chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I did NOT have a single headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Mar2021, for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "I did NOT have a single headache".  Additional information: It was stated that the patient suffered from migraines, its been a 10 year struggle, The Patient received first shot of the vaccine in March and as the patient expected, had a horrific migraine and nausea for 5 days suffice to say, patient was really nervous to receive the second shot but did so April 1st expecting the worst however the patient did not have any symptoms! The patient normally get 6-10 migraines a month and of course take medicine etc. but the patient wanted to let someone know that for a month patient did not have a single headache. The patient requested to look into this.  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-2021530507 same patient/drug, different dose/event.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia, Somnolence
Clinical narrative: She experianced deep numbness in the opposite arm of injection (in the right arm); tingling in the alternative arm. It went away after some time.; felt pain in both of her hands and fingers; felt pain in both of her hands and fingers; sleepiness; experienced sore arm 3 hours later; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 17:30 (Lot number: EW0161) at the age of 65 years 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: LIMB DISCOMFORT (non-serious) with onset 21Apr2021, outcome "recovered" (2021), described as "experienced sore arm 3 hours later"; HYPOAESTHESIA (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "She experianced deep numbness in the opposite arm of injection (in the right arm)"; PARAESTHESIA (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "tingling in the alternative arm. It went away after some time."; SOMNOLENCE (non-serious) with onset 21Apr2021, outcome "unknown", described as "sleepiness"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Apr2021, outcome "recovered" and all described as "felt pain in both of her hands and fingers". Therapeutic measures were taken as a result of limb discomfort..  Additional information: Patients right arm went completely numb, and she couldn't move her right arm without the help of her left arm. Her right arm numbness started 8 hours after her first COVID-19 Vaccine, and lasted a few minutes. She clarified her right arm was in a very deep sleep from her shoulder to her finger tips. She stated she took 1 Tylenol (Extra Strength Tylenol 500mg Rapid Release coated gel cap), and was fine. She said she threw away the Extra Strength Tylenol 500mg Rapid Release coated gel cap bottle, and did not have the NDC, Lot, and Expiration Date. Reported the next day (22Apr2021) she felt pain in both of her hands and fingers. She said it felt like joint pain, and she imagined the pain to be like how arthritis felt. She said her hand and finger pain went away after a couple days.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood test, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: Caller reported that the first dose just swelled her arm; There was pain; It turned red at the injection site that last 6 days and then that went away.; 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 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 08:40 (Lot number: EP7334) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Had for about 6-7 years.; "Arthritis" (ongoing), notes: She has had for years, started when she was little.; "overweight" (ongoing), notes: She is borderline due being overweight, if she lost weight it would probably go away. Family history included: "Rheumatic fever" (unspecified if ongoing), notes: dad; "high blood pressure" (unspecified if ongoing), notes: dad. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "Caller reported that the first dose just swelled her arm"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "There was pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "It turned red at the injection site that last 6 days and then that went away.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, pain in extremity, vaccination site erythema.  Additional Information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none, Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Clinical Course: The first shot was on 02Apr2021, Lot: EP7334, at 8:40am. It was noted that with the first shot, just swelled her arm and there was pain and it turned red at the injection site that last 6 days and then that went away. She took Tylenol and hot water in the shower to treat this event.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: I have talked to numerous people who experienced temporary brain fog as a result of receiving the vaccine./ I can attest to that fact.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "I have talked to numerous people who experienced temporary brain fog as a result of receiving the vaccine./ I can attest to that fact.".  Additional information: Reporter repots that, I have talked to numerous people who experienced temporary brain fog as a result of receiving the vaccine. Especially the first shot. I can attest to that fact. I talked to a semi-truck driver who expressed the fact he was uncomfortable driving on a busy interstate. This point applies to commercial bus drivers and of course especially commercial aircraft pilots. I've had both shots and encourage everyone to do so. The issue of recipients operating machinery needs to be addressed.  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 extremity, Pyrexia
