chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Mental impairment, Myalgia
Clinical narrative: Feeling spacey; severe diarrhea; Sweats; severe body aches; Chills; A spontaneous report was received from a consumer concerning a 78 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe body aches, severe diarrhea, sweats, chills and feeling spacey.  The patient's medical history was not reported. Current condition included lung cancer. Concomitant products included chemotherapy pill for lung cancer.  On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 05 Mar 2021, 3 hours after receiving vaccine, the patient developed severe body aches, severe diarrhea, sweats, chills and feeling spacey.  Treatment information was unknown.  The event of feeling spacey was considered to be serious with criteria of important medical event and the rest events were considered as non-serious.  Action taken with mrna-1273 in response to the events was unknown.   The outcome of event, feeling spacey was considered resolved on 08 Mar 2021 and the remaining events were considered resolved on 07 Mar 2021.; 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient caught covid after first dose; Was due for the the 2nd dose on 10 Feb 2021, it is now a month past the 36-42 days; A spontaneous report was received from a healthcare professional (HCP) concerning a 72-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), developed covid 19 and was due for the 2nd dose on 10-Feb-2021, it was now a month past the 36-42 days/(Missed dose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13-Jan-2021, the patient received his first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, shortly after receiving the first dose, the patient contracted COVID-19.   The patient was hospitalized for six weeks. The patient was due for the second dose on 10-Feb-2021, it was now a month past the 36-42 days.  Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, COVID-19 was unknown.  The outcome of the event, Missed dose was unknown.; Reporter's Comments: This report refers to a case of Product dose Omission issue for mRNA-1273, with associated AE. Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Disorientation, Hallucination
Clinical narrative: she was hallucinating; didn't know where she was; her sugar dropped to 73/ she never had sugar so low; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's  mRNA-1273 and was hallucinating, didn't know where she was, and blood sugar dropped to 73.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Insulin 4 times a day, heart medication, cholesterol medication and  high blood pressure medication.   On 08 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient was hallucinating, didn't know where she was, and her sugar dropped to 73, which never reached this low before.   Treatment for the event included sugar.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events; hallucination, didn't know where she was, and blood sugar dropping to 73, were reported as recovered on 09 Mar 2021.; 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: U
Vaccine: COVID19
Symptoms: Encephalopathy
Clinical narrative: Encephalopathy; A spontaneous report was received from a physician concerning a patient, unknown age or gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced encephalopathy.  No medical history was reported. No concomitant medications were provided.  The patient received both of the two planned doses of mRNA-1273 (Lot numbers not provided) intramuscularly for prophylaxis of COVID-19 infection on an unknown dates.  On an unknown date, the patient experienced encephalopathy. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the event, encephalopathy, was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Fatigue, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: Appendicitis; Flu like symptoms; Pain on Right (R) side; Tired; Nausea; A spontaneous report  was received from a consumer concerning a 50-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced appendicitis, flu like symptoms, pain on right (R) side, tired and nausea.  No medical history was reported. The current condition included thyroid. Concomitant medications included thyroid medication.  On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, Friday, the patient was tired, nauseous, had pain on right (R) side and flu like symptoms. On 06 Mar 2021, Saturday, the patient went to emergency room (ER) where a scan was performed and the patient was diagnosed with appendicitis. On the same day, the patient was sent to a hospital where an appendix surgery was performed. On 07 Mar 2021, Sunday evening, the patient was discharged.  Treatment information included surgery, appendix removed and pain medicine after surgery.  Action taken with mRNA-1273 in response to the events was unknown.  On 07 Mar 2021, the event of appendicitis resolved, while the outcome of the events of flu like symptoms, pain on right (R) side, tired and nausea was 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 event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Scan
