chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No information regarding patients' medical history, concurrent condition nor concomitant therapies was provided. On an unspecified date in approximately 2015 (reported as between 08-SEP-2015 through 02-OCT-2015), the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. The reporter was not able to provide any further details at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LUA - redness, swelling warm to touch started 10/1 - provider seen patient - reports local allergic reaction. Ice/BENADRYL order.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No information regarding patient's medical history, concurrent condition nor concomitant therapies was provided. On an unspecified date in approximately 2015 (reported as between 08-SEP-2015 through 02-OCT-2015), the patient was vaccinated with a dose of improperly COMVAX, (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. The reporter was not able to provide any further details at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored VAQTA (Lot# L017757, exp. 08-APR-2018; Lot# K007791, exp. 22-AUG-2016) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No information regarding patients' medical history, concurrent condition nor concomitant therapies was provided. On an unspecified date in approximately 2015 (reported as between 08-SEP-2015 through 02-OCT-2015), the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB, (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. The reporter was not able to provide any further details at the time of reporting. 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: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored (Oka/Merck) VARIVAX (lot# reported as 1015046, expiration date: 29-APR-2017, route and dose were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Electrocardiogram, Seizure, Syncope, Vomiting
Clinical narrative: Patient had syncopal episode w/ convulsions. Took prolonged time to recover. Emesis x 2. Taken to ED.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored (Merck) PROQUAD (lot# reported as 1019995, expiration date: 02-DEC-2016, route and dose were unknown) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No information regarding patient's medical history, concurrent conditions nor concomitant therapies was provided. On an unspecified date in approximately 2015 (reported as between 08-SEP-2015 through 02-OCT-2015), the patient was vaccinated with a dose of improperly stored GARDASIL or GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse symptoms were reported. The reporter was not able to provided any further details at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a male patient of unknown age. The patient's medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial (subcutaneously, dose, lot# and expiration were not provided) for shingles prevention. On an unknown date, the patient experienced a blister-like rash at the injection site. It was not specified if any treatment was given. The outcome of the blister-like rash at the injection site was not reported. Causality assessment between the blister-like rash at the injection site and the ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her daughter, a female patient of unknown age. There was no information about patient's pertinent medical history, concomitant and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). Additional information is not expected, as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 06-OCT-2015, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number L021608 and expiration date 10-SEP-2016) that was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Half dollar sized, oblong red, raised slightly, non tender, area on back of left upper arm. Onset Thursday 10/2/15  evening at home. No treatment needed at this time.
Age: 0.8
Sex: U
Vaccine: HEP
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a healthcare professional referring to an approximately 8 months old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with a third dose of hepatitis b vaccine, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, in 2015, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash noted 1/2 hour after injection. Ice applied.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient was reported. On 30-SEP-2015, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 vial (lot number: K004542 and expiry date: 19-AUG-2015, dose, site and route of administration was not reported). No concomitant medications were reported. The patient did not experienced any adverse event. The outcome of expired product administered and no adverse event was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Liver function test abnormal, Myalgia
Clinical narrative: Diffuse myalgias, fatigue, joint pains, increased LFT's. Followed at office with Rheumatology consult, GI, ID consult. OTC NSAIDS, increased fluids. Improving.
Age: 16.0
Sex: U
Vaccine: HEP, HEPA, HPVX, MEN
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to a 16 year old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with hepatitis a vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Other suspect therapies included hepatitis b vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided); HPV (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided); and meningococcal vaccine (manufacturer unknown), (dose, route of administration, lot #, expiration date and indication were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. The causality between vaccine adverse experience and hepatitis a vaccine (manufacturer unknown), hepatitis b vaccine (manufacturer unknown), HPV (manufacturer unknown) and meningococcal vaccine (manufacturer unknown) was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain, Swelling, White blood cell count normal
Clinical narrative: Swelling and redness started on 10/8/15 in 7:30 getting bigger now 11.0 cm  longest x 9.8 cm width. (+) pain. WBC - 8.1. Treat with AUGMENTIN for infection. Defer on ROCEPHIN for now. to follow by phone tomorrow. BENADRYL.
