chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pallor
Clinical narrative: Same day as vaccine, developed redness and warmth, followed by ache.  That night, pain worsened and awoke with chills.  +nasal congestion.  Continued pain, redness, warmth with blanching erythema approx 56 hours after injection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeding disorder, Headache, Herpes zoster, Lymphadenopathy
Clinical narrative: 8/27 1:45pm adm Zostavax subQ--right arm. 8/27 7:00pm right arm began to itch. 8/28 6:00am right arm swollen & redness. 8/29 6:00am right arm more swollen with red shingles type rash & gland in right arm pit was swollen. 8/29 12:00pm developed headache & body pain. 8/30  all symptoms continues & pain worsened. 8/31 morning-went to urgent care--Dr confirmed shingles & prescribed hydrocodone for pain and acyclovir for virus. 9/1/15 Morning-upper torso & face covered with spots and right arm pain was worse--went to Emerency Room---Dr examined patient and confirmed both shingles & chicken pox--was very contagious and sent home--Patient become nausceous & could not eat & went on liquid diet. 9/3--PCP talked with patient and prescribed gabapentin--patient started med. 9/4--Patient pain is better and chicken pox rash is going away and shingles rash is better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 8/27 1:45pm adm Zostavax subQ--right arm. 8/27 7:00pm right arm began to itch. 8/28 6:00am right arm swollen & redness. 8/29 6:00am right arm more swollen with red shingles type rash & gland in right arm pit was swollen. 8/29 12:00pm developed headache & body pain. 8/30  all symptoms continues & pain worsened. 8/31 morning-went to urgent care--Dr confirmed shingles & prescribed hydrocodone for pain and acyclovir for virus. 9/1/15 Morning-upper torso & face covered with spots and right arm pain was worse--went to Emerency Room---Dr examined patient and confirmed both shingles & chicken pox--was very contagious and sent home--Patient become nausceous & could not eat & went on liquid diet. 9/3--PCP talked with patient and prescribed gabapentin--patient started med. 9/4--Patient pain is better and chicken pox rash is going away and shingles rash is better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Varicella
Clinical narrative: 8/27 1:45pm adm Zostavax subQ--right arm. 8/27 7:00pm right arm began to itch. 8/28 6:00am right arm swollen & redness. 8/29 6:00am right arm more swollen with red shingles type rash & gland in right arm pit was swollen. 8/29 12:00pm developed headache & body pain. 8/30  all symptoms continues & pain worsened. 8/31 morning-went to urgent care--Dr confirmed shingles & prescribed hydrocodone for pain and acyclovir for virus. 9/1/15 Morning-upper torso & face covered with spots and right arm pain was worse--went to Emerency Room---Dr examined patient and confirmed both shingles & chicken pox--was very contagious and sent home--Patient become nausceous & could not eat & went on liquid diet. 9/3--PCP talked with patient and prescribed gabapentin--patient started med. 9/4--Patient pain is better and chicken pox rash is going away and shingles rash is better.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Asthenia, Dark circles under eyes, Diarrhoea, Influenza like illness, Lethargy
Clinical narrative: Weakness, headache, lethargic, dark circles around eyes Diarrhea, vomiting and muscles weakness.  Flu like symptoms.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Muscular weakness, Vomiting
Clinical narrative: Weakness, headache, lethargic, dark circles around eyes Diarrhea, vomiting and muscles weakness.  Flu like symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Generalised erythema, Pruritus generalised, Swelling, Urticaria
Clinical narrative: Hives all over body, itchy skin all over body, redness all over body, swelling/welts all over body.
