chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as RECOMBIVAX HB (lot # J009374; expiration: 11-JUN-2016) and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48 hours on an unspecified date, and to several other unspecified temperature excursions on unspecified dates. An unspecified number of patients received at least one of these vaccine on unspecified dates. Further it was reported that RECOMBIVAX HB (lot # J009374; expiration: 11-JUN-2016) and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were exposed to 31 F for 15 days (360) hours. However later it was confirmed that GARDASIL was not administered to anyone. On 13-OCT-2014, the patients were vaccinated with improperly exposed RECOMBIVAX HB, intramuscularly, lot # J009374; expiration: 11-JUN-2016. Later it was confirmed with the reporter that RECOMBIVAX HB were improperly exposed to 33 F for 96 hours from 04-SEP-2014 to 08-SEP-2014, and to 34F for 48 hours from 09-SEP-2014 to 11-SEP-2014, and to 34F for 72 hours from 12-SEP-2014 to 15-SEP-2014, and to 33F for 168 hours from 15-SEP-2014 to 22-SEP-2014, and to 31 F for 240 hours from 26-SEP-2014 to 06-OCT-2014, and to 34F for 48 hours from 06-OCT-2014 to 08-OCT-2014, and to 32 F for 96 hours from 09-OCT-2014 to 13-OCT-2014, and to 31F for 24 hours from 14-OCT-2014 to 15-OCT-2014. No adverse effects reported. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as RECOMBIVAX HB, (lot # J009374, expiration: 11-JUN-2016) and GARDASIL vial wet SD 120 Y (lot # K005083; expiration 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48  hours on an unspecified date, and to several other unspecified temperature excursions on unspecified dates. An unspecified number of patients received at least one of these vaccines on unspecified dates. Further it was reported that RECOMBIVAX HB,(lot # j0009374; expiration: 11-JUN-2016) and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were exposed to 31F for 15 days (360 hours). However later it was confirmed that GARDASIL was not administered to anyone. On 20-SEP-2014, the patients were vaccinated with improperly exposed RECOMBIVAX HB vial SD, intramuscularly (lot # J009374, expiry date 11-JUN-2106.  Later it was confirmed with the reporter that RECOMBIVAX HB were improperly exposed to 33F for 96  hours from 04-SEP-2014 to 08-SEP-2014, and to 34F for 48 hours from 09-SEP-2014 to 11-SEP-2014, and to 34F for 72 hours from 12-SEP-2014 to 15-SEP-2014, and to 33F for 168 hours from 15-SEP-2014 to 22-SEP-2014, and to 31F for 240 hours from 26-SEP-2014 to 06-OCT-2014. No adverse effects reports. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.59
Sex: F
Vaccine: MMRV
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician and it refers to a currently 2 year old female patient. The patient has no medical history and no previous drug reactions and allergies. On 12-SEP-2013, the patient was vaccinated with one dose of (Oka/Merck) PROQUAD lot # J004321, exp date: 17-OCT-2014, dose: 0.5 ml, subcutaneous (anatomical location was not reported). There was no concomitant medication. In October 2014, reported as "last week" antibody titers test was performed and antibody titers were found to be negative for measles, mumps, rubella and varicella. The patient sought medical attention, she had an office visit on an unspecified date. No treatment was given for the events. The outcome of the events was unknown (the patient's present status was reported as negative antibody titers). The relatedness between vaccination with (Oka/Merck) PROQUAD and the event was not reported. Additional information is not expected, the reporter does not wish to be contacted.
