chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Malaise, Pain
Clinical narrative: Pt called and stated that he received the shingles vaccination 01/11/16 and felt fine on Monday but Tue evening and Wed, started to not feel well.  Stated that he felt achy all over like he was getting the flu.  Also stated that at the injection site, it is red, warm to touch, and one blister in the area of the injection site.  Stated that it is a little itchy but no pain at this time.  Advised that the shingles vaccination is a live virus and is possible to have this reaction.  Advised to not pop the blister due to the possibility of it spreading.  Pt stated that today he feels much better. Pt asked what he could use for the itching.  Recommended Benadryl Cream.  Advised to monitor and if no improvement or if symptoms worsen to call our office.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Graft versus host disease, Viral infection
Clinical narrative: Patient described being diagnosed with a Graft vs. Host disease of viral etiology and requires treatment with Prograf. She described onset as a few months after her Shingles vaccine.
Age: 91.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Optic neuritis, Paraesthesia
Clinical narrative: Patient reported tingling above left eye started within 2 days. Patient present to office 1 week after vaccine given (1/27/2016) with signs and symptoms consistent with shingles outbreak and optic neuritis. Treated with acyclovir 500mg 5x per day for 1 week and referred to ophthalmology.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Pain in jaw, Photophobia, Pyrexia, Staring
Clinical narrative: Fever above 102, vomiting, jaw/neck pain, light sensitivity, 4 episodes of staring.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Fever above 102, vomiting, jaw/neck pain, light sensitivity, 4 episodes of staring.
Age: 0.62
Sex: M
Vaccine: FLU4
Symptoms: Electroencephalogram normal, Protrusion tongue, Staring, Unresponsive to stimuli
Clinical narrative: Flu vaccine #2 was administered to a 7 mo. old on 1/8/16, 6 days later on 1/14/16 patient's dad called Dr. stating patient had a 2-3 min episode of no response with tongue hanging out.  Dr. sent them to the ER to be evaluated.  Per the ER note patient's dad described 2 episodes of not responding with eyes fixed. 1st episode x 5-10 secs; 2nd 3 mins. ER physician spoke with a pediatric neurologist who recommend follow-up the next morning.  Neurology ordered an EEG to rule out seizure activity, which was negative.  Per neurology note due to follow up in February.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Quarter size swelling, hot, itchy, soreness and redness at injection site. Treating with ice and Ibuprofen. Symptoms greater than a week after injection.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain, warmth (entire upper arm warm to the touch)and swelling to the point of hardness, of entire left upper arm, between shoulder and elbow.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster, Rash
Clinical narrative: I received the hepatitis B vaccine on 1-21-2016. On 1-22-2016, a rash started to develop on my back & chest (both on left side.) It continued to spread & worsen. On 1-25-2016 my physician diagnosed it as shingles. I called to get lot number & expiration. Manufacturer is Merck. lot # L038018 exp 9-13-2017. It seems a strange coincidence that my shingles breakout began the day after my hepatitis B vaccination.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Macule
Clinical narrative: Immediately after shots pt had red macules with no hives in face- no respiratory distress, no wheezing- given Benadryl 1.25ml at office and monitored for 20 min- no change in respiratory status- back to normal self.
Age: 1.36
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Patient was taken to the ER and diagnosed with febrile seizure. We are not sure whether or not the seizure is related to the vaccines.
