chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: approximately 6" below injection site - swelling, itching, and redness.   was hot to the touch, as compared with tissue surrounding site. Actual areainvolved  approximately 4" across and 3" top to bottom.    Started resolution next day.   Hot to touch subsided and slowly swelling went down.    Was not a "dramatic" reaction.  However, two weeks later (today) I can still see the redness slightly..
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Neck pain, Pain, Pain in extremity
Clinical narrative: Soreness throughout left arm, torso, neck, beginning 3-4 hours after the shot. Chills, fatigue,  and body aches beginning around 8 hours after the shot.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Pain down right arm along with swelling.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia
Clinical narrative: Dizziness, difficulty standing up
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Headache and swollen lymph node under right arm
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea
Clinical narrative: Pt. at the observation site felt difficulty breathing and anxious.  Paramedics assessed pt.   Once pt. symptoms subsided she was released by paramedics to leave.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Chest X-ray, Chest discomfort, Electrocardiogram normal, Heart rate increased
Clinical narrative: 12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination  Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia  1/11 lymph nodes swollen under armpit on R side. Sore arm.  Had another episode 2 days later; Tachycardia.  Went to Dr 1/13/2021. Full work up.  Started on BP medicine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Tachycardia
Clinical narrative: 12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination  Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia  1/11 lymph nodes swollen under armpit on R side. Sore arm.  Had another episode 2 days later; Tachycardia.  Went to Dr 1/13/2021. Full work up.  Started on BP medicine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Staff member was waiting 15 min post her last vaccination shot when she began to have dizziness and become light headed. B/P taken and was abnormally high. Staff squaded out to hospital for further evaluation.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: One week after I received the vaccination the area on the right arm where the shot was given had a rash. It it was a little itchy in the afternoon. In the evening when I looked at it the rash was there.  I called the school nurse to report it and was told to take Benadryl  and report the symptom to VAERS. and it will resolve.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Feeling abnormal, Lymphadenopathy, Myalgia
Clinical narrative: Fever, chills, severe muscle and bone pain lasting for 8 hours and treated with IBU.  Followed by swollen glands in then neck lasting 5 days and general fogginess lasting about 1 week.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, severe muscle and bone pain lasting for 8 hours and treated with IBU.  Followed by swollen glands in then neck lasting 5 days and general fogginess lasting about 1 week.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lips started to swell about 45 minutes after vaccine was received, Swelling lasted for about 30 minutes. I took a benedryl and the symptoms dissipated within 2 hours.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hypoaesthesia oral, Urticaria
Clinical narrative: 20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest.  Patient was given 50mg of PO diphenhydramine and was monitored for 60 min.  Refused call to 911.   Flushing and warmth had abated and left clinic under own volition.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: 13 days after my first dose of the Moderna Covid-19 vaccine, I developed an itchy rash around the site of injection.  The itch was mild, but I still have it 3 days later, and it seems to be larger but fading.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site swelling, Migraine, Pain
Clinical narrative: In the early evening after my second Covid vaccine I began to have moderate body aches, fatigue, injection site swelling and headaches. Some of my headaches developed into migraines. The body aches lasted about 14 hours but the headaches persisted for almost two weeks before resolving.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I have been diagnosed with Shingles (head and face)  25 days after receiving my 2nd  Covid Vaccine . I have been a very healthy active person my whole life. I do believe the covid vaccine was related to the shingle outbreak.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Drug eruption, Rash maculo-papular
Clinical narrative: Drug rash-maculopapular rash. (similar to Ampicillin rash)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity
Clinical narrative: Severe pain in L arm, Baseball size knot in deltoid
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac assistance device user, Catheterisation cardiac, Dizziness
Clinical narrative: Patient presented to ED after he became dizzy while shooting pool and felt his defibrillator fire. Patient underwent diagnostic cardiac cath and it was deemed that there would be no intervention at this point. Patient was discharged with plans to follow up with PCP and cardiologist
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling cold, Hypersomnia, Malaise, Nausea
