chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Injection site haemorrhage, Vaccination site erythema
Clinical narrative: 2 days status post injection, erythema and ecchymosis noted in nearly band like distribution distal to the vaccination site.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Ear swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt had fever, vomiting, nausea, ear lobe swelling, possible urticaria
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Feeling abnormal, Hyperhidrosis, Lacrimation increased
Clinical narrative: 6 hours of feeling bad, nausea, eyes tearing, coughing, chill, sweats, no fever
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: 6 hours of feeling bad, nausea, eyes tearing, coughing, chill, sweats, no fever
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Gave the shot and the patient fainted
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient came into pharmacy to report he has a rash or hives that started in the arm he received his Shingrix vaccination in and then proceeded down the arm.  It then spread to the other arm and legs.  Patient treated it by taking over the counter Benadryl.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient stated next day arms was sore to touch and then was bruised for over 3 plus inches going down his arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: After  patient got the shingrix vaccine  she was ready to pick up her prescription.  She complained about dizziness and being not feeling good. We let patient  sit and patient started to lose conciouseness.  We called 911. Nurse practional came to help patient to lay down and gave  water and peanut butter bar. Patient got counscius afrer 2 minutes.  NP checked her vital sign, 128/82, pulse 72, oxygen 98. 911 came and double check her condition. Pt got feel better and left the store with her husband.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Shivering headaches fatigue chills and muscle aches
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Patient reported onset of mild/moderate tinnitus starting the evening of 10/17.   Patient called to report to pharmacy at 5:45PM on 10/21 and reports that symptoms have not resolved.  Patient was advised to follow up with health care professional for evaluation as soon as possible.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Dizziness, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Began feeling arm pain and stiffness 2 hours after injection. Lightheadedness, nausea, body aches and elevated temp@ 1500-19:00. Nausea and vomiting from 22:00-04:30.  body aches continued through 10/08
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Began feeling arm pain and stiffness 2 hours after injection. Lightheadedness, nausea, body aches and elevated temp@ 1500-19:00. Nausea and vomiting from 22:00-04:30.  body aches continued through 10/08
Age: 55.0
Sex: M
Vaccine: FLUR4
Symptoms: Hypersensitivity, Pyrexia, Rash
Clinical narrative: fever overnight (Fri/Sat) 102 F  Rash on chest, back and both arms.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: Patient received the injection and then stood up and walked about 8-10 steps and yelled 'Mom' as she fell to the ground. Her mother ran to her side and tried to pick her up off the ground. Staff at the clinic - Nurse and EMS, instructed mom to leave her daughter laying on the ground and elevated the patients legs, while assessing vital signs. The patient opened her eyes and was talking within 30-45 seconds, she then jumped up and started walking and went down again. She continued to talk as we kept her laying on the ground for about 10 minutes. EMS was called for a second assessment. Patient was not transferred to the hospital, she went home with mom. Follow-up call to mom found that she had no other adverse events. Mom followed up with Pediatrician, the thought is most likely a vasovagal syncope event. The pediatrician instructed mom to have the patient lay down for all future injections.
