, left eyelid was swollen and had a temp of 101 degree F, and some vomiting and diarrhea. Patient was recovering from the rash on cheek (reported as symptom remaining was a mild rash on patient's cheek). Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Mycobacterium tuberculosis complex test, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 24-year-old female patient who received RABAVERT (batch number 566011A, expiry date 20th June 2018). On 24th May 2017, the patient received the 1st dose of RABAVERT (intramuscular) 1 ml. In May 2017, less than a week after receiving RABAVERT, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to RABAVERT. Additional details were reported as follows: The reporter did not know when the fever started in relation to the vaccination and or the severity of the fever. The patient had a tuberculosis test given within 4 weeks of the RABAVERT vaccine.
Age: 25.0
Sex: M
Vaccine: ANTH, JEV, SMALL
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Patient reports having swollen lymph nodes, went to ER with fever, headaches. Whole body had aches.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: PATIENT DEVELOPED SWELLING, REDNESS AT INJECTION SITE. TENDER TO TOUCH. ROUND WELT AND GETTING LARGER. POSSIBLY CELLULITIS. ADVISED PATIENT TO SEE DOCTOR FOR FURTHER TREATMENT.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Emphysema, Pneumonia
Clinical narrative: In prep for a heart pacemaker implant, tests revealed I had emphysema. Exam with my PCP revealed I actually had pneumonia which I think was triggered by vaccine.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Feeling hot, Swelling face
Clinical narrative: Given second Hepatitis A dose on 6/5/2017. Presented at school wellness center on 6/8/17 reporting facial swelling, erythema, and warmth that began the prior evening. treatment included Prednisone, Zantac, Benadryl and referral to PCP for continued management and follow up.
Age: 0.26
Sex: M
Vaccine: MENB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-week-old male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced inappropriate age at vaccination administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: This case was reported by patient's parent. The patient received BEXSERO vaccination at 14 weeks of age, which led to inappropriate age at vaccine administration. The reporter was aware about the minimum time required before receiving the second dose was 1 month but she was asking about the maximum number of months allowable between receiving the first and second BEXSERO dose which would still ensure full immunization.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Pyrexia, Syncope
Clinical narrative: Confusion, Fever and Syncope.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adolescent female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO vaccine on an unknown arm. The patient experienced arm pain on the injected arm. Limited information was provided by the sales representative from the nurse practitioner.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that the patient received 4 doses of GARDASIL (dose, route and site of administration unknown) for prophylaxis, on the following dates: first dose on 25-OCT-2013 (lot # H020002, expiration date 08-AUG-2015), the second dose on 06-MAY-2014 (J006850, expiration date 31-MAR-2016 ), the third dose on 29-JUN-2015 (K007264, expiration date 02-MAR-2017) and the fourth dose on 26-SEP-2016 (lot # unknown, expiration date 06-APR-2017). No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL lot # L028664, expiration date 27-MAY-2017 (dose number and route were not provided) for prophylaxis. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unspecified demographics. No information regarding the patients' medical histories, concomitant medication and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot# N005274, expiration date: 03-APR-2018 (dose and route of administration were not reported). It was reported that the vaccines were exposed to the temperature range from 9 Celsius degrees to 25 Celsius degrees for a time frame of 2 hours 14 minutes. The temperature excursion was recorded by a digital data logger and there were no previous temperature excursions. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information is not expected since there was no consent for further contact. Sender's Comments: US-009507513-1705USA009556: US-009507513-1706USA003431: US-009507513-1706USA003432: US-009507513-1706USA003433.
