chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Headache, Myalgia
Clinical narrative: SECOND DOSE.  Side effects stared about 16 hours after the vaccine.  Started with slight soreness in left arm.  This remained a slight discomfort. Body tingling sensation turned into body aches.  Most were in the lower back and shoulders.  Random shooting pains in thigh muscles.  First temperature check at 8:00 am was 101.1 it increased throughout the day, peaking at 102.6.   I took 500 mg of Extra Strength Tylenol at 3:30 pm .  The fever dropped to 100.1 by 6:30 pm.  I took another 500 mg.  At 11:00 pm, the fever was up slightly to 101.6.  By 7:30 the next morning, the fever was down to 99.8.  It was gone a few hours later. Headache associated with fever, but not severe. NO fatigue, so I could not sleep off the fever.  I was wide awake and miserable. Felt fine by 8:00 am, so side bad side effects lasted approximately 24 hours.  By approximately 40 hours after the vaccine, I felt fine.  Very minimal soreness in arm remaining.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: SECOND DOSE.  Side effects stared about 16 hours after the vaccine.  Started with slight soreness in left arm.  This remained a slight discomfort. Body tingling sensation turned into body aches.  Most were in the lower back and shoulders.  Random shooting pains in thigh muscles.  First temperature check at 8:00 am was 101.1 it increased throughout the day, peaking at 102.6.   I took 500 mg of Extra Strength Tylenol at 3:30 pm .  The fever dropped to 100.1 by 6:30 pm.  I took another 500 mg.  At 11:00 pm, the fever was up slightly to 101.6.  By 7:30 the next morning, the fever was down to 99.8.  It was gone a few hours later. Headache associated with fever, but not severe. NO fatigue, so I could not sleep off the fever.  I was wide awake and miserable. Felt fine by 8:00 am, so side bad side effects lasted approximately 24 hours.  By approximately 40 hours after the vaccine, I felt fine.  Very minimal soreness in arm remaining.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash at injection site for now almost two weeks.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Appetite disorder, Chills, Dry mouth, Insomnia
Clinical narrative: Unable to lift arm. Severe chills, virus dreams, dry mouth despite being well hydrated, unusual night time hunger, unusual insomnia. All symptoms currently happening at 0345 hours. Not going to the doctor as this does not seem life threatening at this time.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Unable to lift arm. Severe chills, virus dreams, dry mouth despite being well hydrated, unusual night time hunger, unusual insomnia. All symptoms currently happening at 0345 hours. Not going to the doctor as this does not seem life threatening at this time.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain at injection site, tenderness, swelling, fatigue, muscle pain
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Injection site pain, Malaise
Clinical narrative: Tenderness/ Pain  on site of the injection for over 48 hours. Feeling un-well for 24 hours. Stomach ache, muscle aches, weakness, fatigue.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain of skin
Clinical narrative: Tenderness/ Pain  on site of the injection for over 48 hours. Feeling un-well for 24 hours. Stomach ache, muscle aches, weakness, fatigue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Dizziness
Clinical narrative: Violent side efdects after injection: 103 degree fever, vomiting, diarrhea, headache, dizziness, low blood pressure, weakness, chills, muscle pain, joint pain, nausea, fatigue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypotension, Myalgia, Nausea
Clinical narrative: Violent side efdects after injection: 103 degree fever, vomiting, diarrhea, headache, dizziness, low blood pressure, weakness, chills, muscle pain, joint pain, nausea, fatigue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Violent side efdects after injection: 103 degree fever, vomiting, diarrhea, headache, dizziness, low blood pressure, weakness, chills, muscle pain, joint pain, nausea, fatigue.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills and fatigue that lasted about 24 hours
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE reported; temperature excursion involving V ARlV AX / the V ARlV AX was administered to one patient; This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.     On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5 ml, lot number S025611 and expiration date of 18-AUG-2021 (route of administration and anatomical location were unknown) for prophylaxis. The vaccine was exposed to a temperature excursion of 16°F with a time frame of 11 hours and 5 minutes. There was no previous temperature excursion. A "data logger" was involved. No other adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Syringe issue, Underdose
