chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site vesicles
Clinical narrative: a clear water blister on the injection site; red around the blister / on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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 VESICLES (non-serious) with onset 01Apr2021, outcome "unknown", described as "a clear water blister on the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 01Apr2021, outcome "unknown", described as "red around the blister / on the injection site".  Additional information: Patient received the second dose of the Pfizer COVID the day before (31Mar2021) and had no problems and no side effects. She mentioned that she did not remove the band aid until this morning (01Arp2021) where it got pulled off as she was changing gowns. She then found out that she had a clear water blister on the injection site. She mentioned that it was small but noticeable and has gotten bigger since she's gotten up. It was red around the blister but it was not painful. She was asking if this was common.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: dizziness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 14:00 (Lot number: ER8727) at the age of 22 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 31Mar2021, outcome "recovered", described as "dizziness"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of dizziness, pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication for asthma within 2 weeks of vaccination not sure what though. The day after receiving the vaccine he experienced severe dizziness which lasted more than 12 hours. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness to his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (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 "Soreness to his arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Pain
Clinical narrative: states that the next day she experienced "a little bit" of chills and achiness but that it went away; states that the next day she experienced "a little bit" of chills and achiness but that it went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6203) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD", start date: 24Mar2021 (ongoing); "Blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pneumonia shot (In early February 2021/ late January 2021. had some swelling and itchiness after pneumonia shot. patient took Benadryl and went away.); Covid-19 (Lot Number : EM9809, for the first dose.). The following information was reported: PAIN (non-serious) with onset 16Mar2021, outcome "not recovered", CHILLS (non-serious) with onset 16Mar2021, outcome "recovered" and all described as "states that the next day she experienced "a little bit" of chills and achiness but that it went away". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, chills.  Additional Information: The report type is initial and not related to study programme. The patient was the reporter. NDC and expiry date of COVID-19 vaccine was unknown. The patient was not taking other medications. The patient was diagnosed ages ago, but her blood pressure is under control. Patient confirms this condition has been ongoing for 25 years at least and Investigation Assessment was done. The patient had first covid vaccine provided with a lot number. The patient takes her usual blood pressure medication and a breathing medication for COPD, but has been taking these for a long time. It was unknown that History of all previous immunization with the Pfizer vaccine considered as suspect. Patient has no NDC, Lot number or expiry date for the pneumonia shot. Patient had no illness at the time of vaccination. No information on Family Medical history relevant to adverse event was provided. Patient had a checkup at the doctor office this week and they drew blood to check cholesterol and stuff like that All labs were good.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: intense dizziness; fatigue; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 12:00 (Lot number: EN6206) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies". The following information was reported: DIZZINESS (non-serious) with onset 12Mar2021, outcome "recovered" (Mar2021), described as "intense dizziness"; FATIGUE (non-serious) with onset 12Mar2021, outcome "recovered" (Mar2021), described as "fatigue"; PAIN (non-serious) with onset 12Mar2021, outcome "recovered" (Mar2021), described as "body aches". The events "intense dizziness", "fatigue" and "body aches" were 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 dizziness, fatigue, pain.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. The patient took other medications in two weeks which included men's multivitamin and probiotic. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. Intense dizziness was experienced for first 3 weeks after vaccination while fatigue and body aches were first 5 days after vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site extravasation
Clinical narrative: patient said there was leakage after the dose was given, a clear liquid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE EXTRAVASATION (non-serious), described as "patient said there was leakage after the dose was given, a clear liquid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ears started to ring; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "ears started to ring".  Additional information: It was reported that the event was experienced within 3 to 4 days after receiving the dose. Event was still continuing and has not resolved. She wanted to know if this could be a side effect of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Lethargy
Clinical narrative: next morning after injection, i was extremely cold and lethargic; next morning after injection, i was extremely cold and lethargic. midbrain, low level headache (sameas after dose 1), started about 2h postinjection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 14:15 (Lot number: EP7534) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Papillary thyroid cancer" (unspecified if ongoing), notes: papillary thyroid cancer survivor. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (lot number: EN6203, vaccine location: Left arm, dose number: 1, administration time: 13:15), administration date: 28Feb2021, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "unusual headache". The following information was reported: HEADACHE (non-serious) with onset 21Mar2021 16:30, outcome "recovered" (23Mar2021), described as "midbrain, low level headache (sameas after dose 1), started about 2h postinjection."; FEELING COLD (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "next morning after injection, i was extremely cold and lethargic"; LETHARGY (non-serious) with onset 22Mar2021, outcome "recovered" (23Mar2021), described as "next morning after injection, i was extremely cold and lethargic.". Therapeutic measures were not taken as a result of headache, lethargy. Therapeutic measures were taken as a result of feeling cold.  Additional information: The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have fever, chills, just constantly felt really cold to the point of double wool socks with hot feet in them, 3 layers of sweatshirts, insulated pants and ski pants, gloves which lasted about 24 hours and then completely disappeared, along with the headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: my elbow started swelling and the crease of the arm around; my elbow started swelling and the crease of the arm around; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8734, Expiration Date: Jul2021) at the age of 63 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: JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 26Mar2021, outcome "unknown" and all described as "my elbow started swelling and the crease of the arm around". The event "my elbow started swelling and the crease of the arm around" and "my elbow started swelling and the crease of the arm around" was evaluated at the physician office visit. Therapeutic measures were taken as a result of joint swelling, peripheral swelling. Additional information: The patient treatment was reported as Benadryl and Tylenol. The patient wanted to know if she should get the second dose since she was scheduled on 16Apr2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced a headache yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "experienced a headache yesterday". Therapeutic measures were taken as a result of headache.  Additional information: Caller mentioned that he received the 1st dose of the Pfizer Covid19 vaccine and is due for his 2nd dose on Monday in the morning. He is asking if he can take pain medications, specifically Ibuprofen, as he gets headaches once or twice a month. He mentioned that it is unrelated to the vaccine, as it usually happens to him during his lifetime, but he experienced a headache yesterday. With Ibuprofen, the headaches would usually go away in 30 minutes to 1 hour and now wants to know if he can take Tylenol before getting the second dose. He is asking because he does not want to "mess up" his vaccination. Caller also taking cholesterol meds, Lipitor. Is it okay to take it? Would that affect the vaccine? Caller mentioned that he plans to stop it for a week as he did before while on vacation and nothing happened.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Feeling abnormal, Headache, Insomnia
Clinical narrative: Major soreness in my arm; i couldn't sleep well on day 1; Day2 i started to feel a little worse but i was functional light headache; Day2 i started to feel a little worse but i was functional light headache; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:15 (Lot number: EL3247) at the age of 53 years as dose 2, single and administered in arm right, administration date 10Mar2021 10:15 (Lot number: EP6955) 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) with onset Mar2021, outcome "recovering", described as "Major soreness in my arm"; INSOMNIA (non-serious) with onset Mar2021, outcome "recovering", described as "i couldn't sleep well on day 1"; FEELING ABNORMAL (non-serious), HEADACHE (non-serious) all with onset Mar2021, outcome "recovering" and all described as "Day2 i started to feel a little worse but i was functional light headache"; ABDOMINAL PAIN UPPER (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), VOMITING (non-serious), SOMNOLENCE (non-serious) all with onset Mar2021, outcome "recovering" and all described as "Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy".  Additional information: The patient had not received any other vaccine within 4 weeks. The patient had not received any other medicine within 2 weeks. Allergies to medications, food, or other products was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Vomiting
Clinical narrative: Major soreness in my arm; i couldn't sleep well on day 1; Day2 i started to feel a little worse but i was functional light headache; Day2 i started to feel a little worse but i was functional light headache; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:15 (Lot number: EL3247) at the age of 53 years as dose 2, single and administered in arm right, administration date 10Mar2021 10:15 (Lot number: EP6955) 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) with onset Mar2021, outcome "recovering", described as "Major soreness in my arm"; INSOMNIA (non-serious) with onset Mar2021, outcome "recovering", described as "i couldn't sleep well on day 1"; FEELING ABNORMAL (non-serious), HEADACHE (non-serious) all with onset Mar2021, outcome "recovering" and all described as "Day2 i started to feel a little worse but i was functional light headache"; ABDOMINAL PAIN UPPER (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), VOMITING (non-serious), SOMNOLENCE (non-serious) all with onset Mar2021, outcome "recovering" and all described as "Day 3 aches and pains in my stomach, back and legs, headaches, vomiting and extremely sleepy".  Additional information: The patient had not received any other vaccine within 4 weeks. The patient had not received any other medicine within 2 weeks. Allergies to medications, food, or other products was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: She was supposed to receive her 2nd dose on 05Mar2021 but became really ill and was not able to get to her appointment; ill; "The initial case was missing the following minimum criteria: like (unspecified adverse event under BNT162B2). Upon receipt of follow-up information on PRD 02Apr2021, this case now contains all required information to be considered valid."  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021365361 (PFIZER).  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 (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: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "She was supposed to receive her 2nd dose on 05Mar2021 but became really ill and was not able to get to her appointment"; ILLNESS (non-serious), outcome "recovered", described as "ill".  Follow up (02Apr2021 and 13May2021): The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (02Apr2021), this case now contains all required information to be considered valid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 10Mar2021 15:15 (Lot number: EN6207) at the age of 56 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "dairy allergy" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing); "gallbladder issues" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. Concomitant medication included: VITAMIN D3. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021 18:15, outcome "unknown", described as "pain in her arm".  Additional information: Additional concomitant medication included: stone blaster - herbs for gallbladder.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: panic attack; panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in upper arm left, administration date 10Mar2021 13:00 (Lot number: EN6208) at the age of 64 years as dose 1, single and administration date 31Mar2021 13:30 (Lot number: ER8733, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Panic attacks" (ongoing). There were no concomitant medications. The following information was reported: PANIC ATTACK (non-serious) with onset 10Mar2021, outcome "recovered" (Mar2021), PANIC ATTACK (non-serious) with onset 31Mar2021, outcome "recovered" (Mar2021) and all described as "panic attack". Therapeutic measures were not taken as a result of panic attack, panic attack.  Additional Information: She had history of panic attacks but has not had one in 5 years. She experienced a panic attack at night on the same day of both her shots with the latest one (2nd doses) being last night. She does not know why she had a panic attack as she was not feeling nervous or anxious at all. Caller stated she wanted to know if people have experienced panic attacks with the vaccine; Caller stated she has experienced 2 panic attacks one after each vaccine. No prior vaccinations (within 4 weeks).No.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: he was wiped out and fatigued and had to lie down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68-year-old 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: FATIGUE (non-serious), outcome "unknown", described as "he was wiped out and fatigued and had to lie down".  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: arm  tenderness; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm  tenderness". Additional information: after 1st dose had little bit arm tenderness. After 2nd dose had little arm tenderness and a slight headache. Want to know if its ok to take Advil or Tylenol. Has not taken anything. patient was also wondering about a possible test we can suggest to take to check efficacy of 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: Illness
Clinical narrative: Both times got very sick; 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 (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Both times got very sick". Additional information: patient took both vaccine shots. Both times got very sick and she would like to get some feedback on why she got and why both times and what was the impact on her immune system going forward.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "don't smoke" (unspecified if ongoing); "occasional drink" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Mild headaches". Clinical information: Patient received the vaccine 28 days ago and getting his second one today (31Mar2021). He had no reaction for the first few days but have been having mild headaches recurring more frequently. Patient stated he do not normally get headaches and need to know if it was anything he need to be concerned about. He is 71-year-old and in good health don't smoke and only an occasional drink.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: having significant fatigue and muscle soreness/ tiredness/ high fatigue; having significant fatigue and muscle soreness/She feels like she has been fighting a war with the muscle aches/ Muscle pain; have a headache; feel like crap; 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 (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021381327 (Pfizer).  A 62-year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8732) at the age of 62 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: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "having significant fatigue and muscle soreness/ tiredness/ high fatigue"; MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "having significant fatigue and muscle soreness/She feels like she has been fighting a war with the muscle aches/ Muscle pain"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "have a headache"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "feel bad".  Additional information: Caller is a 62-year-old female who had the first dose of the Pfizer Covid 19 vaccine on 26Mar2021. She realized this past week she is having significant fatigue and muscle soreness. She did have a headache, but it has resolved. "How long will this last? I feel like crap. And I'd like to know how long I'm going to not feel good. She has been feeling not good for a while and then today all of the sudden she thought maybe it may be from the vaccine. She feels like she has been fighting a war with the muscle aches and fatigue. States she just wants to know how long she can expect it to last. Patient mentioned above lasted for 7 days and that she started to feel better on day 8.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia
Clinical narrative: upset stomach; no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Lot number: ER8727) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 01Apr2021, outcome "unknown", described as "upset stomach"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "no energy".  Additional information: The reporter asked if Pfizer covid-19 vaccine cause upset stomach and no energy several day after the vaccine is given and how long does it last. NDC number, UPC number and expiry date were reported as unknown. The patient can take second dose on 17Apr.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise
Clinical narrative: not feeling good; diarrhea; This is a spontaneous report from a contactable consumer. The reporter is the patient. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Mar2021 (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 "not feeling good"; DIARRHOEA (non-serious) with onset 29Mar2021, outcome "unknown", described as "diarrhea". Clinical course: the patient received a vaccine on 09Mar2021. She had to go back on the 30th. She did not as she was not feeling good. The patient asked how long she has to get 2nd one. She had a bad bout with diarrhea on the 29. The patient also asked if it is ok to get vaccinated when she don't feel good.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "felt body aches".  Additional Information: Patient wanted to know if he could take paracetamol (TYLENOL) to treat the side effect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 26 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headache".  Additional information: Caller stated that he received the first dose of the Pfizer covid-19 vaccine on 29Mar2021. He had a mild headache but no fatigue. He wanted to get a second opinion on what to do after the vaccination. Caller stated that he normally liked to work out and wanted to know if he can work out and drink a caffeinated sports drink after the 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: Cold sweat, Dizziness, Dry eye, Headache, Hyperhidrosis
Clinical narrative: blurry; eyes were just dry; spin; dizziness; vomiting; sweaty; clammy; nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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: VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "blurry"; DRY EYE (non-serious) with onset 2021, outcome "unknown", described as "eyes were just dry"; VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "spin"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "vomiting"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweaty"; COLD SWEAT (non-serious) with onset 2021, outcome "unknown", described as "clammy"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information: Caller got the first dose of the Pfizer COVID-19 vaccine last Friday (02Mar2021). She was doing fine until Tuesday night (30Mar2021). While she was watching TV, her vision started to get blurry and she started to get dizzy but not fully dizzy. She tried to close her eyes because maybe her eyes were just dry but the dizzy sensation just keeps getting worse and worse. She describes the sensation as the spin when you have drunk too much alcohol. Even when she close her eyes, she still has dizziness. She also started vomiting pretty bad and se got sweaty and clammy. When she got better, she started to feel the symptoms again. She said she never ran a fever. She has nausea and a very slight headache in the eyes the next morning and at night. She was told that this reaction couldn't be from the vaccine since 24-72 hours has passed. Her HCP referred her to Pfizer. She wanted to know if the onset could be later than 72 hours. Consumer reported that It was for herself and she knew what the side effects were. She just wanted to know if side effects could occur after 72 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo, Vision blurred, Vomiting
Clinical narrative: blurry; eyes were just dry; spin; dizziness; vomiting; sweaty; clammy; nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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: VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "blurry"; DRY EYE (non-serious) with onset 2021, outcome "unknown", described as "eyes were just dry"; VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "spin"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "vomiting"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweaty"; COLD SWEAT (non-serious) with onset 2021, outcome "unknown", described as "clammy"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information: Caller got the first dose of the Pfizer COVID-19 vaccine last Friday (02Mar2021). She was doing fine until Tuesday night (30Mar2021). While she was watching TV, her vision started to get blurry and she started to get dizzy but not fully dizzy. She tried to close her eyes because maybe her eyes were just dry but the dizzy sensation just keeps getting worse and worse. She describes the sensation as the spin when you have drunk too much alcohol. Even when she close her eyes, she still has dizziness. She also started vomiting pretty bad and se got sweaty and clammy. When she got better, she started to feel the symptoms again. She said she never ran a fever. She has nausea and a very slight headache in the eyes the next morning and at night. She was told that this reaction couldn't be from the vaccine since 24-72 hours has passed. Her HCP referred her to Pfizer. She wanted to know if the onset could be later than 72 hours. Consumer reported that It was for herself and she knew what the side effects were. She just wanted to know if side effects could occur after 72 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: dry heaves; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 86 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "Had fell" (unspecified if ongoing), notes: was home bound. The patient's concomitant medications were not reported. The following information was reported: RETCHING (non-serious), outcome "unknown", described as "dry heaves".  Additional information: She got her first shot and another on the 14th of April. One day, she woke up and had dry heaves after her first shot but that was weeks later. It took her a long time to get this shot. She had fell and was home bound. Patient was querying if she was going to be ok with that one shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: experienced fatigue and tiredness; feeling sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (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, Batch/Lot number: unknown), administration date: 29Jan2021, for covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "experienced fatigue and tiredness"; SOMNOLENCE (non-serious) with onset 2021, outcome "not recovered", described as "feeling sleepy".  Additional information: the reporter stated that 4 weeks later she experienced the events. Asking if these were the reported side effects after 4 weeks of getting the vaccine. The reporter is feeling fatigued and sleepy even a month later.  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: they just had a sore arm after the 1st injection.; 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "they just had a sore arm after the 1st injection.". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient receive any other vaccines within 4 weeks prior to the COVID vaccine, List of any other medications the patient received within 2 weeks of vaccination, Prior to vaccination, was the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in arm left, administration date 09Mar2021 14:30 (Lot number: ENG207) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lactose intolerant" (unspecified if ongoing); "Type 2 Diabetic" (unspecified if ongoing), notes: Type 2 Diabetic. Concomitant medication(s) included: OZEMPIC; FARXIGA; SIMVASTATIN; UBRELVY. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity. Additional Information: The patient was also taking vitamins for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372707 same drug/reporter, different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: have a history of tinnitus and it got really bad; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "tinnitus" (unspecified if ongoing), notes: history of tinnitus. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "have a history of tinnitus and it got really bad".  Additional information: Patient reported that he has a history of tinnitus and it got really bad after he took the first dose. His fear was that it would get worse after the second dose which he was scheduled for three weeks out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; fatigue; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.