chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Aches and pains in joints that kept me awake the Friday night that I got the vaccine. Intense fatigue, intense headache, and continued joint pain despite taking aspirin that was so bad, I had to be pushed in a wheelchair from my plane Sat morning after a 2hour flight from plane to curbside because I could not walk and pull hand luggage.  I took another aspirin and slept 2 hour ride to Dinner only to sleep for 26 more hours with feverish chills, sweats, headache, joint pain and weakness.  I slowly revived after that.  I would NOT recommend this vaccine for anyone under 70.  I thought I was being pro-active for my well-being but after reading the rate of Shingles in my 60s I can only think this is yet another Pharmaceutical marketing push to make money.  I am disappointed the CDC supports the push. It is not for the benefit of the average 60 year old.  and the effects MAY last more than 5 years???? I should have read more on it before getting the vaccine but I had never had side effects to any before, and saw that the CDC supported it,  so never imagined this. I hope they make something better when I am in my 70s. I will never take this again and am counseling all I know and like not to either. Please pull out your support or at least temper it for people in 60s and maybe healthy people in 70s.  it's awful. Try it yourself if you don't believe me!
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Middle insomnia, Pruritus, Rash
Clinical narrative: Pt reported that starting 2 days after administration of Shingrix 1 of 2, redness appeared at injection site. Redness and bumps continued to occur spreading upwards to shoulder and even to his back. Reports no trouble breathing but bumps and red area are itchy and often waking him up at night. No soreness.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia
Clinical narrative: PAIN IN SHOULDER JOINT,  MUSCLE SORENESS,------ NO SWELLING, NO INJECTION SITE REACTION, NO REDNESS
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Chest discomfort, Dizziness, Electrocardiogram, Full blood count
Clinical narrative: injection was given below deltoid and aspiration was not done,  upon withdrawal of the needle blood shot out and continued to bleed until pressure was held for 2 minutes. approximately  20 minutes later I started feeling very dizzy and lightheaded and having tightness across my chest.  I then walked back down to employee health and 20 minutes later went to the ER because symptoms had not resolved.  was found to have new onset PVCs which did not resolve after 1L bolus of NS I was observed for 5 hrs then discharged home to follow up with cardiology.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Metabolic function test, Troponin, Ventricular extrasystoles
Clinical narrative: injection was given below deltoid and aspiration was not done,  upon withdrawal of the needle blood shot out and continued to bleed until pressure was held for 2 minutes. approximately  20 minutes later I started feeling very dizzy and lightheaded and having tightness across my chest.  I then walked back down to employee health and 20 minutes later went to the ER because symptoms had not resolved.  was found to have new onset PVCs which did not resolve after 1L bolus of NS I was observed for 5 hrs then discharged home to follow up with cardiology.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Injection site pain
Clinical narrative: On 10/5/19 patient had fever, pain at injection site, fatigue, muscle pain, fever, decreased appetite, chills. On 10/10/19, the patient developed a rash and used steroid cream to relieve the itching and redness.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pruritus, Pyrexia, Rash
Clinical narrative: On 10/5/19 patient had fever, pain at injection site, fatigue, muscle pain, fever, decreased appetite, chills. On 10/10/19, the patient developed a rash and used steroid cream to relieve the itching and redness.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: reported inflammation soreness, and itching at injection site 10/11/19.  reported to pharmacy on 10/14/19 symptoms had subsided considerably
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Ear pain, Lip swelling, Mouth swelling, Musculoskeletal pain
Clinical narrative: patient noticed neck/back/shoulder/ear pain starting thursday evening. By friday she had rashes all over her body hip level and higher. On saturday her mouth and lips were swollen. She went to the ER and they gave her a prednisone shot. Since the steroid shot her symptoms have been getting better. Pt picked up rx for prednisone, benadryl but has not taken them yet.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Rash
Clinical narrative: patient noticed neck/back/shoulder/ear pain starting thursday evening. By friday she had rashes all over her body hip level and higher. On saturday her mouth and lips were swollen. She went to the ER and they gave her a prednisone shot. Since the steroid shot her symptoms have been getting better. Pt picked up rx for prednisone, benadryl but has not taken them yet.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: pt had both shots on same day in same arm. she later developed redness from the shoulder down to the elbow and swelling in the arm near the elbow. she went to the er where they gave her a shot(s) for treatment and told her she would be ok.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Myalgia
