chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, X-ray limb abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself and from a contactable nurse on behalf of a physician. A 79-year-old male patient received PREVNAR 13, (lot L99261, expiry date Feb2017) at 0.5 ml single, intramuscular in left arm on 17Dec2015 for immunization. Medical history included arthritis in hands, fibromyalgia, blood pressure abnormal, heart surgery, shocks going in him (his body) like electric fire, triple bypass surgery. Ongoing concomitant medications included oral atorvastatin tablet, since 2012, at 7 PM, 80 mg, 1x/day, as he had triple bypass surgery, oral Lisinopril tablet, since 2012 for 7 years, at 7 PM, 10 mg, 1x/day, for blood pressure, oral warfarin tablet, since 2013, 7.5 mg, 3 times a week and 7 mg, 4 times a week, as blood thinner and oral gabapentin capsule since 2016, 300 mg, 3x/day, for shock. On 17Dec2015, the patient experienced rash, swelling, lump at the site of shot and rash on it, his arm hurt for days and days and about 5 to 6 inches from the joint it swelled up. Since then his arm continually hurt, sometime he could hardly move it. No treatment was taken for the events. Due to the events, that the patient had reported to the nurse on 11May2016, he was visited by a physician but he was not hospitalized. He underwent X-ray on an unspecified date which showed arthritis in his arm. The outcome of the events was not recovered. Follow up (18Jul2016): New information reported from a contactable nurse on behalf of a physician includes: suspect product details (lot number, expiry date, route and time of administration), details on patient's visit and no hospitalization, medical confirmation of case. Follow-up (23Sep2016 and 23Sep2016): New information obtained from a contactable consumer includes: date of administration for PREVNAR 13 updated, start date for concomitant drugs updated, onset and outcome of the events, no treatment.
Age: 18.0
Sex: F
Vaccine: MEN, MENB, MNQ
Symptoms: Chills, Impaired work ability, Influenza like illness, Malaise, Pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (patient's mother) reporting for her daughter, and from a contactable physician. A 18-year-old female patient received the first dose of TRUMENBA, (Lot M68769), intramuscular in deltoid at 0.5 ml, single on 28Jun2016 for immunisation along with another meningococcal vaccine at the same time so she (reporter) did not know it was Pfizer's or the other one, and first dose of meningococcal vaccine (MENACTRA, Lot 05260AA), intramuscular in left deltoid. The patient medical history and concomitant medications were not reported. The patient experienced felt very sick on an unspecified date with outcome of recovered, chills on an unspecified date with outcome of unknown, fever on 29Jun2016 with outcome of recovered on 30Jun2016, couldn't go to work on an unspecified date with outcome of unknown, achy on an unspecified date with outcome of unknown and flu like symptoms on an unspecified date with outcome of recovered.  Therapeutic measures were taken as a result of fever and achy included Ibuprofen (200 mg, Pill, Orally). Follow-up (16Sep2016): New information received from a contactable physician includes vaccine details (Lot number, route and site of administration), new non serious event (flu like symptoms), outcome of some events.
Age: 18.0
Sex: F
Vaccine: MEN, MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (patient's mother) reporting for her daughter, and from a contactable physician. A 18-year-old female patient received the first dose of TRUMENBA, (Lot M68769), intramuscular in deltoid at 0.5 ml, single on 28Jun2016 for immunisation along with another meningococcal vaccine at the same time so she (reporter) did not know it was Pfizer's or the other one, and first dose of meningococcal vaccine (MENACTRA, Lot 05260AA), intramuscular in left deltoid. The patient medical history and concomitant medications were not reported. The patient experienced felt very sick on an unspecified date with outcome of recovered, chills on an unspecified date with outcome of unknown, fever on 29Jun2016 with outcome of recovered on 30Jun2016, couldn't go to work on an unspecified date with outcome of unknown, achy on an unspecified date with outcome of unknown and flu like symptoms on an unspecified date with outcome of recovered.  Therapeutic measures were taken as a result of fever and achy included Ibuprofen (200 mg, Pill, Orally). Follow-up (16Sep2016): New information received from a contactable physician includes vaccine details (Lot number, route and site of administration), new non serious event (flu like symptoms), outcome of some events.
