chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 16-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021926 and expiration date: 15-JUL-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The administered dose of the vaccine was stored with the temperature of 1.2 degree Celsius for 3 hours and 9 minutes. There was a digital data logger involved, but there was no previous temperature excursion. The vaccine was reconstituted with a properly stored sterile diluent. No additional adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 05-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021926 and expiration date: 15-JUL-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The administered dose of the vaccine was stored with the temperature of 1.2 degree Celsius for 3 hours and 9 minutes. There was a digital data logger involved, but there was no previous temperature excursion. The vaccine was reconstituted with a properly stored sterile diluent. No additional adverse events reported.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Injection site rash, Pain, Sleep disorder
Clinical narrative: Severe vertigo; Light headedness; 5 rash central to injection site; Pain enough that when I roll over at night it wakes me; some equilibrium; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th January 2020, the patient received Shingles vaccine. On 11th January 2020, 5 days after receiving Shingles vaccine, the patient experienced vertigo and light headedness. In January 2020, the patient experienced injection site rash, pain and disorder equilibrium. On an unknown date, the outcome of the injection site rash, pain, disorder equilibrium and light headedness were unknown and the outcome of the vertigo was recovered/resolved.   It was unknown if the reporter considered the injection site rash, pain, disorder equilibrium, vertigo and light headedness to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient stated that after vaccination had rash central to injection site, pain enough that when roll over at night it wakes me, and some equilibrium. The patient also had severe vertigo initially, but lasted for a few hours, with light headedness persisting throughout day. The patient do not want another vaccine for some time as patient was concerned about reactions. The patient asked whether vertigo related to vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Severe vertigo; Light headedness; 5 rash central to injection site; Pain enough that when I roll over at night it wakes me; some equilibrium; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th January 2020, the patient received Shingles vaccine. On 11th January 2020, 5 days after receiving Shingles vaccine, the patient experienced vertigo and light headedness. In January 2020, the patient experienced injection site rash, pain and disorder equilibrium. On an unknown date, the outcome of the injection site rash, pain, disorder equilibrium and light headedness were unknown and the outcome of the vertigo was recovered/resolved.   It was unknown if the reporter considered the injection site rash, pain, disorder equilibrium, vertigo and light headedness to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient stated that after vaccination had rash central to injection site, pain enough that when roll over at night it wakes me, and some equilibrium. The patient also had severe vertigo initially, but lasted for a few hours, with light headedness persisting throughout day. The patient do not want another vaccine for some time as patient was concerned about reactions. The patient asked whether vertigo related to vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2020 08:15, the patient received Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache and tiredness. On an unknown date, the outcome of the headache and tiredness were unknown.   It was unknown if the reporter considered the headache and tiredness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient wanted to know whether how long mild side effects would last. The patient had a mild side effects, just headache and tiredness after vaccination. The patient received vaccine the day before reporting evening around 8:15 pm and at the time of reporting it was 6:50 pm next day. The headache was just mild to moderate but still felt very tired.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival erythema, Gingival pain, Gingival swelling
Clinical narrative: My gums were red and swollen and this  lasted for 7 days.  They were tender but did not bleed.  I got the shot on a Saturday and it took until the following Sunday for the swelling to go down.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Eczema, Rash, Urticaria
Clinical narrative: Hives, rash all over entire body. Started the night of the vaccine and continued for a week. Then had eczema.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Corneal oedema, Intraocular pressure increased, Iritis, Ophthalmic herpes zoster
Clinical narrative: Patient called reporting he was seen by opthamologist on 1/14/20 with dx of herpes related eye infection. He reports his symptoms started approx. 7 days after the injection of the second dose of the Shingrix. He reports being placed on Valtrex 500mg po bid and pred forte every 4 hours. At baseline, he is on atenolol and brimonidine twice a day for eye related issues followed by their office. He reports the infection has caused corneal edema of the right eye and elevated IOP and iritis of that eye. He was seen again on 1/20/20 for recheck and will follow up with them in 1 week from that date.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, arm flapping
