chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of (Merck) PROQUAD (Lot: L002419 exp: 23-JUL-2016, Lot: K020749 exp: 30-APR-2016, Lot: K022447 exp: 13-MAY-2016 respectively; strength, dosage and route unspecified. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not want to be contacted.
Sex: U
Vaccine: MMRV
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 relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (Oka/Merck) PROQUAD (dose and route were not reported) which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Oka/Merck) PROQUAD: Lot # L002419 with expiration ate 23-JUL-2016 or lot # reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with PEDVAXHIB (dose, strength, frequency and lot number were not reported), that were improperly stored. No adverse experienced reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with oral, ROTATEQ (dose, strength, frequency and lot number were not reported), that were improperly stored. No adverse experienced reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 0.24
Sex: F
Vaccine: DTPHEP, MMR, OPV, UNK
Symptoms: Cold sweat, Crying, Death, Decreased appetite, Laboratory test
Clinical narrative: My daughter got her vaccines and within hours was lethargic, no appetite, clammy to the touch, whimpering and pale.
Age: 0.24
Sex: F
Vaccine: DTPHEP, MMR, OPV, UNK
Symptoms: Lethargy, Pallor
Clinical narrative: My daughter got her vaccines and within hours was lethargic, no appetite, clammy to the touch, whimpering and pale.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient received wrong shot at that time of above.
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: Extreme dizziness at first; followed by severe flu-like symptoms (i.e. muscle soreness throughout body, aches throughout body, fever between 99 and 101 degrees, etc.) lasting more than 3 days.
Age: 2.0
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure, Vomiting
Clinical narrative: Information has been received from a published literature article, referring to a 2 year old male patient. On an unknown date the patient was vaccinated with Rotavirus vaccine, live oral, pentavalent (manufacturer unknown) (strength, dose and lot # not reported), orally. The patient had been fully immunized. On an unknown date in 2013, during the patient's February 2013 school break, on the road of family vacation to a beach, the patient's old sister who had previously complained that she did not feel well, proceeded to vomit. The patient's old sister did not receive rotavirus vaccine. Over the next several days, the patient's old sister was mildly ill with abdominal pain, occasional vomiting, and diarrhea. Although she showed glimmers of improvement, 3 days later she awoke with bilous vomiting and periumbilical abdominal pain. On arrival at the closest pediatric hospital, the physician noted significant dehydration, administered ondansetron, attempted oral hydration, and thought that intravenous rehydration and basic laboratory tests were needed. The physician stated that she probably had gastroenteritis. The patient's old sister's laboratory results were notable for bicarbonate level of 10 mmol/L and an anion gap of 33. On hospital admission, bacterial stool culture and rotavirus antigen tests were ordered. After receiving hydration overnight, the patient's old sister recovered, and they left the hospital to resume their family vacation. On an unknown date in 2013, the patient experienced gastroenteritis rotavirus despite vaccination. Within 5 minutes of returning from the hospital, the patient's 5 year old brother vomited while attempting to reach the bath room. That night, the patient had vomiting and diarrhea, and misses the toilet. 6 of 6 family members of the patient had been ill within 2 weeks. Stool specimens of the patient included rotavirus of genotype G12P (vaccination failure). On an unknown date, the patient recovered from gastroenteritis rotavirus with no lasting effects. The outcome of vaccination failure was unknown. The reporter considered vaccination failure and gastroenteritis rotavirus to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (manufacturer unknown). This is one of the three reports regarding the same article. The patient's sibling's adverse events were captured in 1506USA002868 and 1506USA003701. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a pharmacist via company representative and refers to "80 years old" patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. In approximately 2015 (reported as "recently") (exact date unspecified), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous injection (vial), (lot #, dose not reported). Concomitant medication was not reported. Approximately in May 2015 (reported as "pharmacist received a phone call today, 19-MAY-2015"), the patient "developed shingles". The patient sought medical attention - he called the pharmacy, where the vaccine was administered. No Product Quality Complaint (PQC) was involved. The outcome of adverse event was reported as not recovered at the time of the report. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure, Vomiting
