chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral motor neuropathy, Peripheral sensory neuropathy
Clinical narrative: diffuse sensory and motor polyneuropathy; diffuse sensory and motor polyneuropathy; Information has been received from a lawyer, regarding a case in litigation, referring to a female patient (pt) of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.   On or about 05-FEB-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, anatomical location, strength, dose, lot # and expiration date 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 diffuse sensory and motor polyneuropathy (peripheral sensory neuropathy and peripheral motor neuropathy). As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) vaccine, symptoms have resulted in severe, serious, progressive, incurable and permanent personal injuries/ physical limitations not present prior to vaccination. The pt also experienced mental and emotional distress, significant conscious pain and suffering, loss of enjoyment of life, physical impairment and injury due to resulting physical limitations and seriousness of her condition.  At the reporting time, the outcome of the events was considered as not recovered. The lawyer considered the events to be related to Zoster Vaccine Live (ZOSTAVAX). The pt's experiences were considered to be disabling, due to permanent and incurable personal injuries.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: SWELLING IN ARM THE SIZE OF GRAPEFRUIT, EXTREME SORENESS
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Malaise
Clinical narrative: TDAP vaccine (unknown which brand). Feeling very ill - nausea, headache, no appetite, weak, soreness, chills. No fever. x1 week
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain
Clinical narrative: TDAP vaccine (unknown which brand). Feeling very ill - nausea, headache, no appetite, weak, soreness, chills. No fever. x1 week
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Dizziness, Feeling abnormal, Paraesthesia
Clinical narrative: PATIENT RECEIVED HER FLUZONE HD LOT # UJ285AA EXP 6/2/20.  AFTER 10 DAYS SHE GOT TINGLING IN FEET, DIZZY.  WENT TO URGENT CARE THOUGHT SHE HURT BACK.  GOT MUSCLE RELAXANT.  NEXT DAY FELT TERRIBLE WENT TO HOSPITAL AND WAS HOSPITALIZED FOR THREE WEEKS! Then she was sent to a rehab for 3 more weeks after that. Came back to town and came to see me and was told I needed to fill out a form. Don't know if hospital DID ANYTHING.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Neck pain, Swelling
Clinical narrative: pt stated swelling and redness. pain around the neck. no itching. md on call gave doxycycline on 12/20 thinking it was an infection.  pcp on 12/23 diagnosed a case of shingles
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, RV5, UNK
Symptoms: Autism spectrum disorder, CSF pressure increased, Computerised tomogram, Coordination abnormal, Fontanelle bulging
Clinical narrative: Bulging fontanelle within 14 hours of dose, infantile spasms, hospitalization for 4 days, subdural hygromas discovered. Baby quit hitting developmental milestones, developed hypertone with right sided weakness, underwent surgery at 7 months for a ventricular peritoneal shunt to relieve pressure from fluid. Currently still behind in gross motor skills, multiple therapies weekly to help with muscle tone and coordination, possible cp diagnosis in future.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, RV5, UNK
Symptoms: Full blood count, Gross motor delay, Hemiparesis, Hypertonia, Infantile spasms
Clinical narrative: Bulging fontanelle within 14 hours of dose, infantile spasms, hospitalization for 4 days, subdural hygromas discovered. Baby quit hitting developmental milestones, developed hypertone with right sided weakness, underwent surgery at 7 months for a ventricular peritoneal shunt to relieve pressure from fluid. Currently still behind in gross motor skills, multiple therapies weekly to help with muscle tone and coordination, possible cp diagnosis in future.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, RV5, UNK
Symptoms: Magnetic resonance imaging, Subdural hygroma, Surgery, Ventriculo-peritoneal shunt, X-ray
Clinical narrative: Bulging fontanelle within 14 hours of dose, infantile spasms, hospitalization for 4 days, subdural hygromas discovered. Baby quit hitting developmental milestones, developed hypertone with right sided weakness, underwent surgery at 7 months for a ventricular peritoneal shunt to relieve pressure from fluid. Currently still behind in gross motor skills, multiple therapies weekly to help with muscle tone and coordination, possible cp diagnosis in future.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Peripheral swelling, Rash
