chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Pain in extremity, Peripheral swelling, Vaccination site reaction
Clinical narrative: cannot move it; hand is swollen / Fingers are so swollen they look like sausages; in great pain; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (cannot move it) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 024M(Zor2)0A and 041L(Zor2)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MONOPLEGIA (cannot move it) (seriousness criterion medically significant), PERIPHERAL SWELLING (hand is swollen / Fingers are so swollen they look like sausages), PAIN IN EXTREMITY (in great pain) and VACCINATION SITE REACTION (COVID arm). At the time of the report, MONOPLEGIA (cannot move it), PERIPHERAL SWELLING (hand is swollen / Fingers are so swollen they look like sausages), PAIN IN EXTREMITY (in great pain) and VACCINATION SITE REACTION (COVID arm) had not resolved.            The patient stated that she had a condition for that she went to the emergency room for yesterday (at the time of report). She was told it could be a reaction, but it was an uncommon reaction to getting the Moderna booster. She stated her doctor has even indicated there can be swelling in parts of the body after the injection because of other things like rheumatoid arthritis in the body. The patient could not move her hand quick enough as she was trying to answer questions regarding the adverse event she was reporting.  She had gone to her physician and they took X-rays and blood work, but she was continuing to have symptoms and went to the emergency room yesterday on 03-Oct-2021. The patient stated her physician gave her a brace to keep the swelling down. She will be talking with a rheumatologist. She had no underlying medical conditions.  Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Follow up received and Reporter's contact information updated, added dosing information, events outcome updated as not recovered and emergency room visit ticked and lab data was added in I-narrative.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling, Vaccination site reaction
Clinical narrative: Hand is swollen, cannot move it, in great pain; Hand is swollen, cannot move it, in great pain; Hand is swollen, cannot move it, in great pain; Moderna Arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm). At the time of the report, LIMB DISCOMFORT (Hand is swollen, cannot move it, in great pain), PERIPHERAL SWELLING (Hand is swollen, cannot move it, in great pain), PAIN IN EXTREMITY (Hand is swollen, cannot move it, in great pain) and VACCINATION SITE REACTION (Moderna Arm) outcome was unknown.            No concomitant medications were provided. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Follow-up received contains reporter details, patient details,events were updated.; Sender's Comments: This case concerns a unknown-year-old, female patient with no reported medical history. The patient experienced unlisted non-serious events of Limb discomfort peripheral swelling pain in extremity and vaccination site reaction unspecified days after third dose  (booster dose) of spikevax. Patient experienced AEs after the third dose and no information about first and second dose is available rechallenge not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Believe having side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Believe having side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Believe having side effects). At the time of the report, VACCINATION COMPLICATION (Believe having side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Red hot hard lump on the right of the injection site/hot/still warm to the touch; Red hot hard lump on the right of the injection site; Red hot hard lump on the right of the injection site/hardness; Red hot hard lump on the right of the injection site/redness/still red; Soreness in the arm of the injection/her arm was more sore than before; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch), VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness), VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red) and VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, FOLIC ACID and VITAMINS NOS for an unknown indication.    On 02-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before). On 03-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch), VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness) and VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red). At the time of the report, VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch) and VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red) had not resolved and VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness) and VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before) was resolving.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up was received and contains significant information; suspect product details, concomitant details, additional events were added.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received an expired vaccine as a 1st dose,dose administered after manufacture date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received an expired vaccine as a 1st dose,dose administered after manufacture date of expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received an expired vaccine as a 1st dose,dose administered after manufacture date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received an expired vaccine as a 1st dose,dose administered after manufacture date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug information does not provided. Treatment information does not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: The follow up received on 06-OCT-2021 includes no new information.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: Patient received flu vaccine after that poke hurt/no AE; Initial information received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case involves adult and unknown gender patient received flu vaccine after that poke hurt (vaccination site pain) after receiving vaccine INFLUENZA VACCINE.  The past patient medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 patient received flu vaccine after that poke hurt (vaccination site pain) (same day) 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 a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the batch number for this case for influenza vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown demographic patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, past 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 non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Never had a shot. Never got the flu. Everyone l knew that got the shot got the flu more than once every year."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis
Clinical narrative: Flu; Initial information received on 02-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past 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 non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The efficacy of the flu shot sucks. It is always a hit and miss as to what strains are out there and it is usually a miss. Covid is a different story. We got that as soon as it was available to us. When my mom had cancer she couldn't have the flu shot so the doctor recommended both my dad and I get one to protect her. 2 weeks after I got the shot, I got the flu. Next year comes around and I told the nurse giving the shots about I had contracted the flu following the shot. She assured me that it wasn't from the shot and that I must have already been infected by the virus before I got it. We laughed about bad timing as she gave me the shot. Two weeks later, I got the flu. Third year came and I was reluctant. Still wanting to be a good daughter and protect my mom, I complied. Two weeks later.... I got the flu! My mom sadly lost her battle with the cancer so the following year I didn't get the flu shot. I was healthy all winter. I haven't had the flu shot since. I have gotten a few colds here and there but for the most part I have been healthy. Haven't had the flu shot in 20 years."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Felt like crap the day; Initial information received on 02-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown age and gender patient who reported felt like crap the day (feeling abnormal) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past 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 non-serious felt like crap the day (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Felt like crap the day after but alot better today."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Condition aggravated, Eczema, Injection site reaction, Skin discolouration