Clinical narrative: Information has been received from a published literature article, referring to a 5 year old male patient. On an unknown date the patient was vaccinated with rotavirus vaccine (manufacturer unknown) (strength, dose and lot # not reported), orally. The patient had been fully immunized. On an unknown date in 2013, during the patient's February 2013 school break, on the road of family vacation to a beach, the patient's old sister who had previously complained that she did not feel well, proceeded to vomit. The patient's old sister did not receive rotavirus vaccine. Over the next several days, the patient's old sister was mildly ill with abdominal pain, occasional vomiting, and diarrhea. Although she showed glimmers of improvement, 3 days later she awoke with bilious vomiting and periumbilical abdominal pain. On arrival at the closed pediatric hospital, the physician noted significant dehydration, administered ondansetron, attempted oral hydration, and thought that intravenous rehydration and basic laboratory tests were needed. The physician stated that she probably had gastroenteritis. The patient's old sister's laboratory results were notable for bicarbonate level of 10 mmol/L and an anion gap of 33. On hospital admission, bacterial stool culture and rotavirus antigen tests were ordered. After receiving hydration overnight, the patient's old sister recovered, and they left the hospital to resume their family vacation. On an unknown date in 2013, the patient experienced gastroenteritis rotavirus despite vaccination. Within 5 minutes of returning from the hospital, the patient vomited while attempting to reach the bathroom. That night, the patient had vomiting and diarrhea, and missed the toilet, 6 of 6 family members of the patient had been ill within 2 weeks. Stool specimens of the patient included rotavirus of genotype G12. On an unknown date, the patient recovered from gastroenteritis rotavirus with no lasting effects. The outcome of vaccination failure was unknown. The reporter considered vaccination failure and gastroenteritis rotavirus to be related to rotavirus to be related to Rotavirus vaccine (manufacturer unknown). This is one of the three reports regarding the same article. The patient's sibling's adverse events were captured in 1506USA003700 and 1506USA003701. 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 registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, dose and route were not reported), which underwent supported temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 73 year old patient of unknown gender. On 02-JUL-2013, the patient was vaccinated with the first dose of ZOSTAVAX (lot#, expiration date, dose and route unknown). On 14-MAY-2015 the patient was vaccinated with the second dose of ZOSTAVAX lot # K018173 and expiration date 10-JAN-2016,0.65 ml, subcutaneously. Concomitant therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. There was no adverse event reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Ultrasound Doppler normal
Clinical narrative: Pt went to ER 5-19-15 c/o redness, swelling and pain around injection site in right arm that started that morning. Patient was given BENADRYL and Solu- Medrol in the ER. ER also gave patient RX for prednisone and PERCOCET.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Blood culture negative, Full blood count normal, Generalised tonic-clonic seizure, Metabolic function test normal
Clinical narrative: Seizure (tonic-clonic) 2-3 minutes within 30 seconds-1 min of vaccination witnessed in office.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. had immunization 6-3-15. Return 6-5-15 with redness to RUQ thigh. Script for BENADRYL PO and hydrocortisone topical. Call if worsens. Will check on pt Monday. (see note for additional questions). Area is 7 cm x 5.4 cm red raised. Will check Monday. 6-8-15 - mother state area has improved.
Sex: U
Vaccine: RV5
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a consumer refers to an unknown number of patients (babies) of unknown ages and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ, (route, anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. The reporter stated that the babies who got the ROTATEQ, could have a life threatening adverse reaction. The outcome of vaccination complication was unknown. This is a linked case with 1506USA002070 from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Ear infection, Pyrexia, Rash, Viral infection
Clinical narrative: Patient developed fever of 101 degrees.  We had to take her to the doctor 5 times over the course of April 2015 - June 8, 2015.  Visit 1 she developed an ear infection and fever, visit 2 was pink eye and fever, visit 3 was a virus and fever, vist 4 was a virus, rash, and fever, doctor's visit 5 was another ear infection and fever.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic, Vaccination site erythema
Clinical narrative: Erythema at site of vaccine, and a rash with itching on left arm and legs.  Rash is not blister or red, just raised skin with complaint of a lot of itching.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: Increased pain at injection site, inability to move arm freely and bruising extending 6 inches below injection site.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site infection
Clinical narrative: Patient was treated with antibiotics for injection site infection.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Full blood count normal, Papule, Pruritus
Clinical narrative: Size of a quarter with red papules and itching.