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient given ActHib (Lot UJ176AA (deltoid with sterile water (Merck sterile diluent Lot S025290) vs. 0.41% saline. Per Sanofi Pasteur (Manufacturer), dose needs to be reported. No additional adverse reactions are expected. Mother informed. Replacement dose scheduled minimum 4 wk interval.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events reported; improperly stored Varivax; This spontaneous report was received from an office manager and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported.   On 27-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021926, expiration date 15-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 1.2 degrees Celsius for 3 hours and 9 minutes. There was no previous temperature excursion reported. Data logger was involved. There was no adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Joint injection
Clinical narrative: intense joint pain; unable to walk the stairs in her house; This case was reported by a pharmacist via sales rep and described the occurrence of joint pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain and walking difficulty. On an unknown date, the outcome of the joint pain and walking difficulty were unknown.   It was unknown if the reporter considered the joint pain and walking difficulty to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Post vaccination the patient ended up having such intense joint pain that she was unable to walk the stairs in her house. The patient ended up going to her physician several weeks later. The patient injected her knee to enable her to go on her scheduled trip. The reporter consented to follow up. The case has been linked to case US2020AMR008677, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: numbness LUE since flu shot 10-30-19.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Presyncope
Clinical narrative: Vasovagal
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: next morning 11/21/2019 experiencing burning pain in shoulder and arm area, could not lift arm, could not rotate arm, could not sleep on arm as if rotator cup was out.  12/13/2019 back to clinic because pain was debilitating and to this day 1/21/2020 it still has pain (symptoms related to SIRVA), in which I researched my symptoms, the clinic said they never heard of SIRVA. 12/13/2019 Cortesone, Prendesone given by clinic for pain 1/2/2020 cyclobenzaprine given by clinic
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Incorrect route of product administration, Mass
Clinical narrative: flu vaccine was given SQ instead of IM. called mother on 1/21/20 and mother reported small lump. no fever/no problems.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Altered state of consciousness, Brain oedema, Encephalitis, Fatigue, Intensive care
Clinical narrative: Diagnosed as vaccine induced encephalitis requiring 5 day hospital stay, including ICU care. Per patient, symptoms included loss of awareness, lack of responsiveness, swelling of brain, extreme fatigue, and arm soreness
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Unresponsive to stimuli
Clinical narrative: Diagnosed as vaccine induced encephalitis requiring 5 day hospital stay, including ICU care. Per patient, symptoms included loss of awareness, lack of responsiveness, swelling of brain, extreme fatigue, and arm soreness
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal X-ray, Asthenia, Borrelia test negative, Chest X-ray normal, Computerised tomogram head normal
Clinical narrative: Diagnosed as vaccine induced encephalitis requiring 5 day hospital stay, including ICU care. Per patient, symptoms included loss of awareness, lack of responsiveness, swelling of brain, extreme fatigue, and arm soreness
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dysarthria, Echocardiogram normal, Encephalitis post immunisation, Immediate post-injection reaction, Laboratory test normal
Clinical narrative: Diagnosed as vaccine induced encephalitis requiring 5 day hospital stay, including ICU care. Per patient, symptoms included loss of awareness, lack of responsiveness, swelling of brain, extreme fatigue, and arm soreness
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain normal, Unresponsive to stimuli, West Nile virus test negative, X-ray normal
Clinical narrative: Diagnosed as vaccine induced encephalitis requiring 5 day hospital stay, including ICU care. Per patient, symptoms included loss of awareness, lack of responsiveness, swelling of brain, extreme fatigue, and arm soreness
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Influenza like illness, Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: Almost immediately experienced flu like symptoms combined with body aches/soreness/stiffness in the shoulders, upper arms, girdle groin area, wrists and fingers.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in upper left arm, often when lying on left side, lifting weights
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Started the evening of 1/20/2020.  Complains of 2.8cm rash superior to injection site with tingling sensation.  Erythema, tenderness noted, with a couple of smaller patches of erythema several centimeters below site. Rashes are slightly indurated.  Denies any other symptoms.  Pt seen by physician and instructed to take Loratadine 10mg PO daily, HC cream 1% 1-2x daily.  Told by physician that she is allergic to Shingrix and should not have the second dose. Pt has a history of Shingles July 2019.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Started the evening of 1/20/2020.  Complains of 2.8cm rash superior to injection site with tingling sensation.  Erythema, tenderness noted, with a couple of smaller patches of erythema several centimeters below site. Rashes are slightly indurated.  Denies any other symptoms.  Pt seen by physician and instructed to take Loratadine 10mg PO daily, HC cream 1% 1-2x daily.  Told by physician that she is allergic to Shingrix and should not have the second dose. Pt has a history of Shingles July 2019.
