chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Feeling hot
Clinical narrative: After administering AFLURIA, patient reported feeling "weird." Symptoms included light headedness, feeling warm, skin redness on chest, and feeling as though she might faint. These symptoms came about roughly five to ten minutes after receiving immunization. Before administration, patient reported never having any adverse reaction to an immunization. Patient stated she "used to be allergic to a lot of things" and kept BENADRYL in her purse. She took one dose of BENADRYL 25 mg. I asked if patient was having trouble breathing or felt any swelling in her throat, to which she replied no. I obtained an EPIPEN just in case. After waiting in our immunization room for about 30-40 minutes patient said she was feeling normal again and left. I called patient later in the day to check in and she reported no further symptoms.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient called 10/31/18 about local injection site reaction from a flu shot administered on 10/29/18 by a pharmacist. She endorse pain, soreness, indentation, and swelling. Patient has tried administering pharmacist's recommendation of over-the-counter pain medication and cold compress. Patient was advised to continue with the OTC pain medication as directed, cold compress, and add diphenhydramine for the swelling. Will follow up with patient in 5 days for an update on her reaction.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PATIENT STATED SHE WOKE UP AT NIGHT WITH SWELLING REDNESS, WARM ON ARM BUT NOT EXACTLY AT SITE OF INJECTION, SHE CALLED MD WHO TOLD HER TO APPLY ICE, SHE WAS NOT PRESCRIBED ANTIBIOTICS OR OTHER MEDICATIONS FOR REACTION. SHOWED PICTURE OF REACTION TO PHARMACIST- ARM APPEARED AS DESCRIBED (RED, SWOLLEN, POSSIBLY INFECTED).
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site induration, Injection site mass
Clinical narrative: Pharmacy was doing a flu clinic on 10/31/18. The patient got a flu shot (FLUARIX) and upon injecting and taking needle out, blood came out. More than normal. Gauze was put on to stop bleeding. A band aid was put on. A lump started to form at injection site. It was hard. Ice was applied for about 5 minutes. Patient was doing ok. No other symptoms. Patient was monitored for about 10-15 minutes. Patient was notified to continue to monitor for worsening lump (it was smaller than the bandaid) and with other symptoms such as dizziness to contact doctor. When patient left the hard lump was still there, bleeding had stopped, but hard lump wasn't getting any bigger.  Will be following up with patient with phone call in a couple hours to see how patient is doing.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain, Pruritus
Clinical narrative: States initially lump developed and redness. Sore to touch occurred the day after vaccine. Followed up with patient on Oct31 2018, states no longer sore, but lump still present and itchiness has developed.
Age: 56.0
Sex: M
Vaccine: YF
Symptoms: Decreased appetite, Hyperhidrosis, Lethargy, Nausea
Clinical narrative: 2-3 days after vaccine nausea, sweats, lethargic, no appetite. Got worse over the next 7 days. Unable to complete climb planned. Back to normal after 2 wks.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: WARMTH, RASH, REDNESS, INFLAMMATION BELOW THE DELTOID ON THE LEFT ARM.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Hyperhidrosis, Hypotension, Unresponsive to stimuli
Clinical narrative: Patient received HPV vaccine, seconds later became unresponsive for 1-2 seconds, became diaphoretic, cold-clammy skin, and had low pressure 70/25 Pulse 108. Patient was given 2 bottles of water a total of 472 mL blood pressure repeated and obtained 112/39 P 57. After the two bottles of water, patient was more alert, no longer diaphoretic, and denied dizziness, lightheadedness, N/V, and visual changes.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Muscle spasms, Muscular weakness
Clinical narrative: Muscle ache, fever, chills, muscle weakness, spasms in muscles, stomach pain for a short period followed by nauseous, severe headache.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle ache, fever, chills, muscle weakness, spasms in muscles, stomach pain for a short period followed by nauseous, severe headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 102. Muscle aches, sore throat to the shingles vaccine
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient presented to the Hospital Emergency Department complaining of redness and warmth in Left arm. Physician administered SOLU-MEDROL 125 mg IM x1 and prescribed oral prednisone.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Malaise
Clinical narrative: Developing in evening after Flu Shot, pt is currently experiencing Chills, Low-grade fever, abdominal pains, nausea (no vomiting), fatigue, and mild diarrhea (no blood in stool). Patient instructed to take OTC MOTRIN (her pain med of choice) to help with chills, low-grade fever, and malaise - and to report any worsening of symptoms or symptoms lasting longer than 24 hours to her primary care doctor.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Developing in evening after Flu Shot, pt is currently experiencing Chills, Low-grade fever, abdominal pains, nausea (no vomiting), fatigue, and mild diarrhea (no blood in stool). Patient instructed to take OTC MOTRIN (her pain med of choice) to help with chills, low-grade fever, and malaise - and to report any worsening of symptoms or symptoms lasting longer than 24 hours to her primary care doctor.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Blood test normal, Injection site swelling, Pain, Pain in extremity, Tenderness
