chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm is very sore at the site of the injection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:00 (Lot number: EL3248) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Mar2021 20:00, outcome "not recovered", described as "My arm is very sore at the site of the injection.". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. List of any other medications the patient received within 2 weeks of vaccination, patient took 2 advil the week before. Patient became aware in the evening of 09Mar2021 and reported it on 10Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nasopharyngitis, Nausea
Clinical narrative: cold/cold like symptoms; pressure in head; little queasy stomach; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 (Lot number: EN6200) at the age of 71 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: NASOPHARYNGITIS (non-serious) with onset 10Mar2021, outcome "unknown", described as "cold/cold like symptoms"; HEAD DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "pressure in head"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "little queasy stomach".  Additional information: The patient was scheduled for second Pfizer vaccine tomorrow (11Mar2021) and thinks she had a cold. The patient wanted to know if it's okay to take the second dose (11Mar2021). First dose was on the 18Feb2021 and 2-3 days ago the patient felt like she had a cold going on, had pressure in her head, little queasy stomach.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain and soreness at injection site; Pain and soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 14:00 (Lot number: EL3247) at the age of 33 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: VACCINATION SITE PAIN (non-serious), PAIN (non-serious) all with onset 09Mar2021 14:30, outcome "not recovered" and all described as "Pain and soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain, pain. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: He has dementia and started to improve after Pfizer covid vaccination. Went from being incontinent to saying he had to go to the bathroom, getting up, and going; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Dementia" (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 "He has dementia and started to improve after Pfizer covid vaccination. Went from being incontinent to saying he had to go to the bathroom, getting up, and going".  Additional information: Patient is Father-in-law of friend. It was unknown if patient had tested for covid prior and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: gallbladder attack; This is a spontaneous report received from a contactable reporter (Physician).  A 73-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 23Feb2021 16:20 (Lot number: EM6203) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing); "hypertension" (ongoing); "TIA" (ongoing); "Diabetes Mellitus Type 2" (ongoing); "allergic rhinitis" (ongoing); "Type 2 HSV infection" (unspecified if ongoing). Family history included: "breast cancer" (unspecified if ongoing). Concomitant medications included: ATORVASTATIN CALCIUM, start date: 09Jun2018; IBUPROFEN; NYSTATIN POWDER, start date: 08Mar2021; PANTOPRAZOLE; VALTREX; LISINOPRIL; AMLODIPINE; METOPROLOL; JANUVIA [SITAGLIPTIN PHOSPHATE], start date: 11Sep2020; METFORMIN. Vaccination history included: Bnt162b2 (Dose 1, single; Date and Time: 02Feb2021 16:20; Site and Route of Injection: Left Deltoid, Intramuscular; Batch/Lot No- EM9810), administration date: 02Feb2021, when the patient was 73 years old, for COVID-19 Immunisation, reaction: "Lump under left Armpit". The following information was reported: GALLBLADDER DISORDER (non-serious) with onset 23Feb2021, outcome "recovered" (2021), described as "gallbladder attack". Therapeutic measures were not taken as a result of gallbladder disorder.  The reporter considered "gallbladder attack" not related to bnt162b2.  Additional Information: Vaccination Facility Type was reported as "Other". The event gallbladder attack was reported as non-serious. The patient provided information to the reporter regarding the reported adverse event with the use of the product. The reporter considered the Pfizer Product had no causal effect to the adverse event. The patient received no prior vaccinations and had no relevant tests done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The event gallbladder disorder considered as intercurrent condition and unrelated to product bnt162b2 (BNT162B2).,Linked Report(s) : US-PFIZER INC-2021123466 Same patient and product; Different dose and event.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (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: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache".  Additional information: Caller had 1st shot yesterday and was told not to take any aspirin. Now has headache and wondering if she can take aspirin. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm was sore; This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 11:50 (Lot number: EL9265) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Inflammation" (ongoing); "bone density" (ongoing); "acid reflux" (ongoing); "blood pressure" (ongoing); "Bone health" (ongoing). Concomitant medications included: RALOXIFENE taken for bone density (ongoing); OMEPRAZOLE taken for acid reflux (ongoing); LISINOPRIL taken for blood pressure (ongoing); VITAMIN D3 taken for extra D (ongoing); GARLIC [ALLIUM SATIVUM] taken for extra support (ongoing); TURMERIC [CURCUMA LONGA RHIZOME] taken for inflammation (ongoing); FAMOTIDINE taken for acid reflux (ongoing); CALCIUM taken for bone health (ongoing); COQ10 [UBIDECARENONE] taken for blood pressure (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Feb2021, outcome "recovered" (06Mar2021), described as "Her arm was sore".  Additional Information: Concomitant medication also included multivitamin (ongoing). The patient reported that after first dose, her arm was sore for a couple of hours but it was negligible. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. The event did not require a visit to physician or emergency room. The patient had unknown prior vaccinations within 4 weeks. The patient had no family medical history and no relevant test done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263889 Same reporter, patient, and drug; Different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Pain
Clinical narrative: fatigue/ feeling tired; really bad anxiety; achy; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (reported as patient's age: 66; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 03Mar2021 (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 "fatigue/ feeling tired "; ANXIETY (non-serious) with onset Mar2021, outcome "unknown", described as "really bad anxiety"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "achy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Oropharyngeal pain, Product administration error
Clinical narrative: injected the vaccine/ blue thing never clicked/ needle was left a little longer in the arm until the vaccination provider was able to remove it/ her arm was wet after the injection; sore throat; did not feel right; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 05Mar2021 (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: OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "did not feel right"; PRODUCT ADMINISTRATION ERROR (non-serious) with onset 05Mar2021, outcome "unknown", described as "injected the vaccine/ blue thing never clicked/ needle was left a little longer in the arm until the vaccination provider was able to remove it/ her arm was wet after the injection".  Additional information: This patient's age was reported as 64 (unit: unknown). The patient received the first dose of the vaccine on 05Mar2021 and stated she had a weird thing happened to her. When the vaccination provider injected the vaccine, she said uh oh and mentioned that the blue thing never clicked. The patient explained that the needle was left a little longer in the arm until the vaccination provider was able to remove it. It sounded like a defective needle. The patient stated her arm was wet after the injection. She stated she has been experiencing sore throat and does not feel right since. The patient asked if there are any reports of this and if she should be worried.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Physical examination
Clinical narrative: his arm feels like it has a knife/tries to pick up something, move his arm, or do something he gets a sharp, sharp pain was reported as worsened; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03Jan2021 (Lot number: EK4176) at the age of 69 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 04Jan2021, outcome "not recovered", described as "his arm feels like it has a knife/tries to pick up something, move his arm, or do something he gets a sharp, sharp pain was reported as worsened". The event "his arm feels like it has a knife/tries to pick up something, move his arm, or do something he gets a sharp, sharp pain was reported as worsened" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. Additional Information: He was glad to say that he was healthy as a horse he had got all good numbers for his blood results (taken on unknown date). The patient said that he had his first Pfizer COVID vaccine on 03Jan2021 about 1100 or 1200. On 04Jan2021, his arm felt like it has a knife in it. He can push on the arm in the muscle from the outside and it doesn't hurt but when he tries to pick up something, move his arm, or do something he got a sharp pain. He has tried warm water in the shower and that made it feel better. He also tried an ice pack (over-the-counter ice pack that he kept in the freezer) last night, and his arm seized up when he used it. He then used a heating pad and it worked itself out. The patient also has taken both Ibuprofen and acetaminophen (Tylenol) and they helped a little bit but not much. The Ibuprofen worked better than the acetaminophen worked. The patient stated everything else was fine, he had no issues with the COVID vaccine. He had a physical (unknown results) 2 weeks ago (in 2021), and his provider checked him out and poked at his arm. The provider mentioned that either they hit a muscle or a nerve. The events continued until his second dose of the COVID vaccine on 31Jan2021 (lot# EN5318) on the right arm and it continued up to right now. The patient has no vaccination within 4 weeks prior to COVID-19 vaccine and has no medical history including any illness at time of vaccination and family medical history relevant to the adverse event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021267918 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Bowel movement irregularity, Condition aggravated, Menopausal symptoms
Clinical narrative: bowels are moving more than normal/ was still going to the bathroom and stuff; bowel movements don't smell regular; going through menopause and is getting hot flashed more than normal; going through menopause and is getting hot flashed more than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "menopause" (ongoing); "menopausal hot flushes" (ongoing). The patient's concomitant medications were not reported. The following information was reported: BOWEL MOVEMENT IRREGULARITY (non-serious), outcome "unknown", described as "bowels are moving more than normal/ was still going to the bathroom and stuff"; ABNORMAL FAECES (non-serious), outcome "unknown", described as "bowel movements don't smell regular"; MENOPAUSAL SYMPTOMS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "going through menopause and is getting hot flashed more than normal".  Additional Information: The patient's age was reported as "63" (unit: unknown). The reporter stated that she was on a diet and stopped the diet the day before the vaccine but was still going to the bathroom and stuff. She further asked if bowels were moving more than normal from a diet, if it would this flush the vaccine out.  Her bowel movements don't smell regular and she was guessing the vaccine was mixed in there.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Intense chills; Body Aches; headache; I spent the day in bed- very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Lot number: EL3247) at the age of 55 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 (1st dose (lot/batch number: Pfizer EL8982, Vaccination was given at 13:30 pm on arm right)), administration date: 14Jan2021, when the patient was 55 years old, for Covid-19 Immunization, reaction(s): "Headache", "Intestine pain/ gas", "Bloating", "Diarrhea", "Her arm was sore for 24 hours". The following information was reported: CHILLS (non-serious) with onset Feb2021, outcome "recovering", described as "Intense chills"; PAIN (non-serious) with onset Feb2021, outcome "recovering", described as "Body Aches"; HEADACHE (non-serious) with onset Feb2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset Feb2021, outcome "recovering", described as "I spent the day in bed- very tired".  Additional information: Patient did not report it, but had much more severe reaction to the second shot received on 04Feb2021. After 12 hours of getting shot 2, Patient experienced intense chills and body aches, and headache.  Patient spent the day in bed- very tired. A day later, symptoms subsides and patient had no further issues from the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash at and around injection site; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 26 years 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: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Rash at and around injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Vaccination site pain
Clinical narrative: some weakness in my arms and legs for several seconds; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 10:30 (Lot number: EL3247) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tree" (unspecified if ongoing); "Known allergies: grass pollens" (unspecified if ongoing); "Known allergies: dust mites" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 09Mar2021 10:40, outcome "recovered" (Mar2021), described as "some weakness in my arms and legs for several seconds"; VACCINATION SITE PAIN (non-serious) with onset 09Mar2021, outcome "recovered" (10Mar2021), described as "Injection site pain". Therapeutic measures were not taken as a result of muscular weakness, vaccination site pain. clinical course:  Additional information: The Patient did not receive any other vaccine in four weeks. Patient received Other Medications in two weeks was vitamin D 2000IU daily. About 10 minutes after injection, I felt some weakness in my arms and legs for several seconds. Injection site pain that lasted about a day. The patient did not had covid prior vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Feb 27, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient developed lymphadenopathy/swollen lymph nodes and myalgia/muscle pain, with outcome of unknown. Additional information: She received the second dose on Feb 27, 2021 and experienced swollen lymph nodes and muscle pain. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a non-contactable consumer (patient). An male patient, of unknown age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 10, 2021, single dose, for COVID-19 immunisation. The patient's  medical history and concomitant medications not reported. The patient had fatigue/extreme exhaustion, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Insomnia
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 76-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "I developed acid reflux"; Amoxicillin, reaction(s): "affected ability to sleep". Vaccination history included: Bnt162b2 (Dose 1, Single, Right Arm, Lot# Not Provided), administration date: 08Feb2021, for COVID-19 immunization, reaction(s): "no adverse reaction". The following information was reported: INSOMNIA (non-serious) with onset 06Mar2021, outcome "recovered" (2021), described as "affected ability to sleep"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 06Mar2021, outcome "recovered" (2021), described as "I developed acid reflux". Therapeutic measures were taken as a result of insomnia, gastrooesophageal reflux disease. Additional Information: The patient did not receive any other vaccine in four weeks. The patient has taken diabetic medications in two weeks. The patient has no allergies. The patient did not have COVID-19 Infection prior vaccination and has not tested for COVID-19 since post vaccination. On 06Mar2021, approximately three days after the second Covid vaccination (also reported as 08Mar2021), the patient developed acid reflux, which affected his ability to sleep. The patient didn't know if the condition was caused by the vaccination (there was no such reaction after his first shot). Those problems went away after a course of Omeprazole. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Illness
Clinical narrative: 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 (159558). A 83 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: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Seniors who take the vaccine are 80% effective and don't have to take the second shot"; ILLNESS (non-serious), outcome "unknown", described as "both got very sick/Got so sick".  Additional Context: This is the second case out of two cases. Reporter stated, "They telling everybody to go and get vaccinated (Unspecified vaccine) so I had cousin of mine who is in her 70's, she went to get vaccinated and I also took my mother who is 83 years old and I had her vaccinated and they both got the Pfizer vaccination. They went to the first one and the 2 of them got so sick, so I am afraid to take my mother to the second dose now in April. Somebody told me that senior citizens when you get the first dose they were 80 percent something, they don't have to get the second shot, is that true, with the Pfizer. It's terrible they telling people to get vaccinated, people getting sick. What's the phone number, I got the news to you, and I am going to think twice now and getting the vaccine, seeing how my mother is".  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
Clinical narrative: arm was sore; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was sore".  Additional information: The patient received both doses of the Pfizer vaccine. She received the second dose on 17Feb2021. She stated that she received the second dose "12 days past the 21 days". She stated that she had "no antibodies when they checked". She got an antibody test: they pricked her finger and said she had no antibodies ("negative IgC and IgM). They advised her to come back in 1 month to test again. She stated that after the first vaccine, her "arm was sore".  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-2021273309 Same patient/drug, different dose/event separated in time;US-PFIZER INC-2021273352 Same patient/drug, different dose/event separated in time
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; 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 female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (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: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache". Additional information: The reporter was querying if it was okay to take Advil a day after the vaccination. It was reported that the patient did not have time to speak to Safety and that she knew headache was an expected side effect from the vaccine, but she did not want to jeopardize the efficacy by taking Advil or Tylenol and wanted to know how long she would personally wait or which medication would she take/consider best to take. The patient also queried about the vaccine's efficacy during clinical trials and against the (ethnicity) variant.  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
Clinical narrative: arm was a little sore after the vaccine; The initial case was missing the following minimum criteria: Adverse event. Upon receipt of follow-up information on 11Mar2021, this case now contains all required information to be considered valid. 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 female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Prolia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was a little sore after the vaccine". Additional information: The patient stated that she received the first dose of the Pfizer covid 19 vaccine on 10Mar2021 and was getting Prolia injection on Monday. She has not had the Prolia since 2017. She wanted to know if she can get the Prolia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Syringe issue, Underdose, Vaccination site extravasation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE EXTRAVASATION (non-serious), UNDERDOSE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), SYRINGE ISSUE (non-serious), outcome "unknown" and all described as "the person who administered it didn't give her the full dose of the vaccine since it leaked out of the syringe and came out of her arm". Additional information: Patient got her 1st dose of the Pfizer Covid Vaccine yesterday and stated that the person who administered it didn't give her the full dose of the vaccine since it leaked out of the syringe and came out of her arm. She thinks that she only received about 50% or 3/4 of the dose and wants to know how much is the percentage of protection that the vaccine will give her. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Gait disturbance
Clinical narrative: Vertigo-like imbalance; Walking like a drunk without the booze; It isn't quite debilitating, but I have had to sit or lie down to help navigate the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 07Mar2021 11:00 (Lot number: EN6206) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Chronic bronchitis" (unspecified if ongoing); "seasonal asthma" (unspecified if ongoing); "known allergies: curry spice" (unspecified if ongoing); "have had vertigo" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "allergies".  The following information was reported: BALANCE DISORDER (non-serious) with onset 10Mar2021 22:00, outcome "not recovered", described as "Vertigo-like imbalance"; GAIT DISTURBANCE (non-serious) with onset 10Mar2021 22:00, outcome "not recovered", described as "Walking like a drunk without the booze"; ASTHENIA (non-serious) with onset 10Mar2021 22:00, outcome "not recovered", described as "It isn't quite debilitating, but I have had to sit or lie down to help navigate the day". Therapeutic measures were not taken as a result of balance disorder, gait disturbance, asthenia.  Additional information: The patient experienced vertigo-like imbalance and walking like a drunk without the booze. The patient informed that she had vertigo and it was not vertigo. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks.  The patient did not have COVID prior to vaccination. The patient had not been tested for COVID post- vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 61 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: BACK PAIN (non-serious) with onset 2021, outcome "recovering", described as "back muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: chills; headache; Energy level low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (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: CHILLS (non-serious) with onset 07Mar2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 07Mar2021, outcome "unknown", described as "headache"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "Energy level low".  Additional information: Patient had vaccine March 1st Monday. Energy level was low during the week. Had chills last night when going to bed along with headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: around midnight on 04Mar2021, she started throwing up; she got very, very nauseous with the second COVID-19 Vaccine shot; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 15:00 (Lot number: EN6198) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cerebral palsy" (unspecified if ongoing), notes: Reported she has had cerebral palsy for almost 88 years. No further details provided. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration Time: about 10:30 AM, Route: Intramuscular, Anatomical Location: Arm Right, Lot Number: EN5318), administration date: 09Feb2021, when the patient was 87 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 03Mar2021 22:00, outcome "recovered" (04Mar2021), described as "she got very, very nauseous with the second COVID-19 Vaccine shot"; VOMITING (non-serious) with onset 04Mar2021, outcome "recovered" (04Mar2021 06:00), described as "around midnight on 04Mar2021, she started throwing up". Additional Information: The patient reported she didn't want to take the COVID-19 Vaccine, but her three daughters wanted her to take the COVID-19 vaccine. She said she was concerned something may occur down the road from taking the COVID-19 Vaccine, and that was why she didn't want to take the COVID-19 Vaccine. The patient avoided eating while she was nauseous and throwing up. There was no additional vaccines administered on the same day of vaccination of BNT162b2. The events did not require emergency room or physician office visit. There was no vaccine administered within 4 weeks prior COVID-19 Vaccination. Vaccination facility type: hospital, vaccine was not administered at military facility. No relevant rests/investigations performed.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Feb2021 14:30 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose lot number is EK9231., Time: 09:45 AM,, Anatomical site of injection: Shoulder,, Route of Administration: Intramuscular.), administration date: 22Jan2021, for COVID-19 immunization, reaction(s): "Sore upper arm". The following information was reported: CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "chills".  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Insomnia
Clinical narrative: tired; lightheaded; weak; not eating or sleeping right; not eating or sleeping right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (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 "tired"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; DECREASED APPETITE (non-serious), INSOMNIA (non-serious), outcome "recovered" and all described as "not eating or sleeping right".  Additional Information: He got the shot on a Thursday. He mentioned he was not sure if it was from working long hours and not getting any sleep or if from the vaccination. Now he's hesitant to get the second Covid 19 vaccine. Not eating or sleeping right only lasted about two days, then it went away. He was wondering if he should just get that second dose. Caller declined to file safety report, no further information was provided or obtained.   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, Headache, Myalgia
Clinical narrative: Chills; Headache; Muscle pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old 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: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional Information: The patient reported that she took acetaminophen (TYLENOL) or something on an unspecified date (not specified if taken as treatment or as concomitant medication).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache / slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 12:30 (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: HEADACHE (non-serious) with onset 09Mar2021 15:00, outcome "unknown", described as "Headache / slight headache". Additional Information: The patient was querying if she could take 2 Tylenol because of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: little sore arm; little woozy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jan2021 (Lot number: EL9263) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "difficulty walking" (unspecified if ongoing), notes: The patient had difficulty walking before, she has spinal stenosis.; "spinal stenosis" (unspecified if ongoing), notes: The patient had difficulty walking before, she has spinal stenosis.; "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). Vaccination history included: Flu shot (AE(s) following prior vaccinations flu shot, sore arm, in October LOT/NDC/EXPIRY unknown), reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little sore arm"; DIZZINESS (non-serious), outcome "unknown", described as "little woozy".  Additional information: Reportedly, the first injection was given on 22Jan2021 was the first injection, somewhat of the side effects but not too bad. It was reported that with the first injection the patient had a little sore arm, she was ok, little woozy.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: After second dose my arm hurt so much more than first dose; couldn't sleep well; today I've been nauseated; faint-like feeling; threw up twice; I have no appetite; stomach remains swollen; terrible tiredness; I am feeling bad; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: Unknown, time 16:00, Anatomical Location: Arm Left), administration date: 13Feb2021, for COVID-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "recovering", described as "After second dose my arm hurt so much more than first dose"; SLEEP DISORDER (non-serious) with onset 06Mar2021, outcome "recovering", described as "couldn't sleep well"; NAUSEA (non-serious) with onset 06Mar2021, outcome "recovering", described as "today I've been nauseated"; DIZZINESS (non-serious) with onset 06Mar2021, outcome "recovering", described as "faint-like feeling"; VOMITING (non-serious) with onset 06Mar2021, outcome "recovering", described as "threw up twice"; DECREASED APPETITE (non-serious) with onset 06Mar2021, outcome "recovering", described as "I have no appetite"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Mar2021, outcome "recovering", described as "stomach remains swollen"; FATIGUE (non-serious) with onset 06Mar2021, outcome "recovering", described as "terrible tiredness"; FEELING ABNORMAL (non-serious) with onset 06Mar2021, outcome "recovering", described as "I am feeling bad". Therapeutic measures were taken as a result of pain in extremity, sleep disorder, nausea, dizziness, vomiting, decreased appetite, abdominal discomfort, fatigue, feeling abnormal.  Additional information: Patient not had allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Estradiol within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The arm does not get relieve regardless the patient took acetaminophen every 5 hours. The patient stated that the pain makes not caring to do of the patient day, she just wanted to feel better and that this passes away and she worried but her husband says she have to wait to get better. Since the vaccination, the patient not tested for COVID-19. The patient received treatment with Acetaminophen and Alka-Seltzer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.