chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown dates in April 2016 (also reported as from 05-APR-2016), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L028645, expiry date 25-MAY-2017; lot # L008059, expiry date 18-DEC-2016 and lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the 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 medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (unspecified lot # and expiry date: 18-JUN-2016). Medical assistant reported that the vaccine underwent temperature excursion on unknown dates with following details: unspecified lot # (exposed to 31 and 49 degree Fahrenheit for unknown time frame, 31 F for 1420 hours and 49 F for 700 hours, respectively). No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The medical history of patients and their concurrent conditions were not reported. On an unknown dates in April 2016 (also reported as from 05-APR-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to first temperature excursion of 47 F for a time frame of 48 hours from 04-APR-2016 to 06-APR-2016. The vaccines were also subjected to second temperature excursion of 47 F for a time frame 72 hours from 19-APR-2016 to 22-APR-2016. The vaccine were also subjected to third temperature excursion of 47 F for a time frame of 24 hours from 25-APR-2016 to 26-APR-2016 and fourth temperature excursion of 47 F for a time frame of 24 hours from 27-APR-2016 to 28-APR-2016. Cumulative temperature excursion was reported as 47 F for a time frame of 168 hours. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Malaise, Nausea, Pyrexia, Rash erythematous
Clinical narrative: Patient states red rash developed 24 hrs. after vaccine given. Rash 4 1/2 long X 6 1/2 wide. Sick feeling, fever; joint pain, nausea, starting 36 hours after immunization. Motrin 600 mg every 8 hrs. taken by patient to treat symptoms, along with ZYRTEC. Ice to site.  All but rash subsided in 24 hrs. with some lagging symptoms.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Aphthous ulcer, Lip ulceration, Mouth ulceration
Clinical narrative: Canker sores and labial ulcers.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dyspnoea, Erythema, Use of accessory respiratory muscles, Wheezing
Clinical narrative: Patient received vaccines, discharged from clinic, started having trouble in car before leaving parking lot, mom returned to clinic, child SOB, wheezing, retractions, pulse ox 87%, face red. O2 via nasal cannula, epinephrine given at 11:09AM. Transported to ER for further treatment.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Dysphagia, Seizure, Swollen tongue, Walking aid user
Clinical narrative: Alot of seizures; swelling of the tongue; cant swallow; can't stay balanced I walk with a cane.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Rashes on entire body.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itching at site of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Shingles Vaccination -Redness, Soreness, itching with in 24 hours.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Contusion, Nodule
Clinical narrative: HIB, PCV-13 AND VARICELLA ADMINISTERED IN LEFT THIGH. CHILD HAS KNOT FOR 1 MONTH, MOTHER OF PATIENT IS UNSURE OF FEVERS DUE TO TEETHING. NO ERYTHMA NOTED. MILD BRUISING.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Skin warm
Clinical narrative: Light headed since vaccine, area red, warm, 2.5 x 3.5 inches, non indurated.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Hive L wrist, R pretibial region, abdomen.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site swelling, Neuralgia
Clinical narrative: Swelling at site. Redness. No treatment. Then onset of severe nerve pain.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Per Father, she fainted in the classroom. She said she was feeling dizzy. Paramedics were called and transported her to the ER.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt has been experiencing moderate muscle pain in the site of injection consistently since October. Says she believes it is due to the immunization. Recommended she see a physician as soon as possible.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Chills, Dizziness, Fatigue
Clinical narrative: 9pm: back ache,10pm: feeling generally ill, fever and chills started, could not warm up, teeth chattering, increased body aches 12am: all symptoms persist and headache starts, all continues until morning. 8am: feeling weak and dizzy, feeling like going to faint when standing. 10am: headache and general body aches continue. Fever gone. Extreme fatigue. These symptoms continue for 2 days.  By 3rd day, unusual pains felt on scalp, ribs and extremities. Headache gone by 3rd day, fatigue continued. Developed light red rash on face.Day 4: fatigue and random pains all over body plus scalp continue. Rash gone on face. Day 5: finally feeling well again. Took ADVIL for 4 days to try and control pain. I have had the TDAP vaccine before with NO side effects. This was BOOSTRIX TDAP. Not sure what my last one was 5 years ago. I am a very healthy, active person that exercises at least 2 hours daily. I felt that this reaction was very extreme and I will never take BOOSTRIX again.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Headache, Malaise, Musculoskeletal chest pain, Pain
