chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose decreased
Clinical narrative: Blood glucose levels are constantly monitored using a CGM system.  At the time of vaccine, BG was 180s.  In the three hours after the vaccine, blood glucose levels plummeted to 44 with a double down arrow (rapid life-threathening drop).  Insulin was suspended, and drastic dietary steps were taken to attempt to manage (juice, sugar snacks) the crash.  Levels stayed well under 100 until almost 9pm that evening.  No other factors had changed that day.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia, Rash
Clinical narrative: Fever, chills, weakness, rash on left arm
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized erythema, pain, swelling
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Myalgia, Pruritus
Clinical narrative: Severe muscular pain in my left arm, swelling, itching, chills, 99.7 temperature, tiredness. I have been taking Aleve to mitigate the pain.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Severe muscular pain in my left arm, swelling, itching, chills, 99.7 temperature, tiredness. I have been taking Aleve to mitigate the pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia, Vaccination site pain
Clinical narrative: Fever for 2 days following vaccine. Soreness, redness around vaccine site for at least 4 days.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Biopsy skin, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Left Shoulder and Arm pain, Painful, swollen, red vein in upper left arm
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: High fever 14 days later  Rash all over body  Swollen lymph nodes
Age: 56.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Arthralgia, Hip arthroplasty, Pain in extremity, Pyrexia
Clinical narrative: Patient has total hip replacement surgery on 3/4/2020 at the Hospital. After taking the two vaccines on the same day (on the same arm), about 10 hours later, fever (up to 102 degree) developed and the upper inner thigh joint area of the operative leg hurt very badly (score 10 with scale of 1 to 10). The adverse event went away after 36 hours or so.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Extra dose administered, Wrong patient received product
Clinical narrative: The patient accidentally received a pneumovax23 vaccine that was intended for his wife; he received the vaccine in error instead of his intended shingles vaccine.  Once the error was realized, he still received his shingles vaccine in the other arm. He had completed his pneumonia vaccine series in the past.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever, Fatigue, mild nausea, pain at injection site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Chickenpox like rash
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: sore shoulder at shot location, fatigue, body aches, headache, nausea; took naproxen on 7/11 in the morning at time of onset and in evening before bed, rested entire day; symptoms resolved by following morning 7/12
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient came to pharmacy on 7/11/20, reporting severe side effects from Shingrix. Her left shoulder was significantly swollen, she reported it was hot, and her arm motion was severely limited due to pain and swelling. Symptoms started day of vaccination (7/10/20). Patient was willing to try treating from home by icing swollen/hot/painful areas and using acetaminophen. Patient was instructed to go to urgent care/ER if she was no longer comfortable trying to treat from home or if her symptoms got progressively worse. I spoke with patient this morning (7/12/20) and she reported gaining some limited motion back in her arm, but it was still swollen, hot, and painful. She reported icing five times throughout the previous day and using acetaminophen 650mg every 8 hours. Patient's MD was notified today. Patient plans on contacting MD 7/13/20 and asking for appointment to be seen. Pharmacy will also follow up with patient.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site pain, Injection site warmth, Pain
Clinical narrative: Extreme pain in left shoulder (painful to the touch as well as chronic deep pain), heat at injection site, fever, body aches, headache, sweating, congestion Treated with Extra Strength Tylenol
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Extreme pain in left shoulder (painful to the touch as well as chronic deep pain), heat at injection site, fever, body aches, headache, sweating, congestion Treated with Extra Strength Tylenol
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: muscle aches, headache, sore arm, mild nausea
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A 3 inch area surrounding the injection site is red, swollen and warm
Sex: F
Vaccine: UNK
Symptoms: Encephalitis, Screaming
Clinical narrative: encephalitis screaming all night
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Dermatitis diaper, Diarrhoea, Rash
Clinical narrative: body rash, raised temp, consistent diarrhea needing Pedialyte to stay hydrated causing diaper rash as well
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Craniotomy, Headache, Loss of consciousness, Scan brain