Sex: U
Vaccine: HEP
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a consumer refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with one dose of RECOMBIVAX HB (dose, frequency, route, lot # were not reported). On an unknown date, the patient experienced headaches "on and off" for 4 days after receiving RECOMBIVAX HB. The reporter inquired about the latex content of RECOMBIVAX HB. The reporter stated that the patient did not experienced fever or any other adverse effects. The outcome of headaches "on and off" was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information is not expected as no reporter details were provided.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy blood vessel abnormal, Purpura, Vasculitis
Clinical narrative: Purpura - treated with prednisone 3 times now on dapsone. Biopsy determined vasculitis.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a male patient of unknown age. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine experience was unknown. The reporter did not assess the relatedness from vaccine adverse experience to GARDASIL. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pruritus, Injection site swelling, Pain, Pyrexia
Clinical narrative: 24 hours post vaccine: swelling, itching at site. 36 hours post vaccine: swelling 5 inch diameter at site injection, severe itching at site, mild fever, severe body aches, 10/10 pain, chills quivering. 48 hours post vaccine: symptoms are improving.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a healthcare professional referring an approximately 12 months old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with a first dose of hepatitis a vaccine, inadvertently (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Other suspect therapies included first dose of MMR II (unknown), (dose, therapy type, route of administration, lot # and expiration date were not provided), and first dose of (Oka/Merck) (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided), both vaccines administered also on 04-AUG-2015. Concomitant medication was not reported. On an unknown date, in 2015, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Nausea, Peripheral swelling
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. Information regarding their medical history, concurrent condition and drug reactions/allergies were not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 9strength, dose, frequency, lot # and expiry date were unspecified). No concomitant medications were reported. Reporting healthcare worker stated that the patient experienced following side effects on an unknown date later injection: red circular rash around injection site, pain at injection site, swollen arm, nausea, slight fever, and itchiness. It was unspecified if the patient required medical attention or if received any treatment for the events. Outcome of the events were unknown. The relatedness between the adverse events and vaccination with PNEUMOVAX 23 was not provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pruritus, Pyrexia
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. Information regarding their medical history, concurrent condition and drug reactions/allergies were not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 9strength, dose, frequency, lot # and expiry date were unspecified). No concomitant medications were reported. Reporting healthcare worker stated that the patient experienced following side effects on an unknown date later injection: red circular rash around injection site, pain at injection site, swollen arm, nausea, slight fever, and itchiness. It was unspecified if the patient required medical attention or if received any treatment for the events. Outcome of the events were unknown. The relatedness between the adverse events and vaccination with PNEUMOVAX 23 was not provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: After administration, patient experienced severe pain radiating from wrist to the neck on right side.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness on the right side where DTaP and Polio was given. Pt left Band-Aid and put ice pack directly on the skin for so long.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (R) arm swelling and redness after vaccine delayed reaction. Symptoms started 1 week after administration. Antihistamine oral and topical steroid cream.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Erythema 8 days after injection at injection site (L. Deltoid).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Colonoscopy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old male patient with high blood pressure, diabetes and "other unknown pain related condition". On 30-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Concomitant therapies included amlodipine (manufacturer unknown), hydrocodone, VICTOZA, NOVOLOG, metformin, gabapentin, SINGULAR, PROTONIX, tizanidine (manufacturer unknown), atorvastatin (manufacturer unknown) and prednisone (manufacturer unknown). In 2015, the patient needed to take a higher dose of prednisone (manufacturer unknown) that what was prescribed on 09-MAY-2015 (adverse event). The reporter also mentioned that the patient went for a colonoscopy on an unspecified date after receiving vaccine ZOSTAVAX. At the time of this report, the outcome of adverse event and colonoscopy was not recovered. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis; Treated with cephalexin 500 mg BID x 14 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a pharmacy technician referring to 3 patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route and frequency were not provided). Product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. No adverse symptoms were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: Redness at injecton site, warm to touch, swollen painful arm, tingling in fingers of injection arm. Advised BENADRYL. Call MD if worse.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 6 year old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 19-MAR-2009, the patient was vaccinated with the first of RECOMBIVAX HB, on 20-MAY-2009, the patient received the second dose of RECOMBIVAX HB and on 29-JUL-2009, the patient received the third dose of RECOMBIVAX HB, (inappropriate schedule of drug administration), (dose, route, anatomical location, lot number and expiration date were not reported for all the therapies above described). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Ocular hyperaemia, Pyrexia
