chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nightmare, Restlessness
Clinical narrative: heart started to increase again/keep heart rate to 103 beats per minute; Restlessness/lack of sleep; nightmares; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VITAMIN D COMPLEX; PROBIOTICS. Past drug history included: Torado. Vaccination history included: Bnt162b2 (Dose 1, lot number=EN5318, lot unknown=False, administration date=06Feb2021, administration time=06:30 PM, vaccine location=Left arm.), administration date: 06Feb2021, for Covid-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 07Feb2021 22:00, outcome "recovered" (2021), described as "heart started to increase again/keep heart rate to 103 beats per minute"; RESTLESSNESS (non-serious) with onset 07Feb2021 22:00, outcome "recovered" (2021), described as "Restlessness/lack of sleep"; NIGHTMARE (non-serious) with onset 07Feb2021 22:00, outcome "recovered" (2021), described as "nightmares". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, restlessness, nightmare.  Additional information: After dose 2, 2nd night heart started to increase again this time she learned tips to lower heart rate (cold pack on face) did immediately and was able to keep heart rate to 103 beats per minute, fine next morning. Restlessness/lack of sleep - nightmares and other general common well documented symptoms. No COVID prior vaccination. Not tested COVID post vaccination. No other vaccine in four weeks. other vaccine same date details: [other vaccine same date product= Pfizer, other vaccine same date lot number=EN6203, other vaccine same date vaccine date=25Feb2021, other vaccine same date dose number=2, other vaccine same date vaccine location=Left Arm].  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: Conjunctivitis, Limb discomfort, Pain in extremity
Clinical narrative: night my eye felt sore and the next day I noticed it was red.; My arm felt heavy late that night and sore all the next day; sore all the next day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 10:45 (Lot number: EW0153) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer survivor", start date: 2003 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONJUNCTIVITIS (non-serious) with onset 11Apr2021 20:00, outcome "recovering", described as "night my eye felt sore and the next day I noticed it was red."; LIMB DISCOMFORT (non-serious) with onset 11Apr2021 20:00, outcome "recovering", described as "My arm felt heavy late that night and sore all the next day"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2021 20:00, outcome "recovering", described as "sore all the next day". Therapeutic measures were not taken as a result of conjunctivitis, limb discomfort, pain in extremity.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient received other medications within 2 weeks of vaccination. Patient has not been diagnosed with COVID-19 prior to and since the vaccination. No known allergies to medications, food or other products.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 17:30 (Lot number: EN6202) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: NASACORT; CLARITIN ALLERGIC; LISINOPRIL. Vaccination history included: Bnt162b2 (Product=COVID 19, Lot unknown= ER2613, Administration time=01:15 PM, Dose number=1, Vaccine location=Left arm), administration date: 24Mar2021, when the patient was 47 years old, for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2021 20:00, outcome "recovered" (17Apr2021), described as "sore arm"; HEADACHE (non-serious) with onset 14Apr2021 20:00, outcome "recovered" (17Apr2021), described as "headache". Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: Evening of day of vaccination had a slightly sore arm, was moderately sore the next morning and continued throughout the day. The soreness had resolved the next day (Day 3 after injection). Also had a headache most of the day after vaccination. The headache was resolved by Day 3 after vaccination. Patient took Tylenol as a treatment of adverse events. The patient did not receive other vaccine in four weeks. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Drug screen, Lymph node pain, Lymphadenopathy
Clinical narrative: Left groin lymph node swelling with pain; Left groin lymph node swelling with pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 13Mar2021 (Lot number: EN6208) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid; "Pain" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "surgery" (unspecified if ongoing), notes: had 4 surgeries on my spine I do not know what medical condition it would be. Concomitant medication(s) included: DULOXETINE taken for pain; LEVOTHYROXINE taken for thyroid disorder; GABAPENTIN; NORCO; GLATIRAMER ACETATE taken for multiple sclerosis; LOSARTAN taken for blood pressure measurement; AMLODIPINE taken for blood pressure measurement; VITAMIN D 2000; ACETAMINOPHEN. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "Left groin lymph node swelling with pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional information: Medical Condition included multiple sclerosis, hypertension, thyroid, she had 4 surgeries on her spine. Patient was concerned and stated, she had reaction to her first Pfizer vaccine. She had a swollen lymph node in her left groin because she knew it could go into the armpit but it still there after four weeks, almost five weeks. Nurse stated, it showed up after two days after her first. Nurse stated that left groin lymph node swelling with pain well only when she touched it. Lab test included TSH and urine drug screen. No treatment was given.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Liver function test decreased, Renal function test abnormal, Vitamin D decreased
Clinical narrative: Bloodwork results showed kidney, liver, and vitamin D values plummeted; Bloodwork results showed kidney, liver, and vitamin D values plummeted; Bloodwork results showed kidney, liver, and vitamin D values plummeted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:45 (Lot number: EN0202) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos Disease" (unspecified if ongoing); "CVID (immune deficiency)" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; SYNTHROID; THIOTHIXENE [TIOTIXENE]. Vaccination history included: Bnt162b2 (Lot number: EN9263, in left arm at 09:00 as dose 1, single), administration date: 18Feb2021, when the patient was 72 years old, for COVID-19 immunisation, reaction(s): "Hair changed dramatically after first vaccine", "became very dry, brittle". The following information was reported: RENAL FUNCTION TEST ABNORMAL (non-serious), LIVER FUNCTION TEST DECREASED (non-serious), VITAMIN D DECREASED (non-serious) all with onset 04Apr2021, outcome "not recovered" and all described as "Bloodwork results showed kidney, liver, and vitamin D values plummeted". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of renal function test abnormal, liver function test decreased, vitamin d decreased.  Additional information: The patient's other medications in two weeks included multivitamins. 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. It was further reported that her bloodwork values were previously in normal range when drawn on 07Jan2021. She had never had any out of range kidney or liver values in her life before this and had never had to take IV fluids before for bloodwork issues. Events has necessitated/ treated with weekly IV fluids for six months.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: seeing floaters in right eye; 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 09Apr2021 14:00 (Lot number: EN607) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid cancer", start date: 2008 (unspecified if ongoing); "full thyroidectomy", start date: 2008 (unspecified if ongoing). Concomitant medication(s) included: CALCIUM/VITAMIN D [CALCIUM;ERGOCALCIFEROL]; SYNTHROID. Vaccination history included: Bnt162b2 (Lot number: EN608, in left arm at 13:00 as dose 1, single), administration date: 17Mar2021, when the patient was 47 years old, for COVID-19 immunisation, reaction(s): "Intense eye pain in both eyes". The following information was reported: VITREOUS FLOATERS (non-serious) with onset Apr2021, outcome "not recovered", described as "seeing floaters in right eye". The event "seeing floaters in right eye" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of vitreous floaters.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
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 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 36, on Mar 23, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information was reported: pain in extremity/arm was sore, with outcome of unknown. Additional information: Patient stated her arm was sore after. Event took place after use of product. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: did have a sore throat for a day once more.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05Feb2021 (Lot number: EL9269) at the age of 35 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Eustachian tube disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "benign tumor removed from salivary gland" (unspecified if ongoing); "burning throat disorder", start date: Mar2020 (unspecified if ongoing), notes: after a long bout of strep throat. Concomitant medication(s) included: NORTRIPTYLINE taken for oropharyngeal pain; DEXILANT. Vaccination history included: BNT162B2 (lot number: EL3249,  vaccine location:Left arm, dose number: 1), administration date: 15Jan2021, when the patient was 35 years old, for COVID-19 immunisation, reaction(s): "my throat became extemly sore", "burning in throat". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "recovering", described as "did have a sore throat for a day once more.". The event "did have a sore throat for a day once more." was evaluated at the physician office visit. Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: The patient was not pregnant at time of vaccination. The patient had no known allergies. The patient had no COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. The patient did not receive other vaccine in 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Nausea, Vaccination site pain
Clinical narrative: sore arm at injection site.; Nausea; Dizzy; Weak; Feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 08:45 (Lot number: EN6198) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies:sulfa drug" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 01Mar2021, outcome "recovering", described as "sore arm at injection site."; NAUSEA (medically significant) with onset 01Mar2021, outcome "recovering", described as "Nausea"; DIZZINESS (medically significant) with onset 01Mar2021, outcome "recovering", described as "Dizzy"; ASTHENIA (medically significant) with onset 01Mar2021, outcome "recovering", described as "Weak"; MALAISE (medically significant) with onset 01Mar2021, outcome "recovering", described as "Feeling unwell". The events "sore arm at injection site.", "nausea", "dizzy", "weak" and "feeling unwell" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of vaccination site pain, nausea, dizziness, asthenia, malaise.  Clinical Course: Patient received treatment with Epi pen, steroids, Zyrtec, Famotidine. Patient was did not have covid prior vaccination and not tested for Covid post vaccination. No other vaccine in four weeks. No other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is not feeling well; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (PFIZER COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "she is not feeling well".  Additional Information: The patient was supposed to get the second dose of the vaccine today, 19Apr2021. However, she was not feeling well. The reporter wanted to reschedule the appointment and was asking what will happen if the patient did not follow the 3 weeks time frame.   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: Somnolence
Clinical narrative: after the first shot I came home and slept for 5 hours; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 69-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) at the age of 69 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: SOMNOLENCE (non-serious), outcome "unknown", described as "after the first shot I came home and slept for 5 hours". Additional Information: The patient had the vaccine and the only side effect she had was after the first shot she came home and slept for 5 hours which is a good thing. It went really well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise, Muscle fatigue, Nausea
Clinical narrative: feeling unwell; nausea; brain fog; general fatigue; muscle fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 46 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 16Apr2021 (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: MALAISE (non-serious) with onset 16Apr2021, outcome "not recovered", described as "feeling unwell"; NAUSEA (non-serious) with onset 16Apr2021, outcome "unknown", described as "nausea"; FEELING ABNORMAL (non-serious) with onset 16Apr2021, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 16Apr2021, outcome "unknown", described as "general fatigue"; MUSCLE FATIGUE (non-serious) with onset 16Apr2021, outcome "unknown", described as "muscle fatigue". It was unknown if therapeutic measures were taken as a result of malaise, nausea, feeling abnormal, fatigue, muscle fatigue. Additional information: It was reported as unknown if patient had COVID prior vaccination and unknown if patient was COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast atrophy, Lactation disorder, Vaccination site pain
Clinical narrative: breasts had reduced, by one cup size; no longer lactating; Tenderness at the injection site and some joint pains; Tenderness at the injection site and some joint pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 14:30 (Lot number: EW0153) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart murmur" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies: Penicillin" (unspecified if ongoing); "seafood" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aleve, reaction(s): "Drug allergy". The following information was reported: BREAST ATROPHY (non-serious) with onset 21Apr2021 07:00, outcome "not recovered", described as "breasts had reduced, by one cup size"; LACTATION DISORDER (non-serious) with onset 21Apr2021 07:00, outcome "not recovered", described as "no longer lactating"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 21Apr2021 07:00, outcome "not recovered" and all described as "Tenderness at the injection site and some joint pains". Therapeutic measures were not taken as a result of breast atrophy, lactation disorder, vaccination site pain, arthralgia.  Additional information: Facility type vaccine was reported as Pharmacy or Drug Store. Patient did not received other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient had no COVID prior vaccination. Patient was not tested COVID post vaccination. Patient was breastfeeding until yesterday (as reported). Morning after getting the vaccine, the patient experienced above events. Patient had no fever or sore throat, so far.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021458617 mother
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Presyncope
Clinical narrative: Feeling dizzy like I am going to pass out; Feeling dizzy like I am going to pass out; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 (Lot number: EW0169) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER taken for diabetes mellitus; LEVOTHYROXINE taken for hypothyroidism; LOSARTAN HCTZ taken for hypertension; BABY ASPIRIN. The following information was reported: DIZZINESS (non-serious) with onset 16Apr2021, outcome "not recovered", PRESYNCOPE (non-serious) with onset 16Apr2021, outcome "unknown" and all described as "Feeling dizzy like I am going to pass out"; ASTHENIA (non-serious) with onset 16Apr2021, outcome "unknown", described as "Weakness". Therapeutic measures were taken as a result of dizziness, presyncope, asthenia. Additional information: Clinical course: The patient received the Pfizer vaccine on 14Apr2021 and the first couple of days, she was okay, starting that third day, when she woke up and she was feeling dizzy like she was going to pass out and was kind of weak. Patient looked for the side effect at the sheet that was given to her at the vaccine site. Patient drank plenty of fluids and fluids have electrolyte in it for the events. Events seemed to get any better, but patient still felt the dizziness. The patient was querying if dizziness and weakness were severe reaction to the vaccine. Patient stated that she wanted to report it and wanted the authority to be responsible for anything that will happen to her body because she has no other insurance of anything else. It was reported that the patient took Tylenol extra strength 500mg (2 tablet, once) by mouth on April 15.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: My husband was tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "My husband was tired the next day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: extremely high blood pressure; 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 14Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; MANUFACTUERER UNKNOWN), administration date: 24Mar2021, for Covid-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 2021, outcome "not recovered", described as "extremely high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension.  Additional information: Consumer called, caller got the first dose of the vaccine on 24Mar2021, and the second dose was received on 14Apr2021 (correct dosing schedule). Name withheld said she was experiencing an extremely high blood pressure and she took medications for her blood pressure already, she wanted to know if this was one of the side effects of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Aphasia, Feeling abnormal, Insomnia
Clinical narrative: brain fog; sometimes struggle with words in my head and speech; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: Feb2021, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; APHASIA (non-serious), outcome "unknown", described as "sometimes struggle with words in my head and speech"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia". Additional Information: Customer reported, I had received the first dose of the Covid vaccine in Feb and the second in Mar and still don't feel quite right about a month later. I continue to have brain fog and sometimes struggle with words in my head and speech. There has also been a lot of insomnia where I must be completely exhausted to get any sleep. My research at the time had me convinced that your vaccine would be relatively safe. I fully regret ever receiving it. Please have someone from your legal department contact me.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Poor quality product administered, Product storage error
Clinical narrative: experienced a very sore arm; very tired; concerned about the whole vaccine handling/they did not keep the logs of temperature control; concerned about the whole vaccine handling/they did not keep the logs of temperature control; 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 38 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 38 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: PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "unknown", described as "experienced a very sore arm"; FATIGUE (non-serious) with onset 23Mar2021, outcome "unknown", described as "very tired"; PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 22Mar2021, outcome "unknown" and all described as "concerned about the whole vaccine handling/they did not keep the logs of temperature control".  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-2021449591 Invalid
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: mild headache; pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 13:00 (Lot number: EP7534) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism. Concomitant medication(s) included: LEVOTHYROXINE SODIUM.  The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "mild headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "pain in the arm". Additional information: There was no other vaccine in four weeks. Other medications in two weeks included Levothyroxine 112 mcg. For the first shot patient had a mild headache and pain in the arm for three days after the shot. The patient did not had covid prior vaccination and not tested covid post vaccination. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Insomnia, Pain in extremity
Clinical narrative: arm pain in her left are from her shoulder down to her wrist; arm pain in her left are from her shoulder down to her wrist; arm pain in her left are from her shoulder down to her wrist/it's getting worse; She did not get any sleep last night because of this pain; This is a spontaneous report from a contactable consumer (patient).  A 89-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unknown route, administered in the right arm on 30Mar2021 as dose 1, single (at the age of 89 years old) for COVID-19 immunization. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unknown route, administered in the Arm right on 20Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Apr2021, the patient experienced that she was having arm pain in her left area from her shoulder down to her wrist, since she received the 1st dose, and it's getting worse, and did not get any sleep last night because of this pain. The outcome of the event arm pain in her left are from her shoulder down to her wrist was not recovered; outcome of the event arm pain in her left are from her shoulder down to her wrist/it's getting worse, and insomnia was unknown. Treatment was received for the events arm pain in her left are from her shoulder down to her wrist and arm pain in her left are from her shoulder down to her wrist/it's getting worse.    This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected  Follow-up (21Apr2021): New information received from a contactable consumer: Event (insomnia), vaccination date (30Mar2021), anatomical location (right arm), onset event date (18Apr2021),   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mood altered, Pain
Clinical narrative: feels tired; crummy with body aches; crummy with body aches; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 40 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: FATIGUE (non-serious), outcome "unknown", described as "feels tired"; MOOD ALTERED (non-serious), PAIN (non-serious), outcome "unknown" and all described as "crummy with body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: The first time I got your vaccine, my joints were COMPLETELY pain free for a week and a half after. The second time I got your COVID vaccine, my joints have had ZERO pain for 9 days and counting.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic joint pain" (unspecified if ongoing); "Ehlers-Danlos" (unspecified if ongoing); "Dercum's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The first time I got your vaccine, my joints were COMPLETELY pain free for a week and a half after. The second time I got your COVID vaccine, my joints have had ZERO pain for 9 days and counting.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: her arm is still swollen and hurting; her arm is still swollen and hurting; 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 female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "her arm is still swollen and hurting". 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, Pain in extremity
Clinical narrative: Soreness in arms for days; intermediate headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy with high blood medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Soreness in arms for days"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "intermediate headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches Constantly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Heart block" (unspecified if ongoing), notes: Heart blockage. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Drug allergy", notes: Known allergies: Morphine. The following information was reported: HEADACHE (non-serious) with onset 15Feb2021, outcome "not recovered", described as "Headaches Constantly". The event "headaches constantly" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache: which included treatment with acupuncture/Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The patient also received the second dose of unspecified vaccine (Pfizer) via an unspecified route of administration in the right arm on 30Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: dizziness; She had a really sore arm; 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 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild lingering dizziness", start date: Jan2021 (unspecified if ongoing), notes: In January caller had complaints of dizziness but did not get tested for covid-19 vaccine; "She was ill", start date: Jan2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered" (21Mar2021), described as "dizziness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a really sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: He was so weak, went to get out of bed, had to get fire department, no way of moving, limp as a noodle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 80 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Secondary progressive multiple sclerosis" (ongoing), notes: concurrent condition ; "increase in falls" (ongoing), notes: concurrent condition ; "lost weight" (ongoing), notes: concurrent condition ; "doesn't straighten up" (ongoing), notes: concurrent condition ; "Alzheimer's" (ongoing), notes: concurrent condition ; "Severe spasms worse" (ongoing), notes: concurrent condition ; "MS progression" (ongoing), notes: concurrent condition . Concomitant medication(s) included: OCRELIZUMAB; BACLOFEN; TIZANIDINE; LISINOPRIL; FUROSEMIDE; PREGABALIN; MEMANTINE. The following information was reported: ASTHENIA (non-serious) with onset 12Apr2021, outcome "recovered" (12Apr2021), described as "He was so weak, went to get out of bed, had to get fire department, no way of moving, limp as a noodle".  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, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: Woke feeling lousy; Major chills, Teeth chattering; Quickening pulse; Sore arm last night where he received the jab; Tiredness; Light headache/Headache intensified; This is a spontaneous report received from a contactable reporter (Consumer) from a sales representative. The reporter is the patient.  A 54 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "Sore arm last night where he received the jab"; FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset Apr2021, outcome "recovering", described as "Light headache/Headache intensified"; MALAISE (non-serious) with onset 17Apr2021, outcome "recovering", described as "Woke feeling lousy"; CHILLS (non-serious) with onset 17Apr2021, outcome "recovering", described as "Major chills, Teeth chattering"; HEART RATE INCREASED (non-serious) with onset 17Apr2021, outcome "recovering", described as "Quickening pulse". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had sore arm last night where he received the jab, tiredness and light headache. He woke up feeling lousy, headache intensified as the morning progressed. 24 hours after jab, he started having major chills, teeth chattering, and quickening pulse. Symptoms were lessening one hour after they started.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Woke feeling lousy; Major chills, Teeth chattering; Quickening pulse; Sore arm last night where he received the jab; Tiredness; Light headache/Headache intensified; This is a spontaneous report received from a contactable reporter (Consumer) from a sales representative. The reporter is the patient.  A 54 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "Sore arm last night where he received the jab"; FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset Apr2021, outcome "recovering", described as "Light headache/Headache intensified"; MALAISE (non-serious) with onset 17Apr2021, outcome "recovering", described as "Woke feeling lousy"; CHILLS (non-serious) with onset 17Apr2021, outcome "recovering", described as "Major chills, Teeth chattering"; HEART RATE INCREASED (non-serious) with onset 17Apr2021, outcome "recovering", described as "Quickening pulse". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had sore arm last night where he received the jab, tiredness and light headache. He woke up feeling lousy, headache intensified as the morning progressed. 24 hours after jab, he started having major chills, teeth chattering, and quickening pulse. Symptoms were lessening one hour after they started.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: dizziness; her body hurts a little bit; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on [21Apr2021], this case now contains all required information to be considered valid.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose: 1), for COVID-19 immunisation.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; PAIN (non-serious), outcome "unknown", described as "her body hurts a little bit".  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, Underdose
Clinical narrative: His arm was sore; he has had no reaction at all after this dose which concerns him that he did not receive much of the vaccine; 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 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 "His arm was sore"; UNDERDOSE (non-serious), outcome "unknown", described as "he has had no reaction at all after this dose which concerns him that he did not receive much of the vaccine". Additional information:  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.