chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test positive, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient's medical history included chickenpox in childhood. The patient had immunity to Varicella as shown by a Varicella titer test (performed on an unknown date). Concomitant therapies were not reported. On 05-AUG-2015, the patient was inadvertently vaccinated with the first dose of (Oka/Merck) VARIVAX (lot # L004652, exp. 11-FEB-2017, dose and route of administration not reported) instead of MMR II. No adverse effect was reported. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Daughter called to report patient received a PREVNAR 13 9/1/15. Her arm was red: swollen size of a deck of cards. Appt made to observe bruising of injection site with redness and swelling below injection site. Started 9/2/15 seen in office 9/10/15.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Increased redness but no bump.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored VAQTA (dose, lot number and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Erythema, Swelling
Clinical narrative: Patient received TDAP on 9-6-15 it was administered in back of left arm instead of in Deltoid IM. Patient came back to clinic on 9-8-15 with redness and swelling. No further treatment was indicated.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nausea, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient stated on Saturday a.m. (9-12-15) she was sick at her stomach. She noticed arm being red, rash and swollen, red and warm to touch. Patient was in office today for blood work.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: Macular-papular eruption (R) upper shoulder.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unspecified date, an unspecified number of patients received an unspecified number of doses of improperly stored VARIVAX (Merck) injection lot#L004653, exp date: 11-FEB-2017; lot#K005426, exp date: 15-APR-2016; lot#J014128, exp date: 07-NOV-2015 (dose, frequency and route of administration not provided). No adverse effect reported and no PQC involved. 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 registered nurse refers to an unspecified number of patients. On an unspecified date, an unspecified number of patients received an unspecified number of doses of improperly stored ZOSTAVAX (lot#K010646; exp date: 30-OCT-2015) (dose, frequency and route of administration not provided). No adverse effect reported and no PQC involved. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 09-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (dose and route were not reported, lot # K024035, expiration date 26-NOV-2016) and with an improperly stored dose of VAQTA (dose and route were not reported, lot # L009445, expiration date 01-JUN-2017). There were no adverse effects 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 registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ oral, lot # K011947, expiration ate 07-JUN-2016, Lot K020181 expiration date 24-JUN-2016, Lot K019370 expiration 16-JUL-2016 (dose was not reported). The vaccines underwent supported temperature excursions. No adverse effects reported. This is one of several reports from the same source. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-AUG-2015, the patient was vaccinated with a dose of improperly stored MMR II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 lot # K026246 expiration date 28-JAN-2017, Lot K026247 expiration date 29-JAN-2017, Lot L007560 expiration date 15-JUN-2017 (dose and route were not reported). The vaccines underwent supported temperature excursions. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to a male patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 0.5 ml, intramuscular. On an unknown date, the patient experienced swelling in his face after receiving the initial dose of GARDASIL 9. The patient was given MEDROL and CLARITIN for treatment and has recovered on an unspecified date. The patient planned not to receive the second and third dose of GARDASIL 9. The reporter did not provide the relatedness of the event with GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medcial history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PEDVAXHIB lot # L004740, expiration date 16-NOV-2017 (dose and route were not reported). The vaccine underwent supported temperature excursions. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB lot # K009953, expiration date 03-APR-2016 (dose and route were not reported). The vaccine underwent supported temperature excursions. No adverse effects reported. This is one of several reports 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 medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose and route were not reported, lot # L009445, expiration date 01-JUN-2017). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a "few" unspecified patients of unknown age and genders. The patient's concurrent conditions and medical history were not provided. On unspecified dates, the patients were vaccinated with an unspecified dose of ZOSTAVAX, injection, (dose, route of administration, anatomical location, lot number and expiration date were not reported). There were not concomitant medications provided. On unspecified dates, the patients developed injection site erythema reported as redness at the injection site. The outcome of injection site erythema was not reported. The reporter did not assess the relatedness of injection site erythema with ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old female patient without any pertinent medical history and without any concurrent conditions. On 07-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous injection, 0.65mL, lot # L000461 and expiration date March 2016 (anatomical location and dose number were not reported). Concomitant therapies included LIPITOR and VAGIFEM. On 08-AUG-2015, reporter as "a day or so" after received a dose of ZOSTAVAX, the patient developed injection site erythema reported as redness and injection site pruritus reported as itching at the injection site. On 10-AUG-2015, the patient sought medical attention, she went to the pharmacy and showed the pharmacist her injection site reaction to ZOSTAVAX. The pharmacist reported that the redness at the injection site was "about the size of the palm". The patient did not receive any treatment for the adverse events and no laboratory test was performed. There was no product quality issue involved. The outcome of injection site erythema and injection site pruritus was reported as recovered on 18-AUG-2015, reported as "within 10 days of the redness developing". The reporter did not assess the relatedness of injection site erythema and injection site pruritus with ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose and route of administration not reported) lot # K011562, expiration date 08-APR-2017, that were improperly stored. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 06-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (route, lot#, expiration date and anatomical location were not reported) to prevent shingles. Co-suspect therapy or concomitant medications were not provided. The pharmacist reported that after vaccination, the patient experienced an injection site reaction of a rash with redness and a bump. The patient sought medical attention by returning to pharmacy. It was unspecified if the patient received treatment for the adverse events. The outcome of injection site mass, injection site erythema and injection site rash was reported as recovering. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 years old female patient. No medical history, concurrent conditions or concomitant therapies were reported. On 11-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot # and dose were not reported), subcutaneously in the gluteal region. The patient had not reported an adverse effect. 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 medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose and route were not reported, lot # L009445, expiration date 01-JUN-2017). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner concerning a patient of unknown age and gender. The patient's concurrent condition and historical drugs were not informed. On 11-SEP-2015 the patient was vaccinated with a fourth dose of PEDVAXHIB, lot # L009649, expiration date 29-NOV-2017 (dose, route and frequency were not informed). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with VAQTA strength 25/0.5 (units not provided) (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified 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 unknown date, the patients received improperly stored VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 19 year old patient of unknown gender. There was no medical history or concurrent condition reported. On 21-AUG-2015 the reporter inadvertently administered a pediatric dose of VAQTA (dose, route and lot # were not reported). There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient. Pertinent medical history and drug allergies were none. On 09-SEP-2015 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot # 1011533; expiry: 03-APR-2016). Concmitant therapies included XANAX, ENDOCET, Lisinopril (manufacturer unknown), LASIX, BENICAR, clonidine, ZYRTEC, MOBIC and morphien sulfate (manufacturer unknown). The pharmacist reported that on 11-SEP-2015, the patient developed a slightly raised red area around the injection site "about 2 inches wide" after receiving ZOSTAVAX. No treatment given for events. No further information was provided. The outcome of injection site erythema and injection site swelling was reported as not resolved. Causality assessment was not reported. Additional informatino has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient in her 60's who was enrolled in testing. No information regarding the patient's relevant medical history, concurrent conditions and concomitant medication was reported. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, lot # and expiration date were not provided). On an unknown date in 2015, the patient experienced injection site reaction, rash and redness. On an unknown date in 2015, the patient recovered from the adverse events. The reporter considered the adverse events to be related to ZOSTAVAX. Additional information is not expected as the reporter refused to provide the contact information.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site 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: 0.34
Sex: F
Vaccine: RV1
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX (batch number A41CB512A, expiry date 10th February 2017). On 8th September 2015, the patient received ROTARIX (oral). On 8th September 2015, less than a day after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details provided were as follows: The ROTARIX was administered to the patient, but she spitted it out and it splashed into the eyes and mouth of her mother (see case US2015128886 for accidental exposure to mother).
