chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Fatigue, Head discomfort, Intracranial pressure increased, Laboratory test
Clinical narrative: Fatigue, Pressure in my head, Multiple LP, Diagnosis with Intracranial Hypertension. In the process of seeing Neurosurgeon about getting a shunt put in.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Fatigue, Pressure in my head, Multiple LP, Diagnosis with Intracranial Hypertension. In the process of seeing Neurosurgeon about getting a shunt put in.
Age: 1.92
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Injection site induration, Injection site mass, Peripheral swelling
Clinical narrative: Pt's mother noticed bump on left thigh. Hepatitis A and HIB were both given in right thigh. The Hep. A was above with the HIB given 1 inch below. Nothing abnormal during injection of either vaccination. Bandage applied. Mother noticed firmness next day. During 2 year check up, mother asked about the area that had since turned into a hard pea size lump and was told not to worry. Mother questioned write on 10/23/17 prior to giving patient the flu shot. The pea size hard lump is very easily palpated and when the skin is lightly pulled to the side, the lump is very easily seen. Pt doesn't seem to have pain when pressing on the area and hasn't shown any other abnormal behaviors or symptoms. Mom was told the issue would be put into the VAERS system and to continue to monitor it.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: CSF virus no organisms observed, Encephalitis, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Child was hospitalized 10/11/17-10/14/17  for vomiting and dehydration due to Enterovirus. Upon discharge, child received influenza vaccine.  She subsequently developed neurological sequelae and was re-admitted to hospital 10/15/17-10/18/17.  CSF was negative for viral etiology, but MRI confirmed encephalitis.
Sex: U
Vaccine: FLUX
Symptoms: Arthralgia, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Good morning, On 11-17-15, I was given a flu vaccine shot, here at the prison. On the bottom right, back side of the Vaccine Information Statement I was given it said the following "Vaccine Information Statement Inactivated Influenza Vaccine, 08/07/2015, 42 U.S.C. 30028-26. I myself am writing to you directly to report this reaction I had to the flu vaccine, because the 2 incompetent doctors here, refused to file or send a report of the incident to you, and still refuse. Here is what happened briefly: On 11-17-15, the nurse gave me the flu vaccine injection on my upper left arm. The next morning 11-18-15, my left upper arm swelled up, was bright red and extremely painful down to my wrist, including my shoulder joint too. Later that evening 11-18-15, my heart beat rose up fast and irregular, and my heart shook so hard it made my chest shake. I had to start taking my nitro pills and aspirins too, and I was dizzy, nauseous and weak. This lasted 3 days, and I thought I was going to die from a heart attack. (I was 63 years old at that time). Officers tried to get the doctor to see me, and so did the nurses. The doctors did nothing for me. On 11-19-15, a nurse confirmed in writing, that I was having a reaction to the flu vaccine. On 11-26-15, ten days later, another nurse saw me, and confirmed in writing, I was still having a reaction, and described in her report that my upper left arm was still swollen and red, and my arm was still painful. The doctors still refused to send me out for tests. Nothing was ever done for me. One doctor had the incompetent nerve, to accuse my swollen arm was "Lipoma", which is a swelling of the soft tissue, not a reaction to the flu shot. He said this without doing any biopsy or tests. As of this date, 10-12-17, I still have a large swollen painful lump at the flu vaccine injection site, and my shoulder joint remains sore and painful. I never had any of that until I was given that flu vaccine injection on 11-17-2015, it's obviously never going to fade away. Please make a record of my reaction to that Flu vaccine, and the permanent lump, pain, at the injection site, and shoulder pain I have, as a direct result from that flu vaccine I was given on 11/17/15.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity, Tremor
Clinical narrative: Good morning, On 11-17-15, I was given a flu vaccine shot, here at the prison. On the bottom right, back side of the Vaccine Information Statement I was given it said the following "Vaccine Information Statement Inactivated Influenza Vaccine, 08/07/2015, 42 U.S.C. 30028-26. I myself am writing to you directly to report this reaction I had to the flu vaccine, because the 2 incompetent doctors here, refused to file or send a report of the incident to you, and still refuse. Here is what happened briefly: On 11-17-15, the nurse gave me the flu vaccine injection on my upper left arm. The next morning 11-18-15, my left upper arm swelled up, was bright red and extremely painful down to my wrist, including my shoulder joint too. Later that evening 11-18-15, my heart beat rose up fast and irregular, and my heart shook so hard it made my chest shake. I had to start taking my nitro pills and aspirins too, and I was dizzy, nauseous and weak. This lasted 3 days, and I thought I was going to die from a heart attack. (I was 63 years old at that time). Officers tried to get the doctor to see me, and so did the nurses. The doctors did nothing for me. On 11-19-15, a nurse confirmed in writing, that I was having a reaction to the flu vaccine. On 11-26-15, ten days later, another nurse saw