chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (nurse) refers to unspecified number of patients of unkown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB. No adverse symptoms were reported. The temperature excursion for RECOMBIVAX HB was supported with in-house stability data. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with RECOMBIVAX HB. This case is related to MARRS# 1410USA015443, 1410USA015943 and 1410USA015945. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Rash, Skin warm, Urticaria
Clinical narrative: Patient received vaccine on 10/23/14 and started noticing soreness and warmth on 10/28/14 and a few small dots. On 10/29/14 the patient's arm is hurting and there is a big raised whelp on her arm and the area is hot.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (nurse) refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL. No adverse symptoms were reported. The temperature excursion for GARDASIL was supported with in-house stability data. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with GARDASIL. This case is related to MARRS# 1410USA015443, 1410USA015493 and 1410USA15944. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccination in a 6-month-old male patient who received KINRIX (batch number DR294, expiry date September 2016). On 2nd October 2014, the patient received KINRIX .5 ml. On an unknown date, the dose was an unknown dose. On 2nd October 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the appropriate age at vaccination to be related to KINRIX. Additional information: KINRIX was given to a 6 month old baby. Meanwhile KINRIX is recommended for children between 4 to 6 years. No adverse event reported. No additional information was available. The case was closed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac function test normal, Chest pain, Pain in extremity, Rash vesicular
Clinical narrative: 10 days after vaccination presented to ER x 2 with  (L) side chest pain and (L) arm pain. Presented to our office on 10/27/14 with typical rash of shingles - this appears to be a classic presentation of shingles on the (L) side. Treated with prednisone and hydrocodone.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, raised, redness in a circular pattern that started day after vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history, drug reactions and allergies were not reported. On 05-OCT-2014, the patient was vaccinated with the first dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number was not reported). On 06-OCT-2014, the patient was vaccinated with a second dose of ZOSTAVX, 0.65 ml, subcutaneous (lot number was not provided). No adverse effects reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 15-OCT-2014 the patient was vaccinated with M-M-R II album status unknown (0.5 ml, subcutaneous; dose number and lot number unknown; EXP:13-SEP-2014). It was reported that the patient received an expired dose of M-M-R II. No adverse effect was reported. Additional information has been requested.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site mass, Rash, Vaccination site rash
Clinical narrative: Developed a lump and rash at site of vaccination with reddness as well as rash under (L) eye.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Legs is red-hot, swollen, hard lump parent advised to monitor for now and if any change come into be seen.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient. In approximately 2012 (about 2 years ago) the patient was vaccinated with the first dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified). On 17-OCT-2014 the patient was vaccinated with the second dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug 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, "yesterday", on 27-OCT-2014 the patient was vaccinated with an expired dose of GARDASIL (dose, route not reported, lot # J005661, expiration date 26-SEP-2014). Concomitant medications were not provided. No adverse effect was reported. Additional information is not expected as the reporter did not want to be contacted.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. "Within the last 5 years", on an unspecified date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, route not reported, 0.5 ml/single dose). Concomitant medications were unspecified. The physician reported that the patient developed severe PNEUMOVAX 23. Unspecified treatment was given for the event. The patient had sought medical attention via an unspecified way. Outcome of the event was reported as recovered on an unknown date. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a female healthcare worker of unknown age refers to herself. In 1991, as an infant, the patient was vaccinated with a dose of RECOMBIVAX HB 2.5/0.5 (unit not reported) (dose, route and lot # not reported). On an unknown date the patient had negative titers for Hepatitis B, after receiving RECOMBIVAX HB. The outcome of negative titers for Hepatitis B was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. On an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX (dose, lot no. and route not reported). No concomitant medication was reported. On unspecified dates, the patients developed shingles after vaccination. The outcome of shingles was unknown. PQC was not involved. The causality of event with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a female healthcare worker refers to her unspecified manager of unknown age and gender. On an unspecified date, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, route