chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: tinnitus or ringings in her 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 81-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus or ringings in her ears". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient said that 2 days after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, she experienced tinnitus or ringing in her ears. She said they have been ringing ever since after that. She also mentioned that she heard that some people have also reported ringing in the ears after getting the vaccine. Consumer wants to know if this is a common reaction to the vaccine, and what she should do about it. She said she already consulted an ear specialist, and had a hearing test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in his leg; 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 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: but he immune system problems: asthma and allergies so that could be the reason; "Allergy" (unspecified if ongoing), notes: but he immune system problems: asthma and allergies so that could be the reason. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in his leg".  Additional Information: It was reported that, the patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on 19Apr2021 around 5:30PM in the next morning he got up and had a bagel with cream cheese for breakfast with his husband, his husband told him that the cream cheese was sour, but he could not taste that. He went to work and took a coffee and didn't have taste, it was like water, he had no taste or smell. Next day he went to the doctor to see what was going on if he had COVID-19 and he did a test (Tuesday 10:00AM) and it was negative (the smell and taste came back on Saturday) Next day (Wednesday) he could barely walk, had joint pain, headache and pain in his while body (like a horrible flu). The pain in his leg started after the first dose, however after the second dose the pain was worse, and it's been almost 3 weeks. On Saturday and Sunday, he felt better but he still has joint pain and in his bottom part is worse (leg). It was also mentioned that he feels very weak, has cold sweat all the time and some cough (but he immune system problems: asthma and allergies so that could be the reason). Caller received other 2 tests on Thursday or Friday (same week after second dose) and the results were negative.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: hands are now swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (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: PERIPHERAL SWELLING (non-serious) with onset 30Apr2021, outcome "unknown", described as "hands are now swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: developed small red bumps all over his body/it came to his arm and now it's all over the body; 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 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 12:30 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH PAPULAR (non-serious) with onset 03May2021, outcome "recovering", described as "developed small red bumps all over his body/it came to his arm and now it's all over the body".  Additional Information: Patient took his first Pfizer Covid vaccine dose on 27Apr2021 and states "a couple of days later" he developed small red bumps all over his body. Patient said that he took the first dose of vaccine last week on Tuesday. He forgot the exact date. He is just now experiencing what he would say is an allergic reaction. He is getting a lot of red bumps all over the body. It started 3 days ago on his back and he had his wife rub alcohol on it. Yesterday it came to his arm and now it's all over the body. Patient had not taken prior Vaccinations (within 4 weeks)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: The patient wanted reschedule her appointment for the second dose because she had cold.   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-2021508100 same reporter, drug, event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold".  Additional information: The reporter received first dose and wanted to reschedule her appointment for the second dose because she has a cold. She mentioned that not only her who get a cold and wanted to reschedule but there was 3 others in her household as well. This case is for 1/3.  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-2021508100 same reporter, drug, event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Minor discomfort in same spot after first dose, but no swelling, only last one day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 15:00 (Lot number: ER2613) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "Minor discomfort in same spot after first dose, but no swelling, only last one day". Therapeutic measures were not taken as a result of discomfort.  Additional information: It was reported that Swelling and slight pain in left armpit after second dose (started two days later, worse on third day). Minor discomfort in same spot after first dose, but no swelling, only last one day. 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 did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she is still experiencing fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Family history included: "allergic to sulfa" (unspecified if ongoing); "Lyme's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "she is still experiencing fatigue".  Additional information: The patient stated that she received both doses of the vaccine, the last one was on 26Feb2021 and patient reported that she was still experiencing fatigue. She asked if that was something we have heard of. She had an appointment with the doctor on Tuesday.  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 pain upper, Oropharyngeal pain
