chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient had vasovagal event at Vaccine clinic. LOC < 10 seconds, Reported feeling dizzy, nauseous, and lightheaded. Patient was laid down on cot, VSS. Laid for 10 min, sat with legs dangling for 10 minutes. Given  juice for sugar boost and water. Patient's mother present. States he has had episodes like this in the past. Patient is a vegetarian. Denies HA, difficulty breathing, SOB, CP.  1:08pm VS: BP: 84/62 O2: 98% HR: 52 -  laying  PERRLA, HRR, no vomiting.  1:13pm VS: 90/59, O2:98%, HR:54   Discharged at 1:30pm in stable condition in care of mother. Return/ED precautions given. -
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hot flush, Insomnia, Muscle twitching
Clinical narrative: Severe insomnia persisting for a week (so far, ongoing side effect), muscle twitching (most pronounced when trying to fall asleep at night, contributes so sleep difficulties and keeps me awake), bouts of racing heartbeat and sudden flashes of heat (occurs most often while I?m trying to fall asleep, then persists throughout the nights keeping me awake), dizziness/light headedness/floaty head feeling throughout the day but worse at night when it makes the room feel like it is spinning and keeps me awake.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vertigo
Clinical narrative: Severe insomnia persisting for a week (so far, ongoing side effect), muscle twitching (most pronounced when trying to fall asleep at night, contributes so sleep difficulties and keeps me awake), bouts of racing heartbeat and sudden flashes of heat (occurs most often while I?m trying to fall asleep, then persists throughout the nights keeping me awake), dizziness/light headedness/floaty head feeling throughout the day but worse at night when it makes the room feel like it is spinning and keeps me awake.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Pt had syncopal episode with possible convulsion (passed out for about a minute, face turned purple, and had contractions of the arms and hands with sweating) about 10-15 minutes post injection. 911 called. Checked EKG, vitals, BG and was advised to go the ER but she refused for further evaluation.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I got Pfizer covid vaccine (first shot) on April 9th and have been suffering from prickling (pins and needle) on my body. This prickling happened randomly anywhere in my body (feet, arms, chest, all over the place of the body) and happened frequently everyday since I the second day I received the vaccine.    It is six week now since I got the vaccine, but pins and needle feeling still haul over me. I search online and found there are hundreds of people complaining about the same side effect I had. Some even say that this pins and needle feeling persist for months. I am not sure whether this pins and needle feeling eventually goes away. and I hope someone looks into this side effect and give us some guidance since there is no official document talks about this side effect.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful lymph node in left armpit
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Chills, Decreased appetite, Diarrhoea, Dissociation
Clinical narrative: April 28 to April 30, 2021: low fever, chills, aches, exhaustion, watery diarrhea, fuzzy-brained. "Fuzzy-brained" equals (1) inability to process thought, pull words from the air, tie thoughts together into a cogent sentence, be able to tie different memories together to form a full thought. For instance, I could not recall the names of people plus the projects each was working on and the current status in order to provide a cogent report to my work colleagues -- I could not form any level of complex thought into a sentence, paragraph, or discussion. "Fuzzy-brained" also meant (2) I was unable to form short-term memories. Due to others' observations of me over a period of days, we realized that I did not form any memory of what happened to me on April 29-30, 2021. I, in fact, overdrew my bank account by making a one month error in writing the check for the bill pay, then borrowed money from my son to cover the deficit, then forgot entirely about the episode until reminded today (17 May 2021) that I owed him several hundred dollars. May 8 to May 9, 2021: low fever, chills, aches, lack of appetite, inability to sleep (insomnia). Yeast infection in my female parts. May 17 and May 18, 2021: watery diarrhea, inability to sleep (insomnia).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Fungal infection, Insomnia, Pain
