chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 75-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200), intramuscular, administered in arm left, administration date 01Mar2021. Relevant medical history included: "Diabetic", start date: 2014 (ongoing), notes: onset: 7 years ago Doctor checkup every 3 months w/tests diabetes contracted with w/med approx. 1975.; "gallbladder surgery" (unspecified if ongoing); "hysterectomy", start date: 1973 (unspecified if ongoing). Family history included: "cancer lungs " (unspecified if ongoing), notes: Deceased; "multiple illnesses" (unspecified if ongoing), notes: age 84 deceased. Concomitant medication(s) included: TOUJEO taken for diabetes mellitus (ongoing); HUMALOG taken for diabetes mellitus; TYLENOL taken for sinus headache; AFRIN [OXYMETAZOLINE] taken for sinus disorder. She had received her first dose Bnt162b2 (Dose 1, Single; 09:20 AM; Batch/Lot: EL9261; Expiration date: May2021, Anatomical location: Left arm, Administration route: Intramuscular, administration date: 15Feb2021, for Covid-19 immunization. She received her second dose of Vaccine earlier than recommended (14 days instead of the recommended 19-42 days) which is Off-Label dosing. The patient experienced DIZZINESS (non-serious) with onset 02Mar2021, outcome "recovered" (05Mar2021), described as "extremely dizzy"; THIRST (non-serious) with onset 02Mar2021, outcome "recovered" (05Mar2021), described as "cotton ensided thirst". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, thirst. Additional information: Morning after second injection awake very thirsty and extremely dizzy. Mouth felt like it had cotton inside thirst and dizziness lasted 3 days. Dosser giving first injection entered date for second injection at 2 weeks instead of 3. not thinking that it was set at 2 weeks and went on and got second injection. The staff could not filled my paper original had me to prepare a second one they now the original date on my card.Follow-up (13Apr2021): This is a spontaneous follow-up report received from contactable consumer (patient). Updated information: Batch number, expiry date, route of administration was added for vaccine. Concomitant medications were added. Patient's medical history was added. Family history was added. New events (dizziness and thirst) was added. Laboratory test were added. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; SORE ARM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: EN6202) as dose 1, single and intramuscular, administered in arm left (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "recovered" (2021), PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovered" (2021) and all described as "SORE ARM". Therapeutic measures were not taken as a result of pain in extremity, pain in extremity.  Additional information: Prior Vaccinations: None, Family Medical History Relevant To AE(S) was reported to be good Health, No Relevant Test was performed.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: her husbands blood pressure was fluctuating for 3 days; violent headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Mar2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple myeloma/myeloma cancer (as reported)" (unspecified if ongoing), notes: he has a history of Myeloma cancer, Verbatim: Multiple myeloma; "Blood pressure high" (unspecified if ongoing), notes: usually well managed; "Thyroid issues" (unspecified if ongoing); "sinus infection", start date: Jan2021 (unspecified if ongoing), notes: Back in Jan 2021, he had a sinus infection.; "surgeries" (unspecified if ongoing), notes: had surgeries years and years ago. The patient took concomitant medications. Vaccination history included: Flu shot (whenever he gets a flu shot, he will get chills and feels sluggish right after.), for Flu prevention, reaction(s): "chills", "feels sluggish". The following information was reported: BLOOD PRESSURE FLUCTUATION (non-serious) with onset 13Mar2021, outcome "recovered", described as "her husbands blood pressure was fluctuating for 3 days"; HEADACHE (non-serious) with onset 13Mar2021, outcome "recovered", described as "violent headache"; FATIGUE (non-serious) with onset 13Mar2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had no prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021321065 Same reporter/drug/event and different patient