me, and confirmed in writing, I was still having a reaction, and described in her report that my upper left arm was still swollen and red, and my arm was still painful. The doctors still refused to send me out for tests. Nothing was ever done for me. One doctor had the incompetent nerve, to accuse my swollen arm was "Lipoma", which is a swelling of the soft tissue, not a reaction to the flu shot. He said this without doing any biopsy or tests. As of this date, 10-12-17, I still have a large swollen painful lump at the flu vaccine injection site, and my shoulder joint remains sore and painful. I never had any of that until I was given that flu vaccine injection on 11-17-2015, it's obviously never going to fade away. Please make a record of my reaction to that Flu vaccine, and the permanent lump, pain, at the injection site, and shoulder pain I have, as a direct result from that flu vaccine I was given on 11/17/15.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Febrile infection-related epilepsy syndrome, Headache, Laboratory test, Oropharyngeal pain
Clinical narrative: Fever started 9/29/17, Pt also with cough, vomiting, headache and sore throat.  9/30/17 presented to local ED with seizures and was transported to hospital, she remains there presently. Dx with FIRES syndrome.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Seizure, Vomiting
Clinical narrative: Fever started 9/29/17, Pt also with cough, vomiting, headache and sore throat.  9/30/17 presented to local ED with seizures and was transported to hospital, she remains there presently. Dx with FIRES syndrome.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a reaction in the left arm where her FLUZONE HD flu shot was given. Patient had redness, swelling, warmth to the touch, and pain. She reported having trouble moving the arm. Patient reported that the reaction moved a bit down the arm and into the inner arm. The reaction started on 10/17/17, the day after the vaccine was given. The reaction lasted for approximately 4 days. Reaction was treated with an antihistamine and an ice pack and resolved without any further treatment. Patient reported post-immunization that she has a latex allergy. She did not indicate a latex allergy on her Vaccine Administration Consent Form. All items used to give immunization are labeled latex free.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Axillary pain, Erythema, Headache, Induration, Injection site erythema
Clinical narrative: Developed symptoms of pain and redness at the site of the shingles vaccine with pain up the arm into the armpit with tenderness to touch. She has also had a low grade persistent headache since Friday night and the injection site is irritated and itching. Right arm with a 5 cm area of indurated redness that is warm to touch, no streaking redness or excoriation. Right axilla is tender to palpation and a tense cord is palpable within the anterior axilla. Keflex 500 mg BID x 10 days. Zyrtec or Claritin twice a day for 3-5 days for itching associated with a likely histamine reaction at the site.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site irritation, Injection site pain, Injection site pruritus, Skin warm, Tenderness
Clinical narrative: Developed symptoms of pain and redness at the site of the shingles vaccine with pain up the arm into the armpit with tenderness to touch. She has also had a low grade persistent headache since Friday night and the injection site is irritated and itching. Right arm with a 5 cm area of indurated redness that is warm to touch, no streaking redness or excoriation. Right axilla is tender to palpation and a tense cord is palpable within the anterior axilla. Keflex 500 mg BID x 10 days. Zyrtec or Claritin twice a day for 3-5 days for itching associated with a likely histamine reaction at the site.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy, Musculoskeletal pain, Spinal pain, Swelling, Throat irritation
Clinical narrative: 30 minutes after vaccination, developed pain with a swelling in R c-spine.  Swollen painful R cervcial lymphadenopathy with radiation of pain into the R shoulder and also had a scratchy throat.
Age: 62.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Patient received vaccine on 10/09/17 and experienced mild soreness afterwards. On 10/16/17 shoulder pain started, on 10/19/17 she had difficulty lifting up her arm. Was seen in clinic on 10/23/17.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Muscular weakness
Clinical narrative: Let me begin to say I am a 72 year old male that was diagnosed with post-polio syndrome in 1998. I am not exactly sure when I first noticed what I believe to be an adverse reaction to a flu shot since this was over 1 year ago. Sometime in Oct. 2016, I noticed a significant loss of strength in my right triceps. By significant I mean more than a 70% loss. It has not improved since then. Neither my doctors nor I ever connected the flu shot with this weakness along with a total loss of energy. They always attributed the weakness to post-polio syndrome. I never thought it was due to this medical problem since I never experienced nor heard of post-polio acting in this fashion. I always thought this new weakness was caused by something I ingested but once again I never connected those dots until it was time for this year's flu shot. Then it all seemed to fall into place. I am totally convinced that the flu shot I received in 2016 caused this arm weakness. It may have had something to do with the fact that this shot was the first time I ever received a high dose flu shot.