Clinical narrative: Had shot around 1045 AM. Around 200 PM started having pain down left arm. Continued to worsen to point I could not even touch or move my left arm without horrific pain. There was some swelling at injection site, but minimal at most.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: X-ray limb
Clinical narrative: Had shot around 1045 AM. Around 200 PM started having pain down left arm. Continued to worsen to point I could not even touch or move my left arm without horrific pain. There was some swelling at injection site, but minimal at most.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness/warmth in arm in large area and down to elbow.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site discolouration, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Did not go to doctor return to pharmacy and show the pharmacist 10/30/2018 (pharmacist stated I see had my PCP I don't feel it necessary. The area was extremely sore/tender to touch, injection area was red and very warm, swollen at and around the injection site, knot appeared and remains (reduce in size) as of 10/31/2018, the redness has dissipated at the injection site; however, the injection area is slightly discolored as of 10/31/2018. I felt I should report it. Note: Started feeling nausea and light headache onset 10/30/2018 not sure if its associated with the injection.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Did not go to doctor return to pharmacy and show the pharmacist 10/30/2018 (pharmacist stated I see had my PCP I don't feel it necessary. The area was extremely sore/tender to touch, injection area was red and very warm, swollen at and around the injection site, knot appeared and remains (reduce in size) as of 10/31/2018, the redness has dissipated at the injection site; however, the injection area is slightly discolored as of 10/31/2018. I felt I should report it. Note: Started feeling nausea and light headache onset 10/30/2018 not sure if its associated with the injection.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: Patient reported swelling and warmness but no bruising or redness. This lasted 6 days and is now better.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: THE PATIENT HAS PAIN AT THE SITE, REDNESS AND SWELLING THAT HAS SPREAD TO AXILLA AND SIDE OF BODY.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Lymphadenitis, Pain, Swelling
Clinical narrative: THE PATIENT HAS PAIN AT THE SITE, REDNESS AND SWELLING THAT HAS SPREAD TO AXILLA AND SIDE OF BODY.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site haemorrhage
Clinical narrative: At the injection site, patient instantly had what appear to be a hematoma or quarter sized  bump. The size reduced to a nickel size in 15 minutes. The injection shot bled down to patient's upper elbow. The bleed stopped once Band-Aid was applied.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient complains of pain in shoulder, still occurring, can barely lift arm. Reaching hurts. Can press on back of shoulder on a specific spot and it's painful. Patient believes the needle may have gone into a bursa, maybe not directly into the muscle. Patient has been taking ibuprofen at bedtime which helps but it wears off.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Aches, chills, fever, fatigue.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: It has been five days since the patient had the vaccination and he has been experiencing radiating pain to the shoulder and arm. I'm worried that the vaccine might have been given too high on the arm. He is going to follow up with his doctor.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Pain
Clinical narrative: Injection site and deltoid area was reddened, very warm to touch and swollen. I became achey with "sore" muscles entire body. Muscle aching last 24 hrs. Redness and swelling in injection site arm lasted 2-3 days. I have all my vaccinations, including annual flu shots, but never had a reaction to any of those. There was no reaction to first shot of SHINGRIX on 4/04/18.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Patient called pharmacy and said her arm was very sore and red above the elbow. I suggested that she put ice on it and she said she already had and it was still painful to even lift her arm. I told her to come in and I would look at her arm. I also asked why she got both shots in the same arm and she said because she had a steroid shot in the left arm and asked for both to be put in the right arm. When I saw her arm, it was red from her elbow to at least 4 inches up her arm. Pharmacy paid for her to go to the walk in clinic a block away and the doctor there diagnosed her with cellulitis. We filled a prescription tonight for her for cephalexin and MEDROL dose pack.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Dyspnoea, Headache, Injection site pain, Throat irritation
