chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: slight headache; loose bowels (was in the bathroom 6 times yesterday); slight nausea; general feeling of the flu; weakness; tired/wanted to lay down and sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for immunization, reaction(s): "weakness", "loose bowels", "wanted to lay down and sleep", "slight headache", "all over general feeling of the flu", "slight nausea". The following information was reported: HEADACHE (non-serious) with onset 23Mar2021, outcome "recovered", described as "slight headache"; DIARRHOEA (non-serious) with onset 23Mar2021, outcome "unknown", described as "loose bowels (was in the bathroom 6 times yesterday)"; NAUSEA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "slight nausea"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Mar2021, outcome "unknown", described as "general feeling of the flu"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset 23Mar2021, outcome "unknown", described as "tired/wanted to lay down and sleep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: slight headache; loose bowels (was in the bathroom 6 times yesterday); slight nausea; general feeling of the flu; weakness; tired/wanted to lay down and sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for immunization, reaction(s): "weakness", "loose bowels", "wanted to lay down and sleep", "slight headache", "all over general feeling of the flu", "slight nausea". The following information was reported: HEADACHE (non-serious) with onset 23Mar2021, outcome "recovered", described as "slight headache"; DIARRHOEA (non-serious) with onset 23Mar2021, outcome "unknown", described as "loose bowels (was in the bathroom 6 times yesterday)"; NAUSEA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "slight nausea"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Mar2021, outcome "unknown", described as "general feeling of the flu"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset 23Mar2021, outcome "unknown", described as "tired/wanted to lay down and sleep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: some fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2020 17:15 (Lot number: eH9899) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "some fatigue".  Additional information: No Emergency Room or Physician Office visited.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Hypoaesthesia, Tinnitus
Clinical narrative: got up in the morning with a pounding in her ear; face became numb; stuttering badly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 04Mar2021, outcome "unknown", described as "got up in the morning with a pounding in her ear"; HYPOAESTHESIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "face became numb"; DYSPHEMIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "stuttering badly". The events "got up in the morning with a pounding in her ear", "face became numb" and "stuttering badly" were evaluated at the physician office visit. Additional information: Course of events was described as follows: The patient had her first Pfizer vaccine on 01Mar21 and she did not had a reaction that day but on 04Mar2021, Thursday of the same week, she got up in the morning with a pounding in her ear and her face became numb and she was stuttering badly, which she does not normally do. Patient went to the doctor and he said he did not think that it was a reaction to the vaccine because it was outside of the normal 48 hours timeframe in which it normally appears. The reporter was querying if it was wise for the patient to get the second dose which was supposed to be today, this morning.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue/Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EN6208) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue/Tiredness".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Paresthesia in my hands and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 02Mar2021 (Lot number: EM9810) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "Paresthesia in my hands and legs". Additional information: The dose received by the patient was "0.3". The patient was scheduled to receive the second dose on 23Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had increased blood glucose/elevated blood sugar, onset Mar 2021, with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: Consumer stated the first Pfizer shot was received on Thursday of last week. They have been watching their blood sugar and the sugars have been elevated. Consumer wanted to know if the vaccine affected blood sugar, especially since their blood sugar has been elevated ever since the vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Hearing issue; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "Hearing issue". Additional Information: The consumer stated they have a little bit of problem because I have a hearing issue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural
Clinical narrative: lying prone on his back and as soon as he laid prone on his back his head went into a storm like a brain storm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 95 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2021 14:30 (Lot number: EN6205) at the age of 95 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "slow heartbeat" (ongoing); "thin blood" (ongoing); "cholesterol" (ongoing); "stroke" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, cerebrovascular accident (ongoing); ATORVASTATIN taken for blood cholesterol (ongoing); METOPROLOL taken for heart rate decreased (ongoing); WARFARIN taken for blood disorder (ongoing). The following information was reported: DIZZINESS POSTURAL (non-serious) with onset 15Mar2021, outcome "not recovered", described as "lying prone on his back and as soon as he laid prone on his back his head went into a storm like a brain storm". Therapeutic measures were not taken as a result of dizziness postural.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that the patient left the clinic in good shape and the next morning on Monday 15Mar2021 at the time he got up in morning he goes through a throat exercise for the stroke he had. The reporter stated he was lying prone on his back and as soon as he laid prone on his back his head went into a storm like a brain storm, it was hurricane velocity everything in bedroom was flying all over place in his head. He lifted his head a little bit and that was the end of that storm it broke. The patient got out of the position as fast as he could and was fine. Patient stated that "he relayed to the nurse his experience and the only thing on paperwork he was saying other people have had was dizzy and the nurse put down he was dizzy". It was further reported that on 19Mar2021 (Friday morning), he laid on back in prone position and the same thing happened, he lifted his head a little and saw his mattress coming at him and he grabbed it to hold on and he stated he was not going to try it again. The event stayed about the same and that he was not going to do it anymore it would take a month or two months to try again.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Typical left arm soreness; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Mar2021 (Lot number: EP7534) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing); "back pain" (unspecified if ongoing). Concomitant medications included: BIKTARVY; MELOXICAM; SEROQUEL; GABAPENTIN; VIT D. Vaccination history included: BNT162B2 (Dose 1, single (Lot Number: EN6198) in the left arm at 07:00 PM), administration date: 25Feb2021, when the patient was 50 years old, for Covid-19 immunisation, reactions: "Lump on left breast", "Swollen left breast", "Nipple is sore to the touch or pushing in on it is sore", "Feel some aching in left hand / left arm soreness", "Feel some aching in left hand like arthritis", "Feel some stiffness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "Typical left arm soreness". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient did not have COVID prior vaccination, was not tested for COVID post vaccination, and had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314907 Same reporter, patient and drug; Different dose and events
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Muscle spasms, Somnolence
Clinical narrative: muscle spasm in my calf in her right bottom leg on the outside/ it was in the right side of her bottom leg; very sleepy and she slept a lot; very sleepy and she slept a lot; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 25Feb2021 (Lot number: EN6200) at the age of 77 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: 04Feb2021, when the patient was 77 years old, for COVID-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset 26Feb2021, outcome "recovered" (22Mar2021), described as "muscle spasm in my calf in her right bottom leg on the outside/ it was in the right side of her bottom leg"; SOMNOLENCE (non-serious), HYPERSOMNIA (non-serious) all with onset 26Feb2021, outcome "unknown" and all described as "very sleepy and she slept a lot". The events "muscle spasm in my calf in her right bottom leg on the outside/ it was in the right side of her bottom leg", "very sleepy and she slept a lot" and "very sleepy and she slept a lot" were evaluated at the physician office visit. Therapeutic measures were taken as a result of muscle spasms.  Additional information: The patient experienced muscle spasm in her calf in her right bottom leg on the outside. It started the day after she had the (second) shot (also reported that the event started on 27Feb2021). She went to the doctor and he prescribed a muscle relaxer (unspecified medication) which helped but it did not go away. It was quite severe on different days. On 22Mar2021 (reported as "today"), she was clear and that was almost three weeks since she had the shot; she has experienced no pain at all. She further stated that she got some relief from it (unspecified muscle relaxer) but it made her very sleepy and she slept a lot. So, maybe just relaxing helped it to loosen the spasm but it was always there and it was not necessarily in her calf, it was in the right side of her bottom leg.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: aches; Chills; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number- UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Additional information: Patient experienced chills, aches, headache and nausea after second COVID vaccine dose. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eructation, Headache, Insomnia
Clinical narrative: Sleepy / sleeps all the time; Started to drink a lot of water / very thirsty; Can't sleep at night; Throwing up anything she takes down, whether it's food or water; Feels dizzy; Feels weak / No strength and no energy; Peed all day and all day long; Belching; Headache; Feels terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: SOMNOLENCE (non-serious) with onset Feb2021, outcome "unknown", described as "Sleepy / sleeps all the time"; THIRST (non-serious) with onset Feb2021, outcome "unknown", described as "Started to drink a lot of water / very thirsty"; INSOMNIA (non-serious) with onset Feb2021, outcome "unknown", described as "Can't sleep at night"; VOMITING (non-serious) with onset Feb2021, outcome "unknown", described as "Throwing up anything she takes down, whether it's food or water"; DIZZINESS (non-serious) with onset Feb2021, outcome "unknown", described as "Feels dizzy"; ASTHENIA (non-serious) with onset Feb2021, outcome "unknown", described as "Feels weak / No strength and no energy"; POLLAKIURIA (non-serious) with onset Feb2021, outcome "unknown", described as "Peed all day and all day long"; ERUCTATION (non-serious) with onset Feb2021, outcome "unknown", described as "Belching "; HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset Feb2021, outcome "unknown", described as "Feels terrible".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pollakiuria, Somnolence, Thirst, Vomiting
Clinical narrative: Sleepy / sleeps all the time; Started to drink a lot of water / very thirsty; Can't sleep at night; Throwing up anything she takes down, whether it's food or water; Feels dizzy; Feels weak / No strength and no energy; Peed all day and all day long; Belching; Headache; Feels terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: SOMNOLENCE (non-serious) with onset Feb2021, outcome "unknown", described as "Sleepy / sleeps all the time"; THIRST (non-serious) with onset Feb2021, outcome "unknown", described as "Started to drink a lot of water / very thirsty"; INSOMNIA (non-serious) with onset Feb2021, outcome "unknown", described as "Can't sleep at night"; VOMITING (non-serious) with onset Feb2021, outcome "unknown", described as "Throwing up anything she takes down, whether it's food or water"; DIZZINESS (non-serious) with onset Feb2021, outcome "unknown", described as "Feels dizzy"; ASTHENIA (non-serious) with onset Feb2021, outcome "unknown", described as "Feels weak / No strength and no energy"; POLLAKIURIA (non-serious) with onset Feb2021, outcome "unknown", described as "Peed all day and all day long"; ERUCTATION (non-serious) with onset Feb2021, outcome "unknown", described as "Belching "; HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset Feb2021, outcome "unknown", described as "Feels terrible".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Toothache and thinks crown will need to be replaced; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "Toothache and thinks crown will need to be replaced". Therapeutic measures were not taken as a result of toothache. Additional information: The patient stated that he has an appointment for second shot on Thursday and thinks he will need a crown replaced. The patient would like to know if there is any problem with getting dental work before then or should he wait.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 (Lot number: EN6198) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like reaction; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Fatigue
Clinical narrative: got up of my bed and experienced dizziness; dizziness; fatigue / tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "fatigue / tired"; DIZZINESS POSTURAL (non-serious) with onset 21Mar2021, outcome "not recovered", described as "got up of my bed and experienced dizziness"; DIZZINESS (non-serious) with onset 21Mar2021, outcome "not recovered", described as "dizziness".  Additional information: The patient experienced fatigue and it was not a big deal since it went away. This past Sunday (2 weeks later), the patient got up of his bed and experienced dizziness. It was reported that the events (got up of my bed and experienced dizziness; and dizziness) was continuing until today (day of report) though it was not debilitating but it comes and it goes. The patient was wondering it was just a side effects or something else was going on because the patient was tired again. The patient read on the internet that other people experienced dizziness and was concern regarding the second shot that was supposed to get next week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Musculoskeletal stiffness, Pain, Vaccination site movement impairment
Clinical narrative: exhaustion; stiffness; uncomfortable to walk or roll over; incapable of lifting injection arm; Beginning the evening of vaccine, incredibly uncomfortable body aches.; This is a spontaneous report received from a contactable reporter (Other Healthcare Professional). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Feb2021 15:00 (Lot number: EN6206) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acne cystic" (unspecified if ongoing); "Allergy to codeine" (unspecified if ongoing), notes: Known Allergies: Codeine. Concomitant medication(s) included: PROBIOTICS. The following information was reported: PAIN (non-serious) with onset 27Feb2021 20:00, outcome "recovered" (2021), described as "Beginning the evening of vaccine, incredibly uncomfortable body aches."; FATIGUE (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "exhaustion"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "stiffness"; GAIT DISTURBANCE (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "uncomfortable to walk or roll over"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "incapable of lifting injection arm". Therapeutic measures were not taken as a result of pain, fatigue, musculoskeletal stiffness, gait disturbance, vaccination site movement impairment. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine and received probiotics daily within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has reported allergies to codeine (reported as codiene).  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Muscle pain; Tiredness; Feeling unwell; Chills; Injection site pain; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 18Mar2021 12:00 (Lot number: EN6199) at the age of 45 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Injection site pain"; HEADACHE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Tiredness"; MALAISE (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Feeling unwell"; CHILLS (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 21Mar2021, outcome "not recovered", described as "Muscle pain". Additional information: The patient weighs 220-230 lbs. The patient did not receive prior vaccinations within 4 weeks. The patient had no fever, had no swelling in the injection site, no redness, and does not know about any swollen lymph nodes. When the patient starts to get chills, he covers up, but then he gets really hot. The events tiredness, headache, muscle pain, feeling unwell, and chills were reported to have worsened. The patient claims that the more active he tries to get, the worse he feels. The events did not result in an emergency room or physician office visit, but thinks about going.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscle pain; Tiredness; Feeling unwell; Chills; Injection site pain; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 18Mar2021 12:00 (Lot number: EN6199) at the age of 45 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Injection site pain"; HEADACHE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Tiredness"; MALAISE (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Feeling unwell"; CHILLS (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 21Mar2021, outcome "not recovered", described as "Muscle pain". Additional information: The patient weighs 220-230 lbs. The patient did not receive prior vaccinations within 4 weeks. The patient had no fever, had no swelling in the injection site, no redness, and does not know about any swollen lymph nodes. When the patient starts to get chills, he covers up, but then he gets really hot. The events tiredness, headache, muscle pain, feeling unwell, and chills were reported to have worsened. The patient claims that the more active he tries to get, the worse he feels. The events did not result in an emergency room or physician office visit, but thinks about going.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia
Clinical narrative: weakness; chills; muscle pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "weakness"; CHILLS (non-serious) with onset 18Mar2021, outcome "unknown", described as "chills"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "muscle pain"; HEADACHE (non-serious) with onset 18Mar2021, outcome "unknown", described as "headache".  Additional information: Patient wants to know how long she will be feeling the side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: pain and spasms intensified 2days after vaccine 2; pain and spasms intensified 2days after vaccine 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Mar2021 12:00 (Lot number: EN6205) at the age of 45 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. Vaccination history included: BNT162B2 (lot number=EN6201; administration time=01:30 PM, vaccine location=Left arm, dose number=1), administration date: 26Feb2021, when the patient was 45 years old, for COVID-19 immunisation, reaction(s): "Upper back and Right sided neck pain and stiffness", "Upper back and Right sided neck pain and stiffness", "Upper back and Right sided neck pain and stiffness". The following information was reported: PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 21Mar2021 12:00, outcome "not recovered" and all described as "pain and spasms intensified 2 days after vaccine 2". The event "pain and spasms intensified 2 days after vaccine 2" and "pain and spasms intensified 2days after vaccine 2" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain, muscle spasms.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies. The patient did not receive other vaccine in four weeks. Treatment for the events today 22Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Fatigue, Pain, Pain in extremity
Clinical narrative: Bitter taste in mouth and was eating very little because of bad taste; Sore left arm, it felt like someone punched her; Fatigue; body aches; not being able to taste anything. it came back but it taste bitter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Mar2021 09:41 (Lot number: EP7534, Expiration Date: 31Jul2021) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "Respiratory illness" (unspecified if ongoing); "genetic /chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "very high blood pressure" (unspecified if ongoing), notes: prior to getting the vaccine. There were no concomitant medications. The following information was reported: AGEUSIA (non-serious) with onset Mar2021, outcome "recovered with sequelae", described as "not being able to taste anything. it came back but it taste bitter"; DYSGEUSIA (non-serious) with onset 17Mar2021 03:00, outcome "not recovered", described as "Bitter taste in mouth and was eating very little because of bad taste"; PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 03:00, outcome "recovering", described as "Sore left arm, it felt like someone punched her"; FATIGUE (non-serious) with onset 17Mar2021 03:00, outcome "not recovered", described as "Fatigue"; PAIN (non-serious) with onset 17Mar2021 03:00, outcome "not recovered", described as "body aches".  Additional Information: The vaccine was administered at a clinic at a church. The patient has no family medical history. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that the patient can eat and drink, but it was hard because everything taste bitter like the taste in her mouth. She cannot drink coffee with creamer because it was so bitterer. Everything was so bitter. The patient does not know if it was a side effect or if she should get a COVID test. The day after the report will be a whole week that it has been going on. She called her doctor's office and they advised to contact Pfizer. Events did not result to emergency room nor physician office visit. Return date for second dose was scheduled for 06Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "very tired". Additional information: Patient noted that he gotten up very early to drive to his appointment and believed that likely contributed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm is sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Dec2020 (unspecified if ongoing); "Headache", start date: Dec2020 (unspecified if ongoing); "Loss of appetite", start date: Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: bad head, body, arm, joint and leg ache; bad head, body, arm, joint and leg ache; bad head, body, arm, joint and leg ache; bad head, body, arm, joint and leg ache; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19 positive", start date: 10Dec2020 (unspecified if ongoing), notes: was tested Covid19 positive on 10Dec2020. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "bad head, body, arm, joint and leg ache". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The reporter was tested COVID-19 positive on 10Dec2020. The reporter had the first dose on 18Mar2021 but experienced symptoms of bad head, body, arm, joint and leg ache after the first dose. The reporter was asking if the 2nd dose will be stronger than the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), administered in arm, on Mar 20, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), on Feb 28, 2021, for COVID-19 immunisation. The patient had vaccination site pain (it's really hurting and she feels so bad in her arm where she got the vaccine) and felt abnormal, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: Chills; body aches; nausea; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for Pfizer sponsored programs. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN (non-serious), outcome "unknown", described as "body aches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional Information: Since she was attending a meeting on the day of the report. the patient was asking if she might be contagious   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: she felt very tired a day after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021335230.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "she felt very tired a day after".  Additional information: Is the Reporter a Healthcare Professional (HCP): UNKNOWN, Occupation/Specialty: UNKNOWN, Is the Reporter's contact information available to you or a sub-contracted party: UNKNOWN, Is the reporter the prescribing HCP: UNKNOWN. Verbatim and event description: The caller (Name) said that she received the 1st dose on 16Mar2021, and she felt very tired a day after. She is also scheduled for surgery a day before the 2nd dose schedule and she will miss the appointment. Upon callback, caller stated she wanted state that she would not be able to make the appointment. consumer stated when she got the Pfizer shot, "she was fine the rest of the day, and the next morning, all day long, the 2nd day, felt like a dog. She was just very tired and the next day she was fine. It was not like she was going through COVID at all. Her husband had no reaction. Her relative was very tired the next day after receiving her shot." Caller wanting to confirm if 6 weeks out to receive the 2nd dose is ok. Medical information: were any unaddressed medical questions referred to medical information: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335230 Same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Tooth extraction
Clinical narrative: Have tooth pulled three days ago, extraction of tooth; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A male patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH EXTRACTION (non-serious) with onset Mar2021, outcome "unknown", described as "Have tooth pulled three days ago, extraction of tooth". Therapeutic measures were taken as a result of tooth extraction.  Additional Information: The patient received the first vaccination of Pfizer three weeks ago and was scheduled tomorrow (from the time of report) to take second Pfizer vaccination. He had tooth pulled three days ago (from the time of report) and extraction of tooth. He was put on an antibiotic for one week and had been taken it for four days. He had three more days of antibiotic which was amoxicillin 500 mg (Treatment). The patient wanted to know if he should stop amoxicillin and if it would interfere with his Pfizer shot or if it was okay to take it with the Pfizer shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.