chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pain, Pyrexia, Swelling
Clinical narrative: 101 fever; Body aches; Very swollen/painful axillary lymph node on side of injection; Swollen lymph nodes in neck on both sides; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Right Arm on 08Mar2021 (at the age of 41-years old) as dose 2, single for covid-19 immunisation. The patient medical history included asthma. The patient concomitant medications within 2 weeks included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID], vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS], vitamin a [retinol] (VITAMIN A [RETINOL], zinc (ZINC). No known allergies. The patient previously received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Left Arm on 08Feb2021 12:15 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. The patient was not diagnosed with covid prior vaccination and has not been tested for Covid-19, post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021, the patient experienced 101 fever, body aches, very swollen/painful axillary lymph node on side of injection for more than 1 week, and swollen lymph nodes in neck on both sides. Patient did not receive treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Retching, Vomiting
Clinical narrative: fever, nausea, vomiting, dry heaving, body soreness; fever, nausea, vomiting, dry heaving, body soreness; fever, nausea, vomiting, dry heaving, body soreness; fever, nausea, vomiting, dry heaving, body soreness; fever, nausea, vomiting, dry heaving, body soreness; This is a spontaneous report from a non-contactable consumer (patient herself). A 33-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date in Mar2021, (age at vaccination: 33-years) a dose number unknown single. Patients medical history and concomitant medications were not reported. No other vaccines were administered to patient in four weeks. On 11Mar2021, patient experienced fever, nausea, vomiting, dry heaving, body soreness. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of events was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms; muscle aches; joint pain; lack of appetite; This is a spontaneous report from a non-contactable Nurse(reported for himself). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as Dose Number Unknown, Single (at the age of 62-years-old) for COVID-19 immunization. The patient's medical history included gastroesophageal reflux disease (GERD), high cholesterol. The patient had allergy to bell peppers and mushrooms. Concomitant medications included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]); and colesevelam hydrochloride (WELCHOL). The patient did not receive no other vaccine in four weeks. On 12Mar2021, the patient experienced flu-like symptoms, muscle aches, joint pain, and lack of appetite. The patient did not receive treatment for the events. The patient has got no COVID prior vaccination. The patient has not been COVID tested post vaccination. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: My forearm, my neck is sore; soreness in my neck and that is going in my right arm, right shoulder towards left; every time I turn over it is really hurting me; My forearm, my neck is sore; soreness in my neck and that is going in my right arm, right shoulder towards left; every time I turn over it is really hurting me; My forearm, my neck is sore; soreness in my neck and that is going in my right arm, right shoulder towards left; every time I turn over it is really hurting me; This is a spontaneous report from a contactable consumer. A 55-year-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection; Lot Number: EN6205), via an unspecified route of administration as dose number unknown, single on 11Mar2021 (at the age of 55-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had the vaccine this past Thursday on 11Mar2021 and had some side effects and it has not gone away. Patient's forearm and neck was sore now (on 11Mar2021) and don't know what to do. Patient took Tylenol as treatment, but still had this since Thursday. It was supposed to go away, the first side effect in a day or half but patient still had forearm and neck were sore, soreness in patient's neck and that was going in right arm, right shoulder towards left, every time patient turns over it was really hurting me. Therapeutic measures were taken as a result of event with Tylenol. At the time of this report, the outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza, Pain, Pyrexia
Clinical narrative: Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.; Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.; Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.; Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.; Flu symptoms. Body aches, fatigue, fever, chills, lasting 48 hours.;This is a spontaneous report from a non-contactable other Health Care Professional. A 28-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 18:00 as DOSE 2, SINGLE for Covid-19 immunization).Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. Concomitant medication included duloxetine taken for an unspecified indication, start and stop date were not reported.Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) on an unspecified for covid-19 immunization.The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On 09Feb2021 09:00 the patient experienced flu symptoms. body aches, fatigue, fever, chills, lasting 48 hours. Patient was not received any treatment. On 11-FEB-2021 the outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever at bed time on day of shot 99 F and the next night 98.9 F; Arm sore at the site of shot; Headache; Tiredness; This is a spontaneous report from a non-contactable (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES).  