chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity, Rhinorrhoea
Clinical narrative: he is experiencing too much sweating; runny nose; hurting of the left hand; 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), administration date 15Apr2021 (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: HYPERHIDROSIS (non-serious), outcome "unknown", described as "he is experiencing too much sweating"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "hurting of the left hand".  Additional Information: Patient called to report that he was experiencing too much sweating, runny nose and hurting of the left hand after getting the 1st dose of covid-19 vaccine last 15Apr2021. He was scheduled to receive the 2nd dose on 06May2021. He asked if these were normal to experience.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: some dizziness; rapid heartbeat; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 59 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Mar2021 15:30 (Lot number: EN6206) at the age of 59 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: VITAMINS C; VITAMIN D [COLECALCIFEROL]; ELDERBERRY [SAMBUCUS NIGRA]; ZINC. The following information was reported: DIZZINESS (non-serious) with onset 10Mar2021 15:35, outcome "recovered" (10Mar2021), described as "some dizziness"; HEART RATE INCREASED (non-serious) with onset 10Mar2021 15:35, outcome "recovered" (10Mar2021), described as "rapid heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, heart rate increased. Additional information: Patient had no known allergies or any medical condition, stated she was healthy. She was also taking multivitamins. Patient did not receive any other vaccine within 4 weeks prior to vaccination. After dose 1, she experienced some dizziness and a rapid heartbeat within about 5 minutes of getting the dose. The symptoms went away within about 20-25 minutes with some rest and a cold compress on her head at the vaccine site. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441702 same patient/drug, different dose number/events
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: After 15 minutes I started feel numbness in my left hand; tingling in my left hand; it passed almost 2 months after the first dosis and I still feel some pain and numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 12:45 (at the age of 41-year-old) as dose 1, single; and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 08:45 (at the age of 41-year-old) as a dose 2, single both for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to any medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 13:15, the patient started feeling numbness in left hand and tingling in left hand and it passed almost two months after the first dose and the patient still feels some pain and numbness. Therapeutic measures were taken as a result of the events numbness in left hand and tingling in left hand and still feel some pain and numbness which included treatment with ibuprofen for pain and some cream (unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness in left hand and tingling in left hand and still feel some pain and numbness was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Neuralgia, Pain in extremity
Clinical narrative: Fatigue; chills; hot flashes; sore arm; nerve pain; tingling in arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Apr2021 11:45 (Lot number: ewol64) at the age of 19 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication included: ALBUTEROL SULFATE. The following information was reported: FATIGUE (non-serious) with onset 17Apr2021, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 17Apr2021, outcome "recovering", described as "chills"; HOT FLUSH (non-serious) with onset 17Apr2021, outcome "recovering", described as "hot flashes"; PAIN IN EXTREMITY (non-serious) with onset 17Apr2021, outcome "recovering", described as "sore arm"; NEURALGIA (non-serious) with onset 17Apr2021, outcome "recovering", described as "nerve pain"; PARAESTHESIA (non-serious) with onset 17Apr2021, outcome "recovering", described as "tingling in arm". Therapeutic measures were not taken as a result of fatigue, chills, hot flush, pain in extremity, neuralgia, paraesthesia. Additional Information: Patient has no other vaccine within four weeks. Patient did not tested for COVID since vaccination. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021532882 same patient/drug, different dose number/events
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Fatigue; chills; hot flashes; sore arm; nerve pain; tingling in arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Apr2021 11:45 (Lot number: ewol64) at the age of 19 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication included: ALBUTEROL SULFATE. The following information was reported: FATIGUE (non-serious) with onset 17Apr2021, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 17Apr2021, outcome "recovering", described as "chills"; HOT FLUSH (non-serious) with onset 17Apr2021, outcome "recovering", described as "hot flashes"; PAIN IN EXTREMITY (non-serious) with onset 17Apr2021, outcome "recovering", described as "sore arm"; NEURALGIA (non-serious) with onset 17Apr2021, outcome "recovering", described as "nerve pain"; PARAESTHESIA (non-serious) with onset 17Apr2021, outcome "recovering", described as "tingling in arm". Therapeutic measures were not taken as a result of fatigue, chills, hot flush, pain in extremity, neuralgia, paraesthesia. Additional Information: Patient has no other vaccine within four weeks. Patient did not tested for COVID since vaccination. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021532882 same patient/drug, different dose number/events
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm hurt for 4 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Apr2021), described as "left arm hurt for 4 weeks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 16:55 (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 64 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: HEADACHE (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Nausea".  Additional information: There was no history of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines was Administered on Same Date of the Pfizer Suspect. There was no Prior Vaccinations (within 4 weeks).Patient did not experience any AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: I had extreme pain in my left arm.; I also had numbness in both arms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 11:30 (Lot number: ER8727) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "Thyroid disorder" (unspecified if ongoing); "knee replacement" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "cholestrols" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; RESTASIS; TRIAMTERENE; ATORVASTATIN; SYNTHROID. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 17:00, outcome "recovered", described as "I had extreme pain in my left arm."; HYPOAESTHESIA (non-serious) with onset 31Mar2021, outcome "recovered" (31Mar2021), described as "I also had numbness in both arms.". Therapeutic measures were not taken as a result of pain in extremity, hypoaesthesia. Additional information: The patient also received BNT162B2 in arm left, administration date 21Apr2021 11:30 (Lot number: EW0164) as dose 2, single for covid-19 immunisation. The patient's concomitant medication also included latanaprost. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysphemia, Euphoric mood, Somnolence, Speech disorder
Clinical narrative: drowsiness mode; like he was almost high; was speaking but it made no sense at all; stutter/slow motioned type of speech/speaking to him, about 2 incidents in 1 minute/speech difficulty or impediments; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (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: SOMNOLENCE (non-serious) with onset 06Apr2021, outcome "unknown", described as "drowsiness mode"; EUPHORIC MOOD (non-serious) with onset 06Apr2021, outcome "unknown", described as "like he was almost high"; SPEECH DISORDER (non-serious) with onset 06Apr2021, outcome "unknown", described as "was speaking but it made no sense at all"; DYSPHEMIA (non-serious) with onset 06Apr2021, outcome "recovering", described as "stutter/slow motioned type of speech/speaking to him, about 2 incidents in 1 minute/speech difficulty or impediments".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 16:30 (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 15Apr2021, outcome "unknown", described as "pain in right hand".  Additional information: Caller states that she just had the Pfizer COVID vaccine yesterday 15Apr2021 at about 4:30pm and when she got home around 7:00 PM or 8:00 PM her right hand was hurting. Caller states that it is not really a sharp pain. Caller states that she got the Pfizer COVID vaccine in the left arm.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "My arm was hurting".  Additional information: Patient got first shot but due for second shot. Patient's arm was hurting but patient feels lot better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite
Clinical narrative: Stomachache; Doesn't care to eat anything and that's influenced her diet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 (Lot number: EWO158, Expiration Date: 31Jul2021) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Abscess" (unspecified if ongoing), notes: Verbatim: Abscess on her rear end. Concomitant medication(s) included: FENOFIBRATE. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: ER8732, Expiration date - 30Jun2021, Anatomical site of administration: Right upper arm.), administration date: 25Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Stomachache"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "Doesn't care to eat anything and that's influenced her diet". Therapeutic measures were taken as a result of abdominal pain upper, decreased appetite.  Additional information: Reporter stated, had a shot a Pfizer shot yesterday at, that would be 15Apr2021 and she has special aids and special needs but she usually was never sick and she has a stomachache and doesn't care to eat anything and that's influenced her diet and she was wondering if it's from Pfizer or from something else. Reporter stated, Pfizer Covid-19, It dose was her second. Reporter stated, she don't know if this but she had an abscess on her rear end, and she had operated on they lanced it so that the pus could come out and then she has been taking medicine for pain, but she only got 3 of those, as if the whole bunch and it was an opioid. So she was very careful that she didn't get too much and she has not had it since the second day after she had it and then she's taking another medicine. It's a antibiotic, it has, Sulfamethoxazole and Trimethoprim (Product name not clarified. Hence, not captured in tab) and that she gets 2 pills in the morning and 2 pills at night and that was from Sunday and she is still taking those 2 pills. Reporter further stated, No, because her, let's see one for pain but she only take them 3 of those on Sunday, so it was only but the name Hydrocodone, it said as Myosin (Further clarification unknown. Hence, not captured in tab.) and she was just taking for regular kind a stuff she was taking Fenofibrate. and she loves to eat and she has very little to eat and that's all we care to have stuff so she had nothing to eat today. Treatment for AE-Reporter stated, she did gave her Pepto-Bismol last night just small amount. AE Ongoing- Reporter stated, No, she said that her stomach hurts and she has sort of she maybe she eats soup that come with fine noodles and its sort of like more like of she said she didn't wanna miss that.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Consumer stated, patient had this Covid shot yesterday and today patient had a headache and patient wanted to know if it is safe to take aspirin or tylenol or something. Reporter mentioned seriousness for headache was unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Apr2021 (Lot number: ER2613) 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 2021, outcome "unknown", described as "Fatigue".  Additional Context: Consumer stated, "I am just curious about, I got the COVID-19 the Pfizer shot on Monday and you know, I am pretty athletic but I still feel like I am doing athletic stuff, I feel fatigue. Is that normal?" Date of vaccination: Consumer stated, "Where I got it? It says here on this I got it on 12Apr2021." Consumer was provided with the number of Pfizer Information Department. Consumer hung up the call abruptly, hence, product details reporter type and other details were unknown. Limited information was available over the call. Communication: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional information: The patient missed her 2nd shot as she was not feeling well. But her main concern was if it was okay to drink alcohol after taking the 1st 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: Heart rate, Palpitations
Clinical narrative: heart rate racing up to 125-149 beats per minute; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 18:30 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VITAMIN D [COLECALCIFEROL]; PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]. Past drug history included: Toradol, reaction(s): "Drug allergy: Toradol". The following information was reported: PALPITATIONS (non-serious) with onset 07Feb2021 21:00, outcome "recovered" (Feb2021), described as "heart rate racing up to 125-149 beats per minute". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations.  Additional information: after 1st dose, 2nd night patient heart rate racing up to 125-149 beats per minute, next morning it was fine, 2nd dose 2nd night heart started to increase again this time she learned tips to lower heart rate cold pack on face did immediately and was able to keep heart rate to 103 beats per minute she was fine at next morning. Restlessness/lack of sleep-nightmares and other general common well documented symptoms. patient had not got any prior vaccinations, no tested for Covid post vaccinations.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). An 81-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0161), at the age of 81, in right arm, on Apr 12, 2021, single dose, for COVID-19 immunisation. Medical history included atrial fibrillation (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history include the flu shot. The patient developed a headache (head discomfort/felt like a pressure headache), onset Apr 2021, with outcome of unknown. The action taken for BNT162B2 unknown. Additional information: Head discomfort was minor and only lasted an hour. It was like a pressure headache. She had no arm pain at all. The patient wanted to know what to do about getting the second COVID-19 shot. She did not want to get it before the ablation, and did not want to get it a day or two after the ablation. It would be possible to get it the following week after the ablation either Mar 10, 2021 or May 11, 2021. She did not know if the pharmacy would still even have the COVID-19 shot. That would make the second shot 8-9 days later. She possibly could get it on Mar 8, 2021, but doesn't know. She did not receive any prior vaccinations within 4 weeks. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Potentiating drug interaction
Clinical narrative: sore arm; Potential drug interaction; 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 58 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic reaction" (unspecified if ongoing), notes: Rash; "Rash-hives" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone; Kanalog. Vaccination history included: Bnt162b2 (Dose 1,), administration date: 24Mar2021, for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Potential drug interaction".  Additional Information: Reporter would like to know if there was no interaction between steroids and the vaccine either injected (Kanalog) or oral (Prednisone therapy), if the use of steroids take away the protection from the vaccine. Reporter had not received a steroid yet, however she might have to get one of them after she visited her dermatologist because she had an allergy rash "hive-rash" that started a week ago (6-7 days) it was prior to the second dose of the vaccine, she received it last Thursday, 2 days ago. Even before the first dose of the vaccine like 13 months ago she had the first allergy, they are related to the weather or stress (has not received a test yet). Reporter stated that the only side effect she experienced with the first and second doses of the vaccine was a sore arm, it was very sore she felt like someone punched her really hard, she couldn't lift her arm but it was manageable an lasted around day and a half. She further stated she had her 1st dose of the Pfizer Covid-19 vaccine on 24Mar2021 and was scheduled for 2nd dose on 14Apr2021 but she chose to reschedule it to 15Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feels like she's "coming down with something"; This is a spontaneous report received from a non-contactable reporter (Consumer) for a Pfizer sponsored program (159558). 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: MALAISE (non-serious), outcome "unknown", described as "feels like she's "coming down with something"".  Additional Information: The patient needed to reschedule second dose. She felt like she's "coming down with something." She wasn't able to reschedule it on website. She wanted to know if she could get second dose at another site. She also wanted to know how soon second dose to be effective.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the side of my leg and it is like a sharp shooting pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (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, Lot/batch number: Unknown), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Pain in the side of my leg and it is like a sharp shooting pain".  Additional information: Patient stated, "I have a question regarding a possible side effect after the second shot. So, I got my second shot yesterday at 11 O' Clock and around 4 O' Clock yesterday started having pain in the side of my leg and it is like a sharp shooting pain and it happens like in every 2-3 minutes. Was that a possible side effect? Should I be concerned? Have you heard of this?"  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: Fatigue
Clinical narrative: I have been fatigued; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 12:00 (Lot number: ER8733) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL; RITALIN. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer,, Lot number=EN6206,, Administration time=01:00 PM,, Vaccine location=Left arm,, Dose number=1), administration date: 11Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 01Apr2021 15:30, outcome "not recovered", described as "I have been fatigued". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient been fatigued even two weeks after second dose of the Pfizer vaccine. More concerning is that had noticed that when patient took Methylphenidate prescribed to him, get a headache about 1.5 hours after taking it and it lasts for several hours. Taking that medication also seems to compound the fatigue, so it is very difficult to work. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. Known allergies was reported as None.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Vaccination site discomfort
Clinical narrative: Discomfort at shot area for 48+ hrs; onset of minor flu like symptoms took effect 12 hours after shot and lasted over the next 48 hours.; Needed to take naps during this 48 hour period some dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: FR8734) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type-2 Diabetes milletus" (unspecified if ongoing); "Stage 1 Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METFORMIN; ATENOLOL; ATORVASTATIN. Vaccination history included: Bnt162b2 (covid vaccine details , product-COVID 19 , brand-Pfizer, lot unknown reason- Unable to locate or read the details, lot unknown-True, Administration Date-28Feb2021, Administration Time-08:15 AM, vaccine location=Right arm, Dose number-1, Shot 1: Minor discomfort at shot area loss of energy for 24 hours), administration date: 28Feb2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "Minor discomfort at shot area loss of energy for 24 hours", "Minor discomfort at shot area loss of energy for 24 hours". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Discomfort at shot area for 48+ hrs"; INFLUENZA LIKE ILLNESS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "onset of minor flu like symptoms took effect 12 hours after shot and lasted over the next 48 hours."; DIZZINESS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Needed to take naps during this 48 hour period some dizziness". Therapeutic measures were not taken as a result of vaccination site discomfort, influenza like illness, dizziness.  Additional information: Facility type vaccine-Health clinic/Administration Facility. Patient did not received any other vaccine in four weeks. Patient did not have covid prior to vaccination and had not tested for covid post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Vaccination site pain
Clinical narrative: arm pain with the first shot at the injection site; diarrhea; arm pain with the first shot at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 14:00 (Lot number: EN6204) at the age of 69 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Infectious mononucleosis" (unspecified if ongoing), notes: Verbatim: Mononucleosis; "COVID" (unspecified if ongoing), notes: She had the actual COVID back in November. The patient's concomitant medications were not reported. Past drug history included: Flu shot, notes: flu shot -She would have gotten it in October. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 2021, outcome "recovering" and all described as "arm pain with the first shot at the injection site"; DIARRHOEA (non-serious) with onset 2021, outcome "recovering", described as "diarrhea".  Additional information: Patient had arm pain with the first shot at the injection site. It wasn't excruciating. It felt like a flu shot. The pain was there for a couple of days. She had diarrhea after the first injection of COVID19 Vaccine. It wasn't bad but it was there. That lasted for maybe three days. By Tuesday, she was back to normal or where it was in the past. She would say she was starting to feel better than she had been. She has talked to her one friend that had COVID virus. No one caller knew got it except her. She had mononucleosis when she was a teenager and caller did too. Caller is A positive. She is thinking a lot of people are O and those are the people that have not gotten COVID and not gotten sick with the vaccine. Why did she get sick? No further details provided. AE(s) following prior vaccinations: with a flu shot kind of sort of. It wasn't really bad. She wouldn't get deathly ill. She doesn't have NDC, lot, and expiry for flu shot. She would have gotten it in October, and she always gets them at pharmacy.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had very little arm soreness with the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 10:00 (Lot number: EN6204) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stroke", start date: 2014 (unspecified if ongoing), notes: The first was in 2014.; "blood thinner" (unspecified if ongoing); "Stroke", start date: Dec2018 (unspecified if ongoing), notes: The second was Dec2018.; "She had a MRI to confirm" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for blood disorder, start date: Jan2019 (ongoing). Past drug history included: Eliquis for blood thinner, reaction(s): "couldn't deal with Eliquis very well", notes: For 2.5 years after the first stroke; Eliquis for blood thinner, reaction(s): "made her feel like she was dying", notes: For 2.5 years after the first stroke. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "recovered" (05Mar2021), described as "had very little arm soreness with the first dose". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: he has cold; 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "he has cold".  Additional Information: Reporter called on behalf of her father who has a scheduled shot of vaccine, for tomorrow Saturday and this week he did develop a cold around Tuesday. He was feeling better today and reporter was wondering if she want to reschedule; how much longer do we reschedule or something and the other question is if he has cold Should he be getting by the second shot tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: First dose, I was just tired the next day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:30 (Lot number: EN6199) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies_Amoxicillin". The following information was reported: FATIGUE (non-serious) with onset 23Mar2021, outcome "not recovered", described as "First dose, I was just tired the next day". The event "first dose, i was just tired the next day" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of fatigue.  Additional information: It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6205) at the age of 46 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT taken for thyroid disorder. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: intense eye pain in both eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 13:00 (Lot number: EN608) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid cancer", start date: 2008 (unspecified if ongoing); "full thoracotomy", start date: 2008 (unspecified if ongoing). Concomitant medication(s) included: CALCIUM/VITAMIN D [CALCIUM CARBONATE;ERGOCALCIFEROL]; SYNTHROID. The following information was reported: EYE PAIN (non-serious) with onset 22Mar2021 04:30, outcome "not recovered", described as "intense eye pain in both eyes". The event "intense eye pain in both eyes" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of eye pain.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Cramping but it feels more like period thing and I am not on my period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: ER8734, Expiration Date: 31Jul2021) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing). Concomitant medication(s) included: LORATADINE taken for hypersensitivity; SPIRONOLACTONE; GLYCOPYRROLATE [GLYCOPYRRONIUM]. Vaccination history included: Bnt162b2 (Dose 1, LOT(first dose) ER8730, Expiration date(first dose): 31Jul2021, left arm), administration date: 24Mar2021, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "Cramping but it feels more like period thing and I am not on my period".  Additional information: Patient stated that patient was getting like cramping but it feels more like period thing and patient was not on period and it started like a day after second dose."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: I am going through excruciating pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EW0169) 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 (non-serious), outcome "unknown", described as "I am going through excruciating pain". Relevant laboratory tests and procedures are available in the appropriate section. The reporter considered "i am going through excruciating pain" not related to bnt162b2.  Additional Information: The patient just took the Pfizer first dose of Pfizer vaccine on "Friday" and the day of report was Monday. The patient had some dental work done while the patient had an implant, and was going through excruciating pain. However, the patient heard it was not supposed to be, but the patient's prescription was for 800 mg of ibuprofen, and was asking if it can be taken. The patient was waiting to take the second dose in the first week of May. The patient reported to have no side effect from the vaccine but the patient had some dental work done; the patient had an implant some dental work done in morning of the report and the patient needed to take pain killers and was prescribed 800 mg of ibuprofen and was asking if it can be taken.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, the event of pain is not related to suspected drug of bnt162b2, but related to dental implant. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: chills; body aches; diarrhea; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 20Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 16 year-old 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: CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body aches"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Therapeutic measures were taken as a result of diarrhoea.  Additional Information: The patient took bismuth subsalicylate (PEPTO BISMOL) to treat the diarrhea and the reporter wanted to know if that will affect the Pfizer-BioNTech Covid-19 Vaccine. The reporter also wanted to know diarrhea was a common reaction to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.