Age: 81.0
Sex: M
Vaccine: TD
Symptoms: Myalgia
Clinical narrative: Pt stated 3 days after receiving the vaccine he had muscle pain in his shoulders, trapezius, upper arms and hamstrings. ALEVE did not relieve the pain. The pain continued and he was seen by the physician on 10/24/17 and started on a MEDROL dose pack.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Within days of receiving vaccines in the right upper arm patient has developed redness warmth and tenderness and does not want to move her right arm. She feels a little sick but has not had a fever.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Site of injection was swollen. Recommended to take BENADRYL. Will follow up with patient in 2 days.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis contact, Pain, Rash
Clinical narrative: Vaccine given on 9/14/17 in clinic per protocol without any adverse event. Pt came to clinic on 10/4/17 complaining of rash that started a "few days" prior. Rash: Splotchy on abdomen, scratches on upper thighs. Painful in both areas. Both started at the same time. Not itchy, it "burns". No new medications, soaps, lotions, foods. Unable to identify any triggers. Consulted with MD, Diagnosed with contact dermatitis and treated with Bethamethasone topical cream 0.05% BID x 5 days. Client called clinic on 10/23/17 stating that she figured out the trigger for the rash and feels it is related to the Hepatitis B vaccination.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Patient here with a reaction left arm where she had injection for PNEUMOVAX and flu vaccine. She is widespread achiness and feels feverish. Area of erythema is enlarging slowly.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Restlessness, Vomiting
Clinical narrative: At 12:00am on 10/24 patient started vomiting throughout the night, temp 101 at 0900, chills, restless, no rash, no breathing difficulties.
Age: 40.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Hot flush, Injection site swelling, Pain
Clinical narrative: Patient calling, he got a flu and pneumonia vaccine on 10/19/17. He said that he got chills, hot flashes, swelling at the injection site, fever, body aches for about 2 days. His arm is still tender and redness is getting better.
Age: 40.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Patient calling, he got a flu and pneumonia vaccine on 10/19/17. He said that he got chills, hot flashes, swelling at the injection site, fever, body aches for about 2 days. His arm is still tender and redness is getting better.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called 10/24/17 complaining about extreme arm pain in her left arm (where she claimed she could not lift her arm at all). Patient stated it started the evening of 10/23/17. Advised the patient to ice her arm and take ibuprofen and if symptoms worsen to call her pcp.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Mobility decreased
Clinical narrative: 4th day after injection moderate deep joint pain in shoulder and decreased range of motion unable to lift arm greater then 15 degrees from trunk of body. Also unable to reach behind body.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Pyrexia, Skin warm
Clinical narrative: Patient received 2 vaccines in his left deltoid region last week. Within 2 or 3 days he developed increased redness warmth and tenderness as well as fever sweats and chills. Area of erythema is gradually enlarging.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Tenderness
Clinical narrative: Patient received 2 vaccines in his left deltoid region last week. Within 2 or 3 days he developed increased redness warmth and tenderness as well as fever sweats and chills. Area of erythema is gradually enlarging.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Lymphadenopathy, Nasal congestion
Clinical narrative: Extreme nasal congestion, chills and very swollen lymph nodes.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and referred to a 69-year-old male patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. The patient had no known drug reactions or allergies. On 18-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N010106, expiry date 15-NOV-2018) in the right arm (dose and route of administration were not reported), the indication was reported as "indicated in his age". On an unknown date in September 2017, the patient developed hives on both thighs. On an unknown date in September 2017, the patient was seen by a physician and treated with BENADRYL. On an unknown date in September 2017, the patient recovered from the event.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not provided. On 08-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, route of administration, lot number and expiration date were not specified) for prophylaxis. On 06-OCT-2017 (reported as "now"), the patient visited nurse's office to receive the second dose of GARDASIL 9 (exact dose, route of administration, lot number and expiration date were not specified). No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a currently 67-year-old female patient. The patient's medical history, concomitant medications and drug allergies were not provided. In 2012, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not specified) for prophylaxis. On an unknown date, the patient developed shingles. The patient sought medical attention and contacted the doctor. The outcome of the event was unknown. The relatedness between ZOSTAVAX and the event was not provided. Sender's Comments: US-009507513-1710USA004915.