chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an approximately 60 year old male patient. Patient's medical history included chickenpox, knee operation and melanoma removed. No drug reactions or allergies were reported. On an unknown date, in approximately October 2015 (reported as '3 to 4 weeks ago'), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported) in the right arm and with a dose of Influenza virus vaccine (unspecified) (manufacturer unknown) (dose, route of administration and lot number were not reported). The patient received the doses at a pharmacy at another location. No concomitant medications were reported. On an unknown date, in approximately October 2015, a week after the vaccination, the patient 'broke out in a rash'. According to the reporter, patient's rash appeared to be a varicella-zoster rash, in that it was vesicular, papular, erythematous and pruritic. On 30-OCT-2015, the rash was spread to patient's right thigh. No lab diagnostic studies were reported. PQC was not involved. Patient sought medical attention. On 30-OCT-2015, he visited nurse practitioner. At the visit, nurse practitioner planned to prescribe an antiviral medication for the patient to start at the same day. The outcome of events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Pt received both flu and pneumonia shot on same day. No localized rxn however pt reports feeling weak,  HA, achy, nauseous, sore legs since receiving vaccinations.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Vomiting
Clinical narrative: Severe chills - lasting about 2 hrs. Vomiting. Aching all over. More chills next eve. Lasted 3 days.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Flushing, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: ED doc notes in 10/10/10 ED note: erythematous tender wheal on left delt, decreased ROM secondary to pain but no joint involvement, distal arm neurovascularly intact. Erythema, flushing, swelling. Diphenhydramine 25 mg once, ranitidine 50 mg once, methylprednisolone 125 mg once.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Swelling
Clinical narrative: ED doc notes in 10/10/10 ED note: erythematous tender wheal on left delt, decreased ROM secondary to pain but no joint involvement, distal arm neurovascularly intact. Erythema, flushing, swelling. Diphenhydramine 25 mg once, ranitidine 50 mg once, methylprednisolone 125 mg once.
Age: 99.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Tachycardia
Clinical narrative: Chills, nausea, and tachycardia - lasting 24 hours after vaccine administration. No treatment. All symptoms resolved after 1 day.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, pruritus pneumococcal vaccine.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Swelling-softball size area.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site reaction, Throat tightness
Clinical narrative: Pt called 1 pm, Nov 4, 2015 - no injection site rxn - said felt like had flu during night, throat tightened - fine at time of call.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 62 year old female patient. Patient's medical history and concurrent conditions were not reported. No known allergies were reported. In October 2015, about 30 days ago, the patient was vaccinated with a dose of ZOSTAVAX, (lot # L021610, expiry date 10-SEP-2016), subcutaneously in the left arm. Concomitant medications included unspecified cholesterol medication. In November 2015, the patient complained of pain in the left arm of administration when she held it a certain way, not all the time. The reporter stated that the patient had no redness or swelling at the site, no rash or hives. No treatment was given for the injection site pain, no lab diagnostics studies were performed, and the patient did not seek medical attention. The outcome of injection site pain was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient called on 10-21-15 and said just a red patch around shot area 3" x 2" oval. No itch or pain. Called pt on 10-24-15 to follow up with patient and pt said smaller and lighter color (pink) still no itch.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pt. came into store on 11/6/15 to report extensive redness, swelling, itching, and pain in the arm. She had received the vaccination on 11-4-15. She was referred to urgent care and received Rx for clindamycin.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient reported pain down arm to wrist post injection. Went to orthopaedist and received cortisone injection.
