chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Impaired work ability, Myalgia
Clinical narrative: Extreme shivering 12 hours after vaccine (duration 4 hours); Ache at site of injection; All over body aches; Bad headache; Slight nausea; Woke up morning of 3/23/2018 drenched in sweat, symptoms dissipated after that except for a mild lingering headache the rest of the day. Received vaccine on Thursday afternoon and had to miss work on Friday.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: Extreme shivering 12 hours after vaccine (duration 4 hours); Ache at site of injection; All over body aches; Bad headache; Slight nausea; Woke up morning of 3/23/2018 drenched in sweat, symptoms dissipated after that except for a mild lingering headache the rest of the day. Received vaccine on Thursday afternoon and had to miss work on Friday.
Age: 47.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right arm pain, swelling, and warmth.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash morbilliform, Rhinorrhoea, Rubella antibody test
Clinical narrative: 14-15 days post MMR, morbilliform rash forms on face, then extends to chest, back, buttocks and sporadic on limbs. Low grade fever, runny nose on day 3 of rash. End of day 3, beg of day 4, rash fading.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Pt. ran a low grade fever. She also developed a 3 inch diameter area of erythema and mild edema to injection site within the next 24 hours. Mom gave BENADRYL - MOTRIN every 6 hours for 2 days. Symptoms improved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 15-MAR-2018, the patient was vaccinated with an expired dose of ZOSTAVAX subcutaneous route (dose, frequency, and anatomical location were unknown) with lot # N003697 and expiration date 13-MAR-2018 for prophylaxis. It was confirmed that ZOSTAVAX did not undergo a temperature excursion, and no adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was vaccinated at a physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about May 2016, the patient was treated and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 38 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date the 38 year old patient was vaccinated with first dose of GARDASIL 9 (lot number and expiry date unknown) (dosing regimen and frequency unknown) for prophylaxis. No adverse events were reported. There was no product quality complaint reported.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant via field employee refers to two patients who were older than 65 years of age. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications were unknown. The patients were vaccinated with PREVNAR 13 on unspecified dates one year prior to being vaccinated to PNEUMOVAX 23. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dosing details were not provided) as per routine recommendation. Reporter stated that on unknown dates, both the patients developed swelling in the arm where the suspect vaccine was administered. The swelling lasted for a few days and went away (recovered). Causality assessment was not provided.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture, Culture urine, Febrile convulsion, Full blood count, Metabolic function test
Clinical narrative: Per mother statement: On 03/22/18 afternoon patient began with low grade temperature. In the evening 103 temp. around 4 AM on 03/23/18 patient had a seizure, was taken to ER. Labs done, viral respiratory panel negative. Patient was diagnosed with febrile seizures and sent home. To continue TYLENOL and MOTRIN. Seen in our office for follow up. Patient stable.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Respiratory viral panel, Seizure
Clinical narrative: Per mother statement: On 03/22/18 afternoon patient began with low grade temperature. In the evening 103 temp. around 4 AM on 03/23/18 patient had a seizure, was taken to ER. Labs done, viral respiratory panel negative. Patient was diagnosed with febrile seizures and sent home. To continue TYLENOL and MOTRIN. Seen in our office for follow up. Patient stable.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of leg pain in a 66-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose on 7th December 2017 and experienced leg pain. Refer case US2018046735). Concurrent medical conditions included diabetes mellitus and Cerebrovascular accident. On 7th March 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced leg pain (serious criteria disability) and activities of daily living impaired. On an unknown date, the outcome of the leg pain was not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the leg pain and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that no concurrent vaccines were administered. Approximately within 24 hours of vaccination, the patient experienced pain. He reported less than a month after vaccination, had interference with activities of daily living at the time of reporting. The patient reported a pain intensity of 5 out of 5. This case has been linked with case US2018046735 (same patient) for 1st dose.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Pyrexia
Clinical narrative: This is a serious spontaneous case, initially received from a 53-year-old adult, female patient on 31-Jan-2018. The patient's current condition included thyroid cancer, high blood pressure, asthma and indigestion (since an unspecified date). The concomitant medications included SYNTHROID, COZAAR and loratadine for unknown condition, ZANTAC for indigestion, ADVAIR and albuterol for asthma (on an unspecified date). On unspecified date in 2017 (reported as, in Jan or Feb), the patient was administered with influenza vaccine, (route of administration, intramuscular, anatomical location: right arm, dose, batch number and expiry date: not reported). On the same day of vaccination, in the evening, the patient developed flu and fever. She was treated with TYLENOL OTC and MOTRIN 800 mg. The patient felt better after 2 days. At the time of the report, the patient had recovered from the events.