Clinical narrative: Asthma symptoms (wheezing, difficulty breathing, irritation in throat), headache, soreness at injection site. No treatment. Symptoms mostly alleviated after 1 hour, but still present to a lesser extent.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Asthma symptoms (wheezing, difficulty breathing, irritation in throat), headache, soreness at injection site. No treatment. Symptoms mostly alleviated after 1 hour, but still present to a lesser extent.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Breath sounds abnormal, Chest X-ray normal, Croup infectious, Dyspnoea, Eye swelling
Clinical narrative: Daughter received flu shot on Monday 10/22 and broke out in hives and swollen eyes Friday morning 10/26. Gave BENADRYL and symptoms improved. Woke up at 1230 AM 10/29 with severe breathing problems and paleness. Called 911 and transported to medical center where she was treated for croup even though she didn't have typical croup symptoms. Released later that morning. Followed up with dr on 10/29 at 11:20am. Continued treatment with steroids and inhaler. Symptoms have resolved but do not believe her illness was the croup. I wanted to report this as a possible allergic reaction to the flu shot. She has a sulfa drug allergy.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Pallor, Urticaria
Clinical narrative: Daughter received flu shot on Monday 10/22 and broke out in hives and swollen eyes Friday morning 10/26. Gave BENADRYL and symptoms improved. Woke up at 1230 AM 10/29 with severe breathing problems and paleness. Called 911 and transported to medical center where she was treated for croup even though she didn't have typical croup symptoms. Released later that morning. Followed up with dr on 10/29 at 11:20am. Continued treatment with steroids and inhaler. Symptoms have resolved but do not believe her illness was the croup. I wanted to report this as a possible allergic reaction to the flu shot. She has a sulfa drug allergy.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Shortly after administration, patient complained of pain in left arm. Overnight swelling and redness appeared and patient reported that she was unable to move her arm.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Exposure during pregnancy, Lymph node pain, Urticaria
Clinical narrative: First pregnancy, due January 7 2019. Tenderness in glands of the neck (Day of injection, 5:00 PM), Stomach upset and mild diarrhea (Day of injection, between 3-5 PM), severe breakout of hives (Day of injection, 8:00 PM). Hives continued through the next two days, with almost full body coverage at end of second day. Treated with 3 doses of BENADRYL (25 mg ea, 6 hrs apart) starting at 10:00 PM on the day after the injection. BENADRYL helped but did not completely resolve hive symptoms. Gland tenderness and stomach upset did not reappear after first day. No pain at injection site or in arm that received the injection. Flare up of hives on Day 3 was diminished but still definitely present.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Erythema at injection site growing increasingly worse over the course of 2 days. It was recommended she self treat with NSAID and ice applied to affected area.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever - general feeling of being sick for one night.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Began experiencing signs and symptoms on 10/30/18 around 2:30pm -nausea (intermittent throughout that morning) -numbness in left hand -dizzy -dilated pupils -pallor -hot flashes -sweating -cold/shivering -headache -feelings of passing out -fatigue -decreases appetite -weakness.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Headache, Hot flush, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Began experiencing signs and symptoms on 10/30/18 around 2:30pm -nausea (intermittent throughout that morning) -numbness in left hand -dizzy -dilated pupils -pallor -hot flashes -sweating -cold/shivering -headache -feelings of passing out -fatigue -decreases appetite -weakness.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Mydriasis, Nausea, Pallor
Clinical narrative: Began experiencing signs and symptoms on 10/30/18 around 2:30pm -nausea (intermittent throughout that morning) -numbness in left hand -dizzy -dilated pupils -pallor -hot flashes -sweating -cold/shivering -headache -feelings of passing out -fatigue -decreases appetite -weakness.
Age: 1.25
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Patient has a rash located on side of the injection site on right thigh. Rash appeared 24 hrs after vaccination. No other symptoms reported.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness, soreness of left arm below vaccination site. Diagnosed as cellulitis by primary care doctor. Treating with cephalexin and prednisone.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Eye swelling, Pruritus, Urticaria
Clinical narrative: Received the flu vaccination on 10/18/18 at 1315 and pt developed hives, itching, swelling of eye, redness to chest.
Age: 1.08
Sex: U
Vaccine: FLU4
Symptoms: Blood lactate dehydrogenase, Blood test, Crying, Differential white blood cell count, Fall
Clinical narrative: Child will not walk on leg, falling down, crying, holding the leg where injection was given. Was seen in clinic 10-24-18. Limping, bloodwork ran, and x-rays of hip and knee. 10-29-18 fever and still limping. Ultrasound on left leg. More bloodwork. All negative.
