chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling, Rash
Clinical narrative: she woke up today with a swollen bruised area and a knot up under it that wasn't there before either; she woke up today with a swollen bruised area and a knot up under it that wasn't there before either; Swollen arm/swollen arm and forearm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6206) at the age of 85 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (She says that the LOT for the first dose she got on 12Feb2021 is either EL962F or EL9627 and expiry is 04Jun2021), administration date: 12Feb2021, when the patient was 85 years old, for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 10Mar2021, outcome "unknown", described as "Swollen arm/swollen arm and forearm"; CONTUSION (non-serious), RASH (non-serious), outcome "unknown" and all described as "she woke up today with a swollen bruised area and a knot up under it that wasn't there before either". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: she had her second shot 5 days ago, and the swelling wasn't there then but she woke up today with a swollen bruised area and a knot up under it that wasn't there before either. She says she would like to know if she needs to do something about it, or will it eventually go away. She doesn't understand stuff that is explained to her, she is well past that stage. She says her left arm just started swelling today, she got up this morning and noticed it was bigger than the other. She says she has done no treatment for the swelling. Medical Conditions: Caller says she has the same old age diagnosis and the same medications that she has taken all the time, they have never changed. No further details provided about these medications. She says that she is just a happy old lady.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Grip strength, Grip strength decreased, Pain in extremity
Clinical narrative: right arm pain; Pain in his 2 fingers; he can't grip things with that hand; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  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 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "right arm pain"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in his 2 fingers"; GRIP STRENGTH DECREASED (non-serious), outcome "unknown", described as "he can't grip things with that hand". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: Patient received both doses. 2nd dose the patient had right arm pain, took ibuprofen for it. Still has continuing pain in those two fingers his Index and middle fingers. The pain was worse in the morning, but he can't grip things with that hand. No unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eyelid irritation, Inappropriate schedule of product administration, Investigation, Off label use
Clinical narrative: 1st Pfizer vaccine dose on 22Jan2021. 2nd Pfizer vaccine dose on 15Feb2021; 1st Pfizer vaccine dose on 22Jan2021. 2nd Pfizer vaccine dose on 15Feb2021; eye lids are very puffy/puffy eye lids; Lightheadedness; feeling dizzy/Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021285051 (Pfizer).  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 10:00 (Lot number: SC9262) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (ongoing); "Defibrillator/pacemaker insertion", start date: 2015 (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot: EL8982. It was administered in his left arm.), administration date: 21Jan2021, when the patient was 83 years old, for Covid-19 immunisation, reaction(s): "atrial fibrillation", "cardiac arrhythmia", "dizzy", "light headedness", "shortness of breath". The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "1st Pfizer vaccine dose on 22Jan2021. 2nd Pfizer vaccine dose on 15Feb2021"; DIZZINESS (non-serious) with onset 18Feb2021, outcome "recovering", described as "feeling dizzy/Dizziness"; EYELID IRRITATION (non-serious) with onset 05Mar2021, outcome "not recovered", described as "eye lids are very puffy/puffy eye lids"; DIZZINESS (non-serious) with onset 18Feb2021, outcome "recovering", described as "Lightheadedness". The events "feeling dizzy/dizziness", "eye lids are very puffy/puffy eye lids" and "lightheadedness" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: My arms swelled up down to my fingers; it swelled up really really bad; It was hurting just a little bit; I couldn't take my rings off my fingers; Headache; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EL9262) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Open heart surgery", start date: 2019 (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Blood pressure " (unspecified if ongoing); "compromised immune system" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; CLONAZEPAM taken for anxiety; METOPROLOL taken for blood pressure abnormal; PRILOSEC [OMEPRAZOLE] taken for gastrooesophageal reflux disease. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "My arms swelled up down to my fingers; it swelled up really really bad"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It was hurting just a little bit; I couldn't take my rings off my fingers"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Injection site pain". Therapeutic measures were taken as a result of peripheral swelling, pain in extremity, headache, vaccination site pain.  Additional information: The patient had the Pfizer vaccine a couple of days ago and I had a very bad reaction to it. When he got home arms were hurting just a little bit. It woke me up 3 in the morning swollen and paining and something terrible and all yesterday it was swollen so he called his doctor and he told him to take Benadryl. His arm was swollen so bad until he couldn't take his rings off his fingers. So, it was not as bad today it was still swollen, it was not as bad today and he don't remember reading swelling as one of the side effects, but it was very painful, it was swelled up he couldn't get comfortable, it just hurt bad until it brought me to tears. He still has some swelling in my left arm where they administered the vaccine and still have pain. They said some pain will occur at the injection site and he had the headache. The patient stated event date as 10Mar2021 (Not clarified).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: When her son, who is 46 years old, got his first COVID vaccine, he was so dizzy for an hour that he couldn't drive home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 46-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as " When her son, who is 46 years old, got his first COVID vaccine, he was so dizzy for an hour that he couldn't drive home".  Additional information: The patient got his first COVID vaccine, he was so dizzy for an hour that he couldn't drive home. That was his only reaction to the whole thing. He was young and healthy. He said that he was so dizzy that they had him sitting for an hour until he could walk and go home and what happened with patient was an immediate reaction. The patient got the second COVID vaccine and had no problems other than feeling like he got over the flu the day after his second COVID vaccine. Second one was nothing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight ache around injection site; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 (Lot number: EL3247) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "slight ache around injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Facility type vaccine: Workplace clinic. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not covid tested post vaccination. No known allergies. No other medical history. With first dose, the patient experienced only slight ache around injection site (<24hrs).  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Injection site hypoaesthesia, Injection site swelling
Clinical narrative: Tired; At his injection site, he felt numbness; Swollen arm around injection site; Feels weird; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 11Mar2021 09:06 (Lot number: EN6207, Expiration Date: 31Jul2021) at the age of 19 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Autism Spectrum" (ongoing), notes: Diagnosed at 5 Years of Age; "Asperger's Disorder" (ongoing), notes: Diagnosed at 5 Years of Age; "Heavy metal toxicity" (unspecified if ongoing), notes: He had heavy metal toxicity at 5 years old because he had 3 vaccines on the same day; "Thimerosal Poisoning" (unspecified if ongoing). The patient took concomitant medications included Carlson Cod Liver Oil, Floradix Epresat Liquid Multi Vitamin, D3, Eye liquid vitamin. The following information was reported: FATIGUE (non-serious) with onset 11Mar2021 09:06, outcome "recovering", described as "Tired"; INJECTION SITE HYPOAESTHESIA (non-serious) with onset 11Mar2021 09:06, outcome "recovered" (11Mar2021), described as "At his injection site, he felt numbness"; INJECTION SITE SWELLING (non-serious) with onset 11Mar2021 09:06, outcome "recovered" (11Mar2021), described as "Swollen arm around injection site"; FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "unknown", described as "Feels weird". Therapeutic measures were taken as a result of injection site swelling.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appetite disorder, Body temperature, Body temperature decreased, Headache
Clinical narrative: drop in temperature; Headache; Stomach pain; she felt like vomiting; She couldn't eat for one day, didn't feel like eating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 (Lot number: EL1283) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose Lot number is EL1284), for Covid-19 immunisation. The following information was reported: BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "drop in temperature"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain"; VOMITING (non-serious), outcome "unknown", described as "she felt like vomiting"; APPETITE DISORDER (non-serious), outcome "unknown", described as "She couldn't eat for one day, didn't feel like eating". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information:  Did any AEs require a visit to:   Emergency room: no Physician office: no Prior vaccinations (within 4 weeks): none AE(S) following prior vaccinations: none Patient's Medical History (including any illness at time of vaccination): None  Family Medical History Relevant to AE(s): none Relevant tests:  None Patient said hers was very mild, it was something she expected would be normal No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: drop in temperature; Headache; Stomach pain; she felt like vomiting; She couldn't eat for one day, didn't feel like eating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 (Lot number: EL1283) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose Lot number is EL1284), for Covid-19 immunisation. The following information was reported: BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "drop in temperature"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain"; VOMITING (non-serious), outcome "unknown", described as "she felt like vomiting"; APPETITE DISORDER (non-serious), outcome "unknown", described as "She couldn't eat for one day, didn't feel like eating". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information:  Did any AEs require a visit to:   Emergency room: no Physician office: no Prior vaccinations (within 4 weeks): none AE(S) following prior vaccinations: none Patient's Medical History (including any illness at time of vaccination): None  Family Medical History Relevant to AE(s): none Relevant tests:  None Patient said hers was very mild, it was something she expected would be normal No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: middle finger on left hand is swollen/hand is swollen; hurts when she moves the finger/when she moves finger, feels like bee sting; 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 right, administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "not recovered", described as "middle finger on left hand is swollen/hand is swollen"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "hurts when she moves the finger/when she moves finger, feels like bee sting".  Additional information: After the first dose, about 10 minutes after she got home her middle finger on her left hand started swelling. It's on the opposite hand she got the injection in. She didn't think anything about it. She stayed for 30 minutes after her injection. Now it's worse. Now when she moves the finger it feels like a bee sting, that's how it feels.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Crying, Fatigue, Headache, Nausea, Nightmare
Clinical narrative: Nightmares; Nausea; Tired; Headache; Jumbled speech and crying; Jumbled speech and crying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). A 54-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 11:45 (Lot number: EN6208) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Bnt162b2 (First dose, Lot number: EN6200), administration date: 15Feb2021, when the patient was 54 years old for Covid-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 08Mar2021, outcome "recovered" (10Mar2021), described as "Nausea", FATIGUE (non-serious) with onset 08Mar2021, outcome "not recovered", described as "tired", HEADACHE (non-serious) with onset 08Mar2021, outcome "recovering", described as "Headache", SPEECH DISORDER (non-serious), CRYING (non-serious) all with onset 08Mar2021, outcome "recovered" (08Mar2021) and all described as "jumbled speech and crying", NIGHTMARE (non-serious) with onset 10Mar2021, outcome "recovered" (10Mar2021), described as "Nightmares".  Additional Information: The reported stated that the patient had normal side effects, tired, headache and nausea, states he got the vaccine around 11:45AM, states around 8:45 AM he had fallen asleep and when he woke up a few minutes later he was talking and saying things that did not make any sense, his speech was jumbled, saying things like socks is box and even wrote down the same phrase, does not remember himself having this episode, episode has not happened sense. Then all of a sudden, he started crying, states he has not cried in 20 years. States three days after he was having nightmares.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Nightmares; Nausea; Tired; Headache; Jumbled speech and crying; Jumbled speech and crying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). A 54-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 11:45 (Lot number: EN6208) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Bnt162b2 (First dose, Lot number: EN6200), administration date: 15Feb2021, when the patient was 54 years old for Covid-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 08Mar2021, outcome "recovered" (10Mar2021), described as "Nausea", FATIGUE (non-serious) with onset 08Mar2021, outcome "not recovered", described as "tired", HEADACHE (non-serious) with onset 08Mar2021, outcome "recovering", described as "Headache", SPEECH DISORDER (non-serious), CRYING (non-serious) all with onset 08Mar2021, outcome "recovered" (08Mar2021) and all described as "jumbled speech and crying", NIGHTMARE (non-serious) with onset 10Mar2021, outcome "recovered" (10Mar2021), described as "Nightmares".  Additional Information: The reported stated that the patient had normal side effects, tired, headache and nausea, states he got the vaccine around 11:45AM, states around 8:45 AM he had fallen asleep and when he woke up a few minutes later he was talking and saying things that did not make any sense, his speech was jumbled, saying things like socks is box and even wrote down the same phrase, does not remember himself having this episode, episode has not happened sense. Then all of a sudden, he started crying, states he has not cried in 20 years. States three days after he was having nightmares.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a sore arm after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 71 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu vaccine (she gets a sore arm when she receives her annual flu vaccine. She states that it is recurrent after each vaccine. Caller had no product information to provide in regards to the flu vaccines she received.), reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "she had a sore arm after the first dose".  Additional information: Patient did not visit emergency room or physician office for any AE(s). No other products, no patient history and no relevant tests. Family Medical History Relevant to AE(s): No. Caller stated that she was unsure of lot number. She stated that it was either EL9267 or EL9269. She said that the handwriting on the card was messy; her husband believed that it was EL9269. Sore arm with the first COVID-19 vaccine on 13Feb2021, she had no redness no spots or anything. Caller mentions that she gets a sore arm when she receives her annual flu vaccine. She states that it is recurrent after each vaccine. Caller had no product information to provide in regards to the flu vaccines she received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure abnormal, Blood pressure measurement, Somnolence
Clinical narrative: slept all day; changes with blood pressure; Weakness; 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 left, administration date 09Mar2021 13:15 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thalassaemia" (unspecified if ongoing), notes: She states she has thalassemia anemia; "anemia" (unspecified if ongoing), notes: She states she has thalassemia anemia; "blood pressure", start date: 2020 (unspecified if ongoing), notes: She has been checking her blood pressure since 2020. It is usually around 155/68.; "Asthma" (unspecified if ongoing); "Heart murmur" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM taken for blood pressure abnormal (ongoing); SALMETEROL AND FLUTICASONE taken for asthma (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac murmur (ongoing). The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious) with onset 09Mar2021, outcome "not recovered", described as "changes with blood pressure"; ASTHENIA (non-serious) with onset 09Mar2021, outcome "recovering", described as "Weakness"; SOMNOLENCE (non-serious), outcome "unknown", described as "slept all day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient was using concomitant product fluticasone-salmeterol from over 10 years. Had no Prior Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Peripheral swelling, Skin discolouration
Clinical narrative: My arm swelled all up; I still have a big black and blue mark all like a size of an orange on my arm; I was so tired, I went to bed at 6 o clock at night and didn't wake up to 8:30 in the next morning; I was so cold; I got the chills, I was so cold; 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) (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "My arm swelled all up"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "I still have a big black and blue mark all like a size of an orange on my arm"; FATIGUE (non-serious), outcome "unknown", described as "I was so tired, I went to bed at 6 o clock at night and didn't wake up to 8:30 in the next morning"; FEELING COLD (non-serious), outcome "unknown", described as "I was so cold"; CHILLS (non-serious), outcome "unknown", described as "I got the chills, I was so cold".  Additional information: I went to bed at 6 o clock at night and didn't wake up to 8:30 in the next morning and I am concerned if I should have the second shot or not."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Migraine, Pain
Clinical narrative: Chills; Headache; bodyaches; feels a migraine coming again; Caller is not feeling too good; she wants something to relieve her pain and aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "bodyaches"; MIGRAINE (non-serious), outcome "unknown", described as "feels a migraine coming again"; MALAISE (non-serious), outcome "unknown", described as "Caller is not feeling too good"; PAIN (non-serious), outcome "unknown", described as "she wants something to relieve her pain and aches".  Additional information: Caller is not feeling too good. She is calling to ask what she should do for her symptoms after she got the Pfizer Covid19 vaccine. She reported she now has chills, headache, body aches, and feels a migraine coming again. She has never had migraines this bad. Caller mentions she received the vaccine last Friday. Caller wants to know what she can take to relieve side effects she is having from the vaccine? States this is the reason she called because she can not do anything. She is afraid to get the second shot because of these effects. she wants something to relieve her pain and aches. Caller asks does she need to get the second shot after having these effects?   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pain
Clinical narrative: He was sore and uncomfortable for about 36 hours; He was sore and uncomfortable for about 36 hours; He was fatigued and worn out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: PAIN (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "He was sore and uncomfortable for about 36 hours"; FATIGUE (non-serious), outcome "unknown", described as "He was fatigued and worn out".  Additional information: It was reported that when patient got his second dose of the covid vaccine Pfizer vaccine, he was sore and uncomfortable for about 36 hours. It was further reported that patient was fatigued and worn out after he got the second dose.  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: Fatigue, Headache, Pain
Clinical narrative: extreme fatigue; severe headache; some minor aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 09:00 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "history of seasonal allergies" (unspecified if ongoing), notes: history of seasonal allergies; "Covid-19", start date: Nov2020 (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. The following information was reported: FATIGUE (non-serious) with onset 06Mar2021 07:00, outcome "recovered" (2021), described as "extreme fatigue"; HEADACHE (non-serious) with onset 06Mar2021 07:00, outcome "recovered" (2021), described as "severe headache"; PAIN (non-serious) with onset 06Mar2021 07:00, outcome "recovered" (2021), described as "some minor aches". Therapeutic measures were not taken as a result of fatigue, headache, pain. Additional information: 24 hours after first series vaccination, patient experienced extreme fatigue, severe headache and some minor aches. It is worth noting that she was diagnosed with COVID-19 in Nov2020 and while mostly resolved, experienced continuing effects through mid-Feb2021. The patient had covid prior vaccination. The patient was not tested for covid post vaccination. The Pfizer US Drug safety unit recently received the attached report submitted by you. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. The patient learned of the event on 10Mar2021. I am not the patientthis was reported to me by a patient who is not a Pfizer colleague.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Sinus headache, Vaccination site pain
Clinical narrative: sinus pressure headache; right side migraine; soreness at inject site; Slight fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2021 11:45 (Lot number: EL 3247) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SINUS HEADACHE (non-serious) with onset 10Mar2021 06:00, outcome "recovered" (Mar2021), described as "sinus pressure headache"; MIGRAINE (non-serious) with onset 10Mar2021 06:00, outcome "recovered" (Mar2021), described as "right side migraine"; VACCINATION SITE PAIN (non-serious) with onset 10Mar2021 06:00, outcome "recovered" (Mar2021), described as "soreness at inject site"; FATIGUE (non-serious) with onset 10Mar2021 06:00, outcome "recovered" (Mar2021), described as "Slight fatigue". Therapeutic measures were not taken as a result of sinus headache, vaccination site pain, fatigue. Therapeutic measures were taken as a result of migraine.  Additional information: It was reported that 20 hours after injection, began as sinus pressure headache that turned into a right-side migraine. Patient do have migraines but this one was unaffected by Advil which was typically very effective. Headache remained until 10pm 10Mar2021 at which time it ceased rather abruptly. Also had soreness at inject site for approximately the same amount of time. Slight fatigue which subsided once headache ended. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and no covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pain in extremity
Clinical narrative: She states after her first vaccine dose her arm "was a lot more painful than the 2nd dose and lasted for days; Oh it is oozing and wiped it with an alcohol wipe and put a band aid on it. There was liquid 3 inches down my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 2 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunisation, reaction(s): "fatigue", "She states after her first vaccine dose her arm "was a lot more painful than the 2nd dose and lasted for days/sore arms". The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 09Mar2021, outcome "unknown", described as "Oh it is oozing and wiped it with an alcohol wipe and put a band aid on it. There was liquid 3 inches down my arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She states after her first vaccine dose her arm "was a lot more painful than the 2nd dose and lasted for days".  Additional information: The caller stated after receiving her dose on Tuesday, the nurse vaccinating her said, "Oh it is oozing and wiped it with an alcohol wipe and put a band aid on it. There was liquid 3 inches down my arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen lymph nodes in arm of vaccine ancillary and basilic.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jan2021 09:00 (Lot number: El3248) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Mar2021 12:00, outcome "not recovered", described as "swollen lymph nodes in arm of vaccine ancillary and basilic.". The event "swollen lymph nodes in arm of vaccine ancillary and basilic." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Yes treatment received and Tested again and given Tamiflu. No other vaccine in four weeks and Birth control other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, SARS-CoV-2 test
Clinical narrative: Acute tenderness at injection site that worsened as time has gone on; chills approximately 12 hours after the injection was administered; extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 10:45 (Lot number: EL3247) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: covid prior vaccination: Yes. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer Biontech, lot number: EL3248, lot unknown: False, administration date: 17Feb2021, administration time: 01:00 PM, vaccine location: Left arm, dose number: 1), administration date: 17Feb2021, when the patient was 32 years old, for COVID-19 immunization.  The following information was reported: INJECTION SITE PAIN (non-serious) with onset 11Mar2021 02:00, outcome "unknown", described as "Acute tenderness at injection site that worsened as time has gone on"; CHILLS (non-serious) with onset 11Mar2021 02:00, outcome "unknown", described as "chills approximately 12 hours after the injection was administered"; FATIGUE (non-serious) with onset 11Mar2021 02:00, outcome "unknown", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site pain, chills, fatigue.  Additional information: It was reported that, the patient did not take any other vaccine in four weeks of vaccination. It was reported that, the patient had no Known allergies. Reportedly, the patient had tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: their arms were a lot more sore this time/sore arm/side effects for the 1st injection, their arms were sore. But their arms were much more sore this time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EN6205) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prediabetic" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (FIRST DOSE, Batch/Lot number:EL9264), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "their arms were a lot more sore this time/sore arm/side effects for the 1st injection, their arms were sore. But their arms were much more sore this time". Additional information: Caller is calling about COVID vaccine. She pulled a really stupid, they were going along fine, they got the second injection and their arms were a lot more sore this time and she was putting warm moist compresses on her arm but her husband got the bright idea, he had these packets you pop open they are like hand warmers, they are little disks with adhesive on it and she stuck it to the injection site but it got too hot. He had gotten these hand warmers out and he had his on his arm and he started complaining that his felt too hot and he took his off. She should have taken hers off when he was complaining about his being too hot. She confirms her husbands primary care is the same for her husband as she provided for her. He got his second dose also on Monday 8Mar2021.  She is sure they have a box around there somewhere of the hand warmers, they are about the size of your palm and you squeeze it and it heats up, there is adhesive on one side and she stuck it over her injection site, she had been using a warm wash cloth for a compresses but it just cooled off too quick. They told them to use warm compresses on your arm if they were sore but it cooled off too quick so she thought the hand warmer would be good. She found the package of the hand warmers. It is called Hot Hands and they are actually toe warmers that you stick to the bottom of your socks in your shoes. It says they are made by Kobayashi. Lot number is 8036 80062 expiration is Feb2022. She says this pack is opened so this is the pack that they used from so she confirms this would be the correct lot number for both of them. If she had bothered to read the fine print it probably says do not put directly against the skin, it is not their fault. She confirms her husband had said this thing is too hot and took it off, he was using it on the injection site for the same purpose, for a sore arm. He took his off when he was complaining about it being too hot, he was smarted than she was. They did pretty good with side effects for the 1st injection, their arms were sore. But their arms were much more sore this time.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: routine back pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 15Mar2021, outcome "unknown", described as "routine back pain". Therapeutic measures were taken as a result of back pain. Additional information: The patient received BNT162B2 between 10:00 AM to 10:30 AM (as reported). The patient received ibuprofen (taken at about 12:00 PM to 12:30 PM) as treatment for the event.  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, Nausea
Clinical narrative: nauseous; tired and missed work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; FATIGUE (non-serious), outcome "unknown", described as "tired and missed work". Additional information: Caller States that he received 1st dose of Covid vacccine and that night he was nauseous and the next day he was tired and missed work. His 2nd dose is 16Mar and he is wondering if he can reschedule for a day earlier so that he does not miss work as he heard the 2nd dose will make him feel worse than the 1st dose.   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, Nausea, Pain in extremity
Clinical narrative: I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea; I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea; I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea; 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: NAUSEA (non-serious), FATIGUE (non-serious), outcome "not recovered" and all described as "I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I have been nauseated since I took the shot and have been real tired and fatigue, on 9th my arm was just little bit sore but on the 10th till today I have been real fatigue and having nausea". Patient call the Primary Care Physician to make an appointment with him and they find and said  the people they gave the shot to patient. So, patient took the shot on job premises they were issuing the shot."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.