Clinical narrative: Around 3PM is started feeling nausiated, Then I became extremely cold and could not get warm for about 3 hours.  After that I slept for 14 hours, got up shower.  After being up about 4 hours I slept another 3 hours.  I was not hungry.  Actually food upset my stomach. I still felt somewhat ill until I got up the 2nd day.  I am fine now.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Cerebral haemorrhage, Death
Clinical narrative: Spontaneous intracerebral hemorrhage and death on 2/20/2021
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Gait disturbance, Impaired work ability, Vertigo, Vomiting
Clinical narrative: Woke up the next morning (1/9/21) with severe vertigo. Was unable to walk without assistance. Got worse by the afternoon, unable to tolerate lying down, vomiting. Went to urgent care. Prescibed meclizine and zofran. Meclizine did not really help but able to lay down. By next morning was 70% better, able to walk on my own, slowly. The following Monday (1/11/21) saw ENT, unsure of cause, ears clear of infection. Sent me for hearing test which was done on 1/14/21, normal hearing. Had video visit with Dr. on 1/15/21. suggested exercise for benign positional vertigo. Follow up with ENT on 1/29/21. Symptoms much beter, able to go back to work, room spinning happens ocasionally when lying down.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: The day of - soreness in left arm Day after - severe headache, soreness in left arm 2nd day after - severe headache, extreme tiredness, loss of appetite, felt unwell 3rd day after - extreme tiredness
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Second dose was received on February 13 and instantly when the needle went in, I started having instant pain that went right to the rotator cuff and the next morning I tried to raise my arm and it was sore in the joint. I?ve done heat, cold presses, Tylenol and everything to try to help the pain, the pain is bad.  I received my first dose in January and had the exact same reaction.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Red spot on injection site 9 days after vaccine.faded by day 7 but still seen in shower.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: lf arm & shoulder pain, fever alternating with chills
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: 48 hrs after moderna dose 2 my face swelled.   No other symptoms.  Lasted approximately 30 hrs. My throat was 100% not affected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Allergic Reaction throat closed up
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Patient received dose 1 of the Moderna COVID vaccine on 02/12/21. Patient received a dose of the Pfizer vaccine on 03/03/21. No adverse event occurred at the time of administration; this was an error where the patient received a different brand for their second dose 19 days after the first dose. Patient was observed for 15 minutes after administration and no adverse effects were noted.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Hypersomnia, SARS-CoV-2 test negative
Clinical narrative: The patient reports fatigue beginning the day of the vaccine, and persisting to the time of this report.  He had residual episodes of fatigue (1 per week) after his stroke 11/20, however after the vaccine he has been fatigued all day. His neurologist changed his Plavix to Brilinta on 2/11/2022 due to fatigue, without effect.  During these episodes he sleeps excessively He does not report insomnia, dysarthria, focal weakness/numbness, dizziness or fainting, or new memory issues.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, achy, fatigue- began on 2/27/21 @1am Fever went as high as 101.3 degrees. Soreness on arm at injection site as well.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus, Rash, Swelling
Clinical narrative: patient reports lacey rash to left upper arm s/p approximately 7 days after 1st dose of moderna; itching; still present today; reports localized swelling and firmness to area at day 7 but has since resolved
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea started 24 hours after and for five days out so far
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives started 1 week after vaccine. Started on medrol dose pack, now improving - not yet resolved.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, Axillary vein thrombosis, Chest X-ray abnormal, Erythema, Pleural effusion
Clinical narrative: Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Disturbance in attention, Dizziness, Dyspnoea, Memory impairment
Clinical narrative: At roughly 9:00pm I was scrolling through my phone when it became very difficult to focus and I felt nauseous.  I got up to go to the bathroom and became extremely dizzy and my heart felt like it was going to beat out of my chest.  I was having difficulty breathing  and felt disorientated.  I crawled up the stairs and when I reached the top I stood up to walk and promptly fainted/passed out.  According to my husband I was out for roughly 30 seconds.  He described my body as completely tense (formed fists, shaking). I don't have any recollection of passing out.  When I came to I was overwhelmed with nausea and immediately vomited.  I was sweating profusely and struggling to breath.  After I vomited, within minutes (less than three) I felt fine.  My heart rate returned to normal and I wasn't dizzy or nauseous.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Syncope, Tension, Tremor