Age: 1.09
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Irritability, Rash vesicular
Clinical narrative: Vesicular rash on hand, anus and face (5 pox) 14 days after the vaccine. No fever. Irritability.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. On 17-OCT-2014 the patient was vaccinated with ZOSTAVAX (subcutaneous in the left arm, 0l.65 ml, lot # K007989 EXP 03-SEP-2015; dose no. unknown). The same evening of the vaccination the patient developed redness at the injection site, pain, and swelling. By the next night on Saturday (18-OCT-2014), the patient had red, raised, fluid filled blister hanging outside the skin at the injection site. The reporting pharmacist stated he did not think it was shingles. The patient sought medical attention (in the pharmacy). The outcome of the events was reported as not recovered.  Additional information is not expected since there is no permission to contact physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, concerning to 133 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the an unknown number of patients (of the 133 patients) were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse practitioner that on an unknown date patients were inadvertently administered GARDASIL that had been improperly stored. No adverse effects reported. This is one (1) of four (4) reports from the same source. Additional information is not expected. The nurse practitioner did not gave the consent to contact her.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Lymphadenopathy, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as certified medical assistant) refers to a 62 year old female patient with diabetes, allergy to IV (intravenous) contrast dye and allergy to most narcotics. The patient had a history of allergy while on previous therapy with amitriptyline hydrochloride (manufacturer unknown) (captured in MARRS#1411USA001759). On 23-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (injection, batch/lot # K010016, expiration date 05-AUG-2015; dose number, route, anatomical location not reported). Concomitant therapies included lovastatin (manufacturer unknown).  On 23-OCT-2014, the patient experienced achiness throughout the whole body, a sore throat, swollen lymph nodes, fever (exact values and units unspecified) and chills. The patient did not seek medical attention and no specific treatment was given for the events. The outcome of the events was reported as recovering. Causality was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, concerning to 133 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the an unknown number of patients (of the 133 patients) were vaccinated with a dose of VAQTA (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse practitioner reported that on an unknown date, patients were inadvertently administered VAQTA that had been improperly stored. No adverse effects reported.  This is one (1) of four (4) reports from the same source. Additional information is not expected. The nurse practitioner did not give the consent to contact her.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose decreased, Confusional state, Dyskinesia, Eye movement disorder, Pallor
Clinical narrative: As needle was withdrawn, pt was white and eyes rolling back. His arms were jerking, last approx 5 seconds. He then sat up, confused, asking what happened. He was still pale. MD examined him. Blood glucose was checked - juice and glucagon were administered.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, concerning to 133 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the an unknown number of patients (of the 133 patients) were vaccinated with a dose of RECOMBIVAX HB (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse practitioner reported that on an unknown date, patients were inadvertently administered RECOMBIVAX HB that had been improperly stored. No adverse effects reported.  This is one (1) of four (4) reports from the same source. Additional information is not expected. The nurse practitioner did not give the consent to contact her.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, concerning to 133 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the an unknown number of patients (of the 133 patients) were vaccinated with a dose of PNEUMOVAX23 (dose, dose number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse practitioner reported that on an unknown date, patients were inadvertently administered PNEUMOVAX23 that had been improperly stored. No adverse effects reported.  This is one (1) of four (4) reports from the same source. Additional information is not expected. The nurse practitioner did not give the consent to contact her.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a patient's parent refers to a 13 year old female patient. On 30-OCT-2014 the patient was vaccinated with GARDASIL, dose 4, injection. On 30-OCT-2014 the patient received fourth shot of GARDASIL in error. The patient had completed all the three doses in the previous year approximately in 2013 on an unspecified date. The patient experienced no adverse event. The reporter called to ask a question about the possible effects of receiving a fourth shot. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 12 month old patient of unknown gender. On 28-OCT-2014 (also reported as today) the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneous injection, lot number and expiration date were not reported) and PROQUAD (Merck) (0.5 ml, subcutaneous injection, lot number and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: PT had large, red, warm, raised area.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a two unspecified patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. On 10-OCT-2014, the two unspecified patients were vaccinated with expired PNEUMOVAX23 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified).  No adverse effects were known. Concomitant therapies were not reported.  Follow up information has been received from a pharmacist on 28-OCT-2014. This report concerning a female patient of an unknown age. On 10-OCT-2014, the patient was administered expired does of PNEUMOVAX23 lot number: J007786, expiration date: 25-SEP-2014. This is one of several reports received from the same reporter. Additional  information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: Pt reports progressive pain approx initially 10 hours after vaccination and a rash developed as well. Rash is slightly raised, red, painful x 4 inches square.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified patients (reported as clients) of unknown age. The unspecified patients medical history was not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored PROQUAD (Merck) (dose, frequency, route and lot # were not reported). No adverse effects were reported. No product complaint was reported for PROQUAD (Merck). Additional information is not expected as the reporter did not wish to contact.