Clinical narrative: Patient reported noticing muscle aching and being very tired.  She didn't have any side effects or notice anything right after the vaccine.  This is now over 2 weeks later.  It began yesterday...and was getting better today.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Mild to moderate, dull throbbing headache lasting more than 48 hours
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Immunisation, Syringe issue
Clinical narrative: When injecting Fluzone IM to the patient, the plunger stopped with over half of the vaccine left to inject and would not plunge any further. A second dose was administered from the same lot/box with no issues. Needle used was BD Safety Glide 25 x 1. Pt's two other family members were also given flu shots from the same lot immediately prior to this patients vaccination with no issues
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site scab
Clinical narrative: Right thigh broke out in raised red bumps that lasted 5-7 days. The bumps scabbed over and are still evident after 3 weeks. One spot even appeared near baby's eyelid.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bone pain, Chills, Confusional state
Clinical narrative: On Wednesday Sept 25, I obtained a first vaccination at Pharmacy at about 11.30 am. The second vaccination is due after December.  I am worried that I had significant side effects from the vaccination, and I would like to share those symptoms with you. ? At about 2.30 pm [3h since vaccination] the spot of vaccination on my arm was swollen and quite panful. I know that this can happen, and it didn?t worry me.  ? At 4 pm [4.5h since vaccination] I got short awkward flashes of short sharp headache in the back of my head. Never had those before.  ? At 8 pm [8.5h since vaccination] I started to feel tired and I start to feel muscle pain and muscle tiredness.  I took an ibuprofen. ? At 10 pm [10.5 h after vaccination] I went to bed because I was very tired. ? At 12.30 [13 h after vaccination] I woke up shivering, I had severe muscle pain in all large muscle, pain in all joints, and pain in bones, from my toes to my neck. With 3 thick blankets I was able to feel less cold. I probably had a fever, but I did not check my temperature. ? At 1 am [13.5 h after vaccination] my heart was racing, although I was in total rest in bed. With my phone I measured 98 ? 110 bpm.    I also felt somewhat dizzy and slightly confused, almost as if you have severe flue. I had to walk carefully to not fall. ? At 7 am [19.5 h after vaccination] Muscle and joint pain remained, despite 2 ibuprofens. Felt lack of energy, also very heavy sweating. ? At 12.30 pm [24 h after vaccination] still sever pain in all large muscle groups, some bone and joint pain, a mild but sharp weird headache and a general feeling of not being well. The spot of the vaccination is very painful and hard and slightly swollen. ? At 5.00 pm [30 h after vaccination] similar symptoms as 12.30 pm, but somewhat reduced. ? At 8 am [45h after vaccination [ I noticed a red rash on my chest and back. The rash did not itch or was not painful. I typically see such a rash when I had a virus infection. ? The rash started to disappear after 2 days [90 h after the vaccination]
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: On Wednesday Sept 25, I obtained a first vaccination at Pharmacy at about 11.30 am. The second vaccination is due after December.  I am worried that I had significant side effects from the vaccination, and I would like to share those symptoms with you. ? At about 2.30 pm [3h since vaccination] the spot of vaccination on my arm was swollen and quite panful. I know that this can happen, and it didn?t worry me.  ? At 4 pm [4.5h since vaccination] I got short awkward flashes of short sharp headache in the back of my head. Never had those before.  ? At 8 pm [8.5h since vaccination] I started to feel tired and I start to feel muscle pain and muscle tiredness.  I took an ibuprofen. ? At 10 pm [10.5 h after vaccination] I went to bed because I was very tired. ? At 12.30 [13 h after vaccination] I woke up shivering, I had severe muscle pain in all large muscle, pain in all joints, and pain in bones, from my toes to my neck. With 3 thick blankets I was able to feel less cold. I probably had a fever, but I did not check my temperature. ? At 1 am [13.5 h after vaccination] my heart was racing, although I was in total rest in bed. With my phone I measured 98 ? 110 bpm.    I also felt somewhat dizzy and slightly confused, almost as if you have severe flue. I had to walk carefully to not fall. ? At 7 am [19.5 h after vaccination] Muscle and joint pain remained, despite 2 ibuprofens. Felt lack of energy, also very heavy sweating. ? At 12.30 pm [24 h after vaccination] still sever pain in all large muscle groups, some bone and joint pain, a mild but sharp weird headache and a general feeling of not being well. The spot of the vaccination is very painful and hard and slightly swollen. ? At 5.00 pm [30 h after vaccination] similar symptoms as 12.30 pm, but somewhat reduced. ? At 8 am [45h after vaccination [ I noticed a red rash on my chest and back. The rash did not itch or was not painful. I typically see such a rash when I had a virus infection. ? The rash started to disappear after 2 days [90 h after the vaccination]
