chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Erythema, Feeling abnormal, Feeling hot, Pruritus
Clinical narrative: felt weird; A large(3x4 inches), warm, red, itchy area developed lower on my arm(more inside just above the elbow)/the area is still slightly itchy, and just a little visible; A large(3x4 inches), warm, red, itchy area developed lower on my arm(more inside just above the elbow)/the area is still slightly itchy, and just a little visible; warm, red, itchy area; tightening in the chest which moved up to the neck started happening; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Ewd62), via an unspecified route of administration, administered in Arm Left on 17Apr2021 17:00 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 64 years). The patient medical history included reflux, Blood Pressure and Allergies all from an unknown date and unknown if ongoing. Concomitant medications (Other medications in two weeks) included Lisinopril 10mg, Esomeprazole 40mg, (CLARITIN (loratadine) and Vita all taken for an unspecified indication, start and stop date were not reported. It was reported that, the patient was not a pregnant at the time of vaccination. She did not receive any other vaccine in four weeks prior COVID vaccination. She was not diagnosed with COVID prior vaccination and was not tested with COVID post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Er8730), via an unspecified route of administration, administered in Arm Left on 27Mar2021 16:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 64 years) and experienced normal side effects like sleepy, 2 waves of nausea, chills, feeling out of it, arm ache and soreness for 2 days. On 17Apr2021, 35-40 minutes after receiving the shot while driving home, the patient experienced a tightening in the chest which moved up to the neck started happening. On 18Apr2021, the next day, the patient experienced she felt weird, and had a less severe feeling of the tightening in the chest and neck area, but still there, a large (3x4 inches), warm, red, itchy area developed lower on her arm (more inside just above the elbow) and expanded in size the next day. It expanded a little more and is slowly going away. On 23Apr2021, 6 days later, the patient experienced the area is still slightly itchy, and just a little visible. She called the family physician on 26Apr2021 morning to let them know about the reaction and they had her send a photo. Her physician wants her to see an allergist about the possibility of having to skip a booster shot because of the reaction. The patient has visited physician office as a result of events. Therapeutic measures were taken as a result of events include Benadryl. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chromaturia, Eating disorder, Gait disturbance, Headache
Clinical narrative: Very dark, smelly urine; Very dark, smelly urine; Woke up with savage migraine; Severe neck pain; Severe kidney pain; Could barely walk; Blood pressure was high; Headache so bad; Nausea; Barely eat food; Sleep through all day and next night; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021, at 15:30 (at the age of 49-years-old) as dose 2, single for COVID-19 immunization. Medical history included lyme disease, babesiosis and bilateral kidney angiomyolipoma. The patient had known allergy to most antibiotic (unspecified), allergy to scallops and allergy to some prescription pain killers. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included herbal remedies (MANUFACTURER UNKNOWN) for Lyme disease from an unknown start date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021, at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. On 28Apr2021, at 04:00 morning, the patient woke up savage migraine, severe neck pain and kidney pain due to which she could barely walk; on same day, the patient's blood pressure was high, headache was so bad, which brought nausea to the patient. It was reported that, the patient drank lots of water but there was no relief, could barely eat food and sleep through all day and next night. On 29Apr2021 next day, the patient experienced very dark and smelly urine (which was never happened before) but she felt better, as if she would never been sick the day before. Weird. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of headache and included treatment with paracetamol (TYLENOL) from an unknown start date to an unknown stop date and the TYLENOL did not help while took twice. No therapeutic measures were taken as a result of other events. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, the patient underwent blood pressure test and the result was blood pressure was high. The clinical outcome of the events was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Migraine, Nausea, Neck pain, Renal pain
Clinical narrative: Very dark, smelly urine; Very dark, smelly urine; Woke up with savage migraine; Severe neck pain; Severe kidney pain; Could barely walk; Blood pressure was high; Headache so bad; Nausea; Barely eat food; Sleep through all day and next night; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021, at 15:30 (at the age of 49-years-old) as dose 2, single for COVID-19 immunization. Medical history included lyme disease, babesiosis and bilateral kidney angiomyolipoma. The patient had known allergy to most antibiotic (unspecified), allergy to scallops and allergy to some prescription pain killers. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included herbal remedies (MANUFACTURER UNKNOWN) for Lyme disease from an unknown start date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021, at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. On 28Apr2021, at 04:00 morning, the patient woke up savage migraine, severe neck pain and kidney pain due to which she could barely walk; on same day, the patient's blood pressure was high, headache was so bad, which brought nausea to the patient. It was reported that, the patient drank lots of water but there was no relief, could barely eat food and sleep through all day and next night. On 29Apr2021 next day, the patient experienced very dark and smelly urine (which was never happened before) but she felt better, as if she would never been sick the day before. Weird. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of headache and included treatment with paracetamol (TYLENOL) from an unknown start date to an unknown stop date and the TYLENOL did not help while took twice. No therapeutic measures were taken as a result of other events. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, the patient underwent blood pressure test and the result was blood pressure was high. The clinical outcome of the events was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Urine odour abnormal
Clinical narrative: Very dark, smelly urine; Very dark, smelly urine; Woke up with savage migraine; Severe neck pain; Severe kidney pain; Could barely walk; Blood pressure was high; Headache so bad; Nausea; Barely eat food; Sleep through all day and next night; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021, at 15:30 (at the age of 49-years-old) as dose 2, single for COVID-19 immunization. Medical history included lyme disease, babesiosis and bilateral kidney angiomyolipoma. The patient had known allergy to most antibiotic (unspecified), allergy to scallops and allergy to some prescription pain killers. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included herbal remedies (MANUFACTURER UNKNOWN) for Lyme disease from an unknown start date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021, at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. On 28Apr2021, at 04:00 morning, the patient woke up savage migraine, severe neck pain and kidney pain due to which she could barely walk; on same day, the patient's blood pressure was high, headache was so bad, which brought nausea to the patient. It was reported that, the patient drank lots of water but there was no relief, could barely eat food and sleep through all day and next night. On 29Apr2021 next day, the patient experienced very dark and smelly urine (which was never happened before) but she felt better, as if she would never been sick the day before. Weird. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of headache and included treatment with paracetamol (TYLENOL) from an unknown start date to an unknown stop date and the TYLENOL did not help while took twice. No therapeutic measures were taken as a result of other events. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, the patient underwent blood pressure test and the result was blood pressure was high. The clinical outcome of the events was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Diarrhoea, Migraine, Nausea
Clinical narrative: Severe migraine; Body aches; Cough that got worse; Slight fever; Nauseated; diarrhea; Just wanted to sleep; Made her asthma worse; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported herself. A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ep7533; expiration date was not reported), via an unspecified route of administration, in left arm 02Apr2021 at 09:00 (at the age of 32-years-old) as dose 1, single for covid-19 immunization. Medical history included asthma. The patient previously took Morphine and experienced Known allergies: Morphine. The patient previously received gardasil vaccine from an unknown date and unknown if ongoing and experienced Known allergies: gardasil vaccine. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications within two weeks of vaccination. On 02Apr2021 at 09:00, patient experienced severe migraine and body aches both times; cough that got worse; slight fever; nauseated; had diarrhea; just wanted to sleep and made her asthma worse. Facility type vaccine administered was reported as public health clinic/veterans administration facility. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient was scheduled for second vaccine on 23Apr2021. Therapeutic measures were reported as no, except for event asthma, patient using her rescue inhaler more frequently. The outcome of event cough that got worse was reported as not recovered, while all remaining events was reported as recovering. No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Severe migraine; Body aches; Cough that got worse; Slight fever; Nauseated; diarrhea; Just wanted to sleep; Made her asthma worse; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported herself. A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ep7533; expiration date was not reported), via an unspecified route of administration, in left arm 02Apr2021 at 09:00 (at the age of 32-years-old) as dose 1, single for covid-19 immunization. Medical history included asthma. The patient previously took Morphine and experienced Known allergies: Morphine. The patient previously received gardasil vaccine from an unknown date and unknown if ongoing and experienced Known allergies: gardasil vaccine. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications within two weeks of vaccination. On 02Apr2021 at 09:00, patient experienced severe migraine and body aches both times; cough that got worse; slight fever; nauseated; had diarrhea; just wanted to sleep and made her asthma worse. Facility type vaccine administered was reported as public health clinic/veterans administration facility. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient was scheduled for second vaccine on 23Apr2021. Therapeutic measures were reported as no, except for event asthma, patient using her rescue inhaler more frequently. The outcome of event cough that got worse was reported as not recovered, while all remaining events was reported as recovering. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: HPV4, MENB