Age: 1.0
Sex: M
Vaccine: FLUA3, HEPA, MMRV, PNC13, VARCEL
Symptoms: Computerised tomogram normal, Magnetic resonance imaging normal, Seizure
Clinical narrative: Pt had his shots on the 19th and on the 20th he woke up having a seizure that lasted 20-30 minutes. He had never had a seizure before! He was born extremely early and at birth had a suspicious possible seizure that was never confirmed or saw by any of his healthcare team in the NICU. He had no health problems or sickness prior to receiving this vaccinations.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Urticaria
Clinical narrative: The patient broke out with hives about 30 minutes after receiving the vaccinations.  I spoke with the patient around 7 pm on 10/21/20 and she said after taking benadryl and zyrtec the hives are starting to go away.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Pt called pharmacy 10/21/20 and complained about soreness and tenderness around injection site. Pt also reported limited strength (e.g. trouble lifting a coffee pot) and limited range of motion.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV, FLU4
Symptoms: Erythema, Extensive swelling of vaccinated limb, Localised infection
Clinical narrative: came in on 10/16/2020 with redness and swelling below injection stie came back on 10/17/2020 with extended redness and swelling down left arm  pt called md and left message pt went to urgent care on 10/17/2020 and was told infected, given antibiotic
Age: 69.0
Sex: M
Vaccine: FLU4, PPV, FLU4
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Injection site pain, Insomnia
Clinical narrative: came in on 10/16/2020 with redness and swelling below injection stie came back on 10/17/2020 with extended redness and swelling down left arm  pt called md and left message pt went to urgent care on 10/17/2020 and was told infected, given antibiotic
Age: 69.0
Sex: M
Vaccine: FLU4, PPV, FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: came in on 10/16/2020 with redness and swelling below injection stie came back on 10/17/2020 with extended redness and swelling down left arm  pt called md and left message pt went to urgent care on 10/17/2020 and was told infected, given antibiotic
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash and redness appeared 11 days after the shot. Mostly itchy. Patient is about to take Benadryl and will see a Dr
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Headache, Injection site pain, Pain
Clinical narrative: Headache began night of receiving shot, headache lasted 3 days. Back pain at the spine started following day, very intense, hurt to walk, lasted 5 days. Soreness at site of shot, lasted 1 day
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, Redness, Fever at injection site and surrounding area
Age: 63.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: right arm (shingrix vaccine given) has heat, welt, slight swelling, redness, entire area of redness is size of half dollar coin, no pain or itch. I advised her to apply ice and take ibuprofen or Tylenol and if the area doesn't improve or worsens, then go to doctor for treatment. She said she would visit the pharmacy tomorrow 10/22/20, if it did not improve to show the pharmacist on duty for further consult.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no reaction - extra dose pt was given an extra dose. no adverse reaction Database Did not show that 1st dose was already given
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: rash
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Generalized arthralgia; relieved w/motrin except for residual stiffness, soreness in finger and wrist joint of left hand. Report on 9/27/19 is that arthralgia is gone and selling of left axilla node is better.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Fatigue, Pain in extremity, Pruritus
Clinical narrative: Pain and itching in arm as well as diffuse body itching, fatigue and shortness of breath
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Hallucination, Immediate post-injection reaction, Injection site pain, Irritability, Pain
Clinical narrative: Pain at site of R arm immediately - then quick onset Fever (tactile), severe emotional Irritability, went to parents at night and felt warm, was aching weirdly, ? hallucinating, Fever 100.2 next day w/ R arm pain where vaccine given
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Pyrexia, Skin warm
Clinical narrative: Pain at site of R arm immediately - then quick onset Fever (tactile), severe emotional Irritability, went to parents at night and felt warm, was aching weirdly, ? hallucinating, Fever 100.2 next day w/ R arm pain where vaccine given
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site discomfort
Clinical narrative: Persistent discomfort at the injection site - is slowly improving.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Oedema, Pain
Clinical narrative: Event reported by R.N. Left deltoid IM injection Influenza vaccine afluria 0.5ml Seqirus exp date 6/30/2017 lot # WT55507 Vaccination occurred 9/19/16 symptoms began approx. 1 week later with increasing tenderness at injection site and increasing ROM limitation due to pain Localized erythemia, edema, warmth & tenderness, ROM limitation due to pain, localized erythema, edema, warmth
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Tenderness
