chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX. Indication, lot number, expiry date, route of administration and anatomical location were not reported. On an unknown date after the vaccination the patient experienced numbness (hospitalization). The outcome of numbness is unknown. The reporting pharmacist did not provide a causality statement. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient had no drug allergies or reactions. On 26-AUG-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number J003359 and expiry date  was 21-JUN-2014, route was unknown). On an unknown date, the patient experienced a lump that was red and warm to touch after she received ZOSTAVAX. There was no evidence of any rash. The patient was instructed to use ibuprofen and Benadryl as treatment. The outcome of the events were unknown. The patient sought medical attention (called pharmacy). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient had no drug allergies or reactions. On 26-AUG-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number J003359 and expiry date  was 21-JUN-2014, route was unknown). On an unknown date, the patient experienced a lump that was red and warm to touch after she received ZOSTAVAX. There was no evidence of any rash. The patient was instructed to use ibuprofen and Benadryl as treatment. The outcome of the events were unknown. The patient sought medical attention (called pharmacy). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient had no drug allergies or reactions. On 26-AUG-2013, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number J003359 and expiry date  was 21-JUN-2014, route was unknown). On an unknown date, the patient experienced a lump that was red and warm to touch after she received ZOSTAVAX. There was no evidence of any rash. The patient was instructed to use ibuprofen and Benadryl as treatment. The outcome of the events were unknown. The patient sought medical attention (called pharmacy). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse (Licensed Vocational Nurse) refers to a patient of unknown age and gender reported as child. On an unknown date the patient was inadvertently, instead of VARIVAX (Merck), vaccinated with PROQUAD (Merck), injection (dose and route not provided). No adverse effect was reported. The outcome of events was not reported. This is one of 2 reports from the same source. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Vomiting
Clinical narrative: Flu shot is administered at 10:40 A.M. Patient called back next morning said at about 4 P.M. he started throwing up. Has to be hospitalised and not able to walk right now.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site bruising, Injection site granuloma
Clinical narrative: Sustained a small granuloma at site of injection. This granuloma with surrounding bruising has persisted and not decreased in size despite warm soaks and compresses. There are not significant motor sequelae other than subcutaneous granuloma.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lethargy, Pallor
Clinical narrative: Pt became lethargic with pale lips after the first shot. Signs/symptoms which were reported by mother before the vaccines - mother stated that pt has been getting in this condition when he cries.
Age: 40.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Rash pruritic, Urticaria
Clinical narrative: Developed itchy rash the day after receiving 2 vaccines. Rash persisted for one week without improvement from oral BENADRYL. Came to a walk-in retail clinic for evaluation of the rash Diagnosis urticaria with angioedema or anaphylaxis.
Age: 5.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt. was accidentally vaccinated with BOOSTRIX instead of DAPTACEL for a kindergarten physical. Pt. with mother. No reaction noted after staying 15 min. after injection.
