chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Maternal exposure during pregnancy, Pain, Pregnancy test
Clinical narrative: pregnancy test on 31Jan and was positive; pain in every joint; increasing pain all over body; Elevated liver enzymes; low WBC; UTI symptoms; blood in urine; not felt well; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 28 years of age), dose 1 intramuscular, administered in arm left on 19Jan2021 18:00 (Batch/Lot Number: EL3248) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medication included vitamin d3 (VITAMIN D3), vitamin b complex (VITAMIN B COMPLEX) and prenatal vitamins which the patient received with 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.  The patient was pregnant. It was reported that after receiving vaccine, the patient had not felt well on 20Jan2021. She went into urgent care on Saturday 23Jan2021 for UTI symptoms. She had blood in urine, went to primary care appointment on 27Jan2021 had more blood in urine per urinalysis. She went into the emergency room for increasing pain all over body. CT scan was done, lab work done (both unknown results). She had elevated liver enzymes, low WBC, blood in urine on 28Jan2021. She had extreme pain all over body, pain in every joint on 29Jan2021, was essentially bed bound through 31Jan2021. She took at home pregnancy test on 31Jan2021 and was positive. She was also prescribed MACROBID for UTI from the urgent care, completed the course per primary physician- even though no UTI was determined- just blood in urine. The patient underwent lab tests and procedures which included urine analysis: blood in urine on 23Jan2021, more blood in urine on 27Jan2021 and blood in urine on 28Jan2021; hepatic enzyme increased on 28Jan2021; and white blood cell count: low on 28Jan2021. Therapeutic measures were taken as a result of uti symptoms (urinary tract infection). She was tested for SARS-CoV-1 test through nasal swab on 29Jan2021 with negative result. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measure was taken as a result of UTI and no treatment received from other events. The events are reported non-serious. The outcome of not felt well was recovering while unknown for other events.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Urinary tract infection, Urine analysis, White blood cell count, White blood cell count decreased
Clinical narrative: pregnancy test on 31Jan and was positive; pain in every joint; increasing pain all over body; Elevated liver enzymes; low WBC; UTI symptoms; blood in urine; not felt well; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 28 years of age), dose 1 intramuscular, administered in arm left on 19Jan2021 18:00 (Batch/Lot Number: EL3248) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medication included vitamin d3 (VITAMIN D3), vitamin b complex (VITAMIN B COMPLEX) and prenatal vitamins which the patient received with 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.  The patient was pregnant. It was reported that after receiving vaccine, the patient had not felt well on 20Jan2021. She went into urgent care on Saturday 23Jan2021 for UTI symptoms. She had blood in urine, went to primary care appointment on 27Jan2021 had more blood in urine per urinalysis. She went into the emergency room for increasing pain all over body. CT scan was done, lab work done (both unknown results). She had elevated liver enzymes, low WBC, blood in urine on 28Jan2021. She had extreme pain all over body, pain in every joint on 29Jan2021, was essentially bed bound through 31Jan2021. She took at home pregnancy test on 31Jan2021 and was positive. She was also prescribed MACROBID for UTI from the urgent care, completed the course per primary physician- even though no UTI was determined- just blood in urine. The patient underwent lab tests and procedures which included urine analysis: blood in urine on 23Jan2021, more blood in urine on 27Jan2021 and blood in urine on 28Jan2021; hepatic enzyme increased on 28Jan2021; and white blood cell count: low on 28Jan2021. Therapeutic measures were taken as a result of uti symptoms (urinary tract infection). She was tested for SARS-CoV-1 test through nasal swab on 29Jan2021 with negative result. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measure was taken as a result of UTI and no treatment received from other events. The events are reported non-serious. The outcome of not felt well was recovering while unknown for other events.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site oedema, Vaccination site swelling
Clinical narrative: Severe lightheadedness and fluid accumulation at site of injection from being swollen.; Severe lightheadedness and fluid accumulation at site of injection from being swollen.; Severe lightheadedness and fluid accumulation at site of injection from being swollen.; This is a spontaneous report from a contactable consumer or other non hcp(Patient himself). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 09:15 (at 35-years-old) (Batch/Lot number UNKNOWN) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced severe lightheadedness and fluid accumulation at site of injection from being swollen on 03Feb2021 19:00. Therapeutic measures were taken as a result of severe lightheadedness and fluid accumulation at site of injection from being swollen which included ice packs. The outcome of events was reported as not recovered.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister, Lip swelling, Pain in extremity, Rash vesicular, Tongue ulceration
Clinical narrative: ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and back; Blister of lip; Swollen lips; sore arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on right arm on 12Jan2021 at single dose for covid-19 immunization (to not get symptoms from Covid). Medical history included typically had a strong local reaction to bees or insect bites. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL) for Birth control 1 by daily (had been taking for 15 years and is ongoing). On 12Jan2021, the day patient received the vaccine, she had sore arm which resolved on 13Jan2021. Ten days later on 23Jan2021, she developed a rash with blisters on her hand and back, had blisters/ulcers on the side of her tongue inside her lips and her lips were also swollen and cracked. She states that she treated these symptoms with Benadryl and the rash and swelling resolved. She cannot attribute it to the vaccine. The ulcers in her mouth were better in about a week. She was calling to see if she should receive the second dose of the COVID-19 vaccine and would like to know how effective the Pfizer COVID-19 vaccine is after one dose. Everything that she had seen, this was not a typical reaction. She was wondering if it was safe to get the second dose. She went to the site where she received the vaccine and was unable to get any information. She does not have a physician. The rash has improved. Redness on her skin still can be seen. The blisters on her lips were white places like a canker sore but it was not a canker sore. Her lip was split like mouth ulcers. She took Benadryl and it helped. The outcome of the event ulcers on the side of her tongue was unknown. The outcome was recovered for the events sore arm on 13Jan2021, blister of lip on 31Jan2021 and swollen lips on 01Feb2021. The outcome of the event rash was recovering.  Follow-up (16Apr2021): 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: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain both after First and second jab; This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 02Feb2021 at 02:30 (at the age of 83years old) as a single dose for COVID-19 immunisation. Medical history included old age, BP, mild prediabetic, arthritis of knee. The patient did not have any allergies to medications, food, or other products. 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 did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine on first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown) in left arm on unknown date for covid-19 immunisation. On 04Feb2021 at 12:00 the patient reported that he did not get any adverse reaction except injection site pain both after first and second jab. Will I get antibodies after this shot considering my age is 83. It was unknown if the patient received any treatment for the events. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eyelid pain, Fatigue, Swelling of eyelid
Clinical narrative: Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and fatigued; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Deltoid Right on 28-JAN-2021 16:00 at single dose for COVID-19 immunisation. Patient medical history included COVID-19 Virus and diabetes runs in family, but she just had a physical. Patient did not have diabetes. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29 Jan2021, the patient had experienced very weak and fatigued very weak and fatigued. On 30 Jan 2021, the patient had experienced sharp pain on her left eyelid. On 31 Jan 2021, the patient had experienced left eyelid swollen and purple. Next COVID-19 Vaccine in 18Feb2021. The patient did not received other medications within 2 weeks of vaccination. Patient was not on any prescription or over the counter medications. She took Eye Relief Eye drops and Benadryl for her eyelid swelling. Benadryl and Eye Relief eye drops did not do anything for swollen eyelid. Provided, lab-1451-1.0, on back of fact sheet for recipients and caregivers. On an unspecified date in 2021 the events sharp pain on her left eyelid and very weak and fatigued was resolved. At the time of reporting, the outcome of the event left eyelid swollen and purple was not recovered..
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: My arm was really sore; Muscle soreness; This is a spontaneous report from a contactable Consumer (Patient).  A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 03Feb2021, as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medicines were not reported. Patient stated that she had to take Tylenol 3 times yesterday (on 03Feb2021, on the day of vaccination) for muscle soreness and her arm was really sore, so she took, Tylenol three times yesterday (One day before this report, 03Feb2021) and a friend of her told that they read online that once you get the vaccine then you should not take the Tylenol. Patient was asking that will that Acetaminophen decrease the effectiveness of the vaccine.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: My arm was really sore; Muscle soreness; This is a spontaneous report from a contactable Consumer (Patient).  A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 03Feb2021, as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitant medicines were not reported. Patient stated that she had to take Tylenol 3 times yesterday (on 03Feb2021, on the day of vaccination) for muscle soreness and her arm was really sore, so she took, Tylenol three times yesterday (One day before this report, 03Feb2021) and a friend of her told that they read online that once you get the vaccine then you should not take the Tylenol. Patient was asking that will that Acetaminophen decrease the effectiveness of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: He had very mild muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient got second shot past tuesday. He asked whether he should be worried that he didn't had any side effects. His son was concerned that the vaccine may not be working. It was stated that he had very mild muscle soreness that did not last very long after receiving the vaccine. He did not specify which dose he was referring to. He has had no side effects whatsoever. He was listening to Dr. associate who said he got the vaccine, and he had a reaction to it. This indicated to him that the vaccine was working. He was just wondering since he didn't had a reaction if he should be worried. He just told his son he guesses he was lucky, but his son told him he should call and ask. He would rather have poured gasoline on it and burned it before he had an email. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pruritus
Clinical narrative: itchiness/itching on both legs; body malaise; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3242), second dose via an unspecified route of administration in right arm on 03Feb2021 as SINGLE DOSE for covid-19 immunization. The historical vaccine included First Dose of BNT162B2 which was on 02Jan2021 (Lot: EL3302) in right arm. The patients medical history included diabetes mellitus and blood pressure. Concomitant medications included LISINOPRIL taken for blood pressure and METFORMIN taken for diabetes mellitus, both on unspecified date. On 04Feb2021 the patient experienced body malaise and itchiness/itching on both legs. Outcome of the events was not recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Throbbing headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 77-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EM9810) via an unspecified route of administration at arm right on 04Feb2021 evening as single dose for COVID-19 immunization. Medical history included hypothyroidism, High Cholesterol and allergic to Penicillin. Patient could had not taken Sulfa or steroids and she non-drinker. It was reported that patient had swelling of hands with penicillin when she was a child. She developed oral ocular dermatitis caused by the steroid in Flonase. That was diagnosed by dermatologist. It had been about 3 years now. Concomitant medications included levothyroxine (LEVOTHYROXINE), 75mcg once daily for thyroid disorder, monascus purpureus (RED YEAST RICE) and cinnamomum verum (CINNAMON) for blood cholesterol. It was reported that patient took lots of vitamins and she did not like taking medications because she was allergic to all sorts of stuff, including statins, but had no trouble with any vaccine or flu shots which she was took in October. On 05Feb2021, the patient awoke because experienced throbbing headache in the middle of the night. Patient took a Tylenol 500mg (acetaminophen, lot no. 8JE2158A, Exp. Date Jul2020) once at 6am, after about 12 hours after the shot. The event subsided a little, but it was still there. She said it was rampant. Life had been on hold and she wanted to go back to normal life. The outcome of the event was not recovered.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Sore neck muscles in back for 2 days; Sore neck muscles in back for 2 days; The initial case was the missing following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982) via an unspecified route of administration in left arm on 30Jan2021 at 12:10 (at the age of 76-years-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. In 2021, the patient experienced sore neck muscles in back for 2 days. The patient was asked if it is possible to take the second dose to different place. The patient did not receive any treatments for the events. There was no admission to hospital involved due to the events. The outcome of the events was resolved in 2021. The patient was scheduled to get the vaccine after 4 weeks. On 26Feb2021, the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265), via an unspecified route of administration at single dose for Covid-19 immunization. The patient had no discomfort after second dose.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Body temperature, Circumstance or information capable of leading to medication error, Headache
Clinical narrative: Headache; He took Excedrin, before the first dose of the covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), intramuscular, administered in Arm Left on 29Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that on Friday he received the first shot of the vaccine. He did not had many side effects. Clarified that he had a headache that night and that was about it. Last night on the 10 PM news it was reported that someone had seen on the internet and called the news media to state that people should not take any over the counter aspirin, acetaminophen, or ibuprofen. According to the news they mentioned that it could block some kind of enzyme and may not have the appropriate immune response from the vaccine. He was calling to ask about what he saw on the news, if that was true. About 3 hours before he received the vaccine he had a headache. He did not read anything that said do not take pain medication before taking the vaccine since it could reduce its effectiveness. He was asking if he received the full effect of the vaccine since he took Excedrin 3 hours prior to getting the vaccine. His headache recovered by the time he went to bed. He did not have a fever and he took his temperature with a digital thermometer. He confirms he had no other side effects. This was very vague. People had aches and pains that they take medication for. Nothing says don't do this or that in regard to medications. Other people were probably scratching their heads as well. It does state that participants did have underlying conditions such as hypertension and that they did receive antipyretic medications for post vaccination symptoms, however it doesn't state if they were taking their regular medications, such as blood pressure medications, or not. There was no data available at this time. Referred caller to his HCP and stated that they will have access to clinical data specifically for health care professionals that may help answer questions. The patient underwent lab tests and procedures which included body height: shrunk, body temperature: he did not have a fever. Therapeutic measures were taken as a result of headache (headache) as patient took two over the counter Excedrin which contained aspirin and acetaminophen. The outcome of the event circumstance or information capable of leading to medication error was unknown and for headache it was reported as recovered.  DSU- potential duplicate AE.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Asthenia, Chills, Fatigue
Clinical narrative: Flu like symptom; body aches; joint pains; headache; weakness; chills; feeling unwell; tiredness; anxiety; injection site pain and redness; injection site pain and redness; stiffness in legs and fingers; stiffness in legs and fingers; This is a spontaneous report from a contactable consumer (patient himself). A 70-years-old male patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Batch/lot number: EN5318, Expiration date unknown), via an unspecified route of administration in left arm on 04Feb2021 at 15:30 at a single dose for COVID-19 immunization. Medical history included prostate cancer, autonomic nervous system imbalance, arthritis, drug hypersensitivity from an unspecified date and it was unknown if ongoing. The patient had allergies to medications, food, or other products included Keflex, Sulfa, Citalopram, Levofloxin, Nitrofurantoin Macrocrystalline, Alpha-D-Galactosidase, Famotidine, Metoprolol Tartrate, Doxycycline, and Morphine. Concomitant medications included lorazepam acetaminophen, diltiazem, aspirin (acetylsalicylic acid), simeticone (GAS-X) were taken for an unspecified indication. Neither the patient received any other vaccines within 4 weeks prior to the COVID vaccine nor tested for Covid-19. The patient was not diagnosed with covid-19 prior to vaccination. On 05Feb2021 at 12:00, the patient experienced flu like symptoms body aches, joint pains, headache, weakness, chills, feeling, tiredness, injection site pain and redness, stiffness in legs and fingers. The patient did not receive any treatment for these events. The outcome of events was not recovered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise, Musculoskeletal stiffness, Pain
Clinical narrative: Flu like symptom; body aches; joint pains; headache; weakness; chills; feeling unwell; tiredness; anxiety; injection site pain and redness; injection site pain and redness; stiffness in legs and fingers; stiffness in legs and fingers; This is a spontaneous report from a contactable consumer (patient himself). A 70-years-old male patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Batch/lot number: EN5318, Expiration date unknown), via an unspecified route of administration in left arm on 04Feb2021 at 15:30 at a single dose for COVID-19 immunization. Medical history included prostate cancer, autonomic nervous system imbalance, arthritis, drug hypersensitivity from an unspecified date and it was unknown if ongoing. The patient had allergies to medications, food, or other products included Keflex, Sulfa, Citalopram, Levofloxin, Nitrofurantoin Macrocrystalline, Alpha-D-Galactosidase, Famotidine, Metoprolol Tartrate, Doxycycline, and Morphine. Concomitant medications included lorazepam acetaminophen, diltiazem, aspirin (acetylsalicylic acid), simeticone (GAS-X) were taken for an unspecified indication. Neither the patient received any other vaccines within 4 weeks prior to the COVID vaccine nor tested for Covid-19. The patient was not diagnosed with covid-19 prior to vaccination. On 05Feb2021 at 12:00, the patient experienced flu like symptoms body aches, joint pains, headache, weakness, chills, feeling, tiredness, injection site pain and redness, stiffness in legs and fingers. The patient did not receive any treatment for these events. The outcome of events was not recovered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Flu like symptom; body aches; joint pains; headache; weakness; chills; feeling unwell; tiredness; anxiety; injection site pain and redness; injection site pain and redness; stiffness in legs and fingers; stiffness in legs and fingers; This is a spontaneous report from a contactable consumer (patient himself). A 70-years-old male patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Batch/lot number: EN5318, Expiration date unknown), via an unspecified route of administration in left arm on 04Feb2021 at 15:30 at a single dose for COVID-19 immunization. Medical history included prostate cancer, autonomic nervous system imbalance, arthritis, drug hypersensitivity from an unspecified date and it was unknown if ongoing. The patient had allergies to medications, food, or other products included Keflex, Sulfa, Citalopram, Levofloxin, Nitrofurantoin Macrocrystalline, Alpha-D-Galactosidase, Famotidine, Metoprolol Tartrate, Doxycycline, and Morphine. Concomitant medications included lorazepam acetaminophen, diltiazem, aspirin (acetylsalicylic acid), simeticone (GAS-X) were taken for an unspecified indication. Neither the patient received any other vaccines within 4 weeks prior to the COVID vaccine nor tested for Covid-19. The patient was not diagnosed with covid-19 prior to vaccination. On 05Feb2021 at 12:00, the patient experienced flu like symptoms body aches, joint pains, headache, weakness, chills, feeling, tiredness, injection site pain and redness, stiffness in legs and fingers. The patient did not receive any treatment for these events. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: Gastric problems; This is a spontaneous report from a non-contactable consumer. This consumer reported for a male patient (father). A male patient of an unspecified age received first dose bnt162b2 (Solution for injection) via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunisation. Medical history included ongoing sleeping and pain in joints. Concomitant medication included insulin injection, ropinirole 0.5 mg for sleeping, metformin, lisinopril 40 mg, then we have acetylsalicylic acid (ASPIRIN) 51 mg, blood thinner, acetaminophen for pain in joints, cyanocobalamin (VITAMIN B12), ferrous sulfate (iron)". Caller stated he was not a healthcare professional, he called on behalf of his father, his father received first dose of Pfizer-BioNTech COVID-19 Vaccine on 27Jan2021, already reported "having several side effects, gastric problems in 2021. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Had very little pain at the injection site; severe pain in my left shoulder; could not raise my left arm to the side without severe pain; This is a spontaneous report from a contactable consumer patient(himself). A 83-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on left arm on 27Jan2021 04:30 PM as single dose for COVID-19 immunization. Patient medical history included diabetic, high blood pressure, overweight from unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient didn't have allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not tested for COVID-19 since the post vaccination. The Patient concomitant medication were not reported. Patient took unspecified other medications in two weeks. The patient experienced very little pain at the injection site on 1Feb2021 at 7:00 AM. After about 3 days he awoke with severe pain in his left shoulder and patient could not raise left arm to the side without severe pain in Feb2021. It seemed to be concentrated in the rotor cuff muscle. Patient not received treatment for the adverse events. The outcome of event was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 10:00 (at the age of 57 years old) (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunization. Medical history was none. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. The patient received ibuprofen within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was none. The patient experienced sore injection site on 05Feb2021 15:00. No treatment received for the adverse event. Reporter assessed the event as non serious. Outcome of the event was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test negative, Inappropriate schedule of product administration, SARS-CoV-2 antibody test
Clinical narrative: antibodies test done on 06 February 2021 and it came back negative; I got my Pfizer vaccine on 29th December 2020 and 15th January 2021; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 15Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Dec2020, the patient received first dose of bnt162b2 (inappropriate schedule of product administration) on 06Jan2021, the patient underwent lab tests included sars-cov-2 antibody and it came back negative. The events assessed as non-serious. The outcome of the event was unknown.  Information requested on Lot/ Batch number.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from a Pfizer-sponsored program . A non-contactable female consumer reported for herself that she received first dose of BNT162B2(BNT162B2,Pfizer COVID-19 vaccine,formulation solution for injection,Lot number/Expiration date:unknown) via an unspecified route of administration on unspecified date and time as a single dose for COVID-19 vaccination. Patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced Arm soreness after taking the 1st dose of the Covid-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pruritus, Sleep disorder, Swelling
Clinical narrative: face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; Continued to worsen all day and night. Eyes and lips swelled shut; entire face and neck brilliant red; max amt of itching; neck still red and bumpy; Have been unable to sleep well; This is spontaneous report from a contactable healthcare professional (patient herself). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 04Feb2021 at 15:15 PM (at the age of 63-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included diabetes Type 2, hypothyroid, shingles 10 years ago. Patient had known allergies. Concomitant medications included Synthroid, Rosuvastatin, Metformin, Tresiba and Ozempic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 04Feb2021 at 20:00 by midnight, the patient's face was swelling, bright red, and very itchy. She took one Benadryl. Her face and neck worsened, got into MD in morning. She prescribed Claritin and make appointment with allergist. Patient did both. Events continued to worsen all day and night. Her eyes and lips swelled shut, entire face and neck brilliant red with maximum amount of itching. Patient kept ice on face and neck all night but continued to worsen. She went into hospital Emergency Room at 9:00 AM, received IV Prednisone, Benadryl and one more. Also, prescribed with Famotidine, Prednisone, Benadryl and Tylenol if needed for home. Itching started subsiding, brilliant red remained everywhere, swelling was still significant around eyes and cheeks, neck was still red and bumpy. Patient have been unable to sleep well. She took appointment with allergist 08Feb2021 morning. She wondered if she should take second vaccine and reported that this has been an expensive and emotional nightmare. The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; Continued to worsen all day and night. Eyes and lips swelled shut; entire face and neck brilliant red; max amt of itching; neck still red and bumpy; Have been unable to sleep well; This is spontaneous report from a contactable healthcare professional (patient herself). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 04Feb2021 at 15:15 PM (at the age of 63-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included diabetes Type 2, hypothyroid, shingles 10 years ago. Patient had known allergies. Concomitant medications included Synthroid, Rosuvastatin, Metformin, Tresiba and Ozempic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 04Feb2021 at 20:00 by midnight, the patient's face was swelling, bright red, and very itchy. She took one Benadryl. Her face and neck worsened, got into MD in morning. She prescribed Claritin and make appointment with allergist. Patient did both. Events continued to worsen all day and night. Her eyes and lips swelled shut, entire face and neck brilliant red with maximum amount of itching. Patient kept ice on face and neck all night but continued to worsen. She went into hospital Emergency Room at 9:00 AM, received IV Prednisone, Benadryl and one more. Also, prescribed with Famotidine, Prednisone, Benadryl and Tylenol if needed for home. Itching started subsiding, brilliant red remained everywhere, swelling was still significant around eyes and cheeks, neck was still red and bumpy. Patient have been unable to sleep well. She took appointment with allergist 08Feb2021 morning. She wondered if she should take second vaccine and reported that this has been an expensive and emotional nightmare. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Swelling face
Clinical narrative: Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; Cheek swelling on left side of face. With numbing of lip due to swelling; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El3302), via an unspecified route of administration in left arm on 13Jan2021 10:00 as single dose and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En5318) via an unspecified route of administration in left arm on 04Feb2021 11:00 as single dose for COVID-19 immunization. Patient age was 43-years-old and was not pregnant at the time of vaccination. Vaccine was administered at the military facility. Patient medical history included sleep apnoea syndrome. The patients concomitant medication included melatonin taken for an unspecified indication, start and stop date were not reported. The patient experienced cheek swelling on left side of face with numbing of lip due to swelling with numbing of lip due to swelling on 25Jan2021. No other vaccine in four weeks. Emergency room/department or urgent care. No COVID prior vaccination. No covid tested post vaccination. Therapeutic measures were taken as a result of the event. The outcome of the events was recovering.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Felt real tired; Chills; This is a spontaneous report from a contactable Other HCP (patient himself). A 44-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration in Arm Right on 04Feb2021 at 15:00 as single dose for covid-19 immunization. Historical vaccine included bnt162b2 (COMIRNATY, Formulation; solution for injection, Batch/Lot Number: EL3247), dose 1 via unspecified route of administration, administered in Arm Right on 04Jan2021 at 15:00 for covid 19 immunization. The patient had no medical history and no known allergies. The patient had no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine, no treatment was received for the adverse events, has not been diagnosed with covid-19 prior vaccination. The patient underwent lab tests and procedures, which included Nasal Swab post vaccination on 28Dec2020 which resulted negative. Patient experienced a headache, felt real tired and chills for about 6 hours all on 05Feb2021 at 04:30 PM. After 6 hours the symptoms went away. The outcome of the events was recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair was thinning; This is a spontaneous report from a contactable nurse.   This 53-year-old non-pregnant female nurse reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), via an unspecified route of administration on 13Jan2021 14:30 (Age at vaccination is 53 year) on left arm at single dose for COVID-19 Immunization at workplace clinic. The patient also received second dose on 03Feb2021.Patient medical history included diabetes, hypertension, hypothyroid, obesity, allergies to Sulfa drugs. Concomitant medications included acyclovir, atorvastatin, amlodipine and levothyroxine (Other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. After the first dose of the COVID vaccine patient noticed that her hair was thinning. It was unknown at this time if the damage would be permanent. The outcome for the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Lethargy, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever; chills; chest and head congestion; chest and head congestion; lethargy; over all feeling of sick; This is a spontaneous report from a contactable consumer (reporting herself). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 03Feb2021 at 13:45 as a single dose for COVID-19 immunization. The patient did not received any other vaccines with 4 weeks prior to the COVID vaccine. The patient received metformin, metoprolol with in 2 weeks of COVID vaccination. The patient was allergic to ceclor, codeine. The patient medical history included diabetes, psoriatic, arthritis. On 04Feb2021 at 07:00, the patient experienced fever, chills, chest and head congestion, lethargy, over all feeling of sick. The patient received tylenol, musinex, bed rest, fluids as corrective treatment for the events. The outcome of the events was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: Fever; chills; chest and head congestion; chest and head congestion; lethargy; over all feeling of sick; This is a spontaneous report from a contactable consumer (reporting herself). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 03Feb2021 at 13:45 as a single dose for COVID-19 immunization. The patient did not received any other vaccines with 4 weeks prior to the COVID vaccine. The patient received metformin, metoprolol with in 2 weeks of COVID vaccination. The patient was allergic to ceclor, codeine. The patient medical history included diabetes, psoriatic, arthritis. On 04Feb2021 at 07:00, the patient experienced fever, chills, chest and head congestion, lethargy, over all feeling of sick. The patient received tylenol, musinex, bed rest, fluids as corrective treatment for the events. The outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Noticed a 3 quarters of an inch area at injection site that looks like a mosquito bite that has been scratched; Feel mild itchiness at vaccination site; Redness at the injection site with a diameter of 3/4 inch; This is a spontaneous report from a contactable Consumer. This 68-year-old non-pregnant Caucasian female Consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an Intramuscular injection in left arm on 25Jan2021 at 15:45 as a single dose for COVID-19 immunization. The patients medical history included allergic to penicillin. The patients concomitant medications were not reported. The patient did not undergo any investigations. The patient had not received any additional vaccines on same day of the COVID vaccine. The patient had not received any vaccines with 4 weeks of vaccination. The patient received other unspecified medication with 2 weeks of COVID vaccination. Prior to vaccination the patient was not diagnosed of COVID-19. Post vaccination the patient was not tested for COVID 19. On 02Feb2021 at 14:00, 8 days late, the patient noticed a little bit of itchiness. The patient did not think much of it and the patient did not think it was anything really noticeable, but her husband told her that she had some mild redness. On 03Feb2021, the patient noticed 3 quarters of an inch area that looks like a mosquito bite where it gets bigger and redder as one scratches. The patient not scratching the area, but it looks the patient had a mosquito bite and scratched it. She confirms this was located at the injection site of her left arm. The patient explained that this area at the injection has not got any worse. It was the same. It just started; she did not imagine it was going to get any worse. The patient did not require any emergency room or physician office. The patient did not receive any treatment for the events. While she was sitting on hold waiting to speak to someone, she was reading online and found a doctor that had the same reaction as her except it was with Moderna's vaccine, and the patient also found others that had what they call an 8-day reaction. From reading these articles, it seems she has this reaction because its building up her immune system. The caller just wanted to make sure this is okay and that she can received the second vaccine. Caller states what she read was that it was okay to receive the second vaccine but just to receive the second one in her other arm. Outcome of events was not recovered.