Clinical narrative: Had a headache for 4 days then on the 5th day, 7/23, had a sever headache with vomiting and unconsciousness. A subdural hematoma was diagnosed and had a craniotomy at about 3am on the 24th, then another on the 26th.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Subdural haematoma, Vomiting
Clinical narrative: Had a headache for 4 days then on the 5th day, 7/23, had a sever headache with vomiting and unconsciousness. A subdural hematoma was diagnosed and had a craniotomy at about 3am on the 24th, then another on the 26th.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Insomnia, Myalgia
Clinical narrative: Approx 3 hours post administration: sore left shoulder (where shot given) Approx 11 hours post: swelling and red spot on arm, muscle soreness in arms and legs, shivering, 100.8 degree fever, unable to sleep Approx 19 hours post: fever broke, return to normal termperature, able to sleep 26 hours post: no issues except sore left arm with persisting swelling and red spot
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Approx 3 hours post administration: sore left shoulder (where shot given) Approx 11 hours post: swelling and red spot on arm, muscle soreness in arms and legs, shivering, 100.8 degree fever, unable to sleep Approx 19 hours post: fever broke, return to normal termperature, able to sleep 26 hours post: no issues except sore left arm with persisting swelling and red spot
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever starting 12 hours post-vaccination, lasting until 36 hours post-vaxx.  Body aches, lethargy.  Swollen lymph node (under left armpit) noted approx. 45 hours post-vaxx.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blister, Erythema, Local reaction, Pruritus, Rash vesicular
Clinical narrative: Patient called on 7/12 to report chickenpox-like (itchy red blisters that scab over) cutaneous skin reaction with localized mostly to his legs and feet. Reaction still ongoing, onset noticed by patient a few days after vaccine administration.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Skin reaction
Clinical narrative: Patient called on 7/12 to report chickenpox-like (itchy red blisters that scab over) cutaneous skin reaction with localized mostly to his legs and feet. Reaction still ongoing, onset noticed by patient a few days after vaccine administration.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blister, Erythema, Local reaction, Pruritus, Rash vesicular
Clinical narrative: Husband called on 7/12 to report chickenpox-like (itchy red blisters that scab over) cutaneous skin reaction with localized mostly to her abdomen and back. Reaction still ongoing, onset noticed by patient a few days after vaccine administration. Patient using calamine lotion to help with itchiness, and pharmacist also suggested using antihistamines like Benadryl to alleviate symptoms. Asked to follow up with primary care provider for actual evaluation, and treatment if necessary.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Skin reaction
Clinical narrative: Husband called on 7/12 to report chickenpox-like (itchy red blisters that scab over) cutaneous skin reaction with localized mostly to her abdomen and back. Reaction still ongoing, onset noticed by patient a few days after vaccine administration. Patient using calamine lotion to help with itchiness, and pharmacist also suggested using antihistamines like Benadryl to alleviate symptoms. Asked to follow up with primary care provider for actual evaluation, and treatment if necessary.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Chest pain, Injection site pain, Mobility decreased, Myalgia
Clinical narrative: - First day after vaccination, I had a mild fever, pain in chest near armpit area, pain in muscles, joints especially in shoulders, elbows and feet - Second day after vaccination, the chest pain was gone but I have a sever pain in my elbows, feet and toes. I had to take an Ibuprofen 400mg one time so I can be able walk and tolerate the pain. - Third day after vaccination, the pain in toes was gone. - Fifth day after vaccination, I had a severe pain in both shoulders, I couldn't raise my shoulders up.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: - First day after vaccination, I had a mild fever, pain in chest near armpit area, pain in muscles, joints especially in shoulders, elbows and feet - Second day after vaccination, the chest pain was gone but I have a sever pain in my elbows, feet and toes. I had to take an Ibuprofen 400mg one time so I can be able walk and tolerate the pain. - Third day after vaccination, the pain in toes was gone. - Fifth day after vaccination, I had a severe pain in both shoulders, I couldn't raise my shoulders up.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Developmental delay, Dropped head syndrome, Infantile spasms, Lethargy, Muscle spasms