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Muscle fatigue, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: On Wednesday Sept 25, I obtained a first vaccination at Pharmacy at about 11.30 am. The second vaccination is due after December.  I am worried that I had significant side effects from the vaccination, and I would like to share those symptoms with you. ? At about 2.30 pm [3h since vaccination] the spot of vaccination on my arm was swollen and quite panful. I know that this can happen, and it didn?t worry me.  ? At 4 pm [4.5h since vaccination] I got short awkward flashes of short sharp headache in the back of my head. Never had those before.  ? At 8 pm [8.5h since vaccination] I started to feel tired and I start to feel muscle pain and muscle tiredness.  I took an ibuprofen. ? At 10 pm [10.5 h after vaccination] I went to bed because I was very tired. ? At 12.30 [13 h after vaccination] I woke up shivering, I had severe muscle pain in all large muscle, pain in all joints, and pain in bones, from my toes to my neck. With 3 thick blankets I was able to feel less cold. I probably had a fever, but I did not check my temperature. ? At 1 am [13.5 h after vaccination] my heart was racing, although I was in total rest in bed. With my phone I measured 98 ? 110 bpm.    I also felt somewhat dizzy and slightly confused, almost as if you have severe flue. I had to walk carefully to not fall. ? At 7 am [19.5 h after vaccination] Muscle and joint pain remained, despite 2 ibuprofens. Felt lack of energy, also very heavy sweating. ? At 12.30 pm [24 h after vaccination] still sever pain in all large muscle groups, some bone and joint pain, a mild but sharp weird headache and a general feeling of not being well. The spot of the vaccination is very painful and hard and slightly swollen. ? At 5.00 pm [30 h after vaccination] similar symptoms as 12.30 pm, but somewhat reduced. ? At 8 am [45h after vaccination [ I noticed a red rash on my chest and back. The rash did not itch or was not painful. I typically see such a rash when I had a virus infection. ? The rash started to disappear after 2 days [90 h after the vaccination]
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Vaccination site pain, Vaccination site swelling
Clinical narrative: On Wednesday Sept 25, I obtained a first vaccination at Pharmacy at about 11.30 am. The second vaccination is due after December.  I am worried that I had significant side effects from the vaccination, and I would like to share those symptoms with you. ? At about 2.30 pm [3h since vaccination] the spot of vaccination on my arm was swollen and quite panful. I know that this can happen, and it didn?t worry me.  ? At 4 pm [4.5h since vaccination] I got short awkward flashes of short sharp headache in the back of my head. Never had those before.  ? At 8 pm [8.5h since vaccination] I started to feel tired and I start to feel muscle pain and muscle tiredness.  I took an ibuprofen. ? At 10 pm [10.5 h after vaccination] I went to bed because I was very tired. ? At 12.30 [13 h after vaccination] I woke up shivering, I had severe muscle pain in all large muscle, pain in all joints, and pain in bones, from my toes to my neck. With 3 thick blankets I was able to feel less cold. I probably had a fever, but I did not check my temperature. ? At 1 am [13.5 h after vaccination] my heart was racing, although I was in total rest in bed. With my phone I measured 98 ? 110 bpm.    I also felt somewhat dizzy and slightly confused, almost as if you have severe flue. I had to walk carefully to not fall. ? At 7 am [19.5 h after vaccination] Muscle and joint pain remained, despite 2 ibuprofens. Felt lack of energy, also very heavy sweating. ? At 12.30 pm [24 h after vaccination] still sever pain in all large muscle groups, some bone and joint pain, a mild but sharp weird headache and a general feeling of not being well. The spot of the vaccination is very painful and hard and slightly swollen. ? At 5.00 pm [30 h after vaccination] similar symptoms as 12.30 pm, but somewhat reduced. ? At 8 am [45h after vaccination [ I noticed a red rash on my chest and back. The rash did not itch or was not painful. I typically see such a rash when I had a virus infection. ? The rash started to disappear after 2 days [90 h after the vaccination]
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: My mother had the flue shot and the pneumonia shot at the same time... She  started to itch on 10/09/2019  and then on 10/10/2019 she broke out in hives on her arms, back and hips, and legs..  she started taking Benadryl and it helped with the itch , today is the 10/14/2019 and she still has the hives but they are not as red as they were. She is convinced she is doing better, but I am not sure she is.  I am not sure which shot she got, I would have to check with her doctor for the exact ones... she just told me the flue and pneumonia shot.  If need be and there is a follow up I will get this information.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Rash/Hives near injection site and on torso appearing within 30 minutes after vaccination
Age: 58.0
Sex: U
Vaccine: FLUC4
Symptoms: Vertigo
Clinical narrative: - NO inflamtion @ sight or swellg @ sight (-) Fevers (+) Histy of vertigo (BPV) Feels vertigo @ night in bed. Not sure related  to vaccine but wanted to report it
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Chills, Flushing, Full blood count
Clinical narrative: Immediately felt flush, recovered. 4 hours later felt chilled, was shaking, and weak. Unable to walk with out assistance, no memory of episode. Experienced syncope, nausea and vomiting. Temp of 100 for a couple days. Continues to feel weak.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Immediate post-injection reaction, Liver function test, Metabolic function test, Nausea
