chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Disease recurrence, Emotional disorder, Panic reaction
Clinical narrative: Anxiety; Panicked Feeling; Panicked Feeling; upset/mad; Chills; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history included panicked feeling and stopped on unknown date. Concomitant medications were not reported. The patient previously received the first dose of  BNT162B2 for COVID-19 Immunization and experienced Sore Arm. The patient stated she seemed alright on 20Apr2021. She had chills in the evening 20Apr2021 and took Tylenol and drank water like she was told. this morning on 21Apr2021 she had anxiety. A panicked feeling. She hasn't felt that way in years and felt that how she was feeling now was most likely due to the vaccine. She became upset she even got the vaccine and stated she was mad. The events outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: patient had 103 degree fever; was 'sick for a week; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender 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: patient had covid-19 approximately 1 month prior to shot. The patient concomitant medications were not reported.  On an unspecified date, after the first dose, patient had 103-degree fever and was sick for a week. He had COVID approximately 1 month prior to shot and was unaware of any recommendations to wait a period of time before vaccination. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm after first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration in 2021 (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 experienced sore arm after first dose of the vaccine in 2021. With the first one she had a sore arm, but was otherwise fine. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing and buzzing in her ear nonstop; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm (upper arm, unknown which arm) on 23Feb2021 around 11: 00 AM (Batch/Lot Number: EN6202) as single dose for COVID-19 immunization. The patient previously received first dose bnt162b2 (BNT162B2) via an unspecified route of administration, administered in Arm (upper arm, unknown which arm) on 02Feb2021 (Batch/Lot Number: EM9810) as single dose for COVID-19 immunization.  The patient medical history and patient's concomitant medications were none. Family Medical History Relevant to AEs was none.  The patient had her second shot already on 23Feb2021. She was not really good if something was bothering her to know if it was really bothering her. She had had this ringing and buzzing in her ear nonstop. She was sure that it has been going on for at least a week. She had also gone to the dentist. She clarified that she went to the dentist for just a routine cleaning.  She was not sure if it could have been going on longer. She asked if that was a side effect. It was kind of just a nuisance. It was kind of like when you hit your ear and it pops and then you get a buzzing. It was annoying. When she was listening to TV, she didn't notice it, but she definitely noticed it when in the bed and when it was quiet. Vaccination Facility Type was Pharmacy Department. Vaccine was not Administered at Military Facility. No AE required a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was none. Relevant Tests was None. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable consumer (patient's mother).   A 17-year-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization.  Medical history included coeliac disease from 2014 to an unknown date.     The patient's concomitant medications were none.  The patient previously received first dose bnt162b2 (BNT162B2), via an unspecified route of administration in left arm on 23Mar2021 (Batch/Lot Number: EL9263) as single dose for COVID-19 immunization. The reporter was reporting on behalf of her daughter. When the patient got her second vaccine she started having an allergic reaction. The patient was given BENADRYL and was fine and was told not to get it again or anything else with the same ingredients. This event happened after the patient's second dose. The outcome of the event was recovered on 13Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe stomach pain; Nausea; Vomited, multiple times; Unable to sleep, uncomfortable; Unable to sleep, uncomfortable; Weak; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:30 (Batch/Lot Number: EW0158; Expiration Date: Jul2021, NDC number: 59267-1000-02) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none.  Patient stated she had severe symptoms and side effects and she did not know what to do. Patient stated she had her first shot yesterday at 2:30 in the afternoon. Patient stated she went home and then went to bed at midnight. Patient stated she had severe stomach pain, throughout her stomach, and by 21Apr2021 1 am, she had nausea, and vomited multiple times. Patient stated she had the stomach pain, nausea and vomiting throughout the night. Patient stated, she tried calling Pfizer last night but it was closed. Patient stated she got the number from the vaccine paper, and it also had information about the V-Safe health checker, but it did not give the time that Pfizer was open. Patient stated, she didn't know who to call or what to do. Patient stated she was still in pain and she was not sure if she needs to go to the emergency room. Patient stated she tried to call an emergency room near her house, and they could not evaluate her over the phone, and told her to come to the hospital. Patient stated she did not have health insurance right now.   