chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Erythema, Local reaction, Seizure
Clinical narrative: Local reaction with erythema and increase in seizures, baseline no seizures.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Neck pain, Nodule, Peripheral swelling
Clinical narrative: Patient is describing left arm as being red, swollen, and a large knot. She is also describing neck pain.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Severe shoulder pain, swelling, red and hot to the touch in a 5 inch radius around injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The 2 sites are very red, swollen plump and very hot to touch.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: REDNESS ON LARGE AREA OF ARM AND WARMTH.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: About 2-3 hours after receiving the vaccine, the patient noticed that her arm was sore. The area around where she received the shingles vaccine is red, and the spot where the vaccine was given is raised (about 1 mm, and 1/4 inch circle.) The patient took BENADRYL, but her arm was still sore the next couple days, and her arm still red and raised at the spot.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Myalgia, Swelling
Clinical narrative: Pt called with symptoms of chills, severe muscle pain, swelling, and a red line that started below the injection site and ran to the arm pit.
Age: 80.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started with itching the following day the warm, red and swelling currently hard at injection site; reported by patient spouse.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient received Anthrax .5ml to right deltoid. Reported feeling a burning sensation to arm. Patient reported she was feeling faint. She was assisted to chair and proceeded to have a syncope episode. Patient was assisted with floor and legs/feet were elevated. The entire episode lasted approx. 30 sec. Patient regain consciousness and was oriented to person, place and situation. Patient released back to duty and reported feeling fine. She's had a previous episode in the past while receiving an injection reportedly to have been years ago as a child.
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Continued itching, slight soreness and redness at sight after 3 weeks; slight radiating pain.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Peripheral swelling, Pruritus
Clinical narrative: Patient received vaccine on 09/08/2017 and woke up the next morning 09/09/2017 with a rash at site of infection. Several hours later that rash progressed to swelling of the right arm. Following the swelling of the arm patient began to develop pruritus in abdominal region.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dizziness, Headache, Visual impairment, Vomiting
Clinical narrative: "Major" Dizziness, headache, weakness, vision impairment, vomiting.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Patient claimed to have experienced an "ache all over the body" for 2 days after receiving the 2 vaccines. Claimed to have never experienced body aches before when receiving vaccinations.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Peripheral swelling
Clinical narrative: Patient stated her hands were swollen and she had an itchy rash around the injection site.  I advised her to take a 25mg benadryl and go to the emergency room to be checked out. I called patient at 6:15pm on 9/9 to see how she was doing and she stated that the swelling in her hands and hives had gone down. She decided not to go to the emergency room since she wasn't having trouble breathing and instead to "wait it out".  She is feeling fine now.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient claimed to have "ached all over the body for about 2 days, and has a rash+swelling+hot to the touch reaction at the injection site." Aching subsided but patient still has the rash and swelling at the injection site.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Loss of consciousness, Speech disorder, Unresponsive to stimuli, Vomiting
Clinical narrative: 2hrs after my son would not stop vomiting (when he had not vomited at all previously before this, not even the day before), He passed out and I could not wake him up (when he was a light sleeper before this shot was given and did not have issues waking up before this shot was given). He also had injection site redness. I now believe it's possible that my son may have had brain swelling after this vaccination. Today he has a severe speech delay that is not due to tongue tie... I consulted in nurses and they brushed it off. I consulted in the pediatrician (when she came to our room) as she was getting ready to sign us out of the hospital and she said to me and I quote "weird". His temp was monitored during our stay.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Lethargy, Myalgia, Nausea
