chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: I feel tired; headache; nauseated; sometimes and I have no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 16:30 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfonamides, notes: Verbatim: Sulfa antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I feel tired"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "nauseated"; DECREASED APPETITE (non-serious), outcome "unknown", described as "sometimes and I have no appetite". Therapeutic measures were not taken as a result of fatigue, headache, nausea, decreased appetite. Therapeutic measures were not taken as a result of fatigue, headache, nausea, decreased appetite.  Additional information: I feel tired, I have a headache, I feel nauseated sometimes and I have no appetite, for two days now I've only had two noodles and a couple snacks, this started late Monday. device timestamp: 18May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24Jun2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Mass fatigue 6 hrs post vaccine; Vomit 4.50 hours post vaccine; Nausea 3 hours post vaccine/ nausea lasted all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 09:30 (Lot number: EW0177) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CENTRUM VITAMINTS. Vaccination history included: Bnt162b2 (Lot number: ER8736, Administration time: 11:15 AM, Vaccine location: Left arm, Dose number: 1), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 17May2021 12:30, outcome "recovered" (May2021), described as "Nausea 3 hours post vaccine/ nausea lasted all day"; VOMITING (non-serious) with onset 17May2021 14:20, outcome "recovered" (May2021), described as "Vomit 4.50 hours post vaccine"; FATIGUE (non-serious) with onset 17May2021 15:30, outcome "recovered" (May2021), described as "Mass fatigue 6 hrs post vaccine". Therapeutic measures were not taken as a result of nausea, vomiting, fatigue.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. Patient did not received any other vaccines within 4 weeks prior to Covid vaccine. Reported Event: nausea 3 hours post vaccine. vomit 4.50 hours post vaccine. mass fatigue 6 hrs post vaccine. nausea lasted all day.Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination the patient was not tested for Covi-19. Patient did not had allergies. Device Date: 19May2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site pain
Clinical narrative: Left arm ached at injection site in the evening.; Felt extra warm from evening to morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18May2021 13:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18May2021, outcome "recovering", described as "Left arm ached at injection site in the evening."; FEELING HOT (non-serious) with onset 18May2021, outcome "recovering", described as "Felt extra warm from evening to morning". Therapeutic measures were not taken as a result of vaccination site pain, feeling hot.  Additional information: Unknown if any other medication patient received within 2 weeks of vaccination. Unknown if patient received any other vaccine within 4 weeks prior to the COVID vaccine. Unknown if prior to vaccination patient was diagnosed with COVID-19 and since the vaccination patient was tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: some of the Covid-19 vaccine ran down his arm/ Administrating vaccine too quickly, pulled the needle out of my arm, some of the vaccine squirt back out of my arm; I guess partial dose administered; Sore arm; 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 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19May2021 13:00 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, First Dose: Caller reported that he received his first dose almost 3 weeks ago to the day. Caller reported that he believes that he received his first dose of the Covid-19 vaccine 3 weeks ago yesterday on 27Apr2021. Anatomical Location: Left arm), administration date: 27Apr2021, when the patient was 39 years old, for COVID-19 immunisation, reaction(s): "sore arm".  The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 19May2021 13:00, outcome "unknown", described as "some of the Covid-19 vaccine ran down his arm/ Administrating vaccine too quickly, pulled the needle out of my arm, some of the vaccine squirt back out of my arm; I guess partial dose administered"; PAIN IN EXTREMITY (non-serious) with onset 19May2021 13:00, outcome "unknown", described as "Sore arm".  Additional information: patient reported that the person administering the second dose of the Covid-19 vaccine was either too fast and pulled the plunger out of the syringe too quickly or too fast and pulled the needle out of his arm too quickly. He also reported that some of the Covid-19 vaccine ran down his arm and he doesn't believe that he received a full dose. Patient feels second dose much sharper than the first one. His shoulder hurt to touch almost immediately. The person administrating the vaccine gave it too quickly. They both pressed the plunger on the syringe too quickly and pull the needle out of my arm too quickly, so that when they did pull the needle out of my arm some of the vaccine squirt back out of my arm. Nowhere of knowing how much vaccine I lost or how much I got.