chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting, Weight increased
Clinical narrative: Patient reports that the symptoms started within 30 minutes of receiving the vaccine on 10/11/2017.  She reports that the vaccine was given in a good location. She is an RN. She reports swelling (2+ pitting edema) in the left arm and that it became numb down to the middle and ring fingers of that arm. She feels the numbness was because of the swelling. She reports that she developed a heavy tongue, along with a headache and vomiting. She also developed 2+ pitting edema in her legs. She reports that at the time of the vaccination she was 28 weeks and 5 days pregnant. She reports that she had a 10 pound plus weight gain associated with the event. She notes that she also has a splotchy rash on her chest, arms and legs. She reports that she took Benadryl and this helped with the symptoms. As of today, 10/18/2017 she reports that she has lost 6 of the pounds that she gained. She reports that swelling has resolved, though her arm is still slightly sore. She still gets the rash intermittently. She reports that she has told her Midwife about this event and she states that they did do an ultrasound and the baby is fine.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Patient experienced severe headache, body ache, nausea and chills within 24 hours after vaccine.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema
Clinical narrative: PATIENT PRESENTED BACK TO PHARMACY WITH LARGE REDDENED AREA AT SITE OF INJECTION.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Hypersensitivity, Lip swelling, Oral pain, Swelling face
Clinical narrative: Severe allergic reaction. Child complained of mouth hurting. Then, the right top lip and the right side of the face swell up. Around 7-8pm. Doctor was called, then child was rushed to the hospital.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 1 day after receiving Tdap injection, patient experienced a fever up to 101 F and swelling surrounding the injection site with redness and heat up to 5 inches in diameter. Today on 10/18/17, the fever is gone and the swelling remains. He is not in pain.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Patient states, "My arm hurt for around 4 to 5 days, down to my fingertips and felt like arthritis in my arm/hand. My skin near the injection site became itchy and developed a pink patch that was slightly raised 2 inches across."
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called on 10/18/17, said her arm starting hurting on 10/17/17. The shot was given on 10/16/17. Her arm was red and swollen. She had a colonoscopy done on 10/17/17, so while she was there she asked the MD about her arm, she said he looked at it and advised her to put a hot pack on it. She said she had been doing that, and it had helped the swelling and redness somewhat. She did say it was better than it was a day ago, but still a little red and swollen.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Peripheral swelling, Rash erythematous
Clinical narrative: Following an offsite flu clinic, a patient called and complained of marked swelling of the shoulder/arm with red patchiness and numbness shooting down to her hand. Her flu shot was administered 2 hours prior to her call. Prior to administration, she talked about experiencing a similar event twice before. She was told that she experienced the reactions due to a latex allergy. We looked at the vaccine, and noted that it claims to be "free from natural rubber latex." She says she received the flu vaccine many time before; but it wasn't until those previous two incidents where she had reactions. She did not believe that she had a true latex allergy, but was willing to try the vaccine anyhow. I instructed her to ice the area and report to the emergency room if her condition worsens.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: Terrible arm pain, she said it felt frozen.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Developed chills, threw up and has a 102.8 fever within 6 hours of getting the shot. Was feeling completely fine until then.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Tachycardia, Urticaria
Clinical narrative: Full body hives, tachycardia.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Patient called pharmacy on 10/12 to report ongoing headache that started the morning of 10/8, on the left side of her head and stated that is has not subsided since. She stated taking TYLENOL helps a little, but the headache comes back. Patient states she received the flu shot in her left arm and has had a headache ever since and the flu shot definitely caused her headache. I advised her to please follow up with her primary care physician and that I would report this as an adverse event
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Pt reported to Rx on 10/18/2017 (next day) with reddened erythematous area approx 4"x6" warm to touch enveloping skin tissue for R distal deltoid and all of biceps. Complaint of progressive stiffness and intermittent chill. No raised areas, striations, or encapsulated areas (knots) noted. Placed patient on 25mg diphenhydramine po bid-tid, IBU 400mg q4-6h prn, and cold compresses to site at this time with directions to see MD for steriod if not improved by morning 10/19/2017.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Left axillary lymph node swelling observed by father 22 hours post injection-
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient is complaining of numbness in the injected arm. It tingles and it is painful >2 months after receiving the shot.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Feeling abnormal, Pallor
