chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP, FLUX, HPV9, MEN
Symptoms: Concussion, Head injury, Loss of consciousness
Clinical narrative: The patient passed out; hit her head; concussion; This spontaneous report has been received from a physician via a company representative referring to a 12 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 16-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S022598, by intramuscular route (strength, dose, frequency, and anatomical location were not provided) for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus, meningococcal vaccine (unspecified), and influenza virus vaccine. On the same date, the patient passed out and hit her head (loss of consciousness, concussion and head injury). The outcome of loss of consciousness, concussion and head injury was unknown. The causality assessment was not provided.  Upon internal review, loss of consciousness was determined to be medically significant. 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: S022598; expirationdate: 25-FEB-2022; 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
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 77 year old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In September 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy (strength, dose, frequency, lot # and expiration date were not reported). As a result of her receipt of zoster vaccine live (ZOSTAVAX) on 28-SEP-2016, the patient was caused to suffer shingles, including any and all of its sequelae. On or about 08-May-2016, the patient was treated at the hospital by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a result of her receipt of zoster vaccine live (ZOSTAVAX) the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 29-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Cerebellar ataxia, Computerised tomogram normal, Dysstasia, Gait disturbance
Clinical narrative: acute cerebellar ataxia; vomiting; rectal temperature of "101" was recorded; it was mentioned that patient might have a viral infection; This spontaneous report was received from a physician via employee, referring to a 12-month old male patient. The patient's medical history and concurrent condition were unknown. Concomitant medication included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR).    On 01-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. Other suspect therapies included sterile diluent.   On 15-SEP-2020 (reported as about 2 weeks after vaccine administration), the patient experienced acute cerebellar ataxia and he had a hard time standing with unsteady gait. On an unknown date in September 2020, patient's mom reported to the physician that patient was vomiting. The physician referred the mom to an urgent care. On 18-SEP-2020, the patient visited urgent care, and then went to the emergency room (ER), possibly on the same date as 18-SEP-2020. In the ER, rectal temperature of 101 (unit unknown) was recorded. It was mentioned that patient might have a viral infection. A computerized axial tomography (CAT) scan was done at unknown date in September 2020, which turned up negative. Patient was sent home after CAT Scan. Patient's parent contacted the physician again, and physician recommended seeing a neurologist. On an unknown date in September 2020, the patient was admitted to the hospital where a virology panel would possibly be done. It was unknown if patient was still hospitalized. The outcome of all events was unknown. The causality between all events and suspect drug was not provided.
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: acute cerebellar ataxia; vomiting; rectal temperature of "101" was recorded; it was mentioned that patient might have a viral infection; This spontaneous report was received from a physician via employee, referring to a 12-month old male patient. The patient's medical history and concurrent condition were unknown. Concomitant medication included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR).    On 01-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. Other suspect therapies included sterile diluent.   On 15-SEP-2020 (reported as about 2 weeks after vaccine administration), the patient experienced acute cerebellar ataxia and he had a hard time standing with unsteady gait. On an unknown date in September 2020, patient's mom reported to the physician that patient was vomiting. The physician referred the mom to an urgent care. On 18-SEP-2020, the patient visited urgent care, and then went to the emergency room (ER), possibly on the same date as 18-SEP-2020. In the ER, rectal temperature of 101 (unit unknown) was recorded. It was mentioned that patient might have a viral infection. A computerized axial tomography (CAT) scan was done at unknown date in September 2020, which turned up negative. Patient was sent home after CAT Scan. Patient's parent contacted the physician again, and physician recommended seeing a neurologist. On an unknown date in September 2020, the patient was admitted to the hospital where a virology panel would possibly be done. It was unknown if patient was still hospitalized. The outcome of all events was unknown. The causality between all events and suspect drug was not provided.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient used to work in the medical field and they required for all employees to get the flu shot. Every time the patient got the vaccine, the patient got sick. The patient had not gotten the flu shot in three years and had not exerienced the flu.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness unilateral
Clinical narrative: Hearing loss; This case was reported by a physician via call center representative and described the occurrence of hearing loss in a 46-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number N9A39, expiry date 30th June 2021) for prophylaxis.   On 11th September 2020, the patient received FluLaval Tetra 2020-2021 season. On 11th September 2020, 3 hrs 30 min after receiving FluLaval Tetra 2020-2021 season, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows:  The patient received Flulaval quadrivalent and 3.5 hours after vaccination experienced hearing loss in right ear. No additional information was reported. The vaccine administration facility was same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Pain; Fatigue; Headache; This is a spontaneous report from a contactable other hcp via Pfizer Sales representative  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain, fatigue, headache. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tinnitus, Tremor
Clinical narrative: Fever of 102.7 with chills and shaking that lasted for 5 hours and ringing in the ears (tinnitus) that has not yet resolved.