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 08May2021 (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: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that she and her daughter received the second dose of the Pfizer Covid-19 vaccine on Saturday, 8May2021. Caller reported that on Saturday she had a very high fever of 102, reduced down to 101, then down to 100 and then 99 and she took two tylenol every 6 hours two times and she used Vicks salve on her chest and back. Caller reported her daughter only had a sore arm. Reporter asked is it part of the side effects to have a fever and does it get worse and if you have a low grade fever under 104 is all you are expected to do is take two Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (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: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "cold".  Additional information: The patient had the first dose on 22Apr2021 and scheduled to have her second dose this coming Friday on 14May2021. The patient had colds.  wants to know if it is okay to get the second dose even if she has a cold.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Experiencing a sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (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: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Experiencing a sore throat".  Additional information: The caller (withheld) said that he received the 1st dose of the vaccine on 18Apr2021, and he is scheduled to get the 2nd shot today, but he is experiencing a sore throat and he would like to know if he can still get the scheduled shot today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Norovirus infection
Clinical narrative: wound up getting the stomach virus (NORA virus) between the 3rd and 6th week after the 1st dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NOROVIRUS INFECTION (non-serious), outcome "unknown", described as "wound up getting the stomach virus (NORA virus) between the 3rd and 6th week after the 1st dose".  Additional information: It was reported that no PQC was present. He received the 1st dose of the covid vaccine on 31Mar2021. He would like to know whether he can get his 2nd dose of the vaccine tomorrow. He says his pharmacist may have already reported it. He asked that further questions should be referred to his pharmacist. He and his wife, both aged 60, received their 1st dose of the covid vaccine on 31Mar2021. They both wound up getting the stomach virus (NORA virus) between the 3rd and 6th week after the 1st dose. They were asked to wait a week before getting the next dose, but on the following week, the pharmacy had run out of the Pfizer vaccine.  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) : 2021535377 Same Reporter/Drug/AE, different Patient
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: she is feeling dizzy; having a headache; feels so tired.; 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 female patient received bnt162b2 (BNT162B2), administration date 08May2021 (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: DIZZINESS (non-serious), outcome "unknown", described as "she is feeling dizzy"; HEADACHE (non-serious), outcome "unknown", described as "having a headache"; FATIGUE (non-serious), outcome "unknown", described as "feels so tired.".  Additional information: Patient was feeling dizzy, having a headache but does not have a fever and feels so tired. She asked what medicine she could take and mentioned if she could take Tylenol as an option. Her 2nd dose scheduled on 29May2021.  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
Clinical narrative: tiredness; 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 female patient received bnt162b2 (BNT162B2), administration date 07May2021 (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), outcome "unknown", described as "tiredness".  Additional information: Her second dose was scheduled after 3 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: jaw pain/ had little pains in his jaw; 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 56 year-old male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 16:20 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart attack", start date: Dec2017 (unspecified if ongoing), notes: he did have a heart attack 3-4 years ago (Heart attack (From: Dec 2017 To: Unspecified). Concomitant medication(s) included: IMDUR taken for myocardial infarction; LISINOPRIL taken for myocardial infarction; ATORVASTATIN taken for myocardial infarction; CARVEDILOL taken for myocardial infarction. The following information was reported: PAIN IN JAW (non-serious) with onset Apr2021, outcome "not recovered", described as "jaw pain/ had little pains in his jaw". Therapeutic measures were not taken as a result of pain in jaw.  Additional information: He experienced jaw pain "2 or 3 days" after he had his first shot (07Apr2021) of Pfizer BioNTech Covid-19 Vaccine and experienced shoulder and chest pain 4-5 days after his second shot (30Apr2021). He had a heart attack 3 and a half years ago, and he came across 3 incidents of heart attack in a study in (Privacy) website. Possible AE Duplicate, he states that he talked to someone from Pfizer who got this information however he is unsure if it is someone from (Privacy). Age: 56 / Gender: Male. Description of complaint: Caller states he had the Pfizer Covid vaccine and states he is unsure of the state of when he had the 1st dose of the vaccine but it was on a Wednesday and was three weeks prior to his 2nd dose and the 2nd dose was administered on 30Apr2021. States he did have a heart attack 3-4 years ago and got the 1st shot of the Pfizer COVID vaccine and did not think about it but then had little pains in his jaw and after the 2nd dose began having pressure across his chest. States he got the 2nd dose of the Pfizer COVID Vaccine a week ago on 30Apr2021 and that was about 10-11 days ago and he began having pressure across his chest and looked it up and it said during the trials there were three heart attack type things reported and he wanted to find out if Pfizer had narrowed down that information to a particular medication or it it happened almost right away after the vaccine or if it was a few weeks later. Caller states he takes four medications for his history of heart attack and has been taking them for 3-4 years since his heart attack and his heart attack was in Dec2017.  