Sex: F
Vaccine: FLUX
Symptoms: Drug administration error, Musculoskeletal discomfort
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional (consumer) on 07-Dec-2017, concerns a female patient of an unspecified age. On an unspecified date in Oct-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported). It was reported that, the vaccine was not administered properly, which affected her shoulder and it had been more than 6 weeks. On 11-Dec-2017, at 02:45 pm, the patient's appointment was scheduled with the doctor. At the time of this report, the patient had yet not recovered from the event (shoulder discomfort).
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional on 26-Nov-2017, concerning a male patient of age over 65-year-old. On an unspecified date (reported as 11-15 years ago), the patient received influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, after the vaccination, the patient had fever, chills and weakness. The outcome of the events was not reported. The reporter considered the causality of the events as related to the suspect vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is the most recent shingles vaccination (not-live). Sharp pain with injection, burning and aching. Immediately swelled up to the size of a tennis ball, turned red and hot to the touch. The entire shoulder area ached down the entire length of the arm. Lasted 3-days, and ached severely enough to prevent sleep or touching it. Could see the tennis size swelling through clothing. The older shingles vaccination (live) had NO effect afterwards.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This is the most recent shingles vaccination (not-live). Sharp pain with injection, burning and aching. Immediately swelled up to the size of a tennis ball, turned red and hot to the touch. The entire shoulder area ached down the entire length of the arm. Lasted 3-days, and ached severely enough to prevent sleep or touching it. Could see the tennis size swelling through clothing. The older shingles vaccination (live) had NO effect afterwards.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: The patient presented to the pharmacy on 03/27 stating that he noticed a few  weeks ago after watching a TV commercial from a law firm about issues with vaccinations and that he noticed that he got a rash a few weeks ago and that it resembled what his sister had had when she got a got a shingles outbreak. He stated that he did not see his doctor at the time. The patient presented at the pharmacy with no symptoms and states that he is currently fine (symptom free).
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Headache, Injection site swelling, Muscular weakness, Myalgia
Clinical narrative: Muscle pain, goose egg size swelling on injection site, muscle weakness, balance issues, headache.  Weakness in arm that lasted months.
Age: 0.58
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: Two red firm bumps on left thigh. No fever.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Feeling hot, Foetal hypokinesia, Stillbirth
Clinical narrative: Uneventful pregnancy, close to 30 weeks by vaccination date. Expected due date February 22. Received vaccine at prenatal visit. Around Christmas, felt warmness in abdomen area. By 12/29 did not feel much baby movement so went to get it checked out. Baby was stillborn 12/29/2015.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Flushing, Hyperhidrosis, Impaired work ability, Injection site swelling
Clinical narrative: This is a spontaneous case, initially received on 27-Nov-2017, from Other Non-Health Professional, concerning a 68-year-old, elderly, female patient. It was reported that the patient does not have any medical history. The patient's concomitant medications included: ZOLOFT and XANAX for unknown indications. On 13-Nov-2017, the patient was administered with influenza vaccine (dose: full dose (as reported), anatomical location: upper muscle (shoulder), left arm, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On 15-Nov-2017, after 2 days of vaccination, the patient started sweating. After one week of vaccination, she had swelling at injection site and weakness. On an unspecified date, the patient felt shakiness, flashes on forehead and had sweating. The patient consulted the physician who stated that either the symptoms were probably due to the ZOLOFT (concomitant medication) or strong flu shot was administered. The pharmacist advised the patient to wait for one week for the symptoms to clear up. After a couple of days, the events sweating, and weakness were resolved. At the time of this report, the patient had recovered from the event, swelling at the injection site. The outcome of other events, inability to work, shaky and flashes on forehead was not reported. The reporter assessed the events as non-serious. Follow-up received on 28-Dec-2017: It was reported that the events injection site swelling, and weakness occurred after one week of vaccination. Sweating and weakness resolved after a couple days, hence the outcome was changed from not recovered to recovered. The patient felt shakiness, flashes on forehead and had sweating at the time of report. The physician reported that the patient received strong flu vaccine and the symptoms were probably due to the ZOLOFT. Patient's pharmacist advised to wait for one week for the symptoms to clear up. Added new events inability to work, shaky and flashes on forehead. Narrative was amended accordingly.