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # K024035, expiration date 26-NOV-2016) and with an improperly stored dose of VAQTA (dose and route were not reported, lot # L009445, expiration date 01-JUN-2017). There were no adverse effects reported. This is one of several reports received from the same source. 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 medical assistant refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 24-AUG-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site 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: MMR
Symptoms: Cellulitis, Eye swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to a 2 year old patient of unknown gender. The patient's medical history included mosquito bites and exaggerated swelling response to them. The patient did not have any other known allergies. On 08-SEP-2015, the patient was vaccinated with a dose of M-M-R II, lot # K021952, expiration date 10-NOV-2015 (dose and route of administration were not provided). The patient took no concomitant medications. On 10-SEP-2015, the patient developed "eye swelling". On an unknown date in September 2015, the patient was examined by the physician who documented that the patient had "no discharge and no fever". The physician believed that the patient might had been bitten by mosquito as the patient had a history of an exaggerated swelling response to mosquito bites in the past. The physician diagnosed the patient's eye swelling as cellulitis of the face. The physician prescribed BACTRIM, solution, 6 ml, orally, every 12 hours for 7 days and amoxicillin, 250 mg/5ml orally, every 12 hours for 7 days to the patient as the treatment of the event. No lab diagnostics were performed. At the time of reporting (reported as "currently"), the patient was recovering from the event. The relatedness between the event and M-M-R II was not reported. 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 medical assistant refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored MMR II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site 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: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2015, the patient was vaccinated with doses of improperly stored MMR II, lot number K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site were not reported) and VAQTA, lot number L009445, expiration date: 01-JUN-2017, (dose, dose number, route of administration and injection site 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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site 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: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Approximately in 2010, (reported as "five years ago"), the patient was vaccinated with the first dose of ZOSTAVAX site and route of administration, lot#, expiry date and dose were not reported. On an unknown date, the patient was vaccinated with a ZOSTAVAX, dose, lot#, expiry date, route and site of administration were not reported. On unknown dates, the patient experienced shingles six times. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 39.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 39 year old patient of an unknown gender. No medical history was reported. On 04-SEP-2015, the patient was vaccinated with the expired PNEUMOVAX 23 (dose, frequency, route of administration were not reported) lot # K004542, expiration date: 19-AUG-2015. No concomitant medication was reported. The patient had not reported an adverse effect. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to two patients of unknown age and gender. On an unknown date, the patients missed doses of VARIVAX (Merck) (route, dose, frequency and lot # not reported). No adverse effects were reported. Product quality complained was reported for cracked vials and dislodged flip cap on the VARIVAX (Merck) vials. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Abdominal pain, Dysstasia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Case number PHHY2015US111028, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 558153) website on 10 Sep 2015. This report refers to a 45 year old female patient. Medical history included hypertension, fatty liver and urinary tract infection. Patient was admitted to hospital on an unknown date with complaints of abdominal pain. Patient had received treatment for degenerative spinal issues (unspecified date). This polymedicated patient was vaccinated with FLUVIRIN (batch number: 161281) intramuscular into left arm on 23 Nov 2014. On 24 Nov 2014, the patient was unable to stand or walk under her own strength and had experienced muscle weakness. Patient had visited emergency room and was hospitalized for about 14 days. Patient was treated with human immunoglobulin therapy. Outcome of the events reported to be unchanged. Causality of the event was not reported. No further information was provided.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site discomfort, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Case number PHHY2015US111269, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559364) website on 10 Sep 2015. This report refers to a 35 year old female patient. Medical history and concomitant medication was unknown. The patient was vaccinated with FLUVIRIN (batch number: 146605) intramuscular into right arm on 18 Nov 2014. On the same day post vaccination patient stated that her right arm and shoulder was bothering. She went to her doctor who diagnosed her with bursitis and prescribed an anti-inflammatory. Doctor will follow up with patient. Outcome of the event was unknown. Case was reported to be non-serious and causality of the event was not reported. Seriousness of the event "bursitis" was upgraded based on information available in the source document. No further information was provided.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2015US111307, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 559896) website on 10 Sep 2015. This report refers to a 66 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch lot number: 146605) in left arm on 11 Nov 2014. On the same day, the patient was concomitantly vaccinated with PNEUMOVAX (other manufacturer, batch number: K009107). On 12 Nov 2014, the patient developed redness and swelling near injection site on left arm which was diagnosed as cellulitis. The patient was taken to an emergency room. Outcome of the events was complete recovery. Event was reported as non-serious. Seriousness assessment of the event cellulitis was upgraded based on the information available in the source document. Causality was not reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Complex regional pain syndrome, Injected limb mobility decreased, Injection site pain, Nerve block