Clinical narrative: A few minutes after the shot, the patient said he had a strange feeling, then we made him sit on a chair, by then his face turned read and he asked for water with a face which appeared like difficulty to breath. I administered an epinephrine shot and called 911. He was still talking to us and didn't want us to call 911. After the epipen, he sat upright and started talking again, by then his face started looking very pale. The paramedics arrived by this time and took it over. Paramedics urged the patient to go to ER but he refused. He was at the store for about half an hour more after the event. Then was taken home by his wife. At 7:45 pm, we checked on the patient and he said he was feeling normal.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Injection site erythema
Clinical narrative: General malaise, sweats and chills, anorexia in am. Extreme fatigue by noon, red, swollen, hot arm on injection side with hives and itching.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth, Malaise
Clinical narrative: General malaise, sweats and chills, anorexia in am. Extreme fatigue by noon, red, swollen, hot arm on injection side with hives and itching.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Gave 10 yo patient injection of FLUZONE and she returned to the waiting area with her mother. She stood up and said she knew she was going to faint because it had happened before on the school bus and while reading. Mother stated that she "was out" for just a few seconds, she did not fall as her mother held her up. No other symptoms reported and she said she felt fine minutes later.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Lump, pain, soreness at injection site.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Pruritus, Urticaria
Clinical narrative: Large golf ball size lump, redness, itchiness, hives.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Redness, rash, itchiness, hives at injection site.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash/itchiness-felt down to the bone per pt.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Pain, Pruritus
Clinical narrative: "Tennis" ball size lump, redness, itchiness soreness.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Pain, Pruritus
Clinical narrative: Lump, golf ball size, itchiness, soreness, redness.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchiness, redness at injection site.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Pruritus
Clinical narrative: Golf ball size lump, itchiness, redness.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Mass, Musculoskeletal pain, Musculoskeletal stiffness, Swelling
Clinical narrative: Lump, shoulder pain/stiffness, swelling.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Injection site reaction, Injection site swelling
Clinical narrative: Needle touched bone. Pulled back slightly. Finished injection. Pulled needle out. Immediate bleeding. Bleeding stopped with 1 cotton ball. Immediate swelling and discolouration. Looked like a pool of blood under the skin.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Skeletal injury
Clinical narrative: Needle touched bone. Pulled back slightly. Finished injection. Pulled needle out. Immediate bleeding. Bleeding stopped with 1 cotton ball. Immediate swelling and discolouration. Looked like a pool of blood under the skin.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: One day of body aches and fever.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Arthropathy, Gait inability, Joint swelling
Clinical narrative: Patient apparently developed severe arthralgias and swollen joints approximately 2-3 days following administration of the high dose influenza vaccine for seniors. An inflammatory process of the R wrist and knee joints was documented along with functional decline, arthralgias, and sudden inability to ambulate. This vaccine was administered by a local home health agency operated by a local county health department. The husband and wife both received the vaccine and both developed similar symptoms.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 45-year-old female patient who received FLUARIX QUADRIVALENT (batch number C559A, expiry date 30th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 4th October 2017, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site warmth and injection site swelling. On 5th October 2017, the outcome of the injection site erythema, injection site warmth and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was previously reported to Doctor. The nurse that reported that, the day after the injection, the patient stated there was redness and swelling at the injection site. The patient mentioned that, the skin around the site was felt hot when touched. Two days later when spoke with the nurse, the patient's side effects were resolved.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injection site bruising
