chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 02-FEB-2009, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received the treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 12-JAN-2011, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received the treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2008, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), as prescribed and/or administered by a healthcare provider at a private doctor's office for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of use zoster vaccine live (ZOSTAVAX) use, the patient had and would 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 would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; VARIVAX and PROQUAD administered during same office visit; VARIVAX and PROQUAD administered during same office visit; This spontaneous report as received from a nurse refers to a patient of unknown age or gender. No information on patient's pertinent medical history, concomitant therapies and drug reactions or allergies was provided.   On 08-NOV-2019, the patient was vaccinated one dose each of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015461, expiration date 20-MAY-2021, dose, route of administration and anatomical location were not provided) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S012472, expiration date 20-OCT-2020, dose, route of administration and anatomical location were not provided), both for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: only received one dose of gardasil 9; NO ADVERSE EVENT; This spontaneous report was received from a pharmacist referring to a 17 years old female patient. The patient's concurrent condition, concomitant medications, pertinent medical history, drug reaction/allergies were not reported. On an unknown date, the patient received only one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) of one dosage form (strength, lot number, expiry date, route of administration were not reported) for prophylaxis at age 12 (inappropriate schedule of product administration). No adverse effects were reported. Outcome of the events was unknown. There was no product quality complaint (PQC) present.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody test
Clinical narrative: titres drawn recently which were negative for both mealses and mumps; titres drawn recently which were negative for both mealses and mumps; This spontaneous report was received from a registered pharmacist referred to an adult female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection, 1 dosage form, via subcutaneous route for prophylaxis (lot # and expiry date were not reported). It was not sure if the patient had received the vaccine and the patient did not have medical records from childhood to indicate when, if ever she had received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). On 11-NOV-2019, measles, mumps and rubella titers were drawn and was negative for both measles and mumps. Rubella titer result was unknown. There was no treatment given for the events. The outcome of the events was not resolved. The reporter did not provide any causality assessment. Product quality complaint was not involved.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: My dad ended up with GBS from the flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported for the patient's father. The age at vaccination was not reported. The patient ended up with guillain barre syndrome (GBS) after receiving flu vaccine and never experienced again.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Myalgia; This case was reported by a physician via sales rep and described the occurrence of fever 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, unknown after receiving Shingrix, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after vaccination experienced fever and myalgia. This case has been linked with case US2019AMR204582, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Myalgia, Pyrexia
Clinical narrative: stayed in bed; Fever; Myalgia; This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (received 1st dose on unknown date and experienced fever  ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, myalgia and bedridden. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and myalgia were recovered/resolved and the outcome of the bedridden was unknown.   It was unknown if the reporter considered the fever, myalgia and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, myalgia for about 2 days and stayed in bed. This case has been linked with case US2019AMR204541, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Immune system disorder, Influenza like illness, Injection site pain
Clinical narrative: Flu-like symptoms; Shivering; Tired; does not have a good immune system; Body aches; Injection was very painful/Arm in very sore/Body aches / Pain all over her body; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included polymyalgia rheumatica (experienced before receiving Shingrix). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 9th September 2019 and experienced painful arm,flu-like symptoms, tenderness in throat and neck,refer case US2019203805).   On 7th November 2019, the patient received the 2nd dose of Shingrix. On 7th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 8th November 2019, the patient experienced influenza-like symptoms, shivering, fatigue, immune system disorder and general body pain. The patient was treated with prednisone and methotrexate. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms and shivering were not recovered/not resolved and the outcome of the fatigue, immune system disorder and general body pain were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, shivering, fatigue, immune system disorder and general body pain to be related to Shingrix.  Additional details were provided as follows: At 3:00 pm, the patient received a dose of Shingrix. The patient experienced very painful injection site when Shingrix was administered and her her arm was very sore. The patient felt terrible going in.  The patient also experienced flu-like symptoms, including body aches, shivering, and pain all over her body.   The patient was very tired and her arm hurted terribly. On the day of reporting, she went to her rheumatologist and was told to rest because she did not have a good immune system.  The patient was treated with low dose prednisone daily, and methotrexate weekly. The reporter did not consent to follow-up. The reporter could not provide any additional information.