chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High blood pressure; Bad headache; Hallucinations; Temperature went to 104.6F; A spontaneous report (), was received from a consumer (patient), a 41 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced hallucinations, high blood pressure (hypertension), temperature went to 104.6 F (pyrexia), and bad headache (headache).     The patient's medical history included COVID-19 diagnosed in Oct 2020. Concomitant medication was not provided.   On 05 Feb 2021, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030M20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 06 Feb 2021, post vaccination, the patient's body temperature was 104.6 F, and hallucinations. On 09 Feb 2021, the patient woke up with high blood pressure and had a bad headache. Subsequently, the patient went to emergency room on the same day. Treatment medications included acetaminophen and ibuprofen.   Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, hallucinations, high blood pressure, temperature went to 104.6 F, and bad headache were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received total of three doses of MODERNA COVID 19 Vaccine; A spontaneous report  was received from an HCP concerning an 86 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication error of received total of three doses of moderna COVID 19 vaccine.  The patient's medical history was not reported.  Concomitant medications were not reported.  On 14 Jan 2021, prior to the onset of the events, the patient received two doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient received a third dose of mRNA-1273 (Batch number: unknown) via intramuscular for prophylaxis of COVID-19 infection.  Laboratory test was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events are unknown; Reporter's Comments: This report refers to a case of an 86-year old male patient who received a total of 3 doses of mRNA-1273 (lot # not provided) with no associated AEs.
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: A patient getting over 2nd bout with the flu; Initial information was received on 18-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient).  This case involves a patient (unknown demographics) who getting over 2nd bout with the flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The patient had no medical history, concomitant disease or risk factor.  In October 2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient getting over 2nd bout with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as non-serious.  It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine was not reported.   There were no lab data/results available.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient was recovering from the event.  There will be no information on batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient had a medication error of expired vaccines given to a patient, with no reported adverse event; Initial information regarding this unsolicited valid non-serious case was received from other health care professional and transmitted to Sanofi on 25-Feb-2021.  This case involves a child patient for whom it was reported patient had a medication error of expired vaccine given (expired product administered) for HIB (PRP/T) VACCINE [ACT-HIB] (batch number: unknown and expiration date: 21-Jun-2020) via unknown route and unknown site for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  It was an actual medication error due to the expired vaccine used (latency: unknown).  It was also reported that the staff actually read the expiration day incorrectly so instead of 21June20 being read as June 21, 2020 they interpreted as being June 20 2021. With the years being so close 20 and 21 it was really confusing. When I looked at other manufacturers exp. Dates they all have the year as 4 digits.  At the time of reporting, the patient had no adverse event.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious media case from a consumer or non-healthcare professional via.  This case involves patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE  It was reported that, this is the first year without a flu shot for the patient in years. Each year patient got the flu with having the shot.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Influenza vaccine was also unknown.  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 lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious media case from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who got very sick (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE  The reporter stated that, its not a myth, that the patient was not sick until he/she got the shot. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Influenza Vaccine was also unknown.  Details of laboratory data 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 lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect route of product administration, Injection site injury
Clinical narrative: became injured; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced became injured (injury), while he/she received vaccine INFLUENZA VACCINE.  It was unknown if 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 became injured (injury) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if patients physician provided consent to be contacted It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were 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
Clinical narrative: Sick; Initial information was received on 27-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210302000884).  This case involves an adult patient who experienced sick, while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergic reaction; hives; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced allergic reaction (hypersensitivity) and hives (urticaria), 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 (February), 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 allergic reaction (hypersensitivity) and hives (urticaria) (unknown latency) 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.  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
Clinical narrative: sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced 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 sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that the race to 200M Facebook page. Reported adverse event Information: Well got it. The one and only time patient got the shot never got it again and have never been sick again 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: FLUR4
Symptoms: Pain in extremity
Clinical narrative: Arm pain a week after injection; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographics) who experienced arm pain a week (pain in extremity), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  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 QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2035 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 arm pain a week (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  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.
