chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: Uses a walker / Can't walk today; Legs / extremely painful.; Back / extremely painful.; Bad headache; Could hardly get up; Her legs wouldn't hold her / Legs and back are weak; This case was reported by a consumer via call center representative and described the occurrence of headache in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in September 2020).   On 30th November 2020, the patient received the 2nd dose of Shingrix. On 30th November 2020, less than a day after receiving Shingrix, the patient experienced headache, mobility decreased and muscle weakness. On 1st December 2020, the patient experienced unable to walk, leg pain and back pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the mobility decreased, muscle weakness, unable to walk, leg pain and back pain were unknown.   It was unknown if the reporter considered the headache, mobility decreased, muscle weakness, unable to walk, leg pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient had no problems after her first Shingrix shot. The patient had her second Shingrix shot in right arm a day before reporting and that night she got up to get Tylenol for a bad headache and she could hardly get up, her legs would not hold her. The patient used a walker and she can not walk on the day of reporting, her legs and back were weak and extremely painful. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Headache; Shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 1st dose of Shingrix. On 30th November 2020, less than a day after receiving Shingrix, the patient experienced headache and shivering. On an unknown date, the outcome of the headache and shivering were not recovered/not resolved.   It was unknown if the reporter considered the headache and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine in left arm a day before reporting and headache and shivering presented same night and had continued into the day of reporting. The consented to follow up.
Sex: F
Vaccine: UNK
Symptoms: Allergy to vaccine
Clinical narrative: allergy to the pneumonia shot, saying she had to walk around with an antibiotic in her arm for 5 months afterward; allergy to the pneumonia shot, saying she had to walk around with an antibiotic in her arm for 5 months afterward; This is a spontaneous report from a sponsored program from a contactable consumer reporting for self. This 81-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as "pneumonia shot") via unspecified route of administration on an unspecified date at single dose in her arm for immunization. The patient's medical history and concomitant medications were not reported. The patient reported she had an allergy to the pneumonia shot, saying she had to walk around with an antibiotic in her arm for 5 months afterward.  The outcome of events was unknown.   Company  is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Erythema, Headache
Clinical narrative: light headedness; shortness of breath; headache; some nausea; get some redness to her neck and upper chest; Had elevated BPs; This is a spontaneous report from a contactable pharmacist. A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EH9899), intramuscularly on right arm on 15Dec2020 at 13:30 at single dose for immunization. The COVID-19 vaccine was administered in hospital.  Medical history included arrhythmia - right bundle branch block, GERD (Gastrooesophageal reflux disease), spinal headache, allergy to gabapentin, adhesive, duloxetine hydrochloride (CYMBALTA). The patient wears contact lenses. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN, 5-325 mg), omeprazole, meloxicam, docusate sodium, sennoside a+b (SENNA AND DOCUSATE SODIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Within a few minutes of receiving the shot on 15Dec2020, the patient developed lightheadedness, shortness of breath, headache, and some nausea and was taken to the ED (emergency department). She did get some redness to her neck and upper chest, had elevated blood pressure. O2 saturation was fine. The patient received treatment for the events which included acetaminophen (TYLENOL), dexamethasone, diphenhydramine, famotidine, ketorolac, ondansetron, and 1 L normal saline in ED. The patient was prescribed adrenalin autoinjector (EPIPEN) and prednisone and discharged home. Since the vaccination, the patient hadn't been tested for COVID-19. Outcome of reactions was resolved in Dec2020.; Sender's Comments: Based on the close temporal relationship and the description of the events lightheadedness, shortness of breath, headache, nausea, erythema and high blood pressure, there is a reasonable possibility that the events are related to BNT162b2 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: light headedness; shortness of breath; headache; some nausea; get some redness to her neck and upper chest; Had elevated BPs; This is a spontaneous report from a contactable pharmacist. A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EH9899), intramuscularly on right arm on 15Dec2020 at 13:30 at single dose for immunization. The COVID-19 vaccine was administered in hospital.  Medical history included arrhythmia - right bundle branch block, GERD (Gastrooesophageal reflux disease), spinal headache, allergy to gabapentin, adhesive, duloxetine hydrochloride (CYMBALTA). The patient wears contact lenses. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN, 5-325 mg), omeprazole, meloxicam, docusate sodium, sennoside a+b (SENNA AND DOCUSATE SODIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Within a few minutes of receiving the shot on 15Dec2020, the patient developed lightheadedness, shortness of breath, headache, and some nausea and was taken to the ED (emergency department). She did get some redness to her neck and upper chest, had elevated blood pressure. O2 saturation was fine. The patient received treatment for the events which included acetaminophen (TYLENOL), dexamethasone, diphenhydramine, famotidine, ketorolac, ondansetron, and 1 L normal saline in ED. The patient was prescribed adrenalin autoinjector (EPIPEN) and prednisone and discharged home. Since the vaccination, the patient hadn't been tested for COVID-19. Outcome of reactions was resolved in Dec2020.; Sender's Comments: Based on the close temporal relationship and the description of the events lightheadedness, shortness of breath, headache, nausea, erythema and high blood pressure, there is a reasonable possibility that the events are related to BNT162b2 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect dose administered, Pain, Product preparation issue