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a patient who received FLULAVAL Tetra (batch number 5LR3F, expiry date 30th June 2018) and (batch n umber N7GN5, expiry date 30th April 2018). On an unknown date, the patient received FLULAVAL Tetra (subcutaneous). On an unknown date, the dose was an unknown dose. On an unknown date, less that a year after receiving FLULAVAL Tetra, the patient experienced injection site bruising and inappropriate route of vaccination. On an unknown date, the outcome of the injection site bruising and inappropriate route of vaccination were unknown. Additional information was provided as follows: The age at vaccination was not reported. The health care professional reported that about 4 to 5 patients received doses of FLULAVAL QIV in the subcutaneous region of the arm instead of the deltoid which caused bruising approximately 2 inches in diameter. This led to incorrect route of vaccination. The health care professional was unsure which lot numbers were administered to the patients, so he provided both of the lot number which would have been administered. No further information was provided regarding the event.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 59-year-old female patient who received FLUARIX QUADRIVALENT (batch number D2L7K, expiry date May 2018). On 11th October 2017, the patient received FLUARIX QUADRIVALENT (subcutaneous) .5 ml. On 11th October 2017, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hemorrhage, injection site pain, injection site swelling and intramuscular formulation administered by other route. On 12th October 2017, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site hemorrhage, injection site pain, injection site swelling and intramuscular formulation administered by other route were unknown and the outcome of the injection site bruising was recovering/resolving. It was unknown if the reporter considered the injection site hemorrhage, injection site pain, injection site bruising, injection site swelling and intramuscular formulation administered by other route to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The petite patient received a FLUARIX QUADRIVALENT (intended via intramuscular route) and some of the vaccine have gotten into the subcutaneous tissue inadvertently, which led to intramuscular formulation administered by other route. The healthcare professional (HCP) was uncertain if the vaccine was into subcutaneous or intramuscular tissue. The HCP planned to revaccinate the patient as per Centers for Disease Control and Prevention recommendations following an inappropriately administered dose. After 1 day of vaccination, the patient experienced injection site bruising.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: Rec'd 6mo vaccinations 10/17/17 at 6mo WCE in office. Mom reports 10/18/17, S/S noticed this AM= 100 degree temp and Lt. thigh swollen and tender. Seen 10/18/17 mid-AM for eval. Dx as vaccine reaction. Tx with ice packs, TYLENOL and monitoring.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Around injection site (LT) positive erythema, edema, warmth, tender on palpation. Fever 103.5 degrees). TX BENADRYL 16 mg PO Q8 hours prn Sxs. Good outcome. Sxs started to get better 36 hours after BENADRYL was started and disappeared 48 hours later.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Injection site erythema, Injection site pain, Pain
Clinical narrative: Red rash swollen, pain, weakness, mild fever, only redness-mild pain at injection site remains, cold shivers evening of.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: Red rash swollen, pain, weakness, mild fever, only redness-mild pain at injection site remains, cold shivers evening of.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Gait inability, Paralysis
Clinical narrative: 15 minutes after injection. Patient suffered muscle paralysis from the waist down. She was unable to walk out of the pharmacy and was transported to her car on a motorized scooter. The paralysis lasted 1 hour. She reported chills and fatigue over the next 24 hours. After than, for an additional 24 hours, she felt fatigued. Patient refused to be seen by a provider and recovered.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Blood test, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: 24 hrs after injections administered severe pain from injection site (L) deltoid down "entire" (L) arm to wrist and hand. Inability to lift or turn on flex arm over slightly - "excruciating" pain 3 days - then ER visit. W/Lidocaine patches and Ibuprofen ordered. Pain in (L) shoulder still 10/18/17.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ultrasound scan
Clinical narrative: 24 hrs after injections administered severe pain from injection site (L) deltoid down "entire" (L) arm to wrist and hand. Inability to lift or turn on flex arm over slightly - "excruciating" pain 3 days - then ER visit. W/Lidocaine patches and Ibuprofen ordered. Pain in (L) shoulder still 10/18/17.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Paraesthesia, Rash erythematous, Skin warm, Urticaria
Clinical narrative: Red raised rash/hives on trunk, neck, face, hot, prickly sensation.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient reported red, slightly raised rash on Left arm. Hot to the touch and slight itching.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Upper arm - shoulder and neck severe constant pain.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Rash, Skin exfoliation
Clinical narrative: Rash all over the torso - on top of breasts and under breasts and all over the belly. Redness - very red and peeled. Lasted about 1 week.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: On 10/17 patient came by the pharmacy seeking OTC treatment for sore arm noticed after vaccine administration 2 weeks prior. Reported after vaccine was administered, no pain with the Injection. Next couple of days, described tenderness as expected, no swelling. Noticed 3 to 4 days after administration, she was not able to lift her arm above shoulder and described the pain "similar to a sore muscle", not a nerve pain, but tingling-like sensation. Taking ADVIL occasionally and warm compress to alleviate. Follow up call on 10/18, indicated her arm was feeling better, appreciated the concern and plans to report VAERS. Let the patient know if the pain is not getting better, to see PCP.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: (L) thigh redness/hot to vaccine site.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness, Loss of personal independence in daily activities, Syncope, Tachycardia, Vomiting
