chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Brain scan normal, Breath sounds abnormal, Dialysis, Dizziness, Dyspnoea
Clinical narrative: Heavy breathing; Felt like he had the flu; Was dizzy; Kidney failure; Liver is failing; Organs are failing; Guillain-Barre syndrome; This is a spontaneous case, initially received from consumer via Med Communications (reference number: SEQ19-05245) on 22-Oct-2019, concerning a 62-year-old male patient.  The patient's medical history included obesity.   The patient's concomitant medications were not provided.  On 11-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right deltoid, batch number: 259809, route of administration and expiration date: not reported] for an influenza prophylaxis.   On 12-Oct-2019, one day after vaccination, the patient felt like he had the flu. The patient was dizzy, had fever and all flu symptoms.   On 17-Oct-2019, six days after vaccination, the patient was breathing heavy and made weird sounds. On the same day, the patient was admitted in critical care unit.  Brain scan, cardiac ultrasound and spinal tap were performed and results were negative.   On an unknown date in Oct-2019, the patient's organs were failing and the patient developed kidney and liver failure. The patient was placed on dialysis for kidney failure.  It was reported that one of the physician thought that the patient might have Guillain-Barre syndrome, however no further information was provided.  At the time of initial reporting, the outcome of the events was not resolved.   This case was assessed as serious and causality assessment was not provided.  Company comment: The patient experienced renal failure, hepatic failure, multiple organ dysfunction syndrome, Guillain-Barre syndrome, dyspnoea, influenza and dizziness after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. Medical history of obesity may have contributed to development of the events. No concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Echocardiogram normal, Guillain-Barre syndrome, Hepatic failure, Influenza, Intensive care
Clinical narrative: Heavy breathing; Felt like he had the flu; Was dizzy; Kidney failure; Liver is failing; Organs are failing; Guillain-Barre syndrome; This is a spontaneous case, initially received from consumer via Med Communications (reference number: SEQ19-05245) on 22-Oct-2019, concerning a 62-year-old male patient.  The patient's medical history included obesity.   The patient's concomitant medications were not provided.  On 11-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right deltoid, batch number: 259809, route of administration and expiration date: not reported] for an influenza prophylaxis.   On 12-Oct-2019, one day after vaccination, the patient felt like he had the flu. The patient was dizzy, had fever and all flu symptoms.   On 17-Oct-2019, six days after vaccination, the patient was breathing heavy and made weird sounds. On the same day, the patient was admitted in critical care unit.  Brain scan, cardiac ultrasound and spinal tap were performed and results were negative.   On an unknown date in Oct-2019, the patient's organs were failing and the patient developed kidney and liver failure. The patient was placed on dialysis for kidney failure.  It was reported that one of the physician thought that the patient might have Guillain-Barre syndrome, however no further information was provided.  At the time of initial reporting, the outcome of the events was not resolved.   This case was assessed as serious and causality assessment was not provided.  Company comment: The patient experienced renal failure, hepatic failure, multiple organ dysfunction syndrome, Guillain-Barre syndrome, dyspnoea, influenza and dizziness after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. Medical history of obesity may have contributed to development of the events. No concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Lumbar puncture normal, Multiple organ dysfunction syndrome, Organ failure, Pyrexia, Renal failure
Clinical narrative: Heavy breathing; Felt like he had the flu; Was dizzy; Kidney failure; Liver is failing; Organs are failing; Guillain-Barre syndrome; This is a spontaneous case, initially received from consumer via Med Communications (reference number: SEQ19-05245) on 22-Oct-2019, concerning a 62-year-old male patient.  The patient's medical history included obesity.   The patient's concomitant medications were not provided.  On 11-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right deltoid, batch number: 259809, route of administration and expiration date: not reported] for an influenza prophylaxis.   On 12-Oct-2019, one day after vaccination, the patient felt like he had the flu. The patient was dizzy, had fever and all flu symptoms.   On 17-Oct-2019, six days after vaccination, the patient was breathing heavy and made weird sounds. On the same day, the patient was admitted in critical care unit.  Brain scan, cardiac ultrasound and spinal tap were performed and results were negative.   On an unknown date in Oct-2019, the patient's organs were failing and the patient developed kidney and liver failure. The patient was placed on dialysis for kidney failure.  It was reported that one of the physician thought that the patient might have Guillain-Barre syndrome, however no further information was provided.  At the time of initial reporting, the outcome of the events was not resolved.   This case was assessed as serious and causality assessment was not provided.  Company comment: The patient experienced renal failure, hepatic failure, multiple organ dysfunction syndrome, Guillain-Barre syndrome, dyspnoea, influenza and dizziness after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. Medical history of obesity may have contributed to development of the events. No concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Angioedema, Vaccination site reaction
