chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 11 year old female patient (the physician's niece). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (exact dose, route of administration, lot # and expiration date were not reported). On an unknown date, after having VARIVAX (Merck) received, the patient experienced shingles. The outcome of shingles was unknown. The relatedness between shingles and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Flushing, Urticaria
Clinical narrative: Approximately 5 min. after receiving vaccines, nurse returned to room and noticed child's face was flushed on further exam she noticed hives on arms, face and abdomen. Child was take to provider for evaluation. Provider stated child was having reaction. Order given to give epinephrine 1:1000, 0.15 cc SQ stat. Epinephrine given and symptoms started improving within a couple of minutes. Child observed for over 1/2 hour, symptoms completely resolved. Lungs remained clear. Child was discharged to home. Given instructions to got to ER if any problems.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient. There were no concomitant medications, pertinent medical history, drug reactions or allergies. On 08-MAR-2016, the patient was vaccinated with ZOSTAVAX subcutaneously, lot # reported as L037791, exp. 30-DEC-2016 (dose was not reported). On 08-MAR-2016, the patient experienced redness and swelling at the injection site that was "about the size of a half dollar." The pharmacist stated the patient also reported that the redness "streaked down toward the elbow." No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and the vaccine was not provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Rheumatoid factor
Clinical narrative: Trouble with shoulder joints; pain. Called/went to doctor who sent him for testing for rheumatoid arthritis. Prednisone helped a little. Still has pain.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patent of unknown age. The patient was administered a dose of GARDASIL on 25-OCT-2010 (dose, frequency, indication, route of administration were not reported). On 08-MAR-2016, the patient was in the office and received a dose of GARDASIL 9, (her second dose of a HPV vaccine). No adverse effect reported. This administration schedule was outside the labeled recommendations in both vaccines prescribing information. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 12-MAR-2016, the patient was vaccinated with the dose of ZOSTAVAX injection, lot # L033311, expiration date 01-DEC-2016 (dose and route of administration were not reported). The patient had no concomitant medications. Approximately on 12-MAR-2016 (it was unspecified if the adverse events developed on 12-MAR-2016 or 13-MAR-2016), the patient developed a red, circular rash the size of a half dollar or a little bigger, below the injection site and it itched horribly. The patient sought medical attention via calling pharmacy. No treatment was given for the adverse events and no lab diagnostic studies were performed. The outcome of the adverse events and the causality between the adverse events and ZOSTAVAX were not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date approximately in 2016 (also reported as unspecified dates since 01-FEB-2016) the patient was vaccinated with GARDASIL 9 (lot # L019297, expiry date 18-AUG-2017) (Lot # L004014, expiry date 04-MAR-2017) (lot # L013429, expiry date 21-JUN-2017) (Lot # L043213, expiry date 28-AUG-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 33.4 degrees Fahrenheit for 2 hours and 51.4 degrees Fahrenheit for 1.5 hours. No adverse effects were reported. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of the events was unknown. It was reported that the vaccines that underwent temperature excursion were administered. It was reported that there was no previous temperature excursion. It was also reported that this case was being reported due to a data logger. This case is linked to case numbers 1603USA002167, 1603USA007489, 1603USA007490 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). On 09-FEB-2016, the patient received the second dose of GARDASIL 9 (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). On 10-MAR-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # L045711, expiration date: 08-MAY-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 11-MAR-2016, the patient was inadvertently administered an expired dose of ROTATEQ (Lot # K005273, expiration date: 23-FEB-2016) (dose not provided) oral. Concomitant medications were not provided. No adverse effects were reported. 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 healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date approximately in 2016 (also reported as unspecified dates since 01-FEB-2016) the patient was vaccinated with RECOMBIVAX HB (lot # L027733, expiry date 13-MAR-2017) (Lot # L033343, expiry date 13-SEP-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 33.4 degrees Fahrenheit for 2 hours and 51.4 degrees Fahrenheit for 1.5 hours (incorrect product storage). No adverse effects were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. It was reported that the vaccines that underwent temperature excursion were administered. It was reported that there was no previous temperature excursion. It was also reported that this case was being reported due to a data logger. This case is linked to case numbers 1603USA002167, 1603USA007490, 1603USA007491 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route of administration were not reported) (Lot# L030871, expiration date 10-JUN-2018; Lot# L035880, expiration date 11-AUG-2018). No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of two reports from the same source (1603USA5084). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date approximately in 2016 (also reported as unspecified dates since 01-FEB-2016) the patient was vaccinated with ROTATEQ (lot # L010837, expiry date 16-FEB-2017) (Lot # L027070, expiry date 30-APR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the vaccines were exposed to a temperature of 33.4 degrees Fahrenheit for 2 hours and 51.4 degrees Fahrenheit for 1.5 hours (incorrect product storage). No adverse effects were reported. The action taken with the therapy with ROTATEQ was unknown. The outcome of the events was unknown. It was reported that the vaccines that underwent temperature excursion were administered. It was reported that there was no previous temperature excursion. It was also reported that this case was being reported due to a data logger. This case is linked to case numbers 1603USA002167, 1603USA007489, 1603USA007491 via same reporter link. 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 health professional referring to unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (Lot# K011562, expiration date 08-APR-2017; Lot# L035105, expiration date 14-MAY-2017). No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of two reports from the same source (1603USA007484). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, these patients were vaccinated with incorrectly stored single dose vials of PNEUMOVAX 23 (lot # L019835, expiry date: 23-MAR-2017). The vaccine doses were exposed to the following conditions: 1.7 degree C temperature, for a time frame of 3 months. There were no previous excursions. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dosing regimen and lot # unspecified). No concomitant medications were reported. It was reported that on an unknown date patient was vaccinated with ZOSTAVAX and the patient subsequently developed shingles. No further information pertaining to this event was reported. There was no product quality complaint involved. The outcome of herpes zoster was unknown. Causality assessment was not reported. 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 healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, improperly stored doses of VAQTA lot # K000943 with expiration date 24-SEP-2016 (dose and route of administration not reported) were administered to the patients. It was reported that the vaccines underwent a temperature excursion of 34.4 degrees Fahrenheit for 8 hours. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Nausea
Clinical narrative: About 30 seconds after receiving vaccine, patient felt heart palpitations, felt hot and nauseous/dizzy. Patient's skin became very flushed. Redness lasted around two minutes. Patient felt back to normal after about 6 minutes.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Palpitations
Clinical narrative: About 30 seconds after receiving vaccine, patient felt heart palpitations, felt hot and nauseous/dizzy. Patient's skin became very flushed. Redness lasted around two minutes. Patient felt back to normal after about 6 minutes.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Heart rate decreased, Hyperhidrosis, Hypotension, Pallor, Syncope
Clinical narrative: Patient had a brief syncopal episode after receiving immunizations. Patient became pale diaphoretic, and hypotensive. Patient was transferred per EMS to hospital. Patient was alert and oriented at transportation. Blood pressure and heart rate remained low. Unable to reach parent.
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Anxiety, Pruritus, Urticaria
Clinical narrative: Urticaria pruritus and anxiety. Epinephrine 0.3 mg once.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Syncope
Clinical narrative: Pt experienced syncope within 30 minutes of injection. Pt was held for more minutes until symptoms and vital signs normalized.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On approximately 02-FEB-2016 (reported as 3 weeks before 23-FEB-2016) the patient was vaccinated with ZOSTAVAX injection (lot number, expiry date, dose, administration route, anatomical site of injection and frequency were not reported). In 2016, the patient required to be treated with HUMIRA for an unspecified reason. At the time of this report, the outcome of adverse event was unknown. The reporter did not provide a causality between the reported event and the administration of ZOSTAVAX. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Cold sweat, Pain, Pain in extremity, Photosensitivity reaction, Pyrexia
Clinical narrative: Pt first experienced pain in right arm and down his right side. Pt reports waking up with fever, clamminess, and emesis x 6. Pt also reports photosensitivity on drive over.