Symptoms: Adverse reaction, Pyrexia
Clinical narrative: the patient had a 103 degree fever.; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation; hpv vaccine vlp rl1 4v (yeast) (GARDASIL; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The doctor reported that there was an increased adverse reactions when coadministering Trumenba with Guardasil. In one case, the patient had a 103 degree fever on an unspecified date. Event took place after the use of product. The patient underwent lab tests and procedures which included fever: 103 Fahrenheit on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: her arm swelled up and it hurt, on the arm she got the injection; her arm swelled up and it hurt, on the arm she got the injection; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient herself) reported that a 56-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (also reported as a pneumonia vaccine, the patient did not know the brand name), via an unspecified route of administration, administered in arm on an unspecified date in 2010 (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2010, the patient reported that her arm swelled up and it hurt, on the arm she got the injection. The patient stated she had to go back to the doctor to get a shot, reclarified, for the arm swelling and did not know the name of the medication. The patient also took diphenhydramine hydrochloride (BENADRYL). The patient stated both medications were effective. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  The lot number for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up.
Sex: U
Vaccine: FLUX
Symptoms: Infection
Clinical narrative: Bad infection: Initial information was received on 07-Nov-2021 regarding an unsolicited valid non-serious case received from social media from (under reference number - US-SA-SAC20211111000510) Regulatory Authority.  This case involves adult patient (unknown gender) who was experienced bad infection (infection), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad infection (infection) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got one last year antibiotics for seven days bad infection."  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm would hurt for a day or 2; Initial information was received on 05-Nov-2021 regarding an unsolicited valid social media non-serious case received from Regulatory Authority.  This case involves a patient (unknown age and unknown gender) who experienced arm would hurt for a day or 2 (pain in extremity) 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 experienced arm would hurt for a day or 2 (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got the senior shot in early Oct and had a 4 day reaction to it. Usually with the regular shot my arm would hurt for a day or 2".  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.    At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm: Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Regulatory Authority.  This case involves an elderly patient (exact age and gender not reported) who had slightly sore arm (pain in extremity) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Details for the concomitant medications was not reported.  On an unknown date in 2021, 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 an unknown date in 2021, the patient developed a non-serious slightly sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got my 65 and over flu shot this week....almost no side effects except a slightly sore arm."  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.  At time of reporting, the outcome was unknown for the event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu: Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious case from a social media via a consumer/non-health care professional Regulatory Authority.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got a flu shot once and it gave me the flu"  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.  At time of reporting, outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 07-Nov-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date in 1994, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 1994, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got my first and last flu shot in 1994. Had the flu 7 times that year. Haven't had the shot or the flu since. That's a hard no on any so called vacinations/ shots, immunizations"  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.  At time of reporting, outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: in their shipment of 2021-2022 product they received vials of 2020-2021, with no reported adverse event; 20-staff members and 7-Residents received expired doses, with no reported adverse event; Initial information received on 04-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional and non-health care Regulatory Authority (RA) number: 00842648.  This case is linked to cases US-SA-2021SA370183(CLUSTER), US-SA-2021SA369806, US-SA-2021SA371632, US-SA-2021SA369738, US-SA-2021SA370183, US-SA-2021SA369789, US-SA-2021SA369738, 2021SA371630, 2021SA369738, 2021SA370209 and 2021SA369789 (CLUSTER).  