chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 15-JUL-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 15-OCT-2013, the patient of unknown age and gender vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 11-AUG-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date in 2007, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. It was reported that the patient was vaccinated with the second dose of GARDASIL on an unspecified date in 2008 and with the third dose on 11-MAR-2015. No adverse event was reported. Product quality complaint was not involved. Additional information is not expected because the reporter did not consent further follow up.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Injection site erythema, Injection site swelling
Clinical narrative: Experienced pain in (R) arm 6 hours after vaccine. On 3/26/15, pain of (R) arm, especially with lifting arm. (+) chills. T max 3/27/15 early AM-101 degrees F. (+) nausea, abdominal unsettling feeling. 3/27/15 pain (R) arm improving. Exam (R) arm swelling, warm, erythema around site of injection. TX: NSAIDS, EMETROL for nausea.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Nausea, Pain, Pain in extremity
Clinical narrative: Experienced pain in (R) arm 6 hours after vaccine. On 3/26/15, pain of (R) arm, especially with lifting arm. (+) chills. T max 3/27/15 early AM-101 degrees F. (+) nausea, abdominal unsettling feeling. 3/27/15 pain (R) arm improving. Exam (R) arm swelling, warm, erythema around site of injection. TX: NSAIDS, EMETROL for nausea.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date the patients received improperly stored, GARDASIL (strength, dosage, route, lot# and expiration date were not reported). No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria, Vomiting
Clinical narrative: Vomiting approximately 16 hrs and 20hrs after vaccine. Urticaria approximatley 20hrs. after vaccine - feet, face, arms, trunk.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date the patients received improperly stored RECOMBIVAX HB. (Strength, route, dosage, lot# and expiration date were not reported). No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Inflammation
Clinical narrative: Inflammation and burning sensation in shoulder and along back that also runs down arm accompanied by numbness -still experiencing.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Condition aggravated, Electroencephalogram normal, Febrile convulsion
Clinical narrative: Hx of febrile seizures and after received his DTap and MMRV he had another febrile seizure-the next day actually. EEG was nl.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive
Clinical narrative: This spontaneous report received from a non-medical healthcare worker via company representative refers to a 12 months old female patient who did not feel well before receiving the vaccine. On unknown date the patient was vaccinated with a dose of M-M-R II (dose, lot #, expiration date and route were not reported). On unknown date 10 days after receiving the vaccine the patient was diagnosed with measles. The laboratory confirmed that the patient was experiencing a vaccine related case of measles versus wild type. The patient sought medical attention by office visit on unspecified date. It was not specified if the patient would receive subsequent doses of M-M-R II, due to this event. At the time, of the report the outcome of measles was unknown. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling on the injection site-53mm. Overall fatigue, headache. T99.1.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 04-OCT-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 22-AUG-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 05-SEP-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Age: 6.0
Sex: F
Vaccine: IPV, MMRV, IPV, MMRV
Symptoms: Cough, Morbillivirus test positive, Photophobia, Pyrexia, Rash
Clinical narrative: Fever 105 degrees, rash, cough, photophobia.
Age: 6.0
Sex: F
Vaccine: IPV, MMRV, IPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 105 degrees, rash, cough, photophobia.