Age: 0.5
Sex: F
Vaccine: IPV
Symptoms: Injection site discolouration
Clinical narrative: Black dot where got vaccines (R) thigh (mother brought up at next well visit).
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as PNEUMOVAX23 (sealed vials) (lot # K007824, expiration: 05-NOV-2015) and GARDASIL via wet SD 120 Y (lot # K005083; expiration: 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48 hours on an unspecified date, and to several other unspecified dates. Further it was reported that PNEUMOVAX23 (sealed vials) (lot # K007824, expiration: 05-NOV-2015) were exposed to 31F for 600 hours and GARDASIL (lot # K005083, expiration : 04-NOV-2016) were exposed to 31F for 15 days (360 hours). However later it was confirmed that GARDASIL was not administered to anyone. On 12-SEP-2014, intramuscularly, (lot # K007824, expiration: 05-NOV-2015), for unknown indication. Later it was confirmed with the reporter that the PNEUMOVAX23 were improperly exposed to 33F for 96 hours from 04-SEP-2014 to 08-SEP-2014, and to 34F for 48  hours from 09-SEP-2014 to 11-SEP-2014, and to 34F for 72 hours from 12-SEP-2014 to 15-SEP-2014. No adverse effects reported. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 73 year old female patient. No concurrent conditions or medical history were provided. On 31-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot # K004930 with expiry date: 16-MAR-2015, reported as "05-MAR-2014") 0.5 ml administered intramuscularly in the right arm as a single does, post supported temperature excursion of 10C for 15 hours. No concomitant medications were reported. No adverse effect were noted by patient. The patient did not seek medical attention. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth, Rash
Clinical narrative: Discomfort in area of injection - rash noticed 5 days post injection 6" x 2". 11/5/14 today area 9" x 3" - red/warm.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning an unknown 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 a dose of VAQTA (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that on an unknown date, an unspecified number of improperly stored VAQTA doses were administered to patients. No adverse effects reported. This is one (1) of three (3) 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 was received from a nurse, concerning an unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reportd. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that on an unknown date, an unspecified number of improperly stored RECOMBIVAX HB, doses were administered to patients. No adverse effects reported.  This is one (1) of three (3) reports 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 nurse, concerning an unknown 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 a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported) oral route. Co-suspect and concomitant therapies were not reported. The nurse reported that on an unknown date, an unspecified number of improperly stored ROTATEQ doses were administered to patients. No adverse effects reported. This is one (1) of three (3) reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 11/15/14: Pt. called this am to report "big red blobs" on upper arm near shot injection site. C/O only mild soreness. Arm feels a little warm to the touch. No itchiness. Pt feels fine-able to move arm normally. Denies fever. Band aide removed this am by pt
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a healthy 59 year old female patient. Medical history and drug reactions or allergies were not specified. On unspecified date in 1993 (also reported as since 1993) the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route, lot # not reported). On approximately 1998 (also reported as every 5 years since 1993), the patient was vaccinated with the second dose of PNEUMOVAX23 (dose, route, lot # not reported). On approximately 2003 (also reported as every 5 years since 1993), the patient was vaccinated with the third dose of PNEUMOVAX23 (dose, route, lot # not reported). On approximately 2008 (also reported as about 6 years ago), the patient was vaccinated with the fourth dose of PNEUMOVAX23 (dose, route, lot # not reported). Concomitant medications were not specified. The pharmacist reported that a patient had been receiving PNEUMOVAX23 every 5 years since year 1993 because she worked in public. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inflammation
Clinical narrative: This spontaneous report as received from ma physician refers to a patient of unknown age and gender. On an unspecified date (also reported as years ago), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot # not reported). On an unspecified date, the patient developed an inflammatory response to the PNEUMOVAX23. The outcome of inflammatory response was not reported. The relatedness between the event and PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Skin discolouration, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Large (4 inch) swollen red and white mottled circle appeared at point of vaccination. Muscle pain on outer side of arm between shoulder and elbow. Both symptoms continued for approximately 10 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Burning sensation, Pruritus, Urticaria
Clinical narrative: Half dollar size welt - itching, burning - "angry".