Clinical narrative: 9pm: back ache,10pm: feeling generally ill, fever and chills started, could not warm up, teeth chattering, increased body aches 12am: all symptoms persist and headache starts, all continues until morning. 8am: feeling weak and dizzy, feeling like going to faint when standing. 10am: headache and general body aches continue. Fever gone. Extreme fatigue. These symptoms continue for 2 days.  By 3rd day, unusual pains felt on scalp, ribs and extremities. Headache gone by 3rd day, fatigue continued. Developed light red rash on face.Day 4: fatigue and random pains all over body plus scalp continue. Rash gone on face. Day 5: finally feeling well again. Took ADVIL for 4 days to try and control pain. I have had the TDAP vaccine before with NO side effects. This was BOOSTRIX TDAP. Not sure what my last one was 5 years ago. I am a very healthy, active person that exercises at least 2 hours daily. I felt that this reaction was very extreme and I will never take BOOSTRIX again.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pain of skin, Pyrexia, Rash, Rash erythematous
Clinical narrative: 9pm: back ache,10pm: feeling generally ill, fever and chills started, could not warm up, teeth chattering, increased body aches 12am: all symptoms persist and headache starts, all continues until morning. 8am: feeling weak and dizzy, feeling like going to faint when standing. 10am: headache and general body aches continue. Fever gone. Extreme fatigue. These symptoms continue for 2 days.  By 3rd day, unusual pains felt on scalp, ribs and extremities. Headache gone by 3rd day, fatigue continued. Developed light red rash on face.Day 4: fatigue and random pains all over body plus scalp continue. Rash gone on face. Day 5: finally feeling well again. Took ADVIL for 4 days to try and control pain. I have had the TDAP vaccine before with NO side effects. This was BOOSTRIX TDAP. Not sure what my last one was 5 years ago. I am a very healthy, active person that exercises at least 2 hours daily. I felt that this reaction was very extreme and I will never take BOOSTRIX again.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Headache, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: PCV13: Extreme left shoulder pain and loss of arm use, 3days, (a 10);  10:30 AM hacking cough lasting 48 hrs; continual painful>hurtful>soreness still present today (5-13-2016). Using 600mg ADVIL 3x/day.  Went to emergency room 5-8-16, Dr felt it was work related, gave me exercises. 5-11-16 sinus congestion with headache & coughing started, using pseudo epinephrine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Sinus congestion
Clinical narrative: PCV13: Extreme left shoulder pain and loss of arm use, 3days, (a 10);  10:30 AM hacking cough lasting 48 hrs; continual painful>hurtful>soreness still present today (5-13-2016). Using 600mg ADVIL 3x/day.  Went to emergency room 5-8-16, Dr felt it was work related, gave me exercises. 5-11-16 sinus congestion with headache & coughing started, using pseudo epinephrine.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Blood test
Clinical narrative: This spontaneous report as received from the patient's mother refers to her 13 months old daughter. The patient did not have any concomitant medication, pertinent medical history, known drug reactions or allergies. In November 2012, the patient was vaccinated with her first dose of M-M-R II, 1 shot, subcutaneously (albumin status, lot # and expiration date were not reported). The patient's mother reported that within 24 hours after receiving the M-M-R II, the patient was no longer able to talk (disability). The patient was taken to autism and speech specialists who conducted blood testing (results were not provided), and stated that the event was not a result of the vaccination with M-M-R II. She had been in speech therapy for 18 months and at the time of the report (reported as "now") was able to communicate, but the mother did not elaborate on the patient's speech capabilities. The outcome of the event was reported as recovering. It was also reported that therapy with M-M-R II was discontinued and was not reintroduced. The patient's mother stated she was looking for monovalent vaccines for measles, mumps, and rubella due to the event. The patient's mother did not assess the causal relationship between the event and M-M-R II. The patient's speech loss was considered to be disabling event. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site swelling