Age: 1.08
Sex: U
Vaccine: FLU4
Symptoms: Full blood count, Gait disturbance, Gait inability, Injection site pain, Metabolic function test
Clinical narrative: Child will not walk on leg, falling down, crying, holding the leg where injection was given. Was seen in clinic 10-24-18. Limping, bloodwork ran, and x-rays of hip and knee. 10-29-18 fever and still limping. Ultrasound on left leg. More bloodwork. All negative.
Age: 1.08
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia, Red blood cell sedimentation rate, Streptococcus test, X-ray limb, X-ray of pelvis and hip
Clinical narrative: Child will not walk on leg, falling down, crying, holding the leg where injection was given. Was seen in clinic 10-24-18. Limping, bloodwork ran, and x-rays of hip and knee. 10-29-18 fever and still limping. Ultrasound on left leg. More bloodwork. All negative.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Hypersensitivity, Pain, Wrong technique in product usage process
Clinical narrative: Severe pain, dizziness, allergic reaction. ER gave her IV pain med, steroid and BENADRYL. She was dismissed and states no other pain or problems. Pt states pharmacist gave her a partial injection and then he got a 2nd syringe, squeezed some out and injected her again same arm.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Clonus, Dizziness, Dystonia, Hypoaesthesia, Mobility decreased
Clinical narrative: This spontaneous case, initially received on 19-Oct-2018, reported by other non-healthcare professional (consumer), concerns a 31-year-old, adult female patient. The patient's current conditions included pollen allergy. The patient did not have an egg allergy. The patient's concomitant medication included over-the-counter (OTC) ALLEGRA for allergy. On 04-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported]. On the same day, in the evening, 8-10 hours after vaccination, the patient experienced lightheadedness, dizziness, nausea, extremity and facial numbness. The patient also experienced clonic-like and dystonic type movements of arms and legs, which resulted an inability to move any extremity. Eventually, the emergency medical services (EMS) was called and the patient was taken to a local hospital for evaluation. At the hospital, the patient was treated with BENADRYL which did not relieve but relaxed her and ATIVAN resolved the contractures. On 05-Oct-2018 (past midnight), the patient was discharged from the hospital. On an unspecified date in Oct-2018, 48 hours after onset of the events, the patient had recovered from the events dizziness, nausea, numbness, clonic and dystonic movements and movement disorder. On an unknown date, the patient developed muscle soreness and weakness. On an unspecified date, after returning home from the hospital, the patient contacted her primary care physician (PCP) as well as pharmacy where she was vaccinated. Patient was instructed never to receive flu vaccine again. At the time of this report, the patient had not recovered from the events muscle soreness and weakness. The reporter assessed this case as serious (hospitalization) and considered the causality of the events as related to the suspect vaccine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Movement disorder, Muscle contracture, Muscular weakness, Myalgia, Nausea
Clinical narrative: This spontaneous case, initially received on 19-Oct-2018, reported by other non-healthcare professional (consumer), concerns a 31-year-old, adult female patient. The patient's current conditions included pollen allergy. The patient did not have an egg allergy. The patient's concomitant medication included over-the-counter (OTC) ALLEGRA for allergy. On 04-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported]. On the same day, in the evening, 8-10 hours after vaccination, the patient experienced lightheadedness, dizziness, nausea, extremity and facial numbness. The patient also experienced clonic-like and dystonic type movements of arms and legs, which resulted an inability to move any extremity. Eventually, the emergency medical services (EMS) was called and the patient was taken to a local hospital for evaluation. At the hospital, the patient was treated with BENADRYL which did not relieve but relaxed her and ATIVAN resolved the contractures. On 05-Oct-2018 (past midnight), the patient was discharged from the hospital. On an unspecified date in Oct-2018, 48 hours after onset of the events, the patient had recovered from the events dizziness, nausea, numbness, clonic and dystonic movements and movement disorder. On an unknown date, the patient developed muscle soreness and weakness. On an unspecified date, after returning home from the hospital, the patient contacted her primary care physician (PCP) as well as pharmacy where she was vaccinated. Patient was instructed never to receive flu vaccine again. At the time of this report, the patient had not recovered from the events muscle soreness and weakness. The reporter assessed this case as serious (hospitalization) and considered the causality of the events as related to the suspect vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Tremor