Clinical narrative: the patient received five times the recommended dosage; the patient received the unreconstituted dosage; body aches; headaches; This is a spontaneous report from a contactable Other Health Professional (pharmacy student) reported on behalf of a pharmacist.  A 37-year-old female patient received first dose of BNT162B2 (Pfizer product, batch/lot #: EH9899, NDC number: 59267100001, Expiry Date: 31Mar2021), intramuscularly on 15Dec2020 at single dose (five times the recommended dosage) to prevent the development of COVID 19. There were no medical history and no concomitant medications and no investigation assessment. They did not reconstitute the vial. The patient received five times the recommended dosage and the dosage was unreconstituted on 15Dec2020. The patient experienced body aches and headaches on 15Dec2020 with outcome of not recovered. Reporter seriousness for the patient received five times the recommended dosage was: Medically significant. Seriousness of body aches and headaches was: Too soon to tell. The seriousness of receiving it unreconstituted was: unknown.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events body aches and headaches , there is a reasonable possibility that the events are related to BNT162 vaccine received unreconstituted and five times the recommended dosage. The case will be reassessed upon receipt of follow up information.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Loss of consciousness
Clinical narrative: patient started feeling weak, dizzy and even blacked out a couple times; patient started feeling weak, dizzy and even blacked out a couple times; patient started feeling weak, dizzy and even blacked out a couple times; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2, via an unspecified route of administration, on 16Dec2020 at 12:00 PM at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 17Dec2020, at around 1:00 in the morning, the patient started feeling weak, dizzy and even blacked out a couple times. The outcome of the events was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events  feeling weak, dizzy and blacked out, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Severe fatigue until 48 hours; severe headache still present; fever; chills; nausea; This is a spontaneous report from a contactable physician. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 15Dec2020 at 15:15 (at the age of 30-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications; there were no other medications the patient received within 2 weeks of the vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe fatigue until 48 hours, severe headache still present, fever, chills, and nausea on 16Dec2020 at 03:00. The events were reported as non-serious. No therapeutic measures were taken as a result of the events. The clinical outcome of severe fatigue until 48 hours, severe headache still present, fever, chills, and nausea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and was requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: GH9899), via an unspecified route of administration in the left arm, on 17Dec2020 at 09:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included allergic to unknown food. The patient's concomitant medications were not reported. 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. The patient experienced hives on 17Dec2020 at 16:00. The event was reported as non-serious and did not cause/prolong hospitalization. Therapeutic measures were taken as a result of the event, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of hives was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Flushing, Heart rate increased, Nausea, Panic attack
Clinical narrative: waves of flushing through out her body; severe dry mouth; nausea; elevated heart rate into 120s; panic attack; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2020 (at 0810 her time) at single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter is a Certified Nursing Assistant (CNA) who received the Covid 19 vaccine at 0810 her time. Five minutes after receiving the vaccine (2020) she reported having three episodes of the following symptoms: waves of flushing through out her body, severe dry mouth, nausea and elevated heart rate into 120s. She denied any shortness of breath, swelling or anaphylaxis. She was treated in the Emergency Room (ER) with fluids and lorazepam (ATIVAN) and sent home. She contacted her doctor who advised she was probably having a panic attack and was told her to take lorazepam. She reported sleeping when she got home but experienced the elevated heart rate and flushing again after waking. She spoke to her doctor a second time and was told to return to the ER to be treated for the elevated heart rate. She did not go to the ER because she took more lorazepam and the HR declined into the 90's. She stated her doctor was prescribing a beta blocker for her but advised to go to the ER if her heart rate goes over 100 again. She would like to report and Adverse Event. The outcome of the events was unknown.   Information regarding lot/batch has been requested.; Sender's Comments: Based on the information available as reported at this point, a possible contributory role of the suspect products cannot be excluded for the reported event flushing, dry mouth, heart rate increased, nausea and panic attack due to temporal association.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Hearing loss; Severe tinnitus; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received first dose of BNT162B2 (solution for injection, lot number: EK5730, Expiry Date: 31Mar2021, NDC number: 59267-1000-01), intramuscularly on 16Dec2020 at 0.3 mg, single in deltoid for prevention of COVID viral infection. The patient's medical history and concomitant medications were not reported.  The patient's wife is COVID positive, but he has not been tested and has no other symptoms. On 17Dec2020, the patient experienced hearing loss, and severe tinnitus. There is no additional vaccines administered on same date of the Pfizer suspect. The outcome of both events was not resolved.; Sender's Comments: The reported information is limited. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nervousness, Palpitations, Ventricular extrasystoles
Clinical narrative: Feeling of going to pass out; PVC's; PVC's; Shaking feeling internally from neck down to ankles; Sweating; palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (lot number: FK5730), via an unspecified route of administration at site of right arm at 10:15 on 17Dec2020 at single dose for immunisation. Medical history included Chronic migraine. Occasional PAC/PVC's. Concomitant medication included clonidine (strength: 0.02 mg). Within about 5 minutes of receiving the vaccine, the patient experienced shaking feeling internally from neck down to ankles, sweating, feeling of going to pass out. Some palpitations and PVC's. Shaking Symptoms lasted approx 4 hours. The patient visited emergency due to events. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on 17Dec2020.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Rash, Swollen tongue
Clinical narrative: severe hypersensitivity; swelling of tongue; dyspnea; skin rash; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient administered vaccine and developed swelling of tongue, dyspnea, skin rash on an unspecified date. There is a report of severe hypersensitivity for his awareness. The patient was treated with dexamethasone, Benadryl, IM epinephrine in ER. Outcome of events were unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic, Swelling
Clinical narrative: Bilateral itchy rash, mostly with small areas of erythema especially around arm pits, but also on abdomen, back, neck, arms, forearms, thighs, legs; Bilateral itchy rash, mostly with small areas of erythema especially around arm pits, but also on abdomen, back, neck, arms, forearms, thighs, legs; some less erythematous areas of swelling with well-marked borders at most 1cm in diameter; This is a spontaneous report from a contactable physician. A 28-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, on 15Dec2020 at 02:45 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included lisinopril (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), and vitamin D (MANUFACTURER UNKNOWN) taken for supplement. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced bilateral itchy rash, mostly with small areas of erythema especially around arm pits, but also on abdomen, back, neck, arms, forearms, thighs, legs and some less erythematous areas of swelling with well-marked borders at most 1cm in diameter on 16Dec2020 at 08:00. The events did not cause or prolong hospitalization. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL) and loratadine (CLARITIN). The events improved with loratadine but started to reoccur 18 hours after loratadine use. The clinical outcome of bilateral itchy rash, mostly with small areas of erythema especially around arm pits, but also on abdomen, back, neck, arms, forearms, thighs, legs and some less erythematous areas of swelling with well-marked borders at most 1cm in diameter was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Limb discomfort, Pain in extremity, Sensory disturbance
Clinical narrative: extreme pain in her arms feeling like they are dead and heavy; extreme pain in her arms feeling like they are dead and heavy; She was unable to continue working; This is a spontaneous report from a non-contactable other health professional via Pfizer Sales Representative. This other health professional reported for a 50-year-old female patient (nurse) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration at on 15Dec2020 at single dose for COVID Vaccine. The patient's medical history and concomitant medications were not reported.  Nurse was administered the Pfizer COVID Vaccine on 15Dec2020. On 17Dec2020, at work she complained about extreme pain in her arms feeling like they are dead and heavy. She was unable to continue working and went home. Event took place after use of product. Outcome of events were unknown.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, extreme pain in her arms, feeling like they are dead and heavy and unable to continue working, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: Headache; Dizziness; Nausea; This is a spontaneous report from a contactable other health professional.  A 56-year-old female patient received bnt162b2 (BNT162B2) via intramuscular in right arm on 17Dec2020 at single dose for vaccination. There were no medical history or concomitant medications.  The patient experienced headache, dizziness, nausea all on 17Dec2020. The reporter described that immediately after patient was administered the COVID-19 vaccine injection she was handed the paperwork, stood up and had sudden onset headache, dizziness and nausea. As of time of the report the headache had subsided slightly but came and went in waves. The dizziness and nausea remain persistent. She reported the seriousness criteria as probably medically significant or somewhere between not serious and medically significant. Patient was currently under observation in the ED (emergency department), but had not been admitted to the hospital. The patient had been in the ED for over 30 minutes at time of report, so patient did not believe that these events are vagal. The reporter called to report these events and to ask for recommendations on how to respond to these events relative to this product. The reporter verified that there had been no relevant testing, imaging, lab work or investigations done at this time. The outcome of the event headache was recovering while for all other events was not recovered. Information on the Lot/Batch Number has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, headache, dizziness and nausea, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling hot, Tachycardia