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer. This is the 2nd case out of two cases. An 8-decade-old (in his 70s) male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose in 2015 for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took PNEUMOVAX and experienced pyrexia and tenderness. The patient experienced fever and tenderness on an unspecified date with outcome of unknown. It was reported that the patient was not sure if he had received Pneumovax or Prevnar 13, but he had fever and tenderness following the administration of the shot, he received the shot in 2015.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt seen 8/2/16 with redness/swelling at inj. site given cephalexin and told to go to ER if worse. Admitted through ER hospitalized 8/3-8/5/2016. Dx cellulitis and allergic reaction.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Fatigue, Gait disturbance, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: This initial spontaneous report was received on 29-SEP-2016 from the mother of a female patient (age unknown). Medical history and concomitant medications were not specified. On an unspecified date, the patient was vaccinated with GARDASIL 9 intramuscularly (lot number not reported). The mother reported that her daughter is experiencing "extensive adverse reactions to GARDASIL 9". The pt was experiencing a sore throat, congestion, joint pain, trouble walking and fatigue. The patient sought unspecified medical attention. When asked questions during her phone call, the mother stated "these questions can be answered by my attorney". The events were still present at the time of the report. Additional information is not expected as the mother did not provide contact information.
Sex: M
Vaccine: DTAP, FLUX, MMRV
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a physician referring a 4 year old male patient. Current conditions included developmentally delayed, the patient's medical history was not reported. On 15-SEP-2016, the patient was vaccinated with PROQUAD (lot number, expiration date, concentration, dose, frequency and via were reported as unknown), other suspect therapies included influenza virus vaccine (unspecified) (lot number, expiration date, concentration, dose, frequency and via were not reported) and DAPTACEL (lot number, expiration date, concentration, dose, frequency and via were not reported) that were administrated simultaneously in the same date and were indicated. No concomitant medications were reported. On 15-SEP-2016, during a visit to the physician's office, the patient experienced brief episode of vomiting. No laboratories or studies were performed. At the time of the report, the outcome of vomiting was unknown. The causality between PROQUAD and the adverse event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Nasopharyngitis, Throat irritation
Clinical narrative: Scratch throat, cold-like symptoms, difficulty breathing.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pruritus, Rash
Clinical narrative: Itching, sensitive to touch. Broke out in rash within 1 hr. of receiving vaccine. Break-out of shingles lesions within 6 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash - given BENADRYL and Prednisolone per provider.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Moderate shoulder pain, radiating down towards bicep and forearm. Struggles to lift arm over head.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Cough, Dyspnoea, Injection site erythema, Injection site pain
Clinical narrative: Vaccine site large, red swollen, painful entire (L) arm. Breathing difficult - wheezing. Runny nose - eyes watering. Sore rib cage on (L). Tightness in chest. Some coughing.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Lacrimation increased, Musculoskeletal chest pain, Rhinorrhoea, Wheezing
Clinical narrative: Vaccine site large, red swollen, painful entire (L) arm. Breathing difficult - wheezing. Runny nose - eyes watering. Sore rib cage on (L). Tightness in chest. Some coughing.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Left arm. 8x11 cm redness, swelling, itching. Treated with Clindamycin HCL 300mg take every 8 hours x 10 days.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Local swelling, redness, heat, firm to touch - area measured about 3 1/2".
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Nausea, Pruritus, Urticaria
Clinical narrative: 9/27/16 1pm after FLUCELVAX vaccine, 1/2 hour nausea, dizziness, itching, hives on arms legs, face, trunk, back 50mg BENADRYL. Offered EPI PEN. Patient ref and directed to follow up as needed if not better of if worse at ER. To see primary for follow up.
