chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Coordination abnormal, Gait inability, Guillain-Barre syndrome, Vaccination complication
Clinical narrative: Patient's husband came into store on 10/29 to report an adverse event that occurred. Husband states that 6 days after receiving both Fluzone HD and Shingrix, she was admitted to the ER with the inability to walk/loss of muscle coordination. She was later transferred to Medical Center and was diagnosed with Guillan-Barre syndrome. The staff at Medical Center informed the patient that it occurred likely due to the vaccinations she received at our store. I have not confirmed the diagnosis or the treatment with the staff at Medical Center. The patient is currently still under care at hospital in the rehab facility as of 10/29/20. No extraordinary circumstances occurred during vaccination.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient stated she noticed rash on wrist on 10/28/2020 (the day after receiving shot). On 10/29/2020 patient noticed rash also on ankle and forehead. She states the rash is itchy. Patient was going to call her doctor, to discuss adverse event.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reported on 10/29/20 that he was still experiencing arm soreness. He couldn't remember the exact time it started. The pain is a dull pain that when pressed becomes a sharp pain. I instructed the patient to call his primary care doctor.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: Room spinning vertigo, dizziness upon standing from bed, inability to walk in a straight line whenever I moved my head
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: pharmacist administered flu vaccine L deltoid. Arm ached the next day-felt like normal vaccine soreness. No redness, swelling, heat or localized pain. Deep ache.  Next day pain worsened. Pain seemed to worsen until 10/29 unbearable. Contacted Virtual MD consult. Video consult instructed to take NSAIDs, ICE and follow up with Ortho.  No nerve pain, no fever, redness or other SEs. Deep joint pain persists in L shoulder. Follow up ortho unavailable until Nov.9 on waiting list. Passive ROM exercise with NSAIDs and ICE continue.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Endotracheal intubation, Loss of consciousness, Malaise, Resuscitation, Sudden death
Clinical narrative: Sudden death on 10/25/20, 9:15AM.  Patient's adult daughter reports patient awoke on 10/25/20 AM feeling unwell and eventually lost consciousness.  Had to be resuscitated and eventually intubated.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient had reaction located on are inner arm away from injection site red, swollen, hot. patch on under arm of injection arm
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Myalgia
Clinical narrative: Left upper arm sore, muscle aches, difficult to raise arm. Trouble dressing and moving items.
Age: 20.0
Sex: F
Vaccine: FLUR4
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative, Skin warm, Streptococcus test negative
Clinical narrative: Fever 101.4, rash head to toe and hot to the touch
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Inflammation, Injection site pain, Nausea
Clinical narrative: Patient was very nauseated and had chills the evening  after the vaccine. Her left arm was very sore. She woke up the next morning and arm was very swollen and warm. She said there was pooling  edema and it was warm to the touch. Skin was pinkish/red color to the inflamtion
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Oedema, Peripheral swelling, Skin warm
Clinical narrative: Patient was very nauseated and had chills the evening  after the vaccine. Her left arm was very sore. She woke up the next morning and arm was very swollen and warm. She said there was pooling  edema and it was warm to the touch. Skin was pinkish/red color to the inflamtion
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: patient had 2nd dose of shingrix on 10/27/2020... first dose given 8/25/2020 along with flu shot and had no issues with either.  patient had the second shot of shingrix on 10/27/2020 around 1:15pm.  By 4pm patient was feeling nauseous and started to vomit.  patient was in bed from 5pm on 10/27/2020 until 5am 10/28/2020 with severe vertigo and spinning.  patient had to cancel her plans for the day of 10/28/2020 but was feeling better and coming out of it by 9am 10/28/2020... patient was advised if she got worse or didn't improve to notify her pcp  ASAP.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient called this evening stating that her arm was hurting her. She said it was itchy, warm, and she had some swelling in her arm.
