chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Tachycardia, Tracheostomy, Upper respiratory tract infection, White blood cell count increased
Clinical narrative: A report has been received from a consumer via Health Authority (VAERS), concerning an 18 year old male patient. The patient's medical history included upper respiratory tract infection. Concomitant medications included MMR vaccine, Tdap, hepatitis A vaccine, hepatitis B vaccine, varicella virus vaccine, meningococcal polysaccharide and BCG vaccine. On 22-Sep-2008, the patient started receiving FLUMIST (intranasal). On 06-Oct-2008, the patient experienced fever. He also developed chills, congestion, runny nose, sore throat, nausea and productive cough. The patient was diagnosed with upper respiratory infection. On 15-Oct-2008, numbness of feet, hands and mouth developed. Polyneuropathy idiopathic progressive was diagnosed. The patient also experienced tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. On 16-Oct-2008, the patient developed progressive neurologic symptoms consistent with Guillain-Barre syndrome with respiratory failure requiring ventilator support. The patient was stable. On 20-Oct-2008, the patient was in rehabilitation center. Neuro symptoms were not progressing. On unknown dates, aphonia and dysphagia developed. Acute sensory motor neuro deficit developed. Respiratory ventilator, subsequent tracheostomy, IVIG and plasmapheresis were performed. The patient developed orchitis. Tachycardia, hypertension, haemolysis and hyperbilirubinaemia developed. On an unspecified date, the patient was on a ventilation complicated by aspiration pneumonia. The action taken with FLUMIST was unknown. The outcome of the events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis, hyperbilirubinaemia and Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome as serious due to hospitalization. The events of polyneuropathy, aspiration pneumonia, chills, fever, nausea, productive cough, upper respiratory infection, respiratory failure, dysphagia, aphonia, orchitis, tachycardia, hypertension, haemolysis and hyperbilirubinaemia have been identified by the company physician from the source documents and added as serious adverse events due to hospitalization. Laboratory values and diagnostic test details are available.
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 age and gender. The patient's concurrent conditions, past medical history and concomitant therapies were not reported. On an unknown date since 03-JUN-2015, the patients were vaccinated with improperly stored dose of VAQTA (lot # K019560 exp. date 02-JUN-2017) (dose, frequency and route were not provided). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). Noa adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On 20-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous, (strength and anatomical location were not reported), (lot # K006439 with expiration date: 05-AUG-2015), which was expired. No adverse events were reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a male patient of unknown age. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 31-JUL-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) 0.5 ml (lot# K008823, expiration date 19-JUN-2015) subcutaneously. It was the patient's second dose of this vaccine (date of the first dose of VARIVAX (Merck) was not reported). No adverse effects were reported. No product quality complaints (PQC) was involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Erythema and swelling noted to varicella vaccination site approx. 50 x 70 mm. Skin at site stings and itches. Erythema is lessening per client.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site paraesthesia, Injection site pruritus, Injection site reaction, Rash vesicular
Clinical narrative: Vesicular cluster at area of vaccine with itching/tingling.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Varicella
Clinical narrative: Mother called on 8/17/15 to report pt. has chickenpox as well as pt's father. Mother indicated vesicles erupted on 8/11/15, and began on each side of her thorax. At present they are crusting over. Indicates pt. has no other symptoms. Mother indicated she has approx 50 vesicles (spots). Mother would not count. Vesicles on entire body of pt. and itch. Pt went to MD on 8/17/15. MD ordered Acyclovir 200mg 5ml 10ml 4/d when awake. Note indicated mild chickenpox.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling, redness, itching on the site of injection.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Joint range of motion decreased, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Upper arm pain and limited range of motion. Achy constant pain. I wasn't able to sleep on left side, still can't without discomfort. Occasionally travels down to elbow.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: Upper arm pain and limited range of motion. Achy constant pain. I wasn't able to sleep on left side, still can't without discomfort. Occasionally travels down to elbow.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Irregular breathing, Respiration abnormal, Seizure
Clinical narrative: At 2 mo vaccines-2 days after administration parents called that baby having irregular breathing. Told to go to ER. Resolved. Parents didn't go to ER. After 4 mo vaccines again with episodes of abl breathing and seizure activity. EA for video EEG. Baby admitted, parents refused VEEG after episode period in 10 hours.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema 8 x 16 cm (L) upper arm within 12 hours of getting MENACTRA at that site. No signs of anaphylaxis.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medciations, pertinent medical histories, drug reactions and allergies. On unspecified dates, 17-JUL-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot# K007262, expiration date 25-NOV-2015, doses, route and site of administration were not reported). The vaccines were exposed to temepratures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Abdominal discomfort, Fatigue, Influenza, Mononucleosis heterophile test, Neck pain