Age: 1.34
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 102 degrees F 10 days after vaccine lasing 2 days then appearance of rash on face, torso, arms and legs.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema and induration at site of injection about 5cm in size with redness moving down the arm almost to elbow with width 4cm or so. Tender at indurated area.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Insomnia, Pruritus
Clinical narrative: Within 48 hours of the vaccines being administered the pt complained of extreme itchiness, insomnia and coughing. Recommended she try hydrocortisone cream and ZYRTEC x 5 days.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 12 cm x 11 cm erythema 9 cm x 10 cm induration at site of injection.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Urticaria developed day after vaccine on chest and face -> responding to BENADRYL.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Rec'd PENTACEL, PREVNAR 13, ROTATEQ at 1030A. Went home slept 3 hrs. - woke at 2P - mom called this office at 4P child screaming non-stop x 2h. Advised to give TYLENOL (160/5ml) 2.5 ml - mom called office back at 535P and infant improved and has done fine and was himself after that.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Malaise, Pain in extremity
Clinical narrative: Pt starting feeling ill after vaccination. Arm became red painful and swollen Friday night into Saturday worsened. Shot given on a Wednesday. Redness traveled to axillary area. Pt works in a hospital and MD gave her antibiotics on Saturday.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 69 year old male patient. The patient has high blood pressure and seasonal allergies. Approximately on an unknown date in 2011 (reported as 2 years ago), the patient was vaccinated with ZOSTAVAX. Concomitant medications included unspecified high blood pressure. On 29-AUG-2013, the patient developed shingles after receiving ZOSTAVAX. Unspecified antiviral medication was rendered as a treatment. There were no lab diagnostics performed. The outcome of the event was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Contusion, Fall, Loss of consciousness
Clinical narrative: After all four vaccines administered, 2 minutes had passed, patient slumped forward and fell to floor. He was unconscious for approx. 2 minutes. He then rested in office for 45 minutes. Small contusion to (L) shin. Sent home w/ instructions to drink fluids, rest, and take TYLENOL.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Convulsion, Malaise
Clinical narrative: Patient received FLUVIRIN and ZOSTAVAX on 8-29-13. The following few days she felt under the weather with worsening symptoms on Sunday 9-1-13. She suffered a seizure and was treated at medical center by Dr. She was sent home on KEPPRA with orders to follow up later this week.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Convulsion, Laboratory test abnormal, Vaccination complication
Clinical narrative: Patient received FLUVIRIN and ZOSTAVAX on 8-29-13. The following few days she felt under the weather with worsening symptoms on Sunday 9-1-13. She suffered a seizure and was treated at medical center by Dr. She was sent home on KEPPRA with orders to follow up later this week.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Grand mal convulsion, Injection site erythema, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging
Clinical narrative: Patient received FLUVIRIN and ZOSTAVAX on 8-29-13. The following few days she felt under the weather with worsening symptoms on Sunday 9-1-13. She suffered a seizure and was treated at medical center by Dr. She was sent home on KEPPRA with orders to follow up later this week.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Scan brain
Clinical narrative: Patient received FLUVIRIN and ZOSTAVAX on 8-29-13. The following few days she felt under the weather with worsening symptoms on Sunday 9-1-13. She suffered a seizure and was treated at medical center by Dr. She was sent home on KEPPRA with orders to follow up later this week.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear discomfort
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old male patient, who approximately on 13-AUG-2013, reported as "7 to 8 days ago", was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported). On an unspecified date, approximately in August 2013, the patient experienced "blockage in his ears". The patient sought medical attention, he was seen by doctor and prednisone (manufacturer unknown) 10 mg was prescribed, in a "tapering doses". At the time of report the outcome of patient and causality was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Blister, Pain, Rash, Rash pruritic
Clinical narrative: Received TDaP and CPX vaccine on 8/14/13. On 8/16/13 broke out in rash with small blisters on top of R knee to ankle. No fever but does itch. All of calf rash, worse on knee. Applied hydrocortisone cream and benadryl cream. 9/3/13 till has some blisters, sore in certain areas. Still on R leg - has 3 spots (blisters) on L leg. Started applying Abreva and rash is drying.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Patient came back to clinic 5 days after receiving Tdap with localized redness, warmth around injection site. Pt also reported had pain for the 5 days after injection.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Reports pain and persistent swelling at injection site since injection. Advised ice topically for 10 minutes/hr while awake and ALEVE tabs 2 PO Q 12 hr x 5 days. Also reported numbness/tingling of fingers. to see PCP if sx persist after treatment above.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. had swelling, redness, at site about 2 days later. Pt. was taking benadryl and was told by PCP to go to MD.