Age: 1.28
Sex: M
Vaccine: HIBV, PER, TD
Symptoms: Breath sounds abnormal, Dyspnoea, Respiratory rate increased, Use of accessory respiratory muscles
Clinical narrative: My son started having breathing problems, his chest would go up and down rapidly and you could see his ribs while inhaling and exhaling, he started making heavy breathing noises and required medical attention where they had to put him under the nebulizer, he required 2 doses of their albuterol. My son never had any respiratory issues, nor symptoms of such sort prior to vaccination. The exact date I listed of when he started to show respiratory issues isn't exact but I know it was fairly after receiving his vaccination, and I made sure to come back to his doctor to voice my concerns. He was completely unconcerned and recommended steroids for his condition when it didn't improve and the albuterol stopped working.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Chest X-ray normal, Wheezing
Clinical narrative: Case number PHEH2015US020224, is an initial spontaneous report from a physician received on 08 Oct 2015. This report refers to a 60 years old female patient. The patient had no history of illness. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer: Novartis, batch number: not reported) intramuscularly on 08 Oct 2015. On the same day after vaccination the patient showed signs of moderate to severe bronchitis like reaction (wheezing). The chest X-ray performed indicated negative result. The outcome of event was unknown. Seriousness and causality of the event was not reported. Seriousness assessment of wheezing was upgraded based on information in the source document.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's arm turned red and a little swollen and pain at site of injection.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site joint movement impairment, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Initial localized left shoulder pain and swelling followed by decreased flexion and abduction. Unresponsive to conservative treatment (P.T.) formally diagnosed with frozen shoulder.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rotator cuff syndrome, X-ray limb normal
Clinical narrative: Initial localized left shoulder pain and swelling followed by decreased flexion and abduction. Unresponsive to conservative treatment (P.T.) formally diagnosed with frozen shoulder.
Sex: U
Vaccine: TDAP
Symptoms: Fatigue, Headache, Induration, Peripheral swelling, Pyrexia
Clinical narrative: Headache, fever, tiredness, swelling of the arm, hand hot to touch.
Sex: U
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Headache, fever, tiredness, swelling of the arm, hand hot to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 1-2 hours after getting vaccines, mom states had whelps on hands. Mom came back for us to look at and it had already improved.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (R) thigh - 8 cm x 8 cm red, indurated, warm area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mom reported to MD emesis x 3 within 24 hrs of vaccines with a low grade fever. Emesis was non bloody and non-bilious. "He was fine the next day" per mom.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Erythema, Pain, Pyrexia
Clinical narrative: Pain, redness, swelling, fever, chills and joint pain. Treated with Prednisone and BENADRYL.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Pain, redness, swelling, fever, chills and joint pain. Treated with Prednisone and BENADRYL.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Injection site pruritus, Musculoskeletal pain, Myalgia
Clinical narrative: Fine for 2 days. No reaction at injection site. Next day woke up with severe neck and shoulder pain and fever 101 degrees 0 muscle pain spread to entire body over next 48 hours. Fever 100-101 degrees while on ADVIL for 7-8 days. Severe muscle pain - especially neck shoulders for 2-3 weeks. Mild residual neck and shoulder pain now. 2009 - Developed quarter sized red blistered lesion - extreme itching at injection site - took nearly 6 weeks to heal.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pyrexia
Clinical narrative: Fine for 2 days. No reaction at injection site. Next day woke up with severe neck and shoulder pain and fever 101 degrees 0 muscle pain spread to entire body over next 48 hours. Fever 100-101 degrees while on ADVIL for 7-8 days. Severe muscle pain - especially neck shoulders for 2-3 weeks. Mild residual neck and shoulder pain now. 2009 - Developed quarter sized red blistered lesion - extreme itching at injection site - took nearly 6 weeks to heal.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Skin discolouration
Clinical narrative: Patient presented to the pharmacy on 01/05/2016, with a report of soreness at the site of injection after he got a flu shot at this location on 11/27/2015, two days later he felt the soreness on his right shoulder. He did not report this to a doctor or treat it. He decided to report after he noticed blue discoloration under his arm.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Rhinorrhoea, Swollen tongue, Vomiting
