chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Diarrhea; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Lightheadedness; Weakness; Severe Headache; Left ear was hurting; Chest Tightness; chest feels funny; Throat Tingling and Tightness; Throat Tingling and Tightness; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Chills; disoriented really bad and confused and had a bit of a blurred mind; disoriented really bad and confused and had a bit of a blurred mind; Feels Very Off; Blood Sugar Level Dropped Below 60; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female consumer received first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 08:35 as single dose (at the age of 28-years-old) for covid-19 immunisation. Medical history included drug hypersensitivity penicillin and anything that is a cousin to penicillin. She did not have any prior vaccinations within 4 weeks. There were no concomitant medications. She stated that she took the vaccine at 8:30 by 8:45, she felt very lightheaded and she signaled the nurse, and she was brought into a room. She stated that she took the shot in her left arm. After the vaccine it was like she was disoriented and confused and had a bit of a blurred mind, like she felt confused. States she thought she would be up and ready after but they put her to lay down. Caller states she was disoriented really bad. She felt her left ear hurting and then tingling in the front of throat and her throat and chest began to get tight. She stated that as she was trying to drive home, she had to pull over and she felt like her entire body was on fire. She stated it was on and off. She gets really hot inside and starts to sweat and had cold chills and then it goes away and comes back. She stated she felt hot on her left side of her body then her complete body felt hot until 10:00 PM. She felt hot and weak to the point that couldn't drive this morning. She stated her blood sugar level had dropped to below 60. She stated that many of her side effects come and go, they don't last very long. She was treated with Tylenol. She stated that she was in observation under a tent after her vaccine. On 21Apr2021, in the morning she still feels hot and now had diarrhea, severe headache, her chest feels funny and she felt very off. She asked is it common to have diarrhea. She stated that her main concern is if she should take the second dose since she had this reaction with her first dose. The outcome of all the event was not recovered while the outcome of the events disoriented really bad and confused and had a bit of a blurred mind and left ear hurting was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: states that "they" got their first dose and then "they" got covid that week; This is a spontaneous report from a contactable consumer (wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown, expiry date: unknown), via unspecified route of administration, on an unspecified date, as a single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that "they" got their first dose and then "they" got covid that week, on an unspecified date. She called because "they" are trying to get a second dose but were a little nervous about "how it's going to hit us." Reporter stated that someone said it can wait up to six weeks and asked if that is true. She was not sure about the current recommendation, but medical information team has that Information. She stated that she thinks "they" caught covid from her husband's work ("they" presumably is referring to her and her husband) and that it has nothing to do with the vaccine. She stated her parents both had moderna and they have been around them and her parents did not catch covid. If she changed her mind after the second vaccine, she would call back to give us her information. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: She had Covid; I felt all weird; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at the age of 73-year-old), as dose 1, single for COVID-19 immunization. The medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that patient had no other products, had no history and did not undergo investigation assessment. It was mentioned that not right after but shortly about 2-3 days after vaccination on an unknown date in 2021 the patient got real sick, she felt all weird, had headaches and could not breathe very well. She started coughing and everything. When probed for the treatment, consumer stated, that she got sick so bad that she had got to the hospital and they gave her a test and they confirmed that she had covid on 22nd, plus or minus. They gave her some treatment, but it was like some type of enzymes and then that she had to wait about 8 hours with them and then she started feeling better. They monitored her heart, her breathing, it was like for 3 weeks. There was a product complaint. The patient also mentioned that she was nearing the time when she was supposed to take the second shot and does not know if she should be taking the shot. She was thinking if she was supposed to get the 2nd shot or start it over. The lab test includes SARS-CoV-2 test on an unspecified date in 2021. The outcome of events was unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis continuing until current day
