chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Nausea, Pain, Skin warm, Swelling
Clinical narrative: Red, hot, puffy, pain, nausea, and flat horizontal line presenting below vaccination (FLUZONE QIV given 1 inch below PNEUMOVAX).
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Electrocardiogram, Pregnancy test
Clinical narrative: 20 mins after receiveing vaccine pt had difficulty breathing, she took BENADRYL and used an EPIPEN that she had at home then took ambulance to emergency room.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Joint range of motion decreased, Laboratory test normal, Mass
Clinical narrative: TDAP Vaccine given in the Emergency Room post sharps injury by an Emergency Room staff. The patient reported on 8/20/18 to Employee Health / Occupational Clinic that she developed red, hard lump and significant pain approximately 3 days post injection. She was seen by Dr. No numbness, tingling, weakness or fever noted. Pain with lifting her left arm above shoulder level.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: TDAP Vaccine given in the Emergency Room post sharps injury by an Emergency Room staff. The patient reported on 8/20/18 to Employee Health / Occupational Clinic that she developed red, hard lump and significant pain approximately 3 days post injection. She was seen by Dr. No numbness, tingling, weakness or fever noted. Pain with lifting her left arm above shoulder level.
Age: 27.0
Sex: M
Vaccine: JEV, YF
Symptoms: Cough, Dyspnoea, Feeling hot, Lacrimation increased, Ocular hyperaemia
Clinical narrative: 27yo male received YF-Vax and JE-VC on 14 Jul 2018. Approximately 45m later, he began to feel hot, broke out in hives (neck, chest, and RUE), felt like his throat was closing, experienced tongue tingling, had red watery eyes. He went to the ED, where he reported dyspnea, and had audible wheezing (noted as both inspiratory and expiratory), although respirations even/unlabored, able to speak in complete sentences. Per available notes he was treated with epipen at 13:41 & arrived in ER at 14:10. Initial O2 sat is documented at 94% and exam notes describe urticaria to lateral upper extremities, chest, back and abdomen,, neck swelling and non-productive cough. Patient denies any other known adverse events following immunizations. Patient states he tolerates ingestion of eggs and gelatin and denies any known adverse reactions to latex, neomycin, polymixin, sreptomycin, thimerosal, yeast, or formaldehyde.
Age: 27.0
Sex: M
Vaccine: JEV, YF
Symptoms: Paraesthesia oral, Skin test, Swelling, Throat tightness, Urticaria
Clinical narrative: 27yo male received YF-Vax and JE-VC on 14 Jul 2018. Approximately 45m later, he began to feel hot, broke out in hives (neck, chest, and RUE), felt like his throat was closing, experienced tongue tingling, had red watery eyes. He went to the ED, where he reported dyspnea, and had audible wheezing (noted as both inspiratory and expiratory), although respirations even/unlabored, able to speak in complete sentences. Per available notes he was treated with epipen at 13:41 & arrived in ER at 14:10. Initial O2 sat is documented at 94% and exam notes describe urticaria to lateral upper extremities, chest, back and abdomen,, neck swelling and non-productive cough. Patient denies any other known adverse events following immunizations. Patient states he tolerates ingestion of eggs and gelatin and denies any known adverse reactions to latex, neomycin, polymixin, sreptomycin, thimerosal, yeast, or formaldehyde.
Age: 27.0
Sex: M
Vaccine: JEV, YF
Symptoms: Wheezing
Clinical narrative: 27yo male received YF-Vax and JE-VC on 14 Jul 2018. Approximately 45m later, he began to feel hot, broke out in hives (neck, chest, and RUE), felt like his throat was closing, experienced tongue tingling, had red watery eyes. He went to the ED, where he reported dyspnea, and had audible wheezing (noted as both inspiratory and expiratory), although respirations even/unlabored, able to speak in complete sentences. Per available notes he was treated with epipen at 13:41 & arrived in ER at 14:10. Initial O2 sat is documented at 94% and exam notes describe urticaria to lateral upper extremities, chest, back and abdomen,, neck swelling and non-productive cough. Patient denies any other known adverse events following immunizations. Patient states he tolerates ingestion of eggs and gelatin and denies any known adverse reactions to latex, neomycin, polymixin, sreptomycin, thimerosal, yeast, or formaldehyde.