Clinical narrative: No adverse side effects; Patienr received an incomplete dose of MMR II; There appeared to be leaking from the syringe and needle; There appeared to be leaking from the syringe and needle; There appeared to be leaking from the syringe and needle; This spontaneous report was received from a Medical Assistant, referring to a 12 month old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On 12-FEB-2021, the patient was vaccinated with an incomplete dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with lot # S039310 and expiration date on 14-FEB-2021 (route of administration, dose and strength were not provided) for prophylaxis. The reporter stated, that there appeared to be leaking from the syringe and needle. It was unknown, how much of the vaccine the patient received. No adverse side effects occurred.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: severe swelling of Right parotid gland; developed lymphadenopathy; . This case was reported by a physician and described the occurrence of parotid swelling in a 59-year-old patient who received Herpes zoster (Shingrix) (batch number 3HT5J, expiry date 26th January 2022) for prophylaxis.   On 11th January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced parotid swelling and lymphadenopathy. On an unknown date, the outcome of the parotid swelling and lymphadenopathy were unknown.   It was unknown if the reporter considered the parotid swelling and lymphadenopathy to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. After receiving first dose of Shingrix, the patient experienced swelling of right parotid gland and 1 or 2 days after, on left arm developed lymphadenopathy. The reported batch number 38T5J for 2nd dose of Shingrix did not exist and was updated to 3HT5J per the sales database. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Pneumonia, Pyrexia
Clinical narrative: Chest started getting tight; Coughing; Fever; Pneumonia; Positive for covid; A spontaneous report was received from Healthcare Professional concerning a 75-year-old, female patient who received Moderna's COVID-19 vaccine and experienced fever/ pyrexia, cough, tested positive for covid/ COVID-19, pneumonia, and chest started getting tight/ chest discomfort.  The patient's medical history was not provided. Concomitant product use was not provided.  On 11 Jan 2021 prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an undisclosed date, the patient experienced fever and cough.  Her chest started getting tight when doing breathing exercises at home.  On 15 Jan 2021, the patient tested positive for COVID-19.   On 18 Jan 2021, the patient also tested positive for pneumonia.  The treatment included bamlanivimib.  The action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, fever, cough, chest started getting tight, tested positive for covid, and tested positive for pneumonia, was unknown.; Reporter's Comments: Although a temporal association exist, based on the known etiology for COVID-19, a causal association between the product use and events of cough, COVID-19, pneumonia and chest discomfort is considered unlikely.  The patient most likely had pre-existing COVID infection and the other events are complications from the disease. Fever is consistent with the safety profile of the product and a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chest started getting tight; Coughing; Fever; Pneumonia; Positive for covid; A spontaneous report was received from Healthcare Professional concerning a 75-year-old, female patient who received Moderna's COVID-19 vaccine and experienced fever/ pyrexia, cough, tested positive for covid/ COVID-19, pneumonia, and chest started getting tight/ chest discomfort.  The patient's medical history was not provided. Concomitant product use was not provided.  On 11 Jan 2021 prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an undisclosed date, the patient experienced fever and cough.  Her chest started getting tight when doing breathing exercises at home.  On 15 Jan 2021, the patient tested positive for COVID-19.   On 18 Jan 2021, the patient also tested positive for pneumonia.  The treatment included bamlanivimib.  The action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, fever, cough, chest started getting tight, tested positive for covid, and tested positive for pneumonia, was unknown.; Reporter's Comments: Although a temporal association exist, based on the known etiology for COVID-19, a causal association between the product use and events of cough, COVID-19, pneumonia and chest discomfort is considered unlikely.  The patient most likely had pre-existing COVID infection and the other events are complications from the disease. Fever is consistent with the safety profile of the product and a causal association cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Hallucinations; A spontaneous report was received from a consumer concerning 72-year-old male. The patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucinations, seeing ghost.  The patient's medical history was not provided.  Concomitant product use was not provided.  Prior to the onset of symptoms, on an known date, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided), for prophylaxis of Covid-19 infection.  On 01 Feb 2021 the patient left a voicemail message to Safety stating that he began having, "what I guess you would call hallucinations" after receiving his first dose of Covid -19 vaccination.  He further stated, " I've seen ghosts". "I've never seen ghosts in my life before".  The patient then went on to ponder whether the event was vaccine related or possibly related to the fact that he experienced a problem in his eye some years ago that caused him to "see weird things".  No treatment or other relevant information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event hallucinations was unknown at the time of the report.; Reporter's Comments: 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.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administered with 0.3 ml of the vaccine.; A spontaneous report was received from a pharmacist concerning sixty-seven patients who received Moderna's COVID-19 vaccine (mRNA-1273) and were administered with 0.3 ml of the vaccine.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patients received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. While administering the vaccine, the reporter stated that the patients received less than the 0.5 ml dose of the Moderna COVID-19 vaccine. The reporter also mentioned that the syringe was set to 0.3 ml instead of 0.5 ml. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The event, administered with 0.3 ml of the vaccine, was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of Underdose for mRNA-1273. There were no reported AEs associated with this case.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Galactostasis, Influenza like illness, Mastitis, Maternal exposure during breast feeding
Clinical narrative: Possibly Mastitis; Breast was hard, red, and sore; Milk production dropped; Clogged duct; Flu like symptoms; Received vaccine while breastfeeding; A spontaneous report was received from a consumer who was also a 33-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced received vaccine while breastfeeding (maternal exposure during breast feeding), clogged duct (galactostasis), possible mastitis (mastitis), flu like symptoms (influenza like illness), milk production dropped (suppressed lactation), and breast was hard, red, and sore (breast tenderness).   The patient's medical history included eczema.  Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 31 Dec 2020. On 28 Jan 2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient received the vaccine while breastfeeding and reported having a clogged duct and possible mastitis.  She began to experience flu like symptoms on 29 Jan 2021.  She had a fever and missed pumping breast milk.  On 30 Jan 2021 her milk production was about half of the typical amount.  The flu like symptoms resolved on 31 Jan 2021.  On 01 Feb 2021 her breast became hard, red, and sore.  On 02 Feb 2021 her breast symptoms resolved; however, her milk production was 65-70% of normal. She treated the events with acetaminophen and magnesium sulfate dissolved in water.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events clogged duct, possible mastitis, milk production dropped, and were not reported.  The outcome of the event, received vaccine while breastfeeding, was considered resolved on 28 Jan 2021. The outcome of the event, flu like symptoms, was considered resolved on 31 Jan 2021. The outcome of the event, breast was hard, red, and sore, was considered resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Suppressed lactation
Clinical narrative: Possibly Mastitis; Breast was hard, red, and sore; Milk production dropped; Clogged duct; Flu like symptoms; Received vaccine while breastfeeding; A spontaneous report was received from a consumer who was also a 33-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced received vaccine while breastfeeding (maternal exposure during breast feeding), clogged duct (galactostasis), possible mastitis (mastitis), flu like symptoms (influenza like illness), milk production dropped (suppressed lactation), and breast was hard, red, and sore (breast tenderness).   The patient's medical history included eczema.  Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 31 Dec 2020. On 28 Jan 2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient received the vaccine while breastfeeding and reported having a clogged duct and possible mastitis.  She began to experience flu like symptoms on 29 Jan 2021.  She had a fever and missed pumping breast milk.  On 30 Jan 2021 her milk production was about half of the typical amount.  The flu like symptoms resolved on 31 Jan 2021.  On 01 Feb 2021 her breast became hard, red, and sore.  On 02 Feb 2021 her breast symptoms resolved; however, her milk production was 65-70% of normal. She treated the events with acetaminophen and magnesium sulfate dissolved in water.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events clogged duct, possible mastitis, milk production dropped, and were not reported.  The outcome of the event, received vaccine while breastfeeding, was considered resolved on 28 Jan 2021. The outcome of the event, flu like symptoms, was considered resolved on 31 Jan 2021. The outcome of the event, breast was hard, red, and sore, was considered resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: high temperature of 99.1 F; Patient is under 18 years of age; A spontaneous report  was received from a consumer concerning a 15-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced temperature of 99.1 degree Fahrenheit.  The patient is handicapped, and his medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, patient's mother called and informed that her son was administered Moderna covid-19 vaccine 1st dose on 05 Jan 2021 and 2nd dose on 02 Feb 2021. The patient experienced high temperature of 99.1degree Fahrenheit on 03 Feb 2021. Patient was given Tylenol to treat symptoms.   Action taken with Moderna Covid-19 vaccine was not applicable as patient already received both doses of vaccine.  The outcome of the events temperature of 99.1 degree Fahrenheit was reported as unknown and  inappropriate age at vaccination was  consider as resolved.; Reporter's Comments: This case concerns a 15 year old male who received 1st dose on 05 Jan 2021 and 2nd dose on 02 Feb 2021 of the Moderna Covid-10 vaccine and experienced the non-serious listed event of fever on 03Feb2021 one day later. There were no other reported adverse events in this case of product administered to patient of inappropriate age.