Age: 1.36
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Seizure
Clinical narrative: Fever, rash (all over body). Seizure.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Cx give FLUZONE HD and PREVNAR13 both in left arm 1 inch apart on 9/21/15 on 11/4/15. She is still complaining of arm pain when she lifts arm.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Sinus congestion, Sluggishness, Sneezing
Clinical narrative: Sluggish, cough, sneezing, head stuffy, joints ache. Symptoms lasted 2 days.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 6 days after vaccination she said redness, warmth, slight swelling and pain appeared in the general area of the vaccination site. She saw her physicians P.A. and was prescribed minocycline.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 69 year old female patient. No historical or concurrent conditions were reported. The patient did not have any drug reactions or allergies. On 28-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# unspecified), intramuscularly, in the left arm. No concomitant medications were reported. On an unknown date approximately in October 2015, the patient developed "severe" pain at the injection site to the point that the patient was "unable to lift her arm over her head." No Product Quality Complaint (PQC) was reported. No lab diagnostics studies were performed. The pharmacist was called to seek medical attention. No treatment was given. The outcome of the events was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Pallor
Clinical narrative: Approximately 1040 a - vaccine administered to (L) deltoid. Upon check out, became light headed and dizzy. Pale and gray in color. Brought pt to room, lay down, HR 78 BP 82/48 at 1100. Dizzy, 1130 pt sat elevated BP 90/60. Ate crackers and drank ginger ale while in office. Walked up/down hallway - no dizziness RTO on 11/4 with headache, dizzy.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Swelling and redness on right arm pain going up right side of neck stiffness of neck at night. Could not lift arm - very painful.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling and redness on right arm pain going up right side of neck stiffness of neck at night. Could not lift arm - very painful.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Body temperature increased, Dizziness, Fatigue, Tinnitus, Vision blurred
Clinical narrative: Dizziness and ringing in ears, Blurred vision soon after getting injection and Fatigue and low temp next 3 days.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Injection site pain, Injection site warmth, Local reaction, Neck pain
Clinical narrative: Call received from patient reporting she received flu vaccine in right deltoid. Felt fine after and exercised later in the day. Started to feel the area get warm and painful spreading into neck and chest area on the same side. Advised to apply cold compress to vaccine site and to take an ibuprofen. Local reaction likely from exertion and exercise with vasodilatation. On 11/13, Check-in call to patient. States that she had a fever till about midnight last night and had a bit of a fever this morning but does feel better today. Said the warmth and pain in her neck and chest area is still there, but now it is more sore and not as painful as last night. She is just taking ibuprofen now for the pain/fever. Has never had a reaction to any vaccine before. Says that she believes it was from exercising after receiving the vaccine, as symptoms started very suddenly upon exercising. Advised patient to call if symptoms get worse.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Skin warm
Clinical narrative: Call received from patient reporting she received flu vaccine in right deltoid. Felt fine after and exercised later in the day. Started to feel the area get warm and painful spreading into neck and chest area on the same side. Advised to apply cold compress to vaccine site and to take an ibuprofen. Local reaction likely from exertion and exercise with vasodilatation. On 11/13, Check-in call to patient. States that she had a fever till about midnight last night and had a bit of a fever this morning but does feel better today. Said the warmth and pain in her neck and chest area is still there, but now it is more sore and not as painful as last night. She is just taking ibuprofen now for the pain/fever. Has never had a reaction to any vaccine before. Says that she believes it was from exercising after receiving the vaccine, as symptoms started very suddenly upon exercising. Advised patient to call if symptoms get worse.
Age: 21.0
Sex: F
Vaccine: PPV, TD
Symptoms: C-reactive protein increased, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever to 102F, Tachycardia, Nausea, Injection site pain and swelling.
Age: 21.0
Sex: F
Vaccine: PPV, TD
Symptoms: Red blood cell sedimentation rate normal, Tachycardia, White blood cell count increased
Clinical narrative: Fever to 102F, Tachycardia, Nausea, Injection site pain and swelling.