Clinical narrative: Case number PHEH2015US021775, is an initial spontaneous report from a consumer received on 26 Oct 2015. This report refers to a 59 years old female patient. Concurrent condition included celiac disease. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 22 Oct 2015. On the same day after vaccination the patient experienced runny nose in the night. On 23 Oct 2015 the patient experienced tongue swelling and "map" on her tongue. The patient states she only experiences this event when she receives gluten. Further the patient also experienced diarrhea and vomiting (severe). It was reported that the patient never had these reactions in the past after influenza vaccination. Outcome of swollen tongue was condition unchanged and outcome of other events were unknown. Seriousness and causality of the events were not reported. Seriousness assessment of swollen tongue was upgraded based on information in the source document. The case was lost to follow-up as the patient declined to provide HCP contact information.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Throat tightness
Clinical narrative: Case number PHEH2015US021034 is an initial spontaneous report received from a health care professional on 15 Oct 2015. This report refers to a female patient whose age was not reported. Her current condition included allergy to shell fish. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer: Novartis, trade name and batch number: not reported) intramuscularly on 15 Oct 2015. It was reported that on the same day she came back in with a rash and stated that her throat was closing up. The events outcome was unknown. The seriousness of the event was not reported, but the events were upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 26 year old male patient. The patient's historical drugs included a dose of MMRII when he was a child (dates unspecified). On an unspecified date in November 2015, the patient was vaccinated with a booster dose of M-M-R II (HSA) injection (dose, route, anatomical location and lot # were unspecified). There was no concomitant medication described. On an unknown date, the pharmacist noted that the patient had titers drawn for measles, mumps and rubella at four and six weeks after the administration of M-M-R II, and the titers were undetectable. No product quality issue was informed. At the time of this report, the outcome of undetectable titers was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: 1/26/16 - evening (R) upper arm, red, warm, tight. Denies fever or pain. Called office AM of 1/27/16. Advised MOTRIN, compress, monitor. 1/25/16 spoke with dad - area is smaller, better overall.
Age: 0.15
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 6 week old male patient. The patient's medical history was not reported. On 11-JAN-2016, the patient was inadvertently vaccinated with a dose of VAQTA with lot # K005958 and expiry date: 09-FEB-2017 (inappropriate schedule of drug administration). No adverse effects reported. There was no product quality complaints involved. Additional information had been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical student referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 25-JAN-2016, the patient was vaccinated with the third dose of GARDASIL 9 injection (lot # L014415; route, expiration date and anatomical location were not provided). The reporter stated that this dose was administered outside the dosing recommendations as the patient received the third dose shot at 12 months (it was unspecified if it was since the first or second dose). No adverse reactions were reported. Product quality complaint (PQC) was not involved. 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 Registered Nurse and refers to multiple unspecified patients of unknown age and gender. Patients' concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of VAQTA Lot # L042039, expiry date 14-JAN-2017; lot # L030442, expiry date 19-DEC-2016 (dose and route were not reported) that had been exposed to 34.4 F for 2 hours and then back in the range, were given to unspecified patients on an unspecified dates. It was also confirmed that the vaccine had no previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot number L042039 has been verified to be a valid lot number for VAQTA. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX vial, (lot #, expiry dates, dose, frequency and route of administration not reported). On unspecified dates, after the vaccine was injected, some of the dose leaked out of the injection site. No adverse effect reported for these unspecified patients. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Myalgia
Clinical narrative: This spontaneous report as received from a 25-year-old female patient refers to herself. The patient's concurrent conditions included Human papilloma virus infection diagnosed two years ago. Medical history and concomitant therapies were not reported. On 17-DEC-2015, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot# were not reported), intramuscular. Immediately after the vaccination, the patient experienced chronic injection site and muscular pain. Lab diagnostic studies were not performed and the patient did not seek medical attention. At the time of the report, the patient was still experiencing the pain. The causality between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administration error, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, (lot #, expiry date, dose, frequency and route of administration not reported). During administration of ZOSTAVAX, the needle did not go all the way into the patient's skin therefore a bubble appeared under the skin but then slowly went away. Reporter asked if ZOSTAVAX has to be re-administered because patient's skin "bubbled up" after receiving ZOSTAVAX. Pharmacist reported that none of the dose leaked from the injection site for this unspecified patient. The outcome of "bubbled up skin" was recovered (slowly went away). Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided regarding this unspecified patient. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored M-M-R II lot # K015374, expiry date 03-MAR-2017, K020189, expiry date 11-SEP-2016 on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.98
