chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Renal impairment
Clinical narrative: Low kidney function; A spontaneous report was received from a consumer who was also a 79-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced low kidney function.  The patient's medical history reported include rheumatoid arthritis, and infection. Concomitant medications include medications (unspecified) for rheumatoid arthritis, and antibiotics for infection.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L204A) for prophylaxis of COVID-19 infection.   On an undisclosed date in Jan 2021, the patient's kidney function was low. She reported that her doctor said it was nothing to worry about.  Treatment for the event was not reported.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, low kidney function, was unknown.; Reporter's Comments: This case concerns a 79-year-old, female patient with medical history of rheumatoid arthritis and infection, who experienced an unexpected event of Renal impairment. The event occurred at an unspecified duration after the first dose of mRNA-1273 (Lot number: 025L204A). The patient was taking unspecified antibiotics for unspecified infection. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start  of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site mass
Clinical narrative: Knot on his arm; Vaccine subcutaneously injected; A spontaneous report was received from a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced knot on his arm and vaccine subcutaneously injected.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 subcutaneously in the left deltoid for prophylaxis of COVID-19 infection.   On 11 Jan 2021, during vaccine administration, the patient was given the vaccine subcutaneously and he later noticed a knot on his arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, vaccine subcutaneously injected, was considered resolved on 11 Jan 2021. The outcome of the event, knot on his arm, was not reported.; Reporter's Comments: This report refers to a case of a male patient who experienced non-serious event of mRNA-1273 vaccine was given subcutaneously (Vaccine given subcutaneously ,Vaccine administered at inappropriate site) and event of experienced knot on his arm (lot # unknown, Expiration date-unknown). The event of experienced knot on his arm is temporarily associated with the administration of mRNA-1273 vaccine, hence a causal association cannot be excluded. The event of vaccine given subcutaneously is considered not applicable
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report as received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine administered to left shoulder joint; A spontaneous report was received from a consumer concerning a 44-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine administered to left shoulder joint.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13 Jan 2021, approximately 0 days prior to the onset of the event, the patient received his first dose of mRNA-1273 (Lot number 012L20A)  for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient noticed the site of the injection was more on his shoulder joint rather than the upper arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine administered to left shoulder joint, was considered resolved on 13 Jan 2021.; Reporter's Comments: This case concerns concerning a 44-year old, male patient who received his first dose of mRNA-1273 (Lot number 012L20A) for prophylaxis of COVID-19 infection and the patient noticed the site of the injection was more on his shoulder joint rather than the upper arm. There were no reported adverse events associated with the event of product administered at inappropriate site.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: like a slight paralysis; stiffness in the face; numbness in the face; A spontaneous report was received from a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced like a slight paralysis, stiffness in the face and numbness in the face.   The patient's medical history, as reported, included high blood pressure. Concomitant medications reported included losartan.   On 13 Jan 2021, about 5 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13 Jan 2021, about 5 minutes after getting the Moderna COVID-19 vaccine, the patient experienced a stiffness and numbness in the face, like a slight paralysis. It started in the nose and spread out to the eyes and forehead. After about half an hour, he still experienced it a little bit. No medications were taken for the events.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, like a slight paralysis, stiffness in the face and numbness in the face, was recovering/resolving.; Reporter's Comments: This spontaneous report refers to a case of a 64-year-old, male patient with medical history of high blood pressure who experienced a serious event slight paralysis and non-serious events of stiffness in the face and numbness in the face.  The events occurred 5 minutes after the administration of the mRNA-1273 vaccine (lot # unknown, expiration date-unknown). No treatment was administered, and patient is recovering. Based on the information provided which includes a temporal association, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 01Jan2021 received the dose of the Moderna vaccine, and today 12Jan2021 took the second dose; A spontaneous report was received from a consumer who was also a 70-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 1st Jan 2021 and 12th Jan 2021, resulting in the event inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1st Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (Lot Number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12th Jan 2021, the patient received the second dose of two planned doses of mRNA-1273 (Lot Number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. The four weeks dosing schedule was not observed. The patient did not present any side effects.