chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication, Vision blurred, Visual impairment
Clinical narrative: July 19 All over Muscle ache, Headache, Upset stomach, Fatigue,  soar arm. July 20 still sick. July 21 Dizziness started, still sick. July 22 still sick Missed work. July 23 a little better. July 26 filling suck again. July 28 Morning Ok by 2pm very sick Dizzy Headache across eyes, worse in left eye. Sick in stomach. July 29 sick missed work. Went to Dr. Ordered Meclizine 25mg, Ondansetron 4mg Tylenol 500 mg. July 30 home sick bad headache. July 30 Went to eye DR to check eyes at 4pm went to Emergency Room got CT scan blood work shot for headache. Aug 1ok. Aug 2 Woke up very sick Dizzy and Blurry vision. Aug 3 Woke up bad headache across eyes left side worse. Double vision light hurts eyes. Aug 4 Dizzy light headed double vision. Left Eye Went Crossed Eyed,  and bad pain left eye / head.  2:30 pm Went to ER again. Did more blood work and did a MRI, on head   examined by Neurologist did muscle test left side weaker then right side,  said he thought it might be a side effect from shingle shot, was given another shot for pain.  and prescribed  Methylprednisolone  pack and set up appointment with  Neurologist . Aug 5  Still double vision went back to Eye Dr. for the double vision.   Vision still poor in both eyesAug 6 Still double vision. Aug 7 Shaky tired and Double vision. Aug 9 seen Neurologist did some physical test. Said since symptoms started right after getting the shingle shot. he suspect that it is a adverse reaction to the shot. ,He prescribed another methylprednisolone pack They did several more blood test,  and He has order a MRA test (similar to a MRI) and a spinal tap. Planed for the week of the 19th. Insurance co causing delays. As of Aug 16 2019 Headaches mostly gone. No improvement on Double vision.  No improvement with vision. Still some Dizziness. Left Eye still Crossed.
Age: 54.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Back pain, Swelling face
Clinical narrative: 15 min AFT Getting boTH Vaccines, pt ReportED THAT She Don't Pain - STARTED in Lower back THEN spread - ALSO swollen cheeks noT TonGUe - no SOB WENT TO ER
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Aching joints, soreness at injections site
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Severe flu like symptom: Body aches, head aches, and fever that lasted upto 4 days following  the first and second shot of shingrex. Patient taking Acetaminophen to help with symptoms and to contact physcian.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient called next day reporting that arm started swelling the evening after receiving the vaccine, was warm to the touch, and was sore to the point that she was unable to lift the arm. Instructed patient that this was a possible side effect of the vaccine and that they could alternate Tylenol and Ibuprofen for the pain and inflammation, and they could use an ice pack on the affected arm as well.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: I awoke in the middle of the night convulsing from chills and a fever, I remained awake throughout the night experiencing extreme cold, body pain, and headache, which transitioned to extreme heat and sweating. In the morning I had a migraine and felt nauseous with significant body pain.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: I awoke in the middle of the night convulsing from chills and a fever, I remained awake throughout the night experiencing extreme cold, body pain, and headache, which transitioned to extreme heat and sweating. In the morning I had a migraine and felt nauseous with significant body pain.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: I awoke in the middle of the night convulsing from chills and a fever, I remained awake throughout the night experiencing extreme cold, body pain, and headache, which transitioned to extreme heat and sweating. In the morning I had a migraine and felt nauseous with significant body pain.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site rash
Clinical narrative: Patient presented to pharmacy with a 3 to 4 inch circular rash on her upper left arm not itchy started a week after her immunization on 8/7/19
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Insomnia
Clinical narrative: Increased heart rate, inability to sleep.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient called pharmacy on Sunday 8/18/19 stating her arm was still sore,red and warm to the touch. She had been taking daily Zyrtec and no relief. I suggested adding a cold compress on to the site as well. These are all listed as side effects to both vaccines, and were given in her non dominant arm as she got another vaccine in her dominant arm. Told her to follow up with her primary MD if no relief Monday Am on 8/19/19. Patient stated not getting worse or better but staying the same since the day after the vaccinations.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Got the shingrix the 7th. Noted a papular erythematous rash on his upper inner thighs on the 12th. Then it spread to his lower back and buttocks on the 13th, On the 14th onto his inner knee and calf. The rash was not painful or itchy. Seen 2 days ago - the rash was still present but had not progressed. No treatment given. He will contact me once it has totally resolved.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash, Rash erythematous, Varicella
