chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Ear swelling, Injection site erythema, Injection site rash, Pruritus
Clinical narrative: elevated redness sort of like a rash around the injected area; rash came back in the injected area; it was itchy; my face was swollen and ears; my face was swollen and ears; hives on my face; skin was very dry; rash like; This is a spontaneous report from a contactable healthcare professional reporting for a patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 31Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for Covid-19 immunization. Medical history included tuberculosis (TB) when younger and took medication for it from an unknown date. The patient was allergic to penicillin and breaks out in hives and a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date after the vaccination, the patient experienced elevated redness sort of like a rash around the injected area for 2 days and then it went away, exactly a week later the rash came back in the injected area but did not spread and lasted another two days. On 14Jan2021 at 04:00 the patient experienced broke up in hives on face, face was swollen, and ears and it was itchy. The patient experienced skin was very dry and rash like but not itchy on an unknown date in Jan2021. Therapeutic measures were taken for the swelling face, ear swelling, hives and pruritis which included Benadryl for 2 days which helped the events go down. The clinical outcome of the event injection site erythema, swelling face, ear swelling, hives and pruritus was recovered; injection site rash, dry skin and rash were unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: elevated redness sort of like a rash around the injected area; rash came back in the injected area; it was itchy; my face was swollen and ears; my face was swollen and ears; hives on my face; skin was very dry; rash like; This is a spontaneous report from a contactable healthcare professional reporting for a patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 31Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for Covid-19 immunization. Medical history included tuberculosis (TB) when younger and took medication for it from an unknown date. The patient was allergic to penicillin and breaks out in hives and a rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date after the vaccination, the patient experienced elevated redness sort of like a rash around the injected area for 2 days and then it went away, exactly a week later the rash came back in the injected area but did not spread and lasted another two days. On 14Jan2021 at 04:00 the patient experienced broke up in hives on face, face was swollen, and ears and it was itchy. The patient experienced skin was very dry and rash like but not itchy on an unknown date in Jan2021. Therapeutic measures were taken for the swelling face, ear swelling, hives and pruritis which included Benadryl for 2 days which helped the events go down. The clinical outcome of the event injection site erythema, swelling face, ear swelling, hives and pruritus was recovered; injection site rash, dry skin and rash were unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a claustrophobic; nauseous; Dizzy; headache; fatigue/I'm just exhausted 72 hours later; fever kept rising; I started violently projectile vomiting for a few hours; I got the chills; I was sore; felt "hungover"; the arm soreness; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her right arm, intramuscular on 16Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included anxiety, acid reflux and cholecystectomy.  Concomitant medication included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), clonazepam (CLONAPAM) and an unspecified antacid. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 as first dose. It was reported that 12 hours later after vaccination, the patient felt really hot and nauseous, dizzy, headache and fatigue. But then 24 hours later her fever kept rising. She felt extremely hot/cold sensation in a claustrophobic. At peak of her fever, 100F, she started violently projectile vomiting for a few hours. Then she got the chills. Felt nauseous still. But no more vomiting, fever went down on its own. The next day 48 hours later, she was sore and felt "hungover". This time the arm soreness dissipated twice as fast. Now she just exhausted 72 hours later; all events occurred on 17Jan2021 at 02:00. No treatment was received for the events. The outcome of the events was recovered with sequel.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hangover, Headache, Nausea, Pain