States he takes Imdur 60mg once per day by mouth and initially states he cannot remember the names of the others but then states he takes Lisinopril 10mg once per day by mouth, takes Atorvastatin 40mg once per day by mouth and also takes Carvedilol 6.25mg and takes two per day of one in the morning and one in the evening.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, and unbearable headaches.; Nausea, vomiting, and unbearable headaches.; Nausea, vomiting, and unbearable headaches.; 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 female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date 06May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), VOMITING (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "Nausea, vomiting, and unbearable headaches."  Additional information: The reporter wanted to check when will the symptoms subside. She was experiencing Nausea, vomiting, and unbearable headaches. She got the first dose last 15Apr and got the 2nd dose last 06May.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Malaise, SARS-CoV-2 test
Clinical narrative: Have symptoms of stomach; Headache; Her daughter isn't feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Have symptoms of stomach"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MALAISE (non-serious), outcome "unknown", described as "Her daughter isn't feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller daughter received vaccine 3 week ago and she is scheduled to receive her vaccine today 07May However, her daughter isn't feeling well and have symptoms of stomach and headache. The mother stated that she has gotten tested for covid-19, however, it came out negative. Read ISI. Mother wants to know of it will be safe to give her vaccine in a later date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 2nd dose: has had a mild ache in his arm every day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Feb2021 (Lot number: EL9261) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol high" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR [ATORVASTATIN] taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (Dose number :1, Start date : 20Jan2021, Lot/Batch :EL8982 , vaccine site : left arm), administration date: 20Jan2021, for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "not recovered", described as "2nd dose: has had a mild ache in his arm every day".  Additional information: Vaccination Facility Type was pharmacy, Additional Vaccines Administered on Same Date of the Pfizer Suspect was None, Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was None. Patient's Medical History (including any illness at time of vaccination) was None. Family Medical History Relevant to AE(s) was None, Relevant Tests was None. No Emergency Room and Physician Office. Probed for relevant medical history, concomitant products and test results and caller says no. He doesn't take anything other than his statin every other day that is just for his cholesterol since it was a little high. It is the generic Lipitor and he started taking it 10 years ago. Caller said that this was not an emergency by any means but he just thought he could call Pfizer and report his side effect just in case it was needed. He got his second COVID vaccine on 10FEB2020 and his first COVID vaccine on 20JAN2021 and had no problems after the first dose. Reporter clarified that he actually had his second dose on 10FEB2021, not 10FEB2020 like was originally provided. Ever since his second dose he has had a mild ache in his arm every day. It is not excruciating but it is the kind of ache that you know is there. He doesn't know if anyone else has ever experienced that or not and he doubts that there is anything that anyone can do. It doesn't restrict him but it is just a reminder that he had the COVID vaccine, a friendly reminder he jokingly says. This began shorty after his COVID vaccine, about 2 to 3 days after. Confirmed to be sometime in FEB2021 that the dull ache started but he doesn't remember the exact date. Lot Number: EL9261 or EL9281 or him and his wife think it could also be EL92901. Time the vaccination was given: around 1000 but closer to 1020 when they got in there.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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 (unknown manufacturer)), for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Back pain". Therapeutic measures were taken as a result of back pain.  Additional information: The reporter's lady friend had back pain after the second Pfizer shot. she received her second dose a week apart from the reporter. The patient is on pain killers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: arm was sore; full day of full-body pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Apr2021 (Lot number: EP7533) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing); "covid" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; DAYSEE; PROZAC; HYDROXYZINE. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was sore"; PAIN (non-serious), outcome "recovered", described as "full day of full-body pain". Therapeutic measures were not taken as a result of pain in extremity, pain.  Additional information: Patient reported after the first dose, that she didn't feel pain until 12 hours after. Then she had a full day of full-body pain. Patient told her arm was sore for a full week after. After the second dose, her arm was sore immediately and she had a low grade fever the day after the shot. The pain in the arm passed on day two after the dose. Patient had covid prior vaccination and was not covid tested post vaccination. Patient did not had any vaccine in four weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Fatigue; Chills; Headache; Arm Soreness; ThThis is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Penicillin allergy", notes: Penicillin. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Arm Soreness". Therapeutic measures were not taken as a result of fatigue, chills, headache, pain in extremity.  Additional information: Patient received vaccine dose 1 on Mar2021 at 11:45AM. It was unknown if patient experienced COVID prior vaccination. Patient has not been test COVID post vaccination. Patient didn't take other vaccine in four weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Had a headache really bad; Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter reported same events under the same product for 3 patients. This is one of the 3 reports.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Had a headache really bad"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous".  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, Inappropriate schedule of product administration, Neck pain, Pain
Clinical narrative: Dose Number 1: 25Apr2021/Dose Number 2: 09May2021; Achiness; Headache; Neck ache; Fatigue; Soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09May2021 14:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; VITRON C [ASCORBIC ACID;FERROUS FUMARATE]. Vaccination history included: Bnt162b2 (dose number=1, Batch/lot number  unknown, administration time 14:30, vaccine location Left arm), administration date: 25Apr2021, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09May2021 14:30, outcome "unknown", described as "Dose Number 1: 25Apr2021/Dose Number 2: 09May2021"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "Achiness"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "Headache"; NECK PAIN (non-serious) with onset 2021, outcome "recovering", described as "Neck ache"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were not taken as a result of pain, headache, neck pain, fatigue, vaccination site pain.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  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 pain
Clinical narrative: Dose Number 1: 25Apr2021/Dose Number 2: 09May2021; Achiness; Headache; Neck ache; Fatigue; Soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09May2021 14:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; VITRON C [ASCORBIC ACID;FERROUS FUMARATE]. Vaccination history included: Bnt162b2 (dose number=1, Batch/lot number  unknown, administration time 14:30, vaccine location Left arm), administration date: 25Apr2021, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09May2021 14:30, outcome "unknown", described as "Dose Number 1: 25Apr2021/Dose Number 2: 09May2021"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "Achiness"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "Headache"; NECK PAIN (non-serious) with onset 2021, outcome "recovering", described as "Neck ache"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were not taken as a result of pain, headache, neck pain, fatigue, vaccination site pain.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Lot number: 517121) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CHLORTHALIDONE. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated".  Additional information: The patient stated that after the patient took the Covid vaccine shot on Friday and now she had been getting headache and had been feeling nauseated little bit. The first one was fine but the second one was not.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: 1st dose felt a metallic taste in mouth. Not sure if related. Came on a day or 2 after first shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 16:00 (Lot number: EW0161) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "soy" (unspecified if ongoing); "pollen" (unspecified if ongoing); "tree nuts" (unspecified if ongoing); "stone fruit" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; NUTRAFOL; MULTIVITAMIN & MINERAL. The following information was reported: DYSGEUSIA (non-serious) with onset 06May2021 23:45, outcome "recovered" (2021), described as "1st dose felt a metallic taste in mouth. Not sure if related. Came on a day or 2 after first shot". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: Patient did not take other vaccine in four weeks. Patient did not take other medication in two weeks. Patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: I have been feeling kind of tired and mentally fuzzy, sort of just cloudy and still tired; I have been feeling kind of tired and mentally fuzzy, sort of just cloudy and still tired; I don't feel so great, I feel kind of just not great; 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 07May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset 07May2021, outcome "not recovered" and all described as "I have been feeling kind of tired and mentally fuzzy, sort of just cloudy and still tired"; MALAISE (non-serious) with onset 07May2021, outcome "not recovered", described as "I don't feel so great, I feel kind of just not great".  Additional information: Consumer stated that got the vaccine, the first time on Friday, and have been feeling kind of tired and mentally fuzzy, sort of just cloudy and still tired. Patient was wondering, patient didn't feel so great, feel kind of just not great but Patient didn't feel really terrible in the sense of any kind of pain or anything extreme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Taste disorder
Clinical narrative: I also developed this very very nasty taste in my mouth and I still have that taste; I started breaking out; I get these funny weird headache off and on and I still have the funny weird headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: ER8736) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure measurement" (ongoing), notes: Verbatim: Blood pressure; "Allergy" (unspecified if ongoing), notes: Verbatim: Allergy. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement; CETIRIZINE. Vaccination history included: Bnt162b2 (First dose, Event: I got really gassy and it kind of messed up my bowel movement a little bit), administration date: 07Apr2021, for COVID-19 Immunization, reaction(s): "Bowel movement irregularity". The following information was reported: FEELING ABNORMAL (non-serious) with onset 05May2021, outcome "unknown", described as "I started breaking out"; TASTE DISORDER (non-serious) with onset 06May2021, outcome "not recovered", described as "I also developed this very very nasty taste in my mouth and I still have that taste"; HEADACHE (non-serious) with onset May2021, outcome "not recovered", described as "I get these funny weird headache off and on and I still have the funny weird headache".  Additional information: The patient was taking allergy medicines.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity
Clinical narrative: I got really gassy and it kind of messed up my bowel movement a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: EW0153) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure abnormal" (ongoing); "Hypersensitivity" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; CETIRIZINE.  The following information was reported: BOWEL MOVEMENT IRREGULARITY (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "I got really gassy and it kind of messed up my bowel movement a little bit". Therapeutic measures were taken as a result of bowel movement irregularity.  Additional information: The patient reported that she did her first shot (Covid 19 vaccine) on April 07th and from that one the only side effect, she had that she had that she got really gassy and it kind of messed up bowel movement a little bit, and that happened for like 3 days and then it was back to normal. Consumer stated that the patient had my allergy medicines.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: sick, didn't feel good; sick, didn't feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Batch/Lot number: unknown, Expiration Date: 16Jul2021) at the age of 44 years 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: ILLNESS (non-serious), MALAISE (non-serious) all with onset 16Apr2021, outcome "recovered" (2021) and all described as "sick, didn't feel good".  Additional Information: The reporter explained it was right after the shot and he was not sure what time the event occurred. He said patient got better a couple days later and recovered completely. The reporter did not elaborate on what he meant by sick, was not feeling good. History of all previous immunizations with the Pfizer vaccine considered as suspect, additional vaccines administered on same date, prior vaccinations within 4 weeks and adverse event prior vaccinations were none. The caller confirms that the patient missed her second dose which was scheduled on 07May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pain in extremity
Clinical narrative: arm pain; hypertension; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 17Feb2021 (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 (Pfizer Covid 19 vaccine, First dose), administration date: 27Jan2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; HYPERTENSION (non-serious), outcome "unknown", described as "hypertension". Therapeutic measures were taken as a result of pain in extremity, hypertension.  Additional Information: The patient complained of arm pain for over 10 weeks. Her medical records not with her. She going by what the health officer is asking to relate to Pfizer. She had Arm pain for which treatment taken physical therapy and what medications were involved, she was not sure. She had pain but is unknown if it is the same or worse. prior vaccinations within 4 week was unknown. Unknown if patient is still experiencing this. Patient still has the pain but is unknown if it is the same or worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 2" round oval rash at side of second injection and a little swollen and warm; 2" round oval rash at side of second injection and a little swollen and warm; 2" round oval rash at side of second injection and a little swollen and warm; Redness at Injection Site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 09:00 (Lot number: EW0183) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single; Lot: ER8734; Event onset date: 09Apr2021, Event stop date: 11Apr2021; Duration: 2 days; Outcome: Recovered), administration date: 08Apr2021, when the patient was 63 years old, for COVID-19 immunization, reaction(s): "Arm was sore". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 09May2021, outcome "not recovered" and all described as "2" round oval rash at side of second injection and a little swollen and warm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "Redness at Injection Site". Therapeutic measures were not taken as a result of vaccination site rash, vaccination site swelling, vaccination site warmth, vaccination site erythema.  Additional information: No any additional vaccines administered on same date of the Pfizer suspect. Any AE(s) does not require a visit to emergency room, physician office. Prior Vaccinations (within 4 weeks): Patient has received both doses of the Pfizer Covid Vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Strong Headache; nausea; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 13:30 (Lot number: EW0173) at the age of 52 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 (Dose 1, lot number: EW0158, Location: Left arm), administration date: 12Apr2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "Sore arm for one day after 1st vaccination". The following information was reported: HEADACHE (non-serious) with onset 05May2021 03:30, outcome "not recovered", described as "Strong Headache"; NAUSEA (non-serious) with onset 05May2021 03:30, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 05May2021 03:30, outcome "not recovered", described as "tiredness". Therapeutic measures were not taken as a result of headache, nausea, fatigue.  Additional information: It was reported that the facility type vaccine was Public Health Clinic/Administration facility. The adverse event: strong Headache, nausea, tiredness on day after 2nd vaccination. Headaches on several days after 2nd vaccination He did not receive any other medications within two weeks of the COVID vaccine. The patient did not tested Covid post vaccination. Patient did not had known allergies. He did not have any other medical history. Patient did not had Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.