Clinical narrative: At roughly 9:00pm I was scrolling through my phone when it became very difficult to focus and I felt nauseous.  I got up to go to the bathroom and became extremely dizzy and my heart felt like it was going to beat out of my chest.  I was having difficulty breathing  and felt disorientated.  I crawled up the stairs and when I reached the top I stood up to walk and promptly fainted/passed out.  According to my husband I was out for roughly 30 seconds.  He described my body as completely tense (formed fists, shaking). I don't have any recollection of passing out.  When I came to I was overwhelmed with nausea and immediately vomited.  I was sweating profusely and struggling to breath.  After I vomited, within minutes (less than three) I felt fine.  My heart rate returned to normal and I wasn't dizzy or nauseous.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: At roughly 9:00pm I was scrolling through my phone when it became very difficult to focus and I felt nauseous.  I got up to go to the bathroom and became extremely dizzy and my heart felt like it was going to beat out of my chest.  I was having difficulty breathing  and felt disorientated.  I crawled up the stairs and when I reached the top I stood up to walk and promptly fainted/passed out.  According to my husband I was out for roughly 30 seconds.  He described my body as completely tense (formed fists, shaking). I don't have any recollection of passing out.  When I came to I was overwhelmed with nausea and immediately vomited.  I was sweating profusely and struggling to breath.  After I vomited, within minutes (less than three) I felt fine.  My heart rate returned to normal and I wasn't dizzy or nauseous.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye disorder, Feeling abnormal, Headache, Muscle spasms
Clinical narrative: Dizzy, all day  Brain fog, all day  Hands tingled, for about hour after shot.  Muscle spasms/sore. Sporadically all over the body but last 1-30 minutes at a time. About a week.  Headache everyday since the first dose.  Rash and eye problems came back after the first dose.  On going.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Rash
Clinical narrative: Dizzy, all day  Brain fog, all day  Hands tingled, for about hour after shot.  Muscle spasms/sore. Sporadically all over the body but last 1-30 minutes at a time. About a week.  Headache everyday since the first dose.  Rash and eye problems came back after the first dose.  On going.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: Tiredness, sore throat (mild), sore arm on the injection side
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated 12/29/20 and 1/19/21.   Patient asymptomatic on 2/26/2021 but tested for COVID-19.  PCR positive.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Supraventricular tachycardia, Tenderness, Ultrasound scan
Clinical narrative: about 5-7 days after 1st dose i developed swelling and tenderness on the side and behind my right knee
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: 1 week after injection, swelling, redness, inflammation and itchiness as injection site. 4"x3" in area
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu-like symptoms: fever, chills, headache and nausea
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness, Visual impairment
Clinical narrative: SOB, visual disturbances, hand numbness and weakness. PATIENT REQUESTED SOMEONE COME SPEAK WITH HER DURING THE VACCINATION TO DISTRACT HER BECAUSE SHE DOES NOT LIKE IMMUNIZATIONS. I ASKED SOMEONE TO ACCOMPANY THE PATIENT WHILE I ADMINISTER VACCINE. UPON INJECTION, PATIENT JUMPED AND IMMEDIATELY NOTED SHORTNESS OF BREATH, VISUAL DISTURBANCES, AND HAND NUMBNESS/WEAKNESS. THERE WAS A SMALL DROP OF BLOOD THAT RAN DOWN HER ARM ABOUT 1/2 INCH BEFORE I STOPPED THE BLEEDING WITH A COTTON BALL AND COVERED IT WITH A BANDAGE. I INSTRUCTED HER TO BREATH DEEPLY, SLOWLY, AND EVENLY AND HER BREATHING SEEMED TO BE IMPROVING. SHE CONTINUED TO NOTE HAND NUMBNESS AND WEAKNESS. SHE THEN ACCEPTED OUR INVATIATION TO ESCORT HER TO THE EMERGENCY ROOM. PATIENT REMAIND ALERT AND TALKATIVE AS I ASKED HOW HER BREATHING WAS AND IF SHE HAS HAD ANY REACTION LIKE THIS TO ANY OTHER VACCINE, TO WHICH SHE REPLIED SHE HAD NOT; THAT SHE MAY HAVE REACTED TO THIS BECAUSE THIS IS A DIFFERENT MEDICINE THAN SHE'S HAD IN THE PAST. UPON LEAVING HER AT THE EMERGENCY ROOM, I ASKED HOW HER BREATHING WAS AND IT SEEMED TO HAVE IMPROVED BUT HER HAND WAS STILL NUMB. I ASKED EHR TO STOP BY THE PHARMACY BEFORE LEAVING THE BUILDING SO I KNEW HOW SHE WAS DOING. SHE STOPPED BY AT 10:48AM TO EXPLAIN THAT THE DR. IS HAVING HER MONITOR FOR ANY LOCAL REACTION AND ANAPHYLAXIS TYPE REACTION AND TO REPORT TO ER RIGHT AWAY IF SHE NOTICES ANY SWELLING OF THE MOUTH/THROAT. HER NUMBNESS SEEMED TO BE SUBSIDED AND LOCALIZED MORE TO THE UPPER ARM AREA ABOVE THE ELBOW. SHE WAS GRIPPING HER KEYS IN HER LEFT HAND WITH HER POINTER FINGER POKED THROUGH THE RING ALL THE WAY DOWN TO THE KNUCKLE. SHE WAS STILL INTERESTED IN THE SECOND SHOT BECAUSE SHE HAS FAMILY MEMBERS WHO HAVE HAD SHINGLES AND DOES NOT WANT THAT.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation
Clinical narrative: First felt itching on inner forearms; moved to neck and stomach; throat itching.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Neurological examination
Clinical narrative: BELL'S PALSY, FACIAL PARALYSIS
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral, Swelling, Swelling face
