chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Intraocular pressure increased, Nausea, Pain, Retching, Vaccination complication
Clinical narrative: The night of the injection the patient had a violent 12 hour reaction to the shingles shot. Dry heaves, teeth chattering chills, headache, body aches, nausea and vomiting. The next day she was very exhausted. She coincidentally had an appointment with Dr., her ophthalmologist, glaucoma specialist on 8/8/2019. Her eye pressures had soared from 10 each to 15 and 24.  Due to the high IOP she was placed on numerous medications. She was seen again on 8/22/2019 by Dr as a followup to her 8/8/19 appointment.
Age: 75.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Vomiting
Clinical narrative: The night of the injection the patient had a violent 12 hour reaction to the shingles shot. Dry heaves, teeth chattering chills, headache, body aches, nausea and vomiting. The next day she was very exhausted. She coincidentally had an appointment with Dr., her ophthalmologist, glaucoma specialist on 8/8/2019. Her eye pressures had soared from 10 each to 15 and 24.  Due to the high IOP she was placed on numerous medications. She was seen again on 8/22/2019 by Dr as a followup to her 8/8/19 appointment.
Age: 75.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Psoriasis, Rash erythematous
Clinical narrative: The night of the injection the patient had a violent 12 hour reaction to the shingles shot. Dry heaves, teeth chattering chills, headache, body aches, nausea and vomiting. The next day she was very exhausted. She coincidentally had an appointment with Dr., her ophthalmologist, glaucoma specialist on 8/8/2019. Her eye pressures had soared from 10 each to 15 and 24.  Due to the high IOP she was placed on numerous medications. She was seen again on 8/22/2019 by Dr as a followup to her 8/8/19 appointment.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: REDNESS, SWOLLEN, AND PAINFUL HOURS AFTER INJECTION. IS  IMPROVING 2 DAYS LATER
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: General physical health deterioration, Headache, Kernig's sign, Nystagmus, Phonophobia
Clinical narrative: Severe headache with photosentitivity, phonophobia, fever 104, deteriorated rapidly in clinic with + Kernigs sign and nystagmus, sluggish pupils
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Photosensitivity reaction, Pupillary reflex impaired, Pyrexia
Clinical narrative: Severe headache with photosentitivity, phonophobia, fever 104, deteriorated rapidly in clinic with + Kernigs sign and nystagmus, sluggish pupils
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site swelling, Pain in extremity, Rash
Clinical narrative: rash, swollen injection site and swelling down to elbow, pain in arm, headache, all resolved by day 4.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: The shingrix vaccine was administered manufacturer GlaxoSmithKline  Body ache, headache, fever of 101.6 on Sept 18, shivering
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient came in today after getting flu shot yesterday. Patient had localized redness (approx 2-3 in across x ~1.5 in tall oval on arm around where shot was given). Pt stated the area was itchy, but no fever, no chills, no pain. Only reaction was redness and itching. Pt had flu shot in the past and had used the bandaid in the past with no reaction. Patient stated the shot did not hurt at all when given and still wasn't sore or painful (also mentioned that significant other had gotten injection yesterday as well with no reaction). Confirmed that we cleaned the area with alcohol pad and that the shot was given in the correct location. Area was slightly warm to touch, so instructed patient any signs of illness (fever, chills, etc) or if the area gets worse (starts to hurt, etc) or spreads, that pt should contact the doctor.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Nausea
Clinical narrative: Pt had a very large red circle on her left deltoid.  She said it appeared a few hours after the immunization and it became larger and deeper purple over time.  She said there was a dull persistent pain and she felt a little nauseated.  Today is 9/20.  Three days have past.  She is feeling better but the erythema is still present (very large circle over her left deltoid).