Clinical narrative: Event reported by R.N. Left deltoid IM injection Influenza vaccine afluria 0.5ml Seqirus exp date 6/30/2017 lot # WT55507 Vaccination occurred 9/19/16 symptoms began approx. 1 week later with increasing tenderness at injection site and increasing ROM limitation due to pain Localized erythemia, edema, warmth & tenderness, ROM limitation due to pain, localized erythema, edema, warmth
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Impaired work ability, Pyrexia
Clinical narrative: Time vaccine administered is not documented. Noted symptoms 4 hours after he received vaccine and out of work for 4 days. Did not see MD. Headache & Fever
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Erythema multiforme, Injection site pain, Insomnia, Myalgia
Clinical narrative: Received flu shot earlier in day, later that night experienced severe pain in upper R deltoid, with myalgia and arthralgia. Had difficulty sleeping and noticed odd spots scattered on R arm. Thought that injection might have been administered too high in the deltoid.  Myalgia, Arthralgia, SkinRash, ErythemaMultiform & NA IBUPROFEN 800 mg PRN
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Received flu shot earlier in day, later that night experienced severe pain in upper R deltoid, with myalgia and arthralgia. Had difficulty sleeping and noticed odd spots scattered on R arm. Thought that injection might have been administered too high in the deltoid.  Myalgia, Arthralgia, SkinRash, ErythemaMultiform & NA IBUPROFEN 800 mg PRN
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: & inj site spreading erythema
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site swelling, Muscle spasms, Paraesthesia, Pyrexia
Clinical narrative: For 1-3 days patient had fever + swelling at injection site (improved with ice). Patient has experienced "Charlie horse" in arm + numbness/tingling in fingers. Not constant only when moves arm certain way
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: The area was not initially red on 10/19/20 the area became red, itchy, & PUFFY. No fever. No streaking & no spreading of redness. treatment: oral septra, oral benedryl q 8 hours prn & oral Ibuprofen q 8 hrs prn. F/u if erythema worsening, fever, discharge, or red streaking.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Dizziness, Eye pain
Clinical narrative: Chills, 101.5 fever, body aches, Pounding headache (lasting several days) weakness in upper and lower body, stomach cramping, pain in eyes, nausea, loss of appetite, extreme fatigue. Consulted physician and took Tylenol to reduce fever. Other symptoms remained for several days. Including light headedness which at this time is still present, 1 week later. The fever and chills lasted about 1 day and seemed to be brought under control with Tylenol at 4hr intervals. The remaining symptoms took much longer to subside and at this writing, 1 week later, I still feel slightly lightheaded and easily fatigued. This has been a horrible experience for myself and my family! If not for the current pandemic I think I would have gone to an emergency room for help. I was never so sick in my life.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Muscular weakness, Nausea, Pain
Clinical narrative: Chills, 101.5 fever, body aches, Pounding headache (lasting several days) weakness in upper and lower body, stomach cramping, pain in eyes, nausea, loss of appetite, extreme fatigue. Consulted physician and took Tylenol to reduce fever. Other symptoms remained for several days. Including light headedness which at this time is still present, 1 week later. The fever and chills lasted about 1 day and seemed to be brought under control with Tylenol at 4hr intervals. The remaining symptoms took much longer to subside and at this writing, 1 week later, I still feel slightly lightheaded and easily fatigued. This has been a horrible experience for myself and my family! If not for the current pandemic I think I would have gone to an emergency room for help. I was never so sick in my life.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Chills, 101.5 fever, body aches, Pounding headache (lasting several days) weakness in upper and lower body, stomach cramping, pain in eyes, nausea, loss of appetite, extreme fatigue. Consulted physician and took Tylenol to reduce fever. Other symptoms remained for several days. Including light headedness which at this time is still present, 1 week later. The fever and chills lasted about 1 day and seemed to be brought under control with Tylenol at 4hr intervals. The remaining symptoms took much longer to subside and at this writing, 1 week later, I still feel slightly lightheaded and easily fatigued. This has been a horrible experience for myself and my family! If not for the current pandemic I think I would have gone to an emergency room for help. I was never so sick in my life.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: aRm pain down to wRist hard time lifting
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal discomfort, Oral mucosal blistering, Oral pruritus, Throat irritation, Urticaria
Clinical narrative: Patient was treating at home with diphenhydramine after she developed hives on entire body. It progressed to itching in throat, mouth and nasal irritation and hives on palms of hands. Went to urgent care 10/19/20 and received prednisone and triamcinolone ointment 10/21/20 - Patient returned to urgent care. They continued her prednisone (issued 5 more days worth). They also added lidocaine to swish and spit for mouth blisters.
