chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Metabolic function test normal, Oropharyngeal pain
Clinical narrative: 4 days following injection sore throat began. 6 days later fever began and continued for 10 days. 2 days into fever and 8 days from vaccination, fever spiked to 103.8.  Malaise, bilateral neck lymphadenopathy, shaking chills, loss of appetite and weight loss throughout the time of illness.
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Skin warm
Clinical narrative: REDNESS, WARM TO TOUCH,
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Ear swelling, Eye swelling, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: Patient started with hives on the right arm about 26 hours after vaccination that spread over her entire body , trunk and extremities along with itching. She was started on prednisone by an ER doctor.  I spoke with her today to follow up and she has been to the ER twice this past weekend and started on prednisone, methylprednisolone, Benadryl and Pepcid as well as 3 rounds of IVs in the ER. She has continued to have hives , itching, swelling of her throat, ears and eyes.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine reconstituted with a diluent that expired 8/7/20. No know adverse reaction or harm to patient at time of this form's completion.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: States that he became light headed and dizzy, complained of head feeling "foggy"
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Botulism, Clostridium test, Drooling, Dysphagia, Paralysis
Clinical narrative: 5 days after vaccine administration presented to the ER with decreased swallowing, increased drooling. Progressed while admitted to respiratory failure secondary to suspected paralysis from botulinum toxin. Confirmatory studies pending.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Respiratory failure
Clinical narrative: 5 days after vaccine administration presented to the ER with decreased swallowing, increased drooling. Progressed while admitted to respiratory failure secondary to suspected paralysis from botulinum toxin. Confirmatory studies pending.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Pain at injection site, worse than normal.  As of phone call on 9/8/2020,  patient said her arm did not hurt during the day, but was waking her up in the morning with excruciating pain.  She had placed a phone call to her primary care doctor and left a message.
Age: 1.42
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever, irritability, not eating, sleeping or playing as normal. Cries all day and night.
Age: 1.42
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Sleep disorder
Clinical narrative: Fever, irritability, not eating, sleeping or playing as normal. Cries all day and night.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Rash
Clinical narrative: PATIENT STATED THAT SHE HAD A RASH ALL OVER HER BODY AS WELL AS BRIUSE ON THE INJECTION SITE. PATIENT STATED THAT THE SYMPTOMS STARTED 2-3 DAYS AFTER RECEIVING THE SHOT AND AFTER SHE TOOK BENADRYL, THE RASH DISAPPEARED. I SPOKE WITH STAFF AT DOC (PATIENT'S FAMILY DOCTOR) AND REPORTED THE INCIDENT ON THE SAME DAY PATIENT REPORTED THAT (9-8-20). STAFF STATED THAT SHE WILL SEND THE INFO TO THE DOCTOR.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Nausea
Clinical narrative: patient states he was nauseous and had chills in the middle of the night after the flu vaccine was administered
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Swollen, (raised), warm area  and redness on site of injection even after 7 days from administration. She can hardly move her arm.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Rash, Visual impairment
Clinical narrative: Patient complains of a rash all over his back and shoulders. Arm pain still lingering. Patient states the vision in left eye is affected.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Erythema, Oedema
Clinical narrative: Edema and erythema reported to pharmacist by patient's wife 9 days after vaccine was administered.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Gait disturbance, Pain in extremity, Sleep disorder
Clinical narrative: Legs are aching and hurting so bad I can barely walk until I stand for at least 10 minutes. I cannot sleep my legs hurt so bad, I have tried ibuprophen, tylenol, and now gabapentin. Gabapentin works the best butI still wake up with pain.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Pain