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: My arms is swollen the size of a avocado  seed; It is itching the spot where they injected me is warm, swollen and red; It is itching the spot where they injected me is warm, swollen and red; It is itching the spot where they injected me is warm, swollen and red; It is itching the spot where they injected me is warm, swollen and red; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) at the age of 40 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Known allergies: Chocolate" (unspecified if ongoing), notes: known allergies: chocolate. The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "known allergies: Benadryl", notes: known allergies: Benadryl. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "unknown", described as "My arms is swollen the size of a avocado  seed"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset May2021, outcome "unknown" and all described as "It is itching the spot where they injected me is warm, swollen and red".  Additional information: The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks The patient did not had COVID prior vaccination and since vaccination, patient had not tested with covid 19.Device Date mentioned as 19May2021. 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: Vision blurred
Clinical narrative: vision became blurry; 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 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 (Lot number: EZ0178) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "autoimmune anticardioid lipid" (ongoing). Concomitant medication(s) included: WARFARIN taken for thrombosis. Vaccination history included: Bnt162b2 (Dose: 1, lot number:EW167), when the patient was 57 years old, for Covid-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 19May2021, outcome "not recovered", described as "vision became blurry".  Additional information: Caller is a consumer, asking if her reaction after the vaccine is normal and what she should do about it. Caller reports that about 10 minutes after getting her second dose of the vaccine today her vision started to become blurry. She reports having to take her glasses off to evaluate her vision and she sat for another 5 minutes after which she reports being asked if she wanted an ambulance, she reports declining and was then told to go home and lay down for a few hours to see if she feels better. Caller reports that her vision is still blurry as if she had just cried and her eyes were foggy from the tears. Caller reports that her distance vision is more affected the close-up vision. Caller asking if this is normal and what she should do stating that she doesn't have an HCP. Transmitting for AE data capture. Caller reports that she already spoke with someone prior to being transferred over to address her question, no reference number for that encounter. Caller reports that she doesn't have an HCP. Confirmed Pfizer COVID-19 vaccine. Spoke from attached documentation. Referred to HCP (Health department /Pharm) for evaluation, discussion and guidance. Offered to send documentation via email, caller declined. Caller reports that she already spoke to someone about her reaction before being transferred over, no reference number for that encounter. Caller does not have an HCP. Survey offered. Caller states she got the second dose of the Pfizer COVID-19 vaccine today, 19May2021, and while she was waiting for her 15 min, her vision became blurry, states they kept her there, caller states it is not going away, not sure what to do, have not heard of this before, wants information about this symptom. Caller asks if we can tell her how to treat it. Caller states her arm really blew up after the first dose, states there was a firm bump at the injection site. The caller was provided with (Privacy) phone number of (withheld), option 3, and business hours prior to transfer to (Privacy) queue, hold times are longer than normal. Caller encouraged to reach out to her healthcare provider for any medical advice.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient developed influenza-like illness (flu-like symptom), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 32-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 32, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced decreased mobility (has suffered from "immobility" in the body), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node in right armpit area after 1.5 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17May2021 17:45 (Lot number: ew 0172) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=pfizer,, lot_number=ew 0161,, administration_time=05:15 PM,, dose_number=1,, vaccine_location=Left arm), administration date: 26Apr2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 19May2021 08:00, outcome "not recovered", described as "swollen lymph node in right armpit area after 1.5 days.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient did not received any other vaccines within 4 weeks prior to Covid vaccine. Patient did not received any other medications within 2 weeks of vaccination.Reported Event: swollen lymph node in right armpit area after 1.5 days. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination the patient was not tested for Covid-19. Patient did not had allergies.    No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: weird smell/smell you know feels something different/feeling different in regards to taste and smell; a different taste/I can't taste food, food taste like something different/feeling different in regards to taste and smell; 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 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 13:00 (Lot number: EW0169) at the age of 41 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IRON; VITAMIN D [VITAMIN D NOS]. The following information was reported: PAROSMIA (non-serious) with onset Apr2021, outcome "unknown", described as "weird smell/smell you know feels something different/feeling different in regards to taste and smell"; TASTE DISORDER (non-serious) with onset Apr2021, outcome "not recovered", described as "a different taste/I can't taste food, food taste like something different/feeling different in regards to taste and smell".  Additional information: It was after the first dose is when the patient started to notice the difference in her taste and smell. When she tried to drink coffee, it smelled weird and so she tried a different coffee and it also smelled weird. She sprayed her perfume and did not like the smell. Even the smell of the food is different than before. Taste is totally different. Tomatoes and cucumbers taste and smell different, along with many other foods. She is asking how long this will last. Prior Vaccinations (within 4 weeks) was none. Events did not cause Emergency Room or Physician Office.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip dry
Clinical narrative: Her lips are really dry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 11:30 (Batch/Lot number: unknown) as dose 1, single and administration date 16Mar2021 10:22 (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: LIP DRY (non-serious), outcome "unknown", described as "Her lips are really dry".  Additional information: The reporter reported ulcers in her mouth, her niece 23 years old also has ulcers in her mouth , and sister, 67 y/o, complains her lips are really dry and asked if these are common and can caller receive the second dose. When speaking to caller myself she had only made mention of the ulcers she is experiencing and that she has seen her doctor and was prescribed  Magic Mouth wash. The caller reports on herself and says her sister-in-law said her lips were really dry and she didn't correlate it to the vaccine. She says her sister-in-law hasn't called in any of this information yet. The patient did not have Prior Vaccinations (within 4 weeks). Follow-up attempts ae needed. Further information is requested. Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: This is a spontaneous report received from noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a mass (lump on side of their neck after getting the COVID-19 vaccine), with outcome of unknown. Additional information: Reported this to their physician. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: Very enlarged lymph nodes/One of the lymph nodes being palpable; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), solution for injection, administered in arm right, administration date 22Feb2021 16:15 (Lot number: EN6202) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; GABAPENTIN; MAXZIDE; ESTRADIOL. Past drug history included: Agumentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot number=EL8982, administration date=01Feb2021, administration time=04:15 PM, vaccine location=Right arm), administration date: 01Feb2021, when the patient was 55 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "Very enlarged lymph nodes/One of the lymph nodes being palpable". The event "very enlarged lymph nodes/one of the lymph nodes being palpable" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Other vaccine in four weeks: No. Covid prior vaccination: No. Covid tested post vaccination: No.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Fatigue, Pain
Clinical narrative: severe torso pain/She had severe torso pain from below her rib cage to her pubic bone both times.; fatigue more severe/she was feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in thigh left, administration date 25Mar2021 (Lot number: ER8732) at the age of 62 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Mastectomy", start date: 2012 (unspecified if ongoing), notes: Verbatim: Mastectomy; "Lumpectomy", start date: 2006 (unspecified if ongoing), notes: Verbatim: Lumpectomy. There were no concomitant medications.  