Age: 82.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED HER FIRST FLU SHOT (FLUAD QUAD) ON 9/25/20. SHE THEN CAME IN SIX DAYS LATER AND ASKED FOR HER FLU SHOT. SHE RECEIVED TWO DOSE OF THE FLUAD QUAD IMMUNIZATION. PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS FROM EITHER IMMUNIZATION. DOCTORS OFFICE WAS NOTIFIED.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Mouth swelling
Clinical narrative: Patient came through the drive thru stating they had just gone out for ice cream had swelling in the corner of the mouth stated only thing different was flu shot. No difficulty breathing/swelling. Patient contacted MD MD instructed them to take a Benadryl. Follow up with the pt on 10/19/20 said swelling resolved and feeling good.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Swelling
Clinical narrative: Patient came through the drive thru stating They had just gone for ice cream and had swelling in corner of mouth. Only thing different was flu shot. No difficulty breathing/swallowing. Pt contacted MD instructed to take Benadryl followed up w/ pt the following morning swelling resolved + said feeling good.
Age: 23.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Arm pain since vaccine, very weak/painful  Can't lift arm over head
Age: 62.0
Sex: F
Vaccine: VARZOS, FLUA4
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Received Shingrix #1 on 10/2  in left deltoid- painful arm that continued until October 10/15. On 10/4 red raised area next to where Shingrix shot was given measuring 2 inches by 4 inches (left upper arm) and was badly itching but, couldn't scratch as the area hurt too.  On this day and for the next 3-4 days felt "punky" with a fever, chills, fatigue and myalgia. 10/19 - same symptoms continue - red area on left upper arm slowly beginning to fade away.   10/22 - today have bad myalgia especially in upper arms and can't lift a pot to put in the microwave Covid test done on 10/20 is negative
Age: 62.0
Sex: F
Vaccine: VARZOS, FLUA4
Symptoms: Chest X-ray normal, Chills, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: Received Shingrix #1 on 10/2  in left deltoid- painful arm that continued until October 10/15. On 10/4 red raised area next to where Shingrix shot was given measuring 2 inches by 4 inches (left upper arm) and was badly itching but, couldn't scratch as the area hurt too.  On this day and for the next 3-4 days felt "punky" with a fever, chills, fatigue and myalgia. 10/19 - same symptoms continue - red area on left upper arm slowly beginning to fade away.   10/22 - today have bad myalgia especially in upper arms and can't lift a pot to put in the microwave Covid test done on 10/20 is negative
Age: 62.0
Sex: F
Vaccine: VARZOS, FLUA4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Received Shingrix #1 on 10/2  in left deltoid- painful arm that continued until October 10/15. On 10/4 red raised area next to where Shingrix shot was given measuring 2 inches by 4 inches (left upper arm) and was badly itching but, couldn't scratch as the area hurt too.  On this day and for the next 3-4 days felt "punky" with a fever, chills, fatigue and myalgia. 10/19 - same symptoms continue - red area on left upper arm slowly beginning to fade away.   10/22 - today have bad myalgia especially in upper arms and can't lift a pot to put in the microwave Covid test done on 10/20 is negative
Age: 62.0
Sex: F
Vaccine: VARZOS, FLUA4
Symptoms: Metabolic function test normal, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Received Shingrix #1 on 10/2  in left deltoid- painful arm that continued until October 10/15. On 10/4 red raised area next to where Shingrix shot was given measuring 2 inches by 4 inches (left upper arm) and was badly itching but, couldn't scratch as the area hurt too.  On this day and for the next 3-4 days felt "punky" with a fever, chills, fatigue and myalgia. 10/19 - same symptoms continue - red area on left upper arm slowly beginning to fade away.   10/22 - today have bad myalgia especially in upper arms and can't lift a pot to put in the microwave Covid test done on 10/20 is negative
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe pain in arm when moving or laying on
Age: 55.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe pain in arm when moving or laying on
Sex: U
Vaccine: FLU4, FLU4, FLU4
Symptoms: Pharyngeal swelling, Pruritus
Clinical narrative: anaphylactic reaction; throat immediately started swelling/throat swelling; This case was reported by a consumer and described the occurrence of anaphylactic reaction in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included flu shot (received flu shot every year without complications).   On 16th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 16th October 2020, immediately after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and throat swelling. On an unknown date, the outcome of the anaphylactic reaction and throat swelling were unknown.   It was unknown if the reporter considered the anaphylactic reaction and throat swelling to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient get flu shot every year without complications. The patient was not allergic to eggs or any medications The patient received the Fluarix Quadrivalent 2020/2021 vaccine and immediately started throat swelling and patient had to go to the emergency room. On 17th October 2020, the patient was waiting to post visit Rx to be filled, the throat swelling returned. The patient stated that in clinical trials of approximately 10,000 people only one person had an anaphylactic reaction. The patient wanted to know the reason of clinical trial participant had an anaphylactic reaction? what ingredient triggered them?
