chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Insomnia, Irritability, Pyrexia, Vomiting
Clinical narrative: Swelling and redness at injection site, high fever, extreme irritability, non-stop crying, diarrhea, vomiting, excessive gas, unable to sleep.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reported redness/swelling, increased warmth to right arm from lateral deltoid to elbow. Pneumonia vaccine given in right deltoid, seasonal flu vaccine given in left deltoid. Patient saw personal physician. Given oral antibiotics and diagnosed with cellulitis. This is patient's first pneumonia vaccine.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Reported redness/swelling, increased warmth to right arm from lateral deltoid to elbow. Pneumonia vaccine given in right deltoid, seasonal flu vaccine given in left deltoid. Patient saw personal physician. Given oral antibiotics and diagnosed with cellulitis. This is patient's first pneumonia vaccine.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Pain in Right deltoid area. Redness 8 inches by 7 inches in circle around site. Center of circle has a darker red area with a cluster of blisters. Swelling in deltoid area is double the size of normal.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: C/O red, swollen (L) arm related to Varicella immunization. Instructed per provider to apply ice pack and TYLENOL PO as directed follow up if symptoms persist.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Balance disorder, Dizziness
Clinical narrative: Dizziness, urinary tract infection, little & frequent bowel movements.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Frequent bowel movements, Urinary tract infection
Clinical narrative: Dizziness, urinary tract infection, little & frequent bowel movements.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Injection site erythema
Clinical narrative: Received vaccines 09/04/12, states started having trouble breathing 09/05/12. Both arms started turning red at the injection sites. Presented to office 09/06/12 - no respiratory distress, bilateral reddened areas to arms approximately 3 in. across and 5 inches down the arms. Pt. self-medicated with BENADRYL, which she states helped.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor, Tremor
Clinical narrative: At 0915 received TDAP vaccination - at 0935 turned pale & shaky - BP 110/50. Placed on cot. Feet elevated. 0942 BP 110/55 remains shaky, pale but states feeling better - given cracker & water. 0955 112/80 on standing - 1005 transport to hosp.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Erythema, Rash, Swelling, Tenderness, Vaccination complication
Clinical narrative: 5 year old here for a reaction to the vaccines, he got the KINRIX and the varicella on the left thigh. Mom noticed some swelling and redness, he was walking and running around well. Only hurts when mom touches only, no fever. Associated symptoms include a rash.
Age: 1.54
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Pyrexia, Rash, Urticaria, Vomiting
Clinical narrative: 3 hours past receiving vaccines started with fever & vomiting times 3 episodes. Given TYLENOL by parent/ rash/hives on face during the night. Fever up to 102 degrees. No rash/hives on rest of body. Instructed to take child to doctor.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site pruritus, Injection site rash, Rash papular
Clinical narrative: Large area of papular rash at site of vaccine, spreading over left upper thigh, inguinal region, and over left side of abdomen, over the 7-8 days after vaccine administration mild pruritus using hydrocortisone cream at site.