Clinical narrative: Case number PHHY2015US110785 is an initial spontaneous report received via vaccine adverse events reporting system (VAERS reference number: 560008) on 10 Sep 2015. This report refers to a 42 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 14582P) intramuscularly in the left arm on 01 Dec 2014. On the same day, her injection site was burning. She also had loss of movement in left arm. She went to emergency room and was diagnosed with reflex sympathetic dystrophy (RSD). She was referred to pain management doctor for nerve block and the doctor was not certain of long term damage. The events outcome was reported as condition unchanged. The event was reported as non-serious, but the event RSD was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Ultrasound scan normal, VIth nerve paralysis
Clinical narrative: Information has been received from a physician and a medical assistant on behalf of the physician via Pfizer as other company referring to a 3 month old female patient. No relevant medical or historical conditions were reported. On 12-MAY-2015, the patient was vaccinated with ROTATEQ, 2 ml (frequency and route unknown). On the same date, the patient was also vaccinated with PENTACEL (Sanofi) 0.5 ml (frequency and route unknown) and PREVNAR (Pfizer) 0.5 ml (frequency and route unknown). The doctor mentioned that his concern from a medical point was that the baby got all those 3 shots at the four month check-up, so what would the medical director or the pharmacist recommend for the baby's six month vaccine (Inappropriate schedule of vaccine administered). There was no concomitant medication reported. On 12-MAY-2015, the patient developed a week long side effects that began a few hours after the vaccine. The patient developed "fancy responses" within a couple of hours (also reported by the medical assistant as "very fluffy that night") that and could be only consoled by being held for 6 days. The patient also developed a bulging fontanelle and a right sixth nerve palsy. The patient had got some testing done and she saw a specialist for the sixth nerve palsy in the eye but there was nothing. As far as the treatment, "that could be done other than TYLENOL for fever and things of that nature". Over the 6 day period, the ophthalmology said that everything was normal, the eye was getting better and they did a head ultrasound that showed the right macro cranial (result not provided). The outcome of the events was reported as recovered completely on about 19-MAY-2015 (reported as a week long side effects and "6 days long period"). The reporting medical assistant mentioned that they were thinking that the side effects were caused by the vaccines but they were not sure. Upon internal review, the event of sixth nerve palsy was considered to be medically significant. Additional information is expected.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Agitation, Fontanelle bulging, Inappropriate schedule of drug administration, Pyrexia, Ultrasound scan
Clinical narrative: Information has been received from a physician and a medical assistant on behalf of the physician via Pfizer as other company referring to a 3 month old female patient. No relevant medical or historical conditions were reported. On 12-MAY-2015, the patient was vaccinated with ROTATEQ, 2 ml (frequency and route unknown). On the same date, the patient was also vaccinated with PENTACEL (Sanofi) 0.5 ml (frequency and route unknown) and PREVNAR (Pfizer) 0.5 ml (frequency and route unknown). The doctor mentioned that his concern from a medical point was that the baby got all those 3 shots at the four month check-up, so what would the medical director or the pharmacist recommend for the baby's six month vaccine (Inappropriate schedule of vaccine administered). There was no concomitant medication reported. On 12-MAY-2015, the patient developed a week long side effects that began a few hours after the vaccine. The patient developed "fancy responses" within a couple of hours (also reported by the medical assistant as "very fluffy that night") that and could be only consoled by being held for 6 days. The patient also developed a bulging fontanelle and a right sixth nerve palsy. The patient had got some testing done and she saw a specialist for the sixth nerve palsy in the eye but there was nothing. As far as the treatment, "that could be done other than TYLENOL for fever and things of that nature". Over the 6 day period, the ophthalmology said that everything was normal, the eye was getting better and they did a head ultrasound that showed the right macro cranial (result not provided). The outcome of the events was reported as recovered completely on about 19-MAY-2015 (reported as a week long side effects and "6 days long period"). The reporting medical assistant mentioned that they were thinking that the side effects were caused by the vaccines but they were not sure. Upon internal review, the event of sixth nerve palsy was considered to be medically significant. Additional information is expected.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: VIth nerve paralysis
