chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Gastroenteritis viral, Headache, Influenza like illness
Clinical narrative: Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; Felt like Flu Coming On; Sore Arm; Runny Nose with Mucous; This is a spontaneous case is received from a contactable consumer or other non hcp (patient). A 61-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EN6206) as dose 1 single (at the age of 61-years-old ) for covid-19 immunisation. Medical history included diabetes mellitus from 2009 and ongoing Verbatim: Slightly Diabetic. The patient's concomitant medications were not reported. The patient experienced sore arm on 10Mar2021, runny nose with mucous on 10Mar2021, severe headache on 07Apr2021, muscle ache on 05Apr2021, on 02Apr2021 felt like flu coming, abdominal pain, lost his appetite, had a horrible feeling in his stomach, almost like the stomach flu, cold and had trouble maintaining his body heat, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs over a week. The outcome of the event sore arm was recovered on an unspecified date Mar2021 and rest of the events was recovering.  No follow-up attempts are possible.No further information is expected.  Follow-up (12Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. This report included that: Caller was a male. Patient gender "Male" retained as previous.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pain in extremity, Rhinorrhoea, Weight decreased
Clinical narrative: Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; Felt like Flu Coming On; Sore Arm; Runny Nose with Mucous; This is a spontaneous case is received from a contactable consumer or other non hcp (patient). A 61-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EN6206) as dose 1 single (at the age of 61-years-old ) for covid-19 immunisation. Medical history included diabetes mellitus from 2009 and ongoing Verbatim: Slightly Diabetic. The patient's concomitant medications were not reported. The patient experienced sore arm on 10Mar2021, runny nose with mucous on 10Mar2021, severe headache on 07Apr2021, muscle ache on 05Apr2021, on 02Apr2021 felt like flu coming, abdominal pain, lost his appetite, had a horrible feeling in his stomach, almost like the stomach flu, cold and had trouble maintaining his body heat, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs over a week. The outcome of the event sore arm was recovered on an unspecified date Mar2021 and rest of the events was recovering.  No follow-up attempts are possible.No further information is expected.  Follow-up (12Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. This report included that: Caller was a male. Patient gender "Male" retained as previous.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Gait disturbance, Metabolic function test, Muscle spasms, Myalgia
Clinical narrative: Muscle pain; severe muscle spasms in his legs; Trouble walking around house; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number was not known), first dose via intramuscular route of administration, administered in Arm Left on 03Mar2021 (At the age of 59 year) as DOSE 1, SINGLE for covid-19 immunization. Medical history included arthritis (Verbatim: Arthritis started 5 years ago), degenerative bone disease (started at least 5 years ago, been on pain medications) and hepatic cirrhosis (diagnosed 11 years ago, Quit drinking at that time) from an unknown date and unknown if ongoing. Concomitant medication(s) included oxycodone (10mg/325mg) taken One tablet every 6 hour for pain, start and stop date were not reported. No Prior Vaccinations (within 4 weeks) and no other vaccinations within four weeks. On 04Mar2021 14:30 the patient experienced muscle pain, severe muscle spasms in his legs and trouble walking around house on an unspecified date of 2021. The patient underwent lab tests and procedures which included CBC and Comprehensive metabolic panel found to be with no result on unspecified date. Patient for Treatment involved a shot in the ER after 19 hours, but he doesn't know what that was. He was also given 30 pills of Methocarban. There was no hospitalization involved for patient. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021750210 same reporter, same drug/event, different patient
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This is a spontaneous report from a contactable consumer or other non-health care professional (patient, reported for self). A 71-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EN6208) via an unspecified route of administration, administered in arm left on 19Mar2021 11:00 (at the age of 71-years-old) as dose 2, single for covid-19 immunization, administered in hospital. Patient had no medical history. Concomitant medications included alprazolam (Occasionally) taken for an unspecified indication from an unspecified date in 2013 and ongoing; atorvastatin, bisoprolol fumarate and escitalopram, all taken for an unspecified indication from an unspecified date in 2015 and ongoing. Patient previously (historical vaccine) received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EN6201) via an unspecified route of administration, administered in arm left on 20Feb2021 (at the age of 71-year-old) as dose 1, single for covid-19 immunization and experienced hit my head and woke up the night I had vaccine and almost fell over (Head injury); and on 20Feb2021, extremely dizzy (Dizziness) lasted for about 4.5 day. On 20Mar2021 15:00 (also reported as the next day), patient experienced severe diarrhea, lasted about 4.5 days but not as bad. Adverse event did not require to visit emergency room or physician office visit. The patient did not receive any treatment. Culture was not performed and relevant tests was noted as no. Outcome of the event was recovered (on an unspecified date in 2021).