Age: 1.11
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Leg red, swelling, Temp 101.9 axillary.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, painful area at injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, warmth, induration to size of "an orange" (R) shoulder after vaccines.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, HEPA, VARCEL
Symptoms: Injection site haematoma, Injection site rash, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction to injection site; rash, bruise, swelling, warmth.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness at vaccine site 2.5 inches in diameter hard, warm to touch, reaction is to varicella vaccine.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a redness, swelling, warmth at the injection site on the following day. He was advised to apply cold compress at the reaction site.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema, Oedema peripheral, Skin swelling
Clinical narrative: 9/09/12 07:50 (R) arm 8 x 8 cm redness at injection site, increased temp and soft tissue swelling - Rx KEFLEX 500 TID x 7d, 9/10/12 - 20:00 - edema of (R) arm - mid-humerus to below elbow - skin hot/swollen - 1 gm ROCEPHIN IM. 9/11/12 - 8:11 AM - increased swelling. Prednisone - 30/20/10 each x 2d. 9/13/12 10:00 - marked improvement - no heat to arm, decreased swelling.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: 9/09/12 07:50 (R) arm 8 x 8 cm redness at injection site, increased temp and soft tissue swelling - Rx KEFLEX 500 TID x 7d, 9/10/12 - 20:00 - edema of (R) arm - mid-humerus to below elbow - skin hot/swollen - 1 gm ROCEPHIN IM. 9/11/12 - 8:11 AM - increased swelling. Prednisone - 30/20/10 each x 2d. 9/13/12 10:00 - marked improvement - no heat to arm, decreased swelling.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Incorrect dose administered, Myalgia, Pain, Pyrexia
Clinical narrative: Pt received a second dose of BOOSTRIX (Tdap) inadvertently. Per parents, pt. had fever, muscle aches, soreness.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Skin rash / outbreak.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Asthenia, Decreased appetite, Dysstasia, Fall, Fatigue
Clinical narrative: Day vaccine administered patient with episode of weakness and muscle rigidity. Not able to stand up straight, falling over. No LOC. No eye rolling. No vomit. No headache episode < 10 mins. Then had fever, tired, sleepy, decreased appetite. Better next day. Seen in office for evaluation: No tx.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Muscle rigidity, Pyrexia, Somnolence
Clinical narrative: Day vaccine administered patient with episode of weakness and muscle rigidity. Not able to stand up straight, falling over. No LOC. No eye rolling. No vomit. No headache episode < 10 mins. Then had fever, tired, sleepy, decreased appetite. Better next day. Seen in office for evaluation: No tx.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site irritation, Vaccination site pain, Vaccination site swelling
Clinical narrative: Local irritation at the vaccination area; redness, warm to touch, painful, itching, swollen.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Vaccination site warmth
Clinical narrative: Local irritation at the vaccination area; redness, warm to touch, painful, itching, swollen.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Tracheal ulcer, Urticaria
Clinical narrative: Erythematous hive rash over palms of hands, viral ulcerative lesion (R) pharynx.
Age: 55.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Friday, 9/7 within 3 hrs of injection, arm where 2 vaccines administered swelled. Flu & PNEUMOVAX vaccine given in left arm. Pt called to MD next morn Sat. MD said to ice it & prescribed cephalexin. Swelling subsided Mon am. 3 days after injection.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity, Pain of skin
Clinical narrative: Skin tender & painful where the shot is given. Can not lift arm (left) lots of pain on hand and neck.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness from injection site to below elbow swelling on inside of elbow (sent patient to see doctor).
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt's left arm where PNEUMOVAX was injected was red & swollen & felt warm to touch. Pt went to Dr & was prescribed MEDROL pack and CLARITIN.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Left top quadrant of thoracic area has 4 round shaped red outbreaks smallest 1 cm & largest 4 cm diameter looking like ringworm marks.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: I waited after shot was given and when it was time I went home. Next morning my arm was swollen about size of golf ball, red and hard - went this way for 3 1/2 wks.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 9 few hours of vaccination, (R) upper arm from elbow to shoulder became extremely swollen, hot, painful & red. Reported by pt on 9/14/2012. Tx: ice, elevation, MOTRIN.
Age: 1.01
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Body temperature increased, Injection site pain, Injection site swelling
Clinical narrative: Temp 103.7, (R) thigh swelling & pain.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Limb discomfort, Mobility decreased, Oedema peripheral
Clinical narrative: On 9/12/12 patient spoke with pharmacist. On 9/8/12 she noticed her arm became red and swollen. She contacted her PCP, who advised her to take BENADRYL. As of 9/14/12 - the patient says swelling is gone and arm feels better. Per patient arm was so swollen could not bend it.