Reclarified, she didn't go to the emergency room because she was afraid of the hospital bill, as she didn't have health insurance right now. Reclarified, Patient asks for recommendations as to what she should do about the stomach pain. Patient agrees to continue with a safety report.  Patient stated she did not have a healthcare provider. As for Stomach pain, onset time was midnight or 1 am, outcome was it was improved, it calmed down than, from when it started, but she still feels it in her entire stomach. As for Nausea, onset time was 1 am. As for Vomited, onset time was 1 am. Patient reported that she also was unable to sleep, as she was uncomfortable, and she was weak. As for Unable to sleep, uncomfortable, onset time was 1 am, outcome was patient answers as she hasn't been able to sleep, it has remained the same. As for Weak, onset time was 1 am, outcome was patient answers as it has remained the same. As for facility patient stated a vaccination site was created at the. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No AE required a visit to emergency Room and Physician Office. No Prior Vaccinations (within 4 weeks) and no AE following prior vaccinations. No family Medical History Relevant to AEs. No Relevant Tests. The outcome of the event Severe stomach pain was recovering, of event Vomited, multiple times and Nausea was recovered on 21Apr2021, of other events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Had a sore arm in the area of injection; Fatigue; This is a spontaneous report from a contactable consumer (patient's daughter). A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient in Canada only got the 1st dose of the Pfizer vaccine and had a sore arm in the area of injection. The patient had soreness at the injection site and fatigue. The outcome of the events was unknown. . No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache, Malaise, Nausea
Clinical narrative: Medical history included Mitral valve prolapse, Hypothyroidism and white blood cell count never came back to normal after cancer treatment. Concomitant medication included levothyroxine. The patient previously received first dose of BNT162B2, Lot number EP7534, expiration date 31Jul2021, on 27Mar2021 in left arm and experienced sore after the first dose. The patient received her second Pfizer covid 19 shot on Saturday 17Apr2021. After the second dose of the vaccine, the patient woke up in the middle of the night at 3:00am on Sunday 18Apr2021 and she had a sore arm from the shot and the next day it was in and out. Yesterday, 20Apr2021 the patient started getting dizzy, having nausea, vomiting, no fever, the patient threw up 4 times that day. Today she felt like throwing up but was eating things that were safe. She still had this queasy tummy and a headache on 21Apr2021. Her stomach was still like an ocean and she still isn't feeling well. She slept like 12 hours on Sunday. Her arm burned as soon as the pharmacist put the vaccine in, it was sore just at the site. The outcome of Nausea, Vomiting/ threw up 4 times, Dizzy, Headache, still isn't feeling well was not resolved. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vomiting
Clinical narrative: Medical history included Mitral valve prolapse, Hypothyroidism and white blood cell count never came back to normal after cancer treatment. Concomitant medication included levothyroxine. The patient previously received first dose of BNT162B2, Lot number EP7534, expiration date 31Jul2021, on 27Mar2021 in left arm and experienced sore after the first dose. The patient received her second Pfizer covid 19 shot on Saturday 17Apr2021. After the second dose of the vaccine, the patient woke up in the middle of the night at 3:00am on Sunday 18Apr2021 and she had a sore arm from the shot and the next day it was in and out. Yesterday, 20Apr2021 the patient started getting dizzy, having nausea, vomiting, no fever, the patient threw up 4 times that day. Today she felt like throwing up but was eating things that were safe. She still had this queasy tummy and a headache on 21Apr2021. Her stomach was still like an ocean and she still isn't feeling well. She slept like 12 hours on Sunday. Her arm burned as soon as the pharmacist put the vaccine in, it was sore just at the site. The outcome of Nausea, Vomiting/ threw up 4 times, Dizzy, Headache, still isn't feeling well was not resolved. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Lethargy, Pain, Pyrexia
Clinical narrative: Chills; Body ache; Extreme Lethargy; I am running fever; have been very congested sometimes I started coughing a lot; This is a spontaneous report from a contactable consumer reported for herself.   A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),( Confirmed as Pfizer Covid vaccine) via an unspecified route of administration, administered in arm left on 19Apr2021 at the age of 41-years-old (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation.  There were no medical history and concomitant medications. The patient stated she had the Covid vaccine on Monday on 19Apr2021 and she have been very congested sometimes. Today, she started coughing a lot. She had also sometimes had other side effects like chills, body ache, and extreme lethargy and today she was running fever. The patient asked if she should go to the doctor and if this was a normal side effect. When probed for treatment, patient stated she took some Tylenol. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: sinus congestion; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history included blocked ear.     The patient's concomitant medications were not reported.  The patient experienced sinus congestion on an unspecified date with outcome of unknown. Caller, (Patient name), called to say first time caller consumer had first vaccine on 02Apr2021 and is scheduled for the second 22Apr2021. She is prescribed steroids for blocked ear, she states had before the vaccine. She also had sinus congestion and was started on antibiotics after first dose, which she just finished taking. She has not started on the steroids she is asking will this interfere with her second vaccine.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold
Clinical narrative: Chills; I get really bad for hours during the day and during the night.; Cannot get out of the bed. I am so cold; This is a spontaneous report from a contactable consumer (patient).  A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EN6204), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: EP6955) at the age of 63-years-old as single dose for covid-19 immunisation.  Medical history included diabetes, hypertension and chronic obstructive pulmonary disease (COPD) from an unknown date. The patient's concomitant medications were not reported.  The patient stated she had the Pfizer vaccine on 05Mar2021 and 25Mar2021 and she did not have any soreness or any kind of reaction. But since during the last 2 weeks in Apr2021 it started where she had chills, really bad chills, she was not running fever. But she got really bad for hours during the day and during the night. She cannot get out of the bed. she was so cold. She asked if that could be from the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Pyrexia
Clinical narrative: high fever 102 degress; lite headed; chills; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number/expiration date not reported) as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received the first dose on an unspecified date for Covid-19 Immunization. On an unknown date, the patient experienced High fever 102 degrees, lite headed and chills. The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer reported for herself. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 08:45 (Batch/Lot Number: EW0161) at the age of 62-years-old as single dose for covid-19 immunisation.  Medical history and concomitant medications were None.  The patient previously received first dose BNT162B2 administered in arm left on 28Mar2021 (Lot number: ER8733) for covid-19 immunisation. Prior Vaccinations within 4 weeks was None. Family medical history relevant to adverse event was None. The patient stated she took the second dose on Sunday on 18Apr2021 and did not really start to feel tiredness until last night and today from 20Apr2021. The event did not require a visit to emergency room or physician office. Therapeutic measures were taken as a result of tiredness included she took a Tylenol last night one 500mg. The outcome of the event was not resolved.  No Follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: has a lot of muscle and joint pain; has a lot of muscle and joint pain; This is a spontaneous report from a contactable consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8732) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient was calling about the Pfizer Vaccine that she recently had 3 weeks ago yesterday; she stated she had the second dose scheduled for tomorrow. She had a lot of muscle and joint pain after the first dose of the Pfizer Vaccine and just was wondering how long did the pain last and she was very reluctant to go get the second dose. She was hesitant to go get the second shot due tomorrow and it was more than three weeks from the first dose.  The outcome of the events was unknown.  No Follow-up attempts are needed. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue
Clinical narrative: Tiredness; left ear ache; This is a spontaneous report from a contactable consumer (patient's daughter).   An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 20Apr2021 14:00 at the age of 84-years-old (Batch/Lot Number: Not Provided) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient had the vaccine yesterday on 20Apr2021 and was having side effects. She wanted to go over the side effects and what to do. It was for the Pfizer Coronavirus vaccine. Stated that this was her first dose. Stated that she was sleeping, having tiredness and ear ache in Apr2021. Stated that she got the vaccine at 2pm. Stated that she looked at list of symptoms and has never had ear aches. Wanted to know if ear aches was part of it and what to do about it. Stated that the ear ache was for her left ear. Stated that she received the vaccine on the right. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nasopharyngitis, Nausea, Oropharyngeal pain, Pain
Clinical narrative: A male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Apr2021 13:50 (Lot Number: EW0169; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation.  There was no relevant medical history and concomitant medications. There was no Additional Vaccines Administered on Same Date of bnt162b2. The patient previously received the first dose of bnt162b2 on 29Mar2021 (Lot Number: EP6955; Expiration Date: 30Jun2021) for covid-19 immunisation. The reporter stated he thought he was having side effects. He thought he had a cold, sore throat so he took Nyquil and Tylenol PM. His side effects were nausea and threw up. his whole body was sore from arm to back. Time of Onset was Morning 05:45 on 20Apr2021. The patient also experienced up all night on 19Apr2021. The outcome of Nausea and Threw Up was resolved on 20Apr2021. The events did not require a visit to emergency room or physician office. The outcome of Whole Body is Sore from Arm to Back was not resolved. The outcome of Feels like he has a cold; Sore Throat was resolving. The outcome of up all night and Nausea and Threw Up was resolved on 20Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: A male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Apr2021 13:50 (Lot Number: EW0169; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation.  There was no relevant medical history and concomitant medications. There was no Additional Vaccines Administered on Same Date of bnt162b2. The patient previously received the first dose of bnt162b2 on 29Mar2021 (Lot Number: EP6955; Expiration Date: 30Jun2021) for covid-19 immunisation. The reporter stated he thought he was having side effects. He thought he had a cold, sore throat so he took Nyquil and Tylenol PM. His side effects were nausea and threw up. his whole body was sore from arm to back. Time of Onset was Morning 05:45 on 20Apr2021. The patient also experienced up all night on 19Apr2021. The outcome of Nausea and Threw Up was resolved on 20Apr2021. The events did not require a visit to emergency room or physician office. The outcome of Whole Body is Sore from Arm to Back was not resolved. The outcome of Feels like he has a cold; Sore Throat was resolving. The outcome of up all night and Nausea and Threw Up was resolved on 20Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Oral herpes
Clinical narrative: it was tricking his immune system; had herpes pop out on his lip; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 15:00 as single dose for covid-19 immunisation.  Medical history included herpes. Stated he had a situation in his world where he got herpes if he was in the sun or if he caught a cold and the herpes popped out on his lip. The herpes normally pops out and the Valtrex eliminated the pain because when the herpes pops out and it puts pressure on the lip it hurt a little bit and he has taken the Valtrex over the last year or so and when he has the herpes it happens a couple of times per year. There were no concomitant medications. There was no additional vaccines administered on same date. The patient received the 1st dose on 17Mar2021 10:00am and the 2nd dose was supposed to be administered on 06Apr2021 which was 21 days after the 1st dose, but the 2nd dose was administered on 14Apr2021. Both doses administered in left arm. He stated he was not out in the sun and he had the Pfizer COVID Vaccine 2nd dose and had herpes pop out on his lip and it began he thought on Saturday 17Apr2021 or 2-3 days after the 2nd dose of the shot and the herpes was ongoing and was getting better because he took generic of Valtrex. He took 1 pill per day of the generic Valtrex and it worked.  He had no further treatment for the reported event and stated it took time to heal and it pops out then goes away and he was not sick the next day after the Pfizer COVID Vaccine and did not feel anything in terms of sickness and then after the 2nd dose of the vaccine, the herpes popped up a couple of days later maybe it was his body feeling the illness and it was tricking his immune system. The event did not require a visit to ER or MD office.The outcome of had herpes pop out on his lip was resolving and for the event it was tricking his immune system was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Redness rash; Itching; hives/welt; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (reported as left shoulder) on 12Apr2021 12:15 (Lot Number: EW0153) as single dose for covid-19 immunisation.  There was no relevant medical history or concomitant medications. There were no additional vaccines administered on same date. There were no prior vaccinations within 4 weeks. The patient experienced redness rash and hives on 13Apr2021. Rash and hives started the day following the vaccine and was continuing. It was generally everywhere. If the knee itched and was scratched immediately, it welts up and creates redness and rash all over. Is on her back, neck, arms, feet and torso. If she scratches anywhere on her body it welts up. She clarified, it all started at the same time, the redness the rash and the itching. When asked if experience was improved persisted or worsened, she says it was worse than it was the first day. For the last 4 or 5 days it has stayed the same. She was receiving Benadryl as treatment and it seems to be calming it down a bit. She was also taking an herbal supplement from an acupuncturist. It was a mixture but she only knew the ame of one ingredient which is Huanglian. There was other stuff in the formulation too. The event did not require emergency room or physician office visit. The outcome of all the events was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: A  male patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161 and expiration date was not reported) via an unspecified route of administration, administered in Arm Left (Left Shoulder Side of the Arm s single dose for covid-19 immunisation. Vaccination facility type was other. Reportedly, patient had no history, no other products and no investigational assessment. Patient did not have any family medical relevant history. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 evening the patient experienced left arm sore, on 17Apr2021 patient experienced fever, head pounding, Lower Half of Body was Very Sore; Muscle Aches (muscle pain). The patient states he was calling about his first dose, he got the first dose on this past Friday, 16Apr2021 and he was fine that day and then the following day, Saturday night, he had a fever and he still has a fever 4 days later. Is it normal to have a fever after 5 days. The report was not related to a study or a program. Patient took treatment Montrin. Patient did not went to emergency room or physician office, he went to urgent care. The outcome of the event pyrexia is not recovered, left arm pain recovered on 18Apr2021, muscle pain (Lower Half of Body was Very Sore; Muscle Aches) recovered on 17Apr2021 and head pounding recovered on 18Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: was sick and stayed in bed; This is a spontaneous report from a contactable consumer reporting for a female patient (sister).  A female 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: Not Provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer's sister (patient) took the shot and was sick and stayed in bed on an unspecified date. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea
Clinical narrative: A  male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:30 or 12:35  (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation. Medical history included migraine from 2000 to an unknown date, ongoing hepatitis c. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) taken for migraine. The patient previously took atropine and experienced hypersensitivity. Caller states that he got the vaccine at 12:30 in the morning and he got a headache at 5 or 6 o'clock in the evening. He read also, in his country, that with other vaccines, not Pfizer, that after each shot they had a mild headache.  He states that he read on line that it is normal to get a headache after getting the vaccine and that it can last up to three days. He states that the headache can come on again and off again. He states that once you get a migraine it doesn't go away until you take medication. He states that he has been taking medication for years so he knows that this is a migraine headache and not related to the vaccine. He states the next day after getting the vaccine the headache was gone. From Friday until Sunday he was fine, for 3 days he had nothing. Now he states its a migraine. He woke up and felt like he has motion and wants throw up. He states that if you are hungry and you go to sleep and then you wake up that feeling will come back after sleep. So when he goes to sleep, and wakes up with a migraine, he takes medication and it goes away.  He states that he read online that within 24 hours don't take any medication because it can lessen the effect the vaccine. He states he knew that getting a headache was normal, now he know it is not Pfizer's vaccine effect, he knows it's a migraine. He was just wondering if he can take his medication. He states that he read that you can have a headache for two or three days after the vaccine. He is calling because has been sick with a migraine for a long time. He has been taking Excedrin migraine medication for migraines because it saves him all the time. He wants to know if he can take medication now or should he avoid it. He states that he read somewhere that it is normal to have a headache for up to three days after getting the vaccine so he was ready for it. He also read some where that he should not to take and medication with in 24 hours of getting the vaccine and he wants to know if he can take the medication now. The outcome of the event headache was recovered The outcome for the events migraine and he has a motion and wants to throw up was unknown. No follow-up attempts are needed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; right arm that she received a vaccine in is hurting like hell; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 20Apr2021 (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 previously administered First dose of bnt162b2 on 30Mar2021 in arm right for COVID-19 immunization at the age of 89-year-old and experienced arm pain in her left were from her shoulder down to her wrist on 18Apr2021. The patient stated she received the vaccine in her right arm but her left arm was hurting. She did not get any sleep last night (20Apr2021) because of this pain. The patient stated she has been in pain for 2 to 3 days and she thought it would go away but it is getting worse. The patient stated the second dose of the vaccine was received on 20Apr2021 in her right arm as an injection. The patient experienced right arm that she received a vaccine in was hurting like hell. It didn't hurt when she got it but started last night (on 20Apr2021). The patient experienced Headache which started at 7pm on 20Apr2021. The patient received an ice pack as treatment, and she took a TYLENOL at 1am on 20Apr2021 for her headache. The outcome of event right arm that she received a vaccine in is hurting like hell was unknown, of the event headache was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: had just a sore after the first dose; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included Prolapsed mitral valve and hypothyroidism, both from an unknown date, ongoing white blood cell count never came back to normal after cancer treatment. Concomitant medication included levothyroxine sodium taken for an unspecified indication, start and stop date were not reported. The patient had just a sore after the first dose of the vaccine, it was in and out for a day. The outcome of event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer.  A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 08Apr2021 (Lot Number: EN6207) (at age of 51-year-old) as single dose for covid-19 immunisation.  The patient medical history included blood in his stool. Concomitant medications included mesalazine and tamsulosin, both taken for blood in stool. There was no additional vaccines administered on same date of the Pfizer Suspect. There was no other vaccine in four weeks.The patient was scheduled to get the second dose of the Pfizer Covid Vaccine on 29Apr2021. The patient want to reschedule because he took a Covid test and it came out positive. Event details: Last week ( also reported on 20Apr2021) he had a cold. His primary care doctor prescribed him medicine to take. He was still having headaches and coughing. He did not have a sore throat anymore.  He had a headache Tuesday (20Apr2021) and felt under the weather. He started to cough and had shivers. On Thursday (22Apr2021) he did a telephone meeting with his doctor and she prescribed him medication. He took it and he started to feel better. He still has headaches and coughing. After he took the medicine he started to feel better, and his symptoms weren't surfacing again. He still has some coughing, but he took Tylenol and felt okay. His cough wasn't too aggressive, it was just like a cold type of cough. It was not so severe. Last week (also reported on 20Apr2021) he came home having shivers and a fever. Now he didn't have a fever or shivers. He just has a headache and coughing, and it's not as severe. When she came home her mom said he had started to shiver. On Wednesday (21Apr2021)he started to take Coricidin cold and flu. He started taking those and started to feel a bit better. It reduced the fever and sore throat. They were symptoms of a cold. He took that as well as what the doctor prescribed, Azithromycin. The shivers went away with the cold and flu medicine and what the doctor prescribed. Most of his symptoms went away she believes Thursday or Friday (Apr2021). His fever went away on Wednesday (21Apr2021) when he took the cold and flu medicine and it reduced it. He didn't have a fever anymore. His temperature is always 97 or 98 when they take it. His sore throat started the same time as the fever on Tuesday (20Apr2021) to like Wednesday (21Apr2021). He started to gargle salt water and it went away. On Wednesday(21Apr2021) he took the cold and flu medicine and it helped make it go away. His symptoms started last Tuesday (20Apr2021) in the afternoon when he came home. The events did not result in emergency room visit. He had a new meeting with his primary doctor and told her how he was feeling. The outcome of events headache, cough was recovering, of shivers was resolved in Apr2021, of fever and Sore throat  was resolved on 21Apr2021, of the rest of events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Medical history included ongoing asthma, ongoing hypertension, ongoing mitral valve prolapse, ongoing Tarlov cysts. The concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) for Pain.  The first vaccine she had no problems and just soreness in her arm on an unspecified date. The event outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain
Clinical narrative: her whole body started hurting and she has all of the symptoms that are listed on the paper; chills, muscle pains and it has been going on for the last 2 days; chills, muscle pains and it has been going on for the last 2 days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Patient said that she was calling because she received the first dosage of the COVID vaccine on Saturday and she didn't have anything going on for 2 days and then it was like the third day her whole body started hurting and she had all of the symptoms that are listed on the paper but her question was if there was a chance, like should she get tested for COVID. She had never had it before but she had the vaccine and that was Saturday and today was Wednesday so she was wondering if these symptoms or side effects should keep going on like this. She didn't have anything the first two days but now as she was reading over the paper she sees that she had all of the side effects. She was wondering should she get tested for COVID. She had body pain, chills, muscle pains and it had been going on for the last 2 days and she wanted to know if this was part of it. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's spouse). A 50-year-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:45 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No Prior Vaccinations (within 4 weeks). No AE following prior vaccinations
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Felt a little tired; Sore arm; This is a spontaneous report from a contactable consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient reported that she felt a little tired on 18Apr2021 after receiving the second dose of the Covid-19 vaccine on 17Apr2021. She reported that she experienced less than 24 hours of arm soreness and feeling tired.  She reported that she didn't experience anything severe or unexpected following the Covid-19 vaccine.  She reported that she did not experience anything more than the side effects that were listed as expected. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness
Clinical narrative: my Mom and I have been light headed and had some  diarrhea; my Mom and I have been light headed and had some  diarrhea; This is a spontaneous report from a non-contactable consumer (patient's son).   A female patient of an unspecified age received second dose of (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller stated that his mom (the patient) and he have been light headed and had some diarrhea. She had her 2nd Pfizer vaccine dose 4 weeks ago and he had 2nd dose 2 weeks ago, the caller asked that if the side effects from the Pfizer vaccine can still be present after 2-4 weeks after the 2nd dose. The outcome of events was unknown.  No follow-up attempts are Needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) :different patient, same reporter, drug, event
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling abnormal, Headache, Oropharyngeal pain
Clinical narrative: fever/was 102 and it got down to 100.  It is now 99.9-100; nose will not stop running; thought throat was swollen; throat is scratchy and sore; throat is scratchy and sore; severe headche; vomiting; diarrhea; feels like crap; This is a spontaneous report from a contactable consumer (patient).  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. Medical history included allergic to bees from an unknown date. The patient's concomitant medications were not reported. Last night (on 20Apr2021), he started having severe headache, vomiting, and he had diarrhea and just felt like crap. The patient's fever was 102 and it got down to 100.  It was now 99.9-100. The patient clarified that last night (on 20Apr2021) he thought his throat was swollen like when he got stung by a bee.  He was allergic to bees and that was how his throat felt, but it did not constrict all the way. It was scratchy and sore now.  The patient added that his finger tips feels, and then pauses sentence and stated he did not know and that his nose would not stop running. The patient confirmed that he was calling about the Pfizer Covid19 vaccine and he just wanted to make sure that Pfizer knows this, and that he was assuming he was going to be okay and this was going to pass by. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia, Rhinorrhoea, Throat irritation, Vomiting
Clinical narrative: fever/was 102 and it got down to 100.  It is now 99.9-100; nose will not stop running; thought throat was swollen; throat is scratchy and sore; throat is scratchy and sore; severe headche; vomiting; diarrhea; feels like crap; This is a spontaneous report from a contactable consumer (patient).  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. Medical history included allergic to bees from an unknown date. The patient's concomitant medications were not reported. Last night (on 20Apr2021), he started having severe headache, vomiting, and he had diarrhea and just felt like crap. The patient's fever was 102 and it got down to 100.  It was now 99.9-100. The patient clarified that last night (on 20Apr2021) he thought his throat was swollen like when he got stung by a bee.  He was allergic to bees and that was how his throat felt, but it did not constrict all the way. It was scratchy and sore now.  The patient added that his finger tips feels, and then pauses sentence and stated he did not know and that his nose would not stop running. The patient confirmed that he was calling about the Pfizer Covid19 vaccine and he just wanted to make sure that Pfizer knows this, and that he was assuming he was going to be okay and this was going to pass by. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp received via Pfizer sponsored program COVAX Support. This case is for Female patient (wife). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunization. Reporter stated that she and her husband had their 1st dose of the Pfizer Covid-19 vaccine on 06Apr2021 and are scheduled to return tomorrow on 27Apr2021. Patient stated that however, they experienced mild flu-like symptoms, so she wants to know if it is okay for them to take the 2nd dose tomorrow. The outcome of the event flu-like symptoms was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This is a spontaneous report from a Pfizer sponsored program. This is one of the 2 reports from same reporter. A contactable female consumer reported for her husband (patient) that: a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unknown date in Apr2021, the patient experienced mild flu-like symptoms. They scheduled to return tomorrow, 27Apr2021 for second dose.The reporter wants to know if it is okay for them to take the 2nd dose tomorrow. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.