chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Serum sickness
Clinical narrative: 4.75 x 5 indurated, warm macule left deltoid on 11/4/14 after flu vacc on 11/3/14 in left deltoid. Went to ED 11/25/14 with severe arthralgias and dx'd with poss serum rxn, which improved with steroid taper.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Client stated she can eat cooked eggs. Client given, 25 cc FLUZONE IM, a 1/2 a dose. Within about 30 seconds and 1 minutes; client developed severe SOB, chest tightness and pain; client given epinephrine 0.5 mg (.5 cc) followed by BENADRYL 50 mg IM and 02 2l. By the time the ambulance arrived; she recovered.
Age: 40.0
Sex: F
Vaccine: FLUR3
Symptoms: Dizziness, Dry skin, Eye irritation, Headache, Nausea
Clinical narrative: Administered vaccine to RD at 0830; at 0845, pt began c/o dizziness; BP 112/87, AP 71, R 16; skin W and D; pt stated BP normally decreased - systolic runs 98-100; dizziness cont to increase; BP taken 0850-122/90, AP 16, R-12 nonlabored; pt. began c/o headache and eyes burning; nausea; skin remained warm and dry; no flushing noted.
Age: 40.0
Sex: F
Vaccine: FLUR3
Symptoms: Skin warm
Clinical narrative: Administered vaccine to RD at 0830; at 0845, pt began c/o dizziness; BP 112/87, AP 71, R 16; skin W and D; pt stated BP normally decreased - systolic runs 98-100; dizziness cont to increase; BP taken 0850-122/90, AP 16, R-12 nonlabored; pt. began c/o headache and eyes burning; nausea; skin remained warm and dry; no flushing noted.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: Rec'd vaccine on 10-23; on 10-24, arm became very sore and was painful to move; on 10-25, lymph nodes in (L) axilla became swollen and painful, site began having body aches, chills, fever, headache, sore throat; sxs lasted until 11-1; did not see MD.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Rec'd vaccine on 10-23; on 10-24, arm became very sore and was painful to move; on 10-25, lymph nodes in (L) axilla became swollen and painful, site began having body aches, chills, fever, headache, sore throat; sxs lasted until 11-1; did not see MD.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Back pain, Joint range of motion decreased, Musculoskeletal chest pain, Pain
Clinical narrative: Rec'd Flu vaccine in RD on 11-5; on 11-6, began having extreme pain to right side of back, right axilla, right chest wall, voices pain upon moving right arm, decreased ROM; sxs cont today but are improving.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Eye irritation, Headache, Injection site pain
Clinical narrative: Pt received seasonal flu vaccine 11-5-14 RD; Began having Rt arm pain from shoulder to wrist 11-6-14; Noticed lymph nodes enlargement on 11-6 as well. Weakness, headache, burning eyes, pain and stiffness to (R) side of neck, congestion began pm of 11-6; no fever.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neck pain, Pain in extremity, Upper respiratory tract congestion
Clinical narrative: Pt received seasonal flu vaccine 11-5-14 RD; Began having Rt arm pain from shoulder to wrist 11-6-14; Noticed lymph nodes enlargement on 11-6 as well. Weakness, headache, burning eyes, pain and stiffness to (R) side of neck, congestion began pm of 11-6; no fever.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Lip blister, Lip disorder, Lip swelling, Oral mucosal blistering
Clinical narrative: Pt had flu shot at school flu clinic. At PM (bedtime) pt c/o lips feeling "silky" parent advised to go to bed. When pt awoke in A.M. parent advised lips swollen above nose with 8 blisters on top lip, 4 on bottom lip, blisters inside mouth, and skin "blotchy". Parent gave pt BENADRYL - 11-1-14 pt started vomiting all weekend taken to PCP 11-3-14. PCP uncertain of reaction but advised parent to notify HD. Culture done on blisters (dried) 11-3-14 at PCP per mom. 11/24/14 - cultures were not obtained.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Rash macular, Vomiting
Clinical narrative: Pt had flu shot at school flu clinic. At PM (bedtime) pt c/o lips feeling "silky" parent advised to go to bed. When pt awoke in A.M. parent advised lips swollen above nose with 8 blisters on top lip, 4 on bottom lip, blisters inside mouth, and skin "blotchy". Parent gave pt BENADRYL - 11-1-14 pt started vomiting all weekend taken to PCP 11-3-14. PCP uncertain of reaction but advised parent to notify HD. Culture done on blisters (dried) 11-3-14 at PCP per mom. 11/24/14 - cultures were not obtained.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe redness swelling (2-5 day onset) around injection site. 2-3.5 inch red circles. 1-1 inch red circle.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, Skin reaction, Urticaria
Clinical narrative: Localized skin reaction-hives/itching right arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