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: This is a spontaneous case, initially received on 27-Nov-2017, from Other Non-Health Professional, concerning a 68-year-old, elderly, female patient. It was reported that the patient does not have any medical history. The patient's concomitant medications included: ZOLOFT and XANAX for unknown indications. On 13-Nov-2017, the patient was administered with influenza vaccine (dose: full dose (as reported), anatomical location: upper muscle (shoulder), left arm, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On 15-Nov-2017, after 2 days of vaccination, the patient started sweating. After one week of vaccination, she had swelling at injection site and weakness. On an unspecified date, the patient felt shakiness, flashes on forehead and had sweating. The patient consulted the physician who stated that either the symptoms were probably due to the ZOLOFT (concomitant medication) or strong flu shot was administered. The pharmacist advised the patient to wait for one week for the symptoms to clear up. After a couple of days, the events sweating, and weakness were resolved. At the time of this report, the patient had recovered from the event, swelling at the injection site. The outcome of other events, inability to work, shaky and flashes on forehead was not reported. The reporter assessed the events as non-serious. Follow-up received on 28-Dec-2017: It was reported that the events injection site swelling, and weakness occurred after one week of vaccination. Sweating and weakness resolved after a couple days, hence the outcome was changed from not recovered to recovered. The patient felt shakiness, flashes on forehead and had sweating at the time of report. The physician reported that the patient received strong flu vaccine and the symptoms were probably due to the ZOLOFT. Patient's pharmacist advised to wait for one week for the symptoms to clear up. Added new events inability to work, shaky and flashes on forehead. Narrative was amended accordingly.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dizziness, Pyrexia, Rhinorrhoea
Clinical narrative: This non-serious initial spontaneous case, was received on 26-Nov-2017, from the other health care professional, concerning an elderly male patient (reported as age 65+). On an unspecified date (6-10 years ago), the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) at work place. On an unspecified date, after vaccination, the patient had fever, coughing, runny nose and dizziness. The reporter assessed the events as related.
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Myalgia, Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional on 26-Nov-2017, concerning an adult male patient of unspecified age (51 to 64). On an unspecified date (6 to 10 years ago), the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed fever, muscle aches, coughing and chills. At the time of this report, the outcome of the events was not reported.
Sex: U
Vaccine: FLUX, IPV, PPV, TDAP
Symptoms: Product administered at inappropriate site, Rash
Clinical narrative: This spontaneous case, initially received from Merck (reported to Merck by other non-health professional) on 16-Feb-2018, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medication were unknown. On an unspecified date, the patient was administered with influenza vaccine, (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported). On an unspecified date, the patient was administered with non-company suspect product PNEUMOVAX 23 (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported) and Tdap IPV (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported). It was reported that, the patient received Flu vaccine and PNEUMOVAX 23 at different sites in one arm and TDAP in one arm (explicitly coded as drug administered at inappropriate site). On an unspecified date, after vaccination, the patient experienced a rash on the arm at approximately five years ago. At the time of the report, the outcome of the event (injection site rash) was unknown. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional on 26-Nov-2017, concerning an adult female patient of unspecified age (35 to 50). On an unspecified date (16 to 20 years ago), the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed fever, muscle aches, chills and weakness. At the time of this report, the outcome of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Rhinorrhoea
Clinical narrative: This non-serious initial spontaneous case, was received on 26-Nov-2017, from the other health care professional, concerning an elderly male patient (reported as age 65+). On an unspecified date (6-10 years ago), the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported), at work place. On an unspecified date, after vaccination, the patient had coughing and runny nose. The reporter assessed the events as related.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Headache, Heart rate increased, Myalgia
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional on 26-Nov-2017, concerning an elderly male patient of unspecified age (above 65). On an unspecified date (6 to 10 years ago), the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed headache, fever, muscle aches, chills, weakness, fast heartbeat. At the time of this report, the outcome of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional on 26-Nov-2017, concerning an elderly male patient of unspecified age (above 65). On an unspecified date (6 to 10 years ago), the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed headache, fever, muscle aches, chills, weakness, fast heartbeat. At the time of this report, the outcome of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dizziness, Myalgia, Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional on 26-Nov-2017, concerning a male patient of age over 65-year-old. On an unspecified date (reported as 11-15 years ago), the patient was administered with INN Flu Vaccine Seasonal (dose, batch number, manufacturer, trade name, route of administration, anatomical location and expiry date: not reported) at physician office. On unspecified date, after the vaccination, the patient had fever, muscles aches, coughing and dizziness. At the time of this report, the outcome of the events was not reported. The reporter considered the causality of the events as related.