Clinical narrative: Fever 100.8 (duration 7 hours despite treatment with ibuprofen), severe muscle pain, shaking chills, nausea, severe headache, lethargy (duration 7 hours). Resolved after about 9 hours.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever 100.8 (duration 7 hours despite treatment with ibuprofen), severe muscle pain, shaking chills, nausea, severe headache, lethargy (duration 7 hours). Resolved after about 9 hours.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Patient called me today and stated that she has flu-like symptoms, a fever of 102  F and arm soreness from the PNEUMOVAX 23 injection. Patient stated that it started in the middle of the night of 8/9/2017.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, warm to the touch, erythema, raised.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, raised, warm to the touch, erythema. Had patient apply BENADRYL cream and try ibuprofen.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus
Clinical narrative: Severe itching in the muscle involved in the injection site. Feels like an internal itch.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's right arm red and swollen.  She said if touched it is does hurt a bit.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Adverse event
Clinical narrative: Will bring in all discharge papers. Patient hospitalized after emergency room visit 8/31/17. Given antibiotic therapy 9/9/17.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Injection site irritation, redness and swelling, itching and tenderness.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Gave both FLUAD and PNEUMOVAX 23 in left arm muscle deltoid and it swelled and was red.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Psoriasis, Rash
Clinical narrative: Rash, itching legs and arms. Patient states "he had a sea salt soak" for psoriasis the day after FLUZONE vac.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: A few hours after receiving vaccine the patient experienced edema around elbow. Patient reported adverse effect to me 3 days later and I counseled him on the options. Patient decided to go to emergency room and was given antihistamines for the reaction. Shortly after, patient's adverse effect resolved.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red circle, 3 inches in diameter, warm to touch, a bit swollen, itches occasionally.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Activated partial thromboplastin time normal, Anti-cyclic citrullinated peptide antibody negative, Anti-thyroid antibody, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative
Clinical narrative: Henoch-Schonlein autoimmune purpura appeared the morning of August 15, 2017. The purpura was located on both calves just above the inside of both ankles (photographs available). The purpura resolved over a two week period after an extremely itchy period.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: C-reactive protein normal, Cardiolipin antibody negative, Complement factor C3, Complement factor normal, Double stranded DNA antibody
Clinical narrative: Henoch-Schonlein autoimmune purpura appeared the morning of August 15, 2017. The purpura was located on both calves just above the inside of both ankles (photographs available). The purpura resolved over a two week period after an extremely itchy period.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Full blood count normal, Henoch-Schonlein purpura, Hepatitis C test negative, Histone antibody negative, Metabolic function test normal
Clinical narrative: Henoch-Schonlein autoimmune purpura appeared the morning of August 15, 2017. The purpura was located on both calves just above the inside of both ankles (photographs available). The purpura resolved over a two week period after an extremely itchy period.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Prothrombin time normal, Pruritus, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Smooth muscle antibody negative
Clinical narrative: Henoch-Schonlein autoimmune purpura appeared the morning of August 15, 2017. The purpura was located on both calves just above the inside of both ankles (photographs available). The purpura resolved over a two week period after an extremely itchy period.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Injection site sore. Muscular aches moderate pain #4...#5.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called the pharmacy and let me know her arm was red, warm, and swollen but not very painful.