Clinical narrative: I do routinely get Eczema; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves adult patient (unknown gender and unknown age) patient who experienced "I do routinely get eczema" after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), 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 I do routinely get eczema (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "I received a Flu Vaccine here at work on Friday. Yesterday, I noticed an eczema flare up near the injection site. I do routinely get Eczema and this particular spot flared up last year after I got the Flu Vaccine. Within the weeks following my flu vaccine, I went on a beach trip and this one spot became the only spot on my arm that would not brown in color. I didn't correlate the two at the time but the area still will not brown like the rest of my skin. When I showed the nurse administering the vaccine this year, I asked if she could place the vaccine in the same area and she said no as that was not the ideal location. The area that is flared up with eczema know is approximately two inches from the injection site this year".  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Feeling sick; Initial information was received on 05-Oct-2021 regarding an unsolicited valid Social media non-serious case received from a Consumer.  This case involves a patient (unknown age and unknown gender) who experienced feeling sick (Malaise) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(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 not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient feeling sick (Malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got mine. Felt sucker after this than the Covid vaccine".  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  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 batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Might have got the Flu one year but if it was it was a mild case; Initial information received on 05-Oct-2021 regarding an unsolicited valid Social media non-serious case received from a Consumer.  This case involves an adult patient (unknown age and gender) who experienced might have got the Flu one year but if it was it was a mild case (Influenza) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(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 not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient might have got the Flu one year but if it was it was a mild case (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got mine. Get it every year. Might have got the Flu one year but if it was it was a mild case".  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  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 batch number for this case.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired vaccine/ no AE; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a Patient via Medical Information (Reference number- 00797521) and transmitted to Sanofi on 04-Oct-2021.  This case involves a female patient (unknown age) received an expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  She received no other vaccines.  On 04-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot QFAA2007 and expiry date 19-May-2021] via unknown route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to Expired vaccine used (latency was on same day).  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 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: 0.17
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: an extra Ipol dose was given to a two month old, Pediarix was ordered and it contains Ipol of unknown amount and then the patient was given 0.5 ml of Ipol/ No AE; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via Medical information number: 00797661.  This case involves a two-month-old female patient who received an extra Ipol dose, DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] was ordered and it contains Ipol of unknown amount and then the patient was given 0.5 mls of IPV (VERO) [IPOL] (extra dose administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination respectively.  On 04-Oct-2021, the patient received a 0.5 ml first dose of suspect IPV (VERO) lot number: T1D482M, expiry date 25-Jul-2022, frequency: once, strength: standard via intramuscular route in the left thigh (left leg) for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error due to extra dose administered (latency: same day).   At the time of reporting, 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 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: 46.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired vaccine/ no AE;Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a Consumer via Medical Information (Reference number- 00798692) and transmitted to Sanofi on 05-Oct-2021.   This case involves a 46-year-old male patient who administered an expired IPV (VERO) [IPOL] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 04-Oct-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) [lot R1F972M and expiry date 03-Oct-2021] via unknown route in unknown administration site for prophylactic vaccination.  It was reported "Caller stating that an expired dose of IPOL was administered to a patient and inquiring if there was a "grace period", the caller stated that the label was wrinkled and the date could have been misconstrued, she was wondering if the administration was valid".  Product used: Used First time product used : No Still using product : Yes.  It was a case of actual medication error due to Expired vaccine used (latency was on same day).  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 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: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: product expired was given to a patient inadvertently, with no reported adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid  non-serious case from a other health professional and non health care professional via regulatory authority.  This case involves a 70 years old male patient who was vaccinated inadvertently with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], which was expired (expired product administered).  The patient's past medical history, medical treatment, vaccination, concomitant medication and familyhistory were not provided.  On 05-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Once, lot UJ514AA; expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination..  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "FLUZONE HIGH DOSE was given to a patient inadvertently today, but the product expired on 06/30/2021. Lot: UJ514AA NDC: unavailable" Caller states that the pharmacy buyer is calling to report the event and ask what they should do from here. Pharmacy buyer transferred from Caller. Pharmacy buyer, states the following: Yes, I am calling about a patient who received a dose of FLUZONE HIGH DOSE today (05Oct2021) that had expired on 30Jun2021. I do not have the patient's initials or date of birth. The patient is 70 years old and is a male patient. I am wondering if the patient needs to be revaccinated. No further information was provided."  At time of reporting, no adverse event was reported and the outcome of the event was unknown.   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 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: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Mycobacterium tuberculosis complex test, No adverse event, Product storage error