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dtap, given after the maximum age
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMRV given after the maximum age.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Headache, dizziness, nausea, tired, fatigue, loopy feeling & mild fever At injection sight: muscle ache & tenderness in upper arm
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache, dizziness, nausea, tired, fatigue, loopy feeling & mild fever At injection sight: muscle ache & tenderness in upper arm
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Chronic obstructive pulmonary disease, Cold sweat, Condition aggravated, Culture negative
Clinical narrative: Developed fevers, chills, cold sweats, rapid heart beat, and shortness of breath approx 6:30 pm after 11 am vaccination.  Admitted to hospital for 5 days.  Cultures negative.  Dx at discharge COPD exacerbation
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: Developed fevers, chills, cold sweats, rapid heart beat, and shortness of breath approx 6:30 pm after 11 am vaccination.  Admitted to hospital for 5 days.  Cultures negative.  Dx at discharge COPD exacerbation
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions and allergies was provided. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). On 13-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# R026722, expiry date 17-MAR-2020 or lot # R023499, expiry date13-FEB-2020) for prophylaxis. The nurse did not have the specific lot number/ expiration date administered to the patient but it was one of the two listed. The vaccine experienced two storage temperature excursions (on 12-AUG-2019 and on 13-AUG-2019) from -14 Celsius degrees to -10 Celsius degrees (-11.91 Celsius degrees, multiple) for 8 hours. The data logger was involved. No adverse events were reported.  The outcome of product storage error and no adverse event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: Hearing loss; Shingles; Information has been received from a lawyer regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a physician office for shingles and hearing loss. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued 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, included but not limited to medical losses and costs which included 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. At the time of the report, the outcome of deafness and herpes zoster was considered as not recovered. The lawyer considered herpes zoster and deafness to be related to zoster vaccine Live (ZOSTAVAX).     Upon internal review, deafness was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On or about 03-FEB-2016, pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Headache, Immune system disorder, Osteitis, Pain
Clinical narrative: Extreme Pain; Affected my immune system; Throwing up; Fever; Can't eat; Headache; Feels like every bone is inflamed; This case was reported by a consumer and described the occurrence of pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia.   On 6th September 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, less than a day after receiving Shingrix, the patient experienced pain, immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation. On an unknown date, the outcome of the pain was unknown and the outcome of the immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation were not recovered/not resolved.   It was unknown if the reporter considered the pain, immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation to be related to Shingrix.  Additional details were provided as follows: The patient experienced extreme pain, fever, thrown up after receiving Shingrix. The patient stated her immune system was affected. The patient had history of severe fibromyalgia, which she had kept on sheet. The patient asked how long would the symptoms would last or if she would have them for the rest her life. The patient had researched it online and felt she should not have had the vaccine with the autoimmune problems. The patient was unable to eat since she had received Shingrix. The patient felt like every bone was inflamed. She wanted the company to know that they should have a warning with patients with a history of auto-immune disease not to receive Shingrix. The reporter permitted to contact her physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Extreme Pain; Affected my immune system; Throwing up; Fever; Can't eat; Headache; Feels like every bone is inflamed; This case was reported by a consumer and described the occurrence of pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia.   On 6th September 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, less than a day after receiving Shingrix, the patient experienced pain, immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation. On an unknown date, the outcome of the pain was unknown and the outcome of the immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation were not recovered/not resolved.   It was unknown if the reporter considered the pain, immune system disorder, vomiting, fever, unable to eat, headache and bone inflammation to be related to Shingrix.  Additional details were provided as follows: The patient experienced extreme pain, fever, thrown up after receiving Shingrix. The patient stated her immune system was affected. The patient had history of severe fibromyalgia, which she had kept on sheet. The patient asked how long would the symptoms would last or if she would have them for the rest her life. The patient had researched it online and felt she should not have had the vaccine with the autoimmune problems. The patient was unable to eat since she had received Shingrix. The patient felt like every bone was inflamed. She wanted the company to know that they should have a warning with patients with a history of auto-immune disease not to receive Shingrix. The reporter permitted to contact her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Significant pain at site of injection; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. On first shot the patient had significant pain at site of injection.  The patient used heating pad that night to sleep.  No further information, but patient stated she did subsequently get the 2nd dose shot. The reporter denied permission to follow up.