Clinical narrative: Lethargy began on 9/24/2019; head drops and "spasms" found shortly after. Then, after a few neglectful doctor's visits, patient's mother took child to the emergency room on 10/30/2019. Patient was diagnosed with Infantile Spasms and Global Developmental Delay on 10/31/2019.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: As soon as I got the shot my arm hurt.  After about three hours my arm hurt to move, and I felt tired and my body ached.  I took 1 advil,  The advil did not help.   It felt like someone was stabbing my arm with a knife.  I could not even lay on my arm.  About 5 pm.  I was freezing so I took 2 advil . I put on a sweat shirt and sweat pants, got in bed and put two more covers on me.  I went to sleep and woke up around 11pm soaked.  Changed my clothes, took 2 more advil and bundled back up and went to bed.  Got up at 9 am on Saturday and still felt terrible all day.  Arm was still painful, still had body aches, fever and chills all day.  Did nothing but lay on the sofa.  I continued to take 2 advil every 6 hours all day long.  I had no energy, Went to bed around7pm and slept until Sunday around 9am.  On Sunday I did not take any advil.  I felt tired at first but then felt much better as the day went on.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Pain, Pain in extremity, Pyrexia
Clinical narrative: As soon as I got the shot my arm hurt.  After about three hours my arm hurt to move, and I felt tired and my body ached.  I took 1 advil,  The advil did not help.   It felt like someone was stabbing my arm with a knife.  I could not even lay on my arm.  About 5 pm.  I was freezing so I took 2 advil . I put on a sweat shirt and sweat pants, got in bed and put two more covers on me.  I went to sleep and woke up around 11pm soaked.  Changed my clothes, took 2 more advil and bundled back up and went to bed.  Got up at 9 am on Saturday and still felt terrible all day.  Arm was still painful, still had body aches, fever and chills all day.  Did nothing but lay on the sofa.  I continued to take 2 advil every 6 hours all day long.  I had no energy, Went to bed around7pm and slept until Sunday around 9am.  On Sunday I did not take any advil.  I felt tired at first but then felt much better as the day went on.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain, redness, and swelling at the injection site Tiredness Headache Shivering Upset stomach  Symptoms lasted for 3 days and dissipated over time
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, and swelling at the injection site Tiredness Headache Shivering Upset stomach  Symptoms lasted for 3 days and dissipated over time
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Pain, Pyrexia
Clinical narrative: Patient called 11am next day after receiving vaccination, says fever of over 100, nausea, sore shoulder, body aches. Patient is taking tylenol right now. Also, this was his second Shingrix shot, first was in December 20, 2019, no reaction other than normal injection site pain.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Severe pain (LL arm / shoulder ->, Wrist (24 hours) achy - general malaise - headache - 2 weeks fatigue - 4 weeks.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, C-reactive protein normal, Fatigue, Headache, Injection site pain
Clinical narrative: Severe pain (LL arm / shoulder ->, Wrist (24 hours) achy - general malaise - headache - 2 weeks fatigue - 4 weeks.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: Severe pain (LL arm / shoulder ->, Wrist (24 hours) achy - general malaise - headache - 2 weeks fatigue - 4 weeks.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chest pain, Chills, Computerised tomogram abnormal, Dyspnoea, Echocardiogram abnormal
Clinical narrative: FEVER, SHORTNESS OF BREATH, CHILLS, BODY ACHES, FATIGUE, CHEST PAIN, PATIENT IS CURRENTLY PREGNANT. EDD-9-17-2020 ELEVATED TROPONIN LEVEL
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory, Exposure during pregnancy, Myocarditis, Pyrexia
Clinical narrative: FEVER, SHORTNESS OF BREATH, CHILLS, BODY ACHES, FATIGUE, CHEST PAIN, PATIENT IS CURRENTLY PREGNANT. EDD-9-17-2020 ELEVATED TROPONIN LEVEL
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Troponin, Ultrasound scan
Clinical narrative: FEVER, SHORTNESS OF BREATH, CHILLS, BODY ACHES, FATIGUE, CHEST PAIN, PATIENT IS CURRENTLY PREGNANT. EDD-9-17-2020 ELEVATED TROPONIN LEVEL
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Angiogram, Chest pain, Chills, Dyspnoea, Echocardiogram
Clinical narrative: FEVER, SHORTNESS OF BREATH, CHILLS, BODY ACHES, FATIGUE, CHEST PAIN, PATIENT IS CURRENTLY PREGNANT. EDD-9-17-2020 ELEVATED TROPONIN LEVEL
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Electrocardiogram, Exposure during pregnancy, Fatigue, Laboratory test, Pain
Clinical narrative: FEVER, SHORTNESS OF BREATH, CHILLS, BODY ACHES, FATIGUE, CHEST PAIN, PATIENT IS CURRENTLY PREGNANT. EDD-9-17-2020 ELEVATED TROPONIN LEVEL
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Troponin increased
Clinical narrative: FEVER, SHORTNESS OF BREATH, CHILLS, BODY ACHES, FATIGUE, CHEST PAIN, PATIENT IS CURRENTLY PREGNANT. EDD-9-17-2020 ELEVATED TROPONIN LEVEL
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Less than 24 hours after the vaccine, about 4:30 - 5 PM on 7/3/2020 I began to feel very tired and got "tunnel vision." We were out of the house and it was  hot outside so I ignored it at first. By the time we got home, about 6 PM I began to ache and have chills and felt sick. Took my temperature twice, it was 100.2. My normal temp is 1 degree low, I am normally 97.6, so this is very hot for me. I drank some water and laid down and slept for 3 hours. I got up and felt worse. Felt like a flu - achey all over, headache, muscle aches everywhere, and checked temp again and it was coming down, was 99.6.  Went to bed. Could not eat much on 7/4 or 7/5 and had a stomach ache and diahrea. Fever was gone by 48 hours, or the evening of 7/4. Still was very tired, slept 10 - 11 hours each night, and could not concentrate (and I had work to do, and I just couldn't do it.) I was still lethargic at 72 hours (Sunday evening) but the muscle aches were subsiding. On Monday, I was able to work, but had to take a nap (never do, but I was exhausted) and by Tuesday (over 96 hours from the time of the vaccine) I was more or less back to normal. I only drank water and tea, did not take pain killers or any medications.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypophagia, Influenza like illness, Loss of personal independence in daily activities, Malaise, Myalgia
