chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: One dose Vivotif was taken incorrectly after a 72 hour time lapse; A spontaneous was received on 03AUG2020.  A pharmacist reported that a male consumer (age between 16 and 21) "took one dose of Vivotif incorrectly after a 72-hour time lapse" (PT: Inappropriate schedule of product administered). The consumer was receiving Vivotif for immunization. It was reported that the consumer took all four doses of Vivotif. However, one dose was taken incorrectly after a 72-hour time lapse. The reporter did not know the dates. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the event was unknown at the time of report.  Company Comment: A consumer took one dose of Vivotif incorrectly after a 72-hour time lapse (inappropriate schedule of product administered) instead of taking every other day.This consumer completed taking all four doses of Vivotif. Considering the nature of the event, the causality of inappropriate schedule of product administered is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took one dose of Vivotif incorrectly after a 72-hour time lapse (inappropriate schedule of product administered) instead of taking every other day.This consumer completed taking all four doses of Vivotif. Considering the nature of the event, the causality of inappropriate schedule of product administered is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took two doses of Vivotif on consecutive days; Spontaneous report received on 08AUG2020.  A pharmacist reported that a male consumer "took two doses of Vivotif on consecutive days" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. On an unknown date, the consumer started Vivotif. He took two doses of Vivotif on two consecutive days. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer took two doses of Vivotif on consecutive days (inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer took two doses of Vivotif on consecutive days (inappropriate schedule of product administration) instead of taking Vivotif on every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: slight soreness in the arm; pain upon injection while receiving the first dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and injection site pain. On 4th September 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm and injection site pain to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported experiencing slight soreness in the arm and pain upon injection while receiving the 1st dose of the Shingrix vaccine. The reporter consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020185503.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020185503:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Got a horrible flu after taking the shot; Got a horrible flu after taking the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported. The patient received Flu vaccine and experienced horrible flu. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting
Sex: U
Vaccine: FLUX, PPV, VARZOS
Symptoms: Adverse reaction
Clinical narrative: horrible reactions/If they had been frail it would have killed them; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in an unknown number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Shingles vaccine and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and Shingles vaccine, the patient experienced adverse reaction (serious criteria life threatening). On an unknown date, the outcome of the adverse reaction was unknown.   The reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported applicable for this report. The reporter stated stop pushing death. The patients had horrible reactions from the flu, pneumonia and shingles vaccination. If they had been frail it would have killed them.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189605:same reporter
Age: 70.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PNC13
Symptoms: Contusion, Mass, Product administered to patient of inappropriate age
Clinical narrative: left arm was bruised; big knot on her arm; she received her Menveo and Bexsero; This case was reported by a consumer via call center representative and described the occurrence of bruising of arm in a 70-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABX797AB, expiry date 30th September 2020) for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   The patient's past medical history included spleen operation. Concurrent medical conditions included appendix cancer and platelet count high. Concomitant products included acetylsalicylic acid (Aspirin (Baby)).   On 22nd June 2020, the patient received the 1st dose of Menveo, the 1st dose of Bexsero (intramuscular), the 1st dose of Hib vaccine and the 1st dose of PREVNAR 13. On an unknown date, less than 3 months after receiving Menveo, Bexsero and Hib vaccine, the patient experienced bruising of arm, mass and inappropriate age at vaccine administration. On an unknown date, the outcome of the bruising of arm, mass and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the bruising of arm and mass to be related to Menveo, Bexsero and Hib vaccine.  Additional details were as follows: After receiving 1st dose of Bexsero, the patient experienced left arm was bruised and she had a big knot on her arm from the vaccinations. The patient received Menveo and Bexsero vaccinations at the age of 70 years, which led to inappropriate age at vaccine administration. The patient reported that she had her spleen removed after being diagnosed with appendix cancer and she was told to get the Menveo, Bexsero, Prevnar 13 and Hemophilus influenzae type B (HIB) vaccine after her surgery. It was unknown if the reporter considered the bruising of arm and mass to be related to Prevnar 13. The reporter consented to follow up. The case was considered as medication error with harm. his case has been linked with US2020AMR187009 reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR187009:same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain lower, Chills, Frequent bowel movements, Nausea