Age: 77.0
Sex: F
Vaccine: FLU4, PNC
Symptoms: Erythema, Injection site haemorrhage, Pain, Pruritus
Clinical narrative: Client stated that right arm was "reddened and sore" and she put a heating pad on it.  The client also was on blood thinners, but never disclosed that to the RN. The next day on 9/27/2016 she had a large area of ecchymosis on the right upper arm.  She noted also that she had an "itchiness on her upper chest, although there were no sign of rash, redness, or hives. No sign on any irritation although the client states "itchiness". She tried hydrocortisone cream and took Benadryl to relieve the itching. She came to Local Health Department today 9/30/2016 to talk to a nurse.  RN did note the ecchymosis on upper right arm approx. 8-10cm.  There was nothing noticeable on her upper chest area. No redness, no rash noted.  Explained we would fill out VAERS report and if she felt concerned to notify her physician.  She verbalized understanding of all discussion and nurse recommended that she should apply cold compress to injection site if needed. She stated "It is fine now, it just looks bruised."  She denied any other symptoms or problems and agreed she would consult her Dr. if the itchiness worsened or she had concerns.
Age: 10.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Syncope
Clinical narrative: Syncope, brief, recovered quickly after laying down, offered water and crackers, observed for additional 15 minutes, no further symptoms.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Extrasystoles, Palpitations
Clinical narrative: Around 1:00 PM, I started having heart palpitations. I felt like my heart was skipping beats. Every time it happened, I felt like I had to gasp for breath. This was happening as often as every 2-3 minutes. This persisted throughout the night and into the next day on 9/29/2016. As of today, 9/30/2016, I am still having heart palpitations, just not as often.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt called complaining of pain and swelling in the left arm and a fever of 103 F.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large swelling and erythema at site of Varicella injection. Area warm to touch and slightly itchy. Took po Benadryl and applied cold pack and was much improved by 09/26/2016.
Age: 1.58
Sex: M
Vaccine: DTAP, FLUX, HIBV
Symptoms: Crying, Gait disturbance, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Swollen leg, limping, pain, crying to be held and refusing to walk. Fever of 99 degrees.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient developed pain in the arm. Pain became worse during the night. She had fever 39 C by AM and arm swelling and pain. She was seen in ER and dx'ed with cellulitis. Was treated with Vancomycin and given morphine for pain.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainting lasting less than 1 minute.
Age: 83.0
Sex: M
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site pain
Clinical narrative: SEVERE PAIN AND SORENESS AT THE SITE OF INJECTION.
Age: 83.0
Sex: M
Vaccine: FLU4, PPV, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: SEVERE PAIN AND SORENESS AT THE SITE OF INJECTION.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Influenza like illness, Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received PNEUMOVAX vaccine in left arm on 9/22/16 around 12pm. Started developing flu-like symptoms, fever, and the injection site in left arm became very hot, red, and swollen on the evening of 9/23/16. The injection site formed two pus-filled heads and may need to be lanced. The patient went to The Clinic and was prescribed cephalexin, prednisone, and benzonatate. Patient contacted and spoke with us on 9/29/16 and stated that she was doing better.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Received PNEUMOVAX vaccine in left arm on 9/22/16 around 12pm. Started developing flu-like symptoms, fever, and the injection site in left arm became very hot, red, and swollen on the evening of 9/23/16. The injection site formed two pus-filled heads and may need to be lanced. The patient went to The Clinic and was prescribed cephalexin, prednisone, and benzonatate. Patient contacted and spoke with us on 9/29/16 and stated that she was doing better.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Raised itchy rash on torso.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: On 9/27/16 Lt deltoid was Warm to the touch, swollen. Next day 09/28/16 it was hard to touch, hot to touch and had an in duration of 33mm.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood test, Disturbance in attention, Fatigue, Gait disturbance
Clinical narrative: First symptom was sore throat and headaches, than joint point. All over Joint pain has persisted and gotten much worse. Now having trouble walking raising arms going to see Pediatric Rheumatology. Still sore throat having trouble concentrating and very fatigued.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Mobility decreased, Oropharyngeal pain
Clinical narrative: First symptom was sore throat and headaches, than joint point. All over Joint pain has persisted and gotten much worse. Now having trouble walking raising arms going to see Pediatric Rheumatology. Still sore throat having trouble concentrating and very fatigued.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RAISED, RED AREA BELOW INJECTION SITE ON RIGHT ARM.