Age: 71.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Dyspnoea, Erythema, Joint range of motion decreased, Malaise, Pain in extremity
Clinical narrative: Patient experienced right arm soreness, with redness, swelling, and decreased range of motion. She also experienced a general not 'feeling well'. She had mentioned that 8/22 night, she had to sleep upright, propped up with pillows because she was having difficulty breathing. She is improving with time and no longer had difficulty breathing in the morning.
Age: 71.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Swelling
Clinical narrative: Patient experienced right arm soreness, with redness, swelling, and decreased range of motion. She also experienced a general not 'feeling well'. She had mentioned that 8/22 night, she had to sleep upright, propped up with pillows because she was having difficulty breathing. She is improving with time and no longer had difficulty breathing in the morning.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Immediate post-injection reaction, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Shoulder pain immediately. 6 AM muscle aches over entire body. Unable to function normally for 24 hous. Weakness, shivery. I did have the vaccine several years prior to getting this new vaccine with no adverse effects - only to contract the shingles virus last September 2017 of which the pain of the left side of my body lasted for all of eight to 10 months. I therefore wanted protection from ever getting the shingles again and was happy to hear of the latest vaccine of which I had no problems with the 1st part of the series.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Shoulder pain immediately. 6 AM muscle aches over entire body. Unable to function normally for 24 hous. Weakness, shivery. I did have the vaccine several years prior to getting this new vaccine with no adverse effects - only to contract the shingles virus last September 2017 of which the pain of the left side of my body lasted for all of eight to 10 months. I therefore wanted protection from ever getting the shingles again and was happy to hear of the latest vaccine of which I had no problems with the 1st part of the series.
Age: 19.0
Sex: M
Vaccine: RAB
Symptoms: Head discomfort, Memory impairment, Palpitations, Visual impairment
Clinical narrative: Pt bit in head by bat - per his report - on 8/10/18 - Initial treatment started in ED . 8/13/18 - Received 2nd dose as noted above. 8/15/18 at 4:45 pm calls with c/o "pressure in head", visual disturbance - black spots in peripheral vision and heart pounding. Added has had memory problem since 1st dose - ie - can't remember why he went into a room. Recommended urgent care for evaluation. Pt reported to clinic on 8/17/18 for next dose of Rabies for post exposure (Day number 3). No complaints or concerns verbalized at that time.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Ocular hyperaemia
Clinical narrative: SOB, red eyes. SOLU-MEDROL 125mg inj/BENADRYL 50mg inj.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Tooth infection
Clinical narrative: Teeth rotting and infection almost all teeth upper jaw has been pulled by myself lower as well.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse regarding a 5 year old female patient. There was no information regarding concurrent condition and historical medication. On 02-AUG-2018, the patient was vaccinated with VARIVAX lot # R002051 dose 1, subcutaneous in the right deltoid for prophylaxis and M-M-R II lot # N024703 dose 1, subcutaneous in the left deltoid for prophylaxis. Medication error occurred in the storage in clinical practice (product storage error). Digital data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-AUG-2018, the patient may have received an improperly stored dose of GARDASIL 9 injection, intramuscularly, lot # N035032, expiration date 24-SEP-2020 (exact dose and anatomical localization were not reported). No adverse effect was reported. Data logger was not involved. Administrated doses of GARDASIL 9 were exposed to the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 52 hours. Previous temperature excursion was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult female patient who received SHINGRIX for prophylaxis. On 9th August 2018, the patient received SHINGRIX. On 9th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were unknown. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient had denied permission to contact their physician. The caller terminated the call. No other questions were asked for this report.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt received Varicella vaccine subcutaneous in right lower arm on 8/14/18 -swelling and redness from shoulder to elbow with pain.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody positive, Autoimmune disorder, C-reactive protein increased