Clinical narrative: Less than 24 hours after the vaccine, about 4:30 - 5 PM on 7/3/2020 I began to feel very tired and got "tunnel vision." We were out of the house and it was  hot outside so I ignored it at first. By the time we got home, about 6 PM I began to ache and have chills and felt sick. Took my temperature twice, it was 100.2. My normal temp is 1 degree low, I am normally 97.6, so this is very hot for me. I drank some water and laid down and slept for 3 hours. I got up and felt worse. Felt like a flu - achey all over, headache, muscle aches everywhere, and checked temp again and it was coming down, was 99.6.  Went to bed. Could not eat much on 7/4 or 7/5 and had a stomach ache and diahrea. Fever was gone by 48 hours, or the evening of 7/4. Still was very tired, slept 10 - 11 hours each night, and could not concentrate (and I had work to do, and I just couldn't do it.) I was still lethargic at 72 hours (Sunday evening) but the muscle aches were subsiding. On Monday, I was able to work, but had to take a nap (never do, but I was exhausted) and by Tuesday (over 96 hours from the time of the vaccine) I was more or less back to normal. I only drank water and tea, did not take pain killers or any medications.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tunnel vision
Clinical narrative: Less than 24 hours after the vaccine, about 4:30 - 5 PM on 7/3/2020 I began to feel very tired and got "tunnel vision." We were out of the house and it was  hot outside so I ignored it at first. By the time we got home, about 6 PM I began to ache and have chills and felt sick. Took my temperature twice, it was 100.2. My normal temp is 1 degree low, I am normally 97.6, so this is very hot for me. I drank some water and laid down and slept for 3 hours. I got up and felt worse. Felt like a flu - achey all over, headache, muscle aches everywhere, and checked temp again and it was coming down, was 99.6.  Went to bed. Could not eat much on 7/4 or 7/5 and had a stomach ache and diahrea. Fever was gone by 48 hours, or the evening of 7/4. Still was very tired, slept 10 - 11 hours each night, and could not concentrate (and I had work to do, and I just couldn't do it.) I was still lethargic at 72 hours (Sunday evening) but the muscle aches were subsiding. On Monday, I was able to work, but had to take a nap (never do, but I was exhausted) and by Tuesday (over 96 hours from the time of the vaccine) I was more or less back to normal. I only drank water and tea, did not take pain killers or any medications.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: a patient received dose of improperly stored VARIVAX; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies was not reported.  On 22-JUN-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S020965, expiration date 07-JUL-2021) (strength, route and anatomical site of injection not reported) for prophylaxis (product storage error). Sterile diluent (MERCK STERILE DILUENT) used for reconstitution of the vaccine was properly stored.   The administered dose of the vaccine experienced a temperature 6 Fahrenheit degrees to 14 Fahrenheit degrees (9.5 Fahrenheit degrees) for 1 hour 20 minutes recorded by a data logger. There was no previous temperature excursion.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Irritability, Occult blood negative
Clinical narrative: 3 stools that were yellow with black streaks; patient was "fussy"; stools were "mushy"; This spontaneous report was received from a pediatrician and refers to a 8 week old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies or concurrent conditions. Concomitant therapies included vitamin d.  On 08-JUN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1, orally for prophylaxis (strength, frequency, lot# and expiration date were not reported). On the same date the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) dose 1, for prophylaxis (strength, frequency, route of administration, lot# and expiration date were not reported); diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PEDIARIX) for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were not reported); and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were not reported).   Overnight following the administration, patient was "fussy" (irritability) and experienced at least 3 stools that were yellow with black streaks "like a mashed banana". The pediatrician explained that the stools were "mushy" (diarrhoea) but that was normal for the patient. The patient was brought in to the office on 09-JUN-2020, her physical exam was normal, and the stool was tested for occult blood which was negative. Pediatrician recommended monitoring of stools and advised parents to contact the office with photos of diapers if this continued. The last photo she had received showed the stools were resolving with less black streaks, but there was no follow up from the parents beyond that. Pediatrician believed the issue resolved (discrepant information) after a couple days but did not know the exact date. It was mentioned that the parents had looked up information online and believed the rotavirus vaccine, live, oral, pentavalent(ROTATEQ) might be related to the change in stools.  