A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 14:00 (lot number: EN6205; expiry date: unknown) at the age of 50-years-old, as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included omeprazole; vitamin D NOS, cyanocobalamin (VIT B12), and calcium taken for unspecified indications, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid-19 prior vaccination. On 12Mar2021, at 21:00, the patient experienced arm sore at the site of shot, headache, tiredness, fever at bed time on day of shot 99 Fahrenheit (F) and the next night (13Mar2021) 98.9 F. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6294), via an unspecified route of administration, administered in Arm Right on 09Mar2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 63 years). No vaccine took within 4 weeks. Medical history included Diabetes and Known allergies: Prednisone, Naproxen, Toradol, Levofloxacin. Concomitant medications included metformin; glipizide; venlafaxine; bupropion, Vitamins. The patient experienced severe itching from 24 hrs. post vaccination until day 4 on 10Mar2021, severe headache 2 hours post vaccination, malaise, nausea and fatigue on 09Mar2021 at 11:30. No covid tested post vaccination. No treatment received. The clinical outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6294), via an unspecified route of administration, administered in Arm Right on 09Mar2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 63 years). No vaccine took within 4 weeks. Medical history included Diabetes and Known allergies: Prednisone, Naproxen, Toradol, Levofloxacin. Concomitant medications included metformin; glipizide; venlafaxine; bupropion, Vitamins. The patient experienced severe itching from 24 hrs. post vaccination until day 4 on 10Mar2021, severe headache 2 hours post vaccination, malaise, nausea and fatigue on 09Mar2021 at 11:30. No covid tested post vaccination. No treatment received. The clinical outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever 100; nauseous; joint pain mostly in legs; fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10Mar2021 at 15:30 pm (age at vaccination is 59 years) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any known allergies. Concomitant medications the patient received within 2 weeks of vaccination included irbesartan (AVAPRO), escitalopram oxalate (LEXAPRO), atorvastatin (LIPITOR [ATORVASTATIN]) and vitamin D [vitamin D NOS] all taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11Mar2021 at 09:00 am, the patient experienced fever 100, nauseous, joint pain mostly in legs and fatigue. The patient underwent lab test which included body temperature: 100 (Fever) on 11Mar2021. No treatment was received for the adverse events. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer(patient). A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 07Mar2021 12:00 (Batch/Lot number was not reported; Expiration Date: 30Jun2021) (at the age of 51-year-old) as Dose 1 0.3 ml single for COVID-19 immunization. The patient medical history included overactive bladder and the patient had a reaction from poison sumac and was given a cream or steroid. Concomitant medication taken for overactive bladder(Unspecified). No Family Medical History Relevant to AE, No Relevant Tests. Not visited Physician's office,Emergency room yet. It was reported that The caller started taking medicine for her over active bladder but she didn't have problems in the past when she took it so she doesn't believe it was what caused her rash. Also the day of the vaccine the caller took some Advil that evening for her headache and sore arm. The caller had a sore arm from a flu shot, unknown lot or expiration, received it in the beginning of flu season this year. The patient experienced rash, itchiness, redness on 16Mar2021 and headache on an unspecified date. The redness still red but not getting worse. The rash started in the morning of 16Mar2021 but it hasn't gotten worse. Treatment was taken for headache (Advil). The Outcome of the events rash, itchiness,redness was not recovered. Outcome of the event headache was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Neck pain
Clinical narrative: Headache; Neck was hurting and lymph node was swollen; Neck was hurting and lymph node was swollen; Ache on my left wrist; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. Medical history included wrist fracture from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient states, I got the Pfizer Covid 19 shot and wanted to report side effects. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 23Feb2021 and second dose on 16Mar2021, both given in left arm. On 23Feb2021, within 5 hours after the first dose, I got an ache on my left wrist that I broke years ago, which resolved after 2 hours. I developed headache on unknown date, lasting for 2 days. On the 5th day after the shot, my neck was hurting and lymph node was swollen on 28Feb2021. It felt like a lump and it resolved within a week of onset. I got the second dose on 16Mar2021 and was fine. Today, 17Mar2021, I developed fever of 101.6 F and headache. I took some of my daughter liquid Tylenol. I also have an ache in my left wrist, in left thumb and pointer finger. She agreed to be transferred to Safety but unable to connect due to high call volume. The outcome of the event arthralgia was reported as recovered on 23Feb2021 and while other events was recovered in 2021.