chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer (patient self).  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm Left in Apr2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 50-year-old) for COVID-19 immunisation. The administration time was 10:00 AM.  Medical history included arthritis and gastrooesophageal reflux disease (GERD). Concomitant medications included ASA; celecoxib; esomeprazole sodium (NEXIUM).  The patient previously received BNT162B2 dose 1 in Mar2021 at the age of 50-year-old for COVID-19 Immunization. There was no other vaccine in four weeks.  The patient did not have Covid prior vaccination.  No known allergies.  The patient suffered a stroke on 23Jun2021, with very little to other known risk factors which resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The patient was hospitalized in Jun2021 for 2 days.  Treatment received inluced hospitalization, multiple tests, and new Rxs.  Outcome of the event was resolving.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: he had sore arm; very tired; he broke out in a sweat, 24 hours later that was it; This is a spontaneous report from a contactable consumer (CEP 159558). This consumer (patient's wife; Caregiver) reported for a male patient (Husband) that, A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that on an unspecified date in 2021 he had sore arm, very tired, he broke out in a sweat, 24 hours later that was it. Reporter asked that, What is the mRNA, how does it work. Reporter said allergic to alcohol and did not provide reaction. And Does the vaccine contain alcohol? Reported stated, Thinking about getting the vaccine, but afraid to get vaccine but afraid she was allergic to one of the components. Reporter states, "I cant get near chlorine if that is what you mean. Can't even smell it, I get bleach taste in my mouth and start sneezing and sometimes gives me a headache and Sucrose, what kind of sugar is it and what the mRNA. Reporter stated that she did get the flu shot and not sure how she will take to this shot. Reporter stated she also heard it can cause vertigo. She has had bouts of vertigo. Now hearing it can cause heart inflammation in certain people. She asked, if there is any information on severe reactions, deaths. she heard in the paper that people died from the covid vaccine, didn't say which one vaccine. she did not know how many it was. Reporter stated, "my husband got the Pfizer vaccine, he did have side effects."  She said, he had sore arm and very tired. his doctor said typical.  he broke out in a sweat, 24 hours later that was it. she had one sister that took it and one did. one said to take it the other says don't and the problem it seems everyone has a problem with the second shot why isn't it approved. I take several supplements lots of C and Zinc, elderberry, mushroom complex, garlic. A whole regimen I take to build my immune system. She asked What are nanoparticles - is it relevant to the mRNA, nano technology, Any information on severe reactions, deaths. Outcome of all the events were unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Received both doses of product and Parkinson's symptoms seem to have disappeared/a history of Parkinson's had improvement of his symptoms after the Pfizer covid vaccine, especially the second one.; This is a spontaneous report from a contactable nurse. This nurse reported for a male patient in his sixties 9 years (7-decade) that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history included Parkinsons. Concomitant medications were not reported. The patient also received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, it was reported that the patient received both doses of the product and for some reason his Parkinsons symptoms seem to have disappeared after getting the doses of the Covid vaccine, kind of intriguing. The reporter stated that, last time she saw the patient, he was very happy, held out his hands to show they were not shaking, his Parkinsons symptoms had not been happening at that time. She has no available information on the patient's vaccine and stated that she spoke with him on 08May2021 and that was when he mentioned that his Parkinson's symptoms had stopped since the vaccine. She does not know when the patient was diagnosed with Parkinsons disease. Report was related to a study or programme. Outcome of the event was unknown.  Follow-up (28Jun2021): This is a follow up spontaneous report from a Pfizer sponsored program support. A contactable nurse reported for a male patient which included patient medical comments.  Follow-up (01July2021): This is a follow up spontaneous report from a nurse. A contactable nurse reported for a male patient.  Follow-up (01Jul2021): This is a follow-up spontaneous report received from nurse. This nurse reported for a male patient via telephonic follow-up activity which included event details.  Information on the lot/ batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: heavy menstrual periods/ spotting bleeding lasted for at least three week; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported) via intramuscular, in Left arm, on 25May2021 at 11:00 (at the age of 39-year-old ), as DOSE 1, SINGLE for covid-19 immunization in a pharmacy. There was no medical history and concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  On 07Jun2021, the patient was having heavy menstrual periods for 2.5 weeks further reported as the patient got her period and it was very heavy but it lasted easily, over two and half days. The patient guessed the bleeding lasted for a normal time but spotting bleeding where, patient think the uterine line was shedding, lasted for at least three weeks. The patient wanted to know if this is normal and if she can go ahead and receive the 2nd dose. The patient was scheduled to receive the 2nd dose on 28Jun2021 and it was confirmed that the patient did receive it on that day. No treatment has been taken for the event. The patient stated that, she was fine. The outcome of the event was recovered in Jun2021.  Information about lot/batch number has been requested. .
