chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided.   In or about January 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a clinic, for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In or around August 2013, the pt presented to the physician, with complaints of a painful rash around his left hip, which was diagnosed as shingles. The shingles rash lasted several weeks, causing severe pain and suffering. Symptoms resulted in physical limitations not present prior to vaccination and the pt experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. The pt suffered severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Moreover, the pt had incurred and would continue to incur medical expenses and other economic harm.   The outcome of the event was considered to be not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of shingles was considered to be disabling.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Laboratory test normal, Respiratory distress, Rotavirus test positive
Clinical narrative: on 12/14/2020 the patient was hospitalized due to dehydration; experiencing respiratory distress as well; Caller states on 12/12/2020 the patient began experiencing vomiting and diarrhea; Caller states on 12/12/2020 the patient began experiencing vomiting and diarrhea; rotavirus test positive; This spontaneous report was received from a physician referring to a 9-week-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 10-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliters, orally, lot number 1684163, expiration date 26-JUN-2021 for rotavirus vaccination.         On 12-DEC-2020, patient experienced vomiting and diarrhoea. On 14-DEC-2020, the patient experienced dehydration and respiratory distress. On that same day, the patient was hospitalized due to dehydratation with continued vomiting and diarrhea.  In December 2020, the patient had a positive result for a rotavirus test (GIPCR) and unspecified tests that came back negative.      The outcome of vomiting, rotavirus test positive, respiratory distress, dehydration and diarrhoea was reported as not recovered. The causal relationship between rotavirus vaccine, live, oral, pentavalent(ROTATEQ) and the events was not provided.   Upon internal review, respiratory distress was considered medically significant.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: on 12/14/2020 the patient was hospitalized due to dehydration; experiencing respiratory distress as well; Caller states on 12/12/2020 the patient began experiencing vomiting and diarrhea; Caller states on 12/12/2020 the patient began experiencing vomiting and diarrhea; rotavirus test positive; This spontaneous report was received from a physician referring to a 9-week-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 10-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliters, orally, lot number 1684163, expiration date 26-JUN-2021 for rotavirus vaccination.         On 12-DEC-2020, patient experienced vomiting and diarrhoea. On 14-DEC-2020, the patient experienced dehydration and respiratory distress. On that same day, the patient was hospitalized due to dehydratation with continued vomiting and diarrhea.  In December 2020, the patient had a positive result for a rotavirus test (GIPCR) and unspecified tests that came back negative.      The outcome of vomiting, rotavirus test positive, respiratory distress, dehydration and diarrhoea was reported as not recovered. The causal relationship between rotavirus vaccine, live, oral, pentavalent(ROTATEQ) and the events was not provided.   Upon internal review, respiratory distress was considered medically significant.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional adverse event; MA reports a dose of ROTATEQ was given during a temperature excursion, later found supported; This spontaneous report was received from a medical assistant and refers to a 3-month-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-NOV-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml, orally, lot # 1660954, expiration date 07-MAR-2021, for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 48.4 degrees Fahrenheit for 15 minutes and 32.7 degrees Fahrenheit for 47 hours. Data logger was not involved. There were no previous excursions reported. There was no adverse effect reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Drug eruption, Pruritus, Rash, Rash macular
Clinical narrative: Blotchy skin from chest; full rash on torso and back from hips up to chest/slight rash on thighs/rash on back of knees and legs/Looks like a drug rash; Noticed being a bit itchy that evening; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899) via an unspecified route of administration at the left arm on 15Dec2020 16:00 at a single dose for covid-19 immunisation. Medical history included Iga nephropathy from an unknown date. Concomitant medication included lisinopril. On 15Dec2020, the patient noticed being a bit itchy before going to bed. On 16Dec2020 18:00, the patient noticed blotchy skin from chest up, full rash on torso and back from hips up to chest. The patient also noticed slight rash on thighs and more rash on back of knees and legs by 18Dec2020; looked like drug rash. The patient had no shortness of breath, fever, swelling, etc. The events were reported as non-serious and no treatment was given. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: sent to the emergency room for body rashes and hives.; sent to the emergency room for body rashes and hives.; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 4 patients. This is the 1st of four reports. A patient with unspecified age and gender received BNT162B2 via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history included allergies to bee stings. Concomitant medications were not reported. On unspecified date, the patient was sent to the emergency room for body rashes and hives, and they were recommending that those with a bee sting allergy hold off until they know more.  The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020502533 same reporter/ drug/ events, different patient;US-PFIZER INC-2020502534 same reporter/ drug/ events, different patient;US-PFIZER INC-2020502535 same reporter/ drug/ events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: 4 different individuals sent to the emergency room for body rashes and hives.; 4 different individuals sent to the emergency room for body rashes and hives.; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 4 patients. This is a second of four reports. A patient of unspecified age and gender received BNT162B2 (lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included allergies to bee stings from an unknown date. The patient's concomitant medications were not reported. The patient was sent to the emergency room for body rashes and hives. They are recommending that those with a bee sting allergy hold off until they know more. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020502532 same reporter, event and drug but different patient
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: sent to the emergency room for body rashes and hives.; sent to the emergency room for body rashes and hives.; This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for 4 patients. This is the 4th of four reports. A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration, on an unspecified date at single dose for immunization. Medical history included allergies to bee stings. It was reported that the patient sent to the emergency room post vaccine for body rashes and hives. There seemed to be a commonality of allergies to bee stings for the 4 different individuals. The pharmacist wondered if there are other reports of this. They are recommending that those with a bee sting allergy hold off until knowing more and wondered if any guidance from Pfizer. Event took place after use of product. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020502532 same reporter, drug, event but different patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, SARS-CoV-2 test, Skin warm
Clinical narrative: last night legs began burning like she had rubbed icy hot on them, extending down feet/the feeling was all over her body; This is a spontaneous report from a contactable nurse.  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 17Dec2020 09:30 at single dose for immunization (reported as COVID-19 vaccine). Medical history included vertigo and small whole in heart.  Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), ergocalciferol (VIT D), magnesium taurate, selenium and zinc. The patient previously took Kepra, Oxtellar and Sulfa which she had allergies. The patient experienced that last night (17Dec2020) her legs began burning like she had rubbed icy hot on them, extending down to her feet. Then woke at 2am and the feeling was all over her body. Awoke again at 6am and feeling was still there. She went to work, feeling wass not confined to ankles and feet...icy hot although warm to touch. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 13Nov2020  and sars-cov-2 test: unknown results   on Dec2020. Outcome of event was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysgeusia, Exposure to SARS-CoV-2, Injection site pain
Clinical narrative: anxiety was kicking in really bad/anxiety episode/triggered her anxiety; metallic taste; arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer product, lot EK5730, expiry date Mar2021) via an unspecified route of administration on 18Dec2020 (reported as today at 11:45, unknown if AM or PM) at a single dose on the arm as Covid 19 Vaccine. Medical history included cervical cancer since 2010, both mother and father have had cancer; post-traumatic stress disorder (PTSD); anxiety; had been on therapy counselling. Concomitant medications included hydroxyzine, sometimes uses medical marijuana, sometimes taking prenatal vitamins just because of the whole virus and stuff thing going around; the patient might not be pregnant but become pregnant (consumer was unsure- PENDING CLARIFICATION). She's in the middle of a divorce but she just takes the prenatal vitamins because of the higher doses to help run her immune system because of the virus. The patient received the vaccine today (18Dec2020) and she was not sure what these ingredients were. She's a single mother and an EKG and EEG tech working around Covid positive patients. She inquired if any of the ingredients or the vaccine itself do cause cancer. She really had a bad anxiety and PTSD and she didn't know but her anxiety was kicking in really bad right now. She's currently