Clinical narrative: Immediately felt flush, recovered. 4 hours later felt chilled, was shaking, and weak. Unable to walk with out assistance, no memory of episode. Experienced syncope, nausea and vomiting. Temp of 100 for a couple days. Continues to feel weak.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: Immediately felt flush, recovered. 4 hours later felt chilled, was shaking, and weak. Unable to walk with out assistance, no memory of episode. Experienced syncope, nausea and vomiting. Temp of 100 for a couple days. Continues to feel weak.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Seizure
Clinical narrative: Vaccine was administered on 10/8/19, child had a seizure on 10/9/19 at 8AM. Child was known to have a temp of 101.8 in the ED.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: 25" after received flu vaccine; pt felt like throat closing, hives, wheezing + given epi pen, Benadryl + taken by ambulance ED + Rxed with IV Prednisone. Pt had similar but worse Rxn 4 week prior
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY ON 10/12/19 WITH REDNESS AND SWELLING OF RT. ARM FROM ELBOW TO SHOT LOCATION. PT. COMPLAINING OF PAIN OVER WHOLE AREA.
Age: 59.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Erythema, Peripheral swelling, Tenderness, Urticaria
Clinical narrative: Stated redness, swelling, tenderness and welts on arm starting day after received flu shot. By the next day started looking better with welts and redness decreasing. On 10/14 patient states all redness and swelling gone.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity, Rash
Clinical narrative: Severe pain in whole arm, rash, pt has had difficult sleeping - pt has been taking Tylenol, Aleve, Ibuprofen q4-6h, No relieves
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Skin discolouration
Clinical narrative: The day following the vaccination, the patient reported that she had numbness and a blueish discoloration in the tip of her ring finger. It was on the arm that she had received the Fluad vaccine the day prior. She said the numbness resolved by the second day after the shot, but her finger was still slightly discolored. She did not report any other symptoms.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: received flu shot with no incident + left vaccination room. Within a minute, mother returned to immunization room to report son had fainted. RPh followed mother to waiting area where patient lying on ground but alert. Felt dizzy chose to lie on floor + drink water until felt recovered enough to ( change about 20 min) leave w/mom
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Asthenia, Chest pain, Computerised tomogram normal, Dysarthria
Clinical narrative: 9-30-19 herpetic eye lesion  10-6-19 TIA inability to speak neg CT/MRI  10-8-19 chest pain 10-11-19 slurred speech weakness fatigue
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes ophthalmic, Magnetic resonance imaging normal, Transient ischaemic attack
Clinical narrative: 9-30-19 herpetic eye lesion  10-6-19 TIA inability to speak neg CT/MRI  10-8-19 chest pain 10-11-19 slurred speech weakness fatigue
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: patient complains of limited range of motion in left arm following immunization on 9/19/19.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Vomiting projectile
Clinical narrative: First 2 weeks so fatigued I could only lie on couch. Had nausea, tried to control with Famotidine & Hyoscyamine prescribed by Dr. Started having uncontrollable projectile vomiting morning after shot. Saw Dr in 2 weeks, said I was just having side effects from Vaccine. The extreme fatigue lasted almost 3 months - I still have days of fatigue & having projectile vomiting - have tests
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling, Tenderness
Clinical narrative: Saturday was red and swollen Redness spreading to the lower arm Arm is painful. Tender to touch
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Insomnia, Rash
Clinical narrative: Rash at injection site. Spread to both arms and legs. Pruritis and dizziness
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: Rash at injection site. Spread to both arms and legs. Pruritis and dizziness
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Injection site rash, Pruritus, Rash
Clinical narrative: Rash at injection site. Spread to both arms and legs. Pruritis and dizziness
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Viral rash
Clinical narrative: develop 3 fluid filled blisters across her front midsection; viral exanthem; This case was reported by a consumer via call center representative and described the occurrence of viral exanthem in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral exanthem (had had in the past when her body underwent something stressful).   On 25th July 2019, the patient received the 1st dose of Shingrix. On 26th July 2019, 1 days after receiving Shingrix, the patient experienced viral exanthem. On 27th July 2019, the patient experienced blister. On an unknown date, the outcome of the viral exanthem and blister were resolved with sequelae.   It was unknown if the reporter considered the viral exanthem and blister to be related to Shingrix.  Additional details were provided as follows: The patient experienced viral exanthem, which was something she has had in the past when her body underwent something stressful. The patient also developed 3 fluid filled blisters across her front midsection, more on the left side of her body than the right. The patient stated that the blisters were not viral exanthem, and it looked like pictures of shingles. The patient consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy; Red rash; Tenderness at the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix .5 ml. On 6th September 2019, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On 25th September 2019, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the injection site tenderness was recovered/resolved and the outcome of the itchy rash was recovering/resolving and the outcome of the red rash was unknown.   