Age: 16.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Contusion, Face injury, Fall, Syncope
Clinical narrative: HPV vaccine given. Pt was sitting on exam table. MA was talking to MA when he fell forward onto floor and hit face. Pt had syncopal episode.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 30-AUG-2013, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck)(Lot number J0050177, expiry date was 11-MAR-2014, route was subcutaneous) instead of ZOSTAVAX. No adverse effect was reported. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On 27-AUG-2012, 05-JUN-2013, and 14-AUG-2013 the patient was vaccinated with GARDASIL doses 1,2 and 3 respectively (doses, routes and lot numbers not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age or gender. No medical conditions or allergies were reported. On 14-OCT-2008, also reported as 14-OCT-2013, the patient received the first dose of M-M-R II (dose, route and lot number were not provided). On 26-AUG-2013, the patient received an expired M-M-R II as the second dose, lot number 1123AA and expiration date 12-JUL-2013, (dose and route were not provided). No adverse event reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In November 2010 the patient was vaccinated with her first dose of GARDASIL (dose, route and lot number not provided). On MAY-2013 the patient was vaccinated with her second dose of GARDASIL (dose, route and lot number not provided) and was in the office to receive her third dose of GARDASIL (dose, route, and lot number not provided), on 28-AUG-2013. No adverse effect was reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Pyrexia
Clinical narrative: Warmth, redness, pain, low grade fever. Started 24 hrs after administration that progressed after 48 hrs. Seen in facility. Treated w/ KEFLEX.
Sex: U
Vaccine: HEPA, HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with VAQTA (dose, frequency, route, lot # and expiration date were not provided), PEDVAXHIB (dose, frequency, route, lot # and expiration date were not provided) and GARDASIL (dose, frequency, route, lot # and expiration date were not provided). The licensed practical nurse reported that on an unknown date, the patients might been administered VAQTA, PEDVAXHIB and GARDASIL that were not supported in a temperature excursion. It was unknown if the patients sought medical attention. No adverse effects were reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia, Nausea
Clinical narrative: Chills, nausea, myalgias, redness and swelling of injection site.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Pain, warmth, swollen.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pruritus, Injection site swelling
Clinical narrative: Headache - all of 8/29/2013; Itching and swelling of injection site:  8/30/2013 - 9/2/13; Redness of injection side (palm sized):  8/30-9/2/13; Fatigue:  8/29/13 - 9/2/13.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site abscess, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and soreness to the site.
Age: 17.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Nodule, Swelling
Clinical narrative: Knot redness swelling and heat. Cool pack and Benadryl.
Age: 1.02
Sex: F
Vaccine: FLUX, MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever- highest was 103.3.  Gave IB Profin or Tylenol.  Fever continued on an off for two days. As of 8/30/13 has about 30-40 tiny spots all over body. Still has spots as of 9/3/13.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Noticed that her left upper arm was red and slightly itchy in two adjoining areas. States she doesn't know if this is from the Tdap vaccine she received on 8/28/13 or possibly from bug bites that she may have received when she spent approximately 2 hours at a fair. She noticed the redness and itching shortly after she returned from the fair that evening. Symptoms have stayed the same since that time. She has used an OTC antiseptic ointment. States this treatment has relieved the itch for a period of time.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Started running a fever of around 102.  This continued until around 4:00 AM on 9/2/2013. Reported no other symptoms.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 09/02/2013 @ 7:00 pm 4 y/o male brought by mother for after-hours visit for c/o leg swelling and rash. Noticed yesterday this morning worse.  At first thought perhaps due to bug bites since had been outdoors for a while at night.  However, continued to get worse today. Mother called me this am and I had discussed option of OTC Benadryl.  She gave him children's allergy relief today--helped with itching; however swelling and bumps seemed to get worse bumps and swelling c/o itching and now with c/o pain. Advised to give regular doses of diphenhydramine at 12.5mg q6 hr for today and tomorrow at least.    Discussed s/s to watch for for worsening, and emphasized to call/f/u if sxs persist or worsen.  PrednisoLONE oral syrup 15 mg/5 mL 5mL po bid x5 days (start date: 09/02/2013). Prescription: qty 50 of 15 mg/5 mL  5mL po bid x5 days  (NO refills).
