chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Injection site pain, Nausea, Pyrexia
Clinical narrative: one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events low grade fever, chills and nausea cannot be excluded.  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: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events low grade fever, chills and nausea cannot be excluded.  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: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events low grade fever, chills and nausea cannot be excluded.  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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Investigation, Pain
Clinical narrative: My body aches/My whole body is aching; Fast heartbeat; I have difficulty in breathing; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration from 17Jan2021 at 0.3 mL single for COVID-19 immunization. Medical history included immunotherapy for breathing, for her lungs. Concomitant medication included umeclidinium bromide, vilanterol trifenatate (ANORO) for immunotherapy for breathing. The patient whole body was aching from the shot (Later clarified as COVID 19 Vaccine Pfizer) that she got yesterday (on 17Jan2021). She had fast heart beats and she had difficulty in breathing and her whole body was really aching. Her whole body aches and pain of her body. The patient wanted to know how to get rid of the pain. The patient thought that she took treatment included Advil. And patient was still achy. The due date for next shot was on 07Feb2021. The patient underwent lab tests and procedures which included heart rate fast on 17Jan2021 and had lab work last week (in Jan2021), that was for her blood work. The outcome of the event whole body was aching was not recovered, of the rest events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Chills, Nervousness
Clinical narrative: chills; high anxiety; nervous wreck; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had some chills and high anxiety, also mentioned being a nervous wreck on an unspecified date. Outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received second dose of bnt162b2 (BNT162B2, lot number: EL3249), via an unspecified route of administration on 16Jan2021 07:00 on Left upper Arm at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, High cholesterol, Asthma. Concomitant medication included losartan for high cholesterol, montelukast for asthma, valsartan for blood pressure. The patient woke-up at 5 AM with hives on 17Jan2021. The event was treated with Benadryl and have the hydrocortisone cream that went away and came back, that went away and came back and came back again in the morning of reporting date, so the consumer didn't know it's related. Investigation Assessment: No. The event outcome was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: dizzy; throwing up; Head spinning; nausea; This is a spontaneous report from a contactable nurse (patient).  A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  There were no medical history or concomitant medications.  The patient started to get like extremely dizzy, was throwing up, head spinning, had horrible nausea; started to get really carsick on an unspecified date. The patient went into a walk in a clinic and that gave her ondansetron (ZOFRAN). So, she had been taking that for the nausea and the vomiting. She had also been taking meclozine (MECLIZINE) and dimenhydrinate (DRAMAMINE) too. The outcome of event dizzy was not recovered, while for other events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: GL1283, on 15Jan2021 at 10 AM at single dose for COVID-19 immunization. The patient had some medical history, but not reported. Concomitant medications were not reported. Patient stated, she received her second dose of the COVID Pfizer vaccine (COVID 19 Vaccine) on Friday at 10 AM and usual it pained next day (16Jan2021) but they went away by the end of the day. However, she noticed that yesterday (17Jan2021) and today (18Jan2021) there was redness and little bit of swelling, a patch that was getting bigger just below the site where the injection was made. Yesterday it was smaller. Today the part was larger and little bit swollen So she thought she better see what's going on. Patient stated she was kind of tired. She was old. For treatment, the patient went to the drug store today and got some Benadryl. So, she took two Benadryl tablets at about three hours prior to the report and it hadn't effected it one way or the other. The patient didn't have any lab test. Patient's height was 5'5 and three quarters. The outcome of the events "Pain" and "Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was" was not recovered at the time of report. The outcome of tired was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Fall, Fatigue, Malaise
Clinical narrative: Dizzy; She is not feeling well; When she went home she fell, she had a terrible fall and she got a terrible bruise on her head; When she went home she fell, she had a terrible fall and she got a terrible bruise on her head; Tired; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced dizzy, she was not feeling well, when she went home she fell, she had a terrible fall and she got a terrible bruise on her head, she also tired. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Ischaemia, Surgery, Volvulus
Clinical narrative: volvulus; volvulus and needed surgery followed by further ischemia; This is a spontaneous report from a contactable physician. An 86-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly on 19Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient developed volvulus and needed surgery followed by further ischemia and at end of life. The events onset date reported as 27Jan2021. Patient had 3days hospitalization and died eventually. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this report.  No relevant information regarding the clinical course of the events, the patient's underlying medical conditions were mentioned. Based on the information currently available, lacking any other alternative explanations as so far, the reported volvulus and Intestinal ischaemia are managed as related to COVID-19 vaccine, BNT162B2, for reporting purpose, only.   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 RA, IEC, as appropriate.; Reported Cause(s) of Death: volvulus; ischemia
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Myocardial infarction, SARS-CoV-2 test negative
Clinical narrative: heart attack; This is a spontaneous report from a contactable consumer (patient).   A 67-year-old male patient received bnt162b2 (BNT162B2, lot # EL9263) at single dose at left arm on 23Jan2021 14:15 for Covid-19 immunisation.  Medical history included hypertension, high cholesterol. No known allergies. The patient had not experienced Covid-19 prior vaccination. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  On 24Jan2021 06:00, the morning after he received the COVID-19 vaccine, he had a heart attack. The patient was hospitalized for heart attack for 2 days and evet was considered life threatening. The doctor placed 2 stents in his arteries. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 24Jan2021.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: she had a pneumonia shot where kind of the same thing happened, she had red, bumped up and itchiness at the injection.; she had a pneumonia shot where kind of the same thing happened, she had red, bumped up and itchiness at the injection.; she had a pneumonia shot where kind of the same thing happened, she had red, bumped up and itchiness at the injection.; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as PNEUMONIA SHOT), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient medical history and concomitant medications were not reported. The patient had a pneumonia shot and she had red, bumped up and itchiness at the injection. She didn't remember if she was diagnosed with cellulitis as it was a long time ago and she had no NDC, Lot, or Expiry for the product.  The outcome of the events was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient reports pain and loss of use of arm after receiving Prevnar13.; Patient reports pain and loss of use of arm after receiving Prevnar13; This is a spontaneous report from a contactable consumer (patient) communicated to Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported and concomitant medications were not reported. The patient reported pain and loss of use of arm after receiving Prevnar13. She explains it was two to three years ago and she still does not have full range of motion in the arm and still has pain. Event took place after use of product. The event outcome was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Vision blurred
Clinical narrative: On 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020; extreme blurriness in left eye; Nauseous; intense headache at the base of neck up to eye socket; This is a spontaneous report from a contactable consumer (reporting for himself).  A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot  number: EL8982), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization.  Medical history and concomitant medications were none.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284) on 28Dec2020 for COVID-19 immunization and experienced severe headache and was nauseous.  The patient experienced extreme blurriness in left eye, nauseous, intense headache at the base of neck up to eye socket in Jan2021. On 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020.  Therapeutic measures were taken as a result of extreme blurriness in left eye, nauseous, intense headache at the base of neck up to eye socket and included: ibuprofen 1000mg.  The outcome of extreme blurriness in left eye, nauseous and on 14Jan2021, the patient received the second dose of BNT162B2 and the first dose on 28Dec2020 as unknown and of intense headache at the base of neck up to eye socket was recovered in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: just died; This is a Spontaneous report from a Pfizer Sponsored Program from a contactable consumer. A male patient of an unspecified age 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 just died on an unspecified date.  It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: just died
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: laying in bed with 103.6 temperature; feels like she's dying; Initial information received on 24-Jan-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional.  This case involved a female patient of unknown age who was laying in bed with 103.6 temperature (body temperature increased) and feels like she's dying (feeling abnormal), while she received vaccines INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) patient who was laying in bed with 103.6 temperature (body temperature increased) and feels like she's dying (feeling abnormal) following the administration of suspect vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: F
Vaccine: FLUX
Symptoms: COVID-19, Near death experience, SARS-CoV-2 test positive
Clinical narrative: covid; almost died; Initial information received on 26-Jan-2021 regarding an unsolicited valid serious media case received from a consumer or non-healthcare professional.  This case involves a female patient (age not reported) who developed Covid (covid-19) and almost died (near death experience), while she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed Covid (covid-19) and almost died (near death experience) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  It was reported that reporter's sister got the flu shot still got covid and almost died. Flu shot did not helped her one bit.   Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Positive  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for events.  Information on the batch number was requested.; Sender's Comments: This poorly documented media case concerns a female patient (age not reported) who developed covid-19 during the pandemic and reportedly almost died after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out predisposing etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Every time patient ever got flu shot ,still got the flu.Rarely when patient didnt; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient (unknown demography) who every time ever got flu (influenza),after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient every time had non-serious flu (influenza, unknown latency) after getting INFLUENZA VACCINE. Also reported that the patient had it rarely when he/she did not (As reported in the source by the reporter: "Every time I ever got flu shot I still got the flu...Rarely when I didn't").   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the reported event.  There will be no information on  the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: swelling; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves adult patient of unknown demographics who experienced swelling, while the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  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 a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious swelling following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratory test was reported.   It was not reported if the patient received a corrective treatment.  