Clinical narrative: About 1 or 2 a.m. after having the vaccination. Thursday had a lot of pain. Friday gotten worse. Called doctor. Friday and Saturday applied ice on it. Went to Urgent Care on Saturday and was given Prednisone. It seemed to help a little bit. Still having pain and can't sleep. Still applying ice and heat throughout the day.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient came in for vaccine, documented vaccine information and looked at vaccine information prior to giving the vaccine and I did not catch the expiration date. After I gave the vaccine and I was putting it in to the computer, I noticed that the vaccine had expired in April 2020. I immediately reported the incident to the manager and the physician. The patient's mother was contacted and was told of the incident. Patient's mom was advised to come back in for another dose.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Dizziness, Malaise, Nausea
Clinical narrative: Patient reported dizziness, nausea, chills and malaise for 2 days after the immunization. Slightly better on day 3.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Mobility decreased, Pain in extremity
Clinical narrative: Patient got Boostrix on 9/3/20,  she said right after her arm is sore and it is hard to move. On 9/7/20, it started bruising, the bruising is about 7cm in diameter, no fever. I have advised the patient to use cold compress and have called GSK at 430pm for more recommendations but they are closed. Will follow up on 9/9/20
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Limb discomfort, Peripheral swelling, Tenderness
Clinical narrative: Pt had a swollen arm, Tender to touch, Heavy feeling, No Fever. Mom gave pt IBU at night.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Blood glucose increased, Blood lactic acid increased, Dehydration, Depressed level of consciousness, Diarrhoea
Clinical narrative: Patient is an 11 week ex-35w6d di-di twin who presented on 9/4/2020 with 2 days of diarrhea and one day of altered mental status/sleepiness/decreased alertness found to be hyperglycemic, acidotic (non gap), and tachycardic to HR211 concerning for severe dehydration vs hypovolemic shock. Initial had hyperglycemia to 452 and reported somnolence concerning for DKA, however hyperglycemia resolved by report Glucose 78 in ED following 4 x 10ml/kg boluses. Her lactate downtrended to 3.3 from 8.5. She was transferred to hospital for management of her dehydration and metabolic acidosis secondary to diarrhea. To note, she has had household contact with diarrhea (twin with diarrhea as well) and recent 2 month vaccine shots including rotavirus.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Hyperglycaemia, Mental status changes, Metabolic acidosis, Rotavirus test positive, Somnolence
Clinical narrative: Patient is an 11 week ex-35w6d di-di twin who presented on 9/4/2020 with 2 days of diarrhea and one day of altered mental status/sleepiness/decreased alertness found to be hyperglycemic, acidotic (non gap), and tachycardic to HR211 concerning for severe dehydration vs hypovolemic shock. Initial had hyperglycemia to 452 and reported somnolence concerning for DKA, however hyperglycemia resolved by report Glucose 78 in ED following 4 x 10ml/kg boluses. Her lactate downtrended to 3.3 from 8.5. She was transferred to hospital for management of her dehydration and metabolic acidosis secondary to diarrhea. To note, she has had household contact with diarrhea (twin with diarrhea as well) and recent 2 month vaccine shots including rotavirus.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Tachycardia
Clinical narrative: Patient is an 11 week ex-35w6d di-di twin who presented on 9/4/2020 with 2 days of diarrhea and one day of altered mental status/sleepiness/decreased alertness found to be hyperglycemic, acidotic (non gap), and tachycardic to HR211 concerning for severe dehydration vs hypovolemic shock. Initial had hyperglycemia to 452 and reported somnolence concerning for DKA, however hyperglycemia resolved by report Glucose 78 in ED following 4 x 10ml/kg boluses. Her lactate downtrended to 3.3 from 8.5. She was transferred to hospital for management of her dehydration and metabolic acidosis secondary to diarrhea. To note, she has had household contact with diarrhea (twin with diarrhea as well) and recent 2 month vaccine shots including rotavirus.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache
Clinical narrative: She had severe headache for 4-5 days
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Headache, Migraine with aura, Retinal migraine
Clinical narrative: First Ever episode of retinal migraine involving loss of vision entire right visual field.  Severe headache. Lasted > 6 hours.   Started less than 24 after shot.  Several very minor visual  migraines over following week,  without HA.  1 week later:  2nd retinal migraine right eye with HA lasting 4+ hours.