Age: 24.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: Pt first experienced pain in right arm and down his right side. Pt reports waking up with fever, clamminess, and emesis x 6. Pt also reports photosensitivity on drive over.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysphonia, Eyelid ptosis, Facial paralysis, Lip swelling
Clinical narrative: 68 year old male who presented to clinic 11/09/15 for herpes zoster vaccine administration at 0900; patient had no history of previous drug/vaccine/food allergies or reactions in the past. Patient was administered herpes zoster vaccine (0.65mL, manufacturer Merck, SQ, left-deltoid, lot L021609, Exp. 10/Sept/2016) by RN and provided current V.I.S. in print. Approximately 1 hour post administration patient phoned clinic reporting "swelling to his lips and scratching in his throat", which appeared approximately 30 minutes after vaccine administration. Patient spoke to volunteer who referred patients call to RN, who consulted physician and had patient return to clinic immediately. Patient reported to clinic at approximately 1000 and was found to have right-sided facial swelling, right-sided mouth drooping, bilateral jaw discomfort, slight voice changes, and mild dizziness upon standing from a seated position. Patient's vitals were BP 136/71, P 63, O2 saturation 99%, and RR 18. Patient was administered dexamethasone 4mg IM and diphenhydramine 50mg PO. After 15 minutes of observations symptoms showed no worsening and patient was instructed to have a companion drive him home with instructions to report to ER or call 911 if symptoms worsened. Patient's symptoms had resolved upon follow-up on 12/08/15 at clinic.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in jaw, Swelling face, Throat irritation
Clinical narrative: 68 year old male who presented to clinic 11/09/15 for herpes zoster vaccine administration at 0900; patient had no history of previous drug/vaccine/food allergies or reactions in the past. Patient was administered herpes zoster vaccine (0.65mL, manufacturer Merck, SQ, left-deltoid, lot L021609, Exp. 10/Sept/2016) by RN and provided current V.I.S. in print. Approximately 1 hour post administration patient phoned clinic reporting "swelling to his lips and scratching in his throat", which appeared approximately 30 minutes after vaccine administration. Patient spoke to volunteer who referred patients call to RN, who consulted physician and had patient return to clinic immediately. Patient reported to clinic at approximately 1000 and was found to have right-sided facial swelling, right-sided mouth drooping, bilateral jaw discomfort, slight voice changes, and mild dizziness upon standing from a seated position. Patient's vitals were BP 136/71, P 63, O2 saturation 99%, and RR 18. Patient was administered dexamethasone 4mg IM and diphenhydramine 50mg PO. After 15 minutes of observations symptoms showed no worsening and patient was instructed to have a companion drive him home with instructions to report to ER or call 911 if symptoms worsened. Patient's symptoms had resolved upon follow-up on 12/08/15 at clinic.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration
Clinical narrative: 31 year old male presented to the administrative medicine clinic for a primary care intake exam with PMH significant for hearing loss, astigmatism and sciatica. Patient reported no known drug allergies upon intake. Patient was administered pneumococcal conjugate vaccine (0.5 mL; Left deltoid; Man: Wyeth; Exp: 2/17; Lot # : L99273) at approximately 1130 on 12/18/15. Patient reported no symptoms upon initial administration. Patient phone clinic on 12/22/15 to report worsening erythema and induration to triage nurse. Patient advised to report to clinic 12/23/15 where localized erythema and induration were documented, systemic symptoms including swelling, anaphylaxis, and hives were notably absent. Patient was prescribed a methylprednisolone taper and advised to contact EMS/911 should symptoms worsen or fail to improve. Patient lost to follow-up thereafter.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Bradycardia, Electrocardiogram, Hypotension, Immediate post-injection reaction, Presyncope
Clinical narrative: Vasovagal reaction noted at time of visit immediately following injection of vaccine. Bradycardia and hypotensive; prolonged reaction, x 20 min. ultimately transported via EMD to local ED for further eval. - Pt. was d/c'd after 1-2 h observation.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left posterior thigh developed few days after MMR injection - required course of antibiotics to treat.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: ZOSTAVAX administered 3-10-16 at 4:10 pm. She stated she noticed a red, raised area on the back of her (R) arm after work on Fri, March 11, 2016 at approximately PM. She stated it started itching Saturday. She has only used plain lotion at site. The site measures 1 inch x 1 inch (L x W) today (3-14-16) at 4:10 pm, it is red and raised, but not itchy. There is a discolored area and I also measured this discolored area and the red area together (2 inches x 1 1/2 inches) (L x W).
