chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Visual field defect, Vitreous floaters
Clinical narrative: blindness from floaters; I have blind spot in my right eye after second Moderna vaccine; blindness from floaters; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (blindness from floaters) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLINDNESS (blindness from floaters) (seriousness criterion medically significant), VISUAL FIELD DEFECT (I have blind spot in my right eye after second Moderna vaccine) and VITREOUS FLOATERS (blindness from floaters). At the time of the report, BLINDNESS (blindness from floaters), VISUAL FIELD DEFECT (I have blind spot in my right eye after second Moderna vaccine) and VITREOUS FLOATERS (blindness from floaters) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not reported.  Very limited information has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Back pain, Liver function test, Pyrexia, Urinary retention
Clinical narrative: Throwing up; Fever 102.4 F; Could not urinate; Back pain was so bad after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up), PYREXIA (Fever 102.4 F), URINARY RETENTION (Could not urinate) and BACK PAIN (Back pain was so bad after the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Throwing up) (seriousness criteria hospitalization and life threatening), PYREXIA (Fever 102.4 F) (seriousness criteria hospitalization and life threatening), URINARY RETENTION (Could not urinate) (seriousness criteria hospitalization, medically significant and life threatening) and BACK PAIN (Back pain was so bad after the vaccine) (seriousness criteria hospitalization and life threatening). At the time of the report, VOMITING (Throwing up), PYREXIA (Fever 102.4 F), URINARY RETENTION (Could not urinate) and BACK PAIN (Back pain was so bad after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Aspartate aminotransferase: 90 (Inconclusive) inconclusive and 7000 (abnormal) after being transported to hospital. On 29-May-2021, Liver function test: 1000 (abnormal) in emergency room, 2000 (abnormal) 2000 when admitted in the local hospital and 2500 (abnormal) 2500 after being transported to hospital.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included an unspecified antidepressant for an unknown indication and an unspecified medication for backpain.  Caller stated that his wife received the first dose of Moderna vaccine 1 month ago in her Primary Care Provider's Office as of 31st May 2021 it was reported that she had felt very tired and had vomiting for a day. Caller also mentioned that his wife could not urinate and in the hospital was given 3 liters of fluids and still could not urinate.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up; Fever 102.4 F; Could not urinate; Back pain was so bad after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up), PYREXIA (Fever 102.4 F), URINARY RETENTION (Could not urinate) and BACK PAIN (Back pain was so bad after the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Throwing up) (seriousness criteria hospitalization and life threatening), PYREXIA (Fever 102.4 F) (seriousness criteria hospitalization and life threatening), URINARY RETENTION (Could not urinate) (seriousness criteria hospitalization, medically significant and life threatening) and BACK PAIN (Back pain was so bad after the vaccine) (seriousness criteria hospitalization and life threatening). At the time of the report, VOMITING (Throwing up), PYREXIA (Fever 102.4 F), URINARY RETENTION (Could not urinate) and BACK PAIN (Back pain was so bad after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Aspartate aminotransferase: 90 (Inconclusive) inconclusive and 7000 (abnormal) after being transported to hospital. On 29-May-2021, Liver function test: 1000 (abnormal) in emergency room, 2000 (abnormal) 2000 when admitted in the local hospital and 2500 (abnormal) 2500 after being transported to hospital.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included an unspecified antidepressant for an unknown indication and an unspecified medication for backpain.  Caller stated that his wife received the first dose of Moderna vaccine 1 month ago in her Primary Care Provider's Office as of 31st May 2021 it was reported that she had felt very tired and had vomiting for a day. Caller also mentioned that his wife could not urinate and in the hospital was given 3 liters of fluids and still could not urinate.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information mentioned. Very limited information regarding the event has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: No new information; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis aggravated; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) (seriousness criterion medically significant). On 24-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding the event has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Rheumatoid arthritis
Clinical narrative: The MD thinks he might have had rheumatoid arthritis.; Still been experiencing muscle and joint pain in knees, hands, and shoulders.; Experiencing a lot of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (The MD thinks he might have had rheumatoid arthritis.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ARTHRALGIA (Experiencing a lot of joint pain). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (The MD thinks he might have had rheumatoid arthritis.) (seriousness criterion medically significant) and MYALGIA (Still been experiencing muscle and joint pain in knees, hands, and shoulders.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (The MD thinks he might have had rheumatoid arthritis.), ARTHRALGIA (Experiencing a lot of joint pain) and MYALGIA (Still been experiencing muscle and joint pain in knees, hands, and shoulders.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-201893 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Feeling cold, Insomnia, Malaise
Clinical narrative: fell on the floor; Very strong malaise feeling; Was sore all over, whole body sore, from toes right up to hair; Freezing cold; Very tired; Couldn't get to sleep; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on 01Feb2021 11:00 (Batch/Lot Number: EN5318) as 2st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration in right upper arm on 11jan2021 on (Lot no: EL3246) as single dose for covid-19 immunization. On 02Feb2021 at midnight 01:00 Am 13 hours after the vaccination patient woke up at 1AM with a very strong malaise feeling and was sore all over her whole body was sore from her toes right up to her hair, and she was freezing cold. She could not lay in bed comfortably as patient was very tired and could not get to sleep. This condition lasted until 10AM, she got up at 9AM, she had a terrible time and fell on the floor. Patient took Tylenol 650mg, that that kicked in about a quarter of an hour, and she felt better, but it was the whole day, she took another dose on that evening. the whole day she was dead in her tracks, she didn't want to get up and walk but she wasn't in bed. Malaise went away until the end of the day, might be at 10-11PM, also reported that all these reactions diminished gradually until they were nothing, all probably equal. She has recovered completely from them all.  She was generally a pretty healthy person. She was even healthier now. She wanted to know, why she had no reaction in the first shot, was there sometimes a reaction in second She has gone through so much research, and there is conflicting information, so she thought to reach directly. she doesn't share about the fact she had a reaction to the second. She doesn't want to discourage people from getting the second. Caller reports she lives in an assisted living and she has done a personal survey amongst the residents. Caller reports that about 25% of  people have had reactions to second dose, and they are not allergic reactions. Caller mentions because the word was getting around the residents have had more of a reaction to second dose, some residents are choosing not to get the second dose. Caller mentions she has found some information on website. The outcome of the events was recovered on 02feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: fell on the floor; Very strong malaise feeling; Was sore all over, whole body sore, from toes right up to hair; Freezing cold; Very tired; Couldn't get to sleep; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on 01Feb2021 11:00 (Batch/Lot Number: EN5318) as 2st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration in right upper arm on 11jan2021 on (Lot no: EL3246) as single dose for covid-19 immunization. On 02Feb2021 at midnight 01:00 Am 13 hours after the vaccination patient woke up at 1AM with a very strong malaise feeling and was sore all over her whole body was sore from her toes right up to her hair, and she was freezing cold. She could not lay in bed comfortably as patient was very tired and could not get to sleep. This condition lasted until 10AM, she got up at 9AM, she had a terrible time and fell on the floor. Patient took Tylenol 650mg, that that kicked in about a quarter of an hour, and she felt better, but it was the whole day, she took another dose on that evening. the whole day she was dead in her tracks, she didn't want to get up and walk but she wasn't in bed. Malaise went away until the end of the day, might be at 10-11PM, also reported that all these reactions diminished gradually until they were nothing, all probably equal. She has recovered completely from them all.  She was generally a pretty healthy person. She was even healthier now. She wanted to know, why she had no reaction in the first shot, was there sometimes a reaction in second She has gone through so much research, and there is conflicting information, so she thought to reach directly. she doesn't share about the fact she had a reaction to the second. She doesn't want to discourage people from getting the second. Caller reports she lives in an assisted living and she has done a personal survey amongst the residents. Caller reports that about 25% of  people have had reactions to second dose, and they are not allergic reactions. Caller mentions because the word was getting around the residents have had more of a reaction to second dose, some residents are choosing not to get the second dose. Caller mentions she has found some information on website. The outcome of the events was recovered on 02feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cold sweat, Malaise, Oropharyngeal discomfort
Clinical narrative: not feeling good at all; joint pain; back pain; a little scratching and swelling in the back of my throat; a little scratching and swelling in the back of my throat; clammy in bed; This is a spontaneous report from a contactable consumer (patient). A 65 (unspecified units) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unspecified route of administration on 28Jan2021 as single dose for covid-19 immunization. The patient medical history included sciatica pain and inflammation arthritis. Concomitant medications were not reported. On 29Jan2021 (on the next day of vaccination), the patient was not feeling good at all and on an unspecified date in 2021, stated she experienced joint pain, back pain and "a little scratching and swelling in the back of my throat". She stated that one night she was "clammy in bed". She wanted to know if she could take Benadryl before the 2nd dose of covid vaccine. She wanted to know whether the second dose of covid vaccine is more potent than the first dose. The outcome of the events was unknown.  Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: not feeling good at all; joint pain; back pain; a little scratching and swelling in the back of my throat; a little scratching and swelling in the back of my throat; clammy in bed; This is a spontaneous report from a contactable consumer (patient). A 65 (unspecified units) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unspecified route of administration on 28Jan2021 as single dose for covid-19 immunization. The patient medical history included sciatica pain and inflammation arthritis. Concomitant medications were not reported. On 29Jan2021 (on the next day of vaccination), the patient was not feeling good at all and on an unspecified date in 2021, stated she experienced joint pain, back pain and "a little scratching and swelling in the back of my throat". She stated that one night she was "clammy in bed". She wanted to know if she could take Benadryl before the 2nd dose of covid vaccine. She wanted to know whether the second dose of covid vaccine is more potent than the first dose. The outcome of the events was unknown.  Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Caller has allergies; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient took 1st dose of Covid vaccine today (02Feb2021). She has allergies and would like to know if she can take something for them. Clarified that patient had allergies before taking vaccine. Unknown if vaccine affected allergies. The patient experienced allergies (drug hypersensitivity) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.  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: Body temperature decreased, Chills, Illness, Malaise, Pain
Clinical narrative: she feels horrible, she doesn't feel well/ hasn't been feeling well; chills; low-grade temperature; she's just sick; pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included hip pain (she has hip pain where she always had it and for which she takes Tylenol and oxycodone), hip replacement, phlegm (she has a lot of phlegm (not new she always had it) When she gets bad colds, she can sometimes get an antibiotic for the phlegm and it does clear up. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient stated her breathing was okay, but other than that she feels horrible, she doesn't feel well. She also had an amazing amount of chills, she went to bed right away on Saturday, when she woke up, she got very scared. She hasn't been feeling well since she got the shot, had a low-grade temperature, she's just sick and can't explain it, she doesn't want to move, she was in so pain, she was feeling sick, and was scared. The outcome of the events was unknown.  Information about Lot/Batch number is requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myositis, Pain
Clinical narrative: her back muscles became very inflamed to where she couldn't bend her back; her back muscles became very inflamed to where she couldn't bend her back; couldn't use the toilet because of the screaming pain; This initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program reported from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150), via an unspecified route of administration in left arm on 31Mar2021 as first dose, single for COVID-19 immunization. Medical history included ongoing slightly hypothroid (has been stable for 25-30 years), and flu. Concomitant medications were not reported. Historical vaccines included flu vaccine in 2009 and 11Nov2011 for influenza immunization after which the patient had serum sickness (in 2011 she was so sick after the flu vaccine that she had to stay in bed for 2 weeks and then she got the flu anyways. She had headache, puffy face and puffy eyes, nausea fever, and achy joints. She stated she was in bed for almost two weeks. Her primary diagnosis was serum sickness and secondary diagnosis was bronchitis). The patient experienced back muscles became very inflamed on 10Apr2021. The first 3 days after the patient received the first dose, the symptoms werent that unusual. 10 days after the patient received the first shot on 10Apr2021, her back muscles became very inflamed to where she couldnt bend her back. The caller couldn't use the toilet because of the screaming pain, it was hard getting in and out of the bed. If the patient dropped something then it would just have to stay on the floor. The patient took Tylenol and Ibuprofen. The back muscles being inflamed was intense for 3 days and lasted for a week. The patient had a reprieve for about a week before the second vaccine. The events resolved on 17Apr2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021586357 Same patient/drug/event and different dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eating disorder, Fear, Malaise
Clinical narrative: she got worse; trying to eat but felt worse; Has a fear; This is a spontaneous report received from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. Medical history included cancer and heart condition. The patient's concomitant medications were not reported. On an unspecified date, the patient was experienced an adverse reaction a week ago after the first dose, she was complaining that after the first dose injection, she got worse. The patient was a cancer survivor and had a heart condition and not to mention as stated having medical conditions. She felt really bad after the vaccine trying to eat but felt worse after and had a fear because of it. The outcome f the events was unknown.   Information about Batch/Lot number has been requested.  Follow-up (19Apr2021): 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, COVID19
Symptoms: Condition aggravated, Gait disturbance, Headache, Illness
Clinical narrative: she got worse; trying to eat but felt worse; Has a fear; This is a spontaneous report received from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. Medical history included cancer and heart condition. The patient's concomitant medications were not reported. On an unspecified date, the patient was experienced an adverse reaction a week ago after the first dose, she was complaining that after the first dose injection, she got worse. The patient was a cancer survivor and had a heart condition and not to mention as stated having medical conditions. She felt really bad after the vaccine trying to eat but felt worse after and had a fear because of it. The outcome f the events was unknown.   Information about Batch/Lot number has been requested.  Follow-up (19Apr2021): 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: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination site erythema, Vaccination site swelling
Clinical narrative: "had a allergy to" the Pfizer-BioNTech COVID-19; "swelling" and redness at the injection site; "swelling" and redness at the injection site; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 66-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: unspecified) via unspecified route in the right arm on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a allergy to the Pfizer-BioNTech COVID-19 vaccine. He experienced "swelling" and redness at the injection site, after the receipt of the first dose in the right arm. He specified it was red where the needle was inserted and it got a little big, as the size of a penny. He added it lasted 9 days and it not inapparent now. He asked if he could receive the second dose of the vaccine after reacting to the first dose. The clinical outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Myalgia, Nausea, Vaccination site pain
Clinical narrative: she is not doing so fine; pain at the injection site; muscle pain; chills; nausea; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunization. Medical history of the patient included no spleen, no pancreas, immunocompromised state (her system is a lot more compromised), diabetes and few other things going on (unspecified). All (medical history) occurred many years ago and was prior to getting the vaccine. Concomitant medications of the patient were not reported. On an unspecified date in 2021, after receiving vaccination, patient was not doing so fine and had some side issues but not severe. Patient had pain at the injection site, muscle pain, chills, and nausea. Reporter states that since patient immune system is compromised this could be the reason of patient's symptoms. Reporter asked if patient could take a Tylenol extra strength or something like that. Outcome of the events were unknown. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Malaise, Nausea, Vomiting
Clinical narrative: Not feel so well; Nausea; Vomiting; Fatigue; stomach not feeling well like she wants to vomit; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 72-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route on unspecified date of Feb2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date in Feb2021, after 4 days the patient experienced not feel so well. Since Monday (unspecified date in Feb2021) having nausea, vomiting and fatigue and stomach not feeling well like she wants to vomit. The patient queried that was this normal, can she take something and can she take second dose. The outcome of events was unknown. Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: hsv outbreak; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN5318, expiration date not reported), dose 1 via an unspecified route of administration, administered in arm right on 29Jan2021 09:45 (age at the time of vaccination was 67 years) as 1st dose, single dose for COVID-19 immunization. The patient medical history included allergy to Penicillin, there was no other medical history. Concomitant medications in two weeks included aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]); Vitamins [Ascorbic Acid;Ergocalciferol;Nicotinamide;Retinol;Riboflavin;Thiamine Hydrochloride] (ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE) and Lysine-Monolaurin. The patient did not receive any other vaccine prior to COVID-19 Vaccine in four weeks. The patient did not have COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. On 31Jan2021, the patient experienced HSV outbreak. No treatment was received for the event. Outcome of the event was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: Herpes outbreak on her hands; This is a spontaneous report from a contactable nurse practitioner (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history included: herpes simplex. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date, the patient had Herpes outbreak on her hands. The clinical course included: reporter (Nurse Practitioner) had her second dose of the Pfizer Covid Vaccine a week ago and got herpes simplex; got it from a patient years ago and it was breaking out on her hand. She wanted to know if she can take antiviral medication Valtrex (valacyclovir) one week after taking the second vaccine, to treat the Herpes outbreak on her hands, which she thought she could have contracted from one of their patients. Wants to know if there would be any contraindications if she takes it a week after having her Covid Vaccine. Reporter stated that she already asked her Dermatologist and Pharmacist about this, but they also don't know if she can take the medication or not. This was being reported out of an abundance of caution. The patient did not state Pfizer-BioNTech COVID-19 Vaccine. The outcome of event was unknown.  Information about Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Fever up to 101; Headache; Pain at injection site; Slight stomach upset; Fatigue; This is a spontaneous report from a contactable consumer or other non HCP (patient herself).  A 35-years-old non-pregnant female patient received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:30 (at the age of 35-years-old) as 2nd dose, single dose for covid-19 immunisation. The patient had no other medical history and there were no concomitant medications. The patient previously took bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 22Jan2021 02:30 am as 1st dose, single dose for covid-19 immunisation. The patient previously took bactrim and experienced Known allergies. The patient did not have other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior to vaccination. On 06Feb2021, at 09:30 AM, the patient experienced fever up to 101, headache, pain at injection site, slight stomach upset and fatigue. The patient did not received treatment for the events. The patient not COVD tested post vaccination. The outcome of the events was recovered on Feb2021.  Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever up to 101; Headache; Pain at injection site; Slight stomach upset; Fatigue; This is a spontaneous report from a contactable consumer or other non HCP (patient herself).  A 35-years-old non-pregnant female patient received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:30 (at the age of 35-years-old) as 2nd dose, single dose for covid-19 immunisation. The patient had no other medical history and there were no concomitant medications. The patient previously took bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 22Jan2021 02:30 am as 1st dose, single dose for covid-19 immunisation. The patient previously took bactrim and experienced Known allergies. The patient did not have other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior to vaccination. On 06Feb2021, at 09:30 AM, the patient experienced fever up to 101, headache, pain at injection site, slight stomach upset and fatigue. The patient did not received treatment for the events. The patient not COVD tested post vaccination. The outcome of the events was recovered on Feb2021.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: My granddaughter who is 30 years old had a very bad side effects from it. She was very sick; This is a spontaneous report from a contactable consumer or other non hcp (patient's grandmother). A 30-years-old female patient received first dose of bnt162b2 (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 1st DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very bad side effects from it. she was very sick on an unspecified date. The Outcome of event was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Dizziness, Fatigue, Headache
Clinical narrative: Severely unwell; 101-degree temp; Headache; Fatigue; Nausea; Muscle aches; Dizziness; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported that a 38-year-old female second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL 8982), via intramuscular in left arm on 01Feb2021 17:00, as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EK 9231), via Intramuscular in left arm on Jan2021 at 16:00, as 1st dose, single dose for covid-19 immunisation. Known allergies reported for penicillin, vicodin, percocet. The patient did not receive any vaccines within four weeks prior to the vaccination. No other medications in two weeks. On 02Feb2021, 09:00 the patient experienced a general feeling of being severely unwell, 101-degree temp, headache, fatigue, nausea, muscle aches, dizziness. The patient did receive any treatment for the event was unknown. Adverse event resulted in emergency room/department or urgent care. The outcome for all events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Severely unwell; 101-degree temp; Headache; Fatigue; Nausea; Muscle aches; Dizziness; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported that a 38-year-old female second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL 8982), via intramuscular in left arm on 01Feb2021 17:00, as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EK 9231), via Intramuscular in left arm on Jan2021 at 16:00, as 1st dose, single dose for covid-19 immunisation. Known allergies reported for penicillin, vicodin, percocet. The patient did not receive any vaccines within four weeks prior to the vaccination. No other medications in two weeks. On 02Feb2021, 09:00 the patient experienced a general feeling of being severely unwell, 101-degree temp, headache, fatigue, nausea, muscle aches, dizziness. The patient did receive any treatment for the event was unknown. Adverse event resulted in emergency room/department or urgent care. The outcome for all events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Illness, Malaise, Musculoskeletal chest pain, Musculoskeletal stiffness
Clinical narrative: I am nauseated; I get sick, and nobody cares for me; I feeling unwell and my ribcage on right side hurt,; my ribcage on right side hurt; I feel unwell, and like I said, when I got up this morning, my shot arm was really bad but then it went away and I got this like my rib cage; so tightening and starting to hurt, like I got infection in my chest or something; when I woke up this morning, I told you, woke up this morning my arm started hurting me, my elbow and then it went away and I started moving around; This is a spontaneous report from a contactable consumer. A 75-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN5318), via an unspecified route of administration on 03Feb2021 (Wednesday) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included prostate cancer since, 12 years ago. He has been fighting prostate cancer for 12 years, had radiation treatment in the beginning and then had hormone therapy for 9 years, on and off and is still on hormone therapy pills now; high blood pressure; radiotherapy since, 12 years ago. Concomitant medication(s) included amlodipine besilate (NORVASC) 10 mg taken for hypertension, darolutamide (NUBEQA) taken for prostate cancer, paracetamol (TYLENOL) and buspirone (BUSPIRONE). The patient's vaccination history included polio shot when he was a kid and did not get sick after that. On 05Feb2021, the patient was feeling unwell and ribcage on right side hurt; he feel unwell, and like he said, when he got up this morning, his shot arm was really bad but then it went away and he got this like my rib cage; so tightening and starting to hurt, like he got infection in my chest or something; when he woke up this morning, arm started hurting me, my elbow and then it went away and started moving around; was nauseated ; he gets sick, and nobody cares for him. The patient had to go outside move his car, but rib cage started hurting. Patient was at home and can get no treatment. On an unknown date in 2021, the patient underwent blood test which had no result. The patient had breakfast, was sick to stomach, nauseated but sick like and wanted to know if he can take Pepto-Bismol. The patient says that he stills feels the same way. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: I am nauseated; I get sick, and nobody cares for me; I feeling unwell and my ribcage on right side hurt,; my ribcage on right side hurt; I feel unwell, and like I said, when I got up this morning, my shot arm was really bad but then it went away and I got this like my rib cage; so tightening and starting to hurt, like I got infection in my chest or something; when I woke up this morning, I told you, woke up this morning my arm started hurting me, my elbow and then it went away and I started moving around; This is a spontaneous report from a contactable consumer. A 75-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN5318), via an unspecified route of administration on 03Feb2021 (Wednesday) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included prostate cancer since, 12 years ago. He has been fighting prostate cancer for 12 years, had radiation treatment in the beginning and then had hormone therapy for 9 years, on and off and is still on hormone therapy pills now; high blood pressure; radiotherapy since, 12 years ago. Concomitant medication(s) included amlodipine besilate (NORVASC) 10 mg taken for hypertension, darolutamide (NUBEQA) taken for prostate cancer, paracetamol (TYLENOL) and buspirone (BUSPIRONE). The patient's vaccination history included polio shot when he was a kid and did not get sick after that. On 05Feb2021, the patient was feeling unwell and ribcage on right side hurt; he feel unwell, and like he said, when he got up this morning, his shot arm was really bad but then it went away and he got this like my rib cage; so tightening and starting to hurt, like he got infection in my chest or something; when he woke up this morning, arm started hurting me, my elbow and then it went away and started moving around; was nauseated ; he gets sick, and nobody cares for him. The patient had to go outside move his car, but rib cage started hurting. Patient was at home and can get no treatment. On an unknown date in 2021, the patient underwent blood test which had no result. The patient had breakfast, was sick to stomach, nauseated but sick like and wanted to know if he can take Pepto-Bismol. The patient says that he stills feels the same way. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.