Clinical narrative: Severe headache, fever, eye redness and swelling of injection site approximately 6 inches in length.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Redness.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (route, dose, frequency, Lot. No. and expiration date were not provided). There was no concomitant medication described. On an unknown date, the patient experienced cold sores around the mouth. No product quality issue was involved. At the time of this report, the outcome of cold sores around the mouth was unknown. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, tender, warmth to (L) leg at injection site. C/O pain to touch. Denies fever.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Severe pain at injection site starting 24 hrs after vaccine administration and last approx 12-18 hrs. Redness, swelling.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 5 patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot number 100316 (lot number if not valid for zoster vaccine live), expiration date 30-APR-2016). Concomitant therapy information was not provided. On an unknown date, there was an incorrect product storage as the patients received a dose of improperly stored ZOSTAVAX. No adverse events were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX, lot number 1013068 which is not valid for VARIVAX, expiration date 14-APR-2017. Concomitant therapy information was not provided. On an unknown date, there was an incorrect product storage as the patient received a dose of improperly stored (Oka/Merck) VARIVAX. No adverse events were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Erythema at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of VARIVAX (Merck) (route of administration, anatomical location, expiration date and lot number were not provided). There were not concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 14-AUG-2015, the patient was vaccinated with the first dose of VAQTA (dose, route, lot number and expiration date were not provided). On 10-OCT-2015, the patient was vaccinated with the second dose of VAQTA (dose, route, lot number and expiration date were not provided), earlier than the recommended minimum interval as per prescribing information. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with GARDASIL (lot # K006960 and expiration date 19-FEB-2017) (dose, frequency and route were not reported) that was stored outside recommended temperature range. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis. Cephalexin 500 mg BID.
Age: 82.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: I had a tetanus shot last week and my arm is red and sore. Left upper arm redness noted approximately 1 below shoulder to medial aspect above elbow, warm to touch. Afebrile 98.4 po and cellulitis. Cephalexin 500 mg QID.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to an 11 year old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with GARDASIL, (dose, route of adminstation, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. The causality between vaccine adverse experience and GARDASIL was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to a 17 year old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. The causality between vaccine adverse experience and quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Dry throat, Headache, Injection site erythema, Pain
Clinical narrative: 1600, Started out with feeling low energy, drained. Following that, 1800, body aches. 1830, headache. 2000, dry throat, localized swelling, redness, warmth left deltoid where vaccine administered. 0000, 10/10/2015, symptoms other than localized warmth and redness resolved w/ advil OTC. No medication since initial dose.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: 1600, Started out with feeling low energy, drained. Following that, 1800, body aches. 1830, headache. 2000, dry throat, localized swelling, redness, warmth left deltoid where vaccine administered. 0000, 10/10/2015, symptoms other than localized warmth and redness resolved w/ advil OTC. No medication since initial dose.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Dizziness, headache, nausea, injection site soreness.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Headache, Heart rate increased, Malaise
Clinical narrative: Malaise rapid heartbeat headache sinus congestion weakness low appetite restless dosed with normal Tylenol and allergy Decongestantthroat irritation Halls cough drops. Day Four today..still not 100%.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Restlessness, Sinus congestion, Throat irritation
Clinical narrative: Malaise rapid heartbeat headache sinus congestion weakness low appetite restless dosed with normal Tylenol and allergy Decongestantthroat irritation Halls cough drops. Day Four today..still not 100%.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: Redness at injection site. Soreness.
Age: 24.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Blood test, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Patient was admitted to Neurology floor with possible Guillain Barre.
Age: 24.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Anaesthesia, Ataxia, Computerised tomogram, Dyspnoea, Gait disturbance
Clinical narrative: Patient was admitted to Neurology floor with possible Guillain Barre.
Age: 24.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Guillain-Barre syndrome, Haematology test, Headache, Laboratory test, Muscular weakness
Clinical narrative: Patient was admitted to Neurology floor with possible Guillain Barre.