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site mass
Clinical narrative: 1 mm lump left thigh, noticed a few weeks after vaccines, which led to a doctors visit.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Rash
Clinical narrative: This spontaneous report was received from a physician and a 68 year old female consumer with asthma, chronic obstructive pulmonary disease, anxiety and with no drug reactions or allergies. In approximately March 2015, "about a year ago", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported) in the left arm. Concomitant therapies included PREVNAR 13, Tdap and fluoxetine. The consumer reported that on 04-MAR-2016, "3 days ago", she experienced shingles in the form of a palm size rash on the back of her right leg. The physician did not receive treatment for the shingles. There were no lab diagnosis or studies performed. The physician reported that the patient was seen in the office on 07-MAR-2016 due to developing soreness and an unspecified rash on 06-MAR-2016 at the injection site of where the PREVNAR 13 and Tdap were administered. The outcome of shingles was reported as not recovered. The outcome of soreness and unspecified rash was unknown. Soreness and unspecified rash at the injection site were considered to be related to the vaccination with PREVNAR 13 and Tdap. 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 nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (route and lot # not reported). The nurse reported that the office often saw patients that were diagnosed with the shingles after receiving ZOSTAVAX. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 102.5.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K020800, expiration date 05-JUN-2016, strength, dose, dose# and route unknown). No adverse effect reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse via a company representative referring to a 56 year old female patient who was also a nurse. On 14-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency were not reported) subcutaneously. Approximately on 15-NOV-2013 (reported as 24 to 48 hours after receiving the dose of ZOSTAVAX), the patient developed "weeping blisters" at the injection site and over the entire upper arm. The entire upper arm was also red, swollen, and painful (unspecified date). The patient still had a "dark spot, that was not really a scar, the size of a half-dollar" on her upper arm (unspecified date). The patient sought medical attention via visiting the nurse. Treatment including dry and soothe the area was given for the events. The event of injection site blister was resolved in 2013 (reported as "within 2 to 3 weeks"). The outcome of skin blotches was not recovered. The outcome of the other events was recovered within 2 to 3 weeks (unspecified date). Causality was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Rash macular
Clinical narrative: Information has been received from a nurse via a company representative referring to a 56 year old female patient who was also a nurse. On 14-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency were not reported) subcutaneously. Approximately on 15-NOV-2013 (reported as 24 to 48 hours after receiving the dose of ZOSTAVAX), the patient developed "weeping blisters" at the injection site and over the entire upper arm. The entire upper arm was also red, swollen, and painful (unspecified date). The patient still had a "dark spot, that was not really a scar, the size of a half-dollar" on her upper arm (unspecified date). The patient sought medical attention via visiting the nurse. Treatment including dry and soothe the area was given for the events. The event of injection site blister was resolved in 2013 (reported as "within 2 to 3 weeks"). The outcome of skin blotches was not recovered. The outcome of the other events was recovered within 2 to 3 weeks (unspecified date). Causality was not reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Fever over 104, large lump on thigh where shot was given.  Lump increased in size. Fever lasted several days which required trip to ER.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site
Clinical narrative: Patient has not contacted us. Daughter states that "shot was given too high and her arm has not been right since". Patient did seek medical treatment.
