chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Throat tightness, Tremor
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: W/in 15min the pt had pain on left side up her neck and down her arm. Said neck "aching as if she was getting a sore throat". Had concerns of an allergic rxn so admin 1 dose of benadryl. No reports of difficulty breathing, swelling, or itching. W/in next 10 minutes her voice started cracking severely. Called emergency services number because she started to experience chills and some shaking in addition to voice loss and pains on L side. Declined hospitalization. F/u 3hrs later and pt ok but still no voice.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm both times.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 12:00 (Lot number: EN6207) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Aortic bicuspid heart valve" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Pain in arm both times.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. Patient did not receive any other vaccines within four weeks. Prior to the 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.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: he had been getting headaches for 5 days after the shot but now they have still not gone away; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1 single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date the caller stated he previously called because he had been getting headaches for 5 days after the shot and not gone away. He is scheduled for the second dose that day within an hour and a half from now. Nothing he took care of it, not Aspirin or Tylenol. It was reported that he had headache continuously since the 23rd and said hay he had no history of getting headaches often. He asked if it is safe to get the second dose. He stated he saw his doctor on the 6th and informed that would probably a side effect and should go away and suggested to get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.  Follow-up (16Apr2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for himself that: Patient stated that the headache goes up and down and moves around his head. Somedays it is bad and somedays it is not as bad. He said that he normally does not get headaches. His second dose is scheduled for today 16Apr2021. He wants to make sure that it is not contraindicated for him to get his second dose while he still has a headache. Patient was waiting for the confirmation from Pfizer that it is safer to take second shot No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise
Clinical narrative: weak; tired; feeling "generally unwell"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 (Lot number: EN6205) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing); "Gout" (ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE taken for blood pressure measurement; ALLOPURINOL taken for gout. The following information was reported: ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "weak"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tired"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "feeling "generally unwell".  Additional Information: Patient reported that he received his first dose on Monday, 12Apr2021, and he has been feeling "generally unwell". He also reported that this feelings seems to "come and go". Stated he started feeling weak and tired about 2-3 days after he got the vaccine, maybe Tuesday or Wednesday. She is taking concomitant Amlodipine since 4-5 years and Allopurinol since about 5 years or more.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: hot legs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 89 year-old female 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: FEELING HOT (non-serious), outcome "unknown", described as "hot legs".  Additional information: she lives with an 89 year old woman who had hot legs or problem with her legs after receiving the 1st dose of the Pfizer BioNTech Covid 19 Vaccine. She wants to know if she should still receive the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Head discomfort, Headache
Clinical narrative: Feeling Pressure on the Head; Headaches; Fatigue; Chills; 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 21 year-old female 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: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Feeling Pressure on the Head"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional Information: the patient took Pfizer 1st dose 1.5 week ago and had a Feeling pressure on the head, headaches, fatigue, and chills. Asking whether it was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feels not so good; 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 06Mar2021 (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels not so good".  Additional information: It was reported patient feels "not so good", she got the first dose of Pfizer's COVID-19 vaccine on 06Mar2021 at a mall, she was due for the second dose today, but she had surgery last Thursday and the doctor called her and said to hold off taking second dose for a month.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Paraesthesia, Somnolence
Clinical narrative: a little bit dizzy; On his left side of his face he has a very subtle tingly feeling.; sleepy; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 17:00 (Lot number: EW0158) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to shellfish" (unspecified if ongoing), notes: Allergic to shellfish, shrimp, and lobster; "Abdominal hernia" (ongoing); "hypertension" (unspecified if ongoing), notes: The caller has had hypertension on and off, and he was almost prediabetic but isn't any longer. Family history included: "prostate cancer" (unspecified if ongoing), notes: His dad has prostate cancer; "depression" (unspecified if ongoing), notes: His family has a history of depression and things like that. The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 15Apr2021, outcome "not recovered", described as "sleepy"; FATIGUE (non-serious) with onset 15Apr2021, outcome "not recovered", described as "tired"; DIZZINESS (non-serious) with onset 16Apr2021, outcome "not recovered", described as "a little bit dizzy"; PARAESTHESIA (non-serious) with onset 15Apr2021, outcome "not recovered", described as "On his left side of his face he has a very subtle tingly feeling.". No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, SARS-CoV-2 test negative
Clinical narrative: was sweating a lot; cold shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "Covid", start date: Dec2020, stop date: Dec2020, notes: Caller stated his brother had COVID back in December. The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "was sweating a lot"; CHILLS (non-serious), outcome "unknown", described as "cold shivering". He had COVID back in December and was tested negative on 10Jan2021.  Additional information: It was reported that the brother who received the first dose of Pfizer's COVID vaccine yesterday, 15Apr2021, and was sweating a lot with cold shivering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site has gotten progressively more swollen, it's red and itching; injection site has gotten progressively more swollen, it's red and itching; injection site has gotten progressively more swollen, it's red and itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 2021, outcome "unknown" and all described as "injection site has gotten progressively more swollen, it's red and itching". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pruritus.  Additional Information: Basically patient wanted to know if she was having an allergic reaction as the injection site has gotten progressively more swollen, it's red and itching. Patient have taken the Benadryl tablet as treatment for events. Patient was just curious to know whether this would be like a mild allergic reaction to the vaccine and should she report it to like physician or tell the people who gave me the shot. Patient have the vaccination card, lot number looks like either 8729, reported that she have no idea what the expiration date is, patient can tell the date when the injection was given, there is only, don't have the expiration date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced a bad headache as she stated it feels like a concussion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female 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: HEADACHE (non-serious), outcome "unknown", described as "experienced a bad headache as she stated it feels like a concussion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: She has an ear infection; 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 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: EAR INFECTION (non-serious), outcome "unknown", described as "She has an ear infection".  Additional information: It was reported that she is scheduled for her second dose of the vaccine on Sunday, 18Apr2021. She has an ear infection and was prescribed an ear drop with dexamethasone. She asked if it was okay to take this now before/with the vaccine?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: glands or lymph nodes were swollen; pain in the armpit; injection site pain; she experienced "normal" or mild pain in the 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 32 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 32 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: VACCINATION SITE PAIN (non-serious) with onset 12Apr2021, outcome "not recovered", described as "injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 12Apr2021, outcome "not recovered", described as "she experienced "normal" or mild pain in the arm"; LYMPHADENOPATHY (non-serious) with onset 13Apr2021, outcome "unknown", described as "glands or lymph nodes were swollen"; AXILLARY PAIN (non-serious) with onset 13Apr2021, outcome "not recovered", described as "pain in the armpit".  Additional information: After having the vaccine, she experienced "normal" or mild pain in the arm. One day later (Tuesday), she experienced pain in the armpit area that wraps on her elbow and goes inside of the arm- the same arm where the vaccine was administered. She has also observed that her glands or lymph nodes were swollen. The pain also doesn't really go away according to her. Now she wanted to know if these are commonly reported side effects of taking the vaccine. Now she wanted to know if  how long will these symptoms appear/last. Now she wanted to know if she can take something for the pain. Caller verified if we have any data specific to "pain in the armpit area that wraps on her elbow and goes inside of the arm- the same arm where the vaccine was administered" specifically- used VR-Consumer Inquiry Management (Off-Label or No Info) (v15.0) but qualified also that pain in the injection site is reported AE. Referred to physician/HCP for appropriate diagnosis and further clinical recommendations. Response: Pfizer was unable to make any treatment recommendations for individual patients who may receive the Pfizer-BioNTech COVID-19 Vaccine; clinical judgment made by her physician/HCP based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, SARS-CoV-2 test
Clinical narrative: Chills and muscle aches; Chills and muscle 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 10Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: He tested positive for COVID back in Nov2020 and got sick for a week or so and everything was better. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), MYALGIA (non-serious) all with onset 10Apr2021, outcome "recovered" (2021) and all described as "Chills and muscle aches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the first dose of Pfizer's COVID vaccine last Saturday. The patient had symptoms after receiving the first dose the following day. He had chills and muscle aches and it lasted for just that day, the day after vaccination and then it went away. The patient wanted to know if that was normal. The patient was hearing information regarding antibodies and complications of the vaccine if you've already had antibodies for COVID and was wondering if he should be concerned about receiving the second shot. The patient wanted to know if he was supposed to get tested for antibodies after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sever underarm pain on side of injection barely manageable with acetaminophen and ibuprofen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 13:30 (Batch/Lot number: unknown) at the age of 42 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Apr2021 12:00, outcome "not recovered", described as "Sever underarm pain on side of injection barely manageable with acetaminophen and ibuprofen". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Vaccine administered at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Patient had no known allergies. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Tinnitus
Clinical narrative: Within 45 minutes of Pfizer vaccine dose #2, my head started feeling full / whoozy; my ears started ringing/I now have Tinnitus.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 11:45 (Lot number: ER8734) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Rash" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Allergy: Sulfur". Vaccination history included: Bnt162b2 (ER8730, 10:45 am, left arm, dose 1), administration date: 23Mar2021, for COVID-19 immunisation. The following information was reported: HEAD DISCOMFORT (non-serious) with onset 15Apr2021 12:30, outcome "not recovered", described as "Within 45 minutes of Pfizer vaccine dose #2, my head started feeling full / whoozy"; TINNITUS (non-serious) with onset 15Apr2021 12:30, outcome "not recovered", described as "my ears started ringing/I now have Tinnitus.". The events "within 45 minutes of pfizer vaccine dose #2, my head started feeling full / whoozy" and "my ears started ringing/i now have tinnitus." were evaluated at the physician office visit. Therapeutic measures were taken as a result of head discomfort, tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine administered was Hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had reported it to her doctor. She had also switched her Tylenol to Ibuprofen 800mg to help reduce the immune response. Also she was going to start on a dose of B12 to see if that helps.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Tremor
Clinical narrative: felt weak; shaky; felt extremely tired, worn out, exhausted and fatigued; breathing might be a little bit worse but not much; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 13:55 (Lot number: ER8737) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Emphysema" (unspecified if ongoing); "Depression" (unspecified if ongoing); "neuropathy of the feet" (unspecified if ongoing); "two hernias" (unspecified if ongoing); "brain damage" (unspecified if ongoing), notes: The patient reported that he's got brain damage, he's old and senile, crazy.; "too many concussions" (unspecified if ongoing); "memory department is messed up" (unspecified if ongoing), notes: memory department is messed up from too many concussions. Concomitant medication(s) included: ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE; SPIRIVA RESPIMAT. The following information was reported: ASTHENIA (non-serious) with onset 09Apr2021, outcome "unknown", described as "felt weak"; TREMOR (non-serious) with onset 09Apr2021, outcome "recovered" (09Apr2021), described as "shaky"; FATIGUE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "felt extremely tired, worn out, exhausted and fatigued"; DYSPNOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "breathing might be a little bit worse but not much".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Strong nausea/Received second dose 1300 yesterday very nauseous/Exceedingly nauseous; Vomiting/Caller reported that the patient doesn't seem to be able to keep down any liquid; 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 parent.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Apr2021 13:00 (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: 25Mar2021, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 16Apr2021, outcome "unknown", described as "Strong nausea/Received second dose 1300 yesterday very nauseous/Exceedingly nauseous"; VOMITING (non-serious) with onset 16Apr2021, outcome "unknown", described as "Vomiting/Caller reported that the patient doesn't seem to be able to keep down any liquid". Therapeutic measures were taken as a result of nausea.  Additional information: Reporter on behalf of son, 27. Received second dose 13:00 yesterday very nauseous. Unable to keep anything down. Gave Dramamine. Can't keep anything down. Asking for treatment recommendation. Her son was experiencing strong nausea after his second dose. The reporter was asking what was recommended to take for her son. The first dose was taken last 25Mar2021. Reporter stated that the patient doesn't seem to be able to keep down any liquid. Reporter stated that the patient doesn't throw up unless he takes something. Reporter stated that the patient's vomiting was not continuous, just if he takes something. Reporter stated that she just wants to know what she can give the patient so that he can feel better. Reporter stated that all she wants to know was how she can help her son. Reporter stated that the patient was the only member of their family who had received the Pfizer Covid-19 vaccine and that other family members had received the Moderna Covid-19 vaccine. Reporter stated that the patient was the only family member that had received both doses of the Covid-19 vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Limb discomfort, Mammogram, Pain in extremity
Clinical narrative: discomfort in my left are where the shot was given and I  couldn't lift my left arm, it lasted 48 hours; I am experiencing mild soreness in my left arm 18 days later; 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 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Lot number: ER8727) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stress test" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 28Mar2021, outcome "recovered" (2021), described as "discomfort in my left are where the shot was given and I  couldn't lift my left arm, it lasted 48 hours"; PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "not recovered", described as "I am experiencing mild soreness in my left arm 18 days later". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller received the COVID vaccine, and did some background research so she is  aware that arm soreness is a side effect. She did have soreness for 2-3 days. There after, it did become mild, but she has had mild soreness every day since. It is not severe by any means, but this is her 18th day with continual arm soreness. It is mild soreness on the arm that was vaccinated. Is this normal. She has had no other side effects, but this has been wild. It is continuous arm soreness every day. The shot was 18 days ago. She didn't have a prescribing doctor. Her concern is yes there is soreness, but she is supposed to get her second dose on Monday. She is concerned about that. Since the first two days of arm soreness, the soreness is just mild and persistent.  Honestly since the vaccine her left arm has been through the windmill. One time they had trouble getting an IV in her left arm. They were twisting her arm. She also had a a stress test, a Lexiscan, and they were pulling her arm.  This was all shortly after the vaccine. She has been trying to get a hold of someone for over an hour and 40 minutes.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; body aches/I felt sharp pains up my back (more of an ache, like a body ache); 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 45 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 17:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "urinary tract infection" (unspecified if ongoing); "Flu" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "body aches/I felt sharp pains up my back (more of an ache, like a body ache)". Therapeutic measures were taken as a result of headache.  Additional Information: Patient received the first dose of the Pfizer Covid 19 vaccine last Friday at 5pm. Patient is experiencing headache, body aches, this morning patient had a headache, didn't think anything of it cause she had a few glasses of wine last night, this morning patient took Ibuprofen 400mg and took another 400mg around noon because she  still had a headache. An hour later, patient noticed when she walked, patient felt sharp pains up her back (more of an ache, like a body ache), Patient have had this before, with urinary tract infection and the Flu.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Mammogram
Clinical narrative: she feels kind of weak, like I just want to lie down; she has "not [been] feeling well"; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 10:30 (Lot number: EW0164) at the age of 48 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: MALAISE (non-serious) with onset 16Apr2021, outcome "not recovered", described as "she has "not [been] feeling well""; HEADACHE (non-serious) with onset 15Apr2021, outcome "not recovered", described as "headaches"; ASTHENIA (non-serious), outcome "unknown", described as "she feels kind of weak, like I just want to lie down". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported as, after having first Pfizer covid vaccination yesterday and had not been feeling well. She has a headache. Patient states she feels kind of weak, like she just want to lie down. She had a mammogram before the vaccine. She did not treat her symptoms. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no additional administered Vaccines. She explained after vaccination, she has "not [been] feeling well" and has "headaches". She mentioned she is someone who also gets "headaches once in a while". She asked if medication such as Tylenol can be taken after vaccination, for her symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 37-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot#), at the age of 37, in left arm, on Mar 23, 2021, at 16:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had a headache/headache after the first shot lasted the entire day, with outcome of recovered. No therapeutic measures taken as a result of headache. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19, nor tested for COVID-19 since vaccination. Other medical history reported as none. The patient received the 2nd dose on Apr 13, 2021, at 16:45, in left arm. No other vaccine in four weeks and no other medications in two weeks. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: having sharp pains on the left side of my head on my skull; swollen lymph nodes in my throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (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: LYMPHADENOPATHY (non-serious) with onset 14Apr2021, outcome "recovered" (15Apr2021), described as "swollen lymph nodes in my throat"; HEADACHE (non-serious) with onset 15Apr2021, outcome "unknown", described as "having sharp pains on the left side of my head on my skull".  Additional Information: Caller received her 1st Pfizer vaccine dose on 13Apr2021 Then on 14Apr2021 she states "swollen lymph nodes in my  throat that  lasted for one day and then went away. Today, 15Apr2021, I am having sharp pains on the left side of my head on my skull. Caller received her vaccine dose in  her left arm. Caller states  that "Tylenol not helping." How long will this last and no one told us how we are supposed to treat this pain. "Response received that spoke to caller from the attached documents.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain
Clinical narrative: back pain; chills; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male 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: Bnt162b2 (1st dose), for Covid-19 Immunization, reaction(s): "back pain", "chills", "body aches". The following information was reported: PAIN (non-serious), outcome "not recovered", described as "more intense pain"; BACK PAIN (non-serious), outcome "unknown", described as "back pain"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body aches". Therapeutic measures were taken as a result of pain, back pain, chills, pain.  Additional information: Patient Age was not provided. Event Verbatim: Patient stated he received the second dose of the Pfizer Covid vaccine and has been experiencing more intense pain this time around than the first dose, In particular his back pain, although he was also having chills and body aches, but the most intense was his back pain. He was taking Tylenol which was not helping and would like to take Ibuprofen. Patient wanted to know if it was allowed to take Ibuprofen because Tylenol does not do anything for the pain. In the Pfizer-BioNTech COVID-19 vaccine study, people were allowed to take fever-reducing medications and pain relievers. The Centers for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for the use of COVID-19 mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine) during the Emergency Use Authorization. These interim considerations state that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Middle ear effusion, Product administered at inappropriate site
Clinical narrative: Ear ache; Fluid in the ear; Vaccine administered at inappropriate site (Left leg); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 31Mar2021 10:30 (Lot number: ER8734) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6199; Anatomical location: Left leg; Administration time: 13:30.), administration date: 03Mar2021, when the patient was 42 years old, for COVID-19 immunisation, reaction(s): "vaccine location: Left leg". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31Mar2021 10:30, outcome "unknown", described as "Vaccine administered at inappropriate site (Left leg)"; EAR PAIN (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Ear ache"; MIDDLE EAR EFFUSION (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Fluid in the ear". The events "ear ache" and "fluid in the ear" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of ear pain. Therapeutic measures were taken as a result of middle ear effusion.  Additional information: 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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food, or other products. Patient experienced ear ache, fluid in the ear and drainage on the left side of head. Two weeks and still not cleared up. Therapeutic measures were taken for the event fluid in the ear and included drainage on the left side of the head. The patient reported that treatment included decongestant but was not taken.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Ear ache; Fluid in the ear; Vaccine administered at inappropriate site (Left leg); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 31Mar2021 10:30 (Lot number: ER8734) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6199; Anatomical location: Left leg; Administration time: 13:30.), administration date: 03Mar2021, when the patient was 42 years old, for COVID-19 immunisation, reaction(s): "vaccine location: Left leg". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31Mar2021 10:30, outcome "unknown", described as "Vaccine administered at inappropriate site (Left leg)"; EAR PAIN (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Ear ache"; MIDDLE EAR EFFUSION (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Fluid in the ear". The events "ear ache" and "fluid in the ear" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of ear pain. Therapeutic measures were taken as a result of middle ear effusion.  Additional information: 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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food, or other products. Patient experienced ear ache, fluid in the ear and drainage on the left side of head. Two weeks and still not cleared up. Therapeutic measures were taken for the event fluid in the ear and included drainage on the left side of the head. The patient reported that treatment included decongestant but was not taken.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Otorrhoea, Upper-airway cough syndrome
Clinical narrative: Ear ache; Fluid in the ear; Vaccine administered at inappropriate site (Left leg); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 31Mar2021 10:30 (Lot number: ER8734) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6199; Anatomical location: Left leg; Administration time: 13:30.), administration date: 03Mar2021, when the patient was 42 years old, for COVID-19 immunisation, reaction(s): "vaccine location: Left leg". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31Mar2021 10:30, outcome "unknown", described as "Vaccine administered at inappropriate site (Left leg)"; EAR PAIN (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Ear ache"; MIDDLE EAR EFFUSION (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Fluid in the ear". The events "ear ache" and "fluid in the ear" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of ear pain. Therapeutic measures were taken as a result of middle ear effusion.  Additional information: 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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food, or other products. Patient experienced ear ache, fluid in the ear and drainage on the left side of head. Two weeks and still not cleared up. Therapeutic measures were taken for the event fluid in the ear and included drainage on the left side of the head. The patient reported that treatment included decongestant but was not taken.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia
Clinical narrative: experiencing acute memory loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. 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: AMNESIA (non-serious), outcome "not recovered", described as "experiencing acute memory loss".  Additional information :Patient's second dose was scheduled for Today but he had an issue with work. He tried to reschedule the vaccination at his facility but it was too packed that they told him they cannot schedule him for an appointment until 30 days later. As reported by the patient that he and his male partner received their 1st dose of the vaccine and have been experiencing acute memory loss that has not gone away. He mentions that it was very concerning and has made him vary wary because he can't remember anything anymore such as day to day things like where he placed his key. it was reported by the patient that he and his partner was very healthy, did not take medication, with his partner not been having a vaccine ever since childhood, and are vegetarian. This was the first time that has happen to them, given his old age. he was aware that the side effects of the 2nd dose might be worse than the 1st dose as said by his community members. He also mentioned that he saw in the news today that Dr. mentioned that about 5800 people who got fully vaccinated had full blown covid and even 73 of them died.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427876 same reporter/drug/AE, different patient