Age: 1.34
Sex: F
Vaccine: HIBV
Symptoms: Expired drug administered
Clinical narrative: Expired dose of ACTHIB given. Vaccine expired on 8/18/2013.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Fatigue, Somnolence
Clinical narrative: WORSENING DIZZINESS, TIRED, SOMNOLENT, SEVERAL LOOSE STOOLS APPROX 15-18 HRS AFTER VACCINATION ADMINISTRATION.  SYMPTOMS RESOLVED WITHIN 36 HRS.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Rash with blisters.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Bacterial test negative, Blood culture negative, CSF culture negative, CSF protein increased, CSF white blood cell count increased
Clinical narrative: Fever developed and persisted. Patient admitted on 08/30/13 and spinal tap showed 600 WBCs and 100RBCs with elevated protein. Blood and spinal bacterial cultures were neg but awaiting viral culture result for herpes.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Chest X-ray normal, Full blood count normal, Metabolic function test normal, Pyrexia, Red blood cells CSF positive
Clinical narrative: Fever developed and persisted. Patient admitted on 08/30/13 and spinal tap showed 600 WBCs and 100RBCs with elevated protein. Blood and spinal bacterial cultures were neg but awaiting viral culture result for herpes.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urine analysis normal, Viral test
Clinical narrative: Fever developed and persisted. Patient admitted on 08/30/13 and spinal tap showed 600 WBCs and 100RBCs with elevated protein. Blood and spinal bacterial cultures were neg but awaiting viral culture result for herpes.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Eye swelling, Injection site swelling, Lip swelling
Clinical narrative: At 08/30/2013 patient presented to clinic with complaints of swollen lips and eyes, also local swelling at the injection site (left deltoid muscle).
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Full blood count normal, Laboratory test normal, Oropharyngeal pain
Clinical narrative: Fever, chills, body aches, vomiting, sore throat, cough. Fever to 102.3 on and off throughout coarse of illness which has lasted 12 days. No one else sick at home.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Fever, chills, body aches, vomiting, sore throat, cough. Fever to 102.3 on and off throughout coarse of illness which has lasted 12 days. No one else sick at home.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Brain oedema, Chills, Headache, Piloerection, Pyrexia
Clinical narrative: Severe yawning with quaking/shivering in chest, likeness to shivers from waking from anesthetic. Chills, severe headache. Felt like brain lining was swelled. Fever with goosebumps. Lasted approximately 10 hours.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Yawning
Clinical narrative: Severe yawning with quaking/shivering in chest, likeness to shivers from waking from anesthetic. Chills, severe headache. Felt like brain lining was swelled. Fever with goosebumps. Lasted approximately 10 hours.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: On 08/30/2013 patient presented to the clinic with the left arm swollen (left deltoid area. The swelling was reduced with cold compression.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Ultrasound abdomen abnormal
Clinical narrative: Patient developed abdominal pain the day after his first HPV vaccine.  Seen at hospital and his ultrasound revealed appendicitis. Patient had appendectomy that day.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Axillary pain, Erythema, Injection site discolouration, Injection site pain, Pain in extremity
Clinical narrative: Noticed slight itchy feeling, looked in mirror at back of left arm and it was the color of the wine rose' was 2" x 3" around the site of injection.  Next day redness continued to enlarge and had an orange peel effect(09/02/2013); next day it began to ache in the upper arm (L) and began to fade to the shade of white zinfandel; 09/03/2013 (today) arm still aches, armpit aches, injection site has grown to 7" x 3" but orange peel effect has decreased and the color remains about the same, but the area seems to be flattening out.  This is relieved by moist cool compresses and taking Benadryl 25 mg at night. I am a registered nurse and have sent my FNP a note about this on-line this a.m. I did not report this to the pharmacist yet.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Peau d'orange, Pruritus
Clinical narrative: Noticed slight itchy feeling, looked in mirror at back of left arm and it was the color of the wine rose' was 2" x 3" around the site of injection.  Next day redness continued to enlarge and had an orange peel effect(09/02/2013); next day it began to ache in the upper arm (L) and began to fade to the shade of white zinfandel; 09/03/2013 (today) arm still aches, armpit aches, injection site has grown to 7" x 3" but orange peel effect has decreased and the color remains about the same, but the area seems to be flattening out.  This is relieved by moist cool compresses and taking Benadryl 25 mg at night. I am a registered nurse and have sent my FNP a note about this on-line this a.m. I did not report this to the pharmacist yet.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Noticed slight itchy feeling, looked in mirror at back of left arm and it was the color of the wine rose' was 2" x 3" around the site of injection.  Next day redness continued to enlarge and had an orange peel effect(09/02/2013); next day it began to ache in the upper arm (L) and began to fade to the shade of white zinfandel; 09/03/2013 (today) arm still aches, armpit aches, injection site has grown to 7" x 3" but orange peel effect has decreased and the color remains about the same, but the area seems to be flattening out.  This is relieved by moist cool compresses and taking Benadryl 25 mg at night. I am a registered nurse and have sent my FNP a note about this on-line this a.m. I did not report this to the pharmacist yet.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Appendicitis, Diarrhoea, Surgery, Vomiting
Clinical narrative: Pt had some mild intermittent stomach aches 2 weeks prior to WCC. Had WCC & 1st HPV, then 6 days later seen for vomiting & diarrhea and abdominal pain. Pt diagnosed with acute appendicitis and received surgery.
