chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: Bad headache; Hives; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bad headache and hives on an unspecified date. The outcome of events was unknown.  Additional Context: The patients youngest son had a doctor's appointment and his GI doctor told the patient that headache was common and would go away and that she also had a bad headache. That was just her sons GI doctor that told her the headache was fine. The patient sent an e-mail to her PCPC asking about the hives.  Information about lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic sinusitis, Dysphonia, Headache, Nasopharyngitis, Pain
Clinical narrative: Light headache; His voice is very hoarse; He is throwing something white through his nose; He has pain in his body; His platelets are "a little low", because of his immunodeficiency; He catches a little cold; Chronic sinusitis; He feels sleepy, closes his eyes, falls asleep for a few minutes and wakes up; Little pain in his left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,(Batch/Lot Number: EW0173), via an unspecified route of administration in left arm on 28Apr2021 (at the age of 69-year-old) as 1st dose, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient experienced platelets are "a little low", because of his immunodeficiency, light headache, his voice was very hoarse, he was throwing something white through his nose, pain in his body, his platelets were "a little low", because of his immunodeficiency (platelet count decreased) , he catches a little cold, chronic sinusitis, he felt sleepy, closed his eyes, falls asleep for a few minutes and woke up, little pain in his left arm. The patient underwent lab tests and procedures which included platelet count decreased: low on Platelets are "a little low", because of his immunodeficiency. Therapeutic measures were taken with paradol, tylenol and tea for the events little pain in his left arm, from there he felt nothing else,for 4 days he has felt "light headache", his voice was very hoarse, he was throwing something white through his nose, he had pain in his body. Tomorrow he was going to get the second dose, he didn't think he will and asked was it feasible to wait a few more days or a week for him to get better. He was hoping to make a chicken broth and feel better after eating it. The outcome of the events was reported as unknown.  Information about the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Platelet count decreased, Rhinorrhoea, Somnolence
Clinical narrative: Light headache; His voice is very hoarse; He is throwing something white through his nose; He has pain in his body; His platelets are "a little low", because of his immunodeficiency; He catches a little cold; Chronic sinusitis; He feels sleepy, closes his eyes, falls asleep for a few minutes and wakes up; Little pain in his left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,(Batch/Lot Number: EW0173), via an unspecified route of administration in left arm on 28Apr2021 (at the age of 69-year-old) as 1st dose, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient experienced platelets are "a little low", because of his immunodeficiency, light headache, his voice was very hoarse, he was throwing something white through his nose, pain in his body, his platelets were "a little low", because of his immunodeficiency (platelet count decreased) , he catches a little cold, chronic sinusitis, he felt sleepy, closed his eyes, falls asleep for a few minutes and woke up, little pain in his left arm. The patient underwent lab tests and procedures which included platelet count decreased: low on Platelets are "a little low", because of his immunodeficiency. Therapeutic measures were taken with paradol, tylenol and tea for the events little pain in his left arm, from there he felt nothing else,for 4 days he has felt "light headache", his voice was very hoarse, he was throwing something white through his nose, he had pain in his body. Tomorrow he was going to get the second dose, he didn't think he will and asked was it feasible to wait a few more days or a week for him to get better. He was hoping to make a chicken broth and feel better after eating it. The outcome of the events was reported as unknown.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: chills and vomiting; vomiting; This is a spontaneous report from a contactable consumer (patient's mother). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in 2021 as unknown dose, single for COVID-19 immunization in pharmacy. Medical history included ongoing diabetes for about 5-10 years and had a callus on his big toe referring to diabetic ulcer. The patient's concomitant medications were not reported. The patient experienced two episodes of chills and vomiting in Apr2021. The first episode was in Apr2021 (3-4 weeks ago and about 2 weeks after the shot) while the second episode in May2021 (on that past weekend). The outcome of these events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Rash
Clinical narrative: her fingers hurt; she developed a rash that lasted 4 days,; migraines got worse; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Allergan (manufacturer control number: 2116268US), for bnt162b2.  A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included covid-19 from 16Mar2020 to Jul2020 patient was put on a ventilator for 34 days , paralysis from an unknown date and unknown if ongoing patient learns how to walk again and use her arms, cardiac pacemaker insertion from an unknown date and unknown if ongoing , ongoing pain in extremity. The patient's concomitant medications included: botulinum toxin type a (BOTOX), via an unspecified route of administration on 2021 (Batch/Lot number was not reported), at unspecified dose for migraine.   The patient clarified that she had Botox 3 months ago for migraines. She had about 10 shots total in her head and forehead. She does not have the lot number, exact date, or exact dose. She stated that the migraines got worse. Patient discontinued Botox. She will not take any future injections since migraines got worse.  Patient stated that she received the Pfizer vaccine 6 weeks ago and 2 weeks ago. The first injection she didn't have any side effects but the second injection she developed a rash that lasted 4 days, migraine that lasted 6 days, and her fingers hurt. She stated nobody could touch her fingers for 3 days and it has improved but not fully recovered from that.  The patient experienced migraines got worse (non-serious) on 2021 with outcome of unknown, her fingers hurt (pain in extremity) (non-serious) on Apr2021 with outcome of recovering, she developed a rash that lasted 4 days, (non-serious) on Apr2021 with outcome of recovered.   The action taken in response to the event for botulinum toxin type a was permanently withdrawn on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller's father Covid 19 positive 3-4 days after first dose of the Covid Vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient's son). This is the first of 2 reports from the same reporter involving the same patient. The patient experienced adverse events with both 1st and 2nd dose of the vaccine. This is for the first dose of the vaccine. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown) via an unspecified route of administration on an unknown date in Jan 2021 (at age of 71-year-old) as single dose for covid-19 immunisation. Medical history included prostate cancer from 2020 which was ongoing (this was recurrent prostate cancer that came back in the Fall of 2020), cardiac dysfunction (his fathers heart only functions at about 30 percent due to a prior illness), father was allergic to penicillin. The patient's concomitant medications were not reported. Caller does not know the date or Lot Number for his fathers first dose of the Covid Vaccine. The caller stated that his father became covid 19 positive 3-4 days after first dose of the covid vaccine in Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The outcome of event was unknown.  Follow up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Pain in extremity
Clinical narrative: Bruising under both of my hands; Headaches; severe arm pain; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER 8734), via an unspecified route, administered in left arm on 18May2021 at 08:15 (at the age of 21-year-old), as first dose, single for covid-19 immunization at Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient did not have any medical history and concomitant medication. The patient did not have any allergies at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced bruising under both of her hands, headaches and severe arm pain on 18May2021 13:00. No treatment was received for the events. The outcome was reported as recovering for the reported events.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable other HCP (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included she had an issue with red dye in the past and states her 'throat started closing up' from it. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient stated she had her second Pfizer Covid vaccine dose on Wednesday 12May2021. On Sunday 16May2021 she developed hives and a rash that has gotten progressively worse. She was taking prednisone and Benadryl to help treat it. She wanted to know if this has been reported before and how long it could potentially last. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Headache, Limb discomfort
Clinical narrative: Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 54 years old, in left arm on 06May2021 15:30 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient experienced headache, dizziness, foggy, heavy feeling in chest, shoulders, and arm on 14May2021 05:00. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: patient is not in great health; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) in Jan 2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient was not in great health and was just admitted to nursing home and the nursing home doctor called. She said it was 21 to 42 day out for the second dose and asks for confirmation on that window and asked whether it needs to be started. She says that she asked her to at least do a test for antibodies but she is not sure It was reported that it has now been 3 months out and asked whether the patient can take the second dose and whether it would still be effective. The outcome of event was unknown.  Information on the lot/batch number has been requested. Additional information has been requested; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event asthenia and the administration of the vaccine cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: R arm, then L (1st) at inject area ache/pain that remains 5/20 & gets worse; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8729), at the age of 79 years old, in right arm on 14Apr2021 14:00 at single dose for covid-19 immunisation. Medical history included low thyroid and high blood pressure. Both were medicated. The patient's allergies were unknown. The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included lisinopril at 20 mg and levothyroxine sodium (SYNTHROID) at 112 ug the patient received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to vaccination. On 16Apr2021, the patient experienced R arm, then L (1st) at inject area ache or pain, that remains 20May2021 and got worse. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown and expiration date was not reported), via an unspecified route of administration in left arm, on 19May2021 at 10:00 (at the age of 43 years old) as second dose, single for COVID-19 immunization in pharmacy/drug store. Medical history included grave's disease. The patient had sulfa drug allergy. Concomitant medications included levothyroxine and montelukast sodium (SINGULAIR). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown and expiration date was not reported), via an unspecified route of administration in left arm, on 26Apr2021 at 11:30 (at the age of 43 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced chills and headache on 20May2021. No treatment was received by the patient due to these events. The outcome of these events was recovering at the time of report.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity, Pertussis
