chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: headache; fatigue; weakness; joint pain; pain and redness at injection site; pain and redness at injection site; fever; fogginess; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6198 and Expiry date were not reported) dose 1, via unspecified route of administration, administered in left arm on 03Mar2021 at 17.30, single for COVID-19 immunization. The patient's medical history included a Covid-19, ankylosing spondylitis, hashimoto's thyroiditis, seasonal allergies, dander allergies, indoor allergies, chronic sinusitis, asthma. The patient had allergies with medication prochlorperazine, food chocolate. The patient did not receive any treatment. The patient was not Covid tested post vaccination.The patient took unknown concomitant medications in two weeks. On 03Mar2021 at 07:00 PM(1.30 mins after vaccination), the patient experienced a headache, fatigue, weakness, joint pain, pain and redness at injection site, fever, fogginess. The outcome of events were not recovered.   No follow-up attempts are possible. No further information is expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Severe headache; body aches,; joint aches; chills; nausea; This is a spontaneous report from other HCP (patient).   A 48-years-old non-pregnant female patient started to receive BNT162b2 (BNT162b2, Formulation: Solution for injection, Batch/lot number: 0000, Expiration date was not reported)(at the age of  48-years-old ), via an unspecified route in the Arm left on 03Mar2021 at 11:15, as 2 ND DOSE, SINGLE, for COVID-19 immunisation.  The patient medical history was not reported.  The patient received first dose on 10Feb2021. The patient was not tested for COVID-19.The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included Esomeprazole sodium (NEXIUM), Ibuprofen ,taken for an unknown indication from an unknown date to unknown if ongoing. No known allergies. On 04Mar2021 at 04:00, the patient experienced Severe headache & body aches, joint aches, chills, nausea. The patient did not receive any treatment for these events.  All the events were non-serious. The outcome of all the events were recovering.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Swelling face, Vaccination site warmth
Clinical narrative: Swelling of face and feet; swelling of face and feet; headache; Left arm where shot was administered was hot to the touch.; This is a spontaneous report from a contactable other Health Care Professional (patient). A 50 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En6205 and expiry date was not provided) via unspecified route of administration in the left arm on 05Mar2021 at 02:15 PM as a single dose for COVID-19 immunisation (age at vaccination was 50 years). The patient's medical history was not reported. Patient had no known allergies. Patient's concomitant medication included melatonin, multivitamin and diphenhydramine HCL at 50 mg; all for unknown indication on unspecified dates (with in two weeks of vaccination). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 at 02:30 PM (same day of vaccination) the patient experienced headache and Left arm where shot was administered was hot to the touch. Patient had swelling of face and feet on 06Mar2021. Headache happened right after shot, swelling was the next day (06Mar2021). Patient took Benadryl 50 mg twice as a treatment. The outcome the events headache and Left arm where shot was administered was hot to the touch was recovered on an unknown date in Mar2021; and the events swelling of face and feet were recovered on 06Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: headache; nausea; chills; body ache; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9810), via an unspecified route of administration, administered in left arm on an unspecified date as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization and experienced soreness in arm and took Ibuprofen. After second dose the patient experienced headache, nausea, chills, body ache on 21Feb2021. Patient did not received treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Achy legs; This is a spontaneous report from a contactable other healthcare professional. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), intramuscularly in left arm on 23Feb2021 at 08:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included diabetes, asthma, known allergies: Penicillin. Concomitant medical included diabetes meds plus other medicines prescribed by my doctor, received within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), intramuscularly in left arm on 02Feb2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. No COVID prior vaccination. The patient has not been tested for COVID post vaccination. On 24Feb2021 at 06:00, the patient experienced achy legs, headache, only lasted the next morning until about noon. No treatment medications was received for the adverse events. The outcome of the events was recovered on 25Feb2021.  No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: E_6198 (Patient was unsure of the second value), expiry date not reported) intramuscular in arm on 02Mar2021 (He had the shot around quarter), as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02MAR2021, the patient experienced a headache. He said he was experiencing a little bit of headache and that the headache was not as strong as it was before and it was milder then. The outcome of the event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Photosensitivity reaction
Clinical narrative: headaches; Extreme light sensitivity; migraines; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration on 28Feb2021 at 07:45 as single dose for covid-19 immunization in hospital. The patient medical history was not reported. No known allergies were reported. Concomitant medication included drospirenone, ethinylestradiol (OCELLA) for birth control and vitamins, both received in two weeks. No other vaccine received in four weeks. Patient was not tested positive for Covid prior vaccination. On 28Feb2021 at 21:00, the patient experienced extreme light sensitivity and headaches (patient was not prone to headaches, so she believed these to be migraines). No treatment was received for events. Patient was not tested Covid post vaccination. The outcome of events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nasopharyngitis, Nausea
Clinical narrative: Diarrhea; Headache; Bodyaches; Cold; Nauseous; Very, very, very tired; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 20Feb2021 around 3:10 pm (Batch/Lot Number: JSV6H-KD7BK) as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Prior vaccinations within 4 weeks, the patient had Flu shot but thinks that was a couple of months before the COVID shot. The patient previously took first dose bnt162b2 for covid-19 immunization and flu vaccine. On 21Feb2021 the patient experienced headache, bodyaches, cold, nauseous, very, very, very tired, and on 01Mar2021, diarrhea. The patient received second COVID shot 11 days ago. He was still feeling symptoms. Received second COVID shot on 20Feb2021 and was perfectly fine. Woke up the next day, 21Feb2021 and was sick. From what he has seen, most people are sick for a day or two. The patient clarified it was just what he has seen on the news. Was it normal to be sick for longer than a couple days. Stated the body aches got better, but he was still tired and still has a headache. Has been going on since 21Feb2021.Yesterday, 01Mar2021, started having diarrhea. The patient stated that the body aches got better, but he was still tired and still has a headache. Has been going on since 21Feb2021. The patient had called his doctor, but has not heard back. When querying address for vaccination facility, patient stated his brain was not working. Outcome of the events headache, nauseous, very tired were not recovered, outcome of bodyaches was recovering and outcome of cold and diarrhea was unknown.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Diarrhea; Headache; Bodyaches; Cold; Nauseous; Very, very, very tired; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 20Feb2021 around 3:10 pm (Batch/Lot Number: JSV6H-KD7BK) as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Prior vaccinations within 4 weeks, the patient had Flu shot but thinks that was a couple of months before the COVID shot. The patient previously took first dose bnt162b2 for covid-19 immunization and flu vaccine. On 21Feb2021 the patient experienced headache, bodyaches, cold, nauseous, very, very, very tired, and on 01Mar2021, diarrhea. The patient received second COVID shot 11 days ago. He was still feeling symptoms. Received second COVID shot on 20Feb2021 and was perfectly fine. Woke up the next day, 21Feb2021 and was sick. From what he has seen, most people are sick for a day or two. The patient clarified it was just what he has seen on the news. Was it normal to be sick for longer than a couple days. Stated the body aches got better, but he was still tired and still has a headache. Has been going on since 21Feb2021.Yesterday, 01Mar2021, started having diarrhea. The patient stated that the body aches got better, but he was still tired and still has a headache. Has been going on since 21Feb2021. The patient had called his doctor, but has not heard back. When querying address for vaccination facility, patient stated his brain was not working. Outcome of the events headache, nauseous, very tired were not recovered, outcome of bodyaches was recovering and outcome of cold and diarrhea was unknown.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache all night; This is a spontaneous report from a contactable consumer (reporting for herself). A female patient of an unspecified age received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took for covid-19 immunisation. It was stated that when probed to determine her reporter type, the caller mentions she worked with a doctor year ago, but was never licensed as a healthcare professional herself. Yesterday, she received her second dose of Pfizer's covid vaccine. She asks if she can take her blood pressure medication and cholesterol medications and all those medications now. The patient asks what she take for a headache that she had all night. Caller was informed medical advice cannot be provided. She would need to speak with her doctor. The caller mentions she tried to get in touch with her doctor before, but she will try again. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Movement disorder, Oropharyngeal pain
Clinical narrative: Headache; Achy/ achiness from the neck down to the feet; Soreness; Fatigue; sore throat; just basically I can barely move; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Apr2021 (Lot number was not reported) as SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 via an unspecified route of administration on an unspecified date as SINGLE for covid-19 immunization. It was reported that the patient had the second dose last Wednesday (i.e. 28Apr2021) and still the achy, the headache, the soreness but patient just like when this going to go away. Stated forehead was achy, achiness from the neck down to the feet, patient had a sore throat a coupe day ago, just basically patient can barely move, just fatigue. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; Achy/ achiness from the neck down to the feet; Soreness; Fatigue; sore throat; just basically I can barely move; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Apr2021 (Lot number was not reported) as SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 via an unspecified route of administration on an unspecified date as SINGLE for covid-19 immunization. It was reported that the patient had the second dose last Wednesday (i.e. 28Apr2021) and still the achy, the headache, the soreness but patient just like when this going to go away. Stated forehead was achy, achiness from the neck down to the feet, patient had a sore throat a coupe day ago, just basically patient can barely move, just fatigue. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: I started feeling itchy and then my throat started closing up so I took a Zyrtec, a Benadryl, and it was no going down I ended up going to the ER; started feeling itchy; This is a spontaneous report received from a contactable consumer (patient).   A 30-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6202) 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for covid-19 immunisation. The patient experienced allergic reaction about 5 to 7 days after the vaccine, where her whole body was itchy, and it progressively got worst, and she felt like her skin was on fire. She took some allergy medication; two Zyrtec and a Benadryl and she was fine. She had no history of allergic reaction in the past. On an unspecified date, after her second dose she waited 30 minutes for observations at the clinic. she had no allergic reaction but 3 hours after she started feeling itchy and then her throat started closing, so she took a Zyrtec, a Benadryl, and it was no going down she ended up going to the ER and they (word incomprehensible) with Prednisone she just took a 15 mg (units were not clearly audible) dose of Prednisone. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: Headache; I was weak; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiry Date/ UPC/ NDC number: Unknown), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for covid-19 immunisation. Patient's age at vaccination was 80 years. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient experienced headache and i was weak on 02Mar2021. Additional Context received as, the patient stated, "I got the vaccine, I got the first shot last month and I got the second shot on 01Mar (clarified as 01Mar2021), and I feel nothing on the 02Mar2021, I was okay. Then on 02Mar (not clarified), all of a sudden, I get a headache, not so bad but still a headache and today, in the afternoon, I was weak. I thought I had a fever but I have no fever, I just have a headache but now it is going away. Today, when I wake up, it was fading away and I got it in vaccination facility. When probed to clarify if consumer want to know that headache wais related to the Covid vaccine, consumer stated, as yes. For treatment in response to events, the patient stated, that was yesterday, today, I feel little better. No, I did not take anything. Outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; Sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration on 12Jan2021 (at the age of 68-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included prednisone taken for an unspecified indication from 08Feb2021 to 15Feb2021. The patient experienced headache and sore arm on 12Jan2021. The reporter stated that Just a headache for 24hrs after 1st vaccine dose 12Jan2021 sore arm. The outcome of the events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Gait disturbance
Clinical narrative: joint pain/ knee problem knee pain; muscle pain; I am very cold; Headache; chills; some problems I have had with walking; Tiresome; This is a spontaneous report from a contactable consumer.   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 01Mar2021 03:00 (Batch/Lot Number: EN6205) as single dose for COVID-19 immunisation.  The patient's medical history was not reported.  The patient received unspecified concomitant medications. The patient reported experiencing some problems she's had with walking. She took her vaccine shot on Monday, 01Mar2021 and started having some "like knee problem, knee pain," slight headache, tiresome, join pain, muscle pain, chills, and had been feeling cold.   She was having problems in her joints, she was on a walker and couldn't hardly walk.  The events of feeling cold, slight headache, muscle pain, joint pain, and chills all started on 02Mar2021. She had to make an emergency appoint with her doctor on 03Mar2021 as she thought that it might be something wrong. She begged the doctor to take her because she was hurting so bad.  When she went to the doctor, he sent her for X-Rays for her shoulder and of her leg and knee, but they couldn't find out what was wrong, and on 05Mar2021,  she had an ultrasound on her leg and knee and they didn't see anything wrong. She reported she was going for an MRI but then also commented wasn't taking an MRI. The HCP did give her a prescription for a narcotic pain medicine, but it has not been sent to the her yet. She has been using a pain cream, Healing Salve 600 mg, to help with her joint and muscle pain, and stated it is not helping.  She was going back to the doctor today (08Mar2021) at 2:45PM to go over all of the reports.  She was on a walker and in severe pain. She states "almost fell out " this morning (08Mar2021) trying to make something to eat. Regarding feeling cold, she commented that she had a lot of heat on. Regarding the joint pain, muscle pain, headache and knee pain, she stated that it improved, and was all walking now.  The outcome of problems walking, joint pain  muscle pain, headache were recovering. The outcome of feeling cold was not recovered. The outcome of the remaining events was unknown. She was scheduled to receive her second dose on 22Mar2021 at 3pm. She also commented she was reading over the sheet she received and she had some other symptoms that are risk of the Pfizer COVID-19 Vaccine. She wanted to know how long she will be in this pain for, and how long the chills and everything will last.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Ultrasound scan, X-ray
Clinical narrative: joint pain/ knee problem knee pain; muscle pain; I am very cold; Headache; chills; some problems I have had with walking; Tiresome; This is a spontaneous report from a contactable consumer.   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 01Mar2021 03:00 (Batch/Lot Number: EN6205) as single dose for COVID-19 immunisation.  The patient's medical history was not reported.  The patient received unspecified concomitant medications. The patient reported experiencing some problems she's had with walking. She took her vaccine shot on Monday, 01Mar2021 and started having some "like knee problem, knee pain," slight headache, tiresome, join pain, muscle pain, chills, and had been feeling cold.   She was having problems in her joints, she was on a walker and couldn't hardly walk.  The events of feeling cold, slight headache, muscle pain, joint pain, and chills all started on 02Mar2021. She had to make an emergency appoint with her doctor on 03Mar2021 as she thought that it might be something wrong. She begged the doctor to take her because she was hurting so bad.  When she went to the doctor, he sent her for X-Rays for her shoulder and of her leg and knee, but they couldn't find out what was wrong, and on 05Mar2021,  she had an ultrasound on her leg and knee and they didn't see anything wrong. She reported she was going for an MRI but then also commented wasn't taking an MRI. The HCP did give her a prescription for a narcotic pain medicine, but it has not been sent to the her yet. She has been using a pain cream, Healing Salve 600 mg, to help with her joint and muscle pain, and stated it is not helping.  She was going back to the doctor today (08Mar2021) at 2:45PM to go over all of the reports.  She was on a walker and in severe pain. She states "almost fell out " this morning (08Mar2021) trying to make something to eat. Regarding feeling cold, she commented that she had a lot of heat on. Regarding the joint pain, muscle pain, headache and knee pain, she stated that it improved, and was all walking now.  The outcome of problems walking, joint pain  muscle pain, headache were recovering. The outcome of feeling cold was not recovered. The outcome of the remaining events was unknown. She was scheduled to receive her second dose on 22Mar2021 at 3pm. She also commented she was reading over the sheet she received and she had some other symptoms that are risk of the Pfizer COVID-19 Vaccine. She wanted to know how long she will be in this pain for, and how long the chills and everything will last.  No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: headache; sore throat; very sore arm the following day.; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 33-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on Feb2021 (Batch/Lot Number: EL3247) as UNKNOWN, SINGLE for covid-19 immunisation  .  Medical history included psoriatic arthropathy from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported.  The patient experienced headache (headache) (non-serious) on 25Feb2021 with outcome of recovered , sore throat (oropharyngeal pain) (non-serious) on 25Feb2021 with outcome of recovered , very sore arm the following day. (pain in extremity) (non-serious) on 25Feb2021 with outcome of recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Balance disorder, Blood thyroid stimulating hormone, Chills
Clinical narrative: a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of  BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeling cold, Headache, Illness
Clinical narrative: a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of  BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Taste disorder
Clinical narrative: a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of  BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of  BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I couldn't have it a headache every day; I am having it every day and it's not all days it's just cut and comes on; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown, and Expiration date: unknown), via an unspecified route of administration on an unspecified date in Feb2021 as 1ST dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that I couldn't have it a headache every day since I took the vaccine last week, it was last Friday so do I need to report that or give it a few more days. Treatment: patient stated, No, I am having it every day and it's not all days it's just cut and comes on. The patient did not receive any treatment for event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Headache; Bad migraine; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient received her first dose of the Pfizer vaccine earlier, last week on 26Feb2021 and she started experiencing headache, and it's a bad migraine. The patient wanted to know if it was okay to receive her second vaccine. She also mentioned that she had to drive 5 hours to get that vaccine and she do not think she want to drive the next time with a headache. So, that is why she asked if they could be moved. The patient mentioned treatment as Just Excedrin, Tylenol. Outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN5318 and Expire Date: unknown) in left arm via unspecified route of administration on 10Feb2021 at 12:00 as 1ST DOSE, SINGLE for Covid-19 immunization. Facility type vaccine was Hospital. Medical history included penicillin allergy. Concomitant medications were none. The patient did not take any other vaccines in four weeks. Prior to and since vaccination the patient was not tested with Covid positive. After vaccination, the patient experienced headache on 24Feb2021 at 15:00. The patient had not received any treatment for the event. The patient received second dose of bnt162b2 (Lot number: EN6202) via unspecified route in Left arm on 03Mar2021 at 12:45 PM for Covid-19 immunization. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Night sweats, Pain
Clinical narrative: severe headache/headaches came back/headache will come back later in the day/severe headaches twice a day,and they are pounding; was warm like she had a fever; night sweats; chills; body aches; debilitating; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Feb2021 as 2nd dose, single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. Investigation Assessment was not Provided. On an unspecified date, Patient stated that she had some severe side effects from the COVID-19 vaccine. She got the first dose of the vaccine on 26Jan2021 and had no problems. Patient had the second dose of the vaccine on 17Feb2021 and had no problems. She stated that on the following Sunday, which she believed was 21Feb2021, she had a severe headache, she was warm like she had a fever, night sweats, chills and body aches, and that was how she woke up and she said that she took 2 Advil and ate some food and got better, and she was better throughout that day. But she added that headaches came back during nighttime, but the other stuff subsided some. As she stated, In a couple of days, everything except her headaches was gone. Patient stated that this morning, at 2AM, her headache woke her up, so caller got up and ate, and drank water and she has been drinking at least four 16.9 oz. water bottles a day. She had only one glass of ice tea a day, one cup of coffee, but she was not taken any soda. Since about last Wednesday, all the other stuff went away, and now she is just having the severe headaches twice a day, and they are pounding and debilitating. She wanted to know what to do about the headaches because it will be back. Caller had been taking 2 Aleve or 2 Advil, they both work, but Tylenol doesn't. She knew she was not dehydrated, and she was conscious of her health and she does not want to ruin her kidneys by taking Aleve or Advil everyday. The outcome of event was unknown for severe headache/came back/headache will come back later in the day/severe headaches twice a day, and they are pounding  and debilitating and for rest of the events was recovered.  Description of Product Complaint: Description of complaint: While calling with a question about the suspect product, caller indicated that she has been having severe headaches and two advil or two aleve work to help the pain from the headaches, but Tylenol does not work.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe headache/headaches came back/headache will come back later in the day/severe headaches twice a day,and they are pounding; was warm like she had a fever; night sweats; chills; body aches; debilitating; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Feb2021 as 2nd dose, single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. Investigation Assessment was not Provided. On an unspecified date, Patient stated that she had some severe side effects from the COVID-19 vaccine. She got the first dose of the vaccine on 26Jan2021 and had no problems. Patient had the second dose of the vaccine on 17Feb2021 and had no problems. She stated that on the following Sunday, which she believed was 21Feb2021, she had a severe headache, she was warm like she had a fever, night sweats, chills and body aches, and that was how she woke up and she said that she took 2 Advil and ate some food and got better, and she was better throughout that day. But she added that headaches came back during nighttime, but the other stuff subsided some. As she stated, In a couple of days, everything except her headaches was gone. Patient stated that this morning, at 2AM, her headache woke her up, so caller got up and ate, and drank water and she has been drinking at least four 16.9 oz. water bottles a day. She had only one glass of ice tea a day, one cup of coffee, but she was not taken any soda. Since about last Wednesday, all the other stuff went away, and now she is just having the severe headaches twice a day, and they are pounding and debilitating. She wanted to know what to do about the headaches because it will be back. Caller had been taking 2 Aleve or 2 Advil, they both work, but Tylenol doesn't. She knew she was not dehydrated, and she was conscious of her health and she does not want to ruin her kidneys by taking Aleve or Advil everyday. The outcome of event was unknown for severe headache/came back/headache will come back later in the day/severe headaches twice a day, and they are pounding  and debilitating and for rest of the events was recovered.  Description of Product Complaint: Description of complaint: While calling with a question about the suspect product, caller indicated that she has been having severe headaches and two advil or two aleve work to help the pain from the headaches, but Tylenol does not work.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Headache; Neck Pain from top of shoulder to neck on left side; Neck Stiffness; Really Dry Mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via intramuscular, administered in left arm on 03Mar2021 at 09:30 (at a age of 65-year-old during vaccination) as 1st dose, 0.3ml, single dose for covid-19 immunisation. The patient's medical history and family medical history were reported as none. The patient's concomitant medications were not reported. The patient had not undergone any investigation assessment prior or post vaccination. The patient had not taken any other vaccine 4 weeks prior to Covid vaccine. The patient no adverse events prior to Covid vaccination. On 03Mar2021, the patient almost immediately within 5 mins of vaccination experienced headache. He stated that he went home, and headache still lasting and then within a half hour after the vaccination the patient had neck pain from the top of his shoulder up to his neck and his neck was really stiff, and really dry mouth. He wanted to report his effects, he assumes he had a reaction to the shot. He stated that he was finally starting to feel better. He stated that he has his next one shot in three weeks. The patient had neither visited emergency room nor physician. He stated that his doctor may tell him to go to the ER if events worsened and it was not. The patient took Tylenol as treatment medications for the resulted events. The outcome of the event headache was not recovered and for the rest of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: little bit of headache; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via unspecified route of administration on 02Mar2021 at 17:30, as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced little bit of headache and fever. Consumer asked I was felling little bit headache, it was our first dose this time, So, if we (Clarification unknown) feel like any headache or fever after first dose or second dose. So, can we take Advil". Outcome of both the events were unknown.  Consumer was unwilling to share further information, hence, product details (Expiration date, NDC#, UPC#) and other details were unknown.  Limited information was available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; tired; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unknown date, patient experienced sore arm for a couple of day with outcome of recovered , tired with outcome of not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.