Age: 61.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Feeling abnormal, Feeling hot
Clinical narrative: PATIENT STATES THAT HE FEELS LIKE HE HAS A "BLISTER" FROM HIS CHEST TO THE TOP OF HIS HEAD.  HE STATES THAT HIS FACE IS RED AND HOT
Age: 29.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Tremor
Clinical narrative: A contract employee came in on 8/18/20 for both an MMR and a Varicella Zoster shot, since he was not immune to Mumps, Rubella nor Varicella when his titers were checked, and he did not have immunization records. After receiving the MMR shot and then the VARIVAX shot, the employee started feeling lightheaded. Had him lower his head down between his knees, applied an icepack to his neck and had him breathe slowly in through his nose and out his mouth. After about 10 minutes, the employee did not feel any better and thought he might pass out, so the RN assisted him to the floor of the clinic and raised his legs up onto the seat of a chair.  A few minutes later, his legs started shaking (tremors).  He stated he had never had a seizure nor this type of reaction.  A few minutes later, his arms then also started shaking (tremors). . All along this RN kept asking if he was experiencing trouble breathing, swelling of his tongue or throat, or itching., which he denied throughout.  RN continued to check his vitals and at 1005: BP (132/80), heart rate (92) and pulse ox (88%). RN called the ER charge RN at 1007, who recommended RN call a MET, which was called at 1008. The MET arrived within a couple of minutes and assessed the EE and took him by wheelchair to the ED.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Patient arrived to drop-in immunization clinic with mother. Patient was due for TDaP booster per his historical record. Immunization reviewed with mother, mother gave verbal consent. Immunization screening questions were reviewed, and no contraindications noted. 5 rights reviewed. TDaP vaccine administered per protocol in patient's right deltoid. Approximately 15 seconds after administration, patient postured backward rigidly while seated in his chair. He then slumped over to his right side, and was caught by me. Patient did not fall out of his chair, did not hit the floor, and did not hit his head. Patient was placed seated back in his chair and was A&O x4, but stated he felt "funny and dizzy," and stated he had positive LOC. Skin pale, cool, and clammy. VS taken immediately, all WNL except for BP which was low. Patient was placed onto exam table to lay down and VS were reassessed q5 minutes. Pt was given juice and crackers, and given O2 at 8LPM via face mask. BP did not normalize despite supine positioning, O2, and juice. Pt stated he felt "a little better" after juice and crackers, but still felt dizzy, and that his "head felt funny." Charge nurse was unavailable, but resource RN notified. Pt still A&O x4 but very slow to respond, and skin signs had not improved. Paramedics called, and patient was transported to medical center with mother's consent. All communication assisted with public health staff. Public health RN supervisor notified.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Opisthotonus, Pallor, Posture abnormal, Slow response to stimuli
Clinical narrative: Patient arrived to drop-in immunization clinic with mother. Patient was due for TDaP booster per his historical record. Immunization reviewed with mother, mother gave verbal consent. Immunization screening questions were reviewed, and no contraindications noted. 5 rights reviewed. TDaP vaccine administered per protocol in patient's right deltoid. Approximately 15 seconds after administration, patient postured backward rigidly while seated in his chair. He then slumped over to his right side, and was caught by me. Patient did not fall out of his chair, did not hit the floor, and did not hit his head. Patient was placed seated back in his chair and was A&O x4, but stated he felt "funny and dizzy," and stated he had positive LOC. Skin pale, cool, and clammy. VS taken immediately, all WNL except for BP which was low. Patient was placed onto exam table to lay down and VS were reassessed q5 minutes. Pt was given juice and crackers, and given O2 at 8LPM via face mask. BP did not normalize despite supine positioning, O2, and juice. Pt stated he felt "a little better" after juice and crackers, but still felt dizzy, and that his "head felt funny." Charge nurse was unavailable, but resource RN notified. Pt still A&O x4 but very slow to respond, and skin signs had not improved. Paramedics called, and patient was transported to medical center with mother's consent. All communication assisted with public health staff. Public health RN supervisor notified.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Movement disorder, Pain in extremity
Clinical narrative: Headache; fingers on left hand were numb; very intense pain in left arm; unable to move arm for 2 days.  Symptoms lasted 3 days- the 4th day was much better but still had lingering s/s- resolved by day 5.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient called the day after the vaccine stating his arm was sore and he had body aches.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: Patient reported having sores in his mouth. He was advised that this is not a likely side effect of this vaccine, but he was positive that it was the only change in the last week, so we reported it just in case.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient said that her arm got red and hot approx. 4 inches below her shoulder and 2 inches above her elbow.  The area of concern was below where she received the shot.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: right tricep pain, swelling, heat, redness extending from underarm to elbow for 3 days, much better on the 4th day. Full body muscle aches starting 12 hrs after injection, tiredness, stomach ache lasting 2 days then went away.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Myalgia
Clinical narrative: right tricep pain, swelling, heat, redness extending from underarm to elbow for 3 days, much better on the 4th day. Full body muscle aches starting 12 hrs after injection, tiredness, stomach ache lasting 2 days then went away.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Moderate stomach aching lasting 2 days, moderate diaherra lasting 12 hours. Sore right tricep, swelling, redness, heat 4 inch circumference lasting 3 days, 4th day was much better.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Injection site warmth
Clinical narrative: Moderate stomach aching lasting 2 days, moderate diaherra lasting 12 hours. Sore right tricep, swelling, redness, heat 4 inch circumference lasting 3 days, 4th day was much better.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Vaccine given with Shingrix diluent and no antigen, no symptoms reported to date.