Age: 6.0
Sex: F
Vaccine: IPV, MMRV, IPV, MMRV
Symptoms: Cough, Morbillivirus test positive, Photophobia, Pyrexia, Rash
Clinical narrative: Fever 103 degrees, rash, cough and photophobia
Age: 6.0
Sex: F
Vaccine: IPV, MMRV, IPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 103 degrees, rash, cough and photophobia
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker also reported as nurse assistant refers to group of patients of unknown demographics. Information about patients' medical histories was not provided. On 07-JAN-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, indication and lot # were not reported) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker also reported a nurse assistant refers to group of patients of unknown demographics. Information about patients' medical histories was not provided. On 13-JAN-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, indication and lot # were not specified) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Pain, Peripheral swelling, Rash
Clinical narrative: The shot was administered in the afternoon on 3/3/15. Two days later his mother called, stating that patient's arm became very red and swollen. In the clinic (same day) the PA observed that the redness measured approx. 12 cm x 12 cm. The child only c/o pain upon applying pressure to the rash. The child came back to the clinic 6 days later (3/11/15). Patient's rash circumference decreased, however the color was a darker purple, swelling with firmness noted. No fever at any time. 3/4/15-the patient was given ibuprofen and a cold compress applied to his arm. That is the extent of his treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Skin discolouration, Swelling
Clinical narrative: The shot was administered in the afternoon on 3/3/15. Two days later his mother called, stating that patient's arm became very red and swollen. In the clinic (same day) the PA observed that the redness measured approx. 12 cm x 12 cm. The child only c/o pain upon applying pressure to the rash. The child came back to the clinic 6 days later (3/11/15). Patient's rash circumference decreased, however the color was a darker purple, swelling with firmness noted. No fever at any time. 3/4/15-the patient was given ibuprofen and a cold compress applied to his arm. That is the extent of his treatment.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker also reported as nurse assistant refers to group of patients of unknown demographics. Information about patients' medical histories was not provided. On 21-JAN-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, indication and lot # were not specified) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Arthralgia, Blood culture negative, Chills, Fatigue, Full blood count normal
Clinical narrative: During night after vaccine developed pain at injection site; the next day significant fatigue, joint pain, headache, chills; day 4 rash abdomen (tender, bright erythema, sl raised). Over next several days increased dermatomal pain -> rash=shingles.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Headache, Herpes zoster, Injection site pain, Metabolic function test, Pain of skin
Clinical narrative: During night after vaccine developed pain at injection site; the next day significant fatigue, joint pain, headache, chills; day 4 rash abdomen (tender, bright erythema, sl raised). Over next several days increased dermatomal pain -> rash=shingles.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Rash erythematous, Red blood cell sedimentation rate normal, Tenderness
Clinical narrative: During night after vaccine developed pain at injection site; the next day significant fatigue, joint pain, headache, chills; day 4 rash abdomen (tender, bright erythema, sl raised). Over next several days increased dermatomal pain -> rash=shingles.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Arthralgia, Chills, Fatigue, Headache, Herpes zoster
Clinical narrative: During night after vaccine developed pain at injection site; the next day significant fatigue, joint pain, headache, chills; day 4 rash abdomen (tender, bright erythema, sl raised). Over next several days increased dermatomal pain -> rash=shingles.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Injection site pain, Pyrexia, Rash
Clinical narrative: During night after vaccine developed pain at injection site; the next day significant fatigue, joint pain, headache, chills; day 4 rash abdomen (tender, bright erythema, sl raised). Over next several days increased dermatomal pain -> rash=shingles.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Migraine headacche; ADVIL, TYLENOL appears to 6mm.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a male patient of around 67 or 68 yea old, regarding himself. Patient's pertinent medical history and drug allergies were unspecified. About 7 years ago in 2007, he received PNEUMOVAX23 (dose/frequency, therapy route, lot # and expiry date unspecified). He experienced a red, hot, swelling, itch and tenderness sensations on his arms, at the point of injection. He stated that these symptoms lasted for a week and he recovered on an unspecified date. Causality assessment was not provided. This is one of several reports from the same reporter (MARRS # 1503USA013656). Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg redness, swelling and warmth surround injection site aprx. 12-15 cm in total diameter.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. About two years ago in 2013, the patient received a dose of ZOSTAVAX, .65 ml, subcutaneous. On 25-MAR-2015 the patient inadvertently received a second dose of ZOSTAVAX. No adverse effects were reported. Outcome of the event was unknown. Reporting pharmacist considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Pain in extremity, Skin warm
Clinical narrative: Arm red, hot, and sore 17 week. Did not feel 100%.