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: bumpy blotches; red / at the vaccine site; vaccine site / itching started today; left arm started hurting immediately after the shot; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 12:00 (Lot number: EN6206) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to penicillin" (unspecified if ongoing); "allergic to Tetanus" (unspecified if ongoing), notes: rapid heart beat, states she was in her 30s. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Mar2021, outcome "recovering", described as "left arm started hurting immediately after the shot"; RASH MACULO-PAPULAR (non-serious) with onset 23Mar2021, outcome "not recovered", described as "bumpy blotches"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "red / at the vaccine site"; VACCINATION SITE PRURITUS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "vaccine site / itching started today".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that her arm started hurting immediately after the shot and has gone from severe to mild, and states it was the same day as the shot. The bumpy blotches that are red are at the vaccine site and the itching started today (day of report).  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Diarrhea; runny nose; chills; became deathly ill; Nausea; fatigue and wiped out, drained; bordering dehydration; vomiting; three horrendous headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 08:30 (Lot number: EL9261, Expiration Date: 05Aug2021) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diarrhea", start date: Dec2016 (unspecified if ongoing), notes: in hospital for three weeks, treated with a bunch of diarrhea, dehydration. drinking pedialyte; "Hiatal hernia" (unspecified if ongoing); "Restless legs" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; PANTOPRAZOLE taken for hiatus hernia; ATENOLOL taken for hypertension; MONTELUKAST, start date: Oct2020; ROPINIROLE taken for restless legs syndrome; SIMVASTATIN taken for hypertension. Vaccination history included: Bnt162b2 (dose 1, Lot number: EL9261, Expiry date: May2021, left arm), administration date: 18Feb2021, when the patient was 78 years old, for COVID-19 Immunization, reaction(s): "no adverse event"; Flu shot (gets the flu shot every single year for 40 years, seldom have a reaction), for immunisation. The following information was reported: MALAISE (non-serious) with onset 20Mar2021, outcome "unknown", described as "became deathly ill"; VOMITING (non-serious) with onset 19Mar2021, outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "Diarrhea"; RHINORRHOEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "runny nose"; CHILLS (non-serious) with onset 20Mar2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 19Mar2021, outcome "recovered" (21Mar2021), described as "three horrendous headaches"; NAUSEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "Nausea"; FATIGUE (non-serious) with onset 20Mar2021, outcome "unknown", described as "fatigue and wiped out, drained"; DEHYDRATION (non-serious) with onset 20Mar2021, outcome "unknown", described as "bordering dehydration". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, vomiting, diarrhoea, rhinorrhoea, chills, headache, nausea. Additional information: Patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Rhinorrhoea, Vomiting
Clinical narrative: Diarrhea; runny nose; chills; became deathly ill; Nausea; fatigue and wiped out, drained; bordering dehydration; vomiting; three horrendous headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 08:30 (Lot number: EL9261, Expiration Date: 05Aug2021) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diarrhea", start date: Dec2016 (unspecified if ongoing), notes: in hospital for three weeks, treated with a bunch of diarrhea, dehydration. drinking pedialyte; "Hiatal hernia" (unspecified if ongoing); "Restless legs" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; PANTOPRAZOLE taken for hiatus hernia; ATENOLOL taken for hypertension; MONTELUKAST, start date: Oct2020; ROPINIROLE taken for restless legs syndrome; SIMVASTATIN taken for hypertension. Vaccination history included: Bnt162b2 (dose 1, Lot number: EL9261, Expiry date: May2021, left arm), administration date: 18Feb2021, when the patient was 78 years old, for COVID-19 Immunization, reaction(s): "no adverse event"; Flu shot (gets the flu shot every single year for 40 years, seldom have a reaction), for immunisation. The following information was reported: MALAISE (non-serious) with onset 20Mar2021, outcome "unknown", described as "became deathly ill"; VOMITING (non-serious) with onset 19Mar2021, outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "Diarrhea"; RHINORRHOEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "runny nose"; CHILLS (non-serious) with onset 20Mar2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 19Mar2021, outcome "recovered" (21Mar2021), described as "three horrendous headaches"; NAUSEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "Nausea"; FATIGUE (non-serious) with onset 20Mar2021, outcome "unknown", described as "fatigue and wiped out, drained"; DEHYDRATION (non-serious) with onset 20Mar2021, outcome "unknown", described as "bordering dehydration". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, vomiting, diarrhoea, rhinorrhoea, chills, headache, nausea. Additional information: Patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Illness, Sinusitis