Age: 1.29
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Client was given a varicella and an MMRV that has varicella also.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Very swollen, red at site of injection.  Extremely tender to touch.  Abnormally swollen, slight rash.
Age: 23.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Patient discovered she was pregnant after receiving MMR vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Patient received Zostavax on 5/26/15 with no side effects at time of administration. Patient returned to pharmacy on 6/5 complaining of fever blister that appeared on 6/4. He feels it was caused by vaccine because this is his first fever blister. Patient was advised to contact physician if any further symptoms developed and OTC product was recommended as well as lifestyle modification to avoid further irritation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash on face, upper chest and on extremities.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: 5 MINS AFTER SHOT ADMINISTERED PT GOT LIGHT-HEADED, DIZZY AND SWEATY. HE VOMITED AND WAS GIVEN SOME WATER. WAS ASKED IF HE NEEDED 911 SERVICES. HE SAID NO. TOLD TO REST FOR 30 MINS AND AFTERWARDS FELT BETTER. NO SIGNS OR SX OF ANAPHYLAXIS AND MOTHER TOLD TO MONITOR HIM FOR 48 HRS. THEY LEFT PHARMACY AFTER 30MINS.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash maculo-papular, Rash vesicular
Clinical narrative: Generalized erythematous maculopapular and vesicular lesions. No treatment given.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Diarrhoea, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Pt states that evening she experienced extreme diarrhea that continued for 3 days. She also states she had a headache that evening of the vaccination.  Her arm began to feel sore and states today arm is still very tender and sore.  Today 6/8/15 she had myself evaluate the area.  The area is bruised with an area in the center that is white.  Of note the area is warm to touch compared to lower arm.  The patients bicep also has noticeable swelling until about midpoint of the upper arm.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: Pt states that evening she experienced extreme diarrhea that continued for 3 days. She also states she had a headache that evening of the vaccination.  Her arm began to feel sore and states today arm is still very tender and sore.  Today 6/8/15 she had myself evaluate the area.  The area is bruised with an area in the center that is white.  Of note the area is warm to touch compared to lower arm.  The patients bicep also has noticeable swelling until about midpoint of the upper arm.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Dysarthria, Syncope
Clinical narrative: Started to slur speech and fainted within a minute of receiving vaccine.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Dizziness, Generalised tonic-clonic seizure, Pallor, Postictal state
Clinical narrative: Collapse in office with in 1 minute of vaccine HPV injection. He felt weak, dizzy and fainted on the side of table. Helped pt onto table where he was pale with thready pulse and weak. After about 3 min he had gran mal seizure lasting about 30 sec, following which he was in postictal state. Oxygen was administered and ambulance called. He was taken to the hospital.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Pulse abnormal, Syncope
Clinical narrative: Collapse in office with in 1 minute of vaccine HPV injection. He felt weak, dizzy and fainted on the side of table. Helped pt onto table where he was pale with thready pulse and weak. After about 3 min he had gran mal seizure lasting about 30 sec, following which he was in postictal state. Oxygen was administered and ambulance called. He was taken to the hospital.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Injection site rash, Insomnia, Miliaria, Rash
Clinical narrative: This spontaneous report as received from a consumer of unknown age and gender reporting on her/himself. Medical history and concurrent conditions were not provided. On 19-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (1 injection), (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. The consumer stated that "now" (in May 2015) was experiencing a rash at the injection site (injection site rash), then the rash was spreading from the injection site to the "back" of the body (rash) and was "like a prickly heat rash" (miliaria). It was also reported having issues sleeping at night (sleep disorder) due to the discomfort. The consumer sought unspecified medical attention but the provider was not available until 27-MAY-2015 reported as "tomorrow". The outcome of discomfort, rash, miliaria, sleep disorder and injection site rash was unknown at the time of the report. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected because no reporter details were provided.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 8 x 9 cm swelling and redness at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: 8 x 9 cm swelling and redness at injection site.