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old patient of unknown gender. On 03-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # K009771, expiration date 09-OCT-2015) (strength, route and dose not reported). The pharmacist stated he was preparing a dose of ZOSTAVAX employing a "Vanish point syringe which got stuck would not push out vaccine so the needle retracted spilling ZOSTAVAX on patient's arm and on the floor". Pharmacist also stated that the patient "may have received 25 percent of optimal dose of ZOSTAVAX". The pharmacist treated patient's arm exposure with an alcohol wipe. No other adverse effects reported. The patient was doing wonderful. No other treatment was given to the patient. The patient didn't seek medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a male patient, who on an unspecified date was vaccinated with PNEUMOVAX (lot # K007772, expiration date 01-MAY-2015 and also reported as lot # K0077773) on the right deltoid muscle. On 17-SEP-2014, the patient sustained on the right arm swelling of the area, itchy, redness, warmth to touch and fever. Treatment and outcome of the adverse event were not reported.  Information has been received from a claims representative via an email who reported an anonymous male patient of unspecified age was injected 1 PNEUMOVAX (lot # K007773, expiration date 01-MAY-2015) (also reported as lot # "K0077773') on the right deltoid  muscle. Claimant sustained on the right arm swelling of the area, itchy, redness and warmth to the touch and fever. On 10-OCT-2014, a call was made to the claims representative to verify the lot number as two different lot numbers that had been reported in the case of "Lot # K007773 with an expiration date of 01-MAy-2015" and "lot # K0077773, expiration date 01-MAY-2015 has been accepted as a valid lot #). Neither of the lot numbers which had been originally reported in the claim were correct (conflicting information has noted above: lot # K007773, expiration date 01-MAY-2015 has been accepted as a valid lot #). No further AE information was provided. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chills, Dyspepsia, Headache, Nausea
Clinical narrative: Patient stated that within two hours of receiving the Hepatitis B vaccination, she started having back pain. Symptoms later progressed to headache, generalized body ache, shaking chills, heartburn, nausea and vomiting. Advised to continue Ibuprofen and given prescriptions for PHENERGAN.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Tremor, Vomiting
Clinical narrative: Patient stated that within two hours of receiving the Hepatitis B vaccination, she started having back pain. Symptoms later progressed to headache, generalized body ache, shaking chills, heartburn, nausea and vomiting. Advised to continue Ibuprofen and given prescriptions for PHENERGAN.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness around injection site about 2 inches x 6 inches. No itching or pain, but site is warm to the touch.
Age: 93.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event, Product label issue
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 93 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 20-OCT-2014 the patient was vaccinated with a dose of with ZOSTAVAX (dose, dose number and route were not reported) lot number J005721, expiration date 29-AUG-2014 and also reported as J001721 expiration date 29-AUG-2014. Co-suspect and concomitant therapies were not reported.   The pharmacist reported that on 20-OCT-2014, a patient received a dose of ZOSTAVAX that expired on 29-AUG-2014. The pharmacist reported that the expiration date was not noticed to be past at the time of administration because "the way that the lot number and expiration date was de bossed on the label, it was very difficult to read". The pharmacist stated the neither the nurse who administer the dose to the patient nor she could not discern the lot number of the dose of ZOSTAVAX. No adverse experience was observed or reported. Lot number J001721 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 (Lot # reported as K007825 and expiration date: 13-JAN-2016) (dose, route of administration and lot # were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner, concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 29-APR-2014 the patient received the first dose of PNEUMOVAX23 (dose, dose number, lot number, expiration date and route were not reported). On 23-OCT-2014, the patient was vaccinated with the second does PNEUMOVAX23 (dose, dose number, lot number, expiration date and route were not reported). No adverse symptoms reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a  company representative concerning a 80 year old female patient. Concurrent conditions, medical history and allergies were not reported. On unspecified dates the patient was vaccinated with PNEUMOVAX23 (strength, dose, frequency, anatomical location and lot were not reported) subcutaneous, five times. Other suspect and concomitant therapies were not reported. No adverse event was reported. No further information was provided. Additional information is not expected because the reporter stated he does not want to be contacted.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Migraine, Nuclear magnetic resonance imaging normal, Vestibular disorder