and lot # not reported). On an unknown date the patient had negative titers. The outcome of negative titers was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a Registered Nurse via field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # K004281, exp. date 22-MAR-2015 (strength, dose, frequency and route were not provided). On an unknown date the patient experienced cellulitis, after receiving PNEUMOVAX 23. No further demographics were provided for the patient. Many of the fields in this report were marked, "Unspecified by reporter", because the reporter did not have specific information to provide. The outcome of cellulitis  was unknown. The patient sought medical attention and visited the office on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 month old patient. On 27-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot# not reported) 0.5 ml intramuscular. It was reported that the patient, who was intended to receive PREVNAR, was inadvertently administered PNEUMOVAX 23 on 27-OCT-2014. No adverse effects reported. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a Healthcare Worker via field representative refers to a 58 year old male patient. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K007826, exp. date 03-FEB-2016) injection, 1 dose/once, intramuscular (IM) for chronic risk factors. Concomitant therapies included FLOMAX, atorvastatin, ALEVE and VARENICLINE. On 20-OCT-2014, the patient experienced body aches, cough and fever after receiving PNEUMOVAX 23. The patient also had received an unspecified flu shot on 20-OCT-2014. The outcome of cough, fever and body aches was reported as not recovered/not resolved. It was not report whether the patient sought medical attention. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot#, expiration date, route and dose were unknown) which had been stored improperly. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product quality issue, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. On an unknown date, the patient did not receive a full dose of RECOMBIVAX HB (dose, frequency, lot number and route not provided) because the prefilled syringe leaked. Some of the medication got on the patient's skin. No adverse event was reported. Product quality complaint (PQC) reported because the syringe leaked. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 55 year old female patient. There was no a pertinent medical history and drug reaction or allergies. On 15-OCT-2014, the patient was vaccinated with ZOSTAVAX, strength not reported, single dose, product lot# K007988, expiry date: 03-SEP-2015 subcutaneously in the left arm. The patient did not take any concomitant medication. On 16-OCT-2014, the next day after vaccination the patient developed a rash at the injection site. The patient self treated the rash with application of home laser named Q Laser. The area of the rash was now getting larger and was the size of a credit card. No laboratory diagnostics studies were performed. The patient sought medical attention by visiting pharmacy. No intervention was done to prevent the seriousness criteria. There was no product quality complaint involved. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to two patients of unknown demographics. On 23-OCT-2014, two patients were vaccinated with ZOSTAVAX, subcutaneous as prophylactic vaccination. The reporter stated that patient received ZOSTAVAX that was improperly exposed to 29F for 19 hours 40 minutes. No known adverse effects was reported. No product quality complaint was involved. This is one of the several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On an unknown date (start date reported as several years ago) patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). On an unknown date, the patient developed a low grade fever after ZOSTAVAX vaccination. The pharmacist stated that he had no other details about the event and patient present status was unknown. This is one of the several reports from same reporter source. Additional information has been requested.
Age: 1.43
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 children patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported at the time of reporting. Follow up information has been received from a medical assistant. This report refers to 1 year old patient. On 15-AUG-2014 the patient was vaccinated with PEDVAXHIB (lot no. J01343, expiry: 14-AUG-2016). No concomitant medication was reported. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 patients of unknown age and gender. On 28-OCT-2014 the patient were vaccinated with improperly stored PNEUMOVAX 23 (dose, route of administration, lot# and expiry date were not reported). No adverse effect was reported. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # K007824, expiration date: 04-NOV-2015, dose 0.5 ml) subcutaneously in the arm for immunization. On an unknown date the patient experienced redness and swelling on their arm at the injection site. The patients had sought for medical attention by making a phone call to office. The outcome of the events was unknown. The caller requested a lot check for PNEUMOVAX 23 lot # K007824 with expiration date: 04-NOV-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 children patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported at the time of reporting. Follow up information has been received from medical assistant. This report refers to a 1 month old patient. On 19-AUG-2014 the patient was vaccinated with PEDVAXHIB (lot no. J01343, expiry: 14-AUG-2016). No concomitant medication was reported. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 children patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported at time of reporting. Follow up information has been received from a medical assistant. This report refers to 3 year old patient. On 29-AUG-2014 the patient was vaccinated with PEDVAXHIB (lot no. J01343, expiry: 14-AUG-2016). No concomitant medication was reported. On 29-AUG-2014, patient was vaccinated with improperly stored PEDVAXHIB. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This literature marketed report as received from a pharmacist refers to a 76 year old patient of unknown gender. The patient's drug allergies and medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX while on therapy with paclitaxel and trastuzumab. On an unknown date the patient experienced unspecified rash following the administration which was treated with famcyclovir. The outcome of unspecified rash was unknown. The causality of the unspecified rash was unknown. No product complaint was reported for ZOSTAVAX. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's pertinent medical history and current condition was not reported. On 14-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K007824 and expiry date 05-NOV-2015), 0.5 ml, intramuscular. Other suspect therapies included FLUZONE (high dose). On an unknown date the patient experienced severe reaction with erythema and swelling of the upper arm after receiving PNEUMOVAX 23 and FLUZONE (high dose) in the same arm. The outcome of swelling of the upper arm after receiving PNEUMOVAX 23 and severe reaction with erythema was unknown. Causality was unspecified by the reporter. This is one of the several reports received from the same reporter (MARRS # 1410USA007922, 1410USA012696, 1410USA012695 and 1410USA008504). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with codeine allergy and sulfa allergy. The patient's pertinent medical history was not reported. On 14-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K007824 and expiry date 05-NOV-2015), 0.5 ml, intramuscular. Other suspect therapies included FLUZONE (high dose). On an unknown date the patient experienced severe reaction with erythema and swelling of the upper arm after receiving PNEUMOVAX 23 and FLUZONE (high dose) in the same arm. The outcome of swelling of the upper arm after receiving PNEUMOVAX 23 and severe reaction with erythema and swelling of the upper arm after receiving PNEUMOVAX 23 and FLUZONE (high dose) in the same arm. The outcome of swelling of the upper arm after receiving PNEUMOVAX 23 and severe reaction with erythema was unknown. Causality was unspecified by the reporter. This is one of the several reports received from the same reporter (MARRS # 1410USA007922, 1410USA012696, 1410USA012695 and 1410USA015698). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (health care worker) refers to approximately 23 year old female patient. Current conditions and medical history was not reported. On 24-OCT-2014 (reported as today) the patient was vaccinated with M-M-R II injection, lot # H017432, expiry date 20-SEP-2014, 0.5 milliliter (ml), subcutaneous in the right arm. Concomitant medications were not reported. On 24-OCT-2014 (reported as today) patient was vaccinated with expired M-M-R II vaccine. No adverse effects reported at this time. Product quality complaint was not reported.
Sex: F
Vaccine: PPV
Symptoms: Chills, Lymphadenopathy, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age with no drug reactions/allergies. The patient's medical history included Hepatitis C. On 21-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (route and dose not reported, lot # K010016, expiration date 05-AUG-2015). Concomitant therapies included atorvastatin and omeprazole (manufacturer unknown). On 21-OCT-2014 the patient experienced achiness through the whole body, chills, fever, swollen lymph nodes and a sore throat after receiving PNEUMOVAX 23. There were an unspecified over the counter medications given as a treatment. There was no lab diagnostic studies performed. The outcomes of the events were reported as recovering. The patient did not seek medical attention. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. Pertinent medical history was unknown. Approximately in 2012 (reported as 2 years ago and the reporter was not able to confirm the date) the patient was vaccinated with ZOSTAVAX (dose was reported as 1 vaccination, route of administration, anatomical location and lot number was unknown). Concomitant medications were unspecified by reporter. Approximately on 25-SEP-2014 (reported as 3 weeks ago) the patient experienced mild case of shingles. The outcome of mild case of shingles was unknown. The causality was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist (also reported as healthcare student) refers to a patient of unknown demographics. On 27-OCT-2014 the patient was vaccinated with an expired dose of PEDVAXHIB (thimerosal free), lot # unspecified, expiry date: 24-OCT-2014, intramuscular. Dose supported. No adverse experience was reported. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with PEDVAXHIB. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported that skin around vaccination site became red and hot. About 2 inches in diameter. It also swelled a little. Cleared up in a few days. Approximately 3 days per patient.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, .65 ml, single dose, subcutaneous. On an unknown date the patient developed shingles after receiving ZOSTAVAX. On an unknown date the patient sought unspecified medical attention. Outcome of event was reported as recovered. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an unspecified number of doses of PROQUAD (Merck) (lot number, expiry date unknown) that were improperly stored for many years and no adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: 10/23 Itching chin and scalp. 10/24 Burning feet. 10/24 Rash. 10/25 Swollen hands, erythematous. Swelling tongue and feet. 10/25 Urgent care facility. 10/25 Epinephrine. 10/25 Vomit x 2.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Swollen tongue, Vomiting