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Headache; fatigue; pain from my left side into my stomach that lasted about 3 days; Severe joint pain that is going on 9 days; This is a spontaneous report from a non-contactable consumer or other non hcp. A 42-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 06Mar2021 (age at vaccination:42-Years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient didn't had COVID-19 prior to vaccination, patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had received other medications was Victoza, Jardiance, Naproxen and Fenofibrate within 2 weeks of vaccination. The patient medical history was not reported. Concomitant medications included liraglutide (VICTOZA) taken for an unspecified indication, start and stop date were not reported; empagliflozin (JARDIANCE) taken for an unspecified indication, start and stop date were not reported; naproxen (NAPROXEN) taken for an unspecified indication, start and stop date were not reported; fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported. On 06Mar2021 the patient experienced headache, fatigue, pain from my left side into my stomach that lasted about 3 days, severe joint pain that is going on 9 days. Patient had Emergency room visit for the events. No Therapeutic measures were taken for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Mar2021. The outcome of the events headache, fatigue, pain, arthralgia was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Itchy inside of mouth; thick tongue feeling; Itching all over body; rash under arm of injection; 3" itchy red welt in front of underarm on right side/hives on left thumb; headache; backache in middle of back; tired; nausea; light headed; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 62-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6208) via an unspecified route of administration in right arm on 12Mar2021 10:30 (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took codeine, morphine and erythromycin, Known allergies: codeine, morphine and erythromycin. Patient did not receive any other vaccines within 4 weeks prior to Covid vaccination and patient did not receive any other medications in two weeks. Patient did not have COVID-19 prior vaccination and since vaccination patient has not been tested for COVID-19. The patient experienced itchy inside of mouth, thick tongue feeling, itching all over body, rash under arm of injection, 3" itchy red welt in front of underarm on right side/hives on left thumb, headache, backache in middle of back, tired, light headed 12Mar2021 11:00. Patient did not receive any treatment for the events. Outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Pruritus, Tongue disorder, Urticaria, Vaccination site rash
Clinical narrative: Itchy inside of mouth; thick tongue feeling; Itching all over body; rash under arm of injection; 3" itchy red welt in front of underarm on right side/hives on left thumb; headache; backache in middle of back; tired; nausea; light headed; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 62-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6208) via an unspecified route of administration in right arm on 12Mar2021 10:30 (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took codeine, morphine and erythromycin, Known allergies: codeine, morphine and erythromycin. Patient did not receive any other vaccines within 4 weeks prior to Covid vaccination and patient did not receive any other medications in two weeks. Patient did not have COVID-19 prior vaccination and since vaccination patient has not been tested for COVID-19. The patient experienced itchy inside of mouth, thick tongue feeling, itching all over body, rash under arm of injection, 3" itchy red welt in front of underarm on right side/hives on left thumb, headache, backache in middle of back, tired, light headed 12Mar2021 11:00. Patient did not receive any treatment for the events. Outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching on her hands, legs, calves, scalp and chest.; This is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 08Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included parkinson's disease from an unknown date and unknown if ongoing Parkinson's , chronic obstructive pulmonary disease, obesity from an unknown date and unknown if ongoing obese. The patient's concomitant medications were not reported.On an unspecified date the patient experienced itching on her hands, legs, calves, scalp and chest. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Illness, Pain, Pain in extremity, Pruritus
Clinical narrative: Right arm sore; itching; hurting all over; no appetite; Sick; This is a spontaneous report from a contactable Nurse (daughter) reporting for her mother in response to the HCP letter sent in cross-referenced case.   An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via intramuscular route of administration on 03Feb2021 at 13:00 (at the age of 84-year-old), as dose 2, single in right arm for COVID-19 immunization in Public Health Department. The patient medical history included hypothyroidism long term diagnosis, arthritis, palpitations- SVT, diverticulitis, diverticulosis, placement of PVD stent in left leg in 2019, peripheral neuropathy, osteoporosis, obesity, colon resection x 2 with last one being in Feb2014 and COVID-19 in Jun2020. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via intramuscular route of administration on 06Jan2021 at 01:00 PM (at the age of 84-year-old), as single dose in left arm for COVID-19 immunization and patient was in bed for 2 days, had left arm sore after injection with lump and itching, could not eat, hurting all over and joints aching, fever and was really cold and really sick on 06Jan2021 at 11:30 PM. Events were recovered on unknown dates. She recovered fully in 3-4 days other than her arm being sore and injection site itching which lasted 1.5 to 2 weeks. Arm was fully recovered, and reactions were worse with her 1st dose felt worse symptoms more intense. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 at 02:15, patient experienced right arm sore, itching, hurting all over, no appetite and sick. 2nd COVID vaccine made her sick. No emergency room or physican room visit was required due to adverse events. Pfizer product BNT162B2 had a casual effect to the adverse event. There was a causal relationship and a reasonable possibility that the events were related to suspect product. Therapeutic measures were taken as a result of sick and she took Acetaminophen every 4-6 hours for 2-3 days. Outcome of all the events was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Rash macular
Clinical narrative: fever of 104.6; chills; rash from her ankle to her knees that she describes as blotches. they were not itchy.; achy; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Feb2021 as dose 1, single dose for COVID-19 immunization. The patient states she is scheduled to receive her second dose on 21Mar2021. The patient states she has allergies to metal, shellfish her lip blew up, and iodine. The patient concomitant medications were not reported. The patient states the first day she was fine and the second day she was just achy and then on the fourth day which was Thursday she had a fever of 104.6, chills, and a rash from her ankle to her knees that she describes as blotches. The patient states they were not itchy. The patient would like to know if she should receive the second dose of the vaccine. The patient would like to know if there is any metal or aluminum in the vaccine. The patient would like to have a list of ingredients in the vaccine. The patient states she spoke to her health care provider, and they told her she should not receive the second dose, but it was up to her. The patient would like to know if anyone has reported a fever of 104.6 after the first dose of the vaccine. The patient declined to give more information stating she was at work and needed to get off the phone. The patient was given website name to report adverse reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint range of motion decreased
Clinical narrative: woke up being extra sore in almost every joint; Not easy to get mobile / move around; Feel worn out, like after an excessive exercise workout; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 16Mar2021 at 10:45 AM (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included diabetes, hypertension, COVID-19, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient received unspecified medications in two weeks. Patient was diagnosed with COVID prior vaccination. Patient had not COVID tested post vaccination. On 17Mar2021 at 07:00 AM, the patient experienced woke up being extra sore in almost every joint, not easy to get mobile/move around, feel worn out, like after an excessive exercise workout. Adverse event: Took overnight, woke up being extra sore in almost every joint. Not easy to get mobile/move around. Feel worn out, like after an excessive exercise workout. Outcome of all the events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Rash
Clinical narrative: developed a pimple like rash on her face; developed a pimple like rash on her face; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. Caller received 2nd dose of Covid vaccine yesterday and has developed a pimple like rash on her face on an unspecified date. Wondering if this is a side effect of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: feeling tired; headache; muscle pain; chills; joint pain; nausea; not feeling good; weakness; This is a spontaneous report from a contactable consumer (reporting for father). A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. On 13Mar2021,( since Saturday night) his father (patient) has been experiencing many of the symptoms listed on the Fact Sheet, including: "feeling tired, headache, muscle pain, some chills that come and go, joint pain, little bit of nausea, not feeling good and a little bit of weakness. Caller and his father (patient) want to know if these are common side effects, especially since they have been going on since Saturday. The father has spoken with his HCP regarding his symptoms and was told to take either Tylenol or Ibuprofen and to drink plenty of water. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch can not be obtained.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: feeling tired; headache; muscle pain; chills; joint pain; nausea; not feeling good; weakness; This is a spontaneous report from a contactable consumer (reporting for father). A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. On 13Mar2021,( since Saturday night) his father (patient) has been experiencing many of the symptoms listed on the Fact Sheet, including: "feeling tired, headache, muscle pain, some chills that come and go, joint pain, little bit of nausea, not feeling good and a little bit of weakness. Caller and his father (patient) want to know if these are common side effects, especially since they have been going on since Saturday. The father has spoken with his HCP regarding his symptoms and was told to take either Tylenol or Ibuprofen and to drink plenty of water. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch can not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Myalgia
Clinical narrative: feeling unwell; fever; chills; muscle pain; bottom of the feet were itchy; headache; rash on the chest; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and experienced mild reactions from the 1st dose. On 15Mar2021, the patient experienced reactions from the vaccine at night, feeling unwell, fever, chills, muscle pain, bottom of the feet were itchy, headache, and rash on the chest. The patient underwent lab test and procedures which included body temperature: fever on 15Mar2021. Therapeutic measures were taken as a result of the event rash on the chest. Nurse advised the patient to put hydrocortisone cream for the rash. The patient queried whether there would be a need for 3rd dose of the PFIZER-BIONTECH COVID-19 VACCINE. The clinical outcome for the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: feeling unwell; fever; chills; muscle pain; bottom of the feet were itchy; headache; rash on the chest; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and experienced mild reactions from the 1st dose. On 15Mar2021, the patient experienced reactions from the vaccine at night, feeling unwell, fever, chills, muscle pain, bottom of the feet were itchy, headache, and rash on the chest. The patient underwent lab test and procedures which included body temperature: fever on 15Mar2021. Therapeutic measures were taken as a result of the event rash on the chest. Nurse advised the patient to put hydrocortisone cream for the rash. The patient queried whether there would be a need for 3rd dose of the PFIZER-BIONTECH COVID-19 VACCINE. The clinical outcome for the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable nurse (patient). A 48-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EJ1646), dose 2 via an unspecified route of administration on 19Jan2021 as dose 2, single (at the age of 48-years-old) for COVID-19 immunisation. The patient's medical history included 2 previous gastric bypass surgeries. Last gastric bypass surgery in 2011; hernia repair in 2018; and very low iron stores requiring infusions. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EJ1686), dose 1 via an unspecified route of administration on 29Dec2020 as dose 1, single (at the age of 48-years-old) for COVID-19 immunisation and experienced severe chills for approximately 2 hours. On an unspecified date in Jan 2021, the patient experienced fever for 7 days, and sporadically running fever at various times during the day every day since the second dose. The patient underwent lab tests and procedures which included fever: 99-101.8 Fahrenheit on an unspecified date in Jan2021, and Antibody serum test: 0.1 % on 09Mar2021. The patient had not recovered from the event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021295269 Same patient, drug / different events
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Nausea, Pyrexia
Clinical narrative: high fever; nausea; weakness; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (reporter's husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, on 11Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included Addison's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Mar2021 (after the 1st dose), the patient experienced high fever, nausea and weakness. Outcome of all events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Ear discomfort, Oropharyngeal pain
Clinical narrative: loss of taste; his back throat hurts; felt there's a needle under his ear; This is a spontaneous report from a Pfizer Sponsored Program  Support. A contactable male consumer of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 16Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He reported that he never got a schedule for the second dose because his vaccination card was switched with a different card. On an unspecified date in Feb2021, the patient experienced loss of taste, his back throat hurts and felt there's a needle under his ear. The events accessed as a non serious. The outcome of the events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: my hands got arthritis; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 14Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she got the first shot yesterday, they put them down to 'Easter' to get and she didn't know that was the date on the 14th when they did and she can't get any help, her 'Ackey' will not come on that day, she is taking her family and she can't find anybody take my to take her place and she won't mean she will even get ambulance to go because very short of help that day. On an unspecified date, the patient hands got arthritis. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Tiredness; Slight fever; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 45-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown, Expiry Date: unknown), via an unknown route of administration on 10Mar2021 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. Reason for no lot number of COVID 19 Vaccine consumer stated, "I don't know that it was not on my little card." The patient's medical history included asthma from an unknown date and unknown if ongoing. Consumer stated, "I don't have a Thyroid and I have occasional asthma." Concomitant medications included levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), meloxicam (MELOXICAM); all were taken for an unknown indication from an unknown date. On an unknown date in Mar2021, the patient experienced tiredness and slight fever. The patient stated, "I was just wondering I had my first dose of Pfizer on Wednesday and had 2 days of tiredness and then Saturday and Sunday I have had like slight fever and I was trying to see if that's normal reaction for it to last this long." Patient stated, "It was 6th, no, it was 13Mar. I had tiredness 2 days before but (incomplete sentence)." Consumer stated that he was about 5 (Feet) 6 (inches) and 225 (pounds) (not sure hence not captured in tab)." No investigation assessment. Received Tylenol as treatment. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Ear pain, Ear swelling, Feeding disorder, Hypersensitivity