Clinical narrative: Started with local vaccine reaction at site in left shoulder. Progressed to angioedema that involved entire left arm, left chest to midline and lower neck.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient suffering from shoulder pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient reported having some swelling and redness with warmth after receiving first Shingrix shot. Patient said it resolved fairly quickly and didn't report it at the time because it resolved.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pain, Rash, Swelling
Clinical narrative: Swelling, hurt, rash, hot
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein normal, Full blood count normal, Magnetic resonance imaging brain normal, Optical coherence tomography abnormal, Photopsia
Clinical narrative: Left eye vision changes started about 2 weeks after flu shot.  Seen by optometry, got MRI head, lab work  and referred to ophthalmology.  On exam had 20/20 vision, peripheral visual field defect left eye on formal testing, retinal  foveal granularity, multiple peripheral white dots on retina, macular OCT with outer retina findings.  Three weeks after presentation, has developed photopsia but improving visual field and retina findings improving, resolved white dots but still foveal granularity.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate normal, Retinal exudates, Treponema test negative, Visual field defect, Visual field tests abnormal
Clinical narrative: Left eye vision changes started about 2 weeks after flu shot.  Seen by optometry, got MRI head, lab work  and referred to ophthalmology.  On exam had 20/20 vision, peripheral visual field defect left eye on formal testing, retinal  foveal granularity, multiple peripheral white dots on retina, macular OCT with outer retina findings.  Three weeks after presentation, has developed photopsia but improving visual field and retina findings improving, resolved white dots but still foveal granularity.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment
Clinical narrative: Left eye vision changes started about 2 weeks after flu shot.  Seen by optometry, got MRI head, lab work  and referred to ophthalmology.  On exam had 20/20 vision, peripheral visual field defect left eye on formal testing, retinal  foveal granularity, multiple peripheral white dots on retina, macular OCT with outer retina findings.  Three weeks after presentation, has developed photopsia but improving visual field and retina findings improving, resolved white dots but still foveal granularity.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Injection site pain, Joint dislocation, Mobility decreased, Pain in extremity
Clinical narrative: Next day excrutiating pain in opposite arm from shoulder to elbow then including forearm and eventually spreading to wrist and finger bones. Mostly on r side but also on side of injection. Felt beaten with a hammer and joints out of socket.  Fingers were hot and swollen, skin was tight. Unable to lift arm or bend/straiten
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Next day excrutiating pain in opposite arm from shoulder to elbow then including forearm and eventually spreading to wrist and finger bones. Mostly on r side but also on side of injection. Felt beaten with a hammer and joints out of socket.  Fingers were hot and swollen, skin was tight. Unable to lift arm or bend/straiten
Age: 23.0
Sex: F
Vaccine: FLUA3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pt developed significant pain, limited ROM that lasted several weeks.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Gastrointestinal sounds abnormal, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: First 2 days: Deep burning pain at injection site, unable to move my arm. Trembling/shaking all over. Pain in shoulders, back of neck and head. Fever, nausea, very loud intestinal sounds - I actually recorded them - fatigue. Day 3: less severe but stayed home from work - exhaustion, bright red  itchy rash on neck and shoulders, some pain in left shoulder but more of a stinging sensation instead of burning.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Musculoskeletal pain, Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: First 2 days: Deep burning pain at injection site, unable to move my arm. Trembling/shaking all over. Pain in shoulders, back of neck and head. Fever, nausea, very loud intestinal sounds - I actually recorded them - fatigue. Day 3: less severe but stayed home from work - exhaustion, bright red  itchy rash on neck and shoulders, some pain in left shoulder but more of a stinging sensation instead of burning.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Tremor
Clinical narrative: First 2 days: Deep burning pain at injection site, unable to move my arm. Trembling/shaking all over. Pain in shoulders, back of neck and head. Fever, nausea, very loud intestinal sounds - I actually recorded them - fatigue. Day 3: less severe but stayed home from work - exhaustion, bright red  itchy rash on neck and shoulders, some pain in left shoulder but more of a stinging sensation instead of burning.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Large bruise at site of injection
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Condition aggravated, Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: Patient reported that vaccine was administered too high and due to her arthritis she could not move her arm for 4 to 5 days.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This vaccine gave my son shingles all over his body! From his eyes all the way down to his toes! This happen with in 48 hours of vaccination!