Clinical narrative: Tingling  and swelling to lips with progressive tingling and swelling to chin area and neck about 5-10 mins post injection. Given Benadryl 50mg PO and Epinepherine 0.3mg/0.3mL. EMS called. Pt declined transport to hopital, opted to have wife drive him.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Endoscopy, Fatigue, Haemoglobin abnormal, Haemoglobin decreased
Clinical narrative: Patient presented to ED after her GI specialist referred her for an abnormal hgb level. Patient reported fatigue for past several days but denied any abdominal symptoms or symptoms of bleeding. In the ED, patient's hgb was found to be 5.2. Pt received blood transfusion and was treated with protonix. She underwent an endoscopy and a colonoscopy. Pt was discharged to follow up with GI and PCP
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Transfusion
Clinical narrative: Patient presented to ED after her GI specialist referred her for an abnormal hgb level. Patient reported fatigue for past several days but denied any abdominal symptoms or symptoms of bleeding. In the ED, patient's hgb was found to be 5.2. Pt received blood transfusion and was treated with protonix. She underwent an endoscopy and a colonoscopy. Pt was discharged to follow up with GI and PCP
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Increased swelling and pain at the site to size of egg with redness extending down left arm nearly to elbow over 5 days following injection. Did not subside for approximately 10 days and has left continued sore spot at injection site. Also, accompanied by temp 101.4 times 24 hours followed by gen. malaise day 2 till evening.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Extreme painful flare of psoriasis on legs, still present, using triamcinolone acetonide to treat.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue and very painful headache,  took ibuprofen and a sleep aid, headache resided after about 8 hours and no further fatigue experienced after a good night's rest (9.5 hours of sleep)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Glaucoma drainage device placement, Optic ischaemic neuropathy, Retinal artery occlusion
Clinical narrative: Had a eye stroke to the left eye/retinal artery occlusion
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Endotracheal intubation, Mechanical ventilation
Clinical narrative: Death Narrative: Family was able to be present at bedside shortly after patient was extubated. Fentanyl bolus given 10-15 minutes prior. Patient passed away soon after endotracheal tube removed. Time of death 10:14am.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered; This spontaneous report as received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 ml, lot # S027460, expiration date: 02-MAR-2021 for prophylaxis (route of administration and anatomical location were not reported).  Administered dose of vaccine underwent the temperature excursion of 6 to 14 degrees Fahrenheit (F) (9.3F) for 15 minutes and 6F to 14F (9.1F) for 15 minutes. Digital data logger was involved. There were no previous excursions reported.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects; Medical assistant called to report an administered expired ROT ATEQ vaccine, vaccine expired 30-JAN-2021; This spontaneous report was received from a physician and a practice coordinator who worked at the providers office referring to a 6-month-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 10-FEB-2021, the patient was accidentally vaccinated with a single expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), this was the third dose of the scheme, lot number S012931 and expiration date of 30-JAN-2021, orally for prophylaxis, the patient tolerated the inmmunization well. No side effects.   On the same date, the patient was vaccinated with  the third dose of: diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PEDIARIX) lot number AZ472 expiration date of 28-NOV-2022 intramuscularly at the right vastus lateralis, hib conj vaccine (tet toxoid)(HIBERIX) lot number TF4EB expiration date of 26-SEP-2021 intramuscularly at the right vastus lateralis, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) lot number DP5137 expiration date of 01-JAN-2023 intramuscularly at the left vastus lateralis and influenza virus split virion 3v vaccine inactivated(AFLURIA) lot number P100244052 expiration date of 30-JUN-2021.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection
Clinical narrative: she "has high-risk HPV; This spontaneous report as received from a physician assistant via company representative refers to a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an unknown date, reported as years ago, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) ,0 .5 milliliter, intramuscular for prophylaxis (dose number, and expiration date were not reported), unidentified Merck hpv vaccine administered (name and lot number not provided)". The administration dates of vaccinations were unknown.  It was reported that recently, on an unspecified date, the patient received results (test unspecified) stating that she  "has high-risk HPV" (papilloma viral infection). The outcome of papilloma viral infection was reported as not recovered.   The causal relationship between the aforementioned event hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Flushing