Age: 82.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash generalised
Clinical narrative: Patient developed body rash  the next day (Saturday) and went to the doctor on the next Monday.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Insomnia, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Swollen and painful upper arm (continuing today 9/10) difficulty raising arm. Muscle aches "flu-like" experience, with sleepless night (9/8). Continued muscle aches, diminishing on 9/9.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen and painful upper arm (continuing today 9/10) difficulty raising arm. Muscle aches "flu-like" experience, with sleepless night (9/8). Continued muscle aches, diminishing on 9/9.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Skin warm
Clinical narrative: Patient noticed some warmth at 1530 and took of jacket to see arm.Patient noticed that there was a red area about the size of a half dollar. In the morning of 09/10/2017 patient noticed area had increased by .5 cm so came to clinic. Patient was assessed by Nurse and PA.  Lungs, clear, VS Stable. Patient going on a 45 min flight home. Patient given an epi pen and 50 mg of Benadryl as a precaution.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Erythema, Nodule, Swelling
Clinical narrative: Redness, swelling (baseball size redness on right arm, with nodule of swelling on underarm as well; smaller swelling and redness on left arm). Patient went to emergency room on the evening of 9/9, approximately 48 hours after the injections. Emergency room physician prescribed cephalexin and pain medication and patient reported that the doctor told her it was a cellulitis.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site bruising, Joint range of motion decreased, Joint swelling, Nausea
Clinical narrative: Pt reported to pharmacy approx. 48 hours after vaccines administered. She reported swelling, redness, hot to the touch, from shoulder to wrist. There was bruising at injection site and pt. reported experiencing nausea the day after vaccines were administered. Elbow was extremely swollen and red and she did not have full range of motion of elbow joint. Pt. had been taking Ibuprofen along with ice therapy. Pharmacist advised to take Benadryl in addition to Ibuprofen and if no improvement within 48 hours to report to PCP.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt reported to pharmacy approx. 48 hours after vaccines administered. She reported swelling, redness, hot to the touch, from shoulder to wrist. There was bruising at injection site and pt. reported experiencing nausea the day after vaccines were administered. Elbow was extremely swollen and red and she did not have full range of motion of elbow joint. Pt. had been taking Ibuprofen along with ice therapy. Pharmacist advised to take Benadryl in addition to Ibuprofen and if no improvement within 48 hours to report to PCP.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Pharyngeal oedema
Clinical narrative: Patient states several hours after immunization, she began to experience chest tightness, throat swelling and difficulty breathing. Her family member took her to the local emergency department for treatment. I spoke to the patient the next day and there were no long term adverse effects at the time.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt called pharmacy Sat 9/9 and stated that the vaccine made her arm sore and was red and hot. I told her to put ice on the site and take BENADRYL. She came into the pharmacy on 9/10 to show me her arm. Her arm was very red and very swollen. She said it hurt to move any part of her arm and it was still hot. I suggested that she go see MD about it. Was worse and looked as if it was spreading past her elbow down. She came back with a prescription for clindamycin from the hospital ER.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient states that she was feeling fine during and day vaccination was given. Later on the next day she felt the injection site was warm to touch and was risen. It was red and swollen. Took BENADRYL to ease the swelling and redness.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: PT REQUIRED TO RECEIVE BOTH VACCINES IN RIGHT ARM D/T PREVIOUS MEDICAL CONDITION. PT PRESENTED TO PHARMACY WITH SWELLING FROM BELOW INJECTION SITE TO ELBOW ON INNERSIDE OF RIGHT ARM. PT TOOK BENADRYL AND THE SWELLING DECREASED.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain
Clinical narrative: Excruciating pain - abduction extremely painful - seen a doctor 8/31 - neuropathic pain - know that she hit nerve - but not sure how much damage.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Injection site erythema, Pyrexia
Clinical narrative: Pt started feeling bad on 9/10/2017 around 3pm in the afternoon. Has experienced fever of 101.7 headache, and has redness at site of injection. Advised to go to ER if not feeling better and she said she would keep me informed.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pruritus, Rash, Swelling
Clinical narrative: Patient came in on 9/10/17 and stated she had itching, minor swelling, minor rash, and tiredness after receiving the Tdap vaccine. She took over the counter allergy medication and said that it helped and today was the first day she felt better.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Gave patient a shot on 9/8/17 at 11:22am (right deltoid); patient called and reported on 9/10/17 at 10am; patient had stiff neck/ pain, can not turn her head either left or right; no swelling or pain at injection site; no arm or shoulder pain.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness at sight of injection spreading approximately 3 inches down back of arm with warm sensation and tenderness at sight of injection.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Patient complained of itching, redness. Took Benadryl and it improved. Still had symptoms for over a week, said it wasn't improving and still red and swollen and sore. Recommended seeing a physician incase area was infected. Haven't heard from patient to see if she did see someone.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Diarrhoea, Irritability, Rash
Clinical narrative: Fussiness for 4-5 hours beginning at time mentioned previously. Rash on torso-no new soaps, detergents or foods were introduced: still present at time of report. Loose stools.