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Patient experienced rash on injected arm with 24 hours. Progressed to stinging and itching. Next day experienced extreme redness and stinging on face and low grade fever. Patient went to ER and was diagnosed with Cellulitis. Was given  Rx for Prednisone and Doxycycline. Followed up with patient on 10/25. Reports that symptoms have improved.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient experienced rash on injected arm with 24 hours. Progressed to stinging and itching. Next day experienced extreme redness and stinging on face and low grade fever. Patient went to ER and was diagnosed with Cellulitis. Was given  Rx for Prednisone and Doxycycline. Followed up with patient on 10/25. Reports that symptoms have improved.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: fever presented in the middle of the night about 5 hours after injection - swelling at injection site noticed this morning  - achy/malaise during the night though the next day  contacted DR. this morning 10/25 - - prescribed and antibiotic and steroid
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Chills, Pyrexia, Thirst
Clinical narrative: Within a few hours of the injection, patient experienced fever, chills, thirst, and blood sugar over 200 mg/dl. Patient went to bed early and felt better by the next day.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient called 10/25/19 to report a stabbing pain when he lifts his arm above his head. He said it is not exactly sore still but has this strange stabbing pain when he moves his arm in a certain way. The patient was advised to ice the arm and take ibuprofen or acetaminophen. If the pain persisted over the week-end the patient is to reach out to a medical provider. Currently the patient is without a primary care provider. Patient will follow up with the pharmacy after the week-end.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13, DTAP, HIBV, MMRV, PNC13
Symptoms: Product preparation issue
Clinical narrative: The medication was not mixed with the clear liquid that needs to be mixed with the medication, instead diluent was used in the medication. Contacted parent and is aware. Parent is bringing patient back for re immunization.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13, DTAP, HIBV, MMRV, PNC13
Symptoms: Product preparation issue
Clinical narrative: Medication was not mixed correctly it was mixed with diluent. Patients parent is aware is will being patient back in for re-immunization.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Pt felt dizzy after standing up from a chair and then fainted. Went to bed shortly after and felt better the next day. No prior h/o fainting in pt. No recent illnesses.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Flushing, Headache, Limb discomfort
Clinical narrative: Within 10 min of injection pt felt arm heaviness, flushed. Approx 1 hour after injection, employee was also feeling lightheaded. VS were as follows: Pulse 81, Temp 98.2, BP 154/103, Resp 18. Employee was escorted to ED and admitted. While in ED pt c/o headache, dizziness, flushing. ED administered IV fluids, Fentanyl, steroids, Benadryl via IV. Employee was discharged around 6pm feeling relieved of symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA, VARCEL
Symptoms: Local reaction, Supportive care
Clinical narrative: Local reaction on arm Supportive care - improving
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pruritus, Pyrexia, Scab, Urticaria
Clinical narrative: Every night is a low grade fever AND Massive Hives on thighs, arms, hips, back.  Go away overnight, come back at night.  Now been 15 day.  Took photos.  Chest/neck area are breakout itchy hives, now scabs.  Tookk photos. Minor sore throat has ended.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Given Flu Vaccine at work site night shift woke up next day with severe joint and body aches, while resolved. Extreme fatigue until 10/23/2019. Unable to work 10/21 and 10/22. 10/24/19 all Sx resolved.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: pink large oval on arm around area of vaccine, near 20cm long, 12 wide, some firmnss and tenderness but diffuse   Evaluated on 10/25/19 by Dr. in clinic at 9:45 AM.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain in right deltoid for more than 2 weeks with redness and swelling
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Chest discomfort, Condition aggravated
Clinical narrative: Sudden exacerbation of asthma with chest tightness lasting 2 days, treated with intramuscular corticosteroid injection on second day
