chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Hypersomnia, Pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 11:15 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "uncontrollable chills"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "woke up with a headache"; HYPERSOMNIA (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "slept the whole day with body aches"; DECREASED APPETITE (non-serious) with onset Mar2021, outcome "unknown", described as "no appetite". Therapeutic measures were taken as a result of headache.Additional information: It was reported that, she woke up at 4 AM with uncontrollable chills and was up for awhile. She fell back asleep but woke up with a headache. Therapeutic measures were taken for headache with Tylenol but she slept the whole day with body aches and no appetite. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anger, Back disorder, Emotional disorder
Clinical narrative: her mom was agitated; had a lidocaine injection for a bad back; her mom was angry; her mom was unsettled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 (Lot number: EN6201) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Patient history: Alzheimer's", start date: Nov2019 (unspecified if ongoing), notes: Verbatim: Alzheimer's; "Patient history: Pacemaker", start date: 2015 (ongoing), notes: Verbatim: Pacemaker; "Glucose tolerance impaired", start date: 2018 (ongoing), notes: Verbatim: Borderline diabetes. The patient's concomitant medications were not reported. The following information was reported: AGITATION (non-serious), outcome "unknown", described as "her mom was agitated"; BACK DISORDER (non-serious), outcome "unknown", described as "had a lidocaine injection for a bad back"; ANGER (non-serious), outcome "unknown", described as "her mom was angry"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "her mom was unsettled". Therapeutic measures were taken as a result of back disorder. Additional information: The patient received COVID19 Vaccine in noon and about 3:30AM or 4:00AM she was flying. Reporter was concerned about second dose of COVID19 Vaccine and hasn't set up the second appointment yet for COVID19 Vaccine. Reporter clarified "she was flying" as her mom was agitated, angry, and unsettled. She was buzzed. The patient received Lidocaine for bad back (Back disorder). No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Constipation, Fatigue, Hypersomnia
Clinical narrative: Nauseated; Constipation; Chills; Tired; Weak; Sleeping like 12 to 14 hours a day; Not really feeling very good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; CONSTIPATION (non-serious), outcome "unknown", described as "Constipation"; CHILLS (non-serious), outcome "unknown", described as "Chills"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; ASTHENIA (non-serious), outcome "unknown", described as "Weak"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Sleeping like 12 to 14 hours a day"; MALAISE (non-serious), outcome "unknown", described as "Not really feeling very good".  Additional information:patient stated,  I don't have a fever, I don't have swollen gland or anything because I have a 'sheer' with all that.I had been taking DayQuil and NyQuil and that seemed to help.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Nauseated; Constipation; Chills; Tired; Weak; Sleeping like 12 to 14 hours a day; Not really feeling very good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; CONSTIPATION (non-serious), outcome "unknown", described as "Constipation"; CHILLS (non-serious), outcome "unknown", described as "Chills"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; ASTHENIA (non-serious), outcome "unknown", described as "Weak"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Sleeping like 12 to 14 hours a day"; MALAISE (non-serious), outcome "unknown", described as "Not really feeling very good".  Additional information:patient stated,  I don't have a fever, I don't have swollen gland or anything because I have a 'sheer' with all that.I had been taking DayQuil and NyQuil and that seemed to help.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: nausea; tired and fatigue; headache; felt strange; arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Lot number: EN0198, Expiration Date: 26Feb2021) at the age of 69 years as dose1, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "heart procedure", start date: 19Feb2021 (unspecified if ongoing), notes: ablation for atrial flutter, for fast heartbeat. There were no concomitant medications.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Feb2021, outcome "recovered" (01Mar2021), described as "arm was sore"; HEADACHE (non-serious) with onset 02Mar2021, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "nausea"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "tired and fatigue"; FEELING ABNORMAL (non-serious) with onset 27Feb2021, outcome "unknown", described as "felt strange". Therapeutic measures were taken as a result of headache, nausea.  Additional Information: Anatomical Location of Administration of Pfizer vaccine considered as suspect: left shoulder. Other Conditions: diagnosed 20 years ago and he doesn't take any medicine for it. On Saturday 27Feb2021 and Sunday 28Feb2021 he felt a little different, when asked to clarify "felt different" caller stated he didn't feel like himself, he doesn't know how to break that down, he didn't feel sick but he knew that he felt strange. Caller reported that he didn't feel horrible. Obviously his arm was sore a couple hours after injection, it was sore from injection. When he lift his arm it was sore for a couple days and that has gone away. Then last night he had headache and he woke up with this morning. He took Tylenol (Tylenol Extra Strength capsules, 1 by mouth, he took one on Saturday 27Feb2021, and took one today 03Mar2021) and headache improved. He also woke up with nausea. He had some ginger tea so he doesn't feel nauseous right now. He reported a little fatigue and a little tired. His energy level was not where it usually was. Yesterday, 02Mar2021, he felt great. He washed the car, he ran errands, he did all sorts of things. Then today it was a different experience. He was wondering 5 days after the injection if this should be happening. Caller was not sure if the injection reached the muscle of his shoulder. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) none. Prior Vaccinations (within 4 weeks) no. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast disorder, Headache, Vaccination site pain
Clinical narrative: Her left breast felt much larger than her right breast; Soreness at the injection site; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "Soreness at the injection site"; HEADACHE (non-serious) with onset 28Feb2021, outcome "unknown", described as "headache"; BREAST DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Her left breast felt much larger than her right breast". Therapeutic measures were taken as a result of headache. Additional information: Reporter states that patient had soreness at the injection site and a headache the next morning. Tylenol took care of the headache. The patient said that her left breast has always been a bit larger than her right breast but the difference on 01Mar or 02Mar day was "insane" as she describes it. Her left breast felt much larger than her right breast. She was vaccinated in her left arm. No pain. She said it could also be because she is getting her period. Advised her to call her doctor. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: spent the whole time in bed since the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "spent the whole time in bed since the vaccine".  Additional information: It was reported that the patient is very petite less than 100 lbs. Reporter wanted to know why would someone her size vs someone larger get the same dosage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Lot of pain, quite at extreme; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Lot of pain, quite at extreme". The event "lot of pain, quite at extreme" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain.  Additional information: Reporter stated, she did call to report about her husband. Her husband had an adverse reaction to his COVID Shot and it was quite at extreme, he was in a lot of pain, and they ended up going to the Doctor and getting pain meds and all of that. She guesses she should need to report the fact that he had such an adverse reaction and asking some advice about him getting the next? He was supposed to get it a week from tomorrow. No further information could be probed as the reporter hung up the call abruptly. Hence limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing), notes: has arthritis in her little finger. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "since the covax series the pain is gone". Additional information: Swap from FC-first time caller finished the Pfizer  series as of 21Feb. She states she has arthritis in her little finger and since the series the pain is gone. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat irritation
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2021 (Lot number: EL3249) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eustachian tube disorder" (unspecified if ongoing), notes: other medical history: Eustachian tube disorder.; "ADHD" (unspecified if ongoing), notes: other medical history: ADHD. "benign tumor removed from salivary gland" (unspecified if ongoing), notes: other medical history: tumor removed from salivary gland; "burning throat disorder." (unspecified if ongoing), notes: other medical history: burning throat disorder. "Burning Throat Disorder", start date: Mar2020 (unspecified if ongoing), notes: Last year I started suffering from a rare Burning Throat Disorder in March, 2020 after a long bout of strep throat. At the time I took 20 mg of Nortriptyline for the pain. Concomitant medications included: NORTRIPTYLINE; DEXILANT. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 15Jan2021 19:00, outcome "recovering", described as "my throat became extremely sore"; THROAT IRRITATION (non-serious) with onset 15Jan2021 19:00, outcome "recovering", described as "burning in my throat". The events "my throat became extremely sore" and "burning in my throat" were evaluated at the physician office visit. Therapeutic measures were taken as a result of oropharyngeal pain, throat irritation. Additional information: Patient had Known allergies: No. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reporter stated that Last year I started suffering from a rare Burning Throat Disorder in March 2020 after a long bout of strep throat. At the time I took 20 mg of Nortriptyline for the pain. After I got the vaccine, my throat became extremely sore like I had strep again and the Nortriptyline stopped working completely. I had to add additional nerve pain medications and take Tylenol for the pain. After three days the sore throat went away but the burning in my throat remained and at an even higher burning level. Eventually the Nortriptyline started working again but my pain is still worse than before the vaccine. I still got the second shot and thankfully did not notice an increase in pain again but did have a sore throat for a day once more. My neurologist wanted me to report this to you as we try to find answers for my Burning Throat Disorder altogether. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Abdominal pain upper, Headache
Clinical narrative: headache; stomach ache; Initial information received on 03-Dec-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via social via Digital Media.  This case involves adult patient who had headache and stomachache (abdominal pain upper) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On 04-Dec-2021, the patient developed a non-serious headache, stomach ache (abdominal pain upper)  (unknown latency) following the administration of INFLUENZA VACCINE.  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 events.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: worst flu: Initial information was received on 04-Dec-2021 regarding an unsolicited valid Regulatory Authority non-serious case from a consumer/non-healthcare professional.  This case involves an unknown age and gender patient who experienced worst flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious worst flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  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.  The outcome was unknown for the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: very sick; Initial information received on 05-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown demographic patient who experienced very sick (illness) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Haven't had a flu vaccine in 35 years! I've known so many people that got the flu shot and got very sick. Oh, and how is it the countries that have mandatory C****d vaccines have the highest death rates?"  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: used to get the flu shot, but kept getting the flu; Initial information was received on 06-Dec-2021 regarding an unsolicited valid, social media, non-serious case received from a consumer.  