Age: 1.36
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9.5 x 6.5 erythematous, swollen & warm on (L) thigh.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt. says arm really sore after getting flu shot. She had taken TYLENOL & heat pad treatment, but pain not going away. May seek medical attention.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: Within 2 days of vaccination in left deltoid, patient developed tingling in the left arm and paraesthesias in hands with generalized arthralgias. The joint pains lasted for several weeks.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Colonoscopy normal, Diarrhoea, Myalgia, Oedema peripheral, Pain in extremity
Clinical narrative: 9/8/12 late pm - arm swelling (L), legs & muscles in extreme pain, went to ER, was given BENADRYL & nausea medication, sent home. 9/9/12 late pm - severe vomiting & diarrhea, back to ER, what was thought to be diarrhea was blood. Colonoscopy in March showed no abnormalities, kept at hospital and released 9/12/12 am.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rectal haemorrhage, Vomiting
Clinical narrative: 9/8/12 late pm - arm swelling (L), legs & muscles in extreme pain, went to ER, was given BENADRYL & nausea medication, sent home. 9/9/12 late pm - severe vomiting & diarrhea, back to ER, what was thought to be diarrhea was blood. Colonoscopy in March showed no abnormalities, kept at hospital and released 9/12/12 am.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Pt came in on 9-14-12 with glands swollen - and fever. He was seen at 9:30 am - He returned to the office at 4:30 pm with his glands doubled in size and red streaking from them. We sent him to hospital.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: This spontaneous report was received from a 74 year old female patient concerning herself. The patient s concurrent condition included allergies (unspecified) and drug allergies to penicillin, atropine sulfate, Hyoscyamine sulfate, Phenobarbital, DONNATAL, OMNICEF, LEVAQUIN, NEURONTIN, SULFA, SPRIVA and ASMANEX. On 05-SEP-2012 the patient was vaccinated with PNEUMOVAX 23 IM (injection site not mentioned). On the same day the patient also received AFLURIA (injection site not mentioned). Concomitant medications included omeprazole, estrogens (unspecified) and terbinafine. On 05-SEP-2012, after getting PNEUMOVAX 23 and AFLURIA. The patient experienced extreme pain and itching in her arm and she could not moved her arm. Her whole arm down to the elbow turned red. The patient sought medical attention by phone call and office visit. No lab test performed. She received treatment with ice packs and BENADRYL and prednisone. At the time of reporting, the patient was recovering from the events. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a four unspecified patients of unknown age who on an unspecified dates, in August 2012, were vaccinated with a doses of GARDASIL (lot number 660393/0067X) (doses and routes not reported) that were expired. The vaccines expired on 20-OCT-2010. No adverse effects had been observed or reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: MMRV
Symptoms: Chills, Dyspnoea, Foaming at mouth, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 13 months old male patient with Downs Syndrome and penicillin allergy. The patient was vaccinated with lot # (655267/0971F) dose 1 PROQUAD (Merck) (dose and route not reported) on 04-APR-2007. No concomitant medications were reported. On 05-APR-2007 the patient experienced breathing problems, a "high"fever, chills, a severe headache, and foaming of the mouth. The patient sought medical attention. No lab diagnostics study was performed. The outcome of chills, a severe headache, a "high" fever, breathing problems and foaming of the mouth was reported as recovered/resolved. Additional information has been requested.