Age: 29.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Induration, erythema, tenderness just below the injection site. Monitoring symptoms, no treatment indicated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Information has been received from a physician via field employee referring to a 60 year old female patient. On 22-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAX (subdermal, dose and lot# were unknown). In 2016 the patient's upper arm (unspecified which arm) turned red and became swollen. The underneath side of that same arm was inflamed and swollen as well. The patient went back to the clinic on an unspecified date in 2016 and received an unspecified cortisone cream and an ice treatment to treat the symptoms. The physician stated it took about a week to ten days for the reactions to disappear. The outcome of the events was reported as recovered/resolved in 2016. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was orally vaccinated with improperly stored dose of ROTATEQ (dose, frequency and indication were not reported; lot # L037924 with expiration date: 22-JUN-2017). Concomitant therapy was not reported. No adverse effect 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 was received from a healthcare worker refers to 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, 6 unspecified patients were vaccinated with improperly stored VARIVAX lot # L015046 (expiry date: 29-APR-2017) (dosage not reported). The VARIVAX doses were at a temperature of 8F. The time frame was 29 days. No adverse effects reported. No additional information provided. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to a 23 year old female patient. No concurrent condition or medical history was reported. On 22-FEB-206, the patient was vaccinated with GARDASIL (lot # K016966, exp. 10-MAY-2017, dose 2, dose and route of administration not provided). No concomitant therapy was reported. It was reported that the patient was given pregnancy test on 22-FEB-2016, prior to vaccination, which cam back negative. The healthcare worker reported that on 01-MAR-2016, the patient administered a home pregnancy test which resulted in a positive result. The patient was currently 9 weeks gestation. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date, the patient was vaccinated with improperly stored (temperature 44.2 F and time frame 75 hours) doses of VARIVAX (Merck) (lot # L021211, exp. 10-JUN-2017 and lot # L029467, exp. 06-AUG-2017) (dose and route of administration not provided). No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to a patient of unknown age and gender. On 31-JUL-2012 the patient was vaccinated with the first dose of quadrivalent human papillomavirus recomb. vaccine (unidentified Merck) (strength, dose, frequency and route were unknown). On 09-MAR-2016 the patient was vaccinated with the second dose of quadrivalent human papillomavirus recomb. vaccine (unidentified Merck) (strength, dose, frequency and roué were unknown). No adverse events were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen injection site, hot, and size of tennis ball.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram, Generalised tonic-clonic seizure
Clinical narrative: Grand mal seizures. 1st - 16 hours after vaccination. 2nd - 24 hours after vaccination. Anticonvulsant drugs given.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: X-ray
Clinical narrative: Grand mal seizures. 1st - 16 hours after vaccination. 2nd - 24 hours after vaccination. Anticonvulsant drugs given.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (dose, frequency, route of administration and indication were not reported; lot # L023387 with expiration date: 22-JUN-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Diabetes mellitus
Clinical narrative: This is a spontaneous report from a non contactable Nurse via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 (Exp: May17. Lot. n. M51192) via an unspecified route of administration at single dose on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced diabetes on an unspecified date with outcome of unknown. No follow up attempts possible. No further information expected.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Aphasia, Asthenia, Muscular weakness, Pharyngeal disorder, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable 94-year-old female consumer reporting for herself. A 94-year-old female patient received PREVNAR 13 intramuscular at 0.5ml, single on 01Oct2015. Medical history included renal disorder (she had only one good kidney, the other is working on at 5%), blood pressure high, lung cancer from 2001, arthritis, diphtheria (she had diphtheria when she was young), voice box was paralyzed (her voice box was paralyzed because of diphtheria), leaky valves (treated with COUMADIN), heart rate irregular (treated with CARDIZEM). She had to stop taking Glipizide since she was having bladder infection that was due to the Glipizide and she also was having swollen ankles, that has gone