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 11 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 10-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A. will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. In July 2013 the patient was vaccinated with first dose of GARDASIL (dosing details, lot and expiry date not reported). No concomitant medication was reported. The patient was administered with the second dose in series of GARDASIL (dosing details, lot and expiry date not reported) in July 2015 (inappropriate schedule of drug administration). No adverse effects were reported. There were no product quality complaints (PQC) involved. 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 pharmacist refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # L016427, expiry date 13-APR-2017, (dose, frequency and route of administration not reported). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site irritation, Injection site pain, Injection site vesicles
Clinical narrative: This spontaneous report as received from a 53 year old female patient regarding herself. No concurrent conditions or medical history were reported. The patient had a reaction to niacin and also had an interaction between ADVIL and an unspecified antibiotic. In approximately 2012 (reported as three and one half years ago), the patient was vaccinated with ZOSTAVAX (lot, expiry date, dosing details not reported). Concomitant therapies included simvastatin, DIOVAN and PREVACID. Shortly after the vaccination (approximately in 2012), the patient presented with a "bubbly and perforated" skin irritation around the injection site. As the day went on, the injection site area was a little sore. The patient stated that little blisters formed around the injection site. The next day (approximately in 2012), the patient had a blister that "looked like she burned herself". The blister was circular and approximately two inches in diameter. It was "liquidy inside just like a blister". The patient went to the doctor and was told to give it another day. Over the following weekend (approximately in 2012), the injection site was "uncomfortable". No lab diagnostics studies were performed. The patient was afraid she was going to "pop" the blister-like irritation that formed around the injection site. The affected area was approximately four inches in diameter. The patient went to the emergency room because of the pressure she was feeling in this blister-like reaction at the injection site. The area was drained by the emergency room physician. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of an unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was provided. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored GARDASIL 9 lot# L020015 and expiration date 16-AUG-2017, lot# L018351 and expiration date 11-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored ROTATEQ lot # L000568, expiry date 10-JUL-2016, on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the 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 was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored VAQTA lot # K019560, expiry date 02-JUN-2017 for prophylaxis on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the 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 nurse and refers to an unspecified number of patients of an unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was provided. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PNEUMOVAX 23 lot # K008410 and expiration date: 26-FEB-2016, lot # L014420 and expiration date: 23-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. 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 nurse and refers to an unspecified number of patients of an unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was provided. On multiple unspecified dates, the patients were vaccinated with an unspecified number of doses of improperly stored PEDVAXHIB lot # L030868 and expiration date 09-JUN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist via Poison and Drug Center (Case # US16-002654), refers to a patient of unknown age (reported as possibly over 65 years old) and gender. The patient's medical history, concurrent conditions and concomitant medication were unknown. On an unknown date (reported as approximately 3 to 4 weeks ago), the patient was accidentally vaccinated with a dose of VARIVAX (Merck) (route of administration, dose, frequency, lot number and expiration date were unknown) instead of ZOSTAVAX. ZOSTAVAX was not administered. The patient's lab diagnostic studies were unknown. At the time of reporting, the outcome of the event was unknown and it was unknown if the patient would continue VARIVAX (Merck) vaccination. Additional information is not expected as the reporter declined to provide her contact details.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 14-JAN-2016 the patient was vaccinated with GARDASIL lot # J009993 with expiry date 04-DEC-2015 (expired product administered). The dose number in the series of vaccination was unknown. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 1.32