Age: 19.0
Sex: M
Vaccine: HPVX
Symptoms: Blood pressure decreased, Dizziness, Nausea, Vision blurred
Clinical narrative: Nausea, dizziness, blurred vision.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Fatigue, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: FATHER REPORTED TO PHONE NURSE ON 9/29/16 THAT PATIENT WAS EXTREMELY FATIGUED, SEVERE HEADACHE, SEVERE NECK PAIN WITH STIFFNESS, AND SEVERE BACK PAIN. PT DIRECTED TO ER FOR CHECK ON SYMPTOMS BEING REPORTED.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: 12 hours afterward, pain at site of vaccine. 36 hours later severe pain, diffuse myalgias, fever, chills, nausea and vomiting.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: 12 hours afterward, pain at site of vaccine. 36 hours later severe pain, diffuse myalgias, fever, chills, nausea and vomiting.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient called around 8pm. (She received her flu shot (AFLURIA) at 2:10pm.) She said she had hives on her torso. I told her to take BENADRYL and monitor for signs of anaphylaxis.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Immunization received 9/28/2016 24 hours after injection the left arm injection site is red and tender area approx 25 cent size. 48 hours after injection the area of redness and tenderness has doubled. tx - warm compress. TYLENOL of NSAID.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: Red, tender, swelling at injection site.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria, Wheezing
Clinical narrative: Wheezing, Hives. BENADRYL
Age: 96.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Movement disorder, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt is complaining of painful swelling in right arm after receiving PNEUMOVAX 23. He states that the pain has spread up his neck and it is hard for him to turn around in bed and he needs assistance to get in and out. He tried OTC products but nothing has helped. Pt is planning to go to ER.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Large (9 cm round) area of redness, warmth and tenderness. No better with BENADRYL/TYLENOL. Cool compress.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Blood creatinine normal, Blood urea normal, Eosinophil count normal, Full blood count normal
Clinical narrative: Presented with c/o of lower extremities rash and bilat buttock, hip pain. Began over the weekend worsened yesterday. Rash this AM. No other S/S than red non blanching rash to lower extremities from sock line down below to knee.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Rash, Rash erythematous
Clinical narrative: Presented with c/o of lower extremities rash and bilat buttock, hip pain. Began over the weekend worsened yesterday. Rash this AM. No other S/S than red non blanching rash to lower extremities from sock line down below to knee.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives covering arms, legs, and half of face. These continue to erupt periodically throughout the day. (This is now the 6th day). The hives temporarily go aww3ay for a few hours after taking BENADRYL.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus, Vaccination complication
Clinical narrative: Arm (from shoulder to elbow) itched, burned, swollen, flaming red. Was given prescriptions of famotidine and prednisone.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Rash, Skin warm
Clinical narrative: Tuesday- received shots. Wednesday- rash presented w/heat and soreness at injection site. Thursday- heat and soreness the same rash spreading.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, MMR, PNC13, VARCEL
Symptoms: Petechiae
Clinical narrative: Petechiae on face immediately after receiving vaccines. Watched for 30 min. Prednisone 10mg given
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash/hives all over body x2 weeks since injection - 1-2 days after injection.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash generalised
Clinical narrative: Rash/hives all over body x2 weeks since injection - 1-2 days after injection.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (strength, dosage and route unspecified) with lot # L037554 and expiration date 25-DEC-2017; with lot# M011117 and expiration date 07-DEC-2017. The vaccine with the lot# M011117 was exposed to temperature of 34.9F and the vaccine with the lot# L037554; both for 26.2F for the time frame of 1 hour. Call was because of a date logger. There was no previous temperature excursion. Temperature was back in range. No adverse effects were reported. No product quality complaint involved. No further information was provided. This is two of several reports received of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Influenza like illness
Clinical narrative: Headache and body aches (similar to flu) for 2 days after vaccination.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT NOTICED SWELLING, WARMTH AND REDNESS AT THE SITE OF INJECTION A DAY AFTER THE VACCINE IS GIVEN AND HAS GOTTEN BIGGER.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Red spot at injection site the size of a baseball.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Progressive redness and swelling below site of injection. Area is warm to the touch.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chills, Fatigue, Musculoskeletal stiffness, Myalgia