Clinical narrative: Had an autoimmune response causing Rheumatoid Arthritis. Multiple joints swollen (fingers, thumbs, wrists, shoulders, knees), swelling and warmth, stiffness, and excruciating pain. Primary care Dr. sent him to a Rheumatologist where he is still being treated. The first medication he tried was Methotrexate, but he developed a severe cough and couldn't take it. He is now taking ENBREL injections weekly.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Joint swelling, Musculoskeletal stiffness, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Had an autoimmune response causing Rheumatoid Arthritis. Multiple joints swollen (fingers, thumbs, wrists, shoulders, knees), swelling and warmth, stiffness, and excruciating pain. Primary care Dr. sent him to a Rheumatologist where he is still being treated. The first medication he tried was Methotrexate, but he developed a severe cough and couldn't take it. He is now taking ENBREL injections weekly.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis, Rheumatoid factor, Skin warm, Swelling, X-ray
Clinical narrative: Had an autoimmune response causing Rheumatoid Arthritis. Multiple joints swollen (fingers, thumbs, wrists, shoulders, knees), swelling and warmth, stiffness, and excruciating pain. Primary care Dr. sent him to a Rheumatologist where he is still being treated. The first medication he tried was Methotrexate, but he developed a severe cough and couldn't take it. He is now taking ENBREL injections weekly.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood test normal, Chills, Contusion, Erythema
Clinical narrative: Severe pain, severe loss of strength, range of motion severely limited, redness, bruising, skin sensitivity, inflammation, lethargy, sweats/chills, full body heat rash. Symptoms arrived in 24 hours, symptoms escalated 48 hours, reached peak at 72 hours. It took a full week (7 days) for inflammation/redness/pain and sensitivity to subside. Range of motion and strength restored, but still muscular pain after 9 days.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Hyperaesthesia, Hyperhidrosis, Inflammation, Joint range of motion decreased, Lethargy
Clinical narrative: Severe pain, severe loss of strength, range of motion severely limited, redness, bruising, skin sensitivity, inflammation, lethargy, sweats/chills, full body heat rash. Symptoms arrived in 24 hours, symptoms escalated 48 hours, reached peak at 72 hours. It took a full week (7 days) for inflammation/redness/pain and sensitivity to subside. Range of motion and strength restored, but still muscular pain after 9 days.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Miliaria, Myalgia, Pain, Rash generalised, Ultrasound scan normal
Clinical narrative: Severe pain, severe loss of strength, range of motion severely limited, redness, bruising, skin sensitivity, inflammation, lethargy, sweats/chills, full body heat rash. Symptoms arrived in 24 hours, symptoms escalated 48 hours, reached peak at 72 hours. It took a full week (7 days) for inflammation/redness/pain and sensitivity to subside. Range of motion and strength restored, but still muscular pain after 9 days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Varicella
Clinical narrative: Patient presented 2 days after SHINGRIX Vaccine and had redness of right arm where vaccine was given. There is a 5cm x 3 cm erythemic, warm to touch, raised area to right deltoid area, as well as a satellite type area to about 1cm x 1cm to right. Two weeks after vaccine was given, May 8, 2018, patient reported 2 chicken pox forming.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: High fever all night , muscle aches, headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Injection site swelling
Clinical narrative: Severe headache, dizziness, weakness, nausea, vomiting, body aches, fever, pain and swelling at injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Severe headache, dizziness, weakness, nausea, vomiting, body aches, fever, pain and swelling at injection site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient stated that when he got home he noticed some swelling and redness in left arm where the injection had been given.
Sex: F
Vaccine: HPV4
Symptoms: Off label use, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a magazine article referring to a 97 years old female patient whose squamous cell carcinoma was thought to be untreatable, lesions had developed over much of her right leg, in such numbers and size that chemotherapy and surgery were ruled out as treatments. Approximately in July 2016 (reported as "two years ago from 13-JUL-2018"), on a hunch, her doctor tried an unorthodox approach she injected each tumor with GARDASIL. The result: All the tumors completely and rapidly disappeared. The patient's son stated that the outcome was more than what he had even hoped for, it was like the tumors were going through a dying phase, one by one. And he hoped that this treatment could be further tested and used in clinical trials, as the benefit was just too practical to be ignored. The doctor first administered two vaccine doses in the patient's arm. Several weeks later (in 2016), additional injections were administered directly into some of the patient's tumors. The treatment was applied a total of four times, spread out over an 11-month period. Less than a year following the initial direct-to-tumor vaccine injection, all of the treated tumors disappeared. What's more, over the two year post-treatment period, there has been no skin cancer recurrence. The doctor was surprised that all of the patient's tumors regressed, even