Age: 50.0
Sex: M
Vaccine: TYP
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Patient developed tongue swelling and tingling.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Found in early morning app 0630 layed down at 2200.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: Found in early morning app 0630 layed down at 2200.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pain
Clinical narrative: Pt received PNEUMOVAX 0.5cc IM Rt deltoid on 8-22-13. Pt complained of pain. Instructed him to medicate with APAP or ibuprofen. Pain increased. Pt went to hospital ER 8-24-13 was hospitalized with cellulitis.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 05-JUN-2013 the patient was vaccinated with a second dose of GARDASIL, 0.5 ml, intramuscular injection (site of administration, lot number and exp. date were not reported0. The second dose of GARDASIL was expired. No adverse effects had been reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Body temperature increased, Hyperaesthesia, Influenza like illness, Musculoskeletal discomfort
Clinical narrative: This spontaneous report as received from a 66 year old male patient refers to himself. No medical history and drug reactions/allergies were reported. On 21-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J000495, expiration date 14-APR-2014) vial injection (dose and route not provided). 12 hrs after receiving ZOSTAVAX on 21 or 22-AUG-2013, the patient experienced flu-like symptoms and elevated body temperature. The patient's overall symptoms included upset digestive system, joint discomfort and extremely hyper-sensitive skin. The patient self medicated with TAGAMET. The outcome of the events was unknown. The causality between the events and therapy with ZOSTAVAX was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date and dose unspecified) in her butt muscle. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report for VARIVAX (Merck), a Pregnancy Registry product, was received from a registered nurse refers to a 17 year old female patient with no drug reactions/allergies and no pertinent medical history. On 14-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously, lot # reported as J003704 while she was pregnant. Concomitant therapies included MENVEO and ADACEL. The last menstrual period (LMP), estimated due date (EDD) and date of conception were not provided. The patient delivered the baby on 16-AUG-2013. Both patient and baby were fine. There was not any treatment ordered. There were no lab tests performed. The patient sought medical attention via phone call. Additional information has been requested.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Injection site swelling
Clinical narrative: Baby had temp of about 102 degrees F 24 hours after immun and (L) leg (HIB) swelled significantly at injection site. Reacted to 2 mo shots also.
Age: 54.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient given FLUMIST - patient over age limit.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: There was no adverse event.  An expired pre-filled syringe of last years flu vaccine was squirted up a patients nose.  Our Pharmacist is directing us to fill out a report.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUN4
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Lethargy
Clinical narrative: Heart palpitations, muscle spasms, weak lethargic and tired, joint/muscle pain, headaches, slight fever (99.2).  Took ibuprofen for treatment and slept the next day.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUN4
Symptoms: Muscle spasms, Myalgia, Palpitations, Pyrexia
Clinical narrative: Heart palpitations, muscle spasms, weak lethargic and tired, joint/muscle pain, headaches, slight fever (99.2).  Took ibuprofen for treatment and slept the next day.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site pain, Injection site swelling, Injection site warmth, Middle insomnia
Clinical narrative: "My left arm near by triceps became sore. I didn't think anything of it until the pain/sensitivity work me up at midnight. I had a dull ache, and the skin was really sensitive. I took a Benadryl and got through the night sleeping, but Saturday I experience continued aches and skin sensitivity (couldn't touch my underarm) skin heat and swelling."