down to normal. Concomitant medication included DIOVAN 80 mg, 2x/day from 2001 and ongoing for blood pressure high, CARDIZEM 120 mg, 2x/day started before 2000 and ongoing to regulate the heartbeat, COUMADIN 4mg every day, except for the 2mg on two days ongoing for leaky valves. She was taken Digoxin and PRONESTYL, it did not work anymore. Since PREVNAR 13 vaccination, she has experienced throat problems and one day she could not talk in 2015. She was diagnosed with pneumonia a month or so before this report (she was unable to remember exact date). She also experienced the throat problems within a couple months after having the vaccination. She also had weak legs in 2015 a month after getting vaccination. On 13Feb2016, she had 2 TIAs, where she had garble speech. She will have a MRI relating to her garbled speech. The outcome of TIA was unknown: she stated she was getting a little weak, but there was an age factor also. The outcome of pneumonia and one day she could not talk was recovered. The outcome of throat problems and weak legs was not recovered.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Speech disorder, Transient ischaemic attack
Clinical narrative: This is a spontaneous report from a contactable 94-year-old female consumer reporting for herself. A 94-year-old female patient received PREVNAR 13 intramuscular at 0.5ml, single on 01Oct2015. Medical history included renal disorder (she had only one good kidney, the other is working on at 5%), blood pressure high, lung cancer from 2001, arthritis, diphtheria (she had diphtheria when she was young), voice box was paralyzed (her voice box was paralyzed because of diphtheria), leaky valves (treated with COUMADIN), heart rate irregular (treated with CARDIZEM). She had to stop taking Glipizide since she was having bladder infection that was due to the Glipizide and she also was having swollen ankles, that has gone down to normal. Concomitant medication included DIOVAN 80 mg, 2x/day from 2001 and ongoing for blood pressure high, CARDIZEM 120 mg, 2x/day started before 2000 and ongoing to regulate the heartbeat, COUMADIN 4mg every day, except for the 2mg on two days ongoing for leaky valves. She was taken Digoxin and PRONESTYL, it did not work anymore. Since PREVNAR 13 vaccination, she has experienced throat problems and one day she could not talk in 2015. She was diagnosed with pneumonia a month or so before this report (she was unable to remember exact date). She also experienced the throat problems within a couple months after having the vaccination. She also had weak legs in 2015 a month after getting vaccination. On 13Feb2016, she had 2 TIAs, where she had garble speech. She will have a MRI relating to her garbled speech. The outcome of TIA was unknown: she stated she was getting a little weak, but there was an age factor also. The outcome of pneumonia and one day she could not talk was recovered. The outcome of throat problems and weak legs was not recovered.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Immediate post-injection reaction, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient is a 73-year-old female who presents today for left arm pain and itching right after the shot. She denies any fever, chills. She has not really taken anything for the itchiness. She has not use any cool compresses. She is right-handed. The redness has not spread significantly. It is warm.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Hyperhidrosis, Laboratory test normal
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration, 2 weeks before the report, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced unexplained sweats and chest pressure a week after vaccination and presented to emergency room. The doctors could not find any explanation. 2 weeks later she was admitted to hospital due to the events. Full work-up was done: no reason for her symptoms was found. Patient was otherwise in good health. Outcome of the events was unknown.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Injection site cellulitis, Injection site erythema, Localised infection
Clinical narrative: This is a spontaneous report from a contactable consumer (research scientist at Pfizer) reporting for her brother-in-law. A 67-year-old male patient received pneumococcal 13-val (manufacturer not provided) via an unspecified route of administration, on 24Feb2016, at single dose. Medical history included rheumatoid arthritis. The patient was taking unspecified medications. Since an unspecified date in Feb2016 the patient arm was inflamed and red and they were trying to get him to the urgent care because it looked like an infection. The reporter mentioned that the arm was red where the shot was given and se had seen the picture and it looked like cellulitis or the beginning of it. No treatment was received. Events outcome was unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj in the reporter's country. This may be a duplicate report in situations were another Marketing Authorization Holder of pneumococcal 13-val con vac has submitted the same report to the regulatory authorities.    