chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Shoulder is very sore with limited range of motion.  The shot was given high just below the bone.  felt the pain immediately.
Age: 52.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Product administered at inappropriate site
Clinical narrative: Shoulder is very sore with limited range of motion.  The shot was given high just below the bone.  felt the pain immediately.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Eye pain, Vaccine positive rechallenge
Clinical narrative: Terrible pain behind eye; Blister in Crotch area; This case was reported by a pharmacist via call center representative and described the occurrence of eye pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blister (For tolerance to 1st dose refer linked case US2019AMR235028).   In December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced eye pain and blister. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the eye pain and blister were unknown.   It was unknown if the reporter considered the eye pain and blister to be related to Shingrix.  Additional details were received as follows: The patient experienced even more pain and blister in crotch area.  The patient had terrible pain behind eye. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Nausea, Pruritus, Vomiting
Clinical narrative: flu-like symptoms; nausea; vomiting; itchy all over her body; dizziness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019, the patient received the 1st dose of Shingrix. On 21st December 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, vomiting, generalized pruritus and dizziness. On an unknown date, the outcome of the influenza-like symptoms, nausea, vomiting, generalized pruritus and dizziness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, nausea, vomiting, generalized pruritus and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on December 20th, 2019 at the doctor's office.  On 21st December 2019 Saturday, in morning she woke up with flu like symptoms, nausea, vomiting, itchy all over her body, dizziness.  The patient did not have a fever.  On 22nd December 2019, Sunday she felt better but not completely recovered.  The symptoms were gone at the time of reporting. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Bone pain, Fatigue, Headache, Influenza like illness
Clinical narrative: headache; aching; fatigue; low grade fever; felt like the flu; aching in her joints; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   Previously administered products included Zostavax. Concurrent medical conditions included methylenetetrahydrofolate reductase gene mutation (had methylenetetrahydrofolate reductase mutation, not able to break down folic acid or folate).   In October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). In October 2019, 3 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain were recovered/resolved.   Additional details were provided as follows: The patient received dose of shingrix in an unknown arm and flu vaccine(manufacturer unknown) in an unknown opposite arm at the same time. Approximately 3 to 4 hours after receiving the vaccines, the patient had eadache, aching in her bones and joints, low grade fever, fatigue and felt like had the flu. The patient received high dose of Advil as a treatment medication and stayed in bed. The reporter stated that, the symptoms were lasted for 2 to 3 days. The reporter consented to follow up.  It was unknown if the reporter considered the headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia
Clinical narrative: headache; aching; fatigue; low grade fever; felt like the flu; aching in her joints; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   Previously administered products included Zostavax. Concurrent medical conditions included methylenetetrahydrofolate reductase gene mutation (had methylenetetrahydrofolate reductase mutation, not able to break down folic acid or folate).   In October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). In October 2019, 3 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain were recovered/resolved.   Additional details were provided as follows: The patient received dose of shingrix in an unknown arm and flu vaccine(manufacturer unknown) in an unknown opposite arm at the same time. Approximately 3 to 4 hours after receiving the vaccines, the patient had eadache, aching in her bones and joints, low grade fever, fatigue and felt like had the flu. The patient received high dose of Advil as a treatment medication and stayed in bed. The reporter stated that, the symptoms were lasted for 2 to 3 days. The reporter consented to follow up.  It was unknown if the reporter considered the headache, bone pain, fatigue, low grade fever, influenza like illness and joint pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Electroencephalogram abnormal, Epilepsy, Migraine with aura, Ophthalmological examination abnormal, Seizure
Clinical narrative: Seizures and ocular migraines
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Extreme muscle aches, severe headache, fever (101.5), nausea, dizziness, fatigue
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Extreme muscle aches, severe headache, fever (101.5), nausea, dizziness, fatigue
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events reported or indicated
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event
Clinical narrative: No adverse events reported or indicated
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Body aches, chills, fever 102 and arm swelling.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a peds dose of Hep B instead of an adult dose.    Pt did not have a adverse event reaction.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient came down with a rash that was diffusely across his whole body. It was quite itchy and red.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Shivers fever muscle pain over entire body fatigue.  Nausea
