chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt dizzy; low grade fever (99°F); she felt like if she had the flu; achy all over her body; headache; weak, it was difficult for her to get out of bed; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown), dose 2 via intramuscular on 06Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dizzy, low grade fever (99°f), she felt like if she had the flu, achy all over her body, headache, weak, it was difficult for her to get out of bed on an unspecified date. The treatment included Tylenol seems to help with these symptoms, she takes it every four hours. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This is a spontaneous report received from a contactable consumer (patient's husband).  A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Feb2021 in the afternoon (Batch/Lot Number: EL9266) as single dose at the age of 72-year-old for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swollen arm in Feb2021 for about 12 hours after the first vaccine it might have been the next day. The events were considered non serious. The outcome of swollen arm was completely recovered after about 12 hours in Feb2021. A product complaint to report was filed.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea
Clinical narrative: Nauseous; Stayed in bed as head was hurting; He felt really sick; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 15Mar2021 (Lot Number: EN6206), as single dose, for COVID-19 immunisation. Medical history included hypertension, blood cholesterol and spinal fusion surgery. Concomitant medications included losartan (unknown manufacturer), rosuvastatin (unknown manufacturer) and oxycodone (unknown manufacturer) for spinal fusion surgery (taking from last decade, as needed). The patient experienced nauseous (nausea) (non-serious) in Mar2021 with outcome of recovering, stayed in bed as head was hurting (headache) (non-serious) in Mar2021 with outcome of recovering, he felt really sick (illness) (non-serious) in Mar2021 with outcome of recovering.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Eating disorder, Myalgia
Clinical narrative: Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life; I kept thinking everyday will get better and it's just haven't; Anatomical site of administration-The consumer stated, "On my shoulder, left shoulder."; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left shoulder on 26Feb2021 (Lot Number: EL3247) as single dose (at 63 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]), colecalciferol (VITAMIN D 3). Previously the patient received the first dose of BNT162B2 (Lot Number: EM9810) on 05Feb2021 in the left shoulder for COVID-19 immunisation.  On an unspecified date (as reported), the patient experienced chills, fever, muscle soreness, diarrhea, nausea, I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life, I kept thinking everyday will get better and it's just haven't. Therapeutic measures were taken as a result of diarrhea included antidiarrheal. The outcome of the events was unknown (as reported). The consumer stated, "I had my Pfizer second shot on 26Feb2021 and I had chills and the fever and sore muscles and about four days later I started having Diarrhea, nausea and I had it the entire month and I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life". Anatomical site of administration, the consumer stated, "on my shoulder, left shoulder".  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Thinking abnormal
Clinical narrative: Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life; I kept thinking everyday will get better and it's just haven't; Anatomical site of administration-The consumer stated, "On my shoulder, left shoulder."; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left shoulder on 26Feb2021 (Lot Number: EL3247) as single dose (at 63 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]), colecalciferol (VITAMIN D 3). Previously the patient received the first dose of BNT162B2 (Lot Number: EM9810) on 05Feb2021 in the left shoulder for COVID-19 immunisation.  On an unspecified date (as reported), the patient experienced chills, fever, muscle soreness, diarrhea, nausea, I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life, I kept thinking everyday will get better and it's just haven't. Therapeutic measures were taken as a result of diarrhea included antidiarrheal. The outcome of the events was unknown (as reported). The consumer stated, "I had my Pfizer second shot on 26Feb2021 and I had chills and the fever and sore muscles and about four days later I started having Diarrhea, nausea and I had it the entire month and I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life". Anatomical site of administration, the consumer stated, "on my shoulder, left shoulder".  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: she had a sore arm; Headache from hell; Neck pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included cervical spinal stenosis. Concomitant medications included: nortriptyline, 50mg daily. On an unspecified date, the patient experienced headache from hell, neck pain after Covid 19 shot (first shot). She said next day her headache was gone and neck pain was completely gone, which she said is unusual because she normally has neck pain every day from her cervical spinal stenosis. She said the day after the shot, she had a sore arm. The outcome of the events headache from hell and neck pain was recovered while for the other event it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Sleep disorder, Urticaria
Clinical narrative: a couple days later started getting a rash pretty much/ have rash pretty much all over my whole body; hives; he was up until 1:30am for 3 hours on hold last night and didn't get through and fell asleep; The is a spontaneous report received from contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0150, NDC number: Unknown, UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration at left arm on 31Mar2021 as a single dose for COVID-19 immunisation (everyone is saying he should take it). There was no patient history. There were no AE prior vaccinations. There were no prior vaccinations within 4 weeks. Concomitant medications included allopurinol, atorvastatin, gemfibrozil (patient states he takes these). The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Patient stated took the Pfizer-COVID-19 Vaccine on 31Mar2021, last Wednesday around noon, a couple days later Saturday morning he was breaking out with hives and rash. Started getting a rash pretty much all over his whole body. As of today, he has a rash, second dose is scheduled for 20Apr2021, Patient asked have other people reported the rash and gotten second dose. Patient states the rash is over his whole body now and he doesn't know if it is clearing up. States he is taking Benadryl, that he called his doctor and was told to take Benadryl and see what happens. Patient states he has some questions, he is wondering if he should take something else and he is scheduled for his 2nd shot and he needs help with what to do. Patient relays that it seems the rash may be drying up a little and is wondering is he should still get the 2nd shot. Patient relays that the rash started about 48 hours later on 02Apr2021 in the evening, Saturday, Sunday and a little worse yesterday and today he doesn't know if it is drying up but he still has it all over his body. States the card says 0.3mg and believes that is the dose. Patient asking if his healthcare provider is going to know any information as it's a brand-new drug, states he has 3 friends that are doctors and they have all said to call Pfizer. Patient was asking if other people have reported this. Patient states he was up until 1:30 am for 3 hours on hold last night and didn't get through and fell asleep. Report was not related to a study or programme. There was no investigation assessment. The outcome of event was unknown.  No Follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a headache since then.; This is a spontaneous report from a contactable consumer. Follow-up (PRD 08Apr2021) received from a contactable consumer was processed together with initial information.   A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6205; Expiration Date: 31Mar2021), via an unspecified route of administration, administered in Right arm on 30Mar2021 09:00 as SINGLE DOSE for covid-19 immunization. Dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 09:30 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included Kidney transplant from 2012 and ongoing, hyperglycaemia on an unspecified date, she started out with hypoglycemia then after her kidney transplant had hyperglycemia so maybe it was before her kidney transplant, ongoing hypertension diagnosed when she was 19 years old, on an unspecified date back pain, back injury, ongoing diabetes mellitus, ongoing high blood pressure. On an unspecified date the patient concomitant medication(s) included loratadine taken for back pain LOT: P121557; EXP: Aug2022; acetylsalicylic acid taken for back injury. The patient previously received bnt162b2, dose 1 for COVID-19 immunization and experienced mild headache on 02Mar2021 with recovering. First shot, she had a mild headache for three or four days, that was the only side effect. second shot, she still has a headache, but more intense and for longer. She takes Aspirin and it doesn't seem to go away. Second Dose: Headache, but more intense and for longer: the intense headache started that evening of her second shot, 30Mar2021. She's been taking Aspirin and taking, she has back injuries, so she has some pain medicine and has been taking that. Caller states it will go away and then the pain medications will wear off and it's back. She has had a kidney transplant. Because of a back injury, she takes pain medicine. She hates taking pain meds but sometimes takes it three times a week due to her back pain. The headache will go away. when she takes the pain medicine, as soon as it wears off, the headaches back again. Its nagging, not intense, she just knows it's there. She can function and everything. The patient experienced had a headache since then (headache) on 30Mar2021. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Feeling of body temperature change, Headache, Influenza like illness
Clinical narrative: slight headache; joints have been really achy; hot and cold; feeling a little foggy; flu- like symptoms; This is a spontaneous report from a contactable consumer (patient himself). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left arm on 06Apr2021 at 08:10 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none.  On 07Apr2021, the patient reported slight headache and stated that his joints have been really achy. The patient also had flu- like symptoms and stated that he was hot and cold, and felt a little foggy. Patient stated that his light Headache started this morning around 9:00 and has eased up a bit. Joint ache started around midnight last night, have eased up a bit and was not as bad as last night. Patient also stated that he got the shot yesterday about 8:00 in the morning and the symptoms have eased up but were not as bad as last night. The patient stated that he was a little foggy this morning and last night he was in bed, so he wasn't sure and feels it more whenever he got up and moves around. Patient stated that when he was lying in bed, he didn't notice it as much. The patient in clarifying flu-like symptoms, stated that achy joints, headache, nothing in the nasal cavity, just all in his body and felt like he's been run over by a truck. The patient stated that he had some extra strength Tylenol, and he didn't know, what he could take for comfort. Caller stated that, he was just wondering if he could take something for the events. The patient queried whether he could use extra strength Tyelnol to treat his side effects or if it would interact with the vaccine. The outcome of the events was resolving for headache, joint pain, feeling hot and cold and not resolved for feeling foggy and unknown for flu like symptoms.  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: Feeling of body temperature change, Glycosylated haemoglobin, Headache, Pain
Clinical narrative: freezing and I am hot at same time; head hurts; ache all over; This is a spontaneous report received from a contactable consumer (patient) from . The 76-years-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955; Expiration date: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The medical history of patient included Diabetes, blood pressure and had 2 stents on the lower part of heart. The concomitant medications included Metformin 500 mg, twice a day, blood pressure medicines, Carvedilol 25 mg and Nifedipine 25 mg. Historical vaccine included: first dose of BNT162B2 (lot number: EN6204) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient reported that she had vaccine may be 5 hours ago and took temperature and it only has '1' degree (Further clarification was unknown) but she was freezing and hot at same time and her head hurts and ache all over. She took Tylenol. Patient took her second shot. When paraphrased the concern, the patient stated, she had been in bed and took 2 Tylenol and somebody told her to take Benadryl. She was not running a high fever, she just felt bad enough to be in bed. When she went in the garbage to find something, she thought she might fall and so she thought maybe somebody could get something through the drug store and get something to help. On Dec2020, the patient had laboratory tests and procedures included: sugar was 6.3, it was below 7 (rest of her blood tests were normal). Patient stated that she was not sick before she got the vaccination. The patient did not receive any treatment; she just take her morning medicine and eat breakfast and drink a lot of water and rest. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The patient experienced less soreness at the injection site compared to the 1st vaccine shot; This is a spontaneous report from a contactable consumer (parent).   An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration, administered on left arm on 14Mar2021 at 15:00 (at the age of 18-year-old) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported and concomitant medications were not reported. Patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: ER8735) via an unspecified route of administration, administrated on left arm on 05Apr2021 at 16:00 (at the age of 18-year-old) as a single dose for COVID-19 immunization. It was reported that the patient experienced vaccination site bleeding and vaccination site pain after the second dose of vaccine on 05Apr2021. The patient did not have any known allergies. Patient did not had any other vaccine in four weeks before the covid-19 vaccine dose and No other medications in two weeks. On 14Mar2021, the patient soreness at the injection site. It was reported that the, soreness at the injection site was less when compared to the 1st vaccine shot. The patient did not receive any treatment for the events. She was not having COVID prior to the vaccination, neither was tested for Covid-19 post vaccination. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache
Clinical narrative: severe headache; This is a spontaneous report from a contactable consumer (patient). Follow-ups (05Apr2021) were received from same reporter and processed together with initial information.  A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 26Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced severe headaches 2.5 days following 1st Pfizer shot and she took Tylenol and Ibuprofen. Doctor sent her to hospital for CT Scan which was normal (negative for anything). The patient's headaches dissipated right before receiving 2nd Pfizer shot. The outcome of event was recovered on an unspecified date in Mar 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: chills; fever; fatigue; flu like symptoms; This is a spontaneous report from a contactable consumer (the patient) via a company representative. A male patient in his late 30s received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second shot of vaccine and experienced chills, fever, fatigue and flu-like symptoms. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Feeling abnormal, Gait disturbance
Clinical narrative: weakness in arms and legs; shortness of breath; she felt terrible; achiness; energy level is just no energy; chills; could not walk across the room; This is a spontaneous report received from a contactable consumer (patient). An 81-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder upper arm from 13Mar2021 02:00 to 13Mar2021 02:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No family history. No additional vaccines administered on same date. No Prior Vaccinations within 4 weeks. Patient received 1st dose of the Pfizer COVID vaccine on 13Mar2021 and experienced side effects on 31Mar2021. She mentioned that she could not walk across the room (2021) due to shortness of breath that began 31Mar2021 and was ongoing and about the same, her temperature was not high, down by 1 which would then be the onset of her chills (2021) which would come and go, just like a roller coaster, she felt terrible, had achiness, could not decide what to eat, and would feel better for 2-3 hours but felt bad right away. She mentioned that she felt just terrible and that all she wanted to do was die. Patient had whole body aching that was off and on since 31Mar2021 and not it finally diminished starting yesterday; she had weakness in her arms and legs that began not right away but on 04Apr2021 and was better; her energy level was just no energy and it started on 31Mar2021 and ran through 05Apr2021 and thank goodness the energy finally came back and she is finished now with that and feeling better since yesterday; she felt better but that only lasts 2-3 hours and she felt bad again and the chills start in again. She mentioned that she took acetaminophen and ibuprofen for the achiness, whenever needed. Patient stated she had no treatment, no visit to the HCP or emergency room and just took acetaminophen and ibuprofen and did not know when the took them but it was just in that timeframe. This morning, she had Gatorade to regain electrolytes and felt energized. As of calling, she was finally been feeling better and ally symptoms have decreased. AEs did not require a visit to ER or MD office. Outcome of shortness of breath was not recovered, outcome of achiness and weakness in arms and legs was recovering; outcome of other events was unknown. No investigation assessment.  No follow-up attempts are needed. No further information expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: weakness in arms and legs; shortness of breath; she felt terrible; achiness; energy level is just no energy; chills; could not walk across the room; This is a spontaneous report received from a contactable consumer (patient). An 81-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder upper arm from 13Mar2021 02:00 to 13Mar2021 02:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No family history. No additional vaccines administered on same date. No Prior Vaccinations within 4 weeks. Patient received 1st dose of the Pfizer COVID vaccine on 13Mar2021 and experienced side effects on 31Mar2021. She mentioned that she could not walk across the room (2021) due to shortness of breath that began 31Mar2021 and was ongoing and about the same, her temperature was not high, down by 1 which would then be the onset of her chills (2021) which would come and go, just like a roller coaster, she felt terrible, had achiness, could not decide what to eat, and would feel better for 2-3 hours but felt bad right away. She mentioned that she felt just terrible and that all she wanted to do was die. Patient had whole body aching that was off and on since 31Mar2021 and not it finally diminished starting yesterday; she had weakness in her arms and legs that began not right away but on 04Apr2021 and was better; her energy level was just no energy and it started on 31Mar2021 and ran through 05Apr2021 and thank goodness the energy finally came back and she is finished now with that and feeling better since yesterday; she felt better but that only lasts 2-3 hours and she felt bad again and the chills start in again. She mentioned that she took acetaminophen and ibuprofen for the achiness, whenever needed. Patient stated she had no treatment, no visit to the HCP or emergency room and just took acetaminophen and ibuprofen and did not know when the took them but it was just in that timeframe. This morning, she had Gatorade to regain electrolytes and felt energized. As of calling, she was finally been feeling better and ally symptoms have decreased. AEs did not require a visit to ER or MD office. Outcome of shortness of breath was not recovered, outcome of achiness and weakness in arms and legs was recovering; outcome of other events was unknown. No investigation assessment.  No follow-up attempts are needed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anhedonia, Feeling abnormal, Headache, Insomnia
Clinical narrative: Head was very cloudy; Stomach had very mild symptoms of being upset; I felt like I wanted to be a couch potato for the day; soreness in left arm where I received the injection; mild headache; Throughout the night sleeping, uncharacteristically woke up numerous times and had a hard time falling back to sleep; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 03Apr2021 10:00 am at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 03Apr2021, the patient experienced soreness in left arm where i received the injection at 18:30, mild headache partially relieved with Advil, throughout the night sleeping, uncharacteristically woke up numerous times and had a hard time falling back to sleep. On 04Apr2021, the patient had head was very cloudy, felt like i wanted to be a couch potato for the day, stomach had very mild symptoms of being upset.  The outcome of the events was recovered on 04Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Head was very cloudy; Stomach had very mild symptoms of being upset; I felt like I wanted to be a couch potato for the day; soreness in left arm where I received the injection; mild headache; Throughout the night sleeping, uncharacteristically woke up numerous times and had a hard time falling back to sleep; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 03Apr2021 10:00 am at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 03Apr2021, the patient experienced soreness in left arm where i received the injection at 18:30, mild headache partially relieved with Advil, throughout the night sleeping, uncharacteristically woke up numerous times and had a hard time falling back to sleep. On 04Apr2021, the patient had head was very cloudy, felt like i wanted to be a couch potato for the day, stomach had very mild symptoms of being upset.  The outcome of the events was recovered on 04Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first vaccine and is scheduled to have second vaccine tomorrow and has sore throat and is taking Robitussin. Wanted to know if they should go and have the vaccine or not. Therapeutic measures were taken as a result of sore throat. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Her fever was 100.4; fatigue; sore throat; stuffy nose; This is a spontaneous report received from a contactable consumer reported for herself. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunisation. No pregnant at the time of vaccination. There was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included high blood pressure, allergy. Concomitant medications included blood pressure and allergy medicine; received within 2 weeks of vaccination. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunisation. The patient experienced fever was 100.4 degrees, fatigue, sore throat, stuffy nose on 08Apr2021; no treatment received for the adverse events. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered. The events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Malaise, Nasal congestion, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Congested/stuffy nose; not feeling well; Pressure in the head; Runny nose; a bit of a head cold; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534; Expiration Date: 31Jul2021, NDC number: Unknown), via an unspecified route of administration, administered in left arm on 19Mar2021 at 13:30 (at the age of 53-year-old) at single dose for Preventive Care. Medical history included anxiety. Concomitant medications included sertraline taken for anxiety from 2021 (reported as started taking about a week and a half ago to two weeks before 09Apr2021) and ongoing, he also took vitamins but didn't think vitamin c and vitamin d were going to make the list. Patient reported that he was due for second dose of Pfizer BioNTech Covid 19 vaccine on 09Apr2021 but last night (08Apr2021) and this morning (09Apr2021) had a bit of a head cold, and pressure in the head. Patient couldn't make his second dose today (09Apr2021) because he was not feeling well. He was experiencing head cold symptoms now. Patient stated that his runny nose started last night (08Apr2021) around 2100 or 2200 and then he woke up today (09Apr2021) with congestion and a stuffy nose. Patient stated he had not taken anything for it. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect additional administered vaccines and no prior vaccinations (within 4 weeks). Events were not required a visit to Emergency Room nor Physician Office. No family medical history relevant to AE. No Investigation Assessment and Relevant Tests. No treatment was received for the events. The outcome of the events congested/stuffy nose and runny nose was not recovered, outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site induration
Clinical narrative: right arm, red to dark brown imprint where injection was done; red to dark brown imprint where injection was done; induration as where the band aide was; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported, NDC number: Unknown), via an unspecified route of administration, administered in Right Arm on 30Mar2021 (at the age of 27-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that on 06Apr2021, dark brown induration as where the band aide was. 3 days before on 06Apr2021 at 9:30, patient noticed a red mark at the injection site of his right arm. The area was now changing to dark brown with an imprint where the band aid was. It was not sticky from the residue, it was an imprint in the shape of the band aid. It was not going away. Patient noticed this marking on 06Apr2021 on his right arm. Patient was concerned, would it go away or be a permanent mark his arm. No history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. Events were not required a visit to Emergency Room nor Physician Office. No prior vaccinations (within 4 weeks). No other products. No Investigation Assessment and Relevant Tests. Therapeutic measures were taken as a result of the events included band aid. The outcome of the events 'red to dark brown imprint where injection was done' was not recovered, outcome of the other event was unknown. Seriousness for events 'right arm, red to dark brown imprint where injection was done' was reported as unspecified by reporter.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: felt "zapping", like an "electric choc throughout the body". She says she "felt like she was being tazzered all over the body", and "brain zaps"; This is a spontaneous report from a contactable physician (sister of the patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 26Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that yesterday (on 08Apr2021), patient felt "zapping", like an "electric choc throughout the body". She said she felt like she was being tazzered all over the body, and "brain zaps". The outcome of the event was unknown. This reporter was reported as non-serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain in extremity
Clinical narrative: stomach pains; diarrhea; Sore Arm; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of the Pfizer Covid Vaccine (BNT162B2) on 16Mar2021 (lot number: EP7534) at 82-years-old for COVID-19 immunization and had sore arm from first vaccine. The patient experienced sore arm from second vaccine on 06Apr2021 and stomach pains and diarrhea on 08Apr2021 at 17:00. The reporter stated she had the second dose of the vaccine on Tuesday (06Apr2021). On Thursday (08Apr2021) she got severe stomach pains and had diarrhea for an hour and half straight.  Later that morning it happened, and at 3:30, 4:30 and between 6:00 and 7:00. It happened 6 times and just poured out of her. She had been ok since that. It was really bad. She asked if this is a side effect of the vaccine. The events didn't require a visit to Emergency Room or Physician Office. The patient called physician this morning. Treatment of the event sore arm included Arm Tylenol. The outcome of the event sore arm was recovered on 08Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: headache; soreness to the arm; Too late to get the second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration on 11Jan2021 (at the age of 68-years old) at a single dose for COVID-19 immunization. Medical history included respiratory disorder from Dec2020 and ongoing. Concomitant medications were not reported. The patient received the first dose and stated that she only had a headache and soreness to the arm on an unspecified date. The patient was at the ENT being checked for a respiratory infection when she was contacted to make her second dose appointment. She had the respiratory problem since December and had made the appointment for the ENT prior to the first dose of the vaccine. She confirmed that she was not diagnosed with a respiratory infection. She was told to reschedule her second dose appointment which was originally scheduled for 01Feb2021, but she asked the pharmacy and was told that it was too late to get the second dose. She wanted to know if she can get the second dose after six weeks. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site rash
Clinical narrative: had a weird reaction on her left arm where she got the injection. She noticed that her arm was red then it developed to a rash on her whole upper left arm; had a weird reaction on her left arm where she got the injection. She noticed that her arm was red then it developed to a rash on her whole upper left arm; She also noticed a rash on her right arm; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. patient mentioned that she received her 1st dose of the Pfizer COVID19 Vaccine last Sunday and had a weird reaction on her left arm where she got the injection. She noticed that her arm was red then it developed to a rash on her whole upper left arm. She also noticed a rash on her right arm. She was going to ask if this would most likely happen with her 2nd dose as well. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: her first dose was invalid because it had not been properly stored; her first dose was invalid because it had not been properly stored; she slept for 12 hours after the vaccine; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a call saying that her first dose was invalid because it had not been properly stored, there was a quality assurance measure that was done and the cold chain temperure had been broken. She believes she got some immunity from the first vaccine though because her arm hurt and she slept for 12 hours after the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: aches in my legs; sick; swelling in the arm; I wasn't feeling good; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took first shot (Pfizer's COVIDA vaccine) on 26Mar2021 and she got sick after that. She was wondering if it was ok to get the second shot on the 16Apr2021. She had swelling in the arm, she wasn't feeling good. It wasn't a fever, it was aches in her legs. She was feeling fine now. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Impaired work ability, Peripheral coldness, Pyrexia
Clinical narrative: 1hour after injection severe headache, took 500mg naproxen headache left, slept, got ready for work arrived work5:15am in 4/29/2021 worked 4 hours let management know couldn?t continue  went home freezing fingers felt like icicle?s took hot shower slept fever started 4/30/2021 low grade 99.1 fever stopped 4/30/2021 late afternoon. Still as of 5/1/2021 weak
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Injection site erythema, Injection site reaction
Clinical narrative: 12 hours after the shot, I had pain in my arm that woke me up,  I was also very tired a few hours after the shot and the next day.  24 hours after the shot I developed a welt about the size a quarter on my arm, at the injection site, it was slightly raised and red.  I was feeling a general malaise, and had a headache for about 2 days and developed a little bit of a cough.  About 3 days after the shot, I developed mini lumps below the skin of my jaw on both sides, near the Parotid area.  They felt itchy but never broke the surface, they seemed to be like a skin boil.  They were about 1/4 inch round balls, and they lasted for several days.  I also had a few other itchy hard spots on each arm and one on my back.  I massaged the ones on my face and they went away in about a week.   On April 27th I woke up with a itchy painful skin blemish on the inside of my right arm(other side of the elbow), that had broke the skin, 4 days later is is still very itchy.  I was quite healthy the entire time of quarantine for the past year, after the getting the shot, I feel less healthy.  I am only reporting this now, because I am scheduled to get my second dose in a few days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Malaise, Pain in extremity, Rash, Rash pruritic
Clinical narrative: 12 hours after the shot, I had pain in my arm that woke me up,  I was also very tired a few hours after the shot and the next day.  24 hours after the shot I developed a welt about the size a quarter on my arm, at the injection site, it was slightly raised and red.  I was feeling a general malaise, and had a headache for about 2 days and developed a little bit of a cough.  About 3 days after the shot, I developed mini lumps below the skin of my jaw on both sides, near the Parotid area.  They felt itchy but never broke the surface, they seemed to be like a skin boil.  They were about 1/4 inch round balls, and they lasted for several days.  I also had a few other itchy hard spots on each arm and one on my back.  I massaged the ones on my face and they went away in about a week.   On April 27th I woke up with a itchy painful skin blemish on the inside of my right arm(other side of the elbow), that had broke the skin, 4 days later is is still very itchy.  I was quite healthy the entire time of quarantine for the past year, after the getting the shot, I feel less healthy.  I am only reporting this now, because I am scheduled to get my second dose in a few days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Urticaria
Clinical narrative: 12 hours after the shot, I had pain in my arm that woke me up,  I was also very tired a few hours after the shot and the next day.  24 hours after the shot I developed a welt about the size a quarter on my arm, at the injection site, it was slightly raised and red.  I was feeling a general malaise, and had a headache for about 2 days and developed a little bit of a cough.  About 3 days after the shot, I developed mini lumps below the skin of my jaw on both sides, near the Parotid area.  They felt itchy but never broke the surface, they seemed to be like a skin boil.  They were about 1/4 inch round balls, and they lasted for several days.  I also had a few other itchy hard spots on each arm and one on my back.  I massaged the ones on my face and they went away in about a week.   On April 27th I woke up with a itchy painful skin blemish on the inside of my right arm(other side of the elbow), that had broke the skin, 4 days later is is still very itchy.  I was quite healthy the entire time of quarantine for the past year, after the getting the shot, I feel less healthy.  I am only reporting this now, because I am scheduled to get my second dose in a few days.