chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: to get dizzy/light headed; weak; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (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: DIZZINESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "to get dizzy/light headed"; ASTHENIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "weak". Additional Information: The patient's age was reported as 30 (units unknown). The reporter stated her stepson received vaccine yesterday and felt dizzy, lightheaded and weak. The reporter would like to know if the reported were side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gout, Pain in extremity
Clinical narrative: gout on her feet; her feet were so sore; 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), administration date 29Mar2021 (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: GOUT (non-serious), outcome "unknown", described as "gout on her feet"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her feet were so sore".  Additional Information: The patient reported that she had to go into the cancer center in a wheel chair because her feet was sore. She also asked that if she could take hydrocodone/ acetaminophen.  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
Clinical narrative: "a little soreness" in the arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1 of 2 reports.   A (Age: 75; Unit: Unknown) female 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 was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as ""a little soreness" in the arm".  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-2021353658 same reporter/drug, similar events/ different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was a little sore; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "CHF" (unspecified if ongoing); "thyroid problems" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was a little sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: burning in her throat "like acid reflux"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Down Syndrome" (unspecified if ongoing); "allergic to sulfa" (unspecified if ongoing); "penicillin drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergic amoxicillin". The following information was reported: THROAT IRRITATION (non-serious), outcome "unknown", described as "burning in her throat "like acid reflux"".  Additional information included: At the time of report, reporter wanted to know if patient can safely get the second dose of the vaccine, also reported that, the patient is allergic to 'a lot of medications'. Reporter spoke with an agent who said it was okay for the patient to take the Covid vaccine but additionally would like to re-confirm the answer.  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-2021349175 different patient, same drug and event
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; 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 29Mar2021 (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: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache".  Additional information: Patient called-in saying that she received the 1st dose of our COVID 19 vaccine on 29Mar and currently has a headache. She is asking if it's okay to take Tylenol. Her 2nd dose is scheduled on 19Apr (exactly 21 days apart).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable Nurse. A male patient 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: 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: significant arm pain after COVID vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 36 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "significant arm pain after COVID vaccine". This AE was spontaneously reported to me by a friend after they received the COVID-19 injection.  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: Right arm sore; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  An adult female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm right, administration date Feb2021 (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), outcome "unknown", described as "Right arm sore". Additional Information: The patient received the first dose on Feb2021, 02:00PM. The patient did not receive any other vaccine in four weeks. The patient has not been diagnosed with COVID prior vaccination and has not been tested for COVID post 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-2021362101 same patient, vaccine different dose, different AE.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Nasopharyngitis
Clinical narrative: cold; swollen neck lymph nodes; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer and Other Health Professional) for a Pfizer sponsored program.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast Cancer", start date: 22Feb2021 (unspecified if ongoing). Concomitant medication(s) included: IBRANCE. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen neck lymph nodes"; FATIGUE (non-serious), outcome "recovered", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Mar2021 (Lot number: EN6205) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Afib", start date: Jul2020 (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing), notes: She was diagnosed at 50 years old, so 36 years ago.; "High blood pressure", start date: Jul2020 (unspecified if ongoing); "Osteoarthritis in her left hand" (unspecified if ongoing), notes: She already was diagnosed with osteoarthritis in her left hand before the COVID vaccine. Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation, start date: Jul2020 (ongoing). Vaccination history included: Pneumonia shot; Shingles vaccine; Hiv vaccine; Flu shot (Flu shot: Route: Injection; Anatomical Location: Left arm; No. of Previous Doses: Not provided; Date: Sep2020), administration date: Sep2020.vThe following information was reported: FATIGUE (non-serious) with onset 07Mar2021, outcome "recovered" (09Mar2021), described as "a little tired".  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: Hurt really bad, hurting in arm, bothering in arm; dose was more painful and it felt like she may have pinched a nerve; It was not in the shoulder but felt higher than her previous dose of the vaccine or her previous flu shots/She stated the vaccine was administered high up on arm, in shoulder. not in the deltoid; 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 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 11:00 (Lot number: ER8731) at the age of 28 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 (First Dose, Lot# EN6198, Anatomical location:  left arm , Time 11:40am), administration date: 02Mar2021, for covid 19 immunisation, reaction(s): "This dose was more painful". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, described as "Hurt really bad, hurting in arm, bothering in arm"; NERVE COMPRESSION (non-serious) with onset 24Mar2021, described as "dose was more painful and it felt like she may have pinched a nerve"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 24Mar2021, described as "It was not in the shoulder but felt higher than her previous dose of the vaccine or her previous flu shots/She stated the vaccine was administered high up on arm, in shoulder. not in the deltoid". Therapeutic measures were not taken as a result of vaccination site pain, nerve compression.  Additional information: The patient received second dose of Pfizer BioNTech Covid 19 vaccine a week ago and she feels as though they put it too high in her arm . It was not in the shoulder but felt higher than her previous dose of the vaccine or her previous flu shots. This dose was more painful and it felt like she may have pinched a nerve. She stated it was not in the deltoid. She stated her arm was still hurting her, bothering her. No investigation assessment. Treatment: Not provided.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Depression, Fatigue, Suicidal ideation, Vitamin B12
Clinical narrative: fatigue; her B12 was low; Last night she had suicidal ideation and she has never had that before. She has no plan. She has no desire to hurt others.; Depression; Crying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 15:00 (Lot number: EN6207, Expiration Date: 31Jul2021) at the age of 63 years as dose 1, single for covid-19 immunisation; fluoxetine hydrochloride (PROZAC), since 2020 (ongoing) (Batch/Lot number: unknown) at 40 mg 1x/day (40 mg, 1x/day in the morning) for bipolar i disorder, anxiety; lamotrigine (LAMOTRIGINE, manufacturer: Taro), since 2020 (ongoing) (Batch/Lot number: unknown) at 200 mg 1x/day (200 mg, 1x/day at bedime) for anxiety, bipolar i disorder; lorazepam (LORAZEPAM, manufacturer: Sun Watson Labs) (ongoing) (Batch/Lot number: unknown) at 2 mg 1x/day for anxiety. Relevant medical history included: "Bipolar 1 Disorder" (ongoing); "Anxiety" (ongoing); "Diabetic" (ongoing); "Thyroid" (ongoing); "Liver Problem" (ongoing), notes: bloodwork and MRI of abdomen every 4 weeks for monitoring. The patient took concomitant medications. The patient has diabetic medications to control her diabetes and thyroid medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Flu shot, administration date: 2019, for immunisation, reaction(s): "skin reaction"; Dtap, for immunisation. The patient reported that she had the worst week with depression and crying and felt like she was not taking her psych drugs/ her meds weren't working which started 24 hours after she got the vaccine, 21Mar2021 at 15:00. The patient honestly thought the fatigue was because her B12 was low. She had a doctor's appointment that day (as reported) and got a B12 shot, but that didn't help with the problem either. The depression and crying were ongoing. She has benzos, like Lorazepam and it took the edge off, but it did not keep her from crying. The vaccine was the only thing that she can thought of that was different. The night before the day of report on 29Mar2021, the patient had suicidal ideation and she has never had that before. She had no plan nor desire to hurt others. The patient confirmed that she was not currently having suicidal ideations on the day of report. The events did not result to emergency room nor physician office visit. The patient underwent the following laboratory tests and procedures: vitamin b12: low. The action taken for fluoxetine hydrochloride, lamotrigine and lorazepam was unknown. Therapeutic measures were taken as a result of vitamin b12 decreased which included B12 shot.  The patient has recovered from suicidal ideations but has not recovered from the rest of the events.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12 decreased