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 month old patient of unknown gender. Information regarding the patient's medical history and current conditions were not provided. On 25-JAN-2016 the patient was vaccinated with improperly stored dose of VARIVAX (Merck), lot number-L035129 and expiry date-14-SEP-2017). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant via Company Representative concerning unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (strength, frequency, route, lot # and Exp. date not reported) outside the recommended time frame. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist via other company Pfizer, refers to a 41-year-old female patient with asthma. Patient had no other pertinent medical history. On 26-SEP-2015 around 12:00, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K009107, expiry date 21-JAN-2016, 0.5 ml, intramuscularly in the left deltoid for asthma. Other suspect therapy included the second dose (the first dose was given 1 year before, in 2014) of FLUVIRIN lot# 15721P, expiry date 30-MAY-2016, intramuscularly, into the left deltoid (dose not reported), administered at the same time. Concomitant medications were not reported. There was no illness at the time of vaccination. In October 2015, the patient experienced pain in hand and arm, where the vaccines were administered, and had trouble lifting it. The patient sought medical attention via doctor's visit. No laboratory studies were performed. The outcome of pain in hand and arm was reported as improved (recovering), but the patient still had trouble lifting her arm (not recovered). Causality assessment was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Thalassaemia, Viral titre decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. No information about the patient's medical history and concurrent conditions was reported. No concomitant medications were reported. On an unknown date, as a "kid", the patient might have been vaccinated with doses of MMR II (dose, frequency, lot #, expiration date and route of administration were not specified). On an unknown date (reported as recently), the patient had a MMR titer drawn that resulted low. On an unknown date, the patient experienced thalassemia. The outcome of the events was not reported. The relatedness between the events and MMR II was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a female patient of unknown age. There was no concurrent condition or medical history reported. The nurse noted that several years ago, the patient was administered the first two doses in the GARDASIL (dosage, strength, route and lot # unknown) vaccination series on two unspecified dates. On 26-JAN-2016 the patient was in the office to be administered the third dose of GARDASI (dosage, strength, route and lot # unknown). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL (lot # J006850, expiration date 31-MAR-2016) (Temperature: 33 Fahrenheit for 144 hours and 34 Fahrenheit for 228 hours) (dosage, strength and route unknown). No adverse symptoms was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history, drug reactions, allergies and concomitant medications were unknown. On 25-JAN-2016, the patient was vaccinated with the second dose of ZOSTAVAX lot # L028285, expiry date 28-COT-2016 (dose and route of administration were not reported). The pharmacist mentioned that about 9 months earlier, approximately in April 2015, the patient had been administered the first dose somewhere else (dose, route of administration and lot number were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 26-JAN-2016, the patient was vaccinated with a dose of expired PNEUMOVAX 23, lot # K009105, expiration date 21-JAN-2016, 0.5 ml, intramuscularly in the right deltoid (expired vaccine used). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a 27 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided. On 22-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L038669, expiry date: not provided). The patient experienced pain and lumpiness near the injection site, on the same day after receiving the vaccine. She went back to the physician's office on 25-JAN-2016 to seek treatment for site pain. She was provided with an unspecified treatment for the pain and was fine now. Outcome of injection site pain was reported as recovered while injection site lump was unknown. Reporting physician did not assessed the causality of the events with respect to vaccination with PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. On unspecified dates, the multiple unspecified patients were administered with the dose of VARIVAX (Merck) (dose and route not provided, lot# L030160 with expire date of 11-AUG-2017), which was exposed to temperatures outside of the recommended range (Incorrect product storage) and was used within 3 months. No adverse effects have been reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Chills, Cold sweat, Colitis ulcerative, Diarrhoea
Clinical narrative: Information has been received from a 58 year old male subject enrolled in a study. The subject's concurrent condition included allergic to penicillin manifested by rash, alcohol use (five mixed drinks per month), blood cholesterol increased, depression and herpes simplex. The subject's medical history included colitis ulcerative, chill, tremor, gastric disorder, clostridium difficile colitis and ex-tobacco user. The subject was previously on ENBREL for eight years and discontinued due to unspecified issues with ulcerative colitis; on REMICADE and discontinued due to rigors and sharp shaking; and also on SIMPONI from 2012 to 2013, experienced unspecified gastric issues and clostridium difficile. The subject was not on any biologics from August 2013 to July 2014. Concomitant therapies included VALTREX, citalopram, WELLBUTRIN, pravastatin, influenza virus vaccine (unspecified) and probiotics (unspecified). In July 2014 the subject started HUMIRA (Solution for injection in pre-filled syringe, 40 mg in 2 weeks, route unknown) for plaque psoriasis and psoriatic arthritis. In November 2014, the subject experienced ulcerative colitis flare. It was further described as abdominal pain, diarrhea and increased bowel movements. The events recovered without further treatment. In November 2014, the ulcerative colitis flare resolved. On unknown date in November 2014, he had a flu vaccine. Om 29-DEC-2014, he had PNEUMOVAX 23 (dose and route was not reported). On 29-DEC-2014, the subject experienced injection site pain on left arm. The event was resolved without further treatment. On the same date, the injection site pain on left arm was resolved. On 31-DEC-2014, the subject experienced nasal congestion, chest congestion, muscle aches, cold sweats and flu. On the same day, he experienced chills and general malaise. TYLENOL was taken as a treatment. On 10-JAN-2015, the nasal congestion, chest congestion, muscle aches, cold sweats and flu were resolved. On the same day chills and general malaise were also resolved. He felt that the flu was unrelated to HUMIRA. Action taken with PNEUMOVAX 23 regarding all events was not reported; action taken with HUMIRA regarding injection site pain on left arm, chest congestion, cold sweat and flu was reported as dose not change, regarding general malaise was not reported. The relationship between injection site pain on left arm with PNEUMOVAX 23 was reported as related, the relationship between chest congestion, general malaise, cold sweat and flu with PNEUMOVAX 23 was not reported. The relationship between injection site pain on left arm and general malaise with HUMIRA was not reported, the relationship between chest congestion, cold sweat and flu was reported as not related. Additional information is expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Frequent bowel movements, Influenza, Injection site pain, Malaise, Myalgia
Clinical narrative: Information has been received from a 58 year old male subject enrolled in a study. The subject's concurrent condition included allergic to penicillin manifested by rash, alcohol use (five mixed drinks per month), blood cholesterol increased, depression and herpes simplex. The subject's medical history included colitis ulcerative, chill, tremor, gastric disorder, clostridium difficile colitis and ex-tobacco user. The subject was previously on ENBREL for eight years and discontinued due to unspecified issues with ulcerative colitis; on REMICADE and discontinued due to rigors and sharp shaking; and also on SIMPONI from 2012 to 2013, experienced unspecified gastric issues and clostridium difficile. The subject was not on any biologics from August 2013 to July 2014. Concomitant therapies included VALTREX, citalopram, WELLBUTRIN, pravastatin, influenza virus vaccine (unspecified) and probiotics (unspecified). In July 2014 the subject started HUMIRA (Solution for injection in pre-filled syringe, 40 mg in 2 weeks, route unknown) for plaque psoriasis and psoriatic arthritis. In November 2014, the subject experienced ulcerative colitis flare. It was further described as abdominal pain, diarrhea and increased bowel movements. The events recovered without further treatment. In November 2014, the ulcerative colitis flare resolved. On unknown date in November 2014, he had a flu vaccine. Om 29-DEC-2014, he had PNEUMOVAX 23 (dose and route was not reported). On 29-DEC-2014, the subject experienced injection site pain on left arm. The event was resolved without further treatment. On the same date, the injection site pain on left arm was resolved. On 31-DEC-2014, the subject experienced nasal congestion, chest congestion, muscle aches, cold sweats and flu. On the same day, he experienced chills and general malaise. TYLENOL was taken as a treatment. On 10-JAN-2015, the nasal congestion, chest congestion, muscle aches, cold sweats and flu were resolved. On the same day chills and general malaise were also resolved. He felt that the flu was unrelated to HUMIRA. Action taken with PNEUMOVAX 23 regarding all events was not reported; action taken with HUMIRA regarding injection site pain on left arm, chest congestion, cold sweat and flu was reported as dose not change, regarding general malaise was not reported. The relationship between injection site pain on left arm with PNEUMOVAX 23 was reported as related, the relationship between chest congestion, general malaise, cold sweat and flu with PNEUMOVAX 23 was not reported. The relationship between injection site pain on left arm and general malaise with HUMIRA was not reported, the relationship between chest congestion, cold sweat and flu was reported as not related. Additional information is expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Nasal congestion, Respiratory tract congestion