Age: 40.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Injection site erythema, Injection site swelling, Urticaria, Vomiting
Clinical narrative: Redness and swelling at injection site, hives, upset stomach, vomiting.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Rash, Skin warm
Clinical narrative: Patient was vaccinated in left deltoid on 9/3/15. Patient presents today, Friday (9/4/15), with rash on her right outer hip and slight stomach pain upon awakening. After questioning, she stated that the rash was warm to the touch and had about 5 "pimple-like" bumps that were closer to her inner thigh/groin area. Patient denies fever, difficulty breathing or itch. Patient states she gets the influenza vaccine every year and has never had a reaction. Patient states she takes a Benadryl nightly to help her sleep and took one Thursday night after vaccination.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient presented to pharmacy to fill rx for antibiotic following reaction in vaccination arm. Right arm was visibly swollen, red, and patient said hot to touch.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Erythema, Headache, Local swelling
Clinical narrative: GRANDPARENTS CALLED TO INQUIRE ABOUT LOCALIZED REDNESS, SWELLING, CHILLS AND HEADACHE.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Patient started experience itchiness at and around the site of injection 15 minutes after injection.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Dyskinesia, Hypopnoea, Pallor, Syncope, Tilt table test normal
Clinical narrative: 3 minutes post HPV vaccine patient fainted and was breathing with shallow breaths along with pale complexion. Had 5-8 seconds of mild body jerking with eyes straight ahead. Became conscious and talkative 10 seconds later. TILTS done and were normal.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal faeces, Diarrhoea, Dyspnoea, Faeces discoloured, Hyperhidrosis
Clinical narrative: An hour later, sweating profusely and started blacking out. Visual impairment-was seeing red moving spots and could not see around them. Pain in neck on both sides and very SOB. Serious diarrhea immediately that was white and smelled like metal. At least an hour to subside.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Loss of consciousness, Neck pain, Visual impairment
Clinical narrative: An hour later, sweating profusely and started blacking out. Visual impairment-was seeing red moving spots and could not see around them. Pain in neck on both sides and very SOB. Serious diarrhea immediately that was white and smelled like metal. At least an hour to subside.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Somnolence, Speech disorder, Tremor
Clinical narrative: Severe dizziness, chills causing entire body to tremble, overly groggy, unable to carry on a conversation.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Patient reported severe pain at the injection site of the PREVNAR 13 vaccine.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Peripheral swelling, Rash
Clinical narrative: Swelling of arm, rash, pain.
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via center referring to a 23 year old female patient. The patient's relevant medical history included smoking and she had a 5 month old child. Her relevant past drug history was unknown. On 21-AUG-2015 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # L007720, expiration date 08-JUL-2016), intramuscularly in the left arm. Other suspect therapies included FLUARIX QUADRIVALENT (lot#, expiration date, dose and route unspecified). Concomitant therapies included ethinyl estradiol, norgestimate. On 22-AUG-2015, the patient called pharmacy complaint of left arm swelling at the injection site, bright redness, tenderness, pain, puffiness and unable to lift arm. The pharmacist stated that the reaction might be worse because she received FLUARIX QUADRIVALENT on the same day. It was unknown if there was relevant lab data. As of 23-AUG-2015, the patient was not longer on PNEUMOVAX 23 or FLUARIX QUADRIVALENT, but the events continued. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-SEP-2015, the patient was vaccinated with expired vaccine PNEUMOVAX 23 (unknown strength, route and dose) lot # K004483 with an expiry date of 16-AUG-2015. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (dose, route and lot # not reported). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates in approximately 2015 (reported as since 06-JUN-2015), the patients were vaccinated with a doses of oral ROTATEQ (strength, dose and frequency were not reported) lot # K012432 expiration date 20-MAY-2016 and lot # K016263, expiration date 26-JUN-2016, route defaulted to oral, that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route and lot # not reported). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Bone pain, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 22-JUN-2015, the patients was vaccinated with PNEUMOVAX 23 1 dose, lot# reported as L04915 (route of administration and dose were not reported). On an unknown date in June 2015, reported as within 24 hours of receiving the vaccination, the patient experienced unspecified muscle and bone soreness in an unspecified site. The patient sought an unspecified medical attention. The outcome of the events was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. There is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 28-AUG-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot # K016964 and expiration date 16-JUL-2017) (dose and route were not reported) which were improperly exposed to the following conditions. 25-AUG-2015: 30.2 for 4 hours 30 minutes. 26-AUG-2015: 31.6F for 5 hours. 27-AUG-2015: 33.4F for 2 hours 45 minutes. 