Clinical narrative: April 28 to April 30, 2021: low fever, chills, aches, exhaustion, watery diarrhea, fuzzy-brained. "Fuzzy-brained" equals (1) inability to process thought, pull words from the air, tie thoughts together into a cogent sentence, be able to tie different memories together to form a full thought. For instance, I could not recall the names of people plus the projects each was working on and the current status in order to provide a cogent report to my work colleagues -- I could not form any level of complex thought into a sentence, paragraph, or discussion. "Fuzzy-brained" also meant (2) I was unable to form short-term memories. Due to others' observations of me over a period of days, we realized that I did not form any memory of what happened to me on April 29-30, 2021. I, in fact, overdrew my bank account by making a one month error in writing the check for the bill pay, then borrowed money from my son to cover the deficit, then forgot entirely about the episode until reminded today (17 May 2021) that I owed him several hundred dollars. May 8 to May 9, 2021: low fever, chills, aches, lack of appetite, inability to sleep (insomnia). Yeast infection in my female parts. May 17 and May 18, 2021: watery diarrhea, inability to sleep (insomnia).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: April 28 to April 30, 2021: low fever, chills, aches, exhaustion, watery diarrhea, fuzzy-brained. "Fuzzy-brained" equals (1) inability to process thought, pull words from the air, tie thoughts together into a cogent sentence, be able to tie different memories together to form a full thought. For instance, I could not recall the names of people plus the projects each was working on and the current status in order to provide a cogent report to my work colleagues -- I could not form any level of complex thought into a sentence, paragraph, or discussion. "Fuzzy-brained" also meant (2) I was unable to form short-term memories. Due to others' observations of me over a period of days, we realized that I did not form any memory of what happened to me on April 29-30, 2021. I, in fact, overdrew my bank account by making a one month error in writing the check for the bill pay, then borrowed money from my son to cover the deficit, then forgot entirely about the episode until reminded today (17 May 2021) that I owed him several hundred dollars. May 8 to May 9, 2021: low fever, chills, aches, lack of appetite, inability to sleep (insomnia). Yeast infection in my female parts. May 17 and May 18, 2021: watery diarrhea, inability to sleep (insomnia).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eyelids pruritus, Pain, Pyrexia, Rash
Clinical narrative: Right eyelid started itching, turning red and swelling along with rash on neck within 30 mins of receiving vaccine.  Fever, Body Aches
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Right eyelid started itching, turning red and swelling along with rash on neck within 30 mins of receiving vaccine.  Fever, Body Aches
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Additional menses began 10 days after previous regular menses began
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: Began with 7 hours of deep chills, fevers beginning 10 hrs after shot. Strange metallic smell in nose for one hour.  Some tender mild swelling of lymph nodes for next 10 hrs, headache persisted 6hrs, , then mild congestion for 24 hrs. Malaise persisted throughout 24 hours even with bed rest.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia, Respiratory tract congestion
Clinical narrative: Began with 7 hours of deep chills, fevers beginning 10 hrs after shot. Strange metallic smell in nose for one hour.  Some tender mild swelling of lymph nodes for next 10 hrs, headache persisted 6hrs, , then mild congestion for 24 hrs. Malaise persisted throughout 24 hours even with bed rest.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient describes red, rash, swelling in her vaccine arm and will be following up with her doctor.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Lymphadenopathy
Clinical narrative: Swollen glands & cellulitis
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: 8 days after 1st Moderna vaccine redness circled injection site approx 1.25in diameter appeared around 12pm 5/15.  Approx 3.5 hours later got sudden, severe headache followed by nausea.  Vomited 1x 1 hour later. After resting felt better..  could feel heat radiating in my arm around the injection site without touching it around 6:30pm 5/15/20. Noticed severe swelling around the injection site, approx 5in diameter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 8 days after 1st Moderna vaccine redness circled injection site approx 1.25in diameter appeared around 12pm 5/15.  Approx 3.5 hours later got sudden, severe headache followed by nausea.  Vomited 1x 1 hour later. After resting felt better..  could feel heat radiating in my arm around the injection site without touching it around 6:30pm 5/15/20. Noticed severe swelling around the injection site, approx 5in diameter.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site swelling, Pain
Clinical narrative: Fever, chills, headache, body ache, fatigue and swelling at injection site. The last symptom has not subsided yet
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, body ache, fatigue and swelling at injection site. The last symptom has not subsided yet
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Mobility decreased, Pain
