chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Started 36 hours after shot, itchiness everywhere and hives accompanied. Redness on face, arms, shoulder, legs, chest, and back.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Pain in jaw, Urticaria
Clinical narrative: Shingles like rash along v cranial nerve on the left side only, extreme pain in left ear, left eye, left upper jaw.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient reports feeling faint/dizzy.  VSS BP 118/69, HR82 -- > 103/63, 63.  Observed for 15mins, patient stable and released from vaccination site.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: 8 hours after vaccination: Bad headache, fever (100 degrees with tylenol), fatigue, fogginess, increased need to pee without increased liquid intake. Arm soreness. Next day: still feverish (100 degrees without tylenol), fatigue, mild headache, grogginess. Still arm soreness. Felt about 30% back to normal. Still increased need to pee. Day 3: About 75% back to normal, easily fatigued, continued arm soreness at touch. Day 4: Less easily fatigued, but about 90% back to normal, continued arm soreness but just movement based. Day 5: About 95% back, continued exhaustion/fatigue. Mild arm soreness, only movement based.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Pyrexia, Somnolence
Clinical narrative: 8 hours after vaccination: Bad headache, fever (100 degrees with tylenol), fatigue, fogginess, increased need to pee without increased liquid intake. Arm soreness. Next day: still feverish (100 degrees without tylenol), fatigue, mild headache, grogginess. Still arm soreness. Felt about 30% back to normal. Still increased need to pee. Day 3: About 75% back to normal, easily fatigued, continued arm soreness at touch. Day 4: Less easily fatigued, but about 90% back to normal, continued arm soreness but just movement based. Day 5: About 95% back, continued exhaustion/fatigue. Mild arm soreness, only movement based.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood test, Headache, New daily persistent headache, Pain
Clinical narrative: Received my covid shot Wednesday, March 31st. Experienced a headache afterwards which was tolerable but lasted all day. Had a headache the next day as well, all day. Since receiving the vaccine, I have been experiencing headaches from what appear to be daily, I had experienced headaches before but not this often. It tends to be throbing pain on the right side of my head only.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Very swollen and itchy arm with redness around the injection site lasting for 2 weeks with a fever. Absence of menses
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: "Not feeling well" prior to administration. BP: 122/28 (unsure of accuracy in reporting diastolic value), Pulse:90, Resp:16, O2: 98%, Temp: OK. Patient was given Tylenol and went home from work (explains possible inaccurate recording of BP). No other issues noted.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant ringing in ears (tinnitus), especially left ear began one week after 2nd shot.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Blood pressure of 190 5 mins after injection of second dose. Blood pressure of 220 the following day. Blood pressure over 180 since injection everyday
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Headache, Pain in extremity
Clinical narrative: Shortness of breath, dizziness, faint, anxiety, headache and arm pain. Transported to ER and not able to reach patient for follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Moderna COVID?19 Vaccine EUA 1st dose: 04/06/2021 at approximately 3:45 pm (no significant reactions?left arm injection site slightly sore) 2nd dose: 05/07/2021 at approximately 11:45 am (reactions listed below)  2nd shot: injection in same arm (left as first dose), aches and chills appeared within 10 hours of injection?took Tylenol every 7-8 hours and lasted for 30 hour, insomnia for first 20 hours, fatigue set on at 36 hrs, swollen/red/hard rash at injection site at 48 hours.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Insomnia, Pain, Pain in extremity
Clinical narrative: Moderna COVID?19 Vaccine EUA 1st dose: 04/06/2021 at approximately 3:45 pm (no significant reactions?left arm injection site slightly sore) 2nd dose: 05/07/2021 at approximately 11:45 am (reactions listed below)  2nd shot: injection in same arm (left as first dose), aches and chills appeared within 10 hours of injection?took Tylenol every 7-8 hours and lasted for 30 hour, insomnia for first 20 hours, fatigue set on at 36 hrs, swollen/red/hard rash at injection site at 48 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Blood creatinine normal, Brain natriuretic peptide normal, Dyspnoea, Full blood count normal
Clinical narrative: Got vaccine 4/21/21; local reaction started 5/3/21; developed new onset wheezing and SOB diagnosed 5/5/21, treated with prednisone, albuterol and epi injection.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin I normal, Wheezing