Clinical narrative: "Legs, arms and neck hurting really bad" - put ice packs on them. T 100.8 initially - alternated TYLENOL and MOTRIN. Rash knees to hips - "razor burn" looking x2 days, itchy, increased sleeping and fatigue, "wouldn't even talk". Stomach illness x2 wks.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Pain in extremity, Rash, Rash pruritic, Somnolence, Speech disorder
Clinical narrative: "Legs, arms and neck hurting really bad" - put ice packs on them. T 100.8 initially - alternated TYLENOL and MOTRIN. Rash knees to hips - "razor burn" looking x2 days, itchy, increased sleeping and fatigue, "wouldn't even talk". Stomach illness x2 wks.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On 30-JUL-2015, the patient was vaccinated with an unspecified improperly stored dose of GARDASIL, injection, lot # K006124 and expiration date 02-FEB-2017 (route of administration and anatomical location were not reported). There was not concomitant medication reported. No adverse effect reported. This is one of three cases from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: DTAP, HEPA, HPV4, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Child is 12 yr old. DAPTACEL given instead of ADACEL.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. On 03-AUG-2015, 05-AUG-2015 and 06-AUG-2015 patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # L000569 and expiration date 13-JUL-2016; lot # K019372 and expiration date 16-JUL-2016; lot # K015816 and expiration date 29-MAY-2016; dose not provided; information on which lot number correspondence to each date of administration was not reported). No adverse experiences were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On 01-AUG-2015, the patient was vaccinated with an unspecified improperly stored dose of GARDASIL, injection, lot # K006124 and expiration date 02-FEB-2017 (route of administration and anatomical location were not reported). There was not concomitant medication reported. No adverse effect reported. This is one of three cases from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Drooling, Food allergy, Pharyngeal oedema
Clinical narrative: -Felt like his throat was swelling, was drooling. Like when he had allergic reaction to food -seafood. Self-resolved in 15-20 min without treatment.
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 age and gender. The patients' concurrent conditions, past medical history and concomitant therapies were not reported. On an unknown date since 03-JUN-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J014855 exp. date 16-APR-2016) (dose, frequency and route were not provided). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. 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 nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 30-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On 07-MAY-2015, the patient was vaccinated with an unspecified improperly stored dose of VAQTA injection, lot # J002347 and expiration date 04-SEP-2015 (route of administration and anatomical location were not reported). There was not concomitant medication reported. No adverse effect reported. THis is one of three cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 08-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Day after vaccine given swelling and redness, achy 3 x 2 cm.
Age: 5.0
Sex: M
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 5.0
Sex: F
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: After 1 week of administration patient upper arms are swollen, reddish color with pain and stiffness.
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: Decreased appetite, Erythema, Lethargy, Nausea, Swelling
Clinical narrative: Localized hives lasting 2 weeks which spread to abdomen. Symptoms of lethargy, nausea, loss of appetite, onset to redness/swelling within hours of injection. Hives about 2 days later.
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Localized hives lasting 2 weeks which spread to abdomen. Symptoms of lethargy, nausea, loss of appetite, onset to redness/swelling within hours of injection. Hives about 2 days later.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea psot vaccines.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: One week after GARDASIL 9 was administered patient was still c/o pain, redness and knot to injection site.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Neck pain, Ocular discomfort, Pain, Pyrexia
Clinical narrative: Fever 104.4. Headache with pressure behind eyes and pain shooting and radiating in neck.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, body aches, redness, tenderness, pain at injection site.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Sharp pain w/cramping in left hand, mostly from wrist to knuckles. Pain has gone up to elbow & lasted 15 sec & happens throughout the day. Pain has gotten progressively worse in the past 3 days.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Pt started experiencing pain around 6pm on 6-29-15. Pt call office around 3:30pm  reporting pain, swelling and redness. Assessment of area presented with redness, heat area from acromion process to elbow, 5mm induration over deltoid muscle. Take ibuprofen to decrease inflammation.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Periodic abdominal pain (10-15 minute intervals), lasting 20-30 minutes, with 2 episodes of watery stool, no vomiting. Symptoms lasting for 2 hrs, x2 days.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant via sales representative refers to an unspecified number of patients. No medical history or concurrent conditions reported. On an unknown date, an unspecified number of patients have been administered a second dose of GARDASIL (dose, and route not reported) (confirmed not GARDASIL 9) 2 years after the first dose of GARDASIL. No adverse effects reported nor PQC involved. No concomitant therapy reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 15-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided).  No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 15-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from two pharmacists concerning an unspecified number of patients (demographics unknown). On unknown dates, the patients were possibly vaccinated with doses of improperly stored PNEUMOVAX23 (dose, route and lot# not provided). No adverse effects were reported. One of the pharmacist confirmed that no improperly stored PNEUMOVAX23 were given to patients since 11-AUG-2015. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 16-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. Pertinent medical history or drug allergy/drug reactions were not reported. On 15-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K021485; expiration date 03-NOV-2016) (dose, strength and route of administration were not reported). There was no concomitant medication reported. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 28-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 28-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 06-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 06-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 100.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site papule