those that were not directly injected with GARDASIL. The deputy chief medical officer said "the concept of injecting a vaccine or an infectious agent into a cancer tumor is not in and of itself new. What's new is the use of the HPV vaccine. And what likely has happened here is that by injecting it into the tumor cells the vaccine helped the patient's own defense mechanism respond in such a way as to attack the cancer in that location." The doctor's own research, involving two prior patients (captured in US-009507513-1707USA006525 and US-009507513-1707USA005911), had suggested the vaccine might curb skin cancer growth.; Sender's Comments: US-009507513-1707USA005911: US-009507513-1707USA006525:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N021318 and expiration date on 07-AUG-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The administered dose of the vaccine experienced a temperature excursion of -14 to -10 degrees Celsius for 17 hours. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Patient received the vaccine around 11:00am, and was at home later that afternoon, and around 3:00 pm the patient started experiencing cold-like symptoms. He had a sore throat, runny nose, and some difficulty breathing. When he called this morning to report the adverse event, he was feeling better, but the symptoms were not completely resolved.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Full blood count normal, Hyporesponsive to stimuli, Hypotonia, Hypotonic-hyporesponsive episode, Neurological examination normal
Clinical narrative: Patient had a hypotonic hyporesponsive episode 24 hours following immunizations. He became noticeably hyporesponsive, limp, and pale at 1:50 PM on 8/22/2018. Episode was associated with a brief fever to temperature maximum of 102.4. All symptoms self-resolved, including fever, within an hour. Patient was examined in office approximately 2 hours after start of episode, and he presented like his normal self. Thorough physical examination was normal noting a mild RSOM. CBC was normal with 9,800 WBC, normal diff, PPC, and Hgb. Due to family's lack of proximity to medical care (45 minute drive), patient was treated with OMNICEF to cover possible component of underlying infectious process. An EEG will be scheduled. Phone follow-up with patient's mother on morning of 8/23/2018 revealed patient was doing well, was playful with good appetite. There had been no recurrence of symptoms from the episode, and patient was his normal self.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pallor, Pyrexia
Clinical narrative: Patient had a hypotonic hyporesponsive episode 24 hours following immunizations. He became noticeably hyporesponsive, limp, and pale at 1:50 PM on 8/22/2018. Episode was associated with a brief fever to temperature maximum of 102.4. All symptoms self-resolved, including fever, within an hour. Patient was examined in office approximately 2 hours after start of episode, and he presented like his normal self. Thorough physical examination was normal noting a mild RSOM. CBC was normal with 9,800 WBC, normal diff, PPC, and Hgb. Due to family's lack of proximity to medical care (45 minute drive), patient was treated with OMNICEF to cover possible component of underlying infectious process. An EEG will be scheduled. Phone follow-up with patient's mother on morning of 8/23/2018 revealed patient was doing well, was playful with good appetite. There had been no recurrence of symptoms from the episode, and patient was his normal self.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on face and neck developed - md has her on Benadryl qid.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Contusion, Fatigue, Pain, Pruritus
Clinical narrative: Bruised feeling, achiness, fatigue. Followed by maculopaoular rash on hand, vesicles, then rash on right knee, then rash abdome at waist on right only and 2 hives on face on right only, itchy, no pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash maculo-papular, Urticaria
Clinical narrative: Bruised feeling, achiness, fatigue. Followed by maculopaoular rash on hand, vesicles, then rash on right knee, then rash abdome at waist on right only and 2 hives on face on right only, itchy, no pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site bruising, Injection site pain, Injection site papule, Injection site rash
Clinical narrative: Bruised feeling, achiness, fatigue. Followed by maculopaoular rash on hand, vesicles, then rash on right knee, then rash abdome at waist on right only and 2 hives on face on right only, itchy, no pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Bruised feeling, achiness, fatigue. Followed by maculopaoular rash on hand, vesicles, then rash on right knee, then rash abdome at waist on right only and 2 hives on face on right only, itchy, no pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt received ZOSTAVAX instead of childhood varicella vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site was red and swollen for about 4 weeks, and it was hurtful to lie down on that side of the arm. She took tylenol and ice to help. The site was red and swollen like a ball per patient.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness/pain/heat to injection site.