This case involves a patient (unknown age and gender) who used to get the flu shot but kept getting the flu (Influenza) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient used to get the flu shot but kept getting the flu (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: This case involves a patient (unknown age and gender) who received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (extra dose administered) instead of PNEUMOCOCCAL VACCINE (wrong product administered). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient received two doses of suspect INFLUENZA QUADRIVAL A-B VACCINE, and the extra one was given instead of PNEUMOCOCCAL VACCINE, (lot number and expiry date not reported) each via unknown route in an unknown administration site for prophylactic vaccination respectively on an unknown date. It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (same day latency). It was reported "Nurse says that patient was given two doses of the Flu vaccine. Patient was doses recently with FLUZONE Quad. The nurse is requesting that information be electronic mailed to her to help her reassure the patient that she does not need to worry or if there are any concerns. She would like to know if something is needed to be done for the patient since this happened. Patient was doses recently with FLUZONE Quad" The nurse states that the patient received another Fluzone Quadrivalent vaccine instead of a pneumonia vaccine and they had already received a flu vaccine for this year. She states that it must have happened at another location because there is no documentation at their clinic. She was asked for additional adverse event (AE) information and she states that the hospital will be back in touch with her if additional information is needed. This is all the information she provided at the time of her call." At 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. 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: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: the diluent was given without the actual drug mixed into it/ no AE; Initial information received on 03-Dec-2021 regarding an unsolicited valid non-serious case received from physician via call center via Medical Information (MI) (Reference number- 00883763).  This case involves a 3-year-old male patient who received the diluent portion without mixing of actual drug (powder) portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Product preparation issue).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 02-Dec-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (diluent: lot number: UJ465AA and expiry date: 21-May-2021) (Powder: lot number: U6940BA and expiry date: 21-May-2021) via an intramuscular route in the right arm for prophylactic vaccination.  It was an actual medication error case due to Inappropriate reconstitution technique (latency: same day).  It was reported "he diluent was given without the actual drug mixed into it, Is there any harm in that? Should they proceed with giving another dose immediately?; Nurse asking if the diluent was just given , Will I need to give the vaccine again and is there any harm for just giving the diluent?"  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 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: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Pentacel was administered, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00884020) and transmitted to Sanofi on 03-Dec-2021.  This case involves an unknown age female patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 03-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ390AA and expiry date: 12-Oct-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported "Caller wants to know if there will be any side effects, if they need to repeat the dose and if so, how long do they need to wait before re-administering. Caller stated she was told that the product is still viable for 6 months after the expiration date and wants us to confirm if that is true or not. She asks if there is a grace period past expiration? What are safety concerns? Can it be repeated immediately? This is inactivated vaccine, right? What is (vaccine adverse event reporting system) VAERS reporting"?  This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Animal bite, Asthenia, Headache
Clinical narrative: exposed to bat; headache; weak; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-health care professional via Agency (Reference number- 00884090) and transmitted to Sanofi on 03-Dec-2021.  This case involves a 27-years-old male patient who experienced exposed to bat (animal bite), headache and weak (asthenia), after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history included Animal bite in 2018.  Patient's past vaccination(s) included first 2 doses of IMOVAX pre-exposure regimen 20-APR-2018 (lot M5651M, expiry date: 01-Oct-2018) and 27-APR-2018 (lot N1B902M, expiry date: 01-Mar-2019) however this pre-exposure series was interrupted by a rabies exposure. Patient's states he then began the IMOVAX post-exposure regimen; patient received post-exposure IMOVAX on 12-MAY-2018 (lot N1B902M, expiry date: 01-Mar-2019), 15-May-2018 (lot N1B902M, expiry date 01-Mar-2019) and 19-May-2018 (lot N1B902M, expiry date: 01-Mar-2019). Patient received a different brand of rabies vaccine (states it was manufactured by GSK) on 26-May-2018 (lot 643011E, expiry date 01-May-2020). Patient states in total, he received 6 doses of rabies vaccine during this. On 22-Nov-2018 (lot N1G401M, expiry date 01-Jul-2019). Patient states he then had another exposure to rabies and received post-exposure IMOVAX on 25-NOV-2018.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (HRIG) for Immunisation.  The patient's past medical treatment(s) and family history were not provided.  On 02-Dec-2021, the patient received a 1 mL dose of suspect RABIES (HDC) VACCINE (lot M5651M, expiry date unknown) via an unknown route in the right arm for prophylactic vaccination  On an unknown date, the patient developed a non-serious exposed to bat (animal bite), headache and weak (asthenia) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Details of laboratory data not reported.  On an unknown date, the patient received TYLENOL [PARACETAMOL] as corrective treatment for event (headache).  It was not reported if the patient received any corrective treatment for the events animal bite, asthenia.  At time of reporting, the outcome was unknown for the events.
