chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; nausea; diarrhea; slight fever; chills; This is a spontaneous report from a non-contactable consumer (Patient). A female patient of unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 12:00 as dose 2, single for covid-19 immunisation. Medical history included Auto immune disease from an unknown date and unknown if ongoing. Concomitant medications included (in two weeks) Zoloft, geodon, ambien, allerclear from an unknown date for unknown indication and unknown if ongoing. Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in left arm on 17Feb2021 12:00 as dose 1, single for covid-19 immunisation. It was reported that on 12Mar2021 07:00 patient experienced Sore arm, nausea and diarrhoea 2 days after receiving the 2nd vaccination, slight fever, and chills. Patient did not receive any treatment for the events. Outcome of the event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Movement disorder, Pain in extremity
Clinical narrative: The 2nd shot was very high on my shoulder and painful; unable to move my left arm or fingers without excruciating pain; unable to move my left arm or fingers without excruciating pain; limited movement; it keeps me awake at night.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 09:15 (at the age of 43-Years-old) (Batch/Lot Number: EM9809) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was reported as none. Concomitant medication included doxycycline 40 mg taken for an unspecified indication, start and stop date were not reported. Allergies were not known. Patient did not have Covid prior to vaccination. Patient was not tested for covid after vaccination. Patient did not receive any other vaccine in four weeks. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 01:30 pm (at the age of 43-Years-old) (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. On 27Feb2021 at 10:00, within 1 hour after second shot, the patient experienced the 2nd shot was very high on my shoulder and painful, unable to move my left arm or fingers without excruciating pain, limited movement. On the same day it kept her awake at night. It was reported that some movement gradually returned, but she was 2 weeks out from the vaccine and still had shoulder pain and limited movement so much so that it keeps her awake. No therapeutic measures were taken with respect to events. At the time of this report, the outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Paraesthesia, Rash
Clinical narrative: Painful rash on forearms, inner thighs, back of neck; Tingling nerve pain on forearms, thighs, back of neck and buttocks; Tingling nerve pain on forearms, thighs, back of neck and buttocks; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in arm left on 11Mar2021 10:00 (at the age of 69-years-old) as single dose for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: E19261) via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:45 (at the age of 69-years-old) as single dose for covid-19 immunization from which the patient experienced red rash on both forearms/rash on forearms, inner thighs, numbness on nose and cheeks next to nose/numbness on lips and bridge of nose/cheeks, rash with pain on forearms and tingling thru out mouth and tongue, thick tongue, film back of throat. The patient's medical history included afib (atrial fibrillation) had pacemaker and had known allergies with some antibiotics from an unknown date and unknown if ongoing. Patient denied for any other vaccine in four weeks. 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's concomitant medications included dronedarone hydrochloride (MULTAQ), apixaban (ELIQUIS), metoprolol and alprazolam, all were taken for an unspecified indication, start and stop date were not reported for any. The patient previously took celebrex and experienced drug allergy, start and stop date was not reported. On 11Mar2021 10:45, the patient experienced painful rash on forearms, inner thighs and back of neck and tingling nerve pain on forearms, thighs, back of neck and buttocks. Patient took antihistamine, Tylenol, ice on rash areas as a treatment received. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: has a lot of red welts and hives; itching like crazy; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 74-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection) via unknown route of administration at left arm on 10Mar2021 (lot number: EN6205) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine first dose of bnt162b2 (COMIRNATY, Solution for injection) via unknown route of administration at left arm on 17Feb2021 (lot number: 2L9267) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that, the patient experienced itching like crazy on Mar2021 and has a lot of red welts and hives began late in the afternoon on 11Mar2021 and was worse. Clinical course of events include; she had the 2nd shot on Tuesday and then clarifies later in the call the 2nd dose was administered on 10Mar2021. stated that she thinks she has had a pretty good reaction to it and she did not really start feeling any symptoms until maybe very late in the day on either Tuesday or early Wednesday and the symptoms are that she is itching like crazy and has a lot of red welts and hives.  stated that the itching began either very late on 10Mar2021 or in the early hours of 11Mar2021 and states god yes the itching is ongoing and is much worse than when it began.states the red welts and hives began late in the afternoon on 11Mar2021 and are ongoing and worse. The adverse events did not resulted in emergency room and physician office. The patient was not hospitalized. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Erythema, Eye pain
Clinical narrative: Big red circular below the injection mark; It was like 3 inches in diameter; I was very dizzy I couldn't even get out of bed; I had been feeling nauseous and I was throwing up; I had been feeling nauseous and I was throwing up; My eyeballs hurt and I had joint pain; My eyeballs hurt and I had joint pain; I had a stomach ache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6206; Expiration Date: 30Jun2021, NDC number, UPC number was not reported), via an unspecified route of administration, administered in Arm Left on 09Mar2021(Age at vaccination 71-years-old) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included ongoing cholesterol, ongoing cancer, ongoing restless legs,  ongoing for the back area (back disorder), ongoing for sleeping. Concomitant medication included lovastatin taken for cholesterol gabapentin taken for back disorder, exemestane taken for neoplasm malignant, start; trazodone taken for sleep disorder, ropinirole taken for restless legs syndrome. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single for covid-19 immunisation. Consumer stated, I would just like to go over the Pfizer vaccine second shot that I had on Tuesday at. I did received a side effect yesterday which was concerning which was a big red circular below the injection mark on 13Mar2021. It was like 3 inches in diameter and I still have it today and I woke up yesterday where I was very dizzy on 13Mar2021, I couldn't even get out of bed, I woke up very dizzy and I still don't know what it was. I couldn't get out of bed for couple of hours and then I realized when I went into the shower that this is what got on my arm yesterday that it came out about and I had been feeling nauseous on 13Mar2021 and I was throwing up everything else that I had like. My eyeballs hurt and I had joint pain both on 13Mar2021 and I had a stomach-ache for like 3 days on 09Mar2021. So, I just want to go over the side effects. Consumer stated Yes, 3 days but the rash didn't start until yesterday. Product details Consumer stated, I don't see it. Consumer stated, for the nauseous and everything else I was taking a Tylenol for the joint pain trying to get rid of that. It was just like a stomach-ache and finally I did throw up couple of times, but I was trying to get rid of the joint pain so was taking Tylenol. Consumer further stated no, is this redness going to go away, is this common, because I was trying to look on the internet because I saw on the listed under the list and was trying to find out. Therapeutic measures were taken for event nauseous, Joint pain. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Big red circular below the injection mark; It was like 3 inches in diameter; I was very dizzy I couldn't even get out of bed; I had been feeling nauseous and I was throwing up; I had been feeling nauseous and I was throwing up; My eyeballs hurt and I had joint pain; My eyeballs hurt and I had joint pain; I had a stomach ache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6206; Expiration Date: 30Jun2021, NDC number, UPC number was not reported), via an unspecified route of administration, administered in Arm Left on 09Mar2021(Age at vaccination 71-years-old) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included ongoing cholesterol, ongoing cancer, ongoing restless legs,  ongoing for the back area (back disorder), ongoing for sleeping. Concomitant medication included lovastatin taken for cholesterol gabapentin taken for back disorder, exemestane taken for neoplasm malignant, start; trazodone taken for sleep disorder, ropinirole taken for restless legs syndrome. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single for covid-19 immunisation. Consumer stated, I would just like to go over the Pfizer vaccine second shot that I had on Tuesday at. I did received a side effect yesterday which was concerning which was a big red circular below the injection mark on 13Mar2021. It was like 3 inches in diameter and I still have it today and I woke up yesterday where I was very dizzy on 13Mar2021, I couldn't even get out of bed, I woke up very dizzy and I still don't know what it was. I couldn't get out of bed for couple of hours and then I realized when I went into the shower that this is what got on my arm yesterday that it came out about and I had been feeling nauseous on 13Mar2021 and I was throwing up everything else that I had like. My eyeballs hurt and I had joint pain both on 13Mar2021 and I had a stomach-ache for like 3 days on 09Mar2021. So, I just want to go over the side effects. Consumer stated Yes, 3 days but the rash didn't start until yesterday. Product details Consumer stated, I don't see it. Consumer stated, for the nauseous and everything else I was taking a Tylenol for the joint pain trying to get rid of that. It was just like a stomach-ache and finally I did throw up couple of times, but I was trying to get rid of the joint pain so was taking Tylenol. Consumer further stated no, is this redness going to go away, is this common, because I was trying to look on the internet because I saw on the listed under the list and was trying to find out. Therapeutic measures were taken for event nauseous, Joint pain. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: patient has a fever of 103 degrees; This is a spontaneous report from a contactable consumer (cousin). An adult patient (approximately 25 years old) of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date (on the 2nd day after receiving his 2nd dose), the patient had a fever of 103 degrees. The patient underwent lab tests and procedures which included body temperature: 103 degrees. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia oral, Rash, Throat irritation
Clinical narrative: rash; itchy throat; tingling lips; Very warm sensation in side my legs; This spontaneous report received from a Pfizer sponsored program Pfizer.com - General Company Information via contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Tuesday) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that yesterday two days (on an unspecified date in Mar2021) I have a rash, itchy throat, tingling lips. Very warm sensation inside my legs. This all comes and goes, have been taking (treatment) Benadryl. I am most concerned about going for my next shot. The events outcome was Resolved with Sequel.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Was really itching in my head; started itching all over my trunk, the trunk of my body and I had huge rash all over my stomach; Was really itching in my head; started itching all over my trunk, the trunk of my body and I had huge rash all over my stomach; This is a spontaneous report from a contactable Consumer (patient). A patient of an unknown age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: not reported) Via an unknown route of administration on an unknown date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: not reported) as dose 1, single via an unknown route of administration on an unknown date for Covid-19 immunisation. On 03Mar2021, It started on he's back.  Patient experienced itching, itching in he's head and all of a sudden yesterday and day before yesterday he started itching all over trunk, the trunk of body and  had huge rash all over he's stomach. He feel like it is an immune response. it is really itchy and large. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Erythema, Flushing
Clinical narrative: my face and neck began to turn red; i felt flush; had chest tightened; I felt slightly dizzy; This is a spontaneous report from a non-contactable consumer (Patient). A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 13Mar2021 at 08:30 (at the age of 63-year-old), as dose 1, single in right arm for COVID-19 immunization at hospital. Medical history included cancer of the vocal chord. Patient's past drug included Fosaprepitant and experienced drug allergy. Concomitant medications were not reported. Patient did not receive other vaccines in four weeks. On 13Mar2021 at 09:00 AM, the patient's face and neck began to turn red and the nurse first noticed it. After a few minutes, patient felt flush, chest tightened and felt slightly dizzy. Adverse events resulted in Emergency room/department or Urgent care. Patient received treatment for adverse events with intravenous Benedryl. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was resolved on unspecified dates in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Body temperature increased, Decreased appetite, Dizziness
Clinical narrative: no appetite; slurred speech; red skin on hands, face, neck; balance problems; dizziness; swollen hands; fatigue/severe fatigue/extremely severe fatigue/very tired/some lingering fatigue; severe flu-like symptoms; vertigo; full-body muscle aches; temperature was slightly elevated (98.7) from my "baseline,"  which is around 96.7; This is a spontaneous report from a contactable consumer (patient). A non pregnant 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EM9809 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 12Feb2021 09:00 (at the age of 25-years-old) at dose 1, single for covid-19 immunization. Medical history included known allergies of Pineapple and other medical history included Fibromyalgia, endometriosis, neurological functioning disorder, ADHD, asthma. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); spironolactone; montelukast; pregabalin. The most recent vaccine was administered at Clinic/ facility. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that within 1 hour of injection 12Feb2021 10:00am, patient began experiencing fatigue that got increasingly worsened. By 2:00pm, she had slurred speech; severe fatigue; red skin on hands, face, neck; balance problems and dizziness; swollen hands. That evening through the next morning, she has experienced severe flu-like symptoms, including vertigo, extremely severe fatigue, and full-body muscle aches. Her temperature was slightly elevated (98.7) from my "baseline," which was around 96.7. On Saturday (13Feb2021), she was very tired, no appetite, still experiencing some vertigo and muscle aches. Symptoms improved overnight and by Sunday evening, Patient was mostly back to normal, with some lingering fatigue. The patient underwent lab tests and procedures which included PCR test: Nasal Swab: negative on 17Feb2021, 24Feb2021 and 02Mar2021. No treatment was given for the events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296198 same patient, different vaccine dose, similar event
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Erythema, Fatigue, Influenza like illness, Myalgia
Clinical narrative: no appetite; slurred speech; red skin on hands, face, neck; balance problems; dizziness; swollen hands; fatigue/severe fatigue/extremely severe fatigue/very tired/some lingering fatigue; severe flu-like symptoms; vertigo; full-body muscle aches; temperature was slightly elevated (98.7) from my "baseline,"  which is around 96.7; This is a spontaneous report from a contactable consumer (patient). A non pregnant 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EM9809 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 12Feb2021 09:00 (at the age of 25-years-old) at dose 1, single for covid-19 immunization. Medical history included known allergies of Pineapple and other medical history included Fibromyalgia, endometriosis, neurological functioning disorder, ADHD, asthma. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); spironolactone; montelukast; pregabalin. The most recent vaccine was administered at Clinic/ facility. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that within 1 hour of injection 12Feb2021 10:00am, patient began experiencing fatigue that got increasingly worsened. By 2:00pm, she had slurred speech; severe fatigue; red skin on hands, face, neck; balance problems and dizziness; swollen hands. That evening through the next morning, she has experienced severe flu-like symptoms, including vertigo, extremely severe fatigue, and full-body muscle aches. Her temperature was slightly elevated (98.7) from my "baseline," which was around 96.7. On Saturday (13Feb2021), she was very tired, no appetite, still experiencing some vertigo and muscle aches. Symptoms improved overnight and by Sunday evening, Patient was mostly back to normal, with some lingering fatigue. The patient underwent lab tests and procedures which included PCR test: Nasal Swab: negative on 17Feb2021, 24Feb2021 and 02Mar2021. No treatment was given for the events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296198 same patient, different vaccine dose, similar event
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Vertigo
Clinical narrative: no appetite; slurred speech; red skin on hands, face, neck; balance problems; dizziness; swollen hands; fatigue/severe fatigue/extremely severe fatigue/very tired/some lingering fatigue; severe flu-like symptoms; vertigo; full-body muscle aches; temperature was slightly elevated (98.7) from my "baseline,"  which is around 96.7; This is a spontaneous report from a contactable consumer (patient). A non pregnant 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EM9809 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 12Feb2021 09:00 (at the age of 25-years-old) at dose 1, single for covid-19 immunization. Medical history included known allergies of Pineapple and other medical history included Fibromyalgia, endometriosis, neurological functioning disorder, ADHD, asthma. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); spironolactone; montelukast; pregabalin. The most recent vaccine was administered at Clinic/ facility. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that within 1 hour of injection 12Feb2021 10:00am, patient began experiencing fatigue that got increasingly worsened. By 2:00pm, she had slurred speech; severe fatigue; red skin on hands, face, neck; balance problems and dizziness; swollen hands. That evening through the next morning, she has experienced severe flu-like symptoms, including vertigo, extremely severe fatigue, and full-body muscle aches. Her temperature was slightly elevated (98.7) from my "baseline," which was around 96.7. On Saturday (13Feb2021), she was very tired, no appetite, still experiencing some vertigo and muscle aches. Symptoms improved overnight and by Sunday evening, Patient was mostly back to normal, with some lingering fatigue. The patient underwent lab tests and procedures which included PCR test: Nasal Swab: negative on 17Feb2021, 24Feb2021 and 02Mar2021. No treatment was given for the events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296198 same patient, different vaccine dose, similar event
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Wife had high fever of 100.7; fatigue; chills; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose and had high fever of 100.7- fatigue and chills after a week on an unspecified date. The reporter was concerned about her getting the vaccine was it normal to have side effects after the first dose. The patient underwent lab tests and procedures which included body temperature with 100.7. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: PPV
Symptoms: Limb mass
Clinical narrative: other than maybe a lump on the arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name unknown) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. Medical history included 5 brain tumors, tumors on the adrenals, and a mass on the larynx. The patient's concomitant medications were not reported. After receiving pneumonia vaccine, the patient never had any problems other than maybe a lump on the arm. The outcome of event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 antibody test
Clinical narrative: slight cough; rubbing nose; slight colds; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced slight cough, rubbing nose and slight clods. Patient also mentioned he had his Covid test yesterday but the result was not yet out and asking now if it was okay to have his 2nd shot tomorrow even in that condition. The patient underwent lab tests and procedures which included Covid test with unknown results on 13Mar2021. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Pain in extremity
Clinical narrative: Possible allergic reaction to the vaccine; plump lips; my arm is sore; This is a spontaneous report from a contactable consumer (patient's Friend). A female patient (non-pregnant) of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number : Not reported) Via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Allergies to medications, food or other products were unknown. She was not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19, Since the vaccination, the patient been tested for COVID-19 became unknown. On 17Mar2021, the patient experienced possible allergic reaction to the vaccine. She woke up with plump lips and her arm was sore. Treatment not received for the adverse event. Outcome of the events was recovering.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Petechiae, Skin discolouration
Clinical narrative: discoloration; L 4TH/5TH MTP, R 1ST MTP burning sensation; Petechiae; This is a spontaneous report from a contactable other health professional (patient) in response to HCP follow-up letter sent in cross reference case. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202; Expiration Date: 30Jun2021), intramuscular, administered in arm left on 24Feb2021 06:50 as DOSE 2, 0.1 mg/ml SINGLE for (at the age of 45-year-old) COVID-19 immunisation. Medical history included known allergy of Sulfa, Kiwi and pineapple from Jun2010 and ongoing, sjogren's syndrome from Apr2018 and ongoing, raynaud's phenomenon from Apr2018 and ongoing. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for sjogren's syndrome from Oct2019 to an unspecified stop date; leflunomide taken for sjogren's syndrome from Jun2020 to an unspecified stop date; cyclosporine taken for sjogren's syndrome from Mar2019 to an unspecified stop date; nifedipine taken for raynaud's phenomenon from Feb2021 to an unspecified stop date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284; Expiration Date: 30Apr2021), via an unspecified route of administration on 14Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 15Jan2021, the patient had burning sensation and petechiae. On 15Jan2021, the patient was treated with Ibuprofen 600 mg TID (three times a day) PO (Per oral). On 07Mar2021, the patient had discoloration. On 27Jan2021, the patient had routine PCP visit and review Covid toes. On 25Feb2021 20:00, the patient experienced L 4th/5th MTP, R 1st MTP burning sensation and petechiae. On 07Mar2021, the patient had discoloration. It was reported that Nifedipine minimized pain, redness, swelling of toes. Burning sensation was not appreciated after 2nd Pfizer with nifedipine use. Enable wear shoes due to toe sensitivity, needing 1/2 size longer. Colour changes with sloughing skin affected toes with healing more than 76 weeks after each dosing. Therapeutic measures were taken as a result of L 4th/5th MTP, T 1st MTP burning sensation and petechiae (petechiae). The patient was treated with Ibuprofen for burning sensation/paresthesia. There was a reasonable possibility that the event was related to suspect product. Outcome of skin discolouration unknown and for all the other events recovering on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Dizziness, Fatigue
Clinical narrative: "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; migraines; nausea; dizziness; Fever 100.5 degree F; Fatigue; Severe joint aches unresponsive to naproxen; Crampy abdominal pain; This is a spontaneous report from a contactable physician (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EP7534, Expiration date: Not reported), via an unspecified route of administration in left arm on 14Mar2021 at 15:15 (at the age of 68-years-old) as dose 2, single for COVID-19 immunization in a public health clinic/veterans administration facility. Medical history included pulmonary hypertension, asthma and chronic obstructive pulmonary disease (COPD). The patient's known allergies included cephalosporins. Concomitant medications/other medications received by the patient within 2 weeks included morphine sulfate (MS CONTIN); oxycodone hydrochloride, paracetamol (PERCOCET) and estradiol (ESTRACE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198, Expiration date: Not reported), via an unspecified route of administration in left arm on 19Feb2021 at 13:00 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post-vaccination, the patient was not tested for COVID-19. On 14Mar2021 at 16:00, the patient experienced "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy, daily migraines lasting for a week after both the injections with nausea and dizziness, fever with body temperature of 100.5 degree F, fatigue, severe joint aches unresponsive to naproxen and crampy abdominal pain. These events doesn't result in emergency room visit or physician's office. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; migraines; nausea; dizziness; Fever 100.5 degree F; Fatigue; Severe joint aches unresponsive to naproxen; Crampy abdominal pain; This is a spontaneous report from a contactable physician (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EP7534, Expiration date: Not reported), via an unspecified route of administration in left arm on 14Mar2021 at 15:15 (at the age of 68-years-old) as dose 2, single for COVID-19 immunization in a public health clinic/veterans administration facility. Medical history included pulmonary hypertension, asthma and chronic obstructive pulmonary disease (COPD). The patient's known allergies included cephalosporins. Concomitant medications/other medications received by the patient within 2 weeks included morphine sulfate (MS CONTIN); oxycodone hydrochloride, paracetamol (PERCOCET) and estradiol (ESTRACE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198, Expiration date: Not reported), via an unspecified route of administration in left arm on 19Feb2021 at 13:00 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post-vaccination, the patient was not tested for COVID-19. On 14Mar2021 at 16:00, the patient experienced "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy, daily migraines lasting for a week after both the injections with nausea and dizziness, fever with body temperature of 100.5 degree F, fatigue, severe joint aches unresponsive to naproxen and crampy abdominal pain. These events doesn't result in emergency room visit or physician's office. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy; migraines; nausea; dizziness; Fever 100.5 degree F; Fatigue; Severe joint aches unresponsive to naproxen; Crampy abdominal pain; This is a spontaneous report from a contactable physician (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EP7534, Expiration date: Not reported), via an unspecified route of administration in left arm on 14Mar2021 at 15:15 (at the age of 68-years-old) as dose 2, single for COVID-19 immunization in a public health clinic/veterans administration facility. Medical history included pulmonary hypertension, asthma and chronic obstructive pulmonary disease (COPD). The patient's known allergies included cephalosporins. Concomitant medications/other medications received by the patient within 2 weeks included morphine sulfate (MS CONTIN); oxycodone hydrochloride, paracetamol (PERCOCET) and estradiol (ESTRACE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198, Expiration date: Not reported), via an unspecified route of administration in left arm on 19Feb2021 at 13:00 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post-vaccination, the patient was not tested for COVID-19. On 14Mar2021 at 16:00, the patient experienced "covid arm", 10 cm circumferential red swollen area with a firm knot in the center, and is tender and itchy, daily migraines lasting for a week after both the injections with nausea and dizziness, fever with body temperature of 100.5 degree F, fatigue, severe joint aches unresponsive to naproxen and crampy abdominal pain. These events doesn't result in emergency room visit or physician's office. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Hypersensitivity, Muscle tightness, Oropharyngeal pain, Swelling
Clinical narrative: Allergy reaction; Tight neck; sore throat; some swelling; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Feb2021 at 08:00 (lot number: En6198) in the left arm, dose 1, single and on 18Mar2021 at 08:00 (lot number: En6208) in the right arm, dose 2, single; both via intramuscular for COVID-19 immunisation. Medical history included celiac disease, severe asthma, pituitary gland low function, IgA blood deficiency, blood granular disorder, low hormones chronic hives (long history of 40 years), Allergy to sulfer drugs, antibiotics, milk, wheat, nuts, eggs, preservatives, fragrance, cottonseed oil and allergies (long history of 40 years). Concomitant medication included gabapentin; fluticasone propionate, salmeterol xinafoate (ADVAIR); hydroxychloroquine sulfate (PLAQUENIL); salbutamol (ALBUTEROL); cetirizine hydrochloride (ZYRTEC). Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 25Feb2021 at 09:30, the patient experienced tight neck, sore throat and some swelling and so she took 20 mil. of prednisone. The patient went to her allergist and she recommended that the patient had to take the 20 mil. of prednisone an hour prior to the second dose and it worked very well. It was reported that the patient's pulmonary, primary care physician, rheumatologist and allergist were really unsure if she should get it, but with her IgA decency and severe asthma they said yes. The patient stated that her allergy reaction got controlled. 24 hours later, the patient was symptom free and very happy. The patient said that the only question she had was what level of immunity she would develop with steroids on board. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered on 19Mar2021.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: give her a shot in her knee for pain; This is a spontaneous report from a contactable consumer (patient) via medical information team and Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Mar2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. On 13Mar2021 (also reported as 12Mar2021), patient went to the knee doctor and he gave her a shot of something in her knee for pain as treatment. Patient was not sure what he gave her but thinks it may have been steroids. She asked doctor if the shot would affect the efficacy of the vaccine and he told her no and now she was reading that it could. Her 2nd dose was on 25Mar2021, 16 days after 1st dose and wondering if she should postpone her second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Rash pruritic
Clinical narrative: Allergic reaction in a way of rash; rash was all over on my body; there's rash on my legs, my arms and my stomach ; it's an itchy rash; Allergic reaction in a way of rash; rash was all over on my body; there's rash on my legs, my arms and my stomach ; it's an itchy rash; Allergic reaction in a way of rash; rash was all over on my body; there's rash on my legs, my arms and my stomach ; it's an itchy rash; This is a spontaneous report from a contactable consumer (Patient reported for herself).  A 60-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206) via intramuscularly, in left arm on 10Mar2021 as dose 1, single (at the age of 60-years-old) for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 11Mar2021 the patient had allergic reaction in a way of rash, rash was all over on patient body, there was a rash on patient legs, arms and stomach and it was an itchy rash. Patient reported that she had an allergic reaction in a way of rash appeared 12 to 18 hours after the vaccine and still had the rash and it's been 9 days past the vaccine. Patient queried if rash was seeing in others and was their experience with the second dose. Patient was informed about Pfizer Medical Information and the contact was provided. Patient further queried regarding what is the time frame for the second dose. Patient was again told to contact Medical Information department for all the questions. Patient received the treatment with Benadryl for the reported events. Patient reported that the issue was still persisting and was not improved. Outcome of all the reported events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Hyperhidrosis, Pyrexia, SARS-CoV-2 test
Clinical narrative: she was sweating; had a fever; diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206, patient was 66-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 19Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included metformin (METFORMIN, Formulation: Tablet, Frequency: Twice a day; Route of Administration: Oral) taken for type 2 diabetes mellitus, start and stop date were not reported. On an unspecified date in Mar2021, the patient experienced she was sweating at morning when she woke up, had a fever, diarrhea. The patient underwent lab tests and procedures which included body temperature: temperature but the fever went away, sars-cov-2 test negative both on an unspecified date. The outcomes of events (she was sweating, had a fever) were recovered on an unspecified date in 2021 and the outcome of event (diarrhea) was recovering.  No follow-up attempts are possible. No further information is expected.