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old male patient without any pertinent medical history. On an unknown date of June 2014, the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dose, strength, route and lot number were not reported). Secondary therapies were not reported. There was no concomitant medications.  Physician reported that a patient received ZOSTAVAX and developed dizziness that did not felt like spinning, but the patient stated that it felt like he was always on a boat, in 2014 (onset date reported as "about three weeks" after ZOSTAVAX. Physician stated that an unspecified neurologist diagnosed the patient with vestibular migraine, and referred him to an unspecified physical therapist. Physician stated that the unspecified physical therapist disagreed with the diagnosis. The physician stated that the patient had been referred to her for evaluation of a possible psycho-somatic cause of the dizziness. The outcome of vestibular migraine was reported as not recovered/not resolved.  Patient has performed a Magnetic Resonance Imaging (MRI) which was negative. Patient had received many unspecified treatments but none had relieved the symptoms. The physician stated that although the intensity varies, the patient had constant dizziness. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient developed a headache 24 hr after vaccine. Neck pain and stiffness occurred 48 hr after vaccine. Pain and stiffness have decreased slowly over time.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Redness in the left rarm, itching and hives. Swelling.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red area around injection site described by patient to be the size of a "saucer." Also warm to the touch. Patient has now been prescrobed KEFLEX and BACTRIM.
Age: 0.11
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient began to vomit after ROTATEQ was given.
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Underdose, Vomiting
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 6 week old female patient. Drug reactions and allergies were reported as none. On 28-OCT-2014 the patient was vaccinated with ROTATEQ dose 1, exactly half a dose, oral. On 28-OCT-2014, the patient received half a dose of ROTATEQ and vomited and was unable to take the remainder of the dose.  No treatment was given to the patient. No lab tests were performed. The outcome of vomited and received half a dose is unknown. The reporter considered received half a dose to be not related to ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to 3 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dosing details unknown). On an unknown date the patients experienced shingles after receiving ZOSTAVAX. The outcome of shingles is unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to a 50 year old female patient. On 25-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # K004487, expiration date 21-AUG-2015, 1 dose once) intramuscularly. Concomitant therapies included TRAMADOL and TYLENOL. On 25-SEP-2014, the patient experienced fever, body aches and cough after receiving PNEUMOVAX23. The patient visited the emergency room (ER) on 25-SEP-2014, but was not admitted and went home the same day. The outcome of the events cough, fever and body aches were unknown. This is one of several reports from the same reporter.  Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Severe swelling of back of left arm from shoulder to elbow. Slight itching. No fever occurred day after yellow fever vaccine. Lasting about 3 days.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Cellulitis, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient with no pertinent medical history or drug reactions/allergies. On 21-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, (lot number of K007985, exp. date 03-SEP-2015) subcutaneous. No concomitant therapies were reported. On 23-OCT-2014 (two days after vaccination), the patient experienced the injection site was red and swollen, and he was "feeling tired". She reported that the patient was at his doctor's office for "routine blood work". The pharmacist stated that the patient reported to her that diagnostics studies were performed. The outcome was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cough, Erythema, Malaise, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to several patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX23 (lot #, dose, frequency and route were unknown). On an unknown date the patients experienced fever, achiness, cough, "felt sick", sore arm, redness and swelling from elbow to shoulder of left arm. The outcome of the events was unknown. This is one of two reports from the same reporter. The other report is MARRS#1409USA006595. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to several patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX23 (lot #, dose, frequency and route were unknown). On an unknown date the patients experienced fever, achiness, cough, "felt sick", sore arm, redness and swelling from elbow to shoulder of left arm. The outcome of the events was unknown. This is one of two reports from the same reporter. The other report is MARRS#1409USA006595. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with allergy to sulfur. The patient had no pertinent medical history.; On 14-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported, lot # K000326, expiration date 27-FEB-2015). No concomitant medications were provided. The pharmacist reported that the patient experienced "injection site reaction" and a rash across her back which itches on 21-OCT-2014 after receiving ZOSTAVAX. The pharmacist declined the varicella zoster virus (VZV) packet. No treatment was given for the events. No lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Muscular weakness, Myalgia, Rash
Clinical narrative: Less than 24 hrs after receiving the vaccine - pt reports severe muscle weakness/aches/pains. Pt. also experienced a painful earache and reports a stripe-like rash near her knee.