Sex: U
Vaccine: FLU4, FLU4, FLU4
Symptoms: Anaphylactic reaction, Immediate post-injection reaction, Pharyngeal swelling
Clinical narrative: anaphylactic reaction; throat immediately started swelling/throat swelling; This case was reported by a consumer and described the occurrence of anaphylactic reaction in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included flu shot (received flu shot every year without complications).   On 16th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 16th October 2020, immediately after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and throat swelling. On an unknown date, the outcome of the anaphylactic reaction and throat swelling were unknown.   It was unknown if the reporter considered the anaphylactic reaction and throat swelling to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient get flu shot every year without complications. The patient was not allergic to eggs or any medications The patient received the Fluarix Quadrivalent 2020/2021 vaccine and immediately started throat swelling and patient had to go to the emergency room. On 17th October 2020, the patient was waiting to post visit Rx to be filled, the throat swelling returned. The patient stated that in clinical trials of approximately 10,000 people only one person had an anaphylactic reaction. The patient wanted to know the reason of clinical trial participant had an anaphylactic reaction? what ingredient triggered them?
Sex: U
Vaccine: FLU4, FLU4, FLU4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: anaphylactic reaction; throat immediately started swelling/throat swelling; This case was reported by a consumer and described the occurrence of anaphylactic reaction in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included flu shot (received flu shot every year without complications).   On 16th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 16th October 2020, immediately after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and throat swelling. On an unknown date, the outcome of the anaphylactic reaction and throat swelling were unknown.   It was unknown if the reporter considered the anaphylactic reaction and throat swelling to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient get flu shot every year without complications. The patient was not allergic to eggs or any medications The patient received the Fluarix Quadrivalent 2020/2021 vaccine and immediately started throat swelling and patient had to go to the emergency room. On 17th October 2020, the patient was waiting to post visit Rx to be filled, the throat swelling returned. The patient stated that in clinical trials of approximately 10,000 people only one person had an anaphylactic reaction. The patient wanted to know the reason of clinical trial participant had an anaphylactic reaction? what ingredient triggered them?
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pruritus, Pyrexia
Clinical narrative: Flu like Fever 103 at highest still 101 10/21/2020 Severe headache within 30 minutes  Severe itching systemic, feels like when I had shingles Body pain Bad enough I was tested for COVID on 10/20/2020 @11am- negative as reported on 10/20/2020
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Flu like Fever 103 at highest still 101 10/21/2020 Severe headache within 30 minutes  Severe itching systemic, feels like when I had shingles Body pain Bad enough I was tested for COVID on 10/20/2020 @11am- negative as reported on 10/20/2020
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling, Pruritus, Throat irritation
Clinical narrative: Throat scratchy, generalized severe pruritis, arm swelling, redness nd severe itching at site. Left arm over 2 inches bigger than right.  Required benadryl and epinephrine
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Inflammation, Irritability, Pruritus, Rash
Clinical narrative: Received vaccines on 10/6/20. Rash appeared on face beginning 10/19/20, then spread to entire body. Thought to be an amoxicillin allergy but his twin brother who did not receive amoxicillin developed the same rash 2 days later (twin brother's case was milder). Treated with antihistamine and steroids (Propranolol). Extreme itching and fussiness in both boys. Skin was 90% covered by the rash on and extremely inflamed, approximately 60% on his twin. Applied thick layers of 40% zinc oxide because calamine lotion and oatmeal did not appear to help. Rash faded from the face first on 10/20/20. Now on 10/22/20, the rash has mostly faded but appears like small off color dots on the skin.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Eye pain, Oropharyngeal pain, Pharyngeal swelling, Pyrexia
Clinical narrative: Fever 101dg.  Eyes Hurt, Sore and swollen throat, airway almost blocked, heavy coughing and runny nose. Symptoms lasted about 6 hours. completely gone by 8am.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever 101dg.  Eyes Hurt, Sore and swollen throat, airway almost blocked, heavy coughing and runny nose. Symptoms lasted about 6 hours. completely gone by 8am.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Rash erythematous, Urticaria