Age: 69.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Arthritis, Mobility decreased, Pain, Periarthritis, X-ray abnormal
Clinical narrative: Growing pain over 2 days to severe pain which lasted x 4 nights. Needed pain medication for relief. Now pain is gone, but still experiencing "frozen shoulder" or movement difficulties in affected shoulder. Doctor reported arthritic changes on XRAY.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Erythema, Headache, Nausea
Clinical narrative: Patient started having a reaction a few hours after getting the shot. Her arm swelled down to the elbow, was red and tender to the touch and she had fever, chills, headache, nausea and lightheadedness. Patient took TYLENOL and stayed in bed, symptoms mostly resolved without medical intervention 5 days later, patient's arm was still a little tender 1 week after getting the shot.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Patient started having a reaction a few hours after getting the shot. Her arm swelled down to the elbow, was red and tender to the touch and she had fever, chills, headache, nausea and lightheadedness. Patient took TYLENOL and stayed in bed, symptoms mostly resolved without medical intervention 5 days later, patient's arm was still a little tender 1 week after getting the shot.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Posture abnormal
Clinical narrative: After sitting prone for 10 minutes after administration of Tdap, MCV and HPV-9, the male patient left the exam room without difficulty and stopped at the nurse desk to pick a prize from a box that was chest level to him. Mother was standing beside him and asked him" are you ok" as he began to slump. I was near him and grasped him under both shoulders and gently lowered him to the floor. The physician came out immediately and after 5-8 seconds, the patient was again awake. He stated that "everything went black" and he remembers awakening on the floor. Patient remained on the floor for 5 minutes until dizziness subsided. He was then assisted to a sitting position for another 5 minutes and then to an upright position being supported by myself and the physician. No further dizziness was reported but we assisted the patient back to an exam room, had him seated in a chair and gave water and a rice crispy bar, observing for 10 more minutes. After this time, patient felt fine and he and mom were dismissed and advised to call back for any additional concerns or to see emergency care for s/s of anaphylaxis or trouble breathing. Mother VU to all and agreed with POC.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram abnormal, Computerised tomogram head normal, Fall, Feeling cold
Clinical narrative: "Patient had her 2nd SHINGRIX vaccine on July 25, 2018. She then drove up to the mountains where they have a house there. On the way she had some arm pain. In the middle of the night she woke with chills and feeling cold. She got up to get a blanket and then had a syncopal episode, falling in her closet and striking her lip, sustaining a laceration through and through. She was seen at Hospital. A CT scan of the head was done with no abnormalities as well as CT of the cervical spine. Her wounds were sutured. She was placed on clindamycin. The wound is healing extremely well. She also saw her dentist because she had some lacerations of her gum line. She was reassured that healing well also. She is applying MEDERMA. There was an incidental finding of a nodule on the epiglottis on the CT scan. She was referred to ENT for consult. That is pending, probably in September. She does not have any hoarseness. No voice changes. She does have chronic mucus drainage in the posterior oropharynx and a history of allergies."
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival injury, Lip injury, Middle insomnia, Nodule, Pain in extremity
Clinical narrative: "Patient had her 2nd SHINGRIX vaccine on July 25, 2018. She then drove up to the mountains where they have a house there. On the way she had some arm pain. In the middle of the night she woke with chills and feeling cold. She got up to get a blanket and then had a syncopal episode, falling in her closet and striking her lip, sustaining a laceration through and through. She was seen at Hospital. A CT scan of the head was done with no abnormalities as well as CT of the cervical spine. Her wounds were sutured. She was placed on clindamycin. The wound is healing extremely well. She also saw her dentist because she had some lacerations of her gum line. She was reassured that healing well also. She is applying MEDERMA. There was an incidental finding of a nodule on the epiglottis on the CT scan. She was referred to ENT for consult. That is pending, probably in September. She does not have any hoarseness. No voice changes. She does have chronic mucus drainage in the posterior oropharynx and a history of allergies."
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Secretion discharge, Suture insertion, Syncope
Clinical narrative: "Patient had her 2nd SHINGRIX vaccine on July 25, 2018. She then drove up to the mountains where they have a house there. On the way she had some arm pain. In the middle of the night she woke with chills and feeling cold. She got up to get a blanket and then had a syncopal episode, falling in her closet and striking her lip, sustaining a laceration through and through. She was seen at Hospital. A CT scan of the head was done with no abnormalities as well as CT of the cervical spine. Her wounds were sutured. She was placed on clindamycin. The wound is healing extremely well. She also saw her dentist because she had some lacerations of her gum line. She was reassured that healing well also. She is applying MEDERMA. There was an incidental finding of a nodule on the epiglottis on the CT scan. She was referred to ENT for consult. That is pending, probably in September. She does not have any hoarseness. No voice changes. She does have chronic mucus drainage in the posterior oropharynx and a history of allergies."