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Flu-like symptoms; Shivering; Tired; does not have a good immune system; Body aches; Injection was very painful/Arm in very sore/Body aches / Pain all over her body; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included polymyalgia rheumatica (experienced before receiving Shingrix). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 9th September 2019 and experienced painful arm,flu-like symptoms, tenderness in throat and neck,refer case US2019203805).   On 7th November 2019, the patient received the 2nd dose of Shingrix. On 7th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 8th November 2019, the patient experienced influenza-like symptoms, shivering, fatigue, immune system disorder and general body pain. The patient was treated with prednisone and methotrexate. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms and shivering were not recovered/not resolved and the outcome of the fatigue, immune system disorder and general body pain were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, shivering, fatigue, immune system disorder and general body pain to be related to Shingrix.  Additional details were provided as follows: At 3:00 pm, the patient received a dose of Shingrix. The patient experienced very painful injection site when Shingrix was administered and her her arm was very sore. The patient felt terrible going in.  The patient also experienced flu-like symptoms, including body aches, shivering, and pain all over her body.   The patient was very tired and her arm hurted terribly. On the day of reporting, she went to her rheumatologist and was told to rest because she did not have a good immune system.  The patient was treated with low dose prednisone daily, and methotrexate weekly. The reporter did not consent to follow-up. The reporter could not provide any additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The reporter stated that the patient experienced flu like symptoms after vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Fatigue, Stomatitis, Vaccination complication
Clinical narrative: Fatigue / Being tired; Mouth sores; Difficulty swallowing; This case was reported by a consumer via other manufacturer and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fatigue, sores mouth and swallowing difficult. On an unknown date, the outcome of the fatigue, sores mouth and swallowing difficult were unknown.   It was unknown if the reporter considered the fatigue, sores mouth and swallowing difficult to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in July this year and developed really bad side effects. No additional information was provided. The reporter requesting consent to follow up.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Bedridden, Ear pain, Headache, Pyrexia, Urinary incontinence
Clinical narrative: Fever; Urinary incontinence; "Stuck in bed for 7 days"; Pain behind ears; Pain in head; Vision problems; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 23rd October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 28th October 2019, 5 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever, urinary incontinence, bedridden, ear pain, headache and abnormal vision. On 4th November 2019, the outcome of the urinary incontinence, ear pain and abnormal vision were recovered/resolved. On an unknown date, the outcome of the fever, bedridden and headache were unknown.   It was unknown if the reporter considered the fever, urinary incontinence, bedridden, ear pain, headache and abnormal vision to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient after vaccination experienced multiple symptoms including fever, urinary incontinence, being stuck in bed for 7 days, pain behind ears, pain in head and visual problems.  The patient was advised to report this to her physician. The patient consented to follow up.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Visual impairment
Clinical narrative: Fever; Urinary incontinence; "Stuck in bed for 7 days"; Pain behind ears; Pain in head; Vision problems; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 23rd October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 28th October 2019, 5 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever, urinary incontinence, bedridden, ear pain, headache and abnormal vision. On 4th November 2019, the outcome of the urinary incontinence, ear pain and abnormal vision were recovered/resolved. On an unknown date, the outcome of the fever, bedridden and headache were unknown.   It was unknown if the reporter considered the fever, urinary incontinence, bedridden, ear pain, headache and abnormal vision to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient after vaccination experienced multiple symptoms including fever, urinary incontinence, being stuck in bed for 7 days, pain behind ears, pain in head and visual problems.  The patient was advised to report this to her physician. The patient consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pruritus
Clinical narrative: Generalized itching; Inappropriate Schedule of Vaccine; Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles in January and March 2018). Previously administered products included Zostavax (received when it was first marketed).   On 20th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In September 2019, 14 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced generalized itching and incomplete course of vaccination. The patient was treated with cetirizine hydrochloride (Zyrtec), cetirizine hydrochloride (Cetirizine) and valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, generalized itching and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and generalized itching to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Nurse for her mother. The reporter stated that the patient developed generalized itching two weeks post injection. The patient was treated with prescription for Zyrtec and Cetirizine. In September 2019, patient was confirmed with a case of Shingles by her primary care physician. The patient was treated with 2 weeks of Valacyclovir. Till the time of reporting patient did not receive the vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter for one of her friend. The age at vaccination was not reported. The reporter stated that the patient experienced side effects after vaccination. The reporter did not know what side effects the patient experienced. Reporter did not want to provide further further details. This case has been linked with case US2019202816, reported by the same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Bumpy, itchy, rash predominately on her trunk, and both legs although she has some bumps on her left elbow area; Bumpy rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number EG55L, expiry date 7th December 2021) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th November 2019, 1 days after receiving Shingrix, the patient experienced itchy rash and papular rash. On an unknown date, the outcome of the itchy rash and papular rash were recovering/resolving.   