Clinical narrative: Got vaccine 4/21/21; local reaction started 5/3/21; developed new onset wheezing and SOB diagnosed 5/5/21, treated with prednisone, albuterol and epi injection.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Red rash (inflammation and itchiness) appeared on day 9 of first vaccine dose. Rash was small, about the size of a silver dollar approximately 5 inches below injection site. Treatment was a topical steroid cream (cortisone) applied a couple times a day for 2 days. Itching stopped after 3 days and redness went away after 5 days. No rash has reappeared since.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Spotting started 4/28/21 continued until heavy, cramping, clotting period started 5/4/21 to date (today 5-9-21). Heaviness is starting to subside but still bleeding.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I experienced occasional ringing in the ears after receiving the vaccine, but no other noticeable side effects during the first 48+ hours. However, soon after the 2-day mark had passed, I developed tinnitus (ringing in the ears) that has now been continuous for 24 hours.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and body aches
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Nausea, Pain
Clinical narrative: Lymph node swelling under right arm and on right side of neck. Neck lymph node swelling caused vertigo for a short time the next morning.  Neck lymph node swollen for 3 days. Armpit is still swollen. Aches, joint pain, fatigue, fever 101 have resolved. Nausea continues.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Lymph node swelling under right arm and on right side of neck. Neck lymph node swelling caused vertigo for a short time the next morning.  Neck lymph node swollen for 3 days. Armpit is still swollen. Aches, joint pain, fatigue, fever 101 have resolved. Nausea continues.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Musculoskeletal stiffness, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Stiff/hurt neck on side on shot 5 minutes after injection, subsided in about 3 minutes Super sore arm day 1-2 after Fever day 1 about 8 hours after shot Took acetaminophen & felt better Fever broke next morning (day 2) Day 2 muscle fatigue whole day Day 3 mental grogginess but overall okay
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Stiff/hurt neck on side on shot 5 minutes after injection, subsided in about 3 minutes Super sore arm day 1-2 after Fever day 1 about 8 hours after shot Took acetaminophen & felt better Fever broke next morning (day 2) Day 2 muscle fatigue whole day Day 3 mental grogginess but overall okay
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives starting on eyelids and forehead, all over face, and back of ears. I got these symptoms almost exactly 6 days after each vaccine dose. I treated the hives with hydrocortisone and oral anti histamine medication, it took about 5 days to clear up after the first dose, just starting to see symptoms with the second dose.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Approximately four weeks after receiving the shot I came down with symptoms related to Shingles and was diagnosed with such five days later.  Unsure if there is causation but I thought it was worth reporting because other than receiving the covid vaccine I have had no changes or health issues or anything else that would indicate a change in my immunity status that could have resulted in this onset.  I am a bit on the young side to be experiencing Shingles so thought it was worth reporting.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Headache, Nightmare, Parosmia
Clinical narrative: 2 months ago feeling anxiety and having nightmares - night mares about falling my fear!!- not heights but falling -wakes me up every night and recently started having ice pick pains in my left side of my head and smelling odd odors while trying to sleep
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Dizziness, Vision blurred
Clinical narrative: Missed menstrual period ongoing, last cycle 3/24/21 with multiple negative urine pregnancy tests. Dizziness and blurred vision also experienced shortly after administration.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural
Clinical narrative: Dizziness when bending head down
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion induced, Amniocentesis, Exposure during pregnancy, Gene mutation identification test, Ultrasound scan
Clinical narrative: I was 14 weeks pregnant for shot 1 and 18 weeks pregnant for shot 2.  My 12 week anatomy scan showed my baby was healthy, all NIPT and amnio came back clean. My baby developed Microcephaly by the next ultrasound scan, 19 weeks. Between 19-23 weeks, her brain slowed down in development even further. I terminated the pregnancy
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Blood test, Computerised tomogram, Urine analysis
Clinical narrative: Emergengy Appendicitis surgery
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Friday night I felt extremely tired, sat morning I felt like I never slept. Around 5:30am I started feeling extremely nauseous and had diarrhea. My head hurt something horrible. The nausea lasted all day Saturday. Sunday I still had a pretty major headache
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Sore arm at injection site 2 days Headache 2 days Aches, mild feverishness 1.5 days Fatigue 3 days