Clinical narrative: Upon waking up at 6:30Am passed out (fainted) and followed by tachycardia. One hour later vomiting. Stayed home from school-kept hydrated, gave ATARAX 10mg, gave Ondansetron 4 mg.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received a registered nurse concerning two patients of unknown age. On 03-AUG-2017, the patients were vaccinated with PROQUAD (lot # M006107, expiratory date: 01-AUG-2017; dose and route were not reported) as prophylaxis. No adverse effects were reported. No additional information was available. All telephone attempts on 01-SEP-2017 to obtain follow-up information had been unsuccessful. Follow up information has been received from the registered nurse concerning one 5 years old male patient on 06-OCT-2017. In approximately December 2016 (also reported as eight months before the vaccination), the patient suffered from seizure following unknown vaccine. There was no seizure after that. On 03-AUG-2017 at 14:00, the patient was vaccinated at public health clinic with the second dose of PROQUAD subcutaneously at left arm. So, the vaccine was given 2 days after the expiration date. No further treatment was stated. No re-vaccination was needed. This is one of two reports received from the same reporter.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Cyanosis, Injection site pain, Memory impairment, Seizure, Syncope
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old male patient. Medical history and drug reactions/allergies were reported as "none". The patient did not have pertinent medical history or drug reactions/allergies. On 12-OCT-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # N012093, expiry date 13-JAN-2020), intramuscular in the right deltoid for prophylaxis. Concomitantly the patient was vaccinated with a dose of MENACTRA. On 12-OCT-2017, shortly after receiving the vaccine, the patient stated that his right arm really hurt (pain in extremity). Seconds later the patient turned pale (pallor), fell over on his left side (fall), and began convulsing for approximately 8 to 10 seconds (seizure). The medical assistant reported that after the patient stopped convulsing, he stated that he had no recollection of what happened (amnesia) and he was still pale. The patient stayed at medical practice for approximately 15 minutes after he stopped convulsing, at which time he stated that he felt better and left the medical practice with his mother with no treatment given for the adverse events. The outcome of seizure, amnesia, fall, pallor and pain in extremity was reported as recovered/resolved. No causality assessment was provided by the reporter. Upon internal review seizure was considered to be a medically significant event. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Fall, Memory impairment, Pain in extremity, Pallor, Seizure
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old male patient. Medical history and drug reactions/allergies were reported as "none". The patient did not have pertinent medical history or drug reactions/allergies. On 12-OCT-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # N012093, expiry date 13-JAN-2020), intramuscular in the right deltoid for prophylaxis. Concomitantly the patient was vaccinated with a dose of MENACTRA. On 12-OCT-2017, shortly after receiving the vaccine, the patient stated that his right arm really hurt (pain in extremity). Seconds later the patient turned pale (pallor), fell over on his left side (fall), and began convulsing for approximately 8 to 10 seconds (seizure). The medical assistant reported that after the patient stopped convulsing, he stated that he had no recollection of what happened (amnesia) and he was still pale. The patient stayed at medical practice for approximately 15 minutes after he stopped convulsing, at which time he stated that he felt better and left the medical practice with his mother with no treatment given for the adverse events. The outcome of seizure, amnesia, fall, pallor and pain in extremity was reported as recovered/resolved. No causality assessment was provided by the reporter. Upon internal review seizure was considered to be a medically significant event. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Lip swelling, Tremor
Clinical narrative: Rapid swelling of upper lip over 10-15 minute frame. Child given appropriate dose of BENADRYL per doctor request and told to go to the hospital. Within 5 minutes before BENADRYL was taken, child became very shaky, dizzy, weakness, and difficulty breathing. Parent called 911. Paramedics administered more BENADRYL via IV and transported to local ER. Hospital administered SOLU-MEDROL and discharged child with prescriptions for Epinephrine, Prednisolone, and diphenhydramine.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Dizziness, Dyspnoea, Lip swelling, Tremor
Clinical narrative: Rapid swelling of upper lip over 10-15 minute frame. Child given appropriate dose of BENADRYL per doctor request and told to go to the hospital. Within 5 minutes before BENADRYL was taken, child became very shaky, dizzy, weakness, and difficulty breathing. Parent called 911. Paramedics administered more BENADRYL via IV and transported to local ER. Hospital administered SOLU-MEDROL and discharged child with prescriptions for Epinephrine, Prednisolone, and diphenhydramine.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Very painful body, especially joints; high fever (102.2).