Clinical narrative: PATIENT COMPLAINED OF STIFF NECK, NECK PAIN, FATIGUE, MUSCLE PAIN, JOINT PAIN, FEVER, CHILLS, NAUSEA.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: PATIENT COMPLAINED OF STIFF NECK, NECK PAIN, FATIGUE, MUSCLE PAIN, JOINT PAIN, FEVER, CHILLS, NAUSEA.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site mass, Injection site pain, Injection site paraesthesia
Clinical narrative: Patient reported having soreness, tingling, a lump to the left arm in at the injection site left deltoid about 2 weeks receiving Hep A vaccine (HAVRIX Hep A Adult dose Manufacturer: GlaxoSmithKline, lot# MB3Y2; expiration date 6/10/2018). Patient reported that the lump resolved. However, still reports having tinging and soreness to left arm after 2 months of receiving vaccine.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red, bumpy rash to bilateral waist and progress to bilateral lower legs. BENADRYL 25mg was taken. No fever, no nausea/vomiting.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored ROTATEQ (strength and dosage unspecified) with lot # M017514 and expiration date 07-NOV-2017; with lot# L033694 and expiration date 16-JUN-2017, via oral route. The vaccine with the lot# M017514 was exposed to temperature of 34.9F and the vaccine with the lot# L033694; both for 26.2F for the time frame of 1 hour. Call was because of a data logger. There was no previous temperature excursion. Temperature was back in range. No adverse effects were reported. No product quality complaint involved. No further information was provided. This is two of several reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: DTAP, HPV4, MEN
Symptoms: Anxiety, Disorientation, Eye movement disorder, Syncope
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter as 11 year old female patient. Medical history not reported. Current conditions included allergy to amoxicillin and mild asthma. On an unknown date in June 2016, the patient received her first dose of GARDASIL along with tetanus toxoid (Diphtheria toxoid (+) Pertussis acellular vaccine (unspecified) (+) TE and (unspecified). On an unknown date in June 2016, following the vaccines, the patient was sitting on the exam table and had her eyes roll back and her arm went across her chest and her mom eased her down from the sitting position and she fainted for about 10 seconds and was a little disoriented. On an unknown date in 2016, following the events, everything seemed to return to normal and she participated in dance class that evening. The reporter also mentioned that the patient was particularly anxious that day. The outcome of the events was reported as recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site warmth
Clinical narrative: 1 (+) Edema of (R) leg after receiving PEDIARIX on 9/23/16, feels slightly warm. Treatment was to give TYLENOL BID x 3 days and recheck on 10/1/16 if no better. Give vaccines separately at next scheduled time. Unable to reach 9/28/16, 9/29/16.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The pharmacist report that on approximately 14-SEP-2016 (reported as "six days ago"), the patient was vaccinated with ZOSTAVAX (strength, dosage, frequency and lot# were not provided) and the patient also was prescribed Prednisone (manufacturer unknown) 10 mg, for a pre-existing unspecified medical condition (product use issue). There were not adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of PNEUMOVAX 23 (lot # M006141 with expiration date: 28-MAY-2017 and lot# M006922 with expiration date: 21-JUN-2017) that were improperly stored (freezer: temperature of 31 F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-SEP-2016, unspecified patients were vaccinated with an unspecified number of improperly stored doses of M-M-R II, therapy type: rHA, lot # L028274 (expiry date: 28-JUL-2017), lot# L032181 (expiry date: 25-AUG-2017), lot# L036851 (expiry date: 23-SEP-2017), lot# L037356 (expiry date: 28-SEP-2017), lot# L047133 (expiry date: 24-NOV-2017) and lot# M004063 (expiry date: 25-JAN-2018). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M029599, expiry date: 10-DEC-2017). A data logger was involved. Healthcare worker reported that the vaccine underwent temperature excursion at 19.5F for 23 hours. They stated that the vaccine was previously exposed at 8.5F for 4 hours and 15 minutes. No adverse effect was reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients or unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of VARIVAX (lot # M010480 with expiration date: 01-MAR-2018, lot# M020899 with expiration date: 27-APR-2018 and lot# M009765 with expiration date: 23-FEB-2018) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a multiple unspecified patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PEDVAXHIB (lot # was not provided). No adverse effect was reported. Temperature 48.79 Fahrenheit, time frame was 13 hours for 30 minutes. Previous temperature excursion was 46.5 Fahrenheit for 10 hours 48 minutes. There was no data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patents' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot# M015290, expiry date: 20-SEP-2017) (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: When patient got home a few hours after shot he noticed swelling and tenderness at the site of injection.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Tremor
Clinical narrative: Patient received Fluzone HD immunization. Patient stated that he had the chills, shakes and felt sore all over after about 5 hours of the admin of the immunization.