Age: 12.0
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Dyspnoea, Rash, Throat irritation
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 12 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 06-APR-2012, the patient was vaccinated with a dose of GARDASIL and a dose of VAQTA (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 06-APR-2012 (reported as: "later that day"), the patient developed a "rash on the arms, neck and back, an itchy throat and had trouble breathing. It was reported that the patient's mother gave BENADRYL at home for treatment, additionally the patient sought medical attention. At the time of the report, the outcome of dyspnoea, throat irritation and rash was reported as recovered on an unspecified date. The reporter did not assess the relatedness between the events and GARDASIL and of VAQTA. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Over past couple of days, injection site has become very red and swollen. Patient reports pain at the injection site and moving that arm is painful. She showed me the area and the redness is almost a perfect circle, about 6 inches in diameter. I advised her to take Benadryl and ice the area. She asked if she could use OTC pain cream and I said that was fine. I told her to monitor the site closely - if not better within next few days, call Dr.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Culture, Injection site papule
Clinical narrative: Tiny papules on upper bilateral thighs.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Dyskinesia, Gait disturbance, Injection site warmth, Screaming
Clinical narrative: Pt kept sticking her tongue out in a weird manner when she would scream and the left leg felt pretty warm at the injection site. Pt was not willing to walk after injection, and screamed as if in pain for over an hour after injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fatigue, Herpes zoster, Malaise
Clinical narrative: Pt got the shingles vaccine on 5/27/17 because she was worried about getting shingles (she has had it twice in the past). She said after getting the vaccine she was very tired and didn't feel well. The arm she received the vaccine in got red and swollen. She broke out in a blistered shingles rash on her right side on 6/4/2017. Pt showed me the rash on 6/9/17.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Pt got the shingles vaccine on 5/27/17 because she was worried about getting shingles (she has had it twice in the past). She said after getting the vaccine she was very tired and didn't feel well. The arm she received the vaccine in got red and swollen. She broke out in a blistered shingles rash on her right side on 6/4/2017. Pt showed me the rash on 6/9/17.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pallor, Rash, Rash erythematous, Skin warm
Clinical narrative: Rash, erythema and 6.5 x 6 inch of blanchable erythematous rash on arm and warm to touch. began a few hours after vaccination for pneumo polysac 23 V.
Age: 62.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: BURNING, REDNESS, SWELLING 8 INCHES FROM INJECTION SITE.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Gait disturbance, Injection site pain
Clinical narrative: Patient received HPV9 Vaccine at 0950 in clinic. Father waited with patient for 20 minutes in waiting room following administration with no reaction. Patient ate and Apple juice and started feeling loopy so father returned with patient. Patient presented to the clinic feeling lethargic, stumbling, pale, slow speech. Vital signs stable. Focused assessment completed, patient reports pain in Left arm at site of injection radiating to left neck. Patient reports pain in Abdomen, chest, and in legs.  Patient on Nasal cannula, complained of difficulty breathing. Patient on NRB. Patient shaking and limbs rigid. Patient given Adult EPIPEN at 1125 and TYLENOL 480mg/15ml. Patient transferred to ER for continued care at 1155.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Lethargy, Muscle rigidity, Neck pain, Pain in extremity, Pallor
Clinical narrative: Patient received HPV9 Vaccine at 0950 in clinic. Father waited with patient for 20 minutes in waiting room following administration with no reaction. Patient ate and Apple juice and started feeling loopy so father returned with patient. Patient presented to the clinic feeling lethargic, stumbling, pale, slow speech. Vital signs stable. Focused assessment completed, patient reports pain in Left arm at site of injection radiating to left neck. Patient reports pain in Abdomen, chest, and in legs.  Patient on Nasal cannula, complained of difficulty breathing. Patient on NRB. Patient shaking and limbs rigid. Patient given Adult EPIPEN at 1125 and TYLENOL 480mg/15ml. Patient transferred to ER for continued care at 1155.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Slow speech, Tremor