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Conjunctival hyperaemia, Eye discharge, Purulent discharge, Rash morbilliform
Clinical narrative: Morbilliform rash followed by conjunctival injection and purulent eye discharge.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pruritus, Injection site rash, Rash pruritic
Clinical narrative: Itchy bumps/rash on leg that MMR vaccine was administered.  Went away within a few days.  Same itchy bumps/rash then appeared on inner part of arm near the inner part of elbow area.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site abscess, Injection site erythema
Clinical narrative: Ten days past administration in left thigh Hep A and MMR. Thigh noted to be red and a abscess at injection site was diagnosed. Clindamycin PO soln 75mg/5ml prescribed.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen (size of baseball), hot to touch.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pyrexia, Vomiting
Clinical narrative: Fever, fatigue, vomiting.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient became dizzy and nauseous with vomiting after HPV 3 dose. No reaction to first 2 doses.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned with left upper arm swollen, red, warm to touch under injection site. Patient stated the red swollen arm on upper arm also itched.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Itchinig - Rash - Ice - Benadryl  tablets - Cream (corizone)
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Blood bilirubin increased, Metabolic function test, Pruritus
Clinical narrative: C/O severe itching left plam and mod. itching bottom of left foot. He scratched his palm so much that it was raw. Resolved in 2 days.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria developed the day after Hep A was administered. No recent viral illness or change in food, soap, detergent etc. Pt on no meds at time hives developed this occurred intermittently - responded to BENADRYL but revised had hives on trunk, thighs, and cheeks pt seen 8/22/13 treated with cold compression, AVEENO, cetirizine.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Influenza like illness, Pyrexia
Clinical narrative: Vaccine received about 5 PM. Felt lightheaded that evening. Had fever 103 degrees in morning and flu-like sympt.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth
Clinical narrative: 09/03/13 pt came to pharmacy because there was a red circular area about 1 1/2" diameter around site of injection. It was warm to touch per patient. She also said she had a headache since vaccination on 9/1/13.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site induration
Clinical narrative: Received vaccines on 7/17/13. Came to office on 8/8/13 reporting indurated areas on bilat thighs beginning 1 week after injections.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Oedema peripheral, Skin warm
Clinical narrative: Patient reported swollen forearm with a fluid-like appearance (edema). Red and hot.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Feeling hot, Injection site rash, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: Rash at injection site on 9/1/13 in AM. Pt noticed small red, hot circular rash. Today 9/2/13 pt has larger circumference and hotter rash with dull ache from elbow to wrist and she feels feverish (low-grade).
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Rash
Clinical narrative: Rash on the left arm and swelling at the site of injection.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reported he had moderate pain 3 hours after being vaccinated in his right arm from shoulder to elbow. Soon after, he reports that he had excruciating pain in same arm and immediately went to ER where they told him to take Tylenol.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling at site. Fever.
Age: 0.51
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Eyelid oedema, Vomiting
Clinical narrative: 8/13/13 Swelling to Bilateral Upper Eyelids, Vomited x 1. Time: 5;30 PM duration 2 hrs. TX: Benadryl 0.5 ml PO at home by mother.
