chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 62 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: GOUT (non-serious) with onset 21Apr2021, outcome "unknown", described as "Gout attack". Therapeutic measures were taken as a result of gout.  Additional information: The patient took Colcrys and Allopurinol as a treatment drug.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain upper, Nausea, Pyrexia, Vomiting
Clinical narrative: High fever for 2 days, pain in stomache, resolved then nausea/vomiting 3rd day.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Rash, Swelling
Clinical narrative: The day after the vaccine was given (02/16/22) I experienced major swelling and pain in my armpit area (right arm) which was the same arm I received the vaccine.  After 5 days the pain and swelling still persist and a slight rash around the armpit area.  The injection site itself I have no issues with.
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DEPRESSION (non-serious), outcome "unknown", described as "depression".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481483 same reporter/drug, similar AE, different patient;US-PFIZER INC-2021481530 same reporter/drug, similar AE, different patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister, Lip disorder, Lip pain, Lip swelling
Clinical narrative: Received second dose vaccine on 2/16 at 1:50p, on 2/17 around 10pm noticed my top lip was irritated and sore on outside only. Woke up 2/18 with multiple small bumps/blisters on outside of top lip. Lip was also sore, irritated and swollen.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Laboratory test normal, Pyrexia, Vomiting
Clinical narrative: First pregnancy, estimated due date 2/23/2022. Recieved moderna booster shot with appointment scheduled for 10:15AM 10/30/2021 at Pharmacy. Shortly after I began to "throw up" (my version of throwing up due to pyloric stenosis). I continued to repeatedly throw up throughout the day and into early morning hours. Went into emergency room in early morning hours the following day after throwing up 3-4 times in an hour and having difficulty keeping fever down. Recieved IV fluids and antinausea medications. Symptoms resolved and I went home after a couple hours. Had nausea/vomitting throughout entire pregnancy, but this was the most intense episode during entire pregnancy and required intervention. I did not have so incidents of vomitting throughout the entire pregnancy as I did within the 24 hour time frame following my booster vaccine. The most I threw up per day was 4 times outside of the period following the booster.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Heart rate increased, Musculoskeletal stiffness, Myalgia
Clinical narrative: neck stiffness began at 10pm Feb 18; chills and uncontrollable shaking, muscle aches and pains began at 11:45pm Feb 18; noticed a rapid heartbeat after getting back into bed at 6am on Feb 19; took my temperature orally at 7:20am and got three different, very similar results:  100.9F, 101F, and 100.8F;  plan to take acetominaphen
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: neck stiffness began at 10pm Feb 18; chills and uncontrollable shaking, muscle aches and pains began at 11:45pm Feb 18; noticed a rapid heartbeat after getting back into bed at 6am on Feb 19; took my temperature orally at 7:20am and got three different, very similar results:  100.9F, 101F, and 100.8F;  plan to take acetominaphen
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: depression; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DEPRESSION (non-serious), outcome "unknown", described as "depression".  Additional Information: The report is cross referenced to report ID: RGCF0L8T. The reporter stated that her girlfriend's aunt experienced depression after getting a Pfizer COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481511 same reporter/drug, similar AE, different patient;US-PFIZER INC-2021481483 same reporter/drug, similar AE, different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Heart rate
Clinical narrative: Elevated resting heart rate; weakness; dizzy; extreme fatigue; headache; 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 left, administration date 11Mar2021 08:15 (Lot number: EN6201) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; LEVOTHYROXINE; PROGESTERONE; TESTOSTERONE. The following information was reported: HEART RATE INCREASED (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "Elevated resting heart rate"; ASTHENIA (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "weakness"; DIZZINESS (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "dizzy"; FATIGUE (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "extreme fatigue"; HEADACHE (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, asthenia, dizziness, fatigue, headache.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Elevated resting heart rate; weakness; dizzy; extreme fatigue; headache; 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 left, administration date 11Mar2021 08:15 (Lot number: EN6201) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; LEVOTHYROXINE; PROGESTERONE; TESTOSTERONE. The following information was reported: HEART RATE INCREASED (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "Elevated resting heart rate"; ASTHENIA (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "weakness"; DIZZINESS (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "dizzy"; FATIGUE (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "extreme fatigue"; HEADACHE (non-serious) with onset 12Mar2021 06:00, outcome "recovered with sequelae", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, asthenia, dizziness, fatigue, headache.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eating disorder, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Feeling very bad; Very weak; Very tired; Difficulty eating due to nausea; Difficulty eating due to nausea; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  An 89-year-old female patient received BNT162B2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EP7533) at the age of 89 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Single, Lot Number: EN6199; Left Arm.), administration date: 20Mar2021, when the patient was 89 years old, for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Feeling very bad"; ASTHENIA (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Very weak"; FATIGUE (non-serious) with onset 18Apr2021, outcome "not recovered", described as "Very tired"; NAUSEA (non-serious), EATING DISORDER (non-serious) all with onset 18Apr2021, outcome "not recovered" and all described as "Difficulty eating due to nausea". Additional Information: The patient was not taking any other products. She received the second dose of the Covid Vaccine last Saturday, 17Apr2021 between 1100 and 1200. On Sunday, 18Apr2021, she started feeling very bad, very weak, very tired, and had difficulty eating due to nausea. The patient asked if this should last long or something she could do. The patient stated her symptoms were continuing, they have not gotten any better or worse. She was concerned about the difficulty eating most of all because at her age she does not want to lose any weight. The patient had not additional vaccines administered on same date of the COVID-19 Vaccine. The adverse events did not require emergency room nor physician office visit. The patient has no prior vaccination within 4 weeks and has not adverse events following prior vaccinations. The patient has no medical history including any illness at time of vaccination and has no family medical history relevant to the adverse events. There were no relevant tests done.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, SARS-CoV-1 test negative
Clinical narrative: right arm started twitching / right eye twitches; 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 male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Apr2021 (Lot number: EW0153) at the age of 27 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: MUSCLE TWITCHING (non-serious) with onset 16Apr2021, outcome "not recovered", described as "right arm started twitching / right eye twitches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle twitching. Clinical course: The patient got the first shot of Pfizer vaccine 7 days ago and seconds after, his right arm started twitching and has not stopped twitching. It was persisting and was getting a little bit worse and also right eye twitches as well. He stated that he does not have a doctor or anything else and has not seen a doctor for a while. Patient was scheduled for the 2nd shot on 07May 2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I got the shot and it feel me dizzy, it let me dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EW0170, Expiration Date: 07Jul2021) at the age of 52 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "I got the shot and it feel me dizzy, it let me dizzy". Therapeutic measures were not taken as a result of dizziness.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Suspected COVID-19
Clinical narrative: headache/ head was pounding/ bad headache; dizziness; wondering could the patient has been exposed to COVID again; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 07Apr2021 (Lot number: ER8732) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "exposed to COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "headache/ head was pounding/ bad headache"; DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "dizziness"; SUSPECTED COVID-19 (non-serious) with onset Apr2021, outcome "not recovered", described as "wondering could the patient has been exposed to COVID again".  Additional information: It was reported that the patient experienced the normal side effects that Pfizer listed, every single one of them and then the patient had the headache for probably 48 hours and then it was all last. On 22Apr2021 (previous night), the patient woke up in middle of night with same side effects, same things happened to the patient. It was mentioned that the patient was not a person who normally get sick and was wondering could the patient has been exposed to COVID again.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen infraclavicular lymph node on left side after second vaccine in left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 14:30 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer: Pfizer, Administration time: 04:45 PM, Anatomical location: Right arm, Lot: unknown), administration date: 01Apr2021, when the patient was 31 years old, for COVID-19 immunisation, reaction(s): "Swollen infraclavicular lymph node on right side after first vaccine in right arm.". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "unknown", described as "Swollen infraclavicular lymph node on left side after second vaccine in left arm.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient did not have covid prior vaccination. Patient did not have Covid tested post vaccination. Patient did not take any other vaccine in four weeks.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: I am really fatigue; I am not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Apr2021 (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: FATIGUE (non-serious) with onset 22Apr2021, outcome "unknown", described as "I am really fatigue"; MALAISE (non-serious) with onset 22Apr2021, outcome "unknown", described as "I am not feeling well". Therapeutic measures were taken as a result of fatigue, malaise.  Additional Information: Treatment of adverse effects included paracetamol (TYLENOL 400mg). The patient was scheduled for the second dose on 24Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (MANUFACTURER UNKNOWN)), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 22Apr2021, outcome "recovered" (Apr2021), described as "Chills". Therapeutic measures were taken as a result of chills. Additional information: The patient had his heater on to help with his chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is very sore and hurts to move; This is a spontaneous report received from a non-contactable reporter (Consumer) for a Pfizer sponsored program. 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is very sore and hurts to move".  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: he was so unstable/ almost fell; dizzy; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 21Apr2021 14:00 (Lot number: EW0169) at the age of 72 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "sugar" (unspecified if ongoing). Concomitant medications included: METFORMIN taken for blood glucose abnormal (ongoing); SIMVASTATIN taken for lipid metabolism disorder (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 21Apr2021, outcome "not recovered", described as "dizzy"; BALANCE DISORDER (non-serious) with onset 23Apr2021, outcome "not recovered", described as "he was so unstable/ almost fell". Therapeutic measures were not taken as a result of dizziness, balance disorder.  Additional information: When the patient went to bed on Wednesday (21Apr2021) night, he felt kind of dizzy. When he got up on Thursday morning (22Apr2021) he was really dizzy. It got better during the day. At night, he got dizzy again and on 23Apr2021 (morning) he was so dizzy that he almost fell. It seemed to be worse when he gets up out of bed. He has had to start using a cane because he was so unstable.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: Felt sick; have cold and he think it is a severe cold; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Felt sick"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "have cold and he think it is a severe cold". Additional information: Patient was trying to get his second dose and was asking if he can get his second dose from his local pharmacy. He got his first dose on 24Mar2021, and was scheduled for his second dose last 21Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: arm is a little sore; intense ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 22Apr2021 16:35 (Lot number: EP7533, Expiration Date: Jul2021) at the age of 57 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "vision diminishing" (unspecified if ongoing), notes: as he is getting old; "diagnosed as pre-diabetic" (unspecified if ongoing), notes: had a lab thing done. The patient's concomitant medications were not reported. Past drug history included: Lutein for to mitigate his vision diminishing. Vaccination history included: Rubella, for immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is a little sore"; TINNITUS (non-serious), outcome "unknown", described as "intense ringing in ears". Additional information: The vaccine was administered on his left shoulder. The patient does not take aspirin and stated he took an allergy tablet before (unspecified) about more than a week before vaccination. He did not receive any other vaccines within 4 weeks. The events did not result in a physician or emergency room visit. The patient states will not get his second dose if the side effects last.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hunger, Migraine, Pain, Pain in jaw
Clinical narrative: had the shot in the buttocks; Rapid onset of migraine, headache; Jaw pain; Total body ache; I'm very hungry; I suspect that my blood pressure raises. Because my veins start budging;  I noticed when they budge up when I'm having the pain.; I suspect that my blood pressure raises. Because my veins start budging;  I noticed when they budge up when I'm having the pain.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 69 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunization. Relevant medical history included: "low blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 19Apr2021, outcome "unknown", described as "had the shot in the buttocks"; MIGRAINE (non-serious) with onset Apr2021, outcome "unknown", described as "Rapid onset of migraine, headache"; PAIN IN JAW (non-serious) with onset Apr2021, outcome "unknown", described as "Jaw pain"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Total body ache"; HUNGER (non-serious) with onset Apr2021, outcome "unknown", described as "I'm very hungry"; BLOOD PRESSURE INCREASED (non-serious), VEIN DISORDER (non-serious) all with onset Apr2021, outcome "unknown" and all described as "I suspect that my blood pressure raises. Because my veins start budging;  I noticed when they budge up when I'm having the pain.". Therapeutic measures were taken as a result of migraine, pain in jaw, pain, hunger, blood pressure increased, vein disorder.  Additional information: Consumer called to report adverse effect to 1st COVID shot. It was so bad that she doesn't want to get the 2nd shot. Got rapid onset of migraine, headache. Jaw pain and total body ache. That's all. It was 4 hours after she got the vaccine. It last for about 2 hours and then it disappeared. Then it comes every day for about 2 hours and then disappeared. Yesterday she had 2 and it happened twice. She was very hungry, and she suspected that her blood pressure raised because her veins started budging. Her blood pressure was low all her life. She noticed her veins started budging in her hands and up her arms. They budge up when she was having the pain. She suspected her blood pressure had gone up. She had the shot in the buttocks because her arms were so thin. She was due for her second dose on May 10. Treatment received were Medical Marijuana. Cannabis weed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vein disorder
Clinical narrative: had the shot in the buttocks; Rapid onset of migraine, headache; Jaw pain; Total body ache; I'm very hungry; I suspect that my blood pressure raises. Because my veins start budging;  I noticed when they budge up when I'm having the pain.; I suspect that my blood pressure raises. Because my veins start budging;  I noticed when they budge up when I'm having the pain.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 69 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunization. Relevant medical history included: "low blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 19Apr2021, outcome "unknown", described as "had the shot in the buttocks"; MIGRAINE (non-serious) with onset Apr2021, outcome "unknown", described as "Rapid onset of migraine, headache"; PAIN IN JAW (non-serious) with onset Apr2021, outcome "unknown", described as "Jaw pain"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Total body ache"; HUNGER (non-serious) with onset Apr2021, outcome "unknown", described as "I'm very hungry"; BLOOD PRESSURE INCREASED (non-serious), VEIN DISORDER (non-serious) all with onset Apr2021, outcome "unknown" and all described as "I suspect that my blood pressure raises. Because my veins start budging;  I noticed when they budge up when I'm having the pain.". Therapeutic measures were taken as a result of migraine, pain in jaw, pain, hunger, blood pressure increased, vein disorder.  Additional information: Consumer called to report adverse effect to 1st COVID shot. It was so bad that she doesn't want to get the 2nd shot. Got rapid onset of migraine, headache. Jaw pain and total body ache. That's all. It was 4 hours after she got the vaccine. It last for about 2 hours and then it disappeared. Then it comes every day for about 2 hours and then disappeared. Yesterday she had 2 and it happened twice. She was very hungry, and she suspected that her blood pressure raised because her veins started budging. Her blood pressure was low all her life. She noticed her veins started budging in her hands and up her arms. They budge up when she was having the pain. She suspected her blood pressure had gone up. She had the shot in the buttocks because her arms were so thin. She was due for her second dose on May 10. Treatment received were Medical Marijuana. Cannabis weed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: can't touch the circle, skin was hard; it was warm to touch; it started to swell and this morning it was swollen around the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 22Apr2021 (Lot number: EW0191) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: EW0150), administration date: 01Apr2021, when the patient was 65 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 22Apr2021, outcome "not recovered", described as "it started to swell and this morning it was swollen around the arm"; VACCINATION SITE INDURATION (non-serious) with onset 23Apr2021, outcome "not recovered", described as "can't touch the circle, skin was hard"; VACCINATION SITE WARMTH (non-serious) with onset 23Apr2021, outcome "not recovered", described as "it was warm to touch". Clinical course: Patient had her second vaccine on 22Apr2021 (reported as yesterday) and on 22Apr2021 (reported as last night), it started to swell and this morning it was swollen around the arm, can't touch the circle, skin was hard, and it was warm to touch. Events were persisting. It was reported that the patient took 500 mg, 2 Tylenol "yesterday", right after he got home. Patient was querying if this was normal and if it would be okay.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 10:00 (Lot number: ER8734) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. Vaccination history included: Bnt162b2 (Product: COVID 19, Pfizer, Lot number: er8734, lot unknown: False, Administration date: 22Mar2021, Administration time: 10:00 AM, Dose number 1, Vaccine location: Left arm), administration date: 22Mar2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 22Apr2021, outcome "recovered" (2021), described as "Menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient took other vaccine (unspecified) on same date as of vaccine 20Apr2021. The patient did not take other vaccine in four weeks. She did not have Covid prior vaccination, also she did not underwent test for Covid post vaccination. She did not have no known allergies. The patient had menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021 (PMS symptoms began 2 days after). Periods were always precise/regulated by birth control, so this was very out of the ordinary. She did not think much of it but a friend of her who received her second dose on the same day had the exact same experience.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021482032 same reporter/product/event different patient.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: She also mentioned that he took 4 motrins 2 weeks prior for back pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: BACK PAIN (non-serious), outcome "unknown", described as "She also mentioned that he took 4 motrins 2 weeks prior for back pain".  Additional information: Reporter was asking how long before vaccination would it be considered not okay to take over the counter medications like ibuprofen, aspirin and tylenol. She mentioned that the articles she has read were very vague on this. She mentioned that he took 4 motrins 2 weeks prior for back pain as his doctor advised that it would be safe. Mentioned to reporter that usually, low dose aspirin would be used as a blood thinner and that OTC Medications typically evacuate the body fast but that would depend on the person.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity, Underdose
Clinical narrative: arm is still sore; not all of the vaccine went inside their arm; there was a significant amount of leakage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).   A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 17:25 (Lot number: EW0164) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHICKEN POX VARICELLA VACCINE taken for immunisation, administration date 07Apr2021. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm is still sore"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Apr2021, outcome "unknown", described as "not all of the vaccine went inside their arm"; UNDERDOSE (non-serious) with onset 22Apr2021, outcome "unknown", described as "there was a significant amount of leakage".  No follow-up attempts are possible. No further information is expected.  Follow-up (23Apr2021): This is a spontaneous follow-up report from a contactable consumer via Pfizer-sponsored program 159558. Updated information included: New event (sore arm).  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm and other symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm and other symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484818 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 10:00 (Lot number: er8734) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (a friend of mine who received her second dose on the same day had the exact same experience), for COVID-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021".  Additional Information: Patient's friend reported about menstruation in the middle of birth control pack 5 days after receiving final vaccine on 20Apr2021 (PMS symptoms began 2 days after). Her periods are always precise/regulated by birth control, so this was very out of the ordinary. Didn't think much of it but a friend of reporter (patient) who received her second dose on the same day had the exact same experience. No COVID prior vaccination and COVID twas not tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021482005 same reporter/product/event different patient.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 19Apr2021 08:30 (Lot number: EW0164) at the age of 66 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Borderline AODM" (unspecified if ongoing), notes: no meds. Concomitant medications included: LOSARTAN; ATORVASTATIN; ASPIRINE. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EP 7533), administration date: 31Mar2021 08:30, when the patient was 66 years old, for COVID-19 immunisation, reactions: "Sore arm", "Nausea", "vomiting". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Apr2021, outcome "recovered" (20Apr2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Additional concomitant medication included MVI (as reported). The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Migraine
Clinical narrative: felt tired; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: EW0164) 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: MIGRAINE (non-serious) with onset 22Apr2021, outcome "not recovered", described as "migraine"; FATIGUE (non-serious) with onset 23Apr2021, outcome "unknown", described as "felt tired".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal chest pain
Clinical narrative: When she breathed deeply it caused a pain across her back and ribs; When she breathed deeply it caused a pain across her back and ribs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (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 number: 1, No events), administration date: 05Apr2021, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset 27Apr2021, outcome "unknown" and all described as "When she breathed deeply it caused a pain across her back and ribs". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: she cannot move her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  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: MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "she cannot move her arm.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 10:00 (Lot number: ER8730) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "Her arm was sore".  Additional information: The first dose her arm was sore but it got better pretty quickly. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No family Medical History Relevant to AE(s). No relevant tests was done.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: sore arm pit in lymph nodes; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 10:00 (Lot number: EW0164) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine Name: Covid-19 , Manufacturer: Pfizer , Lot Number: ER8730, Anatomical Location: left arm , Date: 26Mar2021), administration date: 26Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Her arm was sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Apr2021, outcome "not recovered", described as "arm soreness"; AXILLARY PAIN (non-serious) with onset 18Apr2021, outcome "not recovered", described as "sore arm pit in lymph nodes".  Additional information: After getting the second dose her arm has stayed sore longer. Her arm pit has been really sore in the lymph nodes. The soreness in her left arm started in the afternoon after she received the second dose. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tongue blistering
Clinical narrative: Blisters on tongue following second dose only; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]. Vaccination history included: Bnt162b2 (lot number=EP7533, lot unknown=False, administrator route=Intramuscular, administration time=10:00 AM, vaccine location=Left arm), administration date: 01Apr2021, for Covid-19 immunisation, reaction(s): "sore injection site". The following information was reported: TONGUE BLISTERING (non-serious) with onset 23Apr2021 08:00, outcome "not recovered", described as "Blisters on tongue following second dose only". Therapeutic measures were not taken as a result of tongue blistering.  Additional information: The patient had no other vaccine in four weeks. Prior vaccination, the patient had no covid. Post vaccination, the patient not tested for covid. The patient had known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 06Apr2021 (Lot number: ER8727) at the age of 58 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "back problems" (ongoing), notes: started a good 20 years prior. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "recovered" (Apr2021), described as "Sore left arm".  Additional information: The patient mentioned that the first one (dose 1) was administered just above her elbow.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021482372 same patient/drug, different event/dose