Age: 87.0
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: pain in shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 87-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shoulder pain. The patient was treated with dermatologicals nos, dermatologicals nos, dermatologicals nos, dermatologicals nos (Ointment). On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient had pain in shoulder and did not lie on that side. It was been almost a month. (It was been three and a half weeks). The patient talked to his/her primary, said pain would eventually go away. The patient had applied ice and muscle pain ointment. The patient worried that this might become a chronic condition and patient want to know if other people have complained about the same. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: felt bad; felt Tired; Muscle aches; Headaches; This case was reported by a physician via sales rep and described the occurrence of tiredness 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, less than 2 years after receiving Shingrix, the patient experienced tiredness, muscle pain, headache and feeling bad. On an unknown date, the outcome of the tiredness, muscle pain and headache were recovered/resolved and the outcome of the feeling bad was unknown.   The reporter considered the tiredness, muscle pain, headache and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and felt tired, had muscle aches & had headaches consistent with the label. The patient felt bad for 2 days and then went sailing. The reporter agreed to follow up. This case linked with US2019AMR167048, reported by same reporter.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Asthenia, Headache, Nausea, Pain
Clinical narrative: nausea; weakness; headache; pain; swelling; Health issues; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, for tolerance refer case US2019AMR167033).   On 11th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced nausea, weakness, headache, pain, swelling and adverse reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, weakness, headache, pain, swelling and adverse reaction were not recovered/not resolved.   It was unknown if the reporter considered the nausea, weakness, headache, pain, swelling and adverse reaction to be related to Shingrix.  Additional details were provided as follows: On the day before the reporting date, the patient received Shingrix. The patient had many other health issues and was not sure if this was a reaction to the shot or something else and the patient would check it with primary health care provider. The patient asked about the duration of these side effects and how long they last. The call center representative provided general information of side effects that the patient could experience and also advised to contact primary health care provided. The patient made a call to the primary health care provider and was waiting for a reply.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Swelling, Vaccine positive rechallenge
Clinical narrative: nausea; weakness; headache; pain; swelling; Health issues; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, for tolerance refer case US2019AMR167033).   On 11th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced nausea, weakness, headache, pain, swelling and adverse reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, weakness, headache, pain, swelling and adverse reaction were not recovered/not resolved.   It was unknown if the reporter considered the nausea, weakness, headache, pain, swelling and adverse reaction to be related to Shingrix.  Additional details were provided as follows: On the day before the reporting date, the patient received Shingrix. The patient had many other health issues and was not sure if this was a reaction to the shot or something else and the patient would check it with primary health care provider. The patient asked about the duration of these side effects and how long they last. The call center representative provided general information of side effects that the patient could experience and also advised to contact primary health care provided. The patient made a call to the primary health care provider and was waiting for a reply.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Tired; Muscle aches; Headaches; Felt bad; This case was reported by a physician via sales rep and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness, muscle pain, headache and feeling bad. On an unknown date, the outcome of the tiredness, muscle pain, headache and feeling bad were recovered/resolved.   The reporter considered the tiredness, muscle pain, headache and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was a health care professional and had received Shingrix dose. The patient felt tired, had muscle aches and had headaches (these were consistent with the label). The patient felt bad for 2 days and then he went for sailing. The reporter stated, patient's wife also received Shingrix and experienced adverse events, refer case US2019AMR167044.
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Heart rate increased, Laboratory test
Clinical narrative: heart rate; light headed; This case was reported by a other health professional via sales rep and described the occurrence of heart rate increased in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 40 min after receiving Bexsero, the patient experienced heart rate increased and light headedness. On an unknown date, the outcome of the heart rate increased and light headedness were unknown.   It was unknown if the reporter considered the heart rate increased and light headedness to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After 40 min of Bexsero administration, the patient felt light headed and experienced heart rates between 78 to 118 beats per min.  Clinic stated they did report this to VAERS as well. The reporter agreed to follow up from GlaxoSmithKline.      Lab Comments: on an unknown date, lab test was done