It was unknown if the reporter considered the injection site tenderness, itchy rash and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient reported tenderness at the injection the day of the vaccine. On 25th September 2019, a red circle appeared on the left side of the neck. The next day the redness spread to the left side of the chin, down left side of the chest and across the mid-line of the back under the bra strap area. It was red and itchy but no raised bumps. The reporter was consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Rash erythematous, Rash pruritic
Clinical narrative: Itchy; Red rash; Tenderness at the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix .5 ml. On 6th September 2019, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On 25th September 2019, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the injection site tenderness was recovered/resolved and the outcome of the itchy rash was recovering/resolving and the outcome of the red rash was unknown.   It was unknown if the reporter considered the injection site tenderness, itchy rash and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient reported tenderness at the injection the day of the vaccine. On 25th September 2019, a red circle appeared on the left side of the neck. The next day the redness spread to the left side of the chin, down left side of the chest and across the mid-line of the back under the bra strap area. It was red and itchy but no raised bumps. The reporter was consented to follow up.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Developed rash the next day after the shot was given; it started on first on the upper torso, then moved down to the legs and the arms.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Peripheral swelling, Skin warm
Clinical narrative: bruised, hot, swollen arm
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site macule, Injection site swelling, Pain
Clinical narrative: erythematous, swollen macule at site of injection on left upper arm and pain with movement or palpation of arm self- improving without seeking medical evaluation until about 3 weeks afterwards . Mild erythema and some pain at arm remain to date but overall improved
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: received flu shot in left arm at 11:00am area became hot and swollen to touch, itchy  and swollen about 10 minutes after
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Extreme weakness and deep aching to sharp pain. Severe sharp pain when moving in some directions. Numbness to outer upper shoulder with intermittent finger tingling
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: On Oct 7th I was given the flu shot at hospital. The day after on 10/8/19 I felt numbness through my legs and arms around 12pm I went to see my primary doctor right after
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: 1st dose - red rash & swollen area 3x6 inches around injection site & sore arm which lasted about a week 2nd does - red rash & swollen area 3 x 6 inches around injection site & sore arm followed by 101 fever for one day - my normal temp is 99 so this was a high fever - red rash & swollen area still present
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient present to clinic with swelling on the left upper thigh area measuring 13cm x 5 cm. Area was tender and warm to the touch. Mom states that she noticed swelling on the evening of 10/11/19.  Patient was evaluated in clinic and prescribed cephALEXin 250 mg/5 mL oral suspension with instruction to take 4 mL 3 times a day by oral route as directed for 10 days.   Patient was instructed to call office with phone follow-up to let staff know hoe she's doing.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient was given the vaccine while seated.  Patient was accompanied by a family member.  After shot was given patient decided to stay seated while family member paid.   Within minutes, patient passed out and rolled out of chair.   RPh and family member kept patient on her side until patient woke up,  patient remained lying down until medical assistance arrived.  patient only sat up with assistance,  and remained in the pharmacy for 20-30 minutes until felt comfortable to sit up.   Medical assistance checked vitals, and applied cold pack to back of neck.     When patient felt well enough and refused medical transport then medial assistance left.      When patient was comfortable she was transported to vehicle per wheelchair and taken home by family member.     Family member called back at end of day and stated that the patient had rested for several hours and was feeling much better.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Mobility decreased
Clinical narrative: the patient could not move his neck; This spontaneous report as received from a pharmacist via a company representative refers to a male patient in his 70s. The patient ho no concomitant medication. The patient had never had an issue with vaccines in the past. No information regarding the patient's pertinent medical history, drug reactions and allergies was provided.   On an unknown date in September 2019 (reported as sometime last week), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dose (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On the same date, the patient received a dose of influenza virus vaccine (unspecified) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date in September 2019 (reported as the day after receiving vaccines, sometime last week), the patient could not move his neck. The outcome of movement disorder was reported as recovered on an unknown date in 2019.  The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection
Clinical narrative: The pharmacist stated that, the patient did experience an unspecified HPV infection post vaccination; manufacturer origin unknown; This spontaneous report was received from a pharmacist concerning a 34 year old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.     On an unknown date, also reported as (unspecified time in the past patient age was near 20 to 25 years old or so), the pharmacist stated that, the patient had previously completed a vaccination series for human papilloma virus (HPV) (dosage schedule, anatomical location, lot number and expiration date were not reported). That manufacturer was unknown (product origin unknown). On an unspecified date, the patient experienced an unspecified HPV infection post vaccination (papilloma viral infection). The vaccine may not have had protection against the strain the vaccine had.   The outcome of the events papilloma viral infection and product origin unknown and the causal relationship between the events and therapy with HPV vaccine were not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date in 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) by the pharmacist in the pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, she was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was reported as not recovered.  The event of shingles was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: patient fainted after the administered dose; fall and hit head as part of fainting coded; fall and hit head as part of fainting coded; This spontaneous report was received from a nurse via a company representative referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was unknown.    On an unknown date (reported as within last few months), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dosage detail, strength, lot # and expiration date were not reported) intramuscular for prophylaxis. The patient fainted after the administered dose and was observed in the office after fainting, treatment for fainting was not specified. It was also reported that the patient might fall and hit head as part of fainting, office did call 9-1-1 and patient was taken to unspecified medical facility (not believed to be a hospital) for unspecified treatment and release (it was unsure if patient actually experienced fall and heat injure at the time of this report, capture it conservatively). It was unknown if any laboratory tests were performed for the events. The outcome of faint was reported as recovered. The outcome of fall and head injure was not provided. Causality assessment was not provided.  Upon internal review, faint was determined to be medically significant.  This is one of two reports received from the same reporter (linked case # US-009507513-1910USA008773).; Sender's Comments:  US-009507513-1910USA008773:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored vaccine in use; This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. The patient's pertinent medical history and drug reactions or allergies were not reported. The concomitant medication included sterile diluent which was reported to be stored properly. On 18-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dosage information, route of administration and anatomical location were unknown) (lot # R019237 with an expiry date of 04-JUL-2020 or lot # S005078 with an expiry date of 19-FEB-2021 as the nurse was not able to determine which lot was given to the patient) for prophylaxis (product storage error). No adverse effect reported. It was reported that the vaccine was exposed to a temperature of -14 degree Celsius (C) to -10 degree Celsius (-9.74 C) for an unknown time frame. There was no previous temperature excursion reported. Data logger was involved. The outcome of product storage error was unknown. No product quality complaint (PQC) was associated with this report.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Patient received improperly stored VARIVAX; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/ allergies were not reported. Concomitant therapies included sterile diluent which was used for reconstitution of vaccine was stored properly. On 05-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S005078 and expiration date 19-FEB-2021 or R019237 and expiration date 04-JUL-2020 (strength, dose, frequency, route and anatomical location not reported) for prophylaxis (product storage error). It was reported that both lots of varicella virus vaccine live (oka/merck) (VARIVAX) underwent the temperature excursion, but the reporter did not know which lot was given to the patient. The storage temperature was reported as minus 9.74 degree Celsius for an unknown time frame. There was no previous temperature excursion. Digital data logger was involved. No adverse effect reported. No product quality complaint (PQC) present.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. In or around May 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered shingles and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles and post herpetic neuralgia were not recovered. The lawyer considered shingles and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).  The events shingles and post herpetic neuralgia were considered by the lawyer as disability.