Age: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: Malaise, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Pt was immunized with FluBLOK Quadrivalent, which is indicated for patients 18 and over and this pt is 9 years old. As of 9/29/2020 pt has experienced sore arm and malaise.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Expired product administered
Clinical narrative: Administered Expired dose. I week passed expiration date
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: Pt had arm swell up to an extensive degree. He came back immediately to the clinic that same day within 2 hours later with swollen arm. Pt was told to return home and use antihistamines. (Zyrtec and Benadryl) Pt went to school the next day. Arm swollen down to the elbow and up through shoulder. School nurse called mother around 9am to return pain and swelling. Pt went on with his day. He then had a syncopal episode where he lost consciousness while putting things into his locker.  This happened around 1045 am. He was then brought to the ER by ambulance. He was alert and oriented upon arrival to the ED.  He was given IM steroid per weight and sent home on a tapering dosing of oral steroids. Pt's arm remains swollen on assessment.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyskinesia, Tremor
Clinical narrative: The patients said that she had chills and shaking all night long and with jerking of her left arm.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine I week after expiration
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Eye swelling, Lacrimation increased, Pruritus
Clinical narrative: Shortly after getting flu shot at our drive through clinic, patient developed swelling and watering of eyes, facial swelling, coughing, wheezing and chest and throat tightness.  She administered her EpiPen and symptoms all resolved within one hour.  The following day, she woke up with hives and severe itching body wide, this resolved 30 minutes after taking oral bendadryl.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Throat tightness, Urticaria, Wheezing
Clinical narrative: Shortly after getting flu shot at our drive through clinic, patient developed swelling and watering of eyes, facial swelling, coughing, wheezing and chest and throat tightness.  She administered her EpiPen and symptoms all resolved within one hour.  The following day, she woke up with hives and severe itching body wide, this resolved 30 minutes after taking oral bendadryl.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor, Seizure
Clinical narrative: Patient was given 2 injections in right arm without any issues.  Patient passed out immediately after HPV shot was given in left arm.  She was laid down on table and convulsed for about 2 seconds.  Her lips turned white and she was out for about 30-45 seconds.  A wet towel was placed on forehead and she was able to communicate with us.  Patient sat up after a couple of minutes and was okay.  She admitted that she had not eaten since breakfast that morning.  She was walking around and talking without issue within minutes.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Chills, Dizziness, Fall, Loss of consciousness
Clinical narrative: Patient received two immunizations yesterday: pneumovax and HD influenza vaccine. She called this morning and stated she woke up at 1:30 this morning and had chills. She stated she proceeded to take a shower and while she was in the shower she was sitting on her shower chair because she felt dizzy and she slid off her chair and "blacked out". She also reported lack of energy, nausea, and vomiting and generalized weakness. She also stated that she tweaked her back a few days ago and didn't know if that was contributing to her weakness. I advised her to make sure she was staying hydrated, resting, and make sure she had someone there to keep an eye on her. She stated her husband was there and taking care of her. She did say that she was feeling a little better but still was a little nauseated and dizzy. I also made sure she called her provider to notify them of her reaction and "black out." Patient did report being on Eliquis and I advised her that having any type of fall while on that type of medication could be detrimental and was essential to follow up with her doctor. She voiced understanding and stated she would call them after speaking to me.