Sex: F
Vaccine: FLU4
Symptoms: Adverse event following immunisation
Clinical narrative: she has been having horrific side affects; Initial information regarding an unsolicited valid non serious case was received from other health professional via Agency (Reference number- 00884479) and transmitted to Sanofi on 03-Dec-2021.  This case involves a 56-year-old female patient who had been having horrific side effects (adverse event) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In march 2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ273AB, expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious she has been having horrific side effects (adverse event) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Nurse reports that a 56 year-old patient; AG has called multiple times, leaving messages complaining of "horrific side effects" from receiving the FLUZONE vaccine in march of 2021. Patient has not specified what those side effects."  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: They were at 32.0F for less than 72 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00885507) and transmitted to Sanofi on 06-Dec-2021.  This case involves a 19-year-old female patient who administered the one dose of the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and TUBERCULIN TEST [TUBERSOL] 32.0f for less than 72 hours after excursion (product storage error).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection (with and unknown batch number and expiry date) for tuberculin test and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U7187AA and expiry date: 28-Sep-2023) via unknown route in unknown administration site for prophylactic vaccination (product storage error).  It was reported "The caller is requesting stability info for a temp excurision caused by unknown reason".  This case was potential medication error due to product storage error temperature too low (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Stevens-Johnson syndrome; skin on her hands began to peel; injection site reaction consistent with swelling; injection site reaction consistent with redness; injection site reaction consistent with tenderness; injection site reaction consistent with warmth; injection site reaction consistent with itchiness; Initial information received on 06-Dec-2021 regarding an unsolicited valid serious case received from consumer/non-healthcare professional via call center via Medical Information (Reference number- 00885626).  This case involves an 8-year-old female patient who experienced stevens-johnson syndrome, injection site reaction consistent with swelling, redness, tenderness, warmth and itchiness (vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus) and skin on her hands began to peel (skin exfoliation) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's medical treatments, concomitant medication and family history were not provided.  Patient had received flu vaccines before and had never experienced reactions like this with previous flu vaccines.  Patient did have other food allergies, but states she was not allergic to eggs.  On 02-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 02-Dec-2021 the patient developed a serious stevens-johnson syndrome and skin on her hands began to peel (skin exfoliation) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On 02-Dec-2021 the patient developed a non-serious injection site reaction consistent with swelling, redness, tenderness, warmth and itchiness (vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  This injection site reaction measured 1.5 inch across.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The outcome was unknown for the events.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns a 8-year-old female patient who experienced stevens-johnson syndrome, skin exfoliation, vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus same day after vaccination with FLUZONE QIV. The time to onset is compatible. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Skin exfoliation, Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson syndrome; skin on her hands began to peel; injection site reaction consistent with swelling; injection site reaction consistent with redness; injection site reaction consistent with tenderness; injection site reaction consistent with warmth; injection site reaction consistent with itchiness; Initial information received on 06-Dec-2021 regarding an unsolicited valid serious case received from consumer/non-healthcare professional via call center via Medical Information (Reference number- 00885626).  This case involves an 8-year-old female patient who experienced stevens-johnson syndrome, injection site reaction consistent with swelling, redness, tenderness, warmth and itchiness (vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus) and skin on her hands began to peel (skin exfoliation) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's medical treatments, concomitant medication and family history were not provided.  Patient had received flu vaccines before and had never experienced reactions like this with previous flu vaccines.  Patient did have other food allergies, but states she was not allergic to eggs.  On 02-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 02-Dec-2021 the patient developed a serious stevens-johnson syndrome and skin on her hands began to peel (skin exfoliation) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On 02-Dec-2021 the patient developed a non-serious injection site reaction consistent with swelling, redness, tenderness, warmth and itchiness (vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  This injection site reaction measured 1.5 inch across.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The outcome was unknown for the events.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns a 8-year-old female patient who experienced stevens-johnson syndrome, skin exfoliation, vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus same day after vaccination with FLUZONE QIV. The time to onset is compatible. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 54.0