Clinical narrative: Immediately after vaccination Pt broke out in rash/Hives and started having numbness/tingling/swelling in fingers; gave pt Adult dose of Benadryl 50 mg called her PCP/Dr. & to continue Benadryl every 4-6 Hrs. No Anaphylaxis rxn's so no need for Epi-pen. Consulted pt go to urgent care/seek medical Attn  12/22/2019: Pt still taking adult benadryl 50 mg every 4-6 hours swelling in fingers has gone down. Did not seek medical attention as benadryl has been helping.   12/23/19: Symptoms resolved & pAtient is Feeling better.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Immediately after vaccination Pt broke out in rash/Hives and started having numbness/tingling/swelling in fingers; gave pt Adult dose of Benadryl 50 mg called her PCP/Dr. & to continue Benadryl every 4-6 Hrs. No Anaphylaxis rxn's so no need for Epi-pen. Consulted pt go to urgent care/seek medical Attn  12/22/2019: Pt still taking adult benadryl 50 mg every 4-6 hours swelling in fingers has gone down. Did not seek medical attention as benadryl has been helping.   12/23/19: Symptoms resolved & pAtient is Feeling better.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: Patient called 12/19/2019 reporting pain in her joints and general achiness throughout her body. Said it began in the evening of day she received vaccine. She said she was not running a fever. Informed her this was a possible reaction to this vaccine and should get better within 2 to 3 days. Called patient 12/21/19 to follow up and she said symptoms have gone away. Did not have reaction with first dose.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Fall
Clinical narrative: Patient Felt dizzy after leaving Pharmacy. He fell in the Aisle but did not hit his head. We had him Lay There for 5 minutes and Then he sat in a chair for 15 minutes and Then he requested to Leave
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Bursitis
Clinical narrative: Injected very high on left shoulder, Pressure upon injection, severe pain night of injection and achiness the day after injection. Extreme pain for a week and went to Acute Care. Diagnosed with Bursitis due to injection given into bursa. Ultrasound confirmed diagnosis. Cortisone shot given. Pain and limited mobility/loss of strength still occurring.   PRIMARY Care visit last week and awaiting MRI REFERRAL
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Asthenia, Bursal fluid accumulation, Bursitis, Inflammation, Injected limb mobility decreased
Clinical narrative: Injected very high on left shoulder, Pressure upon injection, severe pain night of injection and achiness the day after injection. Extreme pain for a week and went to Acute Care. Diagnosed with Bursitis due to injection given into bursa. Ultrasound confirmed diagnosis. Cortisone shot given. Pain and limited mobility/loss of strength still occurring.   PRIMARY Care visit last week and awaiting MRI REFERRAL
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site discomfort, Pain, Product administered at inappropriate site, Ultrasound scan abnormal
Clinical narrative: Injected very high on left shoulder, Pressure upon injection, severe pain night of injection and achiness the day after injection. Extreme pain for a week and went to Acute Care. Diagnosed with Bursitis due to injection given into bursa. Ultrasound confirmed diagnosis. Cortisone shot given. Pain and limited mobility/loss of strength still occurring.   PRIMARY Care visit last week and awaiting MRI REFERRAL
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site swelling
Clinical narrative: 3 inch raised red area at site of vaccine, itchy and hard
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Emotional distress, Lethargy, Pain, Pyrexia
Clinical narrative: Fever, lethargic, pain  Started day of. Hard to console unless nursing. Once asleep sleeps long stretches
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Blood test normal, Chills, Confusional state, Decreased appetite
Clinical narrative: Headaches nauseau decreased appeitite  muscle aches chills sweats dizziness confusion  body aches muscle and joint pain vertigo had to go to physical therapy to fix vertigo issue  eyes had to be readjusted  took about 3 months have continued to have terrible headaches have been to several neurologist and placed on several meds  and I am now on several new meds and have had  several injections  and occipital nerve block still having the headaches continue to have severe muscle and joint pain was diagnosed with fibromyalgia  I have went to chiropractor and physical therapy which did not help much.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fibromyalgia, Headache, Hyperhidrosis, Magnetic resonance imaging normal
Clinical narrative: Headaches nauseau decreased appeitite  muscle aches chills sweats dizziness confusion  body aches muscle and joint pain vertigo had to go to physical therapy to fix vertigo issue  eyes had to be readjusted  took about 3 months have continued to have terrible headaches have been to several neurologist and placed on several meds  and I am now on several new meds and have had  several injections  and occipital nerve block still having the headaches continue to have severe muscle and joint pain was diagnosed with fibromyalgia  I have went to chiropractor and physical therapy which did not help much.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Nerve block, Pain, Vertigo