Age: 63.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Administration related reaction, Bursitis, Pain in extremity
Clinical narrative: Vaccines were given to the patient on 10/13/20 in the same arm at request of the patient. As of 10/28/20, patient is currently experiencing significant arm pain which required a visit to his primary care physician. PT went to his primary care physician on 10/28 and was provided a script for an anti-inflammatory pain medication, patient states his PCP believes the patient is experiencing bursitis, most likely from receiving both vaccines in the same arm.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: swollen upper lip
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Skin burning sensation
Clinical narrative: The patient reported today, October 29, 2020 that her arm pains her to lift it, for example lifting up bra strap on opposite arm or raising above her head. She stated that it really burnt at the time of injection and that is was high on her arm.  I had her show her arm to me today. There is no redness or swelling. She indicated that it is not as painful as it was and hopes it continues to resolve but wanted to report it due to her concern in the length of time it is bothering her.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: none reported
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Discomfort, Immobile, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient received a vaccine too high up on the arm causing pain as the medication entered and lingering discomfort and immobility.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Musculoskeletal stiffness, X-ray
Clinical narrative: Shoulder pain and stiffness, suspect shoulder injury after vaccine administration (SIRVA)
Age: 70.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Vaccination site injury
Clinical narrative: shoulder injury at vacinnation site
Age: 79.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: PT'S LEFT AREM IS STILL SORE AND PT IS UNABLR TO LIFE ARM ABOUT 90 DEGREES
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia
Clinical narrative: STARTING SEP 2- PT HAD JOINT PAIN AT DIFFERENT JOINTS EACH DAY, SOMETIMES THE KNESS, SOMETIMES THE HANDS, SOMETIMES SWOLLEN WRISTS
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspepsia, Flatulence, Malaise, Nausea, Vomiting
Clinical narrative: patient got flu shot at approximately 6PM. went home and ate dinner. around 11PM she started feeling nauseous, like she had gas or indigestion so she took 2 tums. around 1AM she felt extremely ill and vomited and at 3AM she vomited the rest of the contents of her stomach and felt very ill. she took her temperature but did not have a fever. she was able to eat lunch the following day and felt better. unsure if it was result of vaccine or what she ate but her husband ate the same dinner with no issues. no injection site pain, redness, or swelling. reviewed package insert, N/V listed as side effect for 9.7 and 2.6 (n=663) respectively. pt called following day to report. called back patient at approximately 7:40PM, she was feeling better and requested no further follow up
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: red, raised, rash, warm to touch, located on upper arm
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient called to clinic complaining of swelling redness and warmth to injection site. monitor for now treatment Tylenol and ice packs monitor for now. f/u in clinic in am
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: An hour after the flu shot I had significant pain in my arm. That pain has continued for several weeks and continues to this day. In the last week I have begun experiencing pain in my shoulder joint, both when static and during any movement.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure measurement, Syncope
Clinical narrative: Patient was walking towards the front of the store and fainted into her father's arms. She was offered a chair and she sat. I monitored her blood pressure until it returned to a safe level.
Age: 70.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Limb injury, Pain in extremity, Peripheral swelling
Clinical narrative: shoulder injury pain and swelling on whole upper arm
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient called and reported her arm had a red welt at injection site and was slightly painful. She noticed it the night after the flu shot and it remained through the next day (this is when she called the pharmacy). I advised her to use and ice pack on the injection site to help with swelling and take an otc pain medication such as tylenol or ibuprofen if she needed.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Nausea, Swelling face
