chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin discolouration
Clinical narrative: According to mother, this 13 year old was vaccinated at school and, within minutes, developed significant swelling in her fingers and hand. Her hand was also apparently discolored (purplish color). Her palms were sweaty and her hand also turned white (washed out color in her hand) and had a cold sensation going up her left arm (same arm as vaccine site). She was taken into the emergency room because she couldn't move her left hand. At some point she was also taken to her pediatrician. The vaccine was administered as part of the Flu campaign in schools and the Flu staff was there but was not made aware of any reactions to any vaccines on the day of the clinic.  The Flu staff were notified on November 7, 2018 by the child's pediatrician. The Flu staff contacted mom on 11/8/18 and mom said that the child is okay now.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given the FLUZONE high dose instead of the FLUARIX regular dose by mistake. I was not even aware of the mistake until billing pointed out the error and insurance would not cover the cost. Patient is aged 52 instead of age 65 as indicated. Patient experienced no reported adverse reaction or side effect.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Vaccine given on the posterior side of the left deltoid. The location of the injection seemed high to the parent and the patient had severe pain immediately after the injection was given. The shoulder was especially painful with abduction. There was some improvement in the range of motion and level of pain after about one week. Then, the patient operated a combine for 2 days during harvest. The repetitive movement resulted in increased sharp, stabbing pain in the shoulder and decreased range of motion. Patient rates the pain at 9-10 on a 0-10 scale. Again, the pain is worst when the arm is abducted, and at the end of the day, the shoulder is achy. Patient has tried over the counter pain medications (ibuprofen and acetaminophen), ice, and rest of the joint, with little improvement.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Malaise, Nausea
Clinical narrative: Client reported feeling not well/onset nausea first couple of minutes after vaccines administered; rested supine x 15 minutes; reported feeling better after approx. 5 minutes of lying supine; BP/HR stable/unchanged from baseline Q 5 minutes while supine; nausea subsided after 1 or 2 minutes with no vomiting; after 15 minutes able to sit up then stand without return of symptoms; ambulatory feeling well with return to baseline; left clinic in good condition.
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Neuralgia, Tenderness
Clinical narrative: Nerve sensitivity in the upper torso. Affected area is painful to the touch, a light piece of clothing rubbing the skin is painful. Hot or cold does not seem to have an effect on the pain level, it is more pain with direct contact rather than temperature fluctuations. Almost feels like a severe sunburn, but no visible skin reactions. Primary care phys. and dermatologist both ruled out shingles.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Patient reported on 11/8/18 that he went to his MD because his right shoulder was still sore and stiff. Reported having issues moving/rotating arm over his head. Patient presented a prescription for prednisone from MD, stated that MD did not pinpoint a visible problem but prescribed the prednisone to help reduce inflammation at the site and see if that would relieve the symptoms. We have no knowledge of the patient reporting any muscle soreness prior to 11/8/18.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Patient reported on 11/8/18 that he went to his MD because his right shoulder was still sore and stiff. Reported having issues moving/rotating arm over his head. Patient presented a prescription for prednisone from MD, stated that MD did not pinpoint a visible problem but prescribed the prednisone to help reduce inflammation at the site and see if that would relieve the symptoms. We have no knowledge of the patient reporting any muscle soreness prior to 11/8/18.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Pt reported redness, hot to touch the following day, swelling and aches, lasted 1 1/2 weeks, redness still present 11-8-2018, not hot and not painful, appears like a local reaction.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: Hives on buttocks.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Hypoaesthesia, Pain, Pruritus