Clinical narrative: Patient received HPV9 Vaccine at 0950 in clinic. Father waited with patient for 20 minutes in waiting room following administration with no reaction. Patient ate and Apple juice and started feeling loopy so father returned with patient. Patient presented to the clinic feeling lethargic, stumbling, pale, slow speech. Vital signs stable. Focused assessment completed, patient reports pain in Left arm at site of injection radiating to left neck. Patient reports pain in Abdomen, chest, and in legs.  Patient on Nasal cannula, complained of difficulty breathing. Patient on NRB. Patient shaking and limbs rigid. Patient given Adult EPIPEN at 1125 and TYLENOL 480mg/15ml. Patient transferred to ER for continued care at 1155.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dermatitis, Erythema, Skin warm
Clinical narrative: Patient had normal injection site reaction on day vaccine was given, and then it started to move down her arm each day after, but resolved at previous site. When presented at pharmacy two days later inner arm near elbow was red, inflammed, and warm to the touch. Upon examination of injection site, and rest of upper arm, there was no inflammation, everything looked normal. Patient wasn't experiencing any itching either.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient noted a redness around site of injection along with warmth of the skin. Was and oblong shape, no larger than 2 inches in diameter.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 05/30/2017 Tdap vaccine administered to R deltoid, IM route. 06/01/2017, patient reported by phone local reaction to site including redness, warmth, swelling or firmness. RN recommended ice pack to site, oral Benadryl and/or NSAID for symptom management and advised patient have clinic physician evaluate site. Physician prescribed 10 day course of antibiotic. 06/02/2017, patient reported swelling and redness at site was reduced, firmness to site continued. Denied pain, reported tenderness at site. Reports full ROM, denies numbness or tingling. 06/09/2017, patient reports redness resolved, swelling reduced, firmness continued at site but improved. Reports taking antibiotic as prescribed. Advised to continue to monitor site, report changes to site.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Palpitations, Pollakiuria, Rhinorrhoea
Clinical narrative: Urinary frequency, Rhinorrhea, 'heartbeat in her ears', headache, redness around ZOSTAVAX injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Injection site swelling, Pruritus
Clinical narrative: Immediate dizziness lasting 10 minutes or so followed by slow swelling of injection site which has spread over the last 3 days.  Now itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mom called office 6/8/17 to report quarter size red area outer left thigh. Pt. received DTaP 48 hrs prior in office. Advised to use ice and TYLENOL for discomfort. Mom will monitor area, call office in AM if increases in redness, size or swelling. She reports warmth and increase in size. Pt. in to office to be seen 6/9/17. Apply BENADRYL topically, and antihistamine was Rx'd.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: Hands burning/swelling itchy red bumps on arms/legs.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Client developed fever 6-6-17 p.m. Parents report not able to keep down with TYLENOL. At 12:30 pm on 6-7-17 fever was 103, so took client to ER. ER did strep test and treated fever with TYLENOL rotating with MOTRIN, which is what Dad reported cont. to do on 6-8-17. Still running fever on 6-8-17 at 8:30 a.m. (101 degree F).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 18-year-old female patient who received BEXSERO. On 26th May 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In May 2017, less than a day after receiving BEXSERO, the patient experienced fatigue. On 26th May 2017, the patient experienced nausea, dizziness, injection site pain, headache, injection site erythema, injection site lump and injection site induration. On 27th May 2017, the patient experienced loose stools. On 28th May 2017, the patient experienced chills. The action taken with BEXSERO was unknown. On an unknown date, the outcome of the nausea, fatigue, injection site pain, injection site lump and loose stools were not recovered/not resolved and the outcome of the dizziness, headache, injection site erythema and chills were recovered/resolved and the outcome of the injection site induration was unknown. It was unknown if the reporter considered the nausea, fatigue, dizziness, injection site pain, headache, injection site erythema, injection site lump, loose stools, chills and injection site induration to be related to BEXSERO. Additional details were provided as