Clinical narrative: Patient returned to clinic after 30 min, complaining of dizzines, nausea and facial swelling. Assed patients heart and lungs. Breathe sounds clear to ausculation, no diminished breathing, wheezing or rales noted. Flushed face. Blood pressure 138/98, RR 18, oxygen 100%, HR 114. Patient with pervious anxiety about getting flu vaccine as she could not remember if she had inthe past. Discussed with patient to remain calm, no complaints of throat swelling or shortness of breath. Looked for swellingon her facial but could only find mild redness from where she wore the mask on her face. Airway patent, no swlling of throat or tonsils. Had patient sit for 5 mings, gave her water and a sucker as she could not remember the last time she had something to eat or drink, in several hours. After 5 min HR 98, blood pressure 128/82, RR 18, oxygen 100% , airway still patent. Had patient sit in the clinic in a lounged position for another 10 mints. Reviewed side effects of medication, given VIS sheet. Upon leaving the clinic blood pressure 118/72, RR 18, HR 62, oxygen 100 %. Color returned to face and patient reports that she felt much better, able to talk in complete sentence, aireway patent. Reviewed signs and symptoms of an allergic reaction and when to call 911.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Symptoms: Swelling, pain and rash around administration area, and bruising. Treatment Recommendation for Symptoms: Hydrocortisone Cream and Benadryl.  Outcomes: patient feels fine aside from the symptoms above.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: PATIENT STATES SHE HAS CELLULITIS
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Wrong immunization given, he should have received Fluzone or Flublok
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Tenderness
Clinical narrative: Extreme pain, soreness, tenderness
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: PATIENT STATES SHE HAS CELLULITIS AFTER HER IMZ
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: continuous arm weakness and pain.  limited range of motion
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: That evening, developed a large red pruritic papular rash over left upper arm. The area of redness increased over the next 4 days. The papules had the appearance of small wheals but may have been papules, Uniform in appearance.   On 10/29, rash is less red, the papules are smaller. On exam, fine dry papular rash, not follicular, no vesicle, no pustule, no scabs. No diffuse erythema as there was on photo taken 10/26.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Feeling abnormal, Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: I received TDaP in L arm on 10/28/2020.  I'm a nurse practitioner and felt that it was given high in my arm at the time of injection and felt a weird sensation in my arm during injection but didn't think too much of it.  That night I had a restless night of sleeping because I couldn't get my arm comfortable when laying down but still didn't think too much about it. The next morning when I woke up my shoulder was in pain and I noticed I couldn't barely lift it much past my waist without pain. I was not able to put on my T shirt like normal or lift my arm over my head.  I still didn't think too much about it but as the day went on it continued to hurt and felt worse deep shoulder pain. Then I had a realization moment and said to my husband, I wonder if this shoulder pain is from the injection yesterday? It certainly seemed like it since there was no other aggravating factor or reason for the pain.  I took motrin and had some relief but still having deep, range of motion limiting pain in the shoulder and radiating up left neck. I am very concerned because I have never had any injury or issues whatsoever with my shoulder. And now looking back I felt I was right when I initially thought the injection was given high on my arm. When I removed the bandaid it was near the top of my arm, not in the main fleshy deltoid area.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Neck pain, Pain, Poor quality sleep, Product administered at inappropriate site
Clinical narrative: I received TDaP in L arm on 10/28/2020.  I'm a nurse practitioner and felt that it was given high in my arm at the time of injection and felt a weird sensation in my arm during injection but didn't think too much of it.  That night I had a restless night of sleeping because I couldn't get my arm comfortable when laying down but still didn't think too much about it. The next morning when I woke up my shoulder was in pain and I noticed I couldn't barely lift it much past my waist without pain. I was not able to put on my T shirt like normal or lift my arm over my head.  I still didn't think too much about it but as the day went on it continued to hurt and felt worse deep shoulder pain. Then I had a realization moment and said to my husband, I wonder if this shoulder pain is from the injection yesterday? It certainly seemed like it since there was no other aggravating factor or reason for the pain.  I took motrin and had some relief but still having deep, range of motion limiting pain in the shoulder and radiating up left neck. I am very concerned because I have never had any injury or issues whatsoever with my shoulder. And now looking back I felt I was right when I initially thought the injection was given high on my arm. When I removed the bandaid it was near the top of my arm, not in the main fleshy deltoid area.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Mobility decreased, Pyrexia