Clinical narrative: On Tuesday, October 2 I received a flu vaccine shot at Clinic. I experienced unusual itching in my left foot Thursday afternoon and evening. Friday night I was afflicted with intense burning and itching in my left foot with shooting pain, similar to, but worse than the reaction I've had with Oxycodone and Tramadol following hospital surgery. My usual trick of immersing my foot in ice water helped but did not provide relief. The pain was bad enough that I asked my wife to pack a hospital bag in case I needed the ED. Toward morning, I tried TYLENOL and did get some relief. Saturday I used ice water, diversion and TYLENOL to make it through the day and was able to sleep a few hours several times during the night, resorting to ice water and TYLENOL as required. The condition improved further Sunday, with only one ice water/TYLENOL intervention during the night required. Monday forward I was ok. One lingering result is an increase in neuropathy in my left foot. I've had numb tips of the toes of both feet for some time on Amiodarone, but my left foot feels oddly more numb than before, not so much on the skin surface, but tissue inside the front half of my foot feels numb. I like to think this condition is slowly improving, but time will tell. I resolved to report this reaction, after a conversation with Dr (Psychology) in which she described a similar but less severe reaction she experienced following vaccination, except that it was located in a shin/ankle area.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain and swelling at injection site, nausea, loose stools, generally draggy (no energy), want to sleep most of the day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Pain and swelling at injection site, nausea, loose stools, generally draggy (no energy), want to sleep most of the day.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, Rash macular
Clinical narrative: Rash-raised red rash limited to her L arm, red and blotchy (hot to the touch), fever the next day (low grade) and aches in her upper trunk. She said movement and ice helped.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Rash-raised red rash limited to her L arm, red and blotchy (hot to the touch), fever the next day (low grade) and aches in her upper trunk. She said movement and ice helped.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Erythema, Induration, Local reaction
Clinical narrative: Large Local reaction (erythema, some induration), mild low grade temp 100.6 on day of vaccine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site mass
Clinical narrative: Patient given FLUZONE HD by Sanofi in left deltoid arm muscle using a 1 inch 25g needle and as soon as the needle left her arm a lump about the size of a fifty cent piece immediately arose at the vaccination site. Pt did not complain of pain.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Very sore arm with limited range of motion continuing one month post vaccine.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Death, Influenza
Clinical narrative: Patient's daughter states she received the vaccine Saturday morning and in the afternoon she came down with flu symptoms and passed away that day from complications from the flu.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis in her left arm post vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Head injury, Syncope, Vomiting
Clinical narrative: Patient was vaccinated at around 11:50 am on 11/08/2018. Patient went downstairs with parent after about 15 minutes to make appointment. Patient vomited in waiting area and was brought up by wheelchair to second floor to be reevaluated by medical unit. Patient left wheelchair to walk into unit, fainted and hit side of her head. Patient was reevaluated by provider and released due to patient being in stable condition.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Feeling abnormal
Clinical narrative: Pt received the shot in the morning around 9 am, and called back at around 4 pm, stating he has diarrhea, not feeling good. No other symptoms per pt.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: PATIENT HAS PAIN IN UPPER ARM AREA AND ALSO COMPLAINS OF NUMBNESS IN THE HAND THAT HAS CONTINUED 6 DAYS AFTER SHOT.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Skin warm
Clinical narrative: Pt developed larger than usual rash. Was warm to touch. Received KEFLEX from Dr.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Stated that after vaccine was given he had a Dr appointment and at the office approximately 1.5-2 hours later he experienced syncope and passed out. When aroused by the staff at the MD office they took blood pressure and he stated it was fine.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: PATIENT 16 YEARS OLD HAD THE FLU SHOT AT 235 ON 11082018 AND SHE FAINTED SHE DID NOT LOSE CONSCIOUS.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient reported soreness at injection site hours after receiving vaccine. The next day there was swelling and redness in the left arm and patient also began to experience fever and chills over whole body.