Clinical narrative: Her throat hurts a little bit and her stomach hurts a little bit.; Her throat hurts a little bit and her stomach hurts a little bit.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 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: OROPHARYNGEAL PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "Her throat hurts a little bit and her stomach hurts a little bit.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Malaise, Pain
Clinical narrative: Very achy; Felt Run Down; In bed for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 84 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 84 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "Very achy"; MALAISE (non-serious), outcome "recovered", described as "Felt Run Down"; BEDRIDDEN (non-serious), outcome "recovered", described as "In bed for 2 days". Additional information: On blood thinners at time of vaccine No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received BNT162B2 (Batch/Lot number: unknown, Expiration date: 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: ILLNESS (non-serious), outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day at the age of 60 years as dose 1, single and (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The reporter states she had a sore arm after receiving both doses of the Pfizer COVID vaccine. She states she was 60 at the time she received the doses and she is now 61. No information in PI regarding if someone who administered the vaccine had COVID and still had antibodies is able to pass COVID on to other people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence, Pain in extremity
Clinical narrative: loose bowels; Diarrhea; excess gas/getting a lot of gas. Sounds like a war going on in the stomach; sore arm/Ver, very little pain; 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 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gall bladder out" (unspecified if ongoing), notes: gall bladder out 3 or 4 years ago; "depression" (unspecified if ongoing); "blood cholesterol " (unspecified if ongoing). Concomitant medication(s) included: BUPROPION taken for depression; SERTRALINE HCL taken for depression; SIMVASTATIN taken for blood cholesterol abnormal. The following information was reported: DIARRHOEA (non-serious), outcome "not recovered", described as "loose bowels"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; FLATULENCE (non-serious), outcome "unknown", described as "excess gas/getting a lot of gas. Sounds like a war going on in the stomach"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm/Ver, very little pain". Therapeutic measures were taken as a result of diarrhoea, diarrhoea.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; pretty full body aches, head to toe; 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 34 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW0164, Expiration Date: 31Aug2021) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EP6955, Anatomical location: Right arm), administration date: 26Mar2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "Sore arm", "positive blood test for celiac disease", "Reporter added they basically said to redo all the shots.". The following information was reported: HEADACHE (non-serious) with onset 17Apr2021, outcome "recovered" (17Apr2021), described as "headache"; PAIN (non-serious) with onset 17Apr2021, outcome "recovered" (17Apr2021), described as "pretty full body aches, head to toe".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect was none. No any additional vaccines administered on same date of the Pfizer suspect. Their was no AE's following prior vaccination. The patient had not received any other vaccine within 4 weeks. Adverse events did not require emergency room and physician office visit. Vaccine administered by injection. No patient's medical history (including any illness at time of vaccination).  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Mammogram, Pain in extremity
Clinical narrative: first dose, sore arm for a day or 2; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Muscle achiness" (unspecified if ongoing), notes: Verbatim: Muscle achiness; "high blood pressure" (ongoing), notes: Verbatim: high blood pressure; "breast cancer", start date: 2016 (unspecified if ongoing); "chemo" (unspecified if ongoing), notes: series of 3 months of chemo. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "first dose, sore arm for a day or 2". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has high blood pressure, she takes a prescription blood pressure med for that, she takes supplements like vitamins on her own. No further information provided. She does have a history of breast cancer that developed in 2016 she went through a series of 3 months of chemo and she is being monitored for the cancer. She has been checked regularly for 5 years by her chemo lady and the surgeon. They check her every 3 months, so she is being monitored for that. She does not know if that makes any difference but it was what they called an aggressive, invasive triple negative type cancer. They described it as invasive and aggressive but she had one small lesion and they decided it was a grade 1 but she researched it online and that type has a higher percentage of coming back sooner than 5 years. She does not know if that has any bearing but she has had yearly chest x-rays and mammograms and those have been negative.  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-2021476097 similar report from same reporter
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red Patch on Skin at Injection Site on Left Arm; no pain, no itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 59-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 13:00 (Lot number: EN6204) at the age of 59 years as dose 1, single and administered in arm left, administration date 15Apr2021 13:00 (Lot number: EW0151) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1989 (ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 19Mar2021, described as "Red Patch on Skin at Injection Site on Left Arm; no pain, no itching". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: Caller states had her first vaccine on 18Mar2021 and immediately developed a red patch on her skin. Caller states he doesn't know how common this is. Caller clarifies the red patch is at the injection site and it didn't go away. Caller states she received the second injection in the same spot on 15Apr2021, and she still has the red patch, it has persisted. States it doesn't hurt, no rash, just red. Caller states, just to clarify, the skin is not broken up. Caller states he is calling to see if anything like this has been reported or if it is normal. Caller clarifies that the patient noticed the red patch the next day when she removed the band-aid. Caller clarifies the rash started after the first dose of the vaccine and persisted all the way to the second vaccine and continued to persist. Clarifies there is no pain, no itch, it is just different. Patient did not received any treatment.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain after #1 covax on 12/2; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2020 (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: NECK PAIN (non-serious), outcome "not recovered", described as "Neck pain after #1 covax on 12/2". The event "neck pain after #1 covax on 12/2" was evaluated at the physician office visit. Therapeutic measures were taken as a result of neck pain.  Additional information: The patient reported that Chiropractor more than 10 mins, endocrinologist and there was no improvement, had be on medication and cream.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergies were acting up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Apr2021 (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: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "Allergies were acting up".  Additional information: The reporter asked what were the side effects and does it affect with people with allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: arm sore; couldn't move it; 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 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm sore"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "couldn't move it". Additional information: Reporter state that Has allergies like runny nose that  started  last Saturday. Due for 2nd dose the 20th, Also states her Mother and friend had the vaccine and their allergies were acting up. Her mom says her nose was stuffy. Her boyfriend had his arm sore and couldn't move it but was ok the next day.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: Sore throat from Postnasal drip; Sore throat from Postnasal drip; 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) (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: UPPER-AIRWAY COUGH SYNDROME (non-serious), OROPHARYNGEAL PAIN (non-serious), outcome "unknown" and all described as "Sore throat from Postnasal drip". Additional information: Transferring agent Stated, "(Name) said that she is experiencing sore throat from Postnasal drip right now and today is her second dose schedule of the vaccine she is asking if you have symptoms of allergy, aren't you able to take the COVID 19 Vaccine that is the question." Consumer was provided with the number of Pfizer Medical Information # and was requested to select option 3, timings as and 8 am to 8 pm Monday to Fridays and 9 am to 3 pm on Saturday and Sunday as per (EST). No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Tingling and stiffness on the side I received the shot; Tingling and stiffness on the side I received the shot/limb stiffness; I'm also still having headaches,  to the point I have to take advil (Tylenol was not helping).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 16:15 (Lot number: Ew0171) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Ew0153, Administration time: 10:00, route of administration: unspecified ), administration date: 10Apr2021, when the patient was 35 years old, for COVID-19 immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 02May2021, outcome "not recovered", described as "Tingling and stiffness on the side I received the shot"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 02May2021, outcome "not recovered", described as "Tingling and stiffness on the side I received the shot/limb stiffness"; HEADACHE (non-serious) with onset 02May2021, outcome "not recovered", described as "I'm also still having headaches, to the point I have to take advil (Tylenol was not helping).". Therapeutic measures were not taken as a result of paraesthesia, musculoskeletal stiffness. Therapeutic measures were taken as a result of headache.  Additional information: The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 the patient experienced tingling and stiffness on the side she received the shot. She received the shot in left arm, and had issues in both that arm and leg. The tingling was subsiding in arm. Leg, the tingling and stiffness had subsided below the knee, but still felt it above. She was more uncomfortable than in pain from these issues. Also still having headaches. Patient received ADVIL for headache as TYLENOL was not helping. She also reported that, she may need to contact her doctor soon if this doesn't resolve itself. It had been days at that point. The event 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. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 05May2021, outcome "unknown", described as "not feeling well".  Additional information included patient received the first dose of the vaccine today. She was currently not feeling well. She wanted to know if she can take Tylenol or Advil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swollen feet and hands; 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 parent.  A male patient received bnt162b2 (BNT162B2), administration date 03May2021 (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 : 01), administration date: 12Apr2021, for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 04May2021, outcome "unknown", described as "swollen feet and hands".  Additional Information: Today morning her son had extremely swollen feet and hands, that's why would like to know if this is a normal symptom / side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Feeling of body temperature change, Headache, Nausea
Clinical narrative: Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better; Body aches; Bad Headache; No fever probably some hot and cold feeling; Nausea; Vomiting/Throwing up; Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Lot number: EW0164, Expiration Date: Aug2021) 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, reaction(s): "Her first one she did fine with". The following information was reported: NAUSEA (non-serious) with onset 01May2021, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 01May2021, outcome "unknown", described as "Vomiting/Throwing up"; FEELING ABNORMAL (non-serious) with onset 01May2021, outcome "unknown", DECREASED APPETITE (non-serious), outcome "unknown" and all described as "Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown", described as "Bad Headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "No fever probably some hot and cold feeling". Therapeutic measures were taken as a result of nausea, vomiting.  Additional information: The patient received the Pfizer Covid-19 Vaccine on Friday and she was having some side effects. She had started having a lot of nausea and vomiting last night. She had not really been able to keep anything down. She did not feel good that day, but it was kind of what they expected. This was her second one, her first one she did fine with, had the body aches and did not feel like eating and really did not eat or drink very much and then about 1:30 last night she called the reporter because she was throwing up and she had continued to throw up. She had some Zofran (treatment) on hand had taken that and just like helped for a while but now was throwing up again and since then she had not really eaten anything, so the reporter was concerned about vomiting. The reporter knew nausea could be a side effect. This kind of vomiting, was that something they could see. Along with that she had got a really bad headache, the body aches were better, there was no fever probably some hot and cold feeling which they would expect.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better; Body aches; Bad Headache; No fever probably some hot and cold feeling; Nausea; Vomiting/Throwing up; Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Lot number: EW0164, Expiration Date: Aug2021) 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, reaction(s): "Her first one she did fine with". The following information was reported: NAUSEA (non-serious) with onset 01May2021, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 01May2021, outcome "unknown", described as "Vomiting/Throwing up"; FEELING ABNORMAL (non-serious) with onset 01May2021, outcome "unknown", DECREASED APPETITE (non-serious), outcome "unknown" and all described as "Not really been able to keep anything down side; effects; not feel good; not feel like eating and did not eat or drink; does not get better"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown", described as "Bad Headache"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "No fever probably some hot and cold feeling". Therapeutic measures were taken as a result of nausea, vomiting.  Additional information: The patient received the Pfizer Covid-19 Vaccine on Friday and she was having some side effects. She had started having a lot of nausea and vomiting last night. She had not really been able to keep anything down. She did not feel good that day, but it was kind of what they expected. This was her second one, her first one she did fine with, had the body aches and did not feel like eating and really did not eat or drink very much and then about 1:30 last night she called the reporter because she was throwing up and she had continued to throw up. She had some Zofran (treatment) on hand had taken that and just like helped for a while but now was throwing up again and since then she had not really eaten anything, so the reporter was concerned about vomiting. The reporter knew nausea could be a side effect. This kind of vomiting, was that something they could see. Along with that she had got a really bad headache, the body aches were better, there was no fever probably some hot and cold feeling which they would expect.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: he's had a swollen gland on his left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (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 (1st shot of covid vaccine, No reaction), for Covid-19 immunization, reaction(s): "No reaction". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "unknown", described as "he's had a swollen gland on his left side".  Additional information: Caller got his 2nd dose on 01Apr2021 and for about a week now he's had a swollen gland on his left side. He wants to know if that is normal or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The swelling in his lymph nodes, by his armpit; 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 male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "The swelling in his lymph nodes, by his armpit". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Caller verified that he received Pfizer Covid vaccine, first dose on 13Apr2021, second dose on 04May2021, and asked regarding his experience: "the swelling in his lymph nodes, by his armpit" how long may that last?    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Synovial cyst