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Received brief on Smallpox date of vaccination (08/16/2018), 2 days later (08/18/2018) got new tattoo over site, arrived at tattoo place with band aid in place. On 08/21/2018, noticed red bumps within the tattoo artwork. Followed up for 7 day site check on 08/23/2018 with autoinoculation of the smallpox site to right arm. Non adhering bandages with TEGADERM placed over effected area with instructions to follow up daily to ensure site is covered to prevent further spreading. Patient instructed to wash all clothing and linens today with hot water and detergent. No close contacts. Tattoo place notified and aware that the patient was vaccinated against smallpox and to be on guard for potential cross contamination.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: PARENT NOTICED AREA OF REDNESS AND SWELLING DURING BATH TIME. AREA IS RED, WARM TO TOUCH ABOUT THE SIZE OF A BASEBALL.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative concerning a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitants therapies. On an unknown date, the patient was vaccinated with both VARIVAX and PROQUAD, (dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 22-AUG-2018, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # N025384, expiration date 19-APR-2019, for prophylaxis (dose and route were not reported). No adverse effects reported. The temperature involved was 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour. A previous temperature excursion was not reported, and a data logger was involved.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a non-Health Care Professional. This case was linked with 2018SA226678, 2018SA226689 and 2018SA226688. This case involves a 17 years old female patient who was administered MENACTRA for which shipment was received at 3 days instead of 2 days and administered, while she received vaccine MENACTRA on 13-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Aug-2018, the patient received a 0.5 ml (single dose) second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA, exp: 09-OCT-2019, in the right deltoid. It was a case of actual medication error due to incorrect product storage and extra dose administered. It was not reported whether the patient experienced any adverse events after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old male patient who received first dose of IMOVAX RABIES on 07-Jun-2018 and had a second dose of vaccine lot 966650, expiry date: 26-Feb-2019 in the left deltoid on 08-Aug-2018, that was considered the first. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from a non-Healthcare Professional. This case involves 13 patients of an unknown demographics who received an expired dose of IPOL lot number not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. The patients received IPOL when it was out of range and expired. It was not reported if the patients experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA232580 (same reporter). This case involves a two months old male patient who received Hib component, while he received vaccine PENTACEL lot C5408AB in the right thigh on 15-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PREVNAR 13 for Immunisation. It was also a case of actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA227513 (same reporter). This case involves a 2 months old patient who was vaccinated with a once dose of PENTACEL (batch number:  C5551AA and expiry date: 10-Oct-2019) in the right thigh (dose, dose in series and route of administration were not reported) on 13-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccines were unpacked and storage of the vaccine may not have been within recommended temperatures which puts into question the viability of the vaccine. It was reported that on Monday, 13Aug2018, two patients were immunized with PENTACEL vaccines out of this shipment. On Monday night after business hours, an email was sent to the physician in this practice stating that this order of PENTACEL had taken too long in transfer/transit. Because of this, the storage of the vaccine may not have been within recommended temperatures which puts into question the viability of the vaccine. The vaccine took 3 days to get to the physician's office. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by the sender: None.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a four months old male patient who was vaccinated with second dose of PENTACEL (0.5 ml) (batch number, expiration date, route and site of administration was not reported) on 14-Aug-2018 in the left thigh. The patient's medical history was not reported. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization. It was an actual medication error due to inappropriate reconstitution technique as the patient received second dose of series for PENTACEL without the ACTHIB component. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Erythema, Feeling hot, Inflammation, Pain, Swelling
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 5 child patients who experienced hotness, swelling, soreness, large welts the size of baseball and redness, while he/she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported. On an unknown date, The patient developed a non-serious redness, hotness, swelling, soreness (inflammation) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. On an unknown date, The patient developed a non-serious large welts the size of baseball (urticaria) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Final diagnosis was large welts the size of baseball, redness, soreness, swelling and hotness. Lab test not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for redness, soreness, swelling and hotness and as Unknown for large welts the size of baseball.