Age: 23.0
Sex: M
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Patient got pale and felt faint. He felt nauseated. He asked to lay down. I assisted him to a lying position. I checked his vital signs and had him lay down for about 15 minutes until he felt better and color returned. His vitals remained stable. He never lost consciousness.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Pallor, Respiratory rate decreased, Visual impairment
Clinical narrative: Patient was slightly nervous before receiving vaccine. After vaccine was administered she became pale, nauseous, complained that she couldn't see, felt dizzy. Her breathing was visibly slow, but she never lost consciousness at any point. She placed her head between her knees, her mother and I coached her to breathe for several minutes. She then had some sips of water. After about 5 minutes she was feeling better. She remained seated and after about 5 additional minutes she was okay to stand up. She explained that she had not had anything to eat yet that day and it was close to 1 p.m. I suggested getting something to eat right away and trying some orange juice to bring up her blood sugar.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Pain
Clinical narrative: Patient complains of pain and inflammation after 8 days of injection.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Guillain-Barre; IVIg started 6 Nov 2018.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Guillain-Barre; IVIg started 6 Nov 2018.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Heart rate increased, Tremor
Clinical narrative: Awakened by rapid pulse and heart rate. Moved to severe shaking in all extremities, felt cold. Managed through self administered techniques. Resolved in an hour and a half.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Monoplegia, Oedema
Clinical narrative: Patient has myasthenia gravis and received a pneumonia vaccine and a flu vaccine in the same arm (left arm) and the patient came into the pharmacy on 11/8/18 to tell me she spent the next day in the ER with a paralyzed arm. She said the ER doctor told her it was too much fluid (1 ml) for her muscles to withstand, so they gave her some muscle relaxers and that solved the problem.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Patient came back with red rash on her left arm, slightly swollen.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Fatigue, Nausea, Blinding headache.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Induration, Skin discolouration, Tenderness
Clinical narrative: According to patient: Her arm is purple until elbow, hard and painful to touch. Symptoms started few hours after receiving vaccine.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Pyrexia, Type 1 diabetes mellitus
Clinical narrative: She received 2 hep b shots and 1 tdap shot between 2014-2015. No reaction then other than discomfort and fevers. 2018 dx with type one diabetes. No family history of it.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Pt experienced fever of 103, headache, lethargy after receiving vaccine. Said she took ibuprofen.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Red, warm rash on arm.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dry skin, Injection site erythema, Injection site reaction, Rash, Skin exfoliation
Clinical narrative: Patient had red welts around the injection site within 24 hours. She later developed within the next 2 to 3 days severe skin reactions on the insides of both elbows as well as rash/welts/peeling on both hands and inner thighs. The reaction started out moist and later turned to severe peeling due to dryness.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Skin reaction, Urticaria
Clinical narrative: Patient had red welts around the injection site within 24 hours. She later developed within the next 2 to 3 days severe skin reactions on the insides of both elbows as well as rash/welts/peeling on both hands and inner thighs. The reaction started out moist and later turned to severe peeling due to dryness.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Exposure during pregnancy, Presyncope, Syncope
Clinical narrative: Near fainting- vasovagal syncope. Symptoms of lightheadedness, weakness, dizziness, almost fainting. Recovered after about 5 minutes of sitting down. 8 weeks normal pregnancy.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Rash , heat and swelling. Patient will start applying TOPICORT 0.25% cream.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Myalgia, Pain