Sex: F
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: mucous membrane pemphigoid; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. In or around June 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered mucous membrane pemphigoid. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event mucous membrane pemphigoid was not recovered. The lawyer considered mucous membrane pemphigoid to be related to zoster vaccine live (ZOSTAVAX).   The event mucous membrane pemphigoid was considered by the lawyer as disability.  Upon internal review, the event mucous membrane pemphigoid was determined to be medically significant event.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: One dose at age 12 and second dose at age 16 years; no adverse effect; This spontaneous report as received from a physician refers to a 16 year old adolescent patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On unknown dates, the patient was subsequently vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, anatomical location, Lot # and expiry date was not reported) at age 12 years and 16 years for prophylaxis (inappropriate schedule of product administration). The patient had no adverse event. There was no product quality compliant involved.
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site reaction, Rash erythematous, Vaccination site pustule, Vaccination site swelling
Clinical narrative: Arm was starting to swell around where it was bandaged/ it was a solid, red, raised square around the injection; A large, rash-y redness around all of it; Vaccination site itself looks like it has white looking pus on it; Information received on 13AUG2019 from a consumer.   A female consumer reported that her partner's arm was starting to swell around vaccination site, where it was bandaged/ it was a solid, red, raised square around the injection (PT: Injection site swelling), he had a large, rash-y redness around all of it (PT: Injection site erythema), and vaccination site itself looked like it had white looking pus on it (PT: Injection site pustule), following the administration of ACAM2000. He received ACAM2000 on approximately 01AUG2019. On an unknown date (reported as approximately 09AUG2019) the vaccination site on his arm started to swell around where it was bandaged, the area had a large, rash-y redness around all of it and the vaccination site itself looked like it had a white looking pus on it. On 16AUG2019 additional information was received and it was reported that the rash area was a solid, red, raised square around the injection.  Action taken was not applicable.  Company comment: The described events "injection site swelling, injection site erythema, injection site pustule" are known effects of ACAM2000 possibly caused by a robust take, and therefore are considered to be causally related to the administration of ACAM2000.; Sender's Comments: Company comment: The described events "injection site swelling, injection site erythema, injection site pustule" are known effects of ACAM2000 possibly cause by a robust take, and therefore are considered to be causally related to the administration of ACAM2000.
Sex: U
Vaccine: VARZOS
Symptoms: Multiple sclerosis relapse, Vaccine positive rechallenge
Clinical narrative: MS relapse; This case was reported by a pharmacist and described the occurrence of multiple sclerosis relapse in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of multiple sclerosis relapse (for tolerance, refer case US2019AMR179704). Concurrent medical conditions included multiple sclerosis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced multiple sclerosis relapse (serious criteria GSK medically significant). The patient was treated with prednisolone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the multiple sclerosis relapse was unknown.   It was unknown if the reporter considered the multiple sclerosis relapse to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that the patient recently received the Shingrix vaccinations and each time the patient got the vaccine and started in on an multiple sclerosis (MS) relapse the day after the vaccination. The relapses were curtailed by Prednisone. This left wondering the patient if other MS patients, or those with other autoimmune diseases, had been having similar adverse reactions to the Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Discomfort
Clinical narrative: Uncomfortable side effects; This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient took the first shot and had uncomfortable side effects that lasted 2.5 days. The reporter asked if same side effects would occur after the second shot.