Clinical narrative: Got the shingrix the 7th. Noted a papular erythematous rash on his upper inner thighs on the 12th. Then it spread to his lower back and buttocks on the 13th, On the 14th onto his inner knee and calf. The rash was not painful or itchy. Seen 2 days ago - the rash was still present but had not progressed. No treatment given. He will contact me once it has totally resolved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm was swollen, red, warm, and tender around injection site. Patient states this begin yesterday and she came in today regarding her concern about her arm on 8/18/19 around 12:45 pm. Patient was instructed to put an ice pack on her arm to reduce the swelling and to seek medical attention if the condition worsens.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Condition aggravated, Diabetic ketoacidosis, Ketoacidosis, Ketosis
Clinical narrative: Diabetic ketoacidosis, been in ketosis (sometimes ketoacidosis) ever since.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest pain, Chills, Dysphagia, Dyspnoea
Clinical narrative: Body aches, chills, severe chest, neck, and throat pain, difficulty breathing and swallowing
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: Body aches, chills, severe chest, neck, and throat pain, difficulty breathing and swallowing
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Erythema, Hypoacusis, Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS AT THE INJECTION SIGHT TRAVELED DOWN THE LEFT ARM TO THE LEFT HAND. PATIENT ALSO EXPERIENCING  A "PRESSURE SENSATION BEHIND THE LEFT EAR" AND A "SENSE OF PARTIAL HEARING LOSS"
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: SWELLING AND REDNESS AT THE INJECTION SIGHT TRAVELED DOWN THE LEFT ARM TO THE LEFT HAND. PATIENT ALSO EXPERIENCING  A "PRESSURE SENSATION BEHIND THE LEFT EAR" AND A "SENSE OF PARTIAL HEARING LOSS"
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large red, raised, itchy patch around injection site.  Patient said began evening after vaccine administration and was worse in the morning.  Patch today is about 3 inches in diameter.  She states she took Atarax and applied hydrocortisone cream to the area and it is getting better now.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Large red, raised, itchy rash developed evening of vaccine administration.  Patient has treated with Atarax and topical hydrocortisone cream.  Area today is about 6 inches long spread down toward elbow and around injection site.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Large red, raised, itchy rash developed evening of vaccine administration.  Patient has treated with Atarax and topical hydrocortisone cream.  Area today is about 6 inches long spread down toward elbow and around injection site.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, shivering, head ache, and muscle aches.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, HEAT, PAIN ON INSIDE OF LEFT UPPER ARM
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Ephelides
Clinical narrative: patient stated a few days after had vaccine developed some "freckles" on skin of both forarms and face but has since resolved for the most part
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, pain/soreness at injection site.   Pt went to ER where she was given benadryl and ibuprofen and sent home.  Pt also applied ice pack to the site.   As of today, 8/18/19 pt still has a little soreness in her right arm but not significant.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Eye irritation, Lacrimation increased, Pain, Pain of skin
Clinical narrative: Fever - body aches - lack of energy - burning and watery eyes - even my skin hurts Symptoms began between 5:00-6:00 p.m. (injection was at noon).  I have been controlling symptoms with Advil.  I had EXACTLY the same reaction to the first shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever - body aches - lack of energy - burning and watery eyes - even my skin hurts Symptoms began between 5:00-6:00 p.m. (injection was at noon).  I have been controlling symptoms with Advil.  I had EXACTLY the same reaction to the first shot.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: alopecia, complete loss of hair from scalp, chest, armpit, face, eyebrows, nose, ears, groin within 4 to 6 weeks
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt presents with redness, swelling, warmth, and severe pain of vaccine site.  The sit is noted to be on the medial upper arm, 3 cm above the elbow joint.  Area of erythema measures  3 cm x 4cm.