Clinical narrative: Severe headache ? like the flu is coming, body ache, muscle pain, pain at site of injection. This happened at the first injection a few months ago, too.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Severe headache ? like the flu is coming, body ache, muscle pain, pain at site of injection. This happened at the first injection a few months ago, too.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's entire upper arm was markedly swollen from the should down to elbow and hot to the touch. She reported an extremely limited range of movement and pain associated with the swelling.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Bursitis, Injection site mass, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient presented to pharmacy on 11/8/18 reporting that since his flu shot on 10/30/18, his arm has been sore and there is a slight lump in the area of where he got his shot. He presented with classic signs of bursitis, most likely due to the shot being given too high on his right arm.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: ERYTHEMIA IN AN OVAL PATTERN 5 CM BY 8 CM AROUND INJECTION SITE. PATIENT CAME TO THE MEDICAL CENTER ON THE AFTERNOON OF 10/04/2018 AND THE REACTION WAS RESOLVING WITHOUT MEDICAL TREATMENT. PATIENT WAS TOLD TO COME BACK IF THE REACTION DID NOT RESOLVE.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Anger, Breath holding, Crying, Cyanosis, Hypotonia
Clinical narrative: 10/30/2018: After receiving his immunizations, patient was angry and cried briefly. He suddenly then became cyanotic around his mouth and limp. He had not tonic-clonic movements during this event. Event was witnessed by MPH-MA and patient. Dr was notified within seconds of the event. Upon Dr's arrival, patient was pale. He was awake, but sleepy. Within 30 seconds to a minute, his color began to improve, and he returned to being the smiling infant that he was before his shots. His lungs remained clear. No tachypnea. No retractions. Normal heart sounds without murmur. Normal rate and rhythm. Brachial and femoral pulses 2/4 and symmetric. CRT brisk. PERRL. EOMI after the event. Normal tone after the event. Movement remained symmetrical. His oxygen saturation and pulse WNL (noted below). Review of his history with his mother revealed that he has no history of this activity with he 2 month old immunizations. He doesn't cry often, but when he does, he sometimes does breath hold briefly. He had never lost consciousness before today. Pulse: 97 on 10/30/2018 Oxygen Sat: 100 % on 10/30/2018. 11/1/18 @ 0807: Spoke with mother. She said patient is doing good! He was a little fussy Tuesday night (10/30/18) but she thinks it was just from getting the shots. Yesterday (10/31/18) he was back to his normal happy self. Final diagnosis was breath holding spell.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pallor, Somnolence
Clinical narrative: 10/30/2018: After receiving his immunizations, patient was angry and cried briefly. He suddenly then became cyanotic around his mouth and limp. He had not tonic-clonic movements during this event. Event was witnessed by MPH-MA and patient. Dr was notified within seconds of the event. Upon Dr's arrival, patient was pale. He was awake, but sleepy. Within 30 seconds to a minute, his color began to improve, and he returned to being the smiling infant that he was before his shots. His lungs remained clear. No tachypnea. No retractions. Normal heart sounds without murmur. Normal rate and rhythm. Brachial and femoral pulses 2/4 and symmetric. CRT brisk. PERRL. EOMI after the event. Normal tone after the event. Movement remained symmetrical. His oxygen saturation and pulse WNL (noted below). Review of his history with his mother revealed that he has no history of this activity with he 2 month old immunizations. He doesn't cry often, but when he does, he sometimes does breath hold briefly. He had never lost consciousness before today. Pulse: 97 on 10/30/2018 Oxygen Sat: 100 % on 10/30/2018. 11/1/18 @ 0807: Spoke with mother. She said patient is doing good! He was a little fussy Tuesday night (10/30/18) but she thinks it was just from getting the shots. Yesterday (10/31/18) he was back to his normal happy self. Final diagnosis was breath holding spell.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Loss of personal independence in daily activities, Rash generalised, Urticaria
Clinical narrative: Diffuse skin rash/urticaria - given antihistamines - BENADRYL or ZYRTEC - loss of school days - about 5.
