chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: itching at the injection site; redness; swelling; difficulty sleeping; fatigue; pain at the injection site/pain in the upper arm; This case was reported by a nurse and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site itching, erythema, swelling and difficulty sleeping. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the injection site pain, injection site itching, erythema, swelling, difficulty sleeping and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site itching, erythema, swelling, difficulty sleeping and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was a retired nurse received Shingrix in left upper arm about a month ago from reporting day but she does not know the date. On the same day she had pain at the injection site with redness about 7-8 inches in diameter and swelling which lasted for about 3 days with pain in the upper arm area which was resolved at time of reporting. A week after vaccination patient had some itching at the injection site. Due to the pain at the injected site and upper arm, the patient had difficulty sleeping for about 2 nights. She also reports fatigue which lasted for a week. The patient did not want to provide information about the pharmacy and the MDO. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Redness; Arm soreness; This case was reported by a consumer and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and pain in arm. On an unknown date, the outcome of the erythema and pain in arm were unknown.   It was unknown if the reporter considered the erythema and pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had redness and arm soreness after vaccination. Limited demographics and information gathered, due to caller rushing to end phone call. The repoter did not consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Red arm; Swollen arm (arm blew up); Itchy arm; This case was reported by a nurse and described the occurrence of erythema of extremities in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. The patient was treated with prednisone. On an unknown date, the outcome of the erythema of extremities, swelling arm and itchy upper limbs were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: Registered Nurse unable to provide vaccine details and site of injection.  RN unsure if the vaccine was the patients first or second dose of Shingrix. The patient received a Shingrix dose and had a reaction of red, swollen (arm blew up), itchy arm. The patient was given prednisone and the events went away.  The reporter was unable to provide vaccine details and site of injection and was unsure if the vaccine was the patient's first or second dose of Shingrix. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Product administered at inappropriate site
Clinical narrative: having pain and soreness at the site of injection; Rash in thigh (site of administration); Itching in thigh (site of administration); Thigh (site of administration); This case was reported by a consumer and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site itching and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site rash and injection site itching were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain, injection site rash and injection site itching to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received 1st dose of Shingrix in thigh, which led to vaccine administered at inappropriate site. The patient experienced pain and soreness at the site of injection and also rash and itching in thigh. The reporter did not consent to follow-up. For tolerance in 2nd dose refer case US2020236584.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021001316:Same reporter. FU1 deleted US-GLAXOSMITHKLINE-US2020236584:same reporter, 1st dose
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Pain in extremity
Clinical narrative: fatigue; arm pain; severe pain in the deltoid; This case was reported by a other health professional and described the occurrence of fatigue in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, 6 hrs after receiving Shingrix, the patient experienced fatigue, pain in arm and injection site pain. On an unknown date, the outcome of the fatigue, pain in arm and injection site pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, pain in arm and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and reported experiencing severe pain in the deltoid and arm pain. The pain in the deltoid and arm began shortly after receiving the shot and lasted approximately 3 days. The patient experienced fatigue that began approximately 6 hours after receiving Shingrix and lasted approximately one day and a half. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Feeling cold, Loss of personal independence in daily activities
Clinical narrative: Feel sick; Shivering so severely / thought she would chip a tooth; Hands were shaking so violently / could not brush her teeth; Extremely cold / had to have heating pads; Could not get out of bed / so fatigued / tired; Not feeling well / still does not feel completely well; Fever; Diarrhea; This case was reported by a consumer and described the occurrence of sickness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced sickness, shivering, tremor of hands, coldness, fatigue, feeling unwell and fever. In October 2020, the patient experienced diarrhea. On an unknown date, the outcome of the sickness and tremor of hands were unknown and the outcome of the shivering, feeling unwell and fever were recovered/resolved and the outcome of the coldness and diarrhea were resolved with sequelae and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the sickness, shivering, tremor of hands, coldness, fatigue, feeling unwell, fever and diarrhea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was started to felt at that evening of vaccination. By bedtime she was shivering so severely that she thought she would chip a tooth, it was that severe. Her hands were shaking so violently that she could not brush her teeth. The patient was extremely cold and had to have heating pads place on her by her husband. The next day she could not get out of bed she was so fatigued but the shivering resolved.  On 12th October 2020 she could get out of bed but was  tired and not feeling well. She had a fever that lasted 2 days.  The diarrhea lasted one day.  All reported symptoms expereinced on 9th October 2020 and on next day and on suday symptoms were progressed. By Monday she felt better but it took 2-3 weeks and before she could function. The patient said at the time of reporting that she did not feel completely well. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Pyrexia, Tremor