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, an unspecified number of patients were vaccinated with ROTATEQ via oral (dose, lot # and expiration date were not reported). It was reported that ROTATEQ was involved in excursion of 30.6 F for 90 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Fall, Pallor, Staring
Clinical narrative: As the vaccine was being injected into patient's arm, he started to drop forward. He had is eyes open in a blank stare. He slowly fell into my arms and his dad came to push him back into the chair. He had a blank stare on his face for another few minutes. Then his face lost all coloring and looked as if he had fainted. Then he recognized his surroundings but was confused. His confusion lasted for about 7-10 min and then he was back to normal.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: She came in 12/01, reported rxn with Flu shot on 11/20/14. Pt has uncontrolled shaking starting about 5 hours after shot. Took ASA and BENADRYL and it went away after few hours.
Age: 71.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Swelling
Clinical narrative: Large swelling below injection sight.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Seen in our clinic 2 days after injection w/local redness, swelling and itchiness and injection site. Treated w/BENADRYL.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a 69 year old male patient. Medical history was responded as none. Drug allergy/reactions was reported as none. On 15-NOV-2014 the patient was vaccinated with ZOSTAVAX (strength, dose, frequency not provided) in the left arm for he hasn't had one yet and wanted to get one to be safe. Concomitant therapies included aspirin (manufacturer unknown) and cyanocobalamin (manufacturer unknown). On 16-NOV-2014, the patient woke up in morning drenched. On 17-NOV-2014 patient visited office with red and swollen left arm and high temperature. There was no treatment given for the events. Patient sought medical attention and was seen in the office. The outcome of the events was reported as not recovered/not resolved The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hyperhidrosis, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a 69 year old male patient. Medical history was responded as none. Drug allergy/reactions was reported as none. On 15-NOV-2014 the patient was vaccinated with ZOSTAVAX (strength, dose, frequency not provided) in the left arm for he hasn't had one yet and wanted to get one to be safe. Concomitant therapies included aspirin (manufacturer unknown) and cyanocobalamin (manufacturer unknown). On 16-NOV-2014, the patient woke up in morning drenched. On 17-NOV-2014 patient visited office with red and swollen left arm and high temperature. There was no treatment given for the events. Patient sought medical attention and was seen in the office. The outcome of the events was reported as not recovered/not resolved The reporter did not provide the causality between the events and the suspect therapy. 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 (certified medical assistant) refers to a patient of unknown age. On 13-SEP-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, expiration date, dose and route not reported) which was exposed to unknown out of range temperatures since 25-JUL-2014. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 02-DEC-2013, the two unspecified patients were vaccinated with PROQUAD, 0.5ml subcutaneously, lot # J006569, expiration date 30-NOV-2014. The patients received doses of PROQUAD (Merck) but were supposed to receive M-M-R II. The doses of PROQUAD (Merck0 that were administered were exposed to temperature outside of the proper storage range. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 30-JUL-2014, the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, expiration date, dose and route not reported) which was exposed to unknown out of range temperatures since 25-JUL-2014. No adverse symptoms were reported. This is one of several reports 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 17-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 20-AUG-2014, the patient was vaccinated with a dose of (Merck) VARIVAX (lot#, expiration date, dose and route not reported) which was exposed to unknown out of range temperatures since 25-JUL-2014. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Gait disturbance, Injection site reaction, Injection site warmth, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to his mother who was an 89 year old female patient with hearing impaired and osteoarthritis. On 18-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route not reported) for prevention of shingles. The patient developed injection site reaction after receiving ZOSTAVAX on 18-NOV-2014. The patient reported to the pharmacist that she had "heat at site", general malaise, worsening of pre-existing osteoarthritis, more trouble walking with "aches in all her muscles" since 18-NOV-2014 (reported as 6 days ago). The patient did not seek medical attention and no treatment was given for the events. The outcome of the events was reported as not recovered (ongoing). This is one of several reports received from the same source. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Osteoarthritis