Age: 55.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: At noon, 10/31, I received the PNEUMOVAX 23 and Flu Vaccine Shots at the same time. From 6 pm to 8 pm, I worked out with weights and jogged 7 miles on the treadmill. After returning home and within ten minutes of completing the work-out, I experienced an episode of severe chills, then fever which broke while sleeping with profuse sweating by 3:00 am. Afterwards, I felt fine, but upon working out again the next day, I experienced a similar episode of chills/fever although of much less severity. This continued for day 3 and then reached baseline by day 4. The intensity of the chills/fever was 8/10 on day 1; 3/10 on day 2; 1/10 on day 3. In addition, it is unclear that I needed the PNEUMOVAX 23 vaccine in the first place. I am 55, male, and am in excellent health. The patient information for PNEUMOVAX 23 available from Merck at their website indicates that the vaccine should be used for those aged 50 and older; in addition, there are places on the website for Merck PNEUMOVAX 23 that indicates that the vaccine should be used for those 50 and older. However, contrary to this recommendation, the Merck website and the prescribing information indicates that it should be used for people aged 65 and older, and that for those 50 and older who have certain conditions. Merck should clarify this inconsistency in regard to the age group 50 - 64: one publication implies that all 50-64, should take it; and the other publication indicates that only those with specialized conditions in the age bracket 50-64, should take it. Since, although I am 55, I do not have those specialized conditions, and therefore believe that I should not have taken PNEUMOVAX 23.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Bedridden, Chills, Headache, Injection site pain
Clinical narrative: I was vaccinated 2 times, per protocol for shingles with SHINGRIX. Both times I became bedridden with aches, headache and mild nausea. Injection site swelling and pain and under arm swelling and pain of the same arm (Left). I received an injection for shingles and was told it was 2 shots within 6 months to complete the protection against shingles. The shots were given May 9, 2018 and Oct 24, 2018. The day after each shot, I became very ill. Chills, aches, bad headache, mild nausea. My arm hurt bad and was swollen at the injection site and under my arm (sore arm - left). I called to ask if this was normal and was told it's a very good shot and gives 90% protection against shingles and some people have those reactions and it was normal for this vaccine. I don't think that is a normal reaction and I wanted to report it.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Nausea, Oedema peripheral, Pain
Clinical narrative: I was vaccinated 2 times, per protocol for shingles with SHINGRIX. Both times I became bedridden with aches, headache and mild nausea. Injection site swelling and pain and under arm swelling and pain of the same arm (Left). I received an injection for shingles and was told it was 2 shots within 6 months to complete the protection against shingles. The shots were given May 9, 2018 and Oct 24, 2018. The day after each shot, I became very ill. Chills, aches, bad headache, mild nausea. My arm hurt bad and was swollen at the injection site and under my arm (sore arm - left). I called to ask if this was normal and was told it's a very good shot and gives 90% protection against shingles and some people have those reactions and it was normal for this vaccine. I don't think that is a normal reaction and I wanted to report it.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: I was vaccinated 2 times, per protocol for shingles with SHINGRIX. Both times I became bedridden with aches, headache and mild nausea. Injection site swelling and pain and under arm swelling and pain of the same arm (Left). I received an injection for shingles and was told it was 2 shots within 6 months to complete the protection against shingles. The shots were given May 9, 2018 and Oct 24, 2018. The day after each shot, I became very ill. Chills, aches, bad headache, mild nausea. My arm hurt bad and was swollen at the injection site and under my arm (sore arm - left). I called to ask if this was normal and was told it's a very good shot and gives 90% protection against shingles and some people have those reactions and it was normal for this vaccine. I don't think that is a normal reaction and I wanted to report it.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Dysphonia, Eye discharge, Ocular hyperaemia
Clinical narrative: Patient received a flu shot AFLURIA NDC 3332-0318-01 yesterday and after 4 hours she started to experience side effects and being diagnosed oculo-respiratory syndrome. She had pus came out of her eyes and red eyes. Hoarse, tight chest, fever, ache and chill.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Oculorespiratory syndrome, Pain, Pyrexia
Clinical narrative: Patient received a flu shot AFLURIA NDC 3332-0318-01 yesterday and after 4 hours she started to experience side effects and being diagnosed oculo-respiratory syndrome. She had pus came out of her eyes and red eyes. Hoarse, tight chest, fever, ache and chill.
