chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: Patient was re-vaccinated during office visit as per staff patient administered FLUZONE QUADRIVALENT; vaccine leaked from syringe as the stopper was difficult to pull from  syringe upon preparation of vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case received from an other health professional via call center and transmitted to Sanofi on 06-Nov-2020.  This case involves patient unknown age was re-vaccinated during office visit, as per staff the patient administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number UT7058JA) via unknown route in unknown administration site for prophylactic vaccination (incorrect dose administered) because the vaccine leaked from syringe as the stopper was difficult to pull from syringe upon preparation of vaccine (syringe issue).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  This is a true medication error case since incorrect dose administered since there was a syringe issue (latency unknown).   At the time of this event there was no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; 0.7 ml of Fluzone HD was administered to the patient with no adverse event; A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323872, 2020SA324116, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 11 year old male patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] (wrong product administered, Inappropriate age at vaccine administration) on 13-Nov-2020 (batch number: UJ555AA and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination (overdose).  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered, Inappropriate age at vaccine administration and that it was an overdose (latency: same).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; patient was administered with 0.7 ml of suspect drug with no adverse event; A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323899, 2020SA323872, 2020SA324116 and 2020SA323597 (same reporter).  This case involves a 38 year old female patent for whom it was reported that a pharmacist was supposed to give INFLUENZA VACCINE INACT SPLIT 3V [FLUARIX], however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] (wrong product administered, inappropriate age at vaccine administration) on 13-Nov-2020 (batch number: UJ552AA and expiration date: 20-Jun-2021) at a dose of 0.7 ml via intramuscular route in the left arm for prophylactic vaccination (overdose).  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered, inappropriate age at vaccine administration and overdose (latency: same days).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: An expired Ipol was administered to patient; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00360159) and transmitted to Sanofi on 16-Nov-2020.  This case involves a 10 years old female patient who was administered an expired 0.5 ml fifth dose of suspect IPV (VERO) [IPOL] (lot P1E70, expiry: 09-Nov-2020) via intramuscular route in the left deltoid on 16-Nov-2020 for prophylactic vaccination (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and INFLUENZA VACCINE for prophylactic vaccination.  It was of actual medication error due to Expired vaccine used (latency same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Patient describes discomfort after the shot which continues to persist to present.  No bruising.  No neurologic deficits. Had a telehealth visit on 11/302020 and diagnosed with left arm pain due to trauma (vaccine), sent to physical therapy.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient received an extra dose of PPSV23 vaccine. Prior to administration on 12/10/20 patient had also received a dose in 2019.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site started a few hours post injection.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No other AE; received a dose of VARIVAX that was expired; This spontaneous report was received from a medical assistant, referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 03-DEC-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # r030604 has been verified to be a valid lot number, expiration date 23-OCT-2020 (dose reported as 1 dose, route of administration and injection site were not specified) for prophylaxis. No additional adverse effect was reported.