Clinical narrative: Information has been received from a physician and a medical assistant on behalf of the physician via Pfizer as other company referring to a 3 month old female patient. No relevant medical or historical conditions were reported. On 12-MAY-2015, the patient was vaccinated with ROTATEQ, 2 ml (frequency and route unknown). On the same date, the patient was also vaccinated with PENTACEL (Sanofi) 0.5 ml (frequency and route unknown) and PREVNAR (Pfizer) 0.5 ml (frequency and route unknown). The doctor mentioned that his concern from a medical point was that the baby got all those 3 shots at the four month check-up, so what would the medical director or the pharmacist recommend for the baby's six month vaccine (Inappropriate schedule of vaccine administered). There was no concomitant medication reported. On 12-MAY-2015, the patient developed a week long side effects that began a few hours after the vaccine. The patient developed "fancy responses" within a couple of hours (also reported by the medical assistant as "very fluffy that night") that and could be only consoled by being held for 6 days. The patient also developed a bulging fontanelle and a right sixth nerve palsy. The patient had got some testing done and she saw a specialist for the sixth nerve palsy in the eye but there was nothing. As far as the treatment, "that could be done other than TYLENOL for fever and things of that nature". Over the 6 day period, the ophthalmology said that everything was normal, the eye was getting better and they did a head ultrasound that showed the right macro cranial (result not provided). The outcome of the events was reported as recovered completely on about 19-MAY-2015 (reported as a week long side effects and "6 days long period"). The reporting medical assistant mentioned that they were thinking that the side effects were caused by the vaccines but they were not sure. Upon internal review, the event of sixth nerve palsy was considered to be medically significant. Additional information is expected.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Pyrexia, Ultrasound skull abnormal, VIth nerve paralysis
Clinical narrative: Information has been received from a physician and a medical assistant on behalf of the physician via Pfizer as other company referring to a 3 month old female patient. No relevant medical or historical conditions were reported. On 12-MAY-2015, the patient was vaccinated with ROTATEQ, 2 ml (frequency and route unknown). On the same date, the patient was also vaccinated with PENTACEL (Sanofi) 0.5 ml (frequency and route unknown) and PREVNAR (Pfizer) 0.5 ml (frequency and route unknown). The doctor mentioned that his concern from a medical point was that the baby got all those 3 shots at the four month check-up, so what would the medical director or the pharmacist recommend for the baby's six month vaccine (Inappropriate schedule of vaccine administered). There was no concomitant medication reported. On 12-MAY-2015, the patient developed a week long side effects that began a few hours after the vaccine. The patient developed "fancy responses" within a couple of hours (also reported by the medical assistant as "very fluffy that night") that and could be only consoled by being held for 6 days. The patient also developed a bulging fontanelle and a right sixth nerve palsy. The patient had got some testing done and she saw a specialist for the sixth nerve palsy in the eye but there was nothing. As far as the treatment, "that could be done other than TYLENOL for fever and things of that nature". Over the 6 day period, the ophthalmology said that everything was normal, the eye was getting better and they did a head ultrasound that showed the right macro cranial (result not provided). The outcome of the events was reported as recovered completely on about 19-MAY-2015 (reported as a week long side effects and "6 days long period"). The reporting medical assistant mentioned that they were thinking that the side effects were caused by the vaccines but they were not sure. Upon internal review, the event of sixth nerve palsy was considered to be medically significant. Additional information is expected.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Hypermetropia, Irritability, Pseudostrabismus, Strabismus
Clinical narrative: Information has been received from a physician and a medical assistant on behalf of the physician via Pfizer as other company referring to a 3 month old female patient. No relevant medical or historical conditions were reported. On 12-MAY-2015, the patient was vaccinated with ROTATEQ, 2 ml (frequency and route unknown). On the same date, the patient was also vaccinated with PENTACEL (Sanofi) 0.5 ml (frequency and route unknown) and PREVNAR (Pfizer) 0.5 ml (frequency and route unknown). The doctor mentioned that his concern from a medical point was that the baby got all those 3 shots at the four month check-up, so what would the medical director or the pharmacist recommend for the baby's six month vaccine (Inappropriate schedule of vaccine administered). There was no concomitant medication reported. On 12-MAY-2015, the patient developed a week long side effects that began a few hours after the vaccine. The patient developed "fancy responses" within a couple of hours (also reported by the medical assistant as "very fluffy that night") that and could be only consoled by being held for 6 days. The patient also developed a bulging fontanelle and a right sixth nerve palsy. The patient had got some testing done and she saw a specialist for the sixth nerve palsy in the eye but there was nothing. As far as the treatment, "that could be done other than TYLENOL for fever and things of that nature". Over the 6 day period, the ophthalmology said that everything was normal, the eye was getting better and they did a head ultrasound that showed the right macro cranial (result not provided). The outcome of the events was reported as recovered completely on about 19-MAY-2015 (reported as a week long side effects and "6 days long period"). The reporting medical assistant mentioned that they were thinking that the side effects were caused by the vaccines but they were not sure. Upon internal review, the event of sixth nerve palsy was considered to be medically significant. Additional information is expected.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, VIth nerve paralysis