Age: 51.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Contusion, Erythema, Local swelling
Clinical narrative: Localized swelling, redness, and bruising.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Diarrhoea, Dyspnoea, Hyperhidrosis
Clinical narrative: Started to feel clammy, and sweaty. Shortness of breath, cramps diarrhea and vomiting. Total weakness.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Vomiting
Clinical narrative: Started to feel clammy, and sweaty. Shortness of breath, cramps diarrhea and vomiting. Total weakness.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. RTC 11-5-15. Pt. reported (L) upper outer arm was red/swollen since 11-3/11-4 at 5p 11-3-15 after immunization. On exam pt. (L) upper arm red/swelling. Pt. reported taking BENADRYL, ZANTAC and ibuprofen, cold compress as ordered per Dr. at office visit. Pt. will continue to monitor and call office as needed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness/soreness to left thigh on 10/27/15. Seen in office 10/28/15 with a 10cm x 7cm pink blanching slightly warm erythema left anterior medial area to inner thigh, non tender and no bright erythema. Advised to use BENADRYL, hydrocortisone cream and ice. Parents called next day with increase diameter redness, however redness/tenderness faded the night of 10/29/15.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced swelling and redness at site of injection and was advised to use topical and oral BENADRYL.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Headache, Impaired work ability, Musculoskeletal stiffness
Clinical narrative: Total 48 hrs started with severe headache, progressed to chilling nausea. Overall aching with painful joints. Excruciating headache and very stiff neck. Fever 100.4 degrees F. Considered ER for meningitis symptoms. Resulted in loss of work.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Total 48 hrs started with severe headache, progressed to chilling nausea. Overall aching with painful joints. Excruciating headache and very stiff neck. Fever 100.4 degrees F. Considered ER for meningitis symptoms. Resulted in loss of work.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered
Clinical narrative: None, no ADR. Pt was just double dosed a PREVNAR. Received 4/1/15 also.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Localized pain at site, circular swelling also noted at site, tender to touch. Pt states she has also got this reaction from flu shot but will continue to get vaccines because of her medical condition. No systemic reaction. Advised ice and BENADRYL report back if any changes.
Age: 1.01
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Noticed pain to (L) arm (achy) 6 hours later and then roughly 10-11 hours after injection entire arm was swollen. Swelling and aching decreased around 17 hours after injection. Still mild swelling noted today at 10:00.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Pt states that the PREVNAR 13 that she was give 10/29/15 in the left deltoid had a reaction. Her deltoid was bruised with redness and burning down the arm for 1 week. She also stated it caused burning in her left lower quadrant x 1 week. Pt never called or come in for us to visualize this reaction. Pt had no reaction in clinic.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with VARIVAX lot # L004653 with ex. 11-FEB-2017, (dose and route were not provided). No adverse effects were reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Swelling and pain at injection site 10 cm in size about 8 hours later. Single hive on face. Significant increase in pain/swelling by the next day - not overly remarkable except sib who got vaccine from the same lot # had same reaction.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUZONE Peds administered to patient when she was 5 mo 7 days of age in error. No adverse reactions. (Administration error report only).
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Swelling
Clinical narrative: Redness and swelling developing hours after vaccine. Itchiness at injection site. Approximately 10 cm in size, reaction site with significant redness and swelling with flu shot from same lot #.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: (L) arm with 1+ edema from shoulder to hand, painful to touch and move no erythema. Rx BENADRYL, naproxen, prednisone 20mgm (2 tab daily 3 days).
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cardiac function test, Full blood count, Glycosylated haemoglobin, Injection site cellulitis, Injection site erythema
Clinical narrative: Cellulitis (R) upper extremity. Lesions - lateral aspect of (R) upper arm warm and erythematous. Rednes of area approx 25 cm/mg/12-15 cm wide. No induration. No tenderness. Cephalexin 500 mgm caps QID (5 days) BENADRYL 25 mgm 1/2 q 6 hours PRN itch.