Sex: U
Vaccine: FLUX, UNK
Symptoms: Influenza, Pertussis, Vaccination failure
Clinical narrative: Get the shot and you get it. Just like the flu / goth both / flu or whooping; Get the shot and you get it. Just like the flu / goth both / flu or whooping; Get the shot and you get it. Just like the flu / goth both / flu or whooping; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included PERTUSSIS TOXOID (WHOOPING COUGH VACCINE) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and WHOOPING COUGH VACCINE. 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), whooping cough (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure, whooping cough and influenza were unknown.   It was unknown if the reporter considered the vaccination failure, whooping cough and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received  2 years ago and got both never had a flu or whooping shot. This case was considered as suspected vaccination failure as time to onset, number of doses and laboratory test were unknown at the time of reporting. It was unknown if the reporter considered the vaccination failure, whooping cough and influenza to be related to Whooping cough vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Influenza, Pyrexia
Clinical narrative: High fever, chills it was awful; within 24 hours after taking the shot patient got the flu!; High fever, chills it was awful; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient who within 24 hours after taking the shot got the flu (influenza) high fever, chills (pyrexia), (chills), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, within 24 hours after taking the shot patient got the flu (influenza) high fever, chills (pyrexia), (chills) it was awful (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: I got the flu shot and was sicker; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 04-Nov-2020.  This case involves an unknown age female patient who got the flu shot and was sicker (Illness), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, patient reported that she never got flu shots and was never got sick but on an unknown date 6 years ago patient received the dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination and was sicker (than a dog) for four days (Illness).   No relevant laboratory tests were reported.   It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Illness.  There will be no information regarding batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, H1N1 influenza
Clinical narrative: became very ill with swine Flu; weak; dizziness; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case eceived from a consumer (Patient).  This case involved adult patient who became very ill with swine flu (H1N1 influenza), weak (Asthenia) and dizziness, while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient became very ill with swine flu (H1N1 influenza), weak (Asthenia) and dizziness, unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for weak and dizziness, as resolved for H1N1 influenza.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: came down with COVID few days later; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via Social Media received on 09-Dec-2020.  This case involved a male patient of an unknown age who came down with coronavirus infectious disease (COVID-19) few days later, after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the patient came down with coronavirus infectious disease (COVID-19) few days later after receiving the administration of INFLUENZA VACCINE.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown.  There will be no information available on the batch number for this case.
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event - patient received outside of recommended age range. To date (12/11), has not experienced any adverse events.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Dry skin, Erythema, Periorbital swelling
Clinical narrative: I took 4 oral typhoid capsules as prescribed two days apart beginning on Dec 1 in morning without food for at least an hour and with full glass of water, and then again on Dec 3, Dec 5, and finally Dec 7. Each capsule was taking at approx. 07:00 AM under the same circumstances, no food for at least an hour and with full glass of water.  Between Dec 5 and Dec 7, I noticed dry, red, puffy skin around my right eye that worsened on Dec 7. I used over-the-counter cetaphil eye gel moisturizer on Dec 7 and that treated the symptoms. I used it on Dec 8 and Dec 9 and by Dec 10 the puffy skin had subsided and gone away.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: nausea, low fever 99.4, shivers and aches related to fever
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Given 3 days after expiration
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 12/09/20 at 3:00 AM fever, and shaking chills, headache, body aches -- Tylenol dose for fever taken. Symptoms continued for 2 days. Soreness site of injection, hot, red currently since vaccination
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative, Tremor
Clinical narrative: 12/09/20 at 3:00 AM fever, and shaking chills, headache, body aches -- Tylenol dose for fever taken. Symptoms continued for 2 days. Soreness site of injection, hot, red currently since vaccination
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Tired  Muscle pain Headache Shivering
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: 36 hour fever starting on 12/7/20, full body rash starting on 12/10/20, not yet resolved, joint aches (?) starting 12/10/20 not yet resolved
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: 7cm x 6cm round, warm to touch erythematous, mildly edematous tissue, of the right upper arm near injection sites
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event. Patient received vaccination outside of recommended age range of 18+, but to date (12/11/2020), has not experienced any adverse events.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: Patient came to off-site COVID test & flu shot clinic on 12/3/20.  Per patient's boss's email on 12/4/20: "When he was coming back to work, he passed out while driving, running into a Construction trailer, a stop sign, and damaging the van. (All on our Property)  He woke up and walked into the school where we called the police and filed a police report.  He is fine, I drove him down to the Hospital, on the way we called his Dr. and the nurse said not to come in unless he was feeling Nausea, or other symptoms.  She stated that "He probably just had a reaction to the Flu shot."  I drove him back home last night, and he is at work today."
