chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Serology test, Thyroxine free, Urine analysis
Clinical narrative: Temp 101 on 9/30/16 evening; on 10/1/16 temperature ran from 99 to  100 throughout the day; on 10/2/16 Temp 101-102 increased lethargy, altered mental status, decreased respiration with SATs 75% then atelectasis requiring emergency intubation.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Severe Urticarial Eruption.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Insomnia
Clinical narrative: Insomnia x12 days.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Drug interaction, Dyspnoea, Injection site erythema, Injection site pain, Throat tightness
Clinical narrative: Patient called me a few days after I administered the vaccine indicating of difficulty breathing, throat feeling somewhat closed and very tenderness at the sight of injection with a red mark. Patient also indicated to the staff pharmacist on 10/5/16 that she was in the hospital for a few weeks due to the Zostavax interacting with her Prednisone therapy.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Abasia, Pyrexia
Clinical narrative: UNABLE TO WALK, FEVER.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Mouth swelling, Pain
Clinical narrative: Patient states she had a temp. of 103.4, Body aches, and swollen oral mucosa.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Pyrexia, Retching
Clinical narrative: Fever, retching, abdominal pain for 2 days.
Age: 32.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscular weakness, Pain
Clinical narrative: Severe shoulder pain where injection was given. Severe muscle weakness of Left shoulder joint. Difficulty moving arm due to severe pain and limitation of range of motion.  Severe pain and muscle weakness occurred again on Tuesday morning 10/4/16 and again, to a slightly lesser extent on Friday 10/7/16. Currently still have pain (non-severe) during movement of shoulder joint.  Tried to communicate with prescribing physician the day after vaccinatin administration (9/29/16) as well as the day following, asking to be seen (9/30/16).  Did not receive any return call.  On day of second "flare up" (10/4/16) needed to visit Urgent Care due to severe pain, weakness, and decreased range of motion.  Treated with 3 day supply of prescription pain medication and pending referral for orthopedics.
Age: 32.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: X-ray limb normal
Clinical narrative: Severe shoulder pain where injection was given. Severe muscle weakness of Left shoulder joint. Difficulty moving arm due to severe pain and limitation of range of motion.  Severe pain and muscle weakness occurred again on Tuesday morning 10/4/16 and again, to a slightly lesser extent on Friday 10/7/16. Currently still have pain (non-severe) during movement of shoulder joint.  Tried to communicate with prescribing physician the day after vaccinatin administration (9/29/16) as well as the day following, asking to be seen (9/30/16).  Did not receive any return call.  On day of second "flare up" (10/4/16) needed to visit Urgent Care due to severe pain, weakness, and decreased range of motion.  Treated with 3 day supply of prescription pain medication and pending referral for orthopedics.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Eyelid oedema, Eyelids pruritus
Clinical narrative: Right lower eye lid started to itch and then formed a bubble under eyelid. Swelling then extended to upper eyelid and approximately 1 in in diameter in the lower lid. Swelling has lasted for 72 hours.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: The patient described having diarrhea that she believed was a result of the vaccine.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Feeling hot, Flank pain, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: Excruciating spinal and back pain radiating over entire spine and towards flanks. Warmth along spine. I tried a massage and hot packs but they provided no relief, I laid on floor for two hours until I felt tired enough to sleep. I slept on floor. Advil helps a little, and I slept with pain during night. I awoke to a stiff back and slight back pain, but it was better than previous night. The pain lasted during the day and let up as the day progressed.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Spinal pain
Clinical narrative: Excruciating spinal and back pain radiating over entire spine and towards flanks. Warmth along spine. I tried a massage and hot packs but they provided no relief, I laid on floor for two hours until I felt tired enough to sleep. I slept on floor. Advil helps a little, and I slept with pain during night. I awoke to a stiff back and slight back pain, but it was better than previous night. The pain lasted during the day and let up as the day progressed.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vaccination site rash
Clinical narrative: Patient returned to pharmacy and revealed a large rash on the upper arm in which the vaccine was administered. She stated that it got worse over the weekend but has since improved. The pharmacist recommended ibuprofen and Benadryl (diphenhydramine).