Clinical narrative: Patient reported feelings of pain and extreme soreness in the arm to the extent of not being able to move the arm approximately 4-6 hours post-administration. She reports developing a fever of 101F overnight and a headache.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Dysphagia
Clinical narrative: Patient was counseled to wait around the pharmacy at least 15 minutes after they received both shots as they had not received either type of vaccine before (including flu shot). Noticed difficulty swallowing about minutes after receiving both vaccines, informed customer in line as well as my technician. About 5 minutes later after patient could swallow, was given liquid Benadryl. After paramedics arrived around 25 minutes after vaccine, patient felt normal again.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Fatigue, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Feverish. Body aches. Throat hurt. A lot of pain in the opposite arm from which the flu shot was given (pain in right arm)  Chest area felt like she pulled a muscle  2 days later still fatigued. Still has pain in opposite arm
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Feverish. Body aches. Throat hurt. A lot of pain in the opposite arm from which the flu shot was given (pain in right arm)  Chest area felt like she pulled a muscle  2 days later still fatigued. Still has pain in opposite arm
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Loss of personal independence in daily activities, Myalgia, Neuralgia, Pyrexia
Clinical narrative: For 3 days after receiving the vaccination, patient was incapacitated. She experienced fevers up to 101, muscle aches, chills, and neuralgia. She went to clinic, and was told to take Tylenol/Motrin for her symptoms. She suspected she had COVID and got tested. It has since been a week and patient is mostly recovered. Although she actually had shingles before, she will not be coming back for the second shot in the dose series.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test
Clinical narrative: For 3 days after receiving the vaccination, patient was incapacitated. She experienced fevers up to 101, muscle aches, chills, and neuralgia. She went to clinic, and was told to take Tylenol/Motrin for her symptoms. She suspected she had COVID and got tested. It has since been a week and patient is mostly recovered. Although she actually had shingles before, she will not be coming back for the second shot in the dose series.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pustule
Clinical narrative: Puss pocket filled with fluid occurring at sight of injection.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dyspnoea, Dysstasia, Gait disturbance, Headache
Clinical narrative: Aching. Significant pain in legs and lower body. Tachycardia. Trouble breathing. Numbness. Hard to stand or walk. Burning nerve pain. Headache severe
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Neuralgia, Pain, Pain in extremity, Tachycardia
Clinical narrative: Aching. Significant pain in legs and lower body. Tachycardia. Trouble breathing. Numbness. Hard to stand or walk. Burning nerve pain. Headache severe
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Patient received flu vaccination and while seated passed out.  The event lasted only a few seconds and did not require any emergency measures.  Patient remained seated for about 20 minutes following the event and then was able to walk out of the store with her parent.  Pharmacist called later in the evening to follow up and mother stated that the patient was doing well.
Age: 6.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella-type rash on buttock. Fewer than 50 lesions present.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Per patient the following day she woke up and had 101 degree fever, myalgia, and rash on frontal part of body. Went away after 3 days.
Age: 85.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called a few hours after receiving her pneumo vaccine stating she was having a reaction to the shot. She stated she had a large red swollen area around the site of injection of her left arm and it was itching. She stated she had take 600mg of Ibuprofen.  I recommended she take some benadryl as well and to continue both if needed.  She also received the flu shot in her right arm but had no issues with that arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arthrus reaction, started as a red bump in the morning and progressed to a large, raised, red and warm area surrounding and involving the injection site.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Peripheral swelling, Pyrexia, Skin burning sensation
Clinical narrative: I felt swelling, burning, muscle pain and fever in the left arm. On the third day after the injection the symptoms were worst.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Groin pain, Injection site pain, Lymph node pain, Lymphadenopathy, Mass