Clinical narrative: waves of heat feeling; tachycardia; chest tightness; This is a spontaneous report from contactable physician via Pfizer Sales Representative. A 50-year-old female patient received bnt162b2, via an unspecified route of administration in 2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced waves of heat feeling, tachycardia, chest tightness 15 min after receiving the vaccine in 2020. Patient received several doses of steroid and was kept overnight in hospital and recovered. The outcome of events was recovered in 2020. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, waves of heat feeling, tachycardia, chest tightness, there is a reasonable possibility that the events are related to BNT162 vaccine.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this reviewas well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Some mild nausea; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162B2, via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced some mild nausea on 16Dec2020. The reporter indicated that the patient had some mild nausea that lasted for an hour or two but that it had completely passed.  The outcome of some mild nausea was recovered in Dec2020.      No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient was administered expired Tenivac vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other healthcare professional via phone at call center as a Global Medication Inquiry (GMI) and transmitted to Sanofi on 24-Nov-2020.  This case involved a 68-year old male patient who was administered with 0.5 ml of an expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] vaccine (lot number: U6091AA, expiry date: 12-Oct-2020, single dose vial) via unknown route in the left deltoid for prophylactic vaccination on 23-Nov-2020 (Expired product administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was administered concomitantly.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient did not experience any adverse event.  Reported wanted to know when to vaccinate patient and overall procedure.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001-83-EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Near death experience
Clinical narrative: almost died from the flu; Initial information received on 29-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographics) who almost died from the flu (feeling abnormal) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date of 1984, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient almost died from the flu (feeling abnormal) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: she got deathly I'll every time she took one of those shots; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves an unknown age female patient who got deathly i'll every time she took one of those shots (illness), while she received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, she got deathly ill every time she took one of those shots (illness).   Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
Sex: U
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: my body did hurt this time kind of sore for 4 days; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case involves a patient of unknown demographics whose body did hurt this time kind of sore for 4 days (pain), while the patient received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QUADRIVALENT).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patients received a dose of QUADRIVALENT RECOMBINANT INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated body did hurt this time kind of sore for 4 days (pain) (unknown latency) after the patient got the shot.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: terrible case of the flu; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who got terrible case of the flu (Influenza), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date in 2007, the patient received a dose of INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, within 3 days of receiving INFLUENZA VACCINE, he/she got a terrible case of the flu (Influenza) which took him/her nearly 3 weeks to get over.  It was not reported if the patient received a corrective treatment.  The event was resolved on an unknown date at the time of reporting.  There will be no information about the batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who got flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.  On an unknown date, patient had flu a few days later following the administration of INFLUENZA VACCINE. Had two flu shots - had flu both times, so now feel apprehensive about vaccines(Feeling abnormal).   It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: At  18:45 patient reported development of numbness in back of throat.  Pt. reported no difficulty swallowing.  Patient ate her evening meal without difficulty and symptoms begin to resolve.  Patient took 25 mg of diphenhydramine PO before going to bed. Patient reported no symptoms the next morning.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Patient was nauseas  but did not vomit. Had the patient lay down  and took the patients blood pressure first reading was BP 98/65, second reading was 94/62 with pulse rates of 80 and 67 respectively. Patient started to feel better after 30 minutes
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu from the flu shot; Initial information received on 05-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient of unknown demographics who got the flu from the flu shot (Influenza), after receiving INFLUENZA VACCINE.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.    Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient got the flu from the flu shot (Influenza) and he/she would never do that again.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available on the batch number for this case.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Blood test, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Balance issues, issues walking, numbness in feet, tingling in hands, face and feet. Falling. Was diagnosed with Guillain-Barre Syndrome.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging, Paraesthesia, X-ray
Clinical narrative: Balance issues, issues walking, numbness in feet, tingling in hands, face and feet. Falling. Was diagnosed with Guillain-Barre Syndrome.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Got sick with mild symptoms; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involves two patients (kids) of unknown demographics who got sick with mild symptoms (Illness), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.   On an unknown date, the patient stated that he/she got sick with mild symptoms (Illness), with the INFLUENZA VACCINE afterward.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Oral herpes, Paraesthesia oral
Clinical narrative: Patient began having tingling around her mouth on 12/20/20, stated that cold sore has gotten larger and is worse than previous sores.  Patient is cautious to not spread fluid from sores but they are spreading.  Patient was advised to contact PCP.