The causal relationship between rotavirus vaccine, live, oral, pentavalent(ROTATEQ) and the event irritability was unknown. The causal relationship between the mentioned events and the other suspect therapies was unknown. The outcome of irritability was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received improperly stored PROQUAD on 5/5/2020; This spontaneous report was received from an administrator 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 05-MAY-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)injection (lot # S006019 was an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD); strength, route of administration and dose were not reported) reconstituted in properly stored sterile diluent, for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 10.4 Fahrenheit degrees (F) for 15 minutes. There was previous temperature excursion at 11.1 F for 15 minutes. The call was due to digital data logger. No additional adverse effect were reported.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; Administered vaccine after temperature excursion; Information has been received from a other regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-JUN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  0.5 mL injection, for prophylaxis, lot number S021740 with expiration date in 25-MAR-2021 (route of administration, strength and anatomical location not reported) that underwent a temperature excursion (incorrect product storage).  No adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported.; she was administered dose one of GARDASIL 9 in 2/2018, and dose two of GARDASIL 9 on 7/6/2020.; This spontaneous report was received from a 25 years old female patient referring to herself. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  In Feburay 2018, the patient was vaccinated with dose one of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and on 06-JUL-2020, the patient was vaccinated with dose two of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (both strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported), both for prophylaxis (inappropriate schedule of product administration). No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Burning sensation, Gait disturbance, Herpes zoster, Muscular weakness
Clinical narrative: difficulty walking; muscle weakness; balance issues; severe burning pain on his left leg and was diagnosed with shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions and concomitant medications. On or around 24-AUG-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered severe burning pain on his left leg and was diagnosed with shingles. As a result of the shingles, the pt suffered from difficulty walking, muscle weakness and balance issues requiring extensive physical therapy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles, difficulty walking, muscle weakness and balance issues was considered to be not recovered. The reporter considered the shingles, difficulty walking, muscle weakness and balance issues to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: difficulty walking; muscle weakness; balance issues; severe burning pain on his left leg and was diagnosed with shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions and concomitant medications. On or around 24-AUG-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered severe burning pain on his left leg and was diagnosed with shingles. As a result of the shingles, the pt suffered from difficulty walking, muscle weakness and balance issues requiring extensive physical therapy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles, difficulty walking, muscle weakness and balance issues was considered to be not recovered. The reporter considered the shingles, difficulty walking, muscle weakness and balance issues to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional adverse event; The patient was inadvertently admininstered a dose of PROQUAD, stead of MMR and VARIVAX; The patient was inadvertently admininstered a dose of PROQUAD, stead of MMR and VARIVAX; The patient was inadvertently admininstered a dose of PROQUAD, stead of MMR and VARIVAX; This spontaneous report was received from a medical assistant concerning to a 43-year-old male patient. The patient's concurrent conditions, medical history, concomitant medication, previous drugs reactions and allergies were not reported.   On 06-JUL-2020,  the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), injection, lot # S030210 expiration date reported as 25-MAR-2021, for prophylaxis (strength, dose, route of administration and anatomical site of injection were not reported), stead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (product use issue, wrong product administered and interchange of vaccine products). No additional adverse event. The outcome of the events was unknown.
