chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Headache
Clinical narrative: head aches; double vision; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route on 01Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced head aches on 01Apr2021 and double vision on unspecified date in Apr2021. Patient stated that since he had the second shot Pfizer 01Apr2021, that same day he started having head aches and hasn't stopped since, last week Wednesday, he started having double vision that still exists, went to the eye doctor, bought new glasses. They want him to see a specialist next. Since he had the second shot this has been going on with him that is why he thought it was related to the vaccine. He asked is there anything else he should be doing. Response was a review of the prescribing information for Pfizer BIONTECH COVID 19 VACCINE did not find information regarding double vision. Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BIONTECH COVID 19 VACCINE). Beyond what is described in the <Pfizer BIONTECH COVID 19 VACCINE prescribing Information, Pfizer does not provide any recommendations regarding the management or treatment of potential adverse events/reactions/symptoms that a patient /consumer may experience. Your doctor/healthcare provider is in the best position to advise you about the appropriate action to take as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. There was no PQC present. The outcome of event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster reactivation, Rash vesicular
Clinical narrative: Vesicular rash; Shingles outbreak; This is a spontaneous report from a contactable other healthcare professional (patient's daughter). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in the right arm, on 12Mar2021, as 1st dose, single, for COVID-19 immunisation; and the second dose of hepatitis B vaccine (trade name unspecified, lot number not reported), via an unspecified route of administration, on 15Mar2021, at an unspecified dose, for immunization. The patient's medical history included hemodialysis from 2016 and ongoing (has been on hemodialysis for maybe 5 years), possible shingles and chickenpox when she was a kid. Concomitant medications were unspecified, there is quite an extensive list of medications (unspecified) the patient is on. It was reported that the patient had the hepatitis B shot too close to the COVID-19 vaccine. On 12Mar2021, the patient received the COVID-19 vaccine. On 15Mar2021, at her dialysis treatment, the patient received the second shot of the hepatitis B vaccine. It was reported as an error as it was administered too close to the Pfizer COVID-19 vaccine. By that Friday, 19Mar2021, the patient had a vesicular rash that the reporter would guess was a shingles outbreak. The patient was taken to her primary doctor for the events. The reporter thought this was related to the patient's immune system dealing with 2 vaccines and the virus had the opportunity. Treatment for the events included a whole course of antiviral (unspecified) which started on 19Mar2021. The patient then received her second dose of COVID-19 vaccine on 03Apr2021 (lot number: ER8732) in her right arm. The dialysis clinic said they would continue to give the next hepatitis B shot and the reporter asked them to hold on while she gets more information. The reporter asked about the implications of receiving the hepatitis B vaccine too close to the first dose of COVID-19 vaccine and asked when they should resume the hepatitis B shots. The patient recovered from the events on an unspecified date (reported as "went away at the end of the 10-day course of the antiviral").  No follow up attempts are needed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster aka Shingles; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration, administered on the left arm on 31Mar2021 08:30 (Batch/Lot Number: ER8734) as unknown, single for covid-19 immunisation. Medical history included chronic migraine, wheat allergy and covid-19 prior to vaccination. No other vaccines were received in 4 weeks. Patient was not pregnant. The patient's concomitant medications were not reported.  The patient experienced herpes zoster aka shingles on 03Apr2021 08:00. Event resulted in healthcare professional office/ clinic visit. Unspecified antiviral was given as treatment. Outcome of the event was recovering. The event was considered non-serious by the reporter. Patient had not been tested post-vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: had a virus; This is a spontaneous report from a contactable consumer (patient). A 63 years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EW0150) as single dose at right arm for covid-19 immunisation. Medical history was none. Concomitant medication(s) included amlodipine besilate for blood pressure abnormal. The patient reported that on 22Apr2021, he went to the emergency and they said he had a virus and he had appointment made there, so he want to know did he went there to take his second shot or what did he do next. Consumer stated that No Treatment receive, he was hydrated and they gave him through the bottles in the hospital and send him home the same day. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: labored breathing; heart rate elevated; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 at single dose for COVID-19 immunisation. Medical history included dyslexia. Concomitant medication was not reported. The patient received her first dose of Pfizer vaccine last Monday (19Apr2021). She went to the ER Saturday (24Apr2021) experiencing symptoms when she got home and last week. Is for the Covid 19 vaccine.  She had dyslexia which was before vaccine. She had labored breathing after the vaccine and her heart rate was elevated. She was unable to bring her heart rate down. It was difficult to walk upstairs and read warm ups for her senior citizens. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tendon rupture
