chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Red swollen area size of 2.5" x 2.5"
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; zoster-related conditions; Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 01-JAN-2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX), for the long-term prevention of shingles and zoster-related conditions (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced hearing loss and other zoster-related conditions. On an unknown date, the patient was treated by a health care provider for hearing loss and other zoster-related conditions. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (on unspecified dates), physician care, monitoring, treatment, medications, and supplies. At the time of report, the patient was not recovered from hearing loss and other zoster-related conditions. The reporter considered the adverse events to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, the hearing loss was considered as medically significant event.
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Intensive care, Myocarditis
Clinical narrative: idiosyncratic myocarditis; This spontaneous report was received from a pharmacist on behalf of his son, a 19 year old male patient. the patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On an unknown date (also reported as "in the past"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (additional dosage regimen information was not reported).  On an unknown date (also reported as "within 3 weeks of GARDASIL 9"), the patient had pain in the chest. Then, he was admitted to ICU for 4 days and was diagnosed with myocarditis. It was mentioned that the physicians could not pinpoint what virus could have be lead to myocarditis, but it was diagnosed as idiosyncratic. Due to unknown reasons.  The patient was under care of an immunologist for unknown reasons and would have an unknown lab work done for immunology related reasons.  At the time of the report, the outcome of myocarditis was unknown. No causality assessment was provided.  Upon internal review, myocarditis was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Exposure via skin contact, Fatigue, Inappropriate schedule of product administration, Pruritus
Clinical narrative: Fatigue; Fever; Itchy body; Chills; Lower back pain; Received an underdose / Shot was spilled on the patient and the chair; Shot was spilled on the patient and the chair; Shot was spilled on the patient; interval too long; This case was reported by a pharmacist and described the occurrence of fatigue in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number J79G7, expiry date 27th August 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 18th january 2020, batch number 9H524, refer case US2020240927).   On 2nd December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced fatigue, fever, generalized pruritus, chills, low back pain, accidental underdose, inadvertent exposure to vaccine, exposure via skin contact and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue, accidental underdose, inadvertent exposure to vaccine, exposure via skin contact and drug dose administration interval too long were unknown and the outcome of the fever, generalized pruritus, chills and low back pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever, generalized pruritus, chills and low back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix and experienced fatigue, fever, generalized pruritus, chills, low back pain. The health casre professional(HCP) was not aware what amount of vaccine entered patient's body which led to accidental underdose. The vaccine spilled out on patient which led to inadvertent exposure to vaccine and exposure via skin contact. The patient also experienced the same adverse effects after dose 2 but they resolved quicker within 24 hours. The reporter consented to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240927:Same reporter. Case for dose 1
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Underdose
Clinical narrative: Fatigue; Fever; Itchy body; Chills; Lower back pain; Received an underdose / Shot was spilled on the patient and the chair; Shot was spilled on the patient and the chair; Shot was spilled on the patient; interval too long; This case was reported by a pharmacist and described the occurrence of fatigue in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number J79G7, expiry date 27th August 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 18th january 2020, batch number 9H524, refer case US2020240927).   On 2nd December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced fatigue, fever, generalized pruritus, chills, low back pain, accidental underdose, inadvertent exposure to vaccine, exposure via skin contact and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue, accidental underdose, inadvertent exposure to vaccine, exposure via skin contact and drug dose administration interval too long were unknown and the outcome of the fever, generalized pruritus, chills and low back pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever, generalized pruritus, chills and low back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix and experienced fatigue, fever, generalized pruritus, chills, low back pain. The health casre professional(HCP) was not aware what amount of vaccine entered patient's body which led to accidental underdose. The vaccine spilled out on patient which led to inadvertent exposure to vaccine and exposure via skin contact. The patient also experienced the same adverse effects after dose 2 but they resolved quicker within 24 hours. The reporter consented to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240927:Same reporter. Case for dose 1