Age: 0.09
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 32 days old patient. The patient was vaccinated with the first dose of oral ROTATEQ (lot number, route, dose not reported) on 27-AUG-2012, 10 days before 6 weeks old. No other co-suspects or concomitant medications were reported. The patient was not experiencing any known symptoms. No treatment information was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with the first, the second and the third dose of GARDASIL 0,5 ml, intramuscularly (IM) (lot number not reported) on 15-NOV-2010, 24-MAY-2011 and 25-JUL-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, the patient's outcome was unknown. Additional information will be provided if available. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated subcutaneously with an expired lot # (671022/0745AA exp date 18-AUG-2012), 0.65 ml of ZOSTAVAX on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 56 years old female patient, with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 24-AUG-2012. No other co-suspects were reported. There were no concomitant medications. On 24-AUG-2012 the patient developed a rash at the injection site of vaccine. The patient contacted the pharmacist, no treatment was given and no lab diagnostic tests were performed. The outcome of rash at the injection site was unknown. The relatedness for rash at the injection site was not provided for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated an expired dose of ZOSTAVAX lot # (67061/0618AA, expiration date 26-JUL-2012) (dose and route not reported) on 01-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event was reported. Additional information has been requested. This is one of several reports from the same source.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 05-SEP-2012, was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX23 (lot number 669579/0595AA) that was expired. The vaccine expired on 30-AUG-2012. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a female register nurse reporting on her self, a female patient of unknown age. On 21-AUG-2012, the patient was vaccinated intramuscular with PNEUMOVAX 23 dose and lot: unknown. Other suspect therapies included on 21-AUG-2012, intramuscular ZOSTAVAX (dose lot: unknown). The consumer stated that on 21-AUG-2012, she received ZOSTAVAX and PNEUMOVAX 23 intramuscularly in the same arm. On 22-AUG-2012, the patient developed a red, raised, itchy area that is 3 inches in diameter around the injection site. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. The patient's outcome for red, raised, itchy area that is 3 inches in diameter around the injection site was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist to a patient of unknown age and unknown gender. The patient was vaccinated with ZOSTAVAX (lot number, route, site, dose not reported) on an unknown date. No other co-suspects or concomitant medications were reported. The patient received ZOSTAVAX and two weeks later developed a rash. No treatment information was reported. It was unspecified if the patient had sought medical attention. The outcome of rash was unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age. The pharmacy student reported the patient was inadvertently administered a 0.3 ml dose of PNEUMOVAX 23 (IM) (lot # was unknown) on 05-SEP-2012 due to leakage between the needle hub and the syringe. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Subcutaneous, 0.65 ml, lot # (670613/0657AA), expiration date 04-AUG-2012) on 28-AUG-2012. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 30 years old male patient. The adult client with unknown vaccination history for MMR II (lot number not provided) had low seropositive antibody titers for rubella. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first dose of 0.5 ml VAQTA 25/0.5 U/ml (lot number not reported) on 02-APR-2012 and the second dose on 27-AUG-2012. No other co-suspects or concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. The patient was vaccinated with 1 injection of ZOSTAVAX under the skin (date, dose and lot # unknown). No other co-suspects were reported. No concomitant medications were reported. The patient called and reported getting ZOSTAVAX after having the shingles. She added that she got a 2nd episode of the shingles on an unspecified date after getting the ZOSTAVAX. The patient sought an unspecified medical attention. The outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (Lot#, dose, route were unspecified) in 1992. It was reported that the patient then developed a "wheal and redness at the injection site". The patient then recovered on some unspecified date. It was unspecified weather the patient had sought medical attention or not. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated subcutaneously with 0.65 ml expired ZOSTAVAX (lot number 0693AA, expiration date 11-AUG-2012) on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Type 1 diabetes mellitus