Age: 58.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The pt had swelling and redness around injection site on her right arm that started after getting vaccinated on 8/12/19.  She said the swelling started after she got home and the redness started a few days after that. She returned to the pharmacy on 8/18/19 to ask about the reaction.  She said the arm had been swollen and red for a few days but the swelling had gone down the and redness was not as bad as it had been the day before.  She had been using an ice pack and hydrocortisone at home before coming to the pharmacy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Lethargy, Pain, Pyrexia
Clinical narrative: flu like sx, very lethargic, sore, worn down, fever
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Tongue blistering
Clinical narrative: Blister on both sides of the tongue occurred, patient given dexamethasone to sinse
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Toothache, X-ray dental normal
Clinical narrative: Left sided ed started with pain in tooth #16,  Progressed to involving Left maxilla and madibel.  Intermittent with no trigger. no pattern  and no way to reduce the pain or stop it.  It lasts from 10-15 mins  The longest was 30 mins. At peak of pain it is in the  6/10 pain scale.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Patient's arm swelled and was painful and itchy. She also did not feel well and had a fever
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site reaction, Urticaria
Clinical narrative: I developed a very large welt approximately 20 cm by 10 cm, around and below the site of the injection. I also developed this with the first injection. So only localized. Aside from a headache and fatigue the next day, I was fine. I prefer this to shingles.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: CHGILLS, FEVER 12 HOURS, WEAK BODY SORENESS
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient reported redness and swelling at the injection site along with nausea, vomiting and fever
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swollen injection site,  warm to touch and tender
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Blood pressure increased, Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient reported fever, chills, a painful arm the on 8/13. On 8/14 his blood pressure dropped to 90s/60s (normal BP range 120-130s/90s). On 8/15 he reported a higher than normal blood pressure.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin infection
Clinical narrative: On 08/16/2019 patient reported to the pharmacy with a prescription for antibiotic. Patient stated that they had a skiin infection following Shingrix vaccination. Patient did have a red patch of skin approximately 4 and 1/2 inches on right deltoid.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: Can?t lift arm; muscle aches from neck to butt and sometimes down leg; headaches; fatigue; weakness; fever (101.5); nausea.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Can?t lift arm; muscle aches from neck to butt and sometimes down leg; headaches; fatigue; weakness; fever (101.5); nausea.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Sore arm with significant pain. Could not lift arm above shoulder or lay on the arm.  Redness and swelling where I got the shot. Significant tiredness, full body muscle pain, headache, dizziness, low grade fever-like shivering and nausea. Soreness at injection still present at time of this adverse event entry. Other symptoms resolved 24 hours after they began.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Myalgia, Nausea
Clinical narrative: Sore arm with significant pain. Could not lift arm above shoulder or lay on the arm.  Redness and swelling where I got the shot. Significant tiredness, full body muscle pain, headache, dizziness, low grade fever-like shivering and nausea. Soreness at injection still present at time of this adverse event entry. Other symptoms resolved 24 hours after they began.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm with significant pain. Could not lift arm above shoulder or lay on the arm.  Redness and swelling where I got the shot. Significant tiredness, full body muscle pain, headache, dizziness, low grade fever-like shivering and nausea. Soreness at injection still present at time of this adverse event entry. Other symptoms resolved 24 hours after they began.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fall, Feeling hot, Immediate post-injection reaction, Petit mal epilepsy
Clinical narrative: The patient stated she felt hot as soon as the immunization was administered. She stated she felt weak and hot. About 5 minutes after the shot was given, she slumped over as if she passed out. I checked her pulse. She had a pulse. About 30 seconds after that, she started shaking. The seizure lasted approximately 1 minute. She eventually became alert (about 1 minute after seizing stopped. She began talking and remained seated for about 5 minutes. She then stopped talking and blinking. She was having a different type of seizure (petit mal). Paramedics arrived, but the patient refused treatment. She stated she frequently has seizures.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure, Tremor
Clinical narrative: The patient stated she felt hot as soon as the immunization was administered. She stated she felt weak and hot. About 5 minutes after the shot was given, she slumped over as if she passed out. I checked her pulse. She had a pulse. About 30 seconds after that, she started shaking. The seizure lasted approximately 1 minute. She eventually became alert (about 1 minute after seizing stopped. She began talking and remained seated for about 5 minutes. She then stopped talking and blinking. She was having a different type of seizure (petit mal). Paramedics arrived, but the patient refused treatment. She stated she frequently has seizures.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient presents inflammation and swelling on left arm. She describes painf and hot zone on rednes.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Diarrhoea, Stool analysis normal
Clinical narrative: Dirrhea onset day 2, for several days. Took immodium, some relief, but dirrhea continued whenever off immodium. Continued for 1 month non-stop. * No symptoms after 1st dose just second 5/9/19-6/20/19 symptoms persisted.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: patient had injection site rash 8 hours after was administered PNEUMOVAX 23 on 7/18/2019; This spontaneous report was received from a pharmacist regarding a 72-year-old female patient. The patient's concomitant medication included montelukast, amlodipine and fluticasone propionate (FLONASE) nasal spray. It was reported she did not have any pertinent medical history or drug reactions/allergies.   On 18-JUL-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (dose and route were not provided; lot number and expiration date have been verified as valid: S002582, 10-AUG-2020). Subsequently, 8 hours after the vaccine administration, the patient developed injection site rash. The patient did not receive treatment for the event, no laboratories or studies were performed, and she did not seek medical attention. The rash lasted 3 days and she recovered from it.   The reporter did not provide a causality assessment between the event occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23).