Clinical narrative: Patient vaccinated with PREVNAR 07/06/15, felt generalized weakness and ill next day significant such that nursing home staff wanted to take patient to ED. On 7/12, a crescent shaped rash appeared. An RN visited patient on 7/13 and reports pain in his rash in his groin and he has a rash on his L arm (deltoid) 26cm x 10cm at the widest area crescent shaped. Appears as a allergic reaction, not raised, no vesicles, patient states it burns and itches at the same time. NP visited next day on 7/14 and reported macular rash extending from deltoid to inner aspect of arm to a few inches above elbow. Rash has 1 papule, but predominantly flat, mild erythema-patient states pruritis and burning. Rash 4-5 inches in width. NP ordered hydrocortisone for application to arm site and reports patient responded well to it quickly.
Age: 100.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash, Injection site reaction, Malaise, Rash macular
Clinical narrative: Patient vaccinated with PREVNAR 07/06/15, felt generalized weakness and ill next day significant such that nursing home staff wanted to take patient to ED. On 7/12, a crescent shaped rash appeared. An RN visited patient on 7/13 and reports pain in his rash in his groin and he has a rash on his L arm (deltoid) 26cm x 10cm at the widest area crescent shaped. Appears as a allergic reaction, not raised, no vesicles, patient states it burns and itches at the same time. NP visited next day on 7/14 and reported macular rash extending from deltoid to inner aspect of arm to a few inches above elbow. Rash has 1 papule, but predominantly flat, mild erythema-patient states pruritis and burning. Rash 4-5 inches in width. NP ordered hydrocortisone for application to arm site and reports patient responded well to it quickly.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 10-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Lethargy, Local reaction
Clinical narrative: Localized reaction of hives which appeared other areas than injection site. Onset of redness/swelling at time of injection, hives appeared 2 day later. Also lethargic, nausea, loss of appetite.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Nausea, Urticaria
Clinical narrative: Localized reaction of hives which appeared other areas than injection site. Onset of redness/swelling at time of injection, hives appeared 2 day later. Also lethargic, nausea, loss of appetite.
Age: 8.0
Sex: F
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient had red wheal approx. 2 inches across and surrounding area was red and hot and swollen about 6 inches across. Pt symptoms started in 24 hours and lasted about 4 days, increasingly getting better each day. Pt did not seek medical care.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt turned pale right after MMR. Passed out for couple of seconds.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered medical assistant refers, refers to a 17 year old female patient. Concurrent condition and medical history were not reported. On 09-JUN-2014, the patient was vaccinated with a dose of GARDASIL injection, lot # K00102, expiration date on 06-AUG-2015 (strength, dos3 #, dose, route of administration and anatomical location were not reported). On 25-AUG-2014 the patient received another dose of GARDASIL injection, lot # reported as K001502, expiration date on 06-AUG-2017 (strength, dose #, dose, route of administration and anatomical location were not reported). On 17-AUG-2015 the patient was vaccinated with another dose of GARDASIL injection, # reported as K001138, expiration date on 08-APR-2017 (strength, dose #, dose, route of administration and anatomical location were not reported). There was not concomitant medication reported. No adverse experience has been reported and there was no product quality complaint reported. Lot number K001138 is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: Patient's wife called triage and reported home temperature reading of 103.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray, Electrocardiogram, Full blood count, Injection site pain, Injection site reaction
Clinical narrative: Injection site reaction; Pain and swelling at injection site. Ranitidine 300 mg once, diphenhydramine 50 mg once, doxycycline 100 mg bid.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Metabolic function test
Clinical narrative: Injection site reaction; Pain and swelling at injection site. Ranitidine 300 mg once, diphenhydramine 50 mg once, doxycycline 100 mg bid.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified nursing assistant referring to a multiple unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of (Merck) PROQUAD (lot #, dose, route of administration and frequency were not reported). No adverse effects reported. Concomitant medications were unspecified. This is one of several reports from the same source. 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 certified nursing assistant referring to a multiple unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (lot #, dose, route of administration and frequency were not reported). No adverse effects reported. Concomitant medications were unspecified. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 26-DEC-2014, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2015 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling cold, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, L arm swollen, sore and pink.