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe back pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 09:30 (Batch/Lot Number: EP6955, age at the time of vaccination: 60-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included severe case fibromyalgia from 2006 and ongoing (started more or less 15 years ago, in those days they didn't know much about it, but she was diagnosed in 2006). No concomitant medications. The patient experienced severe back pain on an unknown date in Mar2021. A few days (3 to 4 days) after the vaccine she started to experience severe back pain. It was the in middle of her low back. She just had it and couldn't figure out why. She ignored it, thinking maybe she may have twisted her back or maybe she moved or made the wrong turn, she didn't think it was related to anything. But it never stopped. It was bad but it wasn't like it was that bad. She took Tylenol Extra Strength as a corrective measure. Caller declined to provide physician information. Caller has not disclosed to them her experience. Caller knows we are all so new at this, and how it is. She had spoken with her doctor friends and they have advised her they are all new at this and don't know what the side effects can be. She was waiting and hoping it will go away and it definitely has not. When she would lay down, she has pain. Gets up, pain. When she moves, pain. Caller added, her pain tolerance is very high. Vaccine not Administered at private Facility. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit Emergency Room or physician office due to events. No prior Vaccinations (within 4 weeks) of vaccination. No relevant Tests. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation
Clinical narrative: Whole body inflammation; Major fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A adult non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left (reported as left arm) on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left (reported as left arm) on an unspecified date as dose 2, single both for covid-19 immunization. Patient's relevant medical history included allergy to bee venom, from an unknown date and unknown if ongoing. The patient did not receive any concomitant medications. The patient previously received naproxen (MANUFACTURER UNKNOWN) and cefalexin (KEFLEX) on an unspecified date and experienced drug allergy. Prior to vaccination, it was unknown if the patient was diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced whole body inflammation. and major fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue
Clinical narrative: Depression; extremely tired and sad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DEPRESSION (non-serious) with onset 06May2021 06:30, outcome "recovered" (May2021), described as "Depression"; FATIGUE (non-serious) with onset 06May2021 06:30, outcome "recovered" (May2021), described as "extremely tired and sad". The events "depression" and "extremely tired and sad" were evaluated at the physician office visit. Therapeutic measures were taken as a result of depression, fatigue.  Additional info: The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Therapeutic measures were taken as a result of the event which included mental health counselling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain
Clinical narrative: severe pain in my left ear; I have been in severe pain; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 11:15 (Batch/Lot Number: EN6200) as dose 2, single for covid-19 immunisation. Medical history included Breast Cancer survivor. Concomitant medications included hydrochlorothiazide, triamterene (TRIAM TIAZIDA R) and hctz (HCTZ). The patient received first dose of BNT162B2 on 28Feb2021 (lot number EN6207, administration time 10:00 AM vaccine location Left arm) for covid-19 immunisation. The patient had no known allergies. The patient did not have Covid prior to the vaccination. The patient was not tested for covid post vaccination. The patient did not receive other vaccine in four weeks. On 25Mar2021 at 12:00 AM the patient experienced severe pain in my left ear and i have been in severe pain. Therapeutic measures were taken as a result of both the events. It was reported After the second vaccine, she started having severe pain in left ear and it was going on since March. She had a physical the following month and the doctor saw nothing, but she was given 800 mg IBUPROFIN, which did not help. She went to the ENT Doctor 2 times and they saw nothing. She tried over the counter ear drops for the pain and that did not work. That is when she went to the ENT Doctor which saw nothing but she gave her a prescription, which did not help. She went back to the ENT and saw a different doctor and he saw nothing, she has been in severe pain and do not know what to do. She had a physical last Tuesday and her Doctor mentioned that 3 other patients complained about the same issue. The events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The outcome of both the events was not resolved. Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Dizziness, Emotional distress
Clinical narrative: dizzy; I had face and mouth swelling and could not eat solid foods due to the discomfort; I had face and mouth swelling and could not eat solid foods due to the discomfort; tingling in my muscles and nerves; extreme headache; emotional; upset stomach; diarrhea; I had joint aches and popping in them; fatigue; lymph node swelling it caused after each vaccine shot; stiff neck , shoulders; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration at the right arm on 04Jun2021 10:00 (at age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Other medical history was reported as patient was healthy person with no chronic conditions and illness. Known allergies was reported as some past prescription medications also the patient is sensitive person and had the uncommon side effect. Concomitant medication(s) included multivitamins and magnesium supplements. 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ew0180), via an unspecified route of administration at the right arm on 14May2021 10:00 (at age of 61-years-old) DOSE 1, SINGLE for covid-19 immunisation and experienced a racy feeling and a bit of needing to take deep breaths and had an extreme headache for 3 days along with fatigue, along with the lymph node swelling. After the second dose, on 05Jun2021 (following day), the patient had joint aches and popping in them, fatigue during the whole weekend along with the lymph node swelling and stiff neck, shoulders. On 07Jun2021 (on the day 3), the patient had upset stomach with diarrhea, on 08Jun2021 (on day 4), a very extreme headache that lasted all day on the same day patient being very emotional. On 09Jun2021 (on day 5), the patient had tingling in my muscles and nerves and on 10Jun2021 (on day 6), the patient had face and mouth swelling and could not eat solid foods due to the discomfort. On an unspecified date, patient had a day of feeling a bit dizzy. At the time of report, patient still dealing with the emotional side effect. The events resulted in doctor or other healthcare professional office/clinic visit. The patient went to see her doctor so she could make sure her throat was not swelling also (it didn't). The patient took no treatment for the reported events. Outcome of events were reported as recovering.  No follow-up attempts are possible. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Mouth swelling, Musculoskeletal stiffness