Clinical narrative: Headaches nauseau decreased appeitite  muscle aches chills sweats dizziness confusion  body aches muscle and joint pain vertigo had to go to physical therapy to fix vertigo issue  eyes had to be readjusted  took about 3 months have continued to have terrible headaches have been to several neurologist and placed on several meds  and I am now on several new meds and have had  several injections  and occipital nerve block still having the headaches continue to have severe muscle and joint pain was diagnosed with fibromyalgia  I have went to chiropractor and physical therapy which did not help much.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray normal
Clinical narrative: Headaches nauseau decreased appeitite  muscle aches chills sweats dizziness confusion  body aches muscle and joint pain vertigo had to go to physical therapy to fix vertigo issue  eyes had to be readjusted  took about 3 months have continued to have terrible headaches have been to several neurologist and placed on several meds  and I am now on several new meds and have had  several injections  and occipital nerve block still having the headaches continue to have severe muscle and joint pain was diagnosed with fibromyalgia  I have went to chiropractor and physical therapy which did not help much.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: The patient experienced redness, itchiness, and heat along the length of her arm. The reaction began four days after the vaccine was administered.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Eye pain, Fatigue, Headache, Neck pain
Clinical narrative: He was unusually tired the week prior to the more serious symptoms.  He also reported being anxious and restless.  On 9/21 he had a fever of 100, pain in his neck and the dorsum of his left hand.  9/22:  fever of 100.8, frontal headache, severe pain behind both eyes.  9/22 eve:  fever of 103.  Consulted a homeopath, gave pulsatilla 200C every 3 hours.  9/23 fever 100.  9/24: fever normal but still tired.   The severe eye pain was pretty scary.  I can't imagine a nonverbal baby going through that.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity, Pyrexia, Restlessness
Clinical narrative: He was unusually tired the week prior to the more serious symptoms.  He also reported being anxious and restless.  On 9/21 he had a fever of 100, pain in his neck and the dorsum of his left hand.  9/22:  fever of 100.8, frontal headache, severe pain behind both eyes.  9/22 eve:  fever of 103.  Consulted a homeopath, gave pulsatilla 200C every 3 hours.  9/23 fever 100.  9/24: fever normal but still tired.   The severe eye pain was pretty scary.  I can't imagine a nonverbal baby going through that.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Nausea, Vomiting
Clinical narrative: Profuse joint pain, nausea, vomiting and diarrhea began 36 hours after administration
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: On or about November 27, 2019, I noticed facial pain. By November 29, 2019, shingles rash began developing in the right side of the face, from the right corner of the lip through right nostril, right eye lids, top of the nose between eyebrows, right eyebrow, and continuing to the upper scalp. By Monday December 2, 2019, I had a full-blown case of shingles.  I was prescribed Acyclovir 800 mg/5 per day for fifteen days.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: -shoulder pain - describes as "achy", reports 8 on a pain scale of 1-10 -using capsaison to help treat it -only present after receiving flu shot
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Musculoskeletal pain
Clinical narrative: -shoulder pain - describes as "achy", reports 8 on a pain scale of 1-10 -using capsaison to help treat it -only present after receiving flu shot
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Feeling abnormal, Feeling of body temperature change, Pyrexia
Clinical narrative: Chills; felt I was on fire; I went from burning up to freezing; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (received 1st dose on an unknown date and experienced horrible, refer case US2019AMR231292).   On 10th December 2019, the patient received the 2nd dose of Shingrix .5 ml. On 10th December 2019, 12 hrs after receiving Shingrix, the patient experienced chills, feeling hot, feeling hot and cold and fever. On an unknown date, the outcome of the chills, feeling hot, feeling hot and cold and fever were unknown.   It was unknown if the reporter considered the chills, feeling hot, feeling hot and cold and fever to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination started to get the chills. The patient went to bed and literally felt was on fire all night. The patient went from burning up to freezing and had fever.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Feeling of body temperature change, Pyrexia
Clinical narrative: Chills; felt I was on fire; I went from burning up to freezing; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (received 1st dose on an unknown date and experienced horrible, refer case US2019AMR231292).   On 10th December 2019, the patient received the 2nd dose of Shingrix .5 ml. On 10th December 2019, 12 hrs after receiving Shingrix, the patient experienced chills, feeling hot, feeling hot and cold and fever. On an unknown date, the outcome of the chills, feeling hot, feeling hot and cold and fever were unknown.   It was unknown if the reporter considered the chills, feeling hot, feeling hot and cold and fever to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination started to get the chills. The patient went to bed and literally felt was on fire all night. The patient went from burning up to freezing and had fever.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Feeling cold, Pyrexia