Clinical narrative: It's been over a  month since my injection and I still have severe pain at the injection site & upwards towards my shoulder. I have limited range of motion and lifting above 45° angle is very painful. Pain has been increasing in recent days. During my vaccine I had a very strong burning sensation within my arm that I've never experienced with any other shot. My bruising lasted for 2+ weeks.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: I had a miscarriage at 6 weeks pregnant. I have had 0 miscarriages in the past. I have 2 healthy children.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Magnets sticking to the injection site.  This is not a hoax I am very concerned and this needs to be addressed. The magnets tent my skin and pull at my skin ONLY where the vaccine was administered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Racing heart. My heart used to average 60 beats per minute and now is up to around 90 even up to 100 per minute. I?ve been having to take Propranalol to slow it down. It?s horrible. I don?t know what to do.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic disorder, Heavy menstrual bleeding, Ovarian cyst
Clinical narrative: Hemorrhagic Ovarian Cyst on 5/13 Heavy menstrual  cycle days  after , on 5/16
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Muscular weakness, Palpitations
Clinical narrative: Symptoms began around 10 hrs after administration of shot, first a racing heartbeat for a few moments followed by an intense ringing in the ears and legs felt wobbly, quickly progressed to chills feverish for 9 hours. Headache then began for several hours. Tylenol administered by parent/guardian. General malaise and bed rest followed by congestion. Malaise and some nasal congestion lasted for additional 24 hrs.  Thirst treated with electrolyte based-drink and water.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Tinnitus
Clinical narrative: Symptoms began around 10 hrs after administration of shot, first a racing heartbeat for a few moments followed by an intense ringing in the ears and legs felt wobbly, quickly progressed to chills feverish for 9 hours. Headache then began for several hours. Tylenol administered by parent/guardian. General malaise and bed rest followed by congestion. Malaise and some nasal congestion lasted for additional 24 hrs.  Thirst treated with electrolyte based-drink and water.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Echocardiogram, Heavy menstrual bleeding, Menstruation irregular, Palpitations
Clinical narrative: After receiving the vaccine, increased amounts of heart palpitations were experienced for at least 3 weeks before noticing a little respite in their frequency.  Irregular periods and heavy menstruation have also been experienced. Period following vaccine was heavy and came at a much earlier date than usual for the cycle. The 2nd period after that one started at the end of April and is still going on (as of May 18th). I do not have any history of irregular periods or menorrhagia of this extent.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Injection site pain, Pain
Clinical narrative: Sore arm at injection site, mild body soreness, stomach upset, fatigue, lasted for 48 hours
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I had typical symptoms starting approximately 24 hours after the shot.  But 6 days after the shot I had a delayed allergic reaction.  I had hives that over the course of 3-4 days covered my entire body as they rose and subsided in different areas.  I do have one picture of an arm shortly after they started spreading.  This was much worse than in shot 1, where I had a single welt on my arm show up about a week later.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Embolism venous, Ultrasound Doppler abnormal
Clinical narrative: venous thromboembolism
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Limb discomfort, Mobility decreased, Pain
Clinical narrative: Skin was pinched/bunched upon being administered. Irritation and pain was immediately felt. Swelling, redness, lack of mobility, and pain throughout entire arm has been felt since the injection. At 48 hours out, I developed pain at elbow joint, low-grade fever, and tingling in my pinky finger. I am now 60 hours out, and none of the injection site symptoms have subsided. It appears that it may have been an inadvertent subcutaneous injection, as well as possibly being too high up on my arm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Product administered at inappropriate site, Pyrexia, Skin irritation, Swelling
Clinical narrative: Skin was pinched/bunched upon being administered. Irritation and pain was immediately felt. Swelling, redness, lack of mobility, and pain throughout entire arm has been felt since the injection. At 48 hours out, I developed pain at elbow joint, low-grade fever, and tingling in my pinky finger. I am now 60 hours out, and none of the injection site symptoms have subsided. It appears that it may have been an inadvertent subcutaneous injection, as well as possibly being too high up on my arm.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Syncope
Clinical narrative: Uncontrollable shivering and freezing cold, 14 hours after shot. Fainting, 20 hours after shot.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid oedema, Face oedema, Oedema
