chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Pyrexia
Clinical narrative: e next Day 2 on the 9th I felt rase on the top of my head then on day 4 a lump was above my left eye then the next day a smaller lump showed up above the same eye. day six another lump behind my left ear, Day 7 my eye lid starded to swell, in two day my eye eas almost closed. i had a fever of 99.8 I showed my doctor, he said it was a vaccine issues and should go away soon, but he said i should see a allergist before my second shot. He said to try Zercon to help the symptoms,
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Injection site rash, Post-acute COVID-19 syndrome
Clinical narrative: Rash on arm where the vaccine was injected. Also known as COVID arm - delayed cutaneous hypersensitivity
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pain in extremity, Pruritus, Rash erythematous, Swelling
Clinical narrative: Day after vaccine I had a sore arm for 2 days and it went away. Then 8 days later I noticed a red rash the size of a silver dollar on and around the injection site.  It was slightly itchy and you could feed a bump under the skin.  It is now 4 days later and the bump has decreased but there is a slight rash still there. It seems to be getting  better.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Confusional state, Diarrhoea, Headache
Clinical narrative: Immediate soreness around the injection site and mild pain radiating down right arm. Slowly over time, pain began to worsen and expand down into fingertips, down side and up my neck. By 5pm, experienced severe shooting pain up and down right side, left arm and inability to move neck to the right. Severe tightness of neck muscles, back and arm on right side making movement difficult. Diarrhea, mild confusion, increased heart rate, body aches strong enough to release urinary muscles, chills, and headache. Pain level 8/10. Morning after (almost 24hrs past injection) still shooting pain down both arms, tightness in neck, arm and back, shooting pain down right side to all extremities, nausea, and headache.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site pain, Mobility decreased, Nausea, Neck pain
Clinical narrative: Immediate soreness around the injection site and mild pain radiating down right arm. Slowly over time, pain began to worsen and expand down into fingertips, down side and up my neck. By 5pm, experienced severe shooting pain up and down right side, left arm and inability to move neck to the right. Severe tightness of neck muscles, back and arm on right side making movement difficult. Diarrhea, mild confusion, increased heart rate, body aches strong enough to release urinary muscles, chills, and headache. Pain level 8/10. Morning after (almost 24hrs past injection) still shooting pain down both arms, tightness in neck, arm and back, shooting pain down right side to all extremities, nausea, and headache.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Urinary incontinence
Clinical narrative: Immediate soreness around the injection site and mild pain radiating down right arm. Slowly over time, pain began to worsen and expand down into fingertips, down side and up my neck. By 5pm, experienced severe shooting pain up and down right side, left arm and inability to move neck to the right. Severe tightness of neck muscles, back and arm on right side making movement difficult. Diarrhea, mild confusion, increased heart rate, body aches strong enough to release urinary muscles, chills, and headache. Pain level 8/10. Morning after (almost 24hrs past injection) still shooting pain down both arms, tightness in neck, arm and back, shooting pain down right side to all extremities, nausea, and headache.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Unresponsive to stimuli
Clinical narrative: Patient received the injection at 1734 and was told to wait 15 minutes for monitoring per protocol. Immediately after receiving the injection, the patient became nonverbal with his head tilted back in the chair. NP immediately attempted to re-arouse the patient but was unsuccessful. At approximately 1735 the patient received Epinephrine 0.03 mg.  Patient became awake and responsive.  patient began screaming he ?could not breathe?. Patient verbalized he had a history anxiety.  EMS was contacted and VS were taken. @1745 EMS arrived on scene
