chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Memory impairment
Clinical narrative: memory problems/she has no memory of getting the Prevnar vaccine; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team for a Pfizer sponsored program.  A female patient received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memory problems/she has no memory of getting the Prevnar vaccine". The action taken for pneumococcal 13-val conj vac (dipht crm197 protein) was unknown. Additional information: The patient is insisting on getting another Prevnar vaccine because she has no memory of getting the Prevnar vaccine. The patient's son was in there to get another vaccine on that day, so reporter knows the patient was definitely there and got Prevnar on 22Apr2021. The patient is insisting on getting another vaccine. Reporter asked the staff who said the patient was sharp, but the reporter was not sure if patient had memory problems before the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Musculoskeletal stiffness, Nasopharyngitis, Pain, Somnolence
Clinical narrative: Inappropriate schedule of vaccine administered; slept for an entire day and could not stay awake; extremely cold; back went stiff; in pain for a week; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 30Sep2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "dairy allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "drug allergy". Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: Unknown. , Location of injection: Arm Left), administration date: 16Sep2021, when the patient was 48 years old, for COVID-19 immunisation, reaction(s): "numbness in the legs where they hurt and started swelling", "numbness in the legs where they hurt and started swelling", "numbness in the legs where they hurt and started swelling". The following information was reported: SOMNOLENCE (non-serious) with onset 2021, outcome "recovering", described as "slept for an entire day and could not stay awake"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "extremely cold"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "recovering", described as "back went stiff"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "in pain for a week"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Sep2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered".  Additional information: This report was received via reporter. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive other vaccine in four weeks. The vaccine was administered in Pharmacy or Drug Store. Clinical Course: After the 2nd dose, patient slept for an entire day and could not stay awake and was extremely cold, it took 2 days for this to pass, then my back went stiff and in pain for a week. The events were reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 16Oct2021 (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: PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Contusion, Pain in extremity
Clinical narrative: arm still bruised and still sore; arm still bruised and still sore; possibly allergic to the vaccine; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 06Oct2021 (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: CONTUSION (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "arm still bruised and still sore"; ALLERGY TO VACCINE (non-serious) with onset Oct2021, outcome "not recovered", described as "possibly allergic to the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Paraesthesia, Vaccination site bruising, Vaccination site pain
Clinical narrative: Felt like pins and needles all over my hands and body going through, went away; Dark bruise larger than the size of a quarter in her left arm, the arm where she received the vaccine; Sore everywhere, her body is sore, and when she presses on her arm it is sore; when she presses on her arm it is sore; allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 06Oct2021 (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: PARAESTHESIA (non-serious) with onset Oct2021, outcome "unknown", described as "Felt like pins and needles all over my hands and body going through, went away"; VACCINATION SITE BRUISING (non-serious) with onset Oct2021, outcome "unknown", described as "Dark bruise larger than the size of a quarter in her left arm, the arm where she received the vaccine"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Sore everywhere, her body is sore, and when she presses on her arm it is sore"; VACCINATION SITE PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "when she presses on her arm it is sore"; HYPERSENSITIVITY (non-serious) with onset Oct2021, outcome "unknown", described as "allergic reaction". Additional information: the patient received her first dose of the Pfizer BioNtech covid 19 vaccine on 06Oct2021. She stated that in the beginning it felt like pins and needles all over her hands and body going through, went away. She didn't look at her arm for a while and then now she noticed a few days ago she had a dark bruise larger than the size of a quarter in her left arm, the arm where she received the vaccine. She also reported that she was sore everywhere, her body is sore, and when she presses on her arm it was sore. She was most concerned about the dark bruise and was told by her pharmacist who administered the vaccine to call Pfizer, pharmacist also told her that it could have been an allergic reaction. The patient asked if she should get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Double vaccinated (Name withheld) tests positive for Covid.; Double vaccinated (Name withheld) tests positive for Covid.; The initial case was missing the following minimum criteria. Upon receipt of follow-up information on [04Jan2022], this case now contains all required information to be considered valid.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Double vaccinated (Name withheld) tests positive for Covid.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tests positive for Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: he had arm soreness at the area of injection/Injection site pain/patient mentioned that he was experiencing arm soreness at the site of injection; This is a spontaneous report received from a contactable Pharmacist.  A 10 year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left, administration date 09Nov2021 18:15 (Lot number: FK5127) as dose 1 , 0.2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Nov2021, outcome "recovered", described as "he had arm soreness at the area of injection/Injection site pain/patient mentioned that he was experiencing arm soreness at the site of injection". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: the patient received his first dose of Comirnaty, and mentioned that he had arm soreness at the area of injection approximately 13 hours after receiving the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: injection site pain; felt tired; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A 6 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 08Nov2021 (Batch/Lot number: unknown) at the age of 6 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), for Covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Nov2021, outcome "unknown", described as "injection site pain"; FATIGUE (non-serious) with onset 10Nov2021, outcome "unknown", described as "felt tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Body height, Colonoscopy, Fatigue, Sigmoidoscopy
Clinical narrative: The second one, she was just a little bit tired the second day; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: EN6206) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteopenia" (unspecified if ongoing), notes: diagnosed a number of years ago. that is why she takes Vitamin D; "allergic to penicillin" (unspecified if ongoing); "allergic to antibiotic drug" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; CALCIUM taken for osteopenia (ongoing). The patient took no other medications other than Vitamin D and a Centrum Multivitamin. Prior Vaccinations within 4 weeks of the suspect vaccine was none. Past drug history included: Tamiflu, reaction(s): "Rash"; Z-pak, reaction(s): "Rash". Vaccination history included: Bnt162b2 (Dose 1, Lot as EN6200, Anatomical Location: she is thinking left arm but she can't be sure), administration date: 03Mar2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "With the first one, she had absolutely no reaction.". The following information was reported: FATIGUE (non-serious) with onset 25Mar2021, outcome "unknown", described as "The second one, she was just a little bit tired the second day". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101816544 Same patient/drug and different dose/AEs.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: did not have vertigo or did not have the vertigo this severe with at least the first two doses of their Pfizer Covid vaccines; 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 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 19Jan2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single and administration date 19Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "did not have vertigo or did not have the vertigo this severe with at least the first two doses of their Pfizer Covid vaccines".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101882222 same patient/drug, different dose/event.;US-PFIZER INC-202101883516 same reporter/drug, different patient/event.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: severe anxiety; This is a spontaneous report received from a non-contactable consumer from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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: ANXIETY (non-serious), outcome "unknown", described as "severe anxiety".  Additional information: The reporter stated she has a family member who experienced severe anxiety after getting one dose of BNT162B2 because she thought she was being tracked with a microchip and something was in her body. The reporter asked if BNT162B2 induces anxiety or any other neurocognitive/mental health disorders.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenopia, Energy increased, Heart rate increased, Insomnia
Clinical narrative: arm soreness / pain for my arm; fast heart rate; my eyes are very tired; hyper; anxious; energetic; overnight she couldn't sleep and only slept 4 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 15:45 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 45 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN NOS. The following information was reported: ANXIETY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "anxious"; ENERGY INCREASED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "energetic"; INSOMNIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "overnight she couldn't sleep and only slept 4 hours"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm soreness / pain for my arm"; HEART RATE INCREASED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "fast heart rate"; ASTHENOPIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "my eyes are very tired"; PSYCHOMOTOR HYPERACTIVITY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "hyper". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient stated that that she received her vaccine yesterday at 3:45 and by evening she reports that she was feeling hyper, anxious and energetic. Overnight she couldn't sleep and only slept 4 hours and when she woke up, she was feeling the same way. Also reports arm soreness and asked about what she should do. The patient thinks that she was having a side effect and don't know what she should do, does she go to the emergency room and asked if she can take advil or Benadryl after having the covid vaccine. She stated that last night she couldn't sleep and had like fast heart rate, she feel like really anxious like she could run but yet her eyes were very tired so slept probably a total of 4 hours last night. The only thing she took last night was Advil for pain for my arm. Patient stated she work for an agriculture company. Characterization of drug role (CONCOMITANT): Proprietary medicinal product name: Estrogen patch.  No follow-up attempts were possible. No further information was expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Psychomotor hyperactivity
Clinical narrative: arm soreness / pain for my arm; fast heart rate; my eyes are very tired; hyper; anxious; energetic; overnight she couldn't sleep and only slept 4 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 15:45 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 45 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN NOS. The following information was reported: ANXIETY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "anxious"; ENERGY INCREASED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "energetic"; INSOMNIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "overnight she couldn't sleep and only slept 4 hours"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm soreness / pain for my arm"; HEART RATE INCREASED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "fast heart rate"; ASTHENOPIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "my eyes are very tired"; PSYCHOMOTOR HYPERACTIVITY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "hyper". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The patient stated that that she received her vaccine yesterday at 3:45 and by evening she reports that she was feeling hyper, anxious and energetic. Overnight she couldn't sleep and only slept 4 hours and when she woke up, she was feeling the same way. Also reports arm soreness and asked about what she should do. The patient thinks that she was having a side effect and don't know what she should do, does she go to the emergency room and asked if she can take advil or Benadryl after having the covid vaccine. She stated that last night she couldn't sleep and had like fast heart rate, she feel like really anxious like she could run but yet her eyes were very tired so slept probably a total of 4 hours last night. The only thing she took last night was Advil for pain for my arm. Patient stated she work for an agriculture company. Characterization of drug role (CONCOMITANT): Proprietary medicinal product name: Estrogen patch.  No follow-up attempts were possible. No further information was expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nervousness, Paraesthesia, Tenderness
Clinical narrative: slightly dizzy; tingling in arms and legs; a bit shaky; Soreness on the spot only if i touch it; This is a spontaneous report received from 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 15Mar2021 14:45 (Lot number: en6208) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "low blood pressure (really low)" (unspecified if ongoing), notes: low blood pressure (really low); "mild heart murmur" (unspecified if ongoing), notes: mild heart murmur. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "slightly dizzy"; PARAESTHESIA (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "tingling in arms and legs"; NERVOUSNESS (non-serious) with onset 15Mar2021 16:00, outcome "recovering", described as "a bit shaky"; TENDERNESS (non-serious) with onset 15Feb2021 16:00, outcome "recovering", described as "Soreness on the spot only if i touch it". Therapeutic measures were not taken as a result of dizziness, paraesthesia, nervousness, tenderness.  Additional information: Patient did not receive any other vaccine in four weeks. Patient has taken other medications in past two weeks which include  multivits & herbal supp t-48Hr; muscle relax t-24h. She was not diagnosed with COVID-19 prior to vaccination and was not tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Fatigue, Influenza virus test, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Dark maroonish purple color on her Q-tip when cleaning ears; A little fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 (Lot number: EN6206) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: In 2007, caller had to have a craniotomy and her blood pressure was real high then.; "craniotomy", start date: 2007, stop date: 2007, notes: In 2007, caller had to have a craniotomy and her blood pressure was real high then.; "cold" (unspecified if ongoing), notes: Prior to getting the vaccine: Caller reported that they had had severe weather in (city name) and she came down with a cold.; "Depression" (unspecified if ongoing); "Cough" (unspecified if ongoing); "antibiotics" (unspecified if ongoing); "Sleep/needs more sleep" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2007 (ongoing); CITALOPRAM taken for depression, sleep disorder (ongoing); AMLODIPINE taken for hypertension, start date: 2007 (ongoing); AMBIEN taken for sleep disorder (ongoing); Z-PAK taken for antibiotic therapy; BENZONATATE taken for cough, start date: 25Feb2021. The following information was reported: EAR DISORDER (non-serious) with onset 14Mar2021, outcome "recovering", described as "Dark maroonish purple color on her Q-tip when cleaning ears"; FATIGUE (non-serious) with onset 13Mar2021, outcome "recovered", described as "A little fatigued". Relevant laboratory tests and procedures are available in the appropriate section.  ADDITIONAL INFORMATION: No Vaccinations Prior within 4 weeks, patient had the flu shot in Nov2020, no adverse events prior vaccinations, patient states that went to the ENT last year and she had no issues. Caller reported that she had the Covid shot over the weekend, clarified to be the Pfizer Covid-19 vaccine. Caller stated that her right arm is where the vaccine was administered. She asked if there are side effects of anything in the ear? Caller reported that she cleans her ears on a daily basis and that there was a dark maroonish or purple something color when she cleaned her right ear. She stated it was a lot of it and that the color just continues to come out.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. A female patient received bnt162b2 (BNT162B2 reported as 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 medication were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain". Took 0.5 Tylenol 250 mg for back pain.  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: Asthenia, Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Chills; arm a little sore; weak and tired; weak and tired; sore muscles; 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 69-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6200) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "positive for Covid virus", start date: Nov2020 (unspecified if ongoing), notes: she tested positive for Covid virus last November. The patient's concomitant medications were not reported. Past drug history included: Nickel, reaction(s): "she is also allergic to nickel and cobalt which is in food and vitamin B12", notes: Verbatim: allergies; Formaldehyde, reaction(s): "allergic to formaldehyde bu that never consumed that as far as she knows"; Cobalt, reaction(s): "she is also allergic to nickel and cobalt which is in food and vitamin B12"; Vitamin b12, reaction(s): "Allergic to Vitamin B12". The following information was reported: CHILLS (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "arm a little sore"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 25Feb2021, outcome "recovered" (26Feb2021) and all described as "weak and tired"; MYALGIA (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "sore muscles".  Additional information: Caller clarified that within 12 hours after getting the first dose of the Pfizer Covid vaccine on 25Feb2021, the patient experienced all the events. The patient was also allergic to nickel and cobalt which is in food and vitamin B12, allergic to formaldehyde but that never consumed that as far as she knows. Due for second dose on Wednesday this week.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Menstrual disorder
Clinical narrative: Her menstrual cycle started on Thursday night into Friday night./She doesn't think it caused her cycle. It was due to come. She found she was depleted.; more tired; weaker than usual; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 11:40 (Lot number: EN6206) at the age of 45 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "low hemoglobin" (ongoing), notes: was taking iron in Nov,Dec and Jan. The past few months she went to the emergency room. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 11Mar2021, outcome "recovering", described as "more tired"; ASTHENIA (non-serious) with onset 11Mar2021, outcome "recovering", described as "weaker than usual"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Her menstrual cycle started on Thursday night into Friday night./She doesn't think it caused her cycle. It was due to come. She found she was depleted.".  Additional information: Patient was wondering in terms of side effects. Her menstrual cycle started on Thursday night into Friday night. Patient has had a low hemoglobin. It was acute and bears on her period. The past few months she went to the emergency room. It had been an issue for the past few months. She was taking iron in Nov, Dec and Jan. She did not have issues. This past period cycle she has had the issue. This was an ongoing health issue. The vaccine may not have made it worse. She wanted to be sure her condition was improving and having the vaccine at the same time did a number on her body. Patient did not have any prior Vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Accident
Clinical narrative: She says she had an accident; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (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: ACCIDENT (non-serious), outcome "unknown", described as "She says she had an accident".  Additional information: Caller is calling because she couldn't find the number to get this corrected on anything. She answered some questions on a survey and she had to dial in on this number to see about her appointment on the 17th which is Wednesday at 11 AM. She says she had an accident and she had to go to the orthopedic doctor and they are going to do a medicine report for her on the 17th to ensure her a different pain medication. No further information provided. She clarifies she is calling to try to change her appointment or maybe to get a later time because her appointment is at 9 o'clock but she has a pain med appointment at the orthopedic too. She says these are the only numbers that she has for the contact. So she called to let them know about the appointment and to try to get it scheduled for another time. She doesn't know how to get up with them, she asks if call handler has any kind of way to refer her back to like a back number of Pfizer. She just tried to connect to someone using questionnaire that they gave and this was the only number on the sheet they gave after she had the first shot and they scheduled her for the second shot which is the 17th she just wanted to see if she could get it at a later time in the day. Reporter details: She worked as a caretaker. She does not want any follow up. She has so many appointments and calls to set up and she talks to a lot of people. She is trying to get stuff settled with this appointment now. She declines to provide mailing address and email address. Primary Care details: Caller declines to provide. She would like to keep that private between her doctor and herself. Product details: She does not have her vaccine card with her but it was definitely Pfizer COVID 19 vaccine. They had her a questionnaire and helped her fill it out and it was Pfizer. She does not have the NDC lot expiration to provide or any dose information. She wouldn't know any of that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left (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: ILLNESS (non-serious), outcome "unknown", described as "got sick". 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-2021296342 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick the day after the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick the day after the 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-2021296341 same reporter/drug/event, different patient
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, Constipation
Clinical narrative: constipation; This is a spontaneous report received from contactable reporter(s) (Physician).  A 82 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 23Feb2021 (Lot number: EN5318) at the age of 82 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seafood/shellfish: rash" (unspecified if ongoing); "seafood/shellfish" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL EXTRA STRENGTH; NORVASC; ASPIR 81; TENORMIN; LIORESAL, start date: 21Dec2020; OS-CAL; SINEMET; LOTRISONE; VITAMIN B12 [COBAMAMIDE]; CYMBALTA, start date: 30Jul2020; CRESTOR; LASIX [FUROSEMIDE SODIUM]; MIRALAX; B COMPLEX+C; CALCIUM CARBONATE/VITAMIN D3. Past drug history included: Lisinopril, reaction(s): "Lisinopril: Cough"; Terazosin, reaction(s): "Terazosin: Trouble breathing"; Flomax, reaction(s): "Flomax: Arthralgia"; Oxybutynin, reaction(s): "Oxybutynin: SOB (shortness of breath)". Vaccination history included: Bnt162b2 (First Dose, Anatomical site of injection: Left Deltoid, Route of administration: IM, Lot/Batch number: EL9262), administration date: 26Jan2021, when the patient was 82 years old, for COVID-19 immunisation, reaction(s): "Itchy hands, legs, head, top of head and his face is itchy", "achy and hurts where got the vaccine", "he also has itching also on arm where vaccine given", "Scratch eye", "Dry skin"; Tetanus vaccination; Pneumovax vaccine.  The following information was reported: CONSTIPATION (non-serious) with onset 2021, outcome "unknown", described as "constipation". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: after 2nd dose, patient states that he experienced constipation. The patient did not received any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Pain
Clinical narrative: Chills; Body aches; temperature of a 100 degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EN6206) at the age of 46 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: CHILLS (non-serious) with onset 11Mar2021, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "Body aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 11Mar2021, outcome "not recovered", described as "temperature of a 100 degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Consumer stated that, his first dose of the vaccine was on 08Mar. He was experienced the side effects chills, body aches, temperature of 100 degrees, 7 days after the first shot. Chills began exactly 3 days after the first shot. Body aches began the same day as the chills, 3 days after the shot. He stated that with the temperature of a 100 degrees, the fever goes down through the day but it was high in the morning time when he gets up. He confirms it is off and on but still ongoing. The fever began 3 days after the dose as well.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Feb2021 17:00 (Lot number: EN6203) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson Disease" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose Exp.: 31May2021, lot #EN5318, received: 05Feb2021, Anatomical Site of injection- Shoulder, Route of administration-Intramuscular), administration date: 05Feb2021, when the patient was 73 years old, for Covid-19 immunization, reaction(s): "flu like symptoms". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. This female consumer reports receiving her first injection of the Pfizer-BioNTech COVID-19 vaccine about a month ago. About 3 days ago, she started experiencing dizziness. The dizziness is continuing (not recovered).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Rhinorrhoea, Secretion discharge
Clinical narrative: cold; mucus or nasal discharge; mucus or nasal discharge; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; SECRETION DISCHARGE (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "mucus or nasal discharge"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion". Therapeutic measures were taken as a result of nasal congestion.  Additional information: Patient received second dose on 16Mar2021. He has cold and mucus discharge for which he took Nyquil for congestion on 15Mar2021.   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
Clinical narrative: got tired after the first vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (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 Mar2021, outcome "unknown", described as "got tired after the first vaccine". Additional information: I got tired after the first vaccine and mentioned that it could be because her age was 78, just in general. She don't have any symptoms. She was scheduled on 08Jun2021 for the second one.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: The reporter (patient's wife) stated that her husband who had two shots and had nothing. He was tired.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; 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: ILLNESS (non-serious), outcome "unknown", described as "got sick".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia
Clinical narrative: Chills but no fever; Extreme fatigue; Inability to sleep; This is a spontaneous report received from a contactable reporter (Consumer). A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose; unknown lot number), for COVID-19 immunisation, reaction(s): "not report adverse side effects". The following information was reported: CHILLS (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Chills but no fever"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Extreme fatigue"; INSOMNIA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Inability to sleep". Additional information: The reporter mentioned that the adverse event started and ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she was not feeling well after getting second dose of covid-19 vaccine; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she was not feeling well after getting second dose of covid-19 vaccine". Additional information: the patient also wanted to know how to reschedule her husband's second dose of covid-19 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: Dizziness
Clinical narrative: few mins after the shot the person got lightheaded; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "few mins after the shot the person got lightheaded".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: so sick; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "so sick". Additional information: The patient had the first dose of COVID vaccine but was unable to keep second dose appointment. She had it rescheduled but it was 2 hours away. Someone suggested to call Pfizer if she misses the 2nd dose she will have to start series all over again. The patient stated that she does not really care if she gets the second dose cause she was so sick after the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.