Age: 38.0
Sex: F
Vaccine: FLU3, HEP, PPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: Pt. received 4 vaccines on 5/21/15. Patient presented to health dept. on 5/22 stating that her left arm was very swollen. I observed the swelling from the shoulder to elbow area. Pt had previously asked a ER nurse to look at the area and advised cold compresses and ibuprufen. Same treatment recommend at HD.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Pain
Clinical narrative: Pain, weakness x 1 month and more.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin reaction
Clinical narrative: Per patient arm is really red and swollen real big. One day post injection. Treatment: apply ice and take BENADRYL after he gets back home.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Pt arm was red and hot to the touch. She received cephalexin from dr.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: 2 hours after injection given, pt noticed pain and tingling in (R) arm has gotten progressively worse over 4 days - now severe pain weakness/numbness in extremities decreased grip strength.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Muscular weakness, Neck pain
Clinical narrative: 2 hours after injection given, pt noticed pain and tingling in (R) arm has gotten progressively worse over 4 days - now severe pain weakness/numbness in extremities decreased grip strength.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Pain in extremity, Paraesthesia, Spinal X-ray abnormal
Clinical narrative: 2 hours after injection given, pt noticed pain and tingling in (R) arm has gotten progressively worse over 4 days - now severe pain weakness/numbness in extremities decreased grip strength.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified group of the patients (demographics unknown). Information about patients' medical histories was not provided. On an unknown date, the patients were vaccinated with doses of ROTAETQ (dose, frequency and indication were not specified, route of administration default to oral) (lot # K013661, expiration date: 26-MAY-2016) which were exposed to temperatures outside of the recommended range. Concomitant medication was not reported. No adverse effect has been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Extra dose administered, Herpes zoster, Incorrect route of drug administration, Mobility decreased
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient had allergies to bees and wasps. The patient had no medical history. On 18-JUN-2014 the patient was diagnosed with shingles and given the ZOSTAVAX (dose 1) the same day, which was other-than-indicated in the prescribing Information(off label use). The indication also reported as "prevent another outbreak of shingles". The patient later found out that her initial shot with ZOSTAVAX was expired by two months and that it had been administered(expired product administered) intramuscularly which was other-than-indicated in the prescribing Information(incorrect route of drug administration). The physician for this case did not perform the initial administration, it was administered by an unspecified nurse within the practice. The patient was told be re-vaccinated, and she complied with this direction. The revaccination occurred at a Pharmacy where she was administered another dose of ZOSTAVAX (dose 2) subcutaneously by an unspecified pharmacist on the same date (extra dose administered). No concomitant medication was reported. At that time(18-JUN-2014), she also was experiencing extreme arm pain to the point that she cannot lift her left arm after received the ZOSTAVAX vaccines. There was no treatment given to the events. X-ray was performed(result not provided). The patient sought medical attention by office visit. The outcome extreme arm pain and off label use was reported as not recovered/not resolved. Action taken and causality were not provided. No product quality issue(PQC) was involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, X-ray
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient had allergies to bees and wasps. The patient had no medical history. On 18-JUN-2014 the patient was diagnosed with shingles and given the ZOSTAVAX (dose 1) the same day, which was other-than-indicated in the prescribing Information(off label use). The indication also reported as "prevent another outbreak of shingles". The patient later found out that her initial shot with ZOSTAVAX was expired by two months and that it had been administered(expired product administered) intramuscularly which was other-than-indicated in the prescribing Information(incorrect route of drug administration). The physician for this case did not perform the initial administration, it was administered by an unspecified nurse within the practice. The patient was told be re-vaccinated, and she complied with this direction. The revaccination occurred at a Pharmacy where she was administered another dose of ZOSTAVAX (dose 2) subcutaneously by an unspecified pharmacist on the same date (extra dose administered). No concomitant medication was reported. At that time(18-JUN-2014), she also was experiencing extreme arm pain to the point that she cannot lift her left arm after received the ZOSTAVAX vaccines. There was no treatment given to the events. X-ray was performed(result not provided). The patient sought medical attention by office visit. The outcome extreme arm pain and off label use was reported as not recovered/not resolved. Action taken and causality were not provided. No product quality issue(PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has received from a nurse referring to a patient of unknown age and gender. On 05-JUN-2015 the patient was vaccinated with an expired dose of ROTATEQ (lot# J013587, expire date 03-JUN-2015, dose, frequency were not reported) orally (Expired vaccine used). No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Syncope