28-AUG-2015: 33.8F for 1 hour. It was also reported that LIQUID PEDVAXHIB was improperly exposed on the following dates to following conditions that had been administered to unspecified patients. 29-AUG-2015: 32.9F for 1 hour 30 minutes. 30-AUG-2015: 33.0F for 2 hours 15 minutes. 31-AUG-2015: 33.6F for 4 hours. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L011846 with expired date 16-JUN-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 02-SEP-2015, the patient was inadvertently vaccinated with expired PROQUAD (Merck) (lot # K002483, expiration date 18-AUG-2015, strength, dose and route unknown). No adverse events were reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt describes pain when arm is lifted above shoulder and he has decreased mobility. He says this has persisted since vaccination from 11/3/14. No pain at rest.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, firm, swelling around injection site 2 days after injection, concerning for infection - patient also with MRSA boils on buttocks - history of MRSA.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates in approximately 2015 (reported as since 06-JUN-2015), the patients were vaccinated with a dose of MMR II (strength, dose and frequency were not reported) lot # K006396 expiration date 04-MAY-2016 and lot # K024036, expiration date 26-NOV-2016 that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Administered Tdap and Meningitis vaccine (R) deltoid at Co. Health Dept. On 9/3/15 mother brought child in with c/o red, warm and painful injection site. Went to urgent care and given KEFLEX for 7 days on 9/3/15 after office visit with me.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with GARDASIL 9 lot # K026247, expiration date 29-JAN-2017 (dose strength, route unspecified) post temperature excursion with no adverse effects. No product quality complaint was involved. This case is linked to the case via 1509USA001313 same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a pharmacist, as part of a marketing research program-ZOSTAVAX HCP competitive message testing conducted by the agency, refers to a female patient in her 70's. The concurrent condition and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route and lot details unspecified). The concomitant medication was not reported. On an unknown date, the patient experienced dizziness (non-serious). The action taken with ZOSTAVAX was not applicable. The outcome of dizziness was reported as resolving. The reporter considered dizziness to be related to ZOSTAVAX. Additional information is note expected as the reporter does not wish to be contacted.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of currently 77 years old. No information about medical history, concurrent conditions were reported for the patient. The patient had unspecified reaction to penicillin on an unknown date. Approximately on an unknown date in 2011 (reported as 4 years ago) the patient was vaccinated with ZOSTAVAX 19400 Plaques forming units (Route unspecified) for vaccination. Concomitant therapies included SYNTHROID, TOPROL, ZOCOR and CELEXA. On an unknown date in July 2015 the patient experienced shingles and was treated with unspecified antivirals. The outcome of shingles was reported as recovered/resolved approximately on an unknown date in 2015. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Information has been received from a pharmacy technician via agency (other company US15-041314), referring to a 53 year old female patient who was a smoker. The patient's concomitant medication and past drug history were unknown. On 02-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX 23, lot # K010016, expiration date 05-AUG-2015, Intramuscularly in the left deltoid, once, for prevention of pneumonia. After the vaccine was given it was discovered that the vaccine was expired. After the injection the patient was acting okay. It was unknown if there was any relevant laboratory data. As of 02-SEP-2015 it was unknown if she would receive another PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Between 29-APR-2015 and 17-AUG-2015, the patients were vaccinated with the improperly stored doses of PROQUAD (Merck) (lot # reported as L005294 with expiration date 17-AUG-2016 and lot # L010142 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 19-JUN-2015 the patient received a dose of GARDASIL 9 (lot number expiration date, route and dose were unknown). On 24-AUG-2015, the patient received a dose of GARDASIL (lot number, expiration date, route and dose were unknown). No adverse experienced were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On an unspecified date in 1999 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, lot number, expiration date, dose, route, and anatomical location were not reported. No concomitant therapy was reported. On an unknown date (also reported as shortly after the (Oka/Merck) VARIVAX was administered) the patient developed hives. The duration of the hives was not specified by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route and lot # not reported). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that on 28-AUG-2015, a dose of an expired STERILE DILUENT, lot number: unspecified, expiry: 15-MAY-2015 (dose not provided) was inadvertently used to reconstitute a dose of ZOSTAVAX that was administered to the patient (dose, route of administration, injection site, lot number and expiration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB, HBHEPB
Symptoms: Extra dose administered, No adverse event, Product packaging confusion