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old and 11 months and was given the 1st dose of Moderna COVID vaccine; A spontaneous report was received from a nurse concerning a 17 year old, female patient who was administered a COVID vaccine at an inappropriate age.  She was given the 1st dose of Moderna COVID vaccine.  She came to the vaccine site for her 2nd dose, and they administers need some guidance regarding it. She might have gotten her first dose on 07 Jan 2021.  The patient's medical history was not provided.    On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) possibly intramuscularly for prophylaxis of COVID-19 infection.   Treatment information was unknown.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event vaccine at an inappropriate age was considered as resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 4 Nurshing home patients Died; A Spontaneous report was received from a pharmacist concerning  4 nursing home patients of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and died.  The patients' medical histories were not provided. No relevant concomitant medications were reported.   On unspecified dates, 4 nursing home patients received their first of two planned doses of mRNA-1273 (Lot # 039K20A) for prophylaxis of COVID-19 infection. A pharmacist reported that they just learned 4 nursing home patients died after the first dose of the Modern vaccine. The patients were buried, and no autopsies were conducted. The pharmacist suspected latent Covid-19 on the patients and that the vaccine precipitated this outcome. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not applicable.   The event 4 nursing home patients died was fatal.; Reporter's Comments: This case concerns 4 nursing home patients of unspecified age and gender who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273)Lot # 039K20A) and died. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: died
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Injection site pain, Tinnitus
Clinical narrative: Ringing in left ear; Hearing loss in right ear; Ear ringing in right ear; Mild soreness at the site of injection; A spontaneous report was received from a consumer, a 71 year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hearing loss in right ear/deafness unilateral, ear ringing in right ear/tinnitus, ringing in left ear/tinnitus, and mild soreness at the site of injection/injection site pain.  The patient's medical history included a kidney transplant. Concomitant product use was not provided.   On 19 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) in the left arm for COVID-19 infection prophylaxis.   The patient had some mild soreness at the site of the injection which lasted one to two days. On 21 Jan 2021, he experienced some ear ringing in his right ear which was followed by hearing loss that lasted six hours. Both the ear ringing and hearing loss resolved by the next morning.   On 24 Jan 2021, the patient had ringing in his left ear, but it was not associated with hearing loss. The patient stated he thinks the tromethamine hydrochloride in the vaccine may have induced his hearing loss. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events, hearing loss in right ear and ear ringing in right ear, were considered resolved on 22 Jan 2021. The event, mild soreness at the site of injection, was considered resolved on an unknown date Jan 2021. The outcome for the event, ringing in left ear, was unknown.; Reporter's Comments: This case concerns a 71- year old male patient who experienced hearing loss in right ear/deafness unilateral, ear ringing in right ear/tinnitus, ringing in left ear/tinnitus, and mild soreness at the site of injection/injection site pain, all within 4 days after administration of Moderna's COVID-19 Vaccine (mRNA-1273). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient took her first dose on 15Jan2021 and is scheduled for 05Feb2021. After the first shot, she got sick with diverticulitis and was put on antibiotics. The round of antibiotics will be done 02Feb2021 and on 03Feb2021 she will go through another test. She wanted to know if it is ok to get the second shot after finishing with the antibiotics. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Eating disorder, Hypoacusis, Nausea, Weight
Clinical narrative: she hasn't been eating like she should; lost eye sight for 5 minutes, everything was grey; could hear her niece, but that her niece sounded far away; very nauseated/wanted to throw up but couldn't; This is a spontaneous report from a contactable consumer, reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 29Jan2021 14:00 at a single dose to prevent getting COVID-19. Medical history included cholesterol, high blood pressure, arthritis, medications for her heart, and medication for her stomach. Concomitant medication included amlodipine for high blood pressure and atorvastatin for cholesterol. The patient has been on amlodipine in a good while, 7-8 years and atorvastatin for 5 years. The patient had the COVID shot on Friday, 29Jan2021 at 14:00, and about 4 hours afterward, she had a bad experience. She became very nauseated and lost her sight for 5 minutes. Everything was grey. She was wondering if there is anything she can take afterward. She was scheduled for her next one on 19Feb2021. She was wondering if she will experience the same thing. She has lost about 11 pounds because she has been on a diet. She gave up sugar. After getting the vaccine, she was on her way back. She began to feel very nauseated in the car. Then, all the sudden she wanted to throw up, but couldn't. She couldn't hear her niece or say anything to her. She clarified she could hear her niece, but that her niece sounded far away. She couldn't respond. She rolled the window down to get air in her face. She hadn't eaten. In about 25-30 minutes got better. Since then, she hasn't been eating like she should, so she was still a little nauseated. It has improved though. She got the vaccine in her left arm.  