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site rash
Clinical narrative: patient had injection site rash 8 hours after was administered PNEUMOVAX 23 on 7/18/2019; This spontaneous report was received from a pharmacist regarding a 72-year-old female patient. The patient's concomitant medication included montelukast, amlodipine and fluticasone propionate (FLONASE) nasal spray. It was reported she did not have any pertinent medical history or drug reactions/allergies.   On 18-JUL-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (dose and route were not provided; lot number and expiration date have been verified as valid: S002582, 10-AUG-2020). Subsequently, 8 hours after the vaccine administration, the patient developed injection site rash. The patient did not receive treatment for the event, no laboratories or studies were performed, and she did not seek medical attention. The rash lasted 3 days and she recovered from it.   The reporter did not provide a causality assessment between the event occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23).
Age: 57.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Anxiety, Asthenia, Blood glucose increased, Blood pressure increased, Dizziness
Clinical narrative: Patient felt significantly unwell in the days following immunization, saw his provider and was prescribed a Medrol dose pak. He is now waiting on an evaluation with neurology with concern for Guillan Barre syndrome and neuropathy conditions.
Age: 57.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypoaesthesia, Malaise, Nausea, Pain in extremity
Clinical narrative: Patient felt significantly unwell in the days following immunization, saw his provider and was prescribed a Medrol dose pak. He is now waiting on an evaluation with neurology with concern for Guillan Barre syndrome and neuropathy conditions.
Age: 57.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Malaise
Clinical narrative: Patient felt significantly unwell in the days following immunization, saw his provider and was prescribed a Medrol dose pak. He is now waiting on an evaluation with neurology with concern for Guillan Barre syndrome and neuropathy conditions.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Face injury, Fall, Loss of consciousness, Neck pain, Syncope
Clinical narrative: Faint at the doctor's office.  Ambulance to hospital emergency room.  Patient rested in the hospital for 2 hours and doctor checked OK for discharge.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Faint at the doctor's office.  Ambulance to hospital emergency room.  Patient rested in the hospital for 2 hours and doctor checked OK for discharge.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Gait disturbance
Clinical narrative: The afternoon  of 8/9/19 patient  received the first dose of SHINGRIX vaccine.   The following day he experienced significant discomfort in terms extreme lower back pain that had not been responsive to Tylenol and only slightly responsive to Naproxen. Our office first notified on 8/15. Patient was not seen until 8/19 as patient was out of town on a business trip. Seen by Dr. on 8/19 and reported pain is slowly improving.  Patient prescribed short course of Meloxicam and counseled to return if symptoms worsen or fail to improve.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain
Clinical narrative: The afternoon  of 8/9/19 patient  received the first dose of SHINGRIX vaccine.   The following day he experienced significant discomfort in terms extreme lower back pain that had not been responsive to Tylenol and only slightly responsive to Naproxen. Our office first notified on 8/15. Patient was not seen until 8/19 as patient was out of town on a business trip. Seen by Dr. on 8/19 and reported pain is slowly improving.  Patient prescribed short course of Meloxicam and counseled to return if symptoms worsen or fail to improve.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Decreased appetite, Enema administration, Haematochezia, Intussusception
Clinical narrative: Patient presented with bloody stools, abdominal pain, lethargy on afternoon of 8/16/2019.  Per mom patient had been lethargic and didn't want to eat much all day.  Sent to ER for evaluation.  Diagnosed with intussesception, successfully reduced by air-contrast enema on third attempt, patient monitored overnight and discharged home the next day.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Laboratory test, Lethargy
Clinical narrative: Patient presented with bloody stools, abdominal pain, lethargy on afternoon of 8/16/2019.  Per mom patient had been lethargic and didn't want to eat much all day.  Sent to ER for evaluation.  Diagnosed with intussesception, successfully reduced by air-contrast enema on third attempt, patient monitored overnight and discharged home the next day.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; administered the first dose ofGARDASIL 9 (L040054 12/26/2017) on 10/4/2017 and was administered the second dose of GARDASIL 9 (R004689 11/29/2020) on 7/21/2019; Information has been received from a pharmacy intern referring to a 20 years old patient of unknown gender. The patient's concomitant medication, medical history, drug reactions or allergies were not reported.  On 04-OCT-2017, 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) (lot number: L040054, expiration date: 26-DEC-2017; strength and route were not reported) for prophylaxis. On 21-JUL-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number: R004689, expiration date: 29-NOV-2020; strength and route were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects were reported. The outcome of the event was unknown.
