chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 56-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 55 or 56 years. The patient received both the doses of SHINGRIX and understand that it covers her for life. The patient wanted to know that what would be considered an allergic reaction to SHINGRIX other than the symptoms listed that would require immediate medical attention. The patient's pharmacist believed that she might had an allergic reaction to the 2nd dose of SHINGRIX. On the day of reporting patient had an appointment with physician. The patient has denied permission to contact her physician until she had spoken to the physician. The patient agreed to receive call back.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site bruising, Injection site rash, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site rash (1st dose received on 27th April 2018 and experienced adverse event refer linked case US2018171880). Concomitant products included BENADRYL. On 21st September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site bruising, fatigue, muscle pain and shivering. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the injection site bruising, fatigue, muscle pain and shivering were unknown. The reporter considered the injection site rash, injection site bruising, fatigue, muscle pain and shivering to be related to SHINGRIX. Additional details were provided as follows: The dose was not delivered for months. The patient experienced rash 2 inches below the injection site. The patient received the 1st dose and experienced some events. The patient experienced same reaction with dose 2, in additional to that the patient also experienced fatigue, muscle ache and shivering. Prior to 2nd dose, the patient took 2 doses of BENADRYL, as suggested by primary physician. The rash after 2nd dose disappeared quickly due to continued use of BENADRYL. The reporter was searching for phone calls this dose was very likely only dose available in the area. The VAERS details were updated.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 57-year-old male patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of herpes zoster (1st dose received on 31st July 2018, batch number 95LX9, expiry date 22nd February 2021). Concomitant products included SHINGRIX. On 11th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced fever and pain in arm. On 12th October 2018, the patient experienced rash. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever and pain in arm were unknown and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the fever, pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced 2nd dose of SHINGRIX on left deltoid. On the same day that the patient received the 2nd dose of SHINGRIX, the patient experienced soreness in his left arm and a fever. The patient called the pharmacy on the reporting date and reported that 1 day after receiving SHINGRIX, he had a rash on his right glut that looked and felt like the previous shingles rash that he had. The patient noticed the rash when he woke up on the morning of reporting day. Patient described the rash as the size of a half dollar.
Sex: U
Vaccine: VARZOS
Symptoms: Reactogenicity event
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of reactogenicity event in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (more than 5 years prior to vaccination with SHINGRIX). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced reactogenicity event. On an unknown date, the outcome of the reactogenicity event was unknown. It was unknown if the reporter considered the reactogenicity event to be related to SHINGRIX. Additional details were reported as follows: At medical booth, the health care professional (HCP) asked about whether there were are higher rates of reactogenicity when SHINGRIX were administered in someone having had ZOSTAVAX in the past. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient was not hospitalized. No additional details were provided. The reporter did not agree to follow up from GlakoSmithKline (GSK). This case was linked with case US2018GSK186137, reported by the same reporter. This.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (refer case US2018184703 (1st dose)). Concurrent medical conditions included multiple sclerosis (diagnosed in 1999, takes AVONEX injections for the same) and injection site pain (experienced from 1st August 2018). Concomitant products included AVONEX. On 9th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, chills, fever, influenza-like symptoms and pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the general body pain, chills, fever and influenza-like symptoms were recovered/resolved and the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the general body pain, chills, fever, influenza-like symptoms and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient had only one AVONEX injection in her arm ever, which was several years ago, the patient had a similar reaction as after vaccination with SHINGRIX, since then the patient had always had AVONEX at alternate sites and never had reaction to the same again. The patient stated that after vaccination with the second dose of SHINRIX, the patient had severe pain in her arm where was vaccinated. There was no redness or swelling experienced by the patient. The patient also developed bad flu-like symptoms. The patient had fever, body aches like someone was beating her up with a sledgehammer and bad chill. The patient was taking ibuprofen at the time of reporting and it was only taking the edge off a little. It took a full week for the events to resolve.