Clinical narrative: fatigue; her B12 was low; Last night she had suicidal ideation and she has never had that before. She has no plan. She has no desire to hurt others.; Depression; Crying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 15:00 (Lot number: EN6207, Expiration Date: 31Jul2021) at the age of 63 years as dose 1, single for covid-19 immunisation; fluoxetine hydrochloride (PROZAC), since 2020 (ongoing) (Batch/Lot number: unknown) at 40 mg 1x/day (40 mg, 1x/day in the morning) for bipolar i disorder, anxiety; lamotrigine (LAMOTRIGINE, manufacturer: Taro), since 2020 (ongoing) (Batch/Lot number: unknown) at 200 mg 1x/day (200 mg, 1x/day at bedime) for anxiety, bipolar i disorder; lorazepam (LORAZEPAM, manufacturer: Sun Watson Labs) (ongoing) (Batch/Lot number: unknown) at 2 mg 1x/day for anxiety. Relevant medical history included: "Bipolar 1 Disorder" (ongoing); "Anxiety" (ongoing); "Diabetic" (ongoing); "Thyroid" (ongoing); "Liver Problem" (ongoing), notes: bloodwork and MRI of abdomen every 4 weeks for monitoring. The patient took concomitant medications. The patient has diabetic medications to control her diabetes and thyroid medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Flu shot, administration date: 2019, for immunisation, reaction(s): "skin reaction"; Dtap, for immunisation. The patient reported that she had the worst week with depression and crying and felt like she was not taking her psych drugs/ her meds weren't working which started 24 hours after she got the vaccine, 21Mar2021 at 15:00. The patient honestly thought the fatigue was because her B12 was low. She had a doctor's appointment that day (as reported) and got a B12 shot, but that didn't help with the problem either. The depression and crying were ongoing. She has benzos, like Lorazepam and it took the edge off, but it did not keep her from crying. The vaccine was the only thing that she can thought of that was different. The night before the day of report on 29Mar2021, the patient had suicidal ideation and she has never had that before. She had no plan nor desire to hurt others. The patient confirmed that she was not currently having suicidal ideations on the day of report. The events did not result to emergency room nor physician office visit. The patient underwent the following laboratory tests and procedures: vitamin b12: low. The action taken for fluoxetine hydrochloride, lamotrigine and lorazepam was unknown. Therapeutic measures were taken as a result of vitamin b12 decreased which included B12 shot.  The patient has recovered from suicidal ideations but has not recovered from the rest of the events.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: muscular pain; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. 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: MYALGIA (non-serious), outcome "not recovered", described as "muscular pain"; CHILLS (non-serious), outcome "recovered", described as "chills". Patient had a lot of chills for more than a week, which was a normal stuff.    No follow-up attempts are possible. Information on lot/ batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: When he laid down and closed his eyes he saw a vivid bright yellow lighting line, on the back of his eyelids or brain.; 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 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 02:45 (Lot number: ER8732) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 30Mar2021 03:30, outcome "recovered" (30Mar2021), described as "When he laid down and closed his eyes he saw a vivid bright yellow lighting line, on the back of his eyelids or brain.". Therapeutic measures were not taken as a result of dizziness.  Additional information: No other products and investigation assessment were reported. Caller received his first Covid-19 vaccine today 30Mar2021 and wanted to report what he had experienced. He stated he had the really weirdest experience 45 minutes after receiving the vaccine. He stated when he laid down and closed his eyes he saw a vivid bright yellow lighting line, like a EKG signal turned vertical, coming down to the lower left line of a circle, it looked like a lightning bolt in it, like on the back of his eyelids or brain. Caller said he is fine and not experiencing anymore but it was about 45 minutes after his vaccine and lasting for about 5-10 minutes when he would close his eyes. When he would open his eyes, he felt fine. He stated it was a bizarre incident. He stated he did not know if Pfizer had put a biotech or biomarker in the vaccine that he had received today. Caller stated he was ok for Safety to contact him if there was a need to follow up about the report. No previous history of immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. He was not visited to emergency room and physician office. Prior Vaccinations (within 4 weeks) He was not administered any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No relevant tests were reported. No family history was reported. It was reported he just had 1st dose of covid vaccine. Had unusual experience after getting vaccine. Would like to talk to medical person about experience.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Nausea, Pain, Vaccination site pain
Clinical narrative: body aches; heat/pain at injection site; nausea; skin sensitivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (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 (non-serious) with onset Mar2021, outcome "recovering", described as "body aches"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovering", described as "heat/pain at injection site"; NAUSEA (non-serious) with onset Mar2021, outcome "recovering", described as "nausea"; HYPERAESTHESIA (non-serious) with onset Mar2021, outcome "recovering", described as "skin sensitivity".  Additional Information: Pfizer has permission to contact you about this report. Pfizer does not have permission to contact your/the patient's healthcare provider about this report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Unknown if treatment received for the adverse event. Prior to vaccination, Unknown if the patient diagnosed with COVID-19.Since the vaccination, Unknown if the patient been tested for COVID-19.  Follow-up (06Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: Please provide a response to the below request as soon as possible so the regulatory compliance of AE reporting could be met. The Pfizer US Drug safety unit recently received the attached report submitted by you via Pfizer safety reporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Also, Is patient report this event to you?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Throat irritation
Clinical narrative: After the second dose he had muscle aches, achiness, and a scratchy throat; After the second dose he had muscle aches, achiness, and a scratchy throat; After the second dose he had muscle aches, achiness, and a scratchy throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization, reactions: "fatigued" and "wiped out". The following information was reported: MYALGIA (non-serious), PAIN (non-serious), THROAT IRRITATION (non-serious), outcome "unknown" and all described as "After the second dose he had muscle aches, achiness, and a scratchy throat".  Additional information: Caller reported that her husband was fully vaccinated and he had some mild side effects but he seemed to have sailed through it. She does not know if it was from the vaccine but after the first dose he was wiped out and fatigued and had to lie down. After the second dose he had muscle aches, achiness, and a scratchy throat  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-2021360082 same reporter/patient/drug, different dose/events.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Potentiating drug interaction
Clinical narrative: Back pain; Caller asked how long can she can take taking Aleve or other pain relievers without it interfering with the vaccine?; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 11:00 (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: BACK PAIN (non-serious) with onset 02Apr2021, outcome "unknown", described as "Back pain"; POTENTIATING DRUG INTERACTION (non-serious) with onset Apr2021, outcome "unknown", described as "Caller asked how long can she can take taking Aleve or other pain relievers without it interfering with the vaccine?".  Additional information: She asked if she can take Tylenol & Ibuprofen. She asked how long can she can take taking Aleve or other pain relievers without it interfering with the vaccine. Offered to transfer to Safety (back pain and potential interactions with medication), but Caller declined. Preferred to e-transmit information instead, because Caller said she is not sure if the back pain would be from the shot or from her (has happened before). Response: Spoke from attached documents. Checked the Pfizer-BioNTech COVID-19 EUA PI (LAB-1457-6.0, Revised: 25Feb2021), mentioned no information found on the timeframe before being able to get medications after vaccination, and referred to HCP for guidance. It was unknown if the reporter's contact information available a sub-contracted party. The patient had her 2nd dose of the vaccine yesterday at 11am and she is currently experiencing back pain. She's asking if she can take Tylenol or Ibuprofen. Warm Transfer and created Manual AE Form.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety; This is a spontaneous report received from a non-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 female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing); "burn from her elbow to wrist", start date: 28Mar2021 (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for pain; ADVIL NIGHTTIME taken for pain. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "anxiety".  Additional information: Two days before the 2nd vaccination she suffered an accidental scald burn, her brother, an anesthesiologist recommended and an antibiotic ointment and taking 2 Tylenol + 2 Advil for pain. This was 2 nights before she got her covid vaccine. Then she took a half of a Tylenol the night before she got her vaccine. She didn't want to take anything before the vaccine because she was worried it wouldn't work. Patient states she runs with anxiety in general and states she has a lot of anxiety about this and wants to know if it will affect how the vaccine works for her. Mentioned that not knowing if her medications will impact the COVID-19 vaccine efficacy is causing anxiety.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Headache, Lymphadenopathy, Nausea