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Mobility decreased, Pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 67-year-old female patient. The patient had no pertinent medical history, concomitant medications, drug reactions, or allergies. On 04-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscularly; lot # N012840, expiration date: 20-JAN-2019). On the same day, the patient felt achy, warm and there was redness at injection site, and the redness spread to neck and breast. Patient had swelling, and was unable to lift arm due to pain. The patient was sought medical attention and on 04-OCT-2017 at 08:00 at night, she was calling to the physician's office. On 05-OCT-2017, the patient visited physician's office and was administered prednisone (manufacturer unknown) taper and KEFLEX (500 mg every 8 hours for 7 days). No laboratory diagnostic studies were performed. The outcome the adverse events and the relatedness between the adverse events and PNEUMOVAX 23 were not provided.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 67-year-old female patient. The patient had no pertinent medical history, concomitant medications, drug reactions, or allergies. On 04-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (intramuscularly; lot # N012840, expiration date: 20-JAN-2019). On the same day, the patient felt achy, warm and there was redness at injection site, and the redness spread to neck and breast. Patient had swelling, and was unable to lift arm due to pain. The patient was sought medical attention and on 04-OCT-2017 at 08:00 at night, she was calling to the physician's office. On 05-OCT-2017, the patient visited physician's office and was administered prednisone (manufacturer unknown) taper and KEFLEX (500 mg every 8 hours for 7 days). No laboratory diagnostic studies were performed. The outcome the adverse events and the relatedness between the adverse events and PNEUMOVAX 23 were not provided.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concomitant medications and drug allergies were not reported. On an unknown date, the patient was vaccinated with PROQUAD therapy type rHA, lot # N013865, expiration date 31-OCT-2018. On an unknown date (five days after the first dose), the patient inadvertently received an additional dose of PROQUAD therapy type rHA, lot # N013865, expiration date 31-OCT-2018. The vaccines were reconstituted with sterile diluent. No adverse effects were reported.
Age: 74.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 74 year old female patient with penicillin allergy. No information about the patient's medical history was provided. On 04-OCT-2017, the patient was vaccinated with the first dose of ZOSTAVAX 19400 PFU injection, subcutaneously, lot # N020939 with expiration date: 26-OCT-2018 (dose was not reported) to prevent shingles reconstituted with sterile diluent (manufacturer unknown) lot# M016886 with expiration date: 07-DEC-2018 and with the first dose of FLUAD intramuscularly, lot# 178901 (expiration date and dose were not reported). Concomitant therapies included Carvedilol (unspecified) orally, 50 mg daily, atorvastatin, SINGULAIR, ramipril and PRILOSEC. The patient had no illness at the vaccination time. On 04-OCT-2017, the patient experienced "red circle" at injection site which were still there, 5 days later on 09-OCT-2017. Injection site also itched on the same date as 04-OCT-2017, but had since dissipated. The events lasted longer than usually. No treatment was commenced for the events. The outcome of the events was reported as recovering/resolving. The patient did not seek medical attention. Product quality complaint was not involved. The causality between the event and suspect therapies was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, No adverse event, Product container issue
Clinical narrative: This spontaneous report was received from a male pharmacist of an unknown age who was referring to himself. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-OCT-2017, while preparing to administer a ZOSTAVAX (lot# was reported as N02117 and expiration date: 27-OCT-2018) reported as vaccine, a small hole in the bottom of the vial caused an unknown amount of liquid to leak out on the patient's hand. The patient washed the affected area with soap and water and sterilized the area with rubbing alcohol. No adverse effects have been noted after the exposure. The patient's was recovered at the time of this report. The relatedness between the events and inadvertent exposure to ZOSTAVAX was not reported. Lot number N02117 has been verified to be a non valid lot number for ZOSTAVAX.