Age: 2.08
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This reaction started 4 days ago. Localized reaction to the R thigh. Raised, red, swollen area 80x110cm. It is warm to the touch and pruritic.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia, Autonomic nervous system imbalance, Constipation, Cytogenetic analysis normal, Electrocardiogram
Clinical narrative: POTS, Dysautonomia, Syncope, Constipation, Arm/Shoulder/Joint Pain, Sinus Tachycardia
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Electrocardiogram ambulatory, Electroencephalogram, Implantable cardiac monitor insertion, Laboratory test, Musculoskeletal pain
Clinical narrative: POTS, Dysautonomia, Syncope, Constipation, Arm/Shoulder/Joint Pain, Sinus Tachycardia
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity, Postural orthostatic tachycardia syndrome, Sinus tachycardia, Syncope, Thyroid function test
Clinical narrative: POTS, Dysautonomia, Syncope, Constipation, Arm/Shoulder/Joint Pain, Sinus Tachycardia
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Antibody test, Blood thyroid stimulating hormone, Chest X-ray, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: POTS, Dysautonomia, Syncope, Constipation, Arm/Shoulder/Joint Pain, Sinus Tachycardia
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Full blood count, Metabolic function test, Postural orthostatic tachycardia syndrome, Streptococcus test
Clinical narrative: POTS, Dysautonomia, Syncope, Constipation, Arm/Shoulder/Joint Pain, Sinus Tachycardia
Age: 20.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Nurse administered flu vaccine intra muscular, hpv vaccine intramuscular, then azithromycin po. Then rocephin was administered in left gluteus maximus. Patient became faint after last injection, nurse eased patient to the ground, he did not hit his head. patient came to quickly and nurse kept him for observation for 20 minutes with no adverse reactions. patient stated that he was nervous about the rocephin injection and had his fists clenched tightly at the time of administration.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Vaccine positive rechallenge
Clinical narrative: Sx-  redness, swelling .  Was treated supportively w/ ice packs.   Pt. had same reaction with last year's Flu vaccine administration.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Joint range of motion decreased, Myalgia, Product administered at inappropriate site, Pruritus
Clinical narrative: Info from office visit is this: Flulaval Quad 2019-2020 (PF) 60 mcg (15 mcg x 4)/0.5 mL IM syringe  Sore muscle, itching, range of motion limitation, Note - The shot was given high on my upper arm (left). The assistant put the band aid on lower than the injection site and I pointed it out and we moved the band-aid.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Severe dizziness upon awakening, while lying and attempting to rise and while walking, usually first couple of times arising in middle of night and morning.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dysstasia, Feeling abnormal, Hyperhidrosis, Loss of consciousness
Clinical narrative: passed out; Joint pain; nausea; body aches; i broke into a sweat; feel poorly/ feeling like hit by a truck; tried to stand up; This case was reported by a pharmacist via sales rep and described the occurrence of passed out in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date and did not experience any adverse event ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), joint pain, nausea, general body pain, sweating, feeling abnormal and difficulty in standing. On an unknown date, the outcome of the passed out, joint pain, nausea, general body pain, sweating, feeling abnormal and difficulty in standing were recovering/resolving.   It was unknown if the reporter considered the passed out, joint pain, nausea, general body pain, sweating, feeling abnormal and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The age at vaciantion was not reported. The patient got the Shingrix shot right after lunch and started to feel poorly during the night.  The patient woke up the next day and felt she had been hit by a truck.  She experienced Joint pain, nausea, body aches.  It was reported that when patient was tried to stand up after using the commode, she broke into a sweat and passed out on the bathroom floor.  That first day was the worst. Each day the patient was feeling little better.  The patient was able to leave the house by the fourth day. The case has been linked with the case US2020AMR008685, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: passed out; Joint pain; nausea; body aches; i broke into a sweat; feel poorly/ feeling like hit by a truck; tried to stand up; This case was reported by a pharmacist via sales rep and described the occurrence of passed out in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date and did not experience any adverse event ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), joint pain, nausea, general body pain, sweating, feeling abnormal and difficulty in standing. On an unknown date, the outcome of the passed out, joint pain, nausea, general body pain, sweating, feeling abnormal and difficulty in standing were recovering/resolving.   It was unknown if the reporter considered the passed out, joint pain, nausea, general body pain, sweating, feeling abnormal and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The age at vaciantion was not reported. The patient got the Shingrix shot right after lunch and started to feel poorly during the night.  The patient woke up the next day and felt she had been hit by a truck.  She experienced Joint pain, nausea, body aches.  It was reported that when patient was tried to stand up after using the commode, she broke into a sweat and passed out on the bathroom floor.  That first day was the worst. Each day the patient was feeling little better.  