Clinical narrative: Information has been received from a 58 year old male subject enrolled in a study. The subject's concurrent condition included allergic to penicillin manifested by rash, alcohol use (five mixed drinks per month), blood cholesterol increased, depression and herpes simplex. The subject's medical history included colitis ulcerative, chill, tremor, gastric disorder, clostridium difficile colitis and ex-tobacco user. The subject was previously on ENBREL for eight years and discontinued due to unspecified issues with ulcerative colitis; on REMICADE and discontinued due to rigors and sharp shaking; and also on SIMPONI from 2012 to 2013, experienced unspecified gastric issues and clostridium difficile. The subject was not on any biologics from August 2013 to July 2014. Concomitant therapies included VALTREX, citalopram, WELLBUTRIN, pravastatin, influenza virus vaccine (unspecified) and probiotics (unspecified). In July 2014 the subject started HUMIRA (Solution for injection in pre-filled syringe, 40 mg in 2 weeks, route unknown) for plaque psoriasis and psoriatic arthritis. In November 2014, the subject experienced ulcerative colitis flare. It was further described as abdominal pain, diarrhea and increased bowel movements. The events recovered without further treatment. In November 2014, the ulcerative colitis flare resolved. On unknown date in November 2014, he had a flu vaccine. Om 29-DEC-2014, he had PNEUMOVAX 23 (dose and route was not reported). On 29-DEC-2014, the subject experienced injection site pain on left arm. The event was resolved without further treatment. On the same date, the injection site pain on left arm was resolved. On 31-DEC-2014, the subject experienced nasal congestion, chest congestion, muscle aches, cold sweats and flu. On the same day, he experienced chills and general malaise. TYLENOL was taken as a treatment. On 10-JAN-2015, the nasal congestion, chest congestion, muscle aches, cold sweats and flu were resolved. On the same day chills and general malaise were also resolved. He felt that the flu was unrelated to HUMIRA. Action taken with PNEUMOVAX 23 regarding all events was not reported; action taken with HUMIRA regarding injection site pain on left arm, chest congestion, cold sweat and flu was reported as dose not change, regarding general malaise was not reported. The relationship between injection site pain on left arm with PNEUMOVAX 23 was reported as related, the relationship between chest congestion, general malaise, cold sweat and flu with PNEUMOVAX 23 was not reported. The relationship between injection site pain on left arm and general malaise with HUMIRA was not reported, the relationship between chest congestion, cold sweat and flu was reported as not related. Additional information is expected.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of an unknown age. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. Nurse practitioner reported that patient was scheduled to receive VARIVAX (Merck) and M-M-R (circumstance or information capable of leading to medication error). On 25-JAN-2016, the patient inadvertently received VARIVAX (Merck) and PROQUAD (Merck) (overdose) instead of intended M-M-R. Nurse practitioner did not have patient's chart and could not provide lot # and expiry date for vaccines administered. No adverse effects reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 78 year old female patient with multiple allergies reporting on herself. In approximately December 2015, reported as 1 month ago, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular into the patient's left upper arm (lot number and expiration date were not provided). Concomitant therapy information was not provided. In approximately December 2015, the patient experienced a terrible drug hypersensitivity to PNEUMOVAX 23. 5 hours after the administration of PNEUMOVAX 23, the patient experience nausea and body-shaking. The next day, on an unknown date in December 2015, the patient felt ill and her left upper arm became red, hot and swollen. It was also difficult to raise her left arm. The patient called the doctor's office and was advised to be evaluated at a local urgent care facility. The patient did not go to the facility because she felt too sick to get out of bed. No treatment was given to the patient. There were no laboratory diagnostics studies performed. The patient inquired about the ingredients on the vaccine she might have reacted to, so she could add them to her allergy list. The symptoms gradually improved and resolved within 3 days (in approximately December 2015). The patient considered the event as related to the PNEUMOVAX 23. Additional information is not expected. There was no authorization to contact physician.