chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling of body temperature change, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: fever last night (temperature was not taken); the Patient being hot and cold throughout the night; pain at the injection site only when the injection site is pressed; localized redness at the injection site; localized fluid filled blister only at the injection site; This is a spontaneous report from a contactable consumer (Daughter reported for patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the consumer reported that the patient had a fever last night (temperature was not taken) as the patient reports being hot and cold throughout the night, having pain at the injection site only when the injection site is pressed, localized redness at the injection site and a localized fluid filled blister only at the injection site. The consumer requesting to know if the blistering had been reported as a side effect from the Pfizer COVID-19 vaccine. The patient underwent lab tests and procedures which included body temperature: unknown an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: fever last night (temperature was not taken); the Patient being hot and cold throughout the night; pain at the injection site only when the injection site is pressed; localized redness at the injection site; localized fluid filled blister only at the injection site; This is a spontaneous report from a contactable consumer (Daughter reported for patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the consumer reported that the patient had a fever last night (temperature was not taken) as the patient reports being hot and cold throughout the night, having pain at the injection site only when the injection site is pressed, localized redness at the injection site and a localized fluid filled blister only at the injection site. The consumer requesting to know if the blistering had been reported as a side effect from the Pfizer COVID-19 vaccine. The patient underwent lab tests and procedures which included body temperature: unknown an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; extreme tiredness; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Feb2021 (75-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she was 75 years old and received the first dose of the Pfizer-BioNTech COVID-19 vaccine 2 days ago. She added she had experienced "fever" and "extreme tiredness" after vaccination. She doesn't want to receive the second dose during her vacation for she "would rather be sick at home". She specified she would contemplate to receive her second dose when she returns home around 07Apr2021. She asked how long she can go between the doses of the vaccine and still have a valid protection. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Rash, Rash macular
Clinical narrative: Tingling of my tongue/ tingling in her lower lip and upper lip; upper lip on the left hand side and it's a little bit swollen; Numbing of my upper jaw and the numbing of my lower jaw and a numbing of left side my mouth; I have the numbing of my mouth again; I got 2 red marks on my right hand (dark red blotches); Rash on my chest; rash on my neck; Tingling of my tongue/ tingling in her lower lip and upper lip; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is first case of the 2 cases.  A 68-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration on 24Feb2021 (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. She is not allergic to food or nuts but is allergic to penicillin, cardiac valve disease from an unknown date and unknown if ongoing. Other Medical Conditions: Consumer stated I don't know what this is a problem Damaged Heart Valve. Concomitant medications included Metoprolol (METOPROLOL) 12.5mg taken as It was cut in half so 12.5 twice a day for an unspecified indication, start and stop date were not reported. The patient experienced numbing of my upper jaw and the numbing of my lower jaw and a numbing of left side my mouth, I have the numbing of my mouth again, I got 2 red marks on my right hand (dark red blotches), rash on my chest, rash on my neck, tingling of my tongue/ tingling in her lower lip and upper lip on 24Feb2021. The patient also experienced tingling in her lower lip and upper lip, upper lip on the left hand side and it's a little bit swollen on 25Feb2021 09:00. The clinical course as follows Consumer stated, "No I am a person who just got the vaccine yesterday and I had numbing of my upper jaw and the numbing of my lower jaw and a numbing of my mouth left side my mouth and I got 2 red marks on my right hand. I waited there for 30 minutes and since I did not have itchiness, just the tingling of my tongue, not itchiness, they allowed me to go. I had a rash on my chest but it was not an itchy rash and I had a rash on my neck. It was not an itchy rash either. So, they let me go and they said if I had a problem to call #. I got children's Benadryl (treatment) and it took it away. Well, I have the numbing of my mouth again today and this is my first shot. So, my question is, is this something not to worry about and my second question is can I get the second shot or not.Therapeutic measures were taken as result for all event except upper lip on the left hand side and it's a little bit swollen. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever between 100.2 and 102.3; Aches; This is a spontaneous report from a non-contactable consumer (patient).  A 77-years-old female non-pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (at the age of 77-years-old) (Lot Number: EL9264) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cancer, bi-polar (bipolar disorder), hypothroid, stage 3 kidney disease, allergies to Aspirin and penicillian, all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) and semisodium (DEPAKOTE) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (lot number: EL8982, vaccine location: Left arm) on 28Jan2021 for covid-19 immunisation. It was reported that the patient experienced that fever between 100.2 and 102.3 and aches on 19Feb2021. Patient did not receive any treatment. Prior and post vaccination patient did not tested for covid. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: L hand numbness; This is a spontaneous report from a non-contactable other health care professional. A 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6205) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date during her 15-minute waiting period after the injection, the patient began to experience L hand numbness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient was Stable to go home and follow up with PCP. Therapeutic measures were taken as a result of L hand numbness included Treatment with water. The outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: She has had fever; aches; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198) via an unspecified route of administration in arm left on 23Feb2021 (at the age of 62-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included she had the COVID-19 virus on an unspecified date in Nov2020. The patient's concomitant medications were not reported. It was reported that, the caller had no other vaccines on the same day as her COVID vaccine. Enquired, the patient was 62-year-old, received the first dose of the Pfizer Covid vaccine. On 24Feb2021, the patient has had fever and aches since receiving the vaccine and wanted to know what she should do and whether there was anything she should take for it. The caller stated that, on Tuesday, she went down and got the COVID-19 Vaccine. The caller stated that, yesterday, when she got up was feeling kind of achy around where the shot was and around her neck. Stated that, as the day went on, she got more achy. The caller stated that, in the afternoon yesterday, she developed a fever of 100.5. Stated that, the lowest her temperature has been 99.0. Stated that, her fevers and aches that she was currently feeling, are just like what she had. The caller has been trying to get a hold of her nurse practitioner at the clinic where she goes and she has not gotten an answer from them. The caller was wondering what she needs to do, like does she need to stay home or go get checked out and how long are these symptoms supposed to last. On an unspecified date, the patient underwent lab tests and procedures which included she developed a fever (body temperature), resulted as 100.5 and she developed a fever (body temperature), resulted as 99.0 on an unspecified date. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Had some tingling down my left arm into my thumb and hand.  Little bit of numbness in thumb; Had some tingling down my left arm into my thumb and hand.  Little bit of numbness in thumb; This is a spontaneous report from a contactable other hcp. A 65-years-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL9267), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:30 as DOSE 2,SINGLE for covid-19 immunisation (Age at vaccination 65 years). The patient medical history and concomitant medications were not reported. On 25Feb2021 15:30 patient experienced had some tingling down my left arm into my thumb and hand. little bit of numbness in thumb. Therapeutic measures were taken as a result of events includes ice on hand. No other vaccine in four weeks. The outcome for both events was recovered on an unspecified date in 2021.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: develop a rash on her upper stomach under her breast. Since then the rash is "coming and going" and will appear in different places all over her body; has been breaking out in red blotches; it is red and itchy; This is a spontaneous report from a contactable (patient). A 59-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 59-years-old) (Batch/Lot Number: EK9231) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient was diagnosed when she was 8 years old. There were no concomitant medications. Patient states that about a week (unspecified date in 2021) after receiving the second dose she started to develop a rash on her upper stomach under her breast. Since then the rash was coming and going and will appear in different places all over her body. She also mentioned having the rash on her upper thigh by hear butt and also under her arm. She describes the rash as neither improving nor getting worse, but rather, staying the same except it is intermittent. She states that it will start out as really itchy, then it becomes red and the rash is also accompanied by bumps when it appears. She denies having any rash with the first dose of the Pfizer COVID-19 vaccine. patient states that she was a Type 1 Diabetic and she had a routine virtual appointment with her doctor. She told her doctor about the rash and her doctor told her to keep a close eye on it. Caller wants to know if this has been reported before and if she should see her regular doctor or Dermatologist. The caller states that she has been in quarantine since March and she was told that she wanted to know if she should still be cautious regarding wearing a mask, etc. even though she has received both doses of the Pfizer COVID-19 vaccine. Patient also states that she started breaking out in the red blotches about a week after getting the second dose of the product. Caller states that some of them will start, and then they disappear and reappear in other places on her body, it like switches spots. Caller states that it is red and itchy. The outcome of the event red and itchy was unknown. The outcome of all the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: severe Headache; fever (ranged between 99-101); chills; sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for herself.  A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318, expiration date: not reported), via an unspecified route of administration, in right arm on 12Feb2021 09:00 (at the age of 40-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patients medical history included asthma and migraine. The patients known allergies included Latex, doxycyline, tree nuts and penicillin. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318, expiration date: not reported) via an unspecified route of administration in left arm on 26Jan2021 08:00 as DOSE 1, SINGLE for COVID-19 immunization. Patient was not tested to covid post vaccination and was does not had covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications included Trazadone, cetirizine hydrochloride (ZYRTEC), ibuprofen (ADVIL), PARACETAMOL (TYLENOL) and Multivit. On 18Feb2021 23:30 , the patient experienced severe Headache, fever (ranged between 99-101), chills, sore arm. Patient had not received any treatment for the events reported. The outcome of all the events was recovered on unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated I am calling because I have been experiencing like numbness (on an unspecified date) I don't know how to explain it feels like my hands joint (statement incomplete), to freak (further clarification unknown) you know and ever since I got the Pfizer injection, the first injection it started. And then call got disconnected. Call back was done to gather further details however, it was unsuccessful. Limited information was available over the call. The outcome of the event was unknown. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Paraesthesia
Clinical narrative: My face is tingly and numb Started about 45 min after I and getting worse as day progresses It's been 5 hours now; My face is tingly and numb Started about 45 min after I Justin and getting worse as day progresses It's been 5 hours now; My face is tingly and numb Started about 45 min after I  and getting worse as day progresses It's been 5 hours now; This is a spontaneous report from a contactable other health care professional (Patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on 19Feb2021 09:45 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No COVID prior vaccination nor tested for COVID post vaccination. No known allergies reported. The patient did not receive any other vaccine within 4 weeks prior to vaccination. On 19Feb2021 10:15, the patient's face was tingly and numb started about 45 min after justin and getting worse as day progresses it's been 5 hours (at the time of reporting). No treatment received for events. The outcome of all events was reported as not resolved.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Pain in extremity, Pyrexia
Clinical narrative: fever; headache; sore arm; felt a little sick; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported for a patient that.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2 SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and  concomitant medications were not reported. On an unspecified date the patient experienced fever, headache, sore arm, and felt a little sick. The reporter was unclear if the patient had the Pfizer or Moderna COVID-19 vaccine.  No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Lower left row of teeth in severe pain; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 58-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 09:00 AM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products were reported. On 25Feb2021 at 06:00 PM, the patient experienced lower left row of teeth in severe pain. No seriousness criteria were reported. No treatment received for event. The outcome of event was not recovered.  Information on the lot/batch number has been requested  Follow-up (19MAY2021): Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache lasting 16 days and still goings; This is a spontaneous report from a contactable nurse. A 36-year-old non pregnant female patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: EL9265) via unspecified route of administration, administered in left arm as Dose 1, Single on 04Feb2021 (age at the time of vaccination was 36-year-old) (at 21:45) for Covid-19 immunisation. The patient medical history included acne. The patient's concomitant medications were spironolactone, minocycline, melatonin, ascorbic acid (vitamin c) and ergocalciferol (vitamin d). The patient had Covid prior vaccination and was not tested for covid post vaccination. The patient experienced Severe headache lasting 16 days and still goings on 05Feb2021 (at 04:00). The patient received migraine medication (unspecified) as treatment. Outcome of the event was not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: High fever; Body aches; Injection site pain; Nausea; This is a spontaneous report from a non-contactable other hcp (Patient). A 23-years-old non-pregnant female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 19Feb2021 13:30 (at the age of 23-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, gastroparesis and fructose intolerance from an unknown date and unknown if ongoing. No other vaccine was given within four weeks. Patient Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), fluticasone propionate, salmeterol xinafoate (ADVAIR), bifidobacterium infantis (ALIGN) and daily vitamin taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No known allergies were reported. The patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on unspecified date as single for COVID-19 immunization. On 20Feb2021 at 01:45 the patient experienced high fever, body aches, injection site pain and nausea. (Reporter felt like she had COVID again, although she knows this is not the case) after her second dose. She experienced hardly any side effects after her first dose. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in hand that will not go away; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female non-pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 29Jan2021 at 12:00 (at the age of 51-year-old) (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient received second dose of bnt162b2 via an unspecified route of administration, administered in Left arm on 12Feb2021 at 12:00 (Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history was not reported. Patient had unspecified known allergies. The patient had no covid prior vaccination. Patient had not tested for covid post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks, no other medication in two weeks. The patient experienced numbness in hand that would not go away on 01Feb2021. The patient did not receive treatment in response to event. The clinical outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sensation of foreign body
Clinical narrative: Numbness around mouth, cheeks and nose; Feels like I am swallowing around a pistachio; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 54-year-old), via an unspecified route of administration, administered in arm left on 25Feb2021 18:15 as dose number unknown, single for covid-19 immunization. Patient had no other vaccine in four weeks. Patient had not covid prior vaccination and not tested post vaccination. Patient had no known allergies. The patient medical history was none. Concomitant medications included collagen, colecalciferol (VITAMIN D), ubidecarenone (COQ10) and daily vitamin taken for an unspecified indication. The patient experienced numbness around mouth, cheeks and nose and felt like she was swallowing around a pistachio on 25Feb2021. No treatment received for adverse events. The clinical outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Post herpetic neuralgia
Clinical narrative: Sudden and dramatic resurgence of long-standing but generally dormant post-herpetic neuralgia.; Sudden and dramatic resurgence of long-standing but generally dormant post-herpetic neuralgia.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9269; Expiration date: unknown) via an unspecified route of administration in left arm on 20Feb2021 at 13:15 (age at vaccination 68-year-old) as dose 1, single for covid-19 immunization at hospital. The patients medical history included Inflammatory bowel disease and patient was allergic to penicillin and sulfa. The patients concomitant medications were included mesalamine and budesonide. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Feb2021 at 23:30 patient experienced sudden and dramatic resurgence of long-standing but generally dormant post-herpetic neuralgia. Patient did not receive any treatment for the adverse event. The outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after my 1st shot; This is a spontaneous report from a non-contactable consumer (patient).   A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none and concomitant medications were not reported. No known allergies. On an unspecified date, the patient reported that there were no other issues other than sore arm after the first shot. The adverse event resulted in none of the above as reported. There was no COVID prior vaccination and not COVID tested post vaccination. There was no other vaccine in four weeks. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Slight fever like a 100.7; This is a spontaneous report from a contactable nurse (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Feb2021 (at the age of 76-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's had concomitant medications (unspecified). The patient previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient experienced slight fever like a 100.7 on an unspecified date in Feb2021. The patient got the COVID-19 vaccine last day (19Feb2021), the second dose of Pfizer. And she had just a slight fever like a 100.7. She was just wondering she was just running a little bit of fever like a 100.9. The patient wanted to know if it goes higher, she can take Tylenol. Consumer was suggested to consult the healthcare provider. Consumer stated, she just cannot reach them on Saturday. The patient stated, she thinks there is a causal relationship. Outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: 104-degree fever; very tired; chills; very sore arm at site; headache; This is a spontaneous report from a contactable consumer(patient). A 74-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included covid-19 immediately prior to getting the vaccine. Patient had just recovered from the actual COVID virus days prior to getting the vaccine. The concomitant medications were not reported. The patient experienced 104-degree fever, very tired, chills, very sore arm at site, headache. on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 104-degree on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 104-degree fever; very tired; chills; very sore arm at site; headache; This is a spontaneous report from a contactable consumer(patient). A 74-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included covid-19 immediately prior to getting the vaccine. Patient had just recovered from the actual COVID virus days prior to getting the vaccine. The concomitant medications were not reported. The patient experienced 104-degree fever, very tired, chills, very sore arm at site, headache. on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 104-degree on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hyposmia
Clinical narrative: some loss of smell - I can still realize sharp smell (citrus) but the smell of ground coffee is significantly diminished; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 15:45 hours as dose 1, single (at the age of 74-years-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 06Feb2021, patient had some loss of smell, patient can still realize sharp smell (citrus) but the smell of ground coffee was significantly diminished. Patient received no treatment for the event. The event was reported as non-serious by the patient. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected. Information on the lot/batch number has been requested
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: Fever (100.5 F); some chills; arm sore in the vaccine injection area; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, lot number: EL 3247, expiration date was not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 12:45 (at the age of 29-years-old) as dose 2, single for covid-19 immunization at workplace clinic. The patient medical history included liver disease. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for unknown indication from an unknown date. Other medications the patient received within 2 weeks of vaccination includes LEXAPRO. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration, administered in left arm on 03Feb2021 12:45 PM (at the age of 29-years-old) as dose 1, single for covid-19 immunization. The patient does not have any allergies. The patient did not 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. It was reported that, on 25Feb2021 07:30 the patient experienced, Fever (100.5 F), some chills, arm sore in the vaccine injection area. The patient underwent lab tests and procedures which included fever: 100.5 Fahrenheit on 25Feb2021. No treatment was received for the adverse event. The reporter assessed the seriousness as non-serious. The outcome of the events was reported as recovered on an unspecified date of 2021.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Migraine, Pain
Clinical narrative: heavy migraine; full body soreness; a fever over 100 F; fatigue; loss of strength; This is a spontaneous report from a contactable 25-year-old male consumer reported for himself that received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL3247), dose 2 via unspecified route in left Arm on 25Feb2021 10:00, as dose 2, single for COVID-19 immunization (age at time of vaccination 25 years). The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL3247), dose 1 via unspecified route in left Arm on 04Feb2021 10:00, as dose 1, single for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 02:45 AM the patient experienced a heavy migraine, full body soreness, a fever over 100 F, fatigue, and loss of strength. The patient was did not received treatment for the adverse event. On 26Feb2021 he had lab test Body temperature result was fever over 100 F. The outcome of all events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: heavy migraine; full body soreness; a fever over 100 F; fatigue; loss of strength; This is a spontaneous report from a contactable 25-year-old male consumer reported for himself that received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL3247), dose 2 via unspecified route in left Arm on 25Feb2021 10:00, as dose 2, single for COVID-19 immunization (age at time of vaccination 25 years). The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EL3247), dose 1 via unspecified route in left Arm on 04Feb2021 10:00, as dose 1, single for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 02:45 AM the patient experienced a heavy migraine, full body soreness, a fever over 100 F, fatigue, and loss of strength. The patient was did not received treatment for the adverse event. On 26Feb2021 he had lab test Body temperature result was fever over 100 F. The outcome of all events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; headache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6202) dose number unknown via an unspecified route of administration in Leg Left on Feb2021 (age at vaccination 64years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vac-cine. The patient received any other medications within 2 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in Public Health Clinic/Veterans Administration facility. Since the vaccination, the patient had not been tested positive for COVID-19. On Feb2021 the patient experienced sore arm, headache, fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A little soreness in the VAC shoulder for one day; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 24Feb2021 12:00 (Batch/Lot Number: EN6203) (at the age of 58-years-old) as SINGLE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication(s) included hydrochlorothiazide 25mg, amlodipine 10mg and carvedilol (CARVEDI); all taken for an unspecified indication, start and stop date were not reported. On 24Feb2021, 17:00, the patient experienced a little soreness in the vac shoulder for one day. The patient did not received any treatment. The reporter considered the event as non-serious. The outcome of event was recovered in Feb2021.   Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Nausea, Vaccination site pain
Clinical narrative: Tenderness at injection site; Swelling at injection site; Stiff neck and shoulder; Bad headache; Nausea; Very tired; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for herself. A 61-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 25Feb2021 15:30 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), sarcoidosis, cancer survivor, known allergies Penicillin from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In Pharmacy or Drug Store most recent COVID-19 vaccine was administered. The patient experienced tenderness at injection site, swelling at injection site, stiff neck and shoulder, bad headache, nausea, very tired on 25Feb2021 17:30. No treatment was received for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Tenderness at injection site; Swelling at injection site; Stiff neck and shoulder; Bad headache; Nausea; Very tired; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) reported for herself. A 61-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 25Feb2021 15:30 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), sarcoidosis, cancer survivor, known allergies Penicillin from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In Pharmacy or Drug Store most recent COVID-19 vaccine was administered. The patient experienced tenderness at injection site, swelling at injection site, stiff neck and shoulder, bad headache, nausea, very tired on 25Feb2021 17:30. No treatment was received for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Joint aches; injection site soreness; This is a spontaneous report from a contactable 69-year-old non-pregnant female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 25Feb2021 12:00 PM on left arm (at 69-year-old), as dose 1, single for COVID-19 immunization and secukinumab (Cosentyx) injection taken for an unknown indication on the same day (25Feb2021). The medical history of the patient included Ankelosing spondylitis. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 12:15 PM the patient experienced joint aches and injection site soreness. No treatment was received for the adverse event. On an unknown date in 2021 the patient recovered.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information was expected.