Age: 91.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports having sore/painful arm after injections, arm swelled up but better now. Injections were administered 9/7/2020 around 10:30am, both into her left arm, patient contacted pharmacy regarding side effects on 9/8/2020 at 10:20am. Patient reports putting cream on her arm and that helped it feel better and that her arm has gotten better, not worse. Patient reports no notable side effects from any immunization in the past.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Exposure via eye contact, Exposure via skin contact, Eye irrigation
Clinical narrative: Patient was receiving Fluzone Quad injection at pharmacy by pharmacist using a pre-filled syringe. The injection did not enter the patient's arm but instead the full volume sprayed on his shoulder, neck, and face, including in his left eye. (Patient did not sense the needle actually piercing his arm at any point.)  While pharmacist went to get paper towels, patient found his way to a sink to irrigate his eye and wash his skin. Another pharmacist provided a bottle of eye rinse for further irrigation.  Subsequently, a new pre-filled syringe was used by a new pharmacist to administer the vaccination.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Eye irritation
Clinical narrative: Patient was receiving Fluzone Quad injection at pharmacy by pharmacist using a pre-filled syringe. The injection did not enter the patient's arm but instead the full volume sprayed on his shoulder, neck, and face, including in his left eye. (Patient did not sense the needle actually piercing his arm at any point.)  While pharmacist went to get paper towels, patient found his way to a sink to irrigate his eye and wash his skin. Another pharmacist provided a bottle of eye rinse for further irrigation.  Subsequently, a new pre-filled syringe was used by a new pharmacist to administer the vaccination.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Exposure via eye contact, Exposure via skin contact, Needle issue, Syringe issue, Underdose
Clinical narrative: Patient was receiving Fluzone Quad injection at pharmacy by pharmacist using a pre-filled syringe. The injection did not enter the patient's arm but instead the full volume sprayed on his shoulder, neck, and face, including in his left eye. (Patient did not sense the needle actually piercing his arm at any point.)  While pharmacist went to get paper towels, patient found his way to a sink to irrigate his eye and wash his skin. Another pharmacist provided a bottle of eye rinse for further irrigation.  Subsequently, a new pre-filled syringe was used by a new pharmacist to administer the vaccination.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Petechiae, Rash, Urticaria
Clinical narrative: patient states had an allergic reaction - developed urticaria, petechia, and rash similar to dematitis
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: THE PATIENTS WIFE CONTACTED THE PHARMACY VIA TELEPHONE AND STATED THE PATIENT IS EXPERIENCING A RASH AT THE INJECTION SITE. THE RASH IS COVERING HIS LOWER SHOULDER AND UPPER ARM. THE PATIENT IS NOT EXPERIENCING SWELLING OR RASH ON NECK, MOUTH , FACE OR THROAT. THE PATIENT IS NOT HAVING DIFFICULTY BREATHING.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: The patient reported experiencing a small rash on deltoid at injection site the day after the injection.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Capillary nail refill test, Chills, Erythema, Injection site erythema, Injection site vesicles
Clinical narrative: Pt reports redness at injection site and chills over the weekend. Reports to clinic today with redness/warmth/edema measuring 8.5x8", also has cluster of blisters on anterior left bicept area. Pulses and cap refill normal. Adved to alternate cold compress to help with ithc and warm compress to help with fluid movement. Started on 40mg prednisone x 3days and precautionary keflex BID x7 days
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Oedema, Skin warm
Clinical narrative: Pt reports redness at injection site and chills over the weekend. Reports to clinic today with redness/warmth/edema measuring 8.5x8", also has cluster of blisters on anterior left bicept area. Pulses and cap refill normal. Adved to alternate cold compress to help with ithc and warm compress to help with fluid movement. Started on 40mg prednisone x 3days and precautionary keflex BID x7 days
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Muscular weakness, Pain in extremity
Clinical narrative: Patient complained of severe pain and weakness of her arm and shoulder after receiving vaccine from our pharmacy intern a week after she received it.  After a second week of rest, she continued to complain of pain and weakness that is worse at night and morning and gets better during the day.