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: having high temperatures; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a physician (under reference number: US-SA-SAC20210303000497).  This case involves an adult female patient who experienced having high temperatures (pyrexia), while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.5 ml 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 having high temperatures (pyrexia) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: the ONLY time the flu came into our house is after the husband's flu shot from the work. 3 years in a row it landed my son in the emergency room; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210303000514).  This case involves an adult patient who experienced the only time the flu came into our house is after the husband's flu shot from the work. 3 years in a row it landed my son in the emergency room (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious the only time the flu came into our house is after the husband's flu shot from the work. 3 years in a row it landed my son in the emergency room (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Patient had a reaction to Fluzone High Dose with no other medical issues or explanations; Initial information was received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves elderly patient (age and gender unknown) who experienced patient had a reaction to fluzone high dose with no other medical issues or explanations (vaccination complication), after the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (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 had a reaction to the vaccine (vaccination complication) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At the time of report the event outcome was unknown.  There will be no information available on the lot number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: redness; heat; soreness; Initial information received on 27-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an adolescent male patient who experienced redness, soreness and heat, while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date on Friday, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date on Sunday, the patient developed a non-serious redness (erythema), soreness (pain) and heat (feeling hot) two days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Reported Adverse Event Information: It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: FLUZONE MULTIDOSE VIAL (MDV). It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  The outcome of events was reported as unknown.  There will be no information on the lot number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site nerve damage, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: discomfort in the injected shoulder; tingling sensation in the injected arm; nerve was hit with the injection; lot of pain in the injected shoulder; sometimes the pain shoots up her neck; tingling sensation in the hand; lot of pain in the arm and feels like a rbbit punch; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00469951) and transmitted to Sanofi on 10-Feb-2021.  This case involves a 67-year-old female patient who had nerve was hit with the injection (vaccination site nerve damage), lot of pain in the injected shoulder (arthralgia), pain shoots up her neck (neck pain), tingling sensation in the hand (paraesthesia), lot of pain in the arm and feels like a rabbit punch (pain in extremity), discomfort in the injected shoulder (vaccination site discomfort) and tingling sensation in the injected arm (vaccination site paraesthesia), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 28-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via an intramuscular route in the right shoulder for prophylactic vaccination.  On 28-Oct-2020, the patient developed a non-serious had nerve was hit with the injection(vaccination site nerve damage), lot of pain in the injected shoulder (arthralgia), pain shoots up her neck (neck pain), tingling sensation in the hand (paraesthesia), lot of pain in the arm and feels like a rabbit punch (pain in extremity), discomfort in the injected shoulder (vaccination site discomfort) and tingling sensation in the injected arm (vaccination site paraesthesia), on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The details of laboratory data were not reported.  The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]). She was taking Motrin to treat her symptoms, but her doctor did not want her to continue taking Motrin since it could upset the stomach, so the doctor prescribed another pain medication, which was not helping her symptoms. Patient's doctor had suggested physical therapy or a nerve conduction study. Patient stated that she had not experienced symptoms like this with other vaccines she has received.  At the time of reporting, the patient had not recovered from all the events.  There will be no information on batch number for this case.; Sender's Comments:  00469951:
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain
Clinical narrative: developed a dull pain in his left deltoid; Initial information received on 17-Feb-2021 regarding an unsolicited valid non-serious case from a patient.  This case involves a 30 years old male patient who experienced a dull pain in his left deltoid (Pain in extremity), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 06-Jan-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7115NA and expiration date :30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  On 07-Jan-2021, the patient developed a non-serious a dull pain in his left deltoid (Pain in extremity), 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient did not recover from the event Pain in extremity. As the patient stated that he does not feel like the pain has resolved at all since.
