chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Anxiety, Autoimmune disorder, Blood test abnormal, Obsessive-compulsive disorder
Clinical narrative: Developed severe Obsessive Compulsive Disorder, anxiety, and auto immune problems. Immune system seems to be attacking basal ganglia part of brain. We want our son back and we are treating as if PANDAS  (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections) but no luck solving problems 2 years after onset of symptoms. Missed almost 2 years of school where he was doing B average work before things started.
Age: 54.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site pain
Clinical narrative: Pain and local site of inject. Icing has not help. Recommend continue icing with ibuprofen. Patient also to contact vaccination 800 number.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Sharp Pain at the administration that made y fingers fell pain ( all the way down my arm). Ongoing pain at the site of the needle injections. Now it hurts to lift my arm or press on the spot where the needle punctured. Pain persists when I move my arm to lift or when I try to lay on that side in the bed. It hurt to even try to change my shirt. Pain has worsened since 10/26/16 to present.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Myelitis transverse, Neuromyelitis optica spectrum disorder, Vomiting
Clinical narrative: Severe head pain at base of skull with vomiting. Then severe back pain which led to transverse myelitis. Flown to hospital on 11/23. Diagnosed with Neuro Myelitis Optica.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: RASH AT SITE OF INJECTION WITH MILD ITCH AND ALSO A MILD ITCH OVER RIGHT EYE. NO RASH THERE. PATIENT SAT FOR FULL 20 MINUTES AND GAVE HER BOTTLE OF BENADRYL ELIXIR GENERIC TO TAKE HOME WITH HER WITH INSTRUCTIONS TO CALL ME WHEN SHE GOT HOME AND IF SHE TOOK DOSE AND HOW MUCH. TP SAID SHE FELT OK AND TOOK 20ML OF BENADRYL GENERIC LIQUID. TOLD HER IF MAY MAKE HER DROWSY AND CONFIRMED THAT FAMILY WAS AT HOME WITH HER WILL CALL ME IF ANY FURTHER PROBLEMS AND DEFINITELY WILL FOLLOW UP TOMORROW 12/17/16.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Rash erythematous, Skin warm
Clinical narrative: Red rash, warm to the touch, some numbness used zyrtec and ice.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The patient developed redness and swelling in the arm below where the medication was injected. Pt went to doctor and received steroids and prophylaxis ABX.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Severe pain in left arm and shoulder. Saw my doctor after 2 weeks of severe pain. She referred me to a specialist. He prescribed pain medication (Tramadol HCL 50 mg on 12-13-16. Still very painful to move left arm (appt. to see another specialist on 1-6-17.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Generalised erythema, Hypersensitivity, Pruritus generalised
Clinical narrative: Patient had a severe allergic reaction to the flu shot, he was red all over and complained of feeling like he was on fire and itching all over. His breathing was fine and he was alert. I administered 50mg of diphenhydramine IM which seemed to help. He said he started to see stars and began to shiver. I called 911. Paramedics arrived. Patient was able to leave pharmacy with his mother after 30 min.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Patient had a severe allergic reaction to the flu shot, he was red all over and complained of feeling like he was on fire and itching all over. His breathing was fine and he was alert. I administered 50mg of diphenhydramine IM which seemed to help. He said he started to see stars and began to shiver. I called 911. Paramedics arrived. Patient was able to leave pharmacy with his mother after 30 min.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Mobility decreased, Pain, Swelling
Clinical narrative: Swelling, redness, pain, blisters. Patient reports most severe symptoms day after injection, pain to the point of not being able to move arm. Gradual improvement over 4 days, but still not completely recovered.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Incisional drainage, Infection, Myalgia, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Pfizer) (Manufacturer Report Number: 2016496483) on 16-Dec-2016. This case involves a 71-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QIV (batch number: UI684AD, expiry date: 30-Jun-2017, dose form and frequency not reported) intramuscularly in the deltoid and a 0.5 ml dose of PREVENAR 13 (manufacturer: Pfizer; Batch number: N34936, expiry date: Oct 2017, dose form and frequency not reported) intramuscularly in the deltoid on 20-Oct-2016. Relevant Medical history and concomitant medications were not reported. On 20-Oct-2016, the same day after vaccination it was reported that the patient started experiencing pain "started in her body muscle from arm