Clinical narrative: sinus infection; pretty sick; "horrible burning sensation" in head; 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 male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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: ILLNESS (non-serious) with onset 23Mar2021, outcome "unknown", described as "pretty sick"; BURNING SENSATION (non-serious) with onset 23Mar2021, outcome "unknown", described as ""horrible burning sensation" in head"; SINUSITIS (non-serious), outcome "not recovered", described as "sinus infection".  Additional Information: The patient was reported to be prone to sinus infections this time of year and reported it to be particularly bad. His doctor recommended taking antibiotic and asked if it was okay to take it in between the COVID-19 vaccine doses. The second dose was scheduled on 08Apr2021. The patient mentioned that if he did not take anything within 5-10 days, it's going to be so bad and he will be running a fever and did not think he would even be eligible to take the second dose. He wanted to know his options.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Off label use, Product use issue
Clinical narrative: She is breastfeeding; She is breastfeeding; could not sleep last night; felt chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Mar2021 17:30 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing); "COVID-19", start date: Mar2020 (unspecified if ongoing); "Pregnancy", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 22Mar2021 17:30, outcome "unknown" and all described as "She is breastfeeding"; INSOMNIA (non-serious) with onset 22Mar2021, outcome "unknown", described as "could not sleep last night"; CHILLS (non-serious) with onset 22Mar2021, outcome "recovering", described as "felt chills". Therapeutic measures were not taken as a result of insomnia. Therapeutic measures were taken as a result of chills.  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-2021330252 ;US-PFIZER INC-2021330252 Baby case
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pain in extremity
Clinical narrative: "felt a little spritz" on the bottom of his arm near his wrist at some point during administration/the back of his arm above his elbow felt wet afterward; his arm does feel sore; 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 54 year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (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, SINGLE), for COVID-19 immunization. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as ""felt a little spritz" on the bottom of his arm near his wrist at some point during administration/the back of his arm above his elbow felt wet afterward"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his arm does feel sore".  Additional information: The patient was getting 2nd of dose of covid vaccine yesterday and felt a little spritz on his wrist and neck. He said something to person giving vaccine and they said they didn't notice anything. Also he wiped back of his arm and it was also kind of wet. The patient asked if it was possible to push the plunger and cause spray before the needle was inserted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pain in extremity
Clinical narrative: had chills and aches from my fingertips to my toes; had chills and aches from my fingertips to my toes; general feeling of unwell; sore arm; 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. The reporter is the patient.  A 61 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: CHILLS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "had chills and aches from my fingertips to my toes"; MALAISE (non-serious), outcome "unknown", described as "general feeling of unwell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient took Advil on the advice of her doctor before she could get symptoms, because  she was informed that it is harder to get rid of symptoms once it starts, she took it after vaccination, four hours later before going to bed and states that she had taken three doses. Patient reported that the events were non-serious. There is no product quality complaint. Patient wants to know if you receive the first dose of the vaccine is there any coverage at all. Is there anybody with a certain illness that should not get the shot. Do you have any information on Immuno-compromised people, she do know of someone who received the shot, and she is immunodeficient, and just wondering if she was aware. Is there info stating there is a booster or when you will know about a booster. If in fact you receive the Pfizer vaccine and you are scheduled for 3 weeks but cannot go at three weeks, is it safe to get after three weeks. Are the side effects immediate or could the happen a couple days later? She wanted to be around people. People are getting cysts around eyes when wearing mask. She was having that problem.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Impaired quality of life
