chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: he felt like he was unwell; sick; Nauseated but he is not going to throw up; feels like his head is stuffed up but he does not have a runny nose/  his head was getting ready to flood through his nose; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EN6208) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetic", start date: 2003 (ongoing); "Prostate cancer", start date: 2016 (unspecified if ongoing), notes: PSA test was like 0.05 so it is pretty much under control.; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol abnormal, start date: 2018. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "not recovered", described as "he felt like he was unwell"; ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "sick"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Nauseated but he is not going to throw up"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset Mar2021, outcome "not recovered", described as "feels like his head is stuffed up but he does not have a runny nose/  his head was getting ready to flood through his nose"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "not recovered", described as "feeling bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events did not result to Emergency Room and Physician Office visit. The patient was scheduled on 31Mar2021 for the second dose.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigued for one day (the next day); After my second dose, my left arm was sore for two days (the day of the jab and the next day); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:30 (Lot number: EL3247) at the age of 49 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 covid-19 vaccine captured as historical vaccine, Lot number: EL3247, Time: 10:00 AM, Location: Left arm, Event: my left arm was sore for three days, Event outcome: Recovered), administration date: 03Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Left arm was sore". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovered" (Mar2021), described as "After my second dose, my left arm was sore for two days (the day of the jab and the next day)"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "fatigued for one day (the next day)". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Malaise
Clinical narrative: did not feel well; felt like he was trying to get feverish and really wasn't though; tired and went to bed early; This is a spontaneous report received from a contactable consumer.  An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "controlled diabetes" (unspecified if ongoing), notes: on a salt-less diet; "dementia", start date: 2013 (unspecified if ongoing), notes: because of an accident he had; "borderline anemia" (unspecified if ongoing); "seizures" (unspecified if ongoing); "urinating at night" (unspecified if ongoing). Concomitant medications included: VIMPAT taken for seizure; TAMSULOSIN; FINASTERIDE; CIPROFLOXACIN taken for nocturia, start date: 17Feb2021; IRON; FLU SHOT taken for immunisation, administration date Mar2021. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: Feb2021, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 25Mar2021 14:30, outcome "not recovered", described as "tired and went to bed early"; MALAISE (non-serious) with onset 26Mar2021, outcome "unknown", described as "did not feel well"; FEELING HOT (non-serious) with onset 26Mar2021, outcome "unknown", described as "felt like he was trying to get feverish and really wasn't though".  Additional information: He got first shot at the beginning of Feb2021 (reported as around 03Feb2021, 05Feb2021, or 06Feb2021) and second shot around 26Feb2021 in the afternoon (unknown time), or something. And after that, he waited two weeks and had a flu shot. He was on an iron tablet, but the doctor took him off of it. She added another one after the COVID. No ER or physician's office visit were required.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Illness, Pain
Clinical narrative: Achiness; Cold sweats (no fever); Dizziness; Sick; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 08:30 (Lot number: EP6955) at the age of 38  as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number- EL3248, Administration Time- 16:00, Vaccine location- Left Arm), administration date: 03Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Achiness"; COLD SWEAT (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Cold sweats (no fever)"; DIZZINESS (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Dizziness"; ILLNESS (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Sick"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Fatigue". Therapeutic measures were not taken as a result of pain, cold sweat, dizziness, illness, fatigue. Additional information: Patient was 38-years-old and patient age at vaccination was 38-years-old. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks or any other medications in two weeks. Patient did not have COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Patient did not have any known allergies or any other medical history.  The reported seriousness of the events was non-serious. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. Patient did not have any allergies to medications, food, or other products. She was the one who received the vaccine. She got the vaccine on 24Mar2021, sick on 25Mar2021, reported on 26Mar2021. Became aware on 25Mar2021. On 25Mar2021, patient experienced Fatigue, Achiness, cold sweats (no fever), dizziness, sick. Patient did not receive any treatment for the adverse events. The outcome of the events was resolved on an unspecified date in Mar2021.    No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: has had tinnitus for the past 25 years/ the tinnitus completely disappeared; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 24Mar2021 (Lot number: EN6204) at the age of 76 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "tinnitus" (unspecified if ongoing), notes: in his early 50s (for the past 25 years), due to gunshot noise. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EN6205), administration date: 03Mar2021, when the patient was 76 years old, for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 25Mar2021 20:00, outcome "unknown", described as "has had tinnitus for the past 25 years/ the tinnitus completely disappeared".  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 15:00 (Lot number: EN6206) at the age of 49 years as dose 1, single and administered in arm left, administration date 24Mar2021 12:15 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "arm soreness". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient's concomitant medication included unspecified vitamin (daily; as reported). The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was further reported that the patient only had some arm soreness with first shot; and on 24Mar2021, patient experienced a bit more arm soreness with second shot.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: pain in the back of his neck on the right side; it was like a stiff neck; This is a spontaneous report received from contactable consumer. The reporter is the patient.  An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 16Mar2021 10:00 (Lot number: EN6205) at the age of 81 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EL926F [the writing was hard to read]), administration date: 23Feb2021, when the patient was 81 years old, for COVID-19 immunisation. The following information was reported: NECK PAIN (non-serious) with onset 22Mar2021, outcome "unknown", described as "pain in the back of his neck on the right side"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22Mar2021, outcome "unknown", described as "it was like a stiff neck". Therapeutic measures were taken as a result of neck pain, musculoskeletal stiffness.  Additional information: The patient took concomitant medications which included water pill and blood thinners, 2 pills. Therapeutic measures were taken as a result of neck pain, musculoskeletal stiffness. The patient has been putting heat on it and that it was better with heat.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable nurse. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: for a week or 2. The patient's concomitant medications were not reported. The following information was reported: The patient had COVID pretty bad for a week or 2. Once she was COVID negative, she got the first COVID vaccine and did ok. She got the second vaccine and got pretty sick like she had COVID again (on an unspecified date). The events were reported as non-serious. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of suspected COVID-19 and drug ineffective. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymph node pain, Lymphadenopathy, Vaccination site swelling
Clinical narrative: left lymph nodes swelled up and were painful; left lymph nodes swelled up and were painful; some swelling where they gave her the shot- little knot there; Numbing next to left breast / left her feeling numb as well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 23Mar2021 (Lot number: EL9266) at the age of 76 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing); "Obesity" (ongoing); "Thyroid problems" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 02Mar2021, for COVID-19 immunisation, reaction(s): "right lymph nodes swelled up and were very very painful ", "right lymph nodes swelled up and were very very painful", "Numbing next to right breast / feeling numbish / lymph nodes feeling kind of numb ".  The following information was reported: LYMPH NODE PAIN (non-serious) with onset 23Mar2021 20:00, outcome "recovered", LYMPHADENOPATHY (non-serious) with onset 23Mar2021 20:00, outcome "recovered" (18Mar2021) and all described as "left lymph nodes swelled up and were painful"; VACCINATION SITE SWELLING (non-serious) with onset 23Mar2021 20:00, outcome "unknown", described as "some swelling where they gave her the shot- little knot there"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "recovering", described as "Numbing next to left breast / left her feeling numb as well".  Additional information: The patient reported that with the second dose, it did the opposite; she had the shot in her right arm, but her left lymph nodes swelled up and were painful and left her feeling numb as well.  The patient stated that she is also still having some swelling where they gave her the shot- little knot there, but she is sure it will go away. The patient reported that the pain and swelling started within 24 hours both times.  The patient stated that on her right side, the pain stopped and the numbing is not as bad; on her left side, the lymph nodes stayed numb for about a week, but they stopped.  The patient mentioned that both times she got the shot, it didn't start hurting or numbing until later on that night. The patient clarified that the pain has stopped from the second dose. events did not require a visit to emergency room and physician office. The patient did not receive prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: had a cold; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), 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: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "had a cold".  Additional information: The patient mentioned that she missed the 2nd dose on March 24th because she had a cold.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Middle ear inflammation, Nausea, Tinnitus, Vertigo
Clinical narrative: Vertigo; tinnitus; nausea; middle ear inflammation; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 44-year-old male patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: EP6955) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sciatica" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EN6202)), administration date: 03Mar2021, when the patient was 43 years old, for COVID-19 immunisation, reaction: "High blood pressure". The following information was reported: VERTIGO (non-serious) with onset Mar2021, outcome "not recovered", described as "Vertigo"; TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "tinnitus"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "nausea"; MIDDLE EAR INFLAMMATION (non-serious) with onset Mar2021, outcome "not recovered", described as "middle ear inflammation". The events "vertigo", "tinnitus", "nausea" and "middle ear inflammation" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vertigo, tinnitus, nausea, middle ear inflammation.  Additional Information: After second dose, the patient experienced vertigo, tinnitus, nausea, all probably due to the sudden middle ear inflammation after the shot. The patient received meclizine and dexamethasone as treatment for the adverse events. The patient did not receive other vaccine in four weeks. The patient received other medications in two weeks. 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-2021350614 Same patient and drug; Different dose and event
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 14:00 (Lot number: EN6199, Expiration Date: 30Jun2021) at the age of 51 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: PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "arm sore".  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Malaise, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: Pain in both of her arms / legs hurt / arms hurt; body aches / total body aches all over; feels terrible; feels like she has a cold; she feels like she / is running a fever, but she was not running a fever; back hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 14:00 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 51 years 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 (Lot number: EN6199. Expiry date: 30Jun2021; at 14:00 in left arm), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunisation, reaction(s): "arm sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "Pain in both of her arms / legs hurt / arms hurt"; PAIN (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "body aches / total body aches all over"; MALAISE (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "feels terrible"; NASOPHARYNGITIS (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "feels like she has a cold"; PYREXIA (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "she feels like she / is running a fever, but she was not running a fever"; BACK PAIN (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "back hurts".  Additional information: She felt like she really needed to go to bed in order to feel better. She does not think it has gotten worse, but she was not okay.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain in both of her arms / legs hurt / arms hurt; body aches / total body aches all over; feels terrible; feels like she has a cold; she feels like she / is running a fever, but she was not running a fever; back hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 14:00 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 51 years 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 (Lot number: EN6199. Expiry date: 30Jun2021; at 14:00 in left arm), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunisation, reaction(s): "arm sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "Pain in both of her arms / legs hurt / arms hurt"; PAIN (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "body aches / total body aches all over"; MALAISE (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "feels terrible"; NASOPHARYNGITIS (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "feels like she has a cold"; PYREXIA (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "she feels like she / is running a fever, but she was not running a fever"; BACK PAIN (non-serious) with onset 26Mar2021 03:00, outcome "not recovered", described as "back hurts".  Additional information: She felt like she really needed to go to bed in order to feel better. She does not think it has gotten worse, but she was not okay.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: She had vomiting; muscle aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "heart problem" (unspecified if ongoing); "she is on oxygen" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose), administration date: 04Mar2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "First vaccine she got made her left arm like the area got really big and swelled up". The following information was reported: VOMITING (non-serious) with onset 25Mar2021, outcome "not recovered", described as "She had vomiting"; MYALGIA (non-serious) with onset 25Mar2021, outcome "not recovered", described as "muscle aches". Therapeutic measures were not taken as a result of vomiting, myalgia. Additional information: The patient was on lot of medicine because she has heart problems and other issues.  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 (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 23Mar2021 (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 "not recovered", described as "back pain". Additional Information: The patient would like to know if it is fine to take steroids. She had her 1st dose last 23Mar2021 and she was currently experiencing back pain and would like to take steroids.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Tremor
Clinical narrative: Tremors with Second Vaccine; Fell and had to be helped up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 25Mar2021 (Lot number: ER8733) at the age of 71 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Covid-19", start date: Mar2020 (unspecified if ongoing), notes: States that the patient had Covid with severe symptoms in Mar 2020. There were no concomitant medications. Vaccination history included: Bnt162b2 (in the left arm), administration date: 04Mar2021, when the patient was 71 years old, for Covid-19 immunisation, reaction(s): "Tremors".  The following information was reported: TREMOR (non-serious) with onset 26Mar2021, outcome "unknown", described as "Tremors with Second Vaccine"; FALL (non-serious) with onset 26Mar2021, outcome "recovered" (26Mar2021), described as "Fell and had to be helped up".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: dental issues; 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.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (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 DISORDER (non-serious), outcome "unknown", described as "dental issues". Additional information: It was reported that the reported wanted to know if patient can take pain reliever due to dental issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Condition aggravated, Joint swelling, Peripheral swelling
Clinical narrative: her legs are burning at night when she goes to bed and during the day, too.; Swelling of feet; swelling around the ankle; restless legs got worse; restless legs got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 16Jan2021 14:30 (Lot number: EL3296) at the age of 87 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "restless legs" (unspecified if ongoing), notes: prior to vaccination; "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Water pill" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for diuretic therapy (ongoing); AMLODIPINE BESYLATE taken for cardiac disorder (ongoing); OMEPRAZOLE DR taken for gastrooesophageal reflux disease (ongoing); LISINOPRIL taken for hypertension (ongoing); PRAVASTATIN SODIUM taken for blood cholesterol increased (ongoing). The following information was reported: BURNING SENSATION (non-serious) with onset 16Jan2021, outcome "not recovered", described as "her legs are burning at night when she goes to bed and during the day, too."; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "Swelling of feet"; JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "swelling around the ankle"; RESTLESS LEGS SYNDROME (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "restless legs got worse". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient confirmed that the burning started shortly after receiving the first dose. The burning was persisting, more so at night. The swelling in her feet started a couple of weeks ago. The swelling was not a lot, but she noticed her shoes were a little tight when she puts them on and noticed a little swelling around the ankle. Patient states the swelling was about the same as when it started. The events did not result in a visit to the emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome, Spinal X-ray
Clinical narrative: her legs are burning at night when she goes to bed and during the day, too.; Swelling of feet; swelling around the ankle; restless legs got worse; restless legs got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 16Jan2021 14:30 (Lot number: EL3296) at the age of 87 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "restless legs" (unspecified if ongoing), notes: prior to vaccination; "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Water pill" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for diuretic therapy (ongoing); AMLODIPINE BESYLATE taken for cardiac disorder (ongoing); OMEPRAZOLE DR taken for gastrooesophageal reflux disease (ongoing); LISINOPRIL taken for hypertension (ongoing); PRAVASTATIN SODIUM taken for blood cholesterol increased (ongoing). The following information was reported: BURNING SENSATION (non-serious) with onset 16Jan2021, outcome "not recovered", described as "her legs are burning at night when she goes to bed and during the day, too."; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "Swelling of feet"; JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "swelling around the ankle"; RESTLESS LEGS SYNDROME (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "restless legs got worse". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient confirmed that the burning started shortly after receiving the first dose. The burning was persisting, more so at night. The swelling in her feet started a couple of weeks ago. The swelling was not a lot, but she noticed her shoes were a little tight when she puts them on and noticed a little swelling around the ankle. Patient states the swelling was about the same as when it started. The events did not result in a visit to the emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphadenitis, Lymphadenopathy
Clinical narrative: inflamed lymph nodes/ no swollen lymph node prior to vaccination; inflamed lymph nodes/ no swollen lymph node prior to vaccination; This is a spontaneous report received from a contactable reporter(s) (nurse). The reporter is the patient.  A 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left deltoid, administration date 22Jan2021 (Lot number: EL3247) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: 2017 (unspecified if ongoing); "Breast cancer", start date: 2018 (unspecified if ongoing); "Breast cancer surgery" (unspecified if ongoing). Concomitant medication(s) included: RYTARY taken for parkinson's disease; SELEGILINE; CLARITIN [LORATADINE]; VITAMIN D NOS; VITAMIN C [ASCORBIC ACID]; ZINC; PROBIOTICS; TURMERIC [CURCUMA LONGA]. The following information was reported: LYMPHADENITIS (non-serious), LYMPHADENOPATHY (non-serious) all with onset 23Jan2021, outcome "not recovered" and all described as "inflamed lymph nodes/ no swollen lymph node prior to vaccination". The event "inflamed lymph nodes/ no swollen lymph node prior to vaccination" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenitis, lymphadenopathy.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feel sick after they got the 2nd dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (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), administration date: 03Mar2021, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "Feel sick after they got the 2nd dose of the vaccine".  Additional information: The report was received from a Pfizer sponsored program.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Taste disorder
Clinical narrative: taste was off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6205) at the age of 49 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing); "LOW THYROID" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism and allergy medication. The following information was reported: TASTE DISORDER (non-serious) with onset 10Mar2021, outcome "not recovered", described as "taste was off". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder. The patient's taste was off. This started right away on 10Mar2021 and was ongoing. ON 26Mar2021, it was still off. The patient had to assume it was the vaccine because it happened that night and then when she didn't see it listed, she felt, "Oh no, I could have gotten Covid". So, she went to go get tested and it was clearly a week or more after she had the taste go, start being weird. She tested negative and she had her family tested and they all tested negative. She wanted to report it because it is not listed. It is not listed as one of the possible side effects.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain one week after Vx.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: EN6207) 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: NECK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Neck pain one week after Vx.". It was unknown if therapeutic measures were taken as a result of neck pain.  Additional information: It was unknown is patient was diagnosed with COVID-19 prior to vaccination. It was also unknown if patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Back muscle 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 (BNT162B2), administration date 18Mar2021 (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: MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "Back muscle 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: Pain in extremity
Clinical narrative: mild arm pain 4 hours; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in deltoid left, administration date 11Feb2021 (Batch/Lot number: unknown) as Dose 2, Single for covid-19 immunisation. Relevant medical history included: "Increased Blood Pressure" (unspecified if ongoing); "CAVD (Coronary artery disease)" (unspecified if ongoing); "Hyperlipidemia/ Lipid control" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure increased, start date: 2015 (ongoing); METOPROLOL taken for blood pressure increased, start date: 2015 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for coronary artery disease, start date: 2015 (ongoing); LIPITOR [ATORVASTATIN] taken for hyperlipidaemia, start date: 2015 (ongoing); CLARITINE taken for seasonal allergy, start date: 2016 (ongoing). Vaccination history included: Bnt162b2 (first dose, right deltoid muscle, Intramuscular, Time: 02:00 PM), administration date: 21Jan2021, for COVID-19 Immunisation, reaction(s): "Pain/pain in the right arm/most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example"; Bnt162b2 (first dose, right deltoid muscle, Intramuscular, Time: 02:00 PM), administration date: 21Jan2021, for covid-19 immunisation, reaction(s): "Pain into shoulder area, deltoid muscle nearly totally paralyzed", "pain down arm to elbow", "could not sleep".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "mild arm pain 4 hours". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: the patient (reporter/ physician) provide information regarding the product adverse events with the use of the product. The patient also consider the Pfizer product had a causal effect to the adverse event. Patient prior vaccination was none. The patient noted: "I am not dead".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143343 same patient/drug, different events/dose number
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Redness around where they gave her the shot and it's hot like she has a fever right there; Redness around where they gave her the shot and it's hot like she has a fever right there; This is a spontaneous report received from contactable reporter (Consumer). An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: NOVOLOG taken for diabetes mellitus. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Redness around where they gave her the shot and it's hot like she has a fever right there". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fall, Illness, Memory impairment
Clinical narrative: Sick; Ringing in my ears; My left arm, I can hardly use it; Dizzy; I fall over; I can't really remember what I am doing at the time; I can hardly get up; It did some kind of damage, it hurts; 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 16Mar2021 (Lot number: EP7534) 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), outcome "unknown", described as "Sick"; TINNITUS (non-serious), outcome "unknown", described as "Ringing in my ears"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "My left arm, I can hardly use it"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FALL (non-serious), outcome "unknown", described as "I fall over"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "I can't really remember what I am doing at the time"; DYSSTASIA (non-serious), outcome "unknown", described as "I can hardly get up"; PAIN (non-serious), outcome "unknown", described as "It did some kind of damage, it hurts".  Additional information: The patient just can't get back and it has been about ten days.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain, Tinnitus
Clinical narrative: Sick; Ringing in my ears; My left arm, I can hardly use it; Dizzy; I fall over; I can't really remember what I am doing at the time; I can hardly get up; It did some kind of damage, it hurts; 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 16Mar2021 (Lot number: EP7534) 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), outcome "unknown", described as "Sick"; TINNITUS (non-serious), outcome "unknown", described as "Ringing in my ears"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "My left arm, I can hardly use it"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FALL (non-serious), outcome "unknown", described as "I fall over"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "I can't really remember what I am doing at the time"; DYSSTASIA (non-serious), outcome "unknown", described as "I can hardly get up"; PAIN (non-serious), outcome "unknown", described as "It did some kind of damage, it hurts".  Additional information: The patient just can't get back and it has been about ten days.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I feel bad and I have some effects; 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) (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel bad and I have some effects".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.