Clinical narrative: faint/syncopal episode; faint and flushed; This spontaneous report as received from a finance an business economic reported an  adverse event reported to him by medical assistant at health care professional office refers to a 16-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. Approximately on 26-AUG-2020, reported as 6 months ago, the patient was vaccinated with a dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular for prophylaxis (dose, lot number and expiration date were not reported).   Approximately on 26-AUG-2020, reported as 6 months ago, the patient became "faint and flushed", after adminsitration of the vaccine. The patient was leaned back on table and symptoms resolved, approximately on the same date, on 26-AUG-2020 . The causal relationship between the events and therapy with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) were not reported.  Upon internal review the events faint was considered to be medically significant.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: feverish; Felt fatigued; mild body aches; headache; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In January 2021, the patient received Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season. In January 2021, less than a week after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever, fatigue, general body pain and headache. On an unknown date, the outcome of the fever, fatigue, general body pain and headache were unknown.   The reporter considered the fever, fatigue, general body pain and headache to be possibly related to Shingles vaccine. It was unknown if the reporter considered the fever, fatigue, general body pain and headache to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered Shingrix at the same time as the flu vaccine. The patient was feverish with mild body aches and a headache. The patient felt fatigued when took the shingles vaccine, which had similar side effects. The patient stated that a third of people who take the shingles shot have flu-like feelings. But it was definitely better than getting shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001249:Same reporter
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm for a couple days/ more so than with a flu shot; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had sore arm with a flu shot. This case had been linked with US2021AMR025675, US2021025175 and US2021025187 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025175:same reporter US-GLAXOSMITHKLINE-US2021AMR025675:same reporter US-GLAXOSMITHKLINE-US2021025187:same reporter
Sex: F
Vaccine: FLUX, HEP, HEPA, PPV, VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: sore arm for a day; This case was reported by a consumer and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis, Hepatitis A vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and PNEUMOCOCCAL VACCINE for prophylaxis.   Concurrent medical conditions included sulfonamide allergy.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season, Hepatitis A vaccine, Hepatitis B vaccine and PNEUMOCOCCAL VACCINE. On an unknown date, unknown after receiving Shingles vaccine, Influenza vaccine Quadrivalent unspecified season, Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine, Influenza vaccine Quadrivalent unspecified season, Hepatitis A vaccine and Hepatitis B vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient was a traveler and had all kinds of vaccines. The patient was reported as a very healthy person with no diabetes and overweight. The patient had Shingles shot, pneumonia shot, Flu vaccines, Hepatitis A and Hepatitis B vaccine. Post vaccination the patient had a sore arm for a day. The patient never had fever, headache or nausea. On 21st January 2021, the patient had a COVID 19 vaccine from Pfizer and had skin rash which was recovering at the time of reporting. The reporter consented to follow up.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood glucose abnormal, Brain injury, Cerebral amyloid angiopathy, Cerebral microhaemorrhage, Magnetic resonance imaging head abnormal
Clinical narrative: Development of cerebral amyloid angiopathy / full active case; Broken brain with a path of more micro-bleeds; broken brain; brain cerebral glucose deregulated; This case was reported by a consumer via interactive digital media and described the occurrence of cerebral amyloid angiopathy in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced cerebral amyloid angiopathy (serious criteria GSK medically significant), cerebral microhemorrhage (serious criteria GSK medically significant), brain injury (serious criteria GSK medically significant) and glucose abnormal. On an unknown date, the outcome of the cerebral amyloid angiopathy, cerebral microhemorrhage, brain injury and glucose abnormal were unknown.   It was unknown if the reporter considered the cerebral amyloid angiopathy, cerebral microhemorrhage, brain injury and glucose abnormal to be related to Shingles vaccine.  Additional details were reported as follows: 56 years old patient went to hospital with high blood pressure.  The patient received unknown shingles vaccine.  The patient was at the time brain cerebral glucose deregulated with micro-bleeds to show (M.R.I.)  The development of cerebral amyloid angiopathy in play to encapsulate this Zoster pathogen gave to patient a further broken brain with a path of more micro-bleeds now in a full active case of cerebral amyloid angiopathy of someone 88 plus years old at only 56 plus. The patient stated that, this report was from his or her neurologist.  The patient was retired at 60. A struggle since 57 years old.  No fluff here just facts.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site pain, Myalgia, Rash