This case involves a 89 years old female patient who experienced in their shipment of 2021-2022 product they received vials of 2020-2021, with no reported adverse event administered an expired dose of  INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 03-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number:  UJ507AC and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  At time of reporting, the outcome of the event was reported as unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module Regulatory Authority. 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: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received double dosage of vaccine one week apart with no A/E; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via a consumer via phone call (under Global Medical Information (GMI) Inquiry Number: 00845641).  This case involves a 6 months old female patient who received double dosage of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] one week apart with no adverse event (extra dose administered).  The patient's medical history, past medical treatments, vaccinations, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL). PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for prophylactic vaccination.  On 13-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 20-Oct-2021 she also received a second dose of the same vaccine (lot UT7376LA and expiry date: 30-JUN-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported "Health care professional (HCP) asks if the child still needs to be given another dose of FLUZONE QUADRIVALENT in 4 weeks?"  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 by the regulatory authority. 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: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a dose of Fluzone High-Dose Quadrivalent was administered to a patient, who had already received a high-dose flu shot this season at a pharmacy/ no AE; Initial information was received on 09-Nov-2021 regarding an unsolicited valid non-serious case from a physician via Global Media Information (under reference- 00850127) and transmitted to Sanofi on 09-Nov-2021.   This case involves a 69-year-old female patient who administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and she had already received a high-dose flu shot this season at a pharmacy, with no adverse event (Inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 08-Nov-2021, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ715AB and expiry date 30-Jun-2022] via intramuscular route in unknown administration site for prophylactic vaccination.  It was reported " Caller reporting patient is unsure of the exact date she received the flu shot, but it was in September 2021".  It was a case of actual medication error due to Inappropriate schedule of vaccine administered (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in jaw
Clinical narrative: Both temples were piercing, headache, entire jaw; Both temples were piercing, headache, entire jaw; Blood pressure 260/180, 230/150; Little achy; This spontaneous case was received on 03-Nov-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-05032) and concerned a 71-year old female patient. The patient medical history included borderline hyperlipidemia, arthritis, systemic mastocytosis and diabetes. The patient concomitant medications were not provided. The patient's historical vaccines included all three Moderna vaccines (Covid-19 vaccine). The patient waited four weeks after the last booster.   On 28-Oct-2021, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) as prevention of seasonal influenza. The batch number was not reported. The patient was not aware which of the Seqirus vaccines she had been administered, but it was one of the quadrivalents.   On 29-Oct-2021 and 30-Oct-2021, after receiving influenza virus vaccine polyvalent, the patient was little achy.   On 30-Oct-2021, the patient recovered from 'ache'.   On 31-Oct-2021, in the morning, the patient's blood pressure was 136/72. Later, the patient's both temples were piercing and entire jaw. The patient experienced headache and blood pressure in the afternoon was 260/180. The patient went to emergency room and was hospitalised. The blood pressure while presenting to the emergency room was 230/150. The patient was on a drip to get blood pressure down over night. While hospitalized, the patient was given Hydralazine (hydralazine hydrochloride) as treatment, and computed tomography (CT) scan was performed, but results were not reported.  On 02-Nov-2021, the patient was discharged from the hospital.  At the time of initial reporting, the patient was recovering from the events of hypertension and headache, reported as subsided.   The outcome of 'jaw pain' was not reported.   The patient did not provide causality assessment. The patient was not sure if the events were related to Moderna Covid-19 vaccine or influenza virus vaccine.    The events of 'hypertension', 'headache' and 'jaw pain' were considered as serious due to hospitalisation.  Company comment: A 71-year-old patient experienced hypertension, jaw pain, headache, and ache within three days after receiving influenza virus vaccine polyvalent. The patient concomitant drugs were not provided. Although advance age of patient, systemic mastocytosis and diabetes contributed to the development of the events, causality is assessed as possibly related, due to compatible time relationship.; Sender's Comments: A 71-year-old patient experienced hypertension, jaw pain, headache, and ache within three days after receiving influenza virus vaccine polyvalent. The patient concomitant drugs were not provided. Although advance age of patient, systemic mastocytosis and diabetes contributed to the development of the events, causality is assessed as possibly related, due to compatible time relationship.
Age: 49.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Deafness
Clinical narrative: Sudden total hearing loss in left ear; This spontaneous case was received on 05-Nov-2021 from other non-health professional (consumer) via Pfizer (reference number: 202101440993) with additional information (being processed together) received on the same communication (reference number: SEQW21-05120) and concerned a 49-year-old male patient.  The patient's concurrent condition included codeine allergy. The patient's concomitant medications included omeprazole for unknown indication. The patient's previously received two doses of Pfizer BioNTech COVID-19 vaccine after which the patient did not developed any adverse event.  On 15-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: right arm, dose, route of administration and indication: not reported). The batch number was not reported.  On the same day, the patient was vaccinated with non-company co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; anatomical location: left arm, route of administration, dose, batch number and indication: not reported).  On 23-Oct-2021, eight days after administration of Afluria Quadrivalent and Pfizer BioNTech COVID-19 vaccine, the patient experienced sudden total hearing loss in left ear. The patient was treated with high dose of steroids.   At the time of initial report on 05-Nov-2021, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The event of 'hearing loss' was assessed as serious due to disability and was also considered to be medically significant by a Physician from facilitating company.  Company comment: A 49-year-old, male patient was vaccinated with the suspect Afluria Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccine. Eight days after vaccination the patient developed sudden total hearing loss in left ear. Information regarding the related diagnostic findings has not been provided. Due to limited information provided, causality is unassessable.; Sender's Comments: A 49-year-old, male patient was vaccinated with the suspect Afluria Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccine. Eight days after vaccination the patient developed sudden total hearing loss in left ear. Information regarding the related diagnostic findings has not been provided. Due to limited information provided, causality is unassessable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Pruritus, Pyrexia, Rash
Clinical narrative: Pruritus; Rash; Pyrexia; Revaccination with different COVID-19 vaccine; This case was received via regulatory authority (Reference number: FI-FIMEA-20215765) on 08-Nov-2021 and was forwarded to Moderna on 08-Nov-2021.    This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Pruritus), RASH (Rash), PYREXIA (Pyrexia) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002338) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included ARIPIPRAZOLE for Anxiety, MONTELUKAST and SALBUTAMOL SULFATE (BUVENTOL) for Asthma, THEOPHYLLINE (RETAFYLLIN) for COPD, BUPROPION HYDROCHLORIDE (VOXRA) for Depression, METFORMIN for Diabetes, ENALAPRIL MALEATE (LINATILSAN) for Hypertension, MELATONIN and TEMAZEPAM (TENOX [TEMAZEPAM]) for Insomnia, VERAPAMIL HYDROCHLORIDE (VERPAMIL) for Tachycardia, LORAZEPAM (TEMESTA [LORAZEPAM]) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced PRURITUS (Pruritus) (seriousness criterion disability), RASH (Rash) (seriousness criterion disability), PYREXIA (Pyrexia) (seriousness criterion disability) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) (seriousness criterion disability). At the time of the report, PRURITUS (Pruritus), RASH (Rash), PYREXIA (Pyrexia) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment information was provided.  Company comment: This is a regulatory authority case concerning a 52-year-old female patient with concomitant medication BUPROPION HYDROCHLORIDE, who experienced serious, unexpected events of Pruritus, Rash, Pyrexia and COVID-19 immunisation. The events occurred 8 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. Concomitant medication BUPROPION HYDROCHLORIDE remains a confounder for the events Pruritus and Rash .The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning a 52-year-old female patient with concomitant medication BUPROPION HYDROCHLORIDE, who experienced serious, unexpected events of Pruritus, Rash, Pyrexia and COVID-19 immunisation. The events occurred 8 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. Concomitant medication BUPROPION HYDROCHLORIDE remains a confounder for the events Pruritus and Rash .The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles in my toes; will not get the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine.On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine,the patient experienced shingles and incomplete course of vaccination.On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported for first dose and not applicable for second dose. The patient got the first shot and shingles in her/his toes will not get the second shot heck no,which led to incomplete course of vaccination. The followup would not possible as no contact information was available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extra dose administered, Pain, Pyrexia
Clinical narrative: Fever; Chills; BODY ACHES; After dosing,it was discovered the patient had already received two prior doses; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5393G, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th June 2021, from batch number 7RJ2X with expiry date unknown). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 5th November 2021, the patient received the 3rd dose of Shingrix. On 5th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On 6th November 2021, the patient experienced fever, chills and general body pain. On 7th November 2021, the outcome of the fever, chills and general body pain were recovered/resolved. On an unknown date, the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that, the patient came in to pharmacy and requested second dose of Shingrix to be administered,and injection was administered after dosing, it was discovered the patient had already received two prior doses, which led to extra dose administered. The patient previously received 2nd dose on 19th August 2021. The pharmacist reported that, the patient had the normal side effects post third dose of fever, chills, and body aches, and as of yesterday on 7th November 2021, the patient had returned to her normal state of health. The pharmacist did not have the expiration dates for the vaccines administered. The health care professional gave permission for follow-up
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Left arm Soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient experienced left arm soreness from 1st dose of Shingrix which was received in left deltoid. The reporter provided limited information and stated her phone was going to fail shortly, and subsequently the call ended abruptly. The patient consented to follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heavy menstrual bleeding, Myalgia, Nausea, Pyrexia
Clinical narrative: Prolonged vaginal bleeding after 2nd shot/ Period extended to 11 days after 2nd shot; Fever 101 F after 2nd shot; Body aches after 2nd shot; Nausea after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Prolonged vaginal bleeding after 2nd shot/ Period extended to 11 days after 2nd shot), PYREXIA (Fever 101 F after 2nd shot), MYALGIA (Body aches after 2nd shot) and NAUSEA (Nausea after 2nd shot) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged vaginal bleeding after 2nd shot/ Period extended to 11 days after 2nd shot) and NAUSEA (Nausea after 2nd shot). 01-Nov-2021, the patient experienced PYREXIA (Fever 101 F after 2nd shot) and MYALGIA (Body aches after 2nd shot). On 04-Nov-2021, PYREXIA (Fever 101 F after 2nd shot), MYALGIA (Body aches after 2nd shot) and NAUSEA (Nausea after 2nd shot) had resolved. On 11-Nov-2021, HEAVY MENSTRUAL BLEEDING (Prolonged vaginal bleeding after 2nd shot/ Period extended to 11 days after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f (High) 101 F.         No concomitant medications were reported. Treatment information was not provided.  This case concerns a 23 year-old, female patient with no relevant medical history, with maternal exposure during breastfeeding, who experienced the non serious unexpected event of Heavy menstrual bleeding. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-375543 (Patient Link). Sender's Comments: This case concerns a 23 year-old, female patient with no relevant medical history, with maternal exposure during breastfeeding, who experienced the non serious unexpected event of Heavy menstrual bleeding. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes at the right and left arm, back, chest and everywhere; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes at the right and left arm, back, chest and everywhere) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced RASH (Rashes at the right and left arm, back, chest and everywhere). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rashes at the right and left arm, back, chest and everywhere) outcome was unknown.            Co-suspect drug includes Unspecified Flu-Shot. No concomitant medications was provided by the reporter.