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, ~101F.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Gait disturbance, Injection site pain, Musculoskeletal pain, Sleep disorder
Clinical narrative: Intermittent terrible aching in left and right shoulders down to both elbows, to shoulder blades, interfering with sleep and walking still continuing to today.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Axillary pain, Chest pain, Fatigue, Injected limb mobility decreased
Clinical narrative: Muscles in my left arm where given shot began to have severe pain. Lost strength in my arm also. It seemed to affect my shoulder down to my hand with pain which I began taking ADVIL for. Lots of trouble sleeping, for the many times I had to move my arm to relieve the pain briefly using my right hand to help hold up. As time went pain was under my arm, side of chest also sore putting pressure on shoulder. This is now October 19th and seems like most pain now is where I consider the rotator cup.   Still difficult to sleep even after taking Advil. The arm has gotten better, for now can raise my left arm without pain or help from my right hand. I have not had a fever, but am rather tired at times. I am treating myself, but never thought this problem would last this long. Did NOT go to my doctor, hospital, or have any tests.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Insomnia, Pain in extremity, Tenderness
Clinical narrative: Muscles in my left arm where given shot began to have severe pain. Lost strength in my arm also. It seemed to affect my shoulder down to my hand with pain which I began taking ADVIL for. Lots of trouble sleeping, for the many times I had to move my arm to relieve the pain briefly using my right hand to help hold up. As time went pain was under my arm, side of chest also sore putting pressure on shoulder. This is now October 19th and seems like most pain now is where I consider the rotator cup.   Still difficult to sleep even after taking Advil. The arm has gotten better, for now can raise my left arm without pain or help from my right hand. I have not had a fever, but am rather tired at times. I am treating myself, but never thought this problem would last this long. Did NOT go to my doctor, hospital, or have any tests.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a 45 year old male patient regarding himself. On 02-AUG-2017 the patient should have vaccinated with PREVNAR 13 first only vaccinated the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOCOCCAL VACCINE, POLYVALENT (23-VALENT)), intramuscular in the left deltoid (strength, dose, lot#, expiry date was not reported) (wrong vaccine administered). On 02-AUG-2017, patient is immune-compromised and now the vaccine had been given therefore the damage had been done. The outcome of the event was unknown. Causality of Immunodeficiency was not reported. Upon internal review, the event of immune compromised was considered to be medically significant.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-AUG-2017 at 14:25 hrs, the patient was vaccinated with incorrectly stored dose of ROTATEQ (strength, dose and expiration date were not reported) lot # M046006 dose 2 for prophylaxis (onset date was reported as 02-AUG-2017 08:45 hrs). Other suspect therapies included PENTACEL (strength, dose and expiration date were not reported), lot# C5295AA, dose 2, in left thigh for prophylaxis and PREVNAR (strength, dose and expiration date were not reported), lot# 531255, dose 2, in left thigh for prophylaxis. No adverse event or reaction was reported by the patient. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA001493.