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient was given a dose of Flu vaccine dated from last year.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Pt had swelling and redness a few days after having vaccine administered. She went to doctor's office, who thought it may be a bacterial infection. They gave her antibiotics, and she let me know what happened when she picked up her rx. Alcohol swab and sterile needle were used, as well as individually wrapped bandaid. (Not sure exactly why doctor thought bacterial infection over allergic reaction.)
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported redness, soreness and warmth at the site of injection the evening after receiving FLUZONE HD. It lasted for 3 days and resolved on the evening of the third day.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site rash
Clinical narrative: Patient report to pharmacy with rash surrounding injection site.  Sought treatment from physician and is being treated for cellulitis with Cephalexin 500 mg qid for 7 days.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count normal, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Large area of confluent erythema with central injection area having slight induration. There is a clear geographic border where the erythema stops. No urticarial lesions noted. The whole area is warm to touch but not painful, no fluid collection seen, no abscess palpated.  Not pruritic.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Ultrasound scan abnormal
Clinical narrative: Large area of confluent erythema with central injection area having slight induration. There is a clear geographic border where the erythema stops. No urticarial lesions noted. The whole area is warm to touch but not painful, no fluid collection seen, no abscess palpated.  Not pruritic.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Fatigue, Vomiting
Clinical narrative: Fatigue, dizziness and vomiting.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Hair loss after receiving Hepatitis B vaccine.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient received high dose flu vaccine and developed a rash on his back within minutes of administration. Unclear if rash was the result of the vaccine. Patient has no known drug allergies. He had no swelling of the throat. He was assessed by a medical resident who ordered topical hydrocortisone 1% cream. The rash resolved without any complications.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site in left upper arm was painful and reddened, now has localized redness and swelling.
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: Pharyngeal paraesthesia, Throat irritation
Clinical narrative: PATIENT COMPLAINED OF MILD TINGLING AND ITCHING IN THE THROAT. THIS PERSISTED UNTIL APPROX. 12:00 PM WHEN THE PATIENT REPORTED REACTION TO PHARMACIST AND WAS TOLD TO TAKE ORAL DIPHENHYDRAMINE. SYMPTOMS RESOLVED WITH DIPHENHYDRAMINE.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Herpes zoster, Rash, Tenderness
Clinical narrative: Rash on right thigh, sensitve to the touch, with water filled blisters. Achy joints and pain associated with rash.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Malaise, Rash
Clinical narrative: Adverse reaction to the PNEUMOVAX 23, patient reports blister and rash from the arm to the face. Patient felt ill the evening of the immunization (10/5) and woke the next morning with the rash, which had spread on Friday to the face and formed blisters.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Dizziness, Feeling cold, Gait disturbance
Clinical narrative: Every joint in my body is hurting started in my pinky, I'm freezing cold down to the bones. Every muscle in my body hurts, feeling very weak and lightheaded, feel dehydrated even though I have drank a few liters of water without voiding much, body in so much pain hard to walk or move.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Every joint in my body is hurting started in my pinky, I'm freezing cold down to the bones. Every muscle in my body hurts, feeling very weak and lightheaded, feel dehydrated even though I have drank a few liters of water without voiding much, body in so much pain hard to walk or move.
Age: 50.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Erythema, Headache, Nausea, Pain, Skin warm
Clinical narrative: Swelling, redness, warm to touch, pain, headache, nausea, covered entire back of arm.
Age: 50.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Swelling
Clinical narrative: Swelling, redness, warm to touch, pain, headache, nausea, covered entire back of arm.
Age: 16.0
Sex: M
Vaccine: FLU4, HEP, HPV9, IPV, MENB, MMR, TD, FLU4, MENB
Symptoms: Asthenia, Hyperhidrosis
Clinical narrative: Became weak, diaphoretic. Sat down. BP 70/40. Gave water and crackers. Repeated BP after 10 minutes = 90/50. Patients states he feels better. Stood up slowly. BP = 90/50.
Age: 16.0
Sex: M
Vaccine: FLU4, HEP, HPV9, IPV, MENB, MMR, TD, FLU4, MENB
Symptoms: Asthenia, Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: Became weak, diaphoretic. Sat down. BP 70/40. Gave water and crackers. Repeated BP after 10 minutes = 90/50. Patients states he feels better. Stood up slowly. BP = 90/50.