Clinical narrative: I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a claustrophobic; nauseous; Dizzy; headache; fatigue/I'm just exhausted 72 hours later; fever kept rising; I started violently projectile vomiting for a few hours; I got the chills; I was sore; felt "hungover"; the arm soreness; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her right arm, intramuscular on 16Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included anxiety, acid reflux and cholecystectomy.  Concomitant medication included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), clonazepam (CLONAPAM) and an unspecified antacid. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 as first dose. It was reported that 12 hours later after vaccination, the patient felt really hot and nauseous, dizzy, headache and fatigue. But then 24 hours later her fever kept rising. She felt extremely hot/cold sensation in a claustrophobic. At peak of her fever, 100F, she started violently projectile vomiting for a few hours. Then she got the chills. Felt nauseous still. But no more vomiting, fever went down on its own. The next day 48 hours later, she was sore and felt "hungover". This time the arm soreness dissipated twice as fast. Now she just exhausted 72 hours later; all events occurred on 17Jan2021 at 02:00. No treatment was received for the events. The outcome of the events was recovered with sequel.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting projectile
Clinical narrative: I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a claustrophobic; nauseous; Dizzy; headache; fatigue/I'm just exhausted 72 hours later; fever kept rising; I started violently projectile vomiting for a few hours; I got the chills; I was sore; felt "hungover"; the arm soreness; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her right arm, intramuscular on 16Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included anxiety, acid reflux and cholecystectomy.  Concomitant medication included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), clonazepam (CLONAPAM) and an unspecified antacid. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 as first dose. It was reported that 12 hours later after vaccination, the patient felt really hot and nauseous, dizzy, headache and fatigue. But then 24 hours later her fever kept rising. She felt extremely hot/cold sensation in a claustrophobic. At peak of her fever, 100F, she started violently projectile vomiting for a few hours. Then she got the chills. Felt nauseous still. But no more vomiting, fever went down on its own. The next day 48 hours later, she was sore and felt "hungover". This time the arm soreness dissipated twice as fast. Now she just exhausted 72 hours later; all events occurred on 17Jan2021 at 02:00. No treatment was received for the events. The outcome of the events was recovered with sequel.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling sensation on the left side of her face; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 19Jan2021 09:50 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine today at 9:50am and experienced a tingling sensation on the left side of her face at 10:30-10:45am 19Jan2021. It was described as like she had gotten Lidocaine and it's not worn off yet. The sensation was not getting worse but was still there. She was asking if this a normal reaction and on what she should do.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: lip tingling; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  Medical history included before having the shot, she was being anxious as described by feeling nervous, having sweaty palms, her heart was racing, couldn't listen to the lady that was administering the shot, difficulty in concentration. The patient's concomitant medications were not reported. The patient experienced lip tingling that happened momentarily and went away on its own as an adverse event. The action taken in response to the event(s) for bnt162b2 was not applicable. Because of this event, her employer won't let her have the second shot for the COVID-19 vaccine. She had an appointment with her allergist who assured her that her experience was not an anaphylactic reaction and it was not a contraindication to the vaccine. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness postural, Fatigue, Headache
Clinical narrative: soreness in his hips and back - more sore than usual; soreness in his hips and back - more sore than usual; got rather tired; had a pretty good headache; dizziness when getting up too quickly; heart palpitations; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 17Jan2021 at 10:30 at a single dose for COVID-19 immunisation. Relevant medical history included usual soreness in his hips and back. The patient's concomitant medications were not reported. The patient reported he had a few little side effects and that was fine; he was over it at the time of the report. When the injection was given, it was cold going in. There were no side effects for the first 3-4 hours (hrs) after vaccine on 17Jan2021, then after that he got rather tired; in 12 hours, he had a pretty good headache, dizziness when getting up too quickly, and a couple times he did have heart palpitations. On 18Jan2021, the next morning from shot (less than 24 hour after shot), he had soreness in his hips and back, which was more sore than usual. The patient said that by the end of 36 hours, the symptoms resolved. The patient stated he was "48 hours out and he was feeling fine; he might even feel a little better than when he started this whole thing." The patient also stated that the vaccination provider gave him an option for his 2nd dose appointment (days 18-22 post 1st dose). The patient took the earliest appointment, but was wondering at the time of the report, if that would be 'okay' to get the 2nd dose on day 18 or should he call and reschedule for day 21. The patient further reported that he had a Pfizer vaccine shot on Sunday and had a small amount of side effects, but there was no big deal and no problem. They scheduled him for the second shot only 18 days rather than 3 weeks and wanted to check and see if that was something that's ok or that's too close. The patient recovered from all the events on 18Jan2021.