Clinical narrative: 10/23 Itching chin and scalp. 10/24 Burning feet. 10/24 Rash. 10/25 Swollen hands, erythematous. Swelling tongue and feet. 10/25 Urgent care facility. 10/25 Epinephrine. 10/25 Vomit x 2.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an unspecified number of doses of VARIVAX (Merck) (lot number, expiry date unknown) that were improperly stored for many years and no adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # K007824, expiration date: 04-NOV-2015, dose 0.5 ml) intramuscularly. The patients also received an unspecified Influenza vaccine at the same visit. On an unknown date the patient experienced nausea, vomiting, body aches and a fever with a temperature above 101 degrees F. after receiving PNEUMOVAX 23. The patient had sought for medical attention by making a phone call to office. The outcome of the events was unknown. The caller requested a lot check for PNEUMOVAX 23 lot # K007824 with expiration date: 04-NOV-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Hyperventilation, Injection site pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 13 year old male patient. In October 2014 the patient was vaccinated with the second dose of GARDASIL (dose, route not reported, lot # reported as K006191 with expiration date 02-FEB-2017) . Concomitant therapies included FLUMIST. The physician reported that the patient (about 6 hours after injection) experienced pain at the injection site and "sort of" a hyperventilating episode on 28-OCT-2014 after being administered the second dose of GARDASIL. MOTRIN and hot compresses on arm were given for the events. The patient had sought medical attention by given medical advice over the phone. Outcome of the events was not reported. Additional information is not expected as the physician did not want to be contacted.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Asthma, Decreased appetite, Fatigue, Injection site erythema
Clinical narrative: Anorexia, nausea, asthma, myalgia. Asthenia. Fatigue. Injection site pain, soreness, redness.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea
Clinical narrative: Anorexia, nausea, asthma, myalgia. Asthenia. Fatigue. Injection site pain, soreness, redness.
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. On 27-OCT-2014 (yesterday) the patient was inadvertently administered an expired dose of ZOSTAVAX (lot J008530, expiration date 12-OCT-2014) (dose, route unspecified). No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 60 year old female patient with no known allergies. On 11-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K000326, expiration date 27-FEB-2015, dose not reported, subcutaneously). On 11-OCT-2014 the patient experienced upper respiratory infection after receiving ZOSTAVAX. The patient sought medical attention via seeing physician. The patient was prescribed prednisone (tapering doses) and Z-PAK (also reported Z-PACK) on 28-OCT-2014 to treat the event. The outcome of the event was unknown. Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, PPV, DTAPIPVHIB, PNC13
Symptoms: Crying, Diet refusal, Eating disorder, Insomnia, Screaming
Clinical narrative: The parents reported that "about a half an hour after arriving at home he started crying and screaming in a high pitched tone for 6 hours straight". The parents noted "he could not relax" and his body became straight and stiff the entire 6 hours. He also "was not eating and sleeping the same until days later". He was not seen in our office or the emergency department for this adverse reaction.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, PPV, DTAPIPVHIB, PNC13
Symptoms: Crying, Decreased appetite, Insomnia, Musculoskeletal stiffness, Screaming
Clinical narrative: The parents reported that "about a half an hour after arriving at home he started crying and screaming in a high pitched tone for 6 hours straight". The parents noted "he could not relax" and his body became straight and stiff the entire 6 hours. He also "was not eating and sleeping the same until days later". He was not seen in our office or the emergency department for this adverse reaction.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 58 year old female patient. The patient's medical history included active wild-type shingles before she received ZOSTAVAX (date of the episode of shingles was not specified). The patient had no known drug allergies. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous injection (lot # K000327 expiration date: 05-MAR-2015) 0.65 ml, subcutaneously in the left arm (reproted as left deltoid). Concomitant therapy included unspecified diabetic and thyroid medication. On 10-OCT-2014, the patient experienced redness at her injection site "since she received the dose of ZOSTAVAX". On an unknown date in October 2014, the patient also experienced bumps under the skin. on 17-OCT-2014, when the patient was in the pharmacy, she mentioned her injection-site adverse experience to the pharmacist. The reporter observed the injection site and stated that, in addition to the injection site being red, there appeared to be "bumps under the skin". The patient did not receive any treatment for the adverse events. The reproter stated that the patient spoke freely and was in no apparent distress. The reporter also reported that the patient did not exhibit any other adverse effects and that the patient was unlikely to return to the pharmacy as she didn't seem concerned. There was no product quality complaint involved. The outcome of the events was not reported. Action taken with the suspect product and the causality was not provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 58 year old female patient. The patient's medical history included active wild-type shingles before she received ZOSTAVAX (date of the episode of shingles was not specified). The patient had no known drug allergies. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous injection (lot # K000327 expiration date: 05-MAR-2015) 0.65 ml, subcutaneously in the left arm (reproted as left deltoid). Concomitant therapy included unspecified diabetic and thyroid medication. On 10-OCT-2014, the patient experienced redness at her injection site "since she received the dose of ZOSTAVAX". On an unknown date in October 2014, the patient also experienced bumps under the skin. on 17-OCT-2014, when the patient was in the pharmacy, she mentioned her injection-site adverse experience to the pharmacist. The reporter observed the injection site and stated that, in addition to the injection site being red, there appeared to be "bumps under the skin". The patient did not receive any treatment for the adverse events. The reproter stated that the patient spoke freely and was in no apparent distress. The reporter also reported that the patient did not exhibit any other adverse effects and that the patient was unlikely to return to the pharmacy as she didn't seem concerned. There was no product quality complaint involved. The outcome of the events was not reported. Action taken with the suspect product and the causality was not provided. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Cellulitis, Chest discomfort, Erythema, Local swelling
Clinical narrative: Patient had to go to emergency room and had been diagnosed with cellulitis and was given a script for doxycycline.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient had to go to emergency room and had been diagnosed with cellulitis and was given a script for doxycycline.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: Patient had to go to emergency room and had been diagnosed with cellulitis and was given a script for doxycycline.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Patient had to go to emergency room and had been diagnosed with cellulitis and was given a script for doxycycline.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood test, Cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a patient's daughter refers to her 79 year old mother. The patient's pertinent concurrent condition included diabetes and allergy to penicillin and medical history included atrial fibrillation. On 29-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose and frequency not reported), lot # H018608, expiration date: 02-JUL-2014, injection in the right arm. Concomitant therapies included AFLURIA (vaccinated on 29-SEP-2014 in the left arm), COUMADIN, CRESTOR, BACTRIM, metoprolol, metformin, losartan, digoxin, diltiazem hydrochloride, Omega-3 and vitamins (unspecified). On 29-SEP-2014, in the evening of the vaccination date, the patient complained of soreness in the right arm. She had a restless night trying to sleep. On 30-SEP-2014, the reporter noticed that the mother's arm was red just below the injection site for about 6 inches down including the elbow which was swollen. The redness was about 3 inches wide. The next day the redness had turned purple and the reporter called the doctor who advised the patient to go to the emergency room. The patient was diagnosed as having cellulitis, given an injected antibiotic and medication to take at home: stool softener, pain pills, and an antibiotic, drug names all unspecified. At present, on 02-OCT-2014, the patient was better. The arm was still red. There was no problem with her left arm. On an unspecified date, the patient performed blood work for diabetes (result unknown). The outcome of the adverse events was reported as recovering/resolving. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: This spontaneous report as received from a patient's daughter refers to her 79 year old mother. The patient's pertinent concurrent condition included diabetes and allergy to penicillin and medical history included atrial fibrillation. On 29-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose and frequency not reported), lot # H018608, expiration date: 02-JUL-2014, injection in the right arm. Concomitant therapies included AFLURIA (vaccinated on 29-SEP-2014 in the left arm), COUMADIN, CRESTOR, BACTRIM, metoprolol, metformin, losartan, digoxin, diltiazem hydrochloride, Omega-3 and vitamins (unspecified). On 29-SEP-2014, in the evening of the vaccination date, the patient complained of soreness in the right arm. She had a restless night trying to sleep. On 30-SEP-2014, the reporter noticed that the mother's arm was red just below the injection site for about 6 inches down including the elbow which was swollen. The redness was about 3 inches wide. The next day the redness had turned purple and the reporter called the doctor who advised the patient to go to the emergency room. The patient was diagnosed as having cellulitis, given an injected antibiotic and medication to take at home: stool softener, pain pills, and an antibiotic, drug names all unspecified. At present, on 02-OCT-2014, the patient was better. The arm was still red. There was no problem with her left arm. On an unspecified date, the patient performed blood work for diabetes (result unknown). The outcome of the adverse events was reported as recovering/resolving. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood test, Cellulitis, Injection site erythema, Injection site joint swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a patient's daughter refers to her 79 year old mother. The patient's pertinent concurrent condition included diabetes and allergy to penicillin and medical history included atrial fibrillation. On 29-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose and frequency not reported), lot # H018608, expiration date: 02-JUL-2014, injection in the right arm. Concomitant therapies included AFLURIA (vaccinated on 29-SEP-2014 in the left arm), COUMADIN, CRESTOR, BACTRIM, metoprolol, metformin, losartan, digoxin, diltiazem hydrochloride, Omega-3 and vitamins (unspecified). On 29-SEP-2014, in the evening of the vaccination date, the patient complained of soreness in the right arm. She had a restless night trying to sleep. On 30-SEP-2014, the reporter noticed that the mother's arm was red just below the injection site for about 6 inches down including the elbow which was swollen. The redness was about 3 inches wide. The next day the redness had turned purple and the reporter called the doctor who advised the patient to go to the emergency room. The patient was diagnosed as having cellulitis, given an injected antibiotic and medication to take at home: stool softener, pain pills, and an antibiotic, drug names all unspecified. At present, on 02-OCT-2014, the patient was better. The arm was still red. There was no problem with her left arm. On an unspecified date, the patient performed blood work for diabetes (result unknown). The outcome of the adverse events was reported as recovering/resolving. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Depressed level of consciousness, Glucose urine present, Hypoglycaemia, Somnolence, Unresponsive to stimuli
Clinical narrative: Lethargy, decreased responsiveness developed in the morning of 10/21. Presented to clinic in afternoon, found to be hypothermic, hypoglycemic.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urine ketone body present
Clinical narrative: Lethargy, decreased responsiveness developed in the morning of 10/21. Presented to clinic in afternoon, found to be hypothermic, hypoglycemic.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose decreased, Hypoglycaemia, Hyporesponsive to stimuli, Hypothermia, Lethargy
Clinical narrative: Lethargy, decreased responsiveness developed in the morning of 10/21. Presented to clinic in afternoon, found to be hypothermic, hypoglycemic.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Rash and headache. 59 y/o female who received ZOSTAVAX and influenza vaccines in the left shoulder at pharmacy on Monday 10/21/14. Has had a generalized headaches since Sunday 10/20/14. Two days ago developed a pink raised painful rash on the left anterior scalp, left forehead, and left upper eyelid. Also has a small red rash on left shoulder near injection site. No eye pain or drainage or change in vision. Denies fever or chills. Denies pain in ears, nose, or throat. No other rashes. No neck stiffness.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS, FLU3, VARZOS
Symptoms: Headache, Injection site reaction, Pain, Rash, Rash erythematous
Clinical narrative: Rash and headache. 59 y/o female who received ZOSTAVAX and influenza vaccines in the left shoulder at pharmacy on Monday 10/21/14. Has had a generalized headaches since Sunday 10/20/14. Two days ago developed a pink raised painful rash on the left anterior scalp, left forehead, and left upper eyelid. Also has a small red rash on left shoulder near injection site. No eye pain or drainage or change in vision. Denies fever or chills. Denies pain in ears, nose, or throat. No other rashes. No neck stiffness.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Pt reported developing hives on the evening following flu vaccine (FLUZONE HD). Pt called to ER and was instructed to take BENADRYL for 2 days.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Erythema at the injection site. Swelling and pain at the injection site. A large nodule forming at the injection site. Red rash at the injection site.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Erythema at the injection site. Swelling and pain at the injection site. A large nodule forming at the injection site. Red rash at the injection site.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, X-ray
Clinical narrative: One month later: pain in shoulder.  Loss of range of motion. 10/14/2014  Given Tramadol, Flexeril prescriptions, told to take ibuprofen, recommended x-ray.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Emotional distress, Injection site erythema, Injection site swelling
Clinical narrative: Leg was red and area around shot was swollen, patient was inconsolable for 2 hours; applied ice to leg and held against chest until fell asleep.