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored PROQUAD; No additional AE/PQCs reported; Information has been received from a patient of unknown age and gender who was reporting on theirself. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T021639 and expiration date of 21-DEC-2021, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in an unknown temperature range for 1 hours and 32 minutes. No previous temperature excursion was reported. No adverse effects were reported.   Digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post-herpetic neuralgia; other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 14-NOV-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided), as prescribed and/or administered by a healthcare provider at a community nursing services for the long-term prevention of shingles and/or zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers including by not limited to a physician for shingles, post-herpetic neuralgia, and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles, post-herpetic neuralgia, and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles and other zoster-related conditions; shingles and other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information regarding current condition, historical condition or concomitant medications was provided. In 2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose number, strength, route, batch/lot# and expiration date were unknown) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequently to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: FLUX
Symptoms: Drug ineffective
Clinical narrative: Got one this year with no effect at all with no adverse event; Initial information was received on 06-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got one this year with no effect at all (drug ineffective), while patient was treated with influenza vaccine.  Past vaccination(s) included influenza vaccine (In the past flu shots made me feel real crappie for a couple of days so patient gave them up).  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, patient got one this year with no effect at all (drug ineffective).  No laboratory data was reported.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Had a flu shot 1 time Got the flu; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious social media case from consumer (Patient) via social media.  This case involved a patient with unknown demographic who had a flu shot 1 time got the flu (Influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had a flu shot 1 time got the flu (Influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for the event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient had not had one since that first time patient got sick. Patient did not plan on getting any. It's been years; Initial information was received on 06-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got sick (illness), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, patient had not had one since that first time patient got sick. Patient did not plan on getting any. It's been years (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza like illness
Clinical narrative: sick with symptoms that remarkably mirrored those of the flu; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick with symptoms that remarkably mirrored those of the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick with symptoms that remarkably mirrored those of the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site pain, Platelet count decreased, Pyrexia, Tremor
Clinical narrative: uncontrollable shaking; uncontrollable chills; sore arm; fever; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 65-years-old female patient who experienced uncontrollable shaking (tremor) and chills, sore arm (pain in extremity) and fever (pyrexia), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   While going through a transplant many years ago, it was found patient have an antibody to Platelets, and he would have a rejection reaction if the donor platelets were not HLA-matched. During the very scary rejection reaction, it started as a chill then mild shaking, then extreme uncontrollable shaking and chills. The doctor would give me a Darvon injection to abate the reaction.    The patient's past vaccination, concomitant medication and family history were not provided.  In 2020 at 14:00, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 2020, the patient developed a horrible reaction It was began with shaking (tremor) (at 19:00) and by 20:00 she woke her husband to help her because she was terrified, the shaking had become so bad and became uncontrollable. Staying under a layer of two blankets, she had put on a shirt, a sweatshirt, winter socks, and then slipper socks over those to try to abate the chills. It was not until she added putting on winter gloves that the chills began to subside a bit. But it was the uncontrollable shaking that was the most unnerving. Also had a usual post-immunization reactions of sore arm (pain in extremity) and fever (pyrexia) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  Event description: Patient feels shaking and chills similar to that rejection reaction to platelets with the uncontrollable shaking and chills.  The event outcome was unknown for all events.  There will be no information available on the batch number for this case.
