chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Haemangioma of skin, Paraesthesia, SARS-CoV-2 test, Tinnitus
Clinical narrative: Pins and needles for 11 weeks/left side of face tingling/left arm started tingling and also left leg; Ringing in my ears; Cherry angiomas type marks all over body; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: ER8729) via an unspecified route of administration on 09Apr2021 at 10:45 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported; however, it was reported that there were no other medications taken within two weeks of the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced pins and needles for 11 weeks/left side of face tingling/left arm started tingling and also left leg and on an unspecified date in Apr2021, the patient experienced ringing in my ears and cherry angiomas type marks all over body. The events were reported as serious for disability or permanent damage. The clinical course was reported as follows: The patient's left side of face started tingling within 15 minutes of getting the shot. On the next day, her left arm started tingling and also left leg. She also had ringing in her ears. The patient also stated that she has had pins and needles for 11 weeks post vaccine. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse events and was unspecified. The patient was tested for COVID-19 post vaccination on Jul2021 (nasal swab; PCR) which was negative. The clinical outcomes of the events pins and needles for 11 weeks/left side of face tingling/left arm started tingling and also left leg, ringing in my ears and cherry angiomas type marks all over body were not recovered/ not resolved.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Inappropriate schedule of product administration, Laryngeal oedema, Pneumonia, Product dose omission issue
Clinical narrative: His Adam's apple area is very swollen; currently in the hospital without the ability to swallow/not able to swallow; Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?/it has been over 42 days; Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?"/He received the second dose, 4 days ago, on 19uly2021; doctors think he has an infection, his lungs have pneumonia; his lungs are full; This is a spontaneous report from a contactable consumer (patient's spouse). An 82-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0181), via an unspecified route of administration on 19Jul2021 (82-years-old at the time of vaccination) as single dose for COVID-19 immunization. Medical history included Tested positive for COVID-19 on 05Mar2021, after receiving the first dose of the vaccine on 07Feb2021 (Lot# EN5818). The patient's concomitant medications were not reported. The patient previously took bnt162b2 for COVID-19 immunisation and experienced High temperature (hospitalized from 05Mar2021 to 07Apr2021), No taste or smell -all events were reported as resolved. Patient's wife reported that her 82 years spouse who received his first vaccine on 07Feb2021 and who then tested positive for Covid on 05Mar2021 (also reported he had COVID in Apr2021), had been hospitalized twice with a high fever. Patient wife told it has been over 42 days, that's why the delay in the second vaccine dose, weren't sure if they should get one or not, so does he start all over again or does he just take the second shot? She states she has asked every medical person in town and no one knows, so she is calling the source. As of 23Jul2021 it was further reported that the patient received his second vaccine shot on Sunday [19Jul2021] and 2 days later [21Jul2021] he was not able to swallow. His Adam's apple area was very swollen since 21Jul2021 and he was being in the hospital for 4 days due to swollen Adam's apple, with inability to swallow. He was in emergency for several days and he was getting worse. The patient was currently in hospital. The doctors put their heads together and they can't figure out what is wrong with him; the reporter think's it's a reaction to the vaccine. The doctors think "he has an infection, his lungs have pneumonia, his lungs are full".   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (23Jul2021): New information reported from the same contactable consumer (patient's wife) includes: additional events "inability to swallow", "Adam's apple area is very swollen", "Infection / his lungs have pneumonia", "his lungs are full", all assessed as serious, second vaccine dose date and Lot#. Case upgraded to serious.   Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: His Adam's apple area is very swollen; currently in the hospital without the ability to swallow/not able to swallow; Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?/it has been over 42 days; Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?"/He received the second dose, 4 days ago, on 19uly2021; doctors think he has an infection, his lungs have pneumonia; his lungs are full; This is a spontaneous report from a contactable consumer (patient's spouse). An 82-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0181), via an unspecified route of administration on 19Jul2021 (82-years-old at the time of vaccination) as single dose for COVID-19 immunization. Medical history included Tested positive for COVID-19 on 05Mar2021, after receiving the first dose of the vaccine on 07Feb2021 (Lot# EN5818). The patient's concomitant medications were not reported. The patient previously took bnt162b2 for COVID-19 immunisation and experienced High temperature (hospitalized from 05Mar2021 to 07Apr2021), No taste or smell -all events were reported as resolved. Patient's wife reported that her 82 years spouse who received his first vaccine on 07Feb2021 and who then tested positive for Covid on 05Mar2021 (also reported he had COVID in Apr2021), had been hospitalized twice with a high fever. Patient wife told it has been over 42 days, that's why the delay in the second vaccine dose, weren't sure if they should get one or not, so does he start all over again or does he just take the second shot? She states she has asked every medical person in town and no one knows, so she is calling the source. As of 23Jul2021 it was further reported that the patient received his second vaccine shot on Sunday [19Jul2021] and 2 days later [21Jul2021] he was not able to swallow. His Adam's apple area was very swollen since 21Jul2021 and he was being in the hospital for 4 days due to swollen Adam's apple, with inability to swallow. He was in emergency for several days and he was getting worse. The patient was currently in hospital. The doctors put their heads together and they can't figure out what is wrong with him; the reporter think's it's a reaction to the vaccine. The doctors think "he has an infection, his lungs have pneumonia, his lungs are full".   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (23Jul2021): New information reported from the same contactable consumer (patient's wife) includes: additional events "inability to swallow", "Adam's apple area is very swollen", "Infection / his lungs have pneumonia", "his lungs are full", all assessed as serious, second vaccine dose date and Lot#. Case upgraded to serious.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Migraine, Pain, Pyrexia