Clinical narrative: he lifted a heavy object and tore the bicep distal tendon in that same (left) arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Apr2021 13:30 (Batch/Lot Number: EW0162) (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and spinal disc surgical repair in 2005. Concomitant medications included atorvastatin; cetirizine; aspirin [acetylsalicylic acid] (ASPIRIN), all were taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced rash and wool-lanolin and experienced itch. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received other vaccine in four weeks. On 24Apr2021 18:00, four days after injection into his left arm, he lifted a heavy object and tore the bicep distal tendon in that same (left) arm which resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the event and surgical repair to be scheduled as soon as possible (ASAP). The outcome of event, he lifted a heavy object and tore the bicep distal tendon in that same (left) arm, was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Malaise
Clinical narrative: feel unwell; developed shingles; This is a spontaneous report from a contactable consumer (patient's wife).   A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 23Apr2021 (Batch/Lot Number: ER8735) as 2nd dose, single (at the age of 38 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, at the age of 38 years old for COVID-19 immunisation.  The patient experienced Pfizer covid 19 vaccine on 23Apr2021. he started to feel unwell Sunday into Monday and was formally diagnosed with shingles yesterday (27Apr2021). Treatment for adverse event: Reporter stated, "They just provide valacyclovir, that's the antiviral an the other one is, shingles can cause like nerve pain, Gabapentin. It's 1gram tablet and the tablet has to be taken by mouth three times a day for week. It's 100mg one capsule by mouth 3 times daily for the 30 dosages". The outcome of shingles was not recovered and other event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: the rash across the midline  (Across my face up to my left eye, neck, left and right arms, stomach, right leg); shingles; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced the rash across the midline (Across my face up to my left eye, neck, left and right arms, stomach, right leg) but that's how the patient's family apparently gets shingles on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Angina pectoris, Arthralgia, Back pain, Catheterisation cardiac
Clinical narrative: the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; injection site pain; pain is around his arms/going on the top of his legs; back and wraps down to the heart; major pain up around his shoulders and around the back of neck; I have stomach problems, I am collapsed stomach; This is a spontaneous report from a contactable consumer (patient). This 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in his left arm on 05Apr2021 at single dose for COVID-19 immunisation. Medical history included Arthritis, Sinus problem, Asthma, Bipolar disorder. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date at age of 55 years old for COVID-19 immunisation. The patient experienced injection site pain, severe pain in his left shoulder after that second dose. Some major pain up around his shoulders and around the back of neck, his left side was worst. He said that the pain was shooting down to his heart. So he went to the hospital because he thought it was something to the heart. They tested him, they evaluated him but they ruled out anything that has to do with the heart. They checked his heart, he had a cardiac catheterization, and was ruled out, everything came out negative.  So, he just got out of hospital and was still developing the pain and it's on his left side, it's on his right side (as reported). He called all his doctors, they had no answers for him, now he was still in a lot of pain in both of shoulders like he was saying his left side was still the worst, and it has not gone away and the pain is still shooting down around his heart and shooting down around the back of neck and now it's going on the top of his legs.  He went to the bone doctor and he was getting an MRI done, because the doctors said nothing was torn in his arms or tissues. He stated the pain was around his arms, back and wraps down to the heart. He was in dire pain, 8.5/10 and had a feeling of it was related to the vaccine. He clarified the pain was in both shoulders and the left side was worse and that was the side he had his shot on.  Patient stated he had stomach problems, he was collapsed stomach. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; injection site pain; pain is around his arms/going on the top of his legs; back and wraps down to the heart; major pain up around his shoulders and around the back of neck; I have stomach problems, I am collapsed stomach; This is a spontaneous report from a contactable consumer (patient). This 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in his left arm on 05Apr2021 at single dose for COVID-19 immunisation. Medical history included Arthritis, Sinus problem, Asthma, Bipolar disorder. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date at age of 55 years old for COVID-19 immunisation. The patient experienced injection site pain, severe pain in his left shoulder after that second dose. Some major pain up around his shoulders and around the back of neck, his left side was worst. He said that the pain was shooting down to his heart. So he went to the hospital because he thought it was something to the heart. They tested him, they evaluated him but they ruled out anything that has to do with the heart. They checked his heart, he had a cardiac catheterization, and was ruled out, everything came out negative.  So, he just got out of hospital and was still developing the pain and it's on his left side, it's on his right side (as reported). He called all his doctors, they had no answers for him, now he was still in a lot of pain in both of shoulders like he was saying his left side was still the worst, and it has not gone away and the pain is still shooting down around his heart and shooting down around the back of neck and now it's going on the top of his legs.  He went to the bone doctor and he was getting an MRI done, because the doctors said nothing was torn in his arms or tissues. He stated the pain was around his arms, back and wraps down to the heart. He was in dire pain, 8.5/10 and had a feeling of it was related to the vaccine. He clarified the pain was in both shoulders and the left side was worse and that was the side he had his shot on.  Patient stated he had stomach problems, he was collapsed stomach. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable pharmacist received via the medical information team. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient tested positive for COVID-19. The reporter questioned if there was a specific amount of time the patient had to wait before getting the second dose. The clinical outcome of positive COVID-19 test was unknown.   Information on batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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 agency, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Herpes zoster reactivation
Clinical narrative: Sometimes similar to the feeling she had when she had shingles in the past; She says it feels like period symptoms; This is a spontaneous report received from a contactable consumer  (patient's husband). A 59-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included shingles. The patient's concomitant medications were not reported. The patient has developed issues on Apr2021, she says it feels like period symptoms and sometimes similar to the feeling she had when she had shingles in the past. They recently read of possible side effects that include the vaccine possibly stimulating previous auto immune issues. Should she get the 2nd shot or visit with physician before receiving? The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: body aches; chest pain; pressure on chest; low fever; cold; tested positive for covid 19; This is a spontaneous report from a contactable consumer report for self from a Pfizer sponsored program Covax US Support. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Apr2021 16:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations within 4 weeks. Medical history included ongoing high blood pressure started 8-9 years ago. Concomitant medications included lisinopril (LISINOPRIL) taken for high blood pressure about few years; acetylsalicylic acid (BAYER ASPIRIN) taken to keep the blood thin and blood pressure; Carvedilol taken for heart valve, something to do with his heart since couple years ago. Patient received his first vaccine dose on 10Apr2021 and on 11Apr2021 tested positive for covid 19. He was at Emergency Department on an unspecified date. He went because he had body aches, chest pain, pressure on chest, once in a while had low fever, cold, and achy body. He was given a treatment, but doesn't know the name of what was given. It was through the Intravenous site. Patient no longer has symptoms and has completed his required isolation. He is due to get his second vaccine dose on 01May and asked do he get second dose or should wait. The outcome of events was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: body aches; chest pain; pressure on chest; low fever; cold; tested positive for covid 19; This is a spontaneous report from a contactable consumer report for self from a Pfizer sponsored program Covax US Support. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Apr2021 16:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations within 4 weeks. Medical history included ongoing high blood pressure started 8-9 years ago. Concomitant medications included lisinopril (LISINOPRIL) taken for high blood pressure about few years; acetylsalicylic acid (BAYER ASPIRIN) taken to keep the blood thin and blood pressure; Carvedilol taken for heart valve, something to do with his heart since couple years ago. Patient received his first vaccine dose on 10Apr2021 and on 11Apr2021 tested positive for covid 19. He was at Emergency Department on an unspecified date. He went because he had body aches, chest pain, pressure on chest, once in a while had low fever, cold, and achy body. He was given a treatment, but doesn't know the name of what was given. It was through the Intravenous site. Patient no longer has symptoms and has completed his required isolation. He is due to get his second vaccine dose on 01May and asked do he get second dose or should wait. The outcome of events was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Fatigue, Illness, Pain in extremity, Somnolence
Clinical narrative: caller is disabled and has a bad back and stuff; have tons of ills because of the shot; felt soreness in the arm; Sleepiness; caller was tired; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 28Apr2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 between 09:00-10:00 (Lot Number: EP6955) as 1st dose, single for COVID-19 immunisation. There was no medical history, no family medical history relevant to adverse events.  The patient's concomitant medications were not reported. There were no prior vaccinations within 4 weeks. The patient felt soreness in the arm and it made him sleepy after the first dose of the Pfizer COVID-19 vaccine in the evening of 22Mar2021. When he got back home the same day 22Mar2021 sleepiness began. The patient stated this was probably going to happen anyway, he was disabled and had a bad back and stuff on an unspecified date.  The patient had to drive 30 some miles, 31 miles to be exact to see the doctor to receive the Pfizer Covid Vaccination.  When he returned from the trip he was tired and would go to sleep anyway on 22Mar2021.  The patient stated soreness in the arm had been gone for maybe 3 or 4 days, he was good, no problem with arm, and sleepiness went away. The patient mentioned that he had tons of ills on unspecified date because of the shot. The patient was not experiencing any of this before having the Pfizer Covid Vaccine. The events did not require a visit to Emergency room or Physician office. There were no relevant tests.  The outcome of events felt soreness in the arm and Sleepiness was recovered, and of the other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus inadequate control
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via Medical Information Team. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced worsening control of blood glucose since receiving vaccine on an unspecified date. The patient outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of worsening control of blood glucose.  The reported event likely represent intercurrent medical condition.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.
Sex: F
Vaccine: COVID19
Symptoms: Eye colour change, Eye irritation
Clinical narrative: woke up my eye burned like somebody touch me, was color blue like someone hit me. only right side; woke up my eye burned like somebody touch me, was color blue like someone hit me. only right side; This is a spontaneous report from a non-contactable consumer (patient).  A 59-years-old female patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and  concomitant medications were not reported.  On an unspecified date the caller reported I woke up and  my eye burned like somebody touch me, was color blue like someone hit me. Only right side. I got my injection in the left arm. Consumer inquired What happens in the second vaccine?  Can it be worse after the second? Is there any record of this happening on the inside. (bruising, blood clotting) ? The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate decreased
Clinical narrative: Heart rate is also down from 60 to 49; Her usual blood pressure is 102/60, however it is at 134/64 right now; She has light-headedness/dizziness; This is a spontaneous report received a contactable pharmacist. A female of unspecified age received a dose (unspecified dose number) of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 26Apr2021 (reported as forty-eight hours ago) for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The pharmacist reported that her cousin received the Pfizer COVID vaccine forty-eight hours ago. The pharmacist reported that her cousin's blood pressure is usually 102/60, however it is at 134/64 on 28Apr2021 (reported as right now). The pharmacist also mentioned that her heart rate is also down from 60 to 49 and she has light-headedness and dizziness on 28Apr2021 (reported as right now). The outcome of the events blood pressure 134/64 right now, heart rate is also down from 60 to 49, and light-headedness and dizziness, was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of HR decreased, BP increased and dizziness.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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 agency, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis perforated, Asthenia, Bowel movement irregularity, Faeces soft, Influenza
Clinical narrative: appendix ruptured/aapendicitis; mild flu symptoms; energy level was low; stool is soft; bowel movements are not consistent; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8737), via an unspecified route of administration, administered in the right arm on 29Mar2021 as a single dose for COVID-19 immunization.  Medical history included allergy to penicillin from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE, reported as 'VYVANSE Xr'); duloxetine (manufacturer unknown) and lamotrigine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the patient had stomach ache and pains. On 06Apr2021, the stomach pains were constant and sometimes sharp and there were mild flu symptoms. On 07Apr2021, the patient had severe stomach pain and flu symptoms. The patient took a nasal swab rapid COVID test also which came back negative. In the afternoon of 07Apr2021, the patient's temperature hit 104 and she went to the ER. After the CT scan, appendicitis was confirmed and the patient went into an emergency appendectomy. The patient's appendix ruptured. On 09Apr2021, the patient was released from the hospital. As of 28Apr2021, the most of the patient's symptoms are gone but bowel movements are not consistent and stool is soft. The patient's energy level was low and there was slight lower stomach pain at times. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: appendix ruptured/aapendicitis; mild flu symptoms; energy level was low; stool is soft; bowel movements are not consistent; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8737), via an unspecified route of administration, administered in the right arm on 29Mar2021 as a single dose for COVID-19 immunization.  Medical history included allergy to penicillin from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE, reported as 'VYVANSE Xr'); duloxetine (manufacturer unknown) and lamotrigine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the patient had stomach ache and pains. On 06Apr2021, the stomach pains were constant and sometimes sharp and there were mild flu symptoms. On 07Apr2021, the patient had severe stomach pain and flu symptoms. The patient took a nasal swab rapid COVID test also which came back negative. In the afternoon of 07Apr2021, the patient's temperature hit 104 and she went to the ER. After the CT scan, appendicitis was confirmed and the patient went into an emergency appendectomy. The patient's appendix ruptured. On 09Apr2021, the patient was released from the hospital. As of 28Apr2021, the most of the patient's symptoms are gone but bowel movements are not consistent and stool is soft. The patient's energy level was low and there was slight lower stomach pain at times. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID/Fever, tiredness, cough; diagnosed with COVID/Fever, tiredness, cough; This is a spontaneous report from a contactable female consumer (patient). A 71-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Lot Number: EN6202) at single dose for COVID-19 immunisation.  Medical history included type 2 diabetes from 1995 to an unknown date. The patient's concomitant medications were not reported.  The patient was questioning the vaccine's efficacy because she had received her 1st dose last 05Mar2021 which was 7 and a half weeks ago. She mentioned that this was because 2 days before her supposed scheduled 2nd dose on 26Mar2021, she started running a temperature and suspected that she was infected by her Husband who had COVID at that time. She was diagnosed with COVID on 27Mar2021. She mentioned that she had a cough that would not go away so that was why she made sure that she had no symptoms before getting her 2nd shot. This past weekend, she mentioned that the cough was not as prevalent as before so she decided to get the shot. She mentioned that the nurse at the facility said that she would still be okay until she mentioned that her 1st shot was on 05Mar2021. She mentioned that her husband was healthier than her that's why he got the 2nd dose 6 and a half weeks after the 1st one. She would like to know if it will be still effective with her. She had been coughing and had a fever.  When asked to provide outcome for COVID virus, she stated that she was basically recovered, but was still a little tired.  At night time, she starts coughing.  She did fine during the day, but she was so much better.  She was able to do things.  She just has a little bit of a cough. This all started around 5 days into it.  Fever started 24Mar2021.  It lasted for 13 days and the last day of fever was 05Apr2021.   She started coughing 30Mar2021 or 31Mar2021. She later stated it may have been more like 28Mar2021 or 29Mar2021. She will be 72 on Sunday and said she was old and that just comes with being old. She felt ok.  The tiredness started time same time as the coughing.  She did not feel bad until she started coughing. A couple of days after she was diagnosed was when she started feeling bad.  She was able to drive herself to get the test and took a shower and felt ok.  She took the test on Friday and found out on Saturday.  On Sunday and Monday was when she started coughing.  That was when the fever started and it never got over 100.5 degrees. Adverse events (AE) details and time of onset was reported as: positive COVID virus in the morning; cough in the morning; fever in the afternoon; tiredness in the morning. There was no prescriber.  She just had it because she was a high risk patient. There were additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks), AE following prior vaccination, family medical history and relevant test. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diabetes mellitus, Diarrhoea, Headache, Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's sibling). A currently 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date in Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first Pfizer COVID 19 Vaccine about 6-7 weeks ago (in Mar2021). She has partial kidney function along with diabetes (unspecified onset dates). Two days after the vaccine (in Mar2021) she had an excruciating headache. The following day (in Mar2021), she experienced chills, fever and diarrhea. After several weeks (an unspecified date in 2021), she developed shingles. The clinical outcome of the event "shingles" was not resolved while the outcome of events "partial kidney function along with diabetes", excruciating headache, chills, fever and diarrhea was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476991 same patient, different dose number and event
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal impairment
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's sibling). A currently 65-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date in Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first Pfizer COVID 19 Vaccine about 6-7 weeks ago (in Mar2021). She has partial kidney function along with diabetes (unspecified onset dates). Two days after the vaccine (in Mar2021) she had an excruciating headache. The following day (in Mar2021), she experienced chills, fever and diarrhea. After several weeks (an unspecified date in 2021), she developed shingles. The clinical outcome of the event "shingles" was not resolved while the outcome of events "partial kidney function along with diabetes", excruciating headache, chills, fever and diarrhea was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476991 same patient, different dose number and event
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension
Clinical narrative: sharp pain in her head; high blood pressure; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that she ended in the emergency room (ER) because of a sharp pain in her head and high blood pressure up to 4 days after getting the first dose of vaccine. The patient outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable physician. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date in 2021 (reported as a month before this report) as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in 2021 (reported as a month before this report), the patient experienced Bell's palsy. Outcome was unknown. The reporting physician was asking if the second dose is required. Information on the batch number has been requested.; Sender's Comments: Assuming a plausible temporal association, a reasonable possibility that the reported Bell's palsy is related to BNT162B2 vaccine 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: Positive for COVID; Positive for COVID; Second dose would be administered more than 42 days; Second dose would be administered more than 42 days; This is a spontaneous report received from Medical Information from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose, via an unspecified route of administration on 05Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient received his first dose of the vaccine on 05Mar2021. He tested positive for COVID-19 and received the monoclonal antibodies/ passive antibody therapy on 21Mar2021. The pharmacist inquired if the patient will need to wait 90 days before receiving the second dose of the vaccine. The pharmacist inquired if the patient will need to restart the vaccination over with the second vaccine being about four months out. The second dose would be administered more than 42 days, longer than recommended intervals for mRNA vaccines. The outcome of the events drug ineffective and COVID-19 was unknown.  The lot/batch number for the vaccine was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fall, Muscular weakness
Clinical narrative: After first shot began experiencing weakness in legs; fell several times; This is a spontaneous report received from a contactable consumer (the patient). This is the first of 2 reports. A 71-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262) via an unspecified route of administration in left arm on 30Jan2021 at age of 71-year-old at single dose for COVID-19 immunisation. Relevant medical history included COVID-19 from Nov2020 (Was in hospital with COVID in November. Did well in December and January). Other medical history reported as "none". No known allergies. Concomitant medications (received within 2 weeks of vaccination) included bupropion taken for an unspecified indication from an unspecified date; clonazepam taken for an unspecified indication from an unspecified date and "Celebs" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. After first shot began experiencing weakness in legs and fell several times. The events onset date was 01Feb2021. "Steroids" was received for the event "weakness in legs". CT scans of entire spine and brain with unknown result. The events resulted in Doctor or other healthcare professional office/clinic visit, Hospitalization (for 23 days), Disability or permanent damage. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) :PFIZER INC-2021531421 same patient/reporter/drug, different AE in separated time
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Balance disorder, Burning sensation, Confusional state
Clinical narrative: he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having  a hard time to get a sentence out (felt like his motor skills were affected); having  a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021.  Information about lot/batch number has been requested.