chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Eye movement disorder, Fatigue, Full blood count, Metabolic function test, Muscle rigidity
Clinical narrative: Patient presented to the ER with mother for evaluation of possible seizure. Patient had been sleeping on mother's lap for about an hour when the child went stiff and then began to have rigid uncontrolled movements of extremities, eyes rolled back in his head, and would not respond to verbal commands. Mother stated this lasted approximately 3-4 minutes. Patient was fatigued and mildly confused after the episode. Denies any incontinence, nausea, dental/oral trauma during the incident. Mother informed the ER that child had received immunizations at office 3/27/18 and denies any history of seizures with prior immunizations. At the time of the ER visit patient was alert and per mother is at baseline. Mother also denies any recent illness, recent travel, fever, or other ill family members.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Musculoskeletal stiffness, Red blood cell sedimentation rate, Unresponsive to stimuli
Clinical narrative: Patient presented to the ER with mother for evaluation of possible seizure. Patient had been sleeping on mother's lap for about an hour when the child went stiff and then began to have rigid uncontrolled movements of extremities, eyes rolled back in his head, and would not respond to verbal commands. Mother stated this lasted approximately 3-4 minutes. Patient was fatigued and mildly confused after the episode. Denies any incontinence, nausea, dental/oral trauma during the incident. Mother informed the ER that child had received immunizations at office 3/27/18 and denies any history of seizures with prior immunizations. At the time of the ER visit patient was alert and per mother is at baseline. Mother also denies any recent illness, recent travel, fever, or other ill family members.
Age: 65.0
Sex: F
Vaccine: YF
Symptoms: Aggression, Disorientation, Laboratory test, Mania, Mental status changes
Clinical narrative: Altered mental status, began 3-20-18. Disorientation, combativeness, followed by mania.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. The reporter considered the fever to be almost certainly related to SHINGRIX. Additional information was received as follows: The patient experienced low-grade fever following administration of SHINGRIX. Additional information was not provided. The reporter stated that these incidents occurred a month before the time of reporting and he had forgotten the details at the time of reporting. The reporter did not report GSK initially, as he read in the package insert that low-grade fever was a known adverse event following SHINGRIX administration. This case has been linked to the case US2018052279, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. The reporter considered the fever to be almost certainly related to SHINGRIX. Additional information was received as follows: The patient experienced low-grade fever following administration of SHINGRIX. Additional information was not provided. The reporter stated that these incidents occurred a month before the time of reporting and he had forgotten the details at this time of reporting. The reporter did not report to GSK initially, as he read in the package insert that low-grade fever was a known adverse event following SHINGRIX administration. This case has been linked to the case US2018052280, reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Pt received vaccination 3/30/18, on 3/31/18 she called pharmacy with complaint of body aches and ache at injection site.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After receiving the vaccine that patient began to feel light headed and passed out. She said that she had never passed out after a vaccine previously but had passed out before due to unknown cause. The patient also stated that she had not ate anything yet today. She then passed out a second time.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Dysstasia, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: The patient is stating that she is having muscle and joint pain secondary to the PREVNAR 13 immunization given on 02/23/2018. She states that her shoulder is still sore, and she is having difficulty standing and moving around. The patient also shared that she suffers from Diabate Mellitus 2, COPD, osteoporosis, and weighs close to 400 lbs. She attributes the decline in mobility to the PREVNAR 13 injection.