Age: 65.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site is red and swollen and warm - 2 inch diameter round area
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vomiting
Clinical narrative: PATIENT FELT DIZZY INTERMITTENTLY AFTER VACCINE ADMINISTRATION. SHE ALSO HAD VOMITTING. SHE WAS ACCOMAPNIED BY MOM. MOM SAID SHE HAD FELT DIZZY IN THE PAST AS WELL AFTER INJECTIONS OR BLOOD DRAW. SHE DID NOT HAVE ANY KNOWN HEALTH CONDITION AND WAS NOT ANY MEDICATION EITHER.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Vaccination complication
Clinical narrative: pt here with c/o she got a reaction to the vaccine.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching on leg around injection site starting 3 days after and improving 3 days later
Sex: M
Vaccine: HEP
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Mononucleosis heterophile test negative
Clinical narrative: Headache, fever 102.1F, Body aches and fatigue, also c/o chills and sweats. Symptoms started 9/1/2020 @ night. 9/4/20 developed lacy rash EE was sent for Covid 19 testing 9/2/20 (-) result
Sex: M
Vaccine: HEP
Symptoms: Pain, Pyrexia, Rash, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Headache, fever 102.1F, Body aches and fatigue, also c/o chills and sweats. Symptoms started 9/1/2020 @ night. 9/4/20 developed lacy rash EE was sent for Covid 19 testing 9/2/20 (-) result
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Atrial fibrillation, Dizziness, Electrocardiogram abnormal, Hypotension
Clinical narrative: Patient returned to office 5 hours later due to low blood pressure, dizziness, and weakness. EKG was done in office which showed AFIB. Patient was sent to ER after.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: No adverse event
Clinical narrative: Pt. received several vaccines during doctor's visit. No reaction noted during vaccine administration. Medical Assistant noticed she had given an Adult dose of HepA instead of pediatric dose. Medical Assistant informed LVN. LVN called vaccine manufacturer and informed medical provider. As per Glaxo Smith Kline, no adverse reaction to pt.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: fever, red/swollen/painful injection site got tetanus booster on 4/16/19 and developed fever the next day; had continued fevers for the following few days and a red/swollen/painful injection site; continues to take ibuprofen and tylenol to keep pain and fever down.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Mom noticed a swelling of the area, it increased in size & redness. Next morning whole are was swollen.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site haemorrhage
Clinical narrative: Medical Assistant states pt. started bleeding immediately after she administered The vaccine. MA states that as she was wiping The blood from the pts. arm she noticed hematoma. MA notified provider. 67 Years Male here for f/u. pt has cardio eval and was told everything was normal (no report). pt endorses occasional dizziness with standing and on hot days working out doors. h/o dizziness last 2 mins. occur from sitting to standings. h/o fatigue. h/o hypothyroidism has fatigue denies heat/cold intolerance HTN - Denies headache chest pain leg swelling.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: PT reported pain, redness & extreme swelling. Resolved in a few days
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Day of Prevnar shot, pt started with tingling of hand, pain & fatigue. By 9/3/20, Thursday, the injection site now red/swollen & itching. She called our store to report adverse reaction on 9/6. She ended up going to the clinic. She was given Kefex for cellulitis. Her injection site was swollen about 4x6 in size on 9/6/20. She was told by the NP that her shot may be given too low on her deltoid. She also post a picture to her family doctor & concerned with NP assessment. When I spoke to her on 9/7, she said her injection site has increased to about 5x6 inches but no fever. She'll take the Keflex & follow-up with her family doctor. I asked her to keep me posted in her progress.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Paraesthesia
Clinical narrative: Day of Prevnar shot, pt started with tingling of hand, pain & fatigue. By 9/3/20, Thursday, the injection site now red/swollen & itching. She called our store to report adverse reaction on 9/6. She ended up going to the clinic. She was given Kefex for cellulitis. Her injection site was swollen about 4x6 in size on 9/6/20. She was told by the NP that her shot may be given too low on her deltoid. She also post a picture to her family doctor & concerned with NP assessment. When I spoke to her on 9/7, she said her injection site has increased to about 5x6 inches but no fever. She'll take the Keflex & follow-up with her family doctor. I asked her to keep me posted in her progress.