The patient was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got severely sick; Initial information was received on 25-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (patient).  This case involves patient (unknown demography) who got severely sick (illness), while the patient received INFLUENZA VACCINE [Flu shot].  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got severely sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got flu shot got one 20 years, got severely sick. Never had one since, never had the flu. Will never get one again.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got severely sick; Initial information was received on 25-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (patient).  This case involves patient (unknown demography) who got severely sick (illness), while the patient received INFLUENZA VACCINE [Flu shot].  It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got severely sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got flu shot got one 20 years, got severely sick. Never had one since, never had the flu. Will never get one again.  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Allergy test, Eye swelling, Influenza, Lip swelling
Clinical narrative: lips and eyes swelled up; lips and eyes swelled up; flu symptoms; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional.  This case involved a female patient of unknown age who experienced lips and eyes swelled up (lip swelling and eye swelling) and flu symptoms (influenza), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 22-Oct-2009, the patient received INFLUENZA QUADRIVAL A-B VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in 2009, (latency: unknown) patient who experienced lips and eyes swelled up (lip swelling and eye swelling) and flu symptoms (influenza) following the administration of suspect vaccine.  Relevant laboratory test results included: Allergy test - On an unknown date: [had no allergies].  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: received the doses Fluzone High-Dose Quadrivalent one month apart due to an oversite issue, no AE; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves patient (unknown demographics) who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date not reported) one month apart due to an oversite issue via unknown route in unknown administration site for prophylactic vaccination on an unknown dates (extra dose administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   This was an actual medication error due to extra dose administered [latency was same day].  At the time of reporting, no adverse event was reported to the patient.  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.  There will be no information on the batch number for this case.
Age: 63.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered 0.5 ml of Daptacel in the left deltoid by SS, the vaccine had expired prior to the administration with no AE; Initial information regarding this unsolicited valid non-serious case   This case involves a 63 year old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot: U6101, expiry date: 23-Oct-2020), via intramuscular route at left deltiod, on 19-Jan-2021 (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  It was an actual medication error due to the expired product administered.  At the time of reporting, the 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 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: 12.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient recived vaccine expired on 26-Aug-2020/no AE; Initial information was received on 20-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 12-year-old female patient who received a forth dose of 0.5 ml of IPV (VERO) [IPOL] vaccine which was expired 26-Aug-2020 [lot number: R1D972M] via an intramuscular route in the left deltoid on 07-Jan-2020 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error due to expired vaccine used. (latency: at the time of vaccination)  At the time of report, no adverse event was reported.  It was reported that, normally they(reporter) would not have kept this vaccine for more than 28 days and they do not have an explanation on how this happened.  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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: the powder component of the Pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant, with no reported adverse event; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4-months-old male patient for whom it was reported that the powder component of the pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant, with no reported adverse event (product preparation error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 7v (CRM197) (Prevnar).  On 21-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ337AAA and expiration date: 05-Jul-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of medication error due to product preparation error. (Latency: same day of vaccination).  It was reported that the powder component of the pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant. At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Left arm was slightly sore last night (day of injection).  Provided 400 mg Advil.  Woke up at 5:30 am with a 102 fever, headache, queasiness, and all over body ache.  Provided 400 mg Advil as of 6:00 am and monitoring.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: Client felt nauseous and had palpitation.  Paramedics assess client on site.  Client was released at 10.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Hypotension, Metabolic function test, Pyrexia, Tachycardia
Clinical narrative: Fever, tachycardia,  hypotension, diffuse urticaria
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Fever, tachycardia,  hypotension, diffuse urticaria
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: SEVERE FEVER , WEAKNESS , AND ACHES THAT LASTED ABOUT 20 HOURS.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, temp 101
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhoea
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen/painful lymph nodes behind L collar bone and in L arm
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, headache
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Palpitations, Paraesthesia
Clinical narrative: Face and arm on the side COVID vaccine given started tingling and got warm right away then had numbness and tingling after. For the first 15 mins also had heart palpitations.  12 hours later after waking up face sensation was dull and improved over the night.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site mass, Injection site pain