Sex: M
Vaccine: HPVX
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: This spontaneous report as received from a unknown reporter via company representative refers to a 13 year old male patient. The patient's medical history and current conditions were not reported. On 16-OCT-2017, the patient was vaccinated with first dose of GARDASIL or GARDASIL 9 (dose, route and indication were not reported). In approximately October 2017, the patient became lightheaded and sweaty. The outcome of the events was reported as recovered with no issues, after sitting for a short time. Additional information is not expected. No correspondence contact was provided therefore no correspondence letter can be sent.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5 year old patient of an unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 21-AUG-2017, at 16:02, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M021729, expiry date 29-OCT-2017, 0.5 ml, subcutaneously, in the left upper arm for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion at -14 Celsius degrees to -10 Celsius degrees, during a time frame of 4 hours and 30 minutes. There was no previous temperature excursion. No adverse events were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA010724: US-009507513-1710USA011620:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5 year old patient of an unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 21-AUG-2017, at 12:30, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M021729, expiry date 29-OCT-2017, 0.5 ml, subcutaneously, in the left thigh for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion at -14 Celsius degrees to -10 Celsius degrees, during a time frame of 4 hours and 30 minutes. There was no previous temperature excursion. No adverse events were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1708USA010724: US-009507513-1710USA011619:
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from a consumer on 09-Oct-2017. This case involves a female patient of unknown age who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration were not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed systemic symptoms. The patient's laboratory data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist on 09-Oct-2017. This case involves a seven patient (onset age and gender not reported) who were vaccinated with a single dose of FLUZONE QUADRIVALENT (batch number: UI838AA, expiry date: 30-Jun-2018 and site of administration were not reported) via intramuscular route on 04-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed injection site reaction, rash with warmth and erythema below injection site extending to elbow region. No tenderness or itching reported. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patients were recovered from events. List of documents held by sender: none.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Initial unsolicited report received from a pharmacist on 09-Oct-2017. This case involves an 87-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE HD (batch number: UI808AB) in left deltoid via intramuscular route on 30-Aug-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced still soreness in the left arm. It was stated by reporter that the patient stated he sleeps on his left side. The patient's laboratory data and corrective treatment were not reported. The event outcome reported as unknown. List of documents held by sender: none.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Erythema, Skin warm, Tenderness
Clinical narrative: Initial unsolicited report received from physician on 10-Oct-2017. This case involves a 15-year-old male patient who was vaccinated with a single dose of FLUZONE QUADRIVALENT (Lot number: UI810AA, expiration date 30-Jun-18) in left deltoid via intramuscular route on 04-Oct-2017. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, one day following the vaccination, the patient developed 3x2 inch area with erythema, warmth, tenderness to touch, also had GI upset. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient was recovered from the events. List of documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Induration, Skin warm
Clinical narrative: Mild cellulitis on left arm. Erythema 5.5 cm x 4 cm, warmth and a small amount of induration. No treatment needed cleared up within 4 days per mother.
Age: 63.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Emotional disorder, Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: The patient experienced vasovagal syncope. Was breathing but not responsive. After she became aware of her surroundings, said that she does not handle injections well as she passes out. Daughter became very upset at us. We called 911 due to low BP. Medics brought patient to ER. Patient was coherent upon arrival.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Urticaria
Clinical narrative: PATIENT DEVELOPED A BRIGHT RED RASH WITH A WELT ABOUT 2" PER THE PATIENT THURSDAY NIGHT. I EXAMINED THE SPOT ON FRIDAY AFTERNOON AND IT SEEMED TO BE LARGER THAN 2" (MORE LIKE 6"). SHE WENT TO URGENT CARE FRIDAY AND WAS GIVEN AN ANTIBIOTIC. I FOLLOWED UP WITH PATIENT ON MONDAY AND SHE SAID THAT THE RASH DECREASED BUT STILL ABOUT A QUARTER SIZE ROUND PATCH.
Age: 1.92
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a .5 dose and should have only gotten the .25 dose. Per Dr if you had already received dose last year and got 2 then you would get a .5 dose. We did not realize the brand that we have in office was to only get a .25 dose and gave 2 to equal the .5 dose.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Headache, Hypoaesthesia, Neck pain
Clinical narrative: NUMBNESS IN TIPS OF FINGERS, FACIAL FLUSHING, HEADACHE AND NECK ACHE X 24 HOURS.
Age: 53.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Impaired driving ability
Clinical narrative: 8 days after shot I started having lack of sensation and numbing in all fingertips and both legs. Started in feet and traveled up legs to my waist. Went to ER, diagnosed with Guillian Barre (GBS), received treatment IVIG for 5 days. THANK GOD, it didn't spread anymore upward than it did or I would not be typing this. 6 days in hospital, home now but still have numbness and walking difficulty, can't drive.