Clinical narrative: This spontaneous report as received from a pharmacist refers to his mother who was an 89 year old female patient with hearing impaired and osteoarthritis. On 18-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route not reported) for prevention of shingles. The patient developed injection site reaction after receiving ZOSTAVAX on 18-NOV-2014. The patient reported to the pharmacist that she had "heat at site", general malaise, worsening of pre-existing osteoarthritis, more trouble walking with "aches in all her muscles" since 18-NOV-2014 (reported as 6 days ago). The patient did not seek medical attention and no treatment was given for the events. The outcome of the events was reported as not recovered (ongoing). This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and indication were not provided). On an unknown date the patient experienced severe abdominal pain. The patient sought medical attention by calling the pharmacist to ask her for guidance, and the pharmacist told the patient to call her back if the abdominal pain did not resolved "in a few days." The representative did not know whether or not the patient has recovered, and she did not know if the patient notified her primary healthcare provider. The pharmacist did not hear back from the patient. The representative did not know the date of the ZOSTAVAX administrator any identifying information of the patient. She did not known if the patient received any treatment. The outcome of severe abdominal pain was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to himself of unknown age. In 2012 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (lot#, dose, dose# and route not reported. The patient developed a mild injection site reaction after receiving ZOSTAVAX (in 2012). The outcome of the event was reported as recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown gender and age. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route not reported). On an unknown date the patients were diagnosed with zoster. At the time of reporting, the outcome of zoster was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to his wife of unkonwn age. In 2012 (reported as 2 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route not reported). The patient developed a mild injection site reaction after receiving ZOSTAVAX (in 2012). The outcome of the event was reported as recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Between July 2014 and August 2014, the unspecified number of patients were vaccinated with doses of  (Merck) VARIVAX (dose and frequency not reported, J003706 expiration date 27-MAR-2015) that were improperly stored. The nurse reported that, there had been no reports of adverse events following the vaccination administration. The nurse also reported that the vaccines were administered to a population of pediatric patients "going into the seventh grade". Action taken on (Merck) VARIVAX was not reported. Outcome of the events were not reported. Causality was not reported. This case has been linked to Case# 1411USA007487 as same reporter link. 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 20-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 17-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. Medical history and drug allergies were reported as none. On 04-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose: 0.65 ml, subcutaneous, anatomical location not reported, lot # K009200, expiration date 27-SEP-2015). Concomitant medication included: unspecified pain and hormonal medications. On an unspecified date, approximately in November 2014, date the patient developed redness and itchiness at the injection site. The patient sought medical attention via visit at pharmacy on 07-NOV-2014. The outcome of redness and itchiness at the injection site was not reported. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a midwife refers to a 32 years old female patient. The patient's history of previous pregnancies and live births was unknown. The patient was vaccinated with (Merck) VARIVAX (dose, route and lot # not reported), part of the Merck Pregnancy Registry products "in middle of June of 2012" and the patient was "4 weeks pregnant". The patient was not demonstrating or reporting any adverse effects. No other co-suspects were reported. No concomitant medications were reported. The patient's LMP was on 14-MAY-2012 and EDD was on 18-FEB-2013. Initial exposure to (Merck) VARIVAX was at 4 weeks(s). The patient was exposed to (Merck) (VARIVAX) during trimester 1. No treatment information was reported. The outcome was unknown. Follow up information received on 04-NOV-2014. A phone call was placed to the Midwife. The phone was answered by a receptionist who stated that without patient first and last name, there was no way to locate for outcome pregnancy data. The phone call was finally transferred to Ob/GYN Midwife area, and a message was left. The Midwife might remember the name of the patient. On the same day, a phone call was received from the Midwife. The Midwife was unable to re-call the name of the patient. The name of the patient was needed to recover the patient's records. The Midwife did remember that the pregnancy was without incident. The Midwife had no additional information to share. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Speech disorder
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. There was no medical history and drug reaction or allergies. On 17-OCT-2014, the patient was vaccinated with ZOSTAVAX vial, dose 1 vial taken subcutaneously to prevent shingles. The lot number J014818 is an invalid lot number of zoster vaccine live. The expiry date of the product was reported as 20-FEB-2015. Concomitant therapies included CELEXA, IMDUR, REQUIP, FENOFIBRATE, SYNTHROID, RANEXA, PRAVACHOL, PRILOSEC, LOPRESSOR, NITROSTAT, EFFIENT and AMBIEN. On 18-OCT-2014 (reported as the next day when woke up after vaccination), the patient woke up real hoarse and was barely able to talk. No treatment was given for the adverse event. The patient sought medical attention by calling to the pharmacy on 31-OCT-2014. No intervention was done to prevent the serious criteria. No laboratory diagnostic studies were performed. There was no product quality complaint involved. The reporter stated that on 31-OCT-2014. the patient was still hoarse and he had not heard from since. The outcome of the event "was still hoarse" was not recovered and of the event "barely able to talk" was unknown. The causality was unknown. 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 the unspecified number of patients of unknown age and gender. It was reported that 42 doses of PNEUMOVAX 23 (doses and units were not reported) were improperly stored and administered to patient since 11-SEP-2014. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a third party claims administrator, concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # 1947AA, .05 ml. It was also noted ZOSTAVAX involved in the incident (conflicting information). The patient was diagnosed with cellulitis after receiving the PNEUMOVAX 23. At the time of the report, the outcome of cellulitis was unknown. 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 registered nurse refers to unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with (Merck) VARIVAX (dose, route of administration were not reported) lot number: K002049, expiry date: 10-FEB-2016 that had been improperly stored. No adverse effects were reported. Additional information is not expected because the nurse did not give a consent for the follow-up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Blister, Herpes zoster
Clinical narrative: This spontaneous report as received from a 70 year old male patient who was physician. The patient had drug reactions/allergies to APRESOLINE and sulphonamide. The patient has no pertinent medical history. On an unknown date the patient mistakenly dropped "1 or 2 drops" of ZOSTAVAX onto an open cut on his right thumb while drawing up ZOSTAVAX (indication: accidental exposure). Concomitant therapies included EDARBI, FLOMAX, and NUVIGIL. On an unknown date, the physician stated "2 weeks later" he developed shingles on his "right side which eventually spread all the way up to the right side of his face". The physician stated he had "minimal pain" and self prescribed VALTREX and FAMVIR. The physician stated "I have 2 patches of vesicles that were still present in their tertiary phase". None of lab diagnostics studies were performed. No medical attention was sought. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. It was reported that 4 doses of MMR II (doses and units were not reported) were improperly stored and administered to patients since 11-SEP-2014. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 61 year old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 26-NOV-2014, the patient was vaccinated with expired ZOSTAVAX (0.65 ml, subcutaneously, lot#J007208, exp.date: 20-SEP-2014, anatomical location was not reported). No adverse effects were reported. The outcome of the event was unknown. Additional information is not expected, the reporter does not wish to be contacted.
