chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection
Clinical narrative: bacterial infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: BACTERIAL INFECTION (non-serious), outcome "unknown", described as "bacterial infection". Therapeutic measures were taken as a result of bacterial infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergic sinusitis
Clinical narrative: she got a sinus allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGIC SINUSITIS (non-serious), outcome "unknown", described as "she got a sinus allergy".  Additional information: Caller and Wife have a 2nd dose schedule for tomorrow (10Apr2021) but his wife is not able to get the vaccine because she got a sinus allergy. The caller would like to reschedule their appointment and they want to get the 2nd dose at the same time.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Got redness on the injection site and extended around the whole forearm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 09Apr2021, outcome "unknown", described as "Got redness on the injection site and extended around the whole forearm".  Additional Information: The patient wanted to know if it was okay to take the second dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Left side, jaw is sore. Pretty steady. Also wife has same feeling. She got her shot right after me.Day 3. Jaw still sore. Staring ibuprofen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN JAW (non-serious), outcome "unknown", described as "Left side, jaw is sore. Pretty steady. Also wife has same feeling. She got her shot right after me.Day 3. Jaw still sore. Staring ibuprofen.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402449 Same reporter/drug/event, diff pt
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Toothache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "Toothache".  Additional information: Patient was calling about the Pfizer Covid Vaccine. She woke up and it feels like she was getting a tooth ache, she was going to get her second vaccine today in 2 hours and wants to know if that is okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: I didn't do too well either; I got the side effects like I had the shavers and all that kind of bunch stuff but then by Sunday night I was okay; I didn't do too well either; I got the side effects like I had the shavers and all that kind of bunch stuff but then by Sunday night I was okay; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), MALAISE (non-serious), outcome "recovered" (2021) and all described as "I didn't do too well either; I got the side effects like I had the shavers and all that kind of bunch stuff but then by Sunday night I was okay".  Additional information: Reporter had the Pfizer Covid vaccine and I just have I feel very important question to ask whether it can if you have high blood pressure if it can cause your high blood pressure to go havoc. It is really important because I have a 94 years old mother and it was happened to her when she had the shot. We both had the vaccine on Saturday. I didn't do too well either but I had it you know what I am saying I got the side effects like I had the shavers and all that kind of bunch stuff but then by Sunday night I was okay but she actually for her blood pressure drops drastically by Sunday morning we called the doctor please understand we were she is under in doctor's hand I just want it to hear for she called the doctor again today so there because I am not you know I know the best thing you to supposed to do but all that I am questioning is she also fainted so all that I am questioning is can it in very extreme cases can it cause the blood pressure to go havoc."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: a little sore arm; Felt tired; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "a little sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Felt tired". Additional information: Patient will have her 2nd dose on 28Apr2021. She asked if there's any difference having 28 days intervals from her 1st dose with 21 days intervals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: brain fog; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jan2021 16:00 (Lot number: EN5318) at the age of 68 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (ongoing), notes: Got Pneumonia back in the 1980s, around 1983; and after that he had asthma. asthma is mild; "Pneumonia", start date: 1983 (unspecified if ongoing), notes: Got Pneumonia back in the 1980s, around 1983; and after that he had asthma.; "Concussions" (unspecified if ongoing), notes: States he has had three. The most severe was three years ago. States he was knocked completely unconscious and was unconscious for a while. The patient took concomitant medications.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovering", described as "brain fog"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "tired".  Additional Information: States he has had three. The most severe was three years ago. States he was knocked completely unconscious and was unconscious for a while. Caller states that he got his second dose of the vaccine at the end of February. Says after his first dose he had brain fog and other symptoms that dissipated rapidly. States his brain fog is persisting; it is better, but still there. He wanted to call because he has had three concussions in his life. The last one was three years ago and it was the most severe as he was knocked unconscious. States he was unconscious for a while. He states he is wondering whether Pfizer has any data or information regarding how the vaccine is tolerated in people with similar types of brain injuries. States with the millions of people getting the vaccine he thinks his question may be like looking for a needle in a haystack. Asks how long he will be on hold as he has already been on the phone for a while.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Soreness at injection site and general fatigue.; Soreness at injection site and general fatigue.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Soreness at injection site and general fatigue.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "migraine". Therapeutic measures were taken as a result of migraine.  Additional information included: It was on and-off for 3 weeks and only subsided completely with a Medrol dose pack prescribed by her neurologist.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Body temperature decreased, Neutrophil count
Clinical narrative: increased sleepiness; low grade temp; sore arm; blood pressure slightly elevated; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE taken for breast cancer female, start date: 19Mar2021 (ongoing). Vaccination history included: Covid-19 vaccine (Dose 1 (Manufacturer unknown)), for COVID-19 immunisation. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "increased sleepiness"; BODY TEMPERATURE DECREASED (non-serious), outcome "recovering", described as "low grade temp"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "sore arm"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "blood pressure slightly elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported low white blood count and neutrophil count - to be repeated next week, had covid vaccine dose 2 on 04Apr2021 with increased sleepiness, low grade temp and sore arm the next day but better now, blood pressure slightly elevated and being monitored. No change in medications. Patient saw MD yesterday and aware. Patient was taking Ibrance for 21 days on, 7 off.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, White blood cell count
Clinical narrative: increased sleepiness; low grade temp; sore arm; blood pressure slightly elevated; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE taken for breast cancer female, start date: 19Mar2021 (ongoing). Vaccination history included: Covid-19 vaccine (Dose 1 (Manufacturer unknown)), for COVID-19 immunisation. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "increased sleepiness"; BODY TEMPERATURE DECREASED (non-serious), outcome "recovering", described as "low grade temp"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "sore arm"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "blood pressure slightly elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported low white blood count and neutrophil count - to be repeated next week, had covid vaccine dose 2 on 04Apr2021 with increased sleepiness, low grade temp and sore arm the next day but better now, blood pressure slightly elevated and being monitored. No change in medications. Patient saw MD yesterday and aware. Patient was taking Ibrance for 21 days on, 7 off.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle disorder, Muscle spasms, Pain in extremity
Clinical narrative: sore arm; not feeling well; muscle problems; muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "sore arm"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "not feeling well"; MUSCLE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "muscle problems"; MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "muscle spasm". Therapeutic measures were taken as a result of pain in extremity, malaise, muscle disorder, muscle spasms.  Additional Information: Patient received the first dose of Covid-19 vaccine yesterday April 8. She experienced a sore arm and not feeling well. She also took 2 extra strength Tylenol this morning and 2 in the afternoon. She has muscle problems, muscle spasm on lower back and hasn't taken muscle relaxant in a couple of days. Asked when it is safe to take the muscle relaxant and how long is she going to wait.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: cysts on his hand and wrist; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: CYST (non-serious), outcome "unknown", described as "cysts on his hand and wrist".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: some runny nose last couple of days but WITHOUT fever or cough; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 11Apr2021, outcome "unknown", described as "some runny nose last couple of days but WITHOUT fever or cough"; ILLNESS (non-serious) with onset 11Apr2021, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The consumer was scheduled to take his second shot of the PFIZER-BIONTECH COVID-19 VACCINE this evening and he had some runny nose last couple of days but without fever or cough. He also did a rapid test and came back negative for COVID19 virus just to be sure. He just wanted to know and he is seeking guidance as to whether he should get his second shot. Also, consumer mentioned that it was 30 days since his first shot. Caller called in on behalf of her son, who is about to receive his 2nd dose of our COVID-19 vaccine tomorrow 13Apr2021 but might not be able to attend it since (withheld) has been sick since yesterday 11Apr2021. (Withheld) is not sure when did receive his 1st dose but she thinks it was 3 weeks ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Malaise
Clinical narrative: Abdominal pain; I had little bad night last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization.  The following information was reported: MALAISE (non-serious) with onset Apr2021, outcome "recovering", described as "I had little bad night last night"; ABDOMINAL PAIN (non-serious) with onset 06Apr2021 11:00, outcome "unknown", described as "Abdominal pain".  Additional Information: The patient had second dose yesterday afternoon. When got the first dose patient had the reaction which was not great but second dose much worsened than the first. Had little bad night last night and started actually better this morning but around 11 o'clock this morning, patient started getting abdominal pain and had those now for 5 hours. The patient could recall stomachache like this, know long time and just trying to find out is this a typical reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: he was just tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US074707_NS.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "he was just tired".  Additional information: Patient Slates he got his second COVID vaccine on 26Mar2021. States after getting the vaccine he was just feeling out of it (clarified he meant he was just tired).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Lymphadenopathy
Clinical narrative: dizzy; headache; chills; fatigue; left armpit lymph node swollen; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EP7534) in the left arm at 12:00 PM), administration date: 16Mar2021, when the patient was 30 years old, for COVID-19 Immunization, reactions: "Sore arm", "slight headache". The following information was reported: DIZZINESS (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "dizzy"; HEADACHE (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 06Apr2021 19:00, outcome "recovering", described as "left armpit lymph node swollen". Therapeutic measures were not taken as a result of dizziness, headache, chills, fatigue, lymphadenopathy.  Additional Information: The reporter classified the events as not serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food, or other products. The patient received antihistamines within 2 weeks of vaccination. The patient experienced being dizzy, headache, chills, fatigue, and left armpit lymph node was swollen and still slightly swollen 5 days after the 2nd shot.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392749 Same patient and drug, different dose and events
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphagia, Oropharyngeal pain
Clinical narrative: He ate a light meal noodle soup then after an hour he started having diarrhoea; problem with swallowing; sore throat; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "He ate a light meal noodle soup then after an hour he started having diarrhoea"; DYSPHAGIA (non-serious) with onset Apr2021, outcome "unknown", described as "problem with swallowing"; OROPHARYNGEAL PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "sore throat". Additional information: He ate a light meal noodle soup then after an hour he started having diarrhoea, problem with swallowing and a sore throat.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Glucose level has gone very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE taken for diabetes mellitus; TRULICITY taken for diabetes mellitus; TRESIBA taken for diabetes mellitus. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "Glucose level has gone very high". The event "glucose level has gone very high" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional Information: Patient have taken the shot in the beginning of Mar and patient have changed medicines and patient cannot seem to get it under controlled (further details unknown). Patient stated, it was 1st but after 2nd it got even worse, it started to get elevated like 2-3 days after the first shot but after the second booster, my sugar was elevated. Patient further stated, the only major side effects having is elevated glucose level and it is getting dangerously high were patient cannot get them lower and patient have consulted with my Primary health care profession about it and he changed and increased level of medication and still on 400 to 500 range.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: his platelet count had dropped significantly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021073856_NC .  A 77 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "his platelet count had dropped significantly". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Psychomotor hyperactivity, Restlessness
Clinical narrative: Anxious, hyper, I cannot sit still; Anxious, hyper, I cannot sit still; I could not sit still; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: ER8734) at the age of 71 years as dose 2, single and administration date 17Mar2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT. The following information was reported: PSYCHOMOTOR HYPERACTIVITY (non-serious), ANXIETY (non-serious), outcome "recovered" and all described as "Anxious, hyper, I cannot sit still"; RESTLESSNESS (non-serious), outcome "recovered", described as "I could not sit still". Therapeutic measures were taken as a result of psychomotor hyperactivity, anxiety, restlessness.  Additional Information: Patient stated, when she got the first dose on the 17Mar2021 she felt the same symptoms and then it went away after a couple of days. She took Tylenol as treatment. Then she got the second dose yesterday and she was more anxious yesterday and today than 3 weeks prior. Patient stated, she do take Symbicort periodically. she do not use that every day. Patient stated, she wanted to tell a symptom that she had and it is not on the list of receipt. She did not have any of the symptoms that was in the hand out sheet, no fever, no chills, no joint pains, did not even feel it her my arm. But she felt, she do not know you how you say it where you are, she know you are not from this country. she call it high (incomplete sentence). She experienced it the date she  got it 4/7 April the 7th and April the 8th it lasted 2 days it was very high anxiety; I was anxious hyper. she could not sit still, do you understand how hyper it is, but that is not one of the side effects. And the copy was of Dec2020 that one that I was handed. she know people who are getting this, they can have other health issues. But she do not have, but she could not sit still, that was her reaction and no one that she have spoken to have heard reaction from the Pfizer vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pain
Clinical narrative: cold chills, hot chills; body aches; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious), outcome "unknown", described as "cold chills, hot chills"; PAIN (non-serious), outcome "unknown", described as "body aches"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Feeling abnormal
Clinical narrative: She was feeling loopy; dizzy; had an earache; This is a spontaneous report received from a contactable consumer from a sales representative. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "She was feeling loopy"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; EAR PAIN (non-serious), outcome "unknown", described as "had an earache".  Additional information: She was feeling loopy, dizzy, and had an earache after receiving the first dose of the Covid. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient had fatigue, nausea, headache, pain/general soreness and influenza-like illness (flu-like symptoms), onset Apr 2021, with outcome of recovering. No therapeutic measures taken as a result of fatigue, nausea, headache, pain and influenza-like illness. Additional information: Reportedly, patient had fatigue, nausea, headache and general soreness. Patient also had moderate flu-like symptoms (described as feeling awful) until 24 hours after the second dose. She is presently recovering. These symptoms did not require any treatment or attention by an HCP. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache for 7 days; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Apr2021 10:00 (Lot number: Ap7533) at the age of 61 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "known allergies:sulfur" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: AZELASTINE; APRISO; LIBRAX [CHLORDIAZEPOXIDE;CLIDINIUM BROMIDE]; PANTOPRAZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; VORTIOXETINE. Past drug history included: Compazine, reaction(s): "Drug allergy"; Tigan, reaction(s): "Drug allergy"; Morphine, reaction(s): "Drug allergy"; Promethazine, reaction(s): "Drug allergy". The following information was reported: HEADACHE (non-serious) with onset 02Apr2021 10:15, outcome "recovered" (Apr2021), described as "Bad headache for 7 days". Therapeutic measures were taken as a result of headache. Additional information: Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any vaccines within four weeks prior to the vaccination. Bad headache was treated with sumatriptan and EMGALITY from 04Apr2021 to an unknown stop date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: ER8733) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 06Apr2021, outcome "unknown", described as "Vomiting".  Additional information: Reported that she received the Pfizer vaccine today and tonight she was having, she was vomiting and wanted to know vomiting one of the side effects.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in his hand in the same side os the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in his hand in the same side os the injection site".  Additional information: He has developed tingling in his hand in the same side as the injection site. It had gone down to the top of his hand, it was mild and was very mild now. He was calling because his family was very concerned.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: just didn't feel well; felt "cloudy" with "brain fog" on the drive home/felt "cloudy" with "brain fog" on the drive home; stomach pains; discomfort in the middle of his stomach that led to him vomiting; discomfort in the middle of his stomach that led to him vomiting/throwing up all night; pain level to be a 6 on a scale of 1-10, and it being at an 8 when he was throwing up; exhausted; could not eat; very sore; Horrible reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 29 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "just didn't feel well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt "cloudy" with "brain fog" on the drive home/felt "cloudy" with "brain fog" on the drive home"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pains"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "discomfort in the middle of his stomach that led to him vomiting"; VOMITING (non-serious), outcome "unknown", described as "discomfort in the middle of his stomach that led to him vomiting/throwing up all night"; PAIN (non-serious), outcome "unknown", described as "pain level to be a 6 on a scale of 1-10, and it being at an 8 when he was throwing up"; FATIGUE (non-serious), outcome "unknown", described as "exhausted"; DECREASED APPETITE (non-serious), outcome "unknown", described as "could not eat"; PAIN (non-serious), outcome "unknown", described as "very sore"; VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "Horrible reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (13Apr2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a 29-year-old male patient that:  Additional Context: This consumer called on behalf of the patient who is reporter's partner. The patient is at work. The patient was administered his first dose of Pfizer-BioNTech COVID-19 Vaccine on 31Mar2021. He had a horrible reaction afterwards. Reporter called to see if it was smart for him to get his second dose of Pfizer-BioNTech COVID-19 Vaccine related to his having the horrible reaction after the first dose.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Vaccination site reaction, Vomiting
Clinical narrative: just didn't feel well; felt "cloudy" with "brain fog" on the drive home/felt "cloudy" with "brain fog" on the drive home; stomach pains; discomfort in the middle of his stomach that led to him vomiting; discomfort in the middle of his stomach that led to him vomiting/throwing up all night; pain level to be a 6 on a scale of 1-10, and it being at an 8 when he was throwing up; exhausted; could not eat; very sore; Horrible reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 29 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "just didn't feel well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt "cloudy" with "brain fog" on the drive home/felt "cloudy" with "brain fog" on the drive home"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pains"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "discomfort in the middle of his stomach that led to him vomiting"; VOMITING (non-serious), outcome "unknown", described as "discomfort in the middle of his stomach that led to him vomiting/throwing up all night"; PAIN (non-serious), outcome "unknown", described as "pain level to be a 6 on a scale of 1-10, and it being at an 8 when he was throwing up"; FATIGUE (non-serious), outcome "unknown", described as "exhausted"; DECREASED APPETITE (non-serious), outcome "unknown", described as "could not eat"; PAIN (non-serious), outcome "unknown", described as "very sore"; VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "Horrible reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (13Apr2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a 29-year-old male patient that:  Additional Context: This consumer called on behalf of the patient who is reporter's partner. The patient is at work. The patient was administered his first dose of Pfizer-BioNTech COVID-19 Vaccine on 31Mar2021. He had a horrible reaction afterwards. Reporter called to see if it was smart for him to get his second dose of Pfizer-BioNTech COVID-19 Vaccine related to his having the horrible reaction after the first dose.
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: his immune system was going nuts; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program . The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "his immune system was going nuts". Additional information: Patient was inquiring if that would affect the vaccine effectiveness.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: extremely fatigue; pain in my arm; I couldn't get from one room to another.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory authority. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "extremely fatigue"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "pain in my arm"; ASTHENIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "I couldn't get from one room to another.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021418724 same patient/drug, different dose/AE
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; light headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "open heart surgery", start date: 2016, stop date: 2016; "Allergy for penicillins" (unspecified if ongoing), notes: He got a rash when he took the penicillin. He doesn't know which penicillin caused the rash.; "Allergy for milk" (unspecified if ongoing), notes: allergic to some foods like cantaloupe and milk.; "Allergy for food" (unspecified if ongoing), notes: allergic to some foods like cantaloupe. Concomitant medication(s) included: ASPIRIN (E.C.) (ongoing).  The following information was reported: CHILLS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 01Apr2021, outcome "not recovered", described as "light headaches".  Additional information: The patient reported side effect since he had the first dose of the Pfizer vaccine on 31Mar2021. And had ongoing chills and slight headaches and how long it lasted he wanted to know and asked the recommendations for 2nd dose after experiencing side effects. His symptoms were not severe but they are continuous. He reports he does not take any prescription drugs but he does take Aspirin 81mg one tablet at night. He also takes some vitamins. He saw his cardiologist last week but he did not mention his symptoms to his cardiologist. He did tell his cardiologist he had received his first Covid 19 vaccine. He has an appointment to see his primary care doctor on 10Mar2021. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date with the Pfizer vaccine considered as suspect. The AE(s) did not require to visit to emergency room and physician office. No Prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. No Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extremely sore arm, even more for the second shot than the first; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Extremely sore arm, even more for the second shot than the first". Additional Information: Lot number for BNT162b2 was misplaced or discarded. Patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392780 same drug/reporter/patient, different dose and events