chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram, Fatigue, Feeling abnormal, Nausea
Clinical narrative: dizzy/Dizziness; nausea; body feels really heavy; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 11:30 (Lot number: ER8732) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing), notes: Verbatim: Multiple sclerosis. Concomitant medication(s) included: BABY ASPIRIN; COLLAGEN; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Product Details: First dose: Pfizer Covid-19 vaccine 8Mar2021, Lot number: ANW199. NDC and expiry date unknown. Right arm, dose unknown, and time administered unknown.), administration date: 08Mar2021, when the patient was 66 years old, for Covid-19 Immunisation. The following information was reported: DIZZINESS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "dizzy/Dizziness"; NAUSEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "body feels really heavy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea.  Additional Information: The reporter stated that the patient received the second dose of the Pfizer Covid-19 vaccine yesterday, 29Mar2021, and stated it was normal for her to have an intense immune response to this but today she was experiencing nausea, light headedness and her body feels really heavy. States he was having her drink a lot of water and trying to get her electrolytes up and wanted to know if she could take Dramamine or nausea medicine.The reporter stated that the patient did take Tylenol and he was wondering if she can take Dramamine to help with nausea. Other Conditions was reported as patient was diagnosed in 2019. The reporter stated that the patient had been taking baby aspirin for a month or two exact dose was unknown and stated the patient hadn't taken it yesterday or today. The patient was taking concomitant Products baby aspirin for her blood thinner, had an echocardiogram.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Gait disturbance
Clinical narrative: dizzy spells; Could barely walk; 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 07Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Verbatim: stent placed" (unspecified if ongoing), notes: Cardiologist placed a stent four years ago. He has had no problems. He works out three times a week. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL9266, Expiration Date: 31May2021,  Anatomical Location: Left arm), administration date: 14Feb2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 26Mar2021, outcome "recovering", described as "dizzy spells"; GAIT DISTURBANCE (non-serious) with onset 26Mar2021, outcome "recovering", described as "Could barely walk". The events "dizzy spells" and "could barely walk" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had received the second dose of the Pfizer covid19 Vaccine on 07Mar2021 and experienced no problems afterwards. About 3 weeks after, however, patient was started getting dizzy. It started when patient went down the stairs and subsided until about 3 hours while he was driving, after turning on a red light. Patient was so dizzy that he got out of the car and could barely walk and got his wife to drive. Patient stated, he was fine but there was still a trace of the symptom and it was less severe than it was. He was also on a HF Monitor and will follow up with his doctor. He is a healthy man who does not get sick usually and he was asking if there have been reports of this with the vaccine. Patient did not take his first card with him when he got the second one so he has two cards. He was not sure which lot# EL9266 and EN6205 was his first dose and which was his second dose. Patient would think the one with the earlier expiration date would have been what he got first, but he wants to say it was not. On the card it says first dose Pfizer EL9266. Patient went to the emergency room on 26Mar2021, for dizziness and and his cardiologist but everything was normal. Patient family history was not reported. Patient did not had any AE wit Prior vaccination. The patient had not received prior vaccinations within 4 weeks of getting his first COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy/Dizziness; 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 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EL9264, Expiration Date: May2021) at the age of 53 years as dose1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALLEGRA; FLUOXETINE; LISINOPRIL; OMEPRAZOLE.  The following information was reported: DIZZINESS (non-serious) with onset 30Mar2021, outcome "unknown", described as "dizzy/Dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional Information: Patient had COVID vaccination at approximately 2:15-2:30 (Further not clarified, hence not captured in tab).  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Had wave after waves of nausea; 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 82 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 24Mar2021 13:00 (Lot number: ER8733) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "Had wave after waves of nausea". Therapeutic measures were not taken as a result of nausea.  Additional information: She wanted to know if this was a normal reaction. Caller stated her kids were scheduling their shots too now and wanted to know if there were any bad reactions, or like 3,500 deaths reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines was administered on same date of the Pfizer suspect. No adverse event requires a visit to emergency room and physician Office. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. She was not aware of about family medical history relevant to AE(s). No relevant test performed.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: Its hard to walk.; Lower back pain; 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 60 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 29Mar2021 13:30 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 60 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: BACK PAIN (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Lower back pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Its hard to walk.".  Additional information: Patient has no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer Suspect. No history of prior vaccinations within 4 weeks of suspect administration. The patient did not visit Emergency room and Physician office. No prior vaccinations within 4 weeks. No AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Muscle spasms, Myalgia, Neck pain
Clinical narrative: tingling sensation; numbness around the right foot going up to the half of my leg; cramping; headache; pain in her neck; muscle pain in her neck and shoulder; 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 63 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 15:45 (Lot number: EN6199) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2003 (ongoing), notes: Verbatim: Asthma; "Allergies" (ongoing), notes: States they started a long time ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 ,, Lot:EP6955 ,Right arm), administration date: 06Mar2021, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 29Mar2021, outcome "recovering", described as "tingling sensation"; HYPOAESTHESIA (non-serious) with onset 29Mar2021, outcome "recovering", described as "numbness around the right foot going up to the half of my leg"; MUSCLE SPASMS (non-serious) with onset 29Mar2021, outcome "recovering", described as "cramping"; HEADACHE (non-serious) with onset 27Mar2021, outcome "recovering", described as "headache"; NECK PAIN (non-serious) with onset 27Mar2021, outcome "recovering", described as "pain in her neck"; MYALGIA (non-serious) with onset 27Mar2021, outcome "recovering", described as "muscle pain in her neck and shoulder".  Additional information: The patient stated " she had received the second dose of the Pfizer vaccine Saturday. She had a tingling sensation and numbness around the right foot going up to the half of her leg since yesterday afternoon." The patient wanted to know if these symptoms were reported with the vaccine. Informed the patient that these symptoms had not been reported with the vaccine. She should always talk with a vaccination provider, doctor, or other qualified health care professional about whether a specific treatment or medication was right for her and before starting a new treatment or activity. The patient was calling about the Pfizer, verified Pfizer Covid Vaccine. The patient stated she wanted to know, well she had her second vaccination this past Saturday 27Mar2021 and she felt fine but yesterday she was taking a shower and felt a lot of tingling, cramping and numbness in her foot and part of her leg, was that normal because of the vaccine, was it a side effect? Clarified it was her right foot and leg. The patient stated she also had a headache and pain in her neck that comes and goes. Stated it was like a muscle pain in her neck and shoulder. No treatment received. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) received 1st Dose of Pfizer Covid Vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling sensation; numbness around the right foot going up to the half of my leg; cramping; headache; pain in her neck; muscle pain in her neck and shoulder; 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 63 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 15:45 (Lot number: EN6199) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2003 (ongoing), notes: Verbatim: Asthma; "Allergies" (ongoing), notes: States they started a long time ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 ,, Lot:EP6955 ,Right arm), administration date: 06Mar2021, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 29Mar2021, outcome "recovering", described as "tingling sensation"; HYPOAESTHESIA (non-serious) with onset 29Mar2021, outcome "recovering", described as "numbness around the right foot going up to the half of my leg"; MUSCLE SPASMS (non-serious) with onset 29Mar2021, outcome "recovering", described as "cramping"; HEADACHE (non-serious) with onset 27Mar2021, outcome "recovering", described as "headache"; NECK PAIN (non-serious) with onset 27Mar2021, outcome "recovering", described as "pain in her neck"; MYALGIA (non-serious) with onset 27Mar2021, outcome "recovering", described as "muscle pain in her neck and shoulder".  Additional information: The patient stated " she had received the second dose of the Pfizer vaccine Saturday. She had a tingling sensation and numbness around the right foot going up to the half of her leg since yesterday afternoon." The patient wanted to know if these symptoms were reported with the vaccine. Informed the patient that these symptoms had not been reported with the vaccine. She should always talk with a vaccination provider, doctor, or other qualified health care professional about whether a specific treatment or medication was right for her and before starting a new treatment or activity. The patient was calling about the Pfizer, verified Pfizer Covid Vaccine. The patient stated she wanted to know, well she had her second vaccination this past Saturday 27Mar2021 and she felt fine but yesterday she was taking a shower and felt a lot of tingling, cramping and numbness in her foot and part of her leg, was that normal because of the vaccine, was it a side effect? Clarified it was her right foot and leg. The patient stated she also had a headache and pain in her neck that comes and goes. Stated it was like a muscle pain in her neck and shoulder. No treatment received. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) received 1st Dose of Pfizer Covid Vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sluggishness, Vaccination site pain
Clinical narrative: pain in left arm at injection site pain in left underarm for a few day; pain in left arm at injection site pain in left underarm for a few day; sluggishness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Mar2021 (Lot number: OEN6206) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: EM9809,, lot unknown: False,, dose number: 1), administration date: 19Feb2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Mar2021, outcome "recovered" (2021) and all described as "pain in left arm at injection site pain in left underarm for a few day"; SLUGGISHNESS (non-serious) with onset 14Mar2021, outcome "recovered" (2021), described as "sluggishness". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, sluggishness.  Additional information: Patient had pain in left arm at injection site pain in left underarm for a few days sluggishness the day after second dose.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Somnolence
Clinical narrative: Headache; achy; diarrhea; extremely sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "Headache"; PAIN (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "achy"; DIARRHOEA (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "diarrhea"; SOMNOLENCE (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "extremely sleepy". Therapeutic measures were not taken as a result of headache, pain, diarrhoea, somnolence. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was concomitantly taking unspecified prescription medications.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Intense pain in left arm (can't lift it); Groggy; This is a spontaneous report received from a contactable reporter (consumer) from a sales representative. The reporter is the patient.  A male patient in his 40's received bnt162b2 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: had previously contracted covid. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Intense pain in left arm (can't lift it)"; SOMNOLENCE (non-serious), outcome "unknown", described as "Groggy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 (DOSE 1), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: At Day 9, after first dose I experienced extreme fatigue.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 68 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 01Mar2021 12:00 (Lot number: EN6203) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; CYANOCOBALAMIN; CALCIUM; OCUVITE; OSTEO BI-FLEX. Past drug history included: Diclofenac, reaction(s): "Drug allergy"; Gabapentin, reaction(s): "Drug allergy"; Keflex, reaction(s): "Drug allergy". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021 12:00, outcome "recovering", described as "At Day 9, after first dose I experienced extreme fatigue.". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366577 same patient, vaccine different dose, different AE.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: At Day 9, after first dose I experienced extreme fatigue.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 68 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 01Mar2021 12:00 (Lot number: EN6203) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; CYANOCOBALAMIN; CALCIUM; OCUVITE; OSTEO BI-FLEX. Past drug history included: Diclofenac, reaction(s): "Drug allergy"; Gabapentin, reaction(s): "Drug allergy"; Keflex, reaction(s): "Drug allergy". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021 12:00, outcome "recovering", described as "At Day 9, after first dose I experienced extreme fatigue.". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366577 same patient, vaccine different dose, different AE.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; Slight dizziness; Sweating; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing), notes: Verbatim: Factor V Leiden; "Osteoarthritis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medications included: CITALOPRAM; B12-VITAMIIN; CALCIUM; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]. Past drug history included: Keflex, reaction: "Drug allergy", notes: Verbatim: Keflex; Gabapentin, reaction: "Drug allergy"; Diclofenac, reaction: "Drug allergy". Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6203, Vaccine location left arm, 12:00 PM), administration date: 01Mar2021, when the patient was 68 years old, for COVID-19 immunization, reaction: "Extreme fatigue". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021 12:00, outcome "recovering", described as "Fatigue"; DIZZINESS (non-serious) with onset Mar2021, outcome "recovering", described as "Slight dizziness"; HYPERHIDROSIS (non-serious) with onset Mar2021, outcome "recovering", described as "Sweating". Therapeutic measures were not taken as a result of fatigue, dizziness, hyperhidrosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Fatigue; Slight dizziness; Sweating; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing), notes: Verbatim: Factor V Leiden; "Osteoarthritis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medications included: CITALOPRAM; B12-VITAMIIN; CALCIUM; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]. Past drug history included: Keflex, reaction: "Drug allergy", notes: Verbatim: Keflex; Gabapentin, reaction: "Drug allergy"; Diclofenac, reaction: "Drug allergy". Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6203, Vaccine location left arm, 12:00 PM), administration date: 01Mar2021, when the patient was 68 years old, for COVID-19 immunization, reaction: "Extreme fatigue". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021 12:00, outcome "recovering", described as "Fatigue"; DIZZINESS (non-serious) with onset Mar2021, outcome "recovering", described as "Slight dizziness"; HYPERHIDROSIS (non-serious) with onset Mar2021, outcome "recovering", described as "Sweating". Therapeutic measures were not taken as a result of fatigue, dizziness, hyperhidrosis.  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, Lymph node pain, Lymphadenopathy, Pain in extremity, Vertigo
Clinical narrative: Arm very sore; A lot of soreness in the lymph nodes on her neck; The lymph node near front of neck slightly swollen; Vertigo; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 14:00 (Lot number: ER8727) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: breast cancer 4 years ago. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "Arm very sore"; LYMPH NODE PAIN (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "A lot of soreness in the lymph nodes on her neck"; LYMPHADENOPATHY (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "The lymph node near front of neck slightly swollen"; VERTIGO (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "Vertigo"; DIZZINESS (non-serious) with onset 30Mar2021 18:00, outcome "recovering", described as "Dizziness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not have allergy to medication, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills; Tiredness; headache; full body muscle pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Mar2021 09:15 (Lot number: EP6955) at the age of 24 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3247, Vaccine location: Left arm, Administration time: 09:15), administration date: 08Mar2021, when the patient was 24 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 29Mar2021 21:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 29Mar2021 21:00, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset 29Mar2021 21:00, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 29Mar2021 21:00, outcome "recovering", described as "full body muscle pain". Therapeutic measures were not taken as a result of chills, fatigue, headache, myalgia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The patient's concomitant medication included an unspecified birth control. The patient had no known allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Can barely undress self, can't unhook things, pulling hands to back hurts; Sore 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 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 10:15 (Lot number: EN6203) as dose 2, single and administered in arm left, administration date 24Feb2021 10:15 (Lot number: EL9808) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bladder Cancer" (unspecified if ongoing), notes: States was 5 years ago and has fully recovered.; "Oral Lichen Plantinus" (ongoing), notes: Spelling of condition as provided by caller. States that she was diagnosed several, maybe 5, years ago. States is autoimmune disorder causing sores in her mouth that do not heal. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Sore Arm"; PAIN (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Can barely undress self, can't unhook things, pulling hands to back hurts".  Additional information: The patient had both shots of the Pfizer BioNTech COVID 19 vaccine , both injected into left arm. After the first shot, patient left arm was hurting a lot and felt like a golf ball on the side, hard and round; second one was also hard but more like a square. The pain was still in her left arm when she got the second shot. The patient left arm still hurts and now it was 2 weeks after her second shot; she can barely move to unhook her bra and arm hurts when she reach for something. she can't lean down on left arm. Pain has gotten worse she can now barely undress herself, has issues unhooking things, pulling her arms behind her back is painful. This was persisting, she mentions not being able to undress herself. she have not contacted her doctor yet because she hopes it would be better. She got her second shot and her arm was still hurting at that time from the first shot three weeks earlier. States it continues hurting now, two weeks since her second shot. The patient told administrators of vaccine that her arm was still hurting from the first one when she went to get the second. She asked them about taking the second one in her right arm but they said not to do that because if both arms were hurting she wouldn't be able to use either arm. The patient stated that she usually does have arm pain after vaccines. Mentions she took a flu shot a few months ago. The patient had no additional Vaccines administered on Same Date of the Pfizer Suspect. The patient not visited Emergency Room or Physician Office. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient Sore Arm was reported as worsened. The patient took COVID Shot because she has a weak immune system.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: she woke up with a head cold this morning; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she woke up with a head cold this morning". Clinical course: The patient received the 1st Pfizer COVID 19 vaccine and scheduled to get her 2nd dose tomorrow, but she woke up with a head cold this morning. Patient would like to know if she should get the 2nd dose.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis
Clinical narrative: chills; cold; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single and administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 07Mar2021, outcome "unknown", described as "chills"; NASOPHARYNGITIS (non-serious) with onset 07Mar2021, outcome "unknown", described as "cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anger, Emotional disorder
Clinical narrative: easily getting angry or emotional; easily getting angry or emotional; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization. The following information was reported: ANGER (non-serious), EMOTIONAL DISORDER (non-serious), outcome "unknown" and all described as "easily getting angry or emotional".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had pain in the arm/soreness in the arm (Injection site); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Loratadine, start date: 03Mar2021, notes: I took Loratadine 10mg for my skin allergy 2days prior to my 1st dose; Steroids clobetasol propionate a topical cream, start date: Mar2021, notes: verbatim:steroids Clobetasol propionate a topical cream, Clobetasol 05% topical cream a week after the 1st shot. Vaccination history included: Bnt162b2 (1st Dose), administration date: 07Mar2021, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "had pain in the arm/soreness in the arm (Injection site)". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: It was reported that caller call to say he received the 2nd dose of vaccine on Sunday 28Mar2021, stated he has not had any side effects aside from soreness in the arm (Injection site). He took two medications prior his 1st dose Loratadine (03Mar2021) and antihistamine (05Mar2021) taken this two times prior the 1st shot on 07Mar2021, not sure how long it will stay in his system. Stated a week after he received the 1st dose; he took steroids Clobetasol propionate a topical cream, said he is taking this in between doses. Took Advil a couple of hours after receiving the 2nd dose. Consulting if taking steroids may have an effect with the efficacy of the vaccine. Call transferred to Pfizer Medical Information. Created manual AE form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Tenderness, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness and "warm to touch" at injection site; redness and "warm to touch" at injection site/red patch; It is swollen and tender to touch/injection site swelling; It is swollen and tender to touch; Red patch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 11:00 (Lot number: EP6955) at the age of 86 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (1st Dose,first dose lot# EN6204), when the patient was 86 years old, for COVID-19 IMMUNIZATION. The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "redness and "warm to touch" at injection site"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness and "warm to touch" at injection site/red patch"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "It is swollen and tender to touch/injection site swelling"; TENDERNESS (non-serious), outcome "unknown", described as "It is swollen and tender to touch"; RASH MACULAR (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Red patch".  Additional information: Patient states that with the regular flu shot used to get the symptoms of the flu, but it didn't last long. The patient hasn't had her flu shot for a couple of years. History of all previous immunization with the Pfizer vaccine considered as suspect: no. Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. The adverse event did not required to visit the Emergency Room and Physician Office. Prior Vaccinations (within 4 weeks): no, just the two COVID vaccines.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 'splitting/crushing' headache; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for Covid-19 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 "'splitting/crushing' headache". Additional Information: Patient states that the event was severe. Patient was wondering if it is okay to take acetaminophen (TYLENOL) to treat headache, as she read acetaminophen should not be taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little soreness 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 72-year-old male patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (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 (1 dose), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "a little soreness in the arm".  Additional information: The patient enquired that if it was true that Tylenol should not be taken before receiving the Pfizer BioNTech COVID-19 vaccine. The patient stated that he and his wife received their second shot on Monday and his wife had taken Tylenol before getting her vaccine. The patient reports that both he and his wife experienced a little soreness in the arm after their vaccinations.  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-2021361581 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: a little muscle ache on one of his arms; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "a little muscle ache on one of his arms". Additional Information: Patient found out that there may be side effects after the second dose and the patient did not know about that. Patient's neighbors and family said they want everyone to take a couple days off after the second dose. Patient was scheduled for the second dose on 13Apr2021 but is scheduled to work 4 days straight. Patient asked if there are side effects after the second dose. Patient stated that the first dose didn't affect him, but had a little muscle ache on one of his arms but it went away.   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
Clinical narrative: had a lot of pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient  (Age: 59; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "had a lot of pain". Therapeutic measures were taken as a result of pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm; Soreness at injection site; Limitation of arm movement; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; TYLENOL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2021 20:00, outcome "not recovered", described as "Sore arm"; VACCINATION SITE PAIN (non-serious) with onset 30Mar2021 20:00, outcome "not recovered", described as "Soreness at injection site"; MOVEMENT DISORDER (non-serious) with onset 30Mar2021 20:00, outcome "not recovered", described as "Limitation of arm movement". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain. Therapeutic measures were taken as a result of movement disorder.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to covid19 vaccine and Patient was not diagnosed with COVID 19 prior to vaccination and since the vaccination patient has not been tested for COVID 19 and no allergies to medications, food other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.