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Approximately 10 hours after receiving vaccines, mother reports swelling of face and hives on trunk, upper extremities. She denied pt had any difficulty breathing, swelling of throat, or wheezing. Mother gave one dose of benadryl, and sx resolved within one hour. No further sx occurred.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blindness, Computerised tomogram, Lumbar puncture, Magnetic resonance imaging, Optic nerve injury
Clinical narrative: Gradual loss of eyesight from 08/21/2019 to 09/02/2019      Total loss of eyesight on 09/03/2019     Many tests and doctors Hospitalization for 5 days with 1000 units of IV steroids      Continued steroids for weeks     Gradual improvement over 6 months-not 100%    Some permanent damage to Optic nerve
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient called  and talked to staff in the clinic(date of this phone call is unknown) Staff brought this note to nurse in county health and this nurse called and talked to pt mother about adverse reaction. Mother stated that 1-2-2020 in the pm she noticed that on pt left thigh he had a hard nodule and a bright red area that was hot to the touch to the left thigh where mmr immunization was given. This nurse called and talked to pt mother today and said "redness and hot to the touch area of left leg was gone."  Mother also did not take pt to a doctors office or medical professional for evaluation of this.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Aphonia, Dysphonia, Laboratory test, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: she had no voice; She had a sore throat and a raspy voice; cold; raspy voice; This spontaneous report was received from a consumer who refers to her daughter, a 14-year-old female patient. The patient's concurrent condition included Asperger's disorder. Concomitant therapies included amitriptyline, dantrolene and birth control patch. The patient did not have any known drug reactions or allergies.  On 27-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) a single dose, route reported as "shot in her shoulder" (exact dose and route of administration, lot # and expiration date were no reported) for prevention of cancer. On the same day (27-NOV-2019), she was vaccinated with influenza virus vaccine inactivated (unspecified) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 27-NOV-2019 (also reported as "within that week"), the patient developed a cold, she had a sore throat and raspy voice. On 05-DEC-2019, the patient visited a doctor. On 09-DEC-2019, she had no voice and due to the event, on the same day, the patient went to the doctor again. On 11-DEC-2019, the patient visited an otolaryngologists (ENT), she still had no voice and she was in a speech therapy to learn to speak again. It was reported that the patient also visited a neurologist, however no one was sure what was wrong with the patient. The patient did not received any treatment for the events. She had unspecified laboratory tests performed, however no results were provided.  The outcome of the events was reported as not recovered/not resolved.  The relatedness between the events and the suspect vaccines was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: she has not experienced any adverse symptoms; she received her first dose of GARDASIL 9 on 08/31/2019 and her second dose on 9/29/2019; This spontaneous report was received from a female patient of unknown age, who was reporting on herself. No information regarding, the patient's medical history, concurrent conditions and concomitant medications was provided.  On 31-AUG-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot#, expiration date and route of administration were not provided) for prophylaxis. On 29-SEP-2019, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot#, expiration date and route of administration were not provided), that was considered as inappropriate schedule of product administration. The patient did not experience any adverse symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In 2016, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) as prescribed and/or administered by a healthcare provider at a hospital for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider. As a direct and proximate result of the patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: late in receiving second dose of gardasil 9; no adverse effect; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On an unknown date in February 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, exact dose, route of administration, anatomical location, lot number and expiry date were not reported). It was reported that the patient was late in receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine series as noted in the prescribing information (inappropriate schedule of product administration). No adverse events were reported. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Gait disturbance, Pain, Urinary incontinence
Clinical narrative: vaccine pseudo exacerbation; could barely walk for 36 hr; no bladder control for 48 hr; feeling hot and cold for 48 hr; This case was reported by a consumer via other manufacturer and described the occurrence of walking difficulty in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received Shingrix .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced walking difficulty, bladder incontinence, feeling hot and cold and exacerbation of pain. On an unknown date, the outcome of the walking difficulty, bladder incontinence and feeling hot and cold were recovered/resolved and the outcome of the exacerbation of pain was unknown.   It was unknown if the reporter considered the walking difficulty, bladder incontinence, feeling hot and cold and exacerbation of pain to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received 0.5 ml dose of Shingrix and experienced could barely walk lor 36 hours, no bladder control for 48 hours, leeling hot & cold for 48 hours. Doctor described the symptoms from the vaccine as pseudo exacerbation