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: injection site ache / dull pain at the site of the injection; ache all over the body; This case was reported by a pharmacist and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 16th July 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain and generalized aching. On an unknown date, the outcome of the injection site pain and generalized aching were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and generalized aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of the Shingrix was updated as 4H9G2 from 4H952, as per sales's data sheet. On 16th July 2019, the patient got NDC shot 58160-08232 11 The patient stated that, currently remodeling the house, so did get ache all over the body, but the ache at the site of the injection lingers on. The reporter consented to fiollow up.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, her friend's husband received dose of Shingrix and next day after vaccination experienced nausea. The reporter stated that, the nausea resolved in 1 day. The reporter did not provide additional details. For the tolerance of 2nd dose, refer case US2019167038, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Nausea, Pain
Clinical narrative: Weakness; Chills; Aching; Nausea; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced chills, pain, nausea, fatigue and weakness. On an unknown date, the outcome of the chills, pain, nausea, fatigue and weakness were unknown.   It was unknown if the reporter considered the chills, pain, nausea, fatigue and weakness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient demographic details were not provided. The age at vaccination was not reported. The patient reported that, after vaccination with dose of Shingrix, currently experienced chills, aching, nausea, fatigue and weakness. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dissociative amnesia, Headache, Influenza like illness, Swelling
Clinical narrative: Localized swelling; Flu Like Symptoms; Headache; Fugue like reaction for about 4 hours where she could not remember anything; This case was reported by a physician via call center representative and described the occurrence of swelling in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced swelling, influenza-like symptoms, headache and fugue state. On an unknown date, the outcome of the swelling, influenza-like symptoms, headache and fugue state were recovered/resolved.   It was unknown if the reporter considered the swelling, influenza-like symptoms, headache and fugue state to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 77 or 78 years. The patient received her first dose of Shingrix about 3 weeks ago at pharmacy.  The patient experienced localized swelling, flu like symptoms, headache and fugue like reaction for about 4 hours where she could not remember anything.  The patient recovered from everything within 24 hours, except the swelling which was almost gone. No further details were provided. The reporter gave permission to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received Shingrix. On 10th September 2019, 1 hr after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for the case for herself. The patient received dose of Shingrix in the right arm last night. About an hour later, the patient experienced shoulder pain. On the day of reporting, the patient called, seeking treatment recommendations but was referred to a health care provider. The patient stated that, pain had gotten worse over the night. The health care professional did not asked. This case was linked with the case US2019165574, reported for patient's husband.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain
Clinical narrative: burning; burning on whole body; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Flu vaccine (Several years ago the patient had a reaction to a flu vaccine that caused a skin crawling sensation. This lasted for almost one year before resolving. At that time she thought it might be due to the thimerosal in the vaccine).   On 22nd August 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 22nd August 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site burning and burning sensation. On an unknown date, the outcome of the injection site burning and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site burning and burning sensation to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received vaccine in unknown arm. On evening of 22nd August 2019, the patient started having a burning sensation in her arm around the injection site. The burning later spread to the whole side of her body, and then to her whole body. The reporter did not consent to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix. On 16th August 2019, immediately after receiving Shingrix, the patient experienced pain. Shingrix was continued with no change. On 19th August 2019, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's wife. The patient received vaccine in right arm. The patient developed pain shortly after receiving the vaccine.  The pain resolved after 3 days. The contact information was not available at the time of the call. The reporter did not provide any additional details. The reporter consented to follow up. This case had been linked to the case US2019166402, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; fatigue; sore arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, chills, fatigue and pain in arm. On an unknown date, the outcome of the fever, chills, fatigue and pain in arm were unknown.   It was unknown if the reporter considered the fever, chills, fatigue and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported.  The reporter did not wish to provide demographics or participate in a safety report. The patient received vaccine in unknown arm. The patient experienced fever, chills, fatigue and a sore arm. The reporter did not consent to follow up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number YE53N, expiry date 7th November 2021) for prophylaxis.   On 11th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: The patient reported having fever of 103 degree Fahrenheit. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Myalgia, Pain in extremity
Clinical narrative: arm  sore; fatigue; muscle aches; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE).   On 11th September 2019, the patient received the 1st dose of Shingrix. On 11th September 2019, 7 hrs after receiving Shingrix, the patient experienced pain in arm, fatigue, muscle pain and injection site erythema. On an unknown date, the outcome of the pain in arm, fatigue, muscle pain and injection site erythema were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, muscle pain and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. About 7 hours later, the patient experienced a sore arm, fatigue, muscle aches and redness at the injection site.  The redness at the site was described as about 3 inches in diameter.  The patient did receive an unspecified pneumonia shot in the opposite arm at the same time as Shingrix. The reporter did not consent to follow up.