Age: 53.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Sensory loss
Clinical narrative: 8 days after shot I started having lack of sensation and numbing in all fingertips and both legs. Started in feet and traveled up legs to my waist. Went to ER, diagnosed with Guillian Barre (GBS), received treatment IVIG for 5 days. THANK GOD, it didn't spread anymore upward than it did or I would not be typing this. 6 days in hospital, home now but still have numbness and walking difficulty, can't drive.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Feeling cold, Flushing, Myalgia
Clinical narrative: Patient called and said she had her flu shot at 0830 and one minute after receiving the flu shot I left the flu clinic and went down to the clinic where I work and I was red and flushed then felt freezing and my muscles were aching and had a fever of 101 during the night. My throat got constricted and I was having trouble breathing. They gave me BENADRYL 50 mg in the clinic where I work. After the BENADRYL I still had a little trouble breathing but I stayed at work because I am stubborn. She is back to work today with a few muscle aches but I am fine.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Throat tightness
Clinical narrative: Patient called and said she had her flu shot at 0830 and one minute after receiving the flu shot I left the flu clinic and went down to the clinic where I work and I was red and flushed then felt freezing and my muscles were aching and had a fever of 101 during the night. My throat got constricted and I was having trouble breathing. They gave me BENADRYL 50 mg in the clinic where I work. After the BENADRYL I still had a little trouble breathing but I stayed at work because I am stubborn. She is back to work today with a few muscle aches but I am fine.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Skin warm, Tenderness
Clinical narrative: POSSIBLE CELLULITIS WITH LARGE AREA OF REDNESS/WARMTH/TENDERNESS OVER ENTIRE AREA OF DELTOID MUSCLE. NO OPENING OR DRAINAGE SEEN. 2" LONG BRUISE AT BICEP NOTICED NOT LONG AFTER VACCINE PER PATIENT.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO Adverse Reactions were noted in patient, Reporting because patient was given PEDIARIX and Hep B vaccines on the same day.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: Patient received PREVNAR 13 in the left upper arm (deltoid) first, then, an inch below that shot she received the FLUZONE HD. The patient bled from the injection site, and in about 20 seconds, the injection site swelled up. The patient stated that she did not feel any pain at the injection site, or had any other symptoms. An ice pack was placed at the site and the patient was asked to stay for 20 mins. The injection site did not get any worse, but the patient left with a knot at the injection site after about 25 mins. She was told to contact the pharmacy if the swelling gets any worse or she gets any other symptoms.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoimmune disorder, Blood lactate dehydrogenase increased, Exposure during pregnancy
Clinical narrative: The patient presented to her doctors office with nausea and vomiting. They drew labs and her liver enzymes were elevated, LDH was elevated and platelets were decreased.  She is 23 weeks pregnant at time of hospital admission on 10/16/17. Lab trends: 10/16, AST, 128, ALT, 106, LDH, 360, Platelets, 137; 10/17, AST, 457, ALT, 302, LDH, 873, Platelets, 51; 10/19, ALT, 368, Platelets, 61; 10/21, AST, 108, ALT, 194, Platelets, 125; 10/24, AST, 59, ALT, 132, Platelets, 187. By the time she was admitted Tuesday, she felt normal again but her labs were out of range. She was seen by a maternal fetal medicine specialist and consulted rheumatology. The diagnosis was HELLP syndrome vs. lupus/autoimmune flare vs. flu shot reaction. The patient was discharged 10/24 before I was able to talk with her regarding the location and type of flu shot given. She was given dexamethasone 10 mg IV Q12 hours for 48 hours then changed to oral prednisolone 30 mg oral daily.  Her labs continued to improve during the admission. She was to follow up with her home OB and rheumatologist this week with close lab follow up. At the beginning of the hospital stay, they were considering inducing labor due to possible HELLP syndrome. They did not have to do that as her labs and symptoms improved with the steroids.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: HELLP syndrome, Hepatic enzyme increased, Nausea, Platelet count decreased, Systemic lupus erythematosus
Clinical narrative: The patient presented to her doctors office with nausea and vomiting. They drew labs and her liver enzymes were elevated, LDH was elevated and platelets were decreased.  She is 23 weeks pregnant at time of hospital admission on 10/16/17. Lab trends: 10/16, AST, 128, ALT, 106, LDH, 360, Platelets, 137; 10/17, AST, 457, ALT, 302, LDH, 873, Platelets, 51; 10/19, ALT, 368, Platelets, 61; 10/21, AST, 108, ALT, 194, Platelets, 125; 10/24, AST, 59, ALT, 132, Platelets, 187. By the time she was admitted Tuesday, she felt normal again but her labs were out of range. She was seen by a maternal fetal medicine specialist and consulted rheumatology. The diagnosis was HELLP syndrome vs. lupus/autoimmune flare vs. flu shot reaction. The patient was discharged 10/24 before I was able to talk with her regarding the location and type of flu shot given. She was given dexamethasone 10 mg IV Q12 hours for 48 hours then changed to oral prednisolone 30 mg oral daily.  Her labs continued to improve during the admission. She was to follow up with her home OB and rheumatologist this week with close lab follow up. At the beginning of the hospital stay, they were considering inducing labor due to possible HELLP syndrome. They did not have to do that as her labs and symptoms improved with the steroids.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication, Vomiting