Sex: M
Vaccine: FLUX
Symptoms: General physical health deterioration, Malaise, Pain
Clinical narrative: became terribly sick after the flu shot; Crippling pain; A year later he kept going from bad to worse.; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient's friend) via social media on 03-Dec-2020.  This case involves a  65 years old male patient who became terribly sick after the flu shot (Illness), had crippling pain (pain) and that for whom it was reported that a year later he kept going from bad to worse (general physical health deterioration), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date (unknown latency), the patient became terribly sick after the flu shot (Illness). The patient's doctor said he needed it and that the patient regretted taking it. On an unknown date (latency unknown) the patient was in crippling pain (pain) for four months. The reporter reported that the patient's health did not rebound and that on an unknown date (reported a year later), (latency unknown) the patient kept going from bad to worse (general physical health deterioration). The reporter also advised to build up the immune system and that the vaccines were not good for everyone. People can be allergic to components in the serum.   It was not reported if the patient received a corrective treatment for the events  Outcome of the events were unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Headache, nausea, subjective fever and injection site arm pain.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick for 2 weeks; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved a patient with unknown demographics who got sick for 2 weeks (Illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site.   On an unknown date, unknown latency, the patient took the flu shot 1 time and was sick for 2 weeks (illness) and the patient have not had the flu in 20 years.  No relevant laboratory details were provided.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient was nauseas  and lightheaded. She was instructed to lay down  in which she felt better.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Shortly after receiving injection, I began feeling some lightheadedness.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: patient received COVID-19 vaccine at the ER on 12/21 at 1515 and developed severe allergic reaction to the vaccine. Vitals reported at 1642 were as follow:  BP :148/77 Pulse: 82 Temp: 98.4 °F (36.9 °C) Resp: 18 SpO2: 96 % . Patient received Benadryl 50 mg IV, Epipen 1 mg IM injection, pepcid 20 mg IVP, and solu-medrol 125 mg IVP. She was observed for 2 hours then discharged with no issues
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Patient got sick; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who got sick (illness), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site.   On an unknown date, the patient got sick (illness) (non-serious) about a week after following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchiness and rash on skin.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Tongue disorder
Clinical narrative: Employee reported "tongue thickness"  and dry mouth. Employee was taken to ED for evaluation and treatment.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I took the flu shot 3 years in a row and had the flu 3 years in a row; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 08-Dec-2020.  This case involves a patient of unknown demographics who reported that I took the flu shot 3 years in a row and had the flu 3 years in a row (Influenza), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient took the flu shot three years in a row. It was bad and the last time the patient had it the patient thought like going to die. The patient had not taken the shot in about 18 years and never had the flu before or since.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: generalized hives
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient had a vasovagal syncope with administration. Patient stated when he regained consciousness that he has these episodes during all flue shots.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and Vomiting
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves elderly patient [gender unspecified] who experienced flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient had two shots in 77 years of life and both time got the flu.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain, Pyrexia
Clinical narrative: Fever, chills, body pain
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: fever of 101, fatigue, lethargy
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: arm sore; felt awful for a couple of days; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (Patient).  This case involves a patient of unknown demography who's arm was sore (Pain in extremity) and felt awful for a couple of days (Feeling abnormal), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient received INFLUENZA VACCINE and experienced arm sore (Pain in extremity) and felt awful for a couple of days (Feeling abnormal).  This was the third year patient had received flu shot it made his/her arm sore.   No relevant laboratory details were provided.  It was not reported if the patient received any corrective treatment.  Outcome of the events was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain
Clinical narrative: Body aches, chills, dry cough