Clinical narrative: Shaking chills, temperature 101-lasted less than 12 hours.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: 88 YO AM with Afib, CHF, CAD, and pulmonary HTN received SHINGRIX vaccine on 7/31/2018. The patient reported muscle ache and nausea for nearly a week after the immunization during a follow-up visit on 9/5/2018. Symptoms resolved and no other action was taken. The provider notes that the patient will likely refuse the second dose of SHINGRIX due to the reaction. *Note-Information provided above is about the extent documentation provided within the EHR.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash, Skin discolouration
Clinical narrative: Patient has a rash on her right arm and forehead. 10 cm erythema with slight greenish discoloration of right arm. Second area of erythema over the forehead and right cheek. Patient was given order to purchase ZYRTEC over the counter and to contact our office if rash persists for more than 48 hours.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection sites of Right arm.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash erythematous
Clinical narrative: Administered vaccine on 10/22/18. On 10/27, mom noted few red spots on site of injection site. Follow day 10/28, noted increased swelling, redness at site of injection. On 10/29 night and this morning, mom noted red bumps diffusely on upper/lower (R) extremities and buttocks.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: 5x5 in redness, swelling hot to touch, painful.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Balance disorder, Hypoaesthesia, Nerve conduction studies, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Received flu vaccine 10/3/2018 in left arm. 10/9/2018 laid down in bed and had tingling in bilateral feet and buttocks. 10/10/2018 awoke with numbness and tingling bilaterally from toes to waist including perineum. Saw PCP on 10/12/2018 and was prescribed a prednisone taper over 12 days (60, 40, 20). No improvement of symptoms. Continued numbness and tingling bilaterally and in pelvic area. New loss of balance and pain when walking on flat surfaces and especially walking down stairs. On 10/15/2018 saw chiropractor and he states exam showed increased dullness and decrease in strength on right side lower extremity. On 10/19/2018, had an MRI of lumbar spine. 10/24/2018, saw neurologist. He states exam abnormal.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging thoracic abnormal, Pain, Paraesthesia
Clinical narrative: Received flu vaccine 10/3/2018 in left arm. 10/9/2018 laid down in bed and had tingling in bilateral feet and buttocks. 10/10/2018 awoke with numbness and tingling bilaterally from toes to waist including perineum. Saw PCP on 10/12/2018 and was prescribed a prednisone taper over 12 days (60, 40, 20). No improvement of symptoms. Continued numbness and tingling bilaterally and in pelvic area. New loss of balance and pain when walking on flat surfaces and especially walking down stairs. On 10/15/2018 saw chiropractor and he states exam showed increased dullness and decrease in strength on right side lower extremity. On 10/19/2018, had an MRI of lumbar spine. 10/24/2018, saw neurologist. He states exam abnormal.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Pain, Tenderness
Clinical narrative: On 08/22/2018 - Tdap given at time of PE. She started developing soreness in site and numbness in fingers. Has seen a little bit of improvement. Still tender to touch and move arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Pain, Pyrexia
Clinical narrative: Patient received vaccine on 11/15/2017 at 4:50 pm and later on that evening experienced severe soreness, pain, bruising and a fever of 100. Patient husband came in on evening of 11/20/2017 to report incident and show pics.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Peripheral swelling, Rash
Clinical narrative: Slight rash, mild myalgia, swelling in hands.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: Chills, feverish, felt like he was dying.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt developed hives the night after receiving the flu shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Headache, Induration, Pyrexia, Skin warm
Clinical narrative: Fever 101.9. Redness measured 3.25in x 2.25 in., no induration. Hard to touch and warm. Has had headaches. No drainage at injection site.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site discolouration, Mobility decreased, Pain in extremity, Rash macular
Clinical narrative: 9-24-18 - Patient called - right arm is red/blotchy with yellow/purple area around injection site - arm is sore. 10-3-18 - call her to check - almost back to normal - a bit puffy - can lift arm now.
Age: 46.0
Sex: U
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Severe pain post vaccination with vaccinated extremity limited ROM.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Influenza like illness, Mobility decreased
Clinical narrative: Pain, body aches severe, chills. Arm hurt so bad could not move it. Severe chills. Had shot on Friday, felt awful, flu like all weekend until after Sunday night and when he "sweated it out".
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain, body aches severe, chills. Arm hurt so bad could not move it. Severe chills. Had shot on Friday, felt awful, flu like all weekend until after Sunday night and when he "sweated it out".