Clinical narrative: Chills; felt I was on fire; I went from burning up to freezing; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (received 1st dose on an unknown date and experienced horrible, refer case US2019AMR231292).   On 10th December 2019, the patient received the 2nd dose of Shingrix .5 ml. On 10th December 2019, 12 hrs after receiving Shingrix, the patient experienced chills, feeling hot, feeling hot and cold and fever. On an unknown date, the outcome of the chills, feeling hot, feeling hot and cold and fever were unknown.   It was unknown if the reporter considered the chills, feeling hot, feeling hot and cold and fever to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination started to get the chills. The patient went to bed and literally felt was on fire all night. The patient went from burning up to freezing and had fever.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Chills, Influenza like illness, Lymphadenopathy, Migraine
Clinical narrative: Severe migraine, swelling of lymph nodes, rash over arms that were size of a quarter with a pimple looking white center, stomach flu-like symptoms, chills, aches over body, sore arm of injection within five hours of shot. Symptoms progressively worsened and lasted 30 hours. Horrible symptoms and feeling! This only happened with second dose. First dose was just a very sore arm for several days. The first shot I also had a flu shot. I am not sure which one.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: Severe migraine, swelling of lymph nodes, rash over arms that were size of a quarter with a pimple looking white center, stomach flu-like symptoms, chills, aches over body, sore arm of injection within five hours of shot. Symptoms progressively worsened and lasted 30 hours. Horrible symptoms and feeling! This only happened with second dose. First dose was just a very sore arm for several days. The first shot I also had a flu shot. I am not sure which one.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Arthralgia, Chills, Decreased appetite, Gastritis
Clinical narrative: day of shot 5pm chills sweats, went to bed. 2nd day did nothing chills sweats . 3rd day did not feel to do anything.5th day still did nothing sore muscles and joints,weak. After another week I did not feel like eating stomach was upset, loss 6-8  pounds . Went to doctor who gave shot he said my stomach was inflamed. Told me to take omeprazole 40mg . seemed to fix stomach. Finally back to normal.  In past years before 2019 I always get flu symptoms the day of the shot but next day ok never this bad like 2019. I feel I should not get the high dose.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Influenza, Myalgia, Weight decreased
Clinical narrative: day of shot 5pm chills sweats, went to bed. 2nd day did nothing chills sweats . 3rd day did not feel to do anything.5th day still did nothing sore muscles and joints,weak. After another week I did not feel like eating stomach was upset, loss 6-8  pounds . Went to doctor who gave shot he said my stomach was inflamed. Told me to take omeprazole 40mg . seemed to fix stomach. Finally back to normal.  In past years before 2019 I always get flu symptoms the day of the shot but next day ok never this bad like 2019. I feel I should not get the high dose.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: The patient was seen at an unspecified urgent care center and treated for cellulitis; This spontaneous report was received from a physician assistant, referring to a female patient in her fifties to sixties. The patient's concurrent conditions included breast cancer in remission; her previous drug reactions or allergies, and concomitant medications were unknown by reporter.  On an unspecified date in 2019 reported as "prior to December 2019", the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (dose number was not reported; route of administration, lot number and expiration date were unknown by the reporter) as prophylaxis.  On an unspecified date in 2019 (reported as "late November or early December 2019"), the patient sought medical attention and was seen at an unspecified Urgent Care Center and was treated for cellulitis with antibiotics (unspecified). It was unknown by the reporter if laboratory diagnostics or studies were performed.  The outcome of cellulitis was unknown by the reporter.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the cellulitis was not reported.  Upon internal review, cellulitis was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; a toddler patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a 12-month-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 19-DEC-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection (dose number, route of administration and anatomical location were not reported; lot number S021924 has been verified to be valid, expiration date reported and validated as 15-JUL-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. No adverse effect reported.  The temperature/time frame registered with data logger was of 15 degrees fahrenheit to 46 degrees fahrenheit, 24.3 degrees fahrenheit, multiple, and there was no previous temperature excursions.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Injury associated with device