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 age and gender. The patients' concurrent conditions, past medical history and concomitant therapies were not reported. On an unknown date since 03-JUN-2015, the patients were vaccinated with improperly stored dose of oral, ROTATEQ (lot # L004453 exp. date 27-MAY-2016) (dose and frequency were not provided). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer via a social media site regarding her child (age and gender not specified) who received GARDASIL. Medical history and concomitant medications were not reported. The mother responded to a post that stated "Will you speak out on this? Our youth are having health ruined, too many have died". The mother responded "HPV vaccine has done this to my child". She did not specify what her child experienced. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via field representative, refers to two female patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in 2015 (also reported as in the past month), the patient was vaccinated with ZOSTAVAX, (dose, frequency and route of administration not provided). On an unknown date in 2015 (also reported as in the past month), both patients experienced injection site swelling and redness after receiving ZOSTAVAX. No treatment was given for adverse events. Therapy with ZOSTAVAX was continued. The outcome of events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 24 year old female patient. The patient's concurrent conditions and medical history were not reported. On 17-JUN-2015, the patient while being pregnant was vaccinated with VARIVAX (Merck) lot # J014128 and expiry date of 07-NOV-2015 and GARDASIL lot # K011562 with expiry date of 08-APR-2017. Concomitant medications were not reported. The patient's Last month period (LMP) was 15-MAY-2015 and expected date of delivery is 19-FEB-2016. Initial exposure to VARIVAX (Merck) and GARDASIL was at fourth week of pregnancy. The pregnancy outcome was pending. There were no adverse experiences. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Sometime in July 2015 and August 2015 (specific dates unavailable) these patients received doses of improperly stored GARDASIL (dose was not reported, lot # K008931, expiration date 04-MAR-2017) (incorrect product storage). No symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Sometime in July 2015 and August 2015 (specific date unavailable) these patients received doses of improperly stored RECOMBIVAX HB (dose was not reported, lot # K024552, expiration date 22-OCT-2016). No symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Sometime in July 2015 and August 2015 (specific dates unavailable) these patients received doses of improperly stored ROTATEQ (dose was not reported, lot # K004795, expiration date 11-FEB-2016) orally. No symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-AUG-2015, the patient was vaccinated with third dose of GARDASIL intramuscular lot # J012212 and expiry date of 18-FEB-2015, 2 months earlier than the recommended vaccination schedule by a physician. Concomitant medications were not reported. No adverse reactions were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 17 year old female patient. The patient was not pregnant. There was no history of drug allergies or reactions. Pertinent medical history and concurrent conditions were none. On 06-AUG-2015, the patient was vaccinated with one single shot of ZOSTAVAX instead of VARIVAX (Merck). Concomitant therapies included LEXAPRO. On 06-AUG-2015, since administration, the patient had not felt well. There were no lab diagnostics performed. The patient did not seek medical attention and no treatment was received in response to the event. The outcome of the event was reported as recovering. Causality assessment was no provided. There was no product quality complaint involved. Additional information is not expected as no reporter contact information was available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to an unknown number of patient of unknown age and gender. On an unspecified dates in March 2015 (reported as "between 19-MAR-2015 - 23-MAR-2015"), the patients were inadvertently vaccinated with improperly stored doses of GARDASIL (lot# K006960; expiration date 19-FEB-2017) dose and route of administration were not provided. No adverse effects reported. This is one of the two reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to an unspecified 60 year old patient of unknown gender. Medical history of the patient was not reported. On an unspecified date the patient was inadvertently administered (Merck) PROQUAD (lot#, dose, route and frequency not reported) instead of ZOSTAVAX (Wrong vaccine administered). No adverse effect was reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to an unknown number of patients of unknown age and gender. On an unspecified dates in March 2015 (reported as "between 19-MAR-2015 - 23-MAR-2015"), the patients were inadvertently vaccinated with improperly stored doses of ROTATEQ (lot# K023535; expiration date 22-MAY_2016) dose was not provided. No adverse effects reported. This is one of the two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Laceration, Syringe issue
Clinical narrative: This spontaneous report was received from a female medical assistant of unknown age, via a company representative, referring to herself. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient cut her finger while administering a dose of RECOMNIVAX HB (strength, dose, frequency, route, lot # and expiration date were not reported). The reporter stated that the prefilled syringe broke during the attempt. No concomitant therapies were reported. A product quality complaint was reported. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Skin exfoliation
Clinical narrative: Approximately 3 days after vaccine pt's arm became red about 3-4 cm. around injection site. Gradually grew to a red spot approximately 3 1/2 to 4 inches around the site and became painful. As of 8/23/15 redness has gone down a little but arm began to peel a large area below site.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: FLUN3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This report to VAERS provides the following narrative: A spontaneous report has been received from VAERS via consumer (attorney) concerning a patient of unknown gender. Relevant medical history was not provided. Concomitant medications were not reported. The patient had been receiving FLUMIST (intranasal), started on an unknown date. It was reported that a patient experienced Guillain-Barre syndrome following receipt of FLUMIST. The reporter stated that if improperly shipped and stored FLUMIST had been administered to a patient, then interstate commerce could be involved if a patient got sick. The reporter mentioned that there was a bill which lists influenza as covered for compensation, which was an attempt by company to limit liability towards problems like this. The outcome of the event of Guillain-Barre syndrome was unknown. The reporter considered the event of Guillain-Barre syndrome to be serious with seriousness criteria of important medical event.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Pain, Rhinorrhoea
Clinical narrative: A report has been received from consumer, concerning a 32 year old, female patient. The patient's medical history and concomitant medications were not reported. On 17-Dec-2003, the patient started receiving treatment with FLUMIST (intranasal), 0.5 ml. The patient, a nursing mother, experienced headache, runny nose, body aches, and was feeling tired. As of 19-Dec-2003, all events were unresolved. The patient just found out was not supposed to have FLUMIST because she was breast-feeding. Action taken with FLUMIST was not applicable. The outcome of the event of drug exposure via breast milk was unknown. The report was considered to be non-serious by company physician.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Abasia, Blood test normal, Guillain-Barre syndrome, Muscular weakness, Pain in extremity
Clinical narrative: A report has been received from VAERS concerning a 10 years old male patient. The patient's medical history and concomitant medications were not reported. On 26-Oct-2010, patient received FLUMIST (intranasal). It was reported that on 29-Oct-2010, patient diagnosed Guillain-Barre Syndrome with severe muscle weakness and pain starting in legs progressing to arms and hands. Unable to walk for several days. Tingling sensation in arms and legs. All blood work was normal. At the time of reporting, the event of Guillain-Barre syndrome was ongoing. Reporter considered the event of Guillain-Barre syndrome to be non serious and Required emergency room/doctor visit, but company physician assessed serious as important medical event.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Paraesthesia
Clinical narrative: A report has been received from VAERS concerning a 10 years old male patient. The patient's medical history and concomitant medications were not reported. On 26-Oct-2010, patient received FLUMIST (intranasal). It was reported that on 29-Oct-2010, patient diagnosed Guillain-Barre Syndrome with severe muscle weakness and pain starting in legs progressing to arms and hands. Unable to walk for several days. Tingling sensation in arms and legs. All blood work was normal. At the time of reporting, the event of Guillain-Barre syndrome was ongoing. Reporter considered the event of Guillain-Barre syndrome to be non serious and Required emergency room/doctor visit, but company physician assessed serious as important medical event.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: VIIth nerve paralysis
Clinical narrative: A spontaneous report has been received from a Physician concerning 14 year old, Male patient. The patient's concurrent disease included ADHD. Concomitant medications included dexmethylpheridate hydrochloride, montelukast and fexofenadine hydrochloride. The patient was receiving FLUMIST QUADRIVALENT (intranasal) started on an 05-Jun-2014. The patient experienced the event Bell's palsy. The outcome of the event of Bell's palsy was unknown. The company physician considered the event Bell's palsy as non-serious.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Influenza, Pain, Pyrexia
Clinical narrative: A spontaneous report has been received from a consumer concerning a female patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient received FLUMIST Quadrivalent on 22-NOV-2014. The reporter stated that the patient experienced fever, chills, achy, flu without vomiting. The patient recovered from the event of fever, chills, achy and flu, without vomiting on an unspecified date. The reporter assessed the events fever, chills, achy and flu, without vomiting to be non serious.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist concerning a 13 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient administered by expired FLUMIST Quadrivalent which started on 28-NOV-2014. The outcome of the event of expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that the patient experienced expired FLUMIST Quadrivalent administered which started on 16-NOV-2014. The outcome of the event of expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious.