chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Tinnitus
Clinical narrative: ringing in ears/presented with cricket sound and high pitch tinnitus in both ears; feels fatigued; left arm soreness that had improved; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist).  A 59 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Pollen allergy" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Dust allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1; lot number: unknown), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 18Mar2021, outcome "not recovered", described as "ringing in ears/presented with cricket sound and high pitch tinnitus in both ears"; FATIGUE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "feels fatigued"; PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "recovering", described as "left arm soreness that had improved". The events "ringing in ears/presented with cricket sound and high pitch tinnitus in both ears", "feels fatigued" and "left arm soreness that had improved" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus, fatigue, pain in extremity.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Clinical course: On 18Mar2021, after 3 hours of second dose, the patient experienced ringing in ears. The patient noted high pitched chirping in ears about 3 hours after receiving 2nd vaccine. It was reported that the patient presented with cricket sound and high pitch tinnitus in both ears. The patient did not experience hearing loss, dizziness or headache. The patient felt fatigued and had left arm soreness that had improved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After getting COVID vaccinations, I do not need to take Valtrex. I do not get shingles; 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) (Lot number: EL9269) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing). Concomitant medication(s) included: VALTREX taken for herpes zoster. Vaccination history included: Bnt162b2 (1st dose, Lot number: EL3302), administration date: 13Jan2021, for COVID-19 immunisation, reaction(s): "back pain", "joint pain", "stress-related". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After getting COVID vaccinations, I do not need to take Valtrex. I do not get shingles".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue
Clinical narrative: Really tired; Little stomach ache; 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) (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 "Really tired"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Little stomach ache".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain, Vaccination site pain
Clinical narrative: pain at injection site; pain traveled under her arm pit; pain traveled under her arm pit; 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 Mar2021 (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: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "pain at injection site"; PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "pain traveled under her arm pit".  Additional information: It was reported that it was very painful and wondering if this was a side effect and how long will the events might take to go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; like my arm is on fire/felt like my forearm was on fire all way down to my fingers; When I got the shot it instantly hurt really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 22Mar2021 (Lot number: ER2613) at the age of 46 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: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 22Mar2021, outcome "recovered" (22Mar2021) and all described as "Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire"; BURNING SENSATION (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "like my arm is on fire/felt like my forearm was on fire all way down to my fingers"; VACCINATION SITE PAIN (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "When I got the shot it instantly hurt really bad". Therapeutic measures were not taken as a result of peripheral swelling, erythema, pruritus, vaccination site swelling, vaccination site erythema, vaccination site pruritus, burning sensation, vaccination site pain. Additional information: The events occurred within a couple of minutes. The patient did not receive treatment but was given ice to put on the affected area and stated that the events lasted about half an hour then went away. The second dose was due on 12Apr2021 and the patient was asking if it is safe for her to take it.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire; like my arm is on fire/felt like my forearm was on fire all way down to my fingers; When I got the shot it instantly hurt really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 22Mar2021 (Lot number: ER2613) at the age of 46 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: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 22Mar2021, outcome "recovered" (22Mar2021) and all described as "Forearm got swollen, red and itchy and then the injection site also got the same thing, like my arm is on fire"; BURNING SENSATION (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "like my arm is on fire/felt like my forearm was on fire all way down to my fingers"; VACCINATION SITE PAIN (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "When I got the shot it instantly hurt really bad". Therapeutic measures were not taken as a result of peripheral swelling, erythema, pruritus, vaccination site swelling, vaccination site erythema, vaccination site pruritus, burning sensation, vaccination site pain. Additional information: The events occurred within a couple of minutes. The patient did not receive treatment but was given ice to put on the affected area and stated that the events lasted about half an hour then went away. The second dose was due on 12Apr2021 and the patient was asking if it is safe for her to take it.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pain
Clinical narrative: do not feel well; a lot of muscle aches; a lot of pain; extreme 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: Covid-19 vaccine (DOSE 1, SINGLE (MANUFACTURER UNKNOWN)), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "do not feel well"; MYALGIA (non-serious), outcome "not recovered", described as "a lot of muscle aches"; PAIN (non-serious), outcome "not recovered", described as "a lot of pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme tiredness".  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: she felt like she got hit by a truck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020, stop date: 2020; "Raynaud's disease" (unspecified if ongoing); "Auto-immune disease" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she felt like she got hit by a truck".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Severe dizziness; Moderate nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:15 (Lot number: EP6955) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC ALLERGY. The following information was reported: DIZZINESS (non-serious) with onset 22Mar2021 16:00, outcome "recovering", described as "Severe dizziness"; NAUSEA (non-serious) with onset 22Mar2021 16:00, outcome "recovering", described as "Moderate nausea". Therapeutic measures were not taken as a result of dizziness, nausea.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19. The patient has no known allergies to medications, food, or other products.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Pain in extremity
Clinical narrative: I have the second dose on 25Feb and this made my arm sore; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epileptic seizure" (unspecified if ongoing), notes: She had it since she was born. She had a lot of seizures but haven't had any since 18Feb2020. Concomitant medications included: LEVETIRACETAM; GABAPENTIN, start date: Mar2019. Vaccination history included: BNT162B2 (Dose 1, single (Lot Number: EL9264)), administration date: 04Feb2021, when the patient was 74 years old, for covid-19 immunisation, reactions: "rash", "itching". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "I have the second dose on 25Feb and this made my arm sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient stated that the lot number of second dose was "EH or N 6202". She had a laboratory test and did not know for sure but they probably did a complete blood count (CBC).  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-2021335204 Same patient and drug; Different dose and events
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Spinal pain
Clinical narrative: mild continuous headache; when he walks down the steps, he can feel the pain in his spine; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 69 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 17Mar2021 10:40 (Lot number: EN6207) at the age of 69 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Type 2 Diabetic" (ongoing), notes: Diagnosed probably for ten years; "Spinal Meningitis" (unspecified if ongoing), notes: He had the condition in college over thirty years ago. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Mar2021 03:00, outcome "not recovered", described as "mild continuous headache"; SPINAL PAIN (non-serious) with onset 22Mar2021 03:00, outcome "not recovered", described as "when he walks down the steps, he can feel the pain in his spine". Therapeutic measures were taken as a result of headache.  Additional information: Caller received his first dose on 17Mar2021 at around 10:40. Caller reported he started having a mild continuous headache and when he walked down the steps, he felt it in his spine. The mild continuous headache started at night around 03:00, he woke up with the headache. He felt the pain in his spine started when he woke up at 03:00 and went down the steps. Caller stated that it was strange because he had spinal meningitis when he was in college over 30 years ago. Patient was also diagnosed with Type 2 Diabetic probably for ten years. Caller was taking acetaminophen to alleviate the headache, but even though he took 1000mg of acetaminophen, he could still feel it. He took the acetaminophen about 45 minutes to an hour ago. Caller reported that his headache and pain in his spine were both consistent. He was taking regular medications but declined to go through his medications at this time. The patient had not received any other vaccine within 4 weeks. Patient had no adverse events prior to vaccination and had not been tested.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Muscle spasms, Muscle twitching
Clinical narrative: Involunatry muscle twitching; Involuntary little like muscle spasm in my upper arm; I can like feel it the muscle like contracting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 22-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: ER8727) at the age of 22 years 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: MUSCLE TWITCHING (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Involunatry muscle twitching"; MUSCLE SPASMS (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Involuntary little like muscle spasm in my upper arm"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset 22Mar2021, outcome "not recovered", described as "I can like feel it the muscle like contracting". Therapeutic measures were not taken as a result of muscle twitching, muscle spasms, muscle contractions involuntary.  Additional Information: On 22Mar2021 and 23Mar2021, the patient had like involuntary muscle twitching like involuntary little like muscle spasm in the upper arm where she got the injection. It had not ever happened before and was not sure that's related. It felt like the muscles in her upper left arm are kind of doing like a little involuntary muscle spasm and it felt like a muscle twitching feeling basically. It was like if she put her other hand on it, she can feel like the muscle like contracting. It happened a little, like 20 minutes at a time and then stop for couple of hours and then come back. It happened earlier today but it was not happening right now (23Mar2021).  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes, they swell up then go away, then swell up again; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 15:45 (Batch/Lot number: unknown) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). Family history included: "Hereditary angioedema" (ongoing). Concomitant medication(s) included: BENADRYL taken for hereditary angioedema. Vaccination history included: Flu vaccine, reaction(s): "no adverse reaction"; Pneumonia vaccine, reaction(s): "no adverse reaction". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Swollen Lymph Nodes, they swell up then go away, then swell up again". The event "swollen lymph nodes, they swell up then go away, then swell up again" was evaluated at the physician office visit. Additional Information: The patient was taking Benadryl (unknown strength; pink and white capsule), one in the morning, one at 1500 and two when he goes to bed. The patient was also having hormone shot at clinic every 3-4 months for prostate cancer that he had 16 years ago. The patient has hereditary angioedema and stated that his father also had this condition. It causes fingers to swell, or feet, or hand, or something and he took Benadryl to keep it under control. The patient stated his high blood pressure was under control, every time they check it is normal. On 04Mar2021, the second day after the vaccine, the patient experienced swollen lymph nodes, they swell up a little bit then go away, and they might come back the next day, and they are still doing it. It has not worsened but is persisting. They swell up a bit, go back down, might come up again about halfway. The patient stated right now he can just barely feel them. His doctor told him that the lymph node swelling usually lasts 10-12 days then it is gone.  The patient was concerned because he stated it has been 20 days. He has been to the doctor twice recently; one time was for his physical and the other time was related to his lymph nodes swelling. His doctor recommended that he get the second vaccine but he uncertain if he should get the second vaccine. The patient has no history of all previous immunizations and has no additional vaccines administered on same date of the COVID-19 Vaccine. The patient has no prior vaccinations within 4 weeks and has no adverse events following prior vaccinations. The patient got his Flu and Pneumonia vaccines every year and every time they are due with no adverse reactions. The patient has no family medical history relevant to the adverse events. No relevant tests were done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms". Additional information: The event occurred 5 days after receiving the second dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Started to get sick / had symptoms; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: ILLNESS (non-serious) with onset 2021, outcome "recovered", described as "Started to get sick / had symptoms".  Additional Information: A week later after the first dose, he started to get sick. The patient's wife had COVID and the patient had symptoms but was already okay. The patient's second dose was supposed to be on 19Mar2021 and he wanted to know the protocol with missing his second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First shot: arm hurt a little bit; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "First shot: arm hurt a little bit". Additional Information: The patient had first shot a couple of weeks ago. He was ok, but his arm hurt a little bit and he was fine.   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-2021336056 same patient/drug, different event (2nd dose)
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Somnolence
Clinical narrative: Drowsiness, sleepiness; napping and becoming more drowsy that I typically am; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 76 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Sleep problem" (unspecified if ongoing), notes: Taking diazepam at night to sleep. Concomitant medications included: LISINOPRIL; ALLOPURINOL; PROZAC taken for anxiety; ASPIRIN [ACETYLSALICYLIC ACID]; DIAZEPAM taken for sleep disorder. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, (Lot number: not provided)), for covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious), outcome "not recovered", described as "Drowsiness, sleepiness; napping and becoming more drowsy that I typically am". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence.  Additional information: Concomitant medication also included Multivitamins. Consumer stated that he was having some side effects from the second shot that were lingering and he was just wondering to talk to someone about them. Consumer confirmed the vaccine as Pfizer's Covid 19 vaccine. Consumer stated that he had drowsiness and sleepiness. He had his last shot about 4 weeks ago, maybe 5 and he was noticing himself napping and become drowsier than he typically was, and it doesn't seem to have dissipated. He stated that once or twice a week, like tonight he was sitting watching television, he said he needed to stop his eyes and take a nap which he did, and he slept about 3 hours and woke up and still felt sleepy. He received no treatment for the events and all his lab test came normal according to the nurse. He was wondering if this was something that will eventually go away or he knew with the vaccine it was hard to, everyone has a different reaction to it, but he was just checking if there is anything that he could do to make it different because it was 2-3 times a week, with his first shot he had no effect but with the second one he started getting drowsy. He just wanted to talk to someone at Pfizer about it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Cold sweat
Clinical narrative: Cold sweat; Lower abdomen is very painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EPG955) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: COLD SWEAT (non-serious) with onset 23Mar2021, outcome "unknown", described as "Cold sweat"; ABDOMINAL PAIN LOWER (non-serious) with onset 23Mar2021, outcome "unknown", described as "Lower abdomen is very painful".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (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: BACK PAIN (non-serious), outcome "unknown", described as "back pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Headache
Clinical narrative: headache overnight into the next day; dry mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high levels of stress" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache overnight into the next day"; DRY MOUTH (non-serious), outcome "recovering", described as "dry mouth".  Additional information: It was reported that prior the vaccination, the patient (reported age: 50, unit: unknown) was overall unhealthy and leads an unhealthy lifestyle consisting of poor food choices including little to no vegetables or fruit intake, lack of exercise, and high levels of stress. It was reported that dry mouth subsided the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: flu like symptoms; body aches; chills; 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 22Mar2021 (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: INFLUENZA LIKE ILLNESS (non-serious) with onset 23Mar2021 05:00, outcome "recovering", described as "flu like symptoms"; PAIN (non-serious) with onset 23Mar2021 05:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 23Mar2021 05:00, outcome "recovering", described as "chills". Additional information: On 22Mar I received my second dose of the COVID-19 vaccine. Today on 23Mar, I woke up at approximately 5 AM with flu like symptoms. The symptoms including body aches and chills are getting steadily better over the course of the day.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1 st dose), administration date: 03Feb2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "lightheaded, dizzy", "sudden weakness\felt very weak", "Tightness across stomach", "Stomach Spasms", "I never felt like I had trouble breathing", "It began to subside about 30 min later, felt very weak for about two hours". The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body aches". Additional information: "I received the second shot after talking with Health Dept. and doctor. I did not have any reaction to the second dose- 10Mar2021. I did have chills and body aches about 10 hours after just normal side effects. Lasted into the 2nd day."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Somnolence
Clinical narrative: Fatigue; lightheadedness; sleepiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (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 "unknown", described as "Fatigue"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "lightheadedness"; SOMNOLENCE (non-serious) with onset Mar2021, outcome "unknown", described as "sleepiness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomited; diarrhea; 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 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: VOMITING (non-serious) with onset Mar2021, outcome "unknown", described as "vomited"; DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "diarrhea". Additional information: She had vomited four times after she received the first dose on 16Mar2021 and she's now having bad diarrhea. A week ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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), administered in arm right, administration date 22Jan2021 15:00 (Lot number: EL9261) as dose 1, single and administered in arm right, administration date 13Feb2021 16:30 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High cholesterol" (ongoing); "Allergies" (ongoing); "Calcium" (ongoing); "Vitamin" (ongoing). Concomitant medication(s) included: ZOCOR taken for blood cholesterol increased (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin supplementation (ongoing); CALTRATE [CALCIUM CARBONATE] taken for mineral supplementation (ongoing); CENTRUM A TO ZINC taken for vitamin supplementation (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Jan2021 08:00, outcome "unknown", described as "sore arm".  Additional information: The patient had no prior vaccination. The patient's age at time of vaccination was reported as 65 or 66 years. The batch number for dose 2 was reported as GN620 (Could not read). The events were reported as non-serious. The patient did not undergo any relevant tests.   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: sore arm; 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 female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  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: nausea; 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 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus issue" (unspecified if ongoing), notes: Verbatim: she has had a sinus issue for over one month. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms during the night (same day of vaccination); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Mar2021 10:00 (Batch/Lot number: unknown) at the age of 59 years 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: INFLUENZA LIKE ILLNESS (non-serious) with onset 23Mar2021, outcome "unknown", described as "flu like symptoms during the night (same day of vaccination)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Mild body aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Mild body aches"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Events took place 1 day after receiving dose 2 of the Pfizer-BioNTech vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Gait disturbance, Musculoskeletal discomfort, Speech disorder
Clinical narrative: Fatigued; Can't balance; Can't walk; Speech disturbance; Joint discomfort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4266705.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: SOLUMEDROL taken for premedication, start date: 22Feb2021. The following information was reported: FATIGUE (non-serious) with onset 25Feb2021, outcome "unknown", described as "Fatigued"; BALANCE DISORDER (non-serious) with onset 25Feb2021, outcome "unknown", described as "Can't balance"; GAIT DISTURBANCE (non-serious) with onset 25Feb2021, outcome "unknown", described as "Can't walk"; SPEECH DISORDER (non-serious) with onset 25Feb2021, outcome "unknown", described as "Speech disturbance"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 25Feb2021, outcome "unknown", described as "Joint discomfort".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: General fatigue; Pain; Minimal headache; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "General fatigue"; PAIN (non-serious), outcome "unknown", described as "Pain"; HEADACHE (non-serious), outcome "unknown", described as "Minimal headache".  Additional Information: The patient was healthy. The event took place after use of product - 12 hours after the second vaccine dose (injection). The patient had no fever.   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-202101797815 Same patient; different events and dose
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling really sick; 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 mRNA VACCINE, Solution for injection) (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: MALAISE (non-serious), outcome "unknown", described as "Feeling really sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: terrible tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 15:15 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrobid, reaction(s): "Drug allergy", notes: Known allergies-Macrobid; Cipro, reaction(s): "Drug allergy", notes: Known allergies- Cipro; Bactrim, reaction(s): "Drug allergy", notes: Known allergies- Bactrim. The following information was reported: TINNITUS (non-serious) with onset 19Feb2021, outcome "recovering", described as "terrible tinnitus". Therapeutic measures were not taken as a result of tinnitus. The patient experienced terrible tinnitus after 9 days of first vaccine on 19Feb2021. It was reported that it got somewhat better. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Prior to 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 vaccine within 4 weeks prior to COVID-19 vaccine. The patient received other medications (unspecified) within two weeks of vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Complaining of severe pain in big toe/Gout; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: GOUT (non-serious) with onset 23Mar2021, outcome "recovering", described as "Complaining of severe pain in big toe/Gout". The pain in his toe that he thought might be related to him receiving the vaccine has subsequently been diagnosed as gout.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (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), for Covid-19 immunisation.  The following information was reported: BACK PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "back pain". Additional information: The patient was asking if she could take Tylenol for her back pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.