Clinical narrative: fatigued/tired; could not workout; he was not up to exercising/ He did not have the energy to do it; 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 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 11:15 (Lot number: EN6203) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Irregular Heartbeat" (ongoing), notes: Verbatim: Irregular Heartbeat, A-Fib; "A-Fib" (ongoing), notes: Verbatim: Irregular Heartbeat, A-Fib; "sick", start date: Feb2020, stop date: Feb2020, notes: States he was sick in Feb2020. Concomitant medication(s) included: BYSTOLIC taken for heart rate irregular, atrial fibrillation, start date: 2016 (ongoing). Past drug history included: Metoprolol 100mg, reaction(s): "Irregular Heartbeat"; Metoprolol 100mg, reaction(s): "A-Fib", notes: he was diagnosed about 18 years ago and was on Metoprolol 100mg for about 13 years. Vaccination history included: Flu shot (Caller states that he has gotten the flu shot every year for maybe 28 years.In that time maybe twice he has had chills and a slight fever that lasted about 24 hours.), administration date: Oct2020, reaction(s): "chills", "slight fever".  The following information was reported: FATIGUE (non-serious) with onset 10Mar2021 14:15, outcome "recovered" (15Mar2021), described as "fatigued/tired"; IMPAIRED QUALITY OF LIFE (non-serious) with onset Mar2021, outcome "recovered" (15Mar2021), described as "could not workout"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered" (15Mar2021), described as "he was not up to exercising/ He did not have the energy to do it".  Additional information: He stated that he got his first shot 2 weeks ago. Is curious to hear about possible side effects of the second vaccine. States he had 3-4 days of fatigue after the first shot. Should he expect the same from the second. Stated he is not hearing too much with the first shot. Says three hours after his vaccine he was tired, slept for a few hours. The next couple of days he was not up to exercising. States he always exercises but did not feel like doing so during that time. He did not have the energy to do it. States that he read that some people who had side effects on the first dose may have had Covid previously. Or may not have the same experience for the second shot. Wanting to know if Pfizer has any information available on that.His second dose is due a week from today and wanted to know about it. Surrounded by elderly people., Has young kids, didn't want kids to get him sick and then he gets it and pass it to someone else. No prior vaccinations (within 4 weeks).  . No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Vaccination site pain
Clinical narrative: pain in the injections site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EN9266) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "pain in the injections site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated she received it in the right arm and has had pain in the injections site up until now. She stated it was worse at night. She thought it would only last two or three days. She stated she got the second dose in her left arm and only had soreness for a day or to and then went away. She said with her second COVID-19 Vaccine shot, she didn't have any problems. Reported her right arm pain gets worse at night in the spot where she got the COVID-19 Vaccine. She said she had  , and read that arm pain could be caused by the needle used to give the injection, and the needle may have hit a nerve. Reported she had received her first COVID-19 Vaccine dose on 26Feb2021 between 10:00-11:00 in her right arm, providing Pfizer Lot Number: EN9266. She said her second COVID-19 Vaccine was administered on 19Mar2021 at approximately 10:00 in her left arm, providing Pfizer Lot Number: EN6207. She said there was no NDC Number and Expiration Date listed for the 1st and 2nd COVID-19 Vaccine doses. Clarified her right arm pain as injection site pain. She said the injection site pain started about a day or two after she had her first COVID-19 Vaccine. She said today (24Mar2021), she can hardly feel the right arm injection site pain, and maybe her (right) arm was finally starting to heal. Reported she used Tylenol (clarified as Extra Strength Tylenol 500mg caplet (NDC Number: 50580-937-19, Lot Number: SMA033, Expiration Date: Aug2024) and Atelex Natural (pain cream dispensed in a jar) (UPC Number: 1027103323, Lot Number: 19263 as provided by caller, who stated the Lot Number was faded out and looked like it was smudged off and Expiration Date: Sep2021), ice packs, and a little pain cream (clarified as Atelex Natural) on her right arm injection site pain. Reported she used the Extra Strength Tylenol and Atelex Natural pain cream for a few days on her right arm injection site pain, and was now basically using an ice pack to treat her pain.Reported on 12Feb2021 she had a mammogram, and was told she needed to have another mammogram image done on 31Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ears; 