Age: 1.5
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an 18 month old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 27-MAR-2018, the patient was vaccinated with PROQUAD, subcutaneous route (dose, frequency, anatomical location, lot # and expiration date were unknown) after receiving VARIVAX (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis, reconstituted with sterile diluent (MERCK) (lot # and expiration date were unknown). No adverse effects were reported.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 36 year old female patient. The patient did not have relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 23-MAR-2018, the patient was vaccinated with a dose of VARIVAX, 1 ml subcutaneously once, lot # N009768 and expiration date on 24-MAR-2019, for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK). On 30-MAR-2018 (also reported as "after a week later"), the patient developed a lump around the vaccination site, redness and pain. The patient did not sought medical attention, no treatment was given for the event and no lab diagnostics or studies were performed. The patient was not recovered from the events by the time of the reporting. The reporter did not assess the causal relationship between vaccination with VARIVAX and the events.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Nodule, Pain, Pain in extremity
Clinical narrative: Vax at noon. Mid day knot in arm, painful, achy. Terrible HA, nauseated, head pounding. Went to bed. No fever. Tues HA, Wed HA. Started feeling better by weekend.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: After receiving the vaccine, patient complained of itching. I examined the site and it had the appearance of a bug bite with a small raised area and redness surrounding the bump. It was difficult to tell if the redness was simply due to the patient scratching the site. The patient called later in the day and said the area was warm to touch, hard and there was redness in an oval shape approximately the size of an egg. I advised her to take a BENADRYL and to consider having her physician take a look at the site. She said she was not overly concerned and would take a BENADRYL. I called today (day after vaccine) to check on the patient and she said there was marked improvement and the site no longer itched and was not hard, but still felt a little warm to the touch.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus
Clinical narrative: After receiving the vaccine, patient complained of itching. I examined the site and it had the appearance of a bug bite with a small raised area and redness surrounding the bump. It was difficult to tell if the redness was simply due to the patient scratching the site. The patient called later in the day and said the area was warm to touch, hard and there was redness in an oval shape approximately the size of an egg. I advised her to take a BENADRYL and to consider having her physician take a look at the site. She said she was not overly concerned and would take a BENADRYL. I called today (day after vaccine) to check on the patient and she said there was marked improvement and the site no longer itched and was not hard, but still felt a little warm to the touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Mom took pictures of rash to L and R thighs. Rash appears to be a solid red circle slightly lower than the injection sight. Injection sight appears bruised with a small red dot over puncture site. Mom states injection site was raised and was hot to touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nodule, Pain in extremity, Swelling
Clinical narrative: Patient reports receiving the 1st vaccination of a 2 part series of SHINGRIX on 3/28/18 at 11.00 am. Patient states that at 6:00 pm she started experiencing the following typical Adverse Events: Redness, Soreness and Swelling. Patient states that what concerned her were the following Adverse Events: Chills that were uncontrollable (3/28/18 night) and a knot, swelling and pain in her left arm that lasted for 5 days (3/28/18-4/2/18). Patient also states that she was very fatigued for "a few days" after the vaccination. Patient states that she called the Pharmacy on 3/29/18 and the pharmacist recommended she take TYLENOL 500mg twice a day which helped her pain. On 3/31/18 patient came in to the pharmacy to be assessed by the pharmacist. By Monday 4/2/18, patient states that she was back to normal with no redness, swelling or pain.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Jaundice neonatal, Laboratory test
Clinical narrative: Jaundice, causing a prolonged hospital stay.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Partial vaccine give. Vaccine not mixed.
Age: 0.42
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given a pediatric dose of Hep A at 5 months of age.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Muscular weakness, Nausea
Clinical narrative: Patient had joint and muscle weakness within a few hours of receiving vaccine. He stated his joints felt like they were on fire. By the evening he was running a fever and had difficulty walking and standing. He also had nausea and vomiting. Symptoms resolved within approximately 24 hours from time they started.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient had joint and muscle weakness within a few hours of receiving vaccine. He stated his joints felt like they were on fire. By the evening he was running a fever and had difficulty walking and standing. He also had nausea and vomiting. Symptoms resolved within approximately 24 hours from time they started.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling abnormal, Pruritus, Rash, Rash pruritic