Age: 24.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Vomiting
Clinical narrative: Patient was admitted to Neurology floor with possible Guillain Barre.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient stated that she woke up with soreness and stiffness to right arm, the injection site. She denied any redness or swelling to the area, and denied any itching around site. She also stated she had limited movement to her right arm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Somnolence
Clinical narrative: SIDE EFFECT REPORT: Started feeling sleepy, very tired, then feverish, then chills and shaking, aching muscles. Never before experienced this w/flu shot in last two years. Started drinking copious amounts of water. Shaking/fever was somewhat relieved in about an hour. Slept. Extreme fatigue lasted until next morning.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Thirst, Tremor
Clinical narrative: SIDE EFFECT REPORT: Started feeling sleepy, very tired, then feverish, then chills and shaking, aching muscles. Never before experienced this w/flu shot in last two years. Started drinking copious amounts of water. Shaking/fever was somewhat relieved in about an hour. Slept. Extreme fatigue lasted until next morning.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Blood test, Erythema, Mobility decreased, Pain
Clinical narrative: Fever, Achy, and weak on the night of immunization. 2 days later her arm was red, swollen, patient couldn't lift her arm.  She went to see her Dr on 10/8/2015.  The doctor said injection may have gone into her rotator cuff, causing the swelling and pain. The doctor told the patient it was not the vaccinator's technique that caused the problem.  He told her she may have had a stress reaction to the injection or just be sick.  He drew blood to check her WBC count to see if she might have a virus.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Viral test, White blood cell count
Clinical narrative: Fever, Achy, and weak on the night of immunization. 2 days later her arm was red, swollen, patient couldn't lift her arm.  She went to see her Dr on 10/8/2015.  The doctor said injection may have gone into her rotator cuff, causing the swelling and pain. The doctor told the patient it was not the vaccinator's technique that caused the problem.  He told her she may have had a stress reaction to the injection or just be sick.  He drew blood to check her WBC count to see if she might have a virus.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Erythema, Injection site rash, Pruritus
Clinical narrative: Rash from elbow to shoulder, pruritus, erythema.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nausea, Pyrexia, Tremor
Clinical narrative: Mild fever, shaking chills, nausea.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Pain in extremity, Rotator cuff syndrome, X-ray
Clinical narrative: PAIN AND WEAKNESS OF RIGHT ARM.  HURT FOR SEVERAL WEEKS.  TOOK IBUPROPHEN.  TOLD DOCTOR AT NEXT VISIT. PAIN SUBSIDED, BUT CONTINUOUS. IN FEBRUARY, ROTATOR CUFF TORE AFTER SIMPLE MOVEMENT OF ARM. XRAYS AND MRI - YEAR LATER STILL HURTS.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Myosclerosis, Swelling
Clinical narrative: Patient had severe redness, swelling and muscle hardness. Symptoms were only slightly relieved by 3 doses of Benadryl but were still bothersome 2 days after vaccine adminstration.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site mass
Clinical narrative: ALLERGIC REACTION AT INJECTION SITE. DEVELOPED BIG, INFLAMED LUMP AT AND AROUND INJECTION SITE.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Blister, Erythema, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: ALLERGIC REACTION AT INJECTION SITE. DEVELOPED BIG, INFLAMED LUMP AT AND AROUND INJECTION SITE.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Injection site swelling, Urticaria
Clinical narrative: ALLERGIC REACTION AT INJECTION SITE. DEVELOPED BIG, INFLAMED LUMP AT AND AROUND INJECTION SITE.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Dizziness, Hyperhidrosis
Clinical narrative: Started with persistent cough and chills; then all-over aching and began running very high fever all night. About 4:00 AM started sweating profusely and shaking for a couple of hours. Experience weakness and dizziness throughout the next day (10/06/15). Did not seek medical treatment since I could not even get out of bed to get some Tylenol. (I live alone.)
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pyrexia, Tremor
Clinical narrative: Started with persistent cough and chills; then all-over aching and began running very high fever all night. About 4:00 AM started sweating profusely and shaking for a couple of hours. Experience weakness and dizziness throughout the next day (10/06/15). Did not seek medical treatment since I could not even get out of bed to get some Tylenol. (I live alone.)
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Pruritus generalised
Clinical narrative: Patient developed a bruise approximately 2 to 3 inches in diameter at the injection site on the left tricep. Patient also described some mild general pruritis.
Age: 62.0
Sex: F
Vaccine: FLUR3
Symptoms: Chills, Cough, Dizziness, Facial pain, Fatigue
Clinical narrative: Received a test dose (skin testing). No reaction. Got lightheaded, saw stars, had facial pain/congestion about 1/2 hour after vaccine.  Took Claritin and Benadryl.  When arrived home, was fatigued with sinus pain.  Slept intermittently that evening: had h/a, head congestion, chills, diaphoresis, cough, chest congestion, intestinal cramps, and muscle-aches.  Took Tylenol and Mucinex, then Benadryl later that evening.  Ill for 3 days (submitted on this day) with sinus pain, headache, head and chest congestion, cough, fatigue, and muscle-aches.