Clinical narrative: dizzy; I had face and mouth swelling and could not eat solid foods due to the discomfort; I had face and mouth swelling and could not eat solid foods due to the discomfort; tingling in my muscles and nerves; extreme headache; emotional; upset stomach; diarrhea; I had joint aches and popping in them; fatigue; lymph node swelling it caused after each vaccine shot; stiff neck , shoulders; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration at the right arm on 04Jun2021 10:00 (at age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Other medical history was reported as patient was healthy person with no chronic conditions and illness. Known allergies was reported as some past prescription medications also the patient is sensitive person and had the uncommon side effect. Concomitant medication(s) included multivitamins and magnesium supplements. 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ew0180), via an unspecified route of administration at the right arm on 14May2021 10:00 (at age of 61-years-old) DOSE 1, SINGLE for covid-19 immunisation and experienced a racy feeling and a bit of needing to take deep breaths and had an extreme headache for 3 days along with fatigue, along with the lymph node swelling. After the second dose, on 05Jun2021 (following day), the patient had joint aches and popping in them, fatigue during the whole weekend along with the lymph node swelling and stiff neck, shoulders. On 07Jun2021 (on the day 3), the patient had upset stomach with diarrhea, on 08Jun2021 (on day 4), a very extreme headache that lasted all day on the same day patient being very emotional. On 09Jun2021 (on day 5), the patient had tingling in my muscles and nerves and on 10Jun2021 (on day 6), the patient had face and mouth swelling and could not eat solid foods due to the discomfort. On an unspecified date, patient had a day of feeling a bit dizzy. At the time of report, patient still dealing with the emotional side effect. The events resulted in doctor or other healthcare professional office/clinic visit. The patient went to see her doctor so she could make sure her throat was not swelling also (it didn't). The patient took no treatment for the reported events. Outcome of events were reported as recovering.  No follow-up attempts are possible. No further information is expected
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: dizzy; I had face and mouth swelling and could not eat solid foods due to the discomfort; I had face and mouth swelling and could not eat solid foods due to the discomfort; tingling in my muscles and nerves; extreme headache; emotional; upset stomach; diarrhea; I had joint aches and popping in them; fatigue; lymph node swelling it caused after each vaccine shot; stiff neck , shoulders; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration at the right arm on 04Jun2021 10:00 (at age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Other medical history was reported as patient was healthy person with no chronic conditions and illness. Known allergies was reported as some past prescription medications also the patient is sensitive person and had the uncommon side effect. Concomitant medication(s) included multivitamins and magnesium supplements. 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ew0180), via an unspecified route of administration at the right arm on 14May2021 10:00 (at age of 61-years-old) DOSE 1, SINGLE for covid-19 immunisation and experienced a racy feeling and a bit of needing to take deep breaths and had an extreme headache for 3 days along with fatigue, along with the lymph node swelling. After the second dose, on 05Jun2021 (following day), the patient had joint aches and popping in them, fatigue during the whole weekend along with the lymph node swelling and stiff neck, shoulders. On 07Jun2021 (on the day 3), the patient had upset stomach with diarrhea, on 08Jun2021 (on day 4), a very extreme headache that lasted all day on the same day patient being very emotional. On 09Jun2021 (on day 5), the patient had tingling in my muscles and nerves and on 10Jun2021 (on day 6), the patient had face and mouth swelling and could not eat solid foods due to the discomfort. On an unspecified date, patient had a day of feeling a bit dizzy. At the time of report, patient still dealing with the emotional side effect. The events resulted in doctor or other healthcare professional office/clinic visit. The patient went to see her doctor so she could make sure her throat was not swelling also (it didn't). The patient took no treatment for the reported events. Outcome of events were reported as recovering.  No follow-up attempts are possible. No further information is expected
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Other side effects I am noticing the day after the second dose are joint and muscle pain; Other side effects I am noticing the day after the second dose are joint and muscle pain; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0179), via an unspecified route of administration on 17Jun2021 (at the age of 30-year-old) as dose 2, single for covid-19 immunisation. Medical history included known allergies to sulpha drugs. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (at the age of 30-year-old) as dose 1, single for covid-19 immunisation and had bad breakout of acne on her forehead, nose, and chin. Her cycle was currently over a week late. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient reported that side effects she was noticing the day after the second dose (18Jun2021) were joint and muscle pain. Patient did not receive treatment for adverse events. Patient did not have covid prior vaccination and covid was not tested post vaccination. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; fever; body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Jun2021 10:30 (Lot number: EW0185) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Peaches" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PHENTERMINE; TOPIRAMATE. Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin"; Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (dose number 1, product COVID 19, brand Pfizer, lot number EW0182, administration date 28May2021, administration time 10:15 AM, vaccine location Right arm), administration date: 28May2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 18Jun2021 21:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 18Jun2021 21:00, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 18Jun2021 21:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 18Jun2021 21:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of chills, pyrexia, pain, headache.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 25Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1ST DOSE), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jun2021, outcome "unknown", described as "Fever"; HEADACHE (non-serious) with onset Jun2021, outcome "unknown", described as "Headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Vaccination site reaction
Clinical narrative: Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Jun2021 (Lot number: EW0217) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: quinolones" (unspecified if ongoing); "Known allergies:tetracyclines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), MYALGIA (non-serious), ARTHRALGIA (non-serious), FATIGUE (non-serious), VACCINATION SITE REACTION (non-serious) all with onset 06Jun2021 15:00, outcome "recovered" (2021) and all described as "Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i". Therapeutic measures were not taken as a result of headache, myalgia, arthralgia, fatigue, vaccination site reaction.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive treatment for the events. AE resulted in: None of the above. Other medical history: N/A. Symptoms resolved within 24 hours of injection. Other medications in two weeks was none reported.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Ultrasound breast abnormal
Clinical narrative: had a breast ultrasound, abnormal lymph glands; Initial information received on 10-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional under reference number: US-SA-SAC20211116001364.  This case involves an unknown age female patient who experienced had a breast ultrasound, abnormal lymph glands (Lymphadenopathy) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious had a breast ultrasound, abnormal lymph glands (Lymphadenopathy) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: flu; Initial information received on 15-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Hell No! Never would get one again! Last time I got one I was sick with the flu for 3 weeks."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Erythema, Hypersensitivity, Rash, Rash pruritic
Clinical narrative: allergic reaction; arm got red; Rash was about the palm of my hand, not sore but very itchy; Initial information was received on 16-Nov-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional (patient) via social media (under reference number: US-SA-SAC20211122001377).  This case involves a patient of (unknown demographics) who experienced allergic reaction (hypersensitivity), arm got red (erythema), rash was about the palm of hand, not sore but very itchy (rash pruritic) when 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, 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 allergic reaction (hypersensitivity), arm got red (erythema), rash was about the palm of hand, not sore but very itchy (rash pruritic) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Over the hill, shots were much stronger."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu for a long week; Initial information was received on 17-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional (under reference number: US-SA-SAC20211124000688).  This case involves an adult patient with an unknown gender who experienced flu for a long week  (influenza) after receiving INFLUENZA VACCINE.  The patient's past medical treatments, concomitant medications, vaccinations, and family history were not provided.   The patient had no medical history, concomitant disease, or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu for a long week (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Always gives me the week long flu."  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Death NOS; Initial information received on 20-Nov-2021 regarding an unsolicited valid serious case received from a Social Media via consumer non health care professional under reference number: US-SA-SAC20211127000105.  This case involves an unknown age and unknown gender patient who experienced death Nos (death) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event death Nos (death) (unknown latency) following the administration of INFLUENZA VACCINE.  These event were assessed as medically significant and was leading to death.  Final diagnosis was (fatal) death nos.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the patient was Fatal for the event death.  It was unknown if an autopsy was done. The cause of death was reported as Death Nos.; Sender's Comments: This poorly documented case from Social media concerns a female patient who died after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Influenza
Clinical narrative: This case involves a female patient who experienced headache, chills and flu symptoms (Influenza) after receiving INFLUENZA VACCINE. The patient past vaccination(s) included INFLUENZA VACCINE. Additional medication was reported sulfate allergy. The patient past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious headache, chills, flu symptoms (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Influenza vaccine and sister case (as patient is not sure so the case splitting was not requested). It was reported "The caller declined to provide other demographics. The caller wanted to know what inactive ingredients are in Fluzone Quad and if we can explain why the eggs are soaking in formaldehyde. She reports a history of adverse reaction to flu vaccine in the past, as well as her sister having similar reaction last year and this year with the double vaccine". Details of laboratory data not reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for the reported events. There will be no information available on the batch number for this case.