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 19 year old female patient. On an unknown date the patient, was vaccinated with the first dose of GARDASIL (dose, route of administration and lot # were not reported). After administration, the patient fainted and had a seizure. The outcome of the events was not reported. Relatedness between the events and the vaccination with GARDASIL was not reported. Upon internal review seizure was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 29-MAY-2015 the patient received improperly stored LIQUID PEDVAXHIB (0.5 ml, intramuscular, lot# and expiration date were unknown), exposed to 48.3F for 30 minutes (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Pyrexia
Clinical narrative: Fever 100-101 degrees.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. No concomitant therapy was reported. On 30-APR-2015 (also reported as "since 20-APR-2015"), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous vial (dose, lot#, expiration date and indication were not reported), which underwent supported temperature excursions. NO adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient, the patient had no allergies or drug reaction. On 07-JUN-2015 the patient was vaccinated with one dose of PNEUMOVAX23, (0.5 ml, intramuscularly (also reported as "per protocol"). On 08-JUN-2015, the patient developed swelling and induration at the injection site. Lab diagnostic studies were not performed. The patient sought medical attention (was seen by an unspecified healthcare provider). No treatment was given for adverse events. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected. The reporter did not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. No concomitant therapy was reported. On 19-MAY-2015 (also reported as "since 20-APR-2015"), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous vial (dose, lot#, expiration date and indication were not reported), which underwent supported temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old female patient with no drug reactions and allergies. On 14-MAY-2015, the patient was vaccinated with the dose of ZOSTAVAX lot # L002424, expiration date 23-APR-2016 (dose and route of administration were not reported). No information on patient's concomitant medication was provided. In May 2015, after receiving ZOSTAVAX the patient experienced redness, soreness and a small hardened area around injection site, about size little bigger than half dollar coin. The patient sought medical attention via speaking to the pharmacist. No treatment was given for the adverse events and none lab diagnostics tests were performed. The outcome of adverse events was reported as recovering/resolving. The causality between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reports as received from a nurse refers to an unspecified number of patients. In 2015 (reported as K010325, expiration date reported as 10-MAY-2016, batch/lot # K007244, expiration date 16-MAR-2016, batch/lot # reported as L000434, expiration date reported as 10-JUL-2016 that had been exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was recevied from a nurse and refers to a patient of unknown age and gender. No information about concomitant medication, pertinent medical history and drug reactions was provided. On 10-OCT-2014 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, lot# and expiration date not reported). On 04-MAR-2015 the patient was vaccinated with the second dose of GARDASIL (dose, frequency, lot# and expiration date not reported). On 21-MAY-2015, the patient was vaccinated with the third dose of GARDASIL (dose, frequency, lot# and expiration date not reported). No adverse effects were reported. 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 registered nurse refers to unspecified number of patients of unknown demography. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates, unspecified number of patients were vaccinated with unspecified number of doses of GARDASIL (lot number, dose and frequency unspecified) intramuscularly for prophylaxis at intervals other than the recommended intervals in the prescribing information. Concomitant medications were not reported. No adverse effects were reported for any of the unspecified patients. The outcome of the events were unknown. The causality of the events with GARDASIL was not involved. This case is linked to # 1506USA004662 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an patient of unknown age gender age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-MAY-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (dose, route of administration were not provided)(lot #, expiration date were unspecified). No adverse effect was reported. This is one of several reports received from the same reporter. 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 healthcare worker refers to an unspecified number of patients of unknown demographics. Patients medical history and concurrent conditions were not reported. From 20-APR-2015 to 29-APR-2015, GARDASIL (lot # K009482, expiration dates: 06-MAR-2017) was improperly exposed to 26F for about 216 hours. On an unknown date in 2015, unspecified number of patients might receive (dose, route of administration and anatomical location was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No known adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to an unspecified patient of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the patient was vaccinated with CERVARIX followed by a dose of GARDASIL intramuscular injection (strength, dose, frequency, lot number, expiration date and indication were not reported) on another unspecified date. There was no adverse experienced 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 registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route af administration, lot# and expiration date were not reported0, which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. In 2015 (reported as since 13-MAY-2015), the patients were vaccinated with doses RECOMBIVAX HB batch/lot # J013394, expiration date 25-AUG-2016, batch number/lot # reported as K018180, expiration date reported as 17-SEP-2016 that had been exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports 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 registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product quality complaint) was involved. 