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Myalgia, Pyrexia
Clinical narrative: This initial non-serious spontaneous case, was received on 26-Nov-2017, from the other health care professional concerning an elderly female patient (reported as older than 65). On an unspecified date (reported as more than 20 years ago), patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported), at work place. On an unspecified date, after vaccination the patient had cough, chills, fever and muscle aches. The reporter assessed the events as related to the vaccine.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Rhinorrhoea
Clinical narrative: This initial non-serious spontaneous case, was received on 26-Nov-2017, from the other health care professional concerning an elderly male patient (reported as older than 65 years). On an unspecified date (reported as 6-10 years ago), patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported), at work place. On an unspecified date, after vaccination the patient had cough, difficulty in breathing, and runny nose. The reporter assessed the events as related to the vaccine.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Myalgia, Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional on 26-Nov-2017, concerning a male patient of age over 65-year-old. On an unspecified date (reported as more than 20 years ago), the patient received influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, after the vaccination, the patient had fever, muscle aches and weakness. The outcome of the events was not reported. The reporter considered the causality of the events as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: This non-serious initial spontaneous case, was received on 26-Nov-2017, from the other health care professional, concerning an adult female patient (reported as between the age 51-64). On an unspecified date (more than 20 years ago), the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported), at work place. On an unspecified date, after vaccination, the patient had fever, nausea, muscle aches and runny nose. The reporter assessed the events as related.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Myalgia, Rash
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional, concerning a 78-year-old, elderly, male patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after the vaccination, the patient complained of muscle aches and coughing. He also had rash on his face and was tired. The outcome of the events was not reported. The reporter considered the causality of the events as related.
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This non-serious spontaneous case, initially received on 26-Nov-2017 from other-health professional, concerning a 35-50-year-old, adult female patient. On unspecified date, (reported as, 6-10 years ago) the patient was administered with influenza vaccine (dose, batch number, anatomical location, manufacturer, trade name, batch number, expiry date: not reported). On unspecified date, the patient experienced headache, fever, nausea, muscle aches, swelling/redness/mark at injection site, swelling other than injection site, hives, weakness, and dizziness. The outcome of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Pyrexia, Swelling, Urticaria
Clinical narrative: This non-serious spontaneous case, initially received on 26-Nov-2017 from other-health professional, concerning a 35-50-year-old, adult female patient. On unspecified date, (reported as, 6-10 years ago) the patient was administered with influenza vaccine (dose, batch number, anatomical location, manufacturer, trade name, batch number, expiry date: not reported). On unspecified date, the patient experienced headache, fever, nausea, muscle aches, swelling/redness/mark at injection site, swelling other than injection site, hives, weakness, and dizziness. The outcome of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Nausea, Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional on 26-Nov-2017, concerning an elderly male patient of unspecified age (above 64). On an unspecified date (more than 20 years ago), the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed fever, nausea, chills, weakness. At the time of this report, the outcome of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This spontaneous case, initially received from other non-healthcare professional on 03-Feb-2018, concerning an adult, male patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date in 1985, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, manufacturer, trade name, batch number and expiry date: not reported). On an unspecified date, after vaccination the patient was sick. At the time of the report, the outcome of the event (sickness) was not reported. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Headache, Injection site erythema
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health professional on 26-Nov-2017, concerning an elderly female patient of unspecified age (above 65). On an unspecified date (more than 20 years ago), the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed Headache, fever, nausea, muscle aches, coughing, runny nose, chills, swelling/redness/mark at injection site, paleness and weakness. At the time of this report, the outcome of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Myalgia, Nausea, Pallor, Pyrexia
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health professional on 26-Nov-2017, concerning an elderly female patient of unspecified age (above 65). On an unspecified date (more than 20 years ago), the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed Headache, fever, nausea, muscle aches, coughing, runny nose, chills, swelling/redness/mark at injection site, paleness and weakness. At the time of this report, the outcome of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health professional on 26-Nov-2017, concerning an elderly female patient of unspecified age (above 65). On an unspecified date (more than 20 years ago), the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient developed Headache, fever, nausea, muscle aches, coughing, runny nose, chills, swelling/redness/mark at injection site, paleness and weakness. At the time of this report, the outcome of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This is a non-serious spontaneous case, initially received from other non-health professional on 24-Jan-2018, concerning a male patient of unspecified age. The patient's medical history was not reported. On an unspecified date, the patient was administered with non-company suspect COSENTYX solution (dose: 300 mg, route of administration: subcutaneous, frequency, once every two weeks (qow), batch number and expiry date: not reported) which was explicitly reported as off label use. On an unspecified date (while patient was on the COSENTYX medication), the patient was vaccinated with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). It was reported that, the last time the patient took the flu shot, he was under the medication of COSENTYX and on unspecified date after taking flu vaccine he got really sick. Outcome of the event was not reported. The reporter did not provide the seriousness assessment.