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: soreness in his hips and back - more sore than usual; soreness in his hips and back - more sore than usual; got rather tired; had a pretty good headache; dizziness when getting up too quickly; heart palpitations; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 17Jan2021 at 10:30 at a single dose for COVID-19 immunisation. Relevant medical history included usual soreness in his hips and back. The patient's concomitant medications were not reported. The patient reported he had a few little side effects and that was fine; he was over it at the time of the report. When the injection was given, it was cold going in. There were no side effects for the first 3-4 hours (hrs) after vaccine on 17Jan2021, then after that he got rather tired; in 12 hours, he had a pretty good headache, dizziness when getting up too quickly, and a couple times he did have heart palpitations. On 18Jan2021, the next morning from shot (less than 24 hour after shot), he had soreness in his hips and back, which was more sore than usual. The patient said that by the end of 36 hours, the symptoms resolved. The patient stated he was "48 hours out and he was feeling fine; he might even feel a little better than when he started this whole thing." The patient also stated that the vaccination provider gave him an option for his 2nd dose appointment (days 18-22 post 1st dose). The patient took the earliest appointment, but was wondering at the time of the report, if that would be 'okay' to get the 2nd dose on day 18 or should he call and reschedule for day 21. The patient further reported that he had a Pfizer vaccine shot on Sunday and had a small amount of side effects, but there was no big deal and no problem. They scheduled him for the second shot only 18 days rather than 3 weeks and wanted to check and see if that was something that's ok or that's too close. The patient recovered from all the events on 18Jan2021.  Information on the batch/lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: hives/hives on her lower legs with sporadic patches on other places of her body including her upper legs, some on her arm, some on her torso and her upper chest; soreness (a little bit); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Unknown lot number and expiration), intramuscular in left upper arm on 31Dec2020 at a single dose for COVID-19 prophylaxis.  Medical history included cat allergy/seasonal and animal allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for cat allergy. The patient previously received flu shot for immunization on unspecified date.  The patient reported that she received the first dose of vaccine on 31Dec2020 and experienced soreness (a little bit) but was no difference from the flu shot. Last night (18Jan2021), hives started to appear. She took a Zyrtec this morning (19Jan2021) that she usually takes at night to alleviate the symptoms. She takes Zyrtec because she has a cat allergy and also reported to have changed her laundry detergent. The patient was wondering if there have been any reports of delayed allergic reactions to the COVID-19 vaccine. She said that she just got hives on her lower legs with sporadic patches on other places of her body including her upper legs, some on her arm, some on her torso and her upper chest last night. She may have some on her back, but she has not looked yet. She has had this type of reaction before with an antibiotic in the past. She is supposed to get the second dose on Thursday 21Jan2021. She noticed the hives last night and they seem to have gotten a little bit worse overnight but are about the same since she has gotten up. She said that she has allergies, but they are seasonal and animal allergies. She has also been using the same body wash and laundry detergent and stated that nothing has really changed with her. She also said that her partner that lives with her has not had any skin issues. The patient had not yet recovered from the event hives, while unknown outcome for the remaining event.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Headache, Nausea, Neck pain
Clinical narrative: nausea; heartburn; chills; nightmares; soreness at the back of her neck; headaches; seeing a blank shadow; This is a spontaneous report from a contactable consumer (patient). A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 11:00 AM at single dose for COVID-19 immunisation. Caller received the first dose of the Pfizer COVID vaccine yesterday (18Jan2021) at 11am. Last night, she started to experience nausea, heartburn, chills, nightmares, soreness at the back of her neck, headaches and seeing a blank shadow. She is concerned if these are normal side effects associated with the COVID-19 vaccine. Patient reported had a whole lot of things all night long, and wanted to see if they were normal, the side effects. Outcome of the events was unknown.   Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Visual impairment
Clinical narrative: nausea; heartburn; chills; nightmares; soreness at the back of her neck; headaches; seeing a blank shadow; This is a spontaneous report from a contactable consumer (patient). A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 11:00 AM at single dose for COVID-19 immunisation. Caller received the first dose of the Pfizer COVID vaccine yesterday (18Jan2021) at 11am. Last night, she started to experience nausea, heartburn, chills, nightmares, soreness at the back of her neck, headaches and seeing a blank shadow. She is concerned if these are normal side effects associated with the COVID-19 vaccine. Patient reported had a whole lot of things all night long, and wanted to see if they were normal, the side effects. Outcome of the events was unknown.   Information about Lot/Batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Sore at injection site (felt like bruise); Sore at injection site (felt like bruise); This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in the right arm on 16Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included asthma/allergies and eggplant/zucchini sensitivity. The patient's concomitant medications were not reported. The patient experienced sore at injection site (felt like bruise) on 17Jan2021 that lasted approximately 36 hrs. The patient was okay by 18Jan2021 afternoon. Outcome of the events was reported as recovered on 18Jan2021. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior vaccination and has not tested for COVID-19 post vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Nausea, Swelling face, Vomiting
Clinical narrative: flushing to face and swollen cheeks; flushing to face and swollen cheeks; nausea; vomiting; This is a spontaneous report from a contactable Other Health Professional. A female patient (non-pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation.  Medical history included anxiety, PCOS (polycystic ovarian syndrome), known allergies: sulfa. Concomitant medication included biotin, cannabidiol (CBD OIL), fish oil, ibuprofen, metformin, famotidine (PEPCID AC), spironolactone, ethinylestradiol; ferrous fumarate; norethisterone acetate (TAYTULLA), calcium carbonate (TUMS [CALCIUM CARBONATE]), colecalciferol (VIT D3). The patient experienced flushing to face and swollen cheeks, nausea and vomiting day 4 after vaccine on 18Jan2021 16:00. Therapeutic measures were taken included cetirizine hydrochloride (ZYRTEC) and omeprazole (PRILOSEC). This event resulted in: Doctor or other healthcare professional office/clinic visit. Outcome of the event was not resolved.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: received the second dose of the COVID-19 vaccine/He had tested his patient's antibodies in his commercial laboratory and the result was negative; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient had his first dose of BNT162B2 on unspecified date for covid-19 immunization. It was reported by the physician that he had a patient who received the second dose of the COVID-19 vaccine and had tested his patient's antibodies in his commercial laboratory and the result was negative. The physician was asking if that was an expected result or should it be positive.  The outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included pneumonia, penicillin allergy, diabetec and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included potassium citrate, tamsulosin, glipizide, magnesium sulfate, (6s)-5-methyltetrahydrofolate glucosamine, mecobalamin, pyridoxal phosphate, thioctic acid (PODIAPN), dulaglutide (TRULICITY), carvedilol, rosuvastatin, furosemide, acetylsalicylic acid (BAYER ASPIRIN) , valsartan, ubidecarenone (COQ-10), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA), salbutamol sulfate (PROAIR HFA) and apixaban (ELIQUIS). The patient previously took amoxicillin at 1 DF, 2x/day (one tablet by mouth every 12 hours), azithromycin at 250 mg (250mg, take two tablets by mouth and then one tablet by mouth for four days) and prednisone at 20 mg (20mg, three pills daily for three days then two pills daily for four days). It was reported that the patient had rash toes up to neck. The patient's wife was wondering if it was normal for his husband to experience rashing after getting the vaccine. The patient had a rash that started from his feet. It looks like sunburn. It is going up his legs, body, and chest. It started the day after the vaccine. Two weeks ago he went to his pulmonary doctor and he had pneumonia. They gave him prednisone, Amoxicillin, and Azithromycin and both are forms of penicillin which he is allergic to. He hasn't taken it in years. The doctor knew that. She is not sure if the rash if from that. He ended those medications the Friday before the vaccine, 08Jan2021. She is confused. Everyone she calls says they are not sure if it was the medications or the shot. She is trying to get a dermatologist to see the patient. The rash started on 16Jan2021. It has progressively gotten worse. She is wondering if the patient should go back on the fifth for the second vaccine. She is assuming it is the medication. The nurses and doctor don't know. They said take him to the ER. He is not having trouble breathing. If he was having trouble breathing she would take him to the ER. She can't get anyone to look at the rash. She didn't do anything. He is supposed to get the second dose on 05Feb2021. The outcome of the event was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash
Clinical narrative: rash in the top of right hand/rash on the left hand; looks like dryness; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN9899), via an unspecified route of administration on 15Jan2021 at 13:30 on the left arm at a single dose for COVID-19 immunization.  Medical history included partial seizures complex, asthma, beginning of heart disease and high cholesterol all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no prior vaccination within four weeks. The patient stated she has a rash on the top of her hand right hand and rash on the left hand; it is real dry, it looks like dryness, on 18Jan2021. The patient stated that she doesn't know if it is allergic reaction. She needs help to figure it out. She is asking if she needs to see her doctor. The patient stated that otherwise, the vaccine was healing her and helping her. She stated that she knows you can have a rash all over your body and she wants to know if that is going to happen. She clarified she noticed the rash on the top of her right hand - not the palm. She isn't sure if it came from taking out the trash or cleaning stuff or some other reason. She stated that it is now trying to get on the other left hand too. She said you can't really tell it on her left hand but she noticed it on the night of 18Jan2021. She is unsure if when she washes her hands it is getting from the right hand onto the left hand. She just needs to know if it is from the vaccine or if she needs to stop taking out the trash or maybe wearing gloves. She is scheduled to receive the next dose on 5Feb2021. She lives in a senior facility building. One of the staff members got COVID so they had to get the vaccine. The adverse event did not require a visit to the physician or emergency department (ER). The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This is a spontaneous report from a contactable health care professional nurse, the patient. A 67-years-old non-pregnant female patient (nurse) received the second dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number: EK9231,), intramuscular in the left arm on 07Jan2021 16:00 as a single dose,  for COVID-19 vaccination.  Medical history included gastrooesophageal reflux disease. Concomitant medication included diltiazem (DILTIAZEM). Patient has no known allergies. The patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EH9899, on 18Dec2020; 16:00, Intramuscular, right arm,.  On 08Jan2021 at  04:00 the patient experienced nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache. The events  resulted in a Physician office visit.  Lab tests included body temperature: greater than 100 degrees on 08Jan2021. Treatment given include zofran, APAP, fluids, and  rest.  The clinical outcome of nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache was recovering.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This is a spontaneous report from a contactable health care professional nurse, the patient. A 67-years-old non-pregnant female patient (nurse) received the second dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number: EK9231,), intramuscular in the left arm on 07Jan2021 16:00 as a single dose,  for COVID-19 vaccination.  Medical history included gastrooesophageal reflux disease. Concomitant medication included diltiazem (DILTIAZEM). Patient has no known allergies. The patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EH9899, on 18Dec2020; 16:00, Intramuscular, right arm,.  On 08Jan2021 at  04:00 the patient experienced nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache. The events  resulted in a Physician office visit.  Lab tests included body temperature: greater than 100 degrees on 08Jan2021. Treatment given include zofran, APAP, fluids, and  rest.  The clinical outcome of nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache was recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza, Pain, Pyrexia
Clinical narrative: flu; fever; chills; body ache; fatigue; This is a spontaneous report from a contactable healthcare professional. A 66-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) on her left arm, via an unspecified route of administration on 15Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included Allergies, Asthma, Sleep Apnea, Obesity, IBS, Depression and Arthritis. Concomitant medication included paroxetine hydrochloride (PAXIL), buspirone, unspecified allergy shots. The patient experienced Flu, Fever, Chills, Body Aches, Fatigue; all on 16Jan2021 09:45. No treatment was received for the events. The outcome of the events was recovered on an unspecified date in Jan2021.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK-9231) via an unspecified route of administration into the left arm on 30Dec2020 07:30 at a single dose for covid-19 immunization. Medical history included hypertension, hypercholesterolaemia and psoriasis. Concomitant medication included amlodipine (AMLODIPINE), atorvastatin (ATORVASTATIN), acetylsalicylic acid (BABY ASPIRIN), ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient experienced sore arm and fatigue on 31Dec2020 06:30. The patient did not receive treatment for the events reported. Outcome of events recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: Allergic reaction, sensation of throat closing requiring benadryl; Allergic reaction, sensation of throat closing requiring benadryl; This is a spontaneous report from a non-contactable physician. A 47-year-old female patient (non-pregnant) received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included 1st dose of bnt162b2 for COVID-19 immunisation. The patient experienced allergic reaction, sensation of throat closing requiring diphenhydramine hydrochloride (BENADRYL). Event resulted in emergency room/department or urgent care. Therapeutic measures were taken included diphenhydramine hydrochloride and famotidine (PEPCID). Outcome of the event was resolved.  No follow up attempts are possible. Information about Lot/ Batch could not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable healthcare professional (patient). A patient of unspecified age and gender received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The second dose of vaccine was administered in a hospital setting. The patient's medical history and concomitant medications were not reported. The patient developed hives on 16Jan2021. Antihistamine was given in hospital and was sent home. On 17Jan2021, the event did not improve and was directed to HCP.   Information about lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Ageusia, Anosmia, Diarrhoea, Fatigue
Clinical narrative: nausea; diarrhea; fatigue; loss of taste and smell; loss of taste and smell; stomach upset; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 31Dec2020 at single dose at left arm for covid-19 prophylaxis. There were no medical history and concomitant medications. Patient said that she got the first dose on 31Dec2020. She stated that she got Covid 2 weeks later. She said that she positive test on 12Jan2021. She stated that she was still having mild symptoms of Covid. She said that because of that, she was not cleared to go back to work yet. She stated that she was not having fever or shortness of breath. Patient clarified that her covid-19 symptoms were stomach upset, nausea, diarrhea, loss of taste and smell, and fatigue. She was supposed to get the second dose on 19Jan2021. Outcome of all events was recovering.   Information about Batch/Lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Nausea, SARS-CoV-2 test positive
Clinical narrative: nausea; diarrhea; fatigue; loss of taste and smell; loss of taste and smell; stomach upset; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 31Dec2020 at single dose at left arm for covid-19 prophylaxis. There were no medical history and concomitant medications. Patient said that she got the first dose on 31Dec2020. She stated that she got Covid 2 weeks later. She said that she positive test on 12Jan2021. She stated that she was still having mild symptoms of Covid. She said that because of that, she was not cleared to go back to work yet. She stated that she was not having fever or shortness of breath. Patient clarified that her covid-19 symptoms were stomach upset, nausea, diarrhea, loss of taste and smell, and fatigue. She was supposed to get the second dose on 19Jan2021. Outcome of all events was recovering.   Information about Batch/Lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: nausea; diarrhea; fatigue; loss of taste and smell; loss of taste and smell; stomach upset; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 31Dec2020 at single dose at left arm for covid-19 prophylaxis. There were no medical history and concomitant medications. Patient said that she got the first dose on 31Dec2020. She stated that she got Covid 2 weeks later. She said that she positive test on 12Jan2021. She stated that she was still having mild symptoms of Covid. She said that because of that, she was not cleared to go back to work yet. She stated that she was not having fever or shortness of breath. Patient clarified that her covid-19 symptoms were stomach upset, nausea, diarrhea, loss of taste and smell, and fatigue. She was supposed to get the second dose on 19Jan2021. Outcome of all events was recovering.   Information about Batch/Lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: nausea; diarrhea; fatigue; loss of taste and smell; loss of taste and smell; stomach upset; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 31Dec2020 at single dose at left arm for covid-19 prophylaxis. There were no medical history and concomitant medications. Patient said that she got the first dose on 31Dec2020. She stated that she got Covid 2 weeks later. She said that she positive test on 12Jan2021. She stated that she was still having mild symptoms of Covid. She said that because of that, she was not cleared to go back to work yet. She stated that she was not having fever or shortness of breath. Patient clarified that her covid-19 symptoms were stomach upset, nausea, diarrhea, loss of taste and smell, and fatigue. She was supposed to get the second dose on 19Jan2021. Outcome of all events was recovering.   Information about Batch/Lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling cold, Pain
Clinical narrative: tired so slept; chills (freezing); chills (freezing); aches; fever 100 degree F; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 55-year-old female patient received second single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL1284, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 12Jan2021 07:30 for Covid-19 immunisation. Facility type vaccine: Hospital. Patient previously took first single dose of BNT162B2 (Pfizer, lot number: EJ1685) on 22Dec2020 06:15 (at 54-years-old), vaccine location: Left arm for Covid-19 immunisation. Facility type vaccine: Hospital. The patient was not pregnant. The patient had no known allergies. Patient had no other relevant history. There was no other vaccine given within four weeks. There were no concomitant medications. The patient did not have Covid prior vaccination. On 12Jan2021 22:00, also reported as 12 hours post second dose injection, the patient experienced chills (freezing), aches, and fever at 100 degrees F. The patient took paracetamol (TYLENOL). On 13Jan2021, also reported as in the middle of 1st night, she had 101.1 degrees F. On the same date, in the morning, the chills were gone, and fever was down to 99.9 F. On the second day (14Jan2021), she still had aches with temperature at 99.9 F and was tired, so she slept. The patient took paracetamol again. On the third day (15Jan2021) she had slight aches and no fever. On the Fourth day (16Jan2021) she was normal. No other treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from chills on 13Jan2021, fever recovered on 15Jan2021, while the other events recovered on 16Jan2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tired so slept; chills (freezing); chills (freezing); aches; fever 100 degree F; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 55-year-old female patient received second single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL1284, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 12Jan2021 07:30 for Covid-19 immunisation. Facility type vaccine: Hospital. Patient previously took first single dose of BNT162B2 (Pfizer, lot number: EJ1685) on 22Dec2020 06:15 (at 54-years-old), vaccine location: Left arm for Covid-19 immunisation. Facility type vaccine: Hospital. The patient was not pregnant. The patient had no known allergies. Patient had no other relevant history. There was no other vaccine given within four weeks. There were no concomitant medications. The patient did not have Covid prior vaccination. On 12Jan2021 22:00, also reported as 12 hours post second dose injection, the patient experienced chills (freezing), aches, and fever at 100 degrees F. The patient took paracetamol (TYLENOL). On 13Jan2021, also reported as in the middle of 1st night, she had 101.1 degrees F. On the same date, in the morning, the chills were gone, and fever was down to 99.9 F. On the second day (14Jan2021), she still had aches with temperature at 99.9 F and was tired, so she slept. The patient took paracetamol again. On the third day (15Jan2021) she had slight aches and no fever. On the Fourth day (16Jan2021) she was normal. No other treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from chills on 13Jan2021, fever recovered on 15Jan2021, while the other events recovered on 16Jan2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Gait disturbance
Clinical narrative: can't hardly walk/can't hardly move my legs; I'm terrible. I feel spacey; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her COVID shot yesterday (18Jan2021) and stated "Today, I'm terrible. I feel spacey, can't hardly walk, I'm walking with a cane and I never walked that like that before. Just as soon as I got the first shot, I can't hardly move my leg". The patient asked if this will go away and what was the problem. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Condition aggravated, Dementia, Gait disturbance, Gait inability
Clinical narrative: can't hardly walk/can't hardly move my legs; I'm terrible. I feel spacey; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her COVID shot yesterday (18Jan2021) and stated "Today, I'm terrible. I feel spacey, can't hardly walk, I'm walking with a cane and I never walked that like that before. Just as soon as I got the first shot, I can't hardly move my leg". The patient asked if this will go away and what was the problem. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Malaise, Neuropathy peripheral, Walking aid user
Clinical narrative: can't hardly walk/can't hardly move my legs; I'm terrible. I feel spacey; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her COVID shot yesterday (18Jan2021) and stated "Today, I'm terrible. I feel spacey, can't hardly walk, I'm walking with a cane and I never walked that like that before. Just as soon as I got the first shot, I can't hardly move my leg". The patient asked if this will go away and what was the problem. Outcome of the events was unknown.  Information about lot/batch number has been requested.