having anxiety episode now. The more she got home, the more she's thinking and that's kind of triggered her anxiety. She already has anxiety taking the vaccine/have anxiety about this Covid19 vaccine. She inquired if the lady knew like what triggered the anxiety if there's like any ingredient that could potentially cause cancer, do they spike protein, do those cause cells to mutate which causes cancer, so many answers and questions the patient had and there were no answers to her questions, nobody knew because it's still being studied and that's also where her anxiety was getting triggered and all about this was just unknown. She was just trying to figure out if there's a chemical ingredient made to be administered in the vaccine because being a mother she was trying to find answers and nobody seemed to have any answers and all she heard was she did not have. It was also stated that after she got the vaccine, she had really metallic taste for about an hour and a half and it finally went away. She also had a regular arm pain at the injection site, it's normal like how one get flu shot and stuff. The patient had no investigation assessment. Treatment for the events was reported as no. The outcome of the event metallic taste was recovered on 18Dec2020 while the rest of the event was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, SARS-CoV-2 test negative
Clinical narrative: About 5 minutes after the injection,  got a flushed feeling for a couple of minutes.; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old female patient received bnt162b2 (BNT162B2) lot number: EK5730, intramuscular (left arm), first dose on 16Dec2020 19:00 at a single dose for immunization. Medical history included high blood pressure and known allergies to penicillin and sulfa. Concomitant medication included escitalopram oxalate (LEXAPRO), lisinopril and omeprazole (PRILOSEC [OMEPRAZOLE]). It was reported that about 5 minutes after the injection on 16Dec2020 at  07:15 PM (as reported), the patient got a flushed feeling for a couple of minutes. The patient recovered from flushed feeling for a couple of minutes (16Dec2020). The event was reported as non-serious with no treatment received. The patient had no covid prior vaccination. She had covid tested post vaccination on 18Dec2020 through nasal swab with negative result.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness at the site of injection.; This is a spontaneous report from a contactable consumer, the patient.  A 54 year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EK5730 via an unspecified route of administration on 18Dec2020 at 10:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included loratadine (CLARITIN) from an unknown date and unknown if ongoing, or an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 18Dec2020 at 12:00, the patient experienced soreness at the site of injection. The patient did not receive any treatment for the event. The clinical outcome of the soreness at the site of injection was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Tiredness; Muscle pain; Chills; Fever; Joint pain; Vomiting; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient.  A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), intramuscular in the right arm on 16Dec2020 at 09:30 AM (at the age of 54-year-old) as a single dose for COVID-19 immunization. Medical history included hypertension, sleep apnoea syndrome, glucose tolerance impaired, breast cancer (5 years ago), and anxiety. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included HCTZ, losartan, anastrozole (ARIMIDEX), escitalopram oxalate (LEXAPRO), calcium, ergocalciferol (VITAMIN D), and fish oil; all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Bactrim and experienced drug hypersensitivity. On 17Dec2020, at 10:00 AM, the patient experienced tiredness, muscle pain, chills, fever, joint pain, vomiting, nausea, feeling unwell. The events were reported as non-serious. The patient did not receive any treatment for the tiredness, muscle pain, chills, fever, joint pain, vomiting, nausea, and feeling unwell. The clinical outcome of the events tiredness, muscle pain, chills, fever, joint pain, vomiting, nausea, feeling unwell was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Tiredness; Muscle pain; Chills; Fever; Joint pain; Vomiting; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient.  A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), intramuscular in the right arm on 16Dec2020 at 09:30 AM (at the age of 54-year-old) as a single dose for COVID-19 immunization. Medical history included hypertension, sleep apnoea syndrome, glucose tolerance impaired, breast cancer (5 years ago), and anxiety. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included HCTZ, losartan, anastrozole (ARIMIDEX), escitalopram oxalate (LEXAPRO), calcium, ergocalciferol (VITAMIN D), and fish oil; all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Bactrim and experienced drug hypersensitivity. On 17Dec2020, at 10:00 AM, the patient experienced tiredness, muscle pain, chills, fever, joint pain, vomiting, nausea, feeling unwell. The events were reported as non-serious. The patient did not receive any treatment for the tiredness, muscle pain, chills, fever, joint pain, vomiting, nausea, and feeling unwell. The clinical outcome of the events tiredness, muscle pain, chills, fever, joint pain, vomiting, nausea, feeling unwell was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Confusional state, Fatigue, Headache