Clinical narrative: Vaccine was exposed to 32.9 degree Fahrenheit for 24 hours/ no AE; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician via Regulatory Authority (Reference number- 00799327) and transmitted to Sanofi on 05-Oct-2021.  This case is linked to case 2021SA332413(CLUSTER).  This case involves a 76-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was exposed to 32.9-degree Fahrenheit for 24 hours with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ715AC and expiry date 30-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported " A temperature excursion yesterday and caller stated the temperature given at that time was not correct for the FLUZONE HIGH DOSE QUADRIVALENT. Caller stated the time of the excursion was for 24 hours and the minimum temperature of the refrigerator was 32.9 degrees Fahrenheit and the maximum temperature was 35.9 degrees Fahrenheit. Caller also stated that the Vaccine was given to 5 patients prior to reporting the excursion".  Product used: Used. First time product used : Yes. Still using product : No.   It was a case of actual medication error due to Incorrect product storage (latency was on same day).  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 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: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired FLUZONE QIV HD being administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Regulatory Authority (Reference number- 00801096) and transmitted to Sanofi on 06-Oct-2021.  This case is linked to case 2021SA333475 (same reporter).  This case involves an 82-year-old female patient who vaccinated with a 0.7 mL (total) dose of expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ454AB and expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 06-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, 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 the 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: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired FLUZONE QUADRIVALENT was administered to three patients with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Regulatory authority (Reference number- 00801285) and transmitted to Sanofi on 06-Oct-2021.  This case involves three patients who were received expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patients were not received any other vaccine.   On 06-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073LA, expiry: 30-Jun-2021, formulation: solution for injection) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Caller stated a temperature excursion on Fluzone (high dose) HD expired. Lot: UT7073LA Exp: 06/30/2021 Stated that the expired vaccine was given to 3 different patients. Pharmacist states that a box of FLUZONE QUADRIVALENT from last year's flu season was administered to 3 staff members (Nurses) today. At this time he does not have information on those individuals; identity, age, Et cetera (etc.) All 3 were given today and none of them received any other vaccines."  No other 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 the 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a dose of Pentacel on 06OCT2021 that expired on 01OCT2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician, other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00801434) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 2-month-old male patient received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on 06oct2021 that expired on 01oct2021 (expired product administered).  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 06-Oct-2021, the patient received first 0.5ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ382AA and expiry date: 01-Oct-2021) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered).  It was reported "Caller wished to report this event and receive information on how to proceed".  This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, 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 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache, muscle aches, chills, diarrhea, nausea, loss of appetite, fatigue lasting for over 10 days and continuing. Treated with Tylenol, ibuprofen and rest.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Headache, muscle aches, chills, diarrhea, nausea, loss of appetite, fatigue lasting for over 10 days and continuing. Treated with Tylenol, ibuprofen and rest.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site reaction, Rash, Rash erythematous, Rash papular
Clinical narrative: entire body rash. started on forearm as a vesicular rash on erythematous base. no improvement with topical steroids.  quickly spread to upper right arm as sand paper rash the size of a softball to inner upper arm.  Then large erythematous firm purple tinged almost bruise like on right flank.  another on right inner lower leg.  all rashes of slightly different appearance and inconsistent.  itching, painful, warm.  spares hands and feet and face.  worse with heat, better with cold. no relief with oral or topical meds/steroids.  injection on right arm and all rash symptoms on right side of body.  no other constitutional symptoms.  present for 4 weeks with minimal improvemnt.       pt had previous reaction to HPV vaccine with several weeks of hives and therefore didn't complete the series.  was trying to avoid covid vaccine for fear of hives again but was forced to get vaccinated at place of employment.  first vaccine no reaction, second dose caused the rash
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Rash vesicular, Skin warm
Clinical narrative: entire body rash. started on forearm as a vesicular rash on erythematous base. no improvement with topical steroids.  quickly spread to upper right arm as sand paper rash the size of a softball to inner upper arm.  Then large erythematous firm purple tinged almost bruise like on right flank.  another on right inner lower leg.  all rashes of slightly different appearance and inconsistent.  itching, painful, warm.  spares hands and feet and face.  worse with heat, better with cold. no relief with oral or topical meds/steroids.  injection on right arm and all rash symptoms on right side of body.  no other constitutional symptoms.  present for 4 weeks with minimal improvemnt.       pt had previous reaction to HPV vaccine with several weeks of hives and therefore didn't complete the series.  was trying to avoid covid vaccine for fear of hives again but was forced to get vaccinated at place of employment.  first vaccine no reaction, second dose caused the rash
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: my feet started itching and random bubbles on bottom of sole,  big toe swelled up like a grape  then the next day two little toes swelled up like grapes, each day a different toe followed by hives that filled with water and look like welts (stomache three days then arms another day then legs and buttox ) dizzy spells one time after a hive breakout      hives every day since in random locations
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Back pain, Muscle spasms
Clinical narrative: Menstrual cycle is late by 1 month and significant cramping and lower back pain experience days after first dose. Back pain and cramping still continues after second shot, but menstrual cycle still has not started.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: neuropathy; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around April 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles and neuropathy.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles and neuropathy was considered to be not recovered. The reporter considered shingles and neuropathy to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of shingles and neuropathy were determined to be disabling.  Upon internal review, the event of neuropathy was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around October 2007, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of shingles was determined to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around April 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of hearing loss was considered to be not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant and disabling.