The patient was able to leave the house by the fourth day. The case has been linked with the case US2020AMR008685, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: Nerve damage in arm and neck; This case was reported by a consumer via call center representative and described the occurrence of nerve damage in a 76-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve damage. On an unknown date, the outcome of the nerve damage was unknown.   The reporter considered the nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had nerve damage in my arm and neck.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: after completing the two doses of Shingrix in 2018, patient experienced two episodes of shingles; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number Y24KE, expiry date 11th October 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number HM3NC, expiry date 13th April 2021) for prophylaxis.   In July 2018, the patient received the 1st dose of Shingrix. In November 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number Y2YKE and HM3MC were updated to Y24KE and HM3NC as per sale's data sheet. The reporter stated that, after vaccination with 2 doses of Shingrix, the patient experienced shingles. The reporter stated that, the patient experienced 2 episode of Shingles. The reporter was wondering if th patient could administer a third dose of Shingrix. The reporter consented to follow up. This case was considered as suspected vaccination failure, since time to onset and the details regarding laboratory confirmation for shingles were not provided
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (received 1st dose on an unknown date, refer case US2020AMR008872).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced chills and fever with second dose of Shingrix. The patient did not want to provide demographics and did not want to provide any adverse event information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became red; Injection site became swollen; Injection site started to itch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On 13th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and within two hours of getting the vaccine the injection site became red, swollen, and started to itch. The area involved was two inches in diameter. The reporter consented to follow up.  Unable to obtain additional details because the reporter wanted to end the call.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Erythema, Pruritus, Rash erythematous
Clinical narrative: itching on his legs, back, chest and arms.; blister scattered across both legs; Red spots on chest; red spots on both arms; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 86-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number M5325, expiry date 30th June 2020) for prophylaxis.   On 9th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). In October 2019, less than a week after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced pruritus, blister, red spotty rash and erythema of extremities. On an unknown date, the outcome of the pruritus, red spotty rash and erythema of extremities were recovering/resolving and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the pruritus, blister, red spotty rash and erythema of extremities to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: 2-3 days after receiving the Fluarix Quadrivalent vaccine the patient started to experience itching on his legs, back, chest and arms. He also had blister scattered across both legs.  The patient also reports that he has red spots on his chest and both arms which were very light in color. The red spots on his arms were bigger than the ones on his chest. The blisters on his legs have dried up. The reporter reported  that when he applies heat to his back, chest, legs or arms, it causes them to itch more. Consent to follow up was provided.
Sex: M
Vaccine: MENB
Symptoms: Cough, Nasal congestion, Nasopharyngitis
Clinical narrative: He has a cold with stuffiness and cough; He has a cold with stuffiness and cough; He has a cold with stuffiness and cough; This is a spontaneous report from a non-contactable consumer (mother of the patient) from a Pfizer-sponsored program Customer Service Line.  A male patient of an unspecified age received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a cold with stuffiness and cough on an unspecified date when he was scheduled to get his second dose of meningococcal group b rlp2086. The mother wanted to know if he can still have the injection. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 15.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: receiving  Flublok instead of Fluzone Quadrivalent / no AE; 15 year old patient receiving  Flublok instead of Fluzone Quadrivalent / no AE; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA006329 (same reporter).  This case involves a 15 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot QFAA1935 (Expiry date 30-Jun-2020) via intramuscular route in the left deltoid, on 07-Jan-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered, Inappropriate age at vaccine administration.  It was reported that 15yr old receiving Flublok instead of Fluzone Quadrivalent.  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.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Malaise, Pyrexia
Clinical narrative: coughing; fever; sick; flu like symptoms; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who experienced coughing (cough), fever (pyrexia), really sick (malaise) and flu like symptoms (influenza like illness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious really sick (malaise), coughing (cough), fever on and off (pyrexia), flu like symptoms (influenza like illness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.. It was reported that, patient could not get up for a month.   Final diagnosis was influenza like illness, pyrexia, malaise and cough.   The patient was treated with PREDNISONE,  antibiotics and CODEINE for Cough.  The patient outcome was reported as unknown all events.  Information on the batch number was requested.