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Inflammation, Injection site erythema
Clinical narrative: Red; Hot; Muscle Soreness; Rash; pinkish bumps; Rash on the back of neck; Chills; Swelling; arm  a little itchy; Inflammation; This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ambiguous medication nos (Cortisone (Nos)) for muscle soreness.   On 1st December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Cortisone (Nos) at an unknown dose and frequency. On 3rd December 2019, 2 days after receiving Shingrix, the patient experienced chills and swelling. On 6th December 2019, the patient experienced erythema of extremities, extremities hot feeling of, muscle soreness, red rash, papular rash and rash. In December 2019, the patient experienced inflammation and itchy upper limbs. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On 8th December 2019, the outcome of the erythema of extremities and extremities hot feeling of were recovered/resolved. On an unknown date, the outcome of the chills, swelling and inflammation were recovered/resolved and the outcome of the muscle soreness and itchy upper limbs were unknown and the outcome of the red rash, papular rash and rash were recovering/resolving.   It was unknown if the reporter considered the chills, swelling, erythema of extremities, extremities hot feeling of, muscle soreness, red rash, papular rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, less than 3 weeks after vaccination, the patient experienced muscle soreness and itchy rash. On Friday after the day of vaccination, the patient arm was red and hot below the injection site. Three weeks after vaccination, the patient had an ongoing rash that consist of itchy, reddish/ pinkish bumps on left arm and the back of her neck below her hairline. The patient stated that rash on the back of neck not as bad as the rash on arm. The pharmacist told the patient to use cortisone and an ice pack. The patient stated that, the cortisone made the patient's arm little itchy, but the inflammation went away with ice pack. The patient reported that, the bumps were not oozing or blistering. The reporter stated that, visiting to physician who did not feel rash was shingles or chicken pox and might be visit a skin doctor. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pruritus, Rash, Rash erythematous
Clinical narrative: Red; Hot; Muscle Soreness; Rash; pinkish bumps; Rash on the back of neck; Chills; Swelling; arm  a little itchy; Inflammation; This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ambiguous medication nos (Cortisone (Nos)) for muscle soreness.   On 1st December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Cortisone (Nos) at an unknown dose and frequency. On 3rd December 2019, 2 days after receiving Shingrix, the patient experienced chills and swelling. On 6th December 2019, the patient experienced erythema of extremities, extremities hot feeling of, muscle soreness, red rash, papular rash and rash. In December 2019, the patient experienced inflammation and itchy upper limbs. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On 8th December 2019, the outcome of the erythema of extremities and extremities hot feeling of were recovered/resolved. On an unknown date, the outcome of the chills, swelling and inflammation were recovered/resolved and the outcome of the muscle soreness and itchy upper limbs were unknown and the outcome of the red rash, papular rash and rash were recovering/resolving.   It was unknown if the reporter considered the chills, swelling, erythema of extremities, extremities hot feeling of, muscle soreness, red rash, papular rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, less than 3 weeks after vaccination, the patient experienced muscle soreness and itchy rash. On Friday after the day of vaccination, the patient arm was red and hot below the injection site. Three weeks after vaccination, the patient had an ongoing rash that consist of itchy, reddish/ pinkish bumps on left arm and the back of her neck below her hairline. The patient stated that rash on the back of neck not as bad as the rash on arm. The pharmacist told the patient to use cortisone and an ice pack. The patient stated that, the cortisone made the patient's arm little itchy, but the inflammation went away with ice pack. The patient reported that, the bumps were not oozing or blistering. The reporter stated that, visiting to physician who did not feel rash was shingles or chicken pox and might be visit a skin doctor. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic, Swelling
Clinical narrative: Red; Hot; Muscle Soreness; Rash; pinkish bumps; Rash on the back of neck; Chills; Swelling; arm  a little itchy; Inflammation; This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ambiguous medication nos (Cortisone (Nos)) for muscle soreness.   On 1st December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Cortisone (Nos) at an unknown dose and frequency. On 3rd December 2019, 2 days after receiving Shingrix, the patient experienced chills and swelling. On 6th December 2019, the patient experienced erythema of extremities, extremities hot feeling of, muscle soreness, red rash, papular rash and rash. In December 2019, the patient experienced inflammation and itchy upper limbs. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On 8th December 2019, the outcome of the erythema of extremities and extremities hot feeling of were recovered/resolved. On an unknown date, the outcome of the chills, swelling and inflammation were recovered/resolved and the outcome of the muscle soreness and itchy upper limbs were unknown and the outcome of the red rash, papular rash and rash were recovering/resolving.   