Clinical narrative: Approximately 24 hours after injection (Sept. 26), tenderness in left armpit, upper deltoid above injection site.  Later that day noticed enlarged, rubbery to rigid, painful, lump on upper side of left clavicle.  Lump was somewhat mobile, but movement caused discomfort.  By second day after injection (Sept 27), pain in upper left deltoid less, but not gone.  Left armpit near the pectoral region remained tender, but not painful. Lump (swollen lymph node?) on top side of left clavicle still present and painful.  By evening and that night, noticed growing tenderness around left groin area.  Not actual pain, and no signs of swellings or lumps, but definite soreness and tenderness. Third day after injection (Sept 28), swollen node/lump on left clavicle still swollen and painful, particularly when pressed or moved. Seatbelt in vehicle pressed against it frequently when driving, causing pain.  Left armpit and pectoral areas no longer painful.  Left groin area still ached and tender well into the night.  Fourth day after injection (Sept. 29) lump over left clavicle subsided, no longer painful.  Left groin area no longer tender or sore by end of day/evening. By fifth day after injection (Sept 30) no further signs of side effects, pain or tenderness.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Tenderness
Clinical narrative: Approximately 24 hours after injection (Sept. 26), tenderness in left armpit, upper deltoid above injection site.  Later that day noticed enlarged, rubbery to rigid, painful, lump on upper side of left clavicle.  Lump was somewhat mobile, but movement caused discomfort.  By second day after injection (Sept 27), pain in upper left deltoid less, but not gone.  Left armpit near the pectoral region remained tender, but not painful. Lump (swollen lymph node?) on top side of left clavicle still present and painful.  By evening and that night, noticed growing tenderness around left groin area.  Not actual pain, and no signs of swellings or lumps, but definite soreness and tenderness. Third day after injection (Sept 28), swollen node/lump on left clavicle still swollen and painful, particularly when pressed or moved. Seatbelt in vehicle pressed against it frequently when driving, causing pain.  Left armpit and pectoral areas no longer painful.  Left groin area still ached and tender well into the night.  Fourth day after injection (Sept. 29) lump over left clavicle subsided, no longer painful.  Left groin area no longer tender or sore by end of day/evening. By fifth day after injection (Sept 30) no further signs of side effects, pain or tenderness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Influenza like illness, Nausea
Clinical narrative: SEVERE dizziness and nausea.;  fatigue/weakness; feeling "fluish ~ over the stretch of one week
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Syncope, Unresponsive to stimuli
Clinical narrative: Patient fainted several minutes after vaccine was given. She was stiff and unresponsive for a few seconds. Pharmacy staff called 911, she was transported by EMS to ER and event was determined to be a BRUE (brief, resolved, unexplained event) by ER doctor.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: My child arm extremely swollen it started a week after he got the shot
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: Discomforting muscle aches starting around 9:00 PM. Feeling of flu like symptoms. Retired at 10:00 PM. Awoke at 2:30 AM with heavy sweating. Possible fever but did not check. Awoke again at 5:30 AM feeling better. Arose the next morning at approximately 8:00 AM feeing fine. No other effects afterwards.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Pt reported Swelling to arm at injection site the next day followed by a rash
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Immediate post-injection reaction
Clinical narrative: Extreme fatigue, increased muscle & joint pain, felt sick, no appetite, and had chills. Imm. site was stiff w/ some swelling
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site reaction, Injection site swelling, Malaise, Musculoskeletal stiffness, Myalgia
Clinical narrative: Extreme fatigue, increased muscle & joint pain, felt sick, no appetite, and had chills. Imm. site was stiff w/ some swelling
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient described she had soreness/arm ache 15 minutes after the vaccine was given on 10/22/20. On 10/24/20 morning, she started to develop an extensive bruise from the left elbow to about one-third of the forearm. Patient reported no pain when she visited the pharmacy on 10/29/20. I recommended her to go visit the doctor right away. Patient developed no fever.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Pain in extremity, Pruritus, Skin warm
Clinical narrative: warm indurated area on upper arm with soreness / itchiness
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: Allergic RXN, swelling redness within 4 hrs Txt with antihistamines
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Injection site pain, Pyrexia
Clinical narrative: 10/21/2020 - Fever: 101.1, headache, chills, felt poorly, tenderness at injection sites 10/22/2020 - no fever 10/23/2020 - mild fever, no higher than 99.3
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's right leg became swollen and red at vaccination site after varicella was administered
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Injection site red and irritated 5 days after vaccination was given. Patient advised by her PCP to take Benadryl.