Clinical narrative: Patient/Parent report 3-4 hours after first HPV 9 injection patient developed a pruritic rash located on his forehead which then spread to his ears and behind his ears. Later in the evening, complained his throat "felt different" when swallowing but not swollen, no tongue involvement, no cough or vomiting. Woke this morning with rash on his back and continued rash on forehead and ears. Patient also c/o his buttocks was itchy but no rash noted. Patient was given BENADRYL this morning before assessment and parent noticed some fading. No rash at injection site.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient received a lower dose recommended for age.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: Patient presented 8 days after vaccination with a bruise on her left arm about the size of a quarter and below the bruise about one or 2 inches there was a red, warm, slightly raised area also about the size of a quarter. Patient was advised to follow up with her primary care physician since the area was warm to the touch. Patient said she just noticed the area 4/3/18 but assumed it came up yesterday 4/2/18. Patient told me her doctor told her to report in the morning (4/4/18) if there was any change to the area and they would go from there. At the time of this report the patient has not gone for an office visit because of the adverse reaction.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Altered state of consciousness, Blood pressure increased, Chills, Pallor
Clinical narrative: At approx. 1100 PT was evaluated, cleared for and received both anthrax and typhoid vaccinations in the right deltoid muscle. No immediate issue was noticed, PT was sent to wait in another area with others to wait for a provider. At approx. 1130 it was noticed that patient may be losing consciousness by a coworker and a medic was notified. PT was immediately moved to a nearby stretcher and joined by an LVN, the Immuz acting clinical staff. PT was found to be AOx3, GCS15 but had a graying pallor and stated he felt as though he was passing out. PT was moved to a private room where his VS were taken and found to be WNL, (144/87 HR91 spo2 RR20 100RA) but elevated compared to his pre immunization state (132/84 HR69). PT began shivering and degrading emotionally to a near panic stating he was cold and could not breath. NP was notified and saw the PT. PT reveled to the NP he had had seizures in high school and had a HX of substance abuse. NP decided to have the PT transported to the main ED via EMS. EMS was notified by staff member. PT was transported via EMS to ED.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 30-MAR-2018, the patient inadvertently received an expired dose of ZOSTAVAX 19400 PFU, lot# N011366 with expiry date of 12-MAR-2018 subcutaneously for prophylaxis. The vaccine was reconstituted with sterile diluent lot# N006324 with expiry date of 24-JUL-2019. No adverse effect was reported. No product quality complaint was reported.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Hepatitis B component was given in the PEDIARIX dose as well as an additional Hepatitis B single antigen dose within the same time frame on the same day. No reported adverse effects from vaccination. Infant without S/S reaction.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left upper extremity reveals 10 cm area of erythema, warmth and significant tenderness. Hard to the touch. Cephalexin 500 MG Cap, take one capsule by mouth four times daily for 10 days. No further reports from patient.
Age: 0.42
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Condition aggravated, Crying, Dyskinesia, Electroencephalogram normal, Emotional distress
Clinical narrative: Fever, 101. Red in face. Could not be consoled for 3 plus hours and extreme fussiness for 3 days. Seizure like reaction - no control thrashing head forward beginning 2 to 3 hours after shot and getting worse next 2 days. Continued for 3 to 4 weeks. Caught on video. Arching back for 3 weeks where hard to sit up straight after vaccine. Same thing happened with extreme stiffness and back arching with dTaP and PREVNAR 13 given on 11/15/2017 for 3 weeks after. These vaccines also had side effects of not being able to console him for 3 plus hours, red in face, and high pitched cry. With dTaP and PREVNAR, his breathing also got worse, and his laryngomalacia symptoms were worse during the first night to 4 to 5 days after the vaccines.
Age: 0.42
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Erythema, Infantile back arching, Irritability, Laryngomalacia, Musculoskeletal stiffness
Clinical narrative: Fever, 101. Red in face. Could not be consoled for 3 plus hours and extreme fussiness for 3 days. Seizure like reaction - no control thrashing head forward beginning 2 to 3 hours after shot and getting worse next 2 days. Continued for 3 to 4 weeks. Caught on video. Arching back for 3 weeks where hard to sit up straight after vaccine. Same thing happened with extreme stiffness and back arching with dTaP and PREVNAR 13 given on 11/15/2017 for 3 weeks after. These vaccines also had side effects of not being able to console him for 3 plus hours, red in face, and high pitched cry. With dTaP and PREVNAR, his breathing also got worse, and his laryngomalacia symptoms were worse during the first night to 4 to 5 days after the vaccines.
Age: 0.42
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Pyrexia, Respiration abnormal, Seizure like phenomena
Clinical narrative: Fever, 101. Red in face. Could not be consoled for 3 plus hours and extreme fussiness for 3 days. Seizure like reaction - no control thrashing head forward beginning 2 to 3 hours after shot and getting worse next 2 days. Continued for 3 to 4 weeks. Caught on video. Arching back for 3 weeks where hard to sit up straight after vaccine. Same thing happened with extreme stiffness and back arching with dTaP and PREVNAR 13 given on 11/15/2017 for 3 weeks after. These vaccines also had side effects of not being able to console him for 3 plus hours, red in face, and high pitched cry. With dTaP and PREVNAR, his breathing also got worse, and his laryngomalacia symptoms were worse during the first night to 4 to 5 days after the vaccines.
Age: 0.42
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Condition aggravated, Crying, Developmental delay, Laryngomalacia, Muscle rigidity
Clinical narrative: Fever, 101. Red in face. Could not be consoled for 3 plus hours and extreme fussiness for 3 days. Seizure like reaction - no control thrashing head forward beginning 2 to 3 hours after shot and getting worse next 2 days. Continued for 3 to 4 weeks. Caught on video. Arching back for 3 weeks where hard to sit up straight after vaccine. Same thing happened with extreme stiffness and back arching with dTaP and PREVNAR 13 given on 11/15/2017 for 3 weeks after. These vaccines also had side effects of not being able to console him for 3 plus hours, red in face, and high pitched cry. With dTaP and PREVNAR, his breathing also got worse, and his laryngomalacia symptoms were worse during the first night to 4 to 5 days after the vaccines.