Clinical narrative: After a few days, I start getting itchy with localized hive breakout.  This is normal if I took shrink, crap, or even glucosamine in the pass. So, I though it was some food allergy.  I took allergy medication and it works for a day or two.  But then it reoccur and would not go away.  I also start getting itchy red spots on my thigh and large red patches on my chest, itchy between my legs.  So, I start to suspect my medication and supplement, and stop taking glucosamine, did not work, so I try keeping track of my food intake, nothing suspicious, then I stop all medications and supplement.  Still did not work after 2 weeks.  Then I realize it must be the Shringrix shot.  By the time I discover the course, 2 to 3 months has past since my shot.   I think my allergy will continue for a very long period of time.  Currently had to take over the counter allergy medication every day.  I did not see my doctor to report to him.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood culture negative, Inflammation, Injection site pain, Injection site reaction, Laboratory test
Clinical narrative: Noted throbbing pain within 2 hours of vaccine administration. Within about 12 hours had pain in neck and LUE with swollen lymph nodes in neck and arm pit. Seen in ED 10/10/2020 AM and treated for inflammatory response vs  possible cellulitis with Keflex. Traveled and hospitalized 10/12/2020- 10/14/2020.  Received multiple different antibiotics, but Vancomycin IV for 4 days seemed to be the most effective. (Also received prednisone.) Discharged on Cipro and linezolid. Drove back home. Seen at ED 10/16/20 and again given Vancomycin IV. Then followed up in dermatology clinic 10/20/2020: Assessment: "Favor injection site reaction" as opposed to infection.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Lymphadenopathy, Neck pain, Pain
Clinical narrative: Noted throbbing pain within 2 hours of vaccine administration. Within about 12 hours had pain in neck and LUE with swollen lymph nodes in neck and arm pit. Seen in ED 10/10/2020 AM and treated for inflammatory response vs  possible cellulitis with Keflex. Traveled and hospitalized 10/12/2020- 10/14/2020.  Received multiple different antibiotics, but Vancomycin IV for 4 days seemed to be the most effective. (Also received prednisone.) Discharged on Cipro and linezolid. Drove back home. Seen at ED 10/16/20 and again given Vancomycin IV. Then followed up in dermatology clinic 10/20/2020: Assessment: "Favor injection site reaction" as opposed to infection.
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Body temperature increased, Dyspnoea, Pain
Clinical narrative: evening of vaccine patient developed, reportedly, temperature to 103°,body aches, shortness of breath and elevated blood pressure. Patient took NSAIDs and acetaminophen and was normal the next morning.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; received Gardasil 9 after it had been stored outside of the recommended storage range; This spontaneous report was received from a certified medical assistant (CMA) concerning a patient of unknown age and gender. Information on pertinent medical history, concomitant medications and drug reactions/ allergies was not reported.   On 01-SEP-2020, the patient received a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) after it had been stored outside of the recommended storage range for prophylaxis (lot # T005928, expiration date: 12-APR-2022) (dose, dose number, route of administration, and anatomical location were not reported).   The vaccine was exposed to a temperature of 47.1 degrees Fahrenheit (F) for a timeframe of 30 minutes. There were no previous temperature excursions. It was recorded by a digital data logger. There were no other adverse events 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: T005928; expirationdate: 12-APR-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
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: On multiple unspecified dates, unspecified patients were administered improperly stored ROTA TEQ or PEDV AXHIB; No additional AE details provided; This spontaneous report has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender.  The patients' concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On multiple and unspecified dates, the patients were vaccinated with the following improperly stored vaccines: - Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) formulation not reported but defaulted to oral liquid, Lot # S040076, expiration date 15-JUN-2021 for prophylaxis (dosage regimen was not reported).   - Haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) formulation not reported but defaulted to intramuscular injection, Lot # S023218, expiration date 04-MAR-2022 for prophylaxis (dosage regimen was not reported).    The storage temperature was reported to had been at 8.9 C for 30 minutes.  No additional adverse events details were provided.  There was digital data logger involved and no previous temperature excursion was reported.  This is a non valid case due to lack of patients' identifiers.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; ROTATEQ was improperly stored and administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.       