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; A patient was administered improperly stored VARIVAX; This spontaneous report has been received from a medical assistant concerning 17-month-old child of unknown gender.  Information regarding the patient's current conditions, medical history, concomitant therapies, drug allergies or reactions, and historical drugs were not provided.  On 18-JUN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S028924 has been verified to be a valid lot number, expiration date reported and validated as 16-SEP-2021) as prophylaxis (concentration, dose, dose description, frequency of vaccination scheme and anatomical location of vaccination were not reported).   The varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent a temperature excursion in the rage of 15 to 46 degrees Fahrenheit (29.5 degrees Fahrenheit) for 67 hours, as recorded by the data logger (product storage error). The vaccine was reconstituted with a properly stored sterile diluent.  There were no previous temperature excursions.No adverse effects were reported for the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-00950713-2007USA003079:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; A patient was administered improperly stored VARIVAX; This spontaneous report has been received from a medical assistant concerning 15-month-old child of unknown gender.  Information regarding the patient's current conditions, medical history, concomitant therapies, drug allergies or reactions, and historical drugs were not provided.  On 16-JUN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S010297 has been verified to be a valid lot number, expiration date reported and validated as 03-APR-2021) as prophylaxis (concentration, dose, dose description, frequency of vaccination scheme and anatomical location of vaccination were not reported).   The varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent a temperature excursion in the rage of 15 to 46 degrees Fahrenheit (29.5 degrees Fahrenheit) for 67 hours, as recorded by the data logger (product storage error). The vaccine was reconstituted with a properly stored sterile diluent.  There were no previous temperature excursions.No adverse effects were reported for the patient.    This is one of several reports received from the same reporter.; Sender's Comments:  US-00950713-2007USA003075:
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse side effects; one month old patient received 2 doses of Recombivax in the hospital; This spontaneous report was received from a medical assistant and refers to an 1-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 23-JUN-2020, the patient was in the hospital and received 2 doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (for both lot #, expiration date, strength, dose, site and route of administration were not provided) for prophylaxis (extra dose administered). No adverse side effect was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Multiple unspecified patients were administered improperly stored vaccines; This spontaneous report has been received from a nurse concerning multiple numbers of patients of unknown age and gender. Their past drug and medical history, drug allergies or reactions, as well as their concomitant medications, were not provided.   From 20-FEB-2020 to 08-JUL-2020, the patients were vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA) (PROQUAD) (lot numbers T005406, expiry date 12-AUG-2021,  S027463, expiry date 02-MAR-2021, S012532, expiry date 20-OCT-2020 and T003833, expiry date 01-AUG-2021 have been verified to be valid lot numbers) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S036636, expiry date 14-NOV-2021 and S022756, expiry date 22-JUL-2020 (reported as 22-JUN-2021) as prophylaxis (concentration, dose, dose description, frequency of vaccination scheme and route and anatomical location of vaccination were not reported) ( product storage error). The vaccines were reconstituted with properly stored sterile diluent.   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursions between -14 to -10 degrees Celsius (-10.1 degrees Celsius) for 4 hours and 15 minutes, and from -9 to 8 degrees Celsius (-7.2 degrees Celsius) for 2 hours and 27 minutes, as recorded by a data logger. There were no other previous temperature excursions.   No adverse effects were reported for the patients.  This is a non-valid case due to a lack of patients' identifiers.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The second dose of GARDASIL 9 was missed for the patient on an unspecified date; The second dose of GARDASIL 9 was missed for the patient on an unspecified date; No adverse affects reported; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-MAY-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (strength, frequency, route of administration, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient missed the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (missed dose/incomplete course of vaccination).  No adverse effects were reported.
Age: 0.17
Sex: M
Vaccine: HEP, PNC
Symptoms: Rash
Clinical narrative: patient who had a total body rash; This spontaneous report was received from a registered nurse referring to a 9-week-old male patient. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were unknown by the reporter.  On 13-FEB-2008, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) as prophylaxis and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) the indication was unknown by the reporter ( for both vaccines: concentration, number of administered dose, vaccination scheme frequency route and anatomical location of administration, lot number and expiration were unknown by the reporter).      On 13-FEB-2008, the patient had a total body rash (rash). It was unknown by the reporter if the patient sought medical attention, if any laboratory diagnostic or studies were performed or if any treatment was given to the patient.     The outcome of rash was reported as resolved.   The causality assessment between both suspect therapies and the aforementioned event was not reported.