Age: 0.42
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Pyrexia, Respiration abnormal, Screaming
Clinical narrative: Fever, 101. Red in face. Could not be consoled for 3 plus hours and extreme fussiness for 3 days. Seizure like reaction - no control thrashing head forward beginning 2 to 3 hours after shot and getting worse next 2 days. Continued for 3 to 4 weeks. Caught on video. Arching back for 3 weeks where hard to sit up straight after vaccine. Same thing happened with extreme stiffness and back arching with dTaP and PREVNAR 13 given on 11/15/2017 for 3 weeks after. These vaccines also had side effects of not being able to console him for 3 plus hours, red in face, and high pitched cry. With dTaP and PREVNAR, his breathing also got worse, and his laryngomalacia symptoms were worse during the first night to 4 to 5 days after the vaccines.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Face injury, Fall, Pallor, Skin abrasion, Unresponsive to stimuli
Clinical narrative: AFTER BEING SCREENING, CLEARED AND RECIEVING BOTH STANDARD ANTHRAX AND TYPHOID IM VACCINES IN THE L ARM, PT, PROCEDED TO THE CHECKOUT SECTION WHERE HE LOST COLOR AND STOP RESPONDING TO VOICE. MEDIC! WAS CALLED BUT THE PT FELL TO THE FLOOR STRIKING THE L SIDE OF HIS FACE IN THE PROCESS. UPON TOUCHING THE PTS BACK AND CALLING HIS NAME HE JUMPED UP TO HIS KNEES. A .25 CM ABRASION WAS NOTED ON THE L BROW, NO DEFORMITY, EDEMA OR DISCOLORATION EVIDENT. PT WAS AOX3 GCS15. PT WAS GUIDED TO A WAITING STRETCHER AND TAKEN TO PRIVATE ROOM WERE HE WAS EXAMINED BY PA AND FOUND TO BE STABLE. VSS WNL. PT WAS RELEASED WITH THE INSTRUCTIONS TO PROCEED TO THE ED IF HIS SYMPTOMS WORSEN. NO FURTHER ISSUE WAS REPORTED.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient received a lower dose than recommended for patient's age.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Pain in extremity, Rash, Swelling
Clinical narrative: On 3/30/18 (Friday) patient received PNEUMOVAX 23 (NDC 00006-48-3703) in her left arm. She has no history of having adverse reactions to vaccines. She called in today (4/3/18 Tuesday) stating that Friday night after receiving the vaccine she had a some pain in her arm. And woke up saturday morning with a large rash. The rash turned into huge welts, she said approximately the size of baseballs that were warm to touch and covered from the site of the injection down to her elbow. She states she called the emergency room who recommended she use Benadryl and a heating pad to help bring down the welts. She says she did that and is doing much better, that the rash is much better, but she wanted to call and tell us as an FYI. She said she would have called sooner but she was busy this weekend with family over visiting. I told her that it was recommended to see her doctor in the event that the area was infected, but she was sure that the swelling had gone down to a place she was comfortable with. I told her we would report it to VAERS and let her doctor know. She said she has an appointment with her doctor Thursday for a wellness check and would be letting her doctor know when she sees him.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: On 3/30/18 (Friday) patient received PNEUMOVAX 23 (NDC 00006-48-3703) in her left arm. She has no history of having adverse reactions to vaccines. She called in today (4/3/18 Tuesday) stating that Friday night after receiving the vaccine she had a some pain in her arm. And woke up saturday morning with a large rash. The rash turned into huge welts, she said approximately the size of baseballs that were warm to touch and covered from the site of the injection down to her elbow. She states she called the emergency room who recommended she use Benadryl and a heating pad to help bring down the welts. She says she did that and is doing much better, that the rash is much better, but she wanted to call and tell us as an FYI. She said she would have called sooner but she was busy this weekend with family over visiting. I told her that it was recommended to see her doctor in the event that the area was infected, but she was sure that the swelling had gone down to a place she was comfortable with. I told her we would report it to VAERS and let her doctor know. She said she has an appointment with her doctor Thursday for a wellness check and would be letting her doctor know when she sees him.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Atrial fibrillation, Cardiac monitoring normal, Electrocardiogram abnormal, Fatigue
Clinical narrative: I received an EKG on 14 March 2018 at 3:30PM at the Medical Clinic. I had the SHINGRIX shot at about 3:45PM. The following day I had an EKG at my cardiologists office, on 15 March 2018 at 9:15AM. The EKG showed that I had a very rapid heartbeat and I had Atrial Fibrillation. Since I had no historical record of AFib, I had a portable Zywie Heart Monitor attached to my chest for 1 week. The monitor showed that my heart had gone back to normal by 16 March 2018. Other side effects included pimples and very minor rashes. I was very tired for 3 days after the shot.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Rash