Age: 19.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Anaemia of pregnancy, Delivery, Exposure during pregnancy, Feeling hot, Foetal heart rate abnormal
Clinical narrative: 36 weeks pregnant at time of vaccines. 38 weeks pregnant when gave birth. Went into hospital because I had not felt baby move and was feeling really hot, was told there was no heartbeat for baby.
Age: 19.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Foetal hypokinesia
Clinical narrative: 36 weeks pregnant at time of vaccines. 38 weeks pregnant when gave birth. Went into hospital because I had not felt baby move and was feeling really hot, was told there was no heartbeat for baby.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose increased
Clinical narrative: Blood glucose was in the 500s.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: Received 2 vaccines in L deltoid. Distal to injection sites, area of erythema 3in x 3.5in which initially appeared as several hives (per mom's photos). Not tender. Slight itch, not warm to touch.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: Patient reported dizziness and mild headache right after the shot. Symptoms were resolved within 30 minutes.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: PATIENT CAME IN WITH SEVERE PAIN ON HER LEFT UPPER ARM WHERE SHE WAS GIVEN PREVNAR. THE AREA WAS HARD TO TOUCH BUT WAS NOT WARM OR RED. IT WAS SWOLLEN LITTLE BIT BUT NO INFLAMMATORY SIGNS WERE PRESENT. ADVISED PATIENT TO APPLY ICE AND TAKE NSAIDS AND REPORT IF NO CHANGE TO MD AFTER 3 DAYS.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Blood glucose, Electrocardiogram, Full blood count, Headache, Metabolic function test
Clinical narrative: Syncopal episode twice. One episode on 9/12/16 and one on 9/30/16. Was treated with rest, anti nausea medications and IV fluids. Headache and vomiting and sore arm the night of the vaccine and for 2 days after. (Aug 22, 2016-Aug 25, 2016) Has had episodic vomiting every 2-3 days since the vaccination.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pain in extremity, Syncope, Urine analysis, Vomiting
Clinical narrative: Syncopal episode twice. One episode on 9/12/16 and one on 9/30/16. Was treated with rest, anti nausea medications and IV fluids. Headache and vomiting and sore arm the night of the vaccine and for 2 days after. (Aug 22, 2016-Aug 25, 2016) Has had episodic vomiting every 2-3 days since the vaccination.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PT COMPLAINED OF SORENESS AND REDNESS AROUND THE INJECTION SITE ON THE LEFT ARM. THE REDNESS HAS SPREAD OVER THE PAST 5 DAYS. PT WAS ADVISED TO VISIT THE PRIMARY CARE PHYSICIAN AS SOON AS POSSIBLE AND LET THE PHARMACY KNOW WHEN THIS HAS BEEN DONE.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PATIENT HAD LARGE RED SWOLLEN AREA EXTEDING UP ARM AND AROUND BACK OF ARM AND ON UPPER BACK.  SWOLLEN AND WARM TO THE TOUCH.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Child developed blotchy facial rash within 5 minutes of vaccine administration.  Urticarial appearance on my exam.  No lip or eye swelling.  No wheezing or stridor although crying limited exam.  Had been eating peanut butter cookies just before shot had peanuts multiple times before with no adverse events.  Diphenhydramine 12.5mL was given within 5-10" of reported symptoms.  Child had good relief with diphenhydramine within 5-10".  Mom discharged home at 3:30 PM with prescription for diphenhydramine 12.5mg every 6 hours and instructions to call if recurrence of symptoms as may require PO steroids.  Released home with facial rash almost completely resolved and no complaints, no increased work of breathing or stridor.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Sleep disorder, X-ray normal
Clinical narrative: EXTREME PAIN TO LEFT SHOULDER WITH PAIN EMITTING DOWN THE OUTER PORTION OF THE ARM. MORE INTENSE PAIN WITH CERTAIN MOVEMENTS AND WHILE ATTEMPTING TO SLEEP AT NIGHT. SHOULDER IS NOW BEGINNING TO "LOCK" MAKING THE PAIN ALMOST UNBEARABLE. PHYSICAL THERAPY FOR 4 WEEKS NOW AND AN X-RAY THAT REVEALED NO ABNOMALITIES.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: IMMEDIATE ELECTRICAL SHOOTING PAIN DOWN ANTEROLATERAL ARM. INTERMITTENT SHOOTING PAINS WITH ROM SINCE THE EVENT.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Injection site pain, Pharyngeal oedema, Piloerection
Clinical narrative: Flu shot painful but blamed on need used.Within one hr of shot, swelling in back of throat and tongue.Within 6 hrs, face poofy (all wrinkles gone), tongue and throat swollen, difficult to talk. At 8pm onward, chills set in including goose bumps; couldn't get warm. 5 hrs post shot, ate oatmeal to be sure she could swallow although not hungry. Drank green tea with honey. Went to bed at 9pm, slept until 8:30am. She generally awakens at 6:30am.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder, Swelling face, Swollen tongue