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Patient is 50 yo female employee of Medical Center who received dose of 2019-2020 Afluria influenza vaccine on Monday 21 Oct. That day she had significant discomfort, with fairly severe itchiness all over her body. She treated that with bendryl which provided some relief. That issue evolved to generalized achiness, which has persisted to today. She also developed mild redness and swelling at the vaccine site (L deltoid), which also evolved and worsened until it reached it's peak in redness and itchiness last night (20 Oct). At that time it was ~4 inches in diameter. This morning the localized swelling and redness were improved. She does have a mottled, diffuse rash at the vaccine site. Generalized symptoms were mild to resolved at time of exam, however, she believes this may be due to her use of Benadryl and ibuprofen.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Patient is 50 yo female employee of Medical Center who received dose of 2019-2020 Afluria influenza vaccine on Monday 21 Oct. That day she had significant discomfort, with fairly severe itchiness all over her body. She treated that with bendryl which provided some relief. That issue evolved to generalized achiness, which has persisted to today. She also developed mild redness and swelling at the vaccine site (L deltoid), which also evolved and worsened until it reached it's peak in redness and itchiness last night (20 Oct). At that time it was ~4 inches in diameter. This morning the localized swelling and redness were improved. She does have a mottled, diffuse rash at the vaccine site. Generalized symptoms were mild to resolved at time of exam, however, she believes this may be due to her use of Benadryl and ibuprofen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: When patient came for her 2nd vaccine, she stated that her arm was red and hot for 7 days after injection
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Ear discomfort, Pain in jaw, Parotid gland enlargement, Swelling face
Clinical narrative: Reported approx 30 hrs after vaccination developed large painful approximately 4in swelling at corner of left jaw with swelling up into the parotid gland area and pressure sensation in ear.  Treated on 10/21/2019 with 10 days of cipro and clinda prescribed per Clinic and seen for first visit at our clinic on 10/25/2018 with pain and swelling improving and 3.5cm lymph node palpable at angle of left side of mandible.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: pt experienced painful arm, low grade fever, did not feel well for several days.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Noted medium pink/light red, firm and warm to touch to skin surrounding injection site.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm redness and whelp the size of a dime was present below the injection site of the varivax vaccine. Advised to apply ice and to affected area and give oral antihistamine to reduce swelling and redness.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: On 10/25/19 noticed a rash around injection site on left arm.  Approx. 4 in. in diameter.  No itching and did not receive any follow up care
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Red area with lump under both vaccines on (L) Thigh
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Tremor
Clinical narrative: Medication: Shingrix Vial Kit - Injection - 10/21/19 Adverse Reactions:  Tiredness/fatigue: Began seven hours after & lasted 36 hours. Very violent shaking: Began 14 hours after & lasted three hours.  Headache/muscle aches off-and-on - began seven hours after & lasted 36 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Cold sweat, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: 9/20/19 Around 4.00 P.M I got A HARD, Quick PAiN iN my Left ARm, thEN I feLt ReAL Hot ANd Clammy, I sAt dowN theN I HAD A ExTREmELy HARD PAiN iN THE Top of my Left ARm AND it weNT DowN THE Bottom of my Arm. WheN I Looked At my Arm my shoulder was drooped dowN AND my hand was handing toward my Right leg. The first shot made my Arm Extremely soRE for 2 dAys, So I thought it was going to be soRE real bad. I wANted to go home because I was suppose to work the next 2 days AND I wANTED TO TRy to Get the soreness out After I got home AND then sore PAiN cAme, I couldn't lift my elbow AND if I tried, horrible PAiN, so bAd I screamed ANd I hAd shooting PAiNs just whenever, it was exhausting. I was so tried I would try to sleep but the pAiN would hit and I couldn't. I did fAll Asleep ANd I woke up iN A real cold sweAt, so I thought Everything was done. I tried to get my scrub top off still couldn't lift my Arm or even rAise it with other hANd without it being excruciating pAiN so got off clothes AND took hot As I could Epsom Salt bath. That seem to help for A while then All dAy AND nite. I went thru dealing with the stabbing PAiNs then SuNdAy. I ReAlized I needed to go to ER. STill Arm drooped down (could always move my fingers And hand) They did EKG, ULTRAsound my muscLEs to see if there was Pus, white count high labs out of whack AND Blood PressurE very high and even higher when the pAin hits. They gAve me a torAdol shot in the right leg when se gave me the shot it was like lightning went thru my muscles In my whole Body. I screamed AND Jumped off stretcher to