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site nodule, Swelling
Clinical narrative: Patient felt injection was given too high on shoulder. Had swelling for 1 week after and still has knot at injection site. Still feels shoulder pain and numbness in his left hand. Not getting better
Age: 64.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Tubulointerstitial nephritis
Clinical narrative: Acute kidney failure; Lost 55 - 60 percent of her kidney function; This spontaneous case was received on 23-Oct-2020 from other non-health professional via Health Authority (reference number: SEQW20-04187) and concerned a 64-year-old female patient.  The patient had no relevant medical history. The patient's concomitant medications included mycophenolic acid for unreported indication.  On 24-Oct-2019, the patient was vaccinated with Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 261215, expiration date: 30-Jun-2020.  On 15-Nov-2019, 22 days after vaccination with Flucelvax QIV, the patient was admitted to the hospital with acute kidney failure.  On 18-Nov-2019, the patient had extremely high creatinine levels and kidney biopsy which confirmed acute kidney failure.  On 20-Nov-2019, the patient started the treatment with immunosuppressive therapy.  On 23-Nov-2019, the patient was discharged from the hospital.  On 20-Jul-2020, subsequent kidney biopsy revealed the patient lost 55 - 60 percent of her kidney function.  At the time of initial reporting on 23-Oct-2020, the patient had not recovered from the events. The patient was still on the medication and did not receive any dialysis.  The reporter did not provide a causality assessment.  The reporter assessed the case as serious.  Company comment: A 64-year-old female patient was administered Flucelvax QIV vaccine. On 15-Nov-2019, 22 days after vaccination with Flucelvax QIV, the patient was admitted to the hospital with acute kidney failure. On 20-Jul-2020, subsequent kidney biopsy revealed the patient lost 55 - 60 percent of her kidney function. Reportedly, the patient had no relevant medical history. The patient's concomitant medications included mycophenolic acid for unreported indication. More information regarding indication and medical history is needed. Causality was confounded by concomitant medication, however with information available causal role of the suspect vaccine is unassessable.; Sender's Comments: A 64-year-old female patient was administered Flucelvax QIV vaccine. On 15-Nov-2019, 22 days after vaccination with Flucelvax QIV, the patient was admitted to the hospital with acute kidney failure. On 20-Jul-2020, subsequent kidney biopsy revealed the patient lost 55 - 60 percent of her kidney function. Reportedly, the patient had no relevant medical history. The patient's concomitant medications included mycophenolic acid for unreported indication. More information regarding indication and medical history is needed. Causality was confounded by concomitant medication, however with information available causal role of the suspect vaccine is unassessable.
Age: 64.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Acute kidney injury, Biopsy kidney abnormal, Blood creatinine increased, Immunosuppressant drug therapy, Renal impairment
Clinical narrative: Acute kidney failure; Lost 55 - 60 percent of her kidney function; This spontaneous case was received on 23-Oct-2020 from other non-health professional via Health Authority (reference number: SEQW20-04187) and concerned a 64-year-old female patient.  The patient had no relevant medical history. The patient's concomitant medications included mycophenolic acid for unreported indication.  On 24-Oct-2019, the patient was vaccinated with Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 261215, expiration date: 30-Jun-2020.  On 15-Nov-2019, 22 days after vaccination with Flucelvax QIV, the patient was admitted to the hospital with acute kidney failure.  On 18-Nov-2019, the patient had extremely high creatinine levels and kidney biopsy which confirmed acute kidney failure.  On 20-Nov-2019, the patient started the treatment with immunosuppressive therapy.  On 23-Nov-2019, the patient was discharged from the hospital.  On 20-Jul-2020, subsequent kidney biopsy revealed the patient lost 55 - 60 percent of her kidney function.  At the time of initial reporting on 23-Oct-2020, the patient had not recovered from the events. The patient was still on the medication and did not receive any dialysis.  The reporter did not provide a causality assessment.  The reporter assessed the case as serious.  Company comment: A 64-year-old female patient was administered Flucelvax QIV vaccine. On 15-Nov-2019, 22 days after vaccination with Flucelvax QIV, the patient was admitted to the hospital with acute kidney failure. On 20-Jul-2020, subsequent kidney biopsy revealed the patient lost 55 - 60 percent of her kidney function. Reportedly, the patient had no relevant medical history. The patient's concomitant medications included mycophenolic acid for unreported indication. More information regarding indication and medical history is needed. Causality was confounded by concomitant medication, however with information available causal role of the suspect vaccine is unassessable.; Sender's Comments: A 64-year-old female patient was administered Flucelvax QIV vaccine. On 15-Nov-2019, 22 days after vaccination with Flucelvax QIV, the patient was admitted to the hospital with acute kidney failure. On 20-Jul-2020, subsequent kidney biopsy revealed the patient lost 55 - 60 percent of her kidney function. Reportedly, the patient had no relevant medical history. The patient's concomitant medications included mycophenolic acid for unreported indication. More information regarding indication and medical history is needed. Causality was confounded by concomitant medication, however with information available causal role of the suspect vaccine is unassessable.
