chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist, via Pfizer (other company notification of adverse event) on 04-SEP-2015, refers to a currently 76 year old, female patient. Concurrent condition and medical history were not reported. In 1998 and 2006, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot #, expiration date, route of administration and anatomical location were not reported) for routine vaccination. The pharmacist reported that in 1998 or 2006 (it was clear whether it was in 1998 or 2006) and within 25 hours of receiving PNEUMOVAX 23, the patient developed arm swelling and he required prednisone to decrease the swelling. The prednisone did work. The pharmacist did not have details as to who the prescribing physician was at the time of the event. He presumed, the patient required a doctor's visit to get the prescription for the Prednisone, but the patient may have just called the office. No hospitalization was required. There was not a product quality complaint (PQC) involved. At the time of the report, the patient did not uses any steroids. The reporter stated that he did not aware of any vaccination within four weeks prior, but the patient could have been a flu shot (on unknown date). At the time of the reported, the outcome of the event was reported as recovered and the reporter considered arm swelling was related with the suspect therapy PNEUMOVAX 23. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Feeling hot, Hyperhidrosis, Tinnitus, Vision blurred
Clinical narrative: Blurred vision, ringing in ears, hot, sweaty, "clammy". None responsiveness for about 5 minutes = possible syncope reaction.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling of her left arm near ZOSTAVAX injection.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Erythema and edema of (L) upper arm where 2 vaccines were administered. Also has itching.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients were administered doses of (Oka-Merck) PROQUAD (lot # L008354, expiration date: 11-SEP-2016 and lot # L005293, expiration date: 17-AUG-2016) (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash 5 days after receiving MMR (9/1/15 MMR administered).
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt. came into office on 9-9-15 for second dose of HPV. At that time he informed the Dr. that his arm was numb and he had "pins and needles" since the time of the first. HPV given on 7-8-15. Pt is not having any difficulty using the arm - no limitations.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients were administered doses (Oka/Merck) VARIVAX (lot # K005428, expiration date: 15-APR-2016; lot# K007781, expiration date: 28-MAY-2016; lot # K007983, expiration date: 03-JUN-2016 and lot# L006386, expiration date: 25-FEB-2017) (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling
Clinical narrative: Injection site red, swollen 2 vesicles - one on inner left arm and one on upper left shoulder.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, the multiple patients were vaccinated with a dose of improperly stored GARDASIL 9 lot# K026247, expiry date 29-JAN-2017, dose, site 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.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old patient (gender was not reported). On 31-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 year old patient (gender was not reported). On 12-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient (gender was not reported). On 31-AUG-2015, the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient (gender was not reported). On 31-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects 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 was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (dose was not reported, lot#K009900 with expiration date 04-MAY-2015 or lot # reported ass K025343 with expiration date 22-MAY-2016 or lot # reported as K020181 with expiration date 25-JUN-2016 or lot #L000434 with expiration date 18-JUL-2016). There were no adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Swelling/redness in upper arm below immunization site into lymph nodes and upper chest area near shoulder.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Pain
Clinical narrative: When I saw her 8/31/15 to give her TWINRIX #3 I asked her if she had any problems with the first 2 doses - she states she noted pain in the (L) deltoid after the vaccine. 3/30/15 - she states it hurt to lift her arm - she denied any radiation, swelling, redness or knot. She states it is better but occ. has tenderness in (L) deltoid. No problems following TWINRIX #3 8/31/15.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patient received improperly stored GARDASIL (Incorrect product storage) (lot # K0210215, expiry date: 05-MAY-2017) (one dose). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006821, 1509USA006822, 1509USA006823, 1509USA006824 and 1509USA006825 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to unspecified adult female patient of unknown age. No medical history and concurrent conditions of the patient were reported. On 23-MAY-2012, the patient was vaccinated with first dose of MMR II injection and on 16-JUL-2012, with second dose of MMR II injection (lot number, dose, site and route of administration was not reported). No concomitant medications were reported. The patient had titers drawn on 20-MAY-2013. The titer result for measles was equivocal. The actual titer result was 15.4 for measles. No adverse events were reported. The outcome of hepatitis b surface antibody negative and inappropriate schedule of drug administration was unknown. The causality of hepatitis b surface antibody negative was not reported. No product quality complaint (PQC) was filed. No additional information provided. 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 healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored with GARDASIL 9, 6 doses (lot # L00560, expiry: 15-JUN-2017). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006365, 1509USA006821, 1509USA006822, 1509USA006823, 1509USA006824 and 1509USSSA006825 (same reporter link). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal faeces, Crying, Diarrhoea, Pyrexia, Screaming
Clinical narrative: 1:00 am, patient woke us up screaming, she had a fever of 104.5. She screamed and cried with her eyes halfway open until 6am. She was unable to speak during that time. Since then her stools have been very loose, light colored and malodorous.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: 1:00 am, patient woke us up screaming, she had a fever of 104.5. She screamed and cried with her eyes halfway open until 6am. She was unable to speak during that time. Since then her stools have been very loose, light colored and malodorous.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypopnoea, Pallor, Peripheral coldness
Clinical narrative: Mom says she was breathing shallow, was cold to touch, pale and just seemed to be like a zombie for a week. No rash.
Sex: M
Vaccine: FLUX, PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a consumer and refers to his father, a male patient of unknown age. There was no information about patient's medical history, drug reactions or allergies provided. On 15-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, site and route of administration were not reported); PNEUMOVAX23 (lot #, expiration date, dose, site and route of administration were not reported) and influenza virus vaccine (unspecified). In August 2015, the patient experienced a fever of 102 degrees within 24 hours of receiving vaccinations. The patient took MOTRIN and rested as home treatment. The patient recovered from the event (date unspecified). The relatedness between the event and ZOSTAVAX, PNEUMOVAX23, influenza virus vaccine (unspecified) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a consumer and refers to his mother, a female patient of unknown age. There was no information about patient's pertinent medical history, drug reactions or allergies provided. On 15-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, site and route of administration were not reported), PNEUMOVAX 23 (lot#, expiration date, dose, site and route of administration were not reported) and influenza virus vaccine (unspecified). On unknown date in August 2015, the patient experienced a "bad headache" and probably took MOTRIN as home treatment. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX, PNEUMOVAX 23, influenza virus vaccine (unspecified) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient (gender was not reported). On 27-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever x2 days. 104.0 on 8/25/15. 103.9 on 8/26/15.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored GARDASIL 9 (lot # K026247, expiry date: 29-JAN-2017, one dose). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006822, 1509USA006823, 1509UUSA006824 and 1509USA006825 (same reporter link). 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 healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored, oral, ROTATEQ (lot # K023532, expiry date: 21-JUN-2016, four doses). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006822, 1509USA006821, 1509USA006824 and 1509USA006825 (same reporter link). Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Joint swelling
Clinical narrative: Patient has swelling in right elbow. Right elbow tender and red. Is taking OTC BENADRYL, TYLENOL and icing elbow swelling is below injection site.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Patient has swelling in right elbow. Right elbow tender and red. Is taking OTC BENADRYL, TYLENOL and icing elbow swelling is below injection site.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 18-year-old male patient who received Hepatitis A vaccine. On 30th July 2015, the patient received the 1st dose of Hepatitis A vaccine. On 31st July 2015, 1 days after receiving Hepatitis A vaccine, the patient experienced fever, fatigue, headache, nausea and diarrhea. On an unknown date, the outcome of the fever, fatigue, headache, nausea and diarrhea were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, nausea and diarrhea to be related to Hepatitis A vaccine. The reporter considered the fatigue to be related to Hepatitis A vaccine. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's father. About 10 days before the time of reporting, the patient received a hepatitis A vaccine. The father stated that within a day his son was experiencing side effects, which were not resolved but worsened. The father was not sure which vaccine his son received and he did not have lot and expiration date of the product. The father stated that the patient was not taking other medications but was not sure if he received other vaccines on the same day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient has a 10x10 cm hardened, indurated erythematous area surrounding vaccine of KINRIX and MMR vaccine on 9/8/15. Area developed within a few hours and I saw it on 9/10/15.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored VAQTA (lot# L009445, expiry date: 01-JUN-2017, five doses) (Incorrect product storage). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006821, 1509USA006823, 1509USA006824 and 1509USA006825 (same reporter link). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia, Syncope
Clinical narrative: Pt developed fever, chills and had a syncopal episode during the night after receiving the PNEUMOVAX.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Injection site swelling, Pyrexia
Clinical narrative: Cellulitis - pt had fever, chills, swelling around injection site and a large area of cellulitis. Vaccine was given on lower area of arm.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Mother and patient came in 9/3/15 approx around 3:15 pm with a large area swollen, red, and warm to touch. Mom said patient noticed it today 9/3/15, it was itchy. Dr. examined area and said it was a local reaction to vaccine. Outlined area. Advised to tx w/ BENADRYL, cold compress. If not better next day to come back in.
Age: 10.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Flushing, Lip swelling, Pruritus, Urticaria
Clinical narrative: Several minutes after MMR and varicella administration patient felt itchy. Progressed to swelling of lip, flushed face and ears and hives which began to confluence. Initially given 25mg diphenhydramine when itchy, subsequently given EPI.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever and hive-like rash started several hours after vaccinations. Fever resolved next day but hive-like rash persists.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash, Rhinorrhoea, Varicella post vaccine
Clinical narrative: Vaccine induced varicella, runny nose, fever, rash.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: Patient developed a bump/mass at site of injection on left arm. Arm had stayed sore from day of injection and lasted for several weeks. May need to be surgically removed.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Rash erythematous
Clinical narrative: Injection site is red and blister. Red rash on patient's leg. Went to ER, got methylprednisolone dose pack on 9/12/15.
Age: 28.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Asthenia, Dizziness, Gastric disorder, Headache, Injection site erythema
Clinical narrative: Patient reports feeling dizzy shortly after receiving vaccines. Report walking out of health dept when dizziness began, severe headache hours after vaccine. Reports weakness, nausea and stomach problems on Friday night. Vomited once on Saturday. Reports problems lifting objects. Reports continues to feel weak with nausea and soreness with redness to injection site.
Age: 28.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Patient reports feeling dizzy shortly after receiving vaccines. Report walking out of health dept when dizziness began, severe headache hours after vaccine. Reports weakness, nausea and stomach problems on Friday night. Vomited once on Saturday. Reports problems lifting objects. Reports continues to feel weak with nausea and soreness with redness to injection site.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash generalised, Rash pruritic, Sluggishness
Clinical narrative: Patients husband reported patient experienced fever and sluggishness for 1 week after. Patient also had rash develop a few days after vaccine that is itchy and all over her body and still present on 9/8/15.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives developed within 12 hours of vaccine administration.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Chills, Immediate post-injection reaction, Myalgia
Clinical narrative: Myalgias - immediate in arm, then spread to rest of body of the next day. Weakness also. Joint pain, chills.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a male physician of unknown age and via a company representative reporting on himself. Concurrent conditions and medical history were not report4ed. On an unknown date, the physician was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose and route were not reported. Concomitant medications were not reported. The physician reported that he developed herpes zoster reported as 'shingles and post herpetic neuralgia" on an unspecified date after receiving the ZOSTAVAX. No shingles rash was currently present, however, the physician still experienced transient post herpetic neuralgia pain in the eyes. The outcome of herpes zoster was reported as not recovered. The physician did not assess the relatedness of ZOSTAVAX to herpes zoster. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13
Symptoms: Irritability, Pyrexia, Rash, Rash pustular
Clinical narrative: 9/14/15 at approx. 1040am mother contacted our office to advise 2 days post immunization patient was noted to have dime sized rash "appearance of baby dime" noted to chest and 1/4 of facial area with fist sized area of a somewhat bigger rash with areas of what appeared to be pustules. Low grade fever of 99 Ax. "Crabby", "not herself", and needy. At time of call mom states pt. sx improved. Offered to schedule for further evaluation. Mom declined. Provider notified.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist, refers to a female patient in her 60's, via marketing research program, conducted by the planning shop, international. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with the first dose of ZOSTAVAX (strength, dosage and lot# were not reported). Concomitant therapy was not reported. The pharmacist informed that on an unknown date, the patient experienced injection site reaction, which was described as, red, itchy and inflamed. The outcome of the events was reported as recovering at the time of this report. Additional information is not expected because the reporter did not wish additional contact.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Chronic sore muscle in arm.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On 10-SEP-2015, unspecified patients were vaccinated with unspecified doses of improperly stored PNEUMOVAX 23 (Lot # K008409 Expiration date: 04-MAR-2016) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On 10-SEP-2015, unspecified patients were vaccinated with unspecified doses of improperly stored VAQTA (Lot # L017757 Expiration date: 08-APR-2018) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Back pain, Chills, Injection site rash, Musculoskeletal pain
Clinical narrative: Patient reported rash at inj site the morning after it was given, then said she sustained chills and back/buttock pain leaving her unable to ambulate. She described the pain as burning and deep. Her primary care doctor saw her 9-12-15 and said they did not believe the symptoms to be connected to the ZOSTAVAX shot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient reported rash at inj site the morning after it was given, then said she sustained chills and back/buttock pain leaving her unable to ambulate. She described the pain as burning and deep. Her primary care doctor saw her 9-12-15 and said they did not believe the symptoms to be connected to the ZOSTAVAX shot.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Feeling hot
Clinical narrative: Initial unsolicited report received from a pharmacist on 10 July 2015. A 19-year-old male patient, whose concomitant medications were not reported, had received an intramuscular a dose of TYPHIM VI (batch number- K0330-1, expiration date 18 July 2015) in right deltoid on 10 July 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. On 10 July 2015; few minutes after vaccination, the patient became light headed and he felt very hot. The patient sat in a patient area for a while and began to feel better. Laboratory investigations were reported as none and corrective treatments were not reported. At the time of this report; the patient was recovered from the events. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning multiple unspecified patients (demographics unknown). On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (Lot # L015049; expiration date: 29-APR-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of drug administration, Poor quality sleep
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of sleep restless in a infant patient who received ROTARIX. On 8th September 2015, the patient received ROTARIX. On 8th September 2015, several hours after receiving ROTARIX, the patient experienced sleep restless and inappropriate route of vaccination. On an unknown date, the outcome of the sleep restless and inappropriate route of vaccination were unknown. It was unknown if the reporter considered the sleep restless to be related to ROTARIX. Additional details were received as follows: The patient accidentally received the ROTARIX by injectable route instead of oral, leading to inappropriate route of vaccination. The reporter stated that, he was not sure what type of injection the patient received but it was not given orally. The day of vaccination, the patient had a restless nights sleep.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demographics. On an unknown date, the patients received improperly stored oral, ROTATEQ (lot # K016261, expiry date: 23-JUN-2016, one dose). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006822, 1509USA006823, 1509USA006821 and 1509USA006825 (same reporter link).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 6 unspecified patients of unknown demographics. On unknown dates, the patients were administered improperly stored doses of VARIVAX (Merck) (lot # L009203, expiry date: 17-MAR-2017). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006822, 1509USA006823, 1509USA006824 and 1509USA006821 (same reporter link). Additional information has been requested.
Age: 34.0
Sex: U
Vaccine: TYP
Symptoms: Back pain
Clinical narrative: Initial unsolicited report received from a non-healthcare TYPHIM VI (manufacturer: Sanofi Pasteur SA, batch number: K1183-1, via intramuscular route in the left deltoid, expiry date and dose details were not provided and TWINRIX (manufacturer: GSK, batch number: 3JR4, via intramuscular route in the left deltoid, expiry date and dose details were not provided on 09-Mar-2015. The patient had no illness at time of vaccination. The pre-existing physician diagnosed allergies, birth defects, medical conditions included IBS, she had increased cholesterol, was lactose intolerant, had seasonal allergies, she was allergic to ZYBAN with hives and intolerant to EMYCIN: cramps, diarrhea. Concomitant medications were not reported. On 09-Mar-2015, the patient experienced severe low back pain. She went to Emergency Room on 11-Mar-2015. It was reported that she experienced a potential adverse event with the typhoid vaccination on an unspecified date. Laboratory investigations included U/A (urinalysis). The results were negative. She was prescribed FLEXORIL and Ibuprofen as corrective treatment. At the time of this report, the patient had not recovered from the above mentioned events. List of documents held by sender: none. Follow up information received fro a Physician on 20-Apr-2015. It was reported that the patient had a medical history of intolerance to erythromycin: cramps sand diarrhea and had received a first dose of TYPHIM VI (expiry date: 06-Aug-2016) and TWINRIX (expiry date: 19-Feb-2016) on at 10:30 am 09-Mar-2015. Concomitant medications included Pravastatin one daily, XANAX as needed, BIOTIN, Vitamin D and ALIGN OTC. On 10-Mar-2015 at 3:00 am, one day after receiving vaccination, the patient experienced severe low back pain. Corrective treatments included Ibuprofen and FLEXERIL as prescribed. At the time of this report, the outcome of patient was reported as recovered on 13 March 2015. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Muscle spasms, Pain, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 10 June 2015. A 20-year-old male patient, concomitant medications were not reported, had received a dose of ADACEL (batch number - C4713AA, route of administration, site of administration were not reported) and second dose of VAQTA (batch number- K024697, Manufacturer-Merck, route of administration, site of administration were not reported) on 26 May 2015. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergic to penicillin. On 26 May 2015; within 24 hours after vaccination, the patient experienced fever, arm soreness and body aches. Then within 1 week after vaccination the patient also experienced intermittent "tetany-like" or muscle spasms of arm. Laboratory investigations corrective treatments were not reported. At the time of this report, the patient was not recovered from intermittent muscle spasms and intermittent "tetany-like" or muscle spasms of arm and outcome of other events was unknown. Documents held by sender: none. Follow-up information received from a nurse on 27 July 2015. A male patient had received first dose of VAQTA (expiry date: 28 April 2017) and a dose of ADACEL (expiry date: 01-April 2017) both vaccines via intramuscular route in left deltoid on 26 May 2015 and a dose of TYPHIM VI (batch number K1200, expiry date: 15 April 2016) via intramuscular route in left deltoid on 18 May 2015. The patient had also received a booster dose of VAQTA on "12 January 2015". On an unknown date, one week after vaccination (tdap and hepatitis A vaccine), the patient had developed muscle spasm in left arm. The patient was prescribed with ciprofloxacin 500 mg (quantity: 20), MALARONE 250/100 mg (quantity: 44), ibuprofen as needed (for arm soreness). At the time of the report, the patient was recovered from the event intermittent muscle spasms / intermittent "tetany-like" or muscle spasms of arm, fever and not recovered from arm soreness. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: TYP, YF
Symptoms: Urticaria, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 19-March-2015. A 12-year-old female patient whose medical history included asthma diagnosis and concomitant medications not reported, had received a first dose of YF VAX via subcutaneous route in the left deltoid (batch number: UH841AA and expiry date: 7 February 2016) and TYPHIM VI via intramuscular route in the left deltoid (batch number: J1201 and expiry date: 14 April 2015) on 18-March-2015. On 18-March-2015 fifteen minutes after vaccination, the patient experienced vomiting and one hour after vaccination the patient experienced hives. The patient required ER/doctor visit. Corrective treatment and laboratory investigations were not reported. On 19-March-2015, the outcome of above mentioned events were recovered. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: HEPA, RAB, TYP, YF
Symptoms: Vaccination site bruising, Vaccination site erythema
Clinical narrative: Initial unsolicited case received from a health care professional on 26 June 2015. A 30 year old female patient, whose medical history was none and concomitant medications was not reported, had received a dose of YF VAX (batch number: UI106AA, expiry date: 26-SEP-2016, site of administration was not reported) via intramuscular route and received a dose of IMOVAX (batch number: K1079-1, expiry date: 14-FEB-2016, site of administration was not reported) via intramuscular route on 2 June 2015. It was also reported that the patient received a dose of TYPHIM VI (batch number: K1200-1, expiry date: 15-APR-2016, site of administration was not reported) via intramuscular route and also received a dose of HAVRIX (batch number: Y4R59, expiry date was unknown, manufacturer was GSK, site of administration was not reported) via intramuscular route on 2 June 2015. On 2 June 2015, (same day after vaccination) it was reported that the patient experienced injection site where patient received YF vaccine and it was bruising and vaccination site erythema. Laboratory investigations were none and corrective treatments were not reported. At the time of this report, the patient outcome from the events was not recovered. Documents held by sender: none.
Sex: M
Vaccine: TYP
Symptoms: Hepatic enzyme increased, Metabolic function test abnormal
Clinical narrative: Initial unsolicited report received from a physician on 04 May 2015. A male patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of TYPHIM VI (batch number, expiry date, dose, dose number, route and site of administration were not reported) on unspecified date of April 2015. On April 2015, i.e. after vaccination on an unspecified date, patient had metabolic panel done within a few days with elevated liver enzymes and AST was 750. Illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as not applicable. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Initial unsolicited report received from a Nurse on 04-May-2015. A 54-years-old female patient had received a first dose of TYPHIM VI via intramuscular route in the left deltoid (batch number: K0330-1, expiry date: 18-Jul-2016) and first dose of YF VAX via intramuscular route in the left triceps (batch number: UI091AA, expiry date: 02-Jun-2016) on 01-May-2015. The patient did not have any illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions included asthma and bronchitis. He also took ADVIE inhaler and MEDROL pack was administered three weeks prior to vaccination. Concomitant medications were not reported. On 01-May-2015, post vaccination, the patient experienced left upper arm redness and swelling to elbow. On 03-May-2015, the patient developed a rash on her waist, hips and under the bra line. The patient required Emergency Room/Doctor Visit. She took BENADRYL (Over The Counter) and was administered steroid intramuscularly as a corrective treatment. She was evaluated by a physician who prescribed MEDROL PACK. Laboratory investigations were not reported. At the time of this report, the outcome of the events was reported as unknown. Documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: FLU3, FLUX, JEV1, RAB, TDAP, TYP
Symptoms: Dysphagia, Swelling face
Clinical narrative: Initial unsolicited report received from a consumer on 29 April 2015. A 19-year-old female patient, whose medical history was food allergies and concomitant medications was not reported, had received a second dose of IMOVAX (batch number, expiry date, dose and site of administration were not reported) on an unspecified date (09:00 hours). Patient's mother reported that at around 09:00 hours and at 19:00 hours at night patient developed mild facial swelling and started feeling like she was having difficulty in swallowing. Patient took BENADRYL and EPIPEN and then went to emergency room and received no further treatment at emergency room. It was reported that, vaccinations within four weeks of vaccinations were not provided and patient had one previous dose of IMOVAX. Patient had no illness at the time of vaccination. It was also reported that, pre-existing physician diagnosed allergies, birth defects, medical conditions were severe food allergies. Laboratory investigations were reported as none. At the time of this report, patient had recovered. Documents held by sender: none. Follow-up information received from a physician on 08 June 2015. A 19-year-old female patient had received a 1 ml of IMOVAX (batch number: KI079-1, expiry date: 14 February 2016) via intramuscular route in left deltoid on 16 April 2015 at 09:00 hours. Also, the patient had received ADACEL (batch number: C4765AA), TYPHIM VI (batch number: K1200-1), FLUZONE (batch number: UI197AB), IXIARO (manufacturer: Novartis, batch number: IEV14B59E) [expiry date, dose, dose in series and route of administration were not reported for all] all in left deltoid on 16 April 2015 and Influenza vaccine (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 16 April 2015. The vaccine was purchased with private funds and was vaccinated at private doctor's office/hospital. Reporter causality was not reported. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. In August 2015, the patients were vaccinated with PEDVAXHIB (lot # K019701, expiration date 17-JUL-2017). It was reported that the vaccine administered underwent an temperature excursion which occurred on 15-AUG-2015. No adverse effects 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 professional referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with VARIVAX (Merck) (confirmed Lot# K009759 and expiration date 09-JUL-2016; Lot# K018964 and expiration date 15-OCT-2016; Lot# L001335 and expiration date 13-JAN-2017; Lot# K018961 and expiration date 15-OCT-2016; Lot# K007972 and expiration date 03-JUN-2016; Lot# K010440 and expiration date 22-JUL-2016; Lot# K015943 and expiration date 23-SEP-2016, strength, dose, dose# and route not reported) that was improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. The patient was vaccinated with first, second, and third dose of GARDASIL (dose, route and lot number unspecified) in 2010, 2011 and 2012 respectively. On 22-MAY-2015, the patient was vaccinated with the fourth dose of GARDASIL (1 df, lot# L006549, expiration date 06-APR-2017, route unspecified). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. In August 2014, the patients were vaccinated with RECOMBIVAX HB (lot # J007943, expiration date 05-FEB-2016; route and dosage not reported). It was reported that the vaccine administered underwent an temperature excursion which occurred on 15-AUG-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse 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 doses of improperly stored ZOSTAVAX (lot # K021953 with expired date 10-FEB-2016, dose and route were unknown). No concomitant medication was reported. The reporter could not tell how many doses had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring 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 (lot # K026246, expiration date 28-JAN-2017, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Neck pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Severe pain in right arm that spreads to neck and shoulder. Right fingers swollen and tingly.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itchiness, all increasing in intensity within days of injection.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states her arm hurt from her Prevnar vaccine to the point she can no longer lift her arm. Patient has has tried heat, cold, Tylenol, ibuprofen, and profession massage, and arm still hurts to the point she can no lift it on her own. Patient reported to the pharmacy on 9/15/2015 her symptoms and was advised that if symptoms continue, she should seek additional medical attention.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist reporting about her father who is a male patient of unknown age. The patient's pertinent medical history and concurrent condition was unspecified. On an unspecified date, the patient was vaccinated with either PNEUMOVAX 23 or PREVNAR dose 1 in the arm (not specified). Other suspect therapies included unspecified influenza virus vaccine (reported as Flu shot) taken on the same day on a different arm. It was not specified as to which vaccine was taken in which arm. After the administration of both the vaccine the patient's one of the arm (unspecified which arm and unspecified which vaccine) began to swell, he could not lift his arm and developed pain in one arm. The patient went to the emergency room (ER) and was there for 36 hours. The patient received unspecified treatment at ER. The outcome of events and causality assessment was not reported. No further information was provided. The events were considered serious since the patient required to be in emergency room for 36 hours (considered as hospitalization). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: Excessive redness, heat, tingling and swelling at injection site.  Sun sensitivity, Marble sized knot where injection was administered.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Photosensitivity reaction
Clinical narrative: Excessive redness, heat, tingling and swelling at injection site.  Sun sensitivity, Marble sized knot where injection was administered.