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warm, and swelling at site of injection starting about 12hrs later. Increasing redness and swelling over the next 24 hrs to 15cm x 20cm covering entire anterior thigh. No fever, able to walk without pain. Treated with Prednisone.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Musculoskeletal pain, Peripheral swelling, Skin warm
Clinical narrative: Shoulder pain; swelling, hot and red-swelling radiating down arm to hand and fingers.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient's mother reported hives on chest 2-3 hours after vaccine was administered. Treated with BENADRYL.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Condition aggravated, Vomiting
Clinical narrative: Chills, vomiting, after 4 hrs.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Skin exfoliation
Clinical narrative: Bumpy, red, peeling skin, pain, soreness, ring around shot area on Flu vaccine. Pt brought to pharmacy attention 10-20-18. Bumpy, red, peeling skin on pneumonia vaccine. Pt brought to pharmacy attention on 10-20-2018.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling of body temperature change, Headache, Neck pain, Pyrexia
Clinical narrative: About 4 hours after receiving the vaccine, I experienced fever and chills and neck ache. I shook tremendously and felt very hot and was very cold. In the morning I awoke with only a headache - at the top of my head and also forehead.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Pt received Men B on 7/27/18- (L) deltoid. She describes 1 week H/O (L) arm numbness, weakness, H/A following IMS.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue
Clinical narrative: Fatigue upon exertion.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Last night after the vaccine she had severe swelling, redness and pain. She took TYLENOL and was better this morning, but some swelling remained.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Generalised tonic-clonic seizure, Syncope
Clinical narrative: History of syncope and grand mal seizure 1 hr after influenza vaccine. Seen at hospital. Had complete recovery. Seen in office 48hr after. Asymptomatic normal physical.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Started hurting 10/30 - red and swollen and hot to touch. No fever. Area 6" x 4" arm all red.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Got shot on 9/8/2017, in right arm. Immediately felt hot arm and soreness. Wasn't overly concerned as I was told to expect some reaction. Next day I was in immense pain, site was hot and seemed swollen. We left for a trip shortly after injection. I was extremely sore the entire trip. Had to hold onto my arm while sleeping so that it didn't bump into things. Also could not pull off my shirts without help from my husband. Had almost no lifting capacity. I reported this to my doctor on 10/30/2017 in an office visit, upon returning from my trip. I also had a kidney stone I was passing so the arm was a secondary concern. I have had ongoing flare-ups of the arm. The most recent the past few days/week. It gets hot to the touch and I cannot sleep at night. I try 2 ALEVE tablets and I still get no relief. Nothing seems to help. The pain now seems to be going down from my shoulder along the inside of my right arm all the way to my elbow. Hot intense pain.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve stimulation test, Pain in extremity, Skin warm, Weight bearing difficulty
Clinical narrative: Got shot on 9/8/2017, in right arm. Immediately felt hot arm and soreness. Wasn't overly concerned as I was told to expect some reaction. Next day I was in immense pain, site was hot and seemed swollen. We left for a trip shortly after injection. I was extremely sore the entire trip. Had to hold onto my arm while sleeping so that it didn't bump into things. Also could not pull off my shirts without help from my husband. Had almost no lifting capacity. I reported this to my doctor on 10/30/2017 in an office visit, upon returning from my trip. I also had a kidney stone I was passing so the arm was a secondary concern. I have had ongoing flare-ups of the arm. The most recent the past few days/week. It gets hot to the touch and I cannot sleep at night. I try 2 ALEVE tablets and I still get no relief. Nothing seems to help. The pain now seems to be going down from my shoulder along the inside of my right arm all the way to my elbow. Hot intense pain.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Muscular weakness, Myalgia, Nausea
Clinical narrative: I felt very ill the morning after the injection (gastrointestinal), went to the bathroom, and passed out. After a trip to the ER and my PCP (I have only fainted one other time in my life, in 1979, cutting raw meat). I was told I was fine and it was vasovagal syncope. Almost two weeks later, on 3/5/18, I started having periods of premature ventricular contractions 1.5-2 hours after exercise. The PVCs (~7-10/minute) lasted 3-4 hours. Occasionally, these were accompanied by periods (10-15 minutes in duration) of rapid heartbeat. Since I exercise regularly, this all affected me tremendously. My PCP had me wear a Holter monitor, and then see a cardiologist. The cardiologist said my heart was fine and that PVCs "just sometimes happen without reason." He prescribed a beta blocker to help mask the symptoms. The initial dosage (only 12.5mg, 2x/day) brought my heart rate and blood pressure down too low (I was dizzy and "fuzzy"), so I VERY gradually decreased the dose and VERY gradually increased exercise. By late August 2018, I was about 95% back to normal. Both the cardiologist and PCP said the PVCs were unrelated to the shingles vaccine. In early September, I received the second dose of the vaccine. Five days later, the PVCs were back. I am now convinced it is an immune system response to the vaccine. I am back taking a very small dose of Metropolol, and gradually increasing exercise again - with fervent hope I'll be 100% at some point.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased, Loss of consciousness