It was unknown if the reporter considered the itchy rash and papular rash to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient developed a bumpy, itchy, rash predominately on her trunk, and both legs although she has some bumps on her left elbow area. On 6th November 2019, the patient had more bumps but they were not as itchy. The reporter was  unable to provide any additional details.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: swelling; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional information was reported as follows: The patient received a dose of Shingrix on the right arm. Additional information was not provided. The reporter did not consent to follow-up. For tolerance to 2nd dose refer linked case, reported by the same reporter.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Muscular weakness, Pain
Clinical narrative: Intense burning during shot. ( I told him too.  2 days later, pain began in shoulder area and radiated down left arm. Continual pain for 20 days throughout arm. Some weakness significant loss of use of left arm to do the simplest things. Never had any shoulder issues EVER! Doctor put me on steroids and Tramadol. STILL EXPERIENCING DIFFICULTY using left arm and significant , consistent pain not relieved by Ibuprophen or Tylenol.  Cannot sleep in any position. Going to see an orthopedic doctor Friday, Nov15, 2019
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity
Clinical narrative: Intense burning during shot. ( I told him too.  2 days later, pain began in shoulder area and radiated down left arm. Continual pain for 20 days throughout arm. Some weakness significant loss of use of left arm to do the simplest things. Never had any shoulder issues EVER! Doctor put me on steroids and Tramadol. STILL EXPERIENCING DIFFICULTY using left arm and significant , consistent pain not relieved by Ibuprophen or Tylenol.  Cannot sleep in any position. Going to see an orthopedic doctor Friday, Nov15, 2019
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle tightness, Photopsia, Vision blurred, Visual impairment
Clinical narrative: Some muscle tightness in injected arm, followed by vision disturbance. Initial visual disturbance was left lateral (left eye) blur followed by increasing blurring and then flashing lights in a semicircle, left lateral field of view. This was ongoing and increasing in intensity for approximately 2 hours. Eventually at its worst the flashing lights covered approximately 30-40% of the left lateral visual field of the left eye. The issue resolved without any treatment after the two, to two and half hours.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Small rash appeared on right anterior chest, smaller than the size of a dime.  Patient reported zero pain.  Spot has not resolved, but has not gotten worse and pain has not arisen as of 0851 on 13 November when followed up with.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Feeling abnormal, Feeling of body temperature change, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: In her spouse present, prior to receiving her vaccinations, patient stated that she wasn't good with needle. While receiving the doses, patient breathed in and out very fast to overcome the pain and the fear of needle. As soon as patient received both vaccinations, patient stated that she felt pain on injections sites. She doesn't feel right.  She sat for a little, may be 5 minutes, she started to feel nauseated, ear ringing, seeing spots around the room. She fainted and came out of it on her own. She stated that she felt warm and chill at the same time, with visible perspirations. We sat with her for another 20-30 minutes. She felt better, was able to hold conversation.  I confirmed that she was able to stand up and take steps without assistance prior to leaving the consultation room
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Syncope, Tinnitus, Visual impairment
Clinical narrative: In her spouse present, prior to receiving her vaccinations, patient stated that she wasn't good with needle. While receiving the doses, patient breathed in and out very fast to overcome the pain and the fear of needle. As soon as patient received both vaccinations, patient stated that she felt pain on injections sites. She doesn't feel right.  She sat for a little, may be 5 minutes, she started to feel nauseated, ear ringing, seeing spots around the room. She fainted and came out of it on her own. She stated that she felt warm and chill at the same time, with visible perspirations. We sat with her for another 20-30 minutes. She felt better, was able to hold conversation.  I confirmed that she was able to stand up and take steps without assistance prior to leaving the consultation room
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cold sweat, Hot flush, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient called this reporter today 11/13/19  with complaints of swelling, pain, and vertical rash trending down the patients arm from the injection site. (Pt received flu and pneumovax 11/11/19 n left deltoid.) Pt states that Monday night 11/11/19 they could not sleep due to cold sweats, hot flashes, and pain at injection site. Pt did not take temp on Monday to confirm fevers. Today 11/13/19 patient states left arm is warm to touch and vertical rash is still present. This reporter paged ordering MD. Dr. suggested patient be seen today. Due to patient living far from this medical center. Patient is going to be seen today by PCP.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Insomnia, Skin warm
Clinical narrative: Patient called this reporter today 11/13/19  with complaints of swelling, pain, and vertical rash trending down the patients arm from the injection site. (Pt received flu and pneumovax 11/11/19 n left deltoid.) Pt states that Monday night 11/11/19 they could not sleep due to cold sweats, hot flashes, and pain at injection site. Pt did not take temp on Monday to confirm fevers. Today 11/13/19 patient states left arm is warm to touch and vertical rash is still present. This reporter paged ordering MD. Dr. suggested patient be seen today. Due to patient living far from this medical center. Patient is going to be seen today by PCP.