Clinical narrative: Appendicitis; Flu like symptoms; Pain on Right (R) side; Tired; Nausea; A spontaneous report  was received from a consumer concerning a 50-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced appendicitis, flu like symptoms, pain on right (R) side, tired and nausea.  No medical history was reported. The current condition included thyroid. Concomitant medications included thyroid medication.  On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, Friday, the patient was tired, nauseous, had pain on right (R) side and flu like symptoms. On 06 Mar 2021, Saturday, the patient went to emergency room (ER) where a scan was performed and the patient was diagnosed with appendicitis. On the same day, the patient was sent to a hospital where an appendix surgery was performed. On 07 Mar 2021, Sunday evening, the patient was discharged.  Treatment information included surgery, appendix removed and pain medicine after surgery.  Action taken with mRNA-1273 in response to the events was unknown.  On 07 Mar 2021, the event of appendicitis resolved, while the outcome of the events of flu like symptoms, pain on right (R) side, tired and nausea was 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 event, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Paraesthesia, Sensorimotor disorder
Clinical narrative: Drooping in face; Numbness traveled from right arm to wrist; Tingling in right arm; Motor and strength issues; A spontaneous report was received from a consumer concerning a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed numbness going from right arm to wrist/ Hypoaesthesia, tingling in right arm/ Paraesthesia, motor and strength issues/ Sensorimotor disorder and drooping in face/facial paralysis.  Medical history or concomitant medications were not reported.  On 09 Mar 2021, the patient received her first planned dose of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection. Later, she developed numbness in right arm which went up to wrist. She also had tingling in right arm. Moreover, she also reported motor and strength issues along with drooping in face. Treatment information was not provided.  The event drooping in face was considered to be medically significant.  The action taken with mRNA-1273 in response to the events, numbness going from right arm to wrist, tingling in right arm, motor and strength issues and drooping in face, was unknown.  The outcome of the events, numbness going from right arm to wrist, tingling in right arm, motor and strength issues and drooping in face, was 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; A spontaneous report was received from a consumer concerning a 58-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy (facial paralysis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, approximately eight days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient started showing symptoms of numbness in face. She went to emergency response on 08 Mar 2021 and was diagnosed with Bell's palsy. She said she didn't have drooping or paralysis, but still have numbness. She went to other provider for second opinion and was given high dose of Vitamin B-12 and Acyclovir. No additional treatment information was given.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, Bell's palsy was considered not recovered.; Reporter's Comments: Based on the information provided which includes a temporal association between the reported events, administration of mRNA-1273 vaccine and excluded all other etiologies, a causal association cannot be excluded
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperpyrexia, Pyrexia
Clinical narrative: Each day, her temperature is going up and she had a temperature of 106; Each day, her temperature is going up and she had a temperature of 106; A spontaneous report was received from a consumer, who is a 73-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced each day her temperature is going up and she had a temperature of 106/ hyperpyrexia.  The patient's medication history was not reported. No relevant concomitant medications were reported.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 044A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   Since an unspecified day in 2021, after receiving vaccine, the patient experienced each day her temperature is going up and she had a temperature of 106 (medically significant). Treatment included acetaminophen every 4 hours and her doctor told her to take ibuprofen as well.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event was 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 event, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Death, Feeling abnormal, Vaccination site pain, Vomiting
Clinical narrative: Chest pain; felt really bad; Death; Vomited that night; Sore arm and pain in both arms; A spontaneous report  was received from a consumer concerning a 83-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and pain in both arm /pain in extremity, felt really bad/feeling abnormal, chest pain and the patient died.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Mar 2021, patient experienced sore arm and felt bad. The patient vomited that night. On an unknown date patient reported chest pain and pain in both arms. On 05 Mar 2021, at 12:46pm the patient died.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient died on 05 Mar 2021. The cause of death was reported as unknown. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of death in an 83-year-old male subject with unknown medical history, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Lost hearing in one ear; A spontaneous report was received from a consumer concerning an age unspecified, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of hearing in one ear.  The patient's medical history was not provided. Concomitant medications were not provided.  On 14 Mar 2021, approximately a day prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On the morning of 15 Mar 2021, the reporter states that her sister had no hearing in one ear. Treatment information was not provided by reporter. Lab tests were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, lost hearing in one ear, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, SARS-CoV-2 test