all the way to neck". Patient was referred to emergency room when it was revealed that she had infection and they drained the infection. The patient was hospitalized on 21-Oct-2016 and observed drained from a wound and suppose to have surgery (Today). Relevant laboratory investigations and corrective treatment were not reported. The patient had drained the infection in hospital. At the time of the report the outcome of the events was unknown. Pharmacist reported that patient may have some pain in her arm from it, whether this whole issue was from that, pharmacist don't know. It was also reported that the FLUZONE QIV was administered on another arm. List of documents held by the sender: None. Sender's Comments: This case concerns 82 year old female patient who received INFLUENZA QUADRIVAL A-B VACCINE and PNEUMOCOCCAL POLYSACCHARIDE VACCINE developed infection, myalgia and pain in arm wound. Time to onset was not provided. However in this particular case very limited information has been provided. Further information regarding etiological work up, concomitant medication, concurrent condition at the time of vaccination and reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13
Symptoms: Incisional drainage, Infection, Myalgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Pfizer) (Manufacturer Report Number: 2016496483) on 16-Dec-2016. This case involves a 71-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QIV (batch number: UI684AD, expiry date: 30-Jun-2017, dose form and frequency not reported) intramuscularly in the deltoid and a 0.5 ml dose of PREVENAR 13 (manufacturer: Pfizer; Batch number: N34936, expiry date: Oct 2017, dose form and frequency not reported) intramuscularly in the deltoid on 20-Oct-2016. Relevant Medical history and concomitant medications were not reported. On 20-Oct-2016, the same day after vaccination it was reported that the patient started experiencing pain "started in her body muscle from arm all the way to neck". Patient was referred to emergency room when it was revealed that she had infection and they drained the infection. The patient was hospitalized on 21-Oct-2016 and observed drained from a wound and suppose to have surgery (Today). Relevant laboratory investigations and corrective treatment were not reported. The patient had drained the infection in hospital. At the time of the report the outcome of the events was unknown. Pharmacist reported that patient may have some pain in her arm from it, whether this whole issue was from that, pharmacist don't know. It was also reported that the FLUZONE QIV was administered on another arm. List of documents held by the sender: None. Sender's Comments: This case concerns 82 year old female patient who received INFLUENZA QUADRIVAL A-B VACCINE and PNEUMOCOCCAL POLYSACCHARIDE VACCINE developed infection, myalgia and pain in arm wound. Time to onset was not provided. However in this particular case very limited information has been provided. Further information regarding etiological work up, concomitant medication, concurrent condition at the time of vaccination and reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Arthralgia, Pyrexia, Respiratory tract infection
Clinical narrative: Respiratory infection started about 30 hours ago and progressively getting worse. She has now also developed a fever. She also had the polio vaccine and has complained of joint pain in her leg for the last 5 days.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to one unspecified patient of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On an unspecified date, the patient was vaccinated with improperly stored doses of PNEUMOVAX23 (lot # L014458, expiration date 11-FEB-2018, dose, dose number and route were not provided) for prophylaxis, which were exposed to 48.4 Fahrenheit (F) for 24 hours. There was no previous temperature excursion. No adverse symptoms were reported. The data logger issue was involved. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Amenorrhoea, Discomfort
Clinical narrative: This spontaneous report was received from a the patient's mother referring to her daughter, a female patient of unknown age. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), (strength, frequency, dose, route, lot/batch number and expiration date were not reported) for prophylaxis. It was reported that, on an unknown date, the patient experienced amenorrhoea, reported as "I'm almost positive it triggered a menstrual because she hasn't has one since that vaccine", and discomfort, reported as "She hates it. She says it hurts really bad". The patient's mother stated "I feel bad but if it's not mandated that I won't have her do the last one". The outcome of amenorrhoea and discomfort was unknown. The relationship between the events and the suspect unspecified HPV vaccine was not provided. Additional information is not expected, there is no contact information.