follows: Immediately after receiving vaccination the patient experienced redness, a hard lump under skin and soreness at the injection site. It was reported that, the patient continues to have the hard lump and soreness at the site at the time of reporting. The patient also experienced nausea on the vaccination day's evening, a headache, fatigue within 24 hours and dizziness within 15 minutes of the injection itself. On 27th May 2017, 1 day after vaccination the patient experienced loose stools. On 28th May 2017, 2 days after vaccination the patient experienced chills. The patient was seen at the physician's office for continued issues with nausea, loose stools, and fatigue. The physician had recommended cool compresses to site, ibuprofen and rest. It was also being asked if the patient should receive the second dose of the BEXSERO vaccine, so she was transferred to medical information system. The call center representative forgot to ask lot number and expiry date of the vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 18-year-old female patient who received BEXSERO. On 26th May 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In May 2017, less than a day after receiving BEXSERO, the patient experienced fatigue. On 26th May 2017, the patient experienced nausea, dizziness, injection site pain, headache, injection site erythema, injection site lump and injection site induration. On 27th May 2017, the patient experienced loose stools. On 28th May 2017, the patient experienced chills. The action taken with BEXSERO was unknown. On an unknown date, the outcome of the nausea, fatigue, injection site pain, injection site lump and loose stools were not recovered/not resolved and the outcome of the dizziness, headache, injection site erythema and chills were recovered/resolved and the outcome of the injection site induration was unknown. It was unknown if the reporter considered the nausea, fatigue, dizziness, injection site pain, headache, injection site erythema, injection site lump, loose stools, chills and injection site induration to be related to BEXSERO. Additional details were provided as follows: Immediately after receiving vaccination the patient experienced redness, a hard lump under skin and soreness at the injection site. It was reported that, the patient continues to have the hard lump and soreness at the site at the time of reporting. The patient also experienced nausea on the vaccination day's evening, a headache, fatigue within 24 hours and dizziness within 15 minutes of the injection itself. On 27th May 2017, 1 day after vaccination the patient experienced loose stools. On 28th May 2017, 2 days after vaccination the patient experienced chills. The patient was seen at the physician's office for continued issues with nausea, loose stools, and fatigue. The physician had recommended cool compresses to site, ibuprofen and rest. It was also being asked if the patient should receive the second dose of the BEXSERO vaccine, so she was transferred to medical information system. The call center representative forgot to ask lot number and expiry date of the vaccine.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 16-year-old female patient who received BEXSERO (batch  number 159001A, expiry date 31st March 2018). On 19th May 2017, the patient received the 1st dose of BEXSERO. On 19th May 2017, less than a day after receiving BEXSERO, the patient experienced injection site erythema and  injection site swelling. On 22nd May 2017, the outcome of the injection site erythema was recovered/resolved. On 24th May 2017, the outcome of the injection site swelling was recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on right deltoid muscle. There were no other vaccines given at that visit. The reporter was told about the occurrence on 25th May 2017 by the nurse and she also had a dosing question related to BEXSERO that she talked to a medical science liaison about in a patient room away from her. The nurse forgot to report possible adverse event to medical science liaison so the reporter followed up with her via phone and then submitted this report.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Altered state of consciousness, Dizziness, Hypotension, Pallor
Clinical narrative: Child received immunz. Seemed fine, when she got up to leave felt faint seemed to almost pass out, pale, low B/P. Laid child on table gave Epi 1.7 ml given. Called ambulance sent to ER.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Peripheral swelling, Rash erythematous
Clinical narrative: Swollen arm (L) with a red rash from injection site to elbow. Prednisone 5 ml QD x 7 days, cephalexin 250/5 3 ml Q8 hrs x 10 days. Prescription loratadine 3 ml QD x 14 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen and red arm. AUGMENTIN 81 mg was given.