Clinical narrative: Lower abdominal pain; Stomach is swollen, large and firm to touch; bowel movements; Shiver; nausea; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diverticulosis.   On 2nd July 2020, the patient received the 1st dose of Shingrix. On 2nd July 2020, immediately after receiving Shingrix, the patient experienced shivering, nausea, swelling abdomen and frequent bowel movements. On 8th July 2020, the patient experienced lower abdominal pain. On an unknown date, the outcome of the shivering, nausea and frequent bowel movements were unknown and the outcome of the lower abdominal pain and swelling abdomen were not recovered/not resolved.   It was unknown if the reporter considered the shivering, nausea, lower abdominal pain, swelling abdomen and frequent bowel movements to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. Soon after the 1st dose of the Shingrix vaccine she started to experience lower abdominal pain especially when she had a bowel movements and also as of August 2020, she was stating her stomach was swollen, large and firm to touch. She was stating the lower abdominal pain and swollen stomach had been ongoing and has not resolved. The reporter consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020AMR187582.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR187582:2nd dose
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: mild headache; mild shivering; 99.5 fever; slight tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on unknown date. Please refer the case US2020AMR187682.).   On 16th September 2020, the patient received the 2nd dose of Shingrix. On 17th September 2020, 1 days after receiving Shingrix, the patient experienced headache, shivering, fever and tiredness. On an unknown date, the outcome of the headache, shivering, fever and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, shivering, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 2nd dose the patient experienced the mild headache, mild shivering, 99.5 fever and slight tiredness.  The reporter consent to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR187682:same reporter
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Illness, Injection site rash, Limb discomfort, Oral herpes
Clinical narrative: rash at the injection site; diarrhea; fever blister in the left upper arm which erupted; felt very sick; arm was uncomfortable; arm pain; upper arm was swollen; itching across her chest and general back of the shoulder area; rash and itching across her chest and general back of the shoulder area; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site rash, diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm, sickness and arm discomfort. On an unknown date, the outcome of the injection site rash and sickness were unknown and the outcome of the diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the injection site rash, diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm, sickness and arm discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix in her left deltoid and had a terrible reaction. The patient experienced left whole arm pain for a week and the upper arm was swollen and the arm was uncomfortable for 1 week. There was rash at the injection site. The rash and itching across her chest and general back of the shoulder area for 1 week or longer and she had fever blister in the left upper arm which erupted and took longer to heal. The patient felt very sick. She had diarrhea for 1 and half days. The patient has never had chicken pox before. The reporter consented to follow. This case had been linked to the case US2020187097 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187097:same reporter
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: rash at the injection site; diarrhea; fever blister in the left upper arm which erupted; felt very sick; arm was uncomfortable; arm pain; upper arm was swollen; itching across her chest and general back of the shoulder area; rash and itching across her chest and general back of the shoulder area; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site rash, diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm, sickness and arm discomfort. On an unknown date, the outcome of the injection site rash and sickness were unknown and the outcome of the diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the injection site rash, diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm, sickness and arm discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix in her left deltoid and had a terrible reaction. The patient experienced left whole arm pain for a week and the upper arm was swollen and the arm was uncomfortable for 1 week. There was rash at the injection site. The rash and itching across her chest and general back of the shoulder area for 1 week or longer and she had fever blister in the left upper arm which erupted and took longer to heal. The patient felt very sick. She had diarrhea for 1 and half days. The patient has never had chicken pox before. The reporter consented to follow. This case had been linked to the case US2020187097 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187097:same reporter
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Coordination abnormal, Diarrhoea, Injection site erythema, Nausea
Clinical narrative: injection became red; uncoordinated; felt sick to his stomach; severe diarrhea; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included balance difficulty.   On 11th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, stomach discomfort, diarrhea, nausea and incoordination. On an unknown date, the outcome of the injection site erythema and incoordination were unknown and the outcome of the stomach discomfort, diarrhea and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, stomach discomfort, diarrhea, nausea and incoordination to be related to Shingrix.  Additional details were provided as follows:  The patient had some balance problems and uses a walker. The patient received shingrix vaccine in the right arm and injection site became red. The patient felt sick to his stomach with nausea and severe diarrhea for 2 days. The patient was very uncoordinated because of adverse event. The patient's wife who was the caretaker had to keep him quiet. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187095:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had both doses /  had two cases of shingles / in August, and / in September/ Suspected vaccination failure; shingles / in September / on my lower back; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (once every couple months). Concurrent medical conditions included stress.   In May 2020, the patient received the 1st dose of Shingrix. In August 2020, the patient received the 2nd dose of Shingrix. In September 2020, between 4 and 5 months after receiving Shingrix and between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 77 or 78 years old. The patient had both doses, one in May and then the second three months after the first dose and had two cases of shingles occur. One last month in August, and now one this month in September, and patient was wondering if she should report this to the pharmacy where she got vaccination, or to her doctor; she was under the understanding that the vaccine would prevent her from getting the shingles, but she still getting shingles. The patient had a history of shingles, stating if she was under a lot of stress she used to get shingles maybe once every couple months, and it would just be slight breakout might be the size of a dime, nickel, or quarter, on my lower back. It had been happening off and on for the past 40 years. Consumer gave consent to contact her pharmacy and her physician, though limited contact information was available at the time of call. The reporter also granted consent for safety to follow up with her directly. Consumer was not provided the product lot numbers, but stated she received both vaccine did at the pharmacy. No further details were provided at the time of callback. This case was considered as suspected vaccination failure as time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Skin rashes; This is a spontaneous report from a non-contactable consumer via a sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 17Sep2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced skin rashes 21Sep2020. It was reported that the event took place after use of the product. Outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Cold sweat, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: pale; blood pressure low; belly pain; sweaty; clammy; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case from the physician via medical representative.   This case involves an eight-year-old male patient who experienced pale (pallor), blood pressure was low (hypotension), belly pain (abdominal pain), become sweaty (hyperhidrosis) and clammy (cold sweat), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not provided. At the time of the event, the patient had ongoing seasonal allergy.   On 09-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiration date were not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious pale (pallor), blood pressure was low (hypotension), belly pain (abdominal pain), become sweaty (hyperhidrosis) and clammy (cold sweat), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the events.  There will be no information available on the batch number for this case.
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Injury associated with device
Clinical narrative: Nothing happened to patient. No symptoms, signs at time of administration. Needlestick (employee) happened after administration.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Erythema multiforme, Pyrexia, Rash
Clinical narrative: Patient was seen on 9/15/20 and mother reports rash started yesterday 9/14/20. Patient had immunizations including MMR immunization 14 days ago (9/1/20), fever which started a few days after immunization and ended 3-4 days ago (9/13/20). Pt diagnosed with Erythema multiforme minor by provider.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: -Patient received flu shot 9/15/20 had typical soreness in upper arm for a few days, beginning Saturday 9/19/20 to lower arm began to feel sore pain continued into Monday 9/21/20 along with tingling in arm and hand primary doctor advised her to contact pharmacy by Tuesday 9/22/20 pt said symptoms resolved arm/and felt fine.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Sore arm and hives
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Pyrexia, Tremor
Clinical narrative: Child had a fever as high as 103.5, pulse 176 and tremulousness and had to be treated in the E.R.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Mom reports the patient experienced Diarrhea, rash, and swelling of the left leg. The leg was noted to be hot to touch. Mom gave the patient Tylenol on 09/25/2020 @ 0200. Benadryl administered in the office on 09/25/2020 @ 1145, cool compress applied, oral steroid medication started, patient to follow up on 09/28/2020
Age: 14.0
Sex: M
Vaccine: FLUA4
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: LARGE LOCAL REACTION, PAIN, SWELLING AND REDNESS
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Site swelled into hot red itchy hive size of baseball.  Lasted two days.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain
Clinical narrative: Sever body aches in the back and joints that lasted for approximately 20-30 minutes.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: left shoulder remains painful and swollen from acromian process to bottom of deltoid
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: THIS PATIENT DEVELOPED BELL'S PALSY 7 DAYS AFTER THE INJECTION
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Pyrexia
Clinical narrative: Pt has low grade fever of 99..8 degrees and mild fatigue
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Day 1 just minor arm pain; Day 2 arm pain and flu-like symptoms, chills, minor headache and fatigue with slightly larger area of redness on right arm where shot was administered, Day 3, flu-like symptoms gone but redness on arm and pain persists and area of redness a bit bigger; Day 4 redness on arm seems to have grown to cover an area at least 5x5 inches and there is some swelling as well as persistent low-level soreness. The area also feels warm to the touch.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day 1 just minor arm pain; Day 2 arm pain and flu-like symptoms, chills, minor headache and fatigue with slightly larger area of redness on right arm where shot was administered, Day 3, flu-like symptoms gone but redness on arm and pain persists and area of redness a bit bigger; Day 4 redness on arm seems to have grown to cover an area at least 5x5 inches and there is some swelling as well as persistent low-level soreness. The area also feels warm to the touch.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient reported having significant pain in the arm which the vaccine was administered starting the night after the injection.  Reported that although minor improvements, that she still has pain and discomfort and reduced range of motion in her arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Additional dose, no adverse reactions.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Rash