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site reaction, Injection site warmth, Metabolic function test, Skin lesion
Clinical narrative: Cellulitis (R) upper extremity. Lesions - lateral aspect of (R) upper arm warm and erythematous. Rednes of area approx 25 cm/mg/12-15 cm wide. No induration. No tenderness. Cephalexin 500 mgm caps QID (5 days) BENADRYL 25 mgm 1/2 q 6 hours PRN itch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Severe headache fever 102.4 (L) arm injection swelling 5x5 cm redness 10x10 cm tenderness 2+ 24-36 hours. Vomiting x2 to 24 hours. Rx TYLENOL fluids.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Severe headache fever 102.4 (L) arm injection swelling 5x5 cm redness 10x10 cm tenderness 2+ 24-36 hours. Vomiting x2 to 24 hours. Rx TYLENOL fluids.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Injection site urticaria, Pharyngeal oedema
Clinical narrative: "Large, red, swollen welt at injection site, pt stated she was having trouble breathing and felt like her throat was swollen. Pt said happened a few hrs after shot, she used an EPIPEN, started BENADRYL next day.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to multiple unspecified patients of unknown age. On an unknown, date the patients were vaccinated with (Merck) PROQUAD. No adverse event was reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache which is increasing in severity body aches with fever. Took TYLENOL with no relief. Took MOTRIN with some relief. Onset of symptoms approx. 4-6 hrs after receiving influenza vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received on 28-OCT-2015 from a registered nurse. On an unknown date, an unspecified patient experienced pain at the injection site from administration of GARDASIL 9. The nurse believed the patient was sent to physical therapy because of the reaction. No further information was provided. The outcome of pain at the injection site was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pain, Sleep disorder
Clinical narrative: This spontaneous report as received on 28-OCT-2015 from a registered nurse refers to a 14 year old male patient. On 05-OCT-2015 the patient was vaccinated with GARDASIL 9 (lot # L011846), dose 1. The patient immediately experienced pain at the injection site following the administration. On 28-OCT-2015, the patient was seen at her office still experiencing the pain. The nurse reported the pain is not in the joint but in the muscle at the injection site. The patient rated the pain as 4 out of 10 on the pain scale. The nurse reported the patient has full range of motion but cannot sleep on the affected arm. The patient's mother was intermittently administering ibuprofen. On 28-OCT-2015, the physician initiated a scheduled dose of ibuprofen to the patient (unspecified dose and frequency). The outcome of injection site pain was reported as not recovered/not resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hypertension, Influenza like illness
Clinical narrative: Pt fell down HR and BP very high - stayed on floor until she felt better - she feels like she has the flu - told to go get checked.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not specifically provided. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of GARDASIL 9 (dose and frequency were unspecified) (Lot # L013429, expiration date on 21-JUL-2017). This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with ZOSTAVAX. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not specifically provided. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of ROTATEQ oral (dose, frequency, Lot # and expiration date were unspecified). This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, CD4 lymphocytes increased, Laboratory test
Clinical narrative: This was a retrospective study of pediatric patients attending a hospital from 2006 to 2012. Patients with a diagnosis of DiGeorge syndrome were identified; their charts reviewed and immunologic data were abstracted. To be included in the study, the were required to have received the Hib vaccine, PCV (either 7-valent or 13-valent), diphtheria vaccine, and tetanus vaccine. Immunologic testing done at, or closest to, the time of vaccine titer measurements were included. Patient who did not have titers for the above-mentioned vaccines nor complete immunologic testing, including T- and B-cel subsets, lymphocyte mitogen proliferation, and immunoglobulin levels, were excluded. This study was approved by the review board. Information has been received from the author of a publish literature article regarding 3 pediatric patients of unknown age and gender with DiGeorge's syndrome. On an unspecified date, the patients were vaccinated with a dose of Hib vaccine (Manufacturer unknown) reported as "Hib vaccine" (Lot number, expiration date, dose and frequency were not provided). Concomitant medication was not reported. Overall, mean Hib vaccine (manufacturer unknown) titer was considered protective. Though, the three patients had nonprotective titers which were considered as vaccination failure. The immune parameters were within normal range (average CD3 count 2281 mm3, CD4 count 1536 mm3, CDS count 606 mm3, natural killer cell count (NK) count 947 mm3, IgG 712 mg/dL, IgA 33 mg/dL, IgM 58 mg/dL). Two of the 3 had normal lymphocyte responses to phytohemagglutinin, the third had low-normal response. One of the 3 also did not have a protective response to any of the pneumococcal serotypes, although she had normal T, B and NK cell levels, normal immune globulin levels and normal response to phytohemagglutinin. The outcome of vaccination failure was unknown as this was a retrospective study, additional testing was not done in the three patients. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Natural killer cell count increased, T-lymphocyte count increased, Vaccination failure