Age: 11.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: An 11 year old patient was administered Daptacel instead of Adacel, no AE; An 11 year old patient was administered Daptacel instead of Adacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professionals (2 reporters) via inbound (reference number- 00493320).  This case involves an 11 year old male patient who was administered 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number: C5624AA; expiry date: 10-Jun-2021) via intramuscular route in left deltoid for prophylactic vaccination on 22-Feb-2021, instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]  (wrong product administered) (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration and Wrong vaccine administered (latency same day).  The reporter would like to know when it would be safe to have the patient return to receive the Adacel  At the time of this report, it was unknown if the patient experienced any adverse events.  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. 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: 55.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired Tenivac was given to a patient with no adverse event; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a Nurse Practitioner via Agency (Reference number- 00495304).  This case involves a 55 years old male patient who received an expired dose of  DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] batch number: U6187AA, expiry date: 06-FEB-2021 via unknown route and administration site on 21-Feb-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to expired vaccine used (latency same day).  Reporter causality: not reported. Reporter can be contacted by Sanofi: Yes. Potential product technical complaint (PTC): No. Description: Nurse Practitioner would like to know how to proceed. Does the patient need to be re-vaccinated and are there any health risks. Reviewed case and did not speak with the caller as the caller requested a response via email. Product used.  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 holders 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: 54.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient erroneously received expired dose of Tenivac/no AE; Initial information was received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 54 year-old male patient who was erroneously vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.   On 01-Mar-2021, the patient received 0.5 mL dose (Single dose vials) of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot C5578AA; Strength = standard and expiry date 28-Jan-2021) via an intramuscular route at the right deltoid for prophylactic vaccination.  Caller asking was they need to revaccinate a person who got an expired Tenivac.  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 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest discomfort, Chills, Fatigue, Feeling cold
Clinical narrative: I took the vaccine around 8:15 am at Hospital. They had a special event for Employees. After I was home I felt extremely tired and that improved after i laid down for a bit. However, around 7 PM I became very cold and had a temperature of 100.3 with chills/shakes. It has lasted into the next day with chills being on and off. I experienced muscle cramps as well has some chest discomfort.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: I took the vaccine around 8:15 am at Hospital. They had a special event for Employees. After I was home I felt extremely tired and that improved after i laid down for a bit. However, around 7 PM I became very cold and had a temperature of 100.3 with chills/shakes. It has lasted into the next day with chills being on and off. I experienced muscle cramps as well has some chest discomfort.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: about 7 hours after receiving the vaccine, I developed strong muscle and joint pain, fatigue, and a fever.  Overnight the fever got worse and I developed a headache.  I also felt tired.  A hot shower and some Advil about 24 hours after the vaccine helped.  Within 24 hours of symptom onset, they were better/gone.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Extreme fatigue, chills but not a fever, joints very achy, headache, nausea
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient had a syncopal episode post vaccination with brief unresponsiveness lasting about 5-10 seconds  . At time of episode pallor and diaphoresis was noted and right after brief LOC he became AXOx3. The patient  was placed in the Trendelenburg position while being  evaluated by  EMS:- Vitals:  B/P 99/58   HR: 60  RR20 O2sat 98%.  Blood glucose 132.  Hospital transfer was recommended but the patient refused. Oral fluids were administered and repeat vitals showed improvement in BP to 104/68. Patient ambulated without assistance and reported a return to baseline. Signed to go home against medical advise. Encouraged to seek medical attention  if symptoms returned and see PCP.  Left in the company of his spouse
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient had a syncopal episode post vaccination with brief unresponsiveness lasting about 5-10 seconds  . At time of episode pallor and diaphoresis was noted and right after brief LOC he became AXOx3. The patient  was placed in the Trendelenburg position while being  evaluated by  EMS:- Vitals:  B/P 99/58   HR: 60  RR20 O2sat 98%.  Blood glucose 132.  Hospital transfer was recommended but the patient refused. Oral fluids were administered and repeat vitals showed improvement in BP to 104/68. Patient ambulated without assistance and reported a return to baseline. Signed to go home against medical advise. Encouraged to seek medical attention  if symptoms returned and see PCP.  Left in the company of his spouse