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: It started with a mild headache, a few days later my lymph nodes/glands in my neck were tender and swollen, then nasal drainage/sore throat, now I have deep red hives on my entire body (primarily chest area). I am not sure when the hives started, it is very prevalent today.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: It started with a mild headache, a few days later my lymph nodes/glands in my neck were tender and swollen, then nasal drainage/sore throat, now I have deep red hives on my entire body (primarily chest area). I am not sure when the hives started, it is very prevalent today.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 2-3 days after the vaccine was given she began to get redness on the arm and bullseye itching site. Her doctor told her it looked like covid arm after having the Moderna vaccine. She was advised by the health department health officer to wait an extra week and get her second shot 5 weeks later instead of 4 weeks later. She was using cortisone cream and zyrtec at home and was advised by her family doctor to continue this. She was also informed by the doctor that the bullseye looked lower than it should on the arm based on where the muscle it in the arm.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Day after injection fever, body aches, headache, tired
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral, Asthenia, Blood culture, Chest X-ray, Chills
Clinical narrative: FATIGUE, HEADACHE, WEAKNESS ,MUSCLE LOSS IN ARMS AND LEGS,  PAIN AND CHILLS, HIGH FEVER
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Culture urine, Fatigue
Clinical narrative: FATIGUE, HEADACHE, WEAKNESS ,MUSCLE LOSS IN ARMS AND LEGS,  PAIN AND CHILLS, HIGH FEVER
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lumbar puncture, Magnetic resonance imaging brain, Muscle atrophy, Pain
Clinical narrative: FATIGUE, HEADACHE, WEAKNESS ,MUSCLE LOSS IN ARMS AND LEGS,  PAIN AND CHILLS, HIGH FEVER
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Scan with contrast, Ultrasound Doppler, Urine analysis
Clinical narrative: FATIGUE, HEADACHE, WEAKNESS ,MUSCLE LOSS IN ARMS AND LEGS,  PAIN AND CHILLS, HIGH FEVER
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Lacrimation increased, SARS-CoV-2 test
Clinical narrative: woke up the night of my vaccine with pain in my left eye and significant itching and tearing.  The pain went away in a couple of hours but the itching continued for 3 days. It woke me up from sleep 3 nights in a row. I took Zatidor eyedrops and Allegra with very little improvement.   I get similar eye symptoms with seasonal allergies but this was the worse I have ever experienced and was not accompanied by runny nose, sneezing or coughing which I usually get with seasonal allergies and this is not a typical season for my allergies this may be just a coincidence but since I have read that Covid 19 can give similar ocular symptoms I am concerned about my second dose.  I got a COvid test 2 days ago (no other symptoms) and do not yet have the results
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: Vaccine was administered in my right arm, at 1:10 PM. Around 6:00 PM I started to experience sharp pains in the rib cage on my right side. They are not persistent.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Fever, diarrhea, body pain, chills, headache
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Complete missed period- have never been late or missed a period in my life. Only difference in the month was the vaccine. I track every single month.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: 15 min after injection my arm was tingling, I notified the pharmacist and was cleared to leave. 40 minutes after injection my hands and face went numb, my heart rate elevated for 10 minutes, I was unable to breathe through my nose. 1 hour after injection I regained  feeling in my face and hands; my hands shook for 2 hours after.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Soreness left arm at injection site- 12 hours after injection, Ibuprofen taken, resolved 36 hours after injection Low-grade fever 99.9, at 2 am, approximately 14 hours after injection, Ibuprofen taken, resolved 24 hours after injection Chills- at 2 am, approximately 14 hours after injection, Ibuprofen taken, resolved 24 hours after injection Body aches- at 2 am, approximately 14 hours after injection, ibuprofen taken, resolved 24 hours after injection Tiredness - Began approximately 12 hours after injection, lasted  approximately 32 hours after injection
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder, Sleep terror, Somnambulism
Clinical narrative: Sleep walking with night terrors. When he is awake he thinks the dream is still real. He believes ?they? are trying to kill him. He is terrified. He can?t go to sleep without having the dream. He seems to have had a psychotic break.  This is now  five nights since the vaccination. This morning at 4AM I found him sleepwalking outside in the snow in only a pair of jeans. No shirt, no shoes. No socks. Barefoot in the snow, waiting to be shot by ?them.?
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lacunar stroke, Magnetic resonance imaging head
Clinical narrative: acute right lacunar stroke symptom onset 2/14/2021
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills
Clinical narrative: Shivering and stomach pain. Time 10:30 pm  2/16/21 - 5:00 am 2/17/21
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash below injection site, itchy, hot
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Injection site pain
Clinical narrative: Got vaccine at 9:41AM on Monday Feb. 15. In the evening of the same day, around 7h30 PM while I was sitting on a table talking to my parents, I had a nosebleed, not very bad, just about 10 drops of blood. I had not had nosebleed for  8 or 10 years before that night. I thought it might be because of the dryness in my house, humidity dropped to 30%  from the normal range of 40%-60%. However, last night (Tuesday night) around the same time 7:00pm ~ 7:30pm, I had a nosebleed again while having dinner with my family, a bit less blood dropping this time, but it makes me worried a little bit.    Other than the nosebleed, I don't have any other symptoms, the soreness on the injection arm is close to nothing and I usually forgot about it.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Skin lesion
Clinical narrative: Large red lesion on arm 2 inches below injection site.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Arm was sore after injection but eventually got better in 2 days.  Several days later site became very itchy. By the following week, site was very swollen, hot to touch and redness spread around my whole upper arm. I called a pharmacist who advised me to take an antihistime and see a MD next day if not better.  I went the next day, and doctor said it was a normal reaction to an injection. I applied ice packs over the next couple of days.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: 2 weeks (+/-) after pain in left hip, as if I had fallen on the ice, and landed on my hip.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: 12 hours after vaccination, i experienced chills, fever, headache and very sore arm. My teeth were chattering and I was shivering. Symptoms last for next 72 hours but were on and off. This happened too when I got my 1st dose.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, fever 101, muscle aches, headache, nausea
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza A virus test negative, Influenza virus test negative, Nausea, Rash
Clinical narrative: Began with a rash about midnight. No significant pain at injection site. Throughout the night I had chills and nausea. At 6 am on 2/1 I started having nausea and vomiting. Also, the rash that started on my neck went down around armpit and onto torso area. Symptoms were bad days one and two. Day 3 was a bit better but didn?t fully feel normal until day 4 but rash is still slightly present.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: Began with a rash about midnight. No significant pain at injection site. Throughout the night I had chills and nausea. At 6 am on 2/1 I started having nausea and vomiting. Also, the rash that started on my neck went down around armpit and onto torso area. Symptoms were bad days one and two. Day 3 was a bit better but didn?t fully feel normal until day 4 but rash is still slightly present.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Diplopia, Eyelid ptosis, IIIrd nerve paresis, Laboratory test abnormal
Clinical narrative: Patient reports being in her usual state of good health when she presented for COVID19 Vaccination. She reports onset of diplopia  without other symptom approximately 45 minutes after vaccination.  Later that night she notes  onset of full L eye ptosis which resulted in resolution of the diplopia. She was evaluated by ophthalmology the next day, 2/11, and was referred to the ER where she had a brain CT with no acute changes and unremarkable labs.  Treatment with Plavix 75mg was initiated. She was evaluated in my office on 2/16 for persistent ptosis of her L eye and her exam  is consistent with isolated third nerve palsy.   Diabetes and lipid levels are at target.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: 1/7 vaccination Napped. Woke up to rash over neck and face area. Went to urgent care.  Prescribed cortisone cream and allergy meds, Clariten. Hives went away but came back worse onto other extremities.  I went to a different urgent care. The Dr. prescribed prednisone and Claritin. 'Delayed hypersensitivity reaction'.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Retching, Vomiting
Clinical narrative: Vomiting, Dry-heaving, 102.2 temperature, severe headache
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Rash, Swelling face
Clinical narrative: Woke up to swollen upper lip and face, itching of hands and rash around beltline, abdomen, inner thighs and groin. Taking Benadryl.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2/13/21 None 2/14/21 Late morning, body aches, chills, fever (101.8) Tylenol,  12 hours.  symptoms gone  morning 2/15 2/15  evening checked injection site, pressure sensitive, warm slightly swollen large red area, cool wet compress, no temp 2/16  same as 2/15, took antihistamine 25mg,  informed primary physician 2/17 better, spot that looks like a permanent injection spot. no temp, waiting for doctor reply
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 2/13/21 None 2/14/21 Late morning, body aches, chills, fever (101.8) Tylenol,  12 hours.  symptoms gone  morning 2/15 2/15  evening checked injection site, pressure sensitive, warm slightly swollen large red area, cool wet compress, no temp 2/16  same as 2/15, took antihistamine 25mg,  informed primary physician 2/17 better, spot that looks like a permanent injection spot. no temp, waiting for doctor reply
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema
Clinical narrative: Large Red are with large blister that broke open.  Went to doctor on Feb 16th 2021  Was put on Cephalexin 500MG 3 x daily for 10 days and Mupirocin 2%  3 x daily for 10 days
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infection, Injection site infection, Injection site vesicles, Wound
Clinical narrative: Large Red are with large blister that broke open.  Went to doctor on Feb 16th 2021  Was put on Cephalexin 500MG 3 x daily for 10 days and Mupirocin 2%  3 x daily for 10 days
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Ocular discomfort, Pain
Clinical narrative: 9 hours after, experienced extreme headache, pressure on my eyes 12 hours later, extreme chills and body aches, headache 24 hours later chills, aches, and headache 48 hours later, swollen several lymph nodes in left neck
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Feeling abnormal
Clinical narrative: patient felt funny after shot. EMS was called vitals were taken BP 194/114  BG 143 HR 93. Cardiac Rhythm Disturbance but patient refused additional evaluation and care.  Released against medical advice.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no AE; temperature excursion; dose: 0.5 milliliter; This spontaneous report refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-DEC-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), dose: 0.5 milliliter, lot# 1660942, expiry date: 06-FEB-2021 (dose number, route of administration were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 31.2 degrees Fahrenheit for 30 minutes. There were no previous excursions related. Data logger was involved. No adverse events were reported.; Sender's Comments:  US-009507513-2101USA009961:
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addittional adverse events reported; Gardasil 9 expired 11/30/2020; This spontaneous report has been received from a medical assistant, concerning a 19 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 25-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter,  lot # R009614 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 30-NOV-2020 (frequency, route and anatomical location were not provided) for prophylaxis with no temperature excursions. No additional adverse events reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; Patient administered PROQUAD that expired; This spontaneous report as received from a nurse refers to a 5-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 01-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: S022916, expiration date: 19-JAN-2021; route of administration was not provided) 0.5 ml. No adverse event was reported.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 72-year-old patient of unknown gender. In or about 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for the following injury resulted from zoster vaccine live (ZOSTAVAX) used: shingles. The outcome of herpes zoster was not reported. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 1.33
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 16-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 14-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 15-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 18-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 8.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to an 8-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 27-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 29-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 1.67
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 20-month-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 29-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Lethargy, Tinnitus
Clinical narrative: ringing in his ears / tinnitus; redness and tenderness at injection site; tenderness at injection site; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of tinnitus (1st dose received on 28th September 2020 and the patient experienced lethargy and redness and tenderness at injection site, refer case US2020252578.).   On 15th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness and lethargy. On 20th December 2020, the patient experienced tinnitus. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site tenderness and lethargy were recovered/resolved and the outcome of the tinnitus was not recovered/not resolved.   The reporter considered the injection site erythema, injection site tenderness and lethargy to be related to Shingrix. It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows:  The patient received 2nd dose of Shingrix in right deltoid. Lot and expiration date were not known. After receiving 2nd dose of Shingrix, the patient experienced began to experience ringing in his ears which was intermittent and comes and goes, lethargy and redness and tenderness at injection site. The reporter was asking if this was a known side effect.   Caller declined to provide contact information for his medical doctor. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020252578:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Loss of consciousness, Pyrexia, Urinary incontinence
Clinical narrative: passed out; urinated on herself; could not sleep; chills; fever; A spontaneous report was received from a consumer concerning a 74 year old female patient who received Moderna's COVID-19 vaccine and experienced loss of consciousness, chills, pyrexia, urinary incontinence and insomnia.  The patient's medical history was not provided.  Concomitant medication included unspecified blood pressure medications.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown)  for prophylaxis of COVID-19 infection.    On 02-Feb-2021 the patient received the second of their planned doses of mRNA-1273 (Lot number 041L20A) intramuscularly for prophylaxis of COVID-19 infection.     On 02-Feb-2020, the patient experienced chills, some fever, and could not sleep.  On the morning of 03-Feb-2021, the patient passed out twice and urinated on herself. No treatment information was provided.   Action taken with the mRNA-1273 in response to the events was not applicable.  The outcome of the events of loss of consciousness, chills, pyrexia, urinary incontinence and insomnia were  was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; A spontaneous report received from a healthcare professional concerning a 40-year-old, male patient who received Moderna's COVID-19 vaccine and developed pneumonia.  The patient's medical history provided were, severe developmental disabilities, chronic constipation and allergy induced asthma. No relevant concomitant medications were reported.  On 18 Jan 2021, patient received their first of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, within 3 days after injection, the patient was hospitalized for pneumonia. Patient received the vaccine because he received supported living services. The reporter was reluctant to agree to him receiving the 2nd dose. Treatment for the event was not provided.  Action taken the first dose of mRNA-1273 in response to the event was not reported.  The outcome of the event pneumonia was unknown.; Reporter's Comments: This case concerns a 40 year old male subject, with history of allergy induced asthma, among others, who experienced a serious unexpected event of pneumonia after first dose of mRNA1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site haemorrhage
Clinical narrative: injection was not given properly in the deltoid and that it was given down, wrong way of administration; Arm started bleeding; A spontaneous report (United States) was received, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) reported that the injection not given properly in the deltoid (it was given down, wrong way of administration)/incorrect route of product administration and she experienced bleeding of that arm/vaccination site haemorrhage.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 06 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (LOT# 031020A) intramuscularly for prophylaxis of COVID-19 infection. On 03 Feb 2021, the patient reported that the injection was not given properly in the deltoid (it was given down/ wrong way of administration), and her arm started bleeding.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The event, injection was not given properly in the deltoid (it was given down/ wrong way of administration), was considered resolved on 03 Feb 2021. The outcome of the event, arm bleeding (at vaccination site), was not reported.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  Also, based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site hemorrhage, a causal relationship cannot be excluded.
Sex: F
Vaccine: RAB
Symptoms: Anaphylactic reaction, Urticaria, Wheezing
Clinical narrative: anaphylaxis; Initial information received on 04-Feb-2021 regarding an unsolicited valid serious case from the other health care professional and issued from a literature article.   This case is linked to case 2021SA040002 (same article).  This case involves a female patient of unknown age (current age is 55 year) who experienced anaphylaxis (anaphylactic reaction), after she received RABIES VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for unknown indication.  On an unknown date, the patient developed a serious anaphylaxis (anaphylactic reaction), unknown latency following the administration of RABIES VACCINE. This event was assessed as medically significant.   It was also reported that the Brighton Collaboration case definition uses combinations of symptoms to define levels of diagnostic certainty. Brighton Level 1 represents the highest level of diagnostic certainty that a reported case is indeed a case of anaphylaxis. All patients should be instructed to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination location. Health care providers can play an important role in vaccine safety by being vigilant in recognizing and reporting adverse events after immunization to VAERS.  Details of laboratory data not reported.    This patient received Pfizer-BioNTech COVID-19 vaccine in Dec-2020 and within 5 minutes experienced anaphylaxis with generalized urticaria, wheezing which required inpatient hospitalization and treatment with EPINEPHRINE.  It was unknown if patient received any corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves 55 year old female patient who had anaphylactic reaction after vaccination with RABIES VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Lip swelling, Urticaria
Clinical narrative: Anaphylaxis; Initial information received on 04-Feb-2021 regarding an unsolicited valid serious case from the other health care professional and issued from a literature article.  This case is linked to case 2021SA039986 (same article).  This case involves a female patient of unknown age (current age is 44 year) who experienced anaphylaxis (anaphylactic reaction), after she received INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for unknown indication.  On an unknown date, the patient developed a serious anaphylaxis (anaphylactic reaction), unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.   It was also reported that the Brighton Collaboration case definition uses combinations of symptoms to define levels of diagnostic certainty. Brighton Level 1 represents the highest level of diagnostic certainty that a reported case is indeed a case of anaphylaxis. All patients should be instructed to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination location. Health care providers can play an important role in vaccine safety by being vigilant in recognizing and reporting adverse events after immunization to VAERS (Vaccine Adverse Event Reporting System).  Details of laboratory data not reported.    This patient received Pfizer-BioNTech COVID-19 vaccine in Dec-2020 and within 34 minutes experienced anaphylaxis with generalized urticaria, swollen lips which required visit emergency department and treatment with Epinephrine.  It was unknown if patient received any corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves 44-year-old female patient who had anaphylactic reaction after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.