Clinical narrative: allergy; Initial information received on 30-Apr-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves adult female patient who experienced allergy (hypersensitivity) when received vaccine TETANUS TOXOID.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious (pertussis) allergy (hypersensitivity) (unknown latency) following the administration of TETANUS TOXOID.  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 for the event (allergy).  The event outcome was unknown for allergy.  There will be no information available on the batch number for this case.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was given an expired ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00589040) and transmitted to Sanofi on 05-May-2021.  This case involves a 15 month old male patient who received 0.5 ml dose of expired suspect HIB (PRP/T) VACCINE [ACT-HIB] vaccine (lot number: UJ178AAB; expiry date: 04-May-2021) via unknown route in the right thigh for prophylactic vaccination on 05-May-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot number and expiry date: not reported) for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) (lot number and expiry date: not reported) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter wanted to know if they should revaccinate the patient.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: An expired Pentacel was given to a 15 month old as a 4th dose, no AE; Initial information was received on 07-May-2021 regarding an unsolicited valid  non-serious case from a consumer/non-health care professional.  This case involves a 15-month-old female patient who was administered 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot: DTAP/ IPV: U6395AA, ActHIB: UJ160AA, expiry date: 24-Apr-2021) via intramuscular route in thigh for prophylactic vaccination on 07-May-2021.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA) for prophylactic vaccination.  It was a case of an actual medication error due to Expired product administered (latency same day).  At the time of report, no adverse event was reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MEN, MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient got Menactra when they were supposed to get meningococcal B, no AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (inquiry reference number 00598144).  This case involves a patient of unknown age and gender patient who got MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6521AB and expiration date not reported) when was supposed to get MENINGOCOCCAL VACCINE B not produced by Sanofi Pasteur (lot number U6521AB and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant mediation(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered (same day latency).  It was reported that registered pharmacist was calling to see if a Lot number provided matches the Menactra vaccine that had been given inappropriately. Checked her stock and the lot number did not match. This was given a few months back and the lots have changed. Caller said she was calling from overseas. She was asking to confirm if a certain lot (given here) was Menactra. Caller also stated that a physician noticed in a patient chart recently that this patient got Menactra when they were supposed to get meningococcal B. Caller also said that they were not sure if maybe the nurse who documented this typed in Menactra instead of meningococcal B by mistake. Caller said the lot number documented was U6521AB. Caller does not have any details on patient. She said this happened months ago. They are not even sure if this was an error. If Sanofi can confirm that the lot is not Menactra then it was probably typed wrong by nurse. No AE (adverse event) template done as caller does not have any details.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: Patient was administered ActHib vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00598281) and transmitted to Sanofi on 12-May-2021.  This case involves a 7 months old female patient who was administered with a expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ178AAB and expiry date: 04-May-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 11-May-2021.   The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter wanted to know what to do.  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV, MNQ
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: Vaccines were kept at elevated temperature excursions, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Medical Information (Reference number- 00599790) and transmitted to Sanofi on 13-May-2021.  This case involves a patient (unknown demographics) who received IPV (VERO) [IPOL] (lot number and expiry date not reported) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] ((lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination which were kept at temperature excursions for unknown periods of time on an unknown date (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The reason for the elevated temperature excursions of unknown duration was that the person who was trained to properly use the data loggers stopped showing up to work so that the people who took over did not know that the data loggers had to be periodically cleared, but in addition to that, something is wrong with the data loggers so that they will not download the historical data for the temperature excursions. Practice manager asked for any extended stability information, and information on whether and when to revaccinate. The practice manager reports their data logger was not cleared so it was showing high temps for unknown periods of time. On April 22 it read 9.2 degree Celsius, through the end of the month and then 11.2 degree Celsius and then on May 7 12.6 degree Celsius.   This was a case of actual medication error case due to incorrect product storage (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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 on the batch number for this case.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: A patient received only liquid DTaP-IPV portion without mixing the powder HIB portion, no AE; Initial information regarding an unsolicited valid non-serious case was received from nurse via Medical Information (Reference number- 00599798) and transmitted to Sanofi on 13-May-2021.  This case involves a three-month-old female patient who received 0.5 mL 2nd dose which was only liquid dtap-ipv portion without mixing the powder hib portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ389AB and expiry date: 09-Oct-2021) via an unknown  route in the left thigh for prophylactic vaccination on 13-May-2021 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination.  The caller would like to know if this will be considered a full vaccine for polio or not.  This was a case of actual medication error case due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (Reference number- 00599921) and transmitted to Sanofi on 13-May-2021.  This case involves a patient (unknown demographics, adult) who received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported and expiry date: 08-May-2021) via an intramuscular route in an unknown administration site for prophylactic vaccination on 10-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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 on the batch number for this case.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00600408) and transmitted to Sanofi on 13-May-2021.  This case involves a male patient (age not reported) who received 0.5 mL dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U658BA and expiry date: 20-Apr-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The medical assistant (MA) was calling to get more information in regards to expired MENACTRA had been administered.   This was a case of actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error
Clinical narrative: administered an expired vaccine to a patient, no AE; Initial information received on 13-May-2021 regarding an unsolicited valid non-serious case from a nurse practitioner via Media Information (inquiry reference number 00600500).  This case involves a patient in his 50s was administered with 0.5 ml expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot c5578aa and expiration date :28-Jan-2021) via unknown route in the deltoid (but not sure which one) for prophylactic vaccination on 13-May-2021 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant or no other vaccines were given to the patient.  It was a case of actual medication error due to expired vaccine used (same day latency).   It was reported that a medical assistant (MA) gave a dose of Tenivac yesterday which had expired. Caller mentioned that she sent an email to Pharmacovigilance about this last night and missed return phone call. The nurse practitioner who was reporting the event is currently at home and does not have the patient initials or dob (date of birth) with her. Reported that the caller did not have this with her today, but stated that it was in her previous web inquiry. The lot information documented here was pulled from that web inquiry-GMI -00600500). And was with the question that what are the effects of an expired vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product storage error
Clinical narrative: a patient received a dose of Pentacel vaccine that had been at a temperature of greater than 77 F for 12 hours/ No AE; Initial information received on 17-May-2021 regarding an unsolicited valid non-serious case received from a Nurse educator via physician via Medical Information (Reference number- 00603828).  This case involves a five months old female patient who received a 0.5 ml third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that had been at a temperature of greater than 77 f for 12 hours lot UJ416AA, expiry date: 22-MAR-2022, frequency: once, strength: standard via intramuscular route in the left thigh (left quadriceps) on 15-May-2021for prophylactic vaccination (product storage error).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) via oral route for prophylactic vaccination respectively.  It was an actual medication error due to incorrect product storage (latency same day).  Potential Product Technique Complain: No.  At the time of report no adverse event was reported.  No causality not 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.
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: throwing up bile; Initial information received on 17-May-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who experienced throwing up bile (vomiting), while receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Medical history included Fibromyalgia and she also has something autoimmune going on in her body, but the doctors are not sure of the exact diagnosis. She has some lupus indicators, but they do not think that she has lupus. She remembers she had a topical reaction when she had shoulder surgery to the cleansing wipe she was given. She has not allergic to eggs.  Medical treatment, vaccination, concomitant medication and family history were not provided.  In November 2013, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UH891AA 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 throwing up bile (vomiting) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  It was also reported that If she give a lot number from a flu vaccine that she received the end of 2013, could you tell what are the ingredients. She had a severe reaction to that flu shot and need to know if any of the ingredients overlap with ingredients in the Covid (coronavirus disease) vaccines. She provides lot UH891AA. Checked with Customer Service and found product name as Fluzone. Referred consumer to the website for the labeling archives. She received a flu vaccine from her employer. The caller stated that the first few days of Dec2013 she ended up at the doctor with a reaction to the vaccine. She was throwing up bile for two days. Her gall bladder was fine. She had to call in sick for work, which is rare for her. She has not received a flu shot again after that reaction. She does not react to DTP (Diphtheria, Tetanus, Pertussis)) or MMR (measles, mumps, and rubella) shots.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, patient recovered from the vomiting.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Rash began to occur around the vaccine site by the morning after given. Then by Saturday Morning it had spread across my upper back and shoulders. On Sunday , it was on my right arm and face.   I used Benadryl and Calamine lotion to stop itching and spread.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Blood test, Eye disorder, Musculoskeletal chest pain
Clinical narrative: 1.  3/21 leading up to 3/31 I had a low grade fever that would not go away.  2.  3/31 at 2am, hit with bout of intense nausea which continued through 4/-3.  The most intense was 3/31-4/1.   3.  4/3-4/4 my right side under rib cage was screaming in pain Treatment -- went to doctor's office on 4/2 to make sure not covid (tested negative), given a perscription for nausea.  Called Dr.'s office and advised to go to Primary Care Physician.  Also, advised hot water bottle on organs that hurt.  The hot water bottle soothed the intense pain.  Had soup when could tolerate it.  4.  Went to doctor's office on 4/5 regarding the intense pain on right side.  An abdominal Ultrasound was ordered.    April 25, 4am, my eye sight went to seeing 1/2 of objects and words, then went to tunnel vision.   1.  I saw Primary Physician who referred me to an opthamalogist. 2.  Opthamalogist saw nothing wrong with eye -- suggested taking baby asprin and that there had been a TIA, referred me back to Primary Physician for a referral to Cardiologist / Vascular physician
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Transient ischaemic attack, Tunnel vision, Ultrasound Doppler
Clinical narrative: 1.  3/21 leading up to 3/31 I had a low grade fever that would not go away.  2.  3/31 at 2am, hit with bout of intense nausea which continued through 4/-3.  The most intense was 3/31-4/1.   3.  4/3-4/4 my right side under rib cage was screaming in pain Treatment -- went to doctor's office on 4/2 to make sure not covid (tested negative), given a perscription for nausea.  Called Dr.'s office and advised to go to Primary Care Physician.  Also, advised hot water bottle on organs that hurt.  The hot water bottle soothed the intense pain.  Had soup when could tolerate it.  4.  Went to doctor's office on 4/5 regarding the intense pain on right side.  An abdominal Ultrasound was ordered.    April 25, 4am, my eye sight went to seeing 1/2 of objects and words, then went to tunnel vision.   1.  I saw Primary Physician who referred me to an opthamalogist. 2.  Opthamalogist saw nothing wrong with eye -- suggested taking baby asprin and that there had been a TIA, referred me back to Primary Physician for a referral to Cardiologist / Vascular physician
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: 1.  3/21 leading up to 3/31 I had a low grade fever that would not go away.  2.  3/31 at 2am, hit with bout of intense nausea which continued through 4/-3.  The most intense was 3/31-4/1.   3.  4/3-4/4 my right side under rib cage was screaming in pain Treatment -- went to doctor's office on 4/2 to make sure not covid (tested negative), given a perscription for nausea.  Called Dr.'s office and advised to go to Primary Care Physician.  Also, advised hot water bottle on organs that hurt.  The hot water bottle soothed the intense pain.  Had soup when could tolerate it.  4.  Went to doctor's office on 4/5 regarding the intense pain on right side.  An abdominal Ultrasound was ordered.    April 25, 4am, my eye sight went to seeing 1/2 of objects and words, then went to tunnel vision.   1.  I saw Primary Physician who referred me to an opthamalogist. 2.  Opthamalogist saw nothing wrong with eye -- suggested taking baby asprin and that there had been a TIA, referred me back to Primary Physician for a referral to Cardiologist / Vascular physician
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Erythema, Headache, Lip blister
Clinical narrative: 21yo Active Duty female Navy Sailor currently deployed to UAE reports to Fujairah Detachment medical clinic with c/o bottom lip swelling x 96hrs, which began about 24 hours post receiving the J&J vaccine on 16May21 in Jebel Ali, UAE. Pt denies any pain, tingling, or numbness but does report a throbbing sensation in the lip. Pt denies any dyspnea, SOB, dysphagia, or difficulty eating/drinking. Pt states there is also a blister like red spot on the middle of the lip. Pt denies any fever, body aches, fatigue, n/v, or other skin lesions. Pt denies any history of cold sores/herpes labialis. Pt denies having anything like this from a vaccine in the past. No history of medication, food, or environmental allergies. Pt also reported HA, stomach ache, and feeling weak for 24 hours after vaccination then resolved, but lip then swelling began and persisted prompting medical evaluation. Provider prescribed 25mg Benadryl which significantly decreased the lip swelling over the following 6-8 hours.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling
Clinical narrative: 21yo Active Duty female Navy Sailor currently deployed to UAE reports to Fujairah Detachment medical clinic with c/o bottom lip swelling x 96hrs, which began about 24 hours post receiving the J&J vaccine on 16May21 in Jebel Ali, UAE. Pt denies any pain, tingling, or numbness but does report a throbbing sensation in the lip. Pt denies any dyspnea, SOB, dysphagia, or difficulty eating/drinking. Pt states there is also a blister like red spot on the middle of the lip. Pt denies any fever, body aches, fatigue, n/v, or other skin lesions. Pt denies any history of cold sores/herpes labialis. Pt denies having anything like this from a vaccine in the past. No history of medication, food, or environmental allergies. Pt also reported HA, stomach ache, and feeling weak for 24 hours after vaccination then resolved, but lip then swelling began and persisted prompting medical evaluation. Provider prescribed 25mg Benadryl which significantly decreased the lip swelling over the following 6-8 hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction presenting possibly due to injection higher in the arm than it should be. Bright red and hot to touch. Improved by anti inflammatory oral Medications, unresolved by them entirely. Worsening at day 3 post injection.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Haematochezia; This case was received via FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HAEMATOCHEZIA (Haematochezia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced HAEMATOCHEZIA (Haematochezia) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Haematochezia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant product use was not provided by the reporter.  Patient reported to the nurse at his second COVID vaccine appointment that he had bloody stools for 2 days, and then the bloody stools stopped.  Company Comment: 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.; Sender'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.