Clinical narrative: allergic reaction; swollen lymph node glands; the swelling also was on side of my face all down to the jaw line; swelling above my ears and I can tell that the ear was swollen on the inside; I was had very sharp pain every so often in my ears; sharp pain in my throat; I wasn't able to do too much drinking or eating; under my jaw line was swollen and this was very uncomfortable it hurts; under my jaw line was swollen and this was very uncomfortable it hurts; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206 and Expiry Date of covid 19 vaccine: Unknown), dose 1 via an unspecified route of administration on 07Mar2021 (at the age of 69-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Back problems (she had injection in my back probably 6 weeks ago), Aneurysm that she kept a watch on, High blood pressure, Cholesterol and Thyroid. The patient concomitant medications included a lot of other unspecified medicine. On 11Mar2021, the patient experienced allergic reaction, swollen lymph node glands, the swelling also was on side of her face all down to the jaw line, swelling above her ears and she can tell that the ear was swollen on the inside, very sharp pain every so often in her ears, sharp pain in her throat, she was not able to do too much drinking or eating, under her jaw line was swollen and this was very uncomfortable it hurts. The clinical details of the events as follows: consumer stated, she did not want to use the portal to report this but she wanted to talk about the side effects that she had only received the very first shot of the COVID vaccine and she felt like she had allergic reaction, so she also wondering should she even get the second shot, but her side effects was definitely the swollen lymph node glands, the swelling also was on side of her face all down to the jaw line and also swelling above her ears and she could tell that the ear was swollen on the inside and she was had very sharp pain every so often in her ears and she was not really able to do too much drinking or eating because every time she would swallow she would have sharp pain in her throat, yeah and her swelling lymph node gland was also from her ear down, neck and under her jaw line was swollen that did not take place until 4 days later after she took the shot, the first shot and this was very uncomfortable it hurts. Consumer stated, so she would like someone to basically call me and let her know is it safe for her to take second shot and she worried about it. There was no investigation Assessment provided. No treatment was received for the events. The patient outcome of the events was resolved on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Swelling face
Clinical narrative: allergic reaction; swollen lymph node glands; the swelling also was on side of my face all down to the jaw line; swelling above my ears and I can tell that the ear was swollen on the inside; I was had very sharp pain every so often in my ears; sharp pain in my throat; I wasn't able to do too much drinking or eating; under my jaw line was swollen and this was very uncomfortable it hurts; under my jaw line was swollen and this was very uncomfortable it hurts; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206 and Expiry Date of covid 19 vaccine: Unknown), dose 1 via an unspecified route of administration on 07Mar2021 (at the age of 69-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Back problems (she had injection in my back probably 6 weeks ago), Aneurysm that she kept a watch on, High blood pressure, Cholesterol and Thyroid. The patient concomitant medications included a lot of other unspecified medicine. On 11Mar2021, the patient experienced allergic reaction, swollen lymph node glands, the swelling also was on side of her face all down to the jaw line, swelling above her ears and she can tell that the ear was swollen on the inside, very sharp pain every so often in her ears, sharp pain in her throat, she was not able to do too much drinking or eating, under her jaw line was swollen and this was very uncomfortable it hurts. The clinical details of the events as follows: consumer stated, she did not want to use the portal to report this but she wanted to talk about the side effects that she had only received the very first shot of the COVID vaccine and she felt like she had allergic reaction, so she also wondering should she even get the second shot, but her side effects was definitely the swollen lymph node glands, the swelling also was on side of her face all down to the jaw line and also swelling above her ears and she could tell that the ear was swollen on the inside and she was had very sharp pain every so often in her ears and she was not really able to do too much drinking or eating because every time she would swallow she would have sharp pain in her throat, yeah and her swelling lymph node gland was also from her ear down, neck and under her jaw line was swollen that did not take place until 4 days later after she took the shot, the first shot and this was very uncomfortable it hurts. Consumer stated, so she would like someone to basically call me and let her know is it safe for her to take second shot and she worried about it. There was no investigation Assessment provided. No treatment was received for the events. The patient outcome of the events was resolved on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.