Age: 54.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased, Pyrexia
Clinical narrative: Swelling that spread on (L) deltoid, fever, warmth, painful, decreased ROM of (L) arm Pain started same day of injection fever swelling to follow, had been getting worse
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel that was administered to patients after it underwent a temperature excursion of 30 degrees F/NO AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 25 years male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5667AA, expiry date-26-Sep-21) after it underwent a temperature excursion of 30 degrees Fahrenheit on 26-Aug-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  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 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.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel that was administered to patients after it underwent a temperature excursion of 30 degrees F/NO AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 75 years male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5667AA, expiry date-26-Sep-21) after it underwent a temperature excursion of 30 degrees Fahrenheit on 25-Aug-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  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 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.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel that was administered to patients after it underwent a temperature excursion of 30 degrees F/NO AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 71 years female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5667AA, expiry date-26-Sep-21) after it underwent a temperature excursion of 30 degrees Fahrenheit on 25-Aug-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  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 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.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Seizure
Clinical narrative: seizure; Information has been received from FDA(VAERS ID 829669) on 18-AUG-2020.   This spontaneous report as received from a registered nurse and refers to a 11-year-old female patient. The patient's concurrent conditions included asthma, rhinitis allergic and peanut allergy. Her concomitant therapies included levalbuterol hydrochloride (XOPENEX), montelukast sodium (SINGULAIR), budesonide (PULMICORT) and an unspecified therapy.   On 14-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R032766 dose 1, intramuscular in the right arm), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as Tdap) and meningococcal acyw conj vaccine (crm197)(MENVEO). On 18-AUG-2019, 3 days 14 hrs after onset of therapy the patient experienced seizure, which required Emergency Room visit and then was hospitalized. The patient had no prior history of seizures.   The outcome of seizure was reported as recovered. The causality between the adverse event and the suspect products was not provided.  Follow-up information was received from the nurse on 02-SEP-2020. The nurse stated that there was no patient name or date of birth therefore, they were unable to provide any information regarding the situation. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R032766; expirationdate: 31-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Possible gastroenteritis; Severe abdominal pain; Profusely vomiting; Information has been received from the agency (VAERS 830040) on 18-AUG-2020.  This spontaneous report was received from a registered nurse concerning a 14-year-old non-pregnant female patient. The patient did not have prescription for over the counter medications, dietary supplements or herbal remedies. He did not have known allergies, chronic or longstanding health conditions or other illnesses at the time of vaccination. The patient did not experience adverse events following previous vaccinations.  On 21-AUG-2019 at 14:22, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular route in the right arm, lot number R009614 with expiration date internally validated as 30-NOV-2020 for prophylaxis (dose and strength were not reported).  The patient's mother called stating that when they arrived at cross country running practice, on the same date at approximately 16:00, the patient began profusely vomiting and was complaining of severe abdominal pain. She denied that had been running yet and that had otherwise been healthy. Additionally, denied respiratory distress, hives, rash or other signs of possible allergic reaction. Due to severity of symptoms, was advised to be seen in emergency department (ER). The patient was taken to ER, where they gave her ondansetron (ZOFRAN) and intravenous fluids (IVF). The diagnosis was a possible gastroenteritis and was discharged 4 hours later.     At the reporting time, the patient recovered from the reported events on an unspecified date in August 2019. The reporter did not provide causality assessment between the reported events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The agency considered this report to be non-serious.  Follow-up information has been received from a registered nurse on 03-SEP-2020, she stated that there was no identifying information on the patient, therefore she could not be able to fill out the forms.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Nausea, Pain in extremity
Clinical narrative: Per patient, every since he recieved his vaccination he's been getting left arm pain that goes from his shoulder down to his fingers, and nausea. He's tried Tylenol to relieve the pain, but it just comes back when the Tylenol wares off. This can be a common side effect for the vaccine, but it's been nearly 5 days and he's still feeling these side effects.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Feeling abnormal, Feeling hot, Headache, Malaise