the floor ANd it was PAiNFul! My BP went very high at that moment. So then they discharged me with Robaxin ANd 600 mg Ibuprofen. Followed up with Dr tuesday AND my lAbs wAs NormaL. I just sTArTED BeiNg Able to move my elbow AND rAise my Arm. He put me oN PresNisoNe AND flexeriL. I feLt terrible couldN't sleep but the pAiN wAs better. Just didN't feel real good even weeks later I hAd A AreA top of my arm that did not feel right KiNdA Ached AND Just felt different THEN A couple of weeks Ago I wAs going to bed AND I felt LiKe my Arm wAs TwiTCHiNG But couldN't see it felt it oN the iNside. TheN I woke up At 3oclock AND I could see it twiTCHiNg but it didnT hurt thAt hAs stopped but oN my Arm the AreA that doesN't feel right hAs moved down AT First FeLT Funny AND Achy sometimes. Now doesN't FeeL right
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injected limb mobility decreased, Injection site pain, Insomnia, Laboratory test abnormal
Clinical narrative: 9/20/19 Around 4.00 P.M I got A HARD, Quick PAiN iN my Left ARm, thEN I feLt ReAL Hot ANd Clammy, I sAt dowN theN I HAD A ExTREmELy HARD PAiN iN THE Top of my Left ARm AND it weNT DowN THE Bottom of my Arm. WheN I Looked At my Arm my shoulder was drooped dowN AND my hand was handing toward my Right leg. The first shot made my Arm Extremely soRE for 2 dAys, So I thought it was going to be soRE real bad. I wANted to go home because I was suppose to work the next 2 days AND I wANTED TO TRy to Get the soreness out After I got home AND then sore PAiN cAme, I couldn't lift my elbow AND if I tried, horrible PAiN, so bAd I screamed ANd I hAd shooting PAiNs just whenever, it was exhausting. I was so tried I would try to sleep but the pAiN would hit and I couldn't. I did fAll Asleep ANd I woke up iN A real cold sweAt, so I thought Everything was done. I tried to get my scrub top off still couldn't lift my Arm or even rAise it with other hANd without it being excruciating pAiN so got off clothes AND took hot As I could Epsom Salt bath. That seem to help for A while then All dAy AND nite. I went thru dealing with the stabbing PAiNs then SuNdAy. I ReAlized I needed to go to ER. STill Arm drooped down (could always move my fingers And hand) They did EKG, ULTRAsound my muscLEs to see if there was Pus, white count high labs out of whack AND Blood PressurE very high and even higher when the pAin hits. They gAve me a torAdol shot in the right leg when se gave me the shot it was like lightning went thru my muscles In my whole Body. I screamed AND Jumped off stretcher to the floor ANd it was PAiNFul! My BP went very high at that moment. So then they discharged me with Robaxin ANd 600 mg Ibuprofen. Followed up with Dr tuesday AND my lAbs wAs NormaL. I just sTArTED BeiNg Able to move my elbow AND rAise my Arm. He put me oN PresNisoNe AND flexeriL. I feLt terrible couldN't sleep but the pAiN wAs better. Just didN't feel real good even weeks later I hAd A AreA top of my arm that did not feel right KiNdA Ached AND Just felt different THEN A couple of weeks Ago I wAs going to bed AND I felt LiKe my Arm wAs TwiTCHiNG But couldN't see it felt it oN the iNside. TheN I woke up At 3oclock AND I could see it twiTCHiNg but it didnT hurt thAt hAs stopped but oN my Arm the AreA that doesN't feel right hAs moved down AT First FeLT Funny AND Achy sometimes. Now doesN't FeeL right
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching, Pain, Pain in extremity, Ultrasound scan, White blood cell count increased
Clinical narrative: 9/20/19 Around 4.00 P.M I got A HARD, Quick PAiN iN my Left ARm, thEN I feLt ReAL Hot ANd Clammy, I sAt dowN theN I HAD A ExTREmELy HARD PAiN iN THE Top of my Left ARm AND it weNT DowN THE Bottom of my Arm. WheN I Looked At my Arm my shoulder was drooped dowN AND my hand was handing toward my Right leg. The first shot made my Arm Extremely soRE for 2 dAys, So I thought it was going to be soRE real bad. I wANted to go home because I was suppose to work the next 2 days AND I wANTED TO TRy to Get the soreness out After I got home AND then sore PAiN cAme, I couldn't lift my elbow AND if I tried, horrible PAiN, so bAd I screamed ANd I hAd shooting PAiNs just whenever, it was exhausting. I was so tried I would try to sleep but the pAiN would hit and I couldn't. I did fAll Asleep ANd I woke up iN A real cold sweAt, so I thought Everything was done. I tried to get my scrub top off still couldn't lift my Arm or even rAise it with other hANd without it being excruciating pAiN so got off clothes AND took hot As I could Epsom Salt bath. That seem to help for A while then All dAy AND nite. I went thru dealing with the stabbing PAiNs then SuNdAy. I ReAlized I needed to go to ER. STill Arm drooped down (could always move my fingers And hand) They did EKG, ULTRAsound my muscLEs to see if there was Pus, white count high labs out of whack AND Blood PressurE very high and even higher when the pAin hits. They gAve me a torAdol shot in the right leg when se gave me the shot it was like