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 65 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On approximately 03-OCT-2017, reported as 2 weeks ago, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On unknown date in October 2017, after receiving PNEUMOVAX 23, the patient experienced general muscle aches. The patient had no fever. The outcome of the event was reported as recovered/resolved on an unknown date in October 2017, as the patient was fine at the time of reporting. The relatedness between the general muscle aches and the suspect drug was not reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 22-AUG-2017, the patient was vaccinated with improperly stored PROQUAD injection (lot # N010247 with expiration date on 25-SEP-2018, dose, anatomical location and route not reported) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000870: US-009507513-1709USA001401: US-009507513-1710USA009268: US-009507513-1710USA009269: US-009507513-1710USA009270:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 22-AUG-2017, the patient was vaccinated with improperly stored  PROQUAD injection (lot # N010247 with expiration date on 25-SEP-2018, dose, anatomical location and route not reported) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000870: US-009507513-1710USA009270: US-009507513-1710USA009267: US-009507513-1709USA001401: US-009507513-1710USA009269:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 24-AUG-2017, the patient was vaccinated with improperly stored PROQUAD injection (lot # N010247 with expiration date on 25-SEP-2018, dose, anatomical location and route not reported) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000870: US-009507513-1710USA009270: US-009507513-1710USA009268: US-009507513-1710USA009267: US-009507513-1709USA001401:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored PROQUAD injection (lot # N010247 with expiration date on 25-SEP-2018, dose, anatomical location and route not reported) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000870: US-009507513-1709USA001401: US-009507513-1710USA009267: US-009507513-1710USA009268: US-009507513-1710USA009269.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Anal incontinence, Asthma, Chest pain, Condition aggravated, Cough
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of sickness in a 61-year-old female patient who received Flu Seasonal QIV Dresden. The patient's past medical history included immunocompromised. Previously administered products included oral steroids. Concurrent medical conditions included asthma. Concomitant products included TUMS, Vitamin B12, Vitamin D3, Aspirin, ibuprofen, Levothyroxine, omeprazole, Montelukast, ALLEGRA, biotin, COMBIVENT, DYMISTA, ESTRACE, MUCINEX DM, SPIRIVA, SYMBICORT, ZOLOFT, ALBUTEROL Nebulizer, ATROVENT Nebulizer, Calcium Chews, epinephrine and hydrochlorothiazide. On 2nd October 2017, the patient received Influenza vaccine (intramuscular). On 3rd October 2017, 1 days after receiving Influenza vaccine, the patient experienced sickness (serious criteria life threatening), wheezing (serious criteria life threatening), asthma aggravated (serious criteria life threatening), sleep loss (serious criteria life threatening), urination involuntary (serious criteria life threatening), fecal incontinence (serious criteria life threatening), headache (serious criteria life threatening), chest pain (serious criteria life threatening), cough (serious criteria life threatening) and vomiting (serious criteria life threatening). In October 2017, the patient experienced sleeplessness. On an unknown date, the outcome of the sickness, wheezing, asthma aggravated, sleep loss, urination involuntary, fecal incontinence, headache, chest pain, cough and vomiting were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved. The reporter considered the sickness, wheezing, asthma aggravated and cough to be probably related to Influenza vaccine. It was unknown if the reporter considered the sleep loss, urination involuntary, fecal incontinence, headache, chest pain, vomiting and sleeplessness to be related to Influenza vaccine. Additional details were provided as follows: The patient was a nurse. The brand name of flu vaccine was unknown. The patient was sick since then, further described as asthma exacerbations. The patient also attributes these exacerbations to being immunocompromised and to discontinued oral steroids. Due to these exacerbations, the patient was wheezing and coughing. The patient's coughing causes her to throw up and to pee and poop on herself. Less than a month after receiving Influenza vaccine, the patient was not slept in three days. The coughing also causing her head to hurt and chest to hurt. The patient felt like she was coughing so hard or so much that she could cause a stroke (stated in reference to her head hurting). The patient felt like these events were life-threatening and was on the verge of going to the emergency room or hospital. The patient was calling regarding a question on NUCALA. NUCALA was prescribed, but not started. The patient's prescriber wants her to receive a flu vaccine and the shingles  vaccine prior to starting NUCALA.