The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "severe torso pain/She had severe torso pain from below her rib cage to her pubic bone both times."; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue more severe/she was feeling tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Context: Caller is calling to report she had side effects after both COVID vaccines. She is glad she got them. She had severe torso pain from below her rib cage to her pubic bone both times. She has tried to trigger the pain since and cannot. She had a colonoscopy that showed she had little pockets in her intestines. She has never had any pain or discomfort from it. At first she thought the symptoms she had after the shot was a coincidence. She has ate popcorn and seeds that other people have reported having problems with, and nothing happened. This has happened after both shots. The first time it happened 12 hours after the shot. The second time it happened 1.5 hours after the shot. It lasted all day, 24 hours. It is really severe pain . After the second shot, she had a little pink area that was swollen and mildly tinder like with the flu shot. But it was not bad. She had no flu like symptoms or anything. She got both vaccines in her left thigh. That is where she gets all over her shots because she has lymphedema in her arms from a double mastectomy. She even gets flu shots in her left thigh. The caller's mastectomy was in 2012, and her lumpectomy was in 2006. The pain was constant for the 24 hours. It was just surprising to her. It lasted 24 hours both times.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm pain I was very tired for 3 days; Arm pain I was very tired for 3 days; fell back asleep for 3 days; Like pain and overall discomfort every where; Like pain and overall discomfort every where; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 15:00 (Lot number: Er8735) at the age of 17 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 IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 29Apr2021 18:00, outcome "recovered with sequelae" and all described as "Arm pain I was very tired for 3 days"; SLEEP DISORDER (non-serious) with onset 29Apr2021 18:00, outcome "recovered with sequelae", described as "fell back asleep for 3 days"; PAIN (non-serious), DISCOMFORT (non-serious) all with onset 29Apr2021 18:00, outcome "recovered with sequelae" and all described as "Like pain and overall discomfort every where". Therapeutic measures were not taken as a result of pain in extremity, fatigue, sleep disorder, pain, discomfort.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Product dose omission issue
Clinical narrative: They missed their second dose yesterday; Husband felt really tired like three to four days, he doesn't have energy and can't move; Husband felt really tired like three to four days, he doesn't have energy and can't move; Muscle pain; This is a spontaneous report received from a contactable Consumer or other non HCP.  A 82 year-old male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetic; "heart patient" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "They missed their second dose yesterday"; FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "Husband felt really tired like three to four days, he doesn't have energy and can't move"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: All of my skin is burning, the inside of my skin burns. It feels like Im on fire; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 13:45 (Batch/Lot number: unknown) at the age of 14 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: SKIN BURNING SENSATION (non-serious) with onset 19May2021 04:45, outcome "not recovered", described as "All of my skin is burning, the inside of my skin burns. It feels like Im on fire". Therapeutic measures were not taken as a result of skin burning sensation.  Additional Information: Prior vaccinations within 4 weeks was reported as none. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: ulcers in her mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 32 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, 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: MOUTH ULCERATION (non-serious), outcome "not recovered", described as "ulcers in her mouth".  Additional Information: The patient is the reporter's niece. The reporter said that her niece has the same experience but she didn't report it. She said her niece didn't connect it to vaccine until the reporter told her what side effects she had. She said her niece didn't think it was related to the vaccine. ulcers in her mouth was reported as worsened. The reporter does not have the patient's vaccination card with her. The reporter does not know any information about her niece's primary care provider. The reporter said her niece's ulcers were more in the corner of her mouth. The reporter was not sure of the start date of her niece's ulcers and said her niece got the vaccine about a month before the reporter. She said it ended recently; probably about after a month. The reporter said her niece received both doses but the reporter does not know the dates or times of her niece's vaccinations. She said she got it a month before the reporter. Adverse event does not require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks), Patient's Medical History (including any illness at time of vaccination)- Allergies, Surgeries, Relevant Tests were unknown to reporter. Family Medical History relevant to AE were none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue
Clinical narrative: Chills; Tired; Fatigue; Had hard time getting out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: PLAVIX; ASPIRINE; DIOVAN taken for hypertension. The following information was reported: CHILLS (non-serious) with onset 19Feb2021, outcome "recovered" (21Feb2021), described as "Chills"; FATIGUE (non-serious) with onset 19Feb2021, outcome "recovered" (21Feb2021), described as "Tired"; FATIGUE (non-serious) with onset 19Feb2021, outcome "recovered" (21Feb2021), described as "Fatigue"; BEDRIDDEN (non-serious) with onset 19Feb2021, outcome "recovered" (21Feb2021), described as "Had hard time getting out of bed".  Additional information:Reporter stated was calling in relation to wife her name is withheld. The reason was calling is wife and reporter both live in. We both took the Pfizer vaccine on 19Feb2021had no problem what so ever, once we took the first shot we waited fifteen minutes before we left area, we took the shot and everything was fine. We came home and that evening wife had a reaction, pretty bad reaction. She had chills and she was tired, she was fatigue and she had hard time getting out of bed. She stayed in bed that was on Friday the 19th of February. She stayed in bed the whole night, got up the next day and she pretty much had the same side effects and she stayed in bed all day Saturday and in the Saturday night, she got better on Sunday. She got better and be able to get out of bed and she was able to start moving around. When the time came to get the second shot which took, the second shot on March the 12th. we took the first shot on February 19th and took the second shot on March the 12. The patient's husband never had any problem what so ever, the shoulder was little sore from the shot and wife did not take the second shot she spoke to her doctor and her doctor said may be she should wait ninety days before she takes the second shot. So, she had waited now because she took the first shot on February 19th. So, May 19th which is tomorrow. Tomorrow is May 19th which would be 90 days. She wants to take the second shot. So calling you to ask you for your advice. Do you think she should or maybe think she should not take second shot. That's what am asking you. It was COVID-19 Pfizer shot.Reporter was provided with the number of  Medical information Department.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: have swelling and pain in lymph node; 48 hours after receiving shot my son reported pain in arm pit.; have swelling and pain in lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16May2021 13:00 (Lot number: EW0172) 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: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 04May2021 14:00, outcome "recovering" and all described as "have swelling and pain in lymph node"; PAIN IN EXTREMITY (non-serious) with onset 04May2021 14:00, outcome "recovering", described as "48 hours after receiving shot my son reported pain in arm pit.". Therapeutic measures were taken as a result of lymphadenopathy, pain in extremity, lymph node pain. No follow-up attempts are possible. No further information is expected.  Additional information: 48 hours after receiving shot my son reported pain in arm pit. Continues to have swelling and pain in lymph node. Because vaccine was recently opened up to kids 12-year-old and up I wanted to report this.  No other vaccine in four weeks and Other medications in two weeks.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: The first shot did turn red at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Lot number: EW0171) at the age of 66 years as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "recovered", described as "The first shot did turn red at the injection site".  No follow-up attempts are possible. No further information is expected.  Additional Context: Patient is calling about the Pfizer COVID shot that she got. She got her second dose on 11May2021. She did have two of the side effects that have been reported to Pfizer already. She had swelling and redness that covered almost all of the front part of her upper arm not just at the injection site on her left arm. It was everywhere. Yesterday, it finally started going down. The redness has gone away. She was told she was supposed to call Pfizer and let them know. She got the vaccine on a Tuesday, and on Wednesday night is when she first noticed it. She did not have a prescribing doctor. She just went to (withheld) on (withheld). She went to see the pharmacist after the swelling and redness lasted Wednesday, Thursday, Friday. She just popped in last Friday. She showed up, and the pharmacist's eyes got big like woah. He took a picture of it . She told him it had been there since Wednesday night. He said to call and report it, and to take Ibuprofen and Ice it. It started Wednesday at night. It didn't stat improving until the 18May2021. It looked like a bad sunburn on one arm. Her first vaccine was 19Apr2021 with lot number EW0171 on left arm. She doesn't take any other medication. She did take the ibuprofen for the swelling. The first shot did turn red at the injection site but not all over her whole arm like the second one. It was red and lasted a couple of days and went away. This one went days and days. It covered almost her whole upper arm. If she has to get a booster in a year or so should she get the Pfizer one?