Clinical narrative: This spontaneous report was received from a physician refers to a 13 years old male patient with a family history of diabetes, his father had type two diabetes, who on an unknown date, was vaccinated with a 0.5 ml dose of MMR II (route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that about a week after getting MMR II on an unknown date, the patient had a sudden onset of type one diabetes. The patient was 13 years old at the time of vaccination. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unknown if this was the patient's first dose or not. The patient sought unspecified medical attention. The relatedness for the patient has a sudden onset of type one diabetes was unknown for MMR II. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant refers to a 64 years old female patient with no pertinent medical history and allergy to sulfa who in October 2011, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 671452/1124AA, Exp. Date: 12-OCT-2012). No other co-suspects were reported. No concomitant medications were reported. The physician assistant stated that on 04-SEP-2012, the patient developed shingles even though she had been given ZOSTAVAX in the past. Acyclovir was given as a treatment for the existence. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for the patient developed shingles was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 3 patients of unknown ages and genders. On unspecified date the patients were vaccinated subcutaneously with, 0.65 ml of ZOSTAVAX (lots # not reported). The nurse practitioner (NP) stated that 3 patients had been vaccinated with ZOSTAVAX and developed shingles within a couple of months. The patient sought unspecified medical attention. At the time of the report the 3 patients were recovering from shingles. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of drug administration, Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning 38 unspecified patients of unknown age. The patient's pertinent medical history and drug reactions or allergies were unspecified. On an unspecified date, about 38 patient were vaccinated subcutaneously instead of intramuscularly with a 0.5 ml dose of RECOMBIVAX HB, (lot # 668558/0894AA; Expiration date: 17-MAY-2013, and lot # 1740AA (MARRS#1209USA002375)), that was stored at -5 degrees to 10 degrees C from 11-JUN-2012 to 13-JUN-2012. It was reported that the patient's did not had any adverse effects. It was unknown of patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Mass
Clinical narrative: This spontaneous report as received from a doctor pharmacy refers to a 74 years old female patient with iodine allergy and no pertinent medical history who on 28-AUG-2012, was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot # 672752/1786AA, exp 08-SEP-2012). There was no concomitant medication. The pharmacist stated that 28-AUG-2012 the patient immediately experienced swelling which was described as "a 2 inch lump". There was no treatment given. At the time of the report, the patient had not recovered. The relatedness for swelling which was described as "a 2 inch lump" is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ, UNK
Symptoms: Abdominal pain upper, Arthralgia, Arthritis, Chronic fatigue syndrome, Conjunctival haemorrhage
Clinical narrative: Nausea and vomiting daily for six months, muscle weakness, joint pain, sharp stomach pains, dizziness, loss of appetite, migraines, subconjunctival hemorrhaging, chronic fatigue syndrome, arthritis.
Age: 15.0
Sex: F
Vaccine: MNQ, UNK
Symptoms: Decreased appetite, Dizziness, Influenza virus test negative, Migraine, Mononucleosis heterophile test negative
Clinical narrative: Nausea and vomiting daily for six months, muscle weakness, joint pain, sharp stomach pains, dizziness, loss of appetite, migraines, subconjunctival hemorrhaging, chronic fatigue syndrome, arthritis.
Age: 15.0
Sex: F
Vaccine: MNQ, UNK
Symptoms: Muscular weakness, Nausea, Pregnancy test negative, Vomiting
Clinical narrative: Nausea and vomiting daily for six months, muscle weakness, joint pain, sharp stomach pains, dizziness, loss of appetite, migraines, subconjunctival hemorrhaging, chronic fatigue syndrome, arthritis.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Insomnia, Nausea, Restlessness, Tinnitus
Clinical narrative: Nausea, restless - unable to sleep, joint pain especially hip pain-right and left, ringing in ears.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: High fever (measured at 39.4 C) and violent shaking and chills from 10 pm to 4 am, alleviated with multiple doses of Benadryl PO and Tylenol, total of 2.5 g in about 6 hours. Symptoms improved after breaking of fever at around 4-5 AM.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Chills, Feeling hot, Hyperhidrosis
Clinical narrative: Several hours after the vaccination patient had the following symptoms: throwing up, sweating, chills, tightness in chest, throat constricting, weakness, hot feeling in vaccination arm and down back, weakness, eyes glazed.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Staring, Throat tightness, Vomiting
Clinical narrative: Several hours after the vaccination patient had the following symptoms: throwing up, sweating, chills, tightness in chest, throat constricting, weakness, hot feeling in vaccination arm and down back, weakness, eyes glazed.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Feeling hot, Headache, Injection site pruritus