Clinical narrative: tender at injection site, fatigue, headache, rash neck area chest area and both arms .  does not itch or burn
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Additional dose given, no adverse events.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenitis
Clinical narrative: 6 days after the shringrix, she is having lymphadenitis in her neck and clavicle on the left side; same side of injectin site. I looked up and it is a serious reaction at <0.01 percent.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Bradyphrenia, Chest discomfort, Discomfort, Feeling abnormal, Headache
Clinical narrative: Reported "entire body feels heavy, foggy, slow thinking, decision-making, chest tightness, left frontal headache"
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Pt recieved flublok instead of fluzone
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: 2 days of flu like symptoms. Feverish, pains in legs and hands, fatigue. Arm was very sore for 2 days
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin warm, Swelling
Clinical narrative: rash on multiple sites on body, raised hot and itchy
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: left deltoid redness, warmth, tenderness, lump
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: AREA TO RIGHT UPPER ARM, POSTERIOR,  RED, WARM, SWELLING, KNOT AT INJECTIO SITE, ITCHING APPROX 4.5 INCHES  X 2 INCHES
Age: 2.08
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Both legs swollen, left worse than right. Left thight swollen twice the size as the other leg. Right leg had silver dollar sized swollen area. Hot to touch, red area that covered his whole thigh and itching.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Back injury, Chills, Dizziness, Face injury, Feeling abnormal
Clinical narrative: Pt states that that evening following the flu vaccine she developed a high fever, reports that thermometer said 107 but thinks that it is broken.  During the night she did not sleep well due to chills and shaking.  The next day when she went to take a shower she states that at some point she passed out hitting her back and chin.  She is unsure if she had any dizziness or felt lightheaded prior to passing out.  She reports that after the incident in the shower she then passed out three more times and states that they were in close succession to each other.  Pt states that later in the day she did feel a little lightheaded and thought she may pass out again but did not.  She did not seek any medical treatment. Today she states that at home her temp was 107 again thus making her think that her thermometer is broken because her temp here at work was normal.   She does states that she feels much better today but feels like she was "hit by a truck" due to the soreness from passing out.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Pain, Pyrexia, Tremor
Clinical narrative: Pt states that that evening following the flu vaccine she developed a high fever, reports that thermometer said 107 but thinks that it is broken.  During the night she did not sleep well due to chills and shaking.  The next day when she went to take a shower she states that at some point she passed out hitting her back and chin.  She is unsure if she had any dizziness or felt lightheaded prior to passing out.  She reports that after the incident in the shower she then passed out three more times and states that they were in close succession to each other.  Pt states that later in the day she did feel a little lightheaded and thought she may pass out again but did not.  She did not seek any medical treatment. Today she states that at home her temp was 107 again thus making her think that her thermometer is broken because her temp here at work was normal.   She does states that she feels much better today but feels like she was "hit by a truck" due to the soreness from passing out.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Rash, Rash erythematous, Tachycardia, Urticaria
Clinical narrative: Shortness of breath, urticaria-generalized, diffuse red rash on back, chest. tachycardia,
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Fatigue, Headache, Swelling, Vomiting
Clinical narrative: Headaches, vomit, fatigue, red round raised area
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the pt's was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the pt's was treated by a licensed clinical social worker (LCSW) at her office for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: FLUN3
Symptoms: Autism spectrum disorder
Clinical narrative: SUDDENLY AUTISTIC AT 6 YEARS OLD; A spontaneous report has been received from a consumer. The report concerns a male patient of Unknown ethnic origin (age 11 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal), via nasal route, on an unknown date.     During 2015, the patient experienced suddenly autistic at 6 years old (preferred term: Autism spectrum disorder).     It is unknown if any action was taken with Flumist (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: SICK FOR A WEEK; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal), via nasal route, on an unknown date.     On an unknown date, the patient experienced sick for a week (preferred term: Malaise).     It is unknown if any action was taken with Flumist (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered non-serious.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: Weakness, severe fatigue, body aches
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient recurved DTaP, IPV, MMR, and Varicella on  2/27/2013. Then developed redness, tenderness, and  swelling along the entire front of the leg on which he was had recurved the vaccines.