Age: 1.0
Sex: F
Vaccine: FLUX, MMR, UNK, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash generalised
Clinical narrative: Fever on night of vaccines (9/1/2017). Rash and fever 10 days later (9/10/2017). Rash started on inner thigh, belly button, and chin...in 4 hours had spread to legs, face, eyelid...12 hours in was everywhere and she was running a fever of 102 F.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient was given vaccination around 11:30am and then returned to work. Approximately 1:00, a co-worker came to notify me that an employee was having a "bad reaction." Patient had red, swollen head, neck and chest area and complained of terrible itching in those areas. Patient had already taken 50mg of Benadryl as I walked up. I advised to call 911. Had an Epi-Pen, but didn't feel patient's status required epinephrine at that point. Patient was monitored for the next 30 minutes, with gradual improvement back to normal. Patient stated an allergy to shelf fish.
Age: 62.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Burning sensation, Rash vesicular
Clinical narrative: Patient is complaining of a shingles like rash on his left rib cage. He states that it is burning.
Age: 54.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient developed a large bubble or welt at injection site area - sore, sensitive, burning - developed into soreness on entire upper arm; patient was monitored for 30 mins but did not receive tx - counseled to go to ER if needed.
Age: 54.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Injection site vesicles, Pain in extremity, Urticaria
Clinical narrative: Patient developed a large bubble or welt at injection site area - sore, sensitive, burning - developed into soreness on entire upper arm; patient was monitored for 30 mins but did not receive tx - counseled to go to ER if needed.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 9/8/17-evening injection site hurt and was red, morning 9/9/17 Bicep area below injection site red. Swollen and painful. Pt used ADVIL, Ice and ARNICARE gel no relief. 9/10/17 came to pharmacy recommended adding BENADRYL to ADVIL and Ice if not better for her to see doctor Monday 9/11.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Tremor
Clinical narrative: While patient watched his brother get his vaccine, approximately 4-5 min after his own shots, he fell back and seemed to pass out with eyes open and unusual shaking. Lasted 3-4 seconds.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: A bump appeared next to the injection site which quickly disappeared. Called manufacturers. Pt. doing fine.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site warmth, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Pt complained of pain and rash and swelling in all upper arm right side. She experienced red and hot rash underneath the injection site. Redness and swelling lasted up to 1 week after the shot of PRVENAR13. Pt took BENADRYL. Symptoms subsided after 7 days.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Pt complained of pain and rash and swelling in all upper arm right side. She experienced red and hot rash underneath the injection site. Redness and swelling lasted up to 1 week after the shot of PRVENAR13. Pt took BENADRYL. Symptoms subsided after 7 days.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node in right groin, noticed on Saturday, 9/9/17 approximately 3pm. Tender to touch and still swollen as of 9/10/17.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pain in extremity, Peripheral swelling, X-ray limb
Clinical narrative: Pain and swelling in L arm post vaccination. Immediate care clinic visit. Took X Ray. MD said vaccine was given in the wrong place per pt. She received pain medication and had developed a cough.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Full blood count, Metabolic function test, Pyrexia, Urine analysis
Clinical narrative: Fever (103), diarrhea -4 days after vaccine. Diarrhea continued x 1 week, now loose stools.
Age: 21.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from a other source referring to a 21 years old female patient. Concurrent condition included non-smoker. Information about concomitant medication and medical history of the patient was not provided. On 12-JUL-2017 the patient was vaccinated with excursion vaccines of M-M-R II, varicella virus vaccine live (manufacturer unknown), (unspecified) TDaP and tuberculin purified protein derivative (PPD) (strength, route and lot # were not reported) for prophylaxis (Incorrect product storage and poor quality vaccine administered). This is one of 3 reports received from the same reporter. Sender's Comments: US-009507513-1709USA000698: US-009507513-1709USA000699.