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Patient received two immunizations yesterday: pneumovax and HD influenza vaccine. She called this morning and stated she woke up at 1:30 this morning and had chills. She stated she proceeded to take a shower and while she was in the shower she was sitting on her shower chair because she felt dizzy and she slid off her chair and "blacked out". She also reported lack of energy, nausea, and vomiting and generalized weakness. She also stated that she tweaked her back a few days ago and didn't know if that was contributing to her weakness. I advised her to make sure she was staying hydrated, resting, and make sure she had someone there to keep an eye on her. She stated her husband was there and taking care of her. She did say that she was feeling a little better but still was a little nauseated and dizzy. I also made sure she called her provider to notify them of her reaction and "black out." Patient did report being on Eliquis and I advised her that having any type of fall while on that type of medication could be detrimental and was essential to follow up with her doctor. She voiced understanding and stated she would call them after speaking to me.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Haemorrhage
Clinical narrative: Patient came back to Pharmacy on 9/29/20  to report that a vaccine he received on 9/22/20 has bruised his arm. He reported no pain or fevers or chills just bruising that had not yet resolved.  He said it had been bleeding  when he went home later that day but the bleeding subsided.  He was advised to check in with his doctor to have it assessed.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site rash, Palpitations, Pyrexia, Rash
Clinical narrative: Patient had rash on left arm (from armpit to elbow) starting the night he received the vaccine. He reported a rash, fever, chills, and heart palpitations.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient experienced vasovagal syncope. Became lightheaded almost immediately and then passed out shortly after while still sitting in chair. Was in and out for a few minutes. Had her lay on ground until she felt well enough to get up (approx. 10 minutes)
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Mom said her daughter experienced pain/tingling at the site an down her arm sunday after the shot and into today, 2 days later.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Infection, Pain in extremity, Peripheral swelling
Clinical narrative: patient had swelling, redness, and pain on upper arm. patient tried advil and benadryl. pat went to urgent care. urgent care thinks its an infection
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Adverse reaction, Near death experience
Clinical narrative: horrible reactions/If they had been frail it would have killed them; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.   Additional details were as follows: The age at vaccination was not applicable. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingles vaccine, flu vaccine and pneumonia vaccine  and experienced horrible reactions. It was unknown if the reporter considered the near death experience to be related to Pneumonia vaccine. This case has been linked to US2020AMR189618, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189618:same reporter
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: While I didn't believe my allergic reaction to be severe, so did not call my doctor, I thought it important to report this for your system records.  On May 7, 2018, I received the Pneumococcal Pcv13 Conj injection and had no adverse reactions.  On February 26, 2020, I received the Pneumococcal PPSV23 injection; however, the injection equipment failed (broke apart) during the injection and sprayed all over.  Therefore, it was unknown how much of the injection I actually received (again, I had no side effects).  My doctor stated she was going to check into whether or not I should have the injection redone.  At an appointment on August 10, 2020, she decided that I should receive another injection just to be on the safe
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site irritation
Clinical narrative: immunization was given on 9/21/20 - pt reported within hours area around immunization became bloody, and red, raw irritated. Area appeared to be in the same area  as the inject-safe barrier used. Patient showed pharmacy pictures today on 9/29/20 of bandage/arm. pt reported area fully healed.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms: headache, muscle aches, fatigue, shivers
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Severe swelling and pain at the injection site.  Hurt to move the arm.  Reaction was delayed and happened almost a week later.