Clinical narrative: Client reports that 3 hours after receiving Tdap vaccine the following symptoms presented: "chills, headache, sweating, fatigue, swollen lymph nodes under both arms, injection site warm and swollen, aches all over". Client presented to PCP next day who told her he believes this may be due to the Tdap vaccine.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Lymphadenopathy, Pain
Clinical narrative: Client reports that 3 hours after receiving Tdap vaccine the following symptoms presented: "chills, headache, sweating, fatigue, swollen lymph nodes under both arms, injection site warm and swollen, aches all over". Client presented to PCP next day who told her he believes this may be due to the Tdap vaccine.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Feeling abnormal, Heart rate increased, Injection site swelling, Loss of consciousness
Clinical narrative: Pt became dizzy, vomited, passed out for "5 seconds" per mother. Heart rate elevated. Injection site swollen.  Pt "feels funny". Mother pushed fluids, gave BENADRYL.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Pt became dizzy, vomited, passed out for "5 seconds" per mother. Heart rate elevated. Injection site swollen.  Pt "feels funny". Mother pushed fluids, gave BENADRYL.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dyskinesia, Hypotonia, Pallor, Platelet count increased, Protrusion tongue
Clinical narrative: Seizure 16 hours after shots (PENTACEL, PREVNAR and rotavirus). Jerking episode with protuding tongue then became lump for 10-15 minutes. Associated pallor no cyanosis/apnea.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Seizure, White blood cell count increased
Clinical narrative: Seizure 16 hours after shots (PENTACEL, PREVNAR and rotavirus). Jerking episode with protuding tongue then became lump for 10-15 minutes. Associated pallor no cyanosis/apnea.
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, RV5
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling redness in area of PENTACEL injection fever 100.5 received PENTACEL at 2 mins and did well. Had reaction to PEDVAXHIB (local) 4 mths.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 1-1 1/2 wks after getting vaccines pt. noted red raised bumps on skin in clusters. Itchy, intermittent on arms, legs, stomach and back. No fever. Continues to be a problem 4 mo after vaccines. Pt. thinks it is from varicella.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Mobility decreased, Nervousness, Pain in extremity
Clinical narrative: Patient reported that she is "shaky and shivery", her arm is painful, and she cannot lift her arm.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea, Fluid intake reduced, Irritability, Nasal congestion
Clinical narrative: 8-12 hours later. After vaccines (incl. ROTATEQ)- developed temp 100 and loose watery stools 6-8x/d, vomited twice, decreased appetite, decreased fluid intake, decreased urine output, fussiness, nasal congestion, poor sleep. Sent to ER for fluids after 1 pound weight loss in 2 days in 12 pound baby.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Poor quality sleep, Urine output decreased, Vomiting, Weight decreased
Clinical narrative: 8-12 hours later. After vaccines (incl. ROTATEQ)- developed temp 100 and loose watery stools 6-8x/d, vomited twice, decreased appetite, decreased fluid intake, decreased urine output, fussiness, nasal congestion, poor sleep. Sent to ER for fluids after 1 pound weight loss in 2 days in 12 pound baby.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain
Clinical narrative: Patient came back to the pharmacy 5 days later to report redness/swelling around the area. Went to doctor for pain, muscle ache. Still swollen/red.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Full blood count
Clinical narrative: Approx 12-18 hours after receiving vaccine, pt developed chills, joint pain, lower extremity swelling, shortness of breath, headaches. Reports fatigue x 4 days.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Metabolic function test, Peripheral swelling
Clinical narrative: Approx 12-18 hours after receiving vaccine, pt developed chills, joint pain, lower extremity swelling, shortness of breath, headaches. Reports fatigue x 4 days.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis, diphenhydramine.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Day after receiving final Hep B inj his rt arm became painful with movement and has persisted for 2 wks. and deep joint pain with movement.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema multiforme, Headache, Pyrexia, Swelling
Clinical narrative: Headache, fever, erythema multiform and blister/swelling.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Nausea, Vomiting
Clinical narrative: Anaphylaxis and nausea, vomiting.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash. Treatment: loratadine 10 mg every day; diphenhydramine 25 mg HS.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Rash
Clinical narrative: Rash.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Erythema.