Clinical narrative: This was a retrospective study of pediatric patients attending a hospital from 2006 to 2012. Patients with a diagnosis of DiGeorge syndrome were identified; their charts reviewed and immunologic data were abstracted. To be included in the study, the were required to have received the Hib vaccine, PCV (either 7-valent or 13-valent), diphtheria vaccine, and tetanus vaccine. Immunologic testing done at, or closest to, the time of vaccine titer measurements were included. Patient who did not have titers for the above-mentioned vaccines nor complete immunologic testing, including T- and B-cel subsets, lymphocyte mitogen proliferation, and immunoglobulin levels, were excluded. This study was approved by the review board. Information has been received from the author of a publish literature article regarding 3 pediatric patients of unknown age and gender with DiGeorge's syndrome. On an unspecified date, the patients were vaccinated with a dose of Hib vaccine (Manufacturer unknown) reported as "Hib vaccine" (Lot number, expiration date, dose and frequency were not provided). Concomitant medication was not reported. Overall, mean Hib vaccine (manufacturer unknown) titer was considered protective. Though, the three patients had nonprotective titers which were considered as vaccination failure. The immune parameters were within normal range (average CD3 count 2281 mm3, CD4 count 1536 mm3, CDS count 606 mm3, natural killer cell count (NK) count 947 mm3, IgG 712 mg/dL, IgA 33 mg/dL, IgM 58 mg/dL). Two of the 3 had normal lymphocyte responses to phytohemagglutinin, the third had low-normal response. One of the 3 also did not have a protective response to any of the pneumococcal serotypes, although she had normal T, B and NK cell levels, normal immune globulin levels and normal response to phytohemagglutinin. The outcome of vaccination failure was unknown as this was a retrospective study, additional testing was not done in the three patients. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received on 28-OCT-2015 from a registered nurse. On an unknown date, an unspecified patient experienced pain at the injection site from administration of GARDASIL 9. No further information was provided. The outcome of pain at the injection site was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Headache, Malaise, Nausea, Rash
Clinical narrative: Received call from pt 11.10.15 states she had rash on Lt arm under her breast and around to her back. Has morning headache and nausea for last week - Pt had Flu vaccine and Tdap in same arm. Vaccines given on 11.2.15. Is still home sick.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Computerised tomogram normal, Hypoaesthesia
Clinical narrative: Pt experienced numbness in left face and hand 30 min after H1N1 flu vaccine in 2010. Has not received the influenza vaccine since that event. Reviewed case with 2 neurologists who had differing opinions on whether this was a TIA or not based on documented physical exam from that time, and if it was r/t the vaccine. A 3rd neurologist saw pt and stated that she should not receive the influenza vaccine again. Pt was given the influenza vaccine (AFLURIA, single dose syringe) and was observed for 1 hour. No neurologic events occurred then or within next 24 hours.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Headache, Hypoaesthesia, Nasopharyngitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tunnel vision in a 21-year-old female patient who received FLUARIX QUADRIVALENT (batch number C242G, expiry date June 2016). Concomitant products included OCELLA and ibuprofen. On 5th November 2015 08:00, the patient received FLUARIX QUADRIVALENT .5 ml. On 5th November 2015, several minutes after receiving FLUARIX QUADRIVALENT, the patient experienced tunnel vision (serious criteria GSK medically significant), nausea, felt faint, skin discoloration, numbness facial, headache and tingling lips. On 6th November 2015, the patient experienced fatigue and cold symptoms. On an unknown date, the outcome of the tunnel vision, nausea, felt faint, skin discoloration, numbness facial, headache, tingling lips, fatigue and cold symptoms were unknown. The reporter considered the tunnel vision, nausea, felt faint, skin discoloration, numbness facial, headache, tingling lips, fatigue and cold symptoms to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter called on the behalf of the patient (one of her pharmacy students). There were no other vaccines given on the same date or within 4 weeks prior to suspect vaccine. The time of vaccine administration of FLUARIX was 8:00pm. The reporter stated within a couple of minutes of receiving the injection the patient felt nauseated and almost fainted. In addition, the patient turned white as a ghost and experienced facial numbness, tunnel vision, headache and tingling around the lips. The reporter also stated that when she spoke with the patient at the time of reporting, she was still experiencing a headache, nausea and tingling around her lip and extreme fatigue (she could hardly move). Prior to receiving the injection the patient was fine and then after she became a different person. The patient stated although she just had exam week she felt ran down and thought she was developing cold symptoms. The patient's date of birth and complete expiration date of the vaccination were unknown.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pallor, Paraesthesia oral, Skin discolouration, Tunnel vision