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Syringe issue
Clinical narrative: vaccine came out the side of the syringe pt did not get dose. Pt had to have a second injection
Age: 1.42
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: fever and vesicular rash began 7-8 days after the vaccine; believed to be vaccine associated varicella
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: pt experiencing pain, bruising, swelling  from site of injection
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Irritability, Lymphadenopathy
Clinical narrative: Irritability; swollen neck lymph nodes; redness and swelling at site of injection
Age: 70.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Cardiac monitoring normal, Dyspnoea, Muscle spasms, Oxygen saturation normal, Pain
Clinical narrative: I am a pharmacist that gave this patient 3 shots. I gave him the flu vaccine and pneumonia in the right arm and the tdap in the left arm. When I just got finished giving the tdap in the left arm, the patient became unresponsive to me and was staring into space. I tried to gain his attention for a few seconds and he finally came back around and stated he was having trouble breathing.  At this point I was thinking I needed to get him to the ground but he refused. He slowly regained his breath then had several severe back spasms that was causing him significant pain. At this point I told the other pharmacist on duty to call EMS. The patient's back spasms subsided while we were waiting on EMS to arrive. EMS checked him out thoroughly with a heart monitor and they stated everything was normal. We released the patient after getting all of his information. He was doing fine.
Age: 70.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: I am a pharmacist that gave this patient 3 shots. I gave him the flu vaccine and pneumonia in the right arm and the tdap in the left arm. When I just got finished giving the tdap in the left arm, the patient became unresponsive to me and was staring into space. I tried to gain his attention for a few seconds and he finally came back around and stated he was having trouble breathing.  At this point I was thinking I needed to get him to the ground but he refused. He slowly regained his breath then had several severe back spasms that was causing him significant pain. At this point I told the other pharmacist on duty to call EMS. The patient's back spasms subsided while we were waiting on EMS to arrive. EMS checked him out thoroughly with a heart monitor and they stated everything was normal. We released the patient after getting all of his information. He was doing fine.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: PATIENT REPORTED A RASH BEGAN AROUND THE INJECTION SITE, THEN SPREAD TO HIS CHEST AND UPPER BODY. HE TOOK ONE DOSE OF BENADRYL. PATIENT THINKS IT MAY HAVE BEEN THE ADHESIVE ON THE BANDAGE, AS THE BANDAID IS LATEX FREE. PATIENT REPORTED THIS IS THE FIRST TIME THIS HAS HAPPENED AND HE HAS HAD THE FLU SHOT EVERY YEAR.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUA4, IPV, MMRV
Symptoms: Abdominal pain upper, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: fever of 101.2, sore throat and stomach pains, pain in both legs.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Ear pain, Hyperhidrosis, Muscle spasms, SARS-CoV-2 test negative
Clinical narrative: Received shot in right arm, started with intense ear ache in right ear, started having chills, spasms, ear ache worsened, used heating pad on ear, had chills all night, woke up with sweating.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Patient said their arm was so sore they could not lift it and had no range of motion.  Had to have physical therapy.  Will not get the second dose. Did see their physician who sent them to physical therapy.  Can now lift their arm.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Blood magnesium normal, Calcium ionised normal, Full blood count normal, Metabolic function test normal, Posture abnormal
Clinical narrative: New-onset seizure. This was the first time this patient had seizure (slumped over while mom was braiding her hair - had fixed pupils and was unresponsive for 10-15 seconds). In taking history, she may have been having absence seizures in the past, but it is not entirely clear at the time of history taking.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pupil fixed, Seizure, Unresponsive to stimuli
Clinical narrative: New-onset seizure. This was the first time this patient had seizure (slumped over while mom was braiding her hair - had fixed pupils and was unresponsive for 10-15 seconds). In taking history, she may have been having absence seizures in the past, but it is not entirely clear at the time of history taking.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Local reaction, Mass, Pain
Clinical narrative: Local reaction, redness, hard lump, warm to the touch, pain.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Local reaction, redness, hard lump, warm to the touch, pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Chest X-ray, Computerised tomogram head, Echocardiogram, Electroencephalogram
Clinical narrative: severe vomiting, severe headache, fatigue, followed by memory loss - short term
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Magnetic resonance imaging, SARS-CoV-2 test, Vomiting
Clinical narrative: severe vomiting, severe headache, fatigue, followed by memory loss - short term
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: - Burning sensation right after administration. - Arm  turned bright red and swollen the size of a baseball. - MD suggested ice and  prescribed Meloxicam for 7 days. - Swelling better after 14 days .