Age: 42.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Cold urticaria
Clinical narrative: Developed urticaria - cold induced - new 4 days after the Tdap and Influenza Vaccinations.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large, localized reaction at injection site on right upper arm. Area red, very swollen, tender, warm to touch, firm. Symptoms started a few hours after injection. Patient given MENACTRA and TDaP vaccines on 11/6/18 in right upper arm. Patient's mom called office to report reaction on 11/7/18 around 5pm. Patient seen in the office on 11/8/18 and evaluated by MD.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: Large, localized reaction at injection site on right upper arm. Area red, very swollen, tender, warm to touch, firm. Symptoms started a few hours after injection. Patient given MENACTRA and TDaP vaccines on 11/6/18 in right upper arm. Patient's mom called office to report reaction on 11/7/18 around 5pm. Patient seen in the office on 11/8/18 and evaluated by MD.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Cold sweat, Mental status changes, Pallor, Vomiting
Clinical narrative: Vaccines (HPV and Quadrivalent Flu) administered 11/5/18 and 11/6/18 with 2 brief (1-2 mins) episodes of AMS with emesis. Still slightly pale and clammy.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Pallor, Rash erythematous
Clinical narrative: 7 cm by 6 cm erythematous blanching raised rash surrounding injection site on right upper extremity.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Vomiting
Clinical narrative: Patient reported continuous vomiting and black and blue marks on immunized arm that started the day after vaccine was administered.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Hep B vaccines administered was expired 9-30-2018. Patient notified/no adverse reaction. Health Auth .notified. Merck contacted/imm viable.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Dyspnoea, Throat tightness
Clinical narrative: Tightening of throat, could not breathe. Anaphylactic response. Pt has many allergies.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Pain in extremity, Tremor
Clinical narrative: Patient started noticing the pain on his left arm and 8 inch long bruise around injection site and trembling of his left hand. He is still trembling and complains that the pain still comes and goes.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Paraesthesia, Pyrexia
Clinical narrative: Awoke at 11pm w/fear/tingling in hands and feet/upset stomach. By 7am, temperature was 103 degrees-> given ibuprofen. All symptoms resolved by 10am. Physical exam normal no treatment needed.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (R) arm swelling and red (R) arm.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Eyelid ptosis, Injection site erythema, Myalgia, Pyrexia, Swelling face
Clinical narrative: Fever muscle aches in hours following vaccine administration. Right facial swelling and ptosis (R) eye 2 days later 13x9cm erythematous patch at site 3 days later.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Infant had vaccines on Tuesday 23rd and child was put to bed healthy on Fri 26th; parents checked on him at 1:30 AM Sat 27th and child was dead. Dx-Sudden Infant Death Syndrome.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscle disorder, Muscle strain, Pain in extremity
Clinical narrative: Excruciating pain up and down arm. Naproxen 500mg; Cyclobenzaprine 5mg; TYLENOL 1000mg; Hot/Cold pack on arm; limited activity using arm; splint usage; keep arm elevated.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Peripheral swelling, Pyrexia
Clinical narrative: Mom states that after daughter received DTaP on 3/27/17. She developed fever. Entire arm was swollen down to wrist. Mom states she took child to ER they gave her an antibiotic. Stated daughter had allergic reaction to vaccine. Mom states daughter had Hep B vaccine 7/25/17 and she had the same reaction(listed above with DTaP) Mom reports she did not have transportation did not take her to Dr. "I gave her antibiotic's from the first time this happened, it got better".
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Diarrhoea, Gingival swelling, Headache
Clinical narrative: Almost immediately after the injection, pt got a headache. On the ride home she developed, tingling in her lips, shivering, loose stools, abdominal pain, swelling in her gums and tongue.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Gingival oedema, Headache
Clinical narrative: Almost immediately after the injection, pt got a headache. On the ride home she developed, tingling in her lips, shivering, loose stools, abdominal pain, swelling in her gums and tongue.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Paraesthesia oral, Swollen tongue
Clinical narrative: Almost immediately after the injection, pt got a headache. On the ride home she developed, tingling in her lips, shivering, loose stools, abdominal pain, swelling in her gums and tongue.
Age: 21.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood test normal, Electrocardiogram normal, Heart rate increased, Pyrexia, Urine analysis normal
Clinical narrative: My son is a college student and came home for the weekend. I talked him into getting a flu shot. I had gotten one and had no problems. Around 8:00 pm that night after he had received the flu shot at 11:00 am, he was feeling achy with a fever of 99.2. He took 2 TYLENOL and went to bed. At 2:30 am, he called for me and he was burning up. I gave him water and 2 more TYLENOL. He had a fever of 101.4 I went back to bed and he called for me again around 3:00 am. His watch had alerted him that he needed to seek medical attention as is heart rate was 170! My husband took him to the Emergency Room. Headache, back ache, high fever, fast heart rate, shaking.