Sex: M
Vaccine: MENB, UNK
Symptoms: Chromaturia, Headache, Pyrexia, Urine ketone body present, Urobilinogen urine increased
Clinical narrative: fever/high fever; severe headache; urobilinogen and ketones in his urine; urobilinogen and ketones in his urine; urine was also dark in color; This is a spontaneous report from a contactable physician.    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 second dose of meningococcal vaccine a/c/y/w (MENINGOCOCCAL VACCINE A/C/Y/W) , 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 previously took the first dose of meningococcal vaccine a/c/y/w for immunisation on an unknown date.  The patient experienced high fever  on an unspecified date with outcome of unknown , severe headache on an unspecified date with outcome of unknown , urobilinogen and ketones in his urine on an unspecified date with outcome of unknown , urine was also dark in color on an unspecified date with outcome of unknown. The reported events were considered non serious. The patient underwent lab tests and procedures which included urine analysis: urobilinogen and ketones    on unknown date,  body temperature: pyrexia on an unknown date.  His urine was also dark in color.  The information on the batch number has been requested
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Rash, Rash pruritic, Rash vesicular
Clinical narrative: patient described little to no reaction following  FIRST shingrix dose, however, following second dose, on the same day as the dose was given, in the afternoon patient reports feeling very ill - enough to be on the couch and unable to do normal daily activities until 48 hours later. Also, patient reports the appearance of a rash on her trunk and upper arm resembling chicken pox. the rash she said was very itchy and she used hydrocortisone cream to help. She reports recalling chickenpox as a child - a very severe case - in the summertime. The rash that came following the vaccination appeared approximately 2 weeks after her second dose of shingrix which was given 8/20/2019.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: HPI: erythematous site to RT thigh after receiving immunizations 2 days ago. Pt received MMR/VAR and DTAP/IPV on 9/17/19 and has since developed a pruritic, warm and red lesion to site where INJ were given. Mother has not given an antihistamines in response to reaction. Mother denies any angioedema, difficulty breathing or swallowing. PLAN:  pt may take prednisone <20 mg day <14 days for adverse reaction to live virus vaccine. Will treat adverse reaction with prednisone 5 mg daily x 5 days. Instructed mother to continue Benadryl as needed. Monitor reaction site and notify clinic if borders increase or systemic reaction occurs. Apply cool compresses to site. Encouraged mother to continue with Hep B immunization in one month. Risks vs benefits discussed. Adverse reaction reported to vaccine manufacturer. Mother v/u.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injected limb mobility decreased, Pain in extremity, Poor quality sleep
Clinical narrative: Right arm was very sore after receiving shot. Took some Tylenol and went to bed at approximately 10:00pm. Did not sleep well as my arm hurt. About 4:00 am I woke up shivering uncontrollably, had a horrible headache and could not move right arm at all.  Husband brought me another Tylenol and some water. After a while I dozed off and woke up approximately 6:30. I have had a headache all morning but my arm is not as bad as it was earlier.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: red, swollen, arm.  on day of vaccination  dr prescribed a steroid cream and doxycycline 2 days later
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Pain, Pain in extremity
Clinical narrative: I gave the patient the Shingrix shot. She complained of pain as I gave it but she expected it to hurt. After receiving her flu shot and Prevnar 13 in the opposite arm she felt dizzy. She sat down and I gave her a water. Within a few minutes she felt okay to leave and her husband drove her home. Her husband called the pharmacy and said the patient's arm was hurting very badly and pulsating. He said she already had a primary care doctor appointment within 2 hours and they would let the doctor look at it.
Age: 0.17
Sex: M
Vaccine: RV1, UNK, UNK
Symptoms: Gastrooesophageal reflux disease, Livedo reticularis, Post inflammatory pigmentation change
Clinical narrative: Mottled skin which worsened with heat or precise crying, diagnosed 9/20/19 as Post-Inflammatory Hyperpigmentation   Development of ?silent? reflux
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Insomnia, Pain
Clinical narrative: The evening of receiving the flu vaccine, the individual developed soreness in her left arm. Now, 9 days later, the arm is still sore, approximately 2" posterior to the injection site. The pain covers are area of near her left shoulder to her left elbow. The individual states that she has used hot packs and Tylenol for discomfort, but that she cannot sleep on the arm. She states that she can raise her arm to the side and back, but it is too painful to lift her arm forward. She has not experienced this pain following an injection before, and states that it feel like pain in the joint to the bone. There is no redness, swelling, warmth or hardness around the injection site.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: The evening of receiving the flu vaccine, the individual developed soreness in her left arm. Now, 9 days later, the arm is still sore, approximately 2" posterior to the injection site. The pain covers are area of near her left shoulder to her left elbow. The individual states that she has used hot packs and Tylenol for discomfort, but that she cannot sleep on the arm. She states that she can raise her arm to the side and back, but it is too painful to lift her arm forward. She has not experienced this pain following an injection before, and states that it feel like pain in the joint to the bone. There is no redness, swelling, warmth or hardness around the injection site.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Diarrhoea, Lethargy, Swelling face, Urticaria