Sex: U
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 5 child patients who experienced hotness, swelling, soreness, large welts the size of baseball and redness, while he/she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported. On an unknown date, The patient developed a non-serious redness, hotness, swelling, soreness (inflammation) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. On an unknown date, The patient developed a non-serious large welts the size of baseball (urticaria) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Final diagnosis was large welts the size of baseball, redness, soreness, swelling and hotness. Lab test not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for redness, soreness, swelling and hotness and as Unknown for large welts the size of baseball.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Tinnitus
Clinical narrative: Woke up to rapid heartbeat and pulsatile tinnitus at 3:30 a.m. (day after injection). Had an elevated blood pressure at 9 a.m. (I have normal blood pressure.) Played tennis at 10:30 a.m. until 12:30 p.m. and felt fine. Still had rapid heartbeat that evening. By next morning I was back to normal.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Red hive like spot in 10-15cm surrounding injection site on left arm. Spot is itchy periodically.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: Large, diffuse area of redness and tenderness. Patient reported symptoms 8/22/2018 and states the area is not warm or grossly painful.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: PT STATED PT HAD WELPS TO FACE, SKIN ITCHING, AND REDNESS.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Pain, Peripheral swelling, Skin warm
Clinical narrative: Patients have been experiencing  body shivers , right arm swollen , pain and  warm  and very weak and no energy.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Breast pain, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: Localized discomfort on both arms, extreme pain, solid lump, immobilization on left side. Sore neck extending down to breast and waist on left side and over to collarbone and shoulder blade, fever and chills, severe headache with didn't respond to 600mg dose of ibuprofen, lethargy, extreme tire-ness and sleeping thru first 3 days, unable to lift left arm yet on 4th day. Finally by 6th day post vaccinations, could return to work with normal motility, but still localized lump. Patient called concerned about possible cellulitis, a previous condition, but didn't follow that course. Tried ice on first day, no response. Most severe symptoms came on later on the second day (less than 24 hours from immunization).
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Immobile, Impaired work ability, Injected limb mobility decreased, Lethargy, Limb discomfort
Clinical narrative: Localized discomfort on both arms, extreme pain, solid lump, immobilization on left side. Sore neck extending down to breast and waist on left side and over to collarbone and shoulder blade, fever and chills, severe headache with didn't respond to 600mg dose of ibuprofen, lethargy, extreme tire-ness and sleeping thru first 3 days, unable to lift left arm yet on 4th day. Finally by 6th day post vaccinations, could return to work with normal motility, but still localized lump. Patient called concerned about possible cellulitis, a previous condition, but didn't follow that course. Tried ice on first day, no response. Most severe symptoms came on later on the second day (less than 24 hours from immunization).
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Mass, Musculoskeletal pain, Neck pain, Pain, Pyrexia
Clinical narrative: Localized discomfort on both arms, extreme pain, solid lump, immobilization on left side. Sore neck extending down to breast and waist on left side and over to collarbone and shoulder blade, fever and chills, severe headache with didn't respond to 600mg dose of ibuprofen, lethargy, extreme tire-ness and sleeping thru first 3 days, unable to lift left arm yet on 4th day. Finally by 6th day post vaccinations, could return to work with normal motility, but still localized lump. Patient called concerned about possible cellulitis, a previous condition, but didn't follow that course. Tried ice on first day, no response. Most severe symptoms came on later on the second day (less than 24 hours from immunization).
Age: 72.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dizziness, Dyspnoea, Hypersensitivity
Clinical narrative: The patient received FLUAD in left arm first, followed by PNEUMOVAX in right arm. Seconds after the PNEUMOVAX, patient complained of severe dizziness to which I had him raise his legs and place them on a second chair. Then the patient complained of having difficulty breathing that kept worsening fast. I immediately asked my tech to call 911 and administered 1 dose of epinephrine. The epinephrine did not seem to help. The patient was taking fast and shallow breath. The ambulance arrived a few minutes later and transported the patient to the hospital. The patient did not have any swelling in his lips mouth or airways according to the hospitl staff. It was a severe allergic reaction that most likely exacerbated his COPD. The patient recovered and was set to be discharged the same day.
Age: 72.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Hypopnoea, Respiratory rate increased
Clinical narrative: The patient received FLUAD in left arm first, followed by PNEUMOVAX in right arm. Seconds after the PNEUMOVAX, patient complained of severe dizziness to which I had him raise his legs and place them on a second chair. Then the patient complained of having difficulty breathing that kept worsening fast. I immediately asked my tech to call 911 and administered 1 dose of epinephrine. The epinephrine did not seem to help. The patient was taking fast and shallow breath. The ambulance arrived a few minutes later and transported the patient to the hospital. The patient did not have any swelling in his lips mouth or airways according to the hospitl staff. It was a severe allergic reaction that most likely exacerbated his COPD. The patient recovered and was set to be discharged the same day.