Age: 0.6
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner on 22-OCT-2014 refers to a 6 month old patient of unknown gender. On 22-OCT-2014 (als0 reported as today) the patient was vaccinated with a dose of PNEUMOVAX23 injection (strength, dose and lot # unknown). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a physician via a company representative on 27-OCT-2014 refers to a female patient of unknown age On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 injection (strength, dose and lot # unknown). On an unknown date the patient experienced a Upper Respiratory Infection (URI) after receiving the PNEUMOVAX23. The patient had an office visit on an unspecified date for seeking medical attention. The outcome of URI was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with doses of GARDASIL (dose, dose number, route, lot # not reported). On an unknown date the unspecified number of patients came into the office approximately one year later to continue their GARDASIL series. No adverse symptoms reported. The outcome of event was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient. On 19-MAR-2014 the patient was vaccinated with ZOSTAVAX dose 1. Accidentally, on 25-JUL-2014 the patient was vaccinated with ZOSTAVAX dose 2. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (1 single shot, lot # was not reported). On an unknown date patient developed a rash, was in a lot of pain and went to the ER (demographics unknown). The patient was not admitted into the hospital. The patient received VALTREX and NORCO (doses/frequencies/manufacturers unknown) to treat the event. The outcome of the event was reported as not recovered/not resolved. 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 pharmacist refers to unspecified patients of unknown age and gender. Initially reported as RECOMBIVAX HB (lot # J009374; expiration: 11-JUN-2016) and GARDASIL vial wet SD (lot # K005083; expiration: 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48 hours on an unspecified date, and to several other unspecified temperature excursions on unspecified dates. An unspecified number of patients received at least one of these vaccines on unspecified dates. Further it was reported that RECOMBIVAX HB (lot # J009374; expiration: 11-JUN-2016) and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were exposed to 31F for 15 days (360 hours). However later it was confirmed that GARDASIL was not administered to anyone. On 06-SEP-2014, the patients were vaccinated with improperly exposed RECOMBIVAX HB vial SD, intramuscularly, lot # J009374, expiry date 11-JUN-2016, for unknown indication. Later it was confirmed with the reporter that RECOMBIVAX HB were improperly exposed to 33F for 96 hours from 04-SEP-2014 to 08-SEP-2014. No adverse effects reported. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Dyspnoea, Eye discharge, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Case number PHHY2014US141465 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 542753) on 28 Oct 2014. This report refers to a 68 years old female patient. Her medical history was not reported and concomitant medications included Armour thyroid and amlodipine besylate. She was vaccinated with seasonal influenza (unknown manufacturer, batch number: 4928103565) intramuscularly in the left arm on 05 Sep 2014. On the same day after vaccination, she experienced swollen tongue, throat and mouth, trouble breathing, red swollen itchy eyes with discharge, sore throat and shaking. She went to emergency room. The outcome of the events was reported as complete recovery. The events was assessed as non-serious by the reporter, but was internally upgraded by the agency. The causality of the events was not reported. The quality assurance department confirmed that the reported batch number, 49281039565 was not a valid Novartis lot number and hence the case would be deactivated. Following an internal review on 04 Nov 2014 of the data received on 28 Oct 2014 it was identified that the reported batch number 49281039565 was not a valid Novartis lot number and hence the case was deactivated.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Oedema mouth, Oropharyngeal pain, Pharyngeal oedema, Swollen tongue, Tremor
Clinical narrative: Case number PHHY2014US141465 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 542753) on 28 Oct 2014. This report refers to a 68 years old female patient. Her medical history was not reported and concomitant medications included Armour thyroid and amlodipine besylate. She was vaccinated with seasonal influenza (unknown manufacturer, batch number: 4928103565) intramuscularly in the left arm on 05 Sep 2014. On the same day after vaccination, she experienced swollen tongue, throat and mouth, trouble breathing, red swollen itchy eyes with discharge, sore throat and shaking. She went to emergency room. The outcome of the events was reported as complete recovery. The events was assessed as non-serious by the reporter, but was internally upgraded by the agency. The causality of the events was not reported. The quality assurance department confirmed that the reported batch number, 49281039565 was not a valid Novartis lot number and hence the case would be deactivated. Following an internal review on 04 Nov 2014 of the data received on 28 Oct 2014 it was identified that the reported batch number 49281039565 was not a valid Novartis lot number and hence the case was deactivated.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Cellulitis, Chills, Injection site erythema, Injection site streaking