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Constant headache starting the day after the vaccine. Headache is non stop(temporary relief from Tylenol). It increases in intensity when concentrating or doing physical exercise. It's been over 2 and half months.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: Constant headache starting the day after the vaccine. Headache is non stop(temporary relief from Tylenol). It increases in intensity when concentrating or doing physical exercise. It's been over 2 and half months.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint effusion, Mobility decreased, Osteoarthritis, Pain
Clinical narrative: About 3 weeks after the 2nd Moderna COVID19 vaccine, both my knees became effused and quite painful, so that it was difficult to sit and arise from a chair. Although I have mild DJD in both knees, it seldom bothered me, and less than 1 month before the vaccination, I was able to hike 3 miles up & down hills without knee pain. After onset of symptoms, pain was constant, 7/10 on most days, my knees were palpably effused, and I was having trouble getting out of bed and walking to the bathroom. I suspected a vaccine reaction, and consulted Orthopedist, who injected each of my knees with steroid. Now, 2 wks later, I am back to baseline, and am able to walk 2 miles without knee pain.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray limb abnormal
Clinical narrative: About 3 weeks after the 2nd Moderna COVID19 vaccine, both my knees became effused and quite painful, so that it was difficult to sit and arise from a chair. Although I have mild DJD in both knees, it seldom bothered me, and less than 1 month before the vaccination, I was able to hike 3 miles up & down hills without knee pain. After onset of symptoms, pain was constant, 7/10 on most days, my knees were palpably effused, and I was having trouble getting out of bed and walking to the bathroom. I suspected a vaccine reaction, and consulted Orthopedist, who injected each of my knees with steroid. Now, 2 wks later, I am back to baseline, and am able to walk 2 miles without knee pain.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat closed up; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's sister) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that her sister (patient) who was vaccinated having the same side effects. Caller reported that the patient's throat closed up on unspecified date and the patient is having all kinds of troubles. Caller declined to complete safety report for the patient. Caller reported that she would tell the patient to call Pfizer to file a report. Caller reported that she had just heard through her mom that the patient had reactions to both doses of the Covid-19 vaccine and had to be monitored. Caller reported that her mother informed the caller that the patient's throat closed up. Caller reported that she would have the patient call to make a report as the caller would be unable to provide many details of the patient's experience. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abscess, Chills, Drug ineffective, Furuncle, Inflammation
Clinical narrative: Humira not working well; chills; Muscle pain; pain in arm; Inflammation; big boils in underarms/on thighs; big boils in underarms/on thighs; Abscess; This is a spontaneous report received from a contactable consumer (patient) based on the information received by Pfizer. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) intramuscularly on 02Mar2021 (Batch/Lot number: EN6202) as single dose and received second dose intramuscularly on 23Mar2021 (Batch/Lot number: ER2613) as single dose for Covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from 17Jul2020 to 05Mar2021, at 40 mg, weekly (40 mg, 1 in 1 week) for Hidradenitis Suppurativa. Age at vaccination was 44-year-old. The patient's medical history included breast abscess removal from 12Jun2020, no tobacco use, abstains from alcohol, iodine allergy manifested by anaphylaxis, endometriosis from Jun2020, supplements. Concomitant medications included tranexamic acid (TRANEXAMIC ACID) for endometriosis, tocopherol as supplements and acetylcysteine/ascorbic acid/bromelains/drosera spp./echinacea spp. as supplements. The patient previously took iodine for unknown indication. On an unspecified date, the patient experienced Humira not working well. On an unspecified date in Feb2021, inflammation, big boils in underarms/on thighs and abscess. On 02Mar2021, pain in arm. On 23Mar2021, chills, muscle pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Duration of the events chills, pain in arm was four days. Outcome of chills, muscle pain was recovered on 27Mar2021, pain in arm was recovered on 04Mar2021, Humira not working well was unknown and other events were not recovered.  Causality per reporter (drug/vaccine): chills (probable), inflammation (not related), boil (not related), abscess (not related), pain in arm (probable), muscle pain (probable), lack of drug effect (not reported).  No follow up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Humira not working well; chills; Muscle pain; pain in arm; Inflammation; big boils in underarms/on thighs; big boils in underarms/on thighs; Abscess; This is a spontaneous report received from a contactable consumer (patient) based on the information received by Pfizer. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) intramuscularly on 02Mar2021 (Batch/Lot number: EN6202) as single dose and received second dose intramuscularly on 23Mar2021 (Batch/Lot number: ER2613) as single dose for Covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from 17Jul2020 to 05Mar2021, at 40 mg, weekly (40 mg, 1 in 1 week) for Hidradenitis Suppurativa. Age at vaccination was 44-year-old. The patient's medical history included breast abscess removal from 12Jun2020, no tobacco use, abstains from alcohol, iodine allergy manifested by anaphylaxis, endometriosis from Jun2020, supplements. Concomitant medications included tranexamic acid (TRANEXAMIC ACID) for endometriosis, tocopherol as supplements and acetylcysteine/ascorbic acid/bromelains/drosera spp./echinacea spp. as supplements. The patient previously took iodine for unknown indication. On an unspecified date, the patient experienced Humira not working well. On an unspecified date in Feb2021, inflammation, big boils in underarms/on thighs and abscess. On 02Mar2021, pain in arm. On 23Mar2021, chills, muscle pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Duration of the events chills, pain in arm was four days. Outcome of chills, muscle pain was recovered on 27Mar2021, pain in arm was recovered on 04Mar2021, Humira not working well was unknown and other events were not recovered.  Causality per reporter (drug/vaccine): chills (probable), inflammation (not related), boil (not related), abscess (not related), pain in arm (probable), muscle pain (probable), lack of drug effect (not reported).  No follow up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: Tiredness (exhausted); sweating but no fever Average temp was between 95.7 and 96.; Aches in joints (toes, ankles, right rear right shoulder.; Very watery diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, lot number: ER8733), via unspecified route of administration, administered in left arm on 30Apr2021 at 04:30 PM (at the age of 52-years-old) as dose 2, single for COVID-19 immunization in Hospital. Medical history included right hemicolectomy 1.5 years ago but still have diarrhea, and ongoing burp. Patient had no known allergies. Concomitant medication(s) included omeprazole 20mg taken for burp, hydroxyzine 25mg, and citalopram 40mg; all from unknown start and stop date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, lot number: EW0161), via unspecified route of administration, administered in left arm on 09Apr2021 at 02:30 PM as dose 1, single for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccine within four weeks of vaccination. On 30Apr2021 at 10:00 PM (same day of vaccination), patient experienced tiredness (exhausted), sweating but no fever average temp was between 95.7 and 96, aches in joints (toes, ankles, right and rear right shoulder), and very watery diarrhea (patient had a shortened colon but not usually had diarrhea that bad). Therapeutic measures taken for events included Tylenol 500mg. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering.   No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood blister, Blood test, Electrocardiogram, Oral discomfort
Clinical narrative: Mouth Burning; break out with bumps around his mouth; Scrotum blood blisters; Severe pain in legs and joints; Severe pain in legs and joints; First dose: pain in shoulder; This is a spontaneous report from a contactable consumer.   A male 74-years age patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 11:00 (at the age of 73-years-old) as dose 1, single for covid-19 immunisation at Pharmacy/Clinic. Medical history included cardiac failure congestive from unspecified date in 2018 and ongoing (he was diagnosed with congestive heart failure after having a heart attack in Nov2018), myocardial infarction from unspecified date in Nov2018 to an unknown date (Verbatim: Heart attack), pacemaker syndrome from unspecified date in 2020 and ongoing (Verbatim: Pacemaker), ongoing vertigo (he was diagnosed with vertigo 5 years ago but had vertigo long before that), ongoing chronic obstructive pulmonary disease (he was diagnosed with COPD 12 years ago), ongoing emphysema (he was diagnosed with emphysema 12 years ago), ongoing asthma (he was diagnosed with asthma 12 years ago), ongoing abdominal discomfort (he had gastric bypass back in the 80's) and ongoing gastric bypass (he had gastric bypass in the 1980's). Concomitant medications included B12 shots, Unspecified medications and Unspecified water pill. The patient previously received flu shot in an unspecified date in Nov2020 at local pharmacy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021, the patient experienced first dose: pain in shoulder and on an unspecified date, mouth burning, break out with bumps around his mouth, scrotum blood blisters and severe pain in legs and joints. The reporter reported that the pain in his shoulder began on the night of 02Feb2021 and lasted a day and a half. The patient underwent lab tests and procedures which included blood test: nil, electrocardiogram: nil and x-ray: nil on an unspecified date Apr2021. The event first dose: pain in shoulder was resolved on an unspecified date in Feb2021 and other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Oral disorder, Pain in extremity, X-ray
Clinical narrative: Mouth Burning; break out with bumps around his mouth; Scrotum blood blisters; Severe pain in legs and joints; Severe pain in legs and joints; First dose: pain in shoulder; This is a spontaneous report from a contactable consumer.   A male 74-years age patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 11:00 (at the age of 73-years-old) as dose 1, single for covid-19 immunisation at Pharmacy/Clinic. Medical history included cardiac failure congestive from unspecified date in 2018 and ongoing (he was diagnosed with congestive heart failure after having a heart attack in Nov2018), myocardial infarction from unspecified date in Nov2018 to an unknown date (Verbatim: Heart attack), pacemaker syndrome from unspecified date in 2020 and ongoing (Verbatim: Pacemaker), ongoing vertigo (he was diagnosed with vertigo 5 years ago but had vertigo long before that), ongoing chronic obstructive pulmonary disease (he was diagnosed with COPD 12 years ago), ongoing emphysema (he was diagnosed with emphysema 12 years ago), ongoing asthma (he was diagnosed with asthma 12 years ago), ongoing abdominal discomfort (he had gastric bypass back in the 80's) and ongoing gastric bypass (he had gastric bypass in the 1980's). Concomitant medications included B12 shots, Unspecified medications and Unspecified water pill. The patient previously received flu shot in an unspecified date in Nov2020 at local pharmacy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021, the patient experienced first dose: pain in shoulder and on an unspecified date, mouth burning, break out with bumps around his mouth, scrotum blood blisters and severe pain in legs and joints. The reporter reported that the pain in his shoulder began on the night of 02Feb2021 and lasted a day and a half. The patient underwent lab tests and procedures which included blood test: nil, electrocardiogram: nil and x-ray: nil on an unspecified date Apr2021. The event first dose: pain in shoulder was resolved on an unspecified date in Feb2021 and other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chest discomfort, Chest pain, Chills, Dizziness, Insomnia
Clinical narrative: Chills; Chest pressure was noticeable when he was about to go to sleep; He had a hard time sleeping because of it.; Lightheadedness; A sharp shooting chest pain afterwards; A sore arm/Soreness in left arm; This is a spontaneous report from a contactable consumer (patient) reported that. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 16:30 (age at vaccination 38-year-old) (Batch/Lot number was not reported) as dose 1 single for covid-19 immunization. The patient past Medical history included asthma (has been diagnosed for a couple of months but has had this his whole life),gastroesophageal reflux disease (Additional Information for Other Conditions: caller has been diagnosed for a couple of months but has had this his whole life , death of relative). Concomitant medication included pantoprazole taken for gastroesophageal reflux disease and Albuterol [SALBUTAMOL] for asthma. Patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 04May2021, the patient experienced lightheadedness there was an initial rush right when he got the shot. It subsided and he stayed for 45 minutes and then he felt fine. Then, it came back when he got ready for bed. He is still having it today and he also had chest pain and thought it was from the soreness from his arm, but it is not going away. On an unspecified date the chest pressure was noticeable when he was about to go to sleep. There are still traces of the chest pain. The chest pain was yesterday but was not severe until the evening. It has gotten better and Last night it was was rough. The left arm, soreness is still there like someone hit him with a baseball bat. He wants to know what is normal for side effects of the vaccine, because he knows that like fever and stuff are. He did research online and was not finding much on this. He knew his arm would hurt. The patient is treated for the pain on the arm he took 200 mg Ibuprofen before bed. He has taken a multivitamin this morning. The event outcome was not recovered for a sore arm/Soreness in left arm, chest pain and lightheadedness and for rest of the event was Unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Chills; Chest pressure was noticeable when he was about to go to sleep; He had a hard time sleeping because of it.; Lightheadedness; A sharp shooting chest pain afterwards; A sore arm/Soreness in left arm; This is a spontaneous report from a contactable consumer (patient) reported that. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 16:30 (age at vaccination 38-year-old) (Batch/Lot number was not reported) as dose 1 single for covid-19 immunization. The patient past Medical history included asthma (has been diagnosed for a couple of months but has had this his whole life),gastroesophageal reflux disease (Additional Information for Other Conditions: caller has been diagnosed for a couple of months but has had this his whole life , death of relative). Concomitant medication included pantoprazole taken for gastroesophageal reflux disease and Albuterol [SALBUTAMOL] for asthma. Patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 04May2021, the patient experienced lightheadedness there was an initial rush right when he got the shot. It subsided and he stayed for 45 minutes and then he felt fine. Then, it came back when he got ready for bed. He is still having it today and he also had chest pain and thought it was from the soreness from his arm, but it is not going away. On an unspecified date the chest pressure was noticeable when he was about to go to sleep. There are still traces of the chest pain. The chest pain was yesterday but was not severe until the evening. It has gotten better and Last night it was was rough. The left arm, soreness is still there like someone hit him with a baseball bat. He wants to know what is normal for side effects of the vaccine, because he knows that like fever and stuff are. He did research online and was not finding much on this. He knew his arm would hurt. The patient is treated for the pain on the arm he took 200 mg Ibuprofen before bed. He has taken a multivitamin this morning. The event outcome was not recovered for a sore arm/Soreness in left arm, chest pain and lightheadedness and for rest of the event was Unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: sick in the stomach; lot of nausea; diarrhea,; vomiting; This is a spontaneous report from contactable other health professional from a Pfizer sponsored program A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), via oral route of administration from 2018 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatoid arthritis. Medical history included rheumatoid arthritis. The patients concomitant medications were not reported. Patient reported that she had to stop Xeljanz 5 days after getting her COVID-19vaccine and will be stopping again for 5 days after her second dose on 02May2021 per md instructions. no adverse event reported related to stopping but had COVID-19 vaccine side-effects : "I was sick like a dog", sick in the stomach, a lot of nausea, diarrhea, vomiting" and drunk a lot of gatorade, she took it on a Sunday and feeling better the following Tuesday. patient restarted Xeljanz after md aware. Outcome of the events were recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: missed appointment for second dose 5/2/21 due to illness and caller wanted to know whther they could still get vaccine.... ill after first dose of vaccine; This is a spontaneous report from a Pfizer  from a non-contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient missed appointment for second dose 02May2021 due to illness and caller wanted to know whether they could still get vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Cognitive disorder, Feeling abnormal, Malaise, Myalgia
Clinical narrative: I can't think and I'm having trouble coming up with words; severe brain fog stating "I can't think and I'm having trouble coming up with words, the brain is not working well".; persistent low grade fever; Muscle pain; still is not feeling better; brain is not working well; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (at the age of 37 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included covid-19 in Feb2020. The patient's concomitant medications were not reported. It was reported that Last Friday a week ago the she had her first vaccine dose and had symptoms that are very severe, including a persistent low-grade fever, muscle pain, and a severe brain fog stating she can't think and having trouble coming up with words, the brain is not working well. She reports that she has been off of work for a week and is unable to afford to see her doctor. She told that she was not feeling better and wants to know if that is normal. She also would like to know if she should get the second vaccine dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I can't think and I'm having trouble coming up with words; severe brain fog stating "I can't think and I'm having trouble coming up with words, the brain is not working well".; persistent low grade fever; Muscle pain; still is not feeling better; brain is not working well; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (at the age of 37 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included covid-19 in Feb2020. The patient's concomitant medications were not reported. It was reported that Last Friday a week ago the she had her first vaccine dose and had symptoms that are very severe, including a persistent low-grade fever, muscle pain, and a severe brain fog stating she can't think and having trouble coming up with words, the brain is not working well. She reports that she has been off of work for a week and is unable to afford to see her doctor. She told that she was not feeling better and wants to know if that is normal. She also would like to know if she should get the second vaccine dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Chills, Computerised tomogram, Hyperhidrosis
Clinical narrative: neck and under the arm lymph nodes got swelled up/swelling was worse causing left side inflammation; Swelling was worse causing left side inflammation; Chest pain; Chills; Sweating; Pain in chest due to lymph nodes was very hard and also under the armpit.; This is a spontaneous report from a contactable other health care professional (Patient). A 34-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206, Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 01May2021 13:15 (at the age of 34-year-old), as single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number: EN6206, Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on 01May2021 13:15 in Left Arm as a single dose for COVID-19 immunization. The patient medical history was reported as none. The patient does not have known allergies. The patient concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021 after second dose, the patient experienced swelling was worse causing left side inflammation, chest pain, chills, sweating, pain in chest due to lymph nodes was very hard and also under the armpit. The events resulted in visit to physician or other health professional office. The seriousness of the events was reported as non-serious. Therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events was resolving. The device date was reported as 04May2021.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Lymphadenopathy
Clinical narrative: neck and under the arm lymph nodes got swelled up/swelling was worse causing left side inflammation; Swelling was worse causing left side inflammation; Chest pain; Chills; Sweating; Pain in chest due to lymph nodes was very hard and also under the armpit.; This is a spontaneous report from a contactable other health care professional (Patient). A 34-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206, Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 01May2021 13:15 (at the age of 34-year-old), as single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number: EN6206, Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on 01May2021 13:15 in Left Arm as a single dose for COVID-19 immunization. The patient medical history was reported as none. The patient does not have known allergies. The patient concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021 after second dose, the patient experienced swelling was worse causing left side inflammation, chest pain, chills, sweating, pain in chest due to lymph nodes was very hard and also under the armpit. The events resulted in visit to physician or other health professional office. The seriousness of the events was reported as non-serious. Therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events was resolving. The device date was reported as 04May2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: 2nd shot (L arm) - various purpura; This is a spontaneous report from a contactable other health professional (patient). A 61-year-old non pregnant female patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8733) intramuscular, in the left arm on 03Apr2021 at 10:35 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included restless legs syndrome (RLS), attention deficit hyperactivity disorder (ADHD), mitral valve prolapse (MVP), fracture clavicle (R ORIF clavicle) from 2009, and Raynauds from young age and ongoing. Patient has reported family history of cancer epiglossal breast cancer, diabetes, COPD (chronic obstructive pulmonary disease), stroke (was in 90s age group), HTN (hypertensin), alocholism, meningioma and carpal tunnel. Allergies were not reported. The patient's concomitant medications were reported as none. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6207) intramuscular, in the arm right on 13Mar2021 at 10:35 (Lot Number: EN6207) at the age of 61 years old, as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested with COVID-19 post to vaccination. On 05Apr2021, the patient experienced 2nd shot (left arm) various purpura. 2nd shot Left arm various purpura, individual ones resolving, but the purpura not totally resolving / more unusual bruising. Started after the 2nd vaccination could be coincidental or not. Purpura Never as history of purpura prior to second vaccine in various locations. The patient did not receive any treatment for the event. Seriousness criteria reported as not serious. Adverse event required visit to physician office. Relevant tests included COVID test with result: Negative. Test: COVID antibodies with result: Negative. The outcome of the event was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder pain, Chills, Diarrhoea, Headache, Inappropriate schedule of product administration
Clinical narrative: Diarrhea; vomiting; insomnia; muscle aches/ all over body pain 5 days; muscle aches/ all over body pain 5 days; kidney and bladder cramping pain 2 days; kidney and bladder cramping pain 2 days; chills; low grade fever 101; headaches; Dose Number 1(19Apr2021); Dose Number 2 (03May2021); This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 2W0175 or ZL0175) via unspecified route in right arm single dos for COVID-19 immunization on 03May2021 18:15, at 38-year-old. The patient medical history was not reported. Concomitant medications included echinacea angustifolia root, echinacea purpurea root, hydrastis canadensis root (ECHINACEA & GOLDENSEAL); herbal nos, minerals nos, vitamins nos (WOMENS ULTRA MEGA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730) in right arm for COVID-19 immunization on 19Apr2021 18:15, at 38-year-old; codeine and experienced allergies. The patient had diarrhea 72 hours, vomiting 6 hours, insomnia 4 days, muscle aches/ all over body pain 5 days, kidney and bladder cramping pain 2 days, chills 2 days, low grade fever 101- 6 hours, headaches more than 6 days; all were on 03May2021 20:00, resulted in doctor or other healthcare professional office/clinic visit, with outcome of recovering after receiving treatment (palliative care, over the counter remedies). Outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain, Pyrexia, Renal pain
Clinical narrative: Diarrhea; vomiting; insomnia; muscle aches/ all over body pain 5 days; muscle aches/ all over body pain 5 days; kidney and bladder cramping pain 2 days; kidney and bladder cramping pain 2 days; chills; low grade fever 101; headaches; Dose Number 1(19Apr2021); Dose Number 2 (03May2021); This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 2W0175 or ZL0175) via unspecified route in right arm single dos for COVID-19 immunization on 03May2021 18:15, at 38-year-old. The patient medical history was not reported. Concomitant medications included echinacea angustifolia root, echinacea purpurea root, hydrastis canadensis root (ECHINACEA & GOLDENSEAL); herbal nos, minerals nos, vitamins nos (WOMENS ULTRA MEGA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730) in right arm for COVID-19 immunization on 19Apr2021 18:15, at 38-year-old; codeine and experienced allergies. The patient had diarrhea 72 hours, vomiting 6 hours, insomnia 4 days, muscle aches/ all over body pain 5 days, kidney and bladder cramping pain 2 days, chills 2 days, low grade fever 101- 6 hours, headaches more than 6 days; all were on 03May2021 20:00, resulted in doctor or other healthcare professional office/clinic visit, with outcome of recovering after receiving treatment (palliative care, over the counter remedies). Outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; vomiting; insomnia; muscle aches/ all over body pain 5 days; muscle aches/ all over body pain 5 days; kidney and bladder cramping pain 2 days; kidney and bladder cramping pain 2 days; chills; low grade fever 101; headaches; Dose Number 1(19Apr2021); Dose Number 2 (03May2021); This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 2W0175 or ZL0175) via unspecified route in right arm single dos for COVID-19 immunization on 03May2021 18:15, at 38-year-old. The patient medical history was not reported. Concomitant medications included echinacea angustifolia root, echinacea purpurea root, hydrastis canadensis root (ECHINACEA & GOLDENSEAL); herbal nos, minerals nos, vitamins nos (WOMENS ULTRA MEGA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730) in right arm for COVID-19 immunization on 19Apr2021 18:15, at 38-year-old; codeine and experienced allergies. The patient had diarrhea 72 hours, vomiting 6 hours, insomnia 4 days, muscle aches/ all over body pain 5 days, kidney and bladder cramping pain 2 days, chills 2 days, low grade fever 101- 6 hours, headaches more than 6 days; all were on 03May2021 20:00, resulted in doctor or other healthcare professional office/clinic visit, with outcome of recovering after receiving treatment (palliative care, over the counter remedies). Outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cranial nerve infection, Ear pain, Feeding disorder, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: I can't speak or eat; I can't speak or eat; his whole entire face went numb; he had a viral infection in the nerve ; 7th nerve; Ear ache; he had a viral infection in the nerve ; 7th nerve; This is spontaneous report from a Pfizer sponsored program. A contactable 51-year-old male consumer reported for himself. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 20Apr2021 (at the age of 51-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included dapagliflozin propanediol monohydrate (FORXIGA) 10 mg taken for type 2 diabetes. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), via an unspecified route of administration on 30Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient reported that he had ear ache on 23Apr2021. He went to his ear and throat specialist. He got an MRI done and his whole entire face went numb. It turned out he had a viral infection in the nerve (7 th nerve) and he just wanted to report this. He also stated that his whole face is grooving numb, and he cannot speak or eat. When asked about the treatment, consumer stated, he was currently not taking because any medication cause glucose level increase. Caller also stated that he received the second Pfizer vaccine on 20Apr2021, and he would like some financial assistance with medical issues due to facial numbness as a reaction. Reporter seriousness for I can't speak or eat was unspecified. The patient underwent lab tests and procedures which included magnetic resonance imaging: viral problem (viral something like that in my seventh nerve) on 06May2021. The outcome of ear ache and had a viral infection in the nerve: 7th nerve was not recovered, for I cannot speak or eat outcome was unknown and for Hypoaesthesia outcome was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder, Speech disorder
Clinical narrative: I can't speak or eat; I can't speak or eat; his whole entire face went numb; he had a viral infection in the nerve ; 7th nerve; Ear ache; he had a viral infection in the nerve ; 7th nerve; This is spontaneous report from a Pfizer sponsored program. A contactable 51-year-old male consumer reported for himself. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 20Apr2021 (at the age of 51-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included dapagliflozin propanediol monohydrate (FORXIGA) 10 mg taken for type 2 diabetes. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), via an unspecified route of administration on 30Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient reported that he had ear ache on 23Apr2021. He went to his ear and throat specialist. He got an MRI done and his whole entire face went numb. It turned out he had a viral infection in the nerve (7 th nerve) and he just wanted to report this. He also stated that his whole face is grooving numb, and he cannot speak or eat. When asked about the treatment, consumer stated, he was currently not taking because any medication cause glucose level increase. Caller also stated that he received the second Pfizer vaccine on 20Apr2021, and he would like some financial assistance with medical issues due to facial numbness as a reaction. Reporter seriousness for I can't speak or eat was unspecified. The patient underwent lab tests and procedures which included magnetic resonance imaging: viral problem (viral something like that in my seventh nerve) on 06May2021. The outcome of ear ache and had a viral infection in the nerve: 7th nerve was not recovered, for I cannot speak or eat outcome was unknown and for Hypoaesthesia outcome was unknown.   No follow-up attempts are possible. No further information is expected.