Clinical narrative: 30 minutes after administration of flu and pneumovax vaccines both into left arm, patient began to feel achiness in the left arm and took 2 Advil at 5:30 pm. She then began to feel nausea, itchiness on shot site, chills and throbbing headache of pain level 7 so she laid down. Began to feel heat in her left arm. A friend stayed with her through the night during which time the patient experienced fever and chills until 3:30 a.m. Late evening on 9/14, patient called 911 and was transferred to a hospital. This hospital sent the patient to call another hospital who transferred her from one extension to another and the patient never spoke with anyone who could help her and no emergency team or transport was sent to her. On the morning of 9/15 around 11 am the patient and her friend walked to a nearby physician's office. Doctor diagnosed the patient with cellulitis that is spreading. The doctor prescribed Avelox 400mg.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: 30 minutes after administration of flu and pneumovax vaccines both into left arm, patient began to feel achiness in the left arm and took 2 Advil at 5:30 pm. She then began to feel nausea, itchiness on shot site, chills and throbbing headache of pain level 7 so she laid down. Began to feel heat in her left arm. A friend stayed with her through the night during which time the patient experienced fever and chills until 3:30 a.m. Late evening on 9/14, patient called 911 and was transferred to a hospital. This hospital sent the patient to call another hospital who transferred her from one extension to another and the patient never spoke with anyone who could help her and no emergency team or transport was sent to her. On the morning of 9/15 around 11 am the patient and her friend walked to a nearby physician's office. Doctor diagnosed the patient with cellulitis that is spreading. The doctor prescribed Avelox 400mg.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Headache, Injection site pruritus, Nausea
Clinical narrative: 30 minutes after administration of flu and pneumovax vaccines both into left arm, patient began to feel achiness in the left arm and took 2 Advil at 5:30 pm. She then began to feel nausea, itchiness on shot site, chills and throbbing headache of pain level 7 so she laid down. Began to feel heat in her left arm. A friend stayed with her through the night during which time the patient experienced fever and chills until 3:30 a.m. Late evening on 9/14, patient called 911 and was transferred to a hospital. This hospital sent the patient to call another hospital who transferred her from one extension to another and the patient never spoke with anyone who could help her and no emergency team or transport was sent to her. On the morning of 9/15 around 11 am the patient and her friend walked to a nearby physician's office. Doctor diagnosed the patient with cellulitis that is spreading. The doctor prescribed Avelox 400mg.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: 30 minutes after administration of flu and pneumovax vaccines both into left arm, patient began to feel achiness in the left arm and took 2 Advil at 5:30 pm. She then began to feel nausea, itchiness on shot site, chills and throbbing headache of pain level 7 so she laid down. Began to feel heat in her left arm. A friend stayed with her through the night during which time the patient experienced fever and chills until 3:30 a.m. Late evening on 9/14, patient called 911 and was transferred to a hospital. This hospital sent the patient to call another hospital who transferred her from one extension to another and the patient never spoke with anyone who could help her and no emergency team or transport was sent to her. On the morning of 9/15 around 11 am the patient and her friend walked to a nearby physician's office. Doctor diagnosed the patient with cellulitis that is spreading. The doctor prescribed Avelox 400mg.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Crying, Injected limb mobility decreased, Injection site erythema, Malaise, Muscular weakness
Clinical narrative: Malaise, weepy, achy, immobile right arm, and mild immobile left arm. Next day 5 X 3 inch red mark below shot. Next three day hot to touch. 9/7/2012 Rubbery legs from below knee to about 5 inches toward ankle, for 3 steps.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Skin warm
Clinical narrative: Malaise, weepy, achy, immobile right arm, and mild immobile left arm. Next day 5 X 3 inch red mark below shot. Next three day hot to touch. 9/7/2012 Rubbery legs from below knee to about 5 inches toward ankle, for 3 steps.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Raised red welt around site of injection, swollen, painful upper arm and arm-pit, difficult to move arm. Head-ache. Low-grade fever. Sore throat. Exhaustion. These symptoms persisted through Sunday night (09/09/2012 10pm). The arm stopped hurting after this point, but I still have had symptoms of a (bad) common cold all week long (it is 09/15/2012 today).
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Mobility decreased, Nasopharyngitis, Oropharyngeal pain, Pain in extremity
Clinical narrative: Raised red welt around site of injection, swollen, painful upper arm and arm-pit, difficult to move arm. Head-ache. Low-grade fever. Sore throat. Exhaustion. These symptoms persisted through Sunday night (09/09/2012 10pm). The arm stopped hurting after this point, but I still have had symptoms of a (bad) common cold all week long (it is 09/15/2012 today).