lightning went thru my muscles In my whole Body. I screamed AND Jumped off stretcher to the floor ANd it was PAiNFul! My BP went very high at that moment. So then they discharged me with Robaxin ANd 600 mg Ibuprofen. Followed up with Dr tuesday AND my lAbs wAs NormaL. I just sTArTED BeiNg Able to move my elbow AND rAise my Arm. He put me oN PresNisoNe AND flexeriL. I feLt terrible couldN't sleep but the pAiN wAs better. Just didN't feel real good even weeks later I hAd A AreA top of my arm that did not feel right KiNdA Ached AND Just felt different THEN A couple of weeks Ago I wAs going to bed AND I felt LiKe my Arm wAs TwiTCHiNG But couldN't see it felt it oN the iNside. TheN I woke up At 3oclock AND I could see it twiTCHiNg but it didnT hurt thAt hAs stopped but oN my Arm the AreA that doesN't feel right hAs moved down AT First FeLT Funny AND Achy sometimes. Now doesN't FeeL right
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Rash
Clinical narrative: Got flu vaccine on 10/18. later that evening, site was red w/a knot. Next morning, not as red but bruised at injection site ~ 3 inches in diameter w/hard not, had rash on face. Saw neurologist for apt 10/23 & he advised reporting reaction. As of today, 10/25, rash on face is gone, knot decreasing in size, no pain but bruise still ~ 3 inches in diameter.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Productive cough, Pyrexia, Swelling
Clinical narrative: Fever, swelling, redness @ injection site, and general aches. Pt developed a productive cough within 24 hours of receiving the shot.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Injection site pruritus
Clinical narrative: (R) arm itching, feels flushed
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There is no adverse reaction. This for is being filled out because patient is 4 months old and Flulaval (seasonal influenza) vaccine was given by mistake. Side effects and possible allergic reaction were discussed with vaccine nurse, and Mother was notified as well. Mom agreed to watch for redness/hot on vaccine site, swelling, and high fevers and to inform us right away if any of the symptoms shows up. As of today, 10/24/2019. No symptoms are recorded in patient's chart. No adverse reaction occurred.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Differential white blood cell count, Full blood count, Liver function test, Oedema peripheral
Clinical narrative: (L) axilla edema; (L) arm pain; chills, fever; (L) arm pain with movement;
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Pyrexia, Red blood cell sedimentation rate, Ultrasound scan
Clinical narrative: (L) axilla edema; (L) arm pain; chills, fever; (L) arm pain with movement;
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase, Diarrhoea, Dizziness, Metabolic function test, Nausea
Clinical narrative: Patient reported new onset diarrhea, nausea, vomiting and dizziness. These symptoms last for about 2 weeks.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis, Vomiting, White blood cell count
Clinical narrative: Patient reported new onset diarrhea, nausea, vomiting and dizziness. These symptoms last for about 2 weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eye swelling, Herpes zoster, Pain, Rash
Clinical narrative: there are millions of needles in her eye and her left eye is almost completely swollen; left ear feels like there is stinging in it; Shingles; This spontaneous report was received from a 68 years old female pt. The pt was vaccinated with zoster vaccine live (ZOSTAVAX) one dose injection on 28-AUG-2012. Lo t# and route were unspecified. Concomitant medication included lisinopril.  On 02-SEP-2012 the pt experienced shingles. On 04-SEP-2012, the pt developed a rash all over the left side of her face. On 05-SEP-2012, the reactions became much worse. The patient said it felt like "there were millions of needles in her eye" and her left eye was almost completely swollen. In addition, her "left ear felt like there was stinging in it". On 06-SEP-2012, the patient went to her physician and was prescribed medications. They were: acyclovir, gabapentin, and hydrocodon acetaminophen 7.5-325m. The patient still had shingles and was not recovered yet. No lab diagnostic study was performed.    Follow up information has been received from a lawyer on 21-OCT-2019, referring to the female pt, around August 2012 (also reported as "28-AUG-2012") was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route of vaccination, lot # and expiration date were not provided) for its intended purpose: the prevention of shingles. Shortly after being vaccinated with zoster vaccine live (ZOSTAVAX) the pt suffered shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Furthermore, the pt had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. At the time of the report, the outcome of herpes zoster was considered to be not recovered. The lawyer considered Herpes Zoster to be related to vaccination with zoster vaccine live (ZOSTAVAX).