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse administered Typhim to a 1 year old patient, no AE.; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 year old male patient who was vaccinated by nurse with 0.5 ml dose of vaccine typhoid vi polysaccharide vaccine [typhim vi] (lot number R1B73 and expiration date 20-Mar-2021) via intramuscular route in the left thigh On 06-Dec-2019.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (mmr vaccin).  It was an actual medication error case due to product administered to patient of inappropriate age.  No adverse event reported at the time of reporting.  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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired Pentacel vaccine was given to a patient/no ae; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 month old female patient who was vaccinated with an expired 0.5 mL dose of vaccine  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5552AA, Expiration date: 10-Oct-2019 via unknown route at an unknown administration site).  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  It was unknown whether adverse event was experienced or not.  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.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: Most of the vaccine went down the patient's arm while administeration, no AE.; while adminstering vaccine fluzone HD squirted out at the connection between the syringe and the needle,no AE.; Most of the vaccine went down the patient's arm while administeration, no AE.; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves patient (age and gender unknown) who was vaccinated with the dose of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number UJ308AA and expiration date 30-Jun-2020), while administration most of the vaccine went down the patient's arm (underdose) (exposure via skin contact) and the pharmacist gave additional vaccine since most of the first vaccine was not administered via unknown route in the left deltoid and vaccine fluzone hd squirted out at the connection between the syringe and the needle (syringe issue) on an unknown date.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to underdose, exposure via skin contact.  It is also a case of syringe issue.  No adverse event reported at the time of reporting.  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.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Eye movement disorder, Seizure
Clinical narrative: seizure; eyes rolled back; Initial information received on 13-Jan-2020 regarding an unsolicited valid serious case received from a nurse.  This case involves a 2 months old male patient who experienced seizure (seizure) and eyes rolled back (eye movement disorder), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE (HEPATITIS B VACCIN) second dose and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) first dose.  On 10-Jan-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Daptacel and IPOL lot U6629AA Expiry date 02-May-2021), (ActHIB  lot number UJ208AB Expiry date 02-May-2021) via intramuscular route in the right thigh.  On 10-Jan-2020, the patient developed a serious seizure and eyes rolled back (eye movement disorder) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  No lab data was reported.  Final diagnosis was seizure.   It was not reported if the patient received a corrective treatment.  On 10-Jan-2020, the event outcome is reported as Recovered for seizure and eyes rolled back.; Sender's Comments: This case involves a 2 months old male patient who experienced seizure, while he received vaccine PENTACEL. The time to onset is compatible with the role of vaccine. However, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of suspect vaccine cannot be assessed separately from the concomitant vaccines.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Influenza, Pyrexia, Vaccination failure
Clinical narrative: he was diagnosed with Flu strain A; Influenza A virus infection; developed a fever of 103; chills; cough; Initial information received on 13-Jan-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient's mother).  This case involves a 16 year old male patient who was diagnosed with flu strain A (influenza), with fever of 103 (pyrexia) chills (chills) and cough (cough) while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  In November 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported, of unknown Expiration date) via unknown route at an unknown administration site.  On 11-JAN-2020, the patient developed a serious fever (pyrexia), chills (chills), cough (cough) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were assessed as medically significant (as these were considered symptoms of Influenza).  On 12-JAN-2020, the patient was diagnosed with serious flu strain a (influenza) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  It was a case of vaccination failure and considered medically significant.  Relevant laboratory test results included: Body temperature - On 11-Jan-2020:  [103] then on an unknown date after therapy it was [101]  Final diagnosis was Influenza and vaccination failure.  The patient was treated with OSELTAMIVIR (OSELTAMIVIR) 75mg twice a day for 5 days and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL (NYQUIL COLD & FLU).  The patient had not recovered from all the events at the time of report.  