Age: 21.0
Sex: F
Vaccine: FLUX, MEN, VARCEL, FLUX, MEN
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a the patient's mother refers to her 21 years old daughter. The patient did not had any pertinent medical history, drug reactions or allergies. On 04-MAR-2015, the patient was vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneous. Concomitant therapies included influenza virus vaccine and unspecified bacterial meningitis shot [therapy unspecified]. In March 2015, a couple of days after receiving VARIVAX (Merck), the patient developed sore arm and redness in the injection site. Subsequently, the patient recovered from the adverse events. The patient's mother also reported that on an unspecified date, the patient developed "sore arm" after receiving an unspecified flu vaccine and "sore arm" and redness at the injection site after receiving an unspecified bacterial meningitis shot. The patient did not sought medical attention and did not received treatment for the adverse events. No lab diagnostics studies were performed. No product quality complain was reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLUX, MEN, VARCEL, FLUX, MEN
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report as received from a the patient's mother refers to her 21 years old daughter. The patient did not had any pertinent medical history, drug reactions or allergies. On 04-MAR-2015, the patient was vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneous. Concomitant therapies included influenza virus vaccine and unspecified bacterial meningitis shot [therapy unspecified]. In March 2015, a couple of days after receiving VARIVAX (Merck), the patient developed sore arm and redness in the injection site. Subsequently, the patient recovered from the adverse events. The patient's mother also reported that on an unspecified date, the patient developed "sore arm" after receiving an unspecified flu vaccine and "sore arm" and redness at the injection site after receiving an unspecified bacterial meningitis shot. The patient did not sought medical attention and did not received treatment for the adverse events. No lab diagnostics studies were performed. No product quality complain was reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemorrhoids
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 72 year old female patient with no drug reactions/allergies. The pharmacist reported that on 21-FEB-2015 the patient received ZOSTAVAX (lot # K016325, expiration date 24-DEC-2015, 0.65 ml, subcutaneously). On an unknown date the patient experienced hemorrhoids. On 25-FEB-2015 (also reported as today) the patient came to the pharmacy to have a prescription for hydrocortisone rectal suppositories filled, that were prescribed for hemorrhoids. The patient's outcome was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 11-MAR-2015, the patient was vaccinated with a expired dose of ZOSTAVAX lot # reported as K00995, expiration date 06-MAR-2015 (dose and route were not reported). No co-suspect and concomitant therapies were reported. No adverse effects were noted. Additional information has been requested.
Sex: M
Vaccine: HEPAB
Symptoms: Palpitations
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of palpitation in a male patient who received TWINRIX (batch number 3EX72, expiry date 22nd March 2016). On an unknown date, the patient received TWINRIX (unknown). On an unknown date, an unknown time after receiving TWINRIX, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown. It was unknown if the reporter considered the palpitation to be related to TWINRIX. Additional information was provided as follow: The patient experienced hourly palpitations to his heart lasting about a second. The physician did not wish to provide any information for adverse event report at the time of report.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 26-MAR-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, lot number, expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with 1 dose of VARIVAX (Merck) and 1 dose of M-M-R II that were reconstituted with sterile diluent (dose and lot number unspecified) which was expired at the end of January 2015. It was confirmed that VARIVAX (Merck) and M-M-R II were not expired. No adverse effect was reported. No product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. On 17-FEB-2014, the patient was vaccinated with the first dose and on 27-MAY-2014, the patient was vaccinated with the second dose of GARDASIL, 0.5 ml, intramuscular. At the time of the report, the patient did not received the third yet. The physician was going to give the patient the third soon. No adverse experiences were reported. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Nausea, Nodule
Clinical narrative: Swelling at the site of administration within 60 sec. Patient c/o nausea within 5 min of administration. The nausea cleared after 10-15 min but a knot about 2x3 cm remained. No further swelling or any other symptoms.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Local adverse reaction - thigh cellulitis extends 5 x 7 cm in diameter.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a nurse via other company, refers to herself, currently 72 years old female patient. The patient's concurrent conditions included drug allergy to gabapentin, unspecified nonsteroidal anti-inflammatory drug, tramadol, tetanus antitoxin, lactose intolerance. On an unknown date, the patient was vaccinated with a booster dose of PNEUMOVAX 23 in the left arm (dose, route, lot # and expiration date were not reported). On an unknown date, the patient experienced cellulitis of left upper arm. The outcome of the event was unknown. The relatedness between the event and the vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report was receive from a pharmacist via company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient's grandfather was subcutaneously vaccinated with ZOSTAVAX (dose, anatomical location, lot# and expiration date were not reported). The patient's grandfather did not experience any adverse effects. On an unknown date, the patient was diagnosed with shingles. The outcome of the event was unknown. The relatedness between ZOSTAVAX and the event was not reported. Additional information is not expected, the reporter did not wish to be contacted.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age. On an unknown date in approximately 2013 ("about a year ago") the patient was vaccinated with first dose of ZOSTAVAX (lot #, dose and route were not reported). On approximately 25-NOV-2014 ("about two weeks ago") the patient was vaccinated with the second dose of ZOSTAVAX (lot #, dose and route were not reported), which was considered as an extra dose. No adverse events reported. Follow up information has been received from the pharmacist referring to the 73 year old female patient. On 25-FEB-2013, the patient was vaccinated with her second dose of ZOSTAVAX (lot # H020845, expiration date 20-FEB-2014) subcutaneously in the left arm, which was considered as an extra dose. No reaction was noted. Additional information is not expected since follow up information has been received. Reporter, patient, therapy, event and narrative were updated.