chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thrombosis
Clinical narrative: blood clots; she did get really sick / she was displaying a lot of symptoms; fever; whole body was aching; fatigue; nauseated; bruises on the legs / now she's getting more / she would say they have worsened; This is a spontaneous report received from a contactable consumer (patient's mother). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration in arm left on 14May2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot and experienced nausea. The patient experienced blood clots on an unspecified date, bruises on the legs, she was getting more, she would say they have worsened in May2021, fever on 15May2021, whole body was aching on 15May2021, fatigue on 15May2021, nauseated on 15May2021, and she did get really sick, she was displaying a lot of symptoms on an unspecified date. Patient started having bruises on the legs and thought that it might be related to blood clots. She mentioned that she also experienced the common side effects but she was not concerned of that as people she knew also had those symptoms but was more concerned about the bruising. On patient's legs, she had a bunch of bruises. Reporter was just really nervous about her daughter's bruises. When patient was working, she was not noticing, but today patient noticed her legs and said reporter it was a lot of them. Patient did get really sick with her first shot, she had a fever, she couldn't go to work the next day. Reporter was not sure if the patient should get the second dose on 04Jun2021. Patient's whole body was aching, she was nauseated, she was displaying a lot of symptoms. Reporter checked online and they said it was a normal thing. Patient came down and showed reporter the bruises. Patient wasn't really paying attention to them. Patient had one or two bruises when she noticed and at the time of the report she was getting more. They had worsened. Patient took ibuprofen (ADVIL) for fever and she felt better. Outcome of events blood clots and she did get really sick, she was displaying a lot of symptoms was unknown, of event bruises on the legs, she was getting more, she would say they have worsened was not resolved, and of other events was resolved.
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia; This is a spontaneous report from a contactable consumer (patient's sister-in-law) received via the Medical Information Team from the Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced thrombocytopenia on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Bilateral deep vein thrombosis in both legs.; This is a spontaneous report from a non-contactable consumer (patient). An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 03Apr2021 10:00 AM (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included hypothyroid, high bp, urinary bladder cancer, lung cancer, covid-19. No Known allergies. Patient is not pregnant. The patient's concomitant medications were not reported. No other vaccine in four weeks. Patient previously received the first dose of BNT162B2 on 13Mar2021 10:00 AM (at 86 years old) into left arm for Covid-19 immunisation. The patient experienced bilateral deep vein thrombosis in both legs (hospitalization) on 14Apr2021. The patient was hospitalized for 2 days. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. covid was not tested post vaccination. Treatment received for the event included Xarelto. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: passed out; dizzy; This is a spontaneous report received from a contactable pharmacist via Pfizer sponsored program. A 28 years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left deltoid on 18May2021 6:00 PM central time (Lot Number: EW0185, Expiry Date: Aug2021, NDC Number: 5926-1000-01) at single dose for COVID-19 immunization. The patient's medical history, family medical history and concomitant medications was none. The patient has not had any other vaccines within the last 8 weeks. The patient got dizzy and passed out on 18May2021 after 6:00 PM after the first dose of the vaccine. They ended up calling 911 and the paramedics came. The paramedics checked him and released him, said he was good to go. He was not taken to the hospital. The patient did not visit emergency room neither physician office. The pharmacist assessed the events related to the vaccine and assessed as serious due to medically significant. The outcome of event was recovered completely. The pharmacist asked if he should get the second dose.; Sender's Comments: As there is limited information in the case provided, the causal association between the events loss of consciousness and dizziness and the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 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 to  Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dyskinesia, Fall, Gait disturbance, Muscular weakness