Age: 62.0
Sex: F
Vaccine: FLUR3
Symptoms: Gastrointestinal pain, Headache, Hyperhidrosis, Myalgia, Respiratory tract congestion
Clinical narrative: Received a test dose (skin testing). No reaction. Got lightheaded, saw stars, had facial pain/congestion about 1/2 hour after vaccine.  Took Claritin and Benadryl.  When arrived home, was fatigued with sinus pain.  Slept intermittently that evening: had h/a, head congestion, chills, diaphoresis, cough, chest congestion, intestinal cramps, and muscle-aches.  Took Tylenol and Mucinex, then Benadryl later that evening.  Ill for 3 days (submitted on this day) with sinus pain, headache, head and chest congestion, cough, fatigue, and muscle-aches.
Age: 62.0
Sex: F
Vaccine: FLUR3
Symptoms: Sinus congestion, Sinus headache, Visual impairment
Clinical narrative: Received a test dose (skin testing). No reaction. Got lightheaded, saw stars, had facial pain/congestion about 1/2 hour after vaccine.  Took Claritin and Benadryl.  When arrived home, was fatigued with sinus pain.  Slept intermittently that evening: had h/a, head congestion, chills, diaphoresis, cough, chest congestion, intestinal cramps, and muscle-aches.  Took Tylenol and Mucinex, then Benadryl later that evening.  Ill for 3 days (submitted on this day) with sinus pain, headache, head and chest congestion, cough, fatigue, and muscle-aches.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Pain and swelling in upper arm, tingling in arm and hand.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Shortly after the shot I noticed an itching on both forearms, above and below the elbow crease.  Around 3:00 PM it worsened to redness, small bumps and itching.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Renal pain
Clinical narrative: Severe lower back/kidney pain both sides.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Arm had a 6inch by 4 inch red spot at injection site. Pt stated warm to touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Cough, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Patient received Fluvirin prefilled syringe (NDC 66521-0118-02) on 10/2/15.  On 10/6/15 she experienced fever, aches (legs and back), coughing, fatigue.  Patient stated symptoms resolved on 10/10/15.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: Swelling and numbness in the tongue.
Age: 55.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Hyperhidrosis, Hypotension, Presyncope
Clinical narrative: Vaso Vegal reaction, low blood pressure, sweating.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at site of injection.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Myalgia, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Onset of flu symptoms, stating with upper respiratory (head congestion, sneezing, runny nose), fever of 100F for 2 days, body aches, muscle aches.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Sneezing, Upper respiratory tract congestion
Clinical narrative: Onset of flu symptoms, stating with upper respiratory (head congestion, sneezing, runny nose), fever of 100F for 2 days, body aches, muscle aches.
Age: 63.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Feeling hot
Clinical narrative: Patient received Fluzone and Adacel immunizations on the morning of 10/10/15. Patient denied known allergies and prior adverse reactions to influenza and Tdap vaccinations. Approximately 4 hours after leaving pharmacy, patient returned complaining of "feeling hot in the face". Patient's face was cool to the touch and her BP was 128/81 mmHg with a pulse of 80. She denied shortness of breath, difficulty breathing, hives or any other signs of allergic reaction. Patient denied taking any medication to resolve her current symptoms. Both pharmacists on duty offered to call emergency care, but patient denied emergency care because she stated she was starting to feel better. Patient was advised to seek immediate emergency care in case of a delayed reaction. Patient confirmed understanding of signs/symptoms of an allergic reaction and need for immediate care. Patient was also advised to purchase Benadryl and take those if she starts noticing an allergic reaction, then call 911.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Patient complained of her throat feeling tight after Fluzone quadrivalent vaccine given. Patient was given diphenhydramine 25mg and we called 911. 911 checked her out and said no clinical evidence of severe allergic reaction but gave her another Bendadryl 25mg. Patient refused transport.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: PT COMPLAINED OF SORE ARM NEXT DAY AND THEN SHOWED UP ON 10/10 WITH HER ARM ALL RED AND WAS DIAGNOSED WITH CELLULITIS.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Feeling Dizzy.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Cough, congestion, asthma, fever.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Rash
Clinical narrative: Malaise with mild rash.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site discomfort, Pain
Clinical narrative: Felt like the pharmacist injected too high. At first it wouldn't inject, then moved needle slightly. When injected felt a great pressure in arm. Arm has been hard to move without pain since then.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Abnormal behaviour, Aggression, Anxiety, Aphasia, Childhood disintegrative disorder