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Intense bitter strange taste; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 12:00 (Lot number: EW0179) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: phenergan, compazine, vistaril" (unspecified if ongoing), notes: Known allergies: phenergan, compazine, vistaril. Concomitant medication(s) included: PREVACID; DOXYCYCLINE; ALPRAZOLAM; BUPROPION. Vaccination history included: Bnt162b2 (lot number=ER8733, administration time=04:00 PM,, dose number 1), administration date: 26Mar2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 17May2021 13:00, outcome "not recovered", described as "Intense bitter strange taste". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient received no treatment for ae. Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Computerised tomogram, Condition aggravated, Electrocardiogram
Clinical narrative: nauseous for a couple days; felt tired; strep throat; feeling out of sync, like not right; little more tired than usual; sore throat; 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 62 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 06May2021 14:30 (Lot number: EW0171, Expiration Date: Aug2021) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: Verbatim: high blood pressure. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product name: Covid 19 vaccine, Batch/lot number: EW0153, Anatomical site: left arm, Time of administration: 02:30 pm,, Expire date: Jul2021,, Dose no: 1), administration date: 15Apr2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "First dose: nauseous for a couple days", "First dose: excruciating pain from the top of her chest down to her right breast", "First dose: excruciating pain from the top of her chest down to her right breast", "First dose: pressure in her head", "First dose: pressure in both her ears", "First dose: face got hot", "First dose: kidney function 62%", "First dose: D-Dimer was also elevated, it was 0.7%". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous for a couple days"; FATIGUE (non-serious), outcome "unknown", described as "felt tired"; PHARYNGITIS STREPTOCOCCAL (non-serious), outcome "unknown", described as "strep throat"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling out of sync, like not right"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "little more tired than usual"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". The events "nauseous for a couple days", "felt tired", "strep throat", "feeling out of sync, like not right", "little more tired than usual" and "sore throat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Fibrin D dimer increased, Influenza virus test, Nausea
Clinical narrative: nauseous for a couple days; felt tired; strep throat; feeling out of sync, like not right; little more tired than usual; sore throat; 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 62 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 06May2021 14:30 (Lot number: EW0171, Expiration Date: Aug2021) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: Verbatim: high blood pressure. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product name: Covid 19 vaccine, Batch/lot number: EW0153, Anatomical site: left arm, Time of administration: 02:30 pm,, Expire date: Jul2021,, Dose no: 1), administration date: 15Apr2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "First dose: nauseous for a couple days", "First dose: excruciating pain from the top of her chest down to her right breast", "First dose: excruciating pain from the top of her chest down to her right breast", "First dose: pressure in her head", "First dose: pressure in both her ears", "First dose: face got hot", "First dose: kidney function 62%", "First dose: D-Dimer was also elevated, it was 0.7%". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous for a couple days"; FATIGUE (non-serious), outcome "unknown", described as "felt tired"; PHARYNGITIS STREPTOCOCCAL (non-serious), outcome "unknown", described as "strep throat"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling out of sync, like not right"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "little more tired than usual"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". The events "nauseous for a couple days", "felt tired", "strep throat", "feeling out of sync, like not right", "little more tired than usual" and "sore throat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngitis streptococcal, Streptococcus test, Troponin T
Clinical narrative: nauseous for a couple days; felt tired; strep throat; feeling out of sync, like not right; little more tired than usual; sore throat; 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 62 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 06May2021 14:30 (Lot number: EW0171, Expiration Date: Aug2021) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: Verbatim: high blood pressure. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product name: Covid 19 vaccine, Batch/lot number: EW0153, Anatomical site: left arm, Time of administration: 02:30 pm,, Expire date: Jul2021,, Dose no: 1), administration date: 15Apr2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "First dose: nauseous for a couple days", "First dose: excruciating pain from the top of her chest down to her right breast", "First dose: excruciating pain from the top of her chest down to her right breast", "First dose: pressure in her head", "First dose: pressure in both her ears", "First dose: face got hot", "First dose: kidney function 62%", "First dose: D-Dimer was also elevated, it was 0.7%". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous for a couple days"; FATIGUE (non-serious), outcome "unknown", described as "felt tired"; PHARYNGITIS STREPTOCOCCAL (non-serious), outcome "unknown", described as "strep throat"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling out of sync, like not right"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "little more tired than usual"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". The events "nauseous for a couple days", "felt tired", "strep throat", "feeling out of sync, like not right", "little more tired than usual" and "sore throat" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included cancer (unspecified if ongoing). Concomitant medications not reported. The patient experienced dizziness and nausea, with outcome of unknown. Additional information: The patient's mother had both shots and experienced side effects for about two weeks from the first shot, but not as long or as bad for the second shot. She didn't have chest pain or want to pass-out. She had dizziness and nausea. When ask to make a separate report on herself, she stated she will call back later on herself. This is a clone report created to document the caller's experience. Primary/Prescriber: not provided. Product: Pfizer COVID-19 vaccine; no NDC, lot or expiration date provided. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021567769 same reporter/product, different patient/event.