Clinical narrative: Headache, Soreness and bump at injection site, congestion, some chills, and tiredness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Headache, Soreness and bump at injection site, congestion, some chills, and tiredness.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin irritation
Clinical narrative: 7 days after the shot, the arm that received the shot got very itchy, irritated, and a little red. It is currently 8 days after the shot and my arm is still very itchy and feels a little swollen.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Myalgia, Nausea, Pain
Clinical narrative: Light headed and aches within two hours. At 2am next morning, I could hardly stand due to muscle pain and weakness, neck to toes, with associated nausea and low-grade fever of 99/100 the rest of the day.  I took Advil and Tylenol every 4-6 hours. Some pain and weakness and nausea remain on 2/4/2021 but fever is gone and feeling well enough to return to work.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Light headed and aches within two hours. At 2am next morning, I could hardly stand due to muscle pain and weakness, neck to toes, with associated nausea and low-grade fever of 99/100 the rest of the day.  I took Advil and Tylenol every 4-6 hours. Some pain and weakness and nausea remain on 2/4/2021 but fever is gone and feeling well enough to return to work.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Chest X-ray abnormal, Chest X-ray normal, Echocardiogram normal, Pericarditis
Clinical narrative: Pleuritic chest pain. Admitted due to acute pericariditis. Course complicated with new onset atrial fibrillation.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleural effusion, Pleuritic pain
Clinical narrative: Pleuritic chest pain. Admitted due to acute pericariditis. Course complicated with new onset atrial fibrillation.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hours. Felt very similar to the numbness of after dental work. Did NOT have face paralysis like that of Bell's Palsy just face numbness. After approximately 8 hours feeling was restored. As of 2+ weeks later no lasting effects.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Full blood count, Headache, Loss of consciousness
Clinical narrative: Chills and headache the night of the injection.  Next morning at 6:00 was sitting up in bed and became unconscious and unresponsive to painful stimulus. Called 911 medics.     After about 20 minutes - started to regain conscious. At that point Bp was 50/40.  Taken to  Hospital . Vomiting and Diarrhea.   Was given 1 bag IV saline and adavan.  Release after 4 hours.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Chills and headache the night of the injection.  Next morning at 6:00 was sitting up in bed and became unconscious and unresponsive to painful stimulus. Called 911 medics.     After about 20 minutes - started to regain conscious. At that point Bp was 50/40.  Taken to  Hospital . Vomiting and Diarrhea.   Was given 1 bag IV saline and adavan.  Release after 4 hours.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Disturbance in attention, Dyspnoea, Epistaxis
Clinical narrative: Within 12 hours of receiving vaccine I began to feel fatigue in my muscles and a mild headache.  The next morning I experienced brain fog, inability to formulate thoughts correctly, difficulty thinking, lack of concentration, muscle soreness, aches all over body, tired easily, shortness of breath, fever, chills,  and nausea.  36 hours after receiving vaccine, I still feel uneasy on my feet, light headedness, muscle soreness, stiff neck, nose bleeds, headache, nausea and extreme fatigue.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mental impairment, Muscle fatigue, Musculoskeletal stiffness
Clinical narrative: Within 12 hours of receiving vaccine I began to feel fatigue in my muscles and a mild headache.  The next morning I experienced brain fog, inability to formulate thoughts correctly, difficulty thinking, lack of concentration, muscle soreness, aches all over body, tired easily, shortness of breath, fever, chills,  and nausea.  36 hours after receiving vaccine, I still feel uneasy on my feet, light headedness, muscle soreness, stiff neck, nose bleeds, headache, nausea and extreme fatigue.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Within 12 hours of receiving vaccine I began to feel fatigue in my muscles and a mild headache.  The next morning I experienced brain fog, inability to formulate thoughts correctly, difficulty thinking, lack of concentration, muscle soreness, aches all over body, tired easily, shortness of breath, fever, chills,  and nausea.  36 hours after receiving vaccine, I still feel uneasy on my feet, light headedness, muscle soreness, stiff neck, nose bleeds, headache, nausea and extreme fatigue.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlargement of lymph nodes under left axilla; no treatment to date, lumps are still there after 3 weeks
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site erythema, Pain in extremity
Clinical narrative: Flu like symptoms. Arm pain. Redness at injection site that has not stopped spreading since receiving vaccine.
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Antibody test negative, Measles antibody positive, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: He has no immunity to the vaccine, his immunity is less than 1 .4.; This spontaneous report was received from a physician and refers to a 13-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2008 and an unknown date in 2011, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection (dose number, dose, route of administration, anatomical location, lot # and expiration date were not reported for any) for prophylaxis. Then, on 21-SEP-2018 and on 26-OCT-2018, he received his dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (dose number, dose, route of administration, anatomical location, lot # and expiration date were not reported for any) for prophylaxis.  On an unknown date, the patient had "no immunity to the vaccine", his immunity was less than 1.4 (units not provided) (antibody test negative). It was also reported, that his ELIZA was negative and Measles, Mumps and Rubella was positive. The physician could not find more sensitive test.  The outcome of no immunity was not reported.  The causality assessment between the event of no immunity and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: expired dose; This spontaneous report was received from a registered nurse and refers to a 19 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 20-JAN-2021, the patient was vaccinated withan expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot# reported as "S021617,", expiration date 09-JAN-2021, 1 dose (vaccination site and route were not provided). for prophylaxis.