It was unknown if the reporter considered the chills, swelling, erythema of extremities, extremities hot feeling of, muscle soreness, red rash, papular rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, less than 3 weeks after vaccination, the patient experienced muscle soreness and itchy rash. On Friday after the day of vaccination, the patient arm was red and hot below the injection site. Three weeks after vaccination, the patient had an ongoing rash that consist of itchy, reddish/ pinkish bumps on left arm and the back of her neck below her hairline. The patient stated that rash on the back of neck not as bad as the rash on arm. The pharmacist told the patient to use cortisone and an ice pack. The patient stated that, the cortisone made the patient's arm little itchy, but the inflammation went away with ice pack. The patient reported that, the bumps were not oozing or blistering. The reporter stated that, visiting to physician who did not feel rash was shingles or chicken pox and might be visit a skin doctor. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Redness persisted for 3 weeks; Swelling persisted for 3 weeks; Tender; Warm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FJ59, expiry date 27th November 2021) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema, swelling, tenderness and feeling of warmth. On an unknown date, the outcome of the erythema, swelling, tenderness and feeling of warmth were recovered/resolved.   It was unknown if the reporter considered the erythema, swelling, tenderness and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The patient experienced redness, swelling, tender and warm that persisted for 3 weeks. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Achy; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were unknown.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The reporter stated that, one of her friend experienced achy and tired after 1st dose of shingrix. No additional information was provided. The reporter did not consent to follow up. This case has been linked with case US2020000907 and US2020000905, reporterd by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: arm ache started sunday am, hard to lift arm, by afternoon area red, swollen.. continues to be red , swollen, difficult to move arm..
Age: 38.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fevers, body aches, nausea started on 1/6/2020
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: patient reported a sore arm after receiving shot.  pain and soreness got worse over the next few days.  started to radiate into the shoulder and neck area
Sex: M
Vaccine: DTAP, HIBV, RV1
Symptoms: Laboratory test normal, Respiratory arrest, Seizure like phenomena, Tension
Clinical narrative: Patient started to have seizure-like episodes that last for an average of 5 seconds within 20 minute intervals of less. His entire body became tense and his breath ceased during the episode.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: Shivering began at 10:45 pm and lasted until 12 midnight.  Treatment = Advil Day 2 - No longer shivering, but feel colder than normal.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Headache
Clinical narrative: HEADACHE X 9 DAYS
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Patient described a frozen shoulder that she was seen for 8 weeks after the shot was given. She says that she is going to physical therapy now. She said that she did not notice anything different from a normal vaccination over the first week after the shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Acute lymphocytic leukaemia, Asthenia, Blast cells present, Chemotherapy, Decreased appetite
Clinical narrative: Persistent and long lasting fevers up to 105 degrees F; multiple doctors, ER, and urgent care visits. Diagnoses included recurrent ear infections, upper respiratory infections, and one urinary tract infection. Antibiotics prescribed almost continually. Symptoms included high, long lasting fever (usually 5-8 days), fatigue, weakness, loss of appetite. After months of recurrent infections, blood test ordered on December 10, followed by instruction to report to the emergency room. Additional bloodwork results indicated acute lymphoblastic leukemia, admitted to the hospital, began chemotherapy, discharged in December 19. Ongoing treatment for leukemia.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Ear infection, Fatigue, Infection, Influenza virus test negative, Mononucleosis heterophile test negative
Clinical narrative: Persistent and long lasting fevers up to 105 degrees F; multiple doctors, ER, and urgent care visits. Diagnoses included recurrent ear infections, upper respiratory infections, and one urinary tract infection. Antibiotics prescribed almost continually. Symptoms included high, long lasting fever (usually 5-8 days), fatigue, weakness, loss of appetite. After months of recurrent infections, blood test ordered on December 10, followed by instruction to report to the emergency room. Additional bloodwork results indicated acute lymphoblastic leukemia, admitted to the hospital, began chemotherapy, discharged in December 19. Ongoing treatment for leukemia.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Upper respiratory tract infection, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Persistent and long lasting fevers up to 105 degrees F; multiple doctors, ER, and urgent care visits. Diagnoses included recurrent ear infections, upper respiratory infections, and one urinary tract infection. Antibiotics prescribed almost continually. Symptoms included high, long lasting fever (usually 5-8 days), fatigue, weakness, loss of appetite. After months of recurrent infections, blood test ordered on December 10, followed by instruction to report to the emergency room. Additional bloodwork results indicated acute lymphoblastic leukemia, admitted to the hospital, began chemotherapy, discharged in December 19. Ongoing treatment for leukemia.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Injection site pain, Musculoskeletal chest pain, Nausea, Painful respiration
Clinical narrative: Hoarseness  and  pain underneath  my right rib and  right should er, also when I  inhale I feel the pain in my right side. I did have mild fever the first 2 days with nauseness .