Clinical narrative: I felt very ill the morning after the injection (gastrointestinal), went to the bathroom, and passed out. After a trip to the ER and my PCP (I have only fainted one other time in my life, in 1979, cutting raw meat). I was told I was fine and it was vasovagal syncope. Almost two weeks later, on 3/5/18, I started having periods of premature ventricular contractions 1.5-2 hours after exercise. The PVCs (~7-10/minute) lasted 3-4 hours. Occasionally, these were accompanied by periods (10-15 minutes in duration) of rapid heartbeat. Since I exercise regularly, this all affected me tremendously. My PCP had me wear a Holter monitor, and then see a cardiologist. The cardiologist said my heart was fine and that PVCs "just sometimes happen without reason." He prescribed a beta blocker to help mask the symptoms. The initial dosage (only 12.5mg, 2x/day) brought my heart rate and blood pressure down too low (I was dizzy and "fuzzy"), so I VERY gradually decreased the dose and VERY gradually increased exercise. By late August 2018, I was about 95% back to normal. Both the cardiologist and PCP said the PVCs were unrelated to the shingles vaccine. In early September, I received the second dose of the vaccine. Five days later, the PVCs were back. I am now convinced it is an immune system response to the vaccine. I am back taking a very small dose of Metropolol, and gradually increasing exercise again - with fervent hope I'll be 100% at some point.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Syncope, Ventricular extrasystoles
Clinical narrative: I felt very ill the morning after the injection (gastrointestinal), went to the bathroom, and passed out. After a trip to the ER and my PCP (I have only fainted one other time in my life, in 1979, cutting raw meat). I was told I was fine and it was vasovagal syncope. Almost two weeks later, on 3/5/18, I started having periods of premature ventricular contractions 1.5-2 hours after exercise. The PVCs (~7-10/minute) lasted 3-4 hours. Occasionally, these were accompanied by periods (10-15 minutes in duration) of rapid heartbeat. Since I exercise regularly, this all affected me tremendously. My PCP had me wear a Holter monitor, and then see a cardiologist. The cardiologist said my heart was fine and that PVCs "just sometimes happen without reason." He prescribed a beta blocker to help mask the symptoms. The initial dosage (only 12.5mg, 2x/day) brought my heart rate and blood pressure down too low (I was dizzy and "fuzzy"), so I VERY gradually decreased the dose and VERY gradually increased exercise. By late August 2018, I was about 95% back to normal. Both the cardiologist and PCP said the PVCs were unrelated to the shingles vaccine. In early September, I received the second dose of the vaccine. Five days later, the PVCs were back. I am now convinced it is an immune system response to the vaccine. I am back taking a very small dose of Metropolol, and gradually increasing exercise again - with fervent hope I'll be 100% at some point.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis, Herpes virus test, Laboratory test, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of stroke in a 65-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced stroke (serious criteria GSK medically significant), Bell's palsy (serious criteria GSK medically significant), nausea, headache, speech impairment nos, hearing impaired and nerve pain. On an unknown date, the outcome of the stroke, Bell's palsy, nausea, headache, speech impairment nos, hearing impaired and nerve pain were recovering/resolving. It was unknown if the reporter considered the stroke, Bell's palsy, nausea, headache, speech impairment nos, hearing impaired and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a severe adverse reaction of stroke and Bell's palsy. The reaction began as nausea and then two days later he had a headache around his ear. The patient then got out of bed on a Monday of unknown week and had a stroke with his speech and hearing affected. It had been 3 months later and he was currently at the end of his recovery process.  The patient had made a good recovery, but still had nerve pain from time to time. No additional information was provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Viral test negative
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of stroke in a 65-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced stroke (serious criteria GSK medically significant), Bell's palsy (serious criteria GSK medically significant), nausea, headache, speech impairment nos, hearing impaired and nerve pain. On an unknown date, the outcome of the stroke, Bell's palsy, nausea, headache, speech impairment nos, hearing impaired and nerve pain were recovering/resolving. It was unknown if the reporter considered the stroke, Bell's palsy, nausea, headache, speech impairment nos, hearing impaired and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a severe adverse reaction of stroke and Bell's palsy. The reaction began as nausea and then two days later he had a headache around his ear. The patient then got out of bed on a Monday of unknown week and had a stroke with his speech and hearing affected. It had been 3 months later and he was currently at the end of his recovery process.  The patient had made a good recovery, but still had nerve pain from time to time. No additional information was provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Facial paralysis, Headache, Hypoacusis, Nausea