Age: 68.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Hypertension, Intra-cerebral aneurysm operation, Intracranial aneurysm, Malaise, Surgery
Clinical narrative: Received one (1)  HEP A shot in my arm plus three (3) Globulin shots in my legs (2) in right thigh and (1) in left thigh. Within a few hours I was at the Emergency room with burns on the right side of my forehead,  (I can provide photos, if necessary)  The ER Doc had said it may be shingles and sent me on my way.  I knew it was't shingles because It was a burn, not blisters. The burns lasted about 10 days.  During the week of 5/20/2019, my BP was very high and I wasn't feeling well.  On 5/27/2019 I was diagnosed with a brain aneurysm on the right side of my brain. Surgery was done on 5/30/19.- three (3) clips were inserted along with titanium screws and plates.  I was due to receive the second dose of HEP A yesterday and after talking with medical staff and family, I decided not to receive the HEP A shot. (I can provide photos of the brain surgery, if needed).  My family doctor thought the reaction I had was from the Globulin.
Age: 68.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Thermal burn
Clinical narrative: Received one (1)  HEP A shot in my arm plus three (3) Globulin shots in my legs (2) in right thigh and (1) in left thigh. Within a few hours I was at the Emergency room with burns on the right side of my forehead,  (I can provide photos, if necessary)  The ER Doc had said it may be shingles and sent me on my way.  I knew it was't shingles because It was a burn, not blisters. The burns lasted about 10 days.  During the week of 5/20/2019, my BP was very high and I wasn't feeling well.  On 5/27/2019 I was diagnosed with a brain aneurysm on the right side of my brain. Surgery was done on 5/30/19.- three (3) clips were inserted along with titanium screws and plates.  I was due to receive the second dose of HEP A yesterday and after talking with medical staff and family, I decided not to receive the HEP A shot. (I can provide photos of the brain surgery, if needed).  My family doctor thought the reaction I had was from the Globulin.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Chills, Pain, Pyrexia
Clinical narrative: Started with a extreme body aches followed by fever and chills.  The adverse reaction however was the intense stomach pain.  Lasted about three days.  Started at the top of my stomach in the center and worked it's way down over the course of approximately three days, every day the pain lessening.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms i.e. chills, muscle aches headache.  Pt self treated with acetaminophen and symptoms resolved around 1 hour after taking acetaminophen.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: Patient reported flu like symptoms i.e. nausea, muscle soreness.  Felt like "hit by truck."  Pt self treated with ibuprofen 600mg Q6H.  Symptoms persisted for 48 hours, however pt was able to resume normal daily activities 24 hours after symptom onset.
Age: 15.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Menveo was given to early.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Patient reports pain in his upper arm and difficulty moving one of his fingers. Received the vaccine around 9am and states the symptoms started the same day in the afternoon
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: 48 hours later- symptoms started with pins and needles in foot and went up entire leg. 11/13- still experiencing symptoms in foot. Patient has had this reaction before, in years prior with flu shot. Been treating with tylenol.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Blood culture negative, Injection site cellulitis, Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient developed cellulitis of her right arm, extending from the area of the Pneumovax vaccine.  Symptoms began approximately 12 hours after vaccination (fever of 102, redness extending distally and medially from the injection site, pain, body aches).  She sought ER care and was started on Keflex, but symptoms worsened.  She was subsequently treated with doxycycline, and symptoms improved.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Patient developed cellulitis of her right arm, extending from the area of the Pneumovax vaccine.  Symptoms began approximately 12 hours after vaccination (fever of 102, redness extending distally and medially from the injection site, pain, body aches).  She sought ER care and was started on Keflex, but symptoms worsened.  She was subsequently treated with doxycycline, and symptoms improved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects were reported; the 21 year old patient was inadvertently administered one pediatric dose of VAQTA on 17OCT2019; This spontaneous report as received from a registered nurse refers to a 21 year old patient of unknown gender. No information on patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 17-OCT-2019, the patient was inadvertently vaccinated with one pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date 24-JUL-2020) one 25/0.5 (units not provided) dose, intramuscular for prophylaxis. No adverse effects were reported.