Clinical narrative: rash across the middle of her back and under the breasts in the middle area like a triangle; muscle aches in her back that presented yesterday; redness at the injection site/The red area is 3" x 2" in size; tenderness at the injection site; muscle aches in her back /  back ache; This case was reported by a consumer and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (had rash like this presented in that area under the breasts in the past), allergic reaction (had an allergic reaction to another medication) and back pain (sometimes had a back ache).   On 6th January 2021, the patient received the 1st dose of Shingrix. On 7th January 2021, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness and muscle pain. On 8th January 2021, the patient experienced rash. In January 2021, the patient experienced back pain. On an unknown date, the outcome of the injection site erythema, injection site tenderness, rash and muscle pain were not recovered/not resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, rash, muscle pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 2 days ago and experienced tenderness and redness at the injection site.   The red area was 3 x 2 in size.  The patient noticed a rash across the middle of back and under the breasts in the middle area like a triangle.   The patient said a rash like this presented in that area under the breasts in the past when she had an allergic reaction to another medication.   The patient had muscle aches in her back and although sometimes had a backache so was not sure if that was caused by the vaccine. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Biopsy skin abnormal, Hypersensitivity, Rash
Clinical narrative: diagnosed an allergic reaction; rash presented  on her right wrist and lower arm area / upper extremities, truck area from under the breasts down to the groin, back; This case was reported by a nurse and described the occurrence of allergic reaction in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. In October 2020, 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction and rash. The patient was treated with triamcinolone (Kenalog). On an unknown date, the outcome of the allergic reaction and rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and rash to be related to Shingrix. The reporter considered the allergic reaction and rash to be unrelated to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: This case was reported by patient herself. The reporter stated that two weeks later a rash presented on her right wrist and lower arm area.  It slowly progressed to both upper extremities, truck area from under the breasts down to the groin, back and a little on the lower extremities as well but not as severe as upper extremities.  A biopsy diagnosed an allergic reaction.  She had two shots of kenalog that had not helped.  She also had a flu shot at the time but was not contributing that to her symptoms.  The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats
Clinical narrative: Awakened past midnight / sweating / continued every night / and is unresolved; This case was reported by a consumer via call center representative and described the occurrence of night sweat in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 1st February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a day after receiving Shingrix, the patient experienced night sweat. On an unknown date, the outcome of the night sweat was not recovered/not resolved.   It was unknown if the reporter considered the night sweat to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix vaccine about 2 months before reporting and there were no reports of any events associated with it. Later the evening of receiving 2nd Shingrix vaccine, while the patient was sleeping, she was awakened past midnight and was sweating. The sweating continued every night since the 2nd injection and was unresolved at time of report. Formulation of Shignrix was not known for both injections. The reporter did not consent to follow up. Discrepancy: As per narrative time to onset was considered as less than a day and not 1 day as per provided onset date.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Soreness and Swelling at the injection site; Rash at the injection site; Swelling at the injection site; low grade Fever; Chills; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site swelling, fever, chills and fatigue. On 3rd December 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site rash, injection site swelling, chills and fatigue were recovered/resolved.   The reporter considered the injection site pain, injection site rash, injection site swelling, fever, chills and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had fatigue, Chills, low grade Fever, soreness and swelling at the injection site, and rash at the injection site.  The reactions lasted between three to five days. The reporter consented to follow up. All information was not available.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness and Swelling at the injection site; Rash at the injection site; Swelling at the injection site; low grade Fever; Chills; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site swelling, fever, chills and fatigue. On 3rd December 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site rash, injection site swelling, chills and fatigue were recovered/resolved.   