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: no symptoms of adverse event per family and patient is doing fine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: redness/swelling/heat in the arm.patient reported to dr and was given augmentin 875/125 mg for potential infection
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: a couple of hours after injection her entire upper arm started to swell and become hot to the touch. over the course of days it traveled down to her lower arm and part of her hand
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature fluctuation, Chills, Feeling of body temperature change, Headache, Hyperaesthesia
Clinical narrative: About 5 hours after receiving the flu vaccine, I experienced extreme sensitivity to touch on skin (feels like I?m sunburnt), extreme nausea and vomiting, headache, body aches and chills, headache, body temperature fluctuations (feel too hot when I feel cold or too cold when I feel too hot)
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: About 5 hours after receiving the flu vaccine, I experienced extreme sensitivity to touch on skin (feels like I?m sunburnt), extreme nausea and vomiting, headache, body aches and chills, headache, body temperature fluctuations (feel too hot when I feel cold or too cold when I feel too hot)
Age: 1.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINE GIVEN IN ERROR
Age: 13.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Injection site pain
Clinical narrative: Pt reports tolerating well injection given at 9:00 a.m. HPV was given on same arm pt reports soreness of injection site
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Vaccine was administered in left deltoid, patient immediately had a burning sensation and the feeling of fluid going down her arm, had numbness/tingling down arm, into palm and 3rd and 4th finger. Patient can move shoulder no obvious shoulder pain or discomfort reported. Taking tylenol and ibuprofen, applying  heat, which feels good, cold causes more discomfort. Patient was seen by MD on 9/28/2020 for evaluation.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Pain in right UE, shoulder/arm/elbow/forearm/to fingers after vaccination, lasted 3 days. Elbow/finger pain abated but shoulder discomfort remain, worse with certain movements.
Age: 72.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: pt stated 2 days after vaccination arm became, swollen, red and warm, pt's pcp was contacted and pt was prescribed an antibiotic and antihistamine
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: pt complained of a arm being achy and swollen
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm muscle where administered.  Headache (from an hour or two after administration to present--has not resolved and tylenol has not helped--will try ibuprofin). Low grade fever (99)/chills (first felt around 3:30 pm day after administration to present--perhaps didn't feel sooner because tylenol was working on fever, but not headache).  Other than the pain in the arm, which I expected from both shots, I've never experienced the other symptoms following a flu shot (and have had those most years over the last couple decades).