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient without pertinent medical history or drug reactions/allergies. On 11-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013344, expiration date 22-JAN-2015), injection, (dose and route not reported). Concomitant medication was not provided. On 12-OCT-2014, the patient experienced soreness, tenderness, and redness at the injection site and a swollen arm from the "injection site down to her elbow" after she received PNEUMOVAX 23. The pharmacist reported the patient stated injection site felt hot and she experienced "a little bit" of fever and was sweaty at night. The patient stated to the physician that the PNEUMOVAX 23 affected her muscles as her balance was "off". No lab diagnostics studies was performed. Unspecified "antibiotics and steroids shot" was given for treated the adverse events. At the time of reporting, the outcome of the events was recovering. The patient went to the doctor to seek medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Night sweats, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient without pertinent medical history or drug reactions/allergies. On 11-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013344, expiration date 22-JAN-2015), injection, (dose and route not reported). Concomitant medication was not provided. On 12-OCT-2014, the patient experienced soreness, tenderness, and redness at the injection site and a swollen arm from the "injection site down to her elbow" after she received PNEUMOVAX 23. The pharmacist reported the patient stated injection site felt hot and she experienced "a little bit" of fever and was sweaty at night. The patient stated to the physician that the PNEUMOVAX 23 affected her muscles as her balance was "off". No lab diagnostics studies was performed. Unspecified "antibiotics and steroids shot" was given for treated the adverse events. At the time of reporting, the outcome of the events was recovering. The patient went to the doctor to seek medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient without pertinent medical history or drug reactions/allergies. On 11-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013344, expiration date 22-JAN-2015), injection, (dose and route not reported). Concomitant medication was not provided. On 12-OCT-2014, the patient experienced soreness, tenderness, and redness at the injection site and a swollen arm from the "injection site down to her elbow" after she received PNEUMOVAX 23. The pharmacist reported the patient stated injection site felt hot and she experienced "a little bit" of fever and was sweaty at night. The patient stated to the physician that the PNEUMOVAX 23 affected her muscles as her balance was "off". No lab diagnostics studies was performed. Unspecified "antibiotics and steroids shot" was given for treated the adverse events. At the time of reporting, the outcome of the events was recovering. The patient went to the doctor to seek medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Muscle disorder, Night sweats, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient without pertinent medical history or drug reactions/allergies. On 11-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013344, expiration date 22-JAN-2015), injection, (dose and route not reported). Concomitant medication was not provided. On 12-OCT-2014, the patient experienced soreness, tenderness, and redness at the injection site and a swollen arm from the "injection site down to her elbow" after she received PNEUMOVAX 23. The pharmacist reported the patient stated injection site felt hot and she experienced "a little bit" of fever and was sweaty at night. The patient stated to the physician that the PNEUMOVAX 23 affected her muscles as her balance was "off". No lab diagnostics studies was performed. Unspecified "antibiotics and steroids shot" was given for treated the adverse events. At the time of reporting, the outcome of the events was recovering. The patient went to the doctor to seek medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Cellulitis, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient without pertinent medical history or drug reactions/allergies. On 11-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013344, expiration date 22-JAN-2015), injection, (dose and route not reported). Concomitant medication was not provided. On 12-OCT-2014, the patient experienced soreness, tenderness, and redness at the injection site and a swollen arm from the "injection site down to her elbow" after she received PNEUMOVAX 23. The pharmacist reported the patient stated injection site felt hot and she experienced "a little bit" of fever and was sweaty at night. The patient stated to the physician that the PNEUMOVAX 23 affected her muscles as her balance was "off". No lab diagnostics studies was performed. Unspecified "antibiotics and steroids shot" was given for treated the adverse events. At the time of reporting, the outcome of the events was recovering. The patient went to the doctor to seek medical attention. Additional information has been requested.