Age: 38.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Fatigue, Chills, Fever, Nightsweats, Muscle pain, Headache, Loss of appetite, Swelling at the site of injection, Red streaking local to site. Treatment: Motrin, Tylenol, Bedrest, Cool compresses to site.
Age: 38.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site streaking, Injection site swelling, Myalgia, Night sweats, Pyrexia
Clinical narrative: Fatigue, Chills, Fever, Nightsweats, Muscle pain, Headache, Loss of appetite, Swelling at the site of injection, Red streaking local to site. Treatment: Motrin, Tylenol, Bedrest, Cool compresses to site.
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Influenza like illness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 20-Oct-2014) concerns a female patient who was allergic to eggs. On an unspecified date, the patient received an unknown flu vaccine (manufacturer and batch number not reported). On an unspecified date, the patient was hospitalised after developing flu like symptoms and dehydration after receiving the unknown flu vaccine. Outcome was not reported.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Wrong vaccine administered for age. No illnesses resulted.
Age: 1.78
Sex: F
Vaccine: FLU4, HEP
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: Patient was given #5 Hepatitis B vaccine. Should have received #2 Hepatitis A vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt states 4 hours after injection developed redness, hardness and swelling to site, muscle aches, neck and back hurting. By morning-pain in elbows, fever and legs feeling like jelly. Medicated with ibuprofen.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Neck pain, Pyrexia
Clinical narrative: Pt states 4 hours after injection developed redness, hardness and swelling to site, muscle aches, neck and back hurting. By morning-pain in elbows, fever and legs feeling like jelly. Medicated with ibuprofen.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: 10/20/2014 THE PATIENT REPORT A HARD RED AREA SIZE OF QUARTER THAT ITCHES AND IS HOT TO TOUCH, NO FEVER OR CHILLS NO OFFICE VISIT NECESSARY. ADVISED COOL PACK INTERMITTENTLY, TYLENOL FOR DISCOMFORT, AND BENADRYL FOR ITCHING AT BEDTIME. SHE IS TO REPORT FURTHER SYMPTOMS.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling, Tenderness
Clinical narrative: Pt noticed arm sore that evening. Next day, noticed unusual redness, swelling, tenderness and itchy that lasted 2 days. By 10/31/14, much improved.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness and redness at injection site, Patient was advised to use cold compress and take NSAID for soreness.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Blindness unilateral, Dizziness, Retinal disorder, Vascular occlusion
Clinical narrative: EYE BEGAN TO CLOUD, PATIENT FELT WEAK, DIZZY, WITHIN 3 HOURS OF RECEIVING PREVNAR 13 INJECTION, SIGH IN 1 EYE COMPLETELY GONE.  MD SPECULATES A CLOT BLOCKED BLOOD SUPPLY TO EYE, LEADING TO RETINA FAILURE AND LOSS OF VISION.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Vision blurred
Clinical narrative: EYE BEGAN TO CLOUD, PATIENT FELT WEAK, DIZZY, WITHIN 3 HOURS OF RECEIVING PREVNAR 13 INJECTION, SIGH IN 1 EYE COMPLETELY GONE.  MD SPECULATES A CLOT BLOCKED BLOOD SUPPLY TO EYE, LEADING TO RETINA FAILURE AND LOSS OF VISION.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Ataxia, Computerised tomogram, Diplopia, Enterovirus test negative, Gait disturbance
Clinical narrative: GI illness nausea/vomiting started 10/3/14. Continued for 24 hrs. On 10/4/14 visiual disturbances and gait issues and headache. To ER, dx viral illness continued with symptoms Oct 4 and OCt 5. To clinic Monday the 6th. Concerned possible brain tumor, to another medical center and had MRI and CT done. Transferred to another facility, lumbar puncture and labs done ro meninigis and enterovirus. Ataxia and dipolpia continued 2 doses Immunoglobulin given.