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. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 23-APR-2014, he was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist in the pharmacy. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, he had 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 outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no advesre effect; M-M-R II was administered via the intramuscular route than subcutaneous route; This spontaneous report was received from a pharmacist regarding a 27 year old patient of unknown gender. Information on pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were not reported.       Approximately on 11-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) injection, one dosage form, Lot No. R036580 has been verified to be a valid lot number for (measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live), expiration date reported as 17-DEC-2020 (strength, dose, anatomical location was not reported) via intramuscular route for prophylaxis. Other suspect therapies included sterile diluent injection, lot # has been verified to be a valid lot number for (sterile diluent), expiration date reported as 22-JUL-2021.   On 11-NOV-2019, the patient inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) via the intramuscular route, rather than the recommended subcutaneous route" (incorrect route of product administration). No adverse effects were reported. The outcome of incorrect route of product administration and no adverse event was unknown. No product quality complaint was involved.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) (batch number YE53N, expiry date 7th November 2021) and (batch number QE4SZ ?, expiry date 26th November 2021) for prophylaxis.   On 7th October 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The healthcare professional declined to provide patients initials and date of birth. The vaccine lot number and expiration date provided in report fields were for the powder portion of Shingrix. The patient experienced a rash following a dose of Shingrix. No onset date of rash was provided. The reporter noted the patient went to his doctor and a skin biopsy was sent for review. The results did not returned at time of reporting. No additional information was there to provide. The reporter consent to follow up
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: warm red area below injection site; war at injection site; injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 6th November 2019, the patient experienced erythema and feeling of warmth. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the erythema was not recovered/not resolved and the outcome of the feeling of warmth was unknown.   It was unknown if the reporter considered the injection site pain, erythema and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a sore injection site that day.  The patient had warm, red, area that was huge below the injection site,described as 3.5 inches by 2 inches.He states the arm soreness has resolved, only the red area below remains at this time.  The reporter consented to follow up. The reporter has no further details for this adverse event, declines follow up.
Age: 29.0
Sex: F
Vaccine: ANTH, IPV, TYP
Symptoms: Skin test, Urticaria
Clinical narrative: Urticaria to bilateral upper & lower extremities with an onset about 2 hours after receipt of anthrax #5 (lot # not documented), typhoid #5 ( G1124) & IPV #1 ( as adult, E02041) in JAN 2015. She had no symptoms suggestive of anaphylaxis and was seen by DHA-IHD the day of event 06 JAN 2015.  She was treated with Zyrtec, topical Lidex & prn hydroxyzine and had fully resolved at f/u two days later. POC was anthrax exemption, and prick testing for IPV & typhoid vaccine after deployment.
Age: 71.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Erythema, Insomnia, Peripheral swelling, Pruritus, Rash
Clinical narrative: ARM RASH:        started after receiving injection of influenza and pneumonia in same arm, noticed some swelling and redness, that has progressively worsened, itches, having a hard time sleeping due to pain and itching.        no fever, no chills.        admits to pain and discomfort, making it difficult to sleep. Treatment: Start Keflex Capsule, 500 MG, 1 capsule, Orally, every 12 hrs, 7 days, 14 Capsule, Refills 0 Start Vistaril Capsule, 25 MG, 1-2 capsule as needed, Orally, every 8 hrs, 3 days, 24, Refills 0
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Ammonia normal, Analgesic drug level therapeutic, Angiogram
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alcohol normal
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood creatinine normal, Blood culture negative
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood electrolytes normal, Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein increased, Chest X-ray normal, Confusional state, Culture urine negative
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug screen negative, Dysarthria, Full blood count normal, Incoherent, International normalised ratio normal
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Magnetic resonance imaging brain normal, Pyrexia, Specific gravity urine increased, Tachycardia
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Thyroxine free normal, Troponin normal, Urine ketone body present, Vaccination complication, White blood cell count normal
Clinical narrative: Patient reported she "passed out" (presumably at work) and was driving herself to emergency room.  Possible slurring of speech .  Had difficulty articulating and felt confused.  Mildly tachycardic (HR 120's).  Unable to speak coherently.  Midway through exam, stopped following commands.  Ruled out stroke.  Noted to have fever after admission but started to improve even before antibiotics administered.  ID consult suggested likely reaction to shingrix vaccine.  Speech, mental status and ambulation at baseline on discharge 24 hours later.