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tunnel vision in a 21-year-old female patient who received FLUARIX QUADRIVALENT (batch number C242G, expiry date June 2016). Concomitant products included OCELLA and ibuprofen. On 5th November 2015 08:00, the patient received FLUARIX QUADRIVALENT .5 ml. On 5th November 2015, several minutes after receiving FLUARIX QUADRIVALENT, the patient experienced tunnel vision (serious criteria GSK medically significant), nausea, felt faint, skin discoloration, numbness facial, headache and tingling lips. On 6th November 2015, the patient experienced fatigue and cold symptoms. On an unknown date, the outcome of the tunnel vision, nausea, felt faint, skin discoloration, numbness facial, headache, tingling lips, fatigue and cold symptoms were unknown. The reporter considered the tunnel vision, nausea, felt faint, skin discoloration, numbness facial, headache, tingling lips, fatigue and cold symptoms to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter called on the behalf of the patient (one of her pharmacy students). There were no other vaccines given on the same date or within 4 weeks prior to suspect vaccine. The time of vaccine administration of FLUARIX was 8:00pm. The reporter stated within a couple of minutes of receiving the injection the patient felt nauseated and almost fainted. In addition, the patient turned white as a ghost and experienced facial numbness, tunnel vision, headache and tingling around the lips. The reporter also stated that when she spoke with the patient at the time of reporting, she was still experiencing a headache, nausea and tingling around her lip and extreme fatigue (she could hardly move). Prior to receiving the injection the patient was fine and then after she became a different person. The patient stated although she just had exam week she felt ran down and thought she was developing cold symptoms. The patient's date of birth and complete expiration date of the vaccination were unknown.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage, Pruritus, Swelling
Clinical narrative: On 11/12/15 1st time pt received High Dose Flu vaccine. IM injection given (R) deltoid 2 fingers below acromium process. Sl. bleeding after injection. C/o itching almost immediately after injection cold pack applied x 20 minutes. Slight bruising and swelling spoke w/ patient on 11/13/15. Slight bruise remains. She denies pain, itching or swelling.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Inflammation
Clinical narrative: He received vaccine 11/11/15 and called 11/13/15 to tell us that his arm became red, inflamed, and hard to touch. Advised patient to take BENADRYL to alleviate reaction and to contact PCP to let them know about rxn.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain
Clinical narrative: A little bit of pain, not hot, not tender. Redness spread over 2 days, slight blisters, localized. Saw doctor antibiotics cleared it up.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site induration, Pruritus
Clinical narrative: Right arm redness; swelling; rash; itchiness (patient reports they did not scratch it); hardness at the site of the injection; feels warmth down to the bone; cellulitis that according to the doctor has spread across the arm.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash, Swelling
Clinical narrative: Right arm redness; swelling; rash; itchiness (patient reports they did not scratch it); hardness at the site of the injection; feels warmth down to the bone; cellulitis that according to the doctor has spread across the arm.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 16-SEP-2014, the patient was vaccinated with the first dose of ZOSTAVAX and then on 12-NOV-2015, received a second dose of ZOSTAVAX injection (doses, route, lot # and expiration dates were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient claims that injection given (Fluzone Quad 15-16) was painful after receiving on 10/30/15 at approximately 6:15pm-- sore, slightly warm to the touch, red circle developed around site of injection.  Patient approached pharmacist first on 11/7/15 at approximately 1:30pm to inquire about injection site-- still red circular mark around area at that time (he said was fading some but still there, was very apparent to pharmacist), slightly warm to the touch at that point per patient report.  Pharmacist recommended that he seek advice of his family physician to evaluate to rule out infection or serious issue.  Patient was to report results back to pharmacist early in the week of 11/14/15-- he called patient back on 11/13/15 and state that he visited his family physician, and that he does not feel that there is anything medically wrong with the patient, and that it is just a bruise, possibly that the injection went into a vein that leaked out.  Patient states as of 11/13/15 that site is "just about gone," and much better, and no further assistance is needed at this time.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, DTAP, HEP, MNQ
Symptoms: Chest discomfort, Chest pain, Cold sweat, Cough, Depressed level of consciousness
Clinical narrative: Approx. 5-10 mins after receiving vaccine and bicillin injection the Pt c/o of feet feeling funny and chest discomfort. Stated he felt like he was dying, coughing large amount of frosti sputum, c/o chest pain, capillary refill in fingers and toes 6-8 seconds. Sweaty and clammy decrease LOC. Labor breathing O2 10L given/non re-breather, Epi Pen adult given times, two, Benadryl given, Sol-u-medrol given. IV NS GIVEN PER EMS. 18 G LT ANTCUBITAL. 4:00PM TO 4:16PM. TRANSFERRED TO HOSPITAL.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, DTAP, HEP, MNQ
Symptoms: Dyspnoea, Feeling abnormal, Hyperhidrosis, Productive cough
Clinical narrative: Approx. 5-10 mins after receiving vaccine and bicillin injection the Pt c/o of feet feeling funny and chest discomfort. Stated he felt like he was dying, coughing large amount of frosti sputum, c/o chest pain, capillary refill in fingers and toes 6-8 seconds. Sweaty and clammy decrease LOC. Labor breathing O2 10L given/non re-breather, Epi Pen adult given times, two, Benadryl given, Sol-u-medrol given. IV NS GIVEN PER EMS. 18 G LT ANTCUBITAL. 4:00PM TO 4:16PM. TRANSFERRED TO HOSPITAL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Wheezing
Clinical narrative: Wheezing.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt came to pharmacy today to show me the arm where the vaccine had been administered. Arm was red and swollen. The arm was almost streaked red down the back of her arm. Pt reported that about 1.5 days after she received the vaccine, she experienced all over body aches and pain. She states that her arm was so sore she did not even want to move it and contemplated going to the ER. Advised pt to continue icing inflamed area.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Atrial fibrillation, Chills, Headache, Heart rate increased, Influenza like illness
Clinical narrative: Patient indicates they began having symptoms 2 days after receiving the flu vaccination. They said flu like symptoms occurred after the vaccination as well as atrial fib, increased heart rate, fever, high white blood cell count, headache, chills, and weak legs and stated they went to the ER for symptoms.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pyrexia, White blood cell count increased
Clinical narrative: Patient indicates they began having symptoms 2 days after receiving the flu vaccination. They said flu like symptoms occurred after the vaccination as well as atrial fib, increased heart rate, fever, high white blood cell count, headache, chills, and weak legs and stated they went to the ER for symptoms.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Sensation of foreign body, Urticaria
Clinical narrative: Pt experienced initial reaction at pharmacy - started with cough, hives and then lump in throat.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorganised speech, Erythema, Peripheral swelling, Speech disorder, Thinking abnormal
Clinical narrative: Word disruption; inability to complete thoughts; difficulty speaking; also, patient had redness, swelling over large area of upper arm.
Age: 0.35
Sex: M
Vaccine: HIBV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness during injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Red, painful itchy site and arm. Infection treated by PCP. Says still red and painful "10 days later".
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: Pt reported numbness and tingling in right arm w/some facial swelling. No hospitalization needed was instructed to take BENADRYL 25 mg and ADVIL 200 mg.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Stomatitis
Clinical narrative: Pt received AFLURIA and PNEUMOVAX 23 on 9/23. Pt developed sores in his mouth the next day. He did not seek medical treatment, but missed 1 day of work. Cleared up in a day or 2.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Endotracheal intubation, Epilepsy, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome, Epileptic and Stress Seizures, Right Side Paralysis, Facial Palsy.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Hemiplegia, Nuclear magnetic resonance imaging, Seizure, Stress, VIIth nerve paralysis
Clinical narrative: Guillain Barre Syndrome, Epileptic and Stress Seizures, Right Side Paralysis, Facial Palsy.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Computerised tomogram head normal, Fall, Laceration, Syncope
Clinical narrative: Patient had a syncopal episode and fell off the exam table. He required a visit to the ER for stitches due to a head laceration.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Fever and itchy rash that still persists.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Deep ache in whole arm down to wrist. Movement restricted due to severe pain especially on left shoulder and injection site.  Striking pain upon lifting the hand or elbow, could not lift any weight or left hand above elbow.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Erythema, Infection, Pain, Pain in extremity
Clinical narrative: Redness and pain over his left arm. Temp of 100.8F body aches. Has 2 red welts. Looks like it is infected.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Redness and pain over his left arm. Temp of 100.8F body aches. Has 2 red welts. Looks like it is infected.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Began to feel feverish, tired, nausea. Redness began to spread over upper arm Wed evening: pain and tightness in upper arm, by Thursday the redness had covered most of upper arm to elbow. The patient saw a NP at his physicians office around 4:00PM Thursday and she prescribed a ZPAK.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Skin tightness