Age: 17.0
Sex: F
Vaccine: FLUR4, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event. Patient received injection of FluBlok outside the recommendation of 18 years. To date (12/11/2020) patient has not had any adverse events.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had previously received the smallpox vaccine x30 years ago in her left arm. Pt reports she is now having swelling, redness and warmth at the smallpox vaccination site and NOT the shingles vaccine injection site.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Fatigue, Paraesthesia
Clinical narrative: Dizziness, light headiness, tingling in fingers, weakness, fatigue.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging normal, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient received a influenza vaccine on 11/17/2020. Patient reports that he experienced a dull pain on the arm the day afterwards that has continually worsened. Patient reports that he is having trouble lifting arm for normal day to day activities and the pain is conistent and dull. Patient reports that he saw a chiropractor approximately 2 weeks after vaccine administration. Per patient, chiropractor conducted immaging and found no abnormalities. Patient has not taken anything for pain excpet for using hot compress on the injury area. Patient stated on 12/11/2020 that he has not yet seen his primary care provider regarding this pain.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Associate received the vaccine and was sitting in waiting area. Approximately 20 minutes after she received the vaccine she stated she was having Chest tightness and mild SOB. A MET call was started and the team arrived. BP 160/102, no known history of  HBP.  Associate was taken to the ED  per MD at the scene.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Bursitis, Injection site pain, Insomnia, Mobility decreased, Muscular weakness
Clinical narrative: I don't know the exact name or manufacturer of the vaccine. It was a routine seasonal flu vaccine. I receive this vaccine every year at this time.  The nurse who gave it to me commented, "Boy, your muscle is really tight".  I experienced nothing out of the ordinary for several days. Then I experienced immense pain between my shoulder and elbow. I was unable to lift my arm because of the pain and intense muscle weakness. I had difficulty sleeping. The pain increased and did not go away. I called the doctor's office and was asked to come in on 10/23/20.  I explained that the pain was directly related to the injection and was in the spot where the shot had been administered. The doctor said it was likely biceps tendonitis and told me to try applying ice for the next couple of weeks. Called the office again on 11/3/20 when there was still no relief. Spoke to the nurse who advised that the doctor suggests a visit to the orthopedic. Nurse suggested applying heat in the meantime. Felt marginal relief with heat for several days and then it returned to constant pain. Called for an appointment on 11/20/20 with an orthopedic, per recommendation.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Orthopaedic examination abnormal, Pain, Pain in extremity, Periarthritis, Tendonitis
Clinical narrative: I don't know the exact name or manufacturer of the vaccine. It was a routine seasonal flu vaccine. I receive this vaccine every year at this time.  The nurse who gave it to me commented, "Boy, your muscle is really tight".  I experienced nothing out of the ordinary for several days. Then I experienced immense pain between my shoulder and elbow. I was unable to lift my arm because of the pain and intense muscle weakness. I had difficulty sleeping. The pain increased and did not go away. I called the doctor's office and was asked to come in on 10/23/20.  I explained that the pain was directly related to the injection and was in the spot where the shot had been administered. The doctor said it was likely biceps tendonitis and told me to try applying ice for the next couple of weeks. Called the office again on 11/3/20 when there was still no relief. Spoke to the nurse who advised that the doctor suggests a visit to the orthopedic. Nurse suggested applying heat in the meantime. Felt marginal relief with heat for several days and then it returned to constant pain. Called for an appointment on 11/20/20 with an orthopedic, per recommendation.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: X-ray limb normal
Clinical narrative: I don't know the exact name or manufacturer of the vaccine. It was a routine seasonal flu vaccine. I receive this vaccine every year at this time.  The nurse who gave it to me commented, "Boy, your muscle is really tight".  I experienced nothing out of the ordinary for several days. Then I experienced immense pain between my shoulder and elbow. I was unable to lift my arm because of the pain and intense muscle weakness. I had difficulty sleeping. The pain increased and did not go away. I called the doctor's office and was asked to come in on 10/23/20.  I explained that the pain was directly related to the injection and was in the spot where the shot had been administered. The doctor said it was likely biceps tendonitis and told me to try applying ice for the next couple of weeks. Called the office again on 11/3/20 when there was still no relief. Spoke to the nurse who advised that the doctor suggests a visit to the orthopedic. Nurse suggested applying heat in the meantime. Felt marginal relief with heat for several days and then it returned to constant pain. Called for an appointment on 11/20/20 with an orthopedic, per recommendation.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Asthenia, Blood test, Confusional state, Dyspnoea, Electromyogram normal