Clinical narrative: Very painful injection site 5 hours after injection; Headache; Nausea; Myalgia; Arthralgias; Severe fatigue; Mild confusion; Chills but no sweats or fevers; This is a spontaneous report from a contactable physician. A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EH9899), intramuscular on the right arm on 15Dec2020 06:30 at a single dose for immunization. Medical history included treated hypertension; he had no known allergies. Concomitant medication included chlorthalidone and nifedipine (PROCARDIA). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Dec2020 10:30, the patient experienced very painful injection site 5 hours after injection; 8-10 hours after: headache, nausea, myalgia, arthralgias, severe fatigue, mild confusion, chills but no sweats or fevers; had to take 2 days off work due to severity of symptoms; symptoms decreased but some continue on day 5. The events were reported as non-serious. No treatment was received for the events. The patient was not diagnosed with COVID prior to vaccination and has not been tested post-vaccination. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: Very painful injection site 5 hours after injection; Headache; Nausea; Myalgia; Arthralgias; Severe fatigue; Mild confusion; Chills but no sweats or fevers; This is a spontaneous report from a contactable physician. A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EH9899), intramuscular on the right arm on 15Dec2020 06:30 at a single dose for immunization. Medical history included treated hypertension; he had no known allergies. Concomitant medication included chlorthalidone and nifedipine (PROCARDIA). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Dec2020 10:30, the patient experienced very painful injection site 5 hours after injection; 8-10 hours after: headache, nausea, myalgia, arthralgias, severe fatigue, mild confusion, chills but no sweats or fevers; had to take 2 days off work due to severity of symptoms; symptoms decreased but some continue on day 5. The events were reported as non-serious. No treatment was received for the events. The patient was not diagnosed with COVID prior to vaccination and has not been tested post-vaccination. Outcome of the events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache
Clinical narrative: Headache; Metallic taste; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-BioNTech COVID vaccine; lot number: EL0140; expiration date: unknown), intramuscular left arm on 19Dec2020 06:45 AM at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the COVID vaccine in a hospital. The patient did not have other vaccine in the last four weeks. The patient reported that she had headache and metallic taste on 19Dec2020. The events were non-serious and did not result in hospitalization or prolonged hospitalization. The patient received naproxen (ALEVE) as treatment. The patient was not diagnosed with COVID-19 prior vaccination and the patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Dec2020.  The following information on the batch/lot number has been requested
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Tachycardia
Clinical narrative: Tingling; Tachycardia; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 17Dec2020 at 1 DF, single for Covid-19 vaccination at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination; and reportedly did not have Covid-19 prior to receiving BNT162B2 vaccination. On 17Dec2020 (03:00), the patient had tingling and tachycardia. The patient did not receive any treatment for the adverse event. The outcome of the events, tingling and tachycardia, was recovered in Dec2020. The patient was tested for Covid-19 post-vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site pain, Limb discomfort, Oropharyngeal pain
Clinical narrative: pain at the injection site; I had discomfort in my arm; sore throat; cough/Bit of a cough; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot# not provided), via an unspecified route of administration in Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Thursday (in Dec2020), the patient received her first dose of COVID vaccine that Pfizer makes. By Thursday night and yesterday (Friday), the patient had pain at the injection site. The patient also had discomfort in her arm. It was also mentioned that by Friday afternoon until night, she developed a sore throat and a bit of a cough (she doesn't know if the coughing was because her throat was sore or it's other way around). She also mentioned that she doesn't have a fever and still have her sense of taste and smell. Outcome of the events were unknown.  Information on the Lot/Batch has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: left lower leg paresthesia in the left lateral sural nerve dermatome / felt like a tingling sensation localized to dermatome lateral to shin; felt like a burning sensation localized to dermatome lateral to shin; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: E51685), via an unspecified route of administration on 17Dec2020 05:45 (at the age of 33-years old) as a single dose in the left arm for COVID-19 immunization. Medical history included penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included an unspecified multivitamin received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient experienced left lower leg paresthesia in the left lateral sural nerve dermatome which felt like a tingling/burning sensation localized to dermatome lateral to shin on 18Dec2020 08:00 (reported as about 12 hours after injection). There was no loss of sensory, "temp" or pain detected, as reported. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the lower leg paresthesia in the left lateral sural nerve dermatome which felt like a tingling/burning sensation localized to dermatome lateral to shin was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: sore and tenderness on left arm; soreness on left arm; slight HA (headache) in the morning; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EH9899), via an unspecified route of administration on the left arm on 15Dec2020 09:45 at a single dose for immunization. Medical history included iron deficiency and was diagnosed with COVID-19 on an unspecified date; no known allergies. Concomitant medications included ascorbic acid (VIT C), tocopherol (VIT. E), cetirizine hydrochloride (ALERCET). The patient did not have other vaccinations within four weeks prior to the COVID vaccine. The patient experienced slight HA (headache) in the morning of day 0 (15Dec2020), occasional HA and increased soreness on left arm on day 1 (16Dec2020), still sore and experienced tenderness on left arm on days 2 to 4 but was mild at the time of report. The events were reported as non-serious. The patient took Tylenol and applied heating pad on her left arm. She was diagnosed with COVID prior to the vaccination and has not been tested for COVID post-vaccination. Outcome of the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Mild grade fever (99.8); Unable to leave bed for 24 hrs due to extreme fatigue and muscle soreness; Unable to leave bed for 24 hrs due to extreme fatigue and muscle soreness; Unable to leave bed for 24 hrs due to extreme fatigue and muscle soreness; This is a spontaneous report from a non-contactable healthcare professional. A 32-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Lot Number: EH 9899), intramuscularly in the right arm on an unspecified date (at the age of 32-years-old) as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Medical history was reported as none. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) for an unknown indication from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. On 04Dec2020 at 09:00 (as reported), the patient experienced a mild grade fever (99.8), was unable to leave the bed for 24 hours due to extreme fatigue and muscle soreness. The patient was not treated for the mild grade fever (99.8), was unable to leave the bed for 24 hours due to extreme fatigue and muscle soreness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the mild grade fever (99.8), was unable to leave the bed for 24 hours due to extreme fatigue and muscle soreness was resolved on 06Dec2020 at 9:00 (reported as resolved in 48 hours).   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in jaw
Clinical narrative: Numbness and pain in left jaw line; Numbness and pain in left jaw line; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration at the left arm on 18Dec2020 at 11:15 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no medical history and no known allergies (no allergies to medications, food, or other products). Concomitant medication (other medications in two weeks) included cephalexin (CEPHALEXIN) stopped 1 week prior, and fish oil. The patient experienced numbness and pain in left jaw line on 18Dec2020 at 11:45 AM. The patient did not receive treatment for these events. The clinical outcome of the events was not recovered. The report was reported as non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Fever of 101 for hours; chills; shakes; severe joint pain; body aches; dizziness; This is a spontaneous report from a non-contactable consumer (patient).  A 45-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: ELO140, expiry date not reported), via an unspecified route of administration on the right arm on 18Dec2020 at 10:45 at a single dose in the hospital for immunization.  Medical history included having had COVID-19 prior to vaccination on an unspecified date. The patient had no known allergies. Concomitant medication included bifidobacterium lactis, lactobacillus acidophilus (PRO-IMMUNE) powder (as reported).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101 for hours, chills and shakes, severe joint pain, body aches, dizziness all on 18Dec2020 at 22:45. Treatment was not received for the reported events. The outcome of the events was recovering. Since the vaccination the patient has not been tested for COVID-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Fever of 101 for hours; chills; shakes; severe joint pain; body aches; dizziness; This is a spontaneous report from a non-contactable consumer (patient).  A 45-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: ELO140, expiry date not reported), via an unspecified route of administration on the right arm on 18Dec2020 at 10:45 at a single dose in the hospital for immunization.  Medical history included having had COVID-19 prior to vaccination on an unspecified date. The patient had no known allergies. Concomitant medication included bifidobacterium lactis, lactobacillus acidophilus (PRO-IMMUNE) powder (as reported).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101 for hours, chills and shakes, severe joint pain, body aches, dizziness all on 18Dec2020 at 22:45. Treatment was not received for the reported events. The outcome of the events was recovering. Since the vaccination the patient has not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: Headache; neck and back ache; neck and back ache; injection arm very tender; Nausea; fatigue; This is a spontaneous report from a contactable consumer. A 49-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date was unknown), via an unspecified route of administration on 18Dec2020 10:00 at single dose in the left arm for immunization. Medical history included migraines and COVID-19 from an unknown date. Concomitant medication included acetylsalicylic acid (ASPRIN), potassium, curcuma longa (TURMERIC [CURCUMA LONGA]), ospemifene (OSPHENA) and black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]). The patient previously took penicillin and experienced allergies. On 18Dec2020 19:00, the patient experienced headache, neck and back ache, injection arm very tender, nausea and fatigue. No treatment received all the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  The following information on the batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Headache; neck and back ache; neck and back ache; injection arm very tender; Nausea; fatigue; This is a spontaneous report from a contactable consumer. A 49-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date was unknown), via an unspecified route of administration on 18Dec2020 10:00 at single dose in the left arm for immunization. Medical history included migraines and COVID-19 from an unknown date. Concomitant medication included acetylsalicylic acid (ASPRIN), potassium, curcuma longa (TURMERIC [CURCUMA LONGA]), ospemifene (OSPHENA) and black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]). The patient previously took penicillin and experienced allergies. On 18Dec2020 19:00, the patient experienced headache, neck and back ache, injection arm very tender, nausea and fatigue. No treatment received all the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  The following information on the batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Flushing
Clinical narrative: transient (1-2 minutes) flushing; chest tightness (on the same side as vaccine); lightheadedness; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), via an unspecified route of administration in the left arm on 18Dec2020 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history included Hodgkin's lymphoma from Nov2019 (treated for cure Nov2019 through Feb2020). The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received unspecified concomitant medications within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Dec2020 at 08:45 (as reported), the patient stated that 5-10 minutes after vaccine administration, she experienced transient (1-2 minutes) flushing, chest tightness (on the same side as vaccine), and lightheadedness. The patient was treated for flushing, chest tightness, and lightheadedness with BP measurements (as reported) and oral hydration. The clinical outcome of flushing was recovered on 18Dec2020, while chest tightness and lightheadedness were recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Tremor
Clinical narrative: Chills; shakes; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 18Dec2020 at 11:45 (dose number: 1) as a single dose for COVID-19 immunization. The patient medical history included anxiety. Concomitant medication were not reported. The patient was not pregnant at the time of vaccination and the facility where the most recent COVID-19 vaccine was administered was a hospital. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took clindamycin and had allergies. On 19Dec2020 01:30, the patient experienced chills, shakes, headache and nausea for 2 hours, 13 hours after administration (as reported). The patient did not receive any treatment for the events. The events were assessed as non-serious. The reported outcome of the events was recovering.  Information on lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site swelling
Clinical narrative: Fatigue 24 hrs after vaccination; Swelling and redness at injection site 36 hrs after vaccination; Swelling and redness at injection site 36 hrs after vaccination; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient started to receive started to receive BNT162B2 (Solution for injection, lot number: Eh9899 and expiry date was unknown), via an unspecified route of administration on 17Dec2020 15:00 at single dose in the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included allergies to sulfa drugs and diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. On 18Dec2020 18:30, the patient experienced fatigue 24 hrs after vaccination and swelling and redness at injection site 36 hrs after vaccination. No treatment received for all the events. The outcome of the events was unknown.  The following information on the batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Tremor
Clinical narrative: shaking chills for at least 4 hours; nausea; fatigue; This is a spontaneous report from a non-contactable nurse. A 68-year-old female patient started to receive bnt162b2 (BNT162B2), via an unspecified route of administration from an unspecified date at a single dose unspecified dose for an unspecified indication. Medical history included covid-19 (Prior to vaccination).  The patient's concomitant medications were not reported. It was reported that 24 hours after the first vaccine, the patient had shaking chills for at least 4 hours. She was wrapped in 2 heavy blankets and a heating pad. She also had nausea and fatigue. Symptoms gone the next day. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a contactable Nurse (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 17Dec2020 06:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccines received in four weeks prior to Covid-19 vaccine. No Covid-19 prior vaccination. It was unknown if patient was tested for Covid-19 post vaccination. The patient was not pregnant at the time of vaccination. The patient experienced sore throat on 18Dec2020 05:00. No treatment was received for the adverse event. The event was non-serious. The outcome of the event was recovered on unspecified date in Dec2020.  Information on Lot/Batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypertension, Photosensitivity reaction
Clinical narrative: Light headed; hypertension lasting approximately an hour/hour and a half; "Mental fuzziness" lasted until the headache took place.; "Mental fuzziness" lasted until the headache took place.; photo sensitivity; This is a spontaneous report from a contactable consumer. A 27-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date was unknown), via an unspecified route of administration on 18Dec2020 14:30 at single dose in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. There were no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. On 18Dec2020 14:30, the patient experienced light headed, hypertension lasting approximately an hour/hour and a half, ''Mental fuzziness'' lasted until the headache took place and normal side effects accompanied such as a headache and photo sensitivity. No treatment received for all the events. The outcome of the events was recovered in Dec2020.  The following information on the batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EJ1685, expiry date: Mar2021), via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was experiencing a "really super bad headache" on the day of report (19Dec2020) after receiving the covid vaccine the day before (18Dec2020). She took Tylenol and wanted to know if she can take Advil. She was suffering from a terrible headache and did not know if she can take Advil and there was nobody that can tell her whether it was okay with the vaccine. Outcome of the event was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Dysgeusia
Clinical narrative: have had a metallic taste since then, it has dissipated slightly; This is a spontaneous report from a contactable health care professional (patient).  A 37-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EK5730, expiry date: 01Mar2021), intramuscular on the on the left deltoid on 17Dec2020 (reported as 'at about 12:40 PM') at 0.3 mL at a single dose for COVID-19 immunization and ipratropium bromide (manufacturer unknown, specified as non-Pfizer, lot no: 348501, expiry date: May2022), nasal from an unspecified date to an unspecified date, 2 sprays, in each nostril as needed for rhinitis.  Medical history included seasonal allergy for which the patient receives allergy injections regularly but have not received one recently or within the last 14 days and ongoing rhinitis.  Concomitant medication included fexofenadine hydrochloride (ALLEGRA) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient stated that she was a healthcare worker and received the vaccine at her workplace. She called as she had a question about a very benign symptom that she was wondering if it's related to the vaccine or if it's something separate. She developed a metallic taste in her mouth about 2 hours after getting the vaccine, it's slowly dissipating but it's still there. She said no one else said  that they did have it and actually one other person who she works with said that they also had a slight thing (upon further clarification it was unspecified) but it's not in the list of expected symptoms so she just wanted to call and check. The patient did not receive any treatment for the event. She stated that she also used a nasal spray, Ipratropium Bromide Nasal Solution because she has rhinitis and she did use that and she never had a symptom or side effect with that because she uses it chronically but she did use that right before and noticed the taste develop so she doesn't know if there is a possible interaction between that and the vaccine. That morning she did 2 sprays in each nostril about 6 o'clock in the morning and then she did 2 sprays in each nostril about 2:15 PM and got her vaccine at about 12:40 PM that day. The patient got blood test for serology antibodies on 04Dec2020 with unknown results. The outcome of the event was recovering.