Clinical narrative: Feel sick; Shivering so severely / thought she would chip a tooth; Hands were shaking so violently / could not brush her teeth; Extremely cold / had to have heating pads; Could not get out of bed / so fatigued / tired; Not feeling well / still does not feel completely well; Fever; Diarrhea; This case was reported by a consumer and described the occurrence of sickness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced sickness, shivering, tremor of hands, coldness, fatigue, feeling unwell and fever. In October 2020, the patient experienced diarrhea. On an unknown date, the outcome of the sickness and tremor of hands were unknown and the outcome of the shivering, feeling unwell and fever were recovered/resolved and the outcome of the coldness and diarrhea were resolved with sequelae and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the sickness, shivering, tremor of hands, coldness, fatigue, feeling unwell, fever and diarrhea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was started to felt at that evening of vaccination. By bedtime she was shivering so severely that she thought she would chip a tooth, it was that severe. Her hands were shaking so violently that she could not brush her teeth. The patient was extremely cold and had to have heating pads place on her by her husband. The next day she could not get out of bed she was so fatigued but the shivering resolved.  On 12th October 2020 she could get out of bed but was  tired and not feeling well. She had a fever that lasted 2 days.  The diarrhea lasted one day.  All reported symptoms expereinced on 9th October 2020 and on next day and on suday symptoms were progressed. By Monday she felt better but it took 2-3 weeks and before she could function. The patient said at the time of reporting that she did not feel completely well. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: arm soreness that prevented her from being able to lift her arm over her head; nausea; fever; loss of appetite; experienced arm soreness; This case was reported by a consumer and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020, refer case US2021AMR004144).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, less than a day after receiving Shingrix, the patient experienced nausea, fever, appetite lost and pain in arm. On an unknown date, the patient experienced mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, fever, appetite lost, pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the nausea, fever, appetite lost, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter was a Glaxosmithkline employee who reported an event told to him by the patient who was his sister in law.  The patient reported nausea, fever and loss of appetite the evening following the second dose.  The patient experienced arm soreness that prevented her from being able to lift her arm over her head that lasted 4-5 days. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR004144:same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: arm soreness that prevented her from being able to lift her arm over her head; nausea; fever; loss of appetite; experienced arm soreness; This case was reported by a consumer and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020, refer case US2021AMR004144).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, less than a day after receiving Shingrix, the patient experienced nausea, fever, appetite lost and pain in arm. On an unknown date, the patient experienced mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, fever, appetite lost, pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the nausea, fever, appetite lost, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter was a Glaxosmithkline employee who reported an event told to him by the patient who was his sister in law.  The patient reported nausea, fever and loss of appetite the evening following the second dose.  The patient experienced arm soreness that prevented her from being able to lift her arm over her head that lasted 4-5 days. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR004144:same reporter
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Headache, Malaise, Pain in extremity
Clinical narrative: post occipital headaches; malaise; decrease appetite; lack of stamina; usual sore arm; low grade fever; This case was reported by a physician and described the occurrence of occipital headache in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 months before the date of reporting).   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced occipital headache, malaise, decreased appetite, energy decreased, pain in arm and low grade fever. On an unknown date, the outcome of the occipital headache, malaise, decreased appetite and energy decreased were not recovered/not resolved and the outcome of the pain in arm and low grade fever were unknown.   It was unknown if the reporter considered the occipital headache, malaise, decreased appetite, energy decreased, pain in arm and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient had post occipital headaches, malaise, decreased appetite, and lack of stamina, usual sore arm and low grade fever.  The polymerase chain reaction test was negative for COVID. The patient had no symptoms after the first vaccine.  Lot number and expiration date were not available to physician at the time reporting.  The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: post occipital headaches; malaise; decrease appetite; lack of stamina; usual sore arm; low grade fever; This case was reported by a physician and described the occurrence of occipital headache in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 months before the date of reporting).   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced occipital headache, malaise, decreased appetite, energy decreased, pain in arm and low grade fever. On an unknown date, the outcome of the occipital headache, malaise, decreased appetite and energy decreased were not recovered/not resolved and the outcome of the pain in arm and low grade fever were unknown.   It was unknown if the reporter considered the occipital headache, malaise, decreased appetite, energy decreased, pain in arm and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient had post occipital headaches, malaise, decreased appetite, and lack of stamina, usual sore arm and low grade fever.  The polymerase chain reaction test was negative for COVID. The patient had no symptoms after the first vaccine.  Lot number and expiration date were not available to physician at the time reporting.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site / If the area is touched it feels tender; This case was reported by a consumer and described the occurrence of injection site pain in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced soreness at the injection site.  The reporter reported if the area was touched not, it felt tender. The reporter consented to follow up. This case linked with US2021005938 and US2021005937, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021005938:Same reporter US-GLAXOSMITHKLINE-US2021005937:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever / 100.7; This case was reported by a consumer and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 20th January 2021, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced fever of about 100.7 degree F. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: experiencing symptoms of Bells Palsy /  diagnosed by her HCP with Bells Palsy on 2-3-2021; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th January 2021, 46 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix and experienced bells palsy. The patient was treated with prednisolone for these symptoms. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: A spontaneous report was received from a healthcare professional concerning a patient, of unknown gender and age, who received Moderna's COVID-19 vaccine subcutaneously. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of Covid-19 infection. The nurse was given the mRNA-1273 vaccine subcutaneously instead of intramuscularly (IM). No further information was provided. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event was considered resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Ineligible for second dose because he is 17 years old; A spontaneous report  was received from a consumer concerning a  male patient who received Moderna's COVID-19 vaccine (mRNA-1273) at inappropriate age.  The patient's medical history was not provided. Concomitant medication history was not provided.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  The consumer stated that her son received his first dose and was denied his second dose due to his age being under 18 years old. She requested to have her son be enrolled in a clinical trial in order to get his second dose.    Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, inappropriate age is 17 years old was recovered on 11 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273 (lot number: 027L20A) .
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave vaccine to 17 year olds; A spontaneous report was received from a healthcare professional concerning a 17-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient received the vaccine resulting in the event of inappropriate age of dose of administration.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, inappropriate age of dose of administration, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Batch number: unknown), where the product was administered to inappropriate age. There were no associated AEs.
Sex: U
Vaccine: FLUX
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain in extremity
Clinical narrative: immediate pain in my upper arm; pain in my upper arm it is accompanied by numbness on and off in my are to my fingers tips.; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an adult patient who experienced immediate pain in my upper arm (pain in extremity) and pain in my upper arm it is accompanied by numbness on and off in my are to my fingers tips (hypoaesthesia), while he/she received vaccine INFLUENZA VACCINE.   The patient's past 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious immediate pain in my upper arm (pain in extremity) and pain in my upper arm it is accompanied by numbness on and off in my are to my fingers tips (hypoaesthesia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome for both the events were unknown at the time of reporting.  Information on batch number will not be available.
Sex: U
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: sore muscles all over; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sore muscles all over (myalgia), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  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 developed a non-serious sore muscles all over (myalgia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that patient got really sore muscles all over for about a week when got mine. Patient was really under the weather. Hope it affects you differently.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  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: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: little fever; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographics) who experienced little fever (pyrexia), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  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 developed a non-serious little fever (pyrexia) (next day) following the administration of INFLUENZA VACCINE  It was also reported that patient had shot had little fever next day been 7 days no side effects. They need to talk to someone who knows It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  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: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 01-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (demographics unknown) who had flu (influenza), after received INFLUENZA VACCINE.  The patient's past vaccination(s) included influenza vaccine for prophylactic vaccination. The previous vaccinations had always made the patient not feel good for a couple of days.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment(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 in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) about two weeks later following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events  There were no lab data/results available.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Every time patient got one patient got sick; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who got one and got sick (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that every time patient got one patient got sick (illness), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got sick every time patient got one; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who got one and got sick (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that every time patient got one patient got sick (illness), (latency: unknown) following the administration of suspect vaccine.  No laboratory was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  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 developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that patient only get the flu when patient have been around people that had the flu vaccine It can slough for up to 2 weeks after injection. But hey, your body, your choice.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  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: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: flu; sick; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced flu (influenza) and sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  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 developed a non-serious flu (influenza) and sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Social media case, Product name: product name was not provided. Since this is a public post on flu shot campaign. They are assuming the consumer is referring to the flu vaccine. Reported adverse Event Information: patient skipped the flu shot one year when patient thought that patient could not afford it. Well patient got the flu and it cost 500 dollars Plus patient was sick as hell Think about it comment id: 382901882934023. Medication Details and reason for taking the medicine: Indication, dose and frequency: unknown.   It is unknown if patient physician provided consent to be contacted It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  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: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: told them it would give me flu and it did; Initial information was received on 02-Dec-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case involved an adult patient (age and gender were not reported) who had flu (influenza), after he/she received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. The patient reported that as his/her experience was just the opposite. Parents forced him/her to get flu shot, even though he/she told them it would give flu. And it did. They had both survived the 1918 pandemic as children, so maybe they were paranoid. Ten years earlier, the patients entire family, except the patient, got flu in that pandemic, & they were lucky that the patient did not, because they were out of groceries. The patient walked to the store through waist-deep snow in a blizzard & came back with 2 of those big brown grocery sacks. Couldn't even see over the top of the bags, the patient followed his/her own trail back home. Since that one flu shot, they had no vaccine & no flu. Not starting at the time of reporting & no coronavirus vaccine either. It was the patients personal experience and he/she knew, but that was what the patient go with. The patient trusts his/her immune system. Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  It was unknown if patients physician provided consent to be contacted.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: flu; Initial information was received on 18-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient).  This case involves a patient (unknown demographics) who had flu (influenza) and received INFLUENZA VACCINE.  The patient's medical history included flu (Influenza) and past vaccination(s) included Influenza Vaccine for 20 years.  The patient had no concomitant disease or risk factor.  Past medical treatment (s), concomitant medications 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 in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency)and administered INFLUENZA VACCINE.  The patient had flu every time (for 4 years) but after receiving flu shot no flu occurred.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: make patient and thousands of others deathly ill; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved a patient of unknown age who and thousands of others deathly ill (illness), after patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient and thousands of others deathly ill (illness), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the Flu and almost died the this time; Initial information was received on 05-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (age and gender unspecified) who got the flu and this time almost died (influenza), after patient received INFLUENZA VACCINE.  The patient had past vaccination with flu vaccine [INFLUENZA VACCINE] and had flu [influenza]. Past medical treatment, family history and concomitant medication were not reported. The patient had no other medical history, concomitant disease or risk factor.  On an unknown date, the patient received a second dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other doing details were not reported] for prophylactic vaccination.  On an unknown date, the patient got the flu and this time almost died (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.  It was reported, product name was not provided and it was a public post on the Sanofi flu shot campaign and the Race to 200 M hence reporter assumed that the consumer was referring to the Sanofi flu vaccine.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported for influenza.   There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, SARS-CoV-2 test negative
Clinical narrative: flu shot, patient wear masks & follow the guidelines & yet right now patient ws sick with the flu; Initial information received on 07-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved a patient of unknown age who got flu shot, patient wear masks & follow the guidelines & yet right now patient was sick with the flu (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient got flu shot, patient wear masks & follow the guidelines & yet right now patient was sick with the flu (influenza), (latency: unknown) following the administration of suspect vaccine.  Relevant laboratory test results included: COVID-19 - On an unknown date: Negative [tested for Covid & it was negative].  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: No adverse event, Product preparation issue
Clinical narrative: dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine, no ae; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency (Reference number- 00446341) and transmitted to Sanofi on 26-Jan-2021.  This case involves an one year old male patient who was vaccinated with 0.5 ml  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ336AAA and expiration date :05-Jul-2021) via intramuscular route (other dosing details were unknown) for prophylactic vaccination on 22-Jan-2021 and reported that a dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine (Product preparation issue). Also reported that Caller reported two patients were administered the vaccine but unsure of which patient was only administered the DTap-IPV portion of the vaccine and asked when to re-vaccinate both patients.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE.  It was a case of actual medication error due to an inappropriate reconstitution technique (same day latency).  It was not reported whether the patient had any adverse event.  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: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: 12 year old male patient administered expired dose of Menactra, no AE; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 year old male patient who was vaccinated with expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 01-Feb-2021, the patient received a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AA and expiry date: 26-Jan-2021) (frequency once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (latency on same day).  It was also reported that patient was administered Menactra that was expired for 3 days.  Reporter relationship: Self Product used: Used, first time product used: yes Still using product: no  At the time of reporting, patient had no adverse event.  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 the guidelines. 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: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: The patient received 0.1ml  Ipol intradermally rather than 0.1ml of Tubersol, no AE; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via Medical Information (Reference number- 00457650) and transmitted to Sanofi on 02-Feb-2021.  This case involves an 18 year old female patient who received 0.1 ml dose of suspect IPV (VERO) lot number not reported via intradermal route in unknown administration site for prophylactic vaccination on an unknown date instead of getting tested with TUBERCULIN TEST [TUBERSOL] (Wrong product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was a case of an actual medication error due to wrong product administered (latency same day).  The nurse reported that an employee was undergoing pre-employment health screening, but did not receive the Tubersol 0.1ml for tuberculin sensitivity testing.   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.