Clinical narrative: Flu shot painful but blamed on need used.Within one hr of shot, swelling in back of throat and tongue.Within 6 hrs, face poofy (all wrinkles gone), tongue and throat swollen, difficult to talk. At 8pm onward, chills set in including goose bumps; couldn't get warm. 5 hrs post shot, ate oatmeal to be sure she could swallow although not hungry. Drank green tea with honey. Went to bed at 9pm, slept until 8:30am. She generally awakens at 6:30am.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia
Clinical narrative: KNEE PAIN STILL HURTING SINCE WEEK AFTER INJECTION.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Bladder discomfort, Dysuria, Feeling abnormal, Vision blurred
Clinical narrative: My vision was blurred all day the day I received the vaccine. I started noticing my bladder felt really full and I didn't feel like I could void. This lasted all day then the next day. It was odd. I felt bad too.I can't really attribute this to anything but the flu shot, but I am not certain what caused it.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Dizziness, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Got really cold than nauseous. Over the next hour I started feeling dizzy and my heart was pounding. It continued to get worse. My heart rate was at 126. I felt like I was going to pass out. My head felt really fuzzy. I went home from work and laid down over the next 7 hours they subsided, except for a headache and stomachache.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Nausea, Palpitations
Clinical narrative: Got really cold than nauseous. Over the next hour I started feeling dizzy and my heart was pounding. It continued to get worse. My heart rate was at 126. I felt like I was going to pass out. My head felt really fuzzy. I went home from work and laid down over the next 7 hours they subsided, except for a headache and stomachache.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient states that she has swelling and itching of the arm around the injection site. Additionally, the patient reports that her arm is red from the approximately the elbow to shoulder.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site reaction. Large red spot on leg. Hot to the touch. White ring around the red spot.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness and swelling at injections site. Hot to touch.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain in arm, swollen raised area, hot.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: AREA IS INFLAMED, RED, SWOLLEN AND ITCHY.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Tremor
Clinical narrative: Patient feeling chills, shivering and sweating and shaking.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Bright red itchy patch at site of injection with lump and swelling around it. Next day larger area of redness, itching and swelling. Today redness to my elbow with swelling and itching.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe itching inner thighs, calves, buttocks, and feet, followed by hives and a few large welts on belly and thighs. Slight hives torso and forearms. Treated with Zyrtec allergy medicine and managing so far at 11:49 pm.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness bilateral, Deafness neurosensory, Sudden hearing loss
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hearing loss bilateral in a 76-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2RG54, expiry date 30th June 2017). On 21st September 2016, the patient received FLUARIX QUADRIVALENT. On 23rd September 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced hearing loss bilateral (serious criteria disability and GSK medically significant) and sensorineural hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss bilateral and sensorineural hearing loss were not recovered/not resolved. The reporter considered the hearing loss bilateral and sensorineural hearing loss to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient had no medical history of hearing loss, no precipitating event and no concomitant medication in her chart according to the reporter. The patient received FLUARIX QUADRIVALENT on the left arm. On 23rd September 2016, at 5:00 am, the patient noticed the sudden onset hearing loss. The patient stated that the hearing in the right ear sounded like tunnel hearing and no hearing in the left ear. The physician documented sensory neural hearing loss. The patient was not hospitalized and the event was not assessed as life threatening.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness unilateral, Sudden hearing loss