Clinical narrative: My 12-yr old started having symptoms around 6 pm (10 hours after receiving the flu shot).  She complained of a headache (which she never gets), a stomache-ache, and generally not feeling good. She went to bed around 10 pm (which is early for her, but she wasn't feeling well). Around  12:30 am she came downstairs because she felt like she was going to vomit. I  checked her temperature because she looked ill and felt hot. She had a fever of 101.2. I gave her 500mg of Tylenol and she went back to bed. At 1:00 am she came downstairs again and complained that she can't sleep because she feels more like vomiting and her head is pounding.  Her fever went down to 100.2.  There is no outcome yet as she is still experiencing  symptoms.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Sleep disorder
Clinical narrative: My 12-yr old started having symptoms around 6 pm (10 hours after receiving the flu shot).  She complained of a headache (which she never gets), a stomache-ache, and generally not feeling good. She went to bed around 10 pm (which is early for her, but she wasn't feeling well). Around  12:30 am she came downstairs because she felt like she was going to vomit. I  checked her temperature because she looked ill and felt hot. She had a fever of 101.2. I gave her 500mg of Tylenol and she went back to bed. At 1:00 am she came downstairs again and complained that she can't sleep because she feels more like vomiting and her head is pounding.  Her fever went down to 100.2.  There is no outcome yet as she is still experiencing  symptoms.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injection site pain, Muscle spasms, Nausea, Pain
Clinical narrative: Body aches, chills, nausea and cramping.  Injection site soreness. No fever
Age: 48.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Asthenia, Back pain, Blister, Burning sensation, Hypersensitivity
Clinical narrative: On 9/3 went from dental office to pharmacy in the afternoon to fill prescriptions for amoxicillin and ibuprofen. Decided to get shots for flu and pneumonia while there. Went back to hotel and took the medications twice before going to bed. Slept well and woke up feeling good on 9/4.   Continued taking medications, but began to develop a fever in the evening which soon became very high (didn't have a thermometer).   The next day (9/5) the fever continued to run very high and my arm which was already sore at the spot of the injections (upper left arm) became much sorer and aches spread to my back and down my arm to elbow. Continued taking the amoxicillin until the end of day and then decided to discontinue.   Next day (9/6) the fever subsided and muscle soreness got steadily better. Large light red "bruise" color appeared visible on my inner left arm covering most of the biceps down to the elbow. As the fever subsided, I felt a general allergic response that felt like it was taxing my adrenals (as a lifelong asthmatic, allergy, eczema sufferer I know this feeling, except this felt stronger than normal and made me weak).   On 9/7, the skin on back of my hands and fingers became very thick and swollen (both hands). By the end of the day, small blisters were forming all over the swollen areas. They did not itch like eczema, though there was a slight burning sensation so I iced them down periodically and continued taking ibuprofen to control inflammation.  On 9/8, the blistered areas started to ooze liquid that has a distinct odor (almost smells like industrial oil or lubricant). The ares are starting to dry out a bit and the burning is getting more pronounced. I presume this is part of the healing process. I can still feel a bit of overall allergy response (that adrenal feeling) but less than before.  Finally, I want to add that I get the flu shot every year (for past two decades) and have received many other vaccines including previous ones for pneumonia, hepatitis, and pretty much everything else that was available. I have NEVER had a reaction before to any of them. Usually I barely even experience any soreness at the site of the injection let alone anywhere else.
Age: 48.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Injection site bruising, Injection site pain, Myalgia, Pyrexia, Skin hypertrophy
Clinical narrative: On 9/3 went from dental office to pharmacy in the afternoon to fill prescriptions for amoxicillin and ibuprofen. Decided to get shots for flu and pneumonia while there. Went back to hotel and took the medications twice before going to bed. Slept well and woke up feeling good on 9/4.   Continued taking medications, but began to develop a fever in the evening which soon became very high (didn't have a thermometer).   The next day (9/5) the fever continued to run very high and my arm which was already sore at the spot of the injections (upper left arm) became much sorer and aches spread to my back and down my arm to elbow. Continued taking the amoxicillin until the end of day and then decided to discontinue.   Next day (9/6) the fever subsided and muscle soreness got steadily better. Large light red "bruise" color appeared visible on my inner left arm covering most of the biceps down to the elbow. As the fever subsided, I felt a general allergic response that felt like it was taxing my adrenals (as a lifelong asthmatic, allergy, eczema sufferer I know this feeling, except this felt stronger than normal and made me weak).   On 9/7, the skin on back of my hands and fingers became very thick and swollen (both hands). By the end of the day, small blisters were forming all over the swollen areas. They did not itch like eczema, though there was a slight burning sensation so I iced them down periodically and continued taking ibuprofen to control inflammation.  On 9/8, the blistered areas started to ooze liquid that has a distinct odor (almost smells like industrial oil or lubricant). The ares are starting to dry out a bit and the burning is getting more pronounced. I presume this is part of the healing process. I can still feel a bit of overall allergy response (that adrenal feeling) but less than before.  Finally, I want to add that I get the flu shot every year (for past two decades) and have received many other vaccines including previous ones for pneumonia, hepatitis, and pretty much everything else that was available. I have NEVER had a reaction before to any of them. Usually I barely even experience any soreness at the site of the injection let alone anywhere else.