Age: 29.0
Sex: M
Vaccine: FLUR4, TDAP
Symptoms: Road traffic accident, Syncope
Clinical narrative: Pt wife reported syncope while driving about 20-30 minutes after leaving the store. She states he woke from fainting upon impact with another car.  Do not know if pt will seek further treatment at this time.
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Blood thyroid stimulating hormone normal, Borrelia test negative, C-reactive protein normal
Clinical narrative: The patient received influenza high dose quadrivalent vaccine on 9/3/2020.  He woke up 09/18/2020 at 4:00 AM with the inability to stand.  He was completely normal on the evening before he went to bed (21-22:00).  He fell a few times because he could not lock his legs.  He denied numbness in the feet.  He came to the ED 9/20/2020 and wanted to be discharged home with pain medications and close monitoring, of which he was able to walk with a walker. The patient was admitted to Hospital on 9/21/2020 with sudden onset leg weakness and numbness in the hands. The numbness was involving the inner surface of the hands and slightly in the forearm.  He did not think he is weak in the arms.  He denied any recent trauma.  He had a fall a few days ago, bruising his knees- after the onset of leg weakness. The patient also complained of a transient episode of severe leg and low back pain that started 9/20/2020 and resolved with narcotics. He also complained of a two day history of severe neck pain, radiating to the back of the head, and between the scapular region. The pain was sudden in onset and it spontaneously resolved.  The pain occurred three days before he developed weakness in the legs. Neurology consulted and diagnosed the patient with Guillain-Barré syndrome (GBS). The patient was given 25g of 10% immune globulin IV on 9/21/2020 at 20:33. The patient experienced hypertension that may have been exacerbated by IVIG volume, so treatment was changed to plasma exchange (PLEX) once every other day for a total of 5 treatments over 10 days. Today on 9/25/2020, the patient continues to have weakness in his legs.  He is having trouble swallowing and coughing.  He is receiving the second PLEX session. He still remains hospitalized on 9/25/2020.
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: CSF glucose increased, CSF protein increased, CSF red blood cell count positive, Computerised tomogram head normal, Contusion
Clinical narrative: The patient received influenza high dose quadrivalent vaccine on 9/3/2020.  He woke up 09/18/2020 at 4:00 AM with the inability to stand.  He was completely normal on the evening before he went to bed (21-22:00).  He fell a few times because he could not lock his legs.  He denied numbness in the feet.  He came to the ED 9/20/2020 and wanted to be discharged home with pain medications and close monitoring, of which he was able to walk with a walker. The patient was admitted to Hospital on 9/21/2020 with sudden onset leg weakness and numbness in the hands. The numbness was involving the inner surface of the hands and slightly in the forearm.  He did not think he is weak in the arms.  He denied any recent trauma.  He had a fall a few days ago, bruising his knees- after the onset of leg weakness. The patient also complained of a transient episode of severe leg and low back pain that started 9/20/2020 and resolved with narcotics. He also complained of a two day history of severe neck pain, radiating to the back of the head, and between the scapular region. The pain was sudden in onset and it spontaneously resolved.  The pain occurred three days before he developed weakness in the legs. Neurology consulted and diagnosed the patient with Guillain-Barré syndrome (GBS). The patient was given 25g of 10% immune globulin IV on 9/21/2020 at 20:33. The patient experienced hypertension that may have been exacerbated by IVIG volume, so treatment was changed to plasma exchange (PLEX) once every other day for a total of 5 treatments over 10 days. Today on 9/25/2020, the patient continues to have weakness in his legs.  He is having trouble swallowing and coughing.  He is receiving the second PLEX session. He still remains hospitalized on 9/25/2020.