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number EF4Z9, expiry date 22nd June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (subcutaneous) .5 ml. On 1st October 2018, unknown after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced intramuscular formulation administered by other route. On 2nd October 2018, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that her co-worker was inadvertently administered FLULAVAL QUADRIVALENT 2018-2019 season subcutaneously instead of the indicated intramuscular route, which led to inappropriate route of vaccination. The HCP stated that the patient had redness, swelling, and tenderness at the injection site on the date of reporting, one day later. The HCP did not provide the patient information for this adverse event but did provide the lot number and expiry date for the adverse. This case is 1 of 15 cases, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number EF4Z9, expiry date 22nd June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (subcutaneous) .5 ml. On 1st October 2018, unknown after receiving FLULAVAL QUADIRIVALENT 2018-2019 season, the patient experienced intramuscular formulation administered by other route. On 2nd October 2018, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that her co-worker was inadvertently administered FLULAVAL QUADRIVALENT 2018-2019 season subcutaneously instead of the indicated intramuscular route, which led to inappropriate route of vaccination. The HCP stated that the patient had redness, swelling, and tenderness at the injection site on the date of reporting, one day later. The HCP did not provide the patient information for this adverse event but did provide the lot number and expiry date for the adverse. This case is 1 of 15 cases, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number EF4Z9, expiry date 22nd June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUARIVALENT 2018-2019 season (subcutaneous) .5 ml. On 1st October 2018, unknown after receiving FLULAVAL QUARIVALENT 2018-2019 season, the patient experienced intramuscular formulation administered by other route. On 2nd October 2018, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to FLULAVAL QUARIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that her co-worker was inadvertently administered FLULAVAL QUARIVALENT 2018-2019 season subcutaneously instead of the indicated intramuscular route, which led to inappropriate route of vaccination. The HCP stated that the patient had redness, swelling, and tenderness at the injection site on the date of reporting, one day later. The HCP did not provide the patient information for this adverse event but did provide the lot number and expiry date for the adverse. This case is 1 of 15 cases, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm injection site was red, swollen, sore. Symptoms improved after 24hrs.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Corneal infiltrates, Corneal oedema, Eye inflammation, Keratic precipitates
Clinical narrative: This case was reported in a literature article and described the occurrence of herpes zoster keratitis in a 89-year-old male patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included herpes zoster keratitis (herpes-zoster-associated stromal keratitis,controlled for 1 yr on loteprednol etabonate1% once day). Concomitant products included loteprednol etabonate. On an unknown date, the patient received the 1st dose of Herpes Zoster vaccine. On an unknown date, 21 days after receiving Herpes Zoster vaccine, the patient experienced herpes zoster keratitis (serious criteria GSK medically significant), keratic precipitates (serious criteria GSK medically significant), corneal edema, corneal infiltrates and eye inflammation. The patient was treated with prednisolone acetate. On an unknown date, the outcome of the herpes zoster keratitis, keratic precipitates and corneal infiltrates were unknown and the outcome of the corneal edema and eye inflammation were recovered/resolved. The reporter considered the herpes zoster keratitis, keratic precipitates, corneal edema, corneal infiltrates and eye inflammation to be related to Herpes Zoster vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of reactivation of Herpes Zoster stromal keratitis in 89-year-old male patient who was vaccinated with unspecified herpes zoster adjuvanted subunit (HZ/su) vaccine (manufacturer unknown) for prophylaxis. The patient had a history of herpes-zoster-associated stromal keratitis, controlled for 1 year on loteprednol etabonate 1% (topical corticosteroids) once a day. No information on patient's family history or concurrent condition was provided. On an unspecified date, the patient had received 1st dose of unspecified Herpes zoster adjuvanted subunit vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The age of vaccination was not provided. On an unspecified date, 3 weeks after vaccination, the patient had developed diffuse stromal oedema, anterior stromal granular infiltrate, and keratic precipitates. The patient was diagnosed with recurrent herpes zoster stromal keratitis. The inflammation resolved with topical prednisolone acetate 1% therapy. The author stated "Both humoral and cell-mediated immune responses develop within 1 month of the first dose of the HZ/su vaccine. The authors concluded, "In patients with a history of inflammatory zoster-associated corneal disease, prophylactic increase in steroid therapy is recommended before administration of the HZ/su vaccine."
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This case was reported in a literature article and described the occurrence of herpes zoster keratitis in a 89-year-old male patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included herpes zoster keratitis (herpes-zoster-associated stromal keratitis,controlled for 1 yr on loteprednol etabonate1% once day). Concomitant products included loteprednol etabonate. On an unknown date, the patient received the 1st dose of Herpes Zoster vaccine. On an unknown date, 21 days after receiving Herpes Zoster vaccine, the patient experienced herpes zoster keratitis (serious criteria GSK medically significant), keratic precipitates (serious criteria GSK medically significant), corneal edema, corneal infiltrates and eye inflammation. The patient was treated with prednisolone acetate. On an unknown date, the outcome of the herpes zoster keratitis, keratic precipitates and corneal infiltrates were unknown and the outcome of the corneal edema and eye inflammation were recovered/resolved. The reporter considered the herpes zoster keratitis, keratic precipitates, corneal edema, corneal infiltrates and eye inflammation to be related to Herpes Zoster vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of reactivation of Herpes Zoster stromal keratitis in 89-year-old male patient who was vaccinated with unspecified herpes zoster adjuvanted subunit (HZ/su) vaccine (manufacturer unknown) for prophylaxis. The patient had a history of herpes-zoster-associated stromal keratitis, controlled for 1 year on loteprednol etabonate 1% (topical corticosteroids) once a day. No information on patient's family history or concurrent condition was provided. On an unspecified date, the patient had received 1st dose of unspecified Herpes zoster adjuvanted subunit vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The age of vaccination was not provided. On an unspecified date, 3 weeks after vaccination, the patient had developed diffuse stromal oedema, anterior stromal granular infiltrate, and keratic precipitates. The patient was diagnosed with recurrent herpes zoster stromal keratitis. The inflammation resolved with topical prednisolone acetate 1% therapy. The author stated "Both humoral and cell-mediated immune responses develop within 1 month of the first dose of the HZ/su vaccine. The authors concluded, "In patients with a history of inflammatory zoster-associated corneal disease, prophylactic increase in steroid therapy is recommended before administration of the HZ/su vaccine."
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Fatigue, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 76-year-old female patient received, on 12Jul2018 at 20:00, PREVNAR 13, via an unspecified route of administration, in the left arm, at single dose, for immunization. The patient received also, on an unspecified date, tetanus vaccine and SHINGRIX; both for immunization. She got another vaccine 10 years before this report, but she was unsure of the name of it. Relevant medical history included pneumonia (she has had full blown pneumonia before, but about 50 years before this report). Concomitant medications were unknown. On an unspecified date, in Jul2018, the patient experienced cough and tiredness. On 24Sep2018 pneumonia was diagnosed. Patient's clinical course was the following: patient received PREVNAR 13. She also was vaccinated with tetanus shot and SHINGRIX after receiving pneumococcal 13-val conj vac (dipht crm197 protein) and after she developed the cough that never went away. She had a bit of a cough all summer and she noticed she was tiring easily. The patient was seen by her health care provider and was diagnosed with pneumonia on 24Sep2018. He listened to her chest and then said she should have a chest X-ray. She was prescribed (ZITHROMAX) for 5 days. Clinical outcome of the adverse events was recovering. The information on the lot number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 64-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name not reported) on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient was allergic to pneumococcal vaccine. Event outcome was not reported. Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: M
Vaccine: PNC13
Symptoms: Flashback, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable physician reporting for himself via a Pfizer sales representative. A 54 (unit unknown) male physician received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site and flashback on an unspecified date with outcome of unknown. Pain at the injection site lasted for at least a year, it did not happen all the time but at occasional use of that muscle. It was exactly at the spot where the patient had the injection.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Rash generalised, Swollen tongue
Clinical narrative: 2 Hours after administration developed full body rash, itching, tongue swelling. Received EPI, BENADRYL, SOLUMEDROL and PEPCID in ER. *Never had a reaction to flu vaccines in the past*
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Onset same day of swelling - pain (R) arm. Woke still swollen. Refusing Tx and MD.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Baseball size swelling noted under injection site on (R) upper arm. Warm to touch. Hurts to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema, Injection site erythema, Rash, Urticaria
Clinical narrative: Patient presented to pharmacy with redness at injection site and full body (RPh saw upper torso and abdomen) and upper extremities rash and hives.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm to touch around injection site. Trmt: ibuprofen and cold compress.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: Large knot (per physcian) about softball size, swollen and red.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Local reaction, Swelling, Tenderness
Clinical narrative: Seen in office on 10/5/18- had severe tenderness redness and tense swelling 24 hrs after vaccines- measured 11 x 8 cm. Severe local allergic reaction vs cellulitis. Begun on Cephalexin 75 mg/kg/d. Recheck visit on 10/6/18- patient has complete resolution of redness and swelling. In retrospect, thought to be a severe local allergic reaction to injection. Has had several influenza injections in the past but no reactions. Last influenza injection was 9/12/16.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Feeling abnormal, Influenza like illness, Lethargy
Clinical narrative: Flu-like symptoms, chills, dizziness, muscle aches, lethargic. Downright crappy. Had to rest on the sofa all day with a blanket because I kept having chills.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia
Clinical narrative: Flu-like symptoms, chills, dizziness, muscle aches, lethargic. Downright crappy. Had to rest on the sofa all day with a blanket because I kept having chills.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Flank pain, Muscle spasms
Clinical narrative: @2330 pm developed chills, abdominal pain, flank pain bilaterally. Chill progressed very rapidly, could not get warm with socks and 4 blankets on. Also was hard to speak d/t shakiness, speech changed as well, also muscle cramping on the legs. Was given heating pad by husband and took Ibuprofen 400 mg. Symptoms subside after 2-2.5 hr. On 10/10/18 morning symptoms returned: chills, muscle aches and cramps, abdominal discomfort, was nauseous, vomited x2. Could not take anything by mouth due to nausea, did heating pad, Mylanta and 2 hr later took Ibuprofen. Started slowly to feel better 10/10/18 after 8 pm.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Speech disorder, Tremor, Vomiting
Clinical narrative: @2330 pm developed chills, abdominal pain, flank pain bilaterally. Chill progressed very rapidly, could not get warm with socks and 4 blankets on. Also was hard to speak d/t shakiness, speech changed as well, also muscle cramping on the legs. Was given heating pad by husband and took Ibuprofen 400 mg. Symptoms subside after 2-2.5 hr. On 10/10/18 morning symptoms returned: chills, muscle aches and cramps, abdominal discomfort, was nauseous, vomited x2. Could not take anything by mouth due to nausea, did heating pad, Mylanta and 2 hr later took Ibuprofen. Started slowly to feel better 10/10/18 after 8 pm.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Fatigue, Pain in extremity, Rash, Skin discolouration
Clinical narrative: MY REACTIONS WERE SORE LT ARM WITHIN 2 HOURS BLACK AND BLUE THAT EVENING ALONG WITH RASH ON LT ARM TO ELBOW APPEARING AROUND 10PM. I HAD SCRATCHY THROAT AND FATIGUE. RASH LASTED UNTIL 10/16 EVENING. BRUISE STILL APPARENT (10/18) 2INCHES IN DIAMETER.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: MY REACTIONS WERE SORE LT ARM WITHIN 2 HOURS BLACK AND BLUE THAT EVENING ALONG WITH RASH ON LT ARM TO ELBOW APPEARING AROUND 10PM. I HAD SCRATCHY THROAT AND FATIGUE. RASH LASTED UNTIL 10/16 EVENING. BRUISE STILL APPARENT (10/18) 2INCHES IN DIAMETER.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: PATIENT DEVELOPED A RASH OVER MID-SECTION THAT HAS GOTTEN PROGRESSIVELY WORSE. MY IMPRESSION WAS POSSIBLE SHINGLES OUTBREAK; INSTRUCTED PATIENT TO SEE PCP IF RASH SPREADS OR WORSENS.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Blood electrolytes normal, Computerised tomogram head normal, Postictal state, Seizure
Clinical narrative: Seizure (non-febrile) during sleep of unknown duration. Post-ictal period lasted about 1.5 hours.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness below the site.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Anti-thyroid antibody, Antibody test, Blood thyroid stimulating hormone, Bone pain, Chest X-ray
Clinical narrative: Very high fever, lethargy, loss of appetite, leg pain, weight loss, food allergy, bone pain, extreme emotional reactions, sensory issues with clothing and food.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Culture, Culture urine, Decreased appetite, Differential white blood cell count, Drug screen
Clinical narrative: Very high fever, lethargy, loss of appetite, leg pain, weight loss, food allergy, bone pain, extreme emotional reactions, sensory issues with clothing and food.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Electroencephalogram, Emotional disorder, Food allergy, Full blood count, Lethargy
Clinical narrative: Very high fever, lethargy, loss of appetite, leg pain, weight loss, food allergy, bone pain, extreme emotional reactions, sensory issues with clothing and food.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Lipids, Metabolic function test, Nuclear magnetic resonance imaging, Pain in extremity, Platelet count
Clinical narrative: Very high fever, lethargy, loss of appetite, leg pain, weight loss, food allergy, bone pain, extreme emotional reactions, sensory issues with clothing and food.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Pyrexia, Sensory disturbance, Streptococcus test, Thyroxine free, Toxicologic test
Clinical narrative: Very high fever, lethargy, loss of appetite, leg pain, weight loss, food allergy, bone pain, extreme emotional reactions, sensory issues with clothing and food.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Urine analysis, Vitamin D, Weight decreased