Clinical narrative: Pt. received immunizations including Flu, mother arrived home approximately 20 mins later where it was noted that she was covered with hives and had facial swelling diarrhea and lethargy. EMS called and administer Epi .15mg and 7mg of Benadyl. Patient was transported to ED where she was observed for 4 hours and discharged home
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Headache, Muscle contracture, Nausea
Clinical narrative: After the administration of both influenza and PPD, patient felt dizzy then loss just this briefly. fell into the arms of the MA for 5-10 second. when I enter the room I witnessed patient's arms and legs clench and shaking involuntarily for about 5 seconds Her eyes were closed. No drooling, no bowel or urinary incontinence. When patient regained consciousness she answered all questions appropriately, but felt dizzy with 7 out of 10 headache and nausea. She vomiting and office x 4. She reports history of LOC while given blood 2 years ago, denies   seizures in the past. Never saw a neurologist in the past before. She was sento into the ER for suspected seizures - like activity further evaluation -
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure like phenomena, Tremor, Vomiting
Clinical narrative: After the administration of both influenza and PPD, patient felt dizzy then loss just this briefly. fell into the arms of the MA for 5-10 second. when I enter the room I witnessed patient's arms and legs clench and shaking involuntarily for about 5 seconds Her eyes were closed. No drooling, no bowel or urinary incontinence. When patient regained consciousness she answered all questions appropriately, but felt dizzy with 7 out of 10 headache and nausea. She vomiting and office x 4. She reports history of LOC while given blood 2 years ago, denies   seizures in the past. Never saw a neurologist in the past before. She was sento into the ER for suspected seizures - like activity further evaluation -
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Vomiting, leg pain -> Resolved
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: Received Tdap 9/3/19 - developed pain, swelling, within several hours increased pain & swelling 9/4/19. Seen in ED 9/6/19 - treated with Tylenol, ibuprofren, ice.
Age: 78.0
Sex: U
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red Hot RAsh
Age: 92.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: R Arm became painful, tender to touch, red, warm and swollen. Was treated with ice, Benadryl and hydrocodone. Pain and tenderness lasted 2 days, redness and swelling lasted another 4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Herpes zoster, Pain, Rash pruritic
Clinical narrative: 9/10/19 vaccinated. Initially had fatigue + aches 9/14/19 burning, itchy rash (R) back 9/18/19 office exam - Diagnosed with Shingles
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Urticaria
Clinical narrative: Vaccine admin @ approx 1430 on 9/11/19 and at 1730 9/11/19 noticed Hives + intermittent fever (TMaX 101.7) Hives resolved (self resolved w/o tx) evening of 9/12/19 + Fevers resolved 9/17/19. Pt. now asymptomatic.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect; Varivax was administered via intramuscular instead of subcutaneous; Varivax was given 20 minutes after receiving a properly administered dose of M-M-R II; This spontaneous report was received from a pharmacist refers to a patient of unknown age. There was no information about the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant medication.   On 28-AUG-2019, the patient was vaccinated at an unspecified retail location with varicella virus vaccine live (oka/merck)(VARIVAX) (Lot # S002877 expiration date not reported, but upon internal validation established as 29-JAN-2021), intramuscular instead of subcutaneous for prophylaxis (strength and dosage schedule were not reported). The reporter also stated that the vaccine was given 20 minutes after receiving a properly administered dose of measles virus vaccine live (enders-edmonston), mumps virus vaccine live (jeryl lynn), rubella virus vaccine live (wistar ra 27/3) (M-M-R II) for prophylaxis (strength, dosage schedule, route of administration, lot number and expiration date were not reported) at a different unspecified retail location. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; two patients were administrated an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 16-SEP-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S013489, expiration date 06-MAR-2021 (strength, route of administration and exact dose were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of above 9 Celsius degrees (also reported as 16.8 Celsius degrees) for 3 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA008031:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; two patients were administrated an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 16-SEP-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S013489, expiration date 06-MAR-2021 (strength, route of administration and exact dose were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of above 9 Celsius degrees (also reported as 16.8 Celsius degrees) for 3 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.; Sender's Comments:  US-009507513-1909USA007126: