chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Back disorder, Condition aggravated
Clinical narrative: No sense of taste in my mouth; It is like 75% has gone/no taste, no taste buds/after Covid-19 Vaccine it got worsened; No sense of taste in my mouth; It is like 75% has gone/no taste, no taste buds/after Covid-19 Vaccine it got worsened; chronic back problem, they seem to worsening, in his spine, in his joint, his back in lower back area and in his shoulder part; chronic back problem, they seem to worsening, in his spine, in his joint, his back in lower back area and in his shoulder part; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: EL3247, expiration date unknown), via an unspecified route of administration on 05Feb2021 at the age of 65 years old at a single dose for COVID-19 immunization. The patient's medical history included ongoing arthritis, started experiencing this problem with my taste in Aug2020. Concomitant medications included acetaminophen for arthritis, cetirizine (tablet) at 1 DF, once a day, vitamin D1, vitamins and multivitamins. Patient stated on 05Feb2021, got first Pfizer shot. Patient noticed that they told him to come back in about three weeks. From 05Feb2021, they told him to come back on 26Feb2021. He said okay. First of 15 minutes they told him to stay there to see if he had any reactions. He was okay. He noticed in probably the last week and half though that he had a sense like no taste, no taste buds, and no sense of taste in his mouth. It is like 75% has gone on an unspecified date in 2021. Other symptoms are, patient got some chronic back problem, they seem to worsening, in his spine, in his joint, his back in lower back area and in his shoulder part area also on an unspecified date in 2021. Should he get his second shot coming up 26Feb2021, go ahead and get it?" was his question. Patient stated, "I am disabled vet (not clarified). I am like kind of regarded like 100% disabled vet. I am on 'test' in hospital where I got my shot. "Patient stated, "I just wanted to know if other people called in, told you about they start losing taste buds too, the sense of smell and taste." Patient stated, "I started experiencing this problem with my taste. It seems like around, probably Aug2020, I had like a some taste that I was losing but it seems like after I got this shot about when 4 months later, after I got the shot (Covid-19 Vaccine) I noticed it got worsened. But I am not running, no fever. I haven't had fever, cold or cough or chills or anything." The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Feb2021, this case now contains all required information to be considered valid:  This is a spontaneous report received from a contactable consumer (reporting on herself)] A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 12Feb2021as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Feb2021 (yesterday), patient received her first dose of the Pfizer COVID-19 vaccine. She was calling to find out if it's okay to take Tylenol. The patient has arthritis and states, the weather lately has been making her arthritis worse and she took Tylenol for that but she heard recently on the news that if you take Tylenol with the Pfizer COVID-19 vaccine that it cancels it out, and was asking if that was true. Patient scheduled to receive her second dose of the Pfizer COVID-19 vaccine on 05Mar2021 and wants to know how long she should stop taking Tylenol prior to receiving her second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives all over the body; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration (at the age of 75-years-old) administered in Arm Left on 08Feb2021 14:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included chronic obstructive pulmonary disease, hypertension, ulcerative colitis, blood cholesterol increased, hypersensitivity, rubber sensitivity. Concomitant medications included Detrol, Gabapentin, Tylenol Arthritis, Lialda, Ano. Previously known allergies included tetracycline allergy and latex allergy. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection), dose 1, on 15Jan2021 09:45, Lot number:EL8982 on left arm at a single dose for Covid-19 Immunisation. The patient did not have covid prior to vaccination. The patient was not tested for covid post vaccination. The patient did not receive any other vaccination in four weeks. The patient experienced broke out in hives all over the body on 13Feb2021 12:00. Therapeutic measures were taken as a result of urticaria. Patient was not tested positive for covid prior and post vaccination. Treatment medications included prednisone, vistaril, zyrtec, Pepcid. Event was considered non-serious as reported. Outcome of the event was reported as not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021190875 similar report from same reporter
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash; severe itching; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, batch/lot number were not reported) first dose via an unspecified route of administration, administered in left arm on 25Jan2021 14:00  and second dose on 15Feb2021 via an unspecified route of administration, administered in left arm as single dose for COVID-19 immunization. The patient's medical history included Addisons type II diabetes, had penicillin allergy. The patient concomitant medications were not reported. The patient had taken several prescription meds. He did not have Covid prior vaccination. The patient was not tested post vaccination. On 02Feb2021 13:00, patient experienced with Rash and severe itching. Therapeutic measures were taken as a result of rash and severe itching (Mefication). The outcome of the events were recovering.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: lymph node pain in my armpit; This is a spontaneous report received from a contactable female consumer (patient herself) of 33-years-old non pregnant received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration in Arm Right on 23Jan2021 11:00 AM (Lot number and Expiry date was not reported) and dose 2 via an unspecified route of administration in Arm Right on 18Feb2021 03:30PM (Lot number and expiry date was not reported) both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks and two weeks prior to the vaccine. The patient was not tested for COVID-19 post the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and was not tested post vaccination. On 14Feb2021 03:00AM, the patient experienced lymph node pain in her armpit. Symptoms were started 12 hours post vaccination and have lasted for 24 hours since vaccination. Therapeutic measures were not taken for the event caused. The outcome of the event was recovering.  Information about lot/ batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lymph node pain
Clinical narrative: Painful lymph glands in neck for more that 2 weeks; Profuse sweating every night for more than 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female (non pregnant) patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration at left arm on 13Jan2021 02:00 PM as single dose for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. The patient medical history was not reported. There was no known allergies. The concomitant medications of patient included ibuprofen (IBUPROFEN) (other medications in two weeks). On 31Jan2021 17:00, the patient experienced painful lymph glands in neck, profuse sweating every night. Patient stated adverse event as painful lymph glands in neck for more that 2 weeks. Profuse sweating every night for more than 2 weeks. There was no covid prior vaccination and no covid tested post vaccination. Treatment of event was unknown. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Received vaccine at 12PM 19Feb2021 and on 20Feb2021 at around 9 AM felt mild flu like symptoms.  chills, aching and tired.  Minimum head ache which did not last.  The flue like symptoms lasted until 6 PM; chills; aching; tired; head ache; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old female patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/lot no: EN9581) second dose via an unspecified route of administration, administered in left arm on 19Feb2021 12:00PM and first dose (Batch/lot no: EN5318) on 29Jan2021 17:00 administered in left arm as single dose for COVID-19 immunization. The patient medical history included allergies, colitus, arthritis and surgeries. The patient concomitant medications were not reported. The patient did not receive other vaccines in 4 weeks. The patient did not have COVID-19 prior or since the vaccination. On 20Feb2021 at 09 AM, the patient had mild flu like symptoms, chills, aching and tired also minimum headache which did not last. Flu like symptoms lasted until 6 pm. Events were not treated. The outcome of the events was recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dysgeusia, Headache, Hypoaesthesia
Clinical narrative: Within 5 minutes after my injection my lips and nose became numb/numbing went up my cheek, forehead; Headache; a metallic taste in my mouth; my blood pressure was 180/100; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiration date: unknown), via an unspecified route of administration on 21Feb2021 12:00 on left arm at single dose for COVID-19 immunisation. Medical history included Low Thyroid and allergies to Ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient not diagnosed with COVID-19.Since the vaccination the patient had not been tested for COVID-19. Concomitant medication included Levothyroxine. On 21-Feb-2021 12:00 PM (Within 5 minutes after injection), patient experienced her lips and nose became numb. A nurse brought patient to a doctor where the numbing went up my cheek, forehead, my teeth after almost 5 hours patient was still numb. Patient also had a sight sore throat headache; blood pressure was 180/100 and had a metallic taste in my mouth. Patient visited the physician office but did not received any treatment for events. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Within 5 minutes after my injection my lips and nose became numb/numbing went up my cheek, forehead; Headache; a metallic taste in my mouth; my blood pressure was 180/100; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiration date: unknown), via an unspecified route of administration on 21Feb2021 12:00 on left arm at single dose for COVID-19 immunisation. Medical history included Low Thyroid and allergies to Ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient not diagnosed with COVID-19.Since the vaccination the patient had not been tested for COVID-19. Concomitant medication included Levothyroxine. On 21-Feb-2021 12:00 PM (Within 5 minutes after injection), patient experienced her lips and nose became numb. A nurse brought patient to a doctor where the numbing went up my cheek, forehead, my teeth after almost 5 hours patient was still numb. Patient also had a sight sore throat headache; blood pressure was 180/100 and had a metallic taste in my mouth. Patient visited the physician office but did not received any treatment for events. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: First dose, fever of 103.2 F; Chills; sweating; fatigue; headache; muscle pain; arm pain; insomnia; nausea; This is a spontaneous report received from a contactable other-HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number :UNKNOWN) via an unspecified route of administration in left arm on 17Feb2021 at 05:00 PM (at the age of 41-years-old) as single dose for covid-19 immunization. Facility type vaccine was Hospital. Patient medication history included severe preeclampsia, Patient allergic with penicillin and concomitant medications as ibuprofen (IBUPROFEN), Zolpidem tartarate (AMBIEN) and paracetamol (TYLENOL) were reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. On 18Feb2021 at 03:30 am, the patient experienced fever of 103.2 F, Chills, sweating, fatigue, headache, muscle pain, arm pain, nausea, insomnia. Treatment was given for events. The outcome of the events was recovered. Information about lot/ batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: First dose, fever of 103.2 F; Chills; sweating; fatigue; headache; muscle pain; arm pain; insomnia; nausea; This is a spontaneous report received from a contactable other-HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number :UNKNOWN) via an unspecified route of administration in left arm on 17Feb2021 at 05:00 PM (at the age of 41-years-old) as single dose for covid-19 immunization. Facility type vaccine was Hospital. Patient medication history included severe preeclampsia, Patient allergic with penicillin and concomitant medications as ibuprofen (IBUPROFEN), Zolpidem tartarate (AMBIEN) and paracetamol (TYLENOL) were reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. On 18Feb2021 at 03:30 am, the patient experienced fever of 103.2 F, Chills, sweating, fatigue, headache, muscle pain, arm pain, nausea, insomnia. Treatment was given for events. The outcome of the events was recovered. Information about lot/ batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Ear discomfort, Erythema, Pruritus, Tongue disorder
Clinical narrative: palms of hand and feet itching; pressure ears; vagina slight burning; tongue thick; voice changing; complete body turned red; body shake; This is a spontaneous report from a contactable consumer. A 64-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EM9809), via an unspecified route of administration in left arm on 19Feb2021 at 16:00 pm at single dose for covid-19 immunisation. No other vaccine in four weeks. Medical history included tinea pedis, bottom foot condition (itching), pruritus. No known allergies. concomitant medication(s) included simvastatin (simvastatin), calcium (calcium), curcuma longa (turmeric [curcuma longa]), acetylsalicylic acid (baby aspirin, cyanocobalamin (b12 [cyanocobalamin]). The patient previously took simvastatin 10 mg. The patient was not tested covid positive post vaccination. On 19Feb2021 at 19:30, the patient experienced palms of hand and feet itching, pressure ears, vagina slight burning,tongue thick and voice changing,complete body turned red. Had body shakes. The events assessed as non-serious. She went to the emergency room/department or urgent care. Therapeutic measures of Benadryl, Zyrtec, Pepcid were taken. The outcome of the events were recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vulvovaginal burning sensation
Clinical narrative: palms of hand and feet itching; pressure ears; vagina slight burning; tongue thick; voice changing; complete body turned red; body shake; This is a spontaneous report from a contactable consumer. A 64-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EM9809), via an unspecified route of administration in left arm on 19Feb2021 at 16:00 pm at single dose for covid-19 immunisation. No other vaccine in four weeks. Medical history included tinea pedis, bottom foot condition (itching), pruritus. No known allergies. concomitant medication(s) included simvastatin (simvastatin), calcium (calcium), curcuma longa (turmeric [curcuma longa]), acetylsalicylic acid (baby aspirin, cyanocobalamin (b12 [cyanocobalamin]). The patient previously took simvastatin 10 mg. The patient was not tested covid positive post vaccination. On 19Feb2021 at 19:30, the patient experienced palms of hand and feet itching, pressure ears, vagina slight burning,tongue thick and voice changing,complete body turned red. Had body shakes. The events assessed as non-serious. She went to the emergency room/department or urgent care. Therapeutic measures of Benadryl, Zyrtec, Pepcid were taken. The outcome of the events were recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; vomiting; muscle aches; 99.5 temp x24 hours; This is a spontaneous case from a contactable Nurse. This 45-Year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number: EL9269), via intramuscular, administered in left arm on 15Feb2021 10:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and known allergies: sulfa, bananas, avocados, honey. Concomitant medications included propranolol, lisinopril, fioricet, calcium/magnesium/zinc, VIT C, VIT D and potassium. On 21Feb2021 04:00 the patient experienced nausea, vomiting, muscle aches, 99.5 temp x 24 hours. No treatment was given for the events. No other vaccine in four weeks. No covid tested post vaccination. No covid prior vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tired; after her first dose of the vaccine on Jan 28th, she experienced "swelling and redness at the site as well as a sense of being very tired for a day or so afterwards".; after her first dose of the vaccine on Jan 28th, she experienced "swelling and redness at the site as well as a sense of being very tired for a day or so afterwards".; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 28Jan2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced after her first dose of the vaccine on jan 28th, she experienced "swelling and redness at the site as well as a sense of being very tired for a day or so afterwards". Following administration of the second on Feb 18th, she reports "she had no side effects, not at the site nor any of the other 11 or 12 vaccine effects listed". Stated that she want to know if something went wrong, why she had no effect after, she would assume she would have something. Caller reports concern and fear that she didn't actually get the vaccine stating "there was only a miniscule cut". Caller reports she suspect that she may have been a victim of racial whatever, said she was a nurse, didn't sound like a nurse, she told me afterward that this covid vaccine doesn't protect you from covid but only boosts your immune system, who says that". Caller reports "she was terribly upset and she don't know what to do". Caller reports that her regular HCP died and she doesn't know who to speak to, vocalized fear that if she got a new doctor she would probably be diagnosed with dementia because her concern sounds irrational. Caller was asking how much protection did she get with the first dose and how would she know if a dose was valid, should she get a test. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity
Clinical narrative: her arm was just a little sore/ it was a little sore but nothing compared to the first one; This is a spontaneous report from a contactable consumer or other non hcp.   A 73-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 as SINGLE DOSE for covid-19 immunization.  after receiving the 1st dose of the Pfizer COVID vaccine on 20Jan2021 and 2nd dose on 11Feb2021. She reports a lot of pain with the first one however it coincided with an MRI for a fusion surgery on C5 and C6, a pinched nerve from bending her neck. The 2nd dose in her right arm coincided with a treatment of metho-prednisolone. She reports the vaccination was given higher a bit higher on the arm, she believes it may have been in the nerve rather than the muscle. The pain was from her scapula down throughout the elbow to the forearm and to her fingers on that side. With the second shot, it was given on 11Feb2021 and though she wanted to get it on the same side, with all the issues she was experiencing she got it in the right arm so she would know the difference. It was given more in the middle of her arm, like what she is used to, and it was a little sore, but nothing compared to the first one. For the first injection, her arm was very sore for 2 and half days after the shot. With the second shot, her arm was just a little sore, it was like it wasn't anything in comparison. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on 12Feb2021.   No follow-up attempts are possible, and no information is expired.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: couldn't breathe; This is an initial spontaneous report from a contactable consumer (patient, self-reported). A 49-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were not reported), via unspecified route of administration on 21Feb2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that, the severe allergic reaction was she could not breathe. Within 30 minutes of the first dose patient started having breathing problems. Still patient was not feeling like she is breathing properly. The outcome of the patient's event was unknown.  Information about lot/Batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body height, Diarrhoea, Hot flush
Clinical narrative: excessive weakness; last night his hot flashes were unbelievable; Diarrhea; This is a spontaneous report received from a contactable consumer (patient). A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 13Feb2021 13:00 (Lot Number: EL9269; Expiration Date: May2021) and dose 1 via an unspecified route of administration on 23Jan2021 (Lot Number: EL9263; Expiration Date: May2021), both as single dose for COVID-19 immunization. Medical history included prostate cancer (he survived prostate cancer, working on 12 years with it and he receives a hormone drug, and he has been fighting and working hard at the whole thing). Concomitant medications were not reported. The patient got his first shot, and he got the second one on 13Feb2021 and then on 14Feb2021, he had a battle of diarrhea. On 15Feb2021, he had another bout of diarrhea and then also he has been feeling week. At times the hormone medicine, Lupron can cause him to be weak, but this is excessive weakness and last night excessive weakness. He is improving so he is not complaining but he thought if this could help someone else he wants to share. The patient also reported last night his hot flashes were unbelievable. He confirms the medication he takes is Lupron and he has been taking it for 7 years and it basically eliminates testosterone he is pretty much physically castrated, and he goes through menopause pretty much. The patient has been shrinking his is 5'9" now. He provides his weight and says he has not been able to work out because of the virus he cannot go work out at a gym. He is not trying to complain but he eats organic food, he watches what goes into his body. He eats organic. He says Saturday (13Feb2021) at about 1 pm he got the vaccine. He had a case of diarrhea and he never has diarrhea, he had another case of it about 2 hours ago but it is getting better. He says nothing else would be relevant he watches monitor what goes in his mouth and what comes out of his body. He has survived prostate cancer 11 going on 12 years and he is not trying to brag but he is just trying to say he watches everything. As primary care, the patient had a urologist and a cancer doctor. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral
Clinical narrative: tingling metallic taste on her tongue; tingling metallic taste on her tongue; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that, a female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine; solution for injection) via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tingling metallic taste on her tongue for the first 18 hours after taking the first dose in Jan2021. The outcome of the event was unknown.  Information about lot/ batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: after the initial vaccine like, woke me up at night; This is a spontaneous report from a contactable Nurse. A 49-year-old female patient received first dose of BNT162B2 (solution for injection; Batch/lot number: El1284) via intramuscular in left arm on 05Jan2021 at 11:30 as single dose for COVID-19 immunisation. The patient's medical history and concomitant were not reported. The patient was not pregnant at the time of vaccination, Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Jan2021, the patient received the first vaccine, 16 hours after the initial vaccine, the patient reported that, she woke me up at night at 12:30 am. The outcome of the event was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling under arm that was vaccinated (lymph nodes?); This is a spontaneous case from a contactable consumer (patient).A 76-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6200; Expiration Date: UNKNOWN) via an unspecified route of administration in arm left on 18Feb2021 at 14:00 as a single dose for covid-19 immunization. Medical history included 2X cancer survivor, osteoporosis. Concomitant medications included alendronate sodium (FOSAMAX), pravastatin (PRAVASTATIN), calcium (CALCIUM), pyridoxine hydrochloride (B6) taken for an unspecified indication. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 20Feb2021,The patient experienced swelling under arm that was vaccinated (lymph nodes?)  The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomited on an unspecified date. Solution for injection. The outcome of the event was unknown.  Follow-up attempts are completed. Information the lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Scheduled to receive the second dose today but tested positiveon 4th of February; Scheduled to receive the second dose today but tested positiveon 4th of February; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. It was reported that patient is scheduled to receive the second dose today but tested positive on 04Feb. The reporter wanted to know if she can still give the 2nd dose to the patient. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Rash
Clinical narrative: a large rash on my stomach, back and front of thighs.; chills; body aches; tired; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (solution for injection), via an unspecified route of administration, administered in right arm on 04Feb2021 (Batch/Lot Number: EL9265) as single dose (at the age of 51-year-old) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history was not reported. No known allergies. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN). The patient previously took first dose of BNT162B2 in right arm, lot EL3248, administration date: 15Jan2021, time: 05:45 PM, for covid-19 immunisation. The patient has not been diagnosed with Covid prior to vaccination and has not tested positive since the vaccination. As of 24Feb2021, patient still had a large rash on stomach, back and front of thighs. This rash appeared on day 2, following the 2nd injection, on 06Feb2021. It was post day 18 and it was still a severe rash. Following 2nd injection, she also had chills, body aches and was tired for 2 days. No treatment was received. Outcome of the event rash was not recovered and for other event was recovered on feb2021.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling hot, Headache, Vaccination site pain
Clinical narrative: headache; felt warm in the head; aches, particularly in my lower back; chills; I had pain at the injection site; This is a spontaneous report from a contactable consumer (patient).   A 33-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 09Feb2021 at 04:30, at a single dose for covid-19 immunization. The patient medical history and concomitant medications were none. The patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 19Jan2021 04:30 at single dose for covid-19 immunization. The patient did not receive any other vaccines in 4 weeks. The patient experienced pain at the injection site on 10Feb2021, after receiving the second dose and would compare the feeling to a bad bruise approximately after 17 hours the patient had chills and approximately after 19 hours the patient started to develop aches, particularly in lower back. The aches were not severe and were more of a nuisance. Approximately after 21 hours the patient, developed a headache and felt warm in the head. The headache slowed her down and was bothersome for the remainder of the day. The headache was almost completely gone when she woke up the next day. My head no longer felt warm when I woke up. Events were not treated. All the events were recovered when she wok up next day.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: two days after receiving the vaccine was diagnosed with COVID 19; This is a spontaneous report from contactable Nurse via Pfizer Sales Representative. A patient of unspecified age and gender received (dose number not mentioned) of BNT162B2 (COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration about three weeks ago as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. On an unspecified date, two days after receiving the vaccine, the patient was diagnosed with covid 19 and wants to know if they can receive their scheduled second COVID vaccine tomorrow. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID; This is a spontaneous report received from a contactable consumer (patient himself). A 72-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 13:15 as a single dose for COVID-19 immunization. The Patient's medical history included Vasculitis. Concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine in four weeks. On 08Feb2021 the patient experienced Positive for COVID. The patient not had covid prior vaccination; not tested covid post vaccination. The patient received unspecified treatment for the event. The patient underwent lab test and procedure which included COVID on 08Feb2019: Positive. The outcome of the event is Recovering.  Information of lot/batch number has been raised.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Broke out in a rash and hives from head to toe; Broke out in a rash and hives from head to toe; This is a spontaneous report from a contactable other HCP (Patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 (Batch/Lot number was not reported; 71-year at the time of vaccination) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ciprofloxacin. The patient previously received first single dose of bnt162b2 first dose on 21Jan2021 12:00 Right arm for Covid-19. Patient had Broke out in a rash and hives from head to toe on 10Feb2021 12:00; treatment received with Cortsone shot, benedryl, Claritin; Patient not had covid prior vaccination; not had covid tested post vaccination. The outcome of the events was recovered in Feb2021.  Information about lot/batch number was requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: week later did positive to Covid-19; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced week later did positive to covid-19 (covid-19) (non-serious) on an unspecified date. The outcome of the event was recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: week later did positive to Covid-19; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced week later did positive to covid-19 (covid-19) (non-serious) on an unspecified date. The outcome of the event was recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Chills, Discomfort, Fatigue, Impaired driving ability
Clinical narrative: Couldn't get comfortable; Fatigued; Chills; Didn't think he was being a good driver; He was feeling irritated; Sensing anger and aggression in himself; Skin was very, very irritated; This is a spontaneous report received from a contactable consumer (reporting on himself). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9263 and Expiration Date was not reported) via an unspecified route of administration on 17Feb2021 (at the age of 74-year-old) as single dose for COVID-19 immunization. Medical history included Lyme disease in the past that was treated. He take no day to day medications. The patient's concomitant medications were not reported. It was reported that patient wanted to report experience with BNT162B2. On 17Feb2021 patient received BNT162B2 around mid-day. First day he got the COVID-19 vaccine, by late afternoon his skin was feeling very, very irritated. He was feeling irritated. Started sensing aggression and anger in himself. Couldn't get comfortable. Doesn't know if this is an expected result because he hasn't seen this. Started to get extremely tired. Did have to lay down a couple times later that afternoon to early evening. Worse thing was his whole body felt irritated. 18Feb2021 (Yesterday), he didn't have the same feeling. He had a very good morning. Early afternoon started feeling chills and couldn't get warm. Got into bed with big quilts. Chill sensation lasted two to three hours. Sees that chills are an expected result. 19Feb2021 (Today), so far he has had a good day. He is fatigued now this afternoon. That would be the extent of anything unusual for him. Most concerning was how he was feeling the first day. He doesn't think he was being a good driver at the time. Probably thinks there should be a recommendation to try and not drive or have a designated driver. Patient would like to know if the anger and aggression was within the range of expected results. Stated he doesn't know if there was real value in knowing it at this time unless there are booster shots that come out in the next year or so. Stated he wanted to report to Pfizer so it was known there are other things than what was being seen. The outcome of the events was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Skin irritation
Clinical narrative: Couldn't get comfortable; Fatigued; Chills; Didn't think he was being a good driver; He was feeling irritated; Sensing anger and aggression in himself; Skin was very, very irritated; This is a spontaneous report received from a contactable consumer (reporting on himself). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9263 and Expiration Date was not reported) via an unspecified route of administration on 17Feb2021 (at the age of 74-year-old) as single dose for COVID-19 immunization. Medical history included Lyme disease in the past that was treated. He take no day to day medications. The patient's concomitant medications were not reported. It was reported that patient wanted to report experience with BNT162B2. On 17Feb2021 patient received BNT162B2 around mid-day. First day he got the COVID-19 vaccine, by late afternoon his skin was feeling very, very irritated. He was feeling irritated. Started sensing aggression and anger in himself. Couldn't get comfortable. Doesn't know if this is an expected result because he hasn't seen this. Started to get extremely tired. Did have to lay down a couple times later that afternoon to early evening. Worse thing was his whole body felt irritated. 18Feb2021 (Yesterday), he didn't have the same feeling. He had a very good morning. Early afternoon started feeling chills and couldn't get warm. Got into bed with big quilts. Chill sensation lasted two to three hours. Sees that chills are an expected result. 19Feb2021 (Today), so far he has had a good day. He is fatigued now this afternoon. That would be the extent of anything unusual for him. Most concerning was how he was feeling the first day. He doesn't think he was being a good driver at the time. Probably thinks there should be a recommendation to try and not drive or have a designated driver. Patient would like to know if the anger and aggression was within the range of expected results. Stated he doesn't know if there was real value in knowing it at this time unless there are booster shots that come out in the next year or so. Stated he wanted to report to Pfizer so it was known there are other things than what was being seen. The outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient developed coronavirus 4 weeks after last dose/Nasal Swab (SARS-COV-2): positive; Patient developed coronavirus 4 weeks after last dose/Nasal Swab (SARS-COV-2): positive; This is a spontaneous report from a contactable physician. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) second dose via an intramuscular route on 26Jan2021 and first dose on 05Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies. On 23Feb2021 the patient developed coronavirus 4 weeks after last dose, had weekly negative tests prior to vaccine and immediately after vaccine. On 23Feb2021 the patient underwent lab tests and procedures which included Nasal Swab (SARS-COV-2): positive. No other vaccine in four weeks. No covid prior vaccination. No treatment received. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Dermatitis
Clinical narrative: interface dermatitis; This is a spontaneous report from a contactable Physian. A 82 years male patient received first dose of   BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:unknown), via an unspecified route of administration, administered in Intramuscular left arm on 11 Feb 2021 at the age of 82 years old as single first and second dose for COVID-19 immunisation. Patient medical history included COPD and decreased renal function. concomitant medications were not reported. Patient was allergie to IVP contrast dye. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18 Feb 2021, the patient had experienced Skin eruption distal feet (incl. toes), both palms, both knees. Biopsy reveals interface dermatitis. At the time of reporting, the event was recovering/resolving.  Information about lot/ batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Chills, Decreased appetite, Sleep disorder
Clinical narrative: Could not sleep night the shot; Had chills; No appetite; could not have a bowel movement; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 14:00 (Batch/Lot Number: EWG200) at single dose for covid-19 immunisation. Medical history included covid-19. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]); atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN) colecalciferol (VITAMIN D). No known allergies. The patient not had other vaccine in four weeks. The patient was not tested for COVID post vaccination. The patient could not sleep night the shot. He had chills, chills stopped after 16 hours, No appetite, could not have a bowel movement on 23Feb2021 at 02:00 PM. Outcome of chills was recovered on 24Feb2021 and outcome of other events was recovered on an unspecified date of 2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She got tested positive for the Covid-19 virus; This is a spontaneous report from a Pfizer-sponsored Program, COVAX US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the caller's got her 1st vaccine last 06Feb2021, but after a week last 14Feb2021, she got tested positive for the Covid-19 virus and started seeing symptoms on 15Feb2021. Patient next schedule will be on 27Feb2021, and patient was asking if it will be possible to continue. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.