Age: 21.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: Information has been received from a other source referring to a 21 years old female patient. Concurrent condition included non-smoker. Information about concomitant medication and medical history of the patient was not provided. On 12-JUL-2017 the patient was vaccinated with excursion vaccines of M-M-R II, varicella virus vaccine live (manufacturer unknown), (unspecified) TDaP and tuberculin purified protein derivative (PPD) (strength, route and lot # were not reported) for prophylaxis (Incorrect product storage and poor quality vaccine administered). This is one of 3 reports received from the same reporter. Sender's Comments: US-009507513-1709USA000698: US-009507513-1709USA000699.
Age: 25.0
Sex: M
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from a other source referring to a 25 years old male patient. Concurrent condition included non-smoker. Information about concomitant medication and medical history of the patient was not provided. On 12-JUL-2017 the patient was vaccinated with excursion vaccines of M-M-R II, varicella virus vaccine live (manufacturer unknown), TDaP and tuberculin purified protein derivative (PPD) (strength, route and lot # were not reported) for prophylaxis (Incorrect product storage and poor quality vaccine administered). This is one of 3 reports received from the same reporter. Sender's Comments: US-009507513-1708USA010246: US-009507513-1709USA000699.
Age: 25.0
Sex: M
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: Information has been received from a other source referring to a 25 years old male patient. Concurrent condition included non-smoker. Information about concomitant medication and medical history of the patient was not provided. On 12-JUL-2017 the patient was vaccinated with excursion vaccines of M-M-R II, varicella virus vaccine live (manufacturer unknown), TDaP and tuberculin purified protein derivative (PPD) (strength, route and lot # were not reported) for prophylaxis (Incorrect product storage and poor quality vaccine administered). This is one of 3 reports received from the same reporter. Sender's Comments: US-009507513-1708USA010246: US-009507513-1709USA000699.
Age: 25.0
Sex: M
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a other source referring to a 25 years old male patient. Concurrent condition included non-smoker. Information about concomitant medication and medical history of the patient was not provided. On 12-JUL-2017 the patient was vaccinated with excursion vaccines of M-M-R II, varicella virus vaccine live (manufacturer unknown), TDaP and tuberculin purified protein derivative (PPD) (strength, route and lot # were not reported) for prophylaxis (Incorrect product storage and poor quality vaccine administered). This is one of 3 reports received from the same reporter. Sender's Comments: US-009507513-1708USA010246: US-009507513-1709USA000699.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Borrelia test positive, Contusion, Immunology test, Myalgia
Clinical narrative: Initial unsolicited report received from consumer (Patient's parent) on 30-Aug-2017. This case involves a 11-year-old female patient who was vaccinated with a dose of MENACTRA (Batch number, expiration date, dose, route was not reported) in right arm on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, within several days following the vaccination, the patient experienced unusual bleeding and numbness of arms and legs. It was reported (on 30 Aug 2017) that, it has been 20 days since symptoms started and patient continues to have numbness of her right arm, which is same arm in which she received vaccination. It was reported that, the patient required emergency room visit. Lab data were not reported. Patient was treated (unspecified). The patient was not recovered from events. Upon internal review, the company decided to consider the event serious because of important medical event bleeding. List of documents held by sender: none. Sender's Comments: Patient experienced bleeding (not specified) and numbness of extremities that is continuing till date after vaccination. Time to onset seems to be compatible though the exact date of vaccination is not provided. Further information including confirmed diagnosis, patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Haemorrhage, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from consumer (Patient's parent) on 30-Aug-2017. This case involves a 11-year-old female patient who was vaccinated with a dose of