Clinical narrative: Began to feel feverish, tired, nausea. Redness began to spread over upper arm Wed evening: pain and tightness in upper arm, by Thursday the redness had covered most of upper arm to elbow. The patient saw a NP at his physicians office around 4:00PM Thursday and she prescribed a ZPAK.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash, Pain, Pyrexia
Clinical narrative: Rash, very painful at injection site, fever, aches.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Muscle pain all over legs/arms/shoulders through night over in 24 hours.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Myalgia
Clinical narrative: 24 hour severe muscle pain, more severe than Prevnar! Hardly able to walk.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: My shoulder is in a lot of pain I can't lift it and, it feels like some is torn in my shoulder and a little pain in my arm but in my shoulder bad when I lift it there is a lot of pain.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site, redness, itchy, hot to the touch, pain.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Child had a likely partial syncope within 5 min from vaccine administration, stable pulse and breathing during observation but feeling dizzy, very sleepy, reporting headache, feels mildly sweaty, was pale. Paramedics called and arrived approx 15min later, reported stable BP and released child to mother with advice to get him check by ER or PCP. Child walked away on his own.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Child had a likely partial syncope within 5 min from vaccine administration, stable pulse and breathing during observation but feeling dizzy, very sleepy, reporting headache, feels mildly sweaty, was pale. Paramedics called and arrived approx 15min later, reported stable BP and released child to mother with advice to get him check by ER or PCP. Child walked away on his own.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient developed hives 2 hours after flu vaccine administered. Advised to treat with BENADRYL. Patient with egg allergy/observed for 30 minutes in office post injection, no reaction noted.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort, Local swelling
Clinical narrative: Pt here today for reaction - 9 days later 2 large swollen spots about 2" in size about 1 inch apart pt complains of arm discomfort.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Flushing, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Possible adverse reaction the day following vaccine injection. 1 episode of diarrhea/nausea with flushing of left side of face which lasted 30 minutes. Redness and swelling at the injection site app. 3 inches induration. Warm to touch. Checked today still warm, red, swollen. No systemic symptoms noted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Skin warm
Clinical narrative: Possible adverse reaction the day following vaccine injection. 1 episode of diarrhea/nausea with flushing of left side of face which lasted 30 minutes. Redness and swelling at the injection site app. 3 inches induration. Warm to touch. Checked today still warm, red, swollen. No systemic symptoms noted.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: Patient described adverse reaction to FLUZONE HD that included lymph node inflammation.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Pt states that within first 24 hours, lips swelling occurred.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Fussy infant. No other observed symptoms. Report filed per parents request. (16.21 lbs 11/2/15) 1.25 ml TYLENOL given by parent.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Screaming
Clinical narrative: Fussy infant. No other observed symptoms. Report filed per parents request. (16.21 lbs 11/2/15) 1.25 ml TYLENOL given by parent.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain of left upper arm. Provider advised cool compresses to reduce swelling . Use TYLENOL 500 mg every 6 hours as needed.
Age: 1.59
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site urticaria
Clinical narrative: Left thigh upper leg with large reddened welt covering entire upper muscle - right lower leg - outer aspect with large welt - temperature 101.1 at this time.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Onset 10/29/15 to current. Left arm pain, muscle weakness, OTC ibuprofen, ice,  topical BENGAY. Prescribed TYLENOL #3 for severe pain.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Fever went seen in local ER.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: Injection site arm shows significant redness covering injection site area and bicep. Patient noticed AM on day after vaccination. Skin feels warm. A part from arm soreness, patient reports no other symptoms. As of 1:53 PM on 11/13/15 symptoms are not worsening.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Bursitis, Erythema, Swelling
Clinical narrative: Vaccine was given approx 1330 - later that evening he developed some bursitis/redness and swelling - and then developed some blisters - last x 72 hours.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness at injection site. Treated with KEFLEX 250 mg PO QID x 5 days.