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Injection site bruising, Injection site pain, Insomnia, Pyrexia
Clinical narrative: fever; upper arm injection site pain; patient experienced extreme diarrhoea for a long time/she experienced diarrhea 15x; she has difficulty sleeping deep; injection site is bruise in left upper arm; This non-valid spontaneous report was received from an unspecified reporter via company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot#, expiration date, route, dosing details were unknown) for prophylaxis.   On an unknown date, the patient experienced extreme diarrhea for a long time. The outcome of the event diarrhea was unknown.   The causal relationship between the suspect therapy and the event was not provided.  Follow-up was received on 23-OCT-2019 from the initial reporter, who was an  acupuncturist. Upon receive of follow up information, patient identifiers were provided and the case is now considered valid. This report refers to a 70-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided. It was reported that the patient had never had any adverse event prior to this vaccine.  On 20-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012245, expiration date 09-FEB-2021; route of administration, exact dose and frequency were not provided) in the left upper arm for prophylaxis at clinic. On the same day, the patient was vaccinated with influenza virus vaccine (unspecified) (lot # 3L32N, expiration date 30-JUN-2020; route of administration, exact dose, indication and frequency were not provided).  On 20-SEP-2019 (also reported as on Friday and on 21-SEP-2019) at the night, after vaccination with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced diarrhea with intensity of 15 times and upper arm injection site pain. She also had fever on 21-SEP-2019 (reported as on the next day). On 25-SEP-2019, when she went for acupuncture, the injection site was still bruise on left upper arm. The patient also complained of having difficulty sleeping deep. The reporter stated that according to Traditional Chinese Medicine, the explanation was that lung and large intestine pain could appeared when the vaccine for lung was administered and the patient might have "LI st". The reporter informed the patient's primary care physician (PCP) about the events. The outcome of the events was not reported.     The relatedness between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), influenza virus vaccine (unspecified) and the events was not provided.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015205:
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; a patient was administered improperly stored Vaqta; This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 27-SEP-2019, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot number: S007770, expiration date: 24-JUL-2020; dose and route of administration were not provided). The vaccine was stored at temperature below 36 degrees Fahrenheit (2 degrees Celsius, 35.4 degrees Fahrenheit) for 10 minutes. There was no previous temperature excursion. Digital data lodger was not involved. No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effect reported; the adult patient was inadvertently administered a pediatric dose of V AQT A; the adult patient was inadvertently administered a pediatric dose of V AQT A; This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 02-NOV-2017, the patient was inadvertently administered a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) injection, vial 25/0.5 (unspecified) (lot # N017094 has been verified to be a valid lot number, expiration date 31-AUG-2018) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The outcome of the events was not reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; more than a year ago the patient received Gardasil 9/ in the pharmacy now to receive second dose; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.  On an unknown date, reported as more than a year ago, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number 1637641, expiration date 16-FEB-2022 (exact dose, site and route of administration were not reported) for prophylaxis.  On 09-OCT-2019, reported as "now", the patient was in pharmacy to receive second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received improperly stored dose of vaccine; This spontaneous report was received from a nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medications, medical history and drug reactions/allergies were not provided.   On 23-SEP-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant Human albumin)) (lot # S009756, expiration date 27-SEP-2020; vaccine dosage detail and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (product storage error). Current temperature excursion was -14 Celsius degrees to -10 Celsius degrees (-13 Celsius degrees) for 3 days. There was no previous temperature excursion. No adverse effects were reported. Data logger was involved.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: patient experienced extreme diarrhoea for a long time/she experienced diarrhea 4-5x; fever (low grade); This non-valid spontaneous report was received from an unspecified reporter via company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot#, expiration date, route, dosing details were unknown) for prophylaxis.   On an unknown date, the patient experienced extreme diarrhea for a long time. The outcome of the event diarrhea was unknown.   The causal relationship between the suspect therapy and the event was not provided.  Follow-up was received on 23-OCT-2019 from the initial reporter, who was an  acupuncturist. Upon receive of follow up information, patient identifiers were provided and the case is now considered valid. This report refers to a 70-year-old female patient. No information regarding the patient's concurrent conditions and concomitant medications was provided. It was reported that the patient had a fever after vaccination with influenza virus vaccine (unspecified) when she was 63-year-old (approximately in 2012).  