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Hepatitis B antibody negative, Measles antibody negative, Viral titre
Clinical narrative: patient had negative titers for Hepatitis B; patient had negative titers for Rubeolla; patient had negative titers for Chicken pox; This spontaneous report was received from a medical assistant referring to a 21 years old non-pregnant female patient. Information about concurrent condition, concomitant medications, drug reactions/allergies or medical history was unknown. On unknown dates in 1997, the patient received two separate doses of unspecified hepatitis B vaccine (manufacturer, dosage detail, route, lot number and expiration date unknown) for prophylaxis, and on an unknown date in 1998, the patient received another dose of unspecified Hepatitis B vaccine (manufacturer, dosage detail, route, lot number and expiration date unknown). On an unknown date in 1998, the patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live(M-M-R II) (dosage detail, route, lot number and expiration date unknown) for prophylaxis reconstituted with sterile diluent (manufacture unknown). On an unknown date in 2001, the patient received varicella virus vaccine live (oka/merck)(VARIVAX) (lot number and expiration date unknown) for prophylaxis reconstituted with  sterile diluent (manufacture unknown). On an unknown date in 2002, the patient received another dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live(M-M-R II) (dosage detail, route, lot number and expiration date unknown) for prophylaxis reconstituted with sterile diluent (manufacture unknown). On an unknown date in 2007, the patient received another dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dosage detail, route, lot number and expiration date unknown) for prophylaxis reconstituted with sterile diluent (manufacture unknown). On 17-JUL-2019, the patient performed a blood test and had MMR, chicken pox and hepatitis B titers drawn, the results showed negative titers for "rubeolla", chicken pox and hepatitis B. The patient sought medical attention from physician. No treatment was given for the events. The outcome of the events was not received at the time of this report. The causality between the events and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck)(VARIVAX), the unspecified hepatitis B vaccine were not provided.
Sex: F
Vaccine: HPV9
Symptoms: Cervical conisation, Cervical dysplasia
Clinical narrative: the patient had developed cervical dysplasia; Information has been received from a physician via a company representative, referring to a female patient of unknown age. Information of concurrent condition, medical history and concomitant therapy was not provided.   On an three different unknown dates, the patient was vaccinated with all three of her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, lot# and expiration date were unknown) for prophylaxis.    On an unknown date, the physician learned from the patient's husband who was also a physician that the patient had developed cervical dysplasia and had to get a conization. The outcome of cervical dysplasia was unknown. The relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: patients were administered improperly stored VARIVAX and PROQUAD; No adverse effects; This spontaneous report was received from a vaccine coordinator referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included sterile diluent..  On unknown dates, the patients were administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) not valid lot #S003127, lot #R030798 (verified to be a valid lot number), expiration date reported and established as 22-APR-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot #R023736 (verified to be a valid lot number), expiration date reported and established as 20-AUG-2020 (conflicting information also reported as "08/20/20200"). Both vaccines were used for prophylaxis, were reconstituted with a steril diluent which did not undergo a temperature excursion and were improperly stored at a temperature between 15°F to 46°F (22.8°F), during a time frame of 17 hours and 48 minutes. There was a previous temperature excursion reported at a temperature between 15°F to 46°F (32.4°F) for 34 hours and 45 minutes. The call was not because of a data logger.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: the patient developed a bulls eye appearance rash that is 3-4 inches in diameter, reddened circle at the injection site and a white circle surrounding the red circle. The rash is painful to the touch.; the patient also developed a fever; This spontaneous report was received from a pharmacist referring to a 53 years old female patient, with no concomitant medication, pertinent medical history or drug reactions/allergies. The patient's concurrent condition was not reported.  