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Insomnia, Malaise, Urinary incontinence, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of sickness in a 61-year-old female patient who received Flu Seasonal QIV Dresden. The patient's past medical history included immunocompromised. Previously administered products included oral steroids. Concurrent medical conditions included asthma. Concomitant products included TUMS, Vitamin B12, Vitamin D3, Aspirin, ibuprofen, Levothyroxine, omeprazole, Montelukast, ALLEGRA, biotin, COMBIVENT, DYMISTA, ESTRACE, MUCINEX DM, SPIRIVA, SYMBICORT, ZOLOFT, ALBUTEROL Nebulizer, ATROVENT Nebulizer, Calcium Chews, epinephrine and hydrochlorothiazide. On 2nd October 2017, the patient received Influenza vaccine (intramuscular). On 3rd October 2017, 1 days after receiving Influenza vaccine, the patient experienced sickness (serious criteria life threatening), wheezing (serious criteria life threatening), asthma aggravated (serious criteria life threatening), sleep loss (serious criteria life threatening), urination involuntary (serious criteria life threatening), fecal incontinence (serious criteria life threatening), headache (serious criteria life threatening), chest pain (serious criteria life threatening), cough (serious criteria life threatening) and vomiting (serious criteria life threatening). In October 2017, the patient experienced sleeplessness. On an unknown date, the outcome of the sickness, wheezing, asthma aggravated, sleep loss, urination involuntary, fecal incontinence, headache, chest pain, cough and vomiting were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved. The reporter considered the sickness, wheezing, asthma aggravated and cough to be probably related to Influenza vaccine. It was unknown if the reporter considered the sleep loss, urination involuntary, fecal incontinence, headache, chest pain, vomiting and sleeplessness to be related to Influenza vaccine. Additional details were provided as follows: The patient was a nurse. The brand name of flu vaccine was unknown. The patient was sick since then, further described as asthma exacerbations. The patient also attributes these exacerbations to being immunocompromised and to discontinued oral steroids. Due to these exacerbations, the patient was wheezing and coughing. The patient's coughing causes her to throw up and to pee and poop on herself. Less than a month after receiving Influenza vaccine, the patient was not slept in three days. The coughing also causing her head to hurt and chest to hurt. The patient felt like she was coughing so hard or so much that she could cause a stroke (stated in reference to her head hurting). The patient felt like these events were life-threatening and was on the verge of going to the emergency room or hospital. The patient was calling regarding a question on NUCALA. NUCALA was prescribed, but not started. The patient's prescriber wants her to receive a flu vaccine and the shingles  vaccine prior to starting NUCALA.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of sickness in a 61-year-old female patient who received Flu Seasonal QIV Dresden. The patient's past medical history included immunocompromised. Previously administered products included oral steroids. Concurrent medical conditions included asthma. Concomitant products included TUMS, Vitamin B12, Vitamin D3, Aspirin, ibuprofen, Levothyroxine, omeprazole, Montelukast, ALLEGRA, biotin, COMBIVENT, DYMISTA, ESTRACE, MUCINEX DM, SPIRIVA, SYMBICORT, ZOLOFT, ALBUTEROL Nebulizer, ATROVENT Nebulizer, Calcium Chews, epinephrine and hydrochlorothiazide. On 2nd October 2017, the patient received Influenza vaccine (intramuscular). On 3rd October 2017, 1 days after receiving Influenza vaccine, the patient experienced sickness (serious criteria life threatening), wheezing (serious criteria life threatening), asthma aggravated (serious criteria life threatening), sleep loss (serious criteria life threatening), urination involuntary (serious criteria life threatening), fecal incontinence (serious criteria life threatening), headache (serious criteria life threatening), chest pain (serious criteria life threatening), cough (serious criteria life threatening) and vomiting (serious criteria life threatening). In October 2017, the patient experienced sleeplessness. On an unknown date, the outcome of the sickness, wheezing, asthma aggravated, sleep loss, urination involuntary, fecal incontinence, headache, chest pain, cough and vomiting were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved. The reporter considered the sickness, wheezing, asthma aggravated and cough to be probably related to Influenza vaccine. It was unknown if the reporter considered the sleep loss, urination involuntary, fecal incontinence, headache, chest pain, vomiting and sleeplessness to be related to Influenza vaccine. Additional details were provided as follows: The patient was a nurse. The brand name of flu vaccine was unknown. The patient was sick since then, further described as asthma exacerbations. The patient also attributes these exacerbations to being immunocompromised and to discontinued oral steroids. Due to these exacerbations, the patient was wheezing and coughing. The patient's coughing causes her to throw up and to pee and poop on herself. Less than a month after receiving Influenza vaccine, the patient was not slept in three days. The coughing also causing her head to hurt and chest to hurt. The patient felt like she was coughing so hard or so much that she could cause a stroke (stated in reference to her head hurting). The patient felt like these events were life-threatening and was on the verge of going to the emergency room or hospital. The patient was calling regarding a question on NUCALA. NUCALA was prescribed, but not started. The patient's prescriber wants her to receive a flu vaccine and the shingles  vaccine prior to starting NUCALA.