Clinical narrative: experienced some side effects that led to his hospitalization for 2 days; A spontaneous report was received from consumer concerning a (patient age: unknown) male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some side effects that led to his hospitalization for two days.  The patient's medical history was reported by the reporter as patient previously had COVID back in June/July of 2020. Concomitant medications taken by the patient were not provided.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, patient experienced some side effects that led to his hospitalization for two days. Treatment activities for event was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of event, experienced some side effects that led to his hospitalization for two days was 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 event, a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Insomnia, Musculoskeletal stiffness, Pain
Clinical narrative: woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is a spontaneous report from a contactable healthcare professional (patient). This 41-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 18Feb2021 at 09:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriasis for which he received guselkumab (TREMFYA) injections every 2 months. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 01:30 as a single dose in the right arm for COVID-19. On 19Feb2021 at 00:00 after dose 2 of BNT162B2 the patient experienced mild arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of mid arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is a spontaneous report from a contactable healthcare professional (patient). This 41-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 18Feb2021 at 09:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriasis for which he received guselkumab (TREMFYA) injections every 2 months. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 01:30 as a single dose in the right arm for COVID-19. On 19Feb2021 at 00:00 after dose 2 of BNT162B2 the patient experienced mild arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of mid arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Rectal bleeding; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm, on 25Feb2021 at 15:00 (at the age of 69-years-old) at a single dose for COVID-19 immunisation. Medical history included Waldenstrom's macroglobulinaemia and internal hemorrhoids. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included unspecified medications taken within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: GL9269), in the left arm, on 04Feb2021 at 15:00 (at the age of 69-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced rectal bleeding on 28Feb2021. The clinical course was reported as: The patient noticed rectal bleeding and reported that he occasionally experienced this due to internal hemorrhoids, but it is normally caused by either taking nonsteroidal anti-inflammatory drugs (NSAIDs) or by not chewing food properly or undue stress. This time, though, the patient thought it may be related to the vaccine, as none of the other causes appear to apply. The patient did not receive any treatment for the event. The clinical outcome of rectal bleeding was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Weight, Weight decreased
Clinical narrative: stopped eating and drinking/ appetite lost; lost weight; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not reported) via unspecified route of administration on 10Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The reporter (patient's sister) stated that on unspecified date in 2021, after first dose of vaccination, patient experienced appetite lost as patient stopped eating and drinking which caused her to lose weight (lost weight) and be hospitalized (start date of hospitalization was on unspecified date in 2021). Patient was schedule for second dose on 03Mar2021 and reporter wanted to know what he should do and if her sister could get the second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac valve disease, Pulmonary thrombosis, Thrombosis
Clinical narrative: blood clots found on his arm and lung; blood clots found on his arm and lung; valve blockage; This is a spontaneous report from a contactable consumer (patient's friend) via Medical Information team. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Feb2021 as a single dose for COVID-19 immunization. Relevant medical history included COVID-19 infection from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The reporter stated that the patient was due to receive his second dose the day prior reporting on 02Mar2021, and wanted to know if the patient should receive the second dose of the vaccine if he stayed longer than 3 weeks in the hospital. The patient was currently hospitalized; he received medical attention 2 weeks prior reporting on an unspecified date in Feb2021 due to some blood clots found on his arm and lung. The patient went into the hospital because he had a valve blockage on an unspecified date in Feb2021 and that the patient still had to go to rehab and might miss that 3 week window. The reporter wanted to know if a patient should restart the vaccination series if he could not receive the second dose 42 days after the first one. The patient was hospitalized for the events "blood clots found on his arm and lung and valve blockage" from an unspecified date in 2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lyme disease, Vaccination site pain
Clinical narrative: Lyme disease; pain and soreness at touch around injection site (left arm).; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) at arm left as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported pain and soreness at touch around injection site (left arm). The patient wants to know in which arm should she get the second dose. She was also diagnosed with possible Lyme disease. She has been prescribed a strong antibiotic to take for 3 week BID and probiotics. She is scheduled for the second on 19Mar2021. Therapeutic measures were taken as a result of lyme disease. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: developed life threatening high blood pressure; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 10:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 04Mar2021 at 02:30, the patient developed life threatening high blood pressure. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. The outcome of events was not recovered.; Sender's Comments: Based on the strong temporal relation in the case report, a causal relationship between adverse event Blood pressure increased and suspect product BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 1.25
Sex: M
Vaccine: DTAP, DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 month old patient received a dose of received Quadracel vaccine in error with no adverse event; 15 month old patient received a dose of received Quadracel vaccine (intended Daptacel) in error with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via medical information (Reference number- 00502121).   This case involves a 15 month old male patient who received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] [lot number: C5772AA, expiry date: 17-Sep-2022] via intramuscular route at an left thigh for prophylactic vaccination on 02-Mar-201 in error as patient was intended to receive DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]) [lot number, expiry date and other dosing details not applicable] (product administered to patient of inappropriate age and wrong product administered). (latency: at the same time of vaccination)  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HIB VACCINE CONJ (HIB VACCINE CONJ) (HIB-PRPT).  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong product administered.   It was reported that, there have been several patients 15 months of age had been given QUADRACEL and would like to know how safe that was since it was not meant for that age group. Nurse reports that they typically use Pentacel for children's 15-month vaccines.  This 9-month-old child was receiving his 15-month.  The office was out of Pentacel, so the medical assistant (MA) administered HIB-PRPT with QUADRACEL (intended DAPTACEL) and PREVNAR 13.  No adverse effects reported at the time of reporting.  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: 6.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong patient received product
Clinical narrative: nurse went in the wrong room and administered it to the wrong patient.; Initial information regarding an unsolicited non-serious case was received from a physician via agency (Reference number- 00504028) and transmitted to Sanofi on 04-Mar-2021.  This case involves a six years old male patient who was administered with a 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiration date were not reported) via intramuscular route in left deltoid for prophylactic vaccination by error on 03-Mar-2021 because nurse went in the wrong room and administered the wrong patient (Wrong patient received product ).  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medication included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation.  It was actual medication error due to wrong vaccine administered (on same day).  The reporter states that there was a mix up and a 6 year old patient that was just there to be seen for some other reason (not a vaccine) received a Menactra vaccine that was meant for another patient because the nurse went in the wrong room and administered it to the wrong patient. The reporter questions if there are any side effects that they should be aware of and if this throws off the scheduled 11-year-old vaccine. The reporter would like to know the possible side effects for the patient. The patient was scheduled to receive a flu shot.  At the time of report, the patients experienced no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cervical vertebral fracture, Fall, Hemiplegia, Hypoaesthesia
Clinical narrative: Initial information regarding an unsolicited valid serious case was received from a physician via consumer/non-health care professional via Regulatory Agency (Reference number- 00512481) and transmitted to Sanofi on 10-Mar-2021. This case involves a 60-year-old male patient who had a Guillain Barre syndrome, paralyzed, unable to move his left side at all (hemiplegia), feeling weak (asthenia), unable to hold up the weight of his body, fell (fall), broke C3, loss of sensation on right side, numbness on right side (hypoesthesia) and stroke while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. On 19-Feb-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ493AAA, expiry date: 30-Jun-2021) via unknown route in the left arm for vaccination. In Feb-2021, the patient got out of bed and was feeling weak, unable to hold up the weight of his body and because of this, he fell and broke his C3 and was unable to move his left side at all, approximately 12 hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 20-Feb-2021, the ambulance came and took him to the Hospital. They ruled out a stroke and Guillain Barre syndrome (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date in 2021, the patient was experiencing numbness and loss of sensation on right side (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Initially he could not move left side, but now he could move. On 02-Mar-2021, the patient was transferred to hospital out of state due to help gain mobility. The events were assessed as medically significant, and patient was hospitalized for the events. The Caller