Sex: M
Vaccine: RAB, UNK, RAB
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: while preparation of vaccine diluent was added to another liquid without freeze dried product/ NO AE; patient received of IMOVAX RABIES vaccine 45 minutes to 1 hour after reconstitution/ NO AE; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves male patient who received vaccine in rabies series first dose of suspect IMOVAX RABIES and IMMUNOGLOBULIN ANTI-RABIES on 16-Sep-2020, second dose of suspect RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] and third dose of suspect IMOVAX RABIES (administered 45 minutes to 1 hour after reconstitution) on 23-Sep-2020 (wrong technique in product usage process) on 30-Sep-2020  while administering fourth dose of suspect IMOVAX RABIES patient received diluent which was added to another liquid without freeze dried product which turned pink (inappropriate reconstitution technique) (batch number and other dosing details were not reported) for post-exposure immunization.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not reported.  It was an actual medication error case due to wrong injection technique, inappropriate reconstitution technique (latency was same day).   At the time of reporting, no adverse event was reported.  It was reported that, the patient had fear that the liquid he thought he may have seen in the vial with the freeze dried product prior to it being mixed with the diluent would have caused the product to "not freeze dry enough and have some live rabies in that vial" and he wants to know if that lot is bad.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.  Follow up information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from consumer or non-healthcare professional via phone.  Narrative description updated.  Follow information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  Event and suspect dose updated.
Sex: M
Vaccine: RAB, UNK, RAB
Symptoms: Product preparation issue
Clinical narrative: while preparation of vaccine diluent was added to another liquid without freeze dried product/ NO AE; patient received of IMOVAX RABIES vaccine 45 minutes to 1 hour after reconstitution/ NO AE; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves male patient who received vaccine in rabies series first dose of suspect IMOVAX RABIES and IMMUNOGLOBULIN ANTI-RABIES on 16-Sep-2020, second dose of suspect RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] and third dose of suspect IMOVAX RABIES (administered 45 minutes to 1 hour after reconstitution) on 23-Sep-2020 (wrong technique in product usage process) on 30-Sep-2020  while administering fourth dose of suspect IMOVAX RABIES patient received diluent which was added to another liquid without freeze dried product which turned pink (inappropriate reconstitution technique) (batch number and other dosing details were not reported) for post-exposure immunization.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not reported.  It was an actual medication error case due to wrong injection technique, inappropriate reconstitution technique (latency was same day).   At the time of reporting, no adverse event was reported.  It was reported that, the patient had fear that the liquid he thought he may have seen in the vial with the freeze dried product prior to it being mixed with the diluent would have caused the product to "not freeze dry enough and have some live rabies in that vial" and he wants to know if that lot is bad.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.  Follow up information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from consumer or non-healthcare professional via phone.  Narrative description updated.  Follow information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  Event and suspect dose updated.
Age: 0.42
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Heart rate increased, Muscle spasms, White blood cell count increased
Clinical narrative: Mother states that about an hour after child received vaccines she notices her making jerking movements with her head and extremities once mother laid her down for a nap. They occurred about once a minute for about 20 minutes and then stopped. Mother states that during the night following vaccine administration patient was noted to have a higher heart rate than normal. Parents use an Owlet monitor. Heart rate was noted to be in the upper 160s during most of the night and around 200bpm if upset. Symptoms had resolved by the time patient was evaluated the following morning on 10/20/20. Mother states that she remembers patient had similar movements during the night the last time she received Prevnar and Hib on 8/17/20 but she had no cause for concern at that time. She has not had these symptoms with administration of Pediarix and Rotateq.
Age: 0.42
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dyskinesia, Heart rate increased
Clinical narrative: Mother states that about an hour after child received vaccines she notices her making jerking movements with her head and extremities once mother laid her down for a nap. They occurred about once a minute for about 20 minutes and then stopped. Mother states that during the night following vaccine administration patient was noted to have a higher heart rate than normal. Parents use an Owlet monitor. Heart rate was noted to be in the upper 160s during most of the night and around 200bpm if upset. Symptoms had resolved by the time patient was evaluated the following morning on 10/20/20. Mother states that she remembers patient had similar movements during the night the last time she received Prevnar and Hib on 8/17/20 but she had no cause for concern at that time. She has not had these symptoms with administration of Pediarix and Rotateq.