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse reported that, on 16-MAR-2015, the patient was administered with an expired dose of M-M-R II, lot # J003002, expiration date: 14-MAR-2015, albumin status: HSA, 0.5 ml, subcutaneous. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a healthcare worker referring to patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 23-MAR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), 0.5 ml, subcutaneously (lot # and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 36 year old female patient. The patient's pertinent medical history was not reported. On 16-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K009809, expiration date: 16-MAY-2015 (dose and route of administration were not provided). No information regarding concomitant medications was reported. On 17-MAR-2015, the patient developed a large lump at the injection site that was red and burning. On the same day (on 17-MAR-2015), the patient went to an unspecified urgent care facility for evaluation and she was prescribed an unspecified dose of prednisone. The outcome of the large lump at the injection site that was red and burning was unknown. The relatedness between the event and the vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported. On an unknown date in 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose volume, frequency, lot number, expiry date were not reported). At the time of vaccination, the patient took concomitant medication ZOVIRAX, 800mg daily. The reporter asked if the patient should receive another dose of ZOSTAVAX. The pharmacist's colleague, also the pharmacist, stated that the patient did not experience any adverse effects. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Since 27-FEB-2015 the patients were vaccinated with VARIVAX (Merck) (dose and route of vaccination were not provided) which were exposed to temperatures outside of the recommended range on unspecified. No adverse effects have been reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot to touch, pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received KINRIX vaccine IM in left upper arm 3/17 developed redness, heat and swelling in left arm from elbow to shoulder. Resolved in 2 days. Hx cow's milk allergy-hives, peanut-swelling. Received PEDITRIX and INFANRIX same reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 02-SEP-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a nurse and it refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 18-MAR-2015, the patient was vaccinated with expired dose of PROQUAD (Merck) (0.5 ml, subcutaneously, lot # reported as J009884, expiration date: 12-FEB-2015). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant medication and medical history were not provided. "About a year ago", in approximately 2014, the patient was vaccinated with her first dose of GARDASIL (injection, lot#, dose and route were unspecified). Currently, in approximately March 2015, the patient received her second dose of GARDASIL in the office (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician via field representative referring to a 12 years old female patient. In June 2013 the patient was vaccinated with the first dose of GARDASIL (lot number, dose and route were unknown). Concomitantly the patient received a dose of TDAP in June 2013, shortly after the vaccination, the patient developed a high fever that lasted for 4 hours (considered as recovered). The causality between GARDASIL and the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient were not reported. On 03-DEC-2014 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 22-OCT-2014 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 24-SEP-2014 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. 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: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 13-AUG-2014 the patient was vaccinated with one dose of GARDASISL (lot # J009788, expiration date 17-MAR-2016, dose was unknown, intramuscularly) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received form same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a certificated medical assistant referring to two female patients of unknown age. On 19-MAR-2015 the patients were inadvertently vaccinated with a 0.5ml dose of VAQTA intramuscularly (lot# unknown) (accidental overdose). No adverse effects reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: This spontaneous report as received from a consumer refers to a 23 years old female patient. The patient was vaccinated with first dose of GARDASIL in January 2010 and with second dose on 10-JUN-2010. On 10-JUN-2010 the patient experienced lightheadedness and was feeling fuzzy and weird. The consumer received the second dose six months after the first dose, which is other than indicated in the Prescribing Information and she discontinued the series after the second dose. The patient did not receive treatment. The outcome of events was reported as recovered on 12-JUN-2010. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose, route and lot # not reported) in the gluteus. Additional information is not expected. There is no contact information.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a consumer (patient's husband) refers to the female patient of unknown age. About 7 years ago in 2007, the female patient received PNEUMOVAX23 (dose/frequency, therapy route, lot # and expiry date unspecified) to prevent disease. She experienced a red, hot, swelling, itchy and tenderness sensations on her arms, at the point of injection. Outcome of the events were unknown. Causality assessment was not provided. This is one of several reports from the same reporter (MARRS # 1503USA012500). Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Bursitis, Drug administered at inappropriate site, Injection site discomfort, Injection site injury, Injection site joint inflammation
Clinical narrative: Pharmacist injected high into my joint area which inflamed and have bursitis.  Still having pain and discomfort ongoing since injury occurred.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Pharmacist injected high into my joint area which inflamed and have bursitis.  Still having pain and discomfort ongoing since injury occurred.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood test, Herpes zoster, Myalgia, Polymyalgia rheumatica
Clinical narrative: Developed PMR from Zostavax (Shingles Vaccine) which required numerous doctor visits and blood tests. On going problems, to date (3-28-2014) and continued use of pain medications.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Developed PMR from Zostavax (Shingles Vaccine) which required numerous doctor visits and blood tests. On going problems, to date (3-28-2014) and continued use of pain medications.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Developed PMR from Zostavax (Shingles Vaccine) which required numerous doctor visits and blood tests. On going problems, to date (3-28-2014) and continued use of pain medications.