Clinical narrative: Accidental needle stick after drawing up adjuvant liquid and having a small hole on unspecified finger; Accidental exposure to vaccine; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of needle stick/puncture in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced needle stick/puncture, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the needle stick/puncture, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the needle stick/puncture to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported accidental needle stick after drawing up adjuvant liquid and having a small hole on unspecified finger, which led to needle stick/puncture, inadvertent exposure to vaccine and exposure via skin contact.  The reporter consented to follow up. The pharmacist was reporter and preparer of vaccine.   Follow up information received from pharmacist on 9th December 2019: No adverse event was reported.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphocyte count decreased, Platelet count decreased
Clinical narrative: Values of the platelates were lower than normal; Values of the lymphocytes were lower than normal; This case was reported by a pharmacist via call center representative and described the occurrence of platelets decreased in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 2nd dose of Shingrix. On 30th November 2019, 1 days after receiving Shingrix, the patient experienced platelets decreased and lymphocyte count decreased. On an unknown date, the outcome of the platelets decreased and lymphocyte count decreased were unknown.   It was unknown if the reporter considered the platelets decreased and lymphocyte count decreased to be related to Shingrix.  Additional details were provided as follows: The patient took the blood test and 2 days later got the result and noticed that the values of the platelets and lymphocytes were lower than normal. The reporter needed to know if the vaccine can cause that effect. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: rashy  presented on the arm; red area presented on the arm; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 5th September 2019, the patient received the 1st dose of Shingrix .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced rash and erythema. On an unknown date, the outcome of the rash and erythema were not recovered/not resolved.   It was unknown if the reporter considered the rash and erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in the left arm. The patient received Shingrix and had rash, red area presented on the arm 2-3 inches below the injection site. It presented 24-48 hours after the injection. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Acne, Erythema, Pruritus, Rash macular
Clinical narrative: red blotches on shoulders, face, chest, neck; like a pimple; red, itchy neck; itchy neck; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 10th December 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 17th December 2019, 7 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced erythema and pruritus. On 18th December 2019, the patient experienced red blotches and pimple. On an unknown date, the outcome of the erythema, pruritus, red blotches and pimple were not recovered/not resolved.   It was unknown if the reporter considered the erythema, pruritus, red blotches and pimple to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received Shingrix and a preservative free, quadrivalent flu vaccine from an unknown manufacturer and had a red, itchy neck. The patient had red blotches, like a pimple, on his shoulders, chest, neck and face.  The reporter did not consent to follow up. The reporter did not had any other information for the vaccines in this adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: redness on chest; This case was reported by a physician via call center representative and described the occurrence of localized erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown.   The reporter considered the localized erythema to be unrelated to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but age group was captured as per product indication. The patient received 1st dose of Shingrix and experienced redness on her chest. The reporter did not consent to follow up. The physician was not convinced that this was related to Shingrix as the patient has a history of eczema and did not wish to report this as an adverse event. The reporter submitted limited information as did not wish to report the event and disconnected the call. This case was linked with US2019AMR232984, reported for same patient by same reporter.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Arterial catheterisation normal, Chest discomfort, Chills, Hyperhidrosis, Positron emission tomogram normal