Sex: U
Vaccine: DT, DTAP
Symptoms: Wrong product administered
Clinical narrative: A patient accidentally received a DT vaccine instead of the age appropriate Tdap vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00888053) and transmitted to Sanofi on 07-Dec-2021.  This case involves a 54 year old and unknown gender patient who was accidentally received a DIPHTHERIA AND TETANUS TOXOIDS (dt) vaccine instead of the age appropriate DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (tdap) (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 06-Dec-2021, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong product administered (latency same day).  It was reported "Caller states that a 54 year old patient accidentally received a DT vaccination in the office on 06DEC2021 instead of the age appropriate Tdap vaccine. Caller states that she must attend to a patient and asked for the phone number for Medical Information so that she could call back to provide more information related to this occurrence."  No other adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthritis, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Hand and arm started swelling and hurts like hell/really really hurting and fingers were swollen; Arthritis; Hand and arm started swelling and hurts like hell/really really hurting and fingers were swollen; Chickenpox settled in arm; Headache; This spontaneous case was received on 11-Nov-2021 from other non-healthcare professional (consumer) via Regulatory Authority (reference number: SEQW21-05295) and concerned a 73-year-old, female patient.  The patient's medical history and concomitant were not reported. The patient never had a reaction to a flu shot before.  On 01-Nov-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On 07-Nov-2021, six days after receiving Fluad Quadrivalent, the patient's hand and arm started swelling and hurts like hell, and she had a headache. She used Biofreeze (ilex aquifolium) and her daughter gave Cannabidiol (CBD) cream and it seemed to help. The pain was annoying, first day as reported. The patient thought possibly the vaccine or chicken pox settled in her arm, it could be arthritis or change in pressure related to weather. Pharmacist told her to go to the doctor, but she do not like to go, they did not know anything. She was taking arthritis strength Tylenol (paracetamol).  On 08-Nov-2021, the next day as reported, the pain was horrific.  On an unspecified day in Nov-2021, the patient's fingers were swollen.   At the time on initial reporting, the patient had not recovered from the events as she was still really really hurting and her fingers were swollen.  The reporter did not provide a causality assessment. The patient thought possibly the vaccine or chicken pox settled in her arm, it could be arthritis or change in pressure related to weather.   The case was assessed as non-serious.  Company comment: A 73-year-old patient developed swelling and pain in arm, arthritis, Varicella, and headache six days after receiving the suspect product Fluad Quadrivalent. Causality for the event Varicella is assessed as not related based on biological implausibility. Due to plausible chronology, causality for the rest of the events is assessed as possibly related.; Sender's Comments: A 73-year-old patient developed swelling and pain in arm, arthritis, Varicella, and headache six days after receiving the suspect product Fluad Quadrivalent. Causality for the event Varicella is assessed as not related based on biological implausibility. Due to plausible chronology, causality for the rest of the events is assessed as possibly related.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives popped-up and went away all over her body. Itched badly. Antihistamines have helped.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia
Clinical narrative: At about 5:30pm on the following day of the vaccine injection, a headache began and Tylenol was administered. Headache went away by 7:00pm; at about 8pm- 9pm a stomach ache began and ended.  At 10:45pm, chills and a fever occurred. Tylenol was administered, and at 1:45 am on 12/15/201, Motrin was administered.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual cycle started next morning, although it was not due for 1 week.  Very heavy bleeding & cramping
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 9 year old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On 04-OCT-2021, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck)(VARIVAX) (second dose, lot # T014309, expiration date 24-APR-2022, dose, strength and route were not provided) in the right deltoid for prophylaxis (product storage error). No additional adverse event reported. Operator of vaccine was healthcare professional, who was trained. This is one of two report from same reporter.; Sender's Comments: US-009507513-2110USA002299.