Clinical narrative: her husband might be having a stroke/ To her it almost looks like he had a mild stroke; his legs were weak; he was unable to speak clearly and was unable to open his mouth properly. She said he was just mumbling and muttering words, and could not speak clearly/he is not speaking clearly; Couldn't walk and was kind of falling over; falling over; unable to open his mouth properly; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 11May2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Consumer said her husband received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 11May2021. Then on 20May2021, they noticed that his legs were giving out on him. She said he had to hold onto the furniture to walk, because his legs were weak. She also said he had to use a walker. And when he tried to speak to her, she said he was unable to speak clearly and was unable to open his mouth properly. She said he was just mumbling and muttering words, and could not speak clearly. Consumer thought her husband might be having a stroke. She wanted to know if these side effects have been reported before, and if they are associated with the vaccine. Consumer said her husband was scheduled to receive his 2nd dose on 01Jun2021, and was concerned whether he should still get it. Her HCP was in the best position to assist her husband with the appropriate actions to be taken and would be able to help him decide whether or not to still get the 2nd dose. The patient was due for his second on 12June2021 3 weeks later. On 20May2021, she noticed and he noticed that he couldn't walk and was kind of falling over. They happened to have a walker in the house, and he was using the walker. The other thing she was noticing was now that he came home, since he was not at home, he was not speaking clearly. To her it almost looks like he had a mild stroke. When he talked he was opening his mouth some and muttering. She was very concerned about this. She was looking at the side effects and it said there are others than what was listed. At first she thought maybe he had dizziness and weakness, but then it said there are others. She asked if his symptoms have been reported before. She was advising him not to get the second dose. From what she understands the side effects are worse after the second dose. He already has symptoms now 10 days after the first vaccine. She has never seen him acting like this before. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: her husband might be having a stroke/ To her it almost looks like he had a mild stroke; his legs were weak; he was unable to speak clearly and was unable to open his mouth properly. She said he was just mumbling and muttering words, and could not speak clearly/he is not speaking clearly; Couldn't walk and was kind of falling over; falling over; unable to open his mouth properly; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 11May2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Consumer said her husband received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 11May2021. Then on 20May2021, they noticed that his legs were giving out on him. She said he had to hold onto the furniture to walk, because his legs were weak. She also said he had to use a walker. And when he tried to speak to her, she said he was unable to speak clearly and was unable to open his mouth properly. She said he was just mumbling and muttering words, and could not speak clearly. Consumer thought her husband might be having a stroke. She wanted to know if these side effects have been reported before, and if they are associated with the vaccine. Consumer said her husband was scheduled to receive his 2nd dose on 01Jun2021, and was concerned whether he should still get it. Her HCP was in the best position to assist her husband with the appropriate actions to be taken and would be able to help him decide whether or not to still get the 2nd dose. The patient was due for his second on 12June2021 3 weeks later. On 20May2021, she noticed and he noticed that he couldn't walk and was kind of falling over. They happened to have a walker in the house, and he was using the walker. The other thing she was noticing was now that he came home, since he was not at home, he was not speaking clearly. To her it almost looks like he had a mild stroke. When he talked he was opening his mouth some and muttering. She was very concerned about this. She was looking at the side effects and it said there are others than what was listed. At first she thought maybe he had dizziness and weakness, but then it said there are others. She asked if his symptoms have been reported before. She was advising him not to get the second dose. From what she understands the side effects are worse after the second dose. He already has symptoms now 10 days after the first vaccine. She has never seen him acting like this before. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Herpes zoster, Myocardial infarction
Clinical narrative: Shingles; Heart attack; He might have some bruises on his rib cage; This is a spontaneous report from a contactable consumer (patient). This 57-year old Male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on 05Apr2021. Relevant history included Shingles. Relevant concomitant drug was unknown. The patient had a heart attack on 13May2021 for which he had to take an ambulance and thought he might have some bruises on his rib cage.  He then had the second dose on 18May2021 and he was not aware he had a shingles outbreak on 16May2021. The patient stated that he had internal shingles, which was different from what he previously had. He only had a little rash, which was not that bad on the outside, but experienced much severe pain. He would like to know how having shingles may affect the second dose of the vaccine.  The patient stated he had a heart attack with stent placement, so he was unable to get his second dose of the product around that time. Since then, caller stated that he started getting shingles again, in the same spot that he has had it before, and it showed up around 16May2021. Despite the inside shingles starting on 16May2021, the patient was nearing the 7 week mark to be able to get his second dose of the product, so he went ahead and got it on 18May2021, and by the next day, 19May2021, he was showing the physical signs of shingles as well.  The patient stated that if he did have an adverse effect from the second shot, he would not have been aware of it, because he felt so terrible from having had a full fledge heart attack a few days prior. The patient stated that he knew for a fact that his shingles started flaring up on 16May2021 because he thought initially that he maybe had a blood clot because of the pain in his side, and the shingles didn't initially dawn on him, until a few days later when it started spreading out like tentacles. The outcome of events was unknown.    The information about lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test
Clinical narrative: extreme fatigue; postural orthostatic tachycardia syndrome (POTS)/ heart rate increased dramatically upon standing; This is a spontaneous report from a contactable physician (parent).  A 16-year-old male patient (son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Left arm on 06May2021 13:00 (Lot Number: EW0163) as 2nd dose, single for covid-19 immunisation. The patient medical history was none. no known allergies. concomitant medication was none. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not receive other medications within 2 weeks of vaccination. Patient previously received first dose of BNT162B2 (brand: Pfizer, lot number: EW0161) on 15Apr2021 01:00 PM (at age of 16 years old) via Intramuscular into Left arm for Covid-19 immunization in Hospital. Patient is an extremely fit competitive tennis player, developed extreme fatigue 2 days after the second dose (08May2021 17:00), which has now lasted for more than 2 weeks. After getting an smart watch they noted that his heart rate increased dramatically upon standing, and after excluding other possibilities, believe this to be postural orthostatic tachycardia syndrome (POTS) on 08May2021 17:00. event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient underwent covid tested post vaccination which included Nasal Swab: negative on 14May2021.  Treatment received for the events included so far compression socks, rest and diet changes. Outcome of the events was not recovered.   Follow up needed, further information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, SARS-CoV-2 test, Thrombosis, Ultrasound scan, X-ray
Clinical narrative: I am leaning towards calcified blood clots, however that has not been confirmed yet; felt a bump under my skin in my left arm/more painful bumps had appeared; This is a spontaneous report from a contactable healthcare professional. A 37-year-old female patient received the second dose of BNT162B2 (lot number: EN6205), via an unspecified route of administration in arm left on 18Mar2021 14:00 at single dose for COVID-19 immunisation. Medical history included known allergies: Strawberries. Concomitant medications included muscle relaxers, and anti-inflammatory. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of BNT162B2 (lot number: EN6200) on 24Feb2021 14:00 in left arm for COVID-19 immunization. Shortly after, maybe a week, after getting the second dose patient experienced a bump under her skin in the left arm on 01Apr2021 16:00. Over the last few weeks more painful bumps had appeared. Most of these hard lumps were in her left hand. She had one that she knew of in her right hand. Patient met with her PC doctor and the doctor sent her for X rays and ultrasound. Every tech and doctor that had looked at her hands had never seen anything like this. These masses had been confirmed with the ultrasound and more were found during that visit. Patient was moving forward with getting a magnetic resonance imaging (MRI) of her hands. Patient was leaning towards calcified blood clots (01Apr2021 16:00), however that had not been confirmed yet. Adverse events result in doctor or other healthcare professional office/clinic visit. Nasal swab on 24Apr2021 was negative. Treatment was received for the adverse events. Outcome of the events was not resolved.  Information about lot/batch number was available. Further information was expected.; Sender's Comments: Based on temporal association, a causal association between the reported event and BNT162B2 cannot be fully excluded. Case will be reassessed when 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 RAs, Ethics Committees, and investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral, Lip swelling
Clinical narrative: allergic reaction; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; face was numb and heavy; face was numb and heavy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number: 59267100002), via an unspecified route of administration, administered in the left arm on 09Mar2021 at 15:00 at the age of 47 years old (Batch/Lot number: FN6198/EN6198, and Expiration date: unknown) as the 1st dose, single dose for COVID-19 immunization, to protect herself from getting COVID-19. The patient had no medical history. There were no concomitant medications. The patient reportedly experienced swelling and numbness to her mouth, lips, and tongue on an unspecified date in Mar2021. The patient was asking if there was any research to determine what she might have reacted to in the vaccine and also if there was any information about the kind of reaction she had and if that would relate to a specific ingredient. It was further reported that the patient had an allergic reaction to the first dose of the COVID vaccine and did not provide specifics. The patient wanted to know if there were studies on allergic reactions and if there had been any follow ups and would love to know what she was allergic to, since she had never had an anaphylactic reaction and if there had been any research. The patient stated she was seen at the emergency room and did not know if she should share the doctor's information that had seen her in the emergency room or her primary care doctor. She had mouth, tongue, lip swelling and numbness and so she went right away to the emergency room. She never had breathing distress and was given an intravenous (IV) steroid and also a medication to bring down the swelling. The patient stated she had the vaccine around 3pm in the afternoon and she woke up around 3am during the night on an unspecified date in Mar2021 and her face was numb and heavy and her lips were huge and she realized she was breathing ok, but she went to the emergency room. The patient stated she wanted to get the second dose of the vaccine, but the emergency room doctor did not recommend it. She clarified that the symptom of her mouth tongue lip swelling and numbness had actually occurred sometime in Mar2021, and not Feb2021, since she got the vaccine on 09Mar2021. It lasted for about two days until it went down. The patient stated there had been no changes and she had not had anything different to eat. Therapeutic measures were taken as a result of all the events, which included IV steroid and a medication to bring down the swelling. The patient recovered from all the events on an unspecified date in Mar2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Swollen tongue
Clinical narrative: allergic reaction; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; face was numb and heavy; face was numb and heavy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number: 59267100002), via an unspecified route of administration, administered in the left arm on 09Mar2021 at 15:00 at the age of 47 years old (Batch/Lot number: FN6198/EN6198, and Expiration date: unknown) as the 1st dose, single dose for COVID-19 immunization, to protect herself from getting COVID-19. The patient had no medical history. There were no concomitant medications. The patient reportedly experienced swelling and numbness to her mouth, lips, and tongue on an unspecified date in Mar2021. The patient was asking if there was any research to determine what she might have reacted to in the vaccine and also if there was any information about the kind of reaction she had and if that would relate to a specific ingredient. It was further reported that the patient had an allergic reaction to the first dose of the COVID vaccine and did not provide specifics. The patient wanted to know if there were studies on allergic reactions and if there had been any follow ups and would love to know what she was allergic to, since she had never had an anaphylactic reaction and if there had been any research. The patient stated she was seen at the emergency room and did not know if she should share the doctor's information that had seen her in the emergency room or her primary care doctor. She had mouth, tongue, lip swelling and numbness and so she went right away to the emergency room. She never had breathing distress and was given an intravenous (IV) steroid and also a medication to bring down the swelling. The patient stated she had the vaccine around 3pm in the afternoon and she woke up around 3am during the night on an unspecified date in Mar2021 and her face was numb and heavy and her lips were huge and she realized she was breathing ok, but she went to the emergency room. The patient stated she wanted to get the second dose of the vaccine, but the emergency room doctor did not recommend it. She clarified that the symptom of her mouth tongue lip swelling and numbness had actually occurred sometime in Mar2021, and not Feb2021, since she got the vaccine on 09Mar2021. It lasted for about two days until it went down. The patient stated there had been no changes and she had not had anything different to eat. Therapeutic measures were taken as a result of all the events, which included IV steroid and a medication to bring down the swelling. The patient recovered from all the events on an unspecified date in Mar2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Three or four days later, patient got the COVID and received plasma at the hospital.; This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported for a 69-year-old female patient received 1st dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE) in Feb2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Pharmacist stated that one of her patients received the first dose of the Pfizer BioNTech COVID-19 vaccine in Feb2021. Three or four days later, patient (female) got the COVID and received plasma at the hospital. Patient received her second dose of the Pfizer BioNtech COVID-19 vaccine yesterday 20May2021 (refer to AER# 2021586368). Pharmacist wants to know if she should restart the vaccination. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event COVID-19 most likely represents an intercurrent infection as it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis, Ultrasound scan, X-ray
Clinical narrative: previously injured biceps tendon flared up with extreme pain; doctor believed it could have been an immune response leading to frozen shoulder; doctor believed it could have been an immune response leading to frozen shoulder; extensive calcification of the biceps tendon; range of motion was extremely limited; unable to work, drive, get dressed by herself, or care for her children; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 29Apr2021 at 09:45 AM at the age of 50 years old (Batch/Lot number and Expiration date were unknown) as the 2nd dose, single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient previously received the 1st dose of BNT162B2 on 01Apr2021 at 09:30 AM (Batch/Lot number and Expiration date were unknown) in the left arm for COVID-19 immunization. Relevant medical history included injured biceps tendon, biceps tendonitis, and known allergy to Penicillin, all from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Following the vaccination on 30Apr2021 at 07:00, a previously injured biceps tendon flared up with extreme pain. The patient's doctor believed it could have been an immune response leading to frozen shoulder. Urgent care took x-rays, which revealed extensive calcification of the biceps tendon. The patient's range of motion was extremely limited and pain was difficult to manage with over the counter medication. The patient was unable to work, drive, get dressed by herself, or care for her children. Prednisone was prescribed and brought the pain level way down. The patient later had an ultrasound (US) guided needling and barbitage procedure as well as a cortisone shot in her shoulder to manage the pain. The adverse events started date on 30Apr2021 at 07:00 AM. The adverse events did result in both doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures, which included ultrasound guided needling and barbitage procedure with unknown result on an unspecified date. Therapeutic measures were taken as a result of all the events, which included prednisone, Us guided needling & barbitage, and a cortisone shot, hydrocortisone sodium succinate (CORTIS). The patient was recovering from all the events.  Information on the batch/lot number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Diarrhoea, Dyspnoea, Heart rate
Clinical narrative: Noticed on apple watch HR was going up to 120s/HR still elevated. Goes up to 120 when standing. Went to take a shower and HR was 150; diarrhea; Developed rhinorrhea; Developed a pruritic rash on right side of back; chest heaviness; allergic reaction; SOB; chills; This is a spontaneous report from a contactable nurse. A 12-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported), intramuscular, administered in left arm on 15May2021 as first dose, single dose for covid-19 immunisation. Medical history included allergic rhinitis/conjunctivitis from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included medications the patient received within 2 weeks of vaccination as cetirizine 5mg, and clotrimazole 1% topical cream. The patient previously took amoxicillin and experienced allergies. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been tested for COVID-19 which included Covid 19-PCR (nasal swab) on 16May2021 as negative. On 15May2021, the patient received vaccine (Pfizer) and got chills a couple hours later. On 16May2021, patient developed a pruritic rash on right side of back and mom gave an allergy medicine (cetirizine), developed chest heaviness, and SOB (shortness of breath), no tongue/lip or throat swelling. Patient came to ED and received albuterol and decadron due to concern for an allergic reaction. On 17May2021, patient developed rhinorrhea; and chest and SOB improved, but continued to use albuterol. On 18May2021, patient had rhinorrhea and diarrhea; continued to use albuterol. On 19May2021, patient had diarrhea and noticed on apple watch HR (heart rate) was going up to 120s; last use of albuterol. On 20May2021, patient's diarrhea resolved, HR still elevated, went up to 120 when standing; and went to take a shower and HR was 150. The events were reported as serious medically significant, resulting in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures in response to the events included diphenhydramine, decadron, and albuterol. The patient recovered from the event diarrhea on 20May2021. The outcome of the other events reported was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported).
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersensitivity, Rash pruritic, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Noticed on apple watch HR was going up to 120s/HR still elevated. Goes up to 120 when standing. Went to take a shower and HR was 150; diarrhea; Developed rhinorrhea; Developed a pruritic rash on right side of back; chest heaviness; allergic reaction; SOB; chills; This is a spontaneous report from a contactable nurse. A 12-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported), intramuscular, administered in left arm on 15May2021 as first dose, single dose for covid-19 immunisation. Medical history included allergic rhinitis/conjunctivitis from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included medications the patient received within 2 weeks of vaccination as cetirizine 5mg, and clotrimazole 1% topical cream. The patient previously took amoxicillin and experienced allergies. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been tested for COVID-19 which included Covid 19-PCR (nasal swab) on 16May2021 as negative. On 15May2021, the patient received vaccine (Pfizer) and got chills a couple hours later. On 16May2021, patient developed a pruritic rash on right side of back and mom gave an allergy medicine (cetirizine), developed chest heaviness, and SOB (shortness of breath), no tongue/lip or throat swelling. Patient came to ED and received albuterol and decadron due to concern for an allergic reaction. On 17May2021, patient developed rhinorrhea; and chest and SOB improved, but continued to use albuterol. On 18May2021, patient had rhinorrhea and diarrhea; continued to use albuterol. On 19May2021, patient had diarrhea and noticed on apple watch HR (heart rate) was going up to 120s; last use of albuterol. On 20May2021, patient's diarrhea resolved, HR still elevated, went up to 120 when standing; and went to take a shower and HR was 150. The events were reported as serious medically significant, resulting in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures in response to the events included diphenhydramine, decadron, and albuterol. The patient recovered from the event diarrhea on 20May2021. The outcome of the other events reported was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Head discomfort, Vision blurred
Clinical narrative: right sided facial droop; blurred vision; head pressure; This is a spontaneous report from a contactable healthcare professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 21May2021 14:45 (02:45 PM) (Batch/Lot Number: EW0171) (at age of 48-years-old) as 1st dose, single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient did not have any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 14:45 (02:45 PM), the patient experienced right sided facial droop, blurred vision, and head pressure. It was unknown if the patient has been tested for COVID-19 prior to vaccination. Therapeutic measures were taken as a result of the events which included vitals (as reported). The outcome of the events was recovered on an unspecified date.; 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 event right sided facial paralysis, blurred vision, and head discomfort cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Retching
Clinical narrative: Vomiting; dry heaves; difficulty breathing; weakness; shaking; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 18May2021 13:00 (Lot number unknown as not available/provided to reporter at the time of report completion) as 2ND DOSE, SINGLE DOSE for covid-19 immunization, at facility as "pharmacy or drug store".  The patient's medical history included High Blood pressure (BP), Chronic obstructive pulmonary disease (COPD), Prior history of stroke (not ongoing). The patient was diagnosed with COVID-19 prior to vaccination (not further specified). There was no known allergies. Concomitant medications (other medications received within 2 weeks of vaccination) included lisinopril, nicotine pills, blood thinners, and inhaler for COPD. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of bnt162b2 intramuscular on 27Apr2021 (at the age of 70-year-old) (Lot number unknown as not available/provided to reporter at the time of report completion) for covid-19 immunization. On 19May2021 13:00, the patient experienced Vomiting and dry heaves, difficulty breathing, weakness, shaking, headache, chills. Per the patient, the events were serious as requiring hospitalization. No resulting in death, life threatening, disabling/incapacitating, nor congenital anomaly/birth defect. The events resulted in Emergency room/department or urgent care visit. The patient was not sure if treatment was received for the events. The outcome of the events was recovering. It was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; Information about batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Vomiting; dry heaves; difficulty breathing; weakness; shaking; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 18May2021 13:00 (Lot number unknown as not available/provided to reporter at the time of report completion) as 2ND DOSE, SINGLE DOSE for covid-19 immunization, at facility as "pharmacy or drug store".  The patient's medical history included High Blood pressure (BP), Chronic obstructive pulmonary disease (COPD), Prior history of stroke (not ongoing). The patient was diagnosed with COVID-19 prior to vaccination (not further specified). There was no known allergies. Concomitant medications (other medications received within 2 weeks of vaccination) included lisinopril, nicotine pills, blood thinners, and inhaler for COPD. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of bnt162b2 intramuscular on 27Apr2021 (at the age of 70-year-old) (Lot number unknown as not available/provided to reporter at the time of report completion) for covid-19 immunization. On 19May2021 13:00, the patient experienced Vomiting and dry heaves, difficulty breathing, weakness, shaking, headache, chills. Per the patient, the events were serious as requiring hospitalization. No resulting in death, life threatening, disabling/incapacitating, nor congenital anomaly/birth defect. The events resulted in Emergency room/department or urgent care visit. The patient was not sure if treatment was received for the events. The outcome of the events was recovering. It was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; Information about batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her right wrist; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0150), via an unspecified route of administration, administered in the left arm on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that a few days after the first dose on 01Apr2021 the patient started noticing a rash on her right wrist. She said "she took the first Dose of Pfizer Covid 19 vaccine on April first and second dose on April 29 and few days after the April the first she started noticing a rash on her right wrist and she had taken injection in her left arm. And she said the rash started to clear up little bit but after she got the second dose it actually started getting more severe and now it has  spread through out her entire body , on her arm ,thighs , legs ,chest, belly So she wanna to report that, her doctor prescribed topical steroid cream and Said it should go away after a few weeks, So we just wanna to get it reported for her, She said its bothers in night, She can't  get a good night rest, its like eczema  ,very itchy and scaling skin, most of the part on her upper body ,on her  upper arm its like red spots itchy it has not manifested on to surface of the skin yet on the arms". The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Scratch, Vaccination site haemorrhage, Vaccination site scab, Vaccination site urticaria
Clinical narrative: After the Vaccination he had developed scabs that are now bleeding; After the vaccination he had developed scabs that are now bleeding; he was scratching; injection site on his right arm and left arm had a wheal; There had been some rashes on his left arm and is now up to his face; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 23Mar2021 as single dose for COVID-19 immunization and  second dose of BNT162B2 via an unspecified route of administration in left arm on 14Apr2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. He consulted with his regular dermatologist on 27Apr2021and the doctor noticed he was scratching and noticed that his injection site on the left arm had a wheal and there had been some rashes on his left arm.He was prescribed with a cream for 2 weeks. As of calling the rashes are still there and is now up to his face. The day before, patient noticed that his injection site on his right arm also had a wheal. They were not healing, and he had developed scabs that are now bleeding. He mentioned that he had no allergies to anything. He was asking for what to do and on what basis should he go to the ER. He has an appointment with his primary doctor but it is a month away. The outcome of the events was not recovered.  Information on the Lot/batch number and expiration date has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm
Clinical narrative: Small lump in the head; This is a spontaneous report from a contactable pharmacist (patient's husband) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14May2021 (lot number: EW0179; expiration date: 31Aug2021) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose of BNT162B2 on 14May2021. The pharmacist can't remember the date for the 2nd dose. The patient was feeling good and was not experiencing any side effects. However, the one thing that the patient was experiencing was a small lump in her head. The pharmacist explained that the you can feel the small lump in the patient's head but you can see it. This showed up once she took the 1st dose of the vaccine. The pharmacist stated that the exact date for the event was 2-3 days prior to the time of the report, on the 18th or 19th of May but he was not sure. The outcome of the event was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: diagnosed with cancer at the end of March; has had chemotherapy and no longer has the antibodies from the vaccines; This is spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient) reported that a 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 65-year-old in left arm on 24Feb2021 (Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included HIV for over 20 years. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the age of 65-year-old in left arm on 05Feb2021 (Lot Number: EL9269) as single dose for covid-19 immunisation. He was diagnosed with cancer at the end of March (Mar2021) and had chemotherapy and no longer had the antibodies from the vaccines(SARS-CoV-2 Antibody test: Negative) in 2021. The outcome of the events was unknown.