stated that her stepfather took the flu vaccine and within 24 hours he was paralyzed and is still hospitalized. He is unable to work. The Caller and wife of patient were requesting compensation from the adverse events (AE's) that they feel is a result of the Sanofi flu vaccine. No laboratory data was provided. It was not reported if the patient received a corrective treatment. On an unknown date in 2021, the hemiplegia recovered while outcome of other events was unknown. Sender's Comments: This case concerns 60-year-old male patient who had Guillain-Barre syndrome, hemiplegia, asthenia, weight bearing difficulty, fall, cervical vertebral fracture, sensory loss, hypoesthesia and cerebrovascular accident after vaccination with FLUZONE. The time to onset is compatible with the role of the vaccine. Additional information regarding patient's past medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Impaired work ability, Sensory loss, Weight bearing difficulty
Clinical narrative: Initial information regarding an unsolicited valid serious case was received from a physician via consumer/non-health care professional via Regulatory Agency (Reference number- 00512481) and transmitted to Sanofi on 10-Mar-2021. This case involves a 60-year-old male patient who had a Guillain Barre syndrome, paralyzed, unable to move his left side at all (hemiplegia), feeling weak (asthenia), unable to hold up the weight of his body, fell (fall), broke C3, loss of sensation on right side, numbness on right side (hypoesthesia) and stroke while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. On 19-Feb-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ493AAA, expiry date: 30-Jun-2021) via unknown route in the left arm for vaccination. In Feb-2021, the patient got out of bed and was feeling weak, unable to hold up the weight of his body and because of this, he fell and broke his C3 and was unable to move his left side at all, approximately 12 hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 20-Feb-2021, the ambulance came and took him to the Hospital. They ruled out a stroke and Guillain Barre syndrome (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date in 2021, the patient was experiencing numbness and loss of sensation on right side (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Initially he could not move left side, but now he could move. On 02-Mar-2021, the patient was transferred to hospital out of state due to help gain mobility. The events were assessed as medically significant, and patient was hospitalized for the events. The Caller stated that her stepfather took the flu vaccine and within 24 hours he was paralyzed and is still hospitalized. He is unable to work. The Caller and wife of patient were requesting compensation from the adverse events (AE's) that they feel is a result of the Sanofi flu vaccine. No laboratory data was provided. It was not reported if the patient received a corrective treatment. On an unknown date in 2021, the hemiplegia recovered while outcome of other events was unknown. Sender's Comments: This case concerns 60-year-old male patient who had Guillain-Barre syndrome, hemiplegia, asthenia, weight bearing difficulty, fall, cervical vertebral fracture, sensory loss, hypoesthesia and cerebrovascular accident after vaccination with FLUZONE. The time to onset is compatible with the role of the vaccine. Additional information regarding patient's past medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Hypertension, Tachycardia
Clinical narrative: high blood pressure; tachycardia; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 31-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number M5325, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received Fluarix Tetra 2019-2020 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In October 2019, less than an hour after receiving Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced blood pressure high and tachycardia. On an unknown date, the outcome of the blood pressure high and tachycardia were recovered/resolved.   It was unknown if the reporter considered the blood pressure high and tachycardia to be related to Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported it could be 31 years. In October 2019, the patient received a dose of Fluarix Tetra and within 15 minutes, she experienced high blood pressure and tachycardia. Both the events were resolved. The reporter consented to follow up with her HCP (health care provider).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: office manager that called to report a temperature excursion for V ARlV AX and states that it was administered to a patient; No additional AE; This spontaneous non-valid report was received from an office manager and refers to an unknown patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #T014309, expiration date: 24-APR-2022) (dose and route of administration were not reported) for prophylaxis. The vaccine experienced the temperature excursion of 9 degrees Celsius for 1 hour. Previous temperature excursion was reported as between 6 Fahrenheit degrees (F) to 14 F for 6 minutes, between 6 F to 14 F for 1 minute and from 6 F to 14 F for 1 minute. The event was reported due to digital data logger. The reporter did not have the patient information and was not sure exactly when it was administered. More information would follow. No additional adverse event (AE) was reported.  This case is considered non-valid due to no patient's identifiers.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: broke out with hives behind ears, thoracic region and belly region, a couple behind knees and on arms; This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 28th January 2021, 1 days after receiving Shingrix, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was recovered/resolved.   It was unknown if the reporter considered the generalized urticaria to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received the Shingrix shot into the left arm. The patient broke out with hives behind ears, thoracic region and belly region and a couple behind knees and on arms. They presented the next day and lasted for about a week.  The reporter consented to follow up. For tolerance to the 2nd Shingrix shot, refer case US2021AMR061693.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021061360:same reporter US-GLAXOSMITHKLINE-US2021AMR061693:same patient
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case received from consumer/ non-health professional via social media.  This case involves a male patient of unknown age who experienced flu (influenza), after the patient received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatments, vaccination and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number and expiration date not reported] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu (influenza), (latency: unknown) following the administration of INFLUENZA VACCINE.  It was reported by the patient every darn time.  It is unknown if patient's physician provided consent to be contacted. It is unknown if the patient experienced any additional symptoms/ events. Medication Details and reason for taking the medicine were not provided.  No laboratory data or results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding lot number in this case.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache lasting about 24 hours
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Hypoacusis
Clinical narrative: Patient has had prior left stapes in 1990s. Her hearing has been stable. She got her 2nd Pfizer vaccine on Feb 1 and around the same time or shortly after she noticed her hearing has worsened mainly in the right ear.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Urticaria
Clinical narrative: Uticaria on neck and back, fatigue
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling hot, Injection site swelling, Joint range of motion decreased, Pain
Clinical narrative: First vaccine - left arm swelling, hot, itchy, painful, couldn't raise arm. Second vaccine - extreme fatigue, slept for 36 hours straight, pain, swelling, hot, itchy, can't raise arm and location of first vaccine in left arm swelled, got hot red and itchy again, couldn't raise left arm.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: First vaccine - left arm swelling, hot, itchy, painful, couldn't raise arm. Second vaccine - extreme fatigue, slept for 36 hours straight, pain, swelling, hot, itchy, can't raise arm and location of first vaccine in left arm swelled, got hot red and itchy again, couldn't raise left arm.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient got the Pfizer vaccine after receiving the Moderna vaccine on 2/25/21 for her first injection.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Auditory disorder
Clinical narrative: Patient has history of bilateral Meniere's disease which ahs been managed medically. The hearing loss is sudden. Patient  received COVID-19 vaccine in  late December 2020 Moderna. Did notice mild change in hearing with first vaccine. Bad systemic reaction to second dose. Has progressed significantly since. The change in  hearing was about 2 to 4 weeks after second vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Began to experience Body chills followed by a Low grade fever (approx 100 degrees).  These symptoms developed the next morning around 10:00am and lasted approximately 12 hours.  Extreme fatigue accompanied the fever, however, the fatigue lasted longer (approximately 48 hours). Soreness at the injection site also began the morning after receiving the vaccine. The soreness lasted for 48 hours and  was more extreme than any other shot I?ve received in my bicep.  None of these symptoms were disabling; however the fatigue did prohibit me from participating in my normal daily activities.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Facial nerve disorder, Feeling abnormal, Feeling drunk, Feeling jittery, Hypoaesthesia
Clinical narrative: I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing tingling sensation on the right side of my face and tongue and top of my head. I also felt very jittery or crawling sensation like I had to much coffee. I called the guards to my car twice and was told it was my nerves. I was released even though I wasn't feeling right and felt like was drunk driving on the way home, the worst of it passed within a hour but the fuzzy feeling lingered with numb spots on my face lasted for a few days.   Now I'm afraid to get my second shot due April 3rd.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Malaise, Paraesthesia, Paraesthesia oral
Clinical narrative: I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing tingling sensation on the right side of my face and tongue and top of my head. I also felt very jittery or crawling sensation like I had to much coffee. I called the guards to my car twice and was told it was my nerves. I was released even though I wasn't feeling right and felt like was drunk driving on the way home, the worst of it passed within a hour but the fuzzy feeling lingered with numb spots on my face lasted for a few days.   Now I'm afraid to get my second shot due April 3rd.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Deafness unilateral
Clinical narrative: Patient has history of autoimmune inner ear disease. She has a left cochlear implant and noted hearing loss on right ear compared to her baseline approximately 1 week after first dose of covid vaccine.