Clinical narrative: Very high fever, lethargy, loss of appetite, leg pain, weight loss, food allergy, bone pain, extreme emotional reactions, sensory issues with clothing and food.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: Flu like symptoms. Achey, tired, no energy. Really crappy. Came home from work and went to bed.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Went back to school after his appointment 10/16/18 and at bedtime complained to mom that his arm hurt, she did not look at it until 10/17/18 around noon. He had a fever of 100.6, shortly after he vomited once.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Dizziness, Hypopnoea, Nausea, Palpitations
Clinical narrative: Became very dizzy and nauseous 30 minutes after the vaccine was given while sitting in the lobby. Suddenly I could hear my heartbeat very loudly in the ears and felt as though I was going to faint. My breath became shallow and I felt as though I was going to vomit and that my heart was racing. I started having difficulty focusing my eyes.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Became very dizzy and nauseous 30 minutes after the vaccine was given while sitting in the lobby. Suddenly I could hear my heartbeat very loudly in the ears and felt as though I was going to faint. My breath became shallow and I felt as though I was going to vomit and that my heart was racing. I started having difficulty focusing my eyes.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Local reaction, Oedema, Pruritus
Clinical narrative: 7.5" x 6.5" local reaction of erythema, mild edema, and pruritis.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Eye swelling, Pruritus generalised, Swelling face
Clinical narrative: Full body itching, swollen face and eyes. Treated with BENADRYL and prednisone. Patient is fine now.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Amino acid level normal, Ammonia increased, Blood pyruvic acid normal, Blood test normal, CSF test normal
Clinical narrative: Patient is a 4-month-old, she developed onset of fever of 102, decreased appetite and emesis.  Parents were instructed to do symptomatic treatment with TYLENOL and PEDIALYTE. Later that afternoon she had an episode where she went limp with her eyes wide open, unresponsive, lasting 4-5 seconds. There was no associated apnea or color change. No abnormal movement movements or jerking. They called EMS after which she had 2 more episodes within 30 minutes. She was brought to the emergency room where she had a fourth brief episode of going limp. Vital signs were stable. She was transferred to hospital for admission and further workup. Hospital course included lab testing including blood work and CSF, EEG and MRI all of which was within normal limits. Ammonia level was slightly elevated thought secondary to delayed processing. Pyruvate, amino acids and organic acids were normal. Neurology was consulted and did not recommend any medication at this time. She was discharged home in stable condition.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Electroencephalogram normal, Hypotonia, Nuclear magnetic resonance imaging normal, Organic acid analysis
Clinical narrative: Patient is a 4-month-old, she developed onset of fever of 102, decreased appetite and emesis.  Parents were instructed to do symptomatic treatment with TYLENOL and PEDIALYTE. Later that afternoon she had an episode where she went limp with her eyes wide open, unresponsive, lasting 4-5 seconds. There was no associated apnea or color change. No abnormal movement movements or jerking. They called EMS after which she had 2 more episodes within 30 minutes. She was brought to the emergency room where she had a fourth brief episode of going limp. Vital signs were stable. She was transferred to hospital for admission and further workup. Hospital course included lab testing including blood work and CSF, EEG and MRI all of which was within normal limits. Ammonia level was slightly elevated thought secondary to delayed processing. Pyruvate, amino acids and organic acids were normal. Neurology was consulted and did not recommend any medication at this time. She was discharged home in stable condition.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient is a 4-month-old, she developed onset of fever of 102, decreased appetite and emesis.  Parents were instructed to do symptomatic treatment with TYLENOL and PEDIALYTE. Later that afternoon she had an episode where she went limp with her eyes wide open, unresponsive, lasting 4-5 seconds. There was no associated apnea or color change. No abnormal movement movements or jerking. They called EMS after which she had 2 more episodes within 30 minutes. She was brought to the emergency room where she had a fourth brief episode of going limp. Vital signs were stable. She was transferred to hospital for admission and further workup. Hospital course included lab testing including blood work and CSF, EEG and MRI all of which was within normal limits. Ammonia level was slightly elevated thought secondary to delayed processing. Pyruvate, amino acids and organic acids were normal. Neurology was consulted and did not recommend any medication at this time. She was discharged home in stable condition.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING AT INJECTION SITE INVOLVING ENTIRE UPPER ARM, ITCHING, HEAT, REDNESS, DISCOMFORT.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Child found unresponsive at 0450 am on 9/26/18 and EMS called immediately. CPR was initiated. Child was last seen breathing at midnight. Child taken to the emergency department at hospital. Child pronounced dead at 5:44 am.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Patient reported shoulder impingment post vaccine.