Age: 1.2
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Papule
Clinical narrative: Multiple red 2-4mm papules, mainly on face and chest with some on arms and legs.Some have very small clear centers.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Local vaccine reaction of VARIVAX on left tricep (red, warm to touch about 2 inches nodule at injection site with minimal pain). Advise TYLNEOL, BENADRYL x PRN.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Generalised erythema
Clinical narrative: Vaccine given by employee health nurse; employee reported on 8-30-13 that she had noted an irregularly shaped reddened site to her (L) hip on 8-17-13; other similar sites have spread erratically across her abdomen, neck, chest, arms, legs and feet - hands and face remain unaffected on this date; saw physician 8-28-13 and was prescribed Methylprednisolone 4mg 21 tabs.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye discharge, Eye infection, Purulent discharge
Clinical narrative: Within 1 hour start with an asthmatic type cough. Then throat started feeling tight. I took a ZYRTEC. Then eyes became infected w/mucopurulent discharge. I took BENADRYL 25 mg. Then had a fever of 100.2 with rigors. Took TYLENOL 1000 mg plus MOTRIN 600 mg. Symptoms gone the next day.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Secretion discharge, Throat tightness
Clinical narrative: Within 1 hour start with an asthmatic type cough. Then throat started feeling tight. I took a ZYRTEC. Then eyes became infected w/mucopurulent discharge. I took BENADRYL 25 mg. Then had a fever of 100.2 with rigors. Took TYLENOL 1000 mg plus MOTRIN 600 mg. Symptoms gone the next day.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccines on 8-16-13 as part of a well visit. On the evening of 8-18-13, pt's left upper thigh, where vaccines were administered, swelled, becoming red, hard, and warm to the touch. Seen at ER, dx'ed with cellulitis as a reaction to the vaccine, put on KEFLEX 10 day course. Had a follow-up appt at our office on.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB dose 1. Route, dose and lot number were not provided. The physician reported that the patients failed to seroconvert after receiving RECOMBIVAX according to the appropriate dosing schedule. The physician mentioned he had been administering RECOMBIVAX for 20 years, and approximately 5-10% patients out of every 100 patients he estimated had negative titers after following the recommended vaccination schedule. The outcome of negative titer is unknown. Reporter causality assessment was not reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 39 year old female patient the patients relevant medical history includes measles titre negative. On 30-AUG-2013, the patient was vaccinated with a dose of 0.5 ml PROQUAD (Merck) (lot # H015624, expiry date was 21-FEB-2014) instead of M-M-R II as intended. The patients past drug history and concomitant medications were unknown. It was unknown if any relevant testing was performed after receiving PROQUAD (Merck) vaccine. The outcome was unknown. Additional information is not expected.
Age: 0.45
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chills, Crying, Pyrexia, Tremor
Clinical narrative: 3 hrs after shot patient had "chills/shaking" episodes and fever 102 degrees. TYLENOL given every 4-6 hrs around the clock and fever lasted for 3 days. Patient had consolable crying episodes.
Sex: U
Vaccine: HPV4, MMR, RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse to unspecified number of patients of unknown age and gender who may have been administered unspecified number of doses of ROTATEQ, included M-M-R II, PEDVAXHIB and GARDASIL (Lot number, expiry date, route and dose were not reported for al) that were exposed to 32.4 Fahrenheit for an unspecified amount of time. At the time of the report, it was not known if the vaccine exclusions were supported or unsupported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The consumer reported that he overheard a woman in a store talking about her experience with ZOSTAVAX. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On an unknown date, the patient experienced anaphylactic reaction. The outcome of anaphylactic reaction was unknown. Additional information is not expected.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 01-AUG-2013 the patient was vaccinated at the same office visit with PROQUAD (Merck), injection (lot number, exp date and route not reported) and VARIVAX (Merck), injection (lot number, exp date and route not reported). No adverse effects were reported. The outcome of patient's events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified) early in pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was unknown. No concomitant therapy was reported. Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Nausea
Clinical narrative: Nausea, stomach upset, severe headache, diarrhea.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown demographics. It was reported that on an unknown date, unsupported doses of GARDASIL (lot number, expiry date, dose and route unspecified) which was exposed to 15 degrees Fahrenheit (F) for 18 hours may have been administered to patients. The reporter was unsure if administration had occurred. No concomitant therapy was reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Pt presented to clinic on 8/13/13 with complaint of redness to left arm at injection site. Knot felt to area and pt also complained of sharp pain. Pt educated on applying heat to area and verbalized understanding. Injection administered on 8/6/13.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: Pt rec'd 2 mo. imms - approx 10 min after admin pt developed rash (mild) on thighs, bends of arms, trunk, nape of neck.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Rash
Clinical narrative: Left shoulder faded erythema and edema. Vaccines administered on 8/26/13. Patient seen in office for exanthem on 8/29/13. No treatment.