Age: 69.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: PATIENT CALLED AT 5PM TO REPORT SEVERAL BOUGHTS OF DIARRHEA THROUGHOUT THE DAY AND A RECENT EPISODE OF VOMITING(4:45PM).  WITH LOW GRADE FEVER. PT DID REPORT FEELING BETTER AFTER VOMITING.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: REDNESS ON VACCINE SITE, HOT AT TOUCH, SORENESS.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus generalised
Clinical narrative: Patient stated the evening of her immunization she was 'itchy all over.' She took a benadryl and was better. On 6-9-17, she called and stated she had a silver dollar sized bump at the injection site and there was warmth and redness over the area that was the size of her hand. She was not concerend, would take an anti-inflammatory and use ice.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever - treated with Children's Motrin.  Last 72 hours.  On 06/09/17 at 5:00 PM, rash appeared on child's abdomen, chest, and back.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, VERY painful, hard lump around the injection site.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Moaning, Poor quality sleep, Unresponsive to stimuli
Clinical narrative: Unresponsive for 15 mins 2days after dtap. Also moaned tossed and turned all night.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 103, Parents gave Tylenol for Fever & tepid bath. Temp was taken via  non-contact skin thermometer. advised if temp reaches 104 or above seek medical attention or call PCP. Also on 06/08/2017 & 06/09/2017 had skin rash to upper torso, both limbs seen by a provider. given steroid. Per mom.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth, Musculoskeletal stiffness, Pain
Clinical narrative: Lump the size of a lime at injection site that is itchy and hot to the touch. Soreness in upper arm from elbow to shoulder with any movement and stiffness in shoulder.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: Lump the size of a lime at injection site that is itchy and hot to the touch. Soreness in upper arm from elbow to shoulder with any movement and stiffness in shoulder.
Age: 14.0
Sex: F
Vaccine: YF
Symptoms: Chest discomfort, Dysphagia, Dyspnoea
Clinical narrative: Difficulty breathing, tightness in chest, difficulty swallowing.
Age: 0.08
Sex: F
Vaccine: MENB, MENB
Symptoms: Poor feeding infant, Pyrexia, Somnolence, Wrong drug administered
Clinical narrative: Patient was seen for 1 month physical. Patient was due to receive Hepatitis B vaccine. Medical assistant administered Meningococcal B (TRUMEMBA) vaccine in error. Baby developed fever approx. 13 hours later, sleepy, poor feeding. T 103.3. Admitted to Hospital.
Age: 0.08
Sex: F
Vaccine: MENB, MENB
Symptoms: Anaemia, Laboratory test abnormal, Meningitis aseptic, Pyrexia, Transfusion
Clinical narrative: Patient was seen for 1 month physical. Patient was due to receive Hepatitis B vaccine. Medical assistant administered Meningococcal B (TRUMEMBA) vaccine in error. Baby developed fever approx. 13 hours later, sleepy, poor feeding. T 103.3. Admitted to Hospital.
Age: 0.08
Sex: F
Vaccine: MENB, MENB
Symptoms: Wrong drug administered
Clinical narrative: Patient was seen for 1 month physical. Patient was due to receive Hepatitis B vaccine. Medical assistant administered Meningococcal B (TRUMEMBA) vaccine in error. Baby developed fever approx. 13 hours later, sleepy, poor feeding. T 103.3. Admitted to Hospital.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site infection
Clinical narrative: Injection site infection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Asthenia, Injection site pain, Pyrexia, Rash, Vomiting
Clinical narrative: Fever, emesis, arm pain at site (L) deltoid, rash decreased, decreased energy.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever > 103 x 2 days. Irritable x 3 days. Decreased eating.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local swelling, Skin warm
Clinical narrative: Patient developed a 7 x 7 cm. round, raised warm area distal to injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Hard, swollen, red, hot to touch, greater than 2" diameter at site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Red, swollen, painful, blistering at site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen and painful at site.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm to touch, itching of site.
Age: 17.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Type 2 diabetes mellitus
Clinical narrative: Pt. diagnosed with Type 2 Diabetes June 1st.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash to (L) arm 8 cm in diameter. Warm to touch, red, tender.
Sex: M
Vaccine: PNC13
Symptoms: Chills, Dyspnoea, Panic attack, Vomiting
Clinical narrative: PM after receiving vaccine, he had chills, vomiting, panic attack and shortness of breath. Resolved the next morning.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient came in and asked for immunization printout. He said he came in on a Friday night and got a flu shot here on 10/15/15. He said he has been sore in his arm ever since. He said he had not told that to anyone here at pharmacy until today. He said he read on internet this could be a problem of vaccine.