Age: 65.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: left arm pain to the point of trouble lifting it that radiated into the left chest and an induration at injection site; per patient unrelieved by ibuprofen and difficulty sleeping on left side as of 10/28/2020 when reported to pharmacy; per follow-up phone call to patient on 10/30/2020 provider at the walk-in clinic diagnosed with deep muscle bruising on 10/29/2020; potential capillary involvement was suggested; per patient, pain moderately relieved by apap (enough to sleep); patient will follow up with primary doctor if symptoms do not continue to improve
Age: 65.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Chest pain, Injection site induration, Pain
Clinical narrative: left arm pain to the point of trouble lifting it that radiated into the left chest and an induration at injection site; per patient unrelieved by ibuprofen and difficulty sleeping on left side as of 10/28/2020 when reported to pharmacy; per follow-up phone call to patient on 10/30/2020 provider at the walk-in clinic diagnosed with deep muscle bruising on 10/29/2020; potential capillary involvement was suggested; per patient, pain moderately relieved by apap (enough to sleep); patient will follow up with primary doctor if symptoms do not continue to improve
Age: 41.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Erythema, Pain in extremity, Skin swelling
Clinical narrative: Patient had baseball size welt around site where Pneumovax injection was administered. Red, raised and painful. Flu vaccine site red and painful.
Age: 41.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Erythema, Injection site urticaria, Myalgia, Pain, Swelling
Clinical narrative: Patient had baseball size welt around site where Pneumovax injection was administered. Red, raised and painful. Flu vaccine site red and painful.
Age: 41.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: Patient had baseball size welt around site where Pneumovax injection was administered. Red, raised and painful. Flu vaccine site red and painful.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Malaise, Pain
Clinical narrative: patient felt sick next day with fatigue and body ache and then her arm swelled up with redness at injection site. I advised her to seek medical attention and to get it evaluated for possible site infection.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Lethargy, Loss of consciousness
Clinical narrative: Approximately 10min post vaccination patient was sitting in the lobby and told his father that he felt dizzy. Patient was seen pale, diaphoretic, clammy, and lethargic. Patient was unable to respond to verbal commands and appeared to have loss consciousness. Patient was then laid supine with feet elevated. Shortly after patient was able to respond to verbal commands coherently.  Patient then was able to self ambulate to a provider room.  Patients vitals were taken and were within normal limits. A physical exam was done and patient was discharged shortly after. Patient verbalized during the physical exam that when he sees his own blood that he does faint.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Approximately 10min post vaccination patient was sitting in the lobby and told his father that he felt dizzy. Patient was seen pale, diaphoretic, clammy, and lethargic. Patient was unable to respond to verbal commands and appeared to have loss consciousness. Patient was then laid supine with feet elevated. Shortly after patient was able to respond to verbal commands coherently.  Patient then was able to self ambulate to a provider room.  Patients vitals were taken and were within normal limits. A physical exam was done and patient was discharged shortly after. Patient verbalized during the physical exam that when he sees his own blood that he does faint.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's medical history, concomitant medications and concurrent conditions was not provided.   On 15-OCT-2020 (also reported as today), the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(rHA) (Lot No. T015599, expiration date reported as 02-NOV-2021; route of administration was not reported). The vaccines were exposed to temperature of 5.8 degree Celsius for 22 hours and the data logger was involved. No previous temperature excursion was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX vaccine was improperly stored and administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 30-SEP-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) dose/frequency reported as 1 dose, lot# S030243, expiration date 26-SEP-2021, for prophylaxis (strength and route were not reported).  The temperature excursion was of 10.7 Fahrenheit degrees (F) for 85 minutes. Previous temperature excursion was reported as: 5.7 F for 10 minutes; 6.8 F for 48 minutes; 5.7 F for 21 minutes. A digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly strored VARIVAX administration; This spontaneous report was received from a physician regarding to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.      On 19-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T012551, expiration date 10-APR-2022 for prophylaxis (dose and route of administration were not reported).  The improperly stored suspect vaccine experienced a temperature of 6 degrees Fahrenheit (°F) to 14 °F, with an average of 11.8 °F) for 31 hours; no previous temperature excursion was reported.  The call was made due to a digital data logger. No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored VARIVAX administration.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not reported.     On 13-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T012551, expiration date 10-APR-2022 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  6 degree Fahrenheit (°F) to 14°F (11.8°F) for 31 hours as recorded by a data logger. There was no previous temperature excursion reported.