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Dry eye, Eye pruritus, Injection site erythema, Injection site induration, Sneezing
Clinical narrative: Patient stated that she had excessive sneezing since the vaccination. Warm at site of vaccine. 3 inch diameter of hardness and redness around site of vaccination. Experienced dry, itchy eyes. No fever, runny nose or cough. 3 days later, redness was subsiding.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Vaccination site warmth
Clinical narrative: Patient stated that she had excessive sneezing since the vaccination. Warm at site of vaccine. 3 inch diameter of hardness and redness around site of vaccination. Experienced dry, itchy eyes. No fever, runny nose or cough. 3 days later, redness was subsiding.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Crying, Fall, Musculoskeletal stiffness, Respiratory rate increased
Clinical narrative: Patient was given the shot and after he got up to look on his sister getting shot, he stepped away from vaccination area and fell on floor. Dad picked him up and he was stiff per dad. he started crying and i checked his breathing which was rapid i called 911 after consulting with mom. I grabbed epipen when he was on the floor but he was breathing so i did not adminster it, Mom says he has not had a flu shot since he was a baby. EMT came over he had conversation with parents and checked him out, parents declined to go to ER with child.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Pyrexia
Clinical narrative: Patient experienced a fever and weakness. Consulted with doctor who advised fever reducing medication.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Contusion, Nausea, Pain in extremity
Clinical narrative: Patient work up in the middle of the night feeling nausea and had arm pain  in joint . Patient noticed light bruising on inside of arm up to shoulder and over to breast area.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Hypersensitivity, Pruritus, Rash, Swelling of eyelid
Clinical narrative: Allergic reaction - rash with itching on hands, arms, feet, midsection, neck; swollen eyelids; cough and wheezing breathing starting at 6:30 pm (3.5 hrs after vaccine shot) Took Benedryl at 7:15 - 7:30 pm Called on-call PCP hotline and directed to go to ER for treatment Visited ER at 8:00 pm - treated with Banophen, Pepsid (Famotidine) and steroid (Prednisone) via IV port
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Wheezing
Clinical narrative: Allergic reaction - rash with itching on hands, arms, feet, midsection, neck; swollen eyelids; cough and wheezing breathing starting at 6:30 pm (3.5 hrs after vaccine shot) Took Benedryl at 7:15 - 7:30 pm Called on-call PCP hotline and directed to go to ER for treatment Visited ER at 8:00 pm - treated with Banophen, Pepsid (Famotidine) and steroid (Prednisone) via IV port
Age: 49.0
Sex: M
Vaccine: FLUR4
Symptoms: Diarrhoea, Myalgia, Vomiting
Clinical narrative: Muscle pain, vomiting, and diarrhea
Age: 73.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Chills, Tachycardia, Tremor, Vomiting
Clinical narrative: Per wife Patient is  experiencing  rigors, tremors, vomiting and tachycardia
Age: 73.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Chills, Electrocardiogram, Heart rate, Laboratory test, Nausea
Clinical narrative: Per wife Patient is  experiencing  rigors, tremors, vomiting and tachycardia
Age: 73.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Vomiting, X-ray
Clinical narrative: Per wife Patient is  experiencing  rigors, tremors, vomiting and tachycardia
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Fatigue, Induration, Influenza like illness
Clinical narrative: I woke up feeling flu-like symptoms but without a cough or nasal symptom. My left arm was very swollen, hot, hard sore, and had some red areas on the bicep and tricep area, a couple spots about 2 inches in diameter. I had a fever varying within 100.5-101.7 and severe fatigue and weakness.   The reason I am writing is that I started having difficulty breathing. No wheezing, cough, pain, congestion BUT I felt that I need to exert a lot of effort to breath and take very deep breaths. I put on a finger oxygen saturation measuring device. It consistently read below 90%, getting as low as 78%. With conscious effort of breathing deeply, I could get it back up to 99%, but natural breathing had it drop below 90%. This lasted hours. The device is a Bodimetrics pulse/oxymeter that I have been using for years and have worn for many hours and never saw readings like this. I bought the device for exercise. I put on a new finger probe and got the same readings. After several hours, my readings returned to normal. this wasn't an instrument error, I think my oxygen dropped and it was related to symptoms and fever in an apparent reaction to Shingrix. My fever and most symptoms were gone after a day, but weakness persisted a few days, then I recovered.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Oxygen saturation decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: I woke up feeling flu-like symptoms but without a cough or nasal symptom. My left arm was very swollen, hot, hard sore, and had some red areas on the bicep and tricep area, a couple spots about 2 inches in diameter. I had a fever varying within 100.5-101.7 and severe fatigue and weakness.   