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of stroke in a 65-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced stroke (serious criteria GSK medically significant), Bell's palsy (serious criteria GSK medically significant), nausea, headache, speech impairment nos, hearing impaired and nerve pain. On an unknown date, the outcome of the stroke, Bell's palsy, nausea, headache, speech impairment nos, hearing impaired and nerve pain were recovering/resolving. It was unknown if the reporter considered the stroke, Bell's palsy, nausea, headache, speech impairment nos, hearing impaired and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a severe adverse reaction of stroke and Bell's palsy. The reaction began as nausea and then two days later he had a headache around his ear. The patient then got out of bed on a Monday of unknown week and had a stroke with his speech and hearing affected. It had been 3 months later and he was currently at the end of his recovery process.  The patient had made a good recovery, but still had nerve pain from time to time. No additional information was provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Speech disorder
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of stroke in a 65-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced stroke (serious criteria GSK medically significant), Bell's palsy (serious criteria GSK medically significant), nausea, headache, speech impairment nos, hearing impaired and nerve pain. On an unknown date, the outcome of the stroke, Bell's palsy, nausea, headache, speech impairment nos, hearing impaired and nerve pain were recovering/resolving. It was unknown if the reporter considered the stroke, Bell's palsy, nausea, headache, speech impairment nos, hearing impaired and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a severe adverse reaction of stroke and Bell's palsy. The reaction began as nausea and then two days later he had a headache around his ear. The patient then got out of bed on a Monday of unknown week and had a stroke with his speech and hearing affected. It had been 3 months later and he was currently at the end of his recovery process.  The patient had made a good recovery, but still had nerve pain from time to time. No additional information was provided.
Age: 66.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Balance disorder, Grip strength decreased, Head discomfort, Hypoaesthesia, Muscular weakness
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer or non-HCP. This case involves a 66 years old male patient who experienced strong headache and numbness in arms and legs, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 10-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE (lot number and expiry date was not reported) via intramuscular route in an unknown administration site. On 11-Oct-2018, the patient developed a non-serious strong headache and numbness in arms and legs next day following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data). Final diagnosis was numbness in arms and legs and strong headache. It was not reported if the patient received a corrective treatment. The patient was recovered from the events (reported as over the couple days). List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer or non-HCP. This case involves a 66 years old male patient who experienced strong headache and numbness in arms and legs, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 10-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE (lot number and expiry date was not reported) via intramuscular route in an unknown administration site. On 11-Oct-2018, the patient developed a non-serious strong headache and numbness in arms and legs next day following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data). Final diagnosis was numbness in arms and legs and strong headache. It was not reported if the patient received a corrective treatment. The patient was recovered from the events (reported as over the couple days). List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initially there was pain shortly after the injection and all through that day. Then starting getting very limited range of motion in the left arm. Contacted office on 10/12/2018 to make appointment with her doctor's office which was on the following Tuesday of 10/16/2018. Stiffness progressed over first week until received naproxen. Pain persisted but range of motion improved slightly.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity, X-ray
Clinical narrative: Initially there was pain shortly after the injection and all through that day. Then starting getting very limited range of motion in the left arm. Contacted office on 10/12/2018 to make appointment with her doctor's office which was on the following Tuesday of 10/16/2018. Stiffness progressed over first week until received naproxen. Pain persisted but range of motion improved slightly.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Injection site inflammation, Injection site warmth, Musculoskeletal pain, Pain
Clinical narrative: According to the pt she was seen by a neurologist as a result of the pain she was experiencing post-vaccination. The neurologist concluded that the pain, restricted range of motion and loss of strength is a result of the vaccine administration.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: According to the pt she was seen by a neurologist as a result of the pain she was experiencing post-vaccination. The neurologist concluded that the pain, restricted range of motion and loss of strength is a result of the vaccine administration.