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Raised red welt around site of injection, swollen, painful upper arm and arm-pit, difficult to move arm. Head-ache. Low-grade fever. Sore throat. Exhaustion. These symptoms persisted through Sunday night (09/09/2012 10pm). The arm stopped hurting after this point, but I still have had symptoms of a (bad) common cold all week long (it is 09/15/2012 today).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bee sting mark on left arm(deltoid, warm to touch, swollen and red down side of arm to below elbow.
Age: 37.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: Woke up with burning, itching rash on upper arms only. Eventually spread to trunk and upper legs.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Injection site pain, Oropharyngeal pain, Throat irritation
Clinical narrative: Coughing, hoarseness that worsened over evening, scratchy throat, scratchy left eye, pain at site, sore throat, frequent feeling of needing to swallow and clear throat.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Migraine, Somnolence
Clinical narrative: Drowsiness (may not be related), migraine-like headache, slight dizziness.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Diarrhoea, Immediate post-injection reaction, Injection site irritation, Injection site rash, Injection site urticaria
Clinical narrative: Immediate welts and irritation at the injection site, grew to rash 3.5in in diameter over the course of the next couple days, began vomiting hourly 9/13/12 at 2:00 PM that lasted until 10:00 PM, began having diarrhea 9/15/12 at 4:30 PM every 10-15 minutes that lasted until 8:30 PM.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Vomiting
Clinical narrative: Immediate welts and irritation at the injection site, grew to rash 3.5in in diameter over the course of the next couple days, began vomiting hourly 9/13/12 at 2:00 PM that lasted until 10:00 PM, began having diarrhea 9/15/12 at 4:30 PM every 10-15 minutes that lasted until 8:30 PM.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister
Clinical narrative: Patient developed large blisters on her upper chest and smaller sized blisters on her forehead and hairline on the 8th day after vaccine was administered.
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site swelling, Therapeutic aspiration, X-ray limb
Clinical narrative: Swelling occurred Lt arm at site of inj which required fluid aspiration on 9/4/12 by her physician pt could not lift arm up until 9/7/12 at which time she was totally recovered. Pt was sent for x-rays of left arm also for evaluation.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neuralgia, Pain, Pain in jaw, Toothache
Clinical narrative: Severe nerve pain shooting last -3 seconds (legs) - Day 1 relieved with NEURONTIN (husband's prescription med). Sharp shooting headache (random places in head) Day 2 last 1-3 seconds not as severe as legs. Toothache/jaw ache lasting hours Day 2.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis in the same arm as the vaccination was given.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Oedema peripheral, Pain in extremity, Tongue dry
Clinical narrative: Pt reported swollen, painful, red arm as well as dizziness and dry tongue.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness & soreness at site including a mass, which developed 2 days post vaccination. 3 days post she developed flu like symptoms. Muscle ache respiratory symptoms, cough - went to ER on 9/12 treated w/ Z-PACK, prednisone & ROBAC.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cough, Influenza like illness, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Redness & soreness at site including a mass, which developed 2 days post vaccination. 3 days post she developed flu like symptoms. Muscle ache respiratory symptoms, cough - went to ER on 9/12 treated w/ Z-PACK, prednisone & ROBAC.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Respiratory disorder
Clinical narrative: Redness & soreness at site including a mass, which developed 2 days post vaccination. 3 days post she developed flu like symptoms. Muscle ache respiratory symptoms, cough - went to ER on 9/12 treated w/ Z-PACK, prednisone & ROBAC.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Increased upper airway secretion, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Redness & soreness at site including a mass, which developed 2 days post vaccination. 3 days post she developed flu like symptoms. Muscle ache respiratory symptoms, cough - went to ER on 9/12 treated w/ Z-PACK, prednisone & ROBAC.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia, Respiratory disorder