Clinical narrative: edema of left side of face, upper eyelid; edema of left side of face, upper eyelid; edema of left axilla; This is a spontaneous report from a contactable physician. A 49-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 28Jan2021 08:45 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, anxiety. Concomitant medication included tramadol (TRAMADOL), methylprednisolone (MEDROL), levothyroxine (LEVOTHYROXINE), clonazepam (CLONAZEPAM), baclofen (BACLOFEN). The patient experienced edema of left side of face, upper eyelid, edema of left axilla (oedema) (non-serious) on 30Jan2021 06:00. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not been tested for COVID-19 Since the vaccination. The outcome of the events was recovered.   Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Gynaecological examination, Heavy menstrual bleeding, Physical examination
Clinical narrative: Severe menstrual bleeding and cramping, lasting 10 days and still ongoing.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Severe menstrual bleeding and cramping, lasting 10 days and still ongoing.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Joint swelling, Musculoskeletal stiffness
Clinical narrative: no issues with my first dose, but Feeling fatigued since my 2nd vaccine, and injection site pain, and fingers feel joint soreness, swelling. i still can't get my rings on and has been abnormal for me. fingers feel tight.  facial swelling and edema
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oedema, Swelling face
Clinical narrative: no issues with my first dose, but Feeling fatigued since my 2nd vaccine, and injection site pain, and fingers feel joint soreness, swelling. i still can't get my rings on and has been abnormal for me. fingers feel tight.  facial swelling and edema
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: A few hours after the injection some bumps formed around the injection site and it has since been very itchy, a little sore and feels like two pea sized lumps around the injection site. Main thing it has been very itchy.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Infection, Influenza like illness, Pain, Rash
Clinical narrative: This reaction happened after my second COVID vaccination from PZIFER--not almost immediately the same evening post vaccination I had a mild rash on my neck which resolved immediately and I had some flu like symptoms. But that isn't the reaction. About 9 days after the inoculation, My arm was developing a raised oozing rash which burned--this progressively became worse over the course of several days,, at which point my arm looked like I had a crusted fungal infection (very painful) or necrotizing bacteria--I did see an MD and a dermatologist looked at my arm via pictures--(still have them) It was deemed a vaccine reaction and I was prescribed "Fluocinide" ointment. Eventually my arm healed but it took a couple more weeks,. It was painful and extremely unattractive at the time of reaction.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Specialist consultation
Clinical narrative: This reaction happened after my second COVID vaccination from PZIFER--not almost immediately the same evening post vaccination I had a mild rash on my neck which resolved immediately and I had some flu like symptoms. But that isn't the reaction. About 9 days after the inoculation, My arm was developing a raised oozing rash which burned--this progressively became worse over the course of several days,, at which point my arm looked like I had a crusted fungal infection (very painful) or necrotizing bacteria--I did see an MD and a dermatologist looked at my arm via pictures--(still have them) It was deemed a vaccine reaction and I was prescribed "Fluocinide" ointment. Eventually my arm healed but it took a couple more weeks,. It was painful and extremely unattractive at the time of reaction.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: I took painkillers for pains and Benadryl for itching
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: I woke with stuffy nose,sinus pain, bad headache, ans fever, arm sore.  Pulse 120 Fever 102-100. ,  I checked my heart rate with Pulse Oxyimiter. My blood pressure around 2:30 was 140 over 90.   I took a cold shower, drank 70 ounces of water during day.  Took 2 Tylenol ,  3:00 and 10:30. Also allergy med which was Bromelain, stinging nettles, Quercia in. 10:30 am and midnight.  Also cup of ginger and cinnamon teas.  By midnight temp at 100.  Heart rate around 81-83.  Next day fever down,  slight lightheaded ness,  very faint head pain, little sinus irritation,  heart rate 78 - 68by 11:00pm.  No fever.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Sinus pain, Syncope
Clinical narrative: I woke with stuffy nose,sinus pain, bad headache, ans fever, arm sore.  Pulse 120 Fever 102-100. ,  I checked my heart rate with Pulse Oxyimiter. My blood pressure around 2:30 was 140 over 90.   I took a cold shower, drank 70 ounces of water during day.  Took 2 Tylenol ,  3:00 and 10:30. Also allergy med which was Bromelain, stinging nettles, Quercia in. 10:30 am and midnight.  Also cup of ginger and cinnamon teas.  By midnight temp at 100.  Heart rate around 81-83.  Next day fever down,  slight lightheaded ness,  very faint head pain, little sinus irritation,  heart rate 78 - 68by 11:00pm.  No fever.