Sex: U
Vaccine: HPV4
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, an unspecified number of patients were vaccinated with GARDASIL (route, dose, lot # and expiration date were not reported). It was reported that GARDASIL was improperly stored and the temperature excursion was found to be unsupported with in-house stability data. No adverse symptoms were 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: 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, an unspecified number of patients were vaccinated with VAQTA (route, does, lot # and expiration date were not reported). It was reported that VAQTA was improperly stored and the temperature excursion was found to be unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received 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 an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with PNEUMOVAX 23 (route, dose, lot # and expiration date were not reported). It was reported that PNEUMOVAX 23 was improperly stored and the temperature excursion was found to be supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with PEDVAXHIB (route, dose, lot # and expiration date were not reported). It was reported that PEDVAXHIB was improperly stored and the temperature excursion was found to be unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with RECOMBIVAX HB (route, dose, lot # and expiration date were not reported). It was reported that RECOMBIVAX HB was improperly stored and the temperature excursion was found to be supported with in-house stability data. No adverse symptoms were reported. 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 nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Eyelid oedema, Injection site hypersensitivity, Injection site induration
Clinical narrative: Pt received ZOSTAVAX 11-19-14. Developed swelling from eyebrow to nose next am. Describes skin as swollen, puffy, bags under eyes - reddish/purple in color, skin warm and dry and feels like sandpaper. Injection site swollen, hard, sensitive; NKA to food or meds; hx of environmental allergies. Reported incident 11/24/14 because not improving. Used BENADRYL x2 11/28 without improvement. TC with pt 12/1 - totally resolved with OTC cortisone cream and BENADRYL. Also D/C new face cream.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Skin discolouration, Skin swelling, Skin warm, Swelling face
Clinical narrative: Pt received ZOSTAVAX 11-19-14. Developed swelling from eyebrow to nose next am. Describes skin as swollen, puffy, bags under eyes - reddish/purple in color, skin warm and dry and feels like sandpaper. Injection site swollen, hard, sensitive; NKA to food or meds; hx of environmental allergies. Reported incident 11/24/14 because not improving. Used BENADRYL x2 11/28 without improvement. TC with pt 12/1 - totally resolved with OTC cortisone cream and BENADRYL. Also D/C new face cream.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site reaction
Clinical narrative: This spontaneous report as received from a consumer who is a 73 year old female patient with high blood pressure. On 11-MAY-2014 the patient was vaccinated with ZOSTAVAX, 1 dose (Lot no, unit not reported) in the arm. On 05-NOV-2014, vaccine was administered in the back of her arm. On 06-NOV-2014, 180 days after onset of therapy the patient experienced injection site reaction. Her arm was now hot, red and swollen where the vaccine was administered. The patient stated that she called the pharmacy where she received the vaccination to report her adverse event. The pharmacist who administered the vaccination, advised the patient to take either MOTRIN or ALEVE and use ice to alleviate her symptoms. The patient followed the same. No lab diagnostic studies were performed. Patient sought medical attention through the pharmacist who administered the vaccine. No hospitalization, product quality complaint was involved. The outcome of the event was not recovered/not resolved. The reporter causality was not reported. The patient had a history of allergy while on prior therapy with prednisone (case # MARRS# 1412USA000391). Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: 11/20/14 17 yr. received MCV4 and Tdap vaccine then walked to lobby with mom at side and became dizzy. He sat in chair. RN laid him on floor with legs elevated and gave juice. Child awake all through episode. Pulse 64 and Reg. Child walked to car without help and mom drove home.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Injection site rash, Nausea, Vomiting
Clinical narrative: Patient had ZOSTAVAX on 11/18/2014 at pharmacy. Very dizzy 2 hours after vaccine. Developed nausea and 1 episode of vomiting. Felt weak on 11/19/2014 A.M. Rash at injection site. No oral lesions.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: Child fainted after immunizations were given and gained consciousness immediately.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Arm swollen red raised area painful to touch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been receive from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reproted as 2-5, units not reported) of unknown gender. On 27-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 24-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Received a ZOSTAVAX vaccine on 11/22/2014 at pharmacy. I am itchy all over my body, and during day two, after vaccine injection.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received from a physician concerning 5-10 immunocompromised patients over the age of 65 years. This report refers to the patients with asplenia. The physician revaccinated the patients with PNEUMOVAX 23 every 10 years. No adverse effects reported. This is one of the two cases received from the same reporter. Additional information is not expected as we can not contact the physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of 0.5 ml improperly GARDASIL that exposed to 32F for 39 hours, intramuscular. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received from a physician concerning 5-10 immunocompromised patients over the age of 65 years. This report refers to the patients with chronic obstructive pulmonary disease (COPD). The physician revaccinated the patients with PNEUMOVAX 23 every 10 years. No adverse effects reported. This is one of the two cases received from the same reporter. Additional information is not expected as we can not contact the physician.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Bordetella test positive, Cough, Pertussis, Rhinorrhoea, Sneezing
Clinical narrative: Pt. had runny nose, sneezing, cough that started aprox. 11-7-14. Cough got so bad he would vomit. Dx: on 11-14-14 and 11-16-14 with pertussis. Treated with Z-PAK, treatment started 11-14-14. (Not healed).
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Pt. had runny nose, sneezing, cough that started aprox. 11-7-14. Cough got so bad he would vomit. Dx: on 11-14-14 and 11-16-14 with pertussis. Treated with Z-PAK, treatment started 11-14-14. (Not healed).
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Lt arm swelling with fever x 3days.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old patient of unknown gender. On 14-OCT-2014 the patient was vaccinated with GARDASIL lot # J010668, expiration date 29-APR-2016) (dose and routed not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 the patients were vaccinated with doses of RECOMBIVAX HB (strength, dosage, route, lot number and expiration date were not reported), that were exposed to a supported temperature excursion since 05-NOV-2014. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 the patients were vaccinated with doses of VAQTA (strength, dosage, route, lot number and expiration date were not reported), that were exposed to a supported temperature excursion since 05-NOV-2014. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 the patients were vaccinated with doses of GARDASIL (strength, dosage, route, lot number and expiration date were not reported), that were exposed to a supported temperature excursion since 05-NOV-2014. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Oral herpes, Pain, Pain in jaw
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient's medical history included feeling an itchy tingle on her lip, cold sore and tongue cancer, she finished radiation 1 year ago in July 2013, currently in remission. On 24-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number and expiration date were not reported), subcutaneous. Concomitant therapies included EPISOL and STATIN. The patient stated that on 25-NOV-2014 (reported as this morning), she had a cold sore on her lip. She stated that she has had three cold sores in the past, and that they were little and not as painful as the current cold sore. She stated that the pain radiates down her jaw, and that she was also having eye pain on the same side. At the time of the report the outcome was reported as not recovered. Patient did not performed lab diagnostic test. Patient seek for medical attention at the pharmacy, but did not received treatment for the events. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to 4 or 5 patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient were vaccinated with ZOSTAVAX lot # K000456, expiration date 15-DEC-2014 subcutaneous. The patients were vaccinated in the same "reasonable amount of time" out of the same box and each experienced a very large injection site welt "giant, the size of a racquetball" in addition the area was red, swollen and itching (on an unknown date). Each consumer's adverse reaction resolved in a few days without treatment (on an unknown date). Patients did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 24-NOV-2014, the patient received an improperly stored fourth dose of RECOMBIVAX HB (lot# H010380 and expiration date was 18-NOV-2014). The RECOMBIVAX HB in question did not have any previous temperature excursions. RECOMBIVAX HB was supported with post-expiry data. Reporter stated the patient received a fourth dose of RECOMBIVAX HB because the second and third dose were given too close together. Reporter mentioned the patient also received RECOMBIVAX HB on 17-FEB-2014, 17-MAR-2014, 23-APR-2014. No adverse symptoms reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Rash pruritic, Skin warm, Swelling
Clinical narrative: Soreness started Saturday. Pt did not see rash until today. Red, itchy rash, hot to the touch, swollen. Rash measures approximately 4 inches east to west and 4 inches north to south.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Urticaria, Wheezing
Clinical narrative: Within 30 min of admininstration began to feel burning sensation on (R) cheek and began to develope hives. Within 2 hrs had developed hives on torso. Pt also had wheezing. Tx SOLU-MEDROL BENADRYL, ZANTAC, MEDROL dose pack.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL. Co-suspect and concomitant therapies were not reported. Patient received her 2nd dose of GARDASIL a year after she received her 1st dose. Patient's third dose was received 12 weeks and four days after her second dose. No adverse effects reported. Additional information has been requested.