Sex: U
Vaccine: HEP
Symptoms: Drug dose omission
Clinical narrative: Information has been received from a physician referring to his/her child, an adult patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapies were not reported. It was reported that because the physician used primarily a combined vaccine, he/she did not routinely use the separate hepatitis B doses for his/her pediatrics population. The physician further reported that his/her child was transferred from another practice where the 3rd dose of hepatitis B vaccine (manufacturer unknown) (lot #, expiration date, dose and route were not reported) was missed during routine immunizations. The physician wanted to know how to get one dose of hepatitis B vaccine rather than buying 10 and throwing away 9 doses. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 2 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, each of the patients was vaccinated with a dose of improperly stored ZOSTAVAX (lot # M033335, expiration date 11-OCT-2017, dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored at 8.96 degree Fahrenheit for 2 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates these patients were vaccinated with improperly stored doses of VARIVAX (lot#M024261, expiry date 31-JUL-2018, lot#M023384, expiry date 31-MAY-2018 and lot#M033213, expiry date 30-JUL-2018) for prophylaxis. No adverse effects were reported. The vaccines were exposed to the temperature of 33.9 degree Fahrenheit for 19 hours 32 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of the two reports reported from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013191.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a female registered nurse of currently 32 year old  referring to herself. Concurrent conditions, medical history and historical drugs were not reported. The patient had allergy to sulfa drugs. On an unknown date, when the patient was a child (unknown age and date), she was vaccinated with M-M-R II (strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. On an unknown date (reported as recently), the patient had "low titers for M-M-R II" from an unspecified test conducted by an unspecified medical facility. At the time of the report, the outcome of "low titers for M-M-R II" was unknown. A product quality complaint was not involved. The causal relationship between the event and  M-M-R II was unknown. Additional information is not expected as no permission for contact was granted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number patient of unknown age and gender. Since 02-DEC-2016, the patients were vaccinated with doses of improperly-stored PROQUAD (lot# reported as M034692, expiration date: 24-JAN-2018; strength, dosage, frequency and route unspecified) for prophylaxis.  No adverse effects were reported. Temperature and time frame was reported as 40.7 F for 16 hours and 34 minutes and there was no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013053.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. There was no concomitant medication, pertinent medical history or drug reaction reported. On unspecified dates, the patients were administered improperly stored ZOSTAVAX vial 19,400 (plaque-forming units) PFU (dose, route, Lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA012829.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age. On 12-Dec-2016, the patients were vaccinated with an improperly stored GARDASIL 9 lot # L036301, 20-DEC-2017 intramuscular for prophylaxis. No adverse effects were reported. Temperature 48 F for 65 hours. It was administered. There was no previous temperature excursion. Data logger was yes. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 22 year old male patient. The medical history, concurrent conditions and concomitant medications were not reported. On APR-2016 the patient was vaccinated with first dose of GARDASIL lot # L040459, 06-APR-2017 for prophylaxis. On OCT-2016, the patient was vaccinated with second dose of GARDASIL 9 lot#M018810 28-MAY-2018. The patient had not yet received the last dose in the series. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, frequency, route of administration, lot number and expiry date were not reported). On an unknown date, after receiving ZOSTAVAX, the patient experienced shingles (herpes zoster). The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported.     No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring unspecified number of patients of unknown age. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (dosage regimen were not reported) lot # M004116, expiry date 12-OCT-2017 and lot # M009378, expiry date 23-APR-2018 for prophylaxis (incorrect product storage). Temperature excursion: 47.3F, Cumulative time frame: 50.5 hours data logger was used. No adverse effects (no adverse event) reported. The outcome of incorrect product storage and no adverse event were unknown. This is one of two reports MARRS # 1612USA012828. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient. Pertinent medical histories and concomitant medications were not reported. On 14-DEC-2016, the patient was vaccinated with PROQUAD (dosage regimen were not reported) for prophylaxis and other suspect therapies included M-M-R II (dosage regimen were not reported) for prophylaxis (overdose). No adverse effects (no adverse event) were reported. The outcome of overdose and no adverse event were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 30-AUG-2015, the patient was vaccinated with first dose of GARDASIL, K016966, 10-MAY-2017. The patient received a second dose of GARDASIL 9 lot # L019297, 18-AUG-2017 on 30-DEC-2015. The patient received the third dose of GARDASIL 9, lot# L024993 17-OCT-2017 on 29-FEB-2016. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Information has been received from a clinical practice manager concerning a female patient of unknown age. There was no information about concurrent condition, concomitant medication and medical history. On 01-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # M026317, expiration date 11-JAN-2018) (dose, frequency and route unknown) for prophylaxis. On an unspecified date in 2016 after vaccinated with PNEUMOVAX23, the patient developed cellulitis, which extended beyond the injection sites. Treatment with unspecified antibiotics was given to the patient. The outcome of the event was unknown. The causality between the event and PNEUMOVAX23 was not provided. Upon internal review, cellulitis was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow-up. Sender's Comments: US-009507513-1612USA012869: US-009507513-1612USA012870.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a female patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 03-MAY-2016, the patient received  the first dose of GARDASIL 9 and the second dose 2 months after the first dose (approximately on 03-JUL-2016) and the third dose 2 months after the second dose (approximately 03-SEP-2016). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an approximately 4 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 19-DEC-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 with lot # K009874 and expiration date on 19-MAR-2016 (anatomical route of vaccination was not provided) for prophylaxis. Furthermore, no adverse event was reported and no product quality issue was involved. Additional information has been requested.
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 year old female patient. Pertinent medical history and concomitant medications were not reported. On 16-DEC-2016, the patient was vaccinated with M-M-R II (dosage regimen were not reported) lot # M008589 for prophylaxis and other suspect therapies included PROQUAD (dosage regimen were not reported) (drug administered to patient of inappropriate age, overdose and inappropriate schedule of drug administration). No adverse event (no adverse event) were reported. The outcome of drug administered to patient of inappropriate age, no adverse event, overdose and inappropriate schedule of drug administration were unknown. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer refers two female patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (dosage regimen were not reported) for prophylaxis. On an unknown date, the patient experienced chicken pox (varicella). The outcome of varicella was unknown. The relatedness between the drug and the reported event were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of GARDASIL 9 lot# M028323 with expiry date: 26-SEP-2018, lot# M023169 with expiry date of 13-JUN-2018 and lot# M009378 with expiry date of 23-APR-2018 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes, for prophylaxis (dosing details were not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to 3 patients of unknown age. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (dosage regimen were not reported) lot # M005714, expiry date 07-OCT-2017 for prophylaxis. No adverse effects were reported. The outcome of incorrect product storage and no adverse event were unknown. No further information was available. Additional information has been requested.
Age: 15.0
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 medical assistant refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosage regimen were not reported) for prophylaxis on an unspecified date when the unspecified patient was 13 years old. On an unknown date in August 2016, unspecified patient was 15 years old received GARDASIL 9 (dosage regimen were not reported) for prophylaxis. No adverse events  were reported. The outcome of interchange of vaccine products, no adverse event, incorrect drug administration duration and inappropriate schedule of drug administration were unknown. No further information was available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient experienced injection site reaction. The outcome of injection site reaction was unknown. The causality was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a patient's mother regarding her 12 years old son via company representative. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 20-DEC-2016, the patient experienced nausea, headache and vomiting after receiving GARDASIL. The company representative could not confirm whether it was GARDASIL or GARDASIL 9. Outcome and causality of the events were not reported. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 18-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 27-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Public fund. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 03-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.25
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 04-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 10-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 11-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 18-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M032148, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 18-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 11-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 18-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Private pay/ Insurance. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.