Age: 71.0
Sex: M
Vaccine: FLUC3
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria pruritus.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician via a field representative concerning two unspecified patients of unknown age and gender. No medical history, drug reactions and concomitant medications was reported. On an unknown date, the two patients each received their dose of GARDASIL 9 injection (lot#, dosage and route not provided) too early (inappropriate schedule of drug administration). No adverse effects were reported. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of hepatitis A, inactivated VAQTA injection, lot number L043209, expiry date 19-SEP-2017 and M003011, expiry date 15-NOV-2017 (dose and route were not reported). Additionally, it was reported that improperly stored doses of diphtheria toxid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine and poliovirus vaccine inactivated (vero), PEDIARIX (lot number, dose, route and frequency were not reported), were also administered. Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 13.1 degrees Celsius for 1 hour and 16 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. It was also reported that the vaccine GARDASIL 9 was also improperly stored, however, it was not administered to patients. 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 was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot numbers L045117, expiry date 06-OCT-2018 and M001578, expiry date 21-NOV-2018 (dose and route were not reported). Additionally, it was reported that improperly stored doses of PEDIARIX (reported as "PEDIRIX"), (lot number, dose, route and frequency were not reported), were also administered. Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 13.1 degrees Celsius for 1 hour and 16 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. It was reported that the vaccine GARDASIL 9 was also improperly stored, however, it was not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot numbers L026551, expiry date 16-JUL-2017 and L027591, expiry date 23-JUL-2017 (dose and route were not reported). Additionally, it was reported that improperly stored doses of PEDIARIX (reported as "PEDIRIX"), (lot number, dose, route and frequency were not reported), were also administered. Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 13.1 degrees Celsius for 1 hour and 16 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. It was reported that the vaccine GARDASIL 9 was also improperly stored, however, it was not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient received an unspecified number doses of GARDASIL 9 injection (exact doses, lot #, expiration date, route of administration and intervals were not reported) outside of recommended dosing schedule. There were no adverse symptoms reported. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 19-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot #L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 7 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 20-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 22-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot #L008059, expiry date 18-DEC-2016) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the 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 was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L023588, expiry date: 26-JUN-2017). Medical assistant reported that the vaccine underwent temperature excursion on unknown dates with following details: lot # L023588 (exposed at 10 degree Fahrenheit for an unknown time frame and for 300 hours, respectively). No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD (lot # L030592, expiry date: 12-FEB-2017). Medical assistant reported that the vaccine underwent temperature excursion on unknown dates with following details: lot # L030592 (exposed at 10 degree Fahrenheit or an unknown time frame and for 300 hours, respectively). No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to 3 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX, lot #L044529 with expiry date on 09-FEB-2017, (dose, strength and anatomical site were not reported). Subsequently within 24 hours, each of patients developed a swollen, red zone encircling the injection site. At the time of this report, the outcome of injection site edema and injection site erythema was reported as recovering. The relatedness between the events and vaccination with ZOSTAVAX was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a male patient, who is currently 61 years old. The patient did not have any pertinent medical history or drug reactions/allergies. On 28-OCT-2014, the patient received his first dose of RECOMBIVAX HB (which had a lot # of K010238 and an expiration date of 14-APR-2016; however, dose, route and anatomical site were not reported). Subsequently, he received the second and third dose on 26-DEC-2014 and 29-MAY-2015 respectively, both of which had the same lot number and expiration date. The patient did not have any concomitant medications. It was reported that, after the three dose series, the patient did not seroconvert and his titer was negative (laboratory test performed on an unknown date). It was reported that the patient visited the physician's office on an unknown date, nevertheless, no treatment was given for the reported event. No Product quality complain (PQC) was involved. At the time of reporting, the patient did not recover from the event. The reporter did not provide a causality assessment between the reported event and the suspect vaccine. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's relevant medical history and concurrent condition were not reported. On 02-MAY-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K005574, expiry date 17-APR-2016, (dose, route and anatomical site were not reported). Concomitant medications were not provided. No adverse effect was reported. No product quality complain (PQC) was involved. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 22-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to first temperature excursion of 47 F for a time frame of 48 hours from 04-APR-2016 to 06-APR-2016. It was also subjected to second temperature excursion of 72 hours from 19-APR-2016 to 22-APR-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter.  Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 27-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to first temperature excursion of 47 F for a time frame of 48 hours form 04-APR-2016 to 06-APR-2016. It was also subjected to second temperature excursion of 72 hours from 19-APR-2016 to 22-APR-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions were not reported.  On 22-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to first temperature excursion of 47 F for a time frame of 48 hours from 04-APR-2016 to 06-APR-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter.  Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 21-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to first temperature excursion of 47 degrees F for a time frame of 48 hours from 04-APR-2016 to 06-APR-2016. It was also subjected to second temperature excursion of 48 hours from 19-APR-2016 to 21-APR-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 29-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 28-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria pruritus
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 18-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional refers to a 6 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2015, the patient was inadvertently vaccinated with VAQTA 25/0.5 (units not provided) (dose, route of administration, injection site, lot# and expiration date were not reported) instead of RECOMBIVAX HB 5/0.5 microgram/ ml, although the lot number recorded in the patient's chart (lot # K006825, expiration date: 15-SEP-2016 corresponds to pediatric dose of RECOMBIVAX HB. The reporter stated that the national drug code (NDC) number (0006498101) recorded in the patient's chart corresponds to RECOMBIVAX HB pediatric dose. No adverse event was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 05-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 05-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees Fahrenheit for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.48
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 5 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 06-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.77
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 9 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 05-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a female patient in her sixties. The patient's concurrent conditions included diabetes. The patient had no drug reactions and no allergies. On 03-MAY-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The patient's concomitant medications included LYRICA and SYNTHROID. On 06-MAY-2016, the patient experienced itching at the injection site. The patient did not seek medical attention and did not receive any treatment for the event. The patient recovered from the event on 08-MAY-2016. The relatedness between the event and ZOSTAVAX was not provided. 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 health care worker refers to multiple unspecified patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Lot# L029472, Expiry: 06-SEP-2017; Lot # L040422, Expiry: 15-OCT-2017, Lot# L035124, Expiry: 14-SEP-2017, Lot# L034367, Expiry: 08-SEP-2017, Lot# L043622, Expiry: 03-NOV-2017). The vaccine was stored at 16 F for a duration of 1 hour and 11 minutes. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 11-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 08-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The concurrent condition included diabetes mellitus, hypertension, gout and sulfa drug allergy. On an unknown date, the patient was inadvertently vaccinated with a partial dose of ZOSTAVAX (lot # L040445, Expiry: 15-JAN-2015). Concomitant therapies included EFFEXOR, ZYLOPRIM, COLCRYS, Lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), metformin, simvastatin (manufacturer unknown) and atenolol. On the same day, at unspecified time, the patient experienced slight dizziness. The outcome of dizziness was reported as resolved on the same day. No treatment was rendered for the event. No lab tests were performed. The causality was unspecified. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Feeling abnormal, Pneumonia
Clinical narrative: This spontaneous report as received from a consumer (patient's wife) refers to a 68 year old male patient. The patient's drug reactions/allergies included penicillin, sulfa and clindamycin. The patient's medical history included nose polyps. On an unspecified date in 2012, the patient was vaccinated with PNEUMOVAX23 injection of strength 25/0.5 Y lot # H015780 (expiration date, dose number, dose unspecified) route reported as 'injection'. Concomitant therapies included simvastatin (manufacturer unknown) 20 mg. Approximately on 18-APR-2016, unspecified X-ray was done. On 18-APR-2016, the patient was diagnosed with pneumonia. The patient sought medical attention, went to physician. The patient was treated with unspecified steroids, antibiotics, cortisone and breathing treatments. The patient was "still feeling crappy (approximately April 2016), but getting better" / recovering from the events. It was reported that suspect therapy was not discontinued. Product quality complaint was not involved. Causality assessment was not provided. The reporter did not supply the patient's specific demographic data. No further information was provided. Additional information is not expected as no reporter details were provided.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 06-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 08-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # 029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 8 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 15-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # 029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 18-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # 029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients' were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L019298 with an expiration date of 22-JUN-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. At the time of the report, no adverse event was reported. Furthermore, no product quality issue was involved. Additional information has been requested.