This is a spontaneous report from a contactable consumer (research scientist at Pfizer) reporting for her brother-in-law. A 67-year-old male patient received PREVNAR 13 (manufacturer not provided) via an unspecified route of administration, on 24Feb2016, at single dose. Medical history included rheumatoid arthritis. The patient was taking unspecified medications. Since an unspecified date in Feb2016 the patient arm was inflamed and red and they were trying to get him to the urgent care because it looked like an infection. The reporter mentioned that the arm was red where the shot was given and she had seen the picture and it looked like cellulitis or the beginning of it. No treatment was received. Events outcome was unknown. Pfizer is Marketing Authorization Holder of PREVNAR 13 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of PREVNAR 13 has submitted the same report to the regulatory authorities.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Overdose
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. It was reported that the patient received "four or five" doses (not simultaneously) of GARDASIL over the course of several unspecified dates. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a consumer (the patient's friend) referring to a male patient of unknown age. The patient had polio years ago. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, strength and route unknown). In 2015 (reported as sometime last year) the patient experienced a shingles rash all over his back. The patient sought medical attention by physician visit. The outcome of the event was unknown. Causality was not provided. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. On 11-MAR-2016, the patient was inadvertently vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # and expiry date unspecified). The vaccine was exposed to the following conditions: 87 degree F temperature, for a time from of 8 hours. There were no previous excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was orally vaccinated with improperly stored dose of oral, ROTATEQ (dose, frequency and indication w ere not reported; lot # L037924 with expiration date: 22-JUN-2017). Concomitant therapy was not reported. No adverse effect 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 was received from a medical assistant regarding unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L002419. expiry date-23-JUL-2017 (dose, route and anatomical location were not reported). No adverse effects were reported. Product storage temperature was 18 F, for a time frame of 30 minutes, there were previous administered excursions reported, 6 F for 10 hours and 5 minutes. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was vaccinated with improperly stored dose of oral, ROTATEQ (dose, frequency and indication were not reported; lot # L037924 with expiration date: 22-JUN-2017). Concomitant therapies was not reported. No adverse effect 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 was received from a medical assistant regarding unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored and VARIVAX (Merck) lot #L002217, expiry date 21-JAN-2017 (dose, route and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. Product storage temperature was 18 F, for a time frame of 30 minutes, there were previous administered excursions reported, 6 F for 10 hours and 5 minutes. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant via facility referring to a 13 year old female patient. The patient had no medical history, concurrent condition and past drug history. On 14-MAR-2016 the patient was vaccinated with an adult dose of VAQTA (1 ml, once, lot # L017757, expiry date: 08-APR-2018, route unknown) (overdose). There was no concomitant therapy reported. There was no relevant lab work. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was orally vaccinated with improperly stored dose of ROTATEQ (dose, frequency and indication were not reported; lot # L027726 with expiration date: 10-MAY-2017). Concomitant therapy was not reported. No adverse effect 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 was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (dose, frequency, route of administration and indication were not reported; lot # L023387 with expiration date: 22-JUN-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. RECOMBIVAX HB and VAQTA.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR_2016, the patient was vaccinated with improperly stored dose of VAQTA (dose, frequency, route of administration and indication were not reported; lot # L023936 with expiration date: 15-MAR-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-MAR-2016, the patient was vaccinated with an expired dose of PROAUD (Merck) (lot # K012919, expiration date: 28-FEB-2016; dose and route were not provided). No known adverse effects were reported. Additional information has been requested.