Age: 16.0
Sex: M
Vaccine: FLU4, HEP, HPV9, IPV, MENB, MMR, TD, FLU4, MENB
Symptoms: Asthenia, Hyperhidrosis
Clinical narrative: After waiting 10 minutes, client got up to leave clinic with family. After walking to lobby, he complained of feeling weak, sweaty and pale with blurry vision. He was instructed to sit down; given water and crackers. BP 80/50. After drinking water and eating crackers, he felt better after 10 minutes. BP upon standing 96/50. Denies dizziness or weakness. Left with family.
Age: 16.0
Sex: M
Vaccine: FLU4, HEP, HPV9, IPV, MENB, MMR, TD, FLU4, MENB
Symptoms: Asthenia, Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: After waiting 10 minutes, client got up to leave clinic with family. After walking to lobby, he complained of feeling weak, sweaty and pale with blurry vision. He was instructed to sit down; given water and crackers. BP 80/50. After drinking water and eating crackers, he felt better after 10 minutes. BP upon standing 96/50. Denies dizziness or weakness. Left with family.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Back pain, Chest pain, Pain in extremity
Clinical narrative: General Achiness in both arms, back, knees and chest. Taking aspirin. Little relief.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient described the adverse event as her arm being swollen. It hasn't been itchy and she was prescribed an antibiotic for the reaction.  She isn't sure how long it took for the reaction to arise, but once she notice it she said her arm was swollen and red. She has been prescribed cephalexin and will see her physician for further follow-up.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness. mild swelling, itching.
Age: 40.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, red, soreness of Right arm. Said couldn't really move it much. Went twice to the doctor over next 7 days. Patient believes there is an infection in that arm.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Pyrexia, Tremor
Clinical narrative: Patient started shaking with teeth chattering the evening of the shot. She also felt freezing and felt like she had a fever but did not take her temperature. Symptoms lasted until the next evening.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness at injection site, tender to the touch. Warm to the touch.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Patient contacted pharmacy stating that the injection site was inflamed. Patient did not have hives, redness, or fever. Swelling was localized to the injection site.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysphagia, Head discomfort, Paraesthesia
Clinical narrative: Within approx. 2 min after administration, pt began to have dizziness and experienced tingling to feet. Soon after experienced heaviness to head that she describes 10x heavier than how she came into office. Approximately 15 minutes later patient began to experience difficulty swallowing. Pt was assessed by MD. Throat was clear. Pt was advised to take Benadryl but refused.
Age: 13.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle aches, chills, fatigue, fever 99.2.
Age: 49.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes over her shoulder near her neck. Started on the left, and few days later the right side started too.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: Patient complains of extreme pain (cannot sleep), pain upon touching that radiates to elbow, all day and night.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: Patient came in and stated that it started Friday and the injections site became more inflamed and itchy over the weekend.  The reaction has continued to spread and I referred the patient to her primary care doctor for further follow-up due to the spread.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Injection site pain, Joint range of motion decreased, Muscle atrophy, Musculoskeletal pain
Clinical narrative: The injection of the vaccine in my right deltoid muscle was much more painful than any other that I'd gotten previously (many).It continued to hurt for months, causing loss of range of motion, and also pain in shoulder neck and back. I took muscle relaxants, anti-inflammatories, physical therapy, moist heat, with little relief. The deltoid muscle has atrophied and I am going to another physical therapist currently.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neck pain
Clinical narrative: The injection of the vaccine in my right deltoid muscle was much more painful than any other that I'd gotten previously (many).It continued to hurt for months, causing loss of range of motion, and also pain in shoulder neck and back. I took muscle relaxants, anti-inflammatories, physical therapy, moist heat, with little relief. The deltoid muscle has atrophied and I am going to another physical therapist currently.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pain in extremity, Skin reaction
Clinical narrative: Pt had arm swollen up the next day at the injection site. Arm was sore a little. Pt went to visit her Dr after a few days of swelling not clearing up. Patient was given a course of Doxycyline and prednisone. After following up with patient in a week, pt reported having fully recovered from her skin reaction.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Malaise
Clinical narrative: Patient was only able to describe non-specific symptoms (e.g. "I felt sick", "I had the flu"). He went to the doctor 3 times in 3 days, but doctor didn't prescribe any treatment and symptoms resolved.
