chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash papular, Respiratory symptom
Clinical narrative: Rashes and itchiness on both shins; Rashes and itchiness on both shins; a few red dots/spots on my chest and face; a few red dots/spots on my chest and face; itching in my ears (around the antihelix and canal); redness around the helix; some respiratory symptoms; pins and needles in my left hand for half a day; debilitating fatigue; This is a spontaneous report from a contactable consumer (reported for herself). A 39-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3249/ Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 11Feb2021 at 14:45 (at the age of 39-years-old) as dose 2, single for covid-19 immunisation at other. Medical history included spinal osteoarthritis from an unknown date and unknown if ongoing (Only chronic cervical spine issues). Concomitant medication(s) included toradol (KETOROLAC TROMETHAMINE) taken for an unspecified indication, start and stop date were not reported and cyclobenzaprine (CYCLOBENZAPRINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3248/ Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 21Jan2021 at 10:00 (at the age of 39-years-old) as dose 1, single for covid-19 immunisation at other. On 12Feb2021, the consumer experienced rashes and itchiness on both shins, a few red dots/spots on my chest and face, itching in my ears (around the antihelix and canal) and redness around the helix, some respiratory symptoms, pins and needles in my left hand for half a day and debilitating fatigue. Therapeutic measures were taken as a result of events included treatment with Claritin and Benadryl. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: arm little sore and itching around her arm.; arm little sore and itching around her arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 77; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Patient mentioned that she received the second dose of the covid vaccine last Tuesday and got no symptoms, so she wanted to know if this is working. Later, on an unspecified date, the patient experienced arm little sore and itching around her arm. Patient wanted to know if she could take Benadryl for the itching around her arm. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: injected in the subcutaneous tissue instead of the muscle; site felt itchy that night and there was a big hole a quarter of a penne size/it blistered with an open hole in the arm and was itching; site felt itchy that night and there was a big hole a quarter of a penne size/it blistered with an open hole in the arm and was itching; This is a spontaneous report from a contactable other hcp (nurse (patient itself)) Pfizer-sponsored program. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, Expiry date: unknown), dose 1 subcutaneous route, administered in Arm on 05Feb2021 (at the age of 47-years) as dose 1, single for covid-19 immunisation. Medical history included asthma (treated with asthma inhaler) and diabetes. Concomitant medications included insulin for diabetes, "water pill" and "asthma inhaler". It was reported that patient got her first dose of the COVID-19 vaccine last Friday on 05Feb2021. Patient said she was injected in the subcutaneous tissue instead of the muscle. She reported that site felt itchy that night and there was a big hole a quarter of a penne size. She stated she showed her doctor and it blistered with an open hole in the arm and was itching. She stated she took the band-aid off and it was itching profusely and it was macerated and looked like a blister had busted. It was like a quarter size of a penny, 1/4 size of a penny, and the hole was deep about 2-3 cm below the top layer of skin. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: myalgia; Fever 102.8 F Ear; Swollen axillary lymph nodes; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse reported for herself in response to HCP letter sent in cross reference case. A 48-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number: EL3248), dose 2 via an intramuscular route of administration into left arm on 12Jan2021 at 17:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 48-Yeras-Old). The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number EL0140), dose 1 via an unspecified route of administration into left arm on 23 DEC 2021 at 13:00 as DOSE 1, SINGLE for covid-19 immunization. The patient took vaccination at hospital. On 13jan2021 at 09:00, the patient experienced Myalgia, Fever 102.8 F Ear and swollen axillary lymph nodes. The patient underwent lab tests and procedures, which included fever 102.8. The adverse events did not result in Emergency room and Physician Office. The outcome of the events was recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Facial pain, Feeling abnormal, Neck pain
Clinical narrative: aching in her arm/inoculation my left arm started aching; her arm started to throb; By last night arm was very painful.; her arm was swollen; tingling in her tongue and lips; tingling in her tongue and lips; feeling heavy; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; minor chills; This is a spontaneous report from a contactable consumer or other non hcp.    A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 27Jan2021 at 11:30 as single dose for COVID-19 immunisation.The patient medical history included hypersensitivity from an unknown date and unknown if ongoing and concomitant medications were not reported. The patient experienced feeling heavy, waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face, chills on 06Feb2021. It was reported that the patient had experienced aching in her arm/inoculation her left arm started aching, her arm started to throb, by last night arm was very painful, her arm was swollen, tingling in her tongue and lips on unknown date. Clinical course was given as 10 days after the inoculation her left arm started aching, feeling heavy, waves of pain which then by day 13 had spread to her shoulder and neck on the left side of her face.On Saturday her arm started to throb and it hasn't stopped. She is not really using her arms. By last night arm was very painful. The throbbing and pain spread from her shoulder to her neck.When she put her night on gown her husband noticed that her arm was swollen. The are was 6x4 inches on her arm.Also, tongue and lips were tingling now (not previously) and minor chills. It was reported that patient did not have treatment. The seriousness of events was reported as non-serious.The outcome of events aching in her arm/inoculation her left arm started aching, her arm started to throb, by last night arm was very painful, her arm was swollen, tingling in her tongue and lips were unknown. The outcome of events feeling heavy, waves of pain which then by day 13 has spread to her shoulder and neck on the left side her face, minor chills was not recovered.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia oral, Peripheral swelling
Clinical narrative: aching in her arm/inoculation my left arm started aching; her arm started to throb; By last night arm was very painful.; her arm was swollen; tingling in her tongue and lips; tingling in her tongue and lips; feeling heavy; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face; minor chills; This is a spontaneous report from a contactable consumer or other non hcp.    A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 27Jan2021 at 11:30 as single dose for COVID-19 immunisation.The patient medical history included hypersensitivity from an unknown date and unknown if ongoing and concomitant medications were not reported. The patient experienced feeling heavy, waves of pain which then by day 13 has spread to my shoulder and neck on the left side of my face, chills on 06Feb2021. It was reported that the patient had experienced aching in her arm/inoculation her left arm started aching, her arm started to throb, by last night arm was very painful, her arm was swollen, tingling in her tongue and lips on unknown date. Clinical course was given as 10 days after the inoculation her left arm started aching, feeling heavy, waves of pain which then by day 13 had spread to her shoulder and neck on the left side of her face.On Saturday her arm started to throb and it hasn't stopped. She is not really using her arms. By last night arm was very painful. The throbbing and pain spread from her shoulder to her neck.When she put her night on gown her husband noticed that her arm was swollen. The are was 6x4 inches on her arm.Also, tongue and lips were tingling now (not previously) and minor chills. It was reported that patient did not have treatment. The seriousness of events was reported as non-serious.The outcome of events aching in her arm/inoculation her left arm started aching, her arm started to throb, by last night arm was very painful, her arm was swollen, tingling in her tongue and lips were unknown. The outcome of events feeling heavy, waves of pain which then by day 13 has spread to her shoulder and neck on the left side her face, minor chills was not recovered.  Follow-up attempts completed. No further information expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pyrexia, Vaccination site discomfort, Vaccination site pain
Clinical narrative: a potential exposure to COVID-19 while receiving the vaccine; just a little soreness at the site/small amount of discomfort at injection site; just a little soreness at the site/small amount of discomfort at injection site; fever/has a fever nine days after getting the vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 07Feb2021 (at the age of 85-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 16Feb2021, the patient experienced fever/has a fever nine days after getting the vaccine, just a little soreness at the site/small amount of discomfort at injection site on an unspecified date. The reporter reported that the patient (her mother) had no reaction immediately after receiving the vaccine except "just a little soreness at the site, not much at all." Reporter would like to know if it is common to develop a reaction this far out after receiving the vaccine. She also reported that her mother may have had a potential exposure to COVID-19 while receiving the vaccine and was concerned about whether or not her mother could receive her second dose if she were to test positive for COVID-19. She would like to know if her mother tests positive for COVID-19, would she still be able to receive her second dose of the vaccine. She stated nine days later the patient developed fever. She asked if it was common. She also would like information about testing. Her mother went nine days ago to get the vaccine. She could have been exposed to Covid at that time. If after the first time she gets tested for Covid could she get a false positive result. She reported that her mother has not been tested. If she were to get tested and the results were positive would she get the second dose. Outcome of the events were unknown.   Follow up (16Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for patient (Reporter's mother) included additional event and clinical information.   Information on the lot/batch number has been requested.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash under both arm; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 06Feb2021 as dose 1, single for COVID-19 immunization (at the age of 52-year-old). Medical history included was none. There were no concomitant medications. The patient experienced rash under both arm on 16Feb2021. Patient wanted to know if this is common after the vaccine and if he could take medication Benadryl. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. This consumer reported on behalf of her father. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date Feb 2021, patient's arm bruised after the shot and was still bruised from the shot. She added they gave it at the bottom of the deltoid. She believed that might be why he was experiencing bruising, with outcome of not recovered. Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: headache; fever; chills; nausea; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 as DOSE 2 (Age at Vaccination: 57-years-old), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 of bnt162b2 on 23JAN2021 for Covid-19 Immunization (Lot: EJ3247 or EG3247. She said that she cannot read the handwriting on the card). The patient experienced headache, fever, chills and nausea on 14Feb2021 at 04:00. Treatment was received for headache. Outcome of the events headache, chills and nausea was unknown, fever was Not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Excruciating Pain in lower back.left hip, and thigh; Excruciating Pain in lower back.left hip, and thigh; Excruciating Pain in lower back.left hip, and thigh; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9267), via an unspecified route of administration, administered in Arm Right on 12Feb2021 02:30 (age at vaccination 80-year-old) as single dose for COVID-19 immunisation. Medical history included broken right hip and femur, osteoporosis, both knee replacement. The patient had no COVID prior vaccination. Concomitant medications included Epidural Steroid. RF. SI Joint, Hip, Knee, or Facet Bl in two weeks. The patient did not receive any other vaccine in four weeks. The patient previously received penicillin, alopurinol and experienced allergy. On 13Feb2021 02:30 AM, the patient experienced excruciating pain in lower back. left hip, and thigh. The patient received treatment with Advil. The patient had not tested COVID post vaccination. Outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Rash, Rash macular, Vaccination site pain
Clinical narrative: rash; Sore Left arm at the injection site; I still have the rash, I noticed a few more spots on my shoulders, breast area and waist; loss of sense of smell; This is a spontaneous report from a non-contactable consumer (Patient).   A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included brain surgery on 05Dec2020 because patient had a brain tumor and had meningioma. She had lost sense of smell due to the tumor pressing on the nerves but got it back (sense of smell) after the surgery. She had headaches all of the time, so this is hard to say why and had sinus disease and her doctor feels that these symptoms were more from the brain surgery than anything else. She had history of asthma and had post nasal drip and received a couple of asthma medications. No concomitant medications were reported. Past drug included flu shot. On 13Feb2021, Saturday, she broke out in a rash. Her skin was kind of sensitive and stated that she will notice things, like bites, and had an exaggerated reaction. Her rash was not itchy or bothersome. On an unspecified date in Feb2021, she experienced sore Left arm at the injection site, more spots on shoulders, breast area and waist and lost her sense of smell this weekend and noticed when she put her nose to the bag of coffee and realized that she was back with no sense of smell. She mentioned that if she get a bee sting, or touch a Virginia creeper, she get a severe reaction. Patient stated that she doesn't think she was experiencing anything severe but will call doctor to discuss. At the time of this report, the outcome of rash was not recovered, Sore Left arm at the injection site was recovered on unknown date in Feb2021 and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: lip numb; tongue got swollen; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date patient stated that she experienced with lip numb and tongue got swollen after the first shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Swelling below his armpit about 2 inches by 3 inches; Pain under his armpit; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient reported that he took his second covid vaccine dose and afterwards started having pain under his armpit. He then began having some swelling below his armpit about 2 inches by 3 inches on an unspecified date. He reported that he read that this was a side effect but asked, how long should he expect this to last. There was no rash just swelling. He had slight pain right before this developed. He has read it was a normal reaction to the second vaccine more than the first one and asked how long the swelling was expected to stay before it goes down. Caller declined to proceed with report. He has waited already one and a half hours. There was no answer online. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Headache
Clinical narrative: Injection site redness; swelling is coming down; the site was burning; headache; chills; joint pain; muscle aches; fever; throat hurting (not swollen, but itchy); diarrhea; throat hurting (not swollen, but itchy); This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (age at vaccination 40-years) (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, cancer and tooth infection. Concomitant medication included a steroid shot in between these 2 covid doses, it was a steroid injection, an epidural. Caller stated that she had no Lot number to share for the epidural and amoxicillin taken for tooth infection from 10Feb2021 date. She is directed to take 1 tablet by mouth twice a day for 10 days , Lot SM8719299 Exp Nov2021. She had no vaccines on the same day or in the 4 weeks prior. She had not been to the ER or seen a doctor in regards to her symptoms. she was a single mom, and has a 6yr old son, that will not her rest and so she had gotten no rest. On 20Jan2021 at 1:15PM, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, (Batch/Lot Number: EL1283) as DOSE 1, SINGLE for covid-19 immunisation. On 13Feb2021, patient underwent lab tests and procedures which included body temperature and showed results of 104 and weight might had dropped. On 13Feb2021 at 3AM or 4AM Saturday in the morning, patient experienced headache, chills, joint pain, muscle aches. Also of Saturday by afternoon she has a fever up to 104 and that was without medications, ever since the fever she has been bad. On an unknown date in Feb2021 patient had throat hurting (not swollen, but itchy) and diarrhoea. Her headaches come and go she took Advil and ibuprofen. She had diarrhoea, anything she eats goes right through her. The injection site was noticed on Sunday 14Feb2021 it felt like she got the injection all over again, the site was burning and hurting. On 14Feb2021, she experienced injection site redness, swelling is coming down, the site was burning. Therapeutic measures were taken as a result of headache. At the time of this report the outcome of headache, chills, throat hurting (not swollen, but itchy) was unknown. Joint pain, muscle ache, diarrhoea was not recovered. Fever recovered on unknown date in feb2021 and other events were recovering.  Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Throat irritation, Vaccination site erythema
Clinical narrative: Injection site redness; swelling is coming down; the site was burning; headache; chills; joint pain; muscle aches; fever; throat hurting (not swollen, but itchy); diarrhea; throat hurting (not swollen, but itchy); This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (age at vaccination 40-years) (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, cancer and tooth infection. Concomitant medication included a steroid shot in between these 2 covid doses, it was a steroid injection, an epidural. Caller stated that she had no Lot number to share for the epidural and amoxicillin taken for tooth infection from 10Feb2021 date. She is directed to take 1 tablet by mouth twice a day for 10 days , Lot SM8719299 Exp Nov2021. She had no vaccines on the same day or in the 4 weeks prior. She had not been to the ER or seen a doctor in regards to her symptoms. she was a single mom, and has a 6yr old son, that will not her rest and so she had gotten no rest. On 20Jan2021 at 1:15PM, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, (Batch/Lot Number: EL1283) as DOSE 1, SINGLE for covid-19 immunisation. On 13Feb2021, patient underwent lab tests and procedures which included body temperature and showed results of 104 and weight might had dropped. On 13Feb2021 at 3AM or 4AM Saturday in the morning, patient experienced headache, chills, joint pain, muscle aches. Also of Saturday by afternoon she has a fever up to 104 and that was without medications, ever since the fever she has been bad. On an unknown date in Feb2021 patient had throat hurting (not swollen, but itchy) and diarrhoea. Her headaches come and go she took Advil and ibuprofen. She had diarrhoea, anything she eats goes right through her. The injection site was noticed on Sunday 14Feb2021 it felt like she got the injection all over again, the site was burning and hurting. On 14Feb2021, she experienced injection site redness, swelling is coming down, the site was burning. Therapeutic measures were taken as a result of headache. At the time of this report the outcome of headache, chills, throat hurting (not swollen, but itchy) was unknown. Joint pain, muscle ache, diarrhoea was not recovered. Fever recovered on unknown date in feb2021 and other events were recovering.  Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Weight
Clinical narrative: Injection site redness; swelling is coming down; the site was burning; headache; chills; joint pain; muscle aches; fever; throat hurting (not swollen, but itchy); diarrhea; throat hurting (not swollen, but itchy); This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (age at vaccination 40-years) (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, cancer and tooth infection. Concomitant medication included a steroid shot in between these 2 covid doses, it was a steroid injection, an epidural. Caller stated that she had no Lot number to share for the epidural and amoxicillin taken for tooth infection from 10Feb2021 date. She is directed to take 1 tablet by mouth twice a day for 10 days , Lot SM8719299 Exp Nov2021. She had no vaccines on the same day or in the 4 weeks prior. She had not been to the ER or seen a doctor in regards to her symptoms. she was a single mom, and has a 6yr old son, that will not her rest and so she had gotten no rest. On 20Jan2021 at 1:15PM, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, (Batch/Lot Number: EL1283) as DOSE 1, SINGLE for covid-19 immunisation. On 13Feb2021, patient underwent lab tests and procedures which included body temperature and showed results of 104 and weight might had dropped. On 13Feb2021 at 3AM or 4AM Saturday in the morning, patient experienced headache, chills, joint pain, muscle aches. Also of Saturday by afternoon she has a fever up to 104 and that was without medications, ever since the fever she has been bad. On an unknown date in Feb2021 patient had throat hurting (not swollen, but itchy) and diarrhoea. Her headaches come and go she took Advil and ibuprofen. She had diarrhoea, anything she eats goes right through her. The injection site was noticed on Sunday 14Feb2021 it felt like she got the injection all over again, the site was burning and hurting. On 14Feb2021, she experienced injection site redness, swelling is coming down, the site was burning. Therapeutic measures were taken as a result of headache. At the time of this report the outcome of headache, chills, throat hurting (not swollen, but itchy) was unknown. Joint pain, muscle ache, diarrhoea was not recovered. Fever recovered on unknown date in feb2021 and other events were recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: got the chills after/ no fever; This is a spontaneous report from a contactable pharmacist. A 91-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included constipated sometimes (since start of therapy takes Miralax, sometimes goes 3 times a day, no blood) from an unknown date and unknown if ongoing. Concomitant medication(s) included bumetanide taken for an unspecified indication and macrogol 3350 (MIRALAX) taken for constipation, for both start and stop date were not reported. It was reported that after receiving the second dose of vaccine on an unspecified date the patient got the chills after/ no fever/now resolved. "The reporter stated that patient got his second covid-19 vaccine, 3 days ago, got the chills after/ no fever/now resolved. Told to inform MD. Reporter stated that the patient was on a new medication, stated its for his depression, did not know name, first stated takes 6 pills at a time, then stated takes two pills a day. this nurse instructed to make sure patient is taking medication as prescribed. Reporter then confirmed that their son, who is a nurse, sorts his medications in the daily pill box. Reporter stated patient gets up in the night to urinate, due to patient taking bumex. Reporter stated that the patient still cries in his sleep, stated at one point he stopped, then he was placed on another medication and started again. MD aware. The patient was taking Xeljanz (5 mg, twice daily) for ulcerative colitis. The outcome of the event was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular, Scratch
Clinical narrative: torso and upper arms became blotchy, red and very itchy; torso and upper arms became blotchy, red and very itchy; torso and upper arms became blotchy, red and very itchy; so itchy she scratched so much; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 80-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (80-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included blood clot due to knee replacement last year from an unknown date and unknown if ongoing. It was reported as she had a clot due to knee replacement. She wondered if it could be attributed to the regular tylenol which she took for months post knee replacement. Stated tylenol is toxic to the liver; it did not take away the pain. The patient stated that she developed a blood clot when she had her knee replacement late last year. The patient's concomitant medications were not reported. On an unknown date, the patient's torso and upper arms became blotchy, red and very itchy. It was reported that, 6 days after receiving the first dose, her torso and upper arms became blotchy, red and very itchy. The patient stated it was so itchy she scratched so much. She saw her hcp who prescribed pepcid and zyrtec which resolved the reaction quickly. The patient stated she had a screen test and it was discovered she was not allergic to anything so her hcp attributes her reaction to the vaccine. It was reported that reaction occurred to the first shot but nothing to the second shot. Therapeutic measures were taken for the events. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration as dose 2, single for covid -19 immunisation. The outcome of the events were resolved.  Information on the lot/batch number has been requested  Follow-up attempts are completed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Confusional state, Cough
Clinical narrative: Not sleeping; disoriented; Incontinence; Cough; pain; weakness; fever 102F; chills and aches; chills and aches; This is a spontaneous report from a contactable consumer or other non hcp.   An 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 11Feb2021 (at the age of 88 years), (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2. Callers parents received the second dose of the Pfizer covid19 vaccine on 11Feb2021. Her dad (male, age 92) had no reactions. Her mom (female, age 88) had delayed reactions. On 14Feb2021 she started to have a fever of 101F chills and aches. On 15Feb2021 cough and weakness, fever 102F, chills, pain, stronger cough. It seems to be happened in the evening/night. It was better during the day. At night it got worse. Did they report these side effects after 7 days? Did it go away after 7 days?" The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 14Feb2021, body temperature: 102 Fahrenheit on 15Feb2021. The clinical outcome of the events fever 102F was not recovered, chills and aches, Cough, pain, weakness was recovering, Not sleeping, disoriented, Incontinence was unknown.  Information on lot/batch number has been requested. Follow-up attempts completed. No further information expected.  Follow-up (11May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Incontinence, Pain, Pyrexia, Sleep disorder
Clinical narrative: Not sleeping; disoriented; Incontinence; Cough; pain; weakness; fever 102F; chills and aches; chills and aches; This is a spontaneous report from a contactable consumer or other non hcp.   An 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 11Feb2021 (at the age of 88 years), (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2. Callers parents received the second dose of the Pfizer covid19 vaccine on 11Feb2021. Her dad (male, age 92) had no reactions. Her mom (female, age 88) had delayed reactions. On 14Feb2021 she started to have a fever of 101F chills and aches. On 15Feb2021 cough and weakness, fever 102F, chills, pain, stronger cough. It seems to be happened in the evening/night. It was better during the day. At night it got worse. Did they report these side effects after 7 days? Did it go away after 7 days?" The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 14Feb2021, body temperature: 102 Fahrenheit on 15Feb2021. The clinical outcome of the events fever 102F was not recovered, chills and aches, Cough, pain, weakness was recovering, Not sleeping, disoriented, Incontinence was unknown.  Information on lot/batch number has been requested. Follow-up attempts completed. No further information expected.  Follow-up (11May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache
Clinical narrative: headaches; swollen eyes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not re-ported), via an unspecified route of administration on an unspecified date as a dose number un-known, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headaches and swollen eyes both on an unspecified date. It was reported that, the Reporter's wife experienced headaches and swollen eyes after the vaccine and he was asking if that was normal side effects. The outcome of both the events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 9, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a headache that turned into a migraine on Feb 10, 2021. The reporter calling on behalf of his mom. She took the 1st dose, then right after this morning she experienced a headache that turned into a migraine. Caller asked if his mom could take generic Excedrin. The outcome for all events: unknown. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm is aching; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her arm is aching on an unspecified date. The outcome of the event pain in extremity was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever for less than 24 hours; headaches for 24 hours; shivering; shortness of breath; This is a spontaneous report from a contactable nurse reported for patient that a 28-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 05Feb2021 as single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 12Feb2021, the patient experienced fever for less than 24 hours, headaches for 24 hours, shivering and shortness of breath for 2.5 days. It was explained that he had his first dose of the Pfizer-BioNTech COVID-19 vaccine on 05Feb2021, and he became symptomatic on 12Feb2021. The patient tested negative to a PCR test done on 13Feb2021, for COVID-19. The reporter asked were such symptoms also reported 7 days post-vaccination and She specified that her colleague did not see shortness of breath listed and asked if it was reported as a side effect of the vaccine. The clinical outcome of the events was recovered in Feb2021.  Information about lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Neck pain
Clinical narrative: muscle cramps; chills; neck sore; mostly fatigue; This is a spontaneous report from a contactable consumer or other non-Health Care Professional and report from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 04Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on an unspecified date for covid-19 immunization. The patient's concomitant medications were not reported. On Feb2021 the patient experienced muscle cramps, chills, neck sore, mostly fatigue. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Illness, Nausea, Pain
Clinical narrative: fever; chills; aches and pains/body aches and pains; aches and pains/body aches and pains; light headedness; head was spinning like she had vertigo; head was spinning like she had vertigo; felt sick; dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry date, NDC number and batch/Lot number: not provided), via an unspecified route of administration on 18Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Additional context reported as, the patient calling about the vaccine experience. The patient first dose was on 18Jan2021 and she felt sick on 19Jan2021 after the next day of vaccination. The patient was able to go to work the rest of the week but on Saturday, 23Jan2021, her head was spinning like she had vertigo, patient never had vertigo before but some of her friends told her maybe it was vertigo but it was not. The patient was dizzy and had nausea the next week, on an unspecified date in Jan2021. The patient says she did not have the rest of the side effects except she had fever and chills on an unspecified date every now and then. The thing was that she has a work injury so it adds up more to the aches and pains on an unspecified date. The patient says that was all with the first dose, with the second dose experience that was last 09Feb her side effects were, she worked the whole week last week then Thursday she had light headedness she was sure that was a side effect, the patient experienced it on an unspecified date with her first dose. The patient asks were she any pain reliever in her case, patient had a work injury and she was taking Tramadol also, the patient asks would that be any side effects from that pain medication. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: fever; chills; aches and pains/body aches and pains; aches and pains/body aches and pains; light headedness; head was spinning like she had vertigo; head was spinning like she had vertigo; felt sick; dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry date, NDC number and batch/Lot number: not provided), via an unspecified route of administration on 18Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Additional context reported as, the patient calling about the vaccine experience. The patient first dose was on 18Jan2021 and she felt sick on 19Jan2021 after the next day of vaccination. The patient was able to go to work the rest of the week but on Saturday, 23Jan2021, her head was spinning like she had vertigo, patient never had vertigo before but some of her friends told her maybe it was vertigo but it was not. The patient was dizzy and had nausea the next week, on an unspecified date in Jan2021. The patient says she did not have the rest of the side effects except she had fever and chills on an unspecified date every now and then. The thing was that she has a work injury so it adds up more to the aches and pains on an unspecified date. The patient says that was all with the first dose, with the second dose experience that was last 09Feb her side effects were, she worked the whole week last week then Thursday she had light headedness she was sure that was a side effect, the patient experienced it on an unspecified date with her first dose. The patient asks were she any pain reliever in her case, patient had a work injury and she was taking Tramadol also, the patient asks would that be any side effects from that pain medication. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.