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity, Nausea, Vomiting
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 29-Jan-2018, concerning a 25-year-old, adult male patient. The patient's historical condition included cellulitis of L (left) upper extremity (unspecified date). The patient's current conditions included Crohn's disease and ankle pain (since an unspecified dates). The patient's historical drug included budesonide for an unknown indication. On an unspecified date in 2013, the patient was administered with influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, manufacturer, trade name and expiry date: not reported). On an unspecified date in 2013, after the vaccination, the patient had severe allergic reaction with nausea and vomiting, for 2 days. It was reported that, patient was not on STELARA at the time of vaccination. The patient made a visit to the physician for the events. The patient had recovered from the events nausea and vomiting. The outcome of the event allergic reaction was not reported. The reporter considered, the causality of the events as not related to the suspect vaccine. Follow-up received from other health professional (nurse) on 15-Feb-2018: It was reported that, the patient made a visit the physician for the events. The outcome of the events nausea and vomiting was resolved. The patient's physician reported that, the events were not related to the flu vaccine. Hence, the "As Reported Causality" for the events was changed from not reported to not related. The narrative was amended accordingly.
Age: 34.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 21-Feb-2018, concerning a 34-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 20-Feb-2018, the 34-year-old (under 65 years of age) patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 179002 and expiry date: 31-May-2018). It was reported no adverse events were occurred after the vaccination. The reporter assessed the event as non-serious.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Client was seated upon exam table and received all four vaccines with no complaint. About 5-7 minutes later, client expressed that he felt like he was going to faint. Both RN and client's mother moved toward the client as he seemingly lost consciousness and drifted to the right in a seated position toward his mother. Client's mother and RN supported the client and helped to lay him flat on the exam table with his feet elevated. At this time the client regained consciousness and stated he was feeling better, also asking for something to eat. Client RR and HR WNL. RN applied cool cloth to client's head and provided him with food and water. Client continued to lay flat for about 10-15 minutes and recovered appropriately.
Age: 51.0
Sex: M
Vaccine: HEPA
Symptoms: Balance disorder, Decreased appetite, Diplopia, Dysarthria, Dysgeusia
Clinical narrative: On 3-23-18 client went home, exercised 1 hour, no s/s change, went to bed, at 1:30 am woke up and felt like he was on fire. He went back to bed, up at 6:30 am, felt OK,  exercised 45 min with cardio. At 8:30 went to get in car and felt his equilibrium was off. Left ear "shifted", while driving, began having double vision-drove on side of road. Wife then drove. He then became nauseated and he "felt drunk", with slurring of words. Down to town, looking for furniture with wife, felt fatigued, sat down and slept for 3 hours, which he doesn't remember doing. Started with metallic taste in mouth and felt like he "lost his taste buds". Has had loss of appetite, feeling foggy. On 3-25-18 cont. with most of these S/S. 3-26-18, felt better, no vision problems, but still had foggy feeling, loss of appetite, and metallic taste in mouth. 3-27-18 cont. with loss of appetite, metallic taste in mouth and foggy feeling. Client stated he was seeing his primary care physician this evening, as other co-workers stated it sounded like he might have had a stroke.
