chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9810 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 27Feb2021 (at the age of 42-year-old), as dose 2, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included penicillin allergy. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9265 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 06Feb2021 (at the age of 42-year-old), as dose 1, single, for COVID-19 immunisation. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced dry cough, was feeling chest congestion, headache, fever, tiredness and muscle pain on 28Feb2021. Patient did not receive any treatment for the events. The outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Lethargy, Pain
Clinical narrative: Lethargy; Aches/ pain; Mind fog; Rapid heart rate all week; Skin rash; All torso in hives; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 25Feb2021 14:15 (at the age of 42-year-old) (Lot Number: EL9267) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included heart arrhythmia and had known seasonal allergies. Concomitant medication included ethinyl estradiol  taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced lethargy, aches/ pain, mind fog, rapid heart rate all week, skin rash and had all torso in hives on 25Feb2021 16:00. The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Lethargy; Aches/ pain; Mind fog; Rapid heart rate all week; Skin rash; All torso in hives; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 25Feb2021 14:15 (at the age of 42-year-old) (Lot Number: EL9267) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included heart arrhythmia and had known seasonal allergies. Concomitant medication included ethinyl estradiol  taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced lethargy, aches/ pain, mind fog, rapid heart rate all week, skin rash and had all torso in hives on 25Feb2021 16:00. The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Neck mass, Pain in extremity
Clinical narrative: redness on right arm; lump on neck; right arm sore; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200, expiration date not reported) via intramuscular route, in right arm, on 01Mar2021 12:00 (at the age of 57-years-old), at dose 2, single for covid-19 immunization. Patient had no medical history. There were no concomitant medications. Historical vaccine included (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9261, expiration date not reported) via unspecified route, on 08Feb2021 16:20 (at the age of 57-years-old), at dose 1, single for covid-19 immunization and experienced arm soreness and slight headache The patient did not take any medication for the events. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient experienced right arm sore on 02Mar2021, redness on right arm, lump on neck on 03Mar2021. The patient had no relevant test results. The outcome of the event redness on right arm  was recovering, and other events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Night sweats, Pain in extremity
Clinical narrative: Chills; night sweats; extreme pain in both legs; pain in the upper hip joint; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), via an unspecified route of administration in left arm on 17Feb2021 10:45 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization. Medical history included iodine allergy. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced chills, night sweats, extreme pain in both legs and pain in the upper hip joint on 17Feb2021 22:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Night sweats was resolved after 2 days, pain in the upper hip joint was resolved on 18Feb2021. Outcome of Chills and extreme pain in both legs was resolved on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Rhinorrhoea
Clinical narrative: Chills; Joint pain; Runny nose; tired; slight cough; This is a spontaneous report from a contactable nurse (patient).   A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6201), via intramuscular route, administered in Left  arm on 23Feb2021 17:20 (at the age of 72-years-old) as dose 1, single for covid-19 immunization.  The patient had no medical history and concomitant medication. Prior to vaccination, patient did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Patient experienced chills, joint pain, runny nose, tired, and slight cough which started less than 24 hours after the shot. All her symptoms continued for five days.Her second dose is scheduled for 25Mar2021. Treatment was taken for the events with Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021261813 Same reporter/product, different patient/event
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Skin induration
Clinical narrative: itches.; Large red circle,; hot to touch; hard and itches.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 13:15 at the age of 69-year-old as dose 1 single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), hypertension and augment allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA), salbutamol (ALBUTEROL HFA) and olmesartan all taken for an unspecified indication, start and stop date were not reported.  The patient experienced large red circle, hot to touch, hard and itches on 03Mar2021 17:30. The patient did not receive any treatment in response to the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Malaise, Swelling
Clinical narrative: I got sick and I've been sick/deathly ill; I had swollen cartilage in my nose and lips; I had swollen cartilage in my nose and lips; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as last week) (at the age 70-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included 2 autoimmune suppressants (unspecified) and tofacitinib citrate (XELJANZ XR). The patient stopped taking Xeljanz for a month because she got Covid shot and became deathly ill, got sick and have been sick. The patient had swollen cartilage in nose and lips. Patient was prescribed Xeljanz XR 11 mg. The patient was running low on medication and didn't want to start taking it again until after she received her second shot. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypertension, Nausea, Pain
Clinical narrative: Chest pain radiating to back; Chest pain radiating to back; Nausea; Transient hypertension; This is a spontaneous report from a contactable pharmacist. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 01Mar2021 (at the age of 63-year-old) (Lot Number: EN6205) as dose 2, single for COVID-19 immunization. The vaccine was administered in a hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 08Feb2021 (at the age of 63-year-old) (Lot Number: EM9809) as dose 1, single for COVID-19 immunization. It was unknown prior to vaccination, if patient was diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. It was unknown if patient received other vaccine within 4 weeks prior to COVID vaccine. The patient experienced chest pain radiating to back, nausea, transient hypertension on 01Mar2021. The patient did not receive treatment for the events. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Headache, Influenza
Clinical narrative: didn't hurt until 1 day+ later; all the symptoms of flu; all muscles and joints sore all over; all muscles and joints sore all over; chills; headache; sore throat; ear ache; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: en6203, expiration date not reported) via an unspecified route of administration, on 02Mar2021 19:15 (at the age of 71-years-old), at dose 2, single for covid-19 immunization from Pharmacy or drug store. Medical history included asthma. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: en5318, expiration date not reported) via an unspecified route of administration, on 10Feb2021 (at the age of 71-years-old), at dose 1, single for covid-19 immunization and experienced sore at injection site. 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-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient didn't hurt until 1 day/ later (as reported) described as pain, patient woke up with all the symptoms of flu, all muscles, and joints sore all over, chills, headache, sore throat, and earache on 04Mar2021 06:00. Therapeutic measures were taken included Nuprin and a heating pad. The outcome of the events was recovered on an unspecific date in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain
Clinical narrative: didn't hurt until 1 day+ later; all the symptoms of flu; all muscles and joints sore all over; all muscles and joints sore all over; chills; headache; sore throat; ear ache; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: en6203, expiration date not reported) via an unspecified route of administration, on 02Mar2021 19:15 (at the age of 71-years-old), at dose 2, single for covid-19 immunization from Pharmacy or drug store. Medical history included asthma. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: en5318, expiration date not reported) via an unspecified route of administration, on 10Feb2021 (at the age of 71-years-old), at dose 1, single for covid-19 immunization and experienced sore at injection site. 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-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient didn't hurt until 1 day/ later (as reported) described as pain, patient woke up with all the symptoms of flu, all muscles, and joints sore all over, chills, headache, sore throat, and earache on 04Mar2021 06:00. Therapeutic measures were taken included Nuprin and a heating pad. The outcome of the events was recovered on an unspecific date in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pruritus
Clinical narrative: more intense itching, especially on palms and bottom of feet; more intense lower back pain; mild muscle aches on my thighs; This is a spontaneous report from  a contactable consumer (patient). A 56-year-old female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in left arm, on 28Feb2021 (at the age of 56 year old) as dose 2, single for COVID-19 immunisation. Medical history included high BP, high cholesterol, high thyroid and mild depression from  an unspecified date. Patient has known allergies to phenobarbital. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM); duloxetine hydrochloride (CYMBALTA); gabapentin (GABAPENTIN); valsartan and atorvastatin calcium  all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9263, expiry date: unknown) via unspecified route of administration, in right arm on 31Jan2021 09:00 (age at vaccination: 56-years) as dose 1, single for COVID-19 immunisation and experienced low grade fever for 2 days, itching on her eyelids and pain in lower back joint. Prior vaccination, patient was not diagnosed with COVID-19 and did not receive any other vaccine within 4 weeks. On 01Mar2021 20:00, patient experienced more Intense lower back pain and Itching, especially on palms and bottom of feet. Also, had mild muscle aches on her thighs. It was reported that patient had no fever. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures in response to the events included Tylenol and Benadryl. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: The rash comes and goes; my lips had swelled; random red itchy spots all over body to include face, forearms, top of hands,legs and chest; welts all over body to include face, forearms, top of hands,; getting hives daily; This is a spontaneous report from a contactable other healthcare professional. A 32 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 18Feb2021 (Batch/Lot Number: EN6201) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced the rash that comes and goes, her lips had swelled, random red itchy spots all over body to include face, forearms, top of hands,legs and chest causing pruritus, welts all over body to include face, forearms, top of hands causing urticaria on 26Feb2021 with outcome of recovering.   No follow up attempts are needed; no further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Headache, SARS-CoV-2 test, Scan
Clinical narrative: chest tightness.; headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269), via an unspecified route of administration, administered in arm left on 16Feb2021 08:15 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma and thyroid disease. Concomitant medications included levothyroxine sodium (SYNTHROID); beclometasone dipropionate (QVAR); montelukast sodium (SINGULAIR); iron; and loratadine (CLARITIN [LORATADINE]); all were taken for an unspecified indication, start and stop date were not reported. On 18Feb2021 05:00 AM, the patient experienced chest tightness, bad headache and dizziness. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Feb2021; and scan with an unknown result on an unspecified date. Therapeutic measures were taken as a result of the events as the patient received new strong inhaler, prednisone for 5 days and scan. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: chills; sever body aches; fever; nausea; This is a spontaneous report from a non-contactable consumer. This female consumer reported for herself.  A (non-pregnant) female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown), via unknown route, administered in left arm on 03Mar2021 08:15 as dose 2, single for COVID-19 immunization. patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EH9800, Expiration date: unknown), via unspecified route, administered on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Hashimoto's disease from an unspecified date to unknown ongoing and concomitant medications includes Levothyroxine Sodium (SYNTHROID) and Gabapentin. Past drug event includes Zithromax induced Drug hypersensitivity. On 03Mar2021 06:00 PM, after the vaccination, the patient experienced chills, sever body aches, fever and nausea. No other vaccines were administered in four weeks, Patient was not diagnosed with covid prior vaccination and covid was not tested post vaccination. The outcome of the events was recovered.  No follow-up attempts possible. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flushing
Clinical narrative: Extreme diarrhea; flushing of face and chest; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 34-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EN6198 and Expiry date: Unknown), via an unspecified route of administration on 05Mar2021 at the age of 34-years-old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. The patient received any other vaccines within 4 weeks prior to the Covid vaccine was unknown. The patient did not received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On an unspecified date the patient experienced extreme diarrhea, flushing of face and chest. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia, Swelling
Clinical narrative: Severe joint pain; Headaches; Low Grade Fever; swelling; This is a Spontaneous report from a non-contactable consumer (patient). A 39-year-old male received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 26Feb2021 as dose 2, single (age at vaccination: 39 years) for COVID-19 immunisation. Medical history included none history. Concomitant medications were not reported. Historical vaccine includes received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 05Feb2021 as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks, no other medications in two weeks. No covid prior vaccination and did not tested covid post vaccination. No known allergies. On 26Feb2021, one full week after second dose and still experiencing moderate to severe joint pain. Still experiencing low grade fever. 24-72 hours after both first and second dose had severe joint pain and swelling, fever, headaches. The clinical outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Chills; fever; explosive diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 43-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at 09:00 (at the age of 43-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient did not receive any other vaccine in four weeks. On 02Mar2021 at 16:00, patient experienced chills, fever and explosive diarrhea. Therapeutic measures were not taken due to the events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test result of which was pending. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch no cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: patient was swabbed and tested positive for Covid-19 infection; C symptoms; This is a spontaneous report from a contactable Nurse reported for herself in response to HCP letter sent. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EK5703; Expiration date was not reported), via intramuscular, administered in Deltoid Right on 21Dec2020 (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Clinic. Medical history included obesity, polycystic ovarian syndrome (PCOS), hypertension (HTN) from an unknown date and unknown if ongoing, obstractive sleep apnea (CDAD use while sleeping) from Nov2015 to an unknown date, left ankle surgery in 1995 and 2012. Concomitant medication(s) included metformin (METFORMIN) taken for PCOS from Nov2016 to an unspecified stop date; spironolactone (SPIRONOLACTONE) taken for hypertension, PCOS from Nov2016 to an unspecified stop date; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) taken for PCOS from Mar2016 to an unspecified stop date; acetaminophen (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported. It was reported that patient had the first dose on 21Dec2020. The very next day (on 22Dec2020), patient began C symptoms. Patient thought they were related to the vaccine, and on 25Dec2020 patient was swabbed and tested positive for Covid-19 infection after an exposure at her place of employment listed below. Patient was out of work for 3 weeks with the Covid infection and returned to work with the instruction to get the vaccine (2nd), which she did on 22Jan2021. The patient was not deceased. The patient did not visit Emergency room and Physician Office. Clinical outcome of events was unknown. Reporter did not consider the Pfizer product had a causal effect to the adverse events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Seasonal allergy, Sneezing
Clinical narrative: she has seasonal allergies; Runny nose; Sneezing; This is a spontaneous report from a contactable consumer (general public) reported for herself. A adult female patient on an unknown age (>65 age) received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: not reported, expiry date: not reported), via an unknown route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included pollen allergy and cancer (also stated had cancer last year); both were from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient received flu shot (clarification of full product name/brand name/Lot/NDC/Expiry: Not provided, caller unwilling to complete the report) back in Nov as historical vaccine. On an unknown date, allergies, but not a cold or fever or the flu, runny nose, sneezing, asked if it is ok to get the next Pfizer covid shot next week. Received first dose. Due to receive second dose next week, indicates she has seasonal allergies and stated that she did not had any allergies and HCP does not know. Also stated had cancer last year. It was also informed that she was to have her next Pfizer Covid shot next week. Due to the season and pollen and she has history of allergies this time of year. Usually has a runny nose from the allergies, but not a cold or fever. This was normal for her this time of year because of the oak trees. Had flu shot back in Nov, long before Pfizer Covid shot. Wants to know if it's okay for her to get the next shot next Tuesday. Has had runny nose and sneezing when she has allergies and mentions again this is normal, she does not have a cold or fever or the flu but is it okay for her to get the next shot next week, Tuesday. Mentions she is over 65 years old. Attempts made to slow and clarify details. No further details provided. The outcome of the events was unknown.  Declines to provide her address or email address. Declines report and wants answer to question. No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pain, Paraesthesia, Pyrexia
Clinical narrative: skin lesion on left forearm; swollen; red; painful; low grade fever; body aches; fatigue; very sensitive to light touch; This is a spontaneous report from a contactable consumer. This consumer reported for a 66-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: En6200) via an unspecified route of administration on 22Feb2021 at 07:00 AM on left arm as dose 1, single for COVID-19 immunization. The patient had no medical history and no allergies. It was mentioned that patient received no other vaccine in four weeks, did not covid prior to vaccination and was tested for covid post vaccination. The patient's concomitant medications were not reported. On 02Mar2021 at 07:00 AM the patient experienced skin lesion on left forearm, swollen, red, very sensitive to light touch, painful, low-grade fever, body aches and fatigue. No treatment was received for events. The patient was recovering.  No follow-up attempts were possible. No further information was expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Skin lesion, Swelling
Clinical narrative: skin lesion on left forearm; swollen; red; painful; low grade fever; body aches; fatigue; very sensitive to light touch; This is a spontaneous report from a contactable consumer. This consumer reported for a 66-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: En6200) via an unspecified route of administration on 22Feb2021 at 07:00 AM on left arm as dose 1, single for COVID-19 immunization. The patient had no medical history and no allergies. It was mentioned that patient received no other vaccine in four weeks, did not covid prior to vaccination and was tested for covid post vaccination. The patient's concomitant medications were not reported. On 02Mar2021 at 07:00 AM the patient experienced skin lesion on left forearm, swollen, red, very sensitive to light touch, painful, low-grade fever, body aches and fatigue. No treatment was received for events. The patient was recovering.  No follow-up attempts were possible. No further information was expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eyelid irritation
Clinical narrative: Really itchy eyes, like bad; really uncomfortable; Itchiness on the eyelids where eyelashes are; This is a spontaneous report from a contactable consumer (patient) reported that. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 (Batch/Lot Number: EN6201) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 38 years). The patient past Medical history and concomitant medications were not reported. Consumer stated, after first dose and she never really thought about it until she saw her aunt with maybe a situation similar that she had it, she had allergies (not further clarified). All of a sudden, few hours later, she doesn't remember how many hours because she was not really paying attention and she wasn't thinking of anything of it, but it has not been gone, it is not going away since. she has really itchy eyes, like bad, it's really uncomfortable on an unspecified date in Mar2021. she has been having to take allergy Allegra medication every day and drops 0.035%. and then she has some little pads, it is for like eye scrubs or something like that they are called. But it is just constant. she means, it is all day long that she has. They are just really itchy, and she can't wear makeup around it because they just make it a lot more, not that she wears makeup right now, but she can't put anything around it just because it makes it a lot worse. The event outcome was Unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza, Pain in extremity
Clinical narrative: Little or no upper arm soreness but persistent; Mild Flu symptoms; sore joint persisted longer; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration on 19Feb2021 09:28 (at the age of 76-year-old) as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included, Allergic to bee sting from 10Sep1989 to an unknown date (Stop date: Unknown, visited ER on 10Sep1989, given Benadryl, carry Epi-pen). Concomitant medication(s) included levothyroxine sodium (THYROXINE) taken for an unspecified indication from 1999 and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from 15Mar2020 and ongoing; tamsulosin (TAMSULOSIN) taken for an unspecified indication from 10Jan2018 and ongoing. The patient previously received first dose of BNT162B2 (Batch number: EL9261), administered in deltoid left on 22Jan2021 at 21:30 (at the age of 76-year-old) for COVID-19 immunization and experienced Mild flu-like symptoms, Sore upper arm/Pronounced soreness near injection site, vivid dream, body ache, fever mild, muscle sore and joint sore. Reported that as a secondary note (after receiving 2nd Pfizer dose [EN6200], I had a much stronger reaction to 2nd dose. Little or no upper arm soreness, but persistent, initial moderate and then mild flu symptoms (2 to 3 days post), sore joint persisted longer (2021). No surgical treatment needed for the events. The clinical outcome of events little or no upper arm soreness but persistent and sore joint persisted longer was not recovered and another event outcome was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: trouble breathing; This is a spontaneous report from a contactable consumer (patient reported for herself). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6202; Expiration Date: 30Jan2021) via an unspecified route of administration, administered in left arm on 04Mar2021 16:30 (at the age of 64 years old) dose 1, 0.3 mL, single for covid-19 immunisation. Patient mentioned wanting the vaccine as she wanted to start living her life, she has had enough. There were no concomitant medications. There were no prior vaccinations within 4 weeks. There was no family medical history. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing (reported as diagnosed 10 years ago or probably more); she broke her foot on an unknown date (prior to COVID-19 vaccine) and reported that normally when she goes anywhere she uses a scooter and instead of using her scooter, she used a walker with feet on it (date unknown). Patient mentioned she was on oxygen (ongoing) and thought she was having trouble breathing and thought she brought this on herself. She had episodes where she has to get prednisone. At the time of the report, patient felt like she needed prednisone. She was walking fast with the walker with her mask on and oxygen underneath. She hasn't left her house in a year. There was so much walking and it was stupid on her part. Patient thought she would let Pfizer know just in case it is a side effects. The nurse she spoke with thought she brought this on herself. She was walking fast. She was having no other symptoms. Patient was having trouble breathing just doing the walking to get the COVID-19 Vaccine. By the time she sat down, she was told to catch her breath. It was awful. Trouble breathing began before the vaccine (ongoing). The patient also experienced trouble breathing on 04Mar2021 (as reported; pending clarification). She spoke with her pulmonologist's nurse and will probably be sent prednisone. Patient did not go to physician office or emergency room and stated trouble breathing was not that bad. At the time of the report patient stated the trouble breathing was better. She stated she was fine and walking around the house just fine. She just needed the prednisone. She confirmed she has not started the prednisone yet. She stated in a few days she will be fine. There were no relevant tests. She stated she will take prednisone and if that didn't work then she will have to go to the doctor. Right now, she didn't feel a need to get to the doctor. She confirmed has not started the prednisone yet. Patient asked if she will she be called and told she cannot receive the second dose since this report is filed. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fall, Headache, Malaise
Clinical narrative: feeling unwell; Chills; Joint pain; Headache; Muscle pain; fell getting out of bed; unable to get warm; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 (at the age of 78-year-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 04Mar2021, the patient experienced feeling unwell, chills, fell getting out of bed, joint pain, headache, muscle pain and unable to get warm. The clinical details of the events as follows: Caller stated, she got the shot on Tuesday 02Mar2021, it was fine, no problems, has had everything since then, she never had pain at the injection site and did not have a fever, but other than that she is feeling unwell, chills, was shaking so bad almost fell getting out of bed, unable to get warm, joint pain, headache, muscle pain, scared to get another dose, could she have Covid if she got the shot. It was reported that she had never had a reaction to any other shot. There was no Investigation Assessment provided. The patient outcome of the events feeling unwell, Chills, Joint pain, Headache, Muscle pain was Not resolved, and the outcome of other events was unknown at the time of this report.  No follow-up attempts are possible; No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Temperature intolerance
Clinical narrative: feeling unwell; Chills; Joint pain; Headache; Muscle pain; fell getting out of bed; unable to get warm; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 (at the age of 78-year-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 04Mar2021, the patient experienced feeling unwell, chills, fell getting out of bed, joint pain, headache, muscle pain and unable to get warm. The clinical details of the events as follows: Caller stated, she got the shot on Tuesday 02Mar2021, it was fine, no problems, has had everything since then, she never had pain at the injection site and did not have a fever, but other than that she is feeling unwell, chills, was shaking so bad almost fell getting out of bed, unable to get warm, joint pain, headache, muscle pain, scared to get another dose, could she have Covid if she got the shot. It was reported that she had never had a reaction to any other shot. There was no Investigation Assessment provided. The patient outcome of the events feeling unwell, Chills, Joint pain, Headache, Muscle pain was Not resolved, and the outcome of other events was unknown at the time of this report.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (90-year-old woman) is calling on-behalf of her daughter (female patient). A female patient of unspecified age received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection), via an unspecified route on 04Mar2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 04Mar2021, patient experienced chills after she received her vaccine yesterday (04Mar2021). Then today, her daughter also complained of having a fever and is verbalizing that she is not feeling well. Mother was asking whether there can be an OTC drug that she can give her daughter since she is not feeling well. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: chills; fever; she is not feeling well; This is a spontaneous report from a contactable consumer or other non hcp (parent) from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced chills, fever, she is not feeling well. Verbatim and Event Description: Reporter a 90-year-old woman is calling in-behalf of her daughter. She was asking whether there can be an OTC drug that she can give her daughter since she is not feeling well. She reported that her daughter experienced chills after she received her vaccine yesterday 04Mar2021. Then today, her daughter also complained of having a fever and is verbalizing that she is not feeling well. Consequently, the caller took her first vaccine on 29Jan2021 and took her second vaccine on 26Feb2021. This is more than 21 days. 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: Pain in extremity, Rash
Clinical narrative: sore arm; rashes all over the body; This is a spontaneous report from a Pfizer sponsored program Covax US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number, and Expiration Date: Not Reported) via 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. The patient experienced sore arm and rashes all over the body on an unspecified date. Patient wanted to know what to do with her experience. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: fatigue; body ache; fever; super sweating the night; just laying down it feels like he was laying on brick; arm still hurts like crazy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 04Mar2021 (at the age of 35 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Jul2020 to an unknown date. Concomitant medication included Multi Vitamins , taken for an unspecified indication, start and stop date were not reported. On the same day of vaccination, on 04Mar2021, the patient reported that all of the virus-like symptoms came back specifically fatigue, body ache and she woke up and broke fever. The patient was super sweating the night before the report, on 04Mar2021 and in early morning of the report. The patient thought the symptoms did not changed much and he was just laying down it feels like he was laying on brick on 04Mar2021. The patient's arm still hurts like crazy also on 04Mar2021. Outcome of all events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue; body ache; fever; super sweating the night; just laying down it feels like he was laying on brick; arm still hurts like crazy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 04Mar2021 (at the age of 35 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Jul2020 to an unknown date. Concomitant medication included Multi Vitamins , taken for an unspecified indication, start and stop date were not reported. On the same day of vaccination, on 04Mar2021, the patient reported that all of the virus-like symptoms came back specifically fatigue, body ache and she woke up and broke fever. The patient was super sweating the night before the report, on 04Mar2021 and in early morning of the report. The patient thought the symptoms did not changed much and he was just laying down it feels like he was laying on brick on 04Mar2021. The patient's arm still hurts like crazy also on 04Mar2021. Outcome of all events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lymph node pain, Vaccination site pain
Clinical narrative: had Covid shot on left arm and they are to be sore but gone into the lymph node; had Covid shot on left arm and they are to be sore but gone into the lymph node; little bit pain into the chest; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6198, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 02Mar2021 (at the age of 65-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included "Glucop" (as reported) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021, the patient had COVID shot on left arm and they are to be sore but gone into the lymph node and little bit pain into the chest. It was reported that on third day still it was getting worsen not "bad". It was in the left lymph node on which received the shot and seems to be, the pain was getting worsen not better and she was getting nervous about it. The outcome of the events was unknown.   No follow-up attempts are possible. No further information expected.