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hearing loss bilateral in a 76-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2RG54, expiry date 30th June 2017). On 21st September 2016, the patient received FLUARIX QUADRIVALENT. On 23rd September 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced hearing loss bilateral (serious criteria disability and GSK medically significant) and sensorineural hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss bilateral and sensorineural hearing loss were not recovered/not resolved. The reporter considered the hearing loss bilateral and sensorineural hearing loss to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient had no medical history of hearing loss, no precipitating event and no concomitant medication in her chart according to the reporter. The patient received FLUARIX QUADRIVALENT on the left arm. On 23rd September 2016, at 5:00 am, the patient noticed the sudden onset hearing loss. The patient stated that the hearing in the right ear sounded like tunnel hearing and no hearing in the left ear. The physician documented sensory neural hearing loss. The patient was not hospitalized and the event was not assessed as life threatening.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Bedridden, Blood test normal, Fibromyalgia, Gait disturbance
Clinical narrative: This case was reported by a consumer and described the occurrence of Lyme disease in a 18-year-old female patient who received MENVEO (batch number M15099, expiry date 31st March 2017). Concomitant products included ZOLOFT and Multivitamin. On 18th April 2016, the patient received MENVEO. In June 2016, 61 days after receiving MENVEO, the patient experienced joint pain. On an unknown date, the patient experienced Lyme disease (serious criteria GSK medically significant), walking difficulty, fibromyalgia, mycoplasma infection and general body pain. The patient was treated with Antibiotic and Pain Medication. On an unknown date, the outcome of the Lyme disease, joint pain, walking difficulty, fibromyalgia, mycoplasma infection and general body pain were unknown. It was unknown if the reporter considered the Lyme disease, joint pain, walking difficulty, fibromyalgia, mycoplasma infection and general body pain to be related to MENVEO. Additional details were provided as follows: At the time of the vaccination, the patient was taking ZOLOFT 50 mg and a multivitamin. In June 2016, approximately 2 months after vaccination, the started having pains in her joints and within one week she was bedridden in pain. The patient went to many doctors and still had no answer as to what was wrong with her. Doctors had suggested Lyme, fibromyalgia and mycoplasma disease. They had tried every pain medication and nothing touches the pain. They tried viral meds and antibiotics for Lyme as well. The patient had all tests done including a spinal tap, EMF, blood, urine, and test comes back normal. The patient has been in pain 24 by 7. She could barely walk. The pain was in total body.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Laboratory test normal, Lumbar puncture normal, Lyme disease, Mycoplasma infection, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of Lyme disease in a 18-year-old female patient who received MENVEO (batch number M15099, expiry date 31st March 2017). Concomitant products included ZOLOFT and Multivitamin. On 18th April 2016, the patient received MENVEO. In June 2016, 61 days after receiving MENVEO, the patient experienced joint pain. On an unknown date, the patient experienced Lyme disease (serious criteria GSK medically significant), walking difficulty, fibromyalgia, mycoplasma infection and general body pain. The patient was treated with Antibiotic and Pain Medication. On an unknown date, the outcome of the Lyme disease, joint pain, walking difficulty, fibromyalgia, mycoplasma infection and general body pain were unknown. It was unknown if the reporter considered the Lyme disease, joint pain, walking difficulty, fibromyalgia, mycoplasma infection and general body pain to be related to MENVEO. Additional details were provided as follows: At the time of the vaccination, the patient was taking ZOLOFT 50 mg and a multivitamin. In June 2016, approximately 2 months after vaccination, the started having pains in her joints and within one week she was bedridden in pain. The patient went to many doctors and still had no answer as to what was wrong with her. Doctors had suggested Lyme, fibromyalgia and mycoplasma disease. They had tried every pain medication and nothing touches the pain. They tried viral meds and antibiotics for Lyme as well. The patient had all tests done including a spinal tap, EMF, blood, urine, and test comes back normal. The patient has been in pain 24 by 7. She could barely walk. The pain was in total body.