Age: 48.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Skin odour abnormal, Skin swelling, Skin weeping
Clinical narrative: On 9/3 went from dental office to pharmacy in the afternoon to fill prescriptions for amoxicillin and ibuprofen. Decided to get shots for flu and pneumonia while there. Went back to hotel and took the medications twice before going to bed. Slept well and woke up feeling good on 9/4.   Continued taking medications, but began to develop a fever in the evening which soon became very high (didn't have a thermometer).   The next day (9/5) the fever continued to run very high and my arm which was already sore at the spot of the injections (upper left arm) became much sorer and aches spread to my back and down my arm to elbow. Continued taking the amoxicillin until the end of day and then decided to discontinue.   Next day (9/6) the fever subsided and muscle soreness got steadily better. Large light red "bruise" color appeared visible on my inner left arm covering most of the biceps down to the elbow. As the fever subsided, I felt a general allergic response that felt like it was taxing my adrenals (as a lifelong asthmatic, allergy, eczema sufferer I know this feeling, except this felt stronger than normal and made me weak).   On 9/7, the skin on back of my hands and fingers became very thick and swollen (both hands). By the end of the day, small blisters were forming all over the swollen areas. They did not itch like eczema, though there was a slight burning sensation so I iced them down periodically and continued taking ibuprofen to control inflammation.  On 9/8, the blistered areas started to ooze liquid that has a distinct odor (almost smells like industrial oil or lubricant). The ares are starting to dry out a bit and the burning is getting more pronounced. I presume this is part of the healing process. I can still feel a bit of overall allergy response (that adrenal feeling) but less than before.  Finally, I want to add that I get the flu shot every year (for past two decades) and have received many other vaccines including previous ones for pneumonia, hepatitis, and pretty much everything else that was available. I have NEVER had a reaction before to any of them. Usually I barely even experience any soreness at the site of the injection let alone anywhere else.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chest pain, Cough, Headache, Oropharyngeal pain
Clinical narrative: General body aches started 9/4, note patient was using excavator starting 9/3  thru 9/7.  Body aches and head ache continued through 9/7.  Reported sx 9/8.  9/8 mild sore throat and temp  99.6, continued body aches and malaise, chest hurts with cough.  Per MD doubtful reaction to vaccine, ordered COVID testing, patient will consider testing but  insists "reaction to pneumonia vaccine".  Advised patient will complete VAERS.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: General body aches started 9/4, note patient was using excavator starting 9/3  thru 9/7.  Body aches and head ache continued through 9/7.  Reported sx 9/8.  9/8 mild sore throat and temp  99.6, continued body aches and malaise, chest hurts with cough.  Per MD doubtful reaction to vaccine, ordered COVID testing, patient will consider testing but  insists "reaction to pneumonia vaccine".  Advised patient will complete VAERS.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin irritation
Clinical narrative: Received vaccine on 9/4, noted redness and irritation on the 7th. Pt reported no itching or pain.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's reported; Gardasil 9 that had a temperature excursion and was administered; This spontaneous report was received from a registered nurse and refers to an 11-year-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On 25-AUG-2020, the patient was vaccinated with the first dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S020254, expiration date: 09-DEC-2021; dose, route of administration and anatomical location were not reported) for prophylaxis. On 19-AUG-2020, the vaccine had a temperature excursion and was not supported. The vaccine was exposed to temperature below 2 Celsius degrees (-1.0 Celsius degrees) for 18 hours and 13 minutes; digital data logger was involved. There was no previous temperature excursion. It was the first dose out of a 3 dose series. No additional adverse events (AE's) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability