chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: light pain on the 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 female patient received bnt162b2 (BNT162B2), 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: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "light pain on the injection site". Additional information: She asked if she can take a Aleve before 2nd dose. She has a schedule to take her 2nd dose on 05Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: back spasms with both shots; 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 Feb2021 (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: MUSCLE SPASMS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "back spasms with both shots". It was unknown if therapeutic measures were taken as a result of muscle spasms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: hot flashes were significantly relieved for 2-3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hot flashes due to menopause" (unspecified if ongoing); "hot flashes due to menopause" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), described as "hot flashes were significantly relieved for 2-3 days".  Additional information: Customer stated, after I received my first Covid vaccination, my hot flashes were significantly relieved for 2-3 days. Is there a possibility there is something in the vaccine that can be developed to treat hot flashes due to menopause.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: she had a situation in her arm: it had swelling; she has a hard time trying to raise it to her shoulder/also got pain in the forearm; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "she had a situation in her arm: it had swelling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she has a hard time trying to raise it to her shoulder/also got pain in the forearm"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional information: Reporter mentioned that his mother got the first dose of the Pfizer covid vaccine 2 weeks ago on March 16th and after that 2 week period she had a situation in her arm: it had swelling and she has a hard time trying to raise it to her shoulder and also got pain in the forearm. He said that there is notorious difference between each arm. He calls to report the situation and to know what they can do about it. Patient has arthritis and was born in the year 1956. Response included and explained the reporter that there were reports of pain and swelling in the injection site as well as muscle pain, so this could be most likely a side effect to the covid vaccine. Recommended consulting a physician for medical recommendations and guidance on the situation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: chills; body ache; sore arm after receiving the second dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after receiving the second dose of the vaccine". Additional information: The events took place less than 24 hours after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Spinal pain
Clinical narrative: the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; 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 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 ,single for covid-19 immunisation. Relevant medical history included: "faint" (unspecified if ongoing), notes: As a child , had a negative reaction when i got vaccination I fainted. I'm reminded the event. The patient's concomitant medications were not reported. The following information was reported: SPINAL PAIN (non-serious), BACK PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Anxiety, Back pain, Dizziness, Fall
Clinical narrative: the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; 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 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 ,single for covid-19 immunisation. Relevant medical history included: "faint" (unspecified if ongoing), notes: As a child , had a negative reaction when i got vaccination I fainted. I'm reminded the event. The patient's concomitant medications were not reported. The following information was reported: SPINAL PAIN (non-serious), BACK PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal pain
Clinical narrative: the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; 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 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 ,single for covid-19 immunisation. Relevant medical history included: "faint" (unspecified if ongoing), notes: As a child , had a negative reaction when i got vaccination I fainted. I'm reminded the event. The patient's concomitant medications were not reported. The following information was reported: SPINAL PAIN (non-serious), BACK PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Spinal pain
Clinical narrative: the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; tripped; My anxiety is up; I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation.; 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 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Faint" (unspecified if ongoing), notes: I had to stand in line (to get vaccinated) and it June, it was very hot. I fainted. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), SPINAL PAIN (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached"; FALL (non-serious), outcome "unknown", described as "tripped"; ANXIETY (non-serious), outcome "unknown", described as "My anxiety is up"; DIZZINESS (non-serious), outcome "unknown", described as "I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation.".  Additional information: Patient received the 2nd dose of the Pfizer vaccine. She stated, "While I was sitting there. I did feel, the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached. (caller also shared this prior to getting the 2nd dose) I fell down the stairs as we were leaving (that's unusual) I don't know how I tripped. I'm ok. My anxiety is up. I got my 2nd dose in a rush because my husband was going out of town (he will be away for 4 days). I would like someone to check up on me to make sure I'm doing okay. As a child 1 time before I had a negative reaction under the same circumstances and I had to stand in line (to get vaccinated) and it June, it was very hot. I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation. I'm just concerned since my husband isn't here for the next 4 days. Good idea to have someone give me a call in the afternoon to make sure I'm ok."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Anxiety, Back pain, Dizziness, Fall
Clinical narrative: the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; tripped; My anxiety is up; I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation.; 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 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Faint" (unspecified if ongoing), notes: I had to stand in line (to get vaccinated) and it June, it was very hot. I fainted. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), SPINAL PAIN (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached"; FALL (non-serious), outcome "unknown", described as "tripped"; ANXIETY (non-serious), outcome "unknown", described as "My anxiety is up"; DIZZINESS (non-serious), outcome "unknown", described as "I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation.".  Additional information: Patient received the 2nd dose of the Pfizer vaccine. She stated, "While I was sitting there. I did feel, the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached. (caller also shared this prior to getting the 2nd dose) I fell down the stairs as we were leaving (that's unusual) I don't know how I tripped. I'm ok. My anxiety is up. I got my 2nd dose in a rush because my husband was going out of town (he will be away for 4 days). I would like someone to check up on me to make sure I'm doing okay. As a child 1 time before I had a negative reaction under the same circumstances and I had to stand in line (to get vaccinated) and it June, it was very hot. I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation. I'm just concerned since my husband isn't here for the next 4 days. Good idea to have someone give me a call in the afternoon to make sure I'm ok."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal pain
Clinical narrative: the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; tripped; My anxiety is up; I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation.; 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 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Faint" (unspecified if ongoing), notes: I had to stand in line (to get vaccinated) and it June, it was very hot. I fainted. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), SPINAL PAIN (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached"; FALL (non-serious), outcome "unknown", described as "tripped"; ANXIETY (non-serious), outcome "unknown", described as "My anxiety is up"; DIZZINESS (non-serious), outcome "unknown", described as "I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation.".  Additional information: Patient received the 2nd dose of the Pfizer vaccine. She stated, "While I was sitting there. I did feel, the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached. (caller also shared this prior to getting the 2nd dose) I fell down the stairs as we were leaving (that's unusual) I don't know how I tripped. I'm ok. My anxiety is up. I got my 2nd dose in a rush because my husband was going out of town (he will be away for 4 days). I would like someone to check up on me to make sure I'm doing okay. As a child 1 time before I had a negative reaction under the same circumstances and I had to stand in line (to get vaccinated) and it June, it was very hot. I fainted. and I think I'm reminded of that event. I have that kind of sensitivity if I'm rushed and in a compromised situation. I'm just concerned since my husband isn't here for the next 4 days. Good idea to have someone give me a call in the afternoon to make sure I'm ok."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: back issues; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 10Apr2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE. The following information was reported: BACK DISORDER (non-serious), outcome "unknown", described as "back issues". Therapeutic measures were taken as a result of back disorder.  Additional information: The patient got the first Pfizer COVID-19 shot and he was scheduled to take the second dose of the vaccine this Saturday (10Apr2021). His doctor has prescribed him prednisone for his back issues. He wanted to know if there would be interactions between the Pfizer COVID-19 shot and prednisone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: my tremor was not happening anymore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "parkinsons" (unspecified if ongoing), notes: normally takes medication to control the tremors, but it doesn't control them 100%. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 04Mar2021, outcome "unknown", described as "my tremor was not happening anymore".  Additional information: On Sunday afternoon the 04Mar2021, the patient received the Pfizer vaccine. The patient was 35-year-old Parkinsons patient and after receiving the vaccine about 9 hours later around 11pm I woke up and realized that my tremor was not happening anymore, the effects lasted until about 4 pm the next day. I would really like to speak with someone about the experience I had with your vaccine. Caller stated that he started experiencing tremors around 4:30-5:00 on 05Mar2021 evening. Caller stated that he normally takes medication to control the tremors, but it doesn't control them 100%.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: face and abdomen felt like when you get contrast dye with a CT; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 13:00 (Lot number: EN6198) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ocular rosacea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "Sinus" (unspecified if ongoing), notes: Sinus; "allergies: Penicillin/ allergic to Penicillin" (unspecified if ongoing), notes: allergies: Penicillin/ allergic to Penicillin; "allergies: Yellow Dye #5/ allergic reaction" (unspecified if ongoing), notes: allergies: Yellow Dye #5/ allergic reaction 10 years ago with Yellow Dye 5; "Dermatomyositis" (unspecified if ongoing), notes: Diagnosed after an allergic reaction 10 years ago with Yellow Dye 5 on a low dose Aspirin regimen. Concomitant medication(s) included: LIVALO; ASMANEX; NASOCORT; SINGULAIR; AZELA; AREDS. Past drug history included: Aspirin, reaction(s): "allergies: Aspirin", notes: allergies: Aspirin; Ceclor, reaction(s): "allergies: Ceclor", notes: allergies: Ceclor; Lumify, reaction(s): "allergies: Brimonidine Tartrate/ allergic to Brimonidine Tartrate (Lumify)", notes: allergies: Brimonidine Tartrate/ allergic to Brimonidine Tartrate (Lumify). The following information was reported: SKIN DISORDER (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "face and abdomen felt like when you get contrast dye with a CT". Therapeutic measures were not taken as a result of skin disorder.  Additional information: With her first dose her face and abdomen felt like when you get contrast dye with a CT. lasted 5 minutes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Other. The patient received second dose of Pfizer covid vaccine on 22Mar2021 13:00 (lot number: EN6502) administered in right arm.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 36-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 25, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had dysgeusia (strong metallic taste in her mouth, which lasted only 30 seconds to 1 minute), onset 2021, with outcome of recovered (2021). Clinical course: Reportedly, patient experienced a strong metallic taste in her mouth, which lasted only 30 seconds to 1 minute. It went away afterwards. Patient wanted to know this was normal, and if it is ok to receive the second dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: hard to walk; legs hurts; muscles aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "hard to walk"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "legs hurts"; MYALGIA (non-serious), outcome "unknown", described as "muscles aches".  Additional Information: Took last shot of Pfizer today.  Anybody complain about muscle aches in legs? Has lower back problems.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Vaccination site pain
Clinical narrative: arm was sore at the injection site for a few days; underneath her arm it became sore and stayed that way and it spread to the side of her breast around her ribs; swollen lymph nodes; 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 78-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EL9264) at the age of 78 years as dose 2, single for covid-19 immunization.   Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN; METFORMIN; HYDROCHLOROTHIAZIDE.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm was sore at the injection site for a few days"; PAIN (non-serious), outcome "unknown", described as "underneath her arm it became sore and stayed that way and it spread to the side of her breast around her ribs"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  Additional information: The patient received the second dose of vaccine on 05MAR2021, her arm was sore at the injection site for a few days, but then underneath her arm it became sore and stayed that way and it spread to the side of her breast around her ribs. Patient heard that the vaccine could affect the lymph glands, she consulted a pediatrician who did mention about having a lymph nodes "something". Patient would like to know if this will go away and if the swollen lymph nodes are supposed to last 10 days. Consumer stated that she received antacid pill twice a day it is an just over the counter. The patient had blood work at doctor's office but that was in general for what he was treated and not in reference to the shot.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: lower back pain; My arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 12:45 (Lot number: EP6955) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Pork causes rosacea" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL. Past drug history included: Cipro for Known allergies: Cipro; Nexium for Known allergies: Nexium. Vaccination history included: Bnt162b2 (Dose 1; lot number: EL3247, administration time: 11:15 AM, vaccine location: Left arm), administration date: 12Mar2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Apr2021 08:00, outcome "not recovered", described as "My arm was sore"; BACK PAIN (non-serious) with onset 06Apr2021, outcome "not recovered", described as "lower back pain". Therapeutic measures were taken as a result of pain in extremity, back pain.  Additional information: There was no other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. After second shot the patient went to bed, during the whole night she was not able to turn because her arm was sore, the next morning she woke up without the sore arm but started experiencing lower back pain. She thought it was caused because she stayed in the same position all night, but it has been 4 days and the pain was not going away. The patient confirmed that she started experiencing pain in her lower back the next day after receiving her second vaccine, however, she attributed it to a bad position while sleeping, this has happened to her in the past and the pain usually went away after a few days. She became aware of this event Tuesday 06Apr2021 when her back pain became more severe. Tuesday 06Apr2021 was the day she connected the back pain with the vaccination. Advil has lowered the pain.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast mass
Clinical narrative: doctors found a mass on my breast and I am waiting on results of a biopsy; 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST MASS (non-serious), outcome "unknown", described as "doctors found a mass on my breast and I am waiting on results of a biopsy". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 3, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a headache (pain on the left-side of head/twitching pain in head), onset Apr 4, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Decreased appetite, Delusion
Clinical narrative: delusional; acting confused; has lost 15 pounds; cold chills; poor appetite; weakness; she has changed, she is just different/generally not feeling the same/she is struggling with things that are not real and is not making sense; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (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: DELUSION (non-serious) with onset 2021, outcome "unknown", described as "delusional"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "acting confused"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "has lost 15 pounds"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "cold chills"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "poor appetite"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she has changed, she is just different/generally not feeling the same/she is struggling with things that are not real and is not making sense".  Additional information: Reporter herself was a nurse and stated that her mom was not delusional but different, clarified at times she was delusional. Stated she was complaining of a cold chills and does not want to leave the house because she was having cold and not in her right mind since the vaccine and it has changed her. Reporter wanted to know if these are being caused by the vaccine, before start involving other things since the vaccine was the only thing that has changed. Stated she has been totally healthy and of sound mind and she took the Pfizer vaccine back in Feb2021 and she seems like she has changed, she was just different. States she was struggling with things that were not real and was not making sense.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Weight decreased
Clinical narrative: delusional; acting confused; has lost 15 pounds; cold chills; poor appetite; weakness; she has changed, she is just different/generally not feeling the same/she is struggling with things that are not real and is not making sense; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (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: DELUSION (non-serious) with onset 2021, outcome "unknown", described as "delusional"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "acting confused"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "has lost 15 pounds"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "cold chills"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "poor appetite"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she has changed, she is just different/generally not feeling the same/she is struggling with things that are not real and is not making sense".  Additional information: Reporter herself was a nurse and stated that her mom was not delusional but different, clarified at times she was delusional. Stated she was complaining of a cold chills and does not want to leave the house because she was having cold and not in her right mind since the vaccine and it has changed her. Reporter wanted to know if these are being caused by the vaccine, before start involving other things since the vaccine was the only thing that has changed. Stated she has been totally healthy and of sound mind and she took the Pfizer vaccine back in Feb2021 and she seems like she has changed, she was just different. States she was struggling with things that were not real and was not making sense.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of personal independence in daily activities, Mammogram, Nausea
Clinical narrative: she had to stop what she was doing at the time.; She began to experience waves of nausea; She said she got dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EW0150) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood Pressure" (unspecified if ongoing), notes: Patient taking blood pressure medicine, and her blood pressure was controlled. The patient took concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 04Apr2021, outcome "not recovered", described as "She began to experience waves of nausea"; DIZZINESS (non-serious) with onset 04Apr2021, outcome "not recovered", described as "She said she got dizzy"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she had to stop what she was doing at the time.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient received first dose on 30Mar2021 between 13:00-13:30. On Sunday, 04Apr2021, she began to experience waves of nausea and dizziness that are ongoing and, were "actually even worse today".  The symptoms come and go. The patient had not checked BP because she was at home, didn't have a fever. On Sunday morning (04Apr2021), she had 4 cups of coffee, and started cleaning her son's bathroom. She said she got dizzy and had nausea, clarifying she had to stop what she was doing at the time. She said she couldn't go out to dinner with her children on Sunday because the dizziness and nausea kept waving in and out. She had been on the blood pressure medicine for a while. Additional Vaccines Administered on Same Date of the Pfizer Suspect were None. Prior Vaccinations (within 4 weeks) were None.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: Mononucleosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 18 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: INFECTIOUS MONONUCLEOSIS (non-serious) with onset Mar2021, outcome "unknown", described as "Mononucleosis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 01:30 (Lot number: EN6202) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lyme disease" (unspecified if ongoing), notes: 14 years of Lime disease, treatment successfully completed 3 years ago.; "Food allergy" (unspecified if ongoing), notes: Food sensitivities (many, not anaphylactic). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "recovered" (Mar2021), described as "sore arm for 24 hours". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: dizziness; malaise; aches and pains; carsick type feeling; lethargy; headache; Lack of coordination; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 11:00 (Lot number: 8737) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Major depression; "anxiety" (unspecified if ongoing), notes: generalized anxiety. Concomitant medication(s) included: BUPROPION; KLONOPIN; ESCITALOPRAM; VIT D. The following information was reported: COORDINATION ABNORMAL (non-serious) with onset 05Apr2021 13:00, outcome "not recovered", described as "Lack of coordination"; FATIGUE (non-serious) with onset 05Apr2021 13:00, outcome "not recovered", described as "fatigue"; DIZZINESS (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "dizziness"; MALAISE (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "malaise"; PAIN (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "aches and pains"; FEELING ABNORMAL (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "carsick type feeling"; LETHARGY (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "lethargy"; HEADACHE (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of coordination abnormal, fatigue, dizziness, malaise, pain, feeling abnormal, lethargy, headache.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. Centrum and multi V medications received by the patient within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pain
Clinical narrative: dizziness; malaise; aches and pains; carsick type feeling; lethargy; headache; Lack of coordination; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 11:00 (Lot number: 8737) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: Major depression; "anxiety" (unspecified if ongoing), notes: generalized anxiety. Concomitant medication(s) included: BUPROPION; KLONOPIN; ESCITALOPRAM; VIT D. The following information was reported: COORDINATION ABNORMAL (non-serious) with onset 05Apr2021 13:00, outcome "not recovered", described as "Lack of coordination"; FATIGUE (non-serious) with onset 05Apr2021 13:00, outcome "not recovered", described as "fatigue"; DIZZINESS (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "dizziness"; MALAISE (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "malaise"; PAIN (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "aches and pains"; FEELING ABNORMAL (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "carsick type feeling"; LETHARGY (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "lethargy"; HEADACHE (non-serious) with onset 06Apr2021 09:30, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of coordination abnormal, fatigue, dizziness, malaise, pain, feeling abnormal, lethargy, headache.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. Centrum and multi V medications received by the patient within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Skin abrasion
Clinical narrative: devoloped lesions 1 week later; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (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: SKIN ABRASION (non-serious) with onset 23Mar2021, outcome "unknown", described as "devoloped lesions 1 week later". Therapeutic measures were not taken as a result of skin abrasion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleepy or drowsiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient 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: SOMNOLENCE (non-serious), outcome "unknown", described as "Sleepy or drowsiness". Additional information: The patient wanted to know how long the vaccine was effective for.   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: pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 12Mar2021 (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 (hospitalization) with onset 2021, outcome "unknown", described as "pain". The patient was hospitalized for pain (start date: 2021). Therapeutic measures were taken as a result of pain. Clinical course: It was reported that the patient was just in the hospital and was taking 2 different antibiotics as pain killers. She wanted to known if she should get the 2nd dose tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.