Clinical narrative: I received an EKG on 14 March 2018 at 3:30PM at the Medical Clinic. I had the SHINGRIX shot at about 3:45PM. The following day I had an EKG at my cardiologists office, on 15 March 2018 at 9:15AM. The EKG showed that I had a very rapid heartbeat and I had Atrial Fibrillation. Since I had no historical record of AFib, I had a portable Zywie Heart Monitor attached to my chest for 1 week. The monitor showed that my heart had gone back to normal by 16 March 2018. Other side effects included pimples and very minor rashes. I was very tired for 3 days after the shot.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed a 3 inX6 in rash approximately 12 hours after immunization. Rash is raised, red, and painful with no pustules present. Patient was advised to monitor for increased pain, fever, headache.  Patient was also advised to take antihistamines, ibuprofen, and topical corticosteroid to manage symptoms. We will follow up with patient in 3 days.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest X-ray, Cough, Dizziness, Endoscopy upper gastrointestinal tract
Clinical narrative: Patient reported raised rash at site of the injection on 3/7/18 which she states began 3/6. She took Benadryl and applied ice but the rash quickly spread down her arm and her throat felt tingling/burning/and scratchy and evolved into a persistent cough. She walked into the ED at 5pm on 3/7 and then c/o feeling dizzy, weak, and vertigo also. Patient also had a PPD placed on the left forearm 2/12/18 and again on 2/17/18.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash, Pharyngeal paraesthesia, Rash, Throat irritation, Vertigo
Clinical narrative: Patient reported raised rash at site of the injection on 3/7/18 which she states began 3/6. She took Benadryl and applied ice but the rash quickly spread down her arm and her throat felt tingling/burning/and scratchy and evolved into a persistent cough. She walked into the ED at 5pm on 3/7 and then c/o feeling dizzy, weak, and vertigo also. Patient also had a PPD placed on the left forearm 2/12/18 and again on 2/17/18.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Allergy test, Crying, Eye swelling, Eyelid ptosis, Face oedema
Clinical narrative: Hives (Urticaria) within 12 hrs initial onset. Developed into full body hives within 48 hrs and left sided facial swelling, eye swelling ptosis. Was given 4ml doses of BENADRYL 6 hrs apart. Patient was admitted to Hospital on 3/30/18 at approximately 10:30 pm by parents transport. Increased facial edema, tachycardia +, crying and increased fussiness present. Patient was given a EPIPEN (epinephrine shot) and 2 injections of DECADRON. Released from ER around 1am. Returned the following morning 3/31/18 due to lip swelling and increased hives. Not responding well to BENADRYL. New prescription of ZANTAC and increased frequency of BENADRYL given. Following morning 4/1/18 increased hives but no facial swelling. Symptoms began to dissipate on 4/2/18 and was cleared on 4/3/18. Saw pediatrician who stated it was OK to stop medications and ordered allergy specialist apt.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Lip swelling, Skin test, Swelling face, Tachycardia
Clinical narrative: Hives (Urticaria) within 12 hrs initial onset. Developed into full body hives within 48 hrs and left sided facial swelling, eye swelling ptosis. Was given 4ml doses of BENADRYL 6 hrs apart. Patient was admitted to Hospital on 3/30/18 at approximately 10:30 pm by parents transport. Increased facial edema, tachycardia +, crying and increased fussiness present. Patient was given a EPIPEN (epinephrine shot) and 2 injections of DECADRON. Released from ER around 1am. Returned the following morning 3/31/18 due to lip swelling and increased hives. Not responding well to BENADRYL. New prescription of ZANTAC and increased frequency of BENADRYL given. Following morning 4/1/18 increased hives but no facial swelling. Symptoms began to dissipate on 4/2/18 and was cleared on 4/3/18. Saw pediatrician who stated it was OK to stop medications and ordered allergy specialist apt.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Hives (Urticaria) within 12 hrs initial onset. Developed into full body hives within 48 hrs and left sided facial swelling, eye swelling ptosis. Was given 4ml doses of BENADRYL 6 hrs apart. Patient was admitted to Hospital on 3/30/18 at approximately 10:30 pm by parents transport. Increased facial edema, tachycardia +, crying and increased fussiness present. Patient was given a EPIPEN (epinephrine shot) and 2 injections of DECADRON. Released from ER around 1am. Returned the following morning 3/31/18 due to lip swelling and increased hives. Not responding well to BENADRYL. New prescription of ZANTAC and increased frequency of BENADRYL given. Following morning 4/1/18 increased hives but no facial swelling. Symptoms began to dissipate on 4/2/18 and was cleared on 4/3/18. Saw pediatrician who stated it was OK to stop medications and ordered allergy specialist apt.