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 registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot# and expiration date not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on 22-MAY-2015, the patient was vaccinated with improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning 3 child patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (dose, strength and route were not reported, lot #: K022444, expiry date: 13-MAY-2016 and reported as K19100, expiry date: 15-APR-2016). No adverse were reported. Additional information is not expected because the reporter did not want to be contacted.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old male patient. The patient's concurrent conditions and medical history were not reported. The patient received a mixed regimen of GARDASIL and GARDASIL 9. He received dose number 1 of GARDASIL on 15-OCT-2013 (dose, route, lot# and expiration date were not reported) and dose number 2 with GARDASIL 9 (dose, route, lot# and expiration date were not reported) on 27-MAY-2015. No adverse experiences reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse referring to a female patient of unknown age (reported as old enough to drive). No concurrent or historical conditions were reported. On an unknown date of May 2015 (reported as last week), the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, dose number and route unknown) at the facility here this nurse worked. There was no concomitant medication reported. On an unknown date of May 2015, the patient felt faint as she was walking out of the facility. Another nurse was with her and guided her to the ground. The patient got up quickly and was able to walk and talk; the patient said she had not eaten prior to this happening." The outcome of the event was recovered. This is one of several reports received from the same reports received from the same reporter. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 9 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in November 2010, the patient was inadvertently administered a dose of VAQTA (dose, route of administration, lot # and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-NOV-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). On 02-JUN-2015, the patient was vaccinated with the second dose of the series with GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown age female patient with unspecified medical history or concurrent conditions. On 01-DEC-2004, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot # were not reported). On 28-JUL-2011, the patient was possibly vaccinated with the second dose of VARIVAX (Merck) (dose, route and lot # were not reported) and in approximately May 2015, reported as "last week", the patient was vaccinated with a third dose of VARIVAX (Merck) (dose, route and lot # were not reported). Concomitant therapy was not reported. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (Oka-Merck) PROQUAD (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Oka-Merck) PROQUAD: lot# L002419 with expiration date 23-JUL-2016 or lot# L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. 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 licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant mediations were not reported. The patient was vaccinated with the doses of GARDASIL (intramuscular; dose, lot # and expiration date were not reported) on 05-DEC-2008, 23-MAR-2009 and on 22-APR-2015. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (Oka-Merck) PROQUAD (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Oka-Merck) PROQUAD: lot# L002419 with expiration date 23-JUL-2016 or lot# L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The concurrent condition and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # K023624, Expiry: 19-FEB-2016). The concomitant medications were not reported. The patient reported that she received a letter from her physician's office stating that the ZOSTAVAX was administered was stored improperly and she might need to be re-vaccinated. No adverse effect was reported. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: PPV
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, no pertinent medical history or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX 23 which had been improperly stored (lot # reported as: L003188, expiry date: 06-JUL-2016, route of administration and dosage were not provided). The product had been supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report was received from a physician who heard from an unspecified source via company representative referring to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL injection (dose, route and frequency unspecified). Concomitant therapy was not reported. On an unknown date the representative reported that a patient who received an unspecified number of doses of GARDASIL 9 and then the patient no longer got her period. No further information provided. The outcome of the event was unknown. Causality assessment was not reported. 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 an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.