Clinical narrative: She had lymphatic ganglion after the first dose; Swollen lymph nodes; 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. Other Case identifier(s): US-PFIZER INC-2021498629 (Pfizer).  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 14:00 (Lot number: EW0179) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNOVIAL CYST (non-serious) with onset 03May2021, outcome "not recovered", described as "She had lymphatic ganglion after the first dose"; LYMPHADENOPATHY (non-serious) with onset 03May2021, outcome "recovered" (13May2021), described as "Swollen lymph nodes".  Additional Information: Patient did not visited emergency room or physician office. No prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; Started having flu symptoms; 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 23Apr2021 (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 (non-serious) with onset 2021, outcome "unknown", described as "Started having flu symptoms"; COVID-19 (non-serious) with onset 01May2021, outcome "unknown", described as "tested positive for Covid". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient received first dose of the Pfizer BioNTech Covid 19 on 23Apr2021. That Wednesday she started having flu symptoms and tested positive for Covid on 1May2021. She was due for her second dose 14May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: tenderness and a little swelling at injection site; tenderness and a little swelling at injection site; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 16:00 (Lot number: ER8730) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: known allergies: codeine. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "tenderness and a little swelling at injection site"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, fatigue.  Additional information: The patient received the first dose of BNT162b2 via an unspecified route of administration. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse events did not result in doctor or other healthcare professional office, or clinic visit and emergency room or department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: her muscles became sore.; her arm started getting sore about 3 hours after the vaccine; 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 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: EW0167) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 05May2021, outcome "recovering", described as "her muscles became sore."; VACCINATION SITE PAIN (non-serious) with onset 05May2021, outcome "recovering", described as "her arm started getting sore about 3 hours after the vaccine".  Additional information: Reporter stated that she got the Pfizer Covid-19 vaccine day before and she had some questions regarding the Approval, stated that her muscle was sore day before, stated this was minor. Reporter queried that why the vaccine was not yet approved and asked when the full approval by the would be given. Reporter was wondering why it takes so long for the to give the full approval. Response was Spoke and explained from attached documents, also as per Q&A (section: What is Emergency Use Authorization, Is it the same. Reporter also queried that Pfizer-BioNTech COVID-19 Vaccine; where the vaccines are made. Reporter seriousness for arm sore was Unspecified.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat; Fatigue; She felt sick; 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 23 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; MALAISE (non-serious), outcome "unknown", described as "She felt sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient asked if she could delay her 2nd dose schedule that was supposedly tomorrow. Stated she felt sick and fatigue after her 1st dose and tested negative from covid-19 virus and was supposed to get the second dose of the Pfizer-BioNTech Covid-19 Vaccine today and then because she was sick with past 3 days with fatigue and sore throat. She wanted to know if she could get the second dose. So basically, she was fatigue and Sore throat she was sick for the past 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Malaise
Clinical narrative: extreme fatigue; coldness; He also mentioned that he always don't feel right.; 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 49 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (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: FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; FEELING COLD (non-serious), outcome "unknown", described as "coldness"; MALAISE (non-serious), outcome "unknown", described as "He also mentioned that he always don't feel right.".  Additional Information: The patient had experienced side effects following the vaccine. 5 days after getting the vaccine, patient experienced extreme fatigue and coldness. Patient mentioned that he had almost missed 2-weeks worth of work because of this. Caller said they got their dose on February and had still been experiencing some of the fatigue till today.  Patient wanted to know if we have any reports of lingering fatigue. Patient also mentioned that he always don't feel right.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.