Age: 1.07
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Ear infection, Oral discomfort, Pharyngitis streptococcal, Pyrexia
Clinical narrative: 1 year old vaccines given on 8/19/13. Started running fever, 101.2 rectal, on 8/26 took to the doctor on 8/27/13. Diagnosed with strep throat and ear infection. Placed on antibiotics. Rash noted on 8/28/13. Mom in clinic on 8/30/13 complaints of child's rash. Took child to ER 8/31/13 for crying and rubbing mouth. Diagnosed with scarlet fever and scarlet rash. 9/13/13 - rash dissipated and afebrile.
Age: 1.07
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash scarlatiniform, Scarlet fever, Streptococcus test positive
Clinical narrative: 1 year old vaccines given on 8/19/13. Started running fever, 101.2 rectal, on 8/26 took to the doctor on 8/27/13. Diagnosed with strep throat and ear infection. Placed on antibiotics. Rash noted on 8/28/13. Mom in clinic on 8/30/13 complaints of child's rash. Took child to ER 8/31/13 for crying and rubbing mouth. Diagnosed with scarlet fever and scarlet rash. 9/13/13 - rash dissipated and afebrile.
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Drooling, Listless
Clinical narrative: Listless, drooling, not eating breast milk Nutranigen formula was changed to Similac Alumentum still not eating as well and crying all of the time even after all her needs have been met.
Age: 14.0
Sex: F
Vaccine: FLUN4, MNQ
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Weakness and tingling of legs (right greater than left).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Local reaction, Lymphocyte percentage, Neck pain
Clinical narrative: Office visits 8/21 and 8/22/13. On 8/21 - described as "local reaction" 8/22 with increased c/o pain, vomiting, pain in neck and a 2-2 1/2 in. area of redness to upper arm. Impression was "cellulitis".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Neutrophil percentage increased, Pain, Vomiting, White blood cell count increased
Clinical narrative: Office visits 8/21 and 8/22/13. On 8/21 - described as "local reaction" 8/22 with increased c/o pain, vomiting, pain in neck and a 2-2 1/2 in. area of redness to upper arm. Impression was "cellulitis".
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site cellulitis, Pyrexia, Vomiting
Clinical narrative: Vomiting. Cellulits at injection site. Fever/chills. Went to ER on 08/25/13.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Tdap given in (L) arm and immediately after injection site started swelling and redness appeared around area.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age who on 26-AUG-2013, was vaccinated with a dose of ZOSTAVAX (lot # 0168AE) (dose and route not reported) that was expired. The vaccine expired on 06-MAR-2013. No adverse effects were reported.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no drug reactions or allergies who on 27-AUG-2013, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number J003806). The pharmacist reported that on 28-AUG-2013, the patient developed an injection site of a red rash. The area was also  hard to the touch and there were blisters. The pharmacist instructed the patient to take BENADRYL. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for injection site reaction, blisters, area was also hard to the touch and red rash and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacy refers to an unspecified number of patients of unknown age and gender. No medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot# and dose not provided), subcutaneously in the back of the arm, instead of the deltoid. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician via company representative referring to an unspecified number of patients whom on an unknown dates, were vaccinated with a dose of PNEUMOVAX23 (lot # not reported), intramuscular. The reporter mentioned that a type of red and hot injection site reaction to PNEUMOVAX23 happened all the time to an unspecified number of anonymous patients on unknown dates. This is one of two reports from the same reporter source. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a 85 year old female patient who on 28-AUG-2013, was vaccinated with a dose of PNEUMOVAX23 (lot # not reported), intramuscular. Concomitant therapies included an unspecified flu vaccine. The physician reported that on 28-AUG-2013 the patient had an injection site reaction to PNEUMOVAX23. The PNEUMOVAX23 was administered concomitantly with an unspecified flu vaccine, but these vaccines were administered in separate arms. Other concomitant medication information for this patient was not specified. The injection-site reaction was described as red and hot when the patient spoke to the physician. The outcome of injection site redness and injection site hotness was unknown. This is one of two reports from  the same reporter source. Additional information has been requested.