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Cough, Dysphagia, Dysstasia, Fall, Guillain-Barre syndrome
Clinical narrative: The patient received influenza high dose quadrivalent vaccine on 9/3/2020.  He woke up 09/18/2020 at 4:00 AM with the inability to stand.  He was completely normal on the evening before he went to bed (21-22:00).  He fell a few times because he could not lock his legs.  He denied numbness in the feet.  He came to the ED 9/20/2020 and wanted to be discharged home with pain medications and close monitoring, of which he was able to walk with a walker. The patient was admitted to Hospital on 9/21/2020 with sudden onset leg weakness and numbness in the hands. The numbness was involving the inner surface of the hands and slightly in the forearm.  He did not think he is weak in the arms.  He denied any recent trauma.  He had a fall a few days ago, bruising his knees- after the onset of leg weakness. The patient also complained of a transient episode of severe leg and low back pain that started 9/20/2020 and resolved with narcotics. He also complained of a two day history of severe neck pain, radiating to the back of the head, and between the scapular region. The pain was sudden in onset and it spontaneously resolved.  The pain occurred three days before he developed weakness in the legs. Neurology consulted and diagnosed the patient with Guillain-Barré syndrome (GBS). The patient was given 25g of 10% immune globulin IV on 9/21/2020 at 20:33. The patient experienced hypertension that may have been exacerbated by IVIG volume, so treatment was changed to plasma exchange (PLEX) once every other day for a total of 5 treatments over 10 days. Today on 9/25/2020, the patient continues to have weakness in his legs.  He is having trouble swallowing and coughing.  He is receiving the second PLEX session. He still remains hospitalized on 9/25/2020.
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Headache, Hypertension, Hypoaesthesia, Immunoglobulin therapy, Loss of control of legs
Clinical narrative: The patient received influenza high dose quadrivalent vaccine on 9/3/2020.  He woke up 09/18/2020 at 4:00 AM with the inability to stand.  He was completely normal on the evening before he went to bed (21-22:00).  He fell a few times because he could not lock his legs.  He denied numbness in the feet.  He came to the ED 9/20/2020 and wanted to be discharged home with pain medications and close monitoring, of which he was able to walk with a walker. The patient was admitted to Hospital on 9/21/2020 with sudden onset leg weakness and numbness in the hands. The numbness was involving the inner surface of the hands and slightly in the forearm.  He did not think he is weak in the arms.  He denied any recent trauma.  He had a fall a few days ago, bruising his knees- after the onset of leg weakness. The patient also complained of a transient episode of severe leg and low back pain that started 9/20/2020 and resolved with narcotics. He also complained of a two day history of severe neck pain, radiating to the back of the head, and between the scapular region. The pain was sudden in onset and it spontaneously resolved.  The pain occurred three days before he developed weakness in the legs. Neurology consulted and diagnosed the patient with Guillain-Barré syndrome (GBS). The patient was given 25g of 10% immune globulin IV on 9/21/2020 at 20:33. The patient experienced hypertension that may have been exacerbated by IVIG volume, so treatment was changed to plasma exchange (PLEX) once every other day for a total of 5 treatments over 10 days. Today on 9/25/2020, the patient continues to have weakness in his legs.  He is having trouble swallowing and coughing.  He is receiving the second PLEX session. He still remains hospitalized on 9/25/2020.
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Magnetic resonance imaging spinal normal, Muscular weakness, Neck pain, Pain, Pain in extremity
Clinical narrative: The patient received influenza high dose quadrivalent vaccine on 9/3/2020.  He woke up 09/18/2020 at 4:00 AM with the inability to stand.  He was completely normal on the evening before he went to bed (21-22:00).  He fell a few times because he could not lock his legs.  He denied numbness in the feet.  He came to the ED 9/20/2020 and wanted to be discharged home with pain medications and close monitoring, of which he was able to walk with a walker. The patient was admitted to Hospital on 9/21/2020 with sudden onset leg weakness and numbness in the hands. The numbness was involving the inner surface of the hands and slightly in the forearm.  He did not think he is weak in the arms.  He denied any recent trauma.  He had a fall a few days ago, bruising his knees- after the onset of leg weakness. The patient also complained of a transient episode of severe leg and low back pain that started 9/20/2020 and resolved with narcotics. He also complained of a two day history of severe neck pain, radiating to the back of the head, and between the scapular region. The pain was sudden in onset and it spontaneously resolved.  The pain occurred three days before he developed weakness in the legs. Neurology consulted and diagnosed the patient with Guillain-Barré syndrome (GBS). The patient was given 25g of 10% immune globulin IV on 9/21/2020 at 20:33. The patient experienced hypertension that may have been exacerbated by IVIG volume, so treatment was changed to plasma exchange (PLEX) once every other day for a total of 5 treatments over 10 days. Today on 9/25/2020, the patient continues to have weakness in his legs.  He is having trouble swallowing and coughing.  He is receiving the second PLEX session. He still remains hospitalized on 9/25/2020.