Sex: F
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: Hematoma; A spontaneous report was received from a 44-years-old, female pharmacist, who was also the patient, who received Moderna's COVID-19 vaccine and experienced hematoma.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) in the back of her arm for prophylaxis of COVID-19 infection.  On 05 Jan 2020, the patient developed a hematoma at the site where the vaccine was administered. Treatment for the events included diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event hematoma was considered not resolved.; Reporter's Comments: This case concerns a 44 year old female subject who experienced a nonserious unexpected event of hematoma. The event occurred 9 days after first dose of the study medication administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: erythematous rash on face and chest. no itching or any other symptoms
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Chest discomfort, Chills
Clinical narrative: Started w/chills body aches - then came fever 102.7 - chills w/shaking, muscle, joint and bone ache, nausea, blurred vision, dizziness, weakness fatigue, chest pressure, diarrhea and burning w/deep breath. Hands and feet cold. Continued all day 1/20/21 and has been intermittent 1/21/21
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Myalgia, Nausea, Pain
Clinical narrative: Started w/chills body aches - then came fever 102.7 - chills w/shaking, muscle, joint and bone ache, nausea, blurred vision, dizziness, weakness fatigue, chest pressure, diarrhea and burning w/deep breath. Hands and feet cold. Continued all day 1/20/21 and has been intermittent 1/21/21
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia, Tremor, Vision blurred
Clinical narrative: Started w/chills body aches - then came fever 102.7 - chills w/shaking, muscle, joint and bone ache, nausea, blurred vision, dizziness, weakness fatigue, chest pressure, diarrhea and burning w/deep breath. Hands and feet cold. Continued all day 1/20/21 and has been intermittent 1/21/21
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache start about 13:00 on 1/11/21 - Headache worsened through the evening & night. Tylenol no helpful by 1000 on 1/12/21 body aches were starting and worsened extreme fatigue. Slept off & on from 1800 on 1/12/21 until 0600 on 1/13/21 HA was gone body aches much better & gone by 1000.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Vaccination site pain, Vomiting
Clinical narrative: Sore injection site; sore muscles; joint aches; Headache; Sore injection site, sore muscles, joint aches, headache, vomiting; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 33-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm, single dose for COVID-19 immunization on 09Jan2021, 12:45 PM, at 33-year-old. Medical history included: Crohn's, seasonal allergy. Known allergies reported as: tetracycline. The patient did not have COVID prior vaccination. Concomitant medication in two weeks included: budesonide; spironolactone; diphenhydramine hydrochloride (BENADRYL). No other vaccine received in four weeks. The patient had sore injection site, sore muscles, joint aches, headache, vomiting; all on 09Jan2021, 08:00 AM. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: diarrhea; brutal headache/ severe headache; This is a spontaneous report from a contactable consumer (patient parent). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 07Jan2021 at 34-year-old. Medical history and concomitant medication were not reported. After the first vaccine, the patient got a severe headache and diarrhea. It was reported that within a day (07Jan2021), he got a brutal headache, and the next day (08Jan2021) got diarrhea. Treatment received for diarrhea. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache, Pain
Clinical narrative: Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a spontaneous report from a contactable consumer.  A 48-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 09Jan2021 at 09:00 at 48-years-old at a single dose for COVID-19 immunization. Medical history included Sulfonamide allergy, Factor V Leiden mutation, diabetes; all from an unknown date and unknown if ongoing.  Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D [COLECALCIFEROL]), lisinopril (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN); all taken for an unspecified indication from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: injection pain on 09Jan2021 20:00 with outcome of recovering , headache on 09Jan2021 20:00 with outcome of recovering, tiredness/feeling wornout on 09Jan2021 20:00 with outcome of unknown, chills on 09Jan2021 20:00 with outcome of recovering, body aches on 09Jan2021 20:00 with outcome of recovering, chest tightness on 09Jan2021 20:00 with outcome of recovering. The patient did not receive other vaccines in four weeks; there was no treatment for the adverse events; there was no prior COVID vaccination; there was no post vaccination COVID test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015284 same patient, different event and vaccine