Clinical narrative: Work up sweating, chilled and heavy pressure in the chest.  Initially was concerned I was having a heart event but pulse and blood pressure was normal.  After several hours the symptoms subsided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Incorrect route of product administration, Injection site erythema
Clinical narrative: She developed a fever the next day of 102.0 F. She had headaches, back pain, neck pain, and chills. Left arm was swollen and tender at injection site. When she presented to me three days after receiving injection her symptoms were improving. She was noted to have erythema, warmth, and tenderness at er left posterior arm. It appears that the injection was given mistakenly subcutaneous versus the intended intramuscular route.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Neck pain, Pyrexia
Clinical narrative: She developed a fever the next day of 102.0 F. She had headaches, back pain, neck pain, and chills. Left arm was swollen and tender at injection site. When she presented to me three days after receiving injection her symptoms were improving. She was noted to have erythema, warmth, and tenderness at er left posterior arm. It appears that the injection was given mistakenly subcutaneous versus the intended intramuscular route.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: No additional adverse events; reconstituted with expired DILUENT MRK; reconstituted with expired DILUENT MRK; This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 04-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S018593 has been verified to be a valid lot number, expiration date was reported and upon internal validation established as 17-JUN-2021) for prophylaxis, reconstituted with expired sterile diluent(MERCK STERILE DILUENT) (Lot # M009800 and expiry date : 12-SEP-2018) (product preparation error and expired product administered). There was no additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect.; the patient was inadvertently administered a dose of VARIVAX on 12/3/2019 that had been improperly stored; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 03-DEC-2019, the patient was inadvertently vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S005084, expiration date: 19-FEB-2021; frequency, route and dose details were unknown) for prophylaxis (product storage error). The sterile diluent used for reconstitution was properly stored.  The vaccine was stored at 9.3 degrees Fahrenheit for 1 hour. There were no previous temperature excursions. The digital data logger was involved. No additional adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms.; a patient was administered an improperly stored dose of VARIVAX on 12/12/2019; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.    On 12-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: R030611, expiration date: 23-OCT-2020; strength, frequency and dose details were unknown) subcutaneously for prophylaxis (product storage error). The sterile diluent used for administration was properly stored.  The vaccine was stored at -13.3 degrees Celsius for 29 minutes. There were no previous temperature excursions. The digital data logger was involved. The patient experienced no symptoms.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional symptoms reported; expired  "adult dose " of VAQTA was administered to an 15 year old patient; expired  "adult dose " of VAQTA was administered to an 15 year old patient; expired  "adult dose " of VAQTA was administered to an 15 year old patient; This spontaneous report was received from a medical assistant refers to a 15-year-old patient of unknown gender. The patient's pertinent medical history, concurrent condition, concomitant therapies and drug reactions/allergies were not reported. On 20-NOV-2019, the patient was vaccinated with an expired dose (also reported as " expired adult dose") of hepatitis a vaccine, inactivated (VAQTA) with lot # R025518 has been verified to be a valid lot number for (hepatitis a vaccine, inactivated), expiry date reported as 15-NOV-2019 (strength, dose and route were not reported) for prophylaxis (incorrect dose administered, product administered to patient of inappropriate age and expired product administered). No additional symptoms (adverse event) was reported. The reporter stated that the product was stored properly. No product quality complaint was reported. The outcome of incorrect dose administered, no adverse event, product administered to patient of inappropriate age and expired product administered was unknown.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Inadvertenly admistered a dose of proquad and a dose of varivax on 23-DEC-2019; This spontaneous report was received from a nurse prescriber referring to a 5-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies were not reported. The concomitant therapies included sterile diluent. On 23-DEC-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route, lot # and expiry date were not reported for both the vaccines) for prophylaxis (inappropriate schedule of product administration). There was no product confusion and no adverse symptoms reported (no adverse event).
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; one patient received improperly stored VARIVAX and VAQTA; This spontaneous report was received from a nurse referring to a 12 month old female patient. The patient's pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. Concomitant therapies included sterile diluent. On 23-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot R035221 and expiry date 04-DEC-2019 and hepatitis a vaccine, inactivated (VAQTA) lot number S023499 and expiry date 24-AUG-2020 (product storage error) (strength, dose, route and anatomical locations were not reported) for prophylaxis. The temperature excursion details of varicella virus vaccine live (oka/merck) (VARIVAX) include temperature of (-9 degree Celsius to -8 degree Celsius) -7.8 Celsius with a time frame of 1 hour and 37 minutes. The previous temperature excursion include temperature of (-9 degree Celsius to -8 degree Celsius) -8.6 Celsius with a time frame of 1 hour. The temperature excursion details of hepatitis a vaccine, inactivated (VAQTA) include temperature of (above 9 degree Celsius) 9.7 Celsius with a time frame of 2 hours and 18 minutes. There was no previous temperature excursion. The call was because of a data logger. The diluent used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. No adverse events were reported. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms; Improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions/allergies were not reported. On 20-DEC-2019, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) of one dose (strength, route of administration and anatomical location were unknown) with lot # S005251 and expiration date 20-FEB-2021 for prophylaxis. The patient did not experience any symptoms. The vaccine underwent a temperature excursion of 47 degree Fahrenheit or 9 degree Celsius (55.44 degree Fahrenheit) for a time frame of 5 hours. There was no previous temperature excursion. Digital data logger was involved. There was no product quality complaint associated with the case.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect; administered 2 doses of M-M-R II on the same day; This spontaneous report was received from a nurse referring to a patient of approximately 12 months old. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 23-DEC-2019, the patient was inadvertently vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration and anatomical location were unknown) with lot # R031680 and expiration date 01-NOV-2020 and lot # S005248 and expiration date 20-FEB-2021 for prophylaxis (extra dose administered). No adverse symptoms were reported. The reporter stated that the additional dose was administered due to user error and no product quality complaints or errors in labeling or packaging, there was no product confusion. There was no product quality complaint associated with the case.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; longer than recommended interval; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date in July 2019, the patient was vaccinated with first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration and anatomical location were unknown) with lot # 1621931 and expiration date 26-JAN-2019 for prophylaxis. On 23-DEC-2019 (also reported as longer than reported interval), patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration and anatomical location were unknown)  for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported. There was no product quality complaint associated with the case.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: red oval shaped area near injection site; Warm oval shaped area near area of injection; puffy/oval shaped area near injection site; This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced localized erythema, localized feeling of warmth and tissue puffing. On an unknown date, the outcome of the localized erythema, localized feeling of warmth and tissue puffing were unknown.   It was unknown if the reporter considered the localized erythema, localized feeling of warmth and tissue puffing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 57 or 58 years. The  patient experienced red,warm, puffy, oval shaped area near area of injection. The patient reported this information on the reporting date as they were getting their 2nd dose on the reporting date
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt "horrible"; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient felt horrible after vaccination. The patient did not had fever after vaccination with 1st shot. This case has been linked to US2019AMR231241, reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: shivering; This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 22nd October 2019, the patient received Shingrix (intramuscular). On 22nd October 2019, less than a day after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine and experienced  shivering just on same night of vaccination. The reporter stated that the patient might had shivering felt like a seizure.  The patient did not had seizure.
Age: 61.0
Sex: M
Vaccine: RAB, UNK
Symptoms: Paraesthesia
Clinical narrative: tingling in his left fingers and hand; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 61-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Tetanus NVS (Tetanus vaccine) for prophylaxis and amoxicillin sodium, potassium clavulanate (Augmentin) unknown for drug use for unknown indication.   Concurrent medical conditions included animal bite.   On 20th November 2019, the patient received the 1st dose of RabAvert. On 18th November 2019, the patient received Tetanus vaccine. On an unknown date, the patient started Augmentin at an unknown dose and frequency. On 20th November 2019, less than an hour after receiving RabAvert, 2 days after receiving Tetanus vaccine and an unknown time after starting Augmentin, the patient experienced tingling. On 22nd November 2019, the outcome of the tingling was recovered/resolved.   It was unknown if the reporter considered the tingling to be related to RabAvert, Tetanus vaccine and Augmentin.  Additional details were provided as follows: The patient sustained a squirrel bit and was seen at the emergency room and received a Tetanus shot (unspecified) and antibiotic Augmentin for ten days. Within few minutes after Rabavert vaccination, started to experienced tingling in his left fingers and hand. The patient continued to experience the tingling till 22nd November 2019. He did not have any tingling on 23rd November 2019 and 24th November 2019. Based on the patient's adverse event, the healthcare provider has decided to not administer the other remaining doses. The patient has not provided his address and also healthcare information was not provided. The reporter denied consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Potential Wrong Route of Administration; Circumscribed red area around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lipoma.   On 12th December 2019, the patient received the 1st dose of Shingrix. On 12th December 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In December 2019, the patient experienced injection site erythema. On an unknown date, the outcome of the intramuscular formulation administered by other route and injection site erythema were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself. The patient received a dose of Shingrix in left arm where he has a superficial lipoma. The patient thought that the dose was administered into the lipoma instead of the muscular tissue, which led to intramuscular formulation administered by other route.  He noted there was a circumscribed area around the site which was red, but he did not feel the injection at all.  The reporter consented to follow up.  No further details were provided at the time of the call.