Age: 21.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Activated partial thromboplastin time, Back pain, Blood lactic acid, Blood thyroid stimulating hormone, Burning sensation
Clinical narrative: My son is a college student and came home for the weekend. I talked him into getting a flu shot. I had gotten one and had no problems. Around 8:00 pm that night after he had received the flu shot at 11:00 am, he was feeling achy with a fever of 99.2. He took 2 TYLENOL and went to bed. At 2:30 am, he called for me and he was burning up. I gave him water and 2 more TYLENOL. He had a fever of 101.4 I went back to bed and he called for me again around 3:00 am. His watch had alerted him that he needed to seek medical attention as is heart rate was 170! My husband took him to the Emergency Room. Headache, back ache, high fever, fast heart rate, shaking.
Age: 21.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chest X-ray, Culture, Differential white blood cell count, Drug screen, Electrocardiogram
Clinical narrative: My son is a college student and came home for the weekend. I talked him into getting a flu shot. I had gotten one and had no problems. Around 8:00 pm that night after he had received the flu shot at 11:00 am, he was feeling achy with a fever of 99.2. He took 2 TYLENOL and went to bed. At 2:30 am, he called for me and he was burning up. I gave him water and 2 more TYLENOL. He had a fever of 101.4 I went back to bed and he called for me again around 3:00 am. His watch had alerted him that he needed to seek medical attention as is heart rate was 170! My husband took him to the Emergency Room. Headache, back ache, high fever, fast heart rate, shaking.
Age: 21.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Full blood count, Headache, Heart rate increased, International normalised ratio, Metabolic function test
Clinical narrative: My son is a college student and came home for the weekend. I talked him into getting a flu shot. I had gotten one and had no problems. Around 8:00 pm that night after he had received the flu shot at 11:00 am, he was feeling achy with a fever of 99.2. He took 2 TYLENOL and went to bed. At 2:30 am, he called for me and he was burning up. I gave him water and 2 more TYLENOL. He had a fever of 101.4 I went back to bed and he called for me again around 3:00 am. His watch had alerted him that he needed to seek medical attention as is heart rate was 170! My husband took him to the Emergency Room. Headache, back ache, high fever, fast heart rate, shaking.
Age: 21.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain, Pyrexia, Thyroxine free, Tremor, Troponin
Clinical narrative: My son is a college student and came home for the weekend. I talked him into getting a flu shot. I had gotten one and had no problems. Around 8:00 pm that night after he had received the flu shot at 11:00 am, he was feeling achy with a fever of 99.2. He took 2 TYLENOL and went to bed. At 2:30 am, he called for me and he was burning up. I gave him water and 2 more TYLENOL. He had a fever of 101.4 I went back to bed and he called for me again around 3:00 am. His watch had alerted him that he needed to seek medical attention as is heart rate was 170! My husband took him to the Emergency Room. Headache, back ache, high fever, fast heart rate, shaking.
Age: 21.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Urine analysis
Clinical narrative: My son is a college student and came home for the weekend. I talked him into getting a flu shot. I had gotten one and had no problems. Around 8:00 pm that night after he had received the flu shot at 11:00 am, he was feeling achy with a fever of 99.2. He took 2 TYLENOL and went to bed. At 2:30 am, he called for me and he was burning up. I gave him water and 2 more TYLENOL. He had a fever of 101.4 I went back to bed and he called for me again around 3:00 am. His watch had alerted him that he needed to seek medical attention as is heart rate was 170! My husband took him to the Emergency Room. Headache, back ache, high fever, fast heart rate, shaking.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Head discomfort, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in an elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included immunosuppression. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received 3 month before the time of reporting for tolerance refer case US2018GSK204284). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced convulsion (serious criteria GSK medically significant), muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, shivering, malaise, staggering gait and speech disorder were recovering/resolving and the outcome of the fever and head pressure were unknown. It was unknown if the reporter considered the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had dose 2 about a month before the time of reporting. The patient reported that she experienced convulsions, twitching of body, cannot sleep, pain in right leg, fatigue, shivering, fever, joint pain, head felt like it had pressure inside, staggering gait, and difficulty talking. The specific dates of injection was not known. Onset of symptoms for the events were about 5 days. The patient reported that that symptoms were only slowly improving at the time of reporting. The patient given consent to follow up with her physician and provided address details for the same.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Insomnia, Lethargy, Loss of personal independence in daily activities, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in an elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included immunosuppression. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received 3 month before the time of reporting for tolerance refer case US2018GSK204284). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced convulsion (serious criteria GSK medically significant), muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, shivering, malaise, staggering gait and speech disorder were recovering/resolving and the outcome of the fever and head pressure were unknown. It was unknown if the reporter considered the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had dose 2 about a month before the time of reporting. The patient reported that she experienced convulsions, twitching of body, cannot sleep, pain in right leg, fatigue, shivering, fever, joint pain, head felt like it had pressure inside, staggering gait, and difficulty talking. The specific dates of injection was not known. Onset of symptoms for the events were about 5 days. The patient reported that that symptoms were only slowly improving at the time of reporting. The patient given consent to follow up with her physician and provided address details for the same.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pruritus, Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in an elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included immunosuppression. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received 3 month before the time of reporting for tolerance refer case US2018GSK204284). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced convulsion (serious criteria GSK medically significant), muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, shivering, malaise, staggering gait and speech disorder were recovering/resolving and the outcome of the fever and head pressure were unknown. It was unknown if the reporter considered the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had dose 2 about a month before the time of reporting. The patient reported that she experienced convulsions, twitching of body, cannot sleep, pain in right leg, fatigue, shivering, fever, joint pain, head felt like it had pressure inside, staggering gait, and difficulty talking. The specific dates of injection was not known. Onset of symptoms for the events were about 5 days. The patient reported that that symptoms were only slowly improving at the time of reporting. The patient given consent to follow up with her physician and provided address details for the same.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Gait disturbance, Head discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in an elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included immunosuppression. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received 3 month before the time of reporting for tolerance refer case US2018GSK204284). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced convulsion (serious criteria GSK medically significant), muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, shivering, malaise, staggering gait and speech disorder were recovering/resolving and the outcome of the fever and head pressure were unknown. It was unknown if the reporter considered the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had dose 2 about a month before the time of reporting. The patient reported that she experienced convulsions, twitching of body, cannot sleep, pain in right leg, fatigue, shivering, fever, joint pain, head felt like it had pressure inside, staggering gait, and difficulty talking. The specific dates of injection was not known. Onset of symptoms for the events were about 5 days. The patient reported that that symptoms were only slowly improving at the time of reporting. The patient given consent to follow up with her physician and provided address details for the same.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Malaise, Muscle twitching, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in an elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included immunosuppression. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received 3 month before the time of reporting for tolerance refer case US2018GSK204284). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced convulsion (serious criteria GSK medically significant), muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, shivering, malaise, staggering gait and speech disorder were recovering/resolving and the outcome of the fever and head pressure were unknown. It was unknown if the reporter considered the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had dose 2 about a month before the time of reporting. The patient reported that she experienced convulsions, twitching of body, cannot sleep, pain in right leg, fatigue, shivering, fever, joint pain, head felt like it had pressure inside, staggering gait, and difficulty talking. The specific dates of injection was not known. Onset of symptoms for the events were about 5 days. The patient reported that that symptoms were only slowly improving at the time of reporting. The patient given consent to follow up with her physician and provided address details for the same.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Seizure, Speech disorder, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in an elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included immunosuppression. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received 3 month before the time of reporting for tolerance refer case US2018GSK204284). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced convulsion (serious criteria GSK medically significant), muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, shivering, malaise, staggering gait and speech disorder were recovering/resolving and the outcome of the fever and head pressure were unknown. It was unknown if the reporter considered the convulsion, muscle twitching, sleeplessness, leg pain, joint pain, fatigue, fever, shivering, malaise, head pressure, staggering gait and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had dose 2 about a month before the time of reporting. The patient reported that she experienced convulsions, twitching of body, cannot sleep, pain in right leg, fatigue, shivering, fever, joint pain, head felt like it had pressure inside, staggering gait, and difficulty talking. The specific dates of injection was not known. Onset of symptoms for the events were about 5 days. The patient reported that that symptoms were only slowly improving at the time of reporting. The patient given consent to follow up with her physician and provided address details for the same.