Clinical narrative: Fevers; Body aches; Severe migraines; Severe vomiting; Headaches; Diarrhea; The initial case was assessed as non-serious. Upon receipt of follow-up information on 27Jul2021, this case now contains all required information to be upgraded to serious.  This is a spontaneous report from a contactable consumer (patient). A non-pregnant 35-year-old female patient received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both intramuscular in left arm, on 11May2021 at 06:15 PM (18:15; at the age of 35 years) (Lot Number: EW0168, Expiration Date: Aug2021), as dose 1, single, and then on 01Jun2021 at 18:00 (06:00 PM; at the age of 35 years) (Lot Number: EW0180), as dose 2, single, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a pharmacy or drug store facility. Both doses caused extreme reactions including fevers, body aches, severe migraines, severe vomiting, headaches, and diarrhea on 12May2021 and then again on 02Jun2021. The events required visit to the physician office. The events were considered serious due to persistent or significant disability or incapacity (severe and incapacitating). The patient took medicine as treatment for migraine. The other events did not require the initiation of new medication, other treatment, or procedure. The patient was not tested for COVID-19 post vaccination. The patient was recovering from "Severe migraines". The outcome of "Headaches" and "Diarrhea" was unknown. The patient recovered with lasting effects (with sequel) from "Fever" in 2021; and recovered from the remaining events (without sequel) in 2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fevers; Body aches; Severe migraines; Severe vomiting; Headaches; Diarrhea; The initial case was assessed as non-serious. Upon receipt of follow-up information on 27Jul2021, this case now contains all required information to be upgraded to serious.  This is a spontaneous report from a contactable consumer (patient). A non-pregnant 35-year-old female patient received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both intramuscular in left arm, on 11May2021 at 06:15 PM (18:15; at the age of 35 years) (Lot Number: EW0168, Expiration Date: Aug2021), as dose 1, single, and then on 01Jun2021 at 18:00 (06:00 PM; at the age of 35 years) (Lot Number: EW0180), as dose 2, single, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a pharmacy or drug store facility. Both doses caused extreme reactions including fevers, body aches, severe migraines, severe vomiting, headaches, and diarrhea on 12May2021 and then again on 02Jun2021. The events required visit to the physician office. The events were considered serious due to persistent or significant disability or incapacity (severe and incapacitating). The patient took medicine as treatment for migraine. The other events did not require the initiation of new medication, other treatment, or procedure. The patient was not tested for COVID-19 post vaccination. The patient was recovering from "Severe migraines". The outcome of "Headaches" and "Diarrhea" was unknown. The patient recovered with lasting effects (with sequel) from "Fever" in 2021; and recovered from the remaining events (without sequel) in 2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Oropharyngeal pain
Clinical narrative: I woke up from sleeping around 2:00 am on 8/5 (approx 12 hours after my vaccine) to difficulty breathing and a sore throat. I felt like there was pressure on my chest and although I could still take deep breaths, it was difficult.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Back pain, Computerised tomogram abnormal, Fluid retention
Clinical narrative: Noticed pain in back on 02-13-1921 that patient thought was a kidney infection.  Treated at hospital emergency room on 02-18-1921 for infection and water retention and sent home.  Returned to hospital on 02-19-1921 and was diagnosed with a blood clot in her left lung and heart in A-Fib.  Was in Medical Center for 5 days.  Treated with Warfarin.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Pulmonary thrombosis
Clinical narrative: Noticed pain in back on 02-13-1921 that patient thought was a kidney infection.  Treated at hospital emergency room on 02-18-1921 for infection and water retention and sent home.  Returned to hospital on 02-19-1921 and was diagnosed with a blood clot in her left lung and heart in A-Fib.  Was in Medical Center for 5 days.  Treated with Warfarin.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: patient was exposed to COVID on 07/24, she is asymptomatic, tested positive for COVID on 7/31/2021
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Immunoglobulin therapy, Platelet count decreased, Transfusion
Clinical narrative: Bruising, extreme low platelet count (2000) Platelet infusion, IVIG ( multiple doses), Rituxin Treatment course still underway Diagnosed June 21, 2021- under care of doctor, multiple doctor visits including emergency room
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient was exposed to someone with COVID, asymptomatic, tested positive for COVID on 8/3/2021
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac disorder, Cardiac stress test abnormal, Cardiomegaly, Cardioversion
Clinical narrative: Enlarged and weak heart. Shortness of breath. Very high heart rate 200 plus .all these affects started happening after 2nd shot . heart needed to be shocked to get correct heartbeat. Extreme fatigue. Very weak  and short of breath.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Enlarged and weak heart. Shortness of breath. Very high heart rate 200 plus .all these affects started happening after 2nd shot . heart needed to be shocked to get correct heartbeat. Extreme fatigue. Very weak  and short of breath.