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: No further AEs reported; patient missed a 3rd dose of GARDASIL 9; This spontaneous report has been received from a pharmacist, concerning a 40 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, frequency, route, lot number and expiration date were not provided) for prophylaxis. On 15-JAN-2021, the patient missed the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9). No further adverse events reported.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: negative titer to rubella; This spontaneous report was received from a physician assistant via a field based employee regarding a female patient of unknown age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was unknown.   On unknown dates, the patient was fully vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, route of administration, lot # and expiration date were not reported) as immunization for the prevention of measles, mumps, and rubella.  On an unspecified date, the patient had a negative titer to rubella. There was no additional adverse event. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown by the reporter. The outcome of the event was unknown. The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Syringe issue, Underdose
Clinical narrative: No other AE no PQC reported; Inappropriate dose of vaccine administered; causing some of the medication to leak out; The patinet did not get the full dose of PROQUAD due to possible human error of not placing the office supplied needle on the office supplied syringe correctly; This spontaneous report was received from a physician concerning a 4-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 08-APR-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 1 dosage form lot number T012418 rHA expiration date 06-OCT-2021 (route of administration was not provided) as prophylaxis.  On the same date and during administration, it was reported that the patient did not get the full dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) due to possible human error of not placing the office supplied needle con the office supplied syringe correctly, causing some of the medication to leak out, after withdrawing the medication from the vial. The reported confirmed that there was nothing wrong with the vial or vaccine.  Lot No. T012418 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), reported as 26-OCT-2021, but upon internal validation established as 06-OCT-2021.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Vaccination complication
Clinical narrative: Much more of a reaction; This spontaneous report was received from a pharmacist concerning a 17 years old female patient. The patient's current condition and medical history were not reported. The concomitant vaccine included COVID-19 vaccine.   On an unknown date, the patient was vaccinated with HPV vaccine (hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)) (dose, route and batch/lot# not reported) as prophylaxis. It was reported that the patient had much more of a reaction to the HPV vaccine and besides seeing the doctor they didn't report that either. The outcome of event was not reported.   The causality between the event and suspect vaccine was related.; Sender's Comments:  US-MMM-MGR02XIE:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported at this time; Assistant called in a temperature excursion on PROQUAD. Caller stated PROQUAD had been administered to three patients; This spontaneous report was received from a medical assisstant and refers to a patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 19-APR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)  (dosage regimen and route of administration was not reported), lot # T029099 rHA and expiration date 23-FEB-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -58 degree fahrenheit (°F) and 5°F for 6 hours and 30 seconds and -58°F and 5°F for 7 minutes and 30 seconds; previous temperature excursions were reported with no details.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA008088: US-009507513-2104USA008219: US-009507513-2104USA008302:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event reported; Temperature excursion on PROQUAD that was administered on 04/23/2021 to two patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 23-APR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) first time dose (route of administration was not reported), lot # T037957 rHA and expiration date 09-MAY-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 7.5 fahrenheit (°F) for 30 minutes on 22-APR-2021 and 6.0°F for 15 minutes on 23-APR-2021, for a total time out of range of 45 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2105USA003579:
Age: 60.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 60 year old female was given GARDASIL 9 vaccine by her physician; This spontaneous report was received from a registered pharmacist and refers to a 60-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-MAR-2021, the patient was vaccinated by a physician with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, administered intramuscularly (IM) (lot # 1602281, expiration date: 21-JUL-2021) for prophylaxis (product administered to patient of inappropriate age). 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: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events reported; an adult patient (20 year old) was given a pediatric dose of VAQTA.; an adult patient (20 year old) was given a pediatric dose of VAQTA.; This spontaneous report was received from a registered nurse and refers to a 20-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 26-APR-2021, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter, intramuscularly, lot # reported as T020913, expiration date reported as 31-MAR-2022 (injection site was not provided) for prophylaxis. No additional adverse events were reported.  Lot number T020913 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA). Lot number T020913 does not match ay Company product as confirmed by Lot Verification team.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported a temperature excursion in which PROQUAD was administered to patient(s); No additional AE.; This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender.  The patients' concurrent conditions, medical history and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccines live(PROQUAD) lot # T016990 with expiration date of 11-NOV-2021, 1 (units not provided) dose/frequency, for prophylaxis (route of administration was not provided). The vaccines were exposed to temperature of 14°F to 46°F (41°F) for 30 minutes. The vaccines had previous temperature excursion of 14°F to 46°F (22F) for 3 hour 30 minutes 0 seconds. This was called because of a data logger. Caller unable to provided any further details. No additional AE. No PQC.