MENACTRA (Batch number, expiration date, dose, route was not reported) in right arm on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, within several days following the vaccination, the patient experienced unusual bleeding and numbness of arms and legs. It was reported (on 30 Aug 2017) that, it has been 20 days since symptoms started and patient continues to have numbness of her right arm, which is same arm in which she received vaccination. It was reported that, the patient required emergency room visit. Lab data were not reported. Patient was treated (unspecified). The patient was not recovered from events. Upon internal review, the company decided to consider the event serious because of important medical event bleeding. List of documents held by sender: none. Sender's Comments: Patient experienced bleeding (not specified) and numbness of extremities that is continuing till date after vaccination. Time to onset seems to be compatible though the exact date of vaccination is not provided. Further information including confirmed diagnosis, patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Injection site swelling, Palpitations, Vaccination site pain
Clinical narrative: This spontaneous report as received from a 76 year old male patient regarding himself. The patient was not taking any concomitant medications. The patient had no pertinent medical history of drug reactions/allergies. On 29-AUG-2017 at 13:00, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiry unknown) 0.5 ml intramuscularly in his left upper arm for prophylaxis; by a pharmacist at the local pharmacy store. On the same day within 6 hours of receiving the injection, the patient reported that his left shoulder was stiff and swollen and for a short period of time he experienced heart palpitations. Approximately on 29-AUG-2017, the patient experienced pain. At midnight the patient took an 800 mg unspecified Ibuprofen tablet to reduce the pain and swelling. Approximately on 30-AUG-2017 (reported as the following morning), when the patient woke there was a small red rash about an inch or two from the injection site, which had a hard lump (about the size of a quarter) in the center (mass). The patient did not seek medical attention at the time of reporting but had an appointment with his physician on 31-AUG-2017. The outcome of musculoskeletal stiffness, pain, rash erythematous, mass and joint swelling was reported as recovering/resolving. The outcome of heart palpitations was considered recovered approximately in August 2017 as the patient experienced it for a short period of time. The causality assessment was not reported. There were no product quality complaints (PQC) involved. The patient had reported the adverse experience with Vaccine Adverse Event Reporting System (VAERS) Health and Human Services (HHS) (filed on 30-AUG-2017).
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report as received from a 76 year old male patient regarding himself. The patient was not taking any concomitant medications. The patient had no pertinent medical history of drug reactions/allergies. On 29-AUG-2017 at 13:00, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiry unknown) 0.5 ml intramuscularly in his left upper arm for prophylaxis; by a pharmacist at the local pharmacy store. On the same day within 6 hours of receiving the injection, the patient reported that his left shoulder was stiff and swollen and for a short period of time he experienced heart palpitations. Approximately on 29-AUG-2017, the patient experienced pain. At midnight the patient took an 800 mg unspecified Ibuprofen tablet to reduce the pain and swelling. Approximately on 30-AUG-2017 (reported as the following morning), when the patient woke there was a small red rash about an inch or two from the injection site, which had a hard lump (about the size of a quarter) in the center (mass). The patient did not seek medical attention at the time of reporting but had an appointment with his physician on 31-AUG-2017. The outcome of musculoskeletal stiffness, pain, rash erythematous, mass and joint swelling was reported as recovering/resolving. The outcome of heart palpitations was considered recovered approximately in August 2017 as the patient experienced it for a short period of time. The causality assessment was not reported. There were no product quality complaints (PQC) involved. The patient had reported the adverse experience with Vaccine Adverse Event Reporting System (VAERS) Health and Human Services (HHS) (filed on 30-AUG-2017).