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a spontaneous report from a contactable consumer.  A 48-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 09Jan2021 at 09:00 at 48-years-old at a single dose for COVID-19 immunization. Medical history included Sulfonamide allergy, Factor V Leiden mutation, diabetes; all from an unknown date and unknown if ongoing.  Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D [COLECALCIFEROL]), lisinopril (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN); all taken for an unspecified indication from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: injection pain on 09Jan2021 20:00 with outcome of recovering , headache on 09Jan2021 20:00 with outcome of recovering, tiredness/feeling wornout on 09Jan2021 20:00 with outcome of unknown, chills on 09Jan2021 20:00 with outcome of recovering, body aches on 09Jan2021 20:00 with outcome of recovering, chest tightness on 09Jan2021 20:00 with outcome of recovering. The patient did not receive other vaccines in four weeks; there was no treatment for the adverse events; there was no prior COVID vaccination; there was no post vaccination COVID test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015284 same patient, different event and vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: having intermittent left-sided chest pain/The pain is worsened with deep breathing.; palpitations; This is a spontaneous report from a contactable Other Healthcare professional (HCP) (patient). A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via Intramuscular on left arm on 06Jan2021 at 14:00 at single dose for COVID-19 immunisation. The relevant medical history included known allergies: Penicillin and known allergies: Sulfa. Concomitant medications were reported as none. The patient previously took Ceclor and had known allergies. The day after receiving the first dose, on 07Jan2021 at 15:00 the patient had been having intermittent left sided chest pain. The pain was worsened with deep breathing. Additionally having palpitations. It had caused her enough concern that she went to the ED (Emergency room/department or urgent care). She had been encouraged to follow up in clinic. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 antibody test, Somnolence
Clinical narrative: Headache; Tiredness; Sleepy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 10:00 AM, at 44-year-old. Medical history included: allergies: dust. The patient did not have COVID prior vaccination. Concomitant medication was not reported. No other vaccine received in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on left arm for COVID-19 immunization on 19Dec2020, 10:15 AM. On second day after the second dose of BNT162B2, on 10Jan2021, 08:00 AM, the patient had headache, tiredness, sleepy. No treatment received. The patient was tested for COVID, by saliva with negative result on 16Dec2020, by nasal swab with negative result on 07Jan2021. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Alternating sweating and cold; Alternating sweating and cold; stomachache; Nausea; Fatigue; Headache; This is a spontaneous report from a non-contactable healthcare professional (reporting for herself). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 10:45 in right arm at single dose for COVID-19 immunization. Medical history included hypothyroidism and major depression from an unknown date and unknown if ongoing. The patient had no allergies to medication, food, or other products. The patient had first dose of BNT162B2 on 18Dec2020 15:00 via intramuscular in left arm at single dose for COVID-19 immunization. Concomitant medications included levothyroxine, bupropion hydrochloride (WELLBUTRIN), "birth control" (not further specified, and escitalopram. 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. On 08Jan2021, the patient experienced alternating sweating and cold, stomachache, nausea, fatigue, and headache at 1:00 AM. She was not hospitalized, and the events were reported as non-serious. Therapeutic measures taken as a result of the headache and included acetaminophen. The outcome of the events was resolving. The patient underwent lab tests and procedures which included nasal swab: negative in Nov2020. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Follow-up (14Jan2021): This is a follow-up report combining information from duplicate reports 2021013335 and 2021015838. The current and all subsequent information will be reported under manufacturer report number 2021015838. Additional information included: reaction data (alternating sweating and cold, stomachache, nausea, fatigue, and headache).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: Alternating sweating and cold; Alternating sweating and cold; stomachache; Nausea; Fatigue; Headache; This is a spontaneous report from a non-contactable healthcare professional (reporting for herself). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 10:45 in right arm at single dose for COVID-19 immunization. Medical history included hypothyroidism and major depression from an unknown date and unknown if ongoing. The patient had no allergies to medication, food, or other products. The patient had first dose of BNT162B2 on 18Dec2020 15:00 via intramuscular in left arm at single dose for COVID-19 immunization. Concomitant medications included levothyroxine, bupropion hydrochloride (WELLBUTRIN), "birth control" (not further specified, and escitalopram. 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. On 08Jan2021, the patient experienced alternating sweating and cold, stomachache, nausea, fatigue, and headache at 1:00 AM. She was not hospitalized, and the events were reported as non-serious. Therapeutic measures taken as a result of the headache and included acetaminophen. The outcome of the events was resolving. The patient underwent lab tests and procedures which included nasal swab: negative in Nov2020. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Follow-up (14Jan2021): This is a follow-up report combining information from duplicate reports 2021013335 and 2021015838. The current and all subsequent information will be reported under manufacturer report number 2021015838. Additional information included: reaction data (alternating sweating and cold, stomachache, nausea, fatigue, and headache).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nasal congestion, Pyrexia
Clinical narrative: Nasal congestion/congestion; Runny nose; I ran a fever starting at about 9 PM that evening of 99.6 which increased to 101.4; Arm pain from the injection site; Headache; Extreme fatigue; I just felt very tired; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 11Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration in arm, on 07Jan2021, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated, "I received the vaccination on Thursday of last week (07Jan2021) and I would say by 9 PM, of course I had the usual arm pain from the injection site, no big deal there. I had little bit of headache (07Jan2021) nothing serious. I had extreme fatigue, I just felt very tired when I went to work after that and then I ran a fever starting at about 9 PM that evening (07Jan2021) of 99.6 which increased to 101.4 by 1:00 in the morning (08Jan2021) and then Friday (08Jan2021), I started with some nasal congestion, runny nose, had congestion and that kind of things." The patient had COVID-19 test on 10Jan2021 and when probed about the results, she stated, "No" (Unknown results, pending clarification). Treatment for the events included Tylenol. The outcome of the events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Nasal congestion/congestion; Runny nose; I ran a fever starting at about 9 PM that evening of 99.6 which increased to 101.4; Arm pain from the injection site; Headache; Extreme fatigue; I just felt very tired; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 11Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration in arm, on 07Jan2021, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated, "I received the vaccination on Thursday of last week (07Jan2021) and I would say by 9 PM, of course I had the usual arm pain from the injection site, no big deal there. I had little bit of headache (07Jan2021) nothing serious. I had extreme fatigue, I just felt very tired when I went to work after that and then I ran a fever starting at about 9 PM that evening (07Jan2021) of 99.6 which increased to 101.4 by 1:00 in the morning (08Jan2021) and then Friday (08Jan2021), I started with some nasal congestion, runny nose, had congestion and that kind of things." The patient had COVID-19 test on 10Jan2021 and when probed about the results, she stated, "No" (Unknown results, pending clarification). Treatment for the events included Tylenol. The outcome of the events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration on 09Jan2021 06:30 at a single dose on right arm for COVID-19 immunization. Medical history included depression, obesity, penicillin and bee sting allergies. The patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID prior to vaccination. Concomitant medications included venlafaxine, cetirizine and ibuprofen. The patient previously took ceftriaxone sodium (ROCEPHIN) and experienced allergies. The patient was given first dose of bnt162b2 on 19Dec2020 18:30 on left arm for COVID-19 immunization (lot number: Eh9899). No other vaccines in four weeks prior to COVID vaccine. On 09Jan2021 18:00, the patient experienced malaise, myalgias, arthralgias, headache, fever and nausea from 12 hours post injection until 36 hours post injection. Treatment was given for the adverse events which included acetaminophen and ibuprofen.  The patient has not been tested for COVID post vaccination. The patient was recovering from the events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration on 09Jan2021 06:30 at a single dose on right arm for COVID-19 immunization. Medical history included depression, obesity, penicillin and bee sting allergies. The patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID prior to vaccination. Concomitant medications included venlafaxine, cetirizine and ibuprofen. The patient previously took ceftriaxone sodium (ROCEPHIN) and experienced allergies. The patient was given first dose of bnt162b2 on 19Dec2020 18:30 on left arm for COVID-19 immunization (lot number: Eh9899). No other vaccines in four weeks prior to COVID vaccine. On 09Jan2021 18:00, the patient experienced malaise, myalgias, arthralgias, headache, fever and nausea from 12 hours post injection until 36 hours post injection. Treatment was given for the adverse events which included acetaminophen and ibuprofen.  