On 30-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R029518, expiration date reported as 14-OCT-2000, but upon internal validation established as 14-OCT-2020) (dose and frequency not reported), subcutaneously in the left arm for prophylaxis.  On 01-AUG-2019, the patient developed a bulls eye appearance rash that was 3-4 inches in diameter, reddened circle at the injection site and a white circle surrounding the red circle. The rash was painful to the touch. The patient also developed a fever. She sought medical attention. The pharmacist advised the patient to take acetaminophen (TYLENOL) for fever and to see her physician. No other lab diagnostics/studies were performed. At the reporting time, the outcome of the events were unknown.   The reporter did not provide the causality between the events and varicella virus vaccine live (oka/merck) (VARIVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 72 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 69 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Post herpitic neuralgia; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a 70-year-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.      On 20-MAY-2013, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot number not provided).         On an unknown date, the patient experienced post herpetic neuralgia and was treated by a healthcare provider. The outcome of the events was unknown.  Causality assessment was related.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to an 84-year-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.     On 23-JUL-2013, the patient inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot number not provided).  On an unknown date, the patient experienced herpes zoster and was treated by a doctor. The outcome of the events was unknown.  Causality assessment was related.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a 58-year-old female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.     On 20-OCT-2014, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot number not provided).         On an unknown date, the patient experienced herpes zoster and was treated by a doctor. The outcome of the event was unknown. Causality assessment was related.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a 63-year-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.     On an unspecified date in 2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot number not provided).         On an unknown date, the patient experienced herpes zoster and was treated by a healthcare provider. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: RV5
Symptoms: Combined immunodeficiency, Rotavirus infection, Stem cell transplant
Clinical narrative: This triggered the diagnosis of severe combined immunodeficiency; two cases of infants who were vaccinated with RotaTeq and subsequently developed strain rotavirus (identified by CDC lab); This spontaneous report has been received from a physician referring to two pediatric patients (infants) of unknown age and gender. The patients' concurrent conditions, medical history, concomitant therapies, drug allergies or reactions were not reported.  On unspecified dates, the two patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, lot number and expiration date were not reported) orally for prophylaxis.   Subsequently, the two patients developed vaccine strain rotavirus (identified by centers for disease control and prevention (CDC) lab). This triggered the diagnosis of severe combined immunodeficiency, and these two patients were subsequently treated with stem cell transplants. Post-transplant, the children continued to have rotavirus (detected by routine lab, presumed to be persistent vaccine strain) and received additional experimental treatment in attempt to clear rotavirus. The outcome of the events was unknown. The causality between severe combined immunodeficiency and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported. The reporter considered that rotavirus infection to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  Upon internal review, severe combined immunodeficiency syndrome was determined to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Altered state of consciousness
Clinical narrative: almost passed out; This spontaneous report was received from a Registered Pharmacist via an company representative concerning her two daughters of unknown age. Medical history, drug reactions or allergies and concomitant medication were not reported. On unspecified dates, her daughters were vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis when they were young (route, lot # and expiration date were not reported) and both almost passed out on unspecified dates. They were seen by physician for seeking medical attention. The patients recovered from the adverse event. The causality between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported. Product Quality Complaint (PQC) was not present.
Age: 1.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No adverse effects were reported; during administration the patient jerked her leg and some of the vaccine came out of the needle causing the patient to not get the full dose of MMR II and some of the vaccine to get on the patient's leg; during administration the patient jerked her leg and some of the vaccine came out of the needle causing the patient to not get the full dose of MMR II and some of the vaccine to get on the patient's leg; This spontaneous report was received from a nurse referring to a 12 months and 1 week old female patient. Information about medical history, concurrent conditions and concomitant therapies were not provided.   On 07-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (lot # R030809 and expiration date 24-OCT-2020), which was reconstituted with sterile diluent, subcutaneously for routine vaccination. However, during administration, the patient jerked her leg and some of the vaccine came out of the needle causing the patient to not get the full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) and some of the vaccine to get on the patient's leg (incorrect dose administered and exposure via skin contact). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report has been received from a pharmacist via company employee referring to unspecified female patients of unknown age. The patients' concurrent conditions, medical history, concomitant therapies, drug allergies or reactions were not reported.  On unspecified dates, the patients were vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route, lot number and expiration date were not reported) for prophylaxis and patients experienced fainted. No further information provided. It was unknow if there was treatment given for the adverse event (AE). It was unknow if there were lab diagnostics or studies performed. The outcome of the event was unknown. The causality between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, fainted was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received an improperly stored GARDASIL 9 on an unspecified date in June 2018, received a properly stored GARDASIL on 7/10/2019; received an improperly stored GARDASIL 9; This spontaneous report was received from a nurse referring to a 15 years old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On an unspecified date in June 2018, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, lot# and expiration date were unknown) for prophylaxis. On 10-JUN-2019 the patient received a properly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, lot# and expiration date were unknown). Information about temperature, time frame and previous temperature excursion were unknown. The data logger was involved.   The nurse did not have the detailed information about how the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) administered in 2018 was improperly stored as it was part of "about 300 vaccine doses" that were improperly stored and administered. She could not confirm what vaccines were involved besides hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the excursion in 2018. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant, concerning to a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.   On 09-AUG-2019, the patient was vaccinated with a improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHa) (PROQUAD) one dosage form, for prophylaxis (strength, anatomical site of injection and route of administration were not reported) Lot. No S006828 with expiration date on 02-SEP-2019. No adverse effects reported.   It was reported that the vaccines experienced a temperature of -9 degrees Celsius to 8 degrees Celsius (4.0 degrees Celsius) for 99 hours and 20 minutes. There was not previous temperature excursion. The temperature was recorded by a data logger.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: titer tests done on unspecified dates still show her daughter to have "no immunity."; This spontaneous report was received from a pharmacist via company representative referring to a female patient of an unknown age, who was the pharmacist's daughter. The patient's concurrent conditions and concomitant therapies were not provided. The patient's medical history included unspecified "surgery".     On an unspecified date, the patient had three vaccinations with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, frequency, route, lot# and expiration date were not provided) for prophylaxis.        On an unknown date, titer tests were performed, and the patient still showed to have "no immunity" (antibody test negative). No treatment was prescribed for the event. At the time of the report, the outcome of the event was not reported.    The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: experienced a ''hot, red rash with soreness and swelling" at injection site following administration of PNEUMOVAX 23; experienced a ''hot, red rash with soreness and swelling" at injection site following administration of PNEUMOVAX 23; experienced a ''hot, red rash with soreness and swelling" at injection site following administration of PNEUMOVAX 23; experienced a ''hot, red rash with soreness and swelling" at injection site following administration of PNEUMOVAX 23; This spontaneous report was received from an office manager referring to 71 year-old female patient with no known allergies. The patient's concurrent conditions included hypertension. The patient's medical history was not provided.      On 09-AUG-2019, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) per intramuscular route (unspecified dose), lot# R025296 expiration date 08-JUN-2020 for prevention of pneumococcal disease. Concomitant therapies included loratadine (CLARITIN), hydrochlorothiazide and losartan. On the same date, the patient experienced a "hot (injection site warmth), red rash (injection site rash) with soreness (injection site pain) and swelling (injection site swelling)" at injection site following administration of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). No laboratories were performed.        The outcome of injection site pain, injection site swelling, injection site rash and injection site warmth was reported as not recovered/not resolved.  The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: the patient was administered the 2nd dose of PROQUAD; developed a 100.7 fever/ fever for approximately 4 hours; This spontaneous report was received from a consumer referring to her granddaughter as a 3 years 9 months old female patient. Information about medical history and current conditions was not provided. Information about concomitant medications was unknown.   On an unknown date, the patent was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route, lot # and expiration date were not reported). On 05-AUG-2019, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, lot # and expiration date were not reported, route reported as injection) for prophylaxis (inappropriate schedule of vaccine administered). On an unspecified date in August 2019 (reported as over the past weekend), the patient had the fever for approximately 4 hours and recovered on the same day. Her temperature was 100.7 (unit unknown). The patient didn't seek medical attention or have any laboratory rests. It was unknown if treatment was given for the event. Causality assessment was not provided.