On 14-OCT-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S040076, expiration date 15-JUN-2021 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 11.35 degree Celsius (°C) for 40 hours as recorded by a data logger. There were previous temperature excursions of 9.45 °C for 1 hour and 30 minutes on 07-OCT-2020; 11.86 °C  for 11 hours and 15 minutes on 09-OCT-2020 and 10.23 °C  for 1 hour and 45 minutes on 10-OCT-2020.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; a patient received Rotateq after it bad been stored outside of the recommended storage range; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.      On 01-SEP-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1661000, expiration date 13-MAY-2021) orally for prophylaxis  (dose and vaccination scheme frequency were not reported). No other adverse events reported.  The vaccine was stored in a temperature of 47.1 degree Fahrenheit (°F) for 30 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Nausea, Vomiting
Clinical narrative: shoulder pain at injection site.; She was unable to lift her right shoulder four about 4 weeks.; nausea; vomiting; shoulder pain at injection site.; This spontaneous report has been received from the patient's husband concerning her wife, a 67 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On approximately 21-SEP-2020 (reported as "about 4 weeks ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) single dose administered intramuscularly as standard vaccine for prevention of pneumonia (dose, anatomical location, lot number and expiration date were not provided). On the same date, 2 hours later after having the vaccine, the patient suffered from nausea, vomiting and shoulder pain at injection site (musculoskeletal pain) (injection site pain). She was unable to lift her right shoulder four about 4 weeks (injected limb mobility decreased). The patient did seek medical attention at the site where she received the vaccine and they told her to take naproxen sodium (ALEVE)/acetaminophen (TYLENOL).   At the time of reporting, the patient's husband stated that she still had pain at injection site. The outcome of all the events was reported as recovering.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; She inadvertently administered an expired dose of VARIVAX TO A PATIENT ON 10/16/2020; This spontaneous report has been  received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 16-OCT-2020, the patient was inadvertently vaccinated with an expired dose of  varicella virus vaccine live (oka/merck) (VARIVAX) formulation not reported but defaulted to subcutaneous injection, 0.5 ml,  Lot # R026715,  expiration date 18-SEP-2020 for prophylaxis.       It was reported that the varicella virus vaccine live (oka/merck) (VARIVAX) did not experience any temperature excursion and no additional adverse events were reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu anyway with the shot; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media..  This case involves female patient (age unspecified) who had flu anyway with the shot (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu with the shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Slight muscle soreness; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case is linked to cases 2020SA293225 and 2020SA292917(same reporter).  This case involves a patient with unknown demographics who experienced slight muscle soreness (myalgia), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious slight muscle soreness afterward (myalgia), unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Intense pain in upper arm, not injection site, nausea, almost fainting. Arm sore periodically 10/22/2020
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: 6 hours after vaccine, experienced fatigue and chills. Body temperature was good at 97 degrees F, but felt extream chills and aches. Took over the counter Tylenol and Aleve to help. Slept wrapped in comforter (unusual in SWFL). At about 3:00 AM chills subsided and removed covers. Woke at 6:00am feeling fairly normal again, 23 hours after vaccine.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Cough, Diarrhoea, Headache, Lip swelling, Nausea
Clinical narrative: Severe body aches, constant headache, nausea, sore throat, cough, fever, congestion, diarrhea, hives & swelling of Eurasia and lips
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion, Urticaria
Clinical narrative: Severe body aches, constant headache, nausea, sore throat, cough, fever, congestion, diarrhea, hives & swelling of Eurasia and lips
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Sore shoulder area, over all muscle aches
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Mobility decreased, Pyrexia, Skin reaction
Clinical narrative: Can?t move my are, fever, large red mark on are, very tired, loss of appetite
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event