The patient has not been tested for COVID post vaccination. The patient was recovering from the events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site joint pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness, swelling and itching at injection site; Redness, swelling and itching at injection site; Redness, swelling and itching at injection site; Redness, swelling and itching at injection site with joint pain going distally on arm; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in left arm on 09Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included aspirin [acetylsalicylic acid], diphenhydramine hydrochloride (BENADRYL), ibuprofen and bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). The patient previously took cephalexin, ciprofloxacin, neomycin and macrobid [clarithromycin] and experienced drug allergies. The patient had first dose of  BNT162B2  (lot number: EK5730) via intramuscular in left arm on 19Dec2020 10:15 AM at single dose. On 10Jan2021 08:00 AM, the patient experienced redness, swelling and itching at injection site with joint pain going distally on arm. No treatment received for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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. The outcome of the events was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever with chills (temperature varied from 101-102 and would decrease to 99-100); This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in right arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. The patient's medical history included hypertension, glaucoma, Wolff-Parkinson-White syndrome (treated with ablation previously), and COVID-19 (prior vaccination). The patient's concomitant medications included amlodipine, metoprolol, colecalciferol (VIT D3), ascorbic acid (VIT C), and vitamin B complex (VITAMIN B).  The patient previously took azithromycin (ZITHROMAX) and experienced allergies. No other vaccine was administered in four weeks. The facility where the vaccine was administered was a hospital. On 09Jan2021 (approximately 6 to 8 hours after the vaccine), the patient began running a fever with chills. The patient's temperature varied from 101-102 and would decrease to 99-100 with acetaminophen. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the event in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Episcleritis, Eye pain, Ocular hyperaemia
Clinical narrative: Episcleritis; red, painful eye; red, painful eye; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), intramuscular on the left arm on 22Dec2020 at 16:15 at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included propranolol (PROPRANOLOL), montelukast sodium (SINGULAIR), mometasone furoate (FLONASE [MOMETASONE FUROATE]) and multivitamin with minerals. The patient had no other vaccine in four weeks. The patient previously took and had known allergies with Morphine. The patient had no COVID-19 prior vaccination, had not tested post-vaccination. The patient developed red, painful eye on 04Jan2021 at 06:00 AM. The patient saw the eye doctor. Do with Episcleritis. It was also reported that the patient never had this thing before. The events resulted in healthcare professional office/clinic visit. Treatment for the events included Prednisolone eye drops. The events were resolving.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose, Vaccination site discharge, Vaccination site extravasation
Clinical narrative: If she saw a clear fluid run down the arm from the site of injection, did she actually get the full dose?; If she saw a clear fluid run down the arm from the site of injection, did she actually get the full dose?; If she saw a clear fluid run down the arm from the site of injection, did she actually get the full dose?; If she saw a clear fluid run down the arm from the site of injection, did she actually get the full dose?; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A female patient of an unspecified age started to receive first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 08Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of COVID-19 vaccine on a Friday. After that, at home 2 hours later, she removed the band aid and a clear fluid ran down the arm from the site of injection. The patient was wondering if she actually got the full dose.  Information on the lot/batch number has been requested.  Follow-up (11Jan2021): New information from a contactable consumer via Pfizer Sponsored Program: includes report source. Vaccination site extravasation and discharge; and exposure via skin contact added as adverse events for the term " If she saw a clear fluid run down the arm from the site of injection, did she actually get the full dose."  