Age: 64.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: On Saturday 3/31/18 patient received 4 vaccines in our pharmacy. In her left arm she received ENGERIX B (NDC 58160-0821-43) and SHINGRIX (NDC 58160-0828-03) - ENGERIX B was upper and SHINGRIX was lower. In her right arm she received HAVRIX (NDC 58160-0826-43) and BOOSTRIX (NDC 58160-0842-43) - HAVRIX was lower and BOOSTRIX was upper. Today 4/3/18 (Tuesday) patient came in with swelling and redness in her left arm. She said that Saturday the swelling was much more severe and red. She states that it is warm to touch and itches really bad. She wanted to know what she should do. I recommended OTC therapy to help with symptoms but recommend she see her PCP in the event that it is infected. She said she would try the OTC therapy and if symptoms did not continue to get better she would see her doctor. She said she was a wellness check next Monday she would talk to her doctor then. I told her we would also be contacting her doctor to let her know.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching of area surrounding injection site, approx. 2"x 4".
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Burning sensation, Herpes zoster, Paraesthesia, Rash
Clinical narrative: Patient reported to pharmacy on 4/2/18 she saw her physician on 3/31/18 for shingles-like symptoms. She reported a burning/tingling sensation accompanied by a rash on her right leg. Physician prescribed an anti-viral. Vaccines were administered on 3/24/18.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt completed SMALLPOX vaccination screening form, marked "NO" to #9 (Could YOU or someone you LIVE WITH be pregnant?), as well as "FOR FEMALES ONLY" If you might be pregnant, or likely to become pregnant, please tell us. You may need additional pregnancy testing. 18a. First day of last menstrual period (2018/03/25) 18b. Was your last menstrual period normal and on time? "YES".  Following vaccination earlier in the day, pt proceeded to take a home pregnancy test, which was positive, then reported to the Medical Center ER for confirmation, which was positive. ER referred pt to OB the following day for further evaluation and care. Unclear dates of pregnancy (pt reported on screening questionnaire 3/25/2018 at LMP, but reported "2 weeks ago" to the ER). Other information regarding pregnancy are not available at this time, pt will be following up closely with OB.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Few hours after vaccine given developed severe headache and swelling to lymph node behind (L) ear.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain of skin, Pyrexia
Clinical narrative: Extreme fatigue, fever and headache lasting 24 hours Day 2 painful skin surface under left breast and lt ribcage painful which lasted for 5 days. Pt stated "I felt like I had the flu 10 timesover."
