chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizzy; Nausea; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), the patient's wife.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 10:00 (Batch/Lot number: unknown) at the age of 81 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "(Diabetes) Blood sugar" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 14Mar2021, outcome "not recovered", described as "Dizzy"; NAUSEA (non-serious) with onset 14Mar2021, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 14Mar2021, outcome "not recovered", described as "Vomiting". Therapeutic measures were not taken as a result of dizziness, nausea, vomiting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bite, Rash macular
Clinical narrative: Kind of look like bites on his neck only on the right side; He had red dots behind his ear/ He has three on the back of his neck/wells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63 year-old patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (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), for COVID-19 immunisation. The following information was reported: BITE (non-serious) with onset Mar2021, outcome "unknown", described as "Kind of look like bites on his neck only on the right side"; RASH MACULAR (non-serious) with onset Mar2021, outcome "unknown", described as "He had red dots behind his ear/ He has three on the back of his neck/wells".Additional information: Reporter reported for husband. Patient got the Pfizer Vaccine. He got his second dose on 25Feb2021. It was just 2 weeks on Thursday a couple of days (Mar2021) before that he had red dots behind his ear. They kind of look like bites or may be little 'wells' on his neck only on the right side. He has three on the back of his neck, one next to it and one above his right ear. We were concerned, he had never had anything like that. If that is any type of I do not want to say a reaction but a part of having the COVID-19 Pfizer 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: Influenza like illness
Clinical narrative: Caller went on to report that she didn't have any pain in her arms but "I had flu like symptoms for a couple of days and that was it".; 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) (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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Caller went on to report that she didn't have any pain in her arms but "I had flu like symptoms for a couple of days and that was it".  Additional information: The reporter reported that her husband (82 yo) received his second covid vaccine dose on 04Feb. She reported that 2 weeks later he began having some discomfort in his arm. Later it got worse with pain from his shoulder down to his fingers, his elbow swelled up and he couldn't put pressure on it. He's seen the doctor and had x-rays and they said he had bursitis and arthritis. He was placed on Steroids and then the following week they gave him an injection in his shoulder but he was still having some problems with it. The reporter went on to report that she became suspicious when yesterday her mother in law came over and reported that she received her 1st shot and was having so much pain in her elbow down to her fingers since the injection. The reporter reported that her mother in law already called in to report her symptoms. The reporter went on to report that she didn't have any pain in her arms but she had flu like symptoms for a couple of days and that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: much pain in her elbow down to her fingers since the injection; much pain in her elbow down to her fingers since the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "much pain in her elbow down to her fingers since the injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: the site was red, warm, might be a little fever in it, and hard; the site was red, warm, might be a little fever in it, and hard; she noticed her injection site was red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 42 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 ERYTHEMA (non-serious) with onset 14Mar2021, outcome "unknown", described as "she noticed her injection site was red"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 15Mar2021, outcome "unknown" and all described as "the site was red, warm, might be a little fever in it, and hard". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated on 06Mar2021, she received her first Covid 19 vaccine. She was out with her family yesterday and got home at 6pm. She took a shower. When she got out of the shower, she noticed her injection site was red. This morning, the site was red, warm, might be a little fever in it, and hard. Reports that she does not have a fever, and her temperature was taken this morning at work and was 97.6. It was reported that she got the vaccine through the hospital. 27Mar2021, second vaccine was scheduled. Caller reported that she does not have an HCP.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experience headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 10:00 (Batch/Lot number: unknown) at the age of 72 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (05Mar2021), described as "experience headaches". Therapeutic measures were taken as a result of headache. Additional information: Since the patient was the reporter, she experiences with the COVID vaccine. When she took the first COVID vaccine on 04Mar2021 she experiences headaches. Reporter Details was Declined to provide a physical mailing address, Patient Details was Declined to provide specific "other" ethnicity Primary Healthcare Professional Information includes Unable to provide mailing address, phone number, or email address, Event Details includes Headaches started around 4:30 PM or 5:00 PM after patient received vaccine on 04Mar2021. She took Tylenol about 10:00 PM that same night and when she woke up the next day the headache was gone. Caller confirms she recovered completely. Suspect Product details includes, Probed for NDC, lot number, and expiry date and says that they treated her bad, there is nothing on her COVID vaccine record card, patient hasn't taken her second COVID vaccine yet, she will get that on 25Mar2021. On her COVID vaccine record card it was the first dose and the date of 04Mar2021, no information regarding emergency room, physician office visit, patient has not undergone any other prior vaccinations within 4 weeks. Patient wanted to respond to the pamphlet that she got from Pfizer that had asked that if she had any side effects to report them. Vaccination Facility Type: At a centre.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: lower back is in horrible pain; I can barely walk; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Mar2021 (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: BACK PAIN (non-serious), outcome "unknown", described as "lower back is in horrible pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I can barely walk".  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: sore arm; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain
Clinical narrative: body aches; headache; dizziness; 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 26Jan2021 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EJ1686, Time vaccination was 09:00 am and anatomical location of the administration of the vaccine was arm left), administration date: 05Jan2021, when the patient was 55 years old, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "body aches"; HEADACHE (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "headache"; DIZZINESS (non-serious) with onset 27Jan2021, outcome "recovered" (2021), described as "dizziness". Therapeutic measures were taken as a result of pain, headache, dizziness.  Additional information: Never had a reaction from any other vaccine prior. There was no predisposing factors. The patient was not admitted to hospital. AEs did not require a visit to emergency room or physician office. No culture was performed. Treatment received was only NSAIDS Tylenol and ibuprofen. Causal relationship: there was reasonable possibility that the event was related to suspect product Pfizer.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: no pain at first then it started; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "no pain at first then it started".  Additional information included: Information of expiry Date of COVID 19 vaccine, other products, patient history and investigation assessment were not provided at the time of report. Reporter stated her husband had received the vaccine and had no pain at first then it started. Reporter declined to complete report at that time.  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: Headache, Injection site pain, Neck pain, Spinal pain
Clinical narrative: pain in back of neck and down the upper spine; pain in back of neck and down the upper spine; Headache; arm injection site pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Feb2021 13:30 (Lot number: EN6205) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bell's palsy" (unspecified if ongoing), notes: Verbatim: Bell's palsy; "Arthritis right hip" (unspecified if ongoing); "her allergies to Penicillin IV dye at the facility" (unspecified if ongoing). Concomitant medication(s) included: DICLOFENAC taken for arthritis. The following information was reported: NECK PAIN (non-serious), SPINAL PAIN (non-serious) all with onset 28Feb2021, outcome "recovered" (2021) and all described as "pain in back of neck and down the upper spine"; HEADACHE (non-serious) with onset 28Feb2021, outcome "unknown", described as "Headache"; INJECTION SITE PAIN (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "arm injection site pain". Therapeutic measures were taken as a result of neck pain, spinal pain.  Additional information: concomitant medication Diclofenac, Dosage text: 75mg one every twelve hours as needed by mouth. The patient ibuprofen as a treatment medication.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Headache; Nauseous; Diarrhoea; Throwing up; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6204) at the age of 78 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: HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Headache"; NAUSEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Nauseous"; DIARRHOEA (non-serious) with onset 13Mar2021, outcome "unknown", described as "Diarrhoea"; VOMITING (non-serious) with onset 13Mar2021, outcome "unknown", described as "Throwing up"; HYPERHIDROSIS (non-serious) with onset 13Mar2021, outcome "unknown", described as "Sweating". Therapeutic measures were not taken as a result of headache, nausea, diarrhoea, vomiting, hyperhidrosis.  Additional information: The patient reported that when she got the shot on Friday, she was fine and until the next morning and when she get up she had severe headache, she was nauseous and she had the diarrhoea. she was throwing up, she was sweating and she just wondered if that is normal and if she got that bad through the first shot what she going to do with the second shot. She was getting next vaccine on 01Apr.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: excruciating pain upon injection; injection site and left arm; excruciating pain upon injection; injection site and left arm; Limited Use/Mobility of Left Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 10:00 (Batch/Lot number: unknown) at the age of 80 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: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 25Feb2021, outcome "recovering" and all described as "excruciating pain upon injection; injection site and left arm"; MOBILITY DECREASED (non-serious) with onset 25Feb2021, outcome "recovering", described as "Limited Use/Mobility of Left Arm".  Additional Information: caller states that it is better than it was after 2 weeks but still there slightly. Caller states his second vaccine is on the 18MAR, a few days from now. The patient did not visit Emergency Room and Physician Office. Caller states he hopes that call handler might be permitted to give information as to since he had an acute local reaction if it would be better to choose a different arm for second dose in three days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgraphia, Eye pain, Fatigue, Hypoaesthesia, Limb discomfort
Clinical narrative: numbness in right hand, fingers and arm; lips feel different; cold as ice; she felt a little tired/more tired; Had soreness the next day after vaccine administered; arm feels heavy; she can't write as well; her fingers do not bend; eyes hurt a little, not a lot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 20:00 (Lot number: EL9266) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 1981 (ongoing), notes: diagnosed when she was 23 or 24 years old, around 1981 maybe. The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "cold as ice"; HYPOAESTHESIA (non-serious) with onset 14Mar2021, outcome "not recovered", described as "numbness in right hand, fingers and arm"; FATIGUE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "she felt a little tired/more tired"; LIP DISORDER (non-serious) with onset 14Mar2021, outcome "not recovered", described as "lips feel different"; EYE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "eyes hurt a little, not a lot"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "Had soreness the next day after vaccine administered"; LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "arm feels heavy"; DYSGRAPHIA (non-serious) with onset Mar2021, outcome "unknown", described as "she can't write as well"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Mar2021, outcome "unknown", described as "her fingers do not bend".  Additional information: The patient always gets a reaction from the flu shot, she will end up not feeling well, with aches and pains, a mild reaction, not enough to keep her out of work, just not feeling herself. Usually within few days or 3-4 days she is ok. No NDC, Lot or Expiration known for flu shots, does not have products with her. No further information provided and Vaccination Facility Type: Pharmacy. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) N/A. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines on the same day of vaccine vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Musculoskeletal stiffness, Nasopharyngitis, Vaccination site pain
Clinical narrative: numbness in right hand, fingers and arm; lips feel different; cold as ice; she felt a little tired/more tired; Had soreness the next day after vaccine administered; arm feels heavy; she can't write as well; her fingers do not bend; eyes hurt a little, not a lot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 20:00 (Lot number: EL9266) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 1981 (ongoing), notes: diagnosed when she was 23 or 24 years old, around 1981 maybe. The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "cold as ice"; HYPOAESTHESIA (non-serious) with onset 14Mar2021, outcome "not recovered", described as "numbness in right hand, fingers and arm"; FATIGUE (non-serious) with onset 11Mar2021, outcome "not recovered", described as "she felt a little tired/more tired"; LIP DISORDER (non-serious) with onset 14Mar2021, outcome "not recovered", described as "lips feel different"; EYE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "eyes hurt a little, not a lot"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "Had soreness the next day after vaccine administered"; LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "arm feels heavy"; DYSGRAPHIA (non-serious) with onset Mar2021, outcome "unknown", described as "she can't write as well"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Mar2021, outcome "unknown", described as "her fingers do not bend".  Additional information: The patient always gets a reaction from the flu shot, she will end up not feeling well, with aches and pains, a mild reaction, not enough to keep her out of work, just not feeling herself. Usually within few days or 3-4 days she is ok. No NDC, Lot or Expiration known for flu shots, does not have products with her. No further information provided and Vaccination Facility Type: Pharmacy. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) N/A. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines on the same day of vaccine vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little sore; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Feb2021 08:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing). The following information was reported: PAIN (non-serious) with onset 16Feb2021, outcome "recovered" (17Feb2021), described as "a little sore".  Additional information: The patient has been taking losartan for at least 10 years. The patient has been taking for about 15 years  Men's Multivitamin. The call received the second dose of the Covid-19 vaccine last week. He has been having side effects and is asking if they are unusual. He has heard of headaches and an upset stomach. He has had a headache for a week. He also has an upset stomach. He heard of 24-36 hours but this is dragging.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: She is having to use a walker due to the pain; pain on her left leg from hip to foot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 86 year-old female (not pregnant) patient received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 09Mar2021 10:00 (Lot number: EJ1686) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bypass AAA surgery for the abdominal aorta", start date: 2017 (unspecified if ongoing), notes: Relates patient in 2017 had bypass AAA surgery for the abdominal aorta and had 3 stents applied.; "3 stents applied", start date: 2017 (unspecified if ongoing); "Clogged arteries" (unspecified if ongoing); "Sciatic pain" (unspecified if ongoing), notes: she developed a sciatic pain to her right leg and chronic right foot pain. The patient's concomitant medications were not reported. Past drug history included: Cannabis for leg for pain, reaction(s): "it didn't help"; Tylenol, reaction(s): "didn't help". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "pain on her left leg from hip to foot"; WALKING AID USER (non-serious), outcome "unknown", described as "She is having to use a walker due to the pain". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient on 09Mar2021 at 10:00AM in the left arm, got the first injection. on evening of 12Mar2021 she started to get a pain on her left leg from hip to foot. her husband gave her a massage and it didn't help. He has a jar of body balm with cannabis drug in it and he has used it in the past on her right leg for pain related to past Triple A surgery on right leg. He tried the body balm on the left leg and it didn't help at all. The pain is very severe now. She is having to use a walker due to the pain. They also tried Tylenol and it didn't help. Adds now she can't put any weight on her left leg. The patient had no AE prior to vaccination(within 4 weeks). The patient did not required any physician or ER.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: body aches; chills; fatiquge; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 64 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: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatiquge". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient rapid test was negative, so she was waiting for results from her PCR test.  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: Eczema, Fatigue, Investigation, Pain, Vaccination site pain
Clinical narrative: I thought I had a flare up what I believe to be eczema on my hand but I am not really 100%. I was looking at the side effect and it says rash on your body and for me it has been on my hand; Achy on all over my whole body like my joints; Soreness occurred at the injection site both times; Tired; This is a spontaneous report received from a 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 02Feb2021 (Lot number: EL9261) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARAVIS. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "I thought I had a flare up what I believe to be eczema on my hand but I am not really 100%. I was looking at the side effect and it says rash on your body and for me it has been on my hand"; VACCINATION SITE PAIN (non-serious) with onset 05Mar2021, outcome "recovered", described as "Soreness occurred at the injection site both times"; PAIN (non-serious), outcome "unknown", described as "Achy on all over my whole body like my joints"; FATIGUE (non-serious) with onset 05Feb2021, outcome "recovered", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Oropharyngeal discomfort
Clinical narrative: My throat started bothering me; every day I have saw worst; My throat started bothering me; every day I have saw worst; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Mar2021 (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 DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "My throat started bothering me; every day I have saw worst".  Additional information: Consumer  had the shot last Tuesday and stated that this feedback is being documented in Pfizer Database. In responsefrom Pfizer , the consumer stated, she got the shot (Covid-19 Vaccine by Pfizer) Tuesday, first dose.  And felt fine for two days and then Thursday night, two days later the consumers throat started bothering and every day saw worst and the question was are they delayed symptoms?" Consumer was informed about the Pfizer Medical Information and provided with the number as # and was requested to select option 3, timings as 8 am to 11pm Monday to Friday and on Saturday and Sunday 8am to 8pm as per (EST). When probed for name and telephone#: Consumer stated," the consumer was not ready."and informed about filing a safety report. When requested for probing, consumer hung up the call abruptly.Further probing could not be done as consumer hung up the call abruptly. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Renal pain
Clinical narrative: kidneys are hurting; lower back pain in the area of her kidney; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1. Manufacturer unknown), for COVID-19 immunisation. The following information was reported: RENAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "kidneys are hurting"; BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "lower back pain in the area of her kidney".  Additional information: Report from a Pfizer sponsored program Support. Calling about Pfizer vaccine for COVID 19. Caller had her second dose this weekend and had all the side effects that are listed and it has been almost two full days. Now her kidneys are hurting and not sure if this is a reported side effect and normal. Reporter stated she waited an hour and a half on hold to speak with someone that is supposed to be the medical information department. Verbatim and Event Description: Caller (Name withheld) called in today and said after she got her second dose she experienced lower back pain in the area of her kidney. She wanted to know if that is dangerous and reportable as a side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Somnolence
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 74 year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 74, in right arm, on Mar 4, 2021, at 16:30, single dose, for COVID-19 immunisation. No medical history. There were no concomitant medications. Vaccination history included the 1st dose of BNT162B2 (COVID-19 vaccine, batch/lot# unknown, expiry date: unknown), at the age of 74, intramuscularly, left arm, on Jan 30, 2021, single dose, for COVID-19 immunization; and experienced no reaction(s)/no ill effects. The patient reported fatigue (her husband instantly came down with unbelievable fatigue), somnolence (she and her husband wanted to sleep a lot), onset Mar 5, 2021, with outcome of recovering; asthenia (she and her husband had no energy at all), onset Mar 5, 2021, with outcome of not recovered; and myalgia (her husband's achiness was more specific to his right calf muscle), onset Mar 5, 2021, with outcome of recovered (Mar 2021). She said her husband said his right calf muscle was very painful. Additional information: The reporter said her husband was a very active person before getting his second COVID-19 Vaccine and was in pretty good health. No additional vaccines administered on same date of the Pfizer suspect. Her husband did not take any Tylenol, as suggested by the pharmacist. Her husband did not go to the emergency room or his doctor for treatment of his symptoms. Her husband had not received any other vaccines during the time period within 4 weeks of his COVID-19 vaccine doses or at the same time as his COVID-19 vaccine doses. The patient received second COVID-19 vaccine almost 5 weeks apart from the first COVID-19 vaccine dose. No relevant tests performed. Vaccination Facility Type: Pharmacy/Drug store. The adverse event did not result in emergency room/doctor or other healthcare professional office/clinic visit. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021296207 same reporter, drug and events, different patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling/pin prick sensations on right side of face. Including forehead, around eye, right temple, around ear, cheek, mouth and chin; 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 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 12:30 (Lot number: EN6202) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low thyroid" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Sulfa base. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VITAMIN D [VITAMIN D NOS]. The following information was reported: PARAESTHESIA (non-serious) with onset 09Mar2021, outcome "recovering", described as "Tingling/pin prick sensations on right side of face. Including forehead, around eye, right temple, around ear, cheek, mouth and chin". The event "tingling/pin prick sensations on right side of face. including forehead, around eye, right temple, around ear, cheek, mouth and chin" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not recieve any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Levothyroxine, multivitamin, vitamin D. The adverse event resulted in visit to Doctor or other healthcare professional office or clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation
Clinical narrative: like a ball's eye red inflammation on the arm where the first dose of the vaccine was injected; like a ball's eye red inflammation on the arm where the first dose of the vaccine was injected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (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 INFLAMMATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 05Mar2021, outcome "unknown" and all described as "like a ball's eye red inflammation on the arm where the first dose of the vaccine was injected".  Additional information: The reporter asked if it was okay to get the Covid -19 vaccine second dose scheduled on 25Mar2021 be injected on the same arm as with the first dose of the vaccine given on 25Feb2021 even though she had a very rare side effect 8 days after. She had like a ball's eye red inflammation on the arm where the first dose of the vaccine was injected but she still wanted to get the second dose of the vaccine injected on the same arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Headache, Nausea, Pain in extremity
Clinical narrative: Never had hurt that bad; Arm has been hurting ever since I got the shot; Headache; Lot of anxiety; Anxious; Nauseated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Never had hurt that bad; Arm has been hurting ever since I got the shot"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; ANXIETY (non-serious), outcome "unknown", described as "Lot of anxiety; Anxious"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated".  Additional information: When enquired about reason for no lot number of COVID 19 Vaccine response was "No, it was the vaccine which was not with the patient because second dose was due on the April 1st and patient was not going to get it because the reactions patient have had with the first dose have been worse than actually have COVID ". Patient had the first dose of vaccine the last Thursday. Patient had to stand in line about an hour and a half, that was to get an appointment first of all, out in cold and then when patient finally got the vaccine and everything, it really hurt. Patient have never had hurt that bad and patient have got a high pain tolerance and patient arm had been hurting ever since patient got the shot and patient had been having headaches, patient have a lot of anxiety and patient normally was not that anxious. But it had made patient nauseated, it was horrible and patient was telling everybody patient know not to get the vaccine, that was ridiculous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: sense of taste distorted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 10:30 (Batch/Lot number: unknown) at the age of 43 years 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 (yesterday 21FEB2021 at 09:30AM in the left arm), administration date: 21Feb2021, when the patient was 43 years old, for Covid-19 Immunisation. The following information was reported: TASTE DISORDER (non-serious) with onset 15Mar2021, outcome "unknown", described as "sense of taste distorted". Additional information: Reporter who was mother of patient stated that her daughter who was got the shot and felt fine, but her sense of taste was distorted. She was asked that a side effect of the vaccine. There was not any history of all previous immunization with the Pfizer vaccine. No additional vaccines were administered on same date of the Pfizer suspect. There was no family history. Adverse event did not require a visit to physician or ER. No prior vaccinations (within 4 weeks) were administered. None relevant test were performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Arm was really sore and heavy; Arm was really sore and heavy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2021 13:30 (Lot number: EL0142) at the age of 76 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot, administration date: Sep2020, when the patient was 76 years old, reaction(s): "arm is really sore and heavy", "arm is really sore and heavy". The following information was reported: PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious) all with onset 24Jan2021, outcome "recovered" (2021) and all described as "Arm was really sore and heavy".  Additional information: She initially described event as arm was really sore and heavy with Pfizer-BioNTech COVID-19 Vaccine as being sore the next day like a flu shot where arm is really sore and heavy-but during vaccine supplemental form she clarified that she has no history of adverse events or reactions to prior vaccinations and that she had her flu shot around Sep2020. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity reported as none. Family Medical History Relevant to AE and Relevant Tests reported as one. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. Prior Vaccinations (within 4 weeks) reported as none.   No follow-up attempts are possible. No further information is expected.