Clinical narrative: No adverse events at this time.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Pt began experiencing redness and swelling at injection site within hours of receiving vaccination. Redness spread to cover entire deltoid region (appox 3-4 inches in width) by evening. Redness persisted through the next day and swelling increased. Treated with Benadryl and symptoms are now resolving on day 3.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Pain, Vomiting
Clinical narrative: Pts mother called the next afternoon and spoke with staff at about 3: 27pm on 10/21/2020 stating that the patient came in on 10/20/2020 and had her Tdap and Menactra and both injection sites are puffy, tender, pt is vomiting, and having body aches. Denies shortness of breath and fever
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure decreased, Dizziness, Vertigo
Clinical narrative: Significant dizziness/vertigo from about 8:00pm the day of the vaccination, all of the following day, but better in the morning of the 2nd day after.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain with movement, decreased ROM
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: PATIENT STARTED EXPERIENCING SWELLING IN HER ARM WHERE THE INJECTION WAS GIVEN. ARM WAS ALSO WARM TO TOUCH AND ITCHING. SHE EXPERIENCED BODY ACHES AND CHILLS, BUT NO FEVER. SYMPTOMS BEGAN ABOUT 7 HOURS AFTER THE VACCINE WAS GIVEN.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pharyngeal swelling, Swollen tongue
Clinical narrative: Pt had not received any flu vaccine in last 10 years.  decided to get one this year.  pt got shot on sat 10/10.  she called the next fri 10/16 to explain she had experienced adverse effects (mild throat swelling, tongue swelling, tiredness) with about 24 hours of shot.  Her symptoms while sounding concerning began to resolve and slowly improved over the next couple days.  she did not seek any emergency care.  Her dr would not return messages left, as of our conversation on friday 10/16.  When we talked on Fri, she was concerned about her symptoms, but had improved and was not upset.  I reassured her she had received the correct flu vaccination, and encouraged her to continue to reach out to her dr for any further guidance.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: golf ball sized hard lump on her deltoid, discomfort, redness of the injection site, hot to the touch
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Pain, Shoulder injury related to vaccine administration
Clinical narrative: shoulder injury related to vaccine administration (SIRVA); 55 year old male complaining of right shoulder pain s/p influenza vaccine. Received influenza vaccine through flu clinic 10/05/2020. EE reports that when he received vaccine, he felt immediate, sharp, 10/10, pain in his right shoulder "joint space". EE reports that he is aware vaccines can sometimes cause soreness, but after 5-7 days noted that shoulder still continued to be sore. Ecchymosis formed over injection site and is still slightly visible.  EE has been taking OTC brand NSAID with relief, okay per PCP. EE notes sharp pain with certain movements, ~6-7/10, mostly when reaching arm out or up. EE has no pain in his shoulder at rest. EE denies pain radiating up into neck or clavicle. EE denies pain radiating down into upper arm, lower arm, or hand. EE denies numbness/tingling/weakness in right upper extremity. EE denies posterior shoulder or back pain.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood glucose, CSF protein, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: Pt states he experienced myalgias and neck pain; went to ER on 10/14/2020
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia, Neck pain, SARS-CoV-2 test
Clinical narrative: Pt states he experienced myalgias and neck pain; went to ER on 10/14/2020
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This vaccine combination was given 2 months too late. She had no indication for receiving Hib vaccine after 5 years of age and she was 5 years and 2 months at the time of injection. This was the incorrect choice of vaccine for the patient.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Swelling of left arm, denies loss of movement, signs of infection. Reports increased warmth, pain, redness. Denies fever, erythema, bruising.  Pt received Solumedrol injection 25mg  IM in left thigh from Urgent Care. Pt was transferred care to primary provider for follow up.
Age: 59.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave a HD Flu shot to a patient under the age of 65 instead of the Flucelevax
Age: 0.5
Sex: M
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: WAS GIVEN  VACCINE IN UNTIMELY MANNER
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Right arm immunizations given first, Adacel then influenza.  Left arm next: HPV first then Menactra.  Patient passed out after menactra administered, Layed down on bed. Patient given cool water bottle to put under neck and ice pack to put on forehead. Patient encouraged to stay laying down on exam table. Provider re-examined patient and she was okay for d/c after about 20 mins.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain at the injection site. Shoulder pain and pain going down the arm.   Has difficulty moving arm.  Been taking tylenol and compresses.