Clinical narrative: Approx 9:40 Trembling all over body and short of breath pale, eyes turned upand out over and over and hands turned in convulsions seizure began to occur for approx 1 min . Paramedics-- ambulance called, patient weak and confusion. Parent returned to clinic with patient -- received no further treatment. Patient had headache afterwards. Parent states patient has been since currently having states in sitting position of  blank stares with no knowledge of occurence   Follow - up neurologist recent -testing EMG, 1 yr continue to f/u with appointments
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Headache, Pallor, Seizure, Strabismus, Tremor
Clinical narrative: Approx 9:40 Trembling all over body and short of breath pale, eyes turned upand out over and over and hands turned in convulsions seizure began to occur for approx 1 min . Paramedics-- ambulance called, patient weak and confusion. Parent returned to clinic with patient -- received no further treatment. Patient had headache afterwards. Parent states patient has been since currently having states in sitting position of  blank stares with no knowledge of occurence   Follow - up neurologist recent -testing EMG, 1 yr continue to f/u with appointments
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Unresponsive to stimuli
Clinical narrative: Approx 9:40 Trembling all over body and short of breath pale, eyes turned upand out over and over and hands turned in convulsions seizure began to occur for approx 1 min . Paramedics-- ambulance called, patient weak and confusion. Parent returned to clinic with patient -- received no further treatment. Patient had headache afterwards. Parent states patient has been since currently having states in sitting position of  blank stares with no knowledge of occurence   Follow - up neurologist recent -testing EMG, 1 yr continue to f/u with appointments
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: CT immediately felt AE to PP23 injection; itching @ site. 1.5 hours later, the site was hot to touch, sore, red, swollen. By evening, took picture and shared with PCP. Telemed conference with Dr. @1700. Recommended Benadryl, 911 if shortness of breath. CT felt rash was moving to all over arm. Took  Benadryl, slept. Site still swollen, bicep area, sore to touch, faint, nauseous, vertigo.  CT stated Dr stated her case was 'severe' and 'unusual'.  CT will confer with Dr. if does not hear back.  Dr 'visit' following AE on telemed. CT has photos of injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Nausea, Rash, Vertigo
Clinical narrative: CT immediately felt AE to PP23 injection; itching @ site. 1.5 hours later, the site was hot to touch, sore, red, swollen. By evening, took picture and shared with PCP. Telemed conference with Dr. @1700. Recommended Benadryl, 911 if shortness of breath. CT felt rash was moving to all over arm. Took  Benadryl, slept. Site still swollen, bicep area, sore to touch, faint, nauseous, vertigo.  CT stated Dr stated her case was 'severe' and 'unusual'.  CT will confer with Dr. if does not hear back.  Dr 'visit' following AE on telemed. CT has photos of injection site.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine error: Patient received flu shot at local pharmacy 09/2020 and received second high dose flu shot again 12/2020. Adverse event did not occur and patient was not harmed
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Lot and dose amount I known as I am self reporting.  Got shingles near the injection site, upper left arm.  Experienced extreme fatigue and body aches on the 10th. Was in bed all day. Feel better today.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Palpitations
Clinical narrative: Sore arm, heart palpitations, fatigue, headache, shivering
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Patient Developed a fever to 101.2 F, with redness, swelling, tenderness of the left arm.   Mom called from Grandmothers house.  He was given 2 Aleve tablets and a cold compress. Later on that evening he was given two 200 mg Ibuprofen.  On the following day,  Mom repotted that he still had pain and fever.  He was referred to the  emergency department for evaluation and treatment
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Migraine, Pain
Clinical narrative: Pain injection site; 1 week later severe migraine -- vomitted 2x in result to migraine; no other side effects until 2nd dose 11/25/20 -- sore arm, chills, fever, body aches, sweating ; 11/27-11/29 migraines - for 2 days. After 11/29 no further symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain injection site; 1 week later severe migraine -- vomitted 2x in result to migraine; no other side effects until 2nd dose 11/25/20 -- sore arm, chills, fever, body aches, sweating ; 11/27-11/29 migraines - for 2 days. After 11/29 no further symptoms.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Alopecia, Amnesia, Anxiety, Blood thyroid stimulating hormone decreased, Constipation