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine was exposed to 80.6 degree Fahrenheit for 14 hours 15 minutes/ no AE; Initial information was received on 28-Jul-2021 regarding an unsolicited valid non-serious case received from an Other health professional via Medical Information (Reference number- 00700812) and transmitted to Sanofi on 28-Jul-2021.  This case involves a 16-year-old female patient reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] was exposed to 80.6-degree Fahrenheit for 14 hours 15 minutes with no adverse event (Product storage error) and the patient administered the vaccine after the temperature excursion with no adverse event (Poor quality product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 19-Jul-2021, the patient received a 0.5 ml (once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6877BA and expiry date 28-Feb-2022] via intramuscular route in left deltoid for prophylactic vaccination.  It was a case of actual medication error due to incorrect product storage and poor-quality vaccine administered (latency was on same day).  It was reported that, " MA calling to report a temperature excursion caused by a fridge malfunction that lasted for 14 hours 15 minutes with a high temperature of 80.6°F. Medical Assistant reporting on behalf of a 16-year-old female receiving a Menactra dose after the Menactra was exposed to a temperature excursion that made the vaccine not suitable for use. The caller reported that the temperature excursion was on 25Jun2021 and the vaccine was administered on 19Jul2021 and she wants to know if anything needs to be done in regard to this. Vaccines. Product used: Used. Still using product: No".  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 in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given/ no AE; Initial information was received on 28-Jul-2021 regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00701210) and transmitted to Sanofi on 28-Jul-2021.  This case involves a patient (unknown age and unknown gender) reported that while being treated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given with no adverse event (product preparation error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml (total) dose (once) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, "A Nurse reporting a medication error for Pentacel described as the Hib portion was reconstituted with normal saline and the DTap-IPV portion was not given. The caller reported that information is limited for this report do to not knowing all the facts; that she believes the Hib portion was given with normal saline; that the DTap-IPV portion was not given. PENTACEL blue top was given with just normal saline instead of green top. Is this dose suitable or does it need to be repeated? Product used: Used Still using product : No".  It was a case of actual medication error due to active ingredient not added to diluent (latency was on same day).  At the time of reporting, patient had no adverse event.  There will be no information available on batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received a expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00701286) and transmitted to Sanofi on 28-Jul-2021.  This case involves a 16-month-old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 28-Jul-2021, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (lot UJ358AAB and expiry date: 27-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination (expired product administered).  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: receiving an extra dose with no reported adverse event; Initial information received on 29-Jul-2021 regarding an unsolicited valid  non-serious case received from a other health professional via Media Information (under the reference).  This case involved a 18 years old male patient who had an extra dose with no reported adverse event (extra dose administered) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (MENACTRA).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation.  On 28-Jul-2021, the patient received a dose 3 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (o.5 ml, solution for injection, lot U6921AA and expiration date: 17-apr-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  On 28-JUL-2021 the patient developed a non-serious receiving an extra dose with no reported adverse event (extra dose administered) following the administration vaccine.   It was an actual medication error due to extra dose administered.  It was not reported if the patient received a corrective treatment for the event (receiving an extra dose with no reported adverse event).  No laboratory data reported.  At time of reporting, the outcome was Unknown for the reported 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 guidelines. 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: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of ACTHIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via medical information (Reference number- 00702980) and transmitted to Sanofi on 29-Jul-2021.  This case involves a 3-year-old male patient received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  Medical history, medical treatment, vaccination and family history were not provided.  On 29-Jul-2021, the patient received a 0.5 mL first dose of suspect HIB (PRP/T) VACCINE [total, once, strength: standard, UJ358AA, expiry date: 27-Jul-2021] via an intramuscular route at the right thigh for prophylactic vaccination (expired product administered). (Latency: on the same day)   It was a case of actual medication error due to expired vaccine use.   It was reported that, "nurse practitioner asked for information regarding administration of expired dose".  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: FLU3, FLU3, VARZOS
Symptoms: Gait disturbance, Walking aid user
Clinical narrative: Cannot walk yet without walker; This spontaneous case was received on 27-Jul-2021 from other non-health professional via Sanofi Pasteur (reference numbers 2021SA208806 and US-SA-SAC20210623001028) with additional information (being processed together) received on the same day and concerned a male patient of an unknown age. At the time of initial reporting, the patient was a 76-year-old.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Fluvirin (influenza virus vaccine polyvalent; dose, anatomical location, route of administration: not reported) as a prophylactic vaccination. The batch number was not reported.  On an unspecified date, the patient was vaccinated with non-company, co-suspect vaccine Fluzone High Dose (Influenza vaccine inact split 3v; dose, anatomical location, route of administration: not reported) as a prophylactic vaccination. The batch number was not reported.  On an unspecified date, the patient was vaccinated with non-company, co-suspect vaccine Zostavax (varicella zoster vaccine live (Oka/Merck); dose, anatomical location, route of administration: not reported) as a prophylactic vaccination. The batch number was not reported.  On an unspecified date, unknown amount of time after receiving Fluvirin and non-company, co-suspects Zostavax and Fluzone High Dose, the patient could not walk without walker. Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The event of 'walking difficulty' was assessed as serious due to criteria of disability and medically significance.  Company comment: An elderly male patient was vaccinated with suspect Fluvirin vaccine and non-company co-suspect vaccines Fluzone High Dose and Zostavax. An unknown amount of time after vaccination the patient could not walk without walker. There is a lack of information regarding vaccination dates and event onset date, therefore chronology needs more clarification. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information, causality for the reported event is unassessable.; Sender's Comments: An elderly male patient was vaccinated with suspect Fluvirin vaccine and non-company co-suspect vaccines Fluzone High Dose and Zostavax. An unknown amount of time after vaccination the patient could not walk without walker. There is a lack of information regarding vaccination dates and event onset date, therefore chronology needs more clarification. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information, causality for the reported event is unassessable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hemianaesthesia
Clinical narrative: Left side (where the shot was given,)  went completely numb for 12 hours or so about 3 hours after 2nd dose was administered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dyspepsia, Vertigo
Clinical narrative: Severe vertigo episode 12.5 hours after receiving 1st dose of COVID-19 vaccine. Intermittent episodic dizziness which resolved by week three.  Upon second dose, within 48 hours experienced a major episode of vertigo. Thereafter daily episodes of vertigo and dizziness lasting up to three minutes without warning. Experienced severe stomach pains and indigestion. Symptoms resolved by the end of July.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Dizziness, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Tinnitus in both ears Nearly Constant dizziness Hearing loss in left ear Tingling pins and needles in arms, hands, feet, and legs Tight and numb forehead  Numbness in top gums Frequent headaches  Nauseous when dizzy Sore Throat
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Paraesthesia, Tension headache, Tinnitus
Clinical narrative: Tinnitus in both ears Nearly Constant dizziness Hearing loss in left ear Tingling pins and needles in arms, hands, feet, and legs Tight and numb forehead  Numbness in top gums Frequent headaches  Nauseous when dizzy Sore Throat
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in mouth at age 16, lasted one month). Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (also experienced fatigue after receiving 1st dose on an unknown date refer case US2021AMR165330).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and fatigue. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient decided to request and received Shingles vaccine shots at 60 days intervals. The patient reported that, after receiving 2nd dose of Shingles vaccine he or she experienced sore arm and fatigue symptoms, which only lasted one day. The patient stated glad he or she did, peace of mind. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR165330:same patient/reporter
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Mobility decreased
Clinical narrative: Headache; chills; stomachache; was in the recliner covered up most of the day / could not do anything; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th July 2021, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced headache, chills, stomach pain and mobility decreased. On an unknown date, the outcome of the headache, chills, stomach pain and mobility decreased were recovering/resolving.   It was unknown if the reporter considered the headache, chills, stomach pain and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received Shingles vaccine and experienced headache, chills, stomachache and the patient could not do anything. The patient was in the recliner covered up most of the day. The patient stated he/she was good on the day of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was vaccinated / still got them/ Suspected Vaccination failure; got them; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and got the shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccination and still got them\ suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and got the shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain, Rash
Clinical narrative: arm got huge with a rash.; super painful; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash and pain. On an unknown date, the outcome of the rash and pain were unknown.   It was unknown if the reporter considered the rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that he/she got vaccinated many years ago and his/her arm got huge rash and was super painful. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: her second Menveo- 2 months early according to cir; This case was reported by a other health professional via (Menveo Chatbot) interactive digital media and described the occurrence of drug dose administration interval too short in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's employee administered 2nd dose of Menveo to the patient 2 months earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter asked if they need repeating dose.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash erythematous
Clinical narrative: Diagnosed with shingles; Developed a red rash; Blisters formed on the right side of torso; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than a week after receiving Shingrix, the patient experienced shingles, red rash and blister. On an unknown date, the outcome of the shingles and red rash were not recovered/not resolved and the outcome of the blister was unknown.   It was unknown if the reporter considered the shingles, red rash and blister to be related to Shingrix.  Additional details provided were as follows: The reporter was the patient himself. Patient received Shingrix 1st dose in left deltoid and 4 to 5 days later he developed a Red rash and then Blisters formed on the right side of torso. Patient had a virtual visit with Health care professional and was diagnosed with shingles. Reporter had provided education on Shingrix vaccine, that it is a 2 dose series and it should be given 2-6 months after first dose and that Shingrix is a non- live vaccine. Patient was referred to the health care professional, and provided Medical Information phone number. Reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) frequency time 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with Covid-19 vaccine was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated: 90000187877. The suspected has been confirmed to be non-void based on the evaluation/investigation performed. This case, from the same reporter is linked to 20210801047.; Sender's Comments: V0 - 20210801102- COVID-19 VACCINE: Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: FEELING UNWELL; FEVER; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced feeling unwell, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling unwell, and fever. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 66year old African American, Non-Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, no alcohol use, and non-smoker. The patient had no known allergies, no drug abuse or illicit drug use and the patient was not pregnant at the time of reporting. The Patient was Diabetic and was taking medication for Diabetes The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 28-JUL-2021, the patient took covid-19 antibody test twice and results were negative both the time. The incubation period of 28 days has been completed (Confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188319.; Sender's Comments: V0: 20210804988- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, Pyrexia
Clinical narrative: Diagnosed as MS; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Diagnosed as MS) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Anthrax Vaccine. Past adverse reactions to the above products included Allergy with Anthrax Vaccine. Concurrent medical conditions included Allergy to feathers (goose down), Pollen allergy and Plantar fasciitis since 1998.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Diagnosed as MS) (seriousness criterion medically significant). On 15-Jun-2021, MULTIPLE SCLEROSIS (Diagnosed as MS) had resolved with sequelae. At the time of the report, PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Gorgeous Hair, Skin, and Nails multivitamin, tid ongoing since 01 Feb 2020. No treatment information was reported.  Neurologist ordered blood tests and MRIs and diagnosed the patient with MS.  Company Comment: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Some individuals experience immune response following vaccine administration resulting from  reactivation of an underlying undiagnosed condition.   This case was linked to MOD-2021-258762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received on 16-Jul-2021 does not contain any new information. On 01-Aug-2021: Significant follow up contained patient's demographics and historical conditions. Events were also updated and combined into multiple sclerosis.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Some individuals experience immune response following vaccine administration resulting from  reactivation of an underlying undiagnosed condition.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Anticoagulant therapy, C-reactive protein increased, Catheterisation cardiac, Chest pain
Clinical narrative: chest pain x2 days,  treatment was heparin gtt, heart cath, ct angio and echo
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Fibrin D dimer increased, Glucose tolerance test, Red blood cell sedimentation rate increased, Troponin increased
Clinical narrative: chest pain x2 days,  treatment was heparin gtt, heart cath, ct angio and echo
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Eye swelling, Lymphadenopathy, Pruritus
Clinical narrative: Itching, swelling in the eye/ear area, lymphadenopathy
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Gingival bleeding
Clinical narrative: BLEEDING GUMS AND BLOOD IN URINE
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Chronic headaches since getting vaccine