Sex: F
Vaccine: UNK, UNK
Symptoms: Magnetic resonance imaging normal, Muscular weakness, Trigeminal neuralgia
Clinical narrative: Burning in her arms and down sides of her legs; Leg muscle weakness; Tripping; Felt like she could not lift her legs; Burning in her trigeminal nerves in her face and eyes; Allergic reaction to Imovax/Imogam; Initial information was received on 15-Nov-2021 regarding an unsolicited valid non-serious case received from consumer or non-healthcare professional via Medical Information (MI) - 00857352.  This case involves a 41-year-old female patient who experienced tripping (Gait disturbance), burning in her arms and down sides of her legs (burning sensation), leg muscle weakness(muscular weakness), allergic reaction to imovax/imogam (hypersensitivity), burning in her trigeminal nerves in her face and eyes (trigeminal neuralgia) and felt like she could not lift her legs (asthenia) after receiving IPV (VERO) [IMOVAX] and while treated with HUMAN RABIES IMMUNOGLOBULIN [IMOGAM].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On Sep-2021, the patient received a dose of suspect IPV (VERO) [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On Sep-2021, the patient started taking IMOGAM (HUMAN RABIES IMMUNOGLOBULIN) [Solution for injection, lot - T1E94, expiry date not reported] via unknown route at an unknown administration site.  On an unknown date the patient developed a serious tripping (gait disturbance), burning in her arms and down sides of her legs (burning sensation), leg muscle weakness (muscular weakness), allergic reaction to imovax/imogam (hypersensitivity), serious burning in her trigeminal nerves in her face and eyes (trigeminal neuralgia), felt like she could not lift her legs (asthenia) (unknown latency) following the administration of IPV (VERO) and following the first dose intake and (unknown latency) following the last dose intake of HUMAN RABIES IMMUNOGLOBULIN.   Relevant laboratory test results included: On an unknown date: Magnetic resonance imaging (was ok), Scan brain (was ok).  it was reported "Caller reports she had Imovax and Imogam starting in SEP2021. She reports increasing neurological reaction with each vaccine. She had 3 injections in the series and did not finish. She states after first vaccine she had burning in her arms and down sides of her legs, which she reported to health department but it was recommended she continue the vaccine. She got the second in the series and had burning in her trigeminal nerves in her face and eyes. She again reported this and it was recommended she get the third in the series. She then had leg muscle weakness, tripping and it felt like she could not lift her legs. She was referred to neurologist. She had brain scan and MRI which were ok and was told it was an allergic reaction to Imovax/Imogam."  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.
Age: 13.0
Sex: M
Vaccine: DTAP, HEP, MNQ
Symptoms: Expired product administered
Clinical narrative: an expired dose was administered, no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Agency (Reference number- 00858482) and transmitted to Sanofi on 15-Nov-2021.  This case involves a 13-year-old male patient who received an expired dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) for Immunisation.  On 15-Nov-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (total, lot U6785AA, expiry date: 31-Oct-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired product administered (latency: same day).  It was reported "caller would like information regarding re-vaccination."  At time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: PENTACEL reconstituted with sterile water with no reported adverse event; Initial information was received on 15-Nov-2021 regarding an unsolicited valid non-serious case received from other health professional and non-healthcare professional via Medical information (MI) under reference number - 00858573)  This case involves a 4-months old female patient who was vaccinated with suspect vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] while preparing vaccine reconstituted with sterile water with no adverse event (product preparation error).  The patient's past medical treatments, concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 15-Nov-2021, the patient received a 0.5ml {total} dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] (lot number UJ531AAA and expiry date 22-Jul-2022 was reported) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.