Information on the batch number is requested.; Sender's Comments: This case concerns a 16 year old male patient who presented with influenza A after and despite the administration of vaccine FLUZONE QUADRIVALENT. The time to onset is compatible. However, there is no information regarding patient's condition at time of vaccination, immune status, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: a 38 year old female patient received a dose of Flublok Quadrivalent on 13-JAN-2020 the 8th but did not realize that they were not suitable for use due to shipment delay/No AE; a 38 year old female patient received a dose of Flublok Quadrivalent on the 8th but did not realize that they were not suitable for use/No AE; Initial information received on 13-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 38 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on 13-JAN-2020 the 8th but did not realize that they were not suitable for use due to shipment delay lot QFAA1960, expiry date: 30-JUN-2020 via unknown route in the right arm.  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  It was an actual medication error due to Incorrect product storage.  It was a case of product shipment delay.  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 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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: administered ActHIB with the incorrect diluent/no AE; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] mixed with wrong solution.  The patient's past vaccination(s) included ACT-HIB with three doses on unknown dates. The patient medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 08-Jan-2020, the patient received a 0.5 ml single 4th dose of suspect HIB (PRP/T) VACCINE lot UJ112AA via intramuscular route in the left deltoid.  It was of actual medication error due to wrong solution used in drug reconstitution. The patient was administered an Act-Hib dose that had been reconstituted with Merck sterile water for injection diluent, rather than the diluent included with the ActHib.  It was unknown whether adverse event was experienced or not.  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 and Module VI of the 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: 11.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Contusion, Fall, Head injury, Skin abrasion, Syncope
Clinical narrative: Post vaccination, patient had a syncope episode. Patient sustained a contusion and abrasion to right side of head due to fall. No bleeding from fall. EMS was contacted to evaluate patient. No hospitalization or emergency room required. Patient released to parents.
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: Burning sensation, Conjunctivitis, Eye pain, Feeling hot, Oropharyngeal pain
Clinical narrative: Vax type - Hep B  Eye pain. Painful to move them. Hot, burning sensation of body. Light sensitivity. Could not watch TV. Rushed to Ophthalmologist that evening. Test showed white dots in each eye, similar to conjunctivitis. Prescribed medications. Read to be a possible side effect to HepB vaccine. Returned to Ophthalmologist Dr who agreed there could be a correlation between symptoms and HepB vax. Also symptoms of sore throat dx'd by Dr.
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: Photophobia, Retinal exudates
Clinical narrative: Vax type - Hep B  Eye pain. Painful to move them. Hot, burning sensation of body. Light sensitivity. Could not watch TV. Rushed to Ophthalmologist that evening. Test showed white dots in each eye, similar to conjunctivitis. Prescribed medications. Read to be a possible side effect to HepB vaccine. Returned to Ophthalmologist Dr who agreed there could be a correlation between symptoms and HepB vax. Also symptoms of sore throat dx'd by Dr.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Corneal reflex decreased, Crying, Musculoskeletal stiffness, Sensory disturbance, Speech disorder
Clinical narrative: Patient was meeting all of his milestones perfectly. Notably, after the MMR & Hep A vaccine my son didn't recognize certain animals anymore, wasn't responding to his name, became extremely sensory, started developing eye tics and blinking extremely hard with the mouth smiling or open. Crying most of the time & locking up of limbs at certain times.  This all continued for around 1 year. He is now in Speech Therapy and OT and is not where he should be developmentally for the age of 3.  I also noticed in pictures that his eye was going inward after his 4  month vaccine cluster shots, which I have learned is also a reaction. He was given Tylenol after vaccines which DR told to give.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Strabismus, Tic, Unresponsive to stimuli
Clinical narrative: Patient was meeting all of his milestones perfectly. Notably, after the MMR & Hep A vaccine my son didn't recognize certain animals anymore, wasn't responding to his name, became extremely sensory, started developing eye tics and blinking extremely hard with the mouth smiling or open. Crying most of the time & locking up of limbs at certain times.  This all continued for around 1 year. He is now in Speech Therapy and OT and is not where he should be developmentally for the age of 3.  I also noticed in pictures that his eye was going inward after his 4  month vaccine cluster shots, which I have learned is also a reaction. He was given Tylenol after vaccines which DR told to give.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: patient got pneumovax and shingrix shots same date on her right arm. patient complained of redness and soreness few days after the immunization. patient advised to take tylenol and benadryl if redness doesn't go away and to see PCP if symptoms are worsen.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient began to experience pain in injection arm shortly after vaccine delivery from shoulder to elbow that has persisted for over 2 months.