Age: 51.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Feeling abnormal, Feeling drunk, Feeling hot, Insomnia
Clinical narrative: On 3-23-18 client went home, exercised 1 hour, no s/s change, went to bed, at 1:30 am woke up and felt like he was on fire. He went back to bed, up at 6:30 am, felt OK,  exercised 45 min with cardio. At 8:30 went to get in car and felt his equilibrium was off. Left ear "shifted", while driving, began having double vision-drove on side of road. Wife then drove. He then became nauseated and he "felt drunk", with slurring of words. Down to town, looking for furniture with wife, felt fatigued, sat down and slept for 3 hours, which he doesn't remember doing. Started with metallic taste in mouth and felt like he "lost his taste buds". Has had loss of appetite, feeling foggy. On 3-25-18 cont. with most of these S/S. 3-26-18, felt better, no vision problems, but still had foggy feeling, loss of appetite, and metallic taste in mouth. 3-27-18 cont. with loss of appetite, metallic taste in mouth and foggy feeling. Client stated he was seeing his primary care physician this evening, as other co-workers stated it sounded like he might have had a stroke.
Age: 51.0
Sex: M
Vaccine: HEPA
Symptoms: Memory impairment, Nausea
Clinical narrative: On 3-23-18 client went home, exercised 1 hour, no s/s change, went to bed, at 1:30 am woke up and felt like he was on fire. He went back to bed, up at 6:30 am, felt OK,  exercised 45 min with cardio. At 8:30 went to get in car and felt his equilibrium was off. Left ear "shifted", while driving, began having double vision-drove on side of road. Wife then drove. He then became nauseated and he "felt drunk", with slurring of words. Down to town, looking for furniture with wife, felt fatigued, sat down and slept for 3 hours, which he doesn't remember doing. Started with metallic taste in mouth and felt like he "lost his taste buds". Has had loss of appetite, feeling foggy. On 3-25-18 cont. with most of these S/S. 3-26-18, felt better, no vision problems, but still had foggy feeling, loss of appetite, and metallic taste in mouth. 3-27-18 cont. with loss of appetite, metallic taste in mouth and foggy feeling. Client stated he was seeing his primary care physician this evening, as other co-workers stated it sounded like he might have had a stroke.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pustule, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 55 year old female patient with allergy to unspecified ACTIFED. The patient had no pertinent medical history and did not take any concomitant therapies. On 14-MAR-2018, she was vaccinated with a dose of ZOSTAVAX injection, subcutaneously, in an unspecified arm, lot # N012492, expiration date 17-MAR-2018 (exact dose was not reported) for shingles prevention, which was reconstituted with sterile diluent subcutaneously (strength, dose, frequency, lot # and expiration date were not provided). On 16-MAR-2018, the patient developed a red, swollen and pus-filled area at injection site. She sought medical attention and on an unknown date in March 2018 was admitted to the hospital and diagnosed with cellulitis on 17-MAR-2018. There were no lab diagnostics or studies performed. At the time of the report, the patient remained in the hospital and was receiving treatment with vancomycin, intravenously and ceftriaxone, intravenously. The outcome of the event was reported as recovering. The relatedness between the event and the suspect therapies was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-NOV-2013, the patient was inoculated (by an unspecified health care professional) at a clinic with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 29-APR-2016, the female patient was treated at the same clinic (by an unspecified health care professional), and was diagnosed with Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated at a clinic and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2016, the patient was vaccinated with ZOSTAVAX (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-OCT-2014, the patient was inoculated (by an unspecified health care professional) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of Herpes zoster. On or about May 2016, the female patient was treated by a physician, and was diagnosed with Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 23-MAR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain condition of herpes zoster. On or about May 2016, the patient was treated at a prompt care and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 30-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N017833, with expiration date of 16-NOV-2019, by  intramuscular route (strength, dose and anatomical location were not provided) for prophylaxis. On 25-JAN-2018, the patient received the second dose of GARDASIL 9 lot # M035486, expiration date of 05-JUN-2019, by intramuscular route (strength, dose and anatomical location were not provided) for prophylaxis. Then on 22-MAR-2018, the patient was vaccinated with the third dose of GARDASIL 9 lot # N020139, expiration date of 14-FEB-2020, by intramuscular route (strength, dose and anatomical location were not provided) for prophylaxis. No adverse effects were reported.