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 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Mar2021 13:15 (Lot number: EN6208) at the age of 34 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: TINNITUS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "ringing in the ears". The event "ringing in the ears" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional Information: History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer Suspect both were none. Adverse event(s) following prior vaccinations were none. Reportedly, the patient got vaccinated Monday (22Mar2021; Dose: 0.3 IM injection) at clinic and she developed ringing in ear Tuesday (23Mar2021) when she was waking up. She had no prior symptoms, and she was still having it today. She was getting a little worried especially reading everything about it. She stated she was sorry the ringing in the ear was throwing her off. She didn't have a primary care, but she had seen 2 doctors already this morning. She asked was this a common thing was it happening to other people. She has seen 2 doctors this morning, one was virtual and then she went to a MD walk in clinic. She was prescribed Zyrtec for a possible allergic reaction. Prior Vaccinations (within 4 weeks) was none, she had been at home for a year. She would like to speak to someone with medical information, she doesn't know and can't get any information of if this is going to be permanent, if it was going to continue. Emergency Room, Relevant Tests and investigation assessment was none.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Oropharyngeal discomfort
Clinical narrative: I felt a "metallic feeling in my throat, like the chemicals in my throat; dizzy; 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 47 year-old female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (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 DISCOMFORT (non-serious) with onset 08Mar2021, outcome "unknown", described as "I felt a "metallic feeling in my throat, like the chemicals in my throat"; DIZZINESS (non-serious) with onset 08Mar2021, outcome "unknown", described as "dizzy".  Additional Information: The patient had my first Pfizer Biontech COVID 19 vaccine dose 2 weeks ago on 08Mar2021; second dose scheduled on 31Mar2021. The patient had a reaction to the first dose; as soon as injection went into my arm and felt a "metallic feeling in my throat, like the chemicals in my throat; this feeling lasted about 2 hours. The patient stayed there for 15 minutes and was fine. The patient was dizzy on my drive home. Everything subsided within 2 hours". The patient don't have lot of time." As consumer was not willing to proceed the call. Product details (Expiration date, NDC and UPC), Pharmacy details and treatment could not be probed over the call. Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain, Vaccination site pain
Clinical narrative: body aches; Fatigue; headache; injection site pain; Not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021325744 (Pfizer).  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 11:15 (Lot number: EN6203) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Lot_number=EN6203, administration time=01:30 PM, Vaccine location=Left arm), administration date: 01Mar2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 24Mar2021 02:30, outcome "recovered" (24Mar2021 11:30), described as "body aches"; FATIGUE (non-serious) with onset 24Mar2021 02:30, outcome "recovered" (24Mar2021 11:30), described as "Fatigue"; HEADACHE (non-serious) with onset 24Mar2021 02:30, outcome "recovered" (24Mar2021 11:30), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2021 02:30, outcome "recovered" (24Mar2021 11:30), described as "injection site pain"; MALAISE (non-serious) with onset 23Mar2021 11:00, outcome "recovered" (24Mar2021 11:30), described as "Not feeling well". Therapeutic measures were not taken as a result of pain, fatigue, headache, vaccination site pain. It was unknown if therapeutic measures were taken as a result of malaise.  Additional information: No other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient in question was a Pfizer colleague. The colleague informed on Wednesday morning, 24Mar2021 that she had started not feeling well overnight the previous evening of 23Mar2021, following her 2nd COVID vaccine dose. Subsequent to filing report, the colleague informed that she had returned to feeling well by 11:30 AM 24Mar2021 and she had submitted her own safety report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Oropharyngeal pain
Clinical narrative: sore throat; ears feel like she just got off a plane; This is a spontaneous report received from a contactable Consumer from medical information team. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (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) with onset Mar2021, outcome "unknown", described as "sore throat"; EAR DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "ears feel like she just got off a plane".  Additional information: She is calling about the Covid 19 vaccine. She got her first dose on 05Mar2021 and the past 2 days she feels like she has a sore throat and her ears feel like she's just gotten off an airplane. Her second dose is scheduled for today, she is asking if she should get the second vaccine. She declines to file a safety report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itching on the injection site / kind of red and it is really itchy; itching on the injection site / kind of red and it is really itchy; 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), administration date 06Mar2021 (Lot number: EN6205) 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: INJECTION SITE PRURITUS (non-serious), INJECTION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "itching on the injection site / kind of red and it is really itchy".  Additional Information: The patient just has a question about how common itchiness is at the site of the Pfizer vaccination. I am about to get my 2nd one and I had itchiness like couple a days after at the injection site, kind of red and it is really itchy and I just wanted to know how common that was and whether I should be concerned at all that it will be worse for my second one.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Tiredness/ Fatigue; Muscle aches; Dizziness; Headache; Nausea; Injection soreness that had faded after 2 days; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 02:30 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZINC; GINKOBA; CALCIUM; MAGNESIUM; VITAMIN B; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Mar2021 15:45, outcome "recovered" (22Mar2021 15:45), described as "Injection soreness that had faded after 2 days"; FATIGUE (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Tiredness/ Fatigue"; MYALGIA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Muscle aches"; DIZZINESS (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, myalgia, dizziness, headache, nausea.  Additional Information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness/ fatigue, muscle aches, dizziness, headache and nausea from Day 4 (22Mar2021) to Day 7 (25Mar2021) after the shot.  On Day 07,tiredness/ fatigue, muscle aches, dizziness, headache and nausea were worse. The patient was a part of a weekly CDC asymptomatic COVID-19 testing program at the (name withheld) university. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  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: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Tiredness/ Fatigue; Muscle aches; Dizziness; Headache; Nausea; Injection soreness that had faded after 2 days; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 02:30 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZINC; GINKOBA; CALCIUM; MAGNESIUM; VITAMIN B; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Mar2021 15:45, outcome "recovered" (22Mar2021 15:45), described as "Injection soreness that had faded after 2 days"; FATIGUE (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Tiredness/ Fatigue"; MYALGIA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Muscle aches"; DIZZINESS (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, myalgia, dizziness, headache, nausea.  Additional Information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness/ fatigue, muscle aches, dizziness, headache and nausea from Day 4 (22Mar2021) to Day 7 (25Mar2021) after the shot.  On Day 07,tiredness/ fatigue, muscle aches, dizziness, headache and nausea were worse. The patient was a part of a weekly CDC asymptomatic COVID-19 testing program at the (name withheld) university. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  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, Insomnia, Pain, Pain of skin
Clinical narrative: generalized pain/she needs to lay in bed because of the pain experienced and even be in bed results painful; I cannot really do a lot of work because it like walk more than about an hour; like house hold stuff, cleaning and whatever; I just exhausted; Every time I take shower my skin hurts, my scalp hurts; I cannot sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6199) 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 "not recovered", described as "generalized pain/she needs to lay in bed because of the pain experienced and even be in bed results painful"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "I cannot really do a lot of work because it like walk more than about an hour; like house hold stuff, cleaning and whatever; I just exhausted"; PAIN OF SKIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Every time I take shower my skin hurts, my scalp hurts"; INSOMNIA (non-serious) with onset Mar2021, outcome "not recovered", described as "I cannot sleep". Therapeutic measures were taken as a result of pain, fatigue, pain of skin, insomnia.  Additional information: A Consumer calls for information about if she should be vaccinated considering the side effects she developed for the administration of the first dose of the Pfizer COVID-19 vaccine. The Consumer reports that she was administered with the first dose of the Pfizer COVID-19 vaccine 15 days ago and after that she experienced generalized pain that continues up to this day. The Consumer reports that she needs to lay in bed because of the pain experienced and even be in bed results painful, she cannot walk for a distance because of pain and exhaustion and she needs to take a rest before she can continue, the Consumer reports that even the water from the shower hurts while she is taking a bath. Consumer stated, "Well, I took my vaccine about 15 days ago. I am still aching and I am in pain. Every time I take shower my skin hurts, my scalp hurts. The Consumer reports that she is taking Tylenol for the management of the symptoms. The Consumer reports that she is scheduled for the administration of the second dose on 31Mar. When paraphrased the above concern, Consumer stated, "Right. I am just wondering what to do? Is like every day you know I am just in pain. I am just worried I guess."  No follow-up attempts are possible. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Sinusitis, Tinnitus
Clinical narrative: ringing in ears; headache; sinuse infection.; having a tingling in her ears; 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. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "having a tingling in her ears"; TINNITUS (non-serious) with onset 07Mar2021, outcome "unknown", described as "ringing in ears"; HEADACHE (non-serious) with onset 07Mar2021, outcome "unknown", described as "headache"; SINUSITIS (non-serious) with onset 07Mar2021, outcome "unknown", described as "sinuse infection.". The events "ringing in ears" and "sinuse infection." were evaluated at the emergency room visit.  Additional information: Patient received the 1st dose of the Pfizer covid vaccine 3 weeks ago. She is supposed to get the next one tonight. 3 or 4 days after the 1st dose, she started having a tingling in her ears, like a white noise.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: The first dose of the vaccine I felt really bad; Strong headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "The first dose of the vaccine I felt really bad"; HEADACHE (non-serious), outcome "unknown", described as "Strong headache".  Additional information: Proprietary medicinal product name: Pfizer-BioNTech Covid-19 Vaccine. Patient got the Pfizer-BioNTech Covid-19 Vaccine last week and her husband too, Patient had a family member who got sick with the COVID 7 months ago, she got really sick and had trouble breathing, it was serious and asked whether she should get vaccinated or not. The first dose of the vaccine patient felt really bad, she had a really strong headache and other symptoms, but patient feels better now. It was reported that patient felt the first dose very strong. The report was non-serious  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 assessment, Therapeutic response unexpected
Clinical narrative: noticed that she no longer experienced pain;  the vaccine to help with Fibromyalgia; 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), administration date 27Jan2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 2016 (unspecified if ongoing), notes: I had something called Fibromyalgia I was first diagnosed in 2016. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 28Jan2021, outcome "unknown", described as "noticed that she no longer experienced pain;  the vaccine to help with Fibromyalgia". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Age: 83; Unit: Unknown. Consumer stated, "I took the Pfizer Covid Vaccine on 27Jan and I just wanted to report to them that I had a very unusual reaction to it, it was a positive reaction. Patient had Fibromyalgia, which was first diagnosed in 2016, patient had it before but they couldn't diagnose it. Patient had been on all kind of drugs (Unspecified Medications), all kinds of acupuncture and Medical marijuana and nothing had helped. Patient took the Pfizer Covid vaccine, on 27Jan and woke up next morning and haven't had the Fibromyalgia like it was. Patient went from the pain level of 8 to 10 or 12 everyday but now the pain level was down to between 1 and 2 and in a lot of days, patient had zero or between 0 and 2 but most of the time its zero. I don't know what is in the vaccine or it is just a coincident. I just felt that Pfizer should know about it because there might be something in that vaccine that could help fibromyalgia patients." Patient had second dose on 17Feb2021, Lot number "E19267." ( not appropriately clarified further, hence LOT# for the first shot captured in tab).  No follow-up attempts are possible. No further information is expected.