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Bacterial infection, Cellulitis, Chills, Dehydration, Headache
Clinical narrative: Dehydration, swelling, shivers, headache by 7am on next day, illness. Cellulitis from Bacterial infection.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Swelling
Clinical narrative: Dehydration, swelling, shivers, headache by 7am on next day, illness. Cellulitis from Bacterial infection.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Typical arm soreness after vaccine, but pain got worse; about one month later she went to PCP and got steroid shot and steroid oral dose pack; good for a week, then pain returned; went back to PCP for another steroid shot; still in pain now.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Rash pustular, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Previously administered products included ZOSTAVAX (Received 8 years before reporting date). Concomitant products included Atorvastatin, Tamsulosin, Atenolol-Chlorthalidone, meloxicam, NEXIUM, Potassium Chloride ER, tramadol and zolpidem. On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th February 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, pain and rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles, pain and rash were recovered/resolved. It was unknown if the reporter considered the shingles, pain and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right upper arm. The patient received SHINGRIX on the right upper arm. The pharmacist reported that the patient contacted him to report that the patient experienced shingles the day after receiving the SHINGRIX vaccine. The patient experienced a rash on his right forehead and eye area. The patient was referred to an Ophthalmologist by his physician. The patient saw his doctor 10 days after the symptoms began. The physician prescribed VALTREX. The issues had resolved at that time and no other issues were reported with his Ophthalmologist visit. The patient did not plan to get the 2nd dose at this time.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Previously administered products included ZOSTAVAX (Received 8 years before reporting date). Concomitant products included Atorvastatin, Tamsulosin, Atenolol-Chlorthalidone, meloxicam, NEXIUM, Potassium Chloride ER, tramadol and zolpidem. On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th February 2018, 1 days after receiving SHINGRIX, the patient experienced shingles, pain and rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles, pain and rash were recovered/resolved. It was unknown if the reporter considered the shingles, pain and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right upper arm. The patient received SHINGRIX on the right upper arm. The pharmacist reported that the patient contacted him to report that the patient experienced shingles the day after receiving the SHINGRIX vaccine. The patient experienced a rash on his right forehead and eye area. The patient was referred to an Ophthalmologist by his physician. The patient saw his doctor 10 days after the symptoms began. The physician prescribed VALTREX. The issues had resolved at that time and no other issues were reported with his Ophthalmologist visit. The patient did not plan to get the 2nd dose at this time.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Mobility decreased, Pain in extremity
Clinical narrative: Pt said her arm was very sore, almost to the point she couldn't move it. Also red at the site and slightly warm to the touch.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Swelling, Urticaria
Clinical narrative: Hives and swelling, starting on hip bone. Rash then continued to spread across abdomen and down legs (mostly on right side of body).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine, Rash
Clinical narrative: Severe rash (measles).
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Fall, Head injury, Suture insertion
Clinical narrative: After receiving the BEXSERO vaccine, pt had syncopal event, fell and hit head, and required further medical treatment. The nurse administering the vaccine was in the room with the patient for the first 1-2 minutes post vaccination and then had left the room.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Syncope, X-ray limb normal
Clinical narrative: After receiving the BEXSERO vaccine, pt had syncopal event, fell and hit head, and required further medical treatment. The nurse administering the vaccine was in the room with the patient for the first 1-2 minutes post vaccination and then had left the room.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a field representative and refers to a 14 week old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, "after the patient turned 14 weeks of age", she/he was vaccinated with the first dose in vaccination series ROTATEQ oral liquid, 1 dose, orally (lot # and expiration date were not provided). No adverse effects were reported.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a Registered Nurse referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA 0.5mL by mouth one time, lot number N019924 with expiration date on 02-SEP-2018 (15 doses) and lot number N020689 with expiration date on 22-OCT-2018 (34 doses) or with an improperly stored doses of ROTATEQ 2mL by mouth one time, lot number N010706 with expiration date on 02-DEC-2018 (50 doses), lot number N013885 with expiration date on 09-DEC-2018 (20 doses), lot number N013992 with expiration date on 27-JAN-2019 (10 doses) and lot number N029868 with expiration date 12-MAR-2019 (10 doses), both vaccines for prophylaxis. The administered doses of the vaccines experienced a temperature excursion in the range between 44 degrees Fahrenheit to 77 degrees Fahrenheit (53.1 degrees Fahrenheit) for 4 hours and 30 minutes, as recorded by a data logger. The vaccines had not had a previous temperature excursion. There was no adverse effect reported. No product quality complaint was involved. Lot number N029868 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent. Follow up information has been received from the reporting nurse on 19-MAR-2018, via a phone call. The reporter stated that her vaccines were not at risk, therefore there was no need to identify any patients that received at risk vaccinations.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Hepatitis viral test, Sexually active
Clinical narrative: Information has been received from the authors of a published literature article, regarding  a 21 year old female patient, who was referred for possible hepatitis B virus (HBV) infection following routine testing for sexually transmitted infections (STIs). The patient had a past medical history of iron deficiency anemia and irregular menses. She had unprotected intercourse with a single partner 5 months prior to evaluation, and denied medications, prior surgery, transfusion of blood products, or intravenous drug use. Her paternal grandfather had an unknown type of liver cancer, but neither of her parents had any known liver disease. Review of the patient's medical record revealed she underwent her second hepatitis b vaccine (recombinant) (manufacturer unknown) vaccination (strength, dose, administration route, lot number and expiration date were not reported) for prophylaxis, on an unspecified date the day before her primary physician ordered STI testing. On an unspecified  date, a viral hepatitis panel was drawn 30 hours following her vaccination, and was qualitatively positive for hepatitis B surface antigen (HBsAg), which prompted extensive follow-up lab testing and gastroenterology consultation. The patient's physical exam was without stigmata of chronic liver disease, and was otherwise unremarkable. Repeat testing drawn 6 days after vaccination demonstrated normal liver-associated enzymes, and negative hepatitis B surface antibody (HBsAb), HBsAg, anti-hepatitis B core IgG and IgM, hepatitis B e-antigen and antibody, and undetectable HBV DNA by polymerase chain reaction (PCR). The outcome of hepatitis b surface antigen positive was resolved on an unspecified date. Authors stated that the patient's HBsAg positivity reverted within 6 days of vaccine exposure, but if testing was indicated or clinical uncertainty exists, they recommend deferring at least 2 weeks following vaccination. Hepatitis b surface antigen positive was considered to be related to hepatitis b vaccine (recombinant) (manufacturer unknown). Authors also stated that HBsAg positivity was common following vaccination, and usually did not extend beyond 14 days. Deferring HBV testing for an appropriate period might prevent not only patient anxiety, but also expensive and unnecessary follow-up testing and specialist consultation.