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Very painful, red, got to touch, raised, measure about a quarter in diameter, very itchy on 6/7/2017 most of the day. Applied ice 20 minutes on and off throughout the day to try and decrease swelling and soothe the itching. Never scratched it, by night about the size of a golf ball. By morning, measured 2.8 inches. Notified pharmacy and they communicated with their clinical manager. Went to my primary care doctor and was prescribed Bactria 800 mg BID for 7 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red swelling, itching, hot raised patch around the injection site, sensitive, patient took Benadryl and it helped with the itching.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abnormal dreams, Gait disturbance, Headache, Lethargy, Skin warm
Clinical narrative: Mom calls office morning of 6/10/2017 and states that last night (6/9/2017), child was sending her "bizarre texts." She states that child had complaints of a headache, was lethargic, had difficulty walking, and was having "lucid dreams" from midnight to 0700. Mom also states, per child's father, child felt "feverish."
Age: 35.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Red and warm blotchy area at the site of injection that is approximately 5 inches by 2 inches.
Age: 70.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Chest pain, Feeling hot, Pain
Clinical narrative: Patient felt warm sensation and pain and then had pain in chest area a few days later. Patient went to doctor and was prescribed antibiotics.
Age: 47.0
Sex: M
Vaccine: TTOX
Symptoms: Abdominal pain, Arthralgia, Dyspepsia, Feeling abnormal
Clinical narrative: Tight band of pain across belly, from belly button down to waist, very slow digestion. Also knees were sore, felt odd three hours after the shot and when I woke up they were very sore but resolved during the day.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site itchy, red, swollen (got vaccine on 6/7/17 symptoms started on the 8th she called us the 9th) she went to urgent care. Dx= histamine reaction use BENADRYL cream, ice. They Rx KEFLEX PRN if got worse.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, subjective fever for 1 day the day after administration.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Mobility decreased, Pain in extremity
Clinical narrative: Patient's husband called day after immunization given and reported wife had layed in bed ever since she got immunization. Her left arm has a blue bruise and hurts.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Painful and heated swelling of upper arm. Motion was extremely difficult. Warranted an ER visit.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, MEN
Symptoms: Pyrexia, Seizure
Clinical narrative: High Fever over 103 since 6/8/2017 still has high fever currently as of 6/11/2017, treating with Ibuprofen,Tylenol and cool bath. 2 seizures occurred Thursday both afternoon around 3:00pm and around 9:00pm.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash that burns about 3-4 inches in diameter at site of injection on left arm. warm to touch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Large, red, hard to touch rash that burns at site of injection in left arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Injection site was red with swelling, big blisters started growing (3/4" in size), red area expanded to 5"+, and later to 8"+.  We have photos if you would like to see the reaction.  Patient has not experienced a fever.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV
Symptoms: Acoustic stimulation tests normal, Aggression, Autism spectrum disorder, Dyspraxia, Head banging
Clinical narrative: Regression in speech and signs by May 2016, had lost all words and signs. Isolated play, extremely importance of routines and where items went, became extremely introverted, fears of people who he knew except parents and places he knew. Started having "fits"/outbursts, banging head, etc. when routine changed or out of his house or people were around (except parents), progression got worse to where doctors thought he was autistic, except they knew he was ahead of the curve prior to the vaccines given in August 2015. With intervention, things have improved, autism test negative, diagnosed with severe CAS...apraxia of speech and needs much more help.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV
Symptoms: Ophthalmological examination normal, Sensory disturbance, Social avoidant behaviour, Social fear, Speech disorder developmental
Clinical narrative: Regression in speech and signs by May 2016, had lost all words and signs. Isolated play, extremely importance of routines and where items went, became extremely introverted, fears of people who he knew except parents and places he knew. Started having "fits"/outbursts, banging head, etc. when routine changed or out of his house or people were around (except parents), progression got worse to where doctors thought he was autistic, except they knew he was ahead of the curve prior to the vaccines given in August 2015. With intervention, things have improved, autism test negative, diagnosed with severe CAS...apraxia of speech and needs much more help.