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: denied further adverse event; the patient was administered ROTATEQ on 06-MAY-2021 that expired 01-MAY-2021; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was reported.  On 06-MAY-2021, the patient received an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660994, expiration date: 01-MAY-2021, at dose of 2 milliliter, orally for prophylaxis. The reporter denied further adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-JUN-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a health care provider (HCP) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a HCP for shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). On an unknown date, the pt was admitted to the hospital due to the events. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster and ill-defined disorder was unknown. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no additional AE reported; expired MMR II 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 10-MAY-202, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) lot # R030812, expiration date: 24-OCT-2020 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; a dose of expired PROAQUAD was administered; This spontaneous report was received from a pharmacist and refers to a 17-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-APR-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot # S031881, expiration date: 07-APR-2021, 0.5 milliliter (formulation, strength, frequency, route of administration were not reported) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: vision loss; other zoster-related conditions; other zoster-related conditions; Information was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding current condition, historical condition and concomitant medication was not provided. On or about 07-MAR-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration were unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the pt was treated by a physician for vision loss and other zoster-related conditions. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to 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 included 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 would continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, vision loss was considered as medically significant.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; Administrator report a temperature excursion on ROTATEQ and the doses were administered.; This spontaneous report was received from a administrator referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 03-MAY-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose for prophylaxis (strength and route of administration were not reported; lot # 1742458 had been verified to be a valid number; expiration 22-JAN-2022). It was reported the temperature excursion was at 49.0 degrees Fahrenheit (F) on 09-APR-2021 and 48.7 degree F on 23-APR-2021, for a time frame of 1 hour 15 minutes and 0 seconds (cumulative) excursions. It was reported that no had previous temperature excursion. It was reported that the call was not due to data logger. No signs or symptoms reported.; Sender's Comments:  US-009507513-2105USA002898:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; Administrator report a temperature excursion on ROTATEQ and the doses were administered.; This spontaneous report was received from a administrator referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 27-APR-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose for prophylaxis (strength and route of administration were not reported; lot # 1742458 had been verified to be a valid number; expiration 22-JAN-2022). It was reported the temperature excursion was at 49.0 degrees Fahrenheit (F) on 09-APR-2021 and 48.7 degree F on 23-APR-2021, for a time frame of 1 hour 15 minutes and 0 seconds (cumulative) excursions. It was reported that no had previous temperature excursion. It was reported that the call was not due to data logger. No signs or symptoms reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; Administrator report a temperature excursion on ROTATEQ and the doses were administered.; This spontaneous report was received from a administrator referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-APR-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose for prophylaxis (strength and route of administration were not reported; lot # 1742458 had been verified to be a valid number; expiration 22-JAN-2022). It was reported the temperature excursion was at 49.0 degrees Fahrenheit (F) on 09-APR-2021 and 48.7 degree F on 23-APR-2021, for a time frame of 1 hour 15 minutes and 0 seconds (cumulative) excursions. It was reported that no had previous temperature excursion. It was reported that the call was not due to data logger. No signs or symptoms reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002894:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, Product storage error
Clinical narrative: No additional AE reported; expired dose of M-M-R II was administered; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 12-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) lot # S014436 with expiration date 09-MAY-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The vaccine did not have any prior temperature excursions and no additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; 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-009507513-2105USA002936: US-009507513-2105USA002866: US-009507513-2105USA002933: US-009507513-2105USA002934: US-009507513-2105USA002942: US-009507513-2105USA002941: US-009507513-2105USA002940: US-009507513-2105USA002939: US-009507513-2105USA002938: US-009507513-2105USA002937: US-009507513-2105USA002943: US-009507513-2105USA002935:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; 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-009507513-2105USA002936: US-009507513-2105USA002932: US-009507513-2105USA002934: US-009507513-2105USA002942: US-009507513-2105USA002941: US-009507513-2105USA002940: US-009507513-2105USA002939: US-009507513-2105USA002938: US-009507513-2105USA002937: US-009507513-2105USA002943: US-009507513-2105USA002935: US-009507513-2105USA002866:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; 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-009507513-2105USA002932: US-009507513-2105USA002933: US-009507513-2105USA002934: US-009507513-2105USA002942: US-009507513-2105USA002941: US-009507513-2105USA002940: US-009507513-2105USA002939: US-009507513-2105USA002938: US-009507513-2105USA002937: US-009507513-2105USA002943: US-009507513-2105USA002935: US-009507513-2105USA002866: