chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Lymphadenopathy, Neck pain, Pain
Clinical narrative: she is still experiencing a lot of pain in her head/ also her neck and her head; she is still experiencing a lot of pain in her head, her ears and her arm and arm pit; she is still experiencing a lot of pain in her head, her ears and her arm and arm pit/ her armpit area is giving pain; Her arm pit is swollen like a gland might be flared up; pain in the arm; her armpit area is giving pain, also her neck and her head; pressure in her ears/ eardrums are cold; her ear are giving her discomfort; she's having chills that come and go; hasn't eaten anything since Saturday; fever; Ache; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205, Expiration date: Jun2021), via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included surgery- hole in ear drum from previous surgery and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264, Expiration date: May2021), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patient stated, she would like to check on some side effects that she was experiencing and how long they were supposed to last. Yesterday (27Feb2021) the fever broke, she had a lot of pain in the arm, her armpit area was giving pain, also her neck and her head, she also stated that it was not a headache it like, if your brain was hitting your skull, rattling, her ear were giving her discomfort and also her eardrums were cold, she was having chills that come and go but nothing compared to what it was. She also had not eaten anything since Saturday (27Feb2021). She further stated that, she got it on Saturday and since then Saturday and Sunday she spent in bed with fever, aches, and normal stuff of what was to be expected but now it was Tuesday and she still had really bad aches, she was over the fever, that broke yesterday morning she would say but she was still experiencing a lot of pain in her head, her ears and her arm and arm pit. Her arm pit was swollen like a gland might be flared up. Her arm, her neck and her head hurt. Her head was like not like a headache, it was a feeling as if she could feel her brain hitting her skull type of pain. She had a hole in ear drum from previous surgery but she had never had this much pressure in her ears. The clinical outcome for event prexia was resolved on an unspecified date in 2021, not resolved for aches, she is still experiencing a lot of pain in her head/ also her neck and her head, she is still experiencing a lot of pain in her head, her ears and her arm and arm pit/ her armpit area is giving pain, pain in the arm and unknown for all other events.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: she is still experiencing a lot of pain in her head/ also her neck and her head; she is still experiencing a lot of pain in her head, her ears and her arm and arm pit; she is still experiencing a lot of pain in her head, her ears and her arm and arm pit/ her armpit area is giving pain; Her arm pit is swollen like a gland might be flared up; pain in the arm; her armpit area is giving pain, also her neck and her head; pressure in her ears/ eardrums are cold; her ear are giving her discomfort; she's having chills that come and go; hasn't eaten anything since Saturday; fever; Ache; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205, Expiration date: Jun2021), via an unspecified route of administration in the right arm on 27Feb2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included surgery- hole in ear drum from previous surgery and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264, Expiration date: May2021), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patient stated, she would like to check on some side effects that she was experiencing and how long they were supposed to last. Yesterday (27Feb2021) the fever broke, she had a lot of pain in the arm, her armpit area was giving pain, also her neck and her head, she also stated that it was not a headache it like, if your brain was hitting your skull, rattling, her ear were giving her discomfort and also her eardrums were cold, she was having chills that come and go but nothing compared to what it was. She also had not eaten anything since Saturday (27Feb2021). She further stated that, she got it on Saturday and since then Saturday and Sunday she spent in bed with fever, aches, and normal stuff of what was to be expected but now it was Tuesday and she still had really bad aches, she was over the fever, that broke yesterday morning she would say but she was still experiencing a lot of pain in her head, her ears and her arm and arm pit. Her arm pit was swollen like a gland might be flared up. Her arm, her neck and her head hurt. Her head was like not like a headache, it was a feeling as if she could feel her brain hitting her skull type of pain. She had a hole in ear drum from previous surgery but she had never had this much pressure in her ears. The clinical outcome for event prexia was resolved on an unspecified date in 2021, not resolved for aches, she is still experiencing a lot of pain in her head/ also her neck and her head, she is still experiencing a lot of pain in her head, her ears and her arm and arm pit/ her armpit area is giving pain, pain in the arm and unknown for all other events.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Contusion, Hypotension, Vaccination site discomfort, Vaccination site haemorrhage
Clinical narrative: administrator applied pressure; little blood on the bandage; 2 inch by 1 inch bruise on her arm; wondering if the vaccine has been administered intramuscularly; had to hold pressure because blood came out a little bit; This is a spontaneous report from a contactable Nurse. A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via intramuscular, administered in Arm Left on 24Feb2021 (Age at Vaccination 70-years-old) as single dose for COVID-19 immunization. Medical history included arterial stent insertion from 2011 and ongoing Verbatim: coronary artery stent. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN CHILDREN) taken for ischaemic heart disease prophylaxis from an unspecified start date and ongoing. Patient took first dose of bnt162b2 for COVID-19 Immunization. The patient experienced had to hold pressure because blood came out a little bit on 24Feb2021. The patient experienced administrator applied pressure, little blood on the bandage, 2 inch by 1 inch bruise on her arm and wondering if the vaccine has been administered intramuscularly on an unspecified date.it was reported that After the second dose, the administrator applied pressure and the caller noticed there was a little blood on the bandage. She stated it did not hurt a whole lot and my range of motion was ok. Caller states she was on Aspirin. 6 days later, on 02Mar2021, she noticed a 2 inch by 1 inch bruise on her arm. Caller was wondering if the vaccine has been administered intramuscularly and if the efficacy would be different. She is a little concerned. She hasnt been working in the nursing home because she was 70. She got the second vaccine on the twenty fourth. The person that gave it to her had to hold pressure because blood came out a little bit. She hasnt been able to see the area. She was concerned enough vaccine didnt go into the muscle. The person that gave it to her had to hold pressure because blood came out a little bit. She hasnt been able to see the area. She is concerned enough vaccine didn't go into the muscle. She is not sure if she got enough of the vaccine to produce antibodies since it bled. Caller clarified vaccine as COVID19 Vaccine. The first dose didn't bleed. She just wants to make sure she has enough antibodies. Caller clarified that she was calling to see what the efficacy to produce antibodies would be because she bled when receiving the vaccine. COVID19 Vaccine: had to hold pressure because blood came out a little bit related. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; chills; muscle ache; joint ache; Headache; Injection site pain; This is a spontaneous report received from a contactable other hcp. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EJ1685; Expiration Date: Mar2021) via an intramuscular route of administration in Arm Right on 12Jan2021 16:00 as single dose for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (MOTRIN [IBUPROFEN]) taken for an unspecified indication from 12Jan2021 to 14Jan2021; paracetamol (TYLENOL) taken for an unspecified indication from 12Jan2021 to 14Jan2021. On 12Jan2021 the patient experienced fever, chills, muscle ache, joint ache, headache, injection site pain. The clinical outcome of the event was recovered in 2021. Therapeutic measures were taken as a result of fever, chills, muscle ache, joint ache, headache, injection site pain.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; chills; muscle ache; joint ache; Headache; Injection site pain; This is a spontaneous report received from a contactable other hcp. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EJ1685; Expiration Date: Mar2021) via an intramuscular route of administration in Arm Right on 12Jan2021 16:00 as single dose for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (MOTRIN [IBUPROFEN]) taken for an unspecified indication from 12Jan2021 to 14Jan2021; paracetamol (TYLENOL) taken for an unspecified indication from 12Jan2021 to 14Jan2021. On 12Jan2021 the patient experienced fever, chills, muscle ache, joint ache, headache, injection site pain. The clinical outcome of the event was recovered in 2021. Therapeutic measures were taken as a result of fever, chills, muscle ache, joint ache, headache, injection site pain.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Urticaria
Clinical narrative: Fever; Body aches; headache; severe hives; This is a spontaneous report from a contactable Nurse (patient) received via HCP follow-up letter sent in cross reference case. This case is for dose 2.  A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the left deltoid on 11Jan2021 at 12:30 (at the age of 47-year-old) as a single dose for covid-19 immunization. The patient's medical history included allergy, asthma and sinusitis (started on 02Dec2020 and were ongoing), post-nasal drip, GERD. Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for allergy started on 02Dec2020 daily increase after vaccine reaction twice a day for 4 days] and was ongoing, amoxicillin/clavulanic acid (AUGMENTIN) for sinusitis started on 02Dec2020, omeprazole (PROTONIX) for GERD started on 02Dec2020 and was ongoing, fluticasone propionate/salmeterol xinafoate (ADVAIR) for asthma started on 02Dec2020 and was ongoing, budesonide (PULMICORT) for post nasal started on 02Dec2020 and was ongoing, and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), and guaifenesin, acetaminophen started on 21Dec2020 and antihistamines. The patient did not receive any recent vaccines for any other conditions prior to the event being reported and have not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. Patient previously took SULFA and experienced allergy. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscularly in the left arm on 20Dec2020 at 10:00 as single dose for covid-19 immunization and experienced anaphylactic reaction, headache, soreness on injection site, hives and nausea. On 11Jan2021 at 12:30 after receiving second dose of vaccination, patient experienced severe hives, soreness, headache, body aches, fever. As per reporter there was a reasonable possibility that the event was related to suspect product. Patient was not hospitalized. Patient was being treated with antihistamines. Outcome of the events were not resolved.  Follow-up attempts completed. No further information expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Productive cough, Swollen tongue, Tongue erythema
Clinical narrative: sensation of numbness of tongue; swelling of tongue; tongue reddened; a red cough drop; This is a spontaneous report from a contactable pharmacist. An 89-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN5318) via intramuscularly on 23Jan2021 at 11:00 (at age of 89-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included DM (Diabetes Mellitus), hyperlipidemia, HTN (Hypertension), OPA (Pulmonary Adenomatosis) and SOB (short of breath) and history of recent concussion after a fall. Concomitant medication and medications in two weeks included salbutamol (ALBUTEROL HFA) as needed for SOB (short of breath), ascorbic acid (VITAMIN C) at 1000 mg once a day, calcium citrate at 250mg once a day, colecalciferol (VITAMIN D3) at 2000 IU, once a day, glipizide at 5mg once a day, empagliflozin (JARDIANCE) at 10mg every morning, famotidine 20mg once a day, mirabegron at 50mg once a day and levothyroxine 100mcg once a day. Past drug event included muscle pain due to statins, unknown allergy reaction due to sucralfate, pantoprazole and ipratropium. No other vaccine in four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 23Jan2021 at 11:05 (5 minutes after vaccination), patient experienced sensation of numbness and swelling of tongue, tongue reddened to right side, no visible swelling, patient reports recently having a red cough drop. Treatment received at 11:10 (on same day of vaccination) was diphenhydramine hydrochloride (BENADRYL) 12.5mg oral as 1 dose. Patient appears in NAD (no abnormality detected), resides in rehab center. After medication received patient monitored for additional 30 minutes and discharged back to rehab facility. The outcome of all events was resolved in 2021.  No follow-up attempts are possible. No further information was expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: The patient also received the second dose of vaccine 18 days after the first dose.; pain and swelling at injection site; pain and swelling at injection site; low grade fever (99.5 degrees Fahrenheit); chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 08Feb2021, at 16:00 (Lot Number: EM9810, at the age of 27 years old) as dose 2, single for COVID-19 immunisation. The patient has no known allergies and no other medical history. She was not pregnant at the time of report. Concomitant medications included meloxicam. She did not receive any other vaccine in four weeks prior to vaccination. The patient previously received first dose of BNT162B2, administered in the left arm on 21Jan2021, at 13:30 (Lot Number: EL3246, at the age of 27 years old) for COVID-19 immunisation and experienced pain and swelling at injection site for 36 hours. On an unspecified date in 2021, the patient experienced pain and swelling at injection site, low grade fever (99.5 degrees Fahrenheit), chills, body aches, headache, nausea, and fatigue for approximately 24 hours. The patient also received the second dose of vaccine 18 days after the first dose. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: The patient also received the second dose of vaccine 18 days after the first dose.; pain and swelling at injection site; pain and swelling at injection site; low grade fever (99.5 degrees Fahrenheit); chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 08Feb2021, at 16:00 (Lot Number: EM9810, at the age of 27 years old) as dose 2, single for COVID-19 immunisation. The patient has no known allergies and no other medical history. She was not pregnant at the time of report. Concomitant medications included meloxicam. She did not receive any other vaccine in four weeks prior to vaccination. The patient previously received first dose of BNT162B2, administered in the left arm on 21Jan2021, at 13:30 (Lot Number: EL3246, at the age of 27 years old) for COVID-19 immunisation and experienced pain and swelling at injection site for 36 hours. On an unspecified date in 2021, the patient experienced pain and swelling at injection site, low grade fever (99.5 degrees Fahrenheit), chills, body aches, headache, nausea, and fatigue for approximately 24 hours. The patient also received the second dose of vaccine 18 days after the first dose. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Palpitations
Clinical narrative: Heart was racing; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number- EN6198) via an unspecified route of administration on 02Mar2021 as dose 1 single for COVID-19 immunization. Medical history included autoimmune disease. Concomitant medication included Prednisone for autoimmune disease. Patient stated, she had no high blood pressure and she do not have heart disease and she was not a diabetic. So, she do not have any of those, other than a rare autoimmune disease that she had, she had the Prednisone to take for. Patient stated that she had a shot this morning but she had a severe reaction which lasted for 25 minutes but she went to the holding area that they put us in, a waiting area that they put us in to wait for 15 minutes but she had to wait a half an hour because she have had severe reaction to a drug (Unspecified Medication) before. So, she waited a half and hour but between that her heart was racing and she was slightly dizzy on 02Mar2021. So, her concern was none of that was documented, but she wanted to know do she go back for a second shot after what happened. The patient underwent lab tests and procedures which included heart rate: racing on 02Mar2021. The outcome of the events was recovered on an unspecified in 2021.  No follow-up attempts are possible; Information on lot/batch number could not be requested
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: todays her temperature is 99. Wondering if that a normal side effect; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a female patient (wife). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. Reporter said wifes temperature is normally 97, todays her temperature was 99. He was wondering if that was a normal side effect. Advised to reach out to HCP. The patient underwent lab test which included body temperature measurement, results as 99 on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; chills; headache; body aches; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 32 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 01Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation, aspirin and experienced drug hypersensitivity. The patient experienced fever, chills, headache and body aches on 01Mar2021 with outcome of recovering.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever of 101; Headache; Chills; Extreme body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Feb2021 13:30,at the age of 51 years old,as Dose 2,single for covid-19 immunization.Medical history included thyroid cancer from an unknown date and unknown if ongoing in 2008, hypertension, migraine,seasonal allergy and obesity from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium , metoprolol, cetirizine hydrochloride (Zyrtec) and vitamin d [vitamin d nos] taken for an unspecified indication, start and stop date were not reported.The patient experienced fever of 101, headache, chills and extreme body aches on 25Feb2021 06:00. The patient underwent lab tests and procedures which included body temperature: 101 on  unknown date.The patient historical vaccine included 1st dose of Pfizer vaccine on 04Feb2021 01:30 pm on left arm.The patient was not pregnant at the time of vaccination.The patient had not received any vaccine within 4 weeks.The patient was not diagnosed with covid19 prior vaccination and not tested for covid post vaccination.The patient reported no allergies.The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in the left side of the face; Numbness and tingling in the left side of the face; This is a spontaneous report from a contactable physician (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), intramuscularly, administered in Left arm on 14Feb2021 11:00 at the age of 37-years-old as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Other medical history was reported as none. There were no concomitant medications. The patient previously took first dose of historical vaccine, bnt162b2 (Product- covid-19, Lot unknown- unknown) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. The patient experienced numbness and tingling in the left side of the face on an unspecified date in Feb2021. The patient did not receive treatment for adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: tongue became numb; both cheeks and lower jaw became numb; This is a spontaneous report from a contactable Nurse (patient). A 72-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in left arm on 09Feb2021 at 17:00 (at the age of 72-years-old) (Batch/Lot Number: EL9269; Expiration Date: 31May2021) as first dose, single for COVID-19 immunization. Medical history included asthma, diabetes, arthritis, and known allergies to penicillin. It was reported that the patient received several medications and supplements (unspecified) in two weeks. The patient did not receive any other vaccines in four weeks. On 09Feb2021 at 18:00, both cheeks and lower jaw became numb. By 6:45pm, tongue became numb. By 8:00pm numbness resolved on it's own. No medical treatment was received for the events. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 post vaccination. The outcome of the events was recovered on 09Feb2021 at 20:00.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pyrexia, Tremor
Clinical narrative: Fever; Shaking; Lower back pain; This is a spontaneous report from a contactable consumer (reported for an adult male patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 25Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On 25Feb2021, the patient experienced fever, shaking and lower back pain. It was unknown whether the treatment was given for the events. The outcome of the events was resolved on an unspecified date in 2021.  Health authority comment: Reporter's response: yes the patient mentioned it to me directly in conversation on the Sunday on 28Feb2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This is a spontaneous report from a contactable consumer or other non hcp. An adult male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Feb2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously 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 at dose 1, single for covid-19 immunisation. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19, prior to vaccination. It was unknown whether the patient had been tested for COVID-19, since the vaccination. On 26Feb2021 the patient experienced fever, headache. It was unknown whether the patient received treatment for the adverse events. Query: You reported a case for patient received COVID-19 vaccine and experienced the adverse event Fever, Headache Please confirm if the patient reported this adverse event to you. And we also would like to know when you becomes aware of the adverse event. Response: Yes the patient mentioned it to me directly in conversation on the Sunday 28Feb2021. Outcome of the events was resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: I woke up this morning with a low grade fever 99.3 and I have been just not quite feeling as well as I had then; I woke up this morning with a low grade fever 99.3 and I have been just not quite feeling as well as I had then; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 2, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1, Single for Covid-19 immunization. On an unspecified date the patient woke up this morning with a low-grade fever 99.3 and had been just not quite feeling as well as the patient had then. The patient underwent lab tests and procedures which included body temperature: 99.3 (units unspecified) on an unknown date. The outcome of event was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: Feeling feverish (but no fever when checked); drowsy; fatigued; pain at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3302), via an unspecified route of administration in arm left on 08Jan2021 (at the age of 22-year-old) as a dose number unknown, single for COVID-19 immunization. The patient's medical history included allergic asthma, borderline anemia. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration in arm left on 16Dec2020 (at the age of 22-year-old) as a dose number unknown, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as yes. No covid prior vaccination and no covid tested post vaccination. On 09Jan2021, 12 hours post vaccination, the patient experienced feeling feverish (but no fever when checked), drowsy and fatigued, pain at injection site. The side effects lasted less than 24 hours. Treatment was not received for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: mild fever; This is a spontaneous report received from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced mild fever on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever; chills; headache; muscle pain; weakness; nausea; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) via an unspecified route of administration (Age at vaccination 48-year) in Left Arm on 01Mar2021 at 09:45 AM as dose 2, single for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot number: Em9810) administered in left arm on 06Feb2021 at 10:30 AM for COVID-19 immunization. Facility type vaccine: Hospital. No known allergies were reported. The patient received no other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination was reported. The patient has not tested COVID post vaccination. On 01Mar2021 at 09:00 PM the patient experienced fever, chills, headache, muscle pain, weakness, nausea. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient received no treatment for the adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; headache; muscle pain; weakness; nausea; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) via an unspecified route of administration (Age at vaccination 48-year) in Left Arm on 01Mar2021 at 09:45 AM as dose 2, single for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot number: Em9810) administered in left arm on 06Feb2021 at 10:30 AM for COVID-19 immunization. Facility type vaccine: Hospital. No known allergies were reported. The patient received no other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination was reported. The patient has not tested COVID post vaccination. On 01Mar2021 at 09:00 PM the patient experienced fever, chills, headache, muscle pain, weakness, nausea. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient received no treatment for the adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: fever; fast heart rate; dizziness; pain; headache; tiredness; feeling unwell; This is a spontaneous report from a contactable consumer (son) that. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 25Feb2021 10:30 (Batch/Lot Number: Lot EN5318) as DOSE 2 SINGLE for covid-19 immunization. The patient past Medical history included, deafness from an unknown date and unknown if ongoing His Deafness was diagnosed at birth, tooth impacted from an unknown date and unknown if ongoing Treatment drug:  Amoxicillin 875mg, Motrin and Tylenol 3 with codeine.  The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Caller states that she is calling on the phone on behalf of her son (Name-withheld). She is calling about the Pfizer BioNtech covid vaccine. Her son had the second covid shot and he woke up this morning with a fever of 101, fast heart rate, dizziness, feeling unwell, nausea, pain headache and tiredness On 26Feb2021. Caller states that they are now up at "(withheld)" to be treated. Caller states that she has notified Pfizer of all about side effects, and she needs to know what to do next. Caller was informed that Pfizer could not provide and specific medical treatment or medical advice.  All symptoms started this morning at 8:30AM, he woke up feeling this way. When queried for a physician, caller states that she doesn't know yet because they are at the urgent care and he hasn't been seen yet, she doesn't understand why since his fever is 101 and they are still waiting. She just knows the practice called "(withheld). While caller is on the phone with this call handler, she states that a nurse has taken her son back for his weight and temperature, they are also going to get some blood. Fever: They just checked, and his fever now is 99.7F, it has come down. Caller clarifies that she used a manual temperature at home.  Heart Rate: it is 130 now. Caller states that she does not know what his heart rate was at home. Dizziness: It is not on the list of things, but when he got moving around to get ready to come out, he was ready to throw up. His equilibrium is off because of the deafness, so it doesn't take much to get him off kilter. Nausea: is the same and Headache is worse, he also woke up and had the shakes. The patient underwent lab tests and procedures which included blood test: unknown result on Unspecified date , body temperature: 101 and 99.7 on Unspecified date and heart rate: 130 result on Unspecified date.The event outcome was Recovering for fever and Not recovered for rest of the events.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Malaise, Pain, Pyrexia
Clinical narrative: fever; fast heart rate; dizziness; pain; headache; tiredness; feeling unwell; This is a spontaneous report from a contactable consumer (son) that. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 25Feb2021 10:30 (Batch/Lot Number: Lot EN5318) as DOSE 2 SINGLE for covid-19 immunization. The patient past Medical history included, deafness from an unknown date and unknown if ongoing His Deafness was diagnosed at birth, tooth impacted from an unknown date and unknown if ongoing Treatment drug:  Amoxicillin 875mg, Motrin and Tylenol 3 with codeine.  The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. Caller states that she is calling on the phone on behalf of her son (Name-withheld). She is calling about the Pfizer BioNtech covid vaccine. Her son had the second covid shot and he woke up this morning with a fever of 101, fast heart rate, dizziness, feeling unwell, nausea, pain headache and tiredness On 26Feb2021. Caller states that they are now up at "(withheld)" to be treated. Caller states that she has notified Pfizer of all about side effects, and she needs to know what to do next. Caller was informed that Pfizer could not provide and specific medical treatment or medical advice.  All symptoms started this morning at 8:30AM, he woke up feeling this way. When queried for a physician, caller states that she doesn't know yet because they are at the urgent care and he hasn't been seen yet, she doesn't understand why since his fever is 101 and they are still waiting. She just knows the practice called "(withheld). While caller is on the phone with this call handler, she states that a nurse has taken her son back for his weight and temperature, they are also going to get some blood. Fever: They just checked, and his fever now is 99.7F, it has come down. Caller clarifies that she used a manual temperature at home.  Heart Rate: it is 130 now. Caller states that she does not know what his heart rate was at home. Dizziness: It is not on the list of things, but when he got moving around to get ready to come out, he was ready to throw up. His equilibrium is off because of the deafness, so it doesn't take much to get him off kilter. Nausea: is the same and Headache is worse, he also woke up and had the shakes. The patient underwent lab tests and procedures which included blood test: unknown result on Unspecified date , body temperature: 101 and 99.7 on Unspecified date and heart rate: 130 result on Unspecified date.The event outcome was Recovering for fever and Not recovered for rest of the events.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 99.9; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: El8982) via an unspecified route of administration, administered in Arm Right on 02Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4weeks.The patient medical history and concomitant medications were not reported. Patient had no allergies, patient didn't had covid-19 prior to vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number El3246) via unspecified route of administration on 09Feb2021 11:15 as DOSE 1, SINGLE for covid-19 immunisation. On 03Mar2021 04:00 the patient experienced fever 99.9 () (non-serious) with outcome of recovered.  The patient underwent lab tests and procedures which included body temperature: 99.9 on 03Mar2021.Patient was not tested for covid-19 to post vaccination. No treatment was received for the event. The outcome of the event pyrexia was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: left eye swelling aches; left eye swelling aches; This is a spontaneous report from a contactable (Nurse) other-health care professional (Patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL0140 and expiration date was not reported), first dose via intramuscular route of administration, administered in arm left on 21Dec2020 18:00 (at the age of 24 years) as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Dec2020 18:00 the patient experienced left eye swelling aches. Adverse events did not require a visit to Emergency Room or Physician Office. The outcome of the events was recovered on 23Dec2020.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: she is now experiencing sciatic nerve problem; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer reported for a female patient (Sister in Law). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that Husband (Name) and Sister-in-Law (Name) had their 1st dose (01Feb2021) and 2nd dose (24Feb2021) but sister-in-law can't make it today because she was now experiencing sciatic nerve problem, Caller was calling to report this and appoint/reschedule sister in law's 2nd dose. Their dosing schedules were more than the usual 3weeks interval. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 76, Unit: unknown, as reported) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, lot number: EN6105, expiration date was not reported), via an unspecified route of administration on 02Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, yesterday morning, patient had his second Pfizer vaccine shot and during the middle of the night, he experienced several of the common side effects like fever, chills, body aches on 02Mar2021 and so forth (not clarified further). So, his question is, he feel better now this morning and asks if he is contagious to others. Therapeutic measures were taken as a result of fever, chills, body aches. The outcome of the events was recovered on 03Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; shivering; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received second dose of bnt162b2 (IZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 for covid-19 immunisation. On an unspecified date in 2021 The patient experienced fever, shivering. Reporter had a fever, and he is shivering after the 2nd dose. Reporter is asking if he can take Tylenol after the 2nd dose. Reporter also asked if it will lessen the effectiveness of the vaccine. Reporter had the 2nd dose today 24Feb2021. Outcome of the events was unknown.  No follow up attempts are possible. Information on lot number/batch number cannot be requested. No further information is expected.