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pain, Palpitations
Clinical narrative: This spontaneous report as received from a 76 year old male patient regarding himself. The patient was not taking any concomitant medications. The patient had no pertinent medical history of drug reactions/allergies. On 29-AUG-2017 at 13:00, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiry unknown) 0.5 ml intramuscularly in his left upper arm for prophylaxis; by a pharmacist at the local pharmacy store. On the same day within 6 hours of receiving the injection, the patient reported that his left shoulder was stiff and swollen and for a short period of time he experienced heart palpitations. Approximately on 29-AUG-2017, the patient experienced pain. At midnight the patient took an 800 mg unspecified Ibuprofen tablet to reduce the pain and swelling. Approximately on 30-AUG-2017 (reported as the following morning), when the patient woke there was a small red rash about an inch or two from the injection site, which had a hard lump (about the size of a quarter) in the center (mass). The patient did not seek medical attention at the time of reporting but had an appointment with his physician on 31-AUG-2017. The outcome of musculoskeletal stiffness, pain, rash erythematous, mass and joint swelling was reported as recovering/resolving. The outcome of heart palpitations was considered recovered approximately in August 2017 as the patient experienced it for a short period of time. The causality assessment was not reported. There were no product quality complaints (PQC) involved. The patient had reported the adverse experience with Vaccine Adverse Event Reporting System (VAERS) Health and Human Services (HHS) (filed on 30-AUG-2017).
Age: 1.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Crying, Decreased eye contact, Electroencephalogram, Eye movement disorder, Irritability
Clinical narrative: Mom reports that 1-2 days after these vaccines child started to have shortness of breath- she took her to minute clinic and O2 was normal. They did not find anything concerning on exam. She then noticed about 1wk after the vaccine that child broke out in rash which she was told by the office medical assistant at the time of vaccine administration is a common side effect from the vaccine. Child then started to have episodes a few times per day where she would have eye deviation which was assessed by neurology with normal EEG (per mom). Over the past 2-3 months mom reports today that she has concerns that child is not making eye contact, used to say "dada" and no longer does, she cries out at random times or will laugh at random times and that she "seems different". In my office child does not make good eye contact, is difficult to engage, does not use words that are understandable.
Age: 1.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Personality change, Rash, Unresponsive to stimuli
Clinical narrative: Mom reports that 1-2 days after these vaccines child started to have shortness of breath- she took her to minute clinic and O2 was normal. They did not find anything concerning on exam. She then noticed about 1wk after the vaccine that child broke out in rash which she was told by the office medical assistant at the time of vaccine administration is a common side effect from the vaccine. Child then started to have episodes a few times per day where she would have eye deviation which was assessed by neurology with normal EEG (per mom). Over the past 2-3 months mom reports today that she has concerns that child is not making eye contact, used to say "dada" and no longer does, she cries out at random times or will laugh at random times and that she "seems different". In my office child does not make good eye contact, is difficult to engage, does not use words that are understandable.
Age: 1.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Abnormal behaviour, Blood potassium increased, Crying, Decreased eye contact, Dyspnoea
Clinical narrative: Mom reports that 1-2 days after these vaccines child started to have shortness of breath- she took her to minute clinic and O2 was normal. They did not find anything concerning on exam. She then noticed about 1wk after the vaccine that child broke out in rash which she was told by the office medical assistant at the time of vaccine administration is a common side effect from the vaccine. Child then started to have episodes a few times per day where she would have eye deviation which was assessed by neurology with normal EEG (per mom). Over the past 2-3 months mom reports today that she has concerns that child is not making eye contact, used to say "dada" and no longer does, she cries out at random times or will laugh at random times and that she "seems different". In my office child does not make good eye contact, is difficult to engage, does not use words that are understandable.
Age: 1.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Electroencephalogram normal, Eye movement disorder, Full blood count, Metabolic function test, Rash
Clinical narrative: Mom reports that 1-2 days after these vaccines child started to have shortness of breath- she took her to minute clinic and O2 was normal. They did not find anything concerning on exam. She then noticed about 1wk after the vaccine that child broke out in rash which she was told by the office medical assistant at the time of vaccine administration is a common side effect from the vaccine. Child then started to have episodes a few times per day where she would have eye deviation which was assessed by neurology with normal EEG (per mom). Over the past 2-3 months mom reports today that she has concerns that child is not making eye contact, used to say "dada" and no longer does, she cries out at random times or will laugh at random times and that she "seems different". In my office child does not make good eye contact, is difficult to engage, does not use words that are understandable.