Clinical narrative: Information has been received from a physician and a medical assistant on behalf of the physician via Pfizer as other company referring to a 3 month old female patient. No relevant medical or historical conditions were reported. On 12-MAY-2015, the patient was vaccinated with ROTATEQ, 2 ml (frequency and route unknown). On the same date, the patient was also vaccinated with PENTACEL (Sanofi) 0.5 ml (frequency and route unknown) and PREVNAR (Pfizer) 0.5 ml (frequency and route unknown). The doctor mentioned that his concern from a medical point was that the baby got all those 3 shots at the four month check-up, so what would the medical director or the pharmacist recommend for the baby's six month vaccine (Inappropriate schedule of vaccine administered). There was no concomitant medication reported. On 12-MAY-2015, the patient developed a week long side effects that began a few hours after the vaccine. The patient developed "fancy responses" within a couple of hours (also reported by the medical assistant as "very fluffy that night") that and could be only consoled by being held for 6 days. The patient also developed a bulging fontanelle and a right sixth nerve palsy. The patient had got some testing done and she saw a specialist for the sixth nerve palsy in the eye but there was nothing. As far as the treatment, "that could be done other than TYLENOL for fever and things of that nature". Over the 6 day period, the ophthalmology said that everything was normal, the eye was getting better and they did a head ultrasound that showed the right macro cranial (result not provided). The outcome of the events was reported as recovered completely on about 19-MAY-2015 (reported as a week long side effects and "6 days long period"). The reporting medical assistant mentioned that they were thinking that the side effects were caused by the vaccines but they were not sure. Upon internal review, the event of sixth nerve palsy was considered to be medically significant. Additional information is expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site abscess, Injection site cellulitis, Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Mom called and emailed Dr. (patient provider) and said that "both arms has swelling but left arm was swollen than the right arm, hardness and extremely hot to touch". Mom was advised to go to ER and went.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Mom called and emailed Dr. (patient provider) and said that "both arms has swelling but left arm was swollen than the right arm, hardness and extremely hot to touch". Mom was advised to go to ER and went.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose abnormal, Blood test, Colitis ulcerative, Colonoscopy abnormal, Haemorrhage
Clinical narrative: She began bleeding rectally.  She was hospitalized and then dc for a day and then rehospitalized with extreme cramping and bleeding.  She was given a colonoscopy and was diagnosed with Ulcerative Colitis.  She had no symptoms before the vaccination.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Insulin resistance, Muscle spasms, Rectal haemorrhage, Stool analysis
Clinical narrative: She began bleeding rectally.  She was hospitalized and then dc for a day and then rehospitalized with extreme cramping and bleeding.  She was given a colonoscopy and was diagnosed with Ulcerative Colitis.  She had no symptoms before the vaccination.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Disturbance in attention, Dyspnoea, Eye pruritus
Clinical narrative: Bloodshot itchy eyes, tightness in chest, difficulty taking deep breaths, unable to focus, weakness.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Body temperature increased, Cellulitis, Dizziness, Hypotension
Clinical narrative: Syncope, vomiting, weakness, dizziness, temp over 103, low blood pressure, cellulitis.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Syncope, Vomiting
Clinical narrative: Syncope, vomiting, weakness, dizziness, temp over 103, low blood pressure, cellulitis.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Dizziness, Malaise, Muscular weakness
Clinical narrative: Information has been received from a patient's mother via an online article regarding her 17 year old daughter. There was no relevant medical history or drug reactions/allergies reported. The article stated that "two years ago" the patient's pediatrician recommended the patient to get GARDASIL, which was given in 3 doses. On unknown dates the patient was vaccinated with the first and second doses of GARDASIL (dose, frequency, route, lot# and expiration dates unspecified). After the first dose, the reporter said the patient was fine but after the second dose the patient was sick within a week at the doctors with nausea which had not left her to this day. The patient said "I have nausea 24/7, dizziness, 24/7 muscle pain, weakness in my legs, back pain, joint pain. Some days I have to walk with a cane". "The events had been going on for the past two years". The reporter said "it was devastating for her, because she can't have a normal life". The patient's health got so bad after getting GARDASIL. At the time of reporting, the patient was undergoing IV treatments once per week. Outcome of the events and causality were not provided. This is one of several reports from the same reporter. Upon internal review, the events of muscle pain, weakness in my legs, back pain, joint pain were considered as disable due to some days the patient had to walk with a cane. Additional information is not expected as no follow up available.