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Joint range of motion decreased
Clinical narrative: red hurting itch rash on L arm of vaccination site, changed to triangle shape day and 2 weeks after, still having pain and lost range of motion in that arm, ongoing  1 week red hurting itchy rash on R butt cheek, then on both butt cheeks 2 weeks after, took Zyrtec 3 day and tar cream RX by Dermatologist, clearing up
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: red hurting itch rash on L arm of vaccination site, changed to triangle shape day and 2 weeks after, still having pain and lost range of motion in that arm, ongoing  1 week red hurting itchy rash on R butt cheek, then on both butt cheeks 2 weeks after, took Zyrtec 3 day and tar cream RX by Dermatologist, clearing up
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash, Skin warm
Clinical narrative: Rash on injection arm, below injection sight. Red, hot, and painful.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Joint stiffness, Loss of personal independence in daily activities
Clinical narrative: Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head; could not stand from sitting position without pain). During night, could not turn over in bed without pain. This lasted for 3-4 days. Treated with Advil. Next symptoms were joint pains and stiffness and back pains, which also lasted about a week. Treated with Aleve and hot/cold compresses. Final symptoms are severe swelling and stiffness of hands and fingers, with cracked, peeling skin. I have had this for about a week now and it is not improving. Cannot grasp anything with either hand. Middle and index fingers on both hands useless.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Peripheral swelling, Skin exfoliation
Clinical narrative: Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head; could not stand from sitting position without pain). During night, could not turn over in bed without pain. This lasted for 3-4 days. Treated with Advil. Next symptoms were joint pains and stiffness and back pains, which also lasted about a week. Treated with Aleve and hot/cold compresses. Final symptoms are severe swelling and stiffness of hands and fingers, with cracked, peeling skin. I have had this for about a week now and it is not improving. Cannot grasp anything with either hand. Middle and index fingers on both hands useless.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Tingling in face, mouth; stiff neck; fatigue; joint pain; sore arm; swollen lymph nodes in armpits, more so in left armpit; slight wheezing
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Wheezing
Clinical narrative: Tingling in face, mouth; stiff neck; fatigue; joint pain; sore arm; swollen lymph nodes in armpits, more so in left armpit; slight wheezing
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: Extreme joint pain through body, chills, teeth chattering uncontrollably, headache, couldn?t get out of bed.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Chills, Cold sweat
Clinical narrative: 3/05 @ 9pm - pain on right shoulder (about a 4 for pain). 3/06 @ 4am - diarrhea that lasted until next morning. 3/06 @ 9am - pain on right shoulder, armpit, and back (about 8 for pain); chills, fever (98-99), and headache. 3/06 @ 6pm - pain on right shoulder, armpit, and back (about 6 for pain); chills, cold sweats, and fever (98-99). 3/06 - 3/07 - during the night a had fever, cold sweats, and chills. All my clothing, pillow, and bed sheets were wet on the morning. 3/07 @ 9am - pain on shoulder only (about 4 for pain), chills, and headache. 3/07 @ 9pm - pain on shoulder (about 2 for pain), chills, and headache. 3/08 @ 5am - pain on shoulder almost gone. Just tender to touch. Some chills still persist.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: 3/05 @ 9pm - pain on right shoulder (about a 4 for pain). 3/06 @ 4am - diarrhea that lasted until next morning. 3/06 @ 9am - pain on right shoulder, armpit, and back (about 8 for pain); chills, fever (98-99), and headache. 3/06 @ 6pm - pain on right shoulder, armpit, and back (about 6 for pain); chills, cold sweats, and fever (98-99). 3/06 - 3/07 - during the night a had fever, cold sweats, and chills. All my clothing, pillow, and bed sheets were wet on the morning. 3/07 @ 9am - pain on shoulder only (about 4 for pain), chills, and headache. 3/07 @ 9pm - pain on shoulder (about 2 for pain), chills, and headache. 3/08 @ 5am - pain on shoulder almost gone. Just tender to touch. Some chills still persist.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Pyrexia
Clinical narrative: mild fever and headache starting approximately 6 hours after injection.  100.4F by digital no-touch thermometer acquired in ear.  Fever gone  after 12 hours.  Headache gone after 18hours with 400mg Advil taken 18 hours after start of fever.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Went to bed after getting my shot at 11:00 PM on 3/7/2021, feeling no symptoms.  Woke up at 5:10 AM the next day on 3/8/2021 feeling tired, sore, and a little nauseous, with a headache. These symptoms are very similar to how my COVID symptoms were in early October 2020