Age: 1.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Speech disorder
Clinical narrative: Mom reports that 1-2 days after these vaccines child started to have shortness of breath- she took her to minute clinic and O2 was normal. They did not find anything concerning on exam. She then noticed about 1wk after the vaccine that child broke out in rash which she was told by the office medical assistant at the time of vaccine administration is a common side effect from the vaccine. Child then started to have episodes a few times per day where she would have eye deviation which was assessed by neurology with normal EEG (per mom). Over the past 2-3 months mom reports today that she has concerns that child is not making eye contact, used to say "dada" and no longer does, she cries out at random times or will laugh at random times and that she "seems different". In my office child does not make good eye contact, is difficult to engage, does not use words that are understandable.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Blood pressure increased, Cyanosis, Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: After giving vaccines patient complaint feeling dizzy and fainted. Checked BP 129/114 checked BP 10 mins 115/77 pt waited in store for 20 mins and felt better so left.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Pallor, Posture abnormal, Syncope
Clinical narrative: After giving vaccines patient complaint feeling dizzy and fainted. Checked BP 129/114 checked BP 10 mins 115/77 pt waited in store for 20 mins and felt better so left.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Dizziness, Syncope
Clinical narrative: After giving vaccines patient complaint feeling dizzy and fainted. Checked BP 129/114 checked BP 10 mins 115/77 pt waited in store for 20 mins and felt better so left.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Crying, Dermatitis diaper, Diarrhoea, Injection site rash, Irritability
Clinical narrative: Rash noticed within an hour around injection site, on torso, back of neck and in diaper area. Slimy loose stool 6 hours later with increased crying/irritability. Fever noted by temporal thermometer at ER.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Rash noticed within an hour around injection site, on torso, back of neck and in diaper area. Slimy loose stool 6 hours later with increased crying/irritability. Fever noted by temporal thermometer at ER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site warmth, Myalgia
Clinical narrative: Fever, muscle ache, slept 2 days off and on, head ache, site of shot red and hard and hot to touch and was 6 inches long.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever, muscle ache, slept 2 days off and on, head ache, site of shot red and hard and hot to touch and was 6 inches long.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Axillary pain, Back pain, Dizziness, Fatigue
Clinical narrative: I was inoculated in the upper left arm. I felt the normal pain that comes with the booster as this is my 10th but as the day went on a pain started shooting through my arm pit and down my left leg into my knee that would start twitching. By the evening I was dizzy and extremely tired so I tried to sleep but the body aches got worse. By noon the next day the aches on my left hurt so bad that it slowed me down considerably and then the pain in my back and neck along with the headache became too much so I was escorted to the ER where I was given codeine to help with the pain and was told that it will pass and there is nothing that can be done. In 2003 I had a similar reaction while at work that no one could explain. I wasn't sick but had a temp of 105.8 and was completely delirious, the body aches and pain that I had this time were just like the ones I experienced before. Those lasted for 7 days. I was told it was a miracle I lived considering the conditions.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Muscle twitching, Neck pain, Pain, Pain in extremity
Clinical narrative: I was inoculated in the upper left arm. I felt the normal pain that comes with the booster as this is my 10th but as the day went on a pain started shooting through my arm pit and down my left leg into my knee that would start twitching. By the evening I was dizzy and extremely tired so I tried to sleep but the body aches got worse. By noon the next day the aches on my left hurt so bad that it slowed me down considerably and then the pain in my back and neck along with the headache became too much so I was escorted to the ER where I was given codeine to help with the pain and was told that it will pass and there is nothing that can be done. In 2003 I had a similar reaction while at work that no one could explain. I wasn't sick but had a temp of 105.8 and was completely delirious, the body aches and pain that I had this time were just like the ones I experienced before. Those lasted for 7 days. I was told it was a miracle I lived considering the conditions.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored dose of VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with an improperly stored dose VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.