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, inappropriate schedule of product administration, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot Number: 025L20A) reporting Inappropriate schedule of product administration without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: patient who got the Pfizer vaccine 22DEC2020 got the Moderna vaccine today 13JAN2021; A spontaneous report was received from a professional concerning a 48-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who got the Pfizer vaccine 22 Dec 2020 got the Moderna vaccine today 13 Jan 2021.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Dec 2020, the patient received the Pfizer COVID-19 vaccine for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient received mRNA-1273 (Lot number 029L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced receiving the Moderna vaccine after receiving the Pfizer vaccine.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event patient who got the Pfizer vaccine 22 Dec 2020 got the Moderna vaccine today 13 Jan 2021 was not reported.; Reporter's Comments: This case concerns a 48-year-old female patient who received their first of two planned doses of Pfizer COVID-19 vaccine and second of two planned doses of mRNA-1273 (Lot number 029L20A), reporting Wrong product administered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Fatigue, Injection site pain, Malaise
Clinical narrative: her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia, Throat irritation
Clinical narrative: her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: She received the 1st dose on 28Dec2020. She taShe received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021ested positive to COVID-19 on 06Jan2020.; She received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: )Mar2021 , via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications. The patient received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021. She was still currently in isolation and symptomatic. Her second dose was scheduled on 18Jan2020. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive to COVID-19  based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain, Myalgia, No adverse event
Clinical narrative: twisted his back a little bit/strained his back; he is having some muscle pain; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) reported that a 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he is in good physical health. The patient stated that he is 79 years old, and received his first dose of the COVID vaccine 48 hours ago, on Monday at noon (11Jan2021). The patient strained his back last night (12Jan2021), and he is having some muscle pain, and he would like to know if it is okay to take Ibuprofen, following having received the vaccine. The patient clearly stated that he has had no side effects and he is fine from the vaccine. He also added that it was while he was in the shower last night, he twisted his back a little bit, and that happens to him now and then and that was normally when this happens to him, it takes a few days to get better. But patient stated that this event is totally unrelated to the COVID vaccine. The patient normally just takes a Motrin, and it clears the pain up, it relieves it. But he was just wondering if it is contraindicated to take Motrin after having had the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The events back strain and muscle pain were intercurrent conditions and unrelated to BNT162B2 vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on the left deltoid on 09Jan2021 12:00 at a single dose for Covid-19 immunization. The vaccine was administered at a hospital. Medical history was reported as none. Family medical history included her mother has multiple sclerosis and her sister has lupus. There were no concomitant medications. On the 9th, this past Saturday, she had first dose of COVID vaccine. Then on Monday, the 11th around 2:00 pm (14:00), she started having in her head numbness and tingling. Still has numbness and tingling in the head. The outcome of the events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Dizziness, Hypoaesthesia, Laboratory test, Magnetic resonance imaging head
Clinical narrative: head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on the left deltoid on 09Jan2021 12:00 at a single dose for Covid-19 immunization. The vaccine was administered at a hospital. Medical history was reported as none. Family medical history included her mother has multiple sclerosis and her sister has lupus. There were no concomitant medications. On the 9th, this past Saturday, she had first dose of COVID vaccine. Then on Monday, the 11th around 2:00 pm (14:00), she started having in her head numbness and tingling. Still has numbness and tingling in the head. The outcome of the events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on the left deltoid on 09Jan2021 12:00 at a single dose for Covid-19 immunization. The vaccine was administered at a hospital. Medical history was reported as none. Family medical history included her mother has multiple sclerosis and her sister has lupus. There were no concomitant medications. On the 9th, this past Saturday, she had first dose of COVID vaccine. Then on Monday, the 11th around 2:00 pm (14:00), she started having in her head numbness and tingling. Still has numbness and tingling in the head. The outcome of the events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Insomnia, Nausea, Pain
Clinical narrative: hot and cold chills; body aches; tired; nausea; did not sleep the rest of the night; This is a spontaneous report from a contactable consumer. A 32-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0142, via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a SINGLE DOSE for covid-19 immunization. Medical history included Gluten and dairy allergy. Prior vaccination, patient has had covid-19 from an unknown date to 30Dec2020. Patient was not pregnant during vaccination. Concomitant medications included curcumin, acetylcysteine, ascorbic acid, quercetin, vitamin b complex, vitamin c and colecalciferol. The patient previously took minocycline and zithromax and experienced allergy to both. The patient received the vaccine on 12Jan2021 at 10:30 and started feeling symptoms hot and cold chills, body aches on 13Jan2021 around 1:00 AM. She did not sleep the rest of the night and throughout the day was tired, chills, body aches, nausea. Patient also stated that she started her period the day she received the vaccine which she was not sure if did help her immune system. The outcome of events was recovering. Patient did not received any treatment due to the events. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear neoplasm, Herpes zoster
Clinical narrative: diagnosed with shingles; a lump on my left ear; This is a spontaneous report from a contactable nurse(patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 27Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On 31Dec2020 there was a lump on her left ear.  On 04Jan2021 there was a rash on her eyes. On 05Jan2021, the patient had a rash like shingles and the doctor diagnosed with shingles. She was taking an antiviral: acyclovir. The doctor said it's a side effect from the vaccine. The patient had no history of sickness. It's so rare. The doctor said shingles was dormant, a sleeping virus that's in her spine. She was not sure if it's because Covid was virus, and it activated her dormant virus. Her 2nd vaccine was soon, 5 days from now. She asked that "Is it ok to get the 2nd dose? Do I need to wait? I spoke with my doctor and infectious disease and they stated after a month; if my immune system was better". The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes; abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL3246) via an unspecified route of administration on left arm on 08Jan2021 07:30 at a single dose for covid-19 immunization. The patient got allergies to fluoroquinolones and dairy (milk protein allergy). Prior to vaccination, the patient did not diagnose with COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included famotidine and cetirizine hydrochloride (ZYRTEC). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EH9899) on left arm on 19Dec2020 01:30 PM for covid-19 immunization. The patient experienced abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes on 10Jan2021 16:00. It began about 48hrs after 2nd shot and still persisted to 5 days later. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID 19. The patient received Ibuprofen to treat the events. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: had 2 other patients who have reported metallic taste in their mouth after the vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 2 patients. This is second of two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she also had 2 other patients who had reported metallic taste in their mouth after the vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug/event; different patient
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain, Pyrexia
Clinical narrative: Temp up to 100.3; Body aches; Nausea; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 12Jan2021 11:00 at a single dose on right arm for COVID-19 immunization. Medical history included Hypothyroidism and allergies to Latex, Cephlosporins, Kiwi. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 22Dec2020 11:00 AM at a single dose on right arm for COVID-19 immunization. The patient experienced common listed side effects, Temp up to 100.3, Body aches; Not Listed as common, Nausea on 13Jan2021 16:30. No treatment received for the events. The outcome of the events was recovering. The events were considered as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was the Nursing Home/Senior Living Facility. 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on the left arm, on 12Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included high blood pressure; patient was not pregnant at time of vaccination. Concomitant medications were unspecified (received within 2 weeks of vaccination). The patient experienced nausea, muscle pain, joint pain, headache and tiredness on 13Jan2021 14:00. Treatment was not received for the events. Patient was recovering from the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Urticaria
Clinical narrative: Mild reaction: hives; Mild reaction: Tachycardia; This is a spontaneous report from a contactable other HCP. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild reaction hives and tachycardia on an unspecified date with outcome of unknown. The reporter asked if patient can still continue with the second dose.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Metrorrhagia, Myalgia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Breakthrough bleeding/spotting menses; soreness at injection site; fatigue; muscle aches; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 10:00 at single dose in Left arm for COVID-19 immunization. Medical history included Alports, Alopecia Areata, eczema, all from an unknown date and unknown if ongoing. There were no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC), lisinopril. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient experienced Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches on 23Dec2020 20:30. No treatment received for all reported events Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches. The patient underwent lab tests which included blood test for covid-19 which named SARS-COV-2 IGG on 09Jun2020 was with result Negative and covid-19 test which named SARS-COV-2 BY PCR (2019-NCOV) via Nasal Swab post vaccination on 30Dec2020 was with result Negative. The outcome of the events was recovered on an unspecified date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Breakthrough bleeding/spotting menses; soreness at injection site; fatigue; muscle aches; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 10:00 at single dose in Left arm for COVID-19 immunization. Medical history included Alports, Alopecia Areata, eczema, all from an unknown date and unknown if ongoing. There were no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC), lisinopril. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient experienced Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches on 23Dec2020 20:30. No treatment received for all reported events Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches. The patient underwent lab tests which included blood test for covid-19 which named SARS-COV-2 IGG on 09Jun2020 was with result Negative and covid-19 test which named SARS-COV-2 BY PCR (2019-NCOV) via Nasal Swab post vaccination on 30Dec2020 was with result Negative. The outcome of the events was recovered on an unspecified date.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Dizziness
Clinical narrative: dizzy; She is kind of weak; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 14Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. An 86-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiration date not reported), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date. The patient experienced dizzy and she is kind of weak on 14Jan2021. It was further reported that the events started this morning, she was fine yesterday. The patient underwent lab tests and procedures which included blood glucose: 145 on an unspecified date. The patient did not recover from the events.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Discoloration of skin on left hand (side where vaccine was administered); This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982), via an unspecified route of administration in left arm, on 13Jan2021 at 17:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 14Jan2021 at 06:00 AM, the patient experienced discoloration of skin on left hand (side where vaccine was administered). The patient has not been tested for COVID-19 post-vaccination. No treatment was administered for the event. The patient had not recovered from the event.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity
Clinical narrative: Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 12Jan2021 at 16:00 at a single dose in the clinic for COVID-19 immunization. The patient received the first dose on 22Dec2020 at 16:00 on the left arm for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination and did not have COVID prior to vaccination. Concomitant medication included ibuprofen and tramadol.  The patient experienced very painful lymphnode in arm of injection, pain radiating down arm into fingers on 13Jan2021 at 17:00. Outcome of the events was not recovered.  Information of lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Decreased sensation in the L side of the face; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular via the left arm on 30Dec2020 18:00 at a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ciprofloxacin. It was reported that the patient experienced decreased sensation in the L side of the face that lasted 3 days initially and now comes and goes on 30Dec2020 21:00. No treatment was given for the event. The outcome of the event was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Feeling cold, Hot flush
Clinical narrative: severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Musculoskeletal chest pain, Nausea, Neck pain, Pain
Clinical narrative: severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lymphadenopathy, Myalgia
Clinical narrative: fever to 100; chills; myalgias; headache; axillary lymphadenopathy with swelling and pain; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140 expiration date unknown), via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at a single dose for COVID-19 immunisation.  Medical history included non-celiac gluten induced enteropathy, COVID from 27Sep2020 to an unknown date (had COVID with mild course x2 days), and allergies to NSAIDS and SSRIs. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), amlodipine besilate (NORVASC), colecalciferol (VITAMIN D [COLECALCIFEROL]), and omeprazole (PRILOSEC [OMEPRAZOLE]) on unspecified dates for unspecified indications.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899 expiration date unknown) on 22Dec2020 at 10:45AM in the left arm for COVID-19 immunization; also previously took amoxicillin and experienced allergies. The patient was not pregnant. On 12Jan2021, at 12:00 AM, 12 hours after vaccine, the patient experienced fever to 100, chills, myalgias, headache. The patient was better 12 hours later after one dose of Tylenol. The patient also had axillary lymphadenopathy with swelling and pain, present since day 1 post vaccine (12Jan2021) and still swollen but pain improving. There was no treatment received for the adverse events. The outcome of the events was recovering at the time of report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever to 100; chills; myalgias; headache; axillary lymphadenopathy with swelling and pain; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140 expiration date unknown), via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at a single dose for COVID-19 immunisation.  Medical history included non-celiac gluten induced enteropathy, COVID from 27Sep2020 to an unknown date (had COVID with mild course x2 days), and allergies to NSAIDS and SSRIs. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), amlodipine besilate (NORVASC), colecalciferol (VITAMIN D [COLECALCIFEROL]), and omeprazole (PRILOSEC [OMEPRAZOLE]) on unspecified dates for unspecified indications.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899 expiration date unknown) on 22Dec2020 at 10:45AM in the left arm for COVID-19 immunization; also previously took amoxicillin and experienced allergies. The patient was not pregnant. On 12Jan2021, at 12:00 AM, 12 hours after vaccine, the patient experienced fever to 100, chills, myalgias, headache. The patient was better 12 hours later after one dose of Tylenol. The patient also had axillary lymphadenopathy with swelling and pain, present since day 1 post vaccine (12Jan2021) and still swollen but pain improving. There was no treatment received for the adverse events. The outcome of the events was recovering at the time of report.