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Clostridium difficile infection, Culture stool, Diarrhoea, Muscle spasms
Clinical narrative: Diarrhea and cramping later discovered to be CDiff infection.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis, Gait disturbance, Headache, Hypoaesthesia, Nerve injury
Clinical narrative: Trouble walking, numbness in hands and feet headache, face drawing on one side. Tremendous nerve damage.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt awoke day after vaccination to severe swelling/redness. On entire upper arm and bicep area. Pain/swelling/redness was reduced w/TYLENOL and was on PNEUMOVAX arm not FLUZONE arm resolved in 2 days.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: None stated.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered
Clinical narrative: No treatment needed at this time. Received 2nd dose of PREVNAR pt stated no previous pneumonia vaccine. Administered vaccine. Realized afterwards that she had already received but did not remember. No treatment needed. Seemed to be fine when spoke to pt.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted immediately following shot. Laid chest down and elevated feet. Regained consciousness within 10 seconds. Watch in office for 10 min. Walked out of office.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Blood culture negative, Discomfort, Full blood count abnormal, Injection site erythema, Injection site pain
Clinical narrative: Redness, warmth, swelling, tenderness to left upper arm, approx. 15 cm x 15 cm erythema. BACTRIM DS initiated after blood culture, repeat CBC. Ice for discomfort with OTC analgesic. 10/10/16 only slight redness noted to upper left arm, no tenderness, no swelling.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling, tenderness to left upper arm, approx. 15 cm x 15 cm erythema. BACTRIM DS initiated after blood culture, repeat CBC. Ice for discomfort with OTC analgesic. 10/10/16 only slight redness noted to upper left arm, no tenderness, no swelling.
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: 1 hour after getting vaccine, developed hives on neck area.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on back 3 hours after injection. Pt taking 50mg of diphenhydramine and following up w/PCP in AM.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Tinnitus
Clinical narrative: BP 160, body aches, ear ringing.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Malaise
Clinical narrative: Patient called this morning to report she had fallen ill after receiving the flu shot. Patient reported cough and SOB that had both improved since yesterday.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Syncope
Clinical narrative: Patient received flu shot at 1:30 pm 10/8/16 and shortly after fainted, regained consciousness within 15 seconds, lay on ground recovering for a couple minutes, sat up against wall on ground and fainted again within minutes, regained consciousness quickly again, remained laying on ground conscious until EMS arrived. Stood up and remained fine after.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states that arm has been sore for over 1 month. Now on a course of prednisone.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Patient states that arm has been sore for over 1 month. Now on a course of prednisone.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Death, Dyspnoea, Fatigue, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: January 2015 - patient received vaccine during hip surgery. February 2015 - experienced tingling and numbness in hand/arms and impaired breathing continued and extreme fatigue. May - difficulty walking, used a walker. June 2015 - paralyzed, and was diagnosed with GBS. July 2015 - respiratory distress and had tracheostomy; treatment during period included immunosuppressants. Died on 6/2/16.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypoaesthesia, Paraesthesia, Paralysis, Respiratory distress, Tracheostomy
Clinical narrative: January 2015 - patient received vaccine during hip surgery. February 2015 - experienced tingling and numbness in hand/arms and impaired breathing continued and extreme fatigue. May - difficulty walking, used a walker. June 2015 - paralyzed, and was diagnosed with GBS. July 2015 - respiratory distress and had tracheostomy; treatment during period included immunosuppressants. Died on 6/2/16.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Walking aid user
Clinical narrative: January 2015 - patient received vaccine during hip surgery. February 2015 - experienced tingling and numbness in hand/arms and impaired breathing continued and extreme fatigue. May - difficulty walking, used a walker. June 2015 - paralyzed, and was diagnosed with GBS. July 2015 - respiratory distress and had tracheostomy; treatment during period included immunosuppressants. Died on 6/2/16.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Pain, Painful respiration, Tension
Clinical narrative: A few hours after the shots, pt started to feel the pain, it started to expand to the armpit, side of the chest, pt feels pain when breathing, very tense after 24 hrs of the shots (left arm).
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right deltoid area very red, warm to touch. Edema. Patient apply ice to area.
Age: 12.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness/rash to upper left arm where vaccination was administered. Mother gave pt 25mg of BENADRYL. (Pt had chicken pox in the past - she was required to received one dose of VARICELLA for immigration purposes.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue
Clinical narrative: After 3 weeks of getting FLUZONE HD shot, patient felt very tired, fatigued. Couldn't get out of bed or stay on her feet. This last 2 weeks. She even tried to stop all her medications but she still felt very fatigued. Pt has gotten this vaccine in previous years but never felt this way before.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm swelled up below shot sight. Was red and hot to touch. Had a headache.
Age: 57.0
Sex: U
Vaccine: FLU4
Symptoms: Back pain, Erythema, Fatigue, Herpes zoster, Pain
Clinical narrative: Very tired and achy the evening I received the flu vaccine and developed a red spot on my arm. Day 2 - back pain and very tired. Day 3 - developed shingles rash on my back.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route unknown, lot# L018503, expiration date: 16-MAR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLUX, HPV9
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Nurse reported that on 21-SEP-2016, the patient was vaccinated with an unspecified flu vaccine and intramuscular GARDASIL 9 (lot # L043214, expiry date: 30-AUG-2017). She reported that after the administration of vaccines, the injection site was wet and looked like it oozed out. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Lethargy, Speech disorder
Clinical narrative: This spontaneous report was received from patient's mother regarding her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, dose, lot # and expiry date not reported). Subsequently, on an unknown date, the patient experienced lethargy and had a speech impediment. The outcome of the events was reported as not recovered. The reporter did not assess the relatedness between the event and vaccine. No product quality complaint (PQC) was reported. Additional information is not expected as the reporter refused to provide further information.
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 number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients were vaccinated with improperly stored doses of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) (strength, dosing details, anatomical location were unknown). The vaccine had been stored at 8.1 degree Celsius for 15 minutes, and also at 8.3 degree Celsius for 15 minutes. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L042258, expiry date 18-AUG-2018) (strength, dosing details, anatomical location were unknown). The vaccine had been stored at 8.1 degree Celsius for 15 minutes, and also at 8.3 degree Celsius for 15 minutes. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
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 number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L019297, expiry date 18-AUG-2017 and lot# M007764, expiry date 30-JAN-2018) (strength, dosing details, anatomical location were unknown). The vaccine had been stored at 8.1 degrees Celsius for 15 minutes, and also at 8.3 degree Celsius for 15 minutes. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: M
Vaccine: HPVX
Symptoms: Abnormal behaviour, Foetal exposure during pregnancy, Head banging, Laboratory test normal
Clinical narrative: This spontaneous report was received from a 31year old female referring to her approximately 1 year old son. The patient's pertinent medical history and concurrent conditions were not reported. In October 2012, the patient's mother was vaccinated with an unidentified Merck HPV vaccine intramuscularly (name, strength, dose, lot number and expiration date were not provided). The patient's mother concomitant medications were not reported (Mother's case reported in MARRS #1610USA002292). On an unknown date, since the patient was 1 year old, he had not been able to function in a "normal child setting". He used to bang his head against the wall and had severe behavioral issues. The patient's mother stated, that her son was very intelligent and had a high intelligence quotient (IQ). Also autism tests were performed on unknown dates and he passed them all. He had not been diagnosed with autisms. At the time of the report, the outcome of abnormal behaviour was reported as not recovered and the outcome of head banging was unknown. The outcome of foetal exposure during pregnancy was reported as recovered. The reporter did not provide for a causality between the adverse events and therapy with the unidentified Merck HPV vaccine. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (lot #, expiration date, site and dose were not reported). A week later (date unknown), the patient came back into the office with a rash. The physician stated that he did not believe it was shingles. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Addition information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were administered improperly stored PEDVAXHIB lot#M007762, expiry date: 07-DEC-2018 and lot# M020100, expiry date 07-MAR-2019, (dose, strength, site and route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 51 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # M014310 (dose, expiration date and route of administration were not reported). On an unknown date, the patient developed a 3 to 4 inch area of redness and itching. The patient received BENADRYL as a treatment of redness and itching and MORTIN if any pain would occur. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (route, dose and frequency not reported, lot # reported as M011840, expiration date 01-FEB-2018). The total cumulative temperature excursion was reported as 117 minutes in high temperature (49.1 Fahrenheit) and 225 minutes in low temperature (34.1 Fahrenheit) (the total cumulative time in high and low temperature was reported as 342 minutes). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from a patient's husband refers to 82 year old female patient with high blood pressure and allergy to penicillin. Historical drugs included penicillin. In November 2015, the patient was vaccinated with a dose of ZOSTAVAX in the left arm (dose, route of administration, lot # and expiration date not reported). Concomitant therapies included unspecified "blood pressure medicine". On an unknown date in 2015 (also reported as: about a week after receiving the vaccine), the patient experienced fever and redness at the injection site. The outcome of events was not reported. The relatedness of events was not reported. The relatedness between ZOSTAVAX and the events was not assessed. Additional information is not expected as there was no consent to contact the physician.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Full blood count, Haematochezia
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 4 month old male patient. The patient had no pertinent medical history and no known drug reactions or allergies. The patient had PENTACEL and PREVNAR as concomitant therapies administered on an unknown date. On 04-OCT-2016 the patient was vaccinated with ROTATEQ lot number M014544, expiration date 27-NOV-2017; orally (dose number were not provided). On 04-OCT-2016, 4 hours after receiving ROTATEQ, the patient developed hematochezia stools through the night and 7 episodes of diarrhea through the night. The patient received unspecified treatment for the events and lab diagnosis studies performed included a complete blood count (results were not provided). At the time of the report, on 05-OCT-2016 hematochezia and diarrhea were resolved. There was no product quality complaint involved. Upon internal review, haematochezia was considered to be medically significant. 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 registered nurse and refers to an unspecified number of patients of an unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of PEDVAX HIB (route, dose and frequency not reported, lot # L014429, expiration date 15-MAR-2018, lot # reported as L042386, expiration date 24-AUG-2016, lot # M014925, expiration date 16-FEB-2019). The total cumulative temperature excursion was reported as 117 minutes in high temperature (49.1 Fahrenheit) and 225 minutes in low temperature (34.1 Fahrenheit) (the total cumulative time in high and low temperature was reported as 342 minutes). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 (route, dose and frequency not reported, lot # L033707, expiration date 18-MAY-2017). The total cumulative temperature excursion was reported as 117 minutes in high temperature (49.1 Fahrenheit) and 225 minutes in low temperature (34.1 Fahrenheit) (the total cumulative time in high and low temperature was reported as 342 minutes). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Malaise
Clinical narrative: This spontaneous report as received from a 58-year-old male patient refers to himself. Patient's medical history included herpes zoster. Drug reactions and allergies were not reported. In 2012, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, lot# and expiration date were not reported. No concomitant medications were reported. Subsequently, on an unspecified date 2012, the patient experienced headache for about a month and reported that ever since then he did not feel fully healthy. The patient also reported since then he had a low rate virus of shingles but no rashes appeared. On an unknown date, the patient went to his doctor and received a vaccine for congestion but that made his shingles feel a lot worse. He was going to visit his doctor on Thursday at the time of report. The outcome of adverse events as unknown. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 20 year old pregnant female patient. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions or allergies was reported. On 14-SEP-2016 (reported as 2 weeks ago), the patient was vaccinated with GARDASIL 9 injection, intramuscularly (dose, expiration date, lot # were not provided). On 28-SEP-2016, she had a pregnancy test and the result was positive. The patient became pregnant with Last Menstrual Period (LMP) of 10-SEP-2016 and Estimated Date of Delivery (EDD) of 17-JUN-2017. Pregnancy outcome was pending and the fetal outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 29-SEP-2016, the patient received improperly stored VAQTA (lot# M022556 and expiry date: 26-MAY-2017) (dosing details were not reported). No adverse reaction were not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received on 04-OCT-2016 from a pharmacist, referring to a patient of unknown age and gender. Prior medical history, concomitant therapies and drug/allergies reactions were not reported. On 04-OCT-2016, (reported as: today) the patient was vaccinated inadvertently with a dose of VARIVAX, (route, dose and concentration were not reported), instead of ZOSTAVAX no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant therapy were not provided. On 05-OCT-2016, the patient was vaccinated with an expired dose of 19400 plaque form unit (PFU), 0.65 ml, expiration date: 17-JUL-2016, injection, subcutaneously. Lot number was not specified. The pharmacist stated, the ZOSTAVAX was stored correctly through administration. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not informed. It was reported that on unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX, lots # L046885, M010484 and L024256, (expiration dates, dosages and therapy routes were not provided). Concurrent conditions were not informed. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for follow up was given.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Bursitis, Drug administered at inappropriate site, Injection site pain, Synovitis
Clinical narrative: See letter-vaccination given in wrong anatomical location- See letter - Synovitis/Bursitis. Rt shoulder - (follow up pending). I recently went to a Pharmacy for a PREVNAR 13 vaccination. When I returned home I noticed the vaccine bandage was over the point of my shoulder-not in the widest area of the Deltoid muscle. I am concerned about shoulder injury from a synovitis with an immune mediated inflammatory response. See JAPA paper send and pictures of where needle was placed in my shoulder. It is 48 hours after the injection and the shoulder is still very painful. I would appreciate your response and recommendations.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 30-SEP-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (strength, dose, frequency and route were unknown; lot number L046900 with expiration date 23-FEB-2017). Temperature for vaccine was 22 F with duration of 8 hours. The call was not because of a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unspecified dates, an unspecified number of unspecified patients may have received improperly stored doses of VARIVAX (strength, dose, frequency and route were unknown; lot number M023380 with expiration date 11-MAY-2018). No adverse effects were reported. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot# M013636, expiration date 15-FEB-2018, intramuscular). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients received an improperly stored dose of VARIVAX (lot # M012991, expiration date 14-MAR-2018, lot # L048467, expiration date 02-DEC-2017, lot # M019641, expiration 20-APR-2018, lot # reported as M020900, expiration date 27-APR-2018, lot # reported as M025870, expiration date 24-MAY-2018, subcutaneous). No adverse effects were reported. Temperature Excursion Details: For lot # M012991, expiration date 14-MAR-2018, lot # L048467, expiration date 02-DEC-2017, lot # M019641, expiration date 20-APR-2018, lot # reported as M020900, expiration date 27-APR-2018: 20F for 12 hours, 13F for 4 hours. For lot # reported as M025870, expiration date 24-MAY-2018: 20F for 12 hours. For lot # reported as M020900, expiration date 27-APR-2018, lot # L048467, expiration date 02-DEC-2017, lot # M019641, expiration date 20-APR-2018: 20F for 12 hours, 13F for 4 hours, 15F for 12 hours. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a male patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot number and expiration date were unknown). On an unknown date, the patient experienced shingles. The outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information is not expected as the pharmacist does not want to be contacted for follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored MMR II (lot # K016154, expiration date 24-SEP-2016, subcutaneous). 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: Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored MMR II (lot # K016154, expiration date 24-SEP-2016, subcutaneous). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient was vaccinated with one dose of improperly stored RECOMBIVAX HB 2.5/0.5 unit not provided (lot # L033343, expiration date 13-SEP-2017; dose and route were unknown). No adverse effect was reported. The storage details for this RECOMBIVAX HB were 0.6 Celsius degree for 3 hours 41 minutes, 0.5 Celsius degree for 8 hours 4 minutes, and 0.9 Celsius degree for 2 hours 14 minutes. Additional information had been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.), concerning an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. It was reported that on unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot # M010472, expiration date 01-JUN-2017, (dosage and therapy route were not provided). No adverse effects were reported. Concomitant therapies were not informed. No product quality complaint (PQC) was involved. This is one of the several report of the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Pleuritic pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Congested, nasal drip, coughing (dry), pleuritic chest pain.