Information on the Lot/Batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Cough; muscle aches; joint pain; fatigue; headache; arm pain; This is a spontaneous report from a contactable physician (patient). A 38-year-old male patient received his second dose of BNT162B2 (lot number: EH2184), via an unspecified route of administration in the left arm on 07Jan2021 at 08:30 at single dose for Covid-19 immunization.  Medical history was none. The patient had no known allergies. There were no concomitant medications. The patient received his first dose of BNT162B2 (lot number: EH9899) in the left arm on 17Dec2020 at 09:00 for Covid-19 immunization. The patient had no other vaccine in four weeks nor other medications in two weeks. The patient experienced cough requiring albuterol (the patient had never had any history of reactive airway disease or bronchoconstriction), other post-vaccine symptoms included muscle aches, joint pain, fatigue, headache, and arm pain; all on 08Jan2021 at 20:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had no COVID prior vaccination nor tested with COVID post vaccination. The patient recovered from the events in Jan2021.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Cough; muscle aches; joint pain; fatigue; headache; arm pain; This is a spontaneous report from a contactable physician (patient). A 38-year-old male patient received his second dose of BNT162B2 (lot number: EH2184), via an unspecified route of administration in the left arm on 07Jan2021 at 08:30 at single dose for Covid-19 immunization.  Medical history was none. The patient had no known allergies. There were no concomitant medications. The patient received his first dose of BNT162B2 (lot number: EH9899) in the left arm on 17Dec2020 at 09:00 for Covid-19 immunization. The patient had no other vaccine in four weeks nor other medications in two weeks. The patient experienced cough requiring albuterol (the patient had never had any history of reactive airway disease or bronchoconstriction), other post-vaccine symptoms included muscle aches, joint pain, fatigue, headache, and arm pain; all on 08Jan2021 at 20:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had no COVID prior vaccination nor tested with COVID post vaccination. The patient recovered from the events in Jan2021.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dyspepsia, Headache
Clinical narrative: 2 bouts of diarrhea; bad heartburn; really bad headache; fever of 101.7/Fever of 100.0; chills; body aches; This is a spontaneous report from a contactable Other Health Professional (patient). A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 05Jan2021 13:00 at single dose for COVID-19 immunization.  Medical history was none (known allergies: No, other medical history: None).  Concomitant medication in two weeks included escitalopram oxalate (LEXAPRO). The patient experienced really bad headache, fever of 101.7/fever of 100.0, chills, body aches, all on 10Jan2021 11:00 with outcome of recovering, 2 bouts of diarrhea and bad heartburn on 11Jan2021 with outcome of recovering.  The patient underwent lab tests and procedures which included body temperature: 100 in Jan2021, 101.7 on 10Jan2021, Nasal Swab (Sars CoV-2 nucleic acid amplified test): negative on 10Jan2021. On 10Jan2021 11 am developed really bad headache, fever of 101.7, chills and body aches. On 11Jan2021 morning symptoms slowly improving with paracetamol (TYLENOL) but developed bad heartburn and 2 bouts of diarrhea. Fever of 100.0. No treatment received for heartburn and 2 bouts of diarrhea. AE resulted in: Doctor or other healthcare professional office/clinic visit. Facility type vaccine: Hospital. if other vaccine in four weeks: No. If treatment AE: No. If COVID prior vaccination: No. If COVID tested post vaccination: Yes.  information on the Lot/Batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: 2 bouts of diarrhea; bad heartburn; really bad headache; fever of 101.7/Fever of 100.0; chills; body aches; This is a spontaneous report from a contactable Other Health Professional (patient). A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 05Jan2021 13:00 at single dose for COVID-19 immunization.  Medical history was none (known allergies: No, other medical history: None).  Concomitant medication in two weeks included escitalopram oxalate (LEXAPRO). The patient experienced really bad headache, fever of 101.7/fever of 100.0, chills, body aches, all on 10Jan2021 11:00 with outcome of recovering, 2 bouts of diarrhea and bad heartburn on 11Jan2021 with outcome of recovering.  The patient underwent lab tests and procedures which included body temperature: 100 in Jan2021, 101.7 on 10Jan2021, Nasal Swab (Sars CoV-2 nucleic acid amplified test): negative on 10Jan2021. On 10Jan2021 11 am developed really bad headache, fever of 101.7, chills and body aches. On 11Jan2021 morning symptoms slowly improving with paracetamol (TYLENOL) but developed bad heartburn and 2 bouts of diarrhea. Fever of 100.0. No treatment received for heartburn and 2 bouts of diarrhea. AE resulted in: Doctor or other healthcare professional office/clinic visit. Facility type vaccine: Hospital. if other vaccine in four weeks: No. If treatment AE: No. If COVID prior vaccination: No. If COVID tested post vaccination: Yes.  information on the Lot/Batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Nausea, Oxygen saturation, Pain, Pruritus
Clinical narrative: itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.