Age: 4.0
Sex: U
Vaccine: VARCEL
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. The patient's pertinent medical history, drug reactions and allergies were not reported. On 16-MAR-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # M018436 with an expiration date 13-APR-2018 for prophylaxis (douse, route of administration and anatomical location were not reported). The sterile diluent used to reconstitute the vaccine was not improperly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours. There was not previous temperature excursion. A digital data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB intramuscularly, lot # N016991, expiration date 07-MAR-2018 (dose and site of administration were not reported) for prophylaxis. Vaccine was stored at temperature 9°C to 25°C (16.1°C) for 2 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: HPV9
Symptoms: Haematuria, Penile haemorrhage
Clinical narrative: Information has been received from a physician referring to currently 25 years old ale patient. The patient had no concomitant medication, pertinent medical history and drug reactions/allergies. Concurrent condition was not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (lot# N025429 with expiration date 21-JUL-2020, dose and route unknown) for prophylaxis. On an unknown date, after receiving the first dose the patient developed hematuria in his urine for 1 day and had blood dripping from his penis. The patient did not seek any medical treatment. The hematuria resolved within 24 hours. The outcome of blood dripping from his penis was reported as recovered on an unknown date. No lab diagnostics/studies were performed. No product quality complaint (PQC) was reported. The causality between the events and GARDASIL 9 was not reported. Upon internal review, penile haemorrhage was considered to be medically significant.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain and tenderness on the left upper arm. Cephalexin 500 MG Cap  1 by mouth three times a day for 10 days ordered on 4/1/2018. MD decreased this to 5 days on 4/2/2018 - area improving.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: My arm started really hurting at the injection site within an hour of the shot. I put a cold pack on it in the evening as it hurt so bad I didn't want to move it. I took two extra strength TYELNOL before going to bed. I got very cold in the middle of the night which is unusual for me. I got up in the morning and took my temperature in both ears and it was over 100 both times. I feel very tired and sluggish and my arm still hurts.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Sluggishness
Clinical narrative: My arm started really hurting at the injection site within an hour of the shot. I put a cold pack on it in the evening as it hurt so bad I didn't want to move it. I took two extra strength TYELNOL before going to bed. I got very cold in the middle of the night which is unusual for me. I got up in the morning and took my temperature in both ears and it was over 100 both times. I feel very tired and sluggish and my arm still hurts.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Hypotension, Pain in extremity, Thirst
Clinical narrative: Patient initially developed arm soreness, then thirst, then hypotension beginning the AM after injection. Hypotension was accompanied by lightheadedness. BP checked at home with home monitor while sitting was 85/53, then 72/33. Patient became more lightheaded. Husband was advised to call 911. She is currently in ER undergoing treatment.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dry mouth, Electrocardiogram normal, Hypotension, Injection site discomfort
Clinical narrative: Patient initially developed arm soreness, then thirst, then hypotension beginning the AM after injection. Hypotension was accompanied by lightheadedness. BP checked at home with home monitor while sitting was 85/53, then 72/33. Patient became more lightheaded. Husband was advised to call 911. She is currently in ER undergoing treatment.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Lymphadenopathy
Clinical narrative: Cellulitis, Swollen Lymph Node.