chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Parotid gland enlargement, Salivary gland enlargement, Salivary gland pain
Clinical narrative: sublingual glands were swollen and very painful; sublingual glands were swollen and very painful; My parotid glands are a little puffy; This is a spontaneous report received from a contactable consumer or other non hcp.   A 45-year-old male patient received first dose of bnt162b2 (BNT162B2, Batch/lot number: EL9266, expiry date: unknown) via an unspecified route of administration, administered in the region of left Arm on 13Feb2021 at 09:00 as 1st dose, singlefor covid-19 immunisation. Medical history included allergic to penicillin from an unknown date and unknown if ongoing, mint allergy from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing. Concomitant medications included paroxetine taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; acetaminophen (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported.  Other vaccination in four weeks was reported as no. The patient had no covid prior vaccination nor covid tested post vaccination. On 14FEB2021, the patient experienced sublingual glands were swollen and very painful, parotid glands little puffy. Within 24 hours the patient's sublingual glands were swollen and very painful. It had been a couple of days and they were still swollen and painful, making it difficult to eat. It did not appear to be an allergic reaction, and his doctor said he suspects it is vaccine related. The swelling was anywhere between 3-5 mm in depth. The patient's parotid glands were a little puffy as expected, but not painful. Patient did not receive treatment for AE. The outcome of sublingual gland swelling and very painful was not recovered. The outcome of the event parotid glands little puffy was unknown.  No follow up attempts possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash pruritic, Tenderness
Clinical narrative: red rash appeared on my right arm below the deltoid muscle which is itchy, warm to touch and tender to touch; red rash appeared on my right arm below the deltoid muscle which is itchy, warm to touch and tender to touch; red rash appeared on my right arm below the deltoid muscle which is itchy, warm to touch and tender to touch; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 71-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EL9269) via an unspecified route of administration in arm right on 12Feb2021 at 14:30 PM as 2nd dose single for covid-19 immunisation. Patient historical vaccine included received first dose of BNT162B2 (BNT162B2, lot number: EL3246) via an unspecified route of administration in Right arm on 22Jan2021 as 1st dose single for covid-19 immunisation. Patient medical history included bronchiectasis from an unknown date and unknown if ongoing. Patient concomitant medications included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamins (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. Vaccine Facility information available. Ethnicity information was available. Race information was available. The patient had no allergies to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Feb2021 at 10:00, The patient had red rash appeared on right arm below the deltoid muscle, the rash was approximately 2 inches in length and 1.5 inches in width. The rash, which was itchy, warm to touch and tender to touch. If the rash does not subside in a week, the patient will consult a physician. Treatment was not received for the adverse event. The events were considered as non-serious. The outcome of the events was reported as not recovered.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache; body aches; chills; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received second dose of BNT162B2 (CONMIRATY, Solution for injection, Lot number-EL3247, Expiration date- Unknown), via an unspecified route of administration in left arm on 16Feb2021 at 08:15 AM as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Bupropion XL, 2000u Vitamin D in two weeks.Prior to the vaccination, the patient was not diagnosed with COVID-19.Post vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks. The patient previously took first dose of BNT162B2 (CONMIRATY, Solution for injection, Lot number-EL3247, Expiration date- Unknown), via an unspecified route of administration in left arm on 26Jan2021 at 08:15 AM as single dose for COVID-19 immunization.On 16Feb2021 at 07:00 PM the patient experienced Headache, body aches and chills. No treatment was received for the events.The Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Cheilitis, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: I felt funny; I didn't feel nothing in my arm or anything; I got some pain in back of my neck and head; I got some pain in back of my neck and head; I got had a little sore on my lips; my lip it's all gone rash; I was catching my breath; I got another pimple like cold sore something; I got had a little sore on my lips; my lip it's all gone rash; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at a 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 after vaccination the patient felt funny on Sunday night, it was also reported that patient didn't felt nothing in arm or anything but then on Saturday night patient got the pain, Sunday night he/she got some pain in back of neck and head, so patient took two Advil and wanted to bed and he/she was fine and when patient got up he/she was having up like a sore, Sunday morning patient had a little sore on lips, so that measure fever and had no fever and then patient again and but it was not bad as Sunday. Patient was talking to 'dermatologist' that he/she was catching breath which didn't think he /she was, but they know they can hear me better and then this morning. Patient got up and found that lip it's all gone rash and now got another pimple like cold sore something, but it has been patient had that injection and patient checked fever this morning it was 96.1. So, patient did not know if means anything or not. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lip pain, Neck pain, Oral herpes, Sensory loss
Clinical narrative: I felt funny; I didn't feel nothing in my arm or anything; I got some pain in back of my neck and head; I got some pain in back of my neck and head; I got had a little sore on my lips; my lip it's all gone rash; I was catching my breath; I got another pimple like cold sore something; I got had a little sore on my lips; my lip it's all gone rash; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at a 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 after vaccination the patient felt funny on Sunday night, it was also reported that patient didn't felt nothing in arm or anything but then on Saturday night patient got the pain, Sunday night he/she got some pain in back of neck and head, so patient took two Advil and wanted to bed and he/she was fine and when patient got up he/she was having up like a sore, Sunday morning patient had a little sore on lips, so that measure fever and had no fever and then patient again and but it was not bad as Sunday. Patient was talking to 'dermatologist' that he/she was catching breath which didn't think he /she was, but they know they can hear me better and then this morning. Patient got up and found that lip it's all gone rash and now got another pimple like cold sore something, but it has been patient had that injection and patient checked fever this morning it was 96.1. So, patient did not know if means anything or not. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: she had fever; her arm was bothering her a lot; fatigue/she is tired today; diarrhea; She had chills; nausea; loss of appetite; dizzy; This is a spontaneous report from a contactable consumer. This consumer (patients Husband) reported for a female patient (Wife):  A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration on 23Jan2021, 0.3mL single, via an unspecified route of administration. On 13Feb2021 at 10:15 (Batch/Lot Number: EL9266; Expiration Date: 31May2021) as 2nd dose 0.3mL single for covid-19 immunization. Patients medical and concomitant medications history were not reported. It was reported that, patient experienced tremendous side effects, her arm was bothering her a lot, she had fever until Monday up to 103 and diarrhea. She had chills, nausea, fatigue. The fever stopped today she no longer has fever, but she is still experiencing dizziness and fatigue. She woke up dizzy this morning, she is tired today, she had diarrhea twice again today, but the dizziness is bothering her the most. She also has loss of appetite; she does not want to eat. She wants to know why she is dizzy all these days later. Patient received her second dose 13Feb2021 at 10:15 in the morning. Dizziness started this morning patient was very dizzy. It went away for a while she ate lunch, she forced lunch down, but she is still dizzy now. She was drinking water because her husband thought she was dehydrating herself. She ate a piece of chocolate and sat down incase her sugar was dropping. She had diarrhea starting Saturday and she had the feeling yesterday, but she didn't go then today she went twice. Patient had chills were Saturday, Sunday, and now she is done with the chills and the fever. That went away yesterday. Now she just has the tiredness and the dizziness. The tiredness she can handle but she cant stand buy herself she gets dizzy when she is walking. Outcome of event was recovered for fever and chills, not recovered for dizziness and rest of the events was unknown.   No follow up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: she had fever; her arm was bothering her a lot; fatigue/she is tired today; diarrhea; She had chills; nausea; loss of appetite; dizzy; This is a spontaneous report from a contactable consumer. This consumer (patients Husband) reported for a female patient (Wife):  A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration on 23Jan2021, 0.3mL single, via an unspecified route of administration. On 13Feb2021 at 10:15 (Batch/Lot Number: EL9266; Expiration Date: 31May2021) as 2nd dose 0.3mL single for covid-19 immunization. Patients medical and concomitant medications history were not reported. It was reported that, patient experienced tremendous side effects, her arm was bothering her a lot, she had fever until Monday up to 103 and diarrhea. She had chills, nausea, fatigue. The fever stopped today she no longer has fever, but she is still experiencing dizziness and fatigue. She woke up dizzy this morning, she is tired today, she had diarrhea twice again today, but the dizziness is bothering her the most. She also has loss of appetite; she does not want to eat. She wants to know why she is dizzy all these days later. Patient received her second dose 13Feb2021 at 10:15 in the morning. Dizziness started this morning patient was very dizzy. It went away for a while she ate lunch, she forced lunch down, but she is still dizzy now. She was drinking water because her husband thought she was dehydrating herself. She ate a piece of chocolate and sat down incase her sugar was dropping. She had diarrhea starting Saturday and she had the feeling yesterday, but she didn't go then today she went twice. Patient had chills were Saturday, Sunday, and now she is done with the chills and the fever. That went away yesterday. Now she just has the tiredness and the dizziness. The tiredness she can handle but she cant stand buy herself she gets dizzy when she is walking. Outcome of event was recovered for fever and chills, not recovered for dizziness and rest of the events was unknown.   No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a Non-Contactable Physician. This Physician reported for a 22-Year-old female patient. A 22-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown, via unspecified route, on 20Jan2021 as unknown, single dose for covid-19 immunisation. The Patient's medical history included was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced dizziness yesterday and lasted for a day. Today she is fine with no dizziness. The outcome of the event was recovered in 2021.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021173043 Same Drug/Reporter/Event and Different Patient
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Blister, Blood pressure abnormal, Blood pressure measurement, Blood test
Clinical narrative: Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; My blood pressure was of some concern; I was so sick; mouth is full of sores; it's was an antibiotic, it's Clindamycin I didn't take it because my daughter who is in medical field thinks it probably a viral infection not bacterial.; it's was an antibiotic, it's Clindamycin I didn't take it because my daughter who is in medical field thinks it probably a viral infection not bacterial.; This is a spontaneous report from a contactable other Nurse (Patient). An 85-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6201) via intramuscular route of administration in left arm on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history included hypertension and atrial fibrillation. The patient's historical vaccine included bnt162b2 (Lot number: EL3247) with pain in extremity as reaction. Concomitant medications included alprazolam (ALPRAZOLAM), apixaban (ELIQUIS) taken for atrial fibrillation, furosemide (FUROSEMIDE), losartan (LOSARTAN) and propranolol (PROPRANOLOL). The patient was a retired nurse and stated that her first injection was just perfect, little it of a sore arm and that was all. She started that the injection that she got a week prior for the second injection she was okay until the next day, and then she got a lot of blisters inside her mouth and she was just miserable. She wasn't able to eat for three days. It was really difficult and she just wanted to know if anyone else had that kind of symptoms. She was sure had troubles with that. She stated she was so sick, yesterday at a clinic and her biggest problem was her mouth was full of sores. They did take her blood work and said it was ok. Her blood pressure was of some concern. The patient stated that they gave her four different things. They gave her Ondanse, lidocaine for pain and Valacyclovir. She did not take Valacyclovir as it was an antibiotic. She did not take clindamycin because her daughter, who is in medical field thought it probably was a viral infection and not bacterial. The outcome of the events was unknown.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Illness, Oral pain, Viral infection
Clinical narrative: Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; My blood pressure was of some concern; I was so sick; mouth is full of sores; it's was an antibiotic, it's Clindamycin I didn't take it because my daughter who is in medical field thinks it probably a viral infection not bacterial.; it's was an antibiotic, it's Clindamycin I didn't take it because my daughter who is in medical field thinks it probably a viral infection not bacterial.; This is a spontaneous report from a contactable other Nurse (Patient). An 85-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6201) via intramuscular route of administration in left arm on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history included hypertension and atrial fibrillation. The patient's historical vaccine included bnt162b2 (Lot number: EL3247) with pain in extremity as reaction. Concomitant medications included alprazolam (ALPRAZOLAM), apixaban (ELIQUIS) taken for atrial fibrillation, furosemide (FUROSEMIDE), losartan (LOSARTAN) and propranolol (PROPRANOLOL). The patient was a retired nurse and stated that her first injection was just perfect, little it of a sore arm and that was all. She started that the injection that she got a week prior for the second injection she was okay until the next day, and then she got a lot of blisters inside her mouth and she was just miserable. She wasn't able to eat for three days. It was really difficult and she just wanted to know if anyone else had that kind of symptoms. She was sure had troubles with that. She stated she was so sick, yesterday at a clinic and her biggest problem was her mouth was full of sores. They did take her blood work and said it was ok. Her blood pressure was of some concern. The patient stated that they gave her four different things. They gave her Ondanse, lidocaine for pain and Valacyclovir. She did not take Valacyclovir as it was an antibiotic. She did not take clindamycin because her daughter, who is in medical field thought it probably was a viral infection and not bacterial. The outcome of the events was unknown.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first injection was just perfect, little bit of a sore arm and that was all; This is a spontaneous report from a contactable Nurse(patient). An 85-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247, expiration date unknown) intramuscular, administered in Arm Left on an unspecified date as 1st dose, single for covid-19 immunisation. Medical history included hypertension, atrial fibrillation. Investigation assessment was done. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation; furosemide; losartan; propranolol; alprazolam. On an unknown date patient experienced little bit of a sore arm and that was all. On an unknown date patient took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date unknown) intramuscular, administered in Arm Left for covid-19 immunisation. Retired Nurse stated, my first injection was just perfect, and the patient experienced, little bit of a sore arm and that was all. The injection that patient got a week ago, for the second injection I was okay until the next day, and then I got my mouth got a lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days. It was difficult, and I just wanted to know if you had anyone else that had that kind of symptoms, I sure had troubles with that. Expiration date did not see anywhere here. I was so sick, yesterday at clinic and my biggest problem was my mouth was full of sores they did took blood work and they said it was okay. My blood pressure was of some concern. Treatment they gave me four different things, they gave me it's called Ondanse, Lidocaine for the pain, it's Valacyclovir and I didn't take it. it's was an antibiotic; it's Clindamycin I didn't take it because my daughter who was in medical field thinks it probably a viral infection not bacterial. The outcome of event pain in arm was unknown. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Vaccination site pain
Clinical narrative: Small and painful lump in right armpit (same arm where vaccine was administered).  The lump is sore but more painful if apply pressure to it.; Small and painful lump in right armpit (same arm where vaccine was administered).  The lump is sore but more painful if apply pressure to it.; This is a spontaneous report from a contactable Consumer. A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in right arm on 15Feb2021 at 13:00 at a single dose for COVID-19 immunisation. The patient medical history was not reported. No known allergies were reported. Patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in right arm on 25Jan2021 at 16:00 at a single dose for COVID-19 immunization. Concomitant medication included vitamin c [ascorbic acid] and fish oil (FISH OIL). Other medications in two weeks included Multivitamin and Turmeric. Patient was not pregnant. No COVID tested post vaccination. The patient experienced small and painful lump in right armpit (same arm where vaccine was administered), the lump is sore but more painful if apply pressure to it on 17Feb2021 15:00. No other vaccine in four weeks. No treatment were given for the events. The outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Swelling; Redness in front of left armpit; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 15:00 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included raynaud's phenomenon, osteopenia, hyperlipidaemia, covid-19 from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing reaction 20+ years ago. Concomitant medication included nifedipine (NIFEDIPINE), dhea (DHEA), calcium (CALCIUM), magnesium (MAGNESIUM), raloxifene (RALOXIFENE). The patient experienced swelling, redness in front of left armpit on 17Feb2021 18:00. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Gingivitis
Clinical narrative: if she receives the 2nd dose 6 weeks longer from 1st dose; gum  infection; This is a spontaneous report from a Pfizer Sponsored Program. This report is received from contactable consumer (Patient, Self-reported). An unspecified aged female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: unknown), dose 1 via an unspecified route of administration, on 23Jan2021, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient received her 1st dose on 23Jan2021 and went for a dental appointment and after that developed a gum infection. She was also on amoxicillin which was prescribed by the dentist. She was rescheduled for the 2nd dose on 26Feb. Original date was 13Feb. She was asking what the percentage protection coverage will be if she receives the 2nd dose 6 weeks longer from 1st dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: Ear Infection before second dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (Patient) reported that, an unspecified age of female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection) via an unspecified route of administration, on 02Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date patient experienced an ear infection before her second dose. The outcome of event is unknown. Information about lot/Batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Occipital neuralgia
Clinical narrative: Headache-occipital neuralgia  for more than one month.; This is a spontaneous report from a contactable consumer (patient). This 65 year old female consumer reported for herself that:   A 65-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE;Solution for injection ; Batch/Lot Number: El1283), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 08:30  as SINGLE DOSE for covid-19 immunisation.The patient medical history was not reported. The patient's concomitant medications were not reported.The patient experienced headache-occipital neuralgia  for more than one month.on 25Jan2021 outcome of the events was recovering
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 2 days later he was tested again (after the vaccine) and it came back positive again; This is a spontaneous report from a contactable consumer (mother). Follow-up (01Mar2021) report received in response to mail sent regarding confirmation of reporter and patient name was processed together along with initial information.    A 64-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient who was asymptomatic, had tested positive and was hospitalized for 4 days then came home before vaccination. Two days after vaccination the patient was tested positive for COVID-19. Outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vomiting
Clinical narrative: One week after 1st vaccine, vomited; had a headache; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: EL 9263) via an unspecified route of administration on 26Jan2021 at 14:00 (at the age of 68-years) as 1st dose, single in left arm for covid-19 immunization. Medical history included mitral valve repair from 2018 to an unknown date, known allergies to Demerol, codeine, and walnuts. The patient did not receive other vaccine in four weeks prior to vaccine. Concomitant medications included: atorvastatin (LIPITOR), valaciclovir hydrochloride (VALTREX), bazedoxifene, estrogens conjugated (DUAVEE), calcium, ergocalciferol (VITAMIN D), famotidine (PEPCID). Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On an unspecified date in Feb2021, one week after 1st vaccine, the patient vomited and had a headache. The patient was tested for Covid post vaccination by nasal swab test. On 14Oct2020, the patient underwent lab tests and procedures which included: Nasal Swab test was negative. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cough, Dry throat, Eye swelling
Clinical narrative: very hot temp was 99 at 2PM; slightly achy; minor chill; minor headache; swelling over eyes; sense of heat; dryness in throat; dryness in chest; This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6201; Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 20Feb2021 14:00 1st dose, single for COVID-19 immunization.  Medical history included allergy to metronidazole, sulfonamides, penicillin, cephalosporins, back pain from 1982 to 1989, chronic low back pain/4 surgeries, hemorrhage intracranial from 2015 to an unknown date, endometrial cancer from 2015, had surgery only. Concomitant medication(s) included meloxicam for unknown indication, hydrocodone bitartrate, paracetamol (NORCO) taken for back pain, levetiracetam, verapamil, atorvastatin, taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Feb2021, the patient stated that she experienced "a sense of heat and dryness in throat and chest. Today tired with same sense of dryness, very hot, temp was 99 at 2PM and has gone down and up since then. (First time I have elevated temp since vaccine on 20Feb.) I feel slightly achy, minor chill, minor headache swelling over eyes, like flu. (I had flu shot 5 months ago.) Too tired to go out or do housework Is this a delayed reaction to the vaccine. She asked: Will the meloxicam weaken the shot and "My next Pfizer Covid-19 shot will be on 13Mar2021. I am worried about the shots working well (considering the drugs I've ben taking) and if this is just a normal reaction to the vaccine, or something else. The patient underwent lab tests and procedures which included body temperature increased: 99 Fahrenheit on 20Feb2021 temp was 99 at 2PM and has gone down and up since then (First time I have elevated temp since vaccine on Feb2020). The clinical outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, Pyrexia
Clinical narrative: very hot temp was 99 at 2PM; slightly achy; minor chill; minor headache; swelling over eyes; sense of heat; dryness in throat; dryness in chest; This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6201; Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 20Feb2021 14:00 1st dose, single for COVID-19 immunization.  Medical history included allergy to metronidazole, sulfonamides, penicillin, cephalosporins, back pain from 1982 to 1989, chronic low back pain/4 surgeries, hemorrhage intracranial from 2015 to an unknown date, endometrial cancer from 2015, had surgery only. Concomitant medication(s) included meloxicam for unknown indication, hydrocodone bitartrate, paracetamol (NORCO) taken for back pain, levetiracetam, verapamil, atorvastatin, taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Feb2021, the patient stated that she experienced "a sense of heat and dryness in throat and chest. Today tired with same sense of dryness, very hot, temp was 99 at 2PM and has gone down and up since then. (First time I have elevated temp since vaccine on 20Feb.) I feel slightly achy, minor chill, minor headache swelling over eyes, like flu. (I had flu shot 5 months ago.) Too tired to go out or do housework Is this a delayed reaction to the vaccine. She asked: Will the meloxicam weaken the shot and "My next Pfizer Covid-19 shot will be on 13Mar2021. I am worried about the shots working well (considering the drugs I've ben taking) and if this is just a normal reaction to the vaccine, or something else. The patient underwent lab tests and procedures which included body temperature increased: 99 Fahrenheit on 20Feb2021 temp was 99 at 2PM and has gone down and up since then (First time I have elevated temp since vaccine on Feb2020). The clinical outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had the first dose on the 4th, tested positive on February 9th; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program.  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiry date was not reported) via an unspecified route of administration on 04Feb2021 as a 1st single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Saturday, 06Feb2021, the patient experienced Covid-19 symptoms and assumed it was related to the vaccine. On 09Feb2021, the patient had tested Covid positive. The patient had been through quarantine after he was tested Covid positive and when he was out of quarantine feeling mostly better, but the patient was scheduled to get the second dose of the vaccine on 25Feb2021. He was advised by his doctor to consider not taking it anymore since the 2nd dose reaction was not that okay. The patient wanted to make sure if he can get the 2nd dose considering he was positive of Covid-19. He was looking for some guidance about whether or not he should take the second dose of the Pfizer vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip joint pain on the left side; This is a spontaneous report received from a contactable consumer (reporting on herself). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266; Expiration Date: 31May2021) via an unspecified route of administration in Arm Right on 18Feb2021 13:15, as 2st dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) taken for an unspecified indication from 2019 and ongoing. Patient received first dose of BNT162B2 on 28Jan2021 for COVID-19 immunization. Patient received the second dose of the Covid-19 vaccine and has been having hip joint pain on the left side. Is there anything that she can do. She was concerned that it was from the vaccine. Physician address and zip code are unknown to patient. She received the vaccine on Thursday (18Feb2021) at 1:15pm. The pain started on Friday (19Feb2021). Yesterday it was worse but it is a little better today. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at point of injection; This is a spontaneous report from a non-contactable consumer.   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 19Feb2021 as unknown, single for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies. The patient not had COVI-19 prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 19Feb2021, the patient experienced soreness at point of injection. The patient had not tested COVID-19 post vaccination. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: There is bruising and swelling on two toes on the right foot.; There is bruising and swelling on two toes on the right foot.; This is a spontaneous report from a contactable Other HCP. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EM9809) intramuscularly in right arm on 10Feb2021 16:00 as 2nd single dose and had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EK9231) intramuscularly in right arm on 19Jan2021 18:00 as 1st single dose for COVID-19 immunization. The patient was 37-years-old and was not pregnant at the time of vaccination. Patient medical history included known allergies to sulfa drugs. The concomitant medications were not reported. The vaccination facility type was reported as Hospital. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior to vaccination. On 14Feb2021 patient experienced bruising and swelling on two toes on the right foot. The lab data and procedures included nasal swab test on 22Feb2021 with test result as negative. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not receive any treatments for the adverse event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Myalgia, Pyrexia, Somnolence
Clinical narrative: puffy around injection point; itchy and puffy around injection point; muscle aches; very tired; very sleepy; no appetite; so cold and could not get warm with a little fever; vertigo; This is a spontaneous report from a contactable consumer. This 75-year-old female consumer (patient) reported that:  A 75-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received BNT162b2 (PFIZER_BIONTECH COVID-19 mRNA VACCINE, solution for injection; Lot number: EN6200; expiration date: unknown), via unspecified route in right arm on 16Feb2021 at 16:30 (Patient was 75-years-old at the time of vaccination) as a 2ND DOSE SINGLE for covid-19 immunization. The patient's medical history included mitral valve prolapse, glaucoma, allergies to Lisinopril and penicillin. The patient's concomitant medication included centrum, CoQ10 100mg, diclofenac gel, lumigan, pre. The patient received first dose of BNT162b2 (Lot: EL9265) on right arm, on 26Jan2021, 5:00 pm. The patient do not have COVID-19 prior to vaccination. Since vaccination, the patient was not tested for COVID. On 17Feb2021 at 16:00, the patient experienced muscle aches, so cold and could not get warm with a little fever, no appetite, itchy and puffy around injection point, very tired and very sleepy - not as bad as after first shot. These symptoms started the day after the shot and was fine the following day. 4 days after the shot, the patient experienced vertigo and patient was not sure whether it is related. The patient not received any treatment. The outcome of the events were recovered on 2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vertigo
Clinical narrative: puffy around injection point; itchy and puffy around injection point; muscle aches; very tired; very sleepy; no appetite; so cold and could not get warm with a little fever; vertigo; This is a spontaneous report from a contactable consumer. This 75-year-old female consumer (patient) reported that:  A 75-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received BNT162b2 (PFIZER_BIONTECH COVID-19 mRNA VACCINE, solution for injection; Lot number: EN6200; expiration date: unknown), via unspecified route in right arm on 16Feb2021 at 16:30 (Patient was 75-years-old at the time of vaccination) as a 2ND DOSE SINGLE for covid-19 immunization. The patient's medical history included mitral valve prolapse, glaucoma, allergies to Lisinopril and penicillin. The patient's concomitant medication included centrum, CoQ10 100mg, diclofenac gel, lumigan, pre. The patient received first dose of BNT162b2 (Lot: EL9265) on right arm, on 26Jan2021, 5:00 pm. The patient do not have COVID-19 prior to vaccination. Since vaccination, the patient was not tested for COVID. On 17Feb2021 at 16:00, the patient experienced muscle aches, so cold and could not get warm with a little fever, no appetite, itchy and puffy around injection point, very tired and very sleepy - not as bad as after first shot. These symptoms started the day after the shot and was fine the following day. 4 days after the shot, the patient experienced vertigo and patient was not sure whether it is related. The patient not received any treatment. The outcome of the events were recovered on 2021.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: her arm started feeling funny and she checked it and it was red; itchy; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 94-year-old female patient (94 years age at vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267; Expiration Date: 31May2021), via an unspecified route of administration in right arm on 20Feb2021 (Saturday) at 09:30 as single dose for COVID-19 immunisation. The patient did not have any other prior vaccinations (within 4 weeks) except the COVID-19 vaccine first dose. The patient had been vaccinated with his first dose of COVID-19 vaccine (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021), via an unspecified route of administration in right arm on 30Jan2021. The first shot was fine. She got a little reaction. Other medical history included ongoing blood pressure and cholesterol level (unspecified -high/low) abnormality. The patient's concomitant medications included unspecified cholesterol and a blood pressure medication since unspecified years. She had been on cholesterol medication unspecified years ago and it kept her study. She was on both blood pressure and cholesterol medications when she got the vaccine. She had been visiting the doctor once a year. Two days after vaccination (on 22Feb2021, Monday), the patient experienced her arm started feeling funny and she checked it and it was red. At the time of report, the redness was getting bigger all the time. It was itchy and red. The outcome of events was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: itching; swelling; red and swollen,fever in area, 5x6 cm; This is a Spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and Expiration date was not reported), via unknown route of administration in left arm on 14Feb2021 at 15:15 (at the age of 79-year-old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included known allergies. Concomitant medications were not reported. Patient took unspecified other medications in two weeks of vaccination. The patient did not receive any other vaccine in four weeks. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. On 21Feb2021 at 12:00, the patient had itching, swelling, red and swollen, fever in area, 5x6 cm. No treatment was received for the events. The outcome of the events was reported as recovering.  Follow up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, SARS-CoV-2 test
Clinical narrative: One week after second vaccine had a headache; Nausea; This is a spontaneous report from a contactable Consumer. A 68-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263, Expiration date: Unknown), dose 2 via an unspecified route of administration in the right arm on 26Jan2021 at 2:00 PM (68-years age) 2nd dose single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266: Expiration date: Unknown),dose 1 via an unspecified route of administration on the left arm on 17Feb2021 at 12:00 PM 1st dose single dose for COVID-19 immunization. Patient experienced vomiting and headache after one week after first vaccination. Other Medical History included mitral valve repair in 2018 and the patient allergic to Demerol codeine walnuts. Concomitant medication(s) that patient received in two weeks included atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); valaciclovir hydrochloride (VALTREX); bazedoxifene acetate, estrogens conjugated (DUAVEE [BAZEDOXIFENE ACETATE; ESTROGENS CONJUGATED]); calcium (CALCIUM); ergocalciferol (VIT D); famotidine (PEPCID [FAMOTIDINE]). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Oct2020 the patient underwent Covid-19 nasal swab test which resulted as Negative. On 23Feb2021 at 05:00 PM the patient experienced headache for 2 days and nausea most of the 2 days. No treatment received for reported adverse event. The Outcome of the Events were Recovering.