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Hoarseness  and  pain underneath  my right rib and  right should er, also when I  inhale I feel the pain in my right side. I did have mild fever the first 2 days with nauseness .
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Immediate post-injection reaction, Myalgia
Clinical narrative: Immediate soreness (minor), intensifying to moderate soreness several hours later.   About 11 hours after dose: joint paint, fatigue, muscle aches;  After another hour: chills and shivering followed by low-grade fever (betwe. 100 and 101).  Alternating feelings of chills and fever continued with muscle aches and joint pain and what feels like a sinus headache. Acetaminophen taken and helpful.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Sinus headache
Clinical narrative: Immediate soreness (minor), intensifying to moderate soreness several hours later.   About 11 hours after dose: joint paint, fatigue, muscle aches;  After another hour: chills and shivering followed by low-grade fever (betwe. 100 and 101).  Alternating feelings of chills and fever continued with muscle aches and joint pain and what feels like a sinus headache. Acetaminophen taken and helpful.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Paraesthesia, Rash
Clinical narrative: Patient developed a "tingling feeling" approximately 30 minutes after her second Shingrix immunization. She was told by her physician at that time to take diphenhydramine, but states that she was unable to continue taking  it since she must remain alert while at work.  She developed a generalized rash approximately 1 hour and 15 minutes after receiving the vaccination.  She also stated that she has a warm red spot on her left arm that is below the injection site.  She returned to the pharmacy and urgent care clinic on the evening of 1/6/20.  She was seen by PA., and was prescribed hydroxyzine.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Facial paralysis, Malaise
Clinical narrative: PATIENT RECEIVED IMMUNIZATION ON THURSDAY AFTERNOON.  SHE STATED SHE STARTED TO NOT FEEL WELL OVER WEEKEND AND LEFT ARE WAS RED. ON MONDAY MORNING SHE WOKE UP TO HER FACIAL MUSCLES DROOPING.  SHE THOUGHT SHE HAD A STROKE AND WENT TO  HOSPITAL WHERE THEY DIAGNOSED HER WITH BELL'S PALSY.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; the patient was administered an improperly stored dose of PEDVAHIB; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 18-DEC-2019, the patient was vaccinated with a dose of improperly stored Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, with lot number S006471 which was confirmed to be a valid lot number for Haemophilus b conjugate vaccine (meningococcal protein conjugate) (therapy type: digital data logger) and expiration date reported and established as 22-JAN-2022 for prophylaxis (strength, exact dose, frequency, and anatomical location were not reported).  Temperature excursion (product storage error) was reported as follows: temperature of 48.5 degrees Fahrenheit for a timeframe of 1 hour. There was no previous temperature excursion and the product storage error was identified via a data logger. No additional adverse event information was provided. No product quality complaint was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Sudden hearing loss, Tinnitus
Clinical narrative: asymmetrical sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 07-NOV-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered acute sudden hearing loss and tinnitus. The patient was diagnosed with asymmetrical sensorineural hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) use, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  The event of asymmetrical sensorineural hearing loss was considered to be disabling.  Upon internal review, the event of asymmetrical sensorineural hearing loss was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Cardiac failure congestive, Macular oedema, Retinal vein occlusion, Visual impairment
Clinical narrative: right central retinal vein occlusion with macular edema; right central retinal vein occlusion with macular edema; congestive heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 20-DEC-2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered vision loss in right eye and intermittent graying of vision and was diagnosed with right central retinal vein occlusion with macular edema. The patient also suffered congestive heart failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms have resulted in physical limitations not present prior to the vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) use, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  The events of congestive heart failure and right central retinal vein occlusion with macular edema were considered to be disabling.  Upon internal review, the events of congestive heart failure and right central retinal vein occlusion with macular edema were considered to be medically significant.