Clinical narrative: Peak health at time of smallpox vaccination. Within two weeks, body fell apart. Constipation, depression, weight gain, fatigue, memory loss, heightened anxiety, SEVERE HAIR LOSS, etc. Diagnosis is chronic Hypothyroidism.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Depression, Fatigue, Hypothyroidism, Laboratory test, Weight increased
Clinical narrative: Peak health at time of smallpox vaccination. Within two weeks, body fell apart. Constipation, depression, weight gain, fatigue, memory loss, heightened anxiety, SEVERE HAIR LOSS, etc. Diagnosis is chronic Hypothyroidism.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Oral vaccine given late for initial dose
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rach & UrticariaPruritus
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Narrative: Symptoms: Rash Treatment:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, UrticariaPruritus & RASH DIPHENHYDRAMINE 25 MG Unknown EVERY 6 HOURS WHILTE AWAKE X3D
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: SkinRash Acetaminophen ,Diphenhydramine
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Heart rate increased
Clinical narrative: 12/05/20 Nausea, headache, fever--- next day 12/06/20 diarrhea, shivering, dizziness, rapid heart beat, arm soreness/pain. 12/07/20 relief from all symptoms
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: 12/05/20 Nausea, headache, fever--- next day 12/06/20 diarrhea, shivering, dizziness, rapid heart beat, arm soreness/pain. 12/07/20 relief from all symptoms
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Back pain that radiated to the back of legs. Experienced chills and fever 102.6.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immediate pain at injection site. Patient reports injection was given high in the shoulder. It is tender and sore. Loss of motion.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Pain in right shoulder which started about 12 hours after injection.  A month later it's still very painful, no remission.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Nausea
Clinical narrative: NAUSEA, TIRED, HEADACHE, FEVER, CHILLS, BODY ACHES, STOMACH PAIN, NAUSEA
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: NAUSEA, TIRED, HEADACHE, FEVER, CHILLS, BODY ACHES, STOMACH PAIN, NAUSEA
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Expired product administered
Clinical narrative: Patient presents on 12/08/2020 for a Wellness check up and one of the immunizations corresponding to the patient's age is DTaP ( KINRX ) with a lot # 53F43, administered on left thigh. At the time I was uploading the vaccine information in the system, I couldn't find the lot number, is when I realized, the immunization was expired and let Dr. know about the incident. The same day, Dr. called mother to let her know about the incident.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: She is 47 yo and received HD Fluzone vaccine.  No adverse event occurred.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal dreams, Antinuclear antibody, Attention deficit hyperactivity disorder, Autoantibody test, Blood lactic acid
Clinical narrative: Patient developed acute onset of neuropsychiatric symptoms 10 days after vaccine including refusal to eat/drink, hallucinations, vivid dreams, OCD, ticks, difficult dressing and putting on his shoes, ADHD . He was hospitalized for three days. His EEG was normal and so was his MRI brain. He was diagnosed with PANS. There is no was to definitively prove this was from MMR but it is suspicious that this was the cause. There were no other changes in the family or any other stressors . There were no other viral illness or strep infections.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: C-reactive protein, Electroencephalogram normal, Encephalitis autoimmune, Food refusal, Full blood count
Clinical narrative: Patient developed acute onset of neuropsychiatric symptoms 10 days after vaccine including refusal to eat/drink, hallucinations, vivid dreams, OCD, ticks, difficult dressing and putting on his shoes, ADHD . He was hospitalized for three days. His EEG was normal and so was his MRI brain. He was diagnosed with PANS. There is no was to definitively prove this was from MMR but it is suspicious that this was the cause. There were no other changes in the family or any other stressors . There were no other viral illness or strep infections.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Hallucination, Loss of personal independence in daily activities, Magnetic resonance imaging brain normal, Metabolic function test, Neuropsychiatric symptoms
Clinical narrative: Patient developed acute onset of neuropsychiatric symptoms 10 days after vaccine including refusal to eat/drink, hallucinations, vivid dreams, OCD, ticks, difficult dressing and putting on his shoes, ADHD . He was hospitalized for three days. His EEG was normal and so was his MRI brain. He was diagnosed with PANS. There is no was to definitively prove this was from MMR but it is suspicious that this was the cause. There were no other changes in the family or any other stressors . There were no other viral illness or strep infections.