The reason I am writing is that I started having difficulty breathing. No wheezing, cough, pain, congestion BUT I felt that I need to exert a lot of effort to breath and take very deep breaths. I put on a finger oxygen saturation measuring device. It consistently read below 90%, getting as low as 78%. With conscious effort of breathing deeply, I could get it back up to 99%, but natural breathing had it drop below 90%. This lasted hours. The device is a Bodimetrics pulse/oxymeter that I have been using for years and have worn for many hours and never saw readings like this. I bought the device for exercise. I put on a new finger probe and got the same readings. After several hours, my readings returned to normal. this wasn't an instrument error, I think my oxygen dropped and it was related to symptoms and fever in an apparent reaction to Shingrix. My fever and most symptoms were gone after a day, but weakness persisted a few days, then I recovered.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: I woke up feeling flu-like symptoms but without a cough or nasal symptom. My left arm was very swollen, hot, hard sore, and had some red areas on the bicep and tricep area, a couple spots about 2 inches in diameter. I had a fever varying within 100.5-101.7 and severe fatigue and weakness.   The reason I am writing is that I started having difficulty breathing. No wheezing, cough, pain, congestion BUT I felt that I need to exert a lot of effort to breath and take very deep breaths. I put on a finger oxygen saturation measuring device. It consistently read below 90%, getting as low as 78%. With conscious effort of breathing deeply, I could get it back up to 99%, but natural breathing had it drop below 90%. This lasted hours. The device is a Bodimetrics pulse/oxymeter that I have been using for years and have worn for many hours and never saw readings like this. I bought the device for exercise. I put on a new finger probe and got the same readings. After several hours, my readings returned to normal. this wasn't an instrument error, I think my oxygen dropped and it was related to symptoms and fever in an apparent reaction to Shingrix. My fever and most symptoms were gone after a day, but weakness persisted a few days, then I recovered.
Age: 85.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Back pain, Dizziness, Feeling abnormal
Clinical narrative: Patient states she felt really dizzy and light-headed and felt a sharp pain in her lower back. We sat her down on a chair and gave her some water. We then checked her blood pressure and it was a normal reading. After a few minutes (about 5 or so minutes), patient states she felt better, not as dizzy and her back pain had subsided. She did not want us to call anyone for her. We called patient at her home about 30 minutes later and she said she felt better but her head still felt a little foggy and light headed.
Age: 85.0
Sex: M
Vaccine: FLUA4
Symptoms: Back pain, Blood pressure decreased, Diarrhoea, Neck pain, Syncope
Clinical narrative: Blood Pressure drop, fainted twice, severe pain in neck and back, diarrhea
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: Dizziness about 2.5 hr  after injection.  Almost passed out.  Had a less intense occurrence about 1 hr later.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient had significant bruising down and around her arm- above her elbow area in particular was worse than at the actual injection site. She also said there was pain in her arm for a couple days but that had resolved.
Age: 41.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient reported pain in arm/shoulder. She stated the pain started in her wrist after getting the vaccination and today her arm hurts. No fever reported.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Erythema, Influenza like illness, Nausea, Pain
Clinical narrative: Dizziness, nausea, redness, pain on entire left side, headache, flu like symptoms
Age: 70.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Abdominal pain, Chills, Hot flush, Myalgia, Nausea
Clinical narrative: Deathly ill with chills, fever, hot/cold flashes, abdominal pain, nausea, muscle aches
Age: 70.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Pyrexia
Clinical narrative: Deathly ill with chills, fever, hot/cold flashes, abdominal pain, nausea, muscle aches
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large red circular area at injection site immediately following injection that grew as days went on, lasted about 4 days, eventually bruised then came back a few days later as a red spot. Warm to the touch and hard under the skin. The day after shot, developed hives all over trunk, arms, legs, feet, hands, and back.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Large red circular area at injection site immediately following injection that grew as days went on, lasted about 4 days, eventually bruised then came back a few days later as a red spot. Warm to the touch and hard under the skin. The day after shot, developed hives all over trunk, arms, legs, feet, hands, and back.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Oral herpes, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, runny nose, chills and COLD SORE.duration.... 4 days
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: The patient had received the flu shot and later developed the redness on her arms and face.  As per the patient, it wasn't a rash, and the redness disappeared fairly quickly after taking a dose of benadryl.  She is fine now and is fully recovered.