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Discomfort, Dizziness
Clinical narrative: Immediately after vaccine patient felt dizzy and felt like vomiting. She had nausea for a day after too.  He arm was in excruciating pain form day one through day 5. Advil did not take the pain away completely and she said that she felt like she had nerve damage, it hurt so much. Day 8 she had very bad pain in her stomach, gas that could not be released. This pain caused her to miss 3 days of school and on day 16 she still has the gas and loose bowels. The pain is not as severe, but still very uncomfortable. She also developed an itchy rash on her torso somewhere around day 8. She is also complaining of bad back pain on the spine, slightly below middle back.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Flatulence, Immediate post-injection reaction, Loss of personal independence in daily activities, Nausea, Nerve injury
Clinical narrative: Immediately after vaccine patient felt dizzy and felt like vomiting. She had nausea for a day after too.  He arm was in excruciating pain form day one through day 5. Advil did not take the pain away completely and she said that she felt like she had nerve damage, it hurt so much. Day 8 she had very bad pain in her stomach, gas that could not be released. This pain caused her to miss 3 days of school and on day 16 she still has the gas and loose bowels. The pain is not as severe, but still very uncomfortable. She also developed an itchy rash on her torso somewhere around day 8. She is also complaining of bad back pain on the spine, slightly below middle back.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity, Rash, Rash pruritic, Vomiting
Clinical narrative: Immediately after vaccine patient felt dizzy and felt like vomiting. She had nausea for a day after too.  He arm was in excruciating pain form day one through day 5. Advil did not take the pain away completely and she said that she felt like she had nerve damage, it hurt so much. Day 8 she had very bad pain in her stomach, gas that could not be released. This pain caused her to miss 3 days of school and on day 16 she still has the gas and loose bowels. The pain is not as severe, but still very uncomfortable. She also developed an itchy rash on her torso somewhere around day 8. She is also complaining of bad back pain on the spine, slightly below middle back.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal discomfort, Dizziness, Eructation, Flatulence, Musculoskeletal pain
Clinical narrative: Immediately after vaccine patient felt dizzy and felt like vomiting. She had nausea for a day after too.  He arm was in excruciating pain form day one through day 5. Advil did not take the pain away completely and she said that she felt like she had nerve damage, it hurt so much. Day 8 she had very bad pain in her stomach, gas that could not be released. This pain caused her to miss 3 days of school and on day 16 she still has the gas and loose bowels. The pain is not as severe, but still very uncomfortable. She also developed an itchy rash on her torso somewhere around day 8. She is also complaining of bad back pain on the spine, slightly below middle back.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Pain in extremity, Rash, Urticaria
Clinical narrative: Immediately after vaccine patient felt dizzy and felt like vomiting. She had nausea for a day after too.  He arm was in excruciating pain form day one through day 5. Advil did not take the pain away completely and she said that she felt like she had nerve damage, it hurt so much. Day 8 she had very bad pain in her stomach, gas that could not be released. This pain caused her to miss 3 days of school and on day 16 she still has the gas and loose bowels. The pain is not as severe, but still very uncomfortable. She also developed an itchy rash on her torso somewhere around day 8. She is also complaining of bad back pain on the spine, slightly below middle back.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling and redness in and around injection site. Patient called to complain of these symptoms the day after vaccination and upon follow up the next day (2 days after vaccination), the symptoms were worse. Patient was advised to seek medical attention if redness continued to expand. At this time we are unsure if patient sought medical treatment and therefore have selected  "None of the Above" in Item 21 below.