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling, Swelling face
Clinical narrative: Within 30 min, throat swelled and I could no longer swallow easily. Swelling went down after 25 min without any additional meds administered.  Left side of my face swelled 45min after shot and I experienced bell's palsy for 3-4 hours.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dry mouth, Fatigue, Injection site erythema
Clinical narrative: Injection site red, sore, hard and hot to touch, 2 hrs after injection Injection site sore, red, hard, hot to touch, swollen to marble size, 7 hrs after injection Slight fever, 99.2, 6 hrs after injection Slight fever, 99.8, 21 hrs after injection Chills, 12 hrs after injection Exhaustion, 6 hrs after injection Knee and elbow joint pain, 21 hrs after injection Dry mouth, 5 hrs after injection Slightly swollen lymph nodes (underarm and throat), same side as injection, 3 hours after injection
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Injection site red, sore, hard and hot to touch, 2 hrs after injection Injection site sore, red, hard, hot to touch, swollen to marble size, 7 hrs after injection Slight fever, 99.2, 6 hrs after injection Slight fever, 99.8, 21 hrs after injection Chills, 12 hrs after injection Exhaustion, 6 hrs after injection Knee and elbow joint pain, 21 hrs after injection Dry mouth, 5 hrs after injection Slightly swollen lymph nodes (underarm and throat), same side as injection, 3 hours after injection
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Injection site red, sore, hard and hot to touch, 2 hrs after injection Injection site sore, red, hard, hot to touch, swollen to marble size, 7 hrs after injection Slight fever, 99.2, 6 hrs after injection Slight fever, 99.8, 21 hrs after injection Chills, 12 hrs after injection Exhaustion, 6 hrs after injection Knee and elbow joint pain, 21 hrs after injection Dry mouth, 5 hrs after injection Slightly swollen lymph nodes (underarm and throat), same side as injection, 3 hours after injection
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Dizziness, Fatigue, Headache
Clinical narrative: fever of 101 degrees, blurred vision, nausea,  extreme fatigue, headache, dizziness, sleeplessness due to pain and terrifying nightmares, pain and tenseness in abdomen , itchiness at injection site (red patch 4" in diameter), chills , general achy feeling, and sharp pains that would feel like they would move around and hit in odd places. The heels of the feet for instance, the sensation of charley horses over and over on the morning  after  the vaccine. The second day was the worst. Most painful and most fatigued. By the third day, I was starting to feel better pain-wise, but the dreams were worse. The dreams are so bad, I am afraid to sleep. This is the 4th day, and I only have pain at the injection site (mild), sporadic dizzy spells, sporadic nausea. I monitored my fever and took extra strength Tylenol for fever and pain.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Insomnia, Nausea, Nightmare
Clinical narrative: fever of 101 degrees, blurred vision, nausea,  extreme fatigue, headache, dizziness, sleeplessness due to pain and terrifying nightmares, pain and tenseness in abdomen , itchiness at injection site (red patch 4" in diameter), chills , general achy feeling, and sharp pains that would feel like they would move around and hit in odd places. The heels of the feet for instance, the sensation of charley horses over and over on the morning  after  the vaccine. The second day was the worst. Most painful and most fatigued. By the third day, I was starting to feel better pain-wise, but the dreams were worse. The dreams are so bad, I am afraid to sleep. This is the 4th day, and I only have pain at the injection site (mild), sporadic dizzy spells, sporadic nausea. I monitored my fever and took extra strength Tylenol for fever and pain.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vision blurred
Clinical narrative: fever of 101 degrees, blurred vision, nausea,  extreme fatigue, headache, dizziness, sleeplessness due to pain and terrifying nightmares, pain and tenseness in abdomen , itchiness at injection site (red patch 4" in diameter), chills , general achy feeling, and sharp pains that would feel like they would move around and hit in odd places. The heels of the feet for instance, the sensation of charley horses over and over on the morning  after  the vaccine. The second day was the worst. Most painful and most fatigued. By the third day, I was starting to feel better pain-wise, but the dreams were worse. The dreams are so bad, I am afraid to sleep. This is the 4th day, and I only have pain at the injection site (mild), sporadic dizzy spells, sporadic nausea. I monitored my fever and took extra strength Tylenol for fever and pain.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chills, Cough, Fatigue, Headache
Clinical narrative: Fatigue, body aches, swelling injection site, chills, cough, runny nose, loss of smell,headache
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Rhinorrhoea
Clinical narrative: Fatigue, body aches, swelling injection site, chills, cough, runny nose, loss of smell,headache
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Pain, Pain in extremity, Restless legs syndrome
Clinical narrative: On 07May21 at 11:00PM, I experienced an immense pain on both of my arms that I've never experienced before in my life. Every time I move my arms, fingers, or apply any amount of pressure on any part of my arms, I will get a surge of pain raining down on my arms and only my arms from the shoulder down. At the same time, I also felt a surge of energy/adrenaline flowing throughout my legs, from the pelvis down, urging me to move around. I tried to force myself to sleep (without medication, just forcefully closing my eyes and trying to sleep) to no avail, so I got up and walked around my room and did some leg squats exercises without moving my arms too much from 11:10PM till 3:10AM, (I think getting my blood pumping throughout my body helped ease the pain a bit). The intensity of the pain on my arms decreased about half at around 3:10AM and I was finally able to fall asleep at around 3:30AM. I woke up once at around 7:45AM to go to the bathroom and drink some water. During this time, I think the intensity of the pain had dropped to 1/3 from when I first experienced this pain. I fell back asleep again and woke up at around 11:20AM. Most of the pain is gone by now, I only felt the lingering stings of the dreadful night from before. I continued to feel this phantom pain on both of my arms throughout the day and it wasn't until the day afterwards on the morning of 09May21 that relief was finally bestowed upon me.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Pyrexia, Sleep disorder
Clinical narrative: On 5/7 patient (self) had fever of 101.2 and violent chills as side effects. These subsided 5/8. Adverse event on 5/10 was an intermittent cough and deep chest pain that continued to worsen, preventing sleep. Patient took Ibuprofen 800mg.  Event in progress. Will evaluate on 5/11 and decided if doctor visit is needed.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Vomiting
Clinical narrative: Vomiting multiple times  - over 20 mins  Alternating Chills/sweats, started about 14 hrs after vaccine administration
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm pain increased over the course of the initial day.  24-48 hours after the inital shot, I had low grade fever, bodyaches, chills, nausea.   This lasted several hours until I took tylenol to subdue to the fever.  When I woke up the following morning, i had the same symptoms and needed to take tylenol again to bring down the fever.  All symptoms cleared after 4 days from initial shot.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cough, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Large rash at site of injection. Red, swollen, and itchy. Also experienced cough, nausea, elevated body temperature. Cold compresses provided some relief for rash, Tylenol for elevated temperature.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea
Clinical narrative: Large rash at site of injection. Red, swollen, and itchy. Also experienced cough, nausea, elevated body temperature. Cold compresses provided some relief for rash, Tylenol for elevated temperature.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Oral disorder, Oral herpes, Pain, Pyrexia
Clinical narrative: Fever, body aches, site swelling, oral and vaginal blisters for 14 days.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal lesion
Clinical narrative: Fever, body aches, site swelling, oral and vaginal blisters for 14 days.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Having had no history of this issue, I started to hear bell sounds in my ear while yawning. I searched for it online and looks like the medical term for it is Tinnitus, Also, There was one occasion that I started to hear my blood flow in my ear for a couple of minutes. The bell while yawning hasn't gone away after about 2 weeks. Luckily I don't hear the sound when I am not yawning which is a blessing.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I still have shoulder pain 2 weeks after receiving my first shot.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness in neck and body aches
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling, Post-acute COVID-19 syndrome
Clinical narrative: It has been described online as "Covid Arm."  I began to feel a burning in my upper arm.  I had expected some soreness in my arm.  I actually ran a fever the next day that went over 102, but it quickly resolved.  However, the spot on my arm was quite large, hot, red, and painful.  It has lasted, while gradually getting better, up to the time I am writing this.  The arm is still quite pink, and the redness has migrated around to the inside of my arm somewhat.  It is better now, though, and I am not concerned.  However, I would have chose Pfizer if I had known that this would happen.  My husband got Pfizer and didn't have any trouble at all.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: It has been described online as "Covid Arm."  I began to feel a burning in my upper arm.  I had expected some soreness in my arm.  I actually ran a fever the next day that went over 102, but it quickly resolved.  However, the spot on my arm was quite large, hot, red, and painful.  It has lasted, while gradually getting better, up to the time I am writing this.  The arm is still quite pink, and the redness has migrated around to the inside of my arm somewhat.  It is better now, though, and I am not concerned.  However, I would have chose Pfizer if I had known that this would happen.  My husband got Pfizer and didn't have any trouble at all.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Lymphadenopathy, Pruritus
Clinical narrative: Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swelling of face and under the arms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swelling of face and under the arms.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears, no treatments or outcome as of yet.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events reported; improperly stored doses of GARDASIL 9 was administered; This case was previously considered as non-valid due to lack of patient's identifiers, but upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  This spontaneous report was received from a medical assistant and refers to a 11 years old female patient. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided.  On 01-MAR-2021, the patients were vaccinated with improperly stored dosed of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (the third dose; 0.5 milliliter, lot # T007024, expiration date 23-APR-2022) intramuscularly in left arm for prophylaxis (product storage error). The administered doses were exposed to the temperature of 10.13 degrees Celsius (C) for 1 hour. There were previous temperature excursions reported as 9.17 C for 15 minutes and 8.59 C for 15 minutes. The call was because of a digital data logger. No additional adverse event was reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007465: US-009507513-2104USA008178:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no adverse event; on 29JUN2019 a patient was administered MMRII that expired on 13JUN2018; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 29-JUN-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter (lot # M029919, expiry date 13-JUN-2018; strength and route of administration were not reported) for prophylaxis. No additional adverse events were reported.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Disseminated varicella zoster virus infection, Rash, Rash maculo-papular, Skin lesion, Varicella virus test positive
Clinical narrative: PCR test of one of the lesions was positive for varicella; appeared to be "more of a maculopapular rash"; This spontaneous report was received from a nurse prescriber and refers to a 30-year-old female patient. Before vaccination with varicella virus vaccine live (oka/merck) (VARIVAX), she had a negative varicella titer. Her historical vaccine included SARS-CoV-2 vaccine (unspecified). Her concomitant therapies were not reported.  On 07-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, subcutaneously (SQ), lot # T027303, expiration date (anatomical location was not reported) 12-AUG-2020 for prophylaxis.  On an unknown date in April 2021, the patient reported a localized rash, which appeared to be more of a maculopapular rash before developing into a disseminated rash. The reporter reported polymerase chain reaction (PCR) test of one of the lesions was positive for varicella and the patient had over 100 lesions. It was unknown if the patient received any treatment. The outcome of the events was not reported.   The causal relationship between events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was inadvertently administered a dose of MMR II after its labeled expiry date; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 04-MAY-2021, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S007813, expiration date 14-MAR-2021; strength, dose, route of administration and anatomical location were not reported) for prophylaxis after its labeled expiry date (expired product administered). There were no known temperature excursions. No additional adverse event reported (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the clinic he was going to get his vaccine at is closed due to a cyber attack so they are going to have reschedule his third dose; the clinic he was going to get his vaccine at is closed due to a cyber attack so they are going to have reschedule his third dose; no additional adverse event; This spontaneous report was received from a male patient of unknown age who was reported on himself. His pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 04-MAY-2021, the patient was scheduled for his third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The clinic he was going to get his vaccine at was closed due to a cyber attack so his third dose was going to be rescheduled. When the dose would be rescheduled was unknown at the time of this report. No additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AEs; expired PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAY-202,1 the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) 0.5 ml injection, lot # S030093, expiration date: 24-MAR-2021 (strength and frequency were not reported) for prophylaxis. No additional adverse event was reported.
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: Accidental exposure to product, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; 7 year old patient was administered a dose of GARDASIL9; This spontaneous report has been received from a pharmacist referring to a 7 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 21-APR-2021, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 milliliter(ml)(a dose), lot # 1637651, expiration date 09-JUN-2022; strength, route and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster other zosterrelated; shingles; Information has been received from a lawyer regarding a case in litigation and  refers to a patient of unknown age and gender. On or about September 2016, the patient  was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiry date were not reported), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician in an eye center for shingles and other zoster related conditions. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine the patient has and will 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 the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: I've had 3 vaccines and still getting shingles/ Suspected vaccination failure; Shingles; I've had 3 vaccines; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient had 3 shingles vaccines and still getting shingles. The patient stated it had been over 10 years and the patient was so sick of it. The patient received 3 Shingles vaccines, which led to extra dose administered. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Feeding disorder, Herpes zoster, Insomnia, Pain, Vaccination failure
Clinical narrative: Shingles in my mouth / get my shingles shot last year/ Suspected vaccination failure; Shingles in my mouth; very high tolerance for pain but this is Horrible; Cannot sleep; Cannot eat except liquids; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, sleeplessness and unable to eat. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, sleeplessness and unable to eat were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, sleeplessness and unable to eat to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. In 2020, the patient received Shingles vaccine. The patient got shingles in his/her mouth and stated he/she had a very high tolerance for pain, but this was hell. The patient went to an oral surgeon who put him/her on several medications (unspecified). The patient stated he/she hope this clears up soon and he/she could not sleep or eat except liquids. It was unknown if the reporter considered the shingles, pain, sleeplessness and unable to eat to be related to COVID-19 vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Was vaccinated. Got shingles on right arm anyway/Suspect vaccination Failure; Got shingles on right arm; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and got shingles on right arm. The patient stated the he/she understand the new vaccine was more effective. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Cousin got the shot and got shingles from it./ Suspect vaccination Failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's cousin. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles from it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 56.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: developed / swelling / at injection site; developed / pain / at injection site; developed / warmness (AE) at injection site; developed redness / at injection site; allergic reaction; given / bysubcutaneous route / instead of intramuscular route; This case was reported by a pharmacist via and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 4Y2P4, expiry date 23rd January 2023) for prophylaxis.   Co-suspect products included cefalexin (Cephalexine) for injection site swelling, injection site pain, injection site warmth and injection site erythema.   On 27th April 2021, the patient received the 1st dose of Shingrix (subcutaneous). In May 2021, the patient started Cephalexine at an unknown dose and frequency. On 27th April 2021, unknown after receiving Shingrix and an unknown time after starting Cephalexine, the patient experienced intramuscular formulation administered by other route. In May 2021, the patient experienced allergic reaction. On an unknown date, the patient experienced injection site swelling, injection site pain, injection site warmth and injection site erythema. Cephalexine was discontinued. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site warmth, injection site erythema and allergic reaction were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.  It was unknown if the reporter considered the injection site swelling, injection site pain, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. After vaccination with Shingrix, the patient experienced injection site swelling, injection site pain, injection site warmth, injection site erythema and on 1st May 2021, the patient went to the emergency room. The patient received Shingrix by subcutaneous instead of intramuscular route, which led to  intramuscular formulation administered by other route. The patient was prescribed Cephalexin and discontinued Cephalexin because of an allergic reaction. The patient was prescribed Bactrim DS. The patient had not started the medication Bactrim yet. The health care professional stated that, symptoms had not resolved by 1st May 2021. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: first dose was administered Late Summer 2020 / second dose approximately two months later / On April 12, 2021 shingles / suspected vaccination failure; shingles / "on the inner lip of my crotch" moving outward; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   The patient's past medical history included chickenpox (experienced at 15 year age).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 12th April 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER. In April 2021, less than a year after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination for 1st dose was 56 years and for 2nd dose could be 56 or 57 years. In late Summer of 2020, the patient received 1st dose and approximately 2 months later, the patient received 2nd dose of Shingrix. Several days later after receiving Pfizer COVID-19 vaccine, the patient developed shingles. The patient reported that the outbreak was on the inner lip of her crotch moving outward and the patient admitted to being unable to use the correct anatomic terminology to describe the outbreak. The shingles outbreak had improved, though symptoms persist, and the patient was seeing the healthcare professional on day after reporting date. On 4th May 2021, the patient received the 2nd dose of Pfizer COVID-19 vaccine and planned to report the shingles outbreak to the CDC (Centers for Disease Control and Prevention) for monitoring purposes. It was unknown if the reporter considered the vaccination shingles related to Pfizer COVID-19 vaccine. The reporter consented to follow up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Serology test, Therapy non-responder
Clinical narrative: didn't have immunity for HepB; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In March 2021, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient received the 2nd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Engerix B and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient got the 3 doses of Engerix-B, last dose was given in March 2021. This week patient went to doctor to make a check-up and doctor told her she did not have immunity for hepatitis B. The health care professional was not at work at the time of the call, no information from patient nor vaccines was available and she was calling on behalf of a colleague at the pharmacy. The HCP did not consent nor declined follow-up