Age: 38.0
Sex: M
Vaccine: HEPAB, PNC13
Symptoms: Chills, Decreased appetite, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Symptoms: redness, swelling, pain at site of injection. Tightness of chest. Treatment: patient self-treated with BENADRYL. ER treatment: EPIPEN and Prednisone was getting better by 3/26/15 and no pain by 3/28/15.
Age: 38.0
Sex: M
Vaccine: HEPAB, PNC13
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Symptoms: redness, swelling, pain at site of injection. Tightness of chest. Treatment: patient self-treated with BENADRYL. ER treatment: EPIPEN and Prednisone was getting better by 3/26/15 and no pain by 3/28/15.
Age: 38.0
Sex: M
Vaccine: HEPAB, PNC13
Symptoms: Chest discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Symptoms: redness, swelling, pain at site of injection. Tightness of chest. Treatment: patient self-treated with BENADRYL. ER treatment: EPIPEN and Prednisone was getting better by 3/26/15 and no pain by 3/28/15.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer refers to her 60 years old husband. The patient's medical history, concurrent condition and concomitant medications were not reported. On 07-MAR-2015, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date, route, application site were not reported) for the prevention of shingles. On 08-MAR-2015 (reported as the day after getting ZOSTAVAX) his ears started "feeling funny". On the same day, the he also experienced headache and shooting pains accompanied by a burning sensation, all of which occurred on his face without rash and redness. The patient did not seek medical attention. There was no treatment given for the events. The relatedness between the events and ZOSTAVAX was not reported. The outcome of the events was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Ear discomfort, Facial pain, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to her 60 years old husband. The patient's medical history, concurrent condition and concomitant medications were not reported. On 07-MAR-2015, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date, route, application site were not reported) for the prevention of shingles. On 08-MAR-2015 (reported as the day after getting ZOSTAVAX) his ears started "feeling funny". On the same day, the he also experienced headache and shooting pains accompanied by a burning sensation, all of which occurred on his face without rash and redness. The patient did not seek medical attention. There was no treatment given for the events. The relatedness between the events and ZOSTAVAX was not reported. The outcome of the events was not reported. Additional information has been requested.
Age: 1.79
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Full body rash.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Back pain, Electrocardiogram normal, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: Pt states that immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back.  She also felt nausous all evening and had tingling in her fingers on both hands.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Nausea, Paraesthesia
Clinical narrative: Pt states that immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back.  She also felt nausous all evening and had tingling in her fingers on both hands.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Back pain, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain, Nausea
Clinical narrative: Pt states that immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back.  She also felt nausous all evening and had tingling in her fingers on both hands.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Paraesthesia
Clinical narrative: Pt states that immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back.  She also felt nausous all evening and had tingling in her fingers on both hands.
Age: 1.05
Sex: F
Vaccine: HEP, MMR
Symptoms: Decreased appetite, Fatigue, Poor peripheral circulation, Pyrexia, Rash generalised
Clinical narrative: Fever between 99-102, full body rash, poor circulation in hands and feet, extreme fatigue, loss of appetite.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Myalgia, Nasopharyngitis, Pyrexia, Respiratory tract congestion
Clinical narrative: General cold symptoms: congestion, cough, mild fever. Additionally, mild muscle pain at location of vaccination shot.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site reaction
Clinical narrative: General cold symptoms: congestion, cough, mild fever. Additionally, mild muscle pain at location of vaccination shot.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Injection site pain, Oropharyngeal pain
Clinical narrative: Chills, soreness at site of injection, sore throat, cough.