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased activity, Tinnitus
Clinical narrative: Patient states that she got her flu vaccine and then she began to have decreased hearing in her left ear and rumbling so she went to her doctor.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated noon on 9/19/18 with regards to site appearance. She said she had black/blue bruising and swelling of whole left upper arm, redness and hotness and achy arm. No allergic symptoms reported. She said it looked way worse then she felt.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pyrexia, Urinary incontinence, Vomiting
Clinical narrative: I am severe chills teeth chattering - then vomit (12-14) times urinated while vomiting. Lasted 3:30 hrs then fever took 24 hrs to recover.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Arthralgia, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: Patient received FLUAD vaccination and immediately that evening started to feel unwell. Patient has experienced nausea, joint pain, stomach pain and fever since receiving the vaccine. As of 10/11/18 patient is still unwell.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: Patient received FLUAD vaccination and immediately that evening started to feel unwell. Patient has experienced nausea, joint pain, stomach pain and fever since receiving the vaccine. As of 10/11/18 patient is still unwell.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Sneezing
Clinical narrative: Patient received FLUZONE HD. There were no problems with administration. She called pharmacy several days later to inform us that later in the day that she received the vaccination she had sneezing, itching and body aches and felt that way for the next day before beginning to feel better. She wanted us to report this information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in April 2011 (reported as on or about 21-APR-2011), the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in July 2015 (reported as on or about 14-JUL-2015), the patient was treated for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. On an unknown date in April 2015 (reported as on or about 10-AUG-2015), the patient sought subsequent treatment for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. On an unknown date in August 2015 (reported as on or about 19-AUG-2015), the patient sought additional treatment for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-AUG-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by health professional for the onset of a vesicular rash which was diagnosed as 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. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or about 20-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended at a pharmacy for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On or about 01-JUN-2015, the patient was treated at a clinic for the onset of a severe vesicular rash which was diagnosed as shingles. The patient was prescribed prednisone and hydroxyzine for management of his painful symptoms and chronic pain. As a direct and proximate result of 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, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On or about 11-MAY-2011, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and she subsequently contracted a persistent strain of herpes zoster or shingles. On or about 05-AUG-2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster (onset date unspecified). She was prescribed acyclovir for management of her painful symptoms and chronic pain. On or about 15-FEB-2017, she was treated for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of 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 had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure, herpes zoster and chronic pain was unknown. The reporter considered vaccination failure, herpes zoster and chronic pain to be related to ZOSTAVAX.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 09-OCT-2018, the patient was 9.5 weeks pregnant with last menstrual period on approximately 03-AUG-2018. On that day, she was inadvertently vaccinated with GARDASIL 9 intramuscularly, lot # N035955, expiration date on 09-OCT-2020 (dose, frequency and site of administration were not reported) for prophylaxis (Inadvertent exposure to vaccine, Vaccine exposure during pregnancy, Maternal exposure during pregnancy, first trimester). No adverse effect was reported. At the time of the report the pregnancy outcome was pending with estimated delivery date (EDD) on 10-MAY-2019. The outcome of Vaccine exposure during pregnancy and Maternal exposure during pregnancy was unknown.