Clinical narrative: Information was received from a nurse practitioner referring to a 2 month old patient of unknown gender. There was no information about the patient's medical history and concurrent condition. On 13-AUG-2015 the patient was vaccinated with a dose of COMVAX (strength, dose and route unknown) and PENTACEL (strength, doses and route unknown), resulting in a double dose of hepatitis b vaccine. The reporter stated that the patient was only supposed to receive an unspecified hepatitis B vaccine (manufacturer unknown) with PENTACEL. However, since the boxes for COMVAX and the unspecified hepatitis B vaccine (manufacturer unknown) had an identical color, it resulted in mixing up the two products. No adverse effects were reported. 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 refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route and lot # not reported). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # reported as "K026887", expiration date: 16-DEC-2016 or lot # K005178, expiration date: 10-APR-2016, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose and lot # not reported) orally. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown gender and unknown age. On 19-AUG-2015 ("yesterday"), one dose of PNEUMOVAX 23 injection (lot # K008409, expired date 04-MAR-2016, strength, dose and route were not provided), which was exposed to a temperature outside of the recommended range, was adminsitered to an unspecified patient. The patient had not reported any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to a patient of unknown age and gender. There was no medical history or drug reactions/allergies reported. The patient received the first and second doses of both MMR II and (Oka/Merck) VARIVAX at a different unspecified clinic, at "the inappropriate times", on unspecified dates for prophylaxis (dose, lot#, expired date and route were unknown). On 27-AUG-2015 the patient was inadvertently administered the third dose of both MMR II and (Oka/Merck) VARIVAX at her clinic, which was "shortly after the administration of the second doses". No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates in approximately 2015 (reported as since 06-JUN-2015), the patients were vaccinated with a doses of GARDASIL (strength, dose and frequency were not reported) lot # K007828 expiration date 02-MAR-2017, lot # K023432, expiration date 18-JUN-2016 and lot # K011562, expiration date 08-APR-2017 that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several 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 as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-SEP-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (unknown strength, route and dose) lot # L019997 with expiry date of 02-DEC-2016. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: This spontaneous report was received from a currently 87 year old male patient referring on himself. The patient's concurrent conditions included high blood pressure. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 25 mcg/0.5 ml injection, lot#, expiration date, route and dose were not reported. Concomitant therapies included Lisinopril (manufacturer unknown). On an unknown date, after vaccination, the patient began having pins and needles sensation in arm, back and shoulder. The pain started at injection site, and moved up the arm and shoulders. The pain became more intense in shoulder and upper arm. Pain was intermittent. The patient sought medical attention. An unspecified laboratory diagnostic was performed in approximately February 2015 (reported as '6 months ago'). The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 31-AUG-2015, the patient was vaccinated with an expired dose of PROQUAD (Merck) lot # reported as K02996, expiration date 27-AUG-2015 (strength, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse via company representative, refers to a 49 year old female patient. The patient's pertinent medical history and drug allergies were not reported. Concomitant therapies included IMITREX, verapamil, CYMBALTA, FLEXERIL, FLOVENT, SINGULAIR, DULERA and gabapentin. On 24-AUG-2015, the patient received a "flu shot (unspecified) in the arm (before receiving the PNEUMOVAX 23 injection). On the same day, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and dose were not reported) one time injection, intramuscularly in the same arm for prevention of pneumococcal disease. Subsequently, on that day, the patient experienced a severe site reaction after receiving the injection of the PNEUMOVAX 23. The patient's arm felt hot and was swollen, in the place, where the injection was given. The patient sought medical attention and called to the nurse. As a treatment, the patient was administered two ADVIL tablets. The outcome of the events was unknown. The relatedness between the events and the PNEUMOVAX 23 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 physician refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with 2 doses of improperly stored (Oka/Merck) VARIVAX (L013067, expiration date 14-APR-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. 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 nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 31-AUG-2015, the patient was vaccinated with expired doses of MMR II (lot # J010601, subcutaneous, 0.25 ml). The nurse also reported that as the vaccine was being administered, patient pulled away and received less than full dose. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 28-AUG-2015, the patient was vaccinated with VAQTA (lot # L))1445 and expiration date 15-FEB-2016) (dose and route were not reported) which were improperly exposed to the following conditions. 25-AUG-2015: 30.2F for 4 hours 30 minutes. 26-AUG-2015: 31.6F for 5 hours. 27-AUG-2015: 33.4F for 2 hours 45 minutes. 28-AUG-2015: 33.8F for 1 hour. It was also reported that VAQTA was improperly exposed on the following dates to the following conditions that had been administered to unspecified patients. 29-AUG-2015: 32.9F for 1 hour 30 minutes. 30-AUG-2015: 33.0F for 2 hours 15 minutes. 31-AUG-2015: 33.6F for 4 hours. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 4 month old patient of unknown gender. No concurrent condition or medical history was reported. On 28-AUG-2015, the patient was inadvertently vaccinated with VAQTA (dose and route of administration not provided). No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Acupuncture, Blood test, Computerised tomogram, Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: This spontaneous report as received from an approximately 53 year old female patient regarding herself. The patient's pertinent medical history included allergies (unspecified) (hypersensitivity) and iodine dye allergy. On an unknown date approximately in July 2010 the patient was vaccinated with first dose of RECOMBIVAX HB dose 1, (lot number and expiry date unknown) intramuscularly (dosing regimen and frequency unknown) for prevention of infection of hepatitis B virus. It was reported that the patient was recommended to get the RECOMBIVAX HB due to working in the fire department. Concomitant therapies included SINGULAIR and ALLEGRA. On an unknown date in December 2010 the patient received the second dose, and on an unknown date in February 2011 the patient received the third dose of RECOMBIVAX HB (lot number and expiry date unknown) intramuscularly (dosing regimen and frequency unknown) for prevention of infection of hepatitis B virus). On an unknown date approximately in March 2011 (also reported as about 6-8 weeks after receiving the third shot) the patient experienced tingling numbing feeling in her left eye, the tingling numbing feeling migrated to the nose, cheek, tongue, teeth, and lips all on the left side of the face. It was reported that the tingling numbing feeling stops about half an inch below lip. The patient stated that the feeling was 24 hours a day and it felt like procaine (Novocaine) when it was wearing off. The patient had visited a neurologist (unspecified), and an ear, nose and throat specialist (unspecified) and a neuropathy specialist (unspecified). The patient had also had an acupuncture seen a chiropractor (unspecified) for an MES. The patient visited a dentist (unspecified) who had her wearing a night guard. The patient had undergone a Magnetic resonance imaging (MRI), computerized axial tomography (CAT) Scan and blood tests (unspecified) but the results were not reported. It was reported that the patient did not receive any treatments for the events. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was not recovered. It was also reported that the patient was told that she may have to just live with it. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia oral, Nuclear magnetic resonance imaging, Paraesthesia oral, Specialist consultation
Clinical narrative: This spontaneous report as received from an approximately 53 year old female patient regarding herself. The patient's pertinent medical history included allergies (unspecified) (hypersensitivity) and iodine dye allergy. On an unknown date approximately in July 2010 the patient was vaccinated with first dose of RECOMBIVAX HB dose 1, (lot number and expiry date unknown) intramuscularly (dosing regimen and frequency unknown) for prevention of infection of hepatitis B virus. It was reported that the patient was recommended to get the RECOMBIVAX HB due to working in the fire department. Concomitant therapies included SINGULAIR and ALLEGRA. On an unknown date in December 2010 the patient received the second dose, and on an unknown date in February 2011 the patient received the third dose of RECOMBIVAX HB (lot number and expiry date unknown) intramuscularly (dosing regimen and frequency unknown) for prevention of infection of hepatitis B virus). On an unknown date approximately in March 2011 (also reported as about 6-8 weeks after receiving the third shot) the patient experienced tingling numbing feeling in her left eye, the tingling numbing feeling migrated to the nose, cheek, tongue, teeth, and lips all on the left side of the face. It was reported that the tingling numbing feeling stops about half an inch below lip. The patient stated that the feeling was 24 hours a day and it felt like procaine (Novocaine) when it was wearing off. The patient had visited a neurologist (unspecified), and an ear, nose and throat specialist (unspecified) and a neuropathy specialist (unspecified). The patient had also had an acupuncture seen a chiropractor (unspecified) for an MES. The patient visited a dentist (unspecified) who had her wearing a night guard. The patient had undergone a Magnetic resonance imaging (MRI), computerized axial tomography (CAT) Scan and blood tests (unspecified) but the results were not reported. It was reported that the patient did not receive any treatments for the events. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was not recovered. It was also reported that the patient was told that she may have to just live with it. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. There was no product quality issue reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with 1 dose of improperly stored PROQUAD (Merck) (lot # L008353 with expiration date 11-SEP-2016 and lot # reported as L016394 with expiration date 08-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 20-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L008270 and expiry date: 11-FEB-2017) (dose, route and site of administration was not reported) and no adverse experiences were reported. The outcome of incorrect product storage was unknown. No further information was provided. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Bone pain, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 22-JUN-2015, the patients were vaccinated with PNEUMOVAX 23 1 dose, lot# L003227 (route of administration and dose were not reported). On an unknown date in June 2015, reported as within 24 hours of receiving the vaccination, the patient experienced unspecified muscle and bone soreness in an unspecified date. The patient sought an unspecified medical attention. The outcome of the events was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. There is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates in approximately 2015 (reported as since 06-JUN-2015), the patients were vaccinated with a doses of VARIVAX (Merck) (strength, dose and frequency were not reported) lot # K016127 expiration date 23-SEP-2016 and lot # L007225, expiration date 03-MAR-2017 that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. An unspecified number of doses of improperly stored (Oka/Merck) VARIVAX lot # L013827 exp. 21-APR-2017, lot # L001333 exp. 13-JAN-2017, lot # L010144 exp. 24-MAR-2017, lot # L013827 exp. 21-APR-2017, (route of administration and dose were not reported) were administered to an unspecified number of unspecified patients by an unspecified physician on unspecified dates. There was no adverse events reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Exposure via direct contact, Eye irrigation, Oral administration complication
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 28-AUG-2015, the patient was vaccinated with the third dose in series of ROTATEQ, orally, (dose, lot number and expiration date were not reported) (reported as "6 months well baby shots"). According to the reporting registered nurse, "baby spit some out and some of vaccine possibly went into patient's eye". It was reported that the patient's eye was immediately flushed and no other treatment was implemented at the time of exposure. According to the reporting nurse, there might have been 0.25 ml remaining in oral ROTATEQ tube. The nurse also stated that patient received other unspecified "6 months shots" while present in the office (on 28-AUG-2015) and that the patient's mom said the baby was doing fine. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. An unspecified number of doses of improperly stored ZOSTAVAX lot# reported as L02108, exp. 10-SEP-2016 and lot# reported as L021612, exp. 10-SEP-2016 (route of administration and dose were not reported) were administered to an unspecified number of unspecified patients by an unspecified physician on unspecified dates. There was no adverse events reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Feeling hot, Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. The patient had no drug reactions or allergies. The patient had no pertinent medical history. On 06-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, once, subcutaneous (lot # and expiration date were not provided), to prevent shingles. The patient took no concomitant medications. On 22-AUG-2015, the patient developed "a rash on her chest and back" which was "very hot and burning". The patient sought medical attention by seeing her unspecified healthcare provider on an unspecified date in 2015. The patient received prednisone (manufacturer unknown), hydroxyzine (manufacturer unknown) and BENADRYL as the treatment for the event but "they weren't really working". No lab diagnostics studies were performed. At the time of reporting, the patient did not recover from the event. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports concerning the same patient. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. The patient had no drug reactions or allergies. The patient had no pertinent medical history. On 06-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, once, subcutaneous (lot # and expiration date were not provided), to prevent shingles. The patient took no concomitant medications. On 22-AUG-2015, the patient developed "a rash on her chest and back" which was "very hot and burning". The patient sought medical attention by seeing her unspecified healthcare provider on an unspecified date in 2015. The patient received prednisone (manufacturer unknown), hydroxyzine (manufacturer unknown) and BENADRYL as the treatment for the event but "they weren't really working". No lab diagnostics studies were performed. At the time of reporting, the patient did not recover from the event. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 31-AUG-2015, the patient was vaccinated with VAQTA (lot # L001445 and expiration date 15-FEB-2016) (dose and route were not reported) which were improperly exposed to the following conditions. 25-AUG-2015: 30.2F for 4 hours 30 minutes; 26-AUG-2015: 31.6F for 5 hours; 27-AUG-2015: 33.4F for 2 hours 45 minutes; 28-AUG-2015: 33.8F for 1 hour; 29-AUG-2015: 32.9F for 1 hours 30 minutes; 30-AUG-2015: 33.0F for 2 hours 15 minutes; 31-AUG-2015: 33.6F for 4 hours. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of male patients greater than 15 years old. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9, injection, (dose, route of administration, anatomical location, lot number and expiration date were not reported). There were not concomitant medications provided. The reporter stated that the boys were vaccinated with GARDASIL 9 "because the CDC says that boys older than 15 years can receive the vaccine". No adverse symptoms were reported. There was no product quality issue involved. Additional information is not expected since the reporter did not want to be contacted.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Confusional state, Dizziness, Excessive eye blinking, Headache
Clinical narrative: Right after vaccine as walking from one room in the facility to other eyes felt flurry confusion. When arrive to other room doctor took vitals and were ok. Felt lightheaded, kept blinking because couldn't see at distance. 3 hours later at home headache started for 36 hours. Took TYLENOL, helped a little. Stayed in bed because had upset stomach. 3 days later still had little headache. Injection site was aching, itchy, hot, hard. Today had sore throat.