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Body temperature increased, Chills, Cold sweat, Dyspnoea, Injection site erythema
Clinical narrative: Patient stated that she developed about a quarter sized slight redness at injection site, temperature that peaked at 101, shivering and clammy feeling, difficulty breathing and difficulty cathcing her breath
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Feeling abnormal, Pain
Clinical narrative: PATIENT HAD NO ADVERSE REACTION FOR 6 DAYS. ON THE 7TH DAY, PATIENT EXPERIENCED DULL, ACHEY PAIN ESPECIALLY AT NIGHT. SHE ALSO REPORTED THE FEELING OF THE URGE TO CRACK HER KNUCKLES.  HER INJECTION SITE IS NOT SWOLLEN AND NOT WARM. SHE HAS BEEN TAKING IBUPROFEN FOR THE DISCOMFORT AND IT DOES HELP.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Rash
Clinical narrative: The patient had a rash that started on the left shoulder that started 3 days after she received the vaccine. The following day, she had a rash on the right shoulder and her thigh. She has been taking diphenhydramine and using hydrocortisone to treat the rash.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Upper Left Arm is swelling with redness and no itching
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Patient experienced syncope after getting up from the chair approximately 3 minutes following vaccination
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: After receiving the flu shot, the patient developed adverse reactions of sore arm on the injection site, a low-grade fever, headache, nausea and vomiting.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose normal, Blood pressure decreased, Loss of consciousness, Syncope
Clinical narrative: Pt was given the shot and about a minute later started to faint in her chair. She regained consciousness in less than a minute. Paramedics were called and responded very quickly. Paramedics determined after gathering vitals and blood glucose that pt was alright, but should be seen by a physician tonight. Parents left pharmacy to take child to the hospital.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: My whole Arm became stiff and painful...I could not move my whole arm for the whole night...Then i got nauseous really bad and ran a fever of 101 for the whole night after and into the next day...I also kepted getting weird pain in my head everywhere and it was sharp . It was yesterday i got the shot but still feel very very weak, tired and pain in my arm and neck.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: My whole Arm became stiff and painful...I could not move my whole arm for the whole night...Then i got nauseous really bad and ran a fever of 101 for the whole night after and into the next day...I also kepted getting weird pain in my head everywhere and it was sharp . It was yesterday i got the shot but still feel very very weak, tired and pain in my arm and neck.
Age: 38.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Condition aggravated, Dizziness, Fear of injection, Loss of consciousness, Vomiting
Clinical narrative: I gave patient a flu shot and a Tdap today at 11:43 pm. After that she said she felt dizzy and passed out for a few seconds. I asked employee to call 911 and the ambulance came. While waiting for the ambulance, I taped on her shoulder and she woke up and she threw up water. She said she has a fear for needle a long time ago and she overcame it but may be not this time. She also didn't have food yet. After that she rested and her husband picked her up
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Haematoma
Clinical narrative: Pt received Prevnar 13 vaccine on 9/17, around 2pm. Later that evening she noticed a large bruise develop. She became concerned and consulted with her MD who confirmed it was a hematoma. The hematoma measure about 3-4 inches long and 2 inches wide. Spoke to pt on 9/22 and provided evidence to pharmacist on 9/24 confirming hematoma. Rph tried to follow up with patient on 9/29, but no response.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: Angioedema
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Dyskinesia, Injection site erythema, Injection site swelling
Clinical narrative: Presented to ED 4 days after administration of vaccination with redness and swelling of the right upper arm. He denies any fever, chills, night sweats, nausea, vomiting, diarrhea, or shortness of breath. He describes pain in the back sustained after jerking too quickly.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Fever & chill; tremor
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Syncope
Clinical narrative: Patient fainted 90 minutes after vaccination