Clinical narrative: Mild head/neck upper back ache; Mild head/neck upper back ache; Mild head/neck upper back ache; Mild nausea; Lymphadenopathy axillary and shoulder/neck; Injection arm soreness; Reduced appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 14:00 (Lot number: EP6995) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; PROTONIX [OMEPRAZOLE]; ALIGN; CENTRUM ACTIVE; FIBER. Vaccination history included: Bnt162b2 ({product=COVID, 19, brand=Pfizer, lot_number=EL3247, lot_unknown=False, administration_date=09/03/2021, administration_time=02:00 PM, vaccine_location=Left arm, dose_number=1}]), administration date: 09Mar2021, for Covid-19 immunization at workplace clinic. The following information was reported: HEADACHE (non-serious), NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 31Mar2021 14:00, outcome "unknown" and all described as "Mild head/neck upper back ache"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Injection arm soreness"; DECREASED APPETITE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Reduced appetite"; NAUSEA (non-serious) with onset 31Mar2021 14:00, outcome "unknown", described as "Mild nausea"; LYMPHADENOPATHY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Lymphadenopathy axillary and shoulder/neck". Therapeutic measures were not taken as a result of headache, neck pain, back pain, pain in extremity, decreased appetite, nausea, lymphadenopathy.  Additional information: All began 24 hrs post vax and lasted for 30 hrs post onset. Reporter considered events as non-serious. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no treatment received to the Adverse events. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It is Not aware if patient had any Allergies to medications, food, or other products. other medications that patient received within 2 weeks of vaccination included Vitamin C+D.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Mild head/neck upper back ache; Mild head/neck upper back ache; Mild head/neck upper back ache; Mild nausea; Lymphadenopathy axillary and shoulder/neck; Injection arm soreness; Reduced appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 14:00 (Lot number: EP6995) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; PROTONIX [OMEPRAZOLE]; ALIGN; CENTRUM ACTIVE; FIBER. Vaccination history included: Bnt162b2 ({product=COVID, 19, brand=Pfizer, lot_number=EL3247, lot_unknown=False, administration_date=09/03/2021, administration_time=02:00 PM, vaccine_location=Left arm, dose_number=1}]), administration date: 09Mar2021, for Covid-19 immunization at workplace clinic. The following information was reported: HEADACHE (non-serious), NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 31Mar2021 14:00, outcome "unknown" and all described as "Mild head/neck upper back ache"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Injection arm soreness"; DECREASED APPETITE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Reduced appetite"; NAUSEA (non-serious) with onset 31Mar2021 14:00, outcome "unknown", described as "Mild nausea"; LYMPHADENOPATHY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Lymphadenopathy axillary and shoulder/neck". Therapeutic measures were not taken as a result of headache, neck pain, back pain, pain in extremity, decreased appetite, nausea, lymphadenopathy.  Additional information: All began 24 hrs post vax and lasted for 30 hrs post onset. Reporter considered events as non-serious. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no treatment received to the Adverse events. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It is Not aware if patient had any Allergies to medications, food, or other products. other medications that patient received within 2 weeks of vaccination included Vitamin C+D.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Paraesthesia
Clinical narrative: some sore in her arm; felt a tingling heat sensation and then it felt like a sucker punch in the arm; felt a tingling heat sensation and then it felt like a sucker punch in the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program Support. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8730) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot (Sore Arm with Flu Shot), reaction(s): "sore arm".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "not recovered", described as "some sore in her arm"; PARAESTHESIA (non-serious), FEELING HOT (non-serious) all with onset 31Mar2021, outcome "not recovered" and all described as "felt a tingling heat sensation and then it felt like a sucker punch in the arm". Therapeutic measures were taken as a result of pain in extremity, paraesthesia, feeling hot.  Additional information: Time of vaccination was between 19:30-19:40. The events were treated with Tylenol. Consumer states that patient's first dose was 31Mar2021 and she was scheduled 28Apr2021 for her second dose. She was scheduled later than the normal 21 days. He states her main concern for medical information is for her first dose, she asked the nurse how long have the vaccines been stored and they said they can store it up to 6 days in the fridge. He stated what (name provided) knew was those vaccines can only be stored 5 days in the fridge. He states she was wondering if they vaccinated her with a 6th day stored vaccine and she wanted to know about the lot numbers of the vaccine to know when it has been delivered at facility and for how long.  Caller clarifies when she went there and asked the pharmacist who was distributing the shot, because she knows Pfizer needs to be kept at lower temperature stored, they said they can store in the fridge for up to 6 days, and when she went home it said 5 days. States she is asking if there is a chance that the shot was stored for 6 days in the fridge. Stated maybe they are thinking it can be for 6 days when it is actually 5. Stated she only had arm pain and she had the Covid virus back in January and she heard that if you had Covid you will feel a doozy on the first shot. States she was also wondering if they can trace how long the vaccine was at the (provided). There was no prior Vaccinations (within 4 weeks). There was no family Medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hepatic steatosis, Investigation
Clinical narrative: Headache; I have little liver issue nothing bad but just fatty; 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), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; HEPATIC STEATOSIS (non-serious), outcome "unknown", described as "I have little liver issue nothing bad but just fatty". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got vaccinated on 10Mar2021 and after work, he started to have little of headache and his eyes everything would just gone away so. He had a test done on Wednesday and they told the patient that he/she has a little liver issue nothing bad but just fatty.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: she had sick stomach (nausea); she had sick stomach (nausea); 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Illness at vaccination included: "nausea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "she had sick stomach (nausea)".  Additional information: Shortly after the dose, she had sick stomach (nausea). Someone told her that side effects don't happen right after the dose. It has happened to her after the first dose, yet it is worst this time around. She spoke to someone at the vaccination center who told her that it is a common side effect. She's wondering if it normal to have nausea and what is the time to onset of the side effect. In clinical studies, adverse reactions in participants 16 years of age and older included nausea (1.1%).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Potentiating drug interaction
Clinical narrative: concern on the effect of the Steroid injection; 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. Relevant medical history included: "receives steroid injections for her knee and foot" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "concern on the effect of the Steroid injection".  Additional information: Caller stated that she receives steroid injections for her knee and foot. and has received the Pfizer Covid 19 vaccine 1st dose and is scheduled to receive the second dose on 12Apr2021. In speaking to her HCP there is concern on the effect of the Steroid injection which the caller does not know the name to on the vaccine and would she need a booster. Disclaimer provided: There is no information in the Pfizer Covid 19 vaccine Prescribing Information about a potential interaction or administration with (drug name or drug class or food in question). Please consult with your doctor or pharmacist for further guidance and ensure that your health care providers know all the medications, including over-the-counter (OTC) products, that you are taking, have recently taken or are planning to take. Caller stated that she receives steroid injections for her knee and foot. and has received the Pfizer Covid 19 vaccine 1st dose and is scheduled to receive the second dose on 12Apr2021. In speaking to her HCP there is concern on the effect of the Steroid injection which the caller does not know the name to on the vaccine and would she need a booster. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series. The Regulatory Authority has provided interim considerations for use of Pfizer-BioNTech COVID-19 Vaccine.  These interim clinical considerations from Regulatory Authority note the following But if it is not possible to give the second dose at 3-weeks, it may be given up to 6 weeks (42 days) after the first dose. Please speak to your healthcare provider on this topic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Pain in extremity, Palpitations, Vaccination site pain
Clinical narrative: Her arm was aching; heart feeling like it was raising/beating so much; she wasn't able to go to sleep; Ache in the arm slightly, where she got the vaccine; her heart was racing; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Heart problem" (unspecified if ongoing), notes: pre-existing heart problem. Concomitant medication(s) included: OMEPRAZOLE; HYDROCHLOROTHIAZIDE; LOSARTAN; ASPIRIN [ACETYLSALICYLIC ACID]; METOPROLOL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "unknown", described as "Her arm was aching"; HEART RATE INCREASED (non-serious) with onset 11Mar2021, outcome "unknown", described as "heart feeling like it was raising/beating so much"; INSOMNIA (non-serious) with onset 11Mar2021, outcome "unknown", described as "she wasn't able to go to sleep"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "Ache in the arm slightly, where she got the vaccine"; PALPITATIONS (non-serious) with onset 11Mar2021, outcome "unknown", described as "her heart was racing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip blister
Clinical narrative: blisters along her upper lip; This is a spontaneous report received from a non-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: LIP BLISTER (non-serious), outcome "unknown", described as "blisters along her upper lip".  Additional information: Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on Wednesday. Afterwards, she started to develop blisters along her upper lip. She wants to know if she should do anything to treat it, if this is a common reaction to the vaccine, and if she should still receive the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.