Clinical narrative: Redness & soreness at site including a mass, which developed 2 days post vaccination. 3 days post she developed flu like symptoms. Muscle ache respiratory symptoms, cough - went to ER on 9/12 treated w/ Z-PACK, prednisone & ROBAC.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a 87 years old female consumer refers to herself. In approximately 1992, "about 20 years ago" the patient had a case of the shingles. "A few years ago" the patient received ZOSTAVAX (lot # not reported). Recently (date unspecified) the patient developed a case of shingles on her hand and the tips of her fingers. The patient had a few bumps on the pointer finger tip of her hand and on the palm of the same hand, described as painful. The patient sought for medical attention by speaking with physician. No treatment was given. The outcome was reported as not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Left arm swollen and felt like someone poked her in the chest.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chest discomfort, Oedema peripheral
Clinical narrative: Left arm swollen and felt like someone poked her in the chest.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Nausea, Pyrexia
Clinical narrative: 6:00 PM Fever, chills, weak, nausea.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Rash erythematous, Skin warm, Swelling
Clinical narrative: Warm, red, wollen, patient could not lift or move left arm, Right arm very warm, had 5 red dots.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Body temperature increased, Erythema, Injection site pain, Mass, Rash macular
Clinical narrative: Extremely sore in deltoids, temp 102, red with splotchs about 4x4 inches with and round with a lump the size of a golfball. Had to see her Dr. twice
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pain in extremity, Tenderness
Clinical narrative: Pain left arm when reaching up and across her chest. Painful to the touch, sligh redness. Site is 2 inches down from shoulder. She went to the Dr.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swollen and red from the elbow to the bicep.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Pruritus, Swelling
Clinical narrative: On the evening after vaccine was given, the patient experienced itching and stinging. She also noticed that it was severely swollen and bruised.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pruritus, Skin warm
Clinical narrative: Hot to the touch and itchy. Area was bruised from shoulder to elbow.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pruritus, Rash generalised
Clinical narrative: Rashes on body, hands and feet. itching so that couldn't sleep all night.  Sore on the arm at site of the injection. Still have the reaction at this time 9:00AM on 9/16/2012.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Pruritus, Rash erythematous, Skin lesion
Clinical narrative: Small red spots on day 1, progressing on day 2 to 200+ target lesions on arms, legs, hands, soles.  Severe itching over several days. Oral and topical antihistamines given. Considering prednisone.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Diarrhoea, Erythema, Gastrooesophageal reflux disease, Hypoglycaemia
Clinical narrative: Thursday, 9/6/12: Got the shot done around lunch time. I didn't really have any issues this day. Slight pain in my shoulder before I went to bed, but nothing to complain about. Friday, 9/7/12: Woke up at 3 am because of my arm hurting so bad. Couldn't get back to sleep. The only way that I could manage to get through the day was with pain pills. My arm still hurt, but it was much better. Saturday, 9/8/12: Woke up again at 3 am in pain from my arm. I couldn't use my left arm to get myself into or out of bed. It hurt so bad. I had to take pain pills to get through this day. Sunday, 9/9/12: My arm still had this red welt on it that felt hot, so I decided to google reactions to the Pneumovax vaccination because I was starting to get really paranoid at this point. I read that it could be an allergic reaction, so I took a Benadryl mid-day & before bed. I only needed pain pills in the AM for this day. My arm still had the red welt on it, but it got worst as the day went on (color, size, & pain level). I'm assuming this is due to the Benadryl from the night before wearing off. Overall, my arm was sore and itchy, but it was at a manageable level of pain without pain pills just as long as no one bumped into that area on my arm. I took Benadryl before bed. Tuesdy, 9/11/12: The welt now looks more like a bruise. The pain level is probably back to the pain I felt last Thursday night, right after I got the shot. 9/12/12-9/16/12-Still have slight red circle on arm from vaccination. Stomach issues: -Had massive diarehha, cramping, and nausea the weekend after the shot. As of now, I'm still having really bad acid reflux issues and chewed up food coming back up that hasn't been swallowed properly. I have had quite a few spells of reactive hypoglycemia, which I hadn't had in a long time.