Sex: F
Vaccine: FLUR4
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: the patient pulled away during the injection and did not get much/ no AE; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 year old female patient who received less than 0.5 mL of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatments, vaccinations and family history were not provided.   On 10-Dec-2019, the patient received a dose of less than 0.5 mL suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot QSAA1945, expiry date: 30-JUN-2020] via unknown route in the left deltoid.   It was a case of actual medication error due to Vaccine underdose (underdose). Pharmacist stated that while administering a Flublok vaccine, the patient pulled away, just as he was pushing the plunger. She did not get much, if any of the vaccine.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Pallor
Clinical narrative: Pale; Itching at the site; swelling to 3 cm x 3 cm (wheal); Initial information received on 27-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old male patient who experienced pale (pallor) , itching at the site (injection site pruritus) and swelling to 3 cm x 3 cm (wheal) (injection site swelling), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Dec-2019, the patient received fifth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA and expiry date 09-Oct-2020 via subcutaneous route in the left thigh.  On an unknown date, the patient developed a non-serious (pallor) , itching at the site (injection site pruritus) and swelling to 3 cm x 3 cm (wheal) (injection site swelling) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  The injection was attempted in the left thigh and the child moved quite a bit but a little bit may have been given subcutaneously instead of IM.  Other relevant tests were not reported.  Final diagnosis was pale, swelling to 3 cm x 3 cm (wheal) and itching at the site.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The outcome was reported as recovered for itching at the site, as unknown for pale and swelling to 3 cm x 3 cm (wheal).
Sex: U
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient expired dose of Imovax was administered, no AE; Initial information received on 30-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received an expired vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (lot N1L132M and expiry date: not reported) via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used. It was reported that to the patient an expired dose of Imovax was administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Muscle twitching
Clinical narrative: right hand began to twitch and a couple days later, his left hand started twitching; a reddened area around the injection site; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 9 years old male patient who experienced right hand began to twitch and a couple days later, his left hand started twitching and a reddened area around the injection site, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  On 14-Dec-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6656KA) via unknown route in the right deltoid.  On 14-Dec-2019, the patient developed a non-serious a reddened area around the injection site (injection site erythema) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 23-Dec-2019, the patient developed a non-serious right hand began to twitch and a couple of days later, his left hand started twitching (muscle twitching) nine days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory data was not reported.  Final diagnosis was a reddened area around the injection site and right hand began to twitch and a couple days later, his left hand started twitching.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for both the events.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient experienced red, raised rash which was warm to the touch.  Antibiotics prescribed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: patient presenting with nerve pain on right side that has travelled from her shoulder down her right rib cage into her right hip area. dr said Tylenol 500 every 6 hours as needed on 12/30/2019. I spoke to nurse today and she is going to follow up with the patient again and offer her an office visit for further eval.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Nausea, Vertigo, Vomiting
Clinical narrative: Patient developed vertigo, nausea and vomiting a day after she received the vaccination. Because of the symptoms she couldn't eat anything and she was being hospitalized for 3 days.
Sex: F
Vaccine: IPV, MNQ, TD, TDAP, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given TD and Tdap at same visit. TD to right deltoid and Tdap to left deltoid. No adverse reaction noted, no fever, no rash, no pain, no streaking, no shortness of breath, no syncopal episode, no swelling at site of injection. Pt left facility in no acute distress.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram abdomen, Contusion, Gingival bleeding, Immune thrombocytopenic purpura, Laboratory test
Clinical narrative: Bruising all over body 10/24/19 Bloody Gums 10/28/19 Heavy Menses 11/1/19 Hospital 11/4/19 Platelets decreased 15,000 (ITP) Multiple doctor visits to rule out cause of symptoms Platelets IV - Reaction had to be medicated with Benadryl, antihistamines, steroids. Has to get weekly lab to monitor platelets count. Been on reduction Prednisone (since hospitalization) Dr - Rheumatologist Dr - Hematologist/Oncologist Dr - GI/Family Practice Dr - GYN office visit after event.