The reporter considered the injection site pain, injection site rash, injection site swelling, fever, chills and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had fatigue, Chills, low grade Fever, soreness and swelling at the injection site, and rash at the injection site.  The reactions lasted between three to five days. The reporter consented to follow up. All information was not available.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Muscle pain; Weakness; Headache; Shivering; Nausea; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2021, the patient received the 1st dose of Shingrix. On 5th February 2021, 1 days after receiving Shingrix, the patient experienced muscle pain, weakness, headache, shivering and nausea. On an unknown date, the outcome of the muscle pain, weakness, headache, shivering and nausea were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, weakness, headache, shivering and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient got his first shingrix shot a day before reporting and experienced muscle pain, weakness, headache, shivering, and nausea on the day of reporting. The reporter did not consent to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Magnetic resonance imaging abnormal, Mobility decreased, Nephrolithiasis
Clinical narrative: had some burning before; showed small kidney stones; maybe had a UTI going on; lower back pain; was not able to get up from the bed or the chair; maybe back kidney pain; This case was reported by a consumer via call center representative and described the occurrence of renal stone in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included tamsulosin hydrochloride (Tamsulosin), lidocaine hydrochloride (Lidocaine), tramadol and diclofenac (Diclofenac Topical Gel).   On 14th January 2021, the patient received the 1st dose of Shingrix. On 15th January 2021, 1 days after receiving Shingrix, the patient experienced renal stone (serious criteria GSK medically significant), urinary tract infection, low back pain, mobility decreased and renal pain. On an unknown date, the patient experienced burning sensation. On an unknown date, the outcome of the renal stone, urinary tract infection, low back pain, mobility decreased, renal pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the renal stone, urinary tract infection, low back pain, mobility decreased, renal pain and burning sensation to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's daughter. The patient next day of vaccination started to be had lower back pain. The patient was not able to get up from the bed or the chair. The reporter stated that the patient might be had a UTI (urinary tract infection) going on that we were not aware of or might be back kidney pain and the patient had some burning before, but it was not confirmed. X-Ray or MRI (magnetic resonance imaging) showed small kidney stones. The reporter stated that events had still not resolved. The reporter did not consent to follow up with him/her via email as well as with healthcare professional.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Renal pain, Urinary tract infection, X-ray abnormal
Clinical narrative: had some burning before; showed small kidney stones; maybe had a UTI going on; lower back pain; was not able to get up from the bed or the chair; maybe back kidney pain; This case was reported by a consumer via call center representative and described the occurrence of renal stone in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included tamsulosin hydrochloride (Tamsulosin), lidocaine hydrochloride (Lidocaine), tramadol and diclofenac (Diclofenac Topical Gel).   On 14th January 2021, the patient received the 1st dose of Shingrix. On 15th January 2021, 1 days after receiving Shingrix, the patient experienced renal stone (serious criteria GSK medically significant), urinary tract infection, low back pain, mobility decreased and renal pain. On an unknown date, the patient experienced burning sensation. On an unknown date, the outcome of the renal stone, urinary tract infection, low back pain, mobility decreased, renal pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the renal stone, urinary tract infection, low back pain, mobility decreased, renal pain and burning sensation to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's daughter. The patient next day of vaccination started to be had lower back pain. The patient was not able to get up from the bed or the chair. The reporter stated that the patient might be had a UTI (urinary tract infection) going on that we were not aware of or might be back kidney pain and the patient had some burning before, but it was not confirmed. X-Ray or MRI (magnetic resonance imaging) showed small kidney stones. The reporter stated that events had still not resolved. The reporter did not consent to follow up with him/her via email as well as with healthcare professional.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Muscle strain, Spinal cord injury
Clinical narrative: Disk injury; shingles on my left leg; pulled leg; Back pain; A spontaneous report was received from a consumer who was also a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulled the leg, back pain from disk injury, and shingles on left leg.  The patient's medical history was not provided.  Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  The patient reported she was hospitalized with pulled leg and back pain from disk injury and shingles on left leg.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.