Clinical narrative: The patient presented to her doctors office with nausea and vomiting. They drew labs and her liver enzymes were elevated, LDH was elevated and platelets were decreased.  She is 23 weeks pregnant at time of hospital admission on 10/16/17. Lab trends: 10/16, AST, 128, ALT, 106, LDH, 360, Platelets, 137; 10/17, AST, 457, ALT, 302, LDH, 873, Platelets, 51; 10/19, ALT, 368, Platelets, 61; 10/21, AST, 108, ALT, 194, Platelets, 125; 10/24, AST, 59, ALT, 132, Platelets, 187. By the time she was admitted Tuesday, she felt normal again but her labs were out of range. She was seen by a maternal fetal medicine specialist and consulted rheumatology. The diagnosis was HELLP syndrome vs. lupus/autoimmune flare vs. flu shot reaction. The patient was discharged 10/24 before I was able to talk with her regarding the location and type of flu shot given. She was given dexamethasone 10 mg IV Q12 hours for 48 hours then changed to oral prednisolone 30 mg oral daily.  Her labs continued to improve during the admission. She was to follow up with her home OB and rheumatologist this week with close lab follow up. At the beginning of the hospital stay, they were considering inducing labor due to possible HELLP syndrome. They did not have to do that as her labs and symptoms improved with the steroids.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Eye pain, Headache, Migraine, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 18-year-old female patient who received BEXSERO (batch number 165601, expiry date October 2018). Concomitant products included FLUZONE. On 2nd October 2017, the patient received BEXSERO .5 ml. On 3rd October 2017, 1 days after receiving BEXSERO, the patient experienced headache (serious criteria disability) and migraine (serious criteria disability). On an unknown date, the outcome of the headache and migraine were recovering/resolving. The reporter considered the headache and migraine to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO in the left deltoid. The patient complained of severe headache after receiving the vaccine. During the same day office visit, the patient concomitantly received FLUZONE in the left deltoid (batch number: 20180630,  expiry date: 30th June 2018). However, the patient thought the headache was result of the BEXSERO. The patient came back into the office for 3 additional follow-up visits after initially receiving the vaccine. On 10th October 2017, the patient came back with an acute visit with complaints of severe pain and migraines which had been ongoing for one week. On 13th October 2017, the patient again returned to the office with still headache for two weeks then. The patient returned again on 16th October 2017 with headache behind eyes and middle of forehead. It was reported that with each visit the pain seemed to be resolving, and the patient was able to return to school at the time of report. No further information was reported regarding the event. Healthcare professional would like a copy of the  Adverse Event report mailed to the facility for their records.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Headache, Pyrexia
Clinical narrative: High fever 8hrs after flu shot. Fever lasted 9-10hrs. Had bad headache and stomach aching the next day. Also having body weakness. Able to eat light breakfast but it's not sitting well.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Aches and fever up to 101.2 F with temporal reading.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram abnormal, Bladder catheterisation, Blood test, CSF protein increased, CSF white blood cell count increased
Clinical narrative: I received the flu vaccine on Tuesday, 10/10 at 1:30pm. About three hours later, I started to have a debilitating headache. My headache never subsided. A week later, on 10/17, my headache progressively got worse, in my feet, hands and legs began to tingle and feel numb, and I was unable to void. I went to the emergency room on 10/18 and was admitted to the hospital on the neurology floor. I underwent a CT, MRI, and MRA of the head and an MRA of the spine. I also received an X-ray, EKG, and lumbar puncture. They put in a Foley catheter and received 1300 CCs of urine. A battery of blood tests were run with no conclusive results. I was placed on high dose SOLU-MEDROL of a gram a day for six days. They still do not know what the cause was, but have diagnosed me with transverse myelitis. I was discharged after five nights once I was able to void and have a bowl movement on my own. I still continue to have tingling in my feet/legs as well as headaches. I've been prescribed 9 weeks of prednisone and to follow up with a neurologist who specializes in myelitis.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Central nervous system inflammation, Computerised tomogram, Culture negative, Electrocardiogram, Flavivirus test negative