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal, Vision blurred
Clinical narrative: got blurry, unfocused vision; felt spacey/confused; felt spacey/confused; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EWO187), at the age of 27 years old, in left arm on 09Jun2021 at 13:00 at single dose for COVID-19 immunisation. Medical history included known allergies: lactose intolerance. The patient was not pregnant at time of vaccination. It was unknown that the patient was diagnosed with COVID-19 prior to vaccination.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Immediately after vaccine the patient got blurry, unfocused vision on 09Jun2021 at 13:15 for a week. The patient also felt spacey/confused immediately after the shot on 09Jun2021 at 13:15 and that continued for about 1 week as well. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of all events was recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fear, Feeling abnormal, Headache, Heart rate
Clinical narrative: my heart rate went up/I had a very rapid heart rate of 157 and it was beating so fast; felt very shakey; felt strange/weird; heart pounded so hard; it was frightening/ very scary; going to drop to the floor; felt my whole body was weak, weird, like I was going to drop to the floor; slight nausea; slight headache; This is a spontaneous report from a contactable consumer. This Female consumer (patient) reported that:   A female patient of an unspecified age received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 25Jun2021 at 17:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient Historical vaccine included BNT162B2 for COVID-19 immunization Dose 1. The patient's concomitant medications were not reported. The patient experienced My heart rate went up/I had a very rapid heart rate of 157 and it was beating so fast, I felt like I could die thereon 2021, slight headache, slight nausea, felt very shakey, felt strange, Felt my whole body was weak, weird, like I was going to drop to the floor, Heart pounded so hard, It was frightening/ very scary, Going to drop to the floor on 2021. The patient underwent lab tests and procedures which included heart rate: 154 on Jun2021, Heart rate: 147 on Jun2021, Heart rate: 59 on Jun2021. Upon follow up received on 28Jun2021 NDC number and UPC number of Covid-19 Vaccine were unknown. Consumer was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM as per EST.  Consumer further stated, I am going to do that now. Have you, has anyone reported that to you? No but you are taking the information down from people who had a side effect so, what I am asking you when people have called you, have you heard to mention that? I guess they don't want you to. Okay I will call them; you are going to connect me or should I just redial? Yes, it's nothing, nothing happens when I pull the number and press option 3, thank you so much for your help but I will hold. The outcome for all the events was unknown  Follow-up (28Jun2021): New information received from a contactable consumer. This report Included: dosage details, events and clinical information.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Palpitations, Tremor, Vertigo
Clinical narrative: my heart rate went up/I had a very rapid heart rate of 157 and it was beating so fast; felt very shakey; felt strange/weird; heart pounded so hard; it was frightening/ very scary; going to drop to the floor; felt my whole body was weak, weird, like I was going to drop to the floor; slight nausea; slight headache; This is a spontaneous report from a contactable consumer. This Female consumer (patient) reported that:   A female patient of an unspecified age received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 25Jun2021 at 17:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient Historical vaccine included BNT162B2 for COVID-19 immunization Dose 1. The patient's concomitant medications were not reported. The patient experienced My heart rate went up/I had a very rapid heart rate of 157 and it was beating so fast, I felt like I could die thereon 2021, slight headache, slight nausea, felt very shakey, felt strange, Felt my whole body was weak, weird, like I was going to drop to the floor, Heart pounded so hard, It was frightening/ very scary, Going to drop to the floor on 2021. The patient underwent lab tests and procedures which included heart rate: 154 on Jun2021, Heart rate: 147 on Jun2021, Heart rate: 59 on Jun2021. Upon follow up received on 28Jun2021 NDC number and UPC number of Covid-19 Vaccine were unknown. Consumer was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM as per EST.  Consumer further stated, I am going to do that now. Have you, has anyone reported that to you? No but you are taking the information down from people who had a side effect so, what I am asking you when people have called you, have you heard to mention that? I guess they don't want you to. Okay I will call them; you are going to connect me or should I just redial? Yes, it's nothing, nothing happens when I pull the number and press option 3, thank you so much for your help but I will hold. The outcome for all the events was unknown  Follow-up (28Jun2021): New information received from a contactable consumer. This report Included: dosage details, events and clinical information.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: she had swelling in the legs; This is a spontaneous report from a contactable consumer reported for his wife. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number, expiration date were not reported) via an unspecified route of administration on 09Jun2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient's husband stated that the patient received the vaccine on 09Jun2021 and she had a problem after 10 days, after 1 week, she had swelling in the legs in Jun2021. The patient's husband wanted treatment. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Myocardial Infarction; This is a spontaneous report from a contactable Nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No heart problems issues before, 4 days before 28Jun2021 (on 24Jun2021), patient went to the ER with Myocardial Infarction (MI). The outcome of the event was unknown.  information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect drug to the reported event "Myocardial Infarction" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Inappropriate schedule of product administration
Clinical narrative: Bell's palsy; Patient received his first Pfizer of vaccine on 26Feb2021, follow up on 28Jun2021 to see if the patient should get the 2nd vaccine; This is a spontaneous report from a contactable Other HCP via Medical Information Team. A 69-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single (at the age of 69-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) intramuscularly in left arm on 26Feb2021 17:45 as dose 1, single for COVID-19 immunization. Patient experienced facial muscle weakness and Bells Palsy after the first dose of vaccination. Reporter stated she was calling from a physician office on behalf of a patient who had an adverse reaction to the vaccine. She stated she was calling to follow up as they have not heard back and neither has the patient. She stated that they received it 19Mar2021 and filled it out shortly after that and faxed it. States she is not sure if this was called in and reported or by who. States it was before she started working there and she first saw this when the form came to fill out regarding this. She was a medical assistant. She was calling on behalf of a patient who received his first Pfizer Covid vaccine dose on 26Feb2021. On 01Mar2021, his MDs office for side effects and was diagnosed with Bells Palsy. She stated patient reported this to DSU at that time but did not receive a follow up call. She wanted to know if the patient is ok to receive his second dose of the Pfizer vaccine. Unable to obtain patients age because she disconnected during hold while agent was researching information. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Condition aggravated, Headache, Influenza like illness, Multiple fractures
Clinical narrative: I've broken a bone.; bones hurt; sore throat; a stuffy nose; a little hangover headache; After the second injection, I had arm pain, it was more severe than after the first one; After the second injection, I had arm pain, it was more severe than after the first one; Flu-like symptoms the next day; seasonal allergy symptoms after receiving vaccine injections; Felt wet on my arm, and it was not saline colored; really bad sinus; This is spontaneous report from contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Nov2020 (at age of 36 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on Oct2020 (at age of 36 years old) as single dose for COVID-19 immunization had Chills, Headache, seasonal allergy symptoms after receiving vaccine injections, had arm pain, it was more severe than after the first one. On unknown date, The patient experienced a sore throat and a stuffy nose, but is has been getting better. Patient reported in interview that during her participation in the COVID-19 vaccine clinical trial, in which she received the live vaccine, the staff who administrated injections "missed taking some vitals and I know they missed a pregnancy test before one injection." She also reported, "l think the nurse pulled it out a little too soon. Felt wet on my arm, and it was not saline colored." Patient also reported experiencing seasonal allergy symptoms after receiving vaccine injections: "We've been playing 'is it allergies or is it COVID.' I had a really bad sinus thing a few weeks before and reported it and they did not call me. After the second vaccine, patient reported: "About 18 hours later, it was like a bus hit me full-force, was in bed, shaking, my bones hurt. I could not explain how my bones hurt and I've broken a bone. My immune system was like, ON. A lightbulb went on, we knew from the people who'd reacted, hang on for 24 hours. It didn't even take that long. By the next day it was like had a little hangover headache." "After the second injection, I had arm pain, it was more severe than after the first one, but again, not that bad. But I almost had flu-like symptoms the next day, They were very short-lived, it wasn't bad. The outcome of the events sore throat and a stuffy nose was recovering, for Flu-like symptoms was recovered on unknown date, for other events was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Seasonal allergy, Sinusitis, Skin discolouration
Clinical narrative: I've broken a bone.; bones hurt; sore throat; a stuffy nose; a little hangover headache; After the second injection, I had arm pain, it was more severe than after the first one; After the second injection, I had arm pain, it was more severe than after the first one; Flu-like symptoms the next day; seasonal allergy symptoms after receiving vaccine injections; Felt wet on my arm, and it was not saline colored; really bad sinus; This is spontaneous report from contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Nov2020 (at age of 36 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on Oct2020 (at age of 36 years old) as single dose for COVID-19 immunization had Chills, Headache, seasonal allergy symptoms after receiving vaccine injections, had arm pain, it was more severe than after the first one. On unknown date, The patient experienced a sore throat and a stuffy nose, but is has been getting better. Patient reported in interview that during her participation in the COVID-19 vaccine clinical trial, in which she received the live vaccine, the staff who administrated injections "missed taking some vitals and I know they missed a pregnancy test before one injection." She also reported, "l think the nurse pulled it out a little too soon. Felt wet on my arm, and it was not saline colored." Patient also reported experiencing seasonal allergy symptoms after receiving vaccine injections: "We've been playing 'is it allergies or is it COVID.' I had a really bad sinus thing a few weeks before and reported it and they did not call me. After the second vaccine, patient reported: "About 18 hours later, it was like a bus hit me full-force, was in bed, shaking, my bones hurt. I could not explain how my bones hurt and I've broken a bone. My immune system was like, ON. A lightbulb went on, we knew from the people who'd reacted, hang on for 24 hours. It didn't even take that long. By the next day it was like had a little hangover headache." "After the second injection, I had arm pain, it was more severe than after the first one, but again, not that bad. But I almost had flu-like symptoms the next day, They were very short-lived, it wasn't bad. The outcome of the events sore throat and a stuffy nose was recovering, for Flu-like symptoms was recovered on unknown date, for other events was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I've broken a bone.; bones hurt; sore throat; a stuffy nose; a little hangover headache; After the second injection, I had arm pain, it was more severe than after the first one; After the second injection, I had arm pain, it was more severe than after the first one; Flu-like symptoms the next day; seasonal allergy symptoms after receiving vaccine injections; Felt wet on my arm, and it was not saline colored; really bad sinus; This is spontaneous report from contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Nov2020 (at age of 36 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on Oct2020 (at age of 36 years old) as single dose for COVID-19 immunization had Chills, Headache, seasonal allergy symptoms after receiving vaccine injections, had arm pain, it was more severe than after the first one. On unknown date, The patient experienced a sore throat and a stuffy nose, but is has been getting better. Patient reported in interview that during her participation in the COVID-19 vaccine clinical trial, in which she received the live vaccine, the staff who administrated injections "missed taking some vitals and I know they missed a pregnancy test before one injection." She also reported, "l think the nurse pulled it out a little too soon. Felt wet on my arm, and it was not saline colored." Patient also reported experiencing seasonal allergy symptoms after receiving vaccine injections: "We've been playing 'is it allergies or is it COVID.' I had a really bad sinus thing a few weeks before and reported it and they did not call me. After the second vaccine, patient reported: "About 18 hours later, it was like a bus hit me full-force, was in bed, shaking, my bones hurt. I could not explain how my bones hurt and I've broken a bone. My immune system was like, ON. A lightbulb went on, we knew from the people who'd reacted, hang on for 24 hours. It didn't even take that long. By the next day it was like had a little hangover headache." "After the second injection, I had arm pain, it was more severe than after the first one, but again, not that bad. But I almost had flu-like symptoms the next day, They were very short-lived, it wasn't bad. The outcome of the events sore throat and a stuffy nose was recovering, for Flu-like symptoms was recovered on unknown date, for other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had shortness of breath since having COVID; Had shortness of breath since having COVID; This is a spontaneous report from a contactable consumer (patient's mother). This case is for other son. This consumer reported for a male patient (reporter's son) of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 22Jun2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter notes that her other son (she has 5 children) also had similar side effects following the vaccination however not to the extend that the one she was reporting about today had. The other son did receive his vaccine on the same day (22Jun2021) as the 33-year-old son. He has had shortness of breath since having COVID and got a fever of 100.0 the day (22Jun2021) he received the shot as well as chest heaviness and shortness of breath. The patient lab test included body temperature was 100.0 Fahrenheit on 22Jun2021 and sars-cov-2 test was positive on an unknown date 2021. Reporter stated that her HCP clinic in where they go to be a very large facility, but they had no clue on anything. Reporter would like to know what the follow up care would be for her son who had experienced side effects less than 1 week following his 2nd dose of the COVID19 vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: achy; didn't feel great; This is a spontaneous report from a contactable nurse (patient's wife). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EW0165 and expiry date Aug2021), via an unspecified route of administration, on left arm, on 05May2021 08:15 AM (at the age of 62-year-old), as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took Ibuprofen before getting Covid 19 vaccines. Historical vaccine included first dose of BNT162B2 (solution for injection; lot number EW0161 and expiry date Jul2021) via an unspecified route of administration, on right arm, on 16Apr2021 at 1:00-1:30PM (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation; shingles vaccine and flu vaccine both given on unspecified dates, for immunization with no reactions. The patient did not receive any other vaccinations within four weeks prior to the first administration. On an unspecified date in 2021, after the second Covid 19 vaccine, the patient was achy and he did not feel great. It was reported that the patient never gets sick and healthy. The patient took the covid-19 vaccine to see his mother who was 94 years old.  It was reported that the patient did go to the dentist on 05May2021 and received a Lidocaine injection at that appointment however it was also reported that the patient received a recall letter for lidocaine on 04May2021 (to be confirmed). The outcome for the events were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Skin disorder, Skin warm
Clinical narrative: Patient received his first Pfizer COVID vaccine on 09Feb2021.  Patient then received his first Ilumya shot, which is a SunPharma product, on 26Feb2021; Big red, warm splotches up and down sides; Big red, warm splotches up and down sides; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; tildrakizumab asmn (ILUMYA), via an unspecified route of administration from 26Feb2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose, via an unspecified route of administration from 09Apr2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for psoriasis. Medical history included psoriasis. Concomitant medications included steroids (did not know the specific name of steroid that was prescribed), fluid pills. Reportedly, reporter was calling to report a potential adverse event with the Pfizer COVID Vaccine as a patient received our covid vaccine and their product as well that was an injection. Reporter stated that the patient was transferred to her from their (manufacturing company) Drug Safety Department, and this was the information they provided to her. Patient received his first Pfizer COVID vaccine on 09Feb2021. Patient then received his first ILUMYA shot ( product), on 26Feb2021. After patient got his ILUMYA shot, patient broke out with big red, warm splotches up and down his sides on unspecified date in 2021. Reportedly, assessed as other medically important condition. He had no issues with his first ILUMYA shot or first covid shot but since getting both, he was not sure if there might be some interaction. On 09Apr2021, he got the second ILUMYA shot. Reporter states that ILUMYA was for psoriasis and states that the patient told her that his psoriasis was better. The outcome of events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events " Skin disorder" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Acne, Hypersensitivity, Pruritus
Clinical narrative: I have the side effect because I have allergy, the pimples grow on my body and is itchy; allergy on my skin; I have the side effect because I have allergy, the pimples grow on my body and is itchy; allergy on my skin; I have allergy/allergy on my skin; This is a spontaneous report from a contactable consumer (patient). A  patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose  via an unspecified route of administration on 17Jun2021 at unknown dose single for COVID-19 immunization. Medical history was not reported. No concomitant medication was reported. Patient have the side effect have allergy, the pimples grow on  body and is itchy; allergy on my skin: (From: Unspecified To: Unspecified) the pimples grow on my body and is itchy; allergy on my skin. Consumer stated, "I would like to say I received Covid-19 Vaccine first dose vaccine on 17Jun2021 and I think I have the side effect because I have the allergy because the pimples grow on my body and is itchy, that never happened but I have now." The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling
Clinical narrative: swelling in fingers day after getting vaccine; This is a spontaneous report from a contactable consumer (Patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; and received tofacitinib citrate (XELJANZ XR, Lot Number: EH9982), 11mg oral taken once daily from an unspecified date to an unspecified date for an unspecified indication. Medical history included psoriasis vulgaris, rheumatoid arthritis, psoriatic arthropathy. Concomitant medications included losartan potassium (MANUFACTURER UNKNOWN), clarithromycin (CLARITIN [CLARITHROMYCIN, naproxen (MANUFACTURER UNKNOWN) , lisinopril (MANUFACTURER UNKNOWN), indomethacin [indometacin] (MANUFACTURER UNKNOWN]), sertraline hcl (MANUFACTURER UNKNOWN) , prednisone (MANUFACTURER UNKNOWN) , fexofenadine hydrochloride (ALLEGRA ALLERGY) taken for hypersensitivity, hydrochlorothiazide (MANUFACTURER UNKNOWN), dicyclomine hydrochloride (MANUFACTURER UNKNOWN). On an unknown date, Patient experienced symptoms of swelling in fingers day after getting vaccine. Patient has been prescribed prednisone and meloxicam by mdo, neither of which seem to work. Advised if allergic reaction, can try taking over the counter (otc) allergy medication to see if these work, advise if worsens to contact mdo. Patient understood. The reporter assessed the event as non-serious. The outcome of the event was unknown. Information on Lot/Batch number has been requested.  Information on Lot/Batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Hot flush, Insomnia, Migraine
Clinical narrative: The weeks that passed the symptoms grew stronger and more frequent and on came the sleepless nights; The weeks that passed the symptoms grew stronger and more frequent and on came the sleepless nights; I felt light headed; Got hot flashes; Migraine; This is a spontaneous report from a contactable consumer (patient herself). A 29-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 11May2021 22:45 (Batch/Lot Number: Unknown) as dose1, single for covid-19 immunization. The Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, since vaccination.  The patient experienced i felt light headed, got hot flashes, migraine On 11May2021 at 22:50, the weeks that passed the symptoms grew stronger and more frequent and on came the sleepless nights (condition aggravated) on 20May2021 10:45 , the weeks that passed the symptoms grew stronger and more frequent and on came the sleepless nights (insomnia) on 20May2021 22:45. It was reported that After receiving her first dose, she made the pharmacist know after about 5minutes  that she felt light headed and got hot flashes. Following was a migraine. They instructed that it was ok and will be fine it's temporary. The weeks that passed the symptoms grew stronger and more frequent and on came the sleepless nights. After getting my second dose she again got lightheaded and hot flashes a few moments later. It has now been weeks and the hours of sleep she got less and less. she cannot sleep and hot flashes along with migraines are an every day and night thing. She was being tested like a rat in a lab by doctors and they have no answers. she understand this is all new and there isn't much research but she needed help. A mother of 2 experiencing this is not ideal. She need answers as fast advice on what to do. She enquired if this was happening to anyone else or just to her?  She cannot comfortably recommend to others to get the vaccine when she was living miserable since. Please help me. Any feedback would be greatly appreciated. Adverse event result in visit to Doctor or other healthcare professional office/clinic visit/ Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The device date was 28Jun2021. The patient did not receive any treatment. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Influenza like illness, Pain in extremity
Clinical narrative: turned into flu aches the next day.; sore arm; had aches in my bones which started like working out aches; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0175 expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 07May2021 12:00, as DOSE 1, SINGLE for Covid-19 immunization. Medical history included cardiomyopathy and Penicillin allergy from an unknown date and un-known if ongoing. Concomitant medications included metoprolol (METOPROLOL), valeriana officinalis root, valeriana officinalis root extract (VALERIAN ROOT EXTRACT), vitamins nos (DAILY VITA-MINS), ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. Patient did not have other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since the vaccination. On 18Jun2021 12:00 AM, the patient had a very sore arm the 1st shot, had aches in her bones which started like working out aches and turned into flu aches the next day. The patient did not receive treatment for adverse events. The outcome of the events was reported as not resolved  Information on lot/batch number was available. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pallor, Pulse abnormal, Rash
Clinical narrative: I lost the feeling in my left finger tip all 4 fingers except the thumb went numb; I lost sensation in my right hand and my right arm is very very weak and it really started getting scary; my right arm is very very weak; He noticed visible blanching in my fingers; my pulse is extremely weak on my right side; Treatment for the rashes; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0178, expiration date: unknown), via intramuscular, administered in left arm on 26May2021 13:30 (at the age of 51-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiration date: unknown) on an unspecified date. The patient's medical history includes hypertension and Lyme disease. Concomitant medications include BENAZEPRIL HYDROCHLORIDE 10 mg once daily and AMLODIPINE BESILATE 5mg once daily, both for hypertension and unspecified antidepressants. No other vaccines prior to 4 weeks. On 28May2021, 1 day 10 hours after the vaccination, the patient experienced loss of feeling in left fingertip, all 4 fingers except the thumb went numb, later, on an unknown date, patient experienced   loss of sensation in right hand and right arm is very weak, patient's doctor noticed visible blanching in fingers, extremely weak pulse on right side and rashes. Patient visited her doctor and his doctor marked it as adverse COVID 19 vaccine reaction and patient was waiting for the specialist to watch in. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: I lost the feeling in my left finger tip all 4 fingers except the thumb went numb; I lost sensation in my right hand and my right arm is very very weak and it really started getting scary; my right arm is very very weak; He noticed visible blanching in my fingers; my pulse is extremely weak on my right side; Treatment for the rashes; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0178, expiration date: unknown), via intramuscular, administered in left arm on 26May2021 13:30 (at the age of 51-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiration date: unknown) on an unspecified date. The patient's medical history includes hypertension and Lyme disease. Concomitant medications include BENAZEPRIL HYDROCHLORIDE 10 mg once daily and AMLODIPINE BESILATE 5mg once daily, both for hypertension and unspecified antidepressants. No other vaccines prior to 4 weeks. On 28May2021, 1 day 10 hours after the vaccination, the patient experienced loss of feeling in left fingertip, all 4 fingers except the thumb went numb, later, on an unknown date, patient experienced   loss of sensation in right hand and right arm is very weak, patient's doctor noticed visible blanching in fingers, extremely weak pulse on right side and rashes. Patient visited her doctor and his doctor marked it as adverse COVID 19 vaccine reaction and patient was waiting for the specialist to watch in. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Rash, Swelling of eyelid
Clinical narrative: covid toad; Eyelid swelling; constant rashes on hand; This is a spontaneous report from a contactable consumer. A male patient (husband) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on Mar2021 as dose 2, single and first dose via an unspecified route of administration on Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Since vaccination the patient had COVID toad, eyelid swelling and constant rashes on hand. It was stated this was never an issue before the Pfizer covid-19 vaccine and wants to know how to treat it or how to proceed with these side effects. The outcome of the events was unknown.   Information on lot/ batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Memory impairment, Swelling face
Clinical narrative: her memory was kind of worse; swelling in the face, forehead, eyebrows and she feels it moving; swollen over her eyebrows, over eyes and lips; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 (at the age of 77-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus (she is a diabetic on an insulin pump), breast cancer, kidney disease and patient had unknown allergy (she was allergic to something but cannot provide what it is specifically). The concomitant medications of patient were not reported. Patient stated that her face was swollen up, wondering if this is a symptom. She just got the last one, it swelled up with the first one, but she didn't call, this is the second one. Caller stated that her face swelled up the second or third day after the first shot. She stated that she got her both doses on 03Jun2021 (1st dose) and 24Jun2021 (2nd dose). Caller declared that her face has swollen up after her 1st dose and has persisted since the 2nd dose. It was swollen over her eyebrows, over eyes and lips. She also noticed it moved from one side to the other in a matter of hours. She knows she was allergic to something but cannot provide what it is specifically. Caller informed the vaccination site that she has serious case of diabetes, allergy, kidney problems and had cancer. Caller mentioned that she was questioned if she does have the cancer again. However, the vaccinator proceeded with her shot. Another thing she noticed was her memory was kind of worse. That started after, she noticed more after the shot, the first shot. She stated seems like it was improving, as soon as she found out what was wrong, as soon as she was alerted, she was not remembering too good. After the first dose of the vaccine on 03Jun2021, she experienced swelling in the face, forehead, eyebrows and she feels it moving. The doctor wanted to do biopsy of it. Caller stated that she was scheduled for biopsy today (29Jun2021) and wanted to know if that is too soon, with not even been a week since she had the COVID shot. Caller wanted to know if more than 1 vial can be used to give the vaccine as she thinks that more than 1 vial of the Pfizer covid vaccine was used to give her shot. She was asking if Pfizer use two vials with the vaccine because she saw them use two vials and wanted to know if something is mixed with that. Seriousness was reported as no. The outcome of event memory impairment was recovering and for rest of the events outcome was unknown.  Information on Lot/Batch number has been requested.