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Severe, Additional Details: Approximately 5 minutes after administration of moderna vaccine, pt reported feeling hot to observer. RN came out to check pt and pt then rolled eyes to left and back and passed out in chair. RN helped pt to sit upright in chair as was about to fall off chair. After 10 seconds patient able to talk with patient. She stated she still felt tingling in arms but cooling down. Had additional tingling/warm and vomitting episode. Paramedics called. Pt refused transport, parent going to drive to ER.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin warm, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Severe, Additional Details: Approximately 5 minutes after administration of moderna vaccine, pt reported feeling hot to observer. RN came out to check pt and pt then rolled eyes to left and back and passed out in chair. RN helped pt to sit upright in chair as was about to fall off chair. After 10 seconds patient able to talk with patient. She stated she still felt tingling in arms but cooling down. Had additional tingling/warm and vomitting episode. Paramedics called. Pt refused transport, parent going to drive to ER.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: After 7 days, arm became sore, itchy, red and swollen. Soreness subsided after 2 days but redness and swelling persists but has improved but not gone.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 11 days after vaccination my arm is itchy around the injection site and I have a red raised rash.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Nausea, Pyrexia, Syncope
Clinical narrative: Work up at 12:30 a.m. very hot and nauseous.   When I tried to stand up I fainted.  When I came to I crawled to the bathroom and vomited several times.  Continued to run fever for about an hour or so.  Then headache began.  As of 7:00 I still feel nauseous and have a slight headache.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Work up at 12:30 a.m. very hot and nauseous.   When I tried to stand up I fainted.  When I came to I crawled to the bathroom and vomited several times.  Continued to run fever for about an hour or so.  Then headache began.  As of 7:00 I still feel nauseous and have a slight headache.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Large reddened area at injection site, occurring about 10 days after the injection. Slightly tender and somewhat itchy
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: My shot was Feb. 24th and I had the initial soreness that I typically get with any shot.  That soreness only lasted a few days.  On March 5th, my injection site started to hurt.  It was swollen and hot to the touch.  It was itchy and felt somewhat hard.  The first day of this it was really itchy, hot and painful.  I took 2 benadryl.  The next day it was not as itchy or hot.  Today is March 8th and the injection site is still sore but not as bad as it was.  No more itching or hotness.  I did not get a rash.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My shot was Feb. 24th and I had the initial soreness that I typically get with any shot.  That soreness only lasted a few days.  On March 5th, my injection site started to hurt.  It was swollen and hot to the touch.  It was itchy and felt somewhat hard.  The first day of this it was really itchy, hot and painful.  I took 2 benadryl.  The next day it was not as itchy or hot.  Today is March 8th and the injection site is still sore but not as bad as it was.  No more itching or hotness.  I did not get a rash.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Pallor, Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient fainted from seated position. Hit left side of head from this distance. Patient regained consciousness within a few moments and legs were elevated while laying on back. Reported vision tunneling occured before fainting (once she came to). Patient was pale but regained color 15+ minutes later. Patient answered all questions 2 paramedic crews had/checked her BP/O2 sats etc. Declined hospital and signed off with father present who was called in. Father drove her home.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Syncope
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal sleep-related event
Clinical narrative: SLEEP = the BEST few night's sleep that I have experienced this YEAR
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: pt repoted redness on left arm 7 days after dose
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Paraesthesia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Extreme Migraine, nausea, puking,
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body aches came on on suddenly at 11pm.  Took ibuprofen at 5 a.m. Fever and chills gone by 7a.m.  Then felt low energy, tired on 3/6 fine by 6 p.m.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dysgeusia, Fatigue, Headache
Clinical narrative: Thursday...3:05pm...metallic taste, sore/hot arm/beginning to swell... Tylenol taken Friday...5pm...severe chills, severe body aches, high fever, exhaustion, thirst until 2:30 am...Motrin taken at around 7pm...Dayquil taken around 1am Saturday 2:30 am chills subside, body aches continue, fever continues, exhaustion continues, thirst continues until 10am Saturday 10am fever subsides and sweating/clamminess begins, body aches subside. Tired Arm is still swollen at this time, burning and itching. Rash appears. Saturday 4pm no longer sweating, slight head ache Monday I still have a rash on the injection point and soreness and slight swelling. Still tired.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: Thursday...3:05pm...metallic taste, sore/hot arm/beginning to swell... Tylenol taken Friday...5pm...severe chills, severe body aches, high fever, exhaustion, thirst until 2:30 am...Motrin taken at around 7pm...Dayquil taken around 1am Saturday 2:30 am chills subside, body aches continue, fever continues, exhaustion continues, thirst continues until 10am Saturday 10am fever subsides and sweating/clamminess begins, body aches subside. Tired Arm is still swollen at this time, burning and itching. Rash appears. Saturday 4pm no longer sweating, slight head ache Monday I still have a rash on the injection point and soreness and slight swelling. Still tired.