Sex: M
Vaccine: PPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse effects reported; A dose of PNEUMOVAX 23 was administered intravenous push; This spontaneous report was received from a pharmacist concerning a 44 year old male patient. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies or concomitant medications  On 08-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), via intravenous route for prophylaxis (dose, frequency, anatomical location, lot number and expiration date were not provided).
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Vaccination complication
Clinical narrative: hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated for zoster-related hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Herpes zoster, Influenza like illness, Malaise, Rash
Clinical narrative: Felt crummy; Flu like symptoms; No energy; She had bumps (could not see but could feel) on face; Shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2013US000834).  This spontaneous report was received from an other health professional referring to a 69 years old female patient. The patient's concurrent condition included bladder infection. The patient's medical history and drug allergy or reactions were not reported. Concomitant therapies included amlodipine besylate (+) hydrochlorothiazide (+) olmesartan medoxomil (TRIBENZOR), gemfibrozil, atenolol, pravastatin and nitrofurantoin (MACROBID).       On 18-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 1 dosage form, subcutaneously (lot # 0073AC is an invalid lot number for zoster vaccine live (ZOSTAVAX), expiration date was not reported) and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2012/2013) 1 dosage form, intramuscularly (lot #1204701, expiration date was not reported) for immunisation (strength, exact dose and dose number were not reported for both vaccine).   On an unknown date, the patient experienced felt crummy, flu like symptoms, no energy, she had bumps (could not see but could feel) on face and shingles. The outcome of the events was reported as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was not reported. The causality between the event flu like symptoms and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2012/2013) was reported as not assessable; the causality between other events and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2012/2013) was reported as suspected.  The events felt crummy, flu like symptoms, no energy, she had bumps (could not see but could feel) on face and shingles were considered to be medically significant by the reporter.
Sex: M
Vaccine: FLUX, MMR, TDAP, VARCEL
Symptoms: Pain, Pyrexia, Varicella post vaccine
Clinical narrative: Body aches; Chickenpox; Fever; Information has been downloaded from Agency (US-CHIRONMA-PHHY2016US032372).  This spontaneous report was received from a healthcare professional concerning a 58 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 18-DEC-2015, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 dosage form, for immunization (route of administration and lot number were reported as unknown, strength and expiration date were not provided); with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dosage form, for immunization (route of administration and lot number were reported as unknown; strength and expiration date were not provided; with influenza virus vaccine (unspecified) 1 dosage form, for immunization (route of administration and lot number were reported as unknown, strength and expiration date were not provided); and with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid 1 dosage form, for immunization (route of administration and lot number were reported as unknown, strength and expiration date were not provided).  On 31-DEC-2015, the patient experienced pain, pyrexia and varicella. The outcome of the aforementioned events was reported as not recovered.   The causality assessment between the suspect drugs and the events occurrence was reported as related.   The healthcare professional reported the events pain, pyrexia and varicella as medically significant.; Sender's Comments:  617319:
Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Vesicular rash started that is all over the patient body, on her entire legs, back, stomach adn arms; Vesicular rash started that is all over the patient body, on her entire legs, back, stomach adn arms; Information has been downloaded from Agency (US-CHIRONMA-PHHY2017US030236).  This spontaneous report was received from a other health professional referring to a 59 years old female patient. The patient's concomitant therapy included levothyroxine sodium (SYNTHROID). The patient's concurrent condition and medical history were not reported.      On 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 1 dosage form, subcutaneously (lot # M019646, expiration date was not reported, but upon internal validation established as 18-JUL-2017) for immunisation. On the same date, the patient was also vaccinated with influenza virus sag 3v vaccine inactivated (FLUVIRIN) 1 dosage form, intramusculary (lot# 1618621, expiration date was not reported) for immunisation.    On 30-OCT-2016, vesicular rash started that was all over the patient body, on her entire legs, back, stomach and arms. The outcome of the events was recovering. The causality between the events and all the suspect therapies was not provided.    The reporter considered vesicular rash started that was all over the patient body, on her entire legs, back, stomach and arms to be serious for the following reason: medically significant.