Clinical narrative: Restless sleep, loud screaming, crying kicking for unknow reason. Out of character for my healthy child who normally slept through the night. Continued for 5 nights. Resulted in putting child in bed with mother. Child then lost little language he had, stopped pointing, using silverwear, interacting with children or adults. Child isolated himself for months. So far he has been treated by early intervention, speech therapists, occupational therapists and is in ASD public school program. Child is still non verbal, has no communication skills, does not interact with peers, and has uncontrollable anxiety and tantrums! The restless sleep still occurs, wakes in the night laughing or crying. Screams, kicks, bites and throws himself into doors for unknown reasons. This child was perfectly fine, without any of these symptoms until his vaccinations.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Communication disorder, Crying, Poor quality sleep, Screaming, Social avoidant behaviour
Clinical narrative: Restless sleep, loud screaming, crying kicking for unknow reason. Out of character for my healthy child who normally slept through the night. Continued for 5 nights. Resulted in putting child in bed with mother. Child then lost little language he had, stopped pointing, using silverwear, interacting with children or adults. Child isolated himself for months. So far he has been treated by early intervention, speech therapists, occupational therapists and is in ASD public school program. Child is still non verbal, has no communication skills, does not interact with peers, and has uncontrollable anxiety and tantrums! The restless sleep still occurs, wakes in the night laughing or crying. Screams, kicks, bites and throws himself into doors for unknown reasons. This child was perfectly fine, without any of these symptoms until his vaccinations.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site nodule, Injection site swelling
Clinical narrative: Localized nodule/swelling at injection site immediately following administration. Treated with cold pack and monitoring, no change following 30 minutes.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness 3x5 inches circular around injection site; hot to touch. Gave patient Benadryl and cold compress.
Age: 1.89
Sex: M
Vaccine: FLU4
Symptoms: Irritability, Lethargy, Muscle twitching, Myoclonic epilepsy, Pyrexia
Clinical narrative: Patient had onset of 102-105 deg fever with lethargy at 11PM after vaccine, Tylenol did not bring fever down and did not improve patient affect, at 11AM started having myoclonic seizures (muscle twitches every 30-60 seconds that lasted for 1-2 sec at a time for 7 hours). Patient getting Tylenol every 4 hours with no change at 5 pm on 10/09/15 patient started getting Motrin. At 6pm patient had end of myoclonic seizures. Fever remained but at 101 and patient began speaking again. Patient recieved Motrin and Tylenol throughout night of 10/9/15 and maintained a fever and was fussy but no further neurological signs. At 8 am on 10/10/15 patient had no further fever and was back to himself. Medicine stopped.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Acne, Chills, Decreased appetite, Headache, Migraine
Clinical narrative: Acne outbreak, muscle weakness, loss of appetite, nausea with vomiting, migraine headache, body aches and pains, stuffy nose and fever with chills.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Nasal congestion, Nausea, Pain, Pyrexia
Clinical narrative: Acne outbreak, muscle weakness, loss of appetite, nausea with vomiting, migraine headache, body aches and pains, stuffy nose and fever with chills.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Acne outbreak, muscle weakness, loss of appetite, nausea with vomiting, migraine headache, body aches and pains, stuffy nose and fever with chills.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of (L) upper arm (3 x3).
Age: 52.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted within five minutes after the vaccines were administered. She recovered in about ten seconds and felt fine but continued to feel dizzy for another hour and a half she received water and rested.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: See attached sheet.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain with lifting and moving left arm, not alleviated with TYLENOL.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle twitching, Pain in extremity
Clinical narrative: Severe arm pain, sudden onset. Twitching muscles in arm and chest.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Per pt. experienced red, itchy rash surrounding site of administration and believes it was unrelated to any reaction from bandage adhesive.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Swelling
Clinical narrative: Black and blue at injection site-first arm redness about half way down arm. Minor swelling.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to an unspecified patients of unknown age and unknown gender. Since 21-SEP-2015, the patients were vaccinated with improperly stored ZOSTAVAX (lot# L011353 and expiry date: 03-JUL-2016). No adverse effects were reported. Additional information has been requested.