Her right arm is mostly metal. She decided to get it because she is over 70 and wanted to prevent getting COVID-19. It was also reported that she was also on an arthritis medication, medications for her heart and a medication for her stomach. She has had no problems with those medications though. The patient underwent lab tests and procedures which included weight: lost on an unspecified date. She has lost about 11 pounds because she has been on a diet. She gave up sugar. The outcome of the events "lost eye sight for 5 minutes, everything was grey", "could hear her niece, but that her niece sounded far away" and "very nauseated/wanted to throw up but couldn't" was recovered on 29Jan2021 while the outcome of all other events was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy - Left sided; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9263) intramuscular in left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included DMII (Type II diabetes mellitus), Parkinson's disease, and CAD (coronary artery disease). Concomitant medications were not reported. The patient previously took metformin and experienced allergy. Prior to vaccination, patient was not diagnosed with COVID-19; and since vaccination, patient has not been tested. Facility where the most recent COVID-19 vaccine was administered: Other (Public Health Department). On 24Jan2021, the patient experienced Bells Palsy - Left sided. The event required physician office visit (Doctor or other healthcare professional office/clinic visit). No treatment was received for the event. Outcome of the event was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure increased, Body temperature increased, Nausea, SARS-CoV-2 test
Clinical narrative: ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown.   The following information on the batch/lot number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown.   The following information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dry throat, Fatigue, Headache
Clinical narrative: a cold that is in her chest; feels as if she has caught the flu; very fatigue; chills; headache; dry throat (feeling as if something is stuck in her throat); dry throat (feeling as if something is stuck in her throat); runny nose; cough; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as 60 no unit reported) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that ever since she received the vaccine, she felt as if she has caught the flu. She experienced symptoms such as chills, headache, dry throat (feeling as if something is stuck in her throat), a cold that is in her chest, runny nose, cough, and very fatigue. She stated that she has been taking cold medicine, but it doesn't seem to be working. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lower respiratory tract infection, Rhinorrhoea, Sensation of foreign body
Clinical narrative: a cold that is in her chest; feels as if she has caught the flu; very fatigue; chills; headache; dry throat (feeling as if something is stuck in her throat); dry throat (feeling as if something is stuck in her throat); runny nose; cough; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as 60 no unit reported) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that ever since she received the vaccine, she felt as if she has caught the flu. She experienced symptoms such as chills, headache, dry throat (feeling as if something is stuck in her throat), a cold that is in her chest, runny nose, cough, and very fatigue. She stated that she has been taking cold medicine, but it doesn't seem to be working. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased, Throat tightness
Clinical narrative: shortness of breath; throat tightening; Increased HR over 120 bpm; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 29Jan2021 14:30 in left arm, at single dose for covid-19 immunization. Medical history included known allergies: sulfa, and peanuts. Concomitant medication included prednisone. The patient previously took iodine and experienced allergy, and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 08Jan2021 15:30 in left arm, at single dose for covid-19 immunization and experienced facial swelling within a couple hours of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 2nd dose within 30 minutes, 29Jan2021 15:00, the patient had Increased HR over 120 bpm, shortness of breath, dizziness and throat tightening, which all caused hospitalized and Emergency room. Epinephrine injection, fluid, and rest was received as treatment. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Amendment: This follow-up report is being submitted to amend previous reported information: historical vaccine information was added.; Sender's Comments: Based on the compatible time association, the events shortness of breath, dizziness ,throat tightening and heart rate increased are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Hypotonia, Sensory loