chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Felt like she was getting shot in her throat; Not feeling well; Itching, but didn't break out; A little headache / Head hurting so bad she can't see out of her eyes right; Throughout the night wasn't feeling right; Didn't have enough strength to go to the bathroom / Doesn't have enough strength to talk/Weakness / Can barely hold the phone; So tired / Real fatigued; Nauseous; Chills; Left side of neck is stiff; Muscle and joint pain, like someone punched her all over; Dizziness; Vomited all over; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration in left arm on 22Apr2021 at 15:15 (at the age of 42-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had first dose on 22Apr2021 (yesterday), at about 15:15 in her left arm. In Apr2021, when she got the shot it felt like she was getting a shot in her throat. Then she was ok. She started itching a little afterwards, but didn't break out. She got home and was ok. She was getting a little headache. Throughout the night she was not feeling right. She did not have enough strength to go to the bathroom. She was so tired. She was getting her crew ready (the morning of this report) for work and was getting real nauseous. Had chills. Head had been hurting so bad she could not see out of her eyes right. Left side of her neck was stiff. Was having pain, clarified as muscle and joint pain, and felt like someone had punched her all over. Was having weakness and dizziness. Was real fatigued. Her bosses had to drive her home and her car was at work. She got home a little before 10:00 and had tried to rest. She vomited all over at work. Did not have enough strength to talk (Apr2021). She was not sure why this was happening. Wanted to report what was going on with her and was hoping to be guided in the right direction as well. She was advised to follow up with her primary care physician or local health care provider for treatment recommendations and medical advice. The outcome of all the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Musculoskeletal pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Felt like she was getting shot in her throat; Not feeling well; Itching, but didn't break out; A little headache / Head hurting so bad she can't see out of her eyes right; Throughout the night wasn't feeling right; Didn't have enough strength to go to the bathroom / Doesn't have enough strength to talk/Weakness / Can barely hold the phone; So tired / Real fatigued; Nauseous; Chills; Left side of neck is stiff; Muscle and joint pain, like someone punched her all over; Dizziness; Vomited all over; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration in left arm on 22Apr2021 at 15:15 (at the age of 42-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had first dose on 22Apr2021 (yesterday), at about 15:15 in her left arm. In Apr2021, when she got the shot it felt like she was getting a shot in her throat. Then she was ok. She started itching a little afterwards, but didn't break out. She got home and was ok. She was getting a little headache. Throughout the night she was not feeling right. She did not have enough strength to go to the bathroom. She was so tired. She was getting her crew ready (the morning of this report) for work and was getting real nauseous. Had chills. Head had been hurting so bad she could not see out of her eyes right. Left side of her neck was stiff. Was having pain, clarified as muscle and joint pain, and felt like someone had punched her all over. Was having weakness and dizziness. Was real fatigued. Her bosses had to drive her home and her car was at work. She got home a little before 10:00 and had tried to rest. She vomited all over at work. Did not have enough strength to talk (Apr2021). She was not sure why this was happening. Wanted to report what was going on with her and was hoping to be guided in the right direction as well. She was advised to follow up with her primary care physician or local health care provider for treatment recommendations and medical advice. The outcome of all the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pruritus, Vomiting
Clinical narrative: Felt like she was getting shot in her throat; Not feeling well; Itching, but didn't break out; A little headache / Head hurting so bad she can't see out of her eyes right; Throughout the night wasn't feeling right; Didn't have enough strength to go to the bathroom / Doesn't have enough strength to talk/Weakness / Can barely hold the phone; So tired / Real fatigued; Nauseous; Chills; Left side of neck is stiff; Muscle and joint pain, like someone punched her all over; Dizziness; Vomited all over; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration in left arm on 22Apr2021 at 15:15 (at the age of 42-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had first dose on 22Apr2021 (yesterday), at about 15:15 in her left arm. In Apr2021, when she got the shot it felt like she was getting a shot in her throat. Then she was ok. She started itching a little afterwards, but didn't break out. She got home and was ok. She was getting a little headache. Throughout the night she was not feeling right. She did not have enough strength to go to the bathroom. She was so tired. She was getting her crew ready (the morning of this report) for work and was getting real nauseous. Had chills. Head had been hurting so bad she could not see out of her eyes right. Left side of her neck was stiff. Was having pain, clarified as muscle and joint pain, and felt like someone had punched her all over. Was having weakness and dizziness. Was real fatigued. Her bosses had to drive her home and her car was at work. She got home a little before 10:00 and had tried to rest. She vomited all over at work. Did not have enough strength to talk (Apr2021). She was not sure why this was happening. Wanted to report what was going on with her and was hoping to be guided in the right direction as well. She was advised to follow up with her primary care physician or local health care provider for treatment recommendations and medical advice. The outcome of all the events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Dizziness, Nausea
Clinical narrative: Chills; Fever; stomach hurt; back hurt; Nausea; feel like she is about to pass out; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feel like she was about to pass out on Apr2021. On 28Apr2021 the patient developed chills, fever, stomach hurt, back hurt and nausea. The event outcome was reported as unknown.   No follow-up attempts are needed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Fever; stomach hurt; back hurt; Nausea; feel like she is about to pass out; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feel like she was about to pass out on Apr2021. On 28Apr2021 the patient developed chills, fever, stomach hurt, back hurt and nausea. The event outcome was reported as unknown.   No follow-up attempts are needed. No further information expected
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood pressure increased, Chills, Fatigue
Clinical narrative: could not get warm; She said that she feels like she has trouble even lifting her legs up.; blood pressure elevated; her head started hurting; weakness in her legs; leg is hurting; Chills; Tiredness; Weakness; stomach hurts; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiry Date: Unknown)), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 as dose 1, single for COVID-19 immunization (at the age of 67-year-old). Medical history included ongoing asthma and breathing problems. The patient's concomitant medications were not reported. The patient previously took singulair for asthma. On 08Apr2021, the patient experienced chills, tiredness, weakness, stomach hurts, wheezing; on an unspecified date, could not get warm, she said that she feels like she has trouble even lifting her legs up, blood pressure elevated, her head started hurting, weakness in her legs and leg was hurting. Consumer clarified that she wanted to report some side effects and said that she had chills and could not get warm, she still has tiredness and weakness. She said that she has asthma, but started wheezing after receiving the vaccine and is having more wheezing now. Caller said that she is having weakness in her legs. Stated that her stomach hurts. She said that she has a ulcer, but was not hurting like this prior to the vaccine. She said that she went to the doctor to see if it was a UTI making her stomach hurt and the doctor ruled that out and said that it was not a UTI. She stated that her legs feel like it is giving out like when someone bumps you in the back of your legs. She said that she feels like she has trouble even lifting her legs up. Consumer stated that she was due to take the second dose tomorrow and was trying to see if she should take it or what. She stated that her blood pressure elevated too. She stated that she has asthma and has breathing problems sometimes, but she was fine prior to the shot. Chills started 30 minutes after the vaccine and stated that her head started hurting. She said that she could not get warm even though it was warm outside. She said that her stomach hurting could be confused with the ulcer. She stated that her stomach hurts anyway. Stated that the first letter of the Lot number could be a P. Consumer stated that she was taking asthma medication prior to receiving the Covid vaccine and her doctor wanted to her to finish that medication before taking the vaccine. She said that she went back to taking her regular medication a couple of days after the shot. She said that she takes Singulair and things like that. The outcome of the events tiredness, weakness, stomach hurts, wheezing, could not get warm was not recovered and unknown for all other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: could not get warm; She said that she feels like she has trouble even lifting her legs up.; blood pressure elevated; her head started hurting; weakness in her legs; leg is hurting; Chills; Tiredness; Weakness; stomach hurts; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiry Date: Unknown)), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 as dose 1, single for COVID-19 immunization (at the age of 67-year-old). Medical history included ongoing asthma and breathing problems. The patient's concomitant medications were not reported. The patient previously took singulair for asthma. On 08Apr2021, the patient experienced chills, tiredness, weakness, stomach hurts, wheezing; on an unspecified date, could not get warm, she said that she feels like she has trouble even lifting her legs up, blood pressure elevated, her head started hurting, weakness in her legs and leg was hurting. Consumer clarified that she wanted to report some side effects and said that she had chills and could not get warm, she still has tiredness and weakness. She said that she has asthma, but started wheezing after receiving the vaccine and is having more wheezing now. Caller said that she is having weakness in her legs. Stated that her stomach hurts. She said that she has a ulcer, but was not hurting like this prior to the vaccine. She said that she went to the doctor to see if it was a UTI making her stomach hurt and the doctor ruled that out and said that it was not a UTI. She stated that her legs feel like it is giving out like when someone bumps you in the back of your legs. She said that she feels like she has trouble even lifting her legs up. Consumer stated that she was due to take the second dose tomorrow and was trying to see if she should take it or what. She stated that her blood pressure elevated too. She stated that she has asthma and has breathing problems sometimes, but she was fine prior to the shot. Chills started 30 minutes after the vaccine and stated that her head started hurting. She said that she could not get warm even though it was warm outside. She said that her stomach hurting could be confused with the ulcer. She stated that her stomach hurts anyway. Stated that the first letter of the Lot number could be a P. Consumer stated that she was taking asthma medication prior to receiving the Covid vaccine and her doctor wanted to her to finish that medication before taking the vaccine. She said that she went back to taking her regular medication a couple of days after the shot. She said that she takes Singulair and things like that. The outcome of the events tiredness, weakness, stomach hurts, wheezing, could not get warm was not recovered and unknown for all other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: could not get warm; She said that she feels like she has trouble even lifting her legs up.; blood pressure elevated; her head started hurting; weakness in her legs; leg is hurting; Chills; Tiredness; Weakness; stomach hurts; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiry Date: Unknown)), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 as dose 1, single for COVID-19 immunization (at the age of 67-year-old). Medical history included ongoing asthma and breathing problems. The patient's concomitant medications were not reported. The patient previously took singulair for asthma. On 08Apr2021, the patient experienced chills, tiredness, weakness, stomach hurts, wheezing; on an unspecified date, could not get warm, she said that she feels like she has trouble even lifting her legs up, blood pressure elevated, her head started hurting, weakness in her legs and leg was hurting. Consumer clarified that she wanted to report some side effects and said that she had chills and could not get warm, she still has tiredness and weakness. She said that she has asthma, but started wheezing after receiving the vaccine and is having more wheezing now. Caller said that she is having weakness in her legs. Stated that her stomach hurts. She said that she has a ulcer, but was not hurting like this prior to the vaccine. She said that she went to the doctor to see if it was a UTI making her stomach hurt and the doctor ruled that out and said that it was not a UTI. She stated that her legs feel like it is giving out like when someone bumps you in the back of your legs. She said that she feels like she has trouble even lifting her legs up. Consumer stated that she was due to take the second dose tomorrow and was trying to see if she should take it or what. She stated that her blood pressure elevated too. She stated that she has asthma and has breathing problems sometimes, but she was fine prior to the shot. Chills started 30 minutes after the vaccine and stated that her head started hurting. She said that she could not get warm even though it was warm outside. She said that her stomach hurting could be confused with the ulcer. She stated that her stomach hurts anyway. Stated that the first letter of the Lot number could be a P. Consumer stated that she was taking asthma medication prior to receiving the Covid vaccine and her doctor wanted to her to finish that medication before taking the vaccine. She said that she went back to taking her regular medication a couple of days after the shot. She said that she takes Singulair and things like that. The outcome of the events tiredness, weakness, stomach hurts, wheezing, could not get warm was not recovered and unknown for all other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza, Injection site erythema, Malaise, Neck pain
Clinical narrative: Fever off and on; Chills; She was feeling very rough; Severe pain on the right side of her neck and then on the left side; Her legs and arms ached; She noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon; She had the worst flu she had ever had, 10 times worse than a regular flu; She noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 68-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ Lot number was not reported), via an unspecified route of administration on 27Apr2021 10:00 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine includes bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ Lot number was not reported), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified day the patient presented with fever off and on, chills, she was feeling very rough, a head (took ibuprofen), she had the worst flu she had ever had, 10 times worse than a regular flu, she presented severe pain on the right side of her neck and then on the left side, her legs and arms ached. The patient stated that when she looked into the mirror she noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon. The patient stated that her doctor prescribed Benadryl. Therapeutic measures were taken as a result of fever off and on (pyrexia), chills (chills), she was feeling very rough (malaise). The events outcome was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Fever off and on; Chills; She was feeling very rough; Severe pain on the right side of her neck and then on the left side; Her legs and arms ached; She noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon; She had the worst flu she had ever had, 10 times worse than a regular flu; She noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 68-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ Lot number was not reported), via an unspecified route of administration on 27Apr2021 10:00 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine includes bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ Lot number was not reported), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified day the patient presented with fever off and on, chills, she was feeling very rough, a head (took ibuprofen), she had the worst flu she had ever had, 10 times worse than a regular flu, she presented severe pain on the right side of her neck and then on the left side, her legs and arms ached. The patient stated that when she looked into the mirror she noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon. The patient stated that her doctor prescribed Benadryl. Therapeutic measures were taken as a result of fever off and on (pyrexia), chills (chills), she was feeling very rough (malaise). The events outcome was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: lot of pain in my knees and my joints; It is in my left knee and right knee only; I can hardly walk; This is a spontaneous report from contactable consumer (patient).  A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiry date: unknown), via an unspecified route of administration on 26Mar2021 (at the age of 60 years old) as dose 1, single for COVID-19 immunisation. The patient medical history included COVID-19 in Oct2020. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma once a day. The patient experienced 10 days later lot of pain in his knees and his joints; it was in his left knee and right knee only (reported as worsened), he could hardly walk on 05Apr2021. Clinical course reported as I had the Pfizer shot 26Mar and 10 days later lot of pain in my knees and my joints. It is in my left knee and right knee only today and I can hardy walk and my question is I had Covid back in October, 1st of November and I had the first shot in March, will the second shot be worse? I am really concerned because I can hardly walk the way it is. Therapeutic measures were taken as a result of the events not as an Ibuprofen, they say over the counter like Aspirin. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: slight fever; headache; achiness; This is a spontaneous report from a contactable consumer (patient) reported in response to non-Healthcare Professional letter sent. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264, Expiration date: unknown) intramuscular, administered in left arm on 06Mar2021 at 09:15 am (age at vaccination was 39 years) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for headache from 13Feb2021 to 13Feb2021 and scopolamine aminoxide taken for vertigo from 15Feb2021 to 18Feb2021. The patient did not have any past medication history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3302, Expiration date: unknown) intramuscular, administered in left arm on 13Feb2021 at 09:15 am (age at vaccination was 38 years) as dose 1, single for COVID-19 immunization and experienced vertigo, nausea/nauseous, could not sit up or stand without falling down/unable to be upright for much more than 30 mins at a time, felt weak and foggy feeling. The patient underwent lab test which included COVID-19 test: negative on 19Feb2021. The patient was advised by her doctor to move forward with her 2nd dose. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021, the patient experienced a headache and slight fever, achiness the night of 2nd dose but was normal by day 2. The outcome of the events was resolved on 08Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Lump on her arm It is still there and it is swollen; It itches and she has been scratching it; Caller stated it is hard and where they stuck the needle is swollen; Sore: Her arm has felt sore since Thursday 22APR2021; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number ERFWO171, Expiration Date: was not reported) via an unspecified route of administration on 21Apr2021 at around 07:00 in the morning (at the age of 64-year-old) in upper right arm as dose 2, single for covid-19 immunization. Medical history included dialysis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number E7R8737, Expiration Date: was not reported) via an unspecified route of administration on 31Mar2021 (at the age of 64-year-old) in upper right arm as dose 1, single for covid-19 immunization. The patient did not receive any prior vaccination within four weeks. The patient was not having family medical history related to adverse events. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. It was reported that the patient received her second dose of vaccine, and she had a slight lump on her arm in morning and was still there and it was swollen. The patient stated, people at dialysis still felt it on her arm. It was hard and where they stuck the needle was swollen. She clarified it was the upper right arm because she cannot be stuck on the left arm since it was her dialysis arm. The patient stated it itches and she had been scratching it. As treatment she had been using an over-the-counter steroid, hydrocortisone cream on her arm. Her arm had felt sore in morning since Thursday (22Apr2021) and was still sore. The patient stated it may be from her scratching she does not know. She got the second shot on Wednesday and that last week Thursday, Friday, Saturday, and Sunday it had been sore and swollen. The second dose of vaccine caused the lump on her arm and the soreness she felt. She just kept a warm cloth and heating pad on her arm. The adverse events did not result in emergency room or physician office visit. The outcome of all the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Chills, Fatigue, Headache
Clinical narrative: Headache; Fever; Chills; He is very weak; Balance past 2 to 3 weeks is little off; Exhausted; kind of impacting every area of his legs at this point; This is a spontaneous report from a contactable consumer reported for her husband. An 83-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration on 02Apr2021 (at the age of 83-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included shingles in the past and has had the shingles shot and the reporter thinks last year. Concomitant medications were not reported. The patient previously received Valacyclovir (MANUFACTURER UNKNOWN) for Herpes which is being dormant for many years. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration on 12Mar2021 (at the age of 83-year-old) as dose 1, single for COVID-19 immunisation and had no reaction. The patient had many health issues and was on many different medications. On an unspecified date in 2021, within 2 or 3 days of vaccination, the patient experienced headache, fever, chills, he is very weak, balance past 2 to 3 weeks is little off, exhausted and kind of impacting every area of his legs at this point. The reporter just wonders if the vaccine could have awakened all of these other viruses that the patient has that has been dormant and the patient was not showing any reasons from Herpes. The seriousness of the events was not specified. The patient received Tylenol 500 mg as treatment for the events. The outcome of all events was not resolved.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488774 Same reporter, different patient/events
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pyrexia
Clinical narrative: Headache; Fever; Chills; He is very weak; Balance past 2 to 3 weeks is little off; Exhausted; kind of impacting every area of his legs at this point; This is a spontaneous report from a contactable consumer reported for her husband. An 83-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration on 02Apr2021 (at the age of 83-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included shingles in the past and has had the shingles shot and the reporter thinks last year. Concomitant medications were not reported. The patient previously received Valacyclovir (MANUFACTURER UNKNOWN) for Herpes which is being dormant for many years. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration on 12Mar2021 (at the age of 83-year-old) as dose 1, single for COVID-19 immunisation and had no reaction. The patient had many health issues and was on many different medications. On an unspecified date in 2021, within 2 or 3 days of vaccination, the patient experienced headache, fever, chills, he is very weak, balance past 2 to 3 weeks is little off, exhausted and kind of impacting every area of his legs at this point. The reporter just wonders if the vaccine could have awakened all of these other viruses that the patient has that has been dormant and the patient was not showing any reasons from Herpes. The seriousness of the events was not specified. The patient received Tylenol 500 mg as treatment for the events. The outcome of all events was not resolved.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488774 Same reporter, different patient/events
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling cold, Pyrexia
Clinical narrative: feeling tired; like my body was cold; I had little fever; weak; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: EW0162, Expiration date, NDC and UPC number was unknown) via an unspecified route of administration, administered in left arm on 21Apr2021 as dose 1, single (at the age of 45-years-old) for COVID-19 immunisation. Medical history included high blood pressure from unknown date to unknown if ongoing. The patient's concomitant medications included unspecified medications and like water pills for the high blood pressure. On 21Apr2021, when patient took the first shot, it was okay but on Apr2021, (22Apr2021 (the next day after) or 23Apr2021 (last night)), really bad, her body had little fever, just really like came down, like her body was cold, was weak and feeling little tired. Patient received no treatment for the events. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness; arm pain; This is a spontaneous report from a contactable consumer or other non hcp (patients mother). A 37-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 14:30 (at the age of 37-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the covid vaccination. It was reported that after first dose on 20Mar2021, reporter stated that the patient had just soreness and arm pain on an unspecified date. The patient is a self-employed, owner/operator with a transporter that he drives for, he transports automobiles. The patient did not require emergency room or physician Office as result of events. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 (at the age of: 37-years-old) as dose 2, single for covid-19 immunisation. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Localized chest pain; palpitations; This is a spontaneous report from a non-contactable consumer (Patient). This report was received via a sales representative. A 40-year-old female patient received Second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection Batch/Lot number: Not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown whether patient was pregnant at the time of vaccination. On 27Apr2021, the patient experienced localized chest pain, palpitations lasted 24 hours. The outcome of event was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Drug level, Drug level increased, Dyspnoea
Clinical narrative: Shortness of breath; I didn't had much of an appetite so I lost 4-5 pounds; I had cold, chills and then sweat; Coumadin number was way high, way elevated; I didn't had much of an appetite so I lost 4-5 pounds; I had cold, chills and then sweat; With the nausea I didn't had much of an appetite so I lost 4-5 pounds; Fatigue; Dull Headache; I had cold, chills and then sweat; This is a spontaneous report from a contactable consumer, the patient.  A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER2613), via an unspecified route of administration on 20Mar2021 as dose 1, single (age at vaccination 71 years) for covid-19 immunisation. Medical history included congestive heart failure, atrial fibrillation, prediabetes , osteopetrosis since an unknown date. Concomitant medication(s) included warfarin sodium (COUMADIN); diltiazem taken for heart congestion; alendronate sodium (FOSAMAX) taken for osteopetrosis; metformin taken for glucose tolerance impaired; atorvastatin; metoprolol; lisinopril all since an unknown date. On an unknown date in 2021 the patient had shortness of breath, had nausea, and was fatigued very fatigued, had cold, chills and then sweat, had a dull headache and with the nausea didn't had much of an appetite so lost 4-5 pounds and this was over two weeks period after the second shot. The patient was also on Coumadin and she had gone in 6 days later for her regular Coumadin checkup and her Coumadin number was way high, way elevated on an unknown date in 2021. The patient underwent lab tests and procedures which included drug level number for Coumadin was way high, way elevated on an unknown date in 2021. The patient was now fine. The outcome of the events was recovered for shortness of breath and unknown for the rest of the events.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Nasopharyngitis, Nausea
Clinical narrative: Shortness of breath; I didn't had much of an appetite so I lost 4-5 pounds; I had cold, chills and then sweat; Coumadin number was way high, way elevated; I didn't had much of an appetite so I lost 4-5 pounds; I had cold, chills and then sweat; With the nausea I didn't had much of an appetite so I lost 4-5 pounds; Fatigue; Dull Headache; I had cold, chills and then sweat; This is a spontaneous report from a contactable consumer, the patient.  A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER2613), via an unspecified route of administration on 20Mar2021 as dose 1, single (age at vaccination 71 years) for covid-19 immunisation. Medical history included congestive heart failure, atrial fibrillation, prediabetes , osteopetrosis since an unknown date. Concomitant medication(s) included warfarin sodium (COUMADIN); diltiazem taken for heart congestion; alendronate sodium (FOSAMAX) taken for osteopetrosis; metformin taken for glucose tolerance impaired; atorvastatin; metoprolol; lisinopril all since an unknown date. On an unknown date in 2021 the patient had shortness of breath, had nausea, and was fatigued very fatigued, had cold, chills and then sweat, had a dull headache and with the nausea didn't had much of an appetite so lost 4-5 pounds and this was over two weeks period after the second shot. The patient was also on Coumadin and she had gone in 6 days later for her regular Coumadin checkup and her Coumadin number was way high, way elevated on an unknown date in 2021. The patient underwent lab tests and procedures which included drug level number for Coumadin was way high, way elevated on an unknown date in 2021. The patient was now fine. The outcome of the events was recovered for shortness of breath and unknown for the rest of the events.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Shortness of breath; I didn't had much of an appetite so I lost 4-5 pounds; I had cold, chills and then sweat; Coumadin number was way high, way elevated; I didn't had much of an appetite so I lost 4-5 pounds; I had cold, chills and then sweat; With the nausea I didn't had much of an appetite so I lost 4-5 pounds; Fatigue; Dull Headache; I had cold, chills and then sweat; This is a spontaneous report from a contactable consumer, the patient.  A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER2613), via an unspecified route of administration on 20Mar2021 as dose 1, single (age at vaccination 71 years) for covid-19 immunisation. Medical history included congestive heart failure, atrial fibrillation, prediabetes , osteopetrosis since an unknown date. Concomitant medication(s) included warfarin sodium (COUMADIN); diltiazem taken for heart congestion; alendronate sodium (FOSAMAX) taken for osteopetrosis; metformin taken for glucose tolerance impaired; atorvastatin; metoprolol; lisinopril all since an unknown date. On an unknown date in 2021 the patient had shortness of breath, had nausea, and was fatigued very fatigued, had cold, chills and then sweat, had a dull headache and with the nausea didn't had much of an appetite so lost 4-5 pounds and this was over two weeks period after the second shot. The patient was also on Coumadin and she had gone in 6 days later for her regular Coumadin checkup and her Coumadin number was way high, way elevated on an unknown date in 2021. The patient underwent lab tests and procedures which included drug level number for Coumadin was way high, way elevated on an unknown date in 2021. The patient was now fine. The outcome of the events was recovered for shortness of breath and unknown for the rest of the events.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: Has been running a fever 2 times daily since receiving the 1st dose; Had a severe allergic reaction after a previous dose/to any ingredient of this vaccine.; This is a spontaneous report from a contactable Pharmacist. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient experienced has been running a fever 2 times daily since receiving the 1st dose, Had a severe allergic reaction after a previous dose/to any ingredient of this vaccine. It was reported that, the patient was for the second dose of the Pfizer COVID vaccine who states that he was been running a fever 2 times daily since receiving the 1st dose of the vaccine. Is it appropriate to give the second dose if he was running a fever. The outcome of the event fever 2 times daily was not recovered. The outcome of the event severe allergic reaction was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site swelling; injection site redness; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: not reported) on Friday (date unspecified) via an unspecified route of administration as DOSE 1, single for covid-19 immunisation. Patient medical history and concomitant medication was not reported. On an unspecified date, after the vaccination patient experienced injection site redness and injection site swelling. She wanted to know if this was something that was reported, and how long does this side effect last and if she can use ice to control the symptoms. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on hands and arms after receiving the covid-19 vaccine; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives on hands and arms after receiving the covid-19 vaccine. Patient came to get the second dose today and so, they were little unsure if they should not give it because it said that if had any allergic reaction to the vaccine it was a contraindication but then it said that if had Covid arms, so it was okay to give, so they were little unsure. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Lymphadenopathy, Nasopharyngitis, Nausea
Clinical narrative: Nausea; Very tired; Swollen lymph nodes under left armpit; Fever; Right armpit pain; Really cold; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's wife) reported for a 45-years-old male (Reporter's husband) received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 15Apr2021, at 15:45 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced swollen lymph nodes under left armpit, fever, right armpit pain, really cold. On 28Apr2021, the patient experienced nausea, very tired. Clarified swollen lymph nodes are in the left armpit. Left arm was injection arm. Swollen lymph nodes in are not as bad. Right armpit pain: Hurts, but not as bad. Currently is no swelling under the right armpit. Pain is gone as of now. Nausea: Started this morning, but is not as bad. Fever: Complained of being really cold last night. Had a slight temperature of 99.8. It broke sometime during the night because caller just took patient's temperature and he does not have a fever. Very tired: Is very tired this morning. Patient is laying in bed, which he doesn't normally do. The outcome of the events swollen lymph nodes under left armpit, nausea was recovering. The outcome of the events fever, right armpit pain, really cold was recovered on 28Apr2021. The outcome of the event very tired was not recovered.   No follow-up attempts are needed. No further information is expected.