Clinical narrative: I received the flu vaccine on Tuesday, 10/10 at 1:30pm. About three hours later, I started to have a debilitating headache. My headache never subsided. A week later, on 10/17, my headache progressively got worse, in my feet, hands and legs began to tingle and feel numb, and I was unable to void. I went to the emergency room on 10/18 and was admitted to the hospital on the neurology floor. I underwent a CT, MRI, and MRA of the head and an MRA of the spine. I also received an X-ray, EKG, and lumbar puncture. They put in a Foley catheter and received 1300 CCs of urine. A battery of blood tests were run with no conclusive results. I was placed on high dose SOLU-MEDROL of a gram a day for six days. They still do not know what the cause was, but have diagnosed me with transverse myelitis. I was discharged after five nights once I was able to void and have a bowl movement on my own. I still continue to have tingling in my feet/legs as well as headaches. I've been prescribed 9 weeks of prednisone and to follow up with a neurologist who specializes in myelitis.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Laboratory test, Myelitis transverse, Nuclear magnetic resonance imaging brain
Clinical narrative: I received the flu vaccine on Tuesday, 10/10 at 1:30pm. About three hours later, I started to have a debilitating headache. My headache never subsided. A week later, on 10/17, my headache progressively got worse, in my feet, hands and legs began to tingle and feel numb, and I was unable to void. I went to the emergency room on 10/18 and was admitted to the hospital on the neurology floor. I underwent a CT, MRI, and MRA of the head and an MRA of the spine. I also received an X-ray, EKG, and lumbar puncture. They put in a Foley catheter and received 1300 CCs of urine. A battery of blood tests were run with no conclusive results. I was placed on high dose SOLU-MEDROL of a gram a day for six days. They still do not know what the cause was, but have diagnosed me with transverse myelitis. I was discharged after five nights once I was able to void and have a bowl movement on my own. I still continue to have tingling in my feet/legs as well as headaches. I've been prescribed 9 weeks of prednisone and to follow up with a neurologist who specializes in myelitis.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Urinary retention, West Nile virus test negative, X-ray
Clinical narrative: I received the flu vaccine on Tuesday, 10/10 at 1:30pm. About three hours later, I started to have a debilitating headache. My headache never subsided. A week later, on 10/17, my headache progressively got worse, in my feet, hands and legs began to tingle and feel numb, and I was unable to void. I went to the emergency room on 10/18 and was admitted to the hospital on the neurology floor. I underwent a CT, MRI, and MRA of the head and an MRA of the spine. I also received an X-ray, EKG, and lumbar puncture. They put in a Foley catheter and received 1300 CCs of urine. A battery of blood tests were run with no conclusive results. I was placed on high dose SOLU-MEDROL of a gram a day for six days. They still do not know what the cause was, but have diagnosed me with transverse myelitis. I was discharged after five nights once I was able to void and have a bowl movement on my own. I still continue to have tingling in my feet/legs as well as headaches. I've been prescribed 9 weeks of prednisone and to follow up with a neurologist who specializes in myelitis.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Loss of consciousness, Nausea
Clinical narrative: Patient initially tolerated her immunizations well. Patient passed out a couple minutes after administration. She fell from her chair to the floor and woke up in a few seconds. She woke up feeling dizzy. This nurse was in the room at the time of event. Doctor was called into room  immediately. Patient was evaluated by Dr., P.A. and RN. Dr. evaluated her head due to falling and she was without injury. Patient was given apple juice, blood pressure was taken and was 92/58. Patient generally tolerated apple juice well but still felt a little nauseated. She was brought to a table to lie down. Later, she felt well enough to walk out of the office on her own in roughly 45 minutes. By that time her color was normal and her blood pressure was 110/68.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Acute disseminated encephalomyelitis, Hemiparesis, Hypoaesthesia, Lumbar puncture, Muscle twitching
Clinical narrative: Left sided numbness/ weakness/ muscle twitching/ presyncope/ lower extremity weakness/ ADEM.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Presyncope
Clinical narrative: Left sided numbness/ weakness/ muscle twitching/ presyncope/ lower extremity weakness/ ADEM.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Seizure
Clinical narrative: PER MOM CHILD HAD 30 SECOND SEIZURE AFTER RECEIVING VACCINES AT AROUND 6 PM. NO FEVER PRIOR TO VACCINES AND LOW GRADE 99 FEVER AFTER SEIZURE PER MOM.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Myalgia, Pain, Pain in extremity
Clinical narrative: My arm was immediately sore after the shot, which was to be expect. Now, after a month has passed, it is not any better. I actually think it is worse. It is painful to move my arm. I have been using it since the vaccine was give - I have not been keeping it still. The pain is deep in the muscle.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Patient felt a swollen lymph node that was causing pain the next day after being vaccinated on the same arm. The patient was instructed to see her primary doctor. The physician did not believe the swollen lymph node was associated to the vaccine. The patient was asked to place a warm compress on the area and take TYLENOL.