On 25-SEP-2019 at 11:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S009945, expiration date 10-OCT-2021; route of administration, exact dose and frequency were not provided) for prophylaxis at a clinic. At the same time, the patient was vaccinated with influenza virus vaccine (unspecified) (lot # 3L32N, expiration date 30-JUN-2020; route of administration, exact dose, indication and frequency were not provided).  On 25-SEP-2019 at 22:30, after vaccination with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza virus vaccine (unspecified), the patient experienced diarrhea with intensity of 4-5 times without (w/o) cramp and she experienced fever (low grade). There was no treatment administered for the event. The patient drank a lot of warm water to recover from these events. The outcome of the events was reported as recovered/resolved on an unspecified date in 2019.  The relatedness between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), influenza virus vaccine (unspecified) and the events was not provided.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA000369:
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site warmth, Reaction to excipient
Clinical narrative: red; Feeling hot; Reaction to thimerasol; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced injection site erythema, injection site warmth and reaction to excipient. On an unknown date, the outcome of the injection site erythema, injection site warmth and reaction to excipient were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and reaction to excipient to be related to Hepatitis B vaccine.  Additional details were provided as follows: The patient states she received a hepatitis B vaccine series years and experienced a red, hot site reaction. The patient believed it was related to products that have thimerasol in them.   The patient noted that was what the common denominator was years ago. She stated that with the recent flu vaccine of three weeks ago, she asked for non thimerosal containing products. The reporter did not consent to follow-up. This case has been linked with US2019186993, reported by the same reporter for same patient.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Headache, Pain, Pyrexia
Clinical narrative: PATIENT CLAIMS SHE HAD A FEVER, CHILLS, ACHES AND PAINS, HEADACHE, NO APPETITE FOR 3 DAYS
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Erythema, Inflammation
Clinical narrative: PT RECEVIED FLU AND PNEUMONIA IN LEFT ARM BY REQUEST --- REPORTS CELLULITIS IN ARM AFTER SEEING PHYSICIAN - PT IS ALREADY HAS INFLAMMATION AND REDNESS TO ARM, NO DIFFICULTY BREATHING - WILL REPORT TO VAERS
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Injection site urticaria, Swelling
Clinical narrative: pt developed localized swelling and induration with erythema. 4cm diameter wheal to injection site.  No streaking.   Grandmother was advised to use ice and motrin and monitor for any further reaction.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: severe left arm pain and redness
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Flushing, Injection site urticaria, Lip swelling
Clinical narrative: Client received Flu vaccine at School flu clinic between 2 and 4 pm on 10/15/2019.  The flu clinic was operated by County Health Department registered nurses.  Clients mom came by the office on 10/21/2019 requesting a handout with the vaccine ingredients due to the fact that her son had a reaction to the vaccine and she was taking him to see his pediatrician on 10/21/2019.  Mom reported that hives at the injection site started within 24 hours of receiving vaccine.  She gave him Benadryl but the hives continued to spread.  On 10/20/2019 he started having swelling of the lips and she took him to urgent care.  He was prescribed Prednisone, Zantac and Zyrtec. Clients mom took him to his pediatricians office, on 10/21/2019 and was seen by FNP. Health Dept received information from Peds on 10/21/2019 that the client was seen; allergy testing was done, lungs were clear, cheeks were flushed, no rash on body or lips seen; stated client felt better.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Feeling of body temperature change, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Shot was administered into shoulder instead of arm muscle. Intense pain began immediately but I didnt realize it was that bad until I returned home. I cannot lift the arm and there are waves of warm and cold as well as tingling and pain.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia, Product administered at inappropriate site
Clinical narrative: Shot was administered into shoulder instead of arm muscle. Intense pain began immediately but I didnt realize it was that bad until I returned home. I cannot lift the arm and there are waves of warm and cold as well as tingling and pain.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure normal, Dizziness
Clinical narrative: Patient received the flu shot on Monday and she started feeling dizzy on Tuesday and have been feeling dizzy throughout the day ever since. She's not on any blood pressure medications.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood pressure increased, Headache, Vomiting
Clinical narrative: The patient's husband reported that after the immunization the patient had an elevated blood pressure, vomiting, and headache which required hospitalization for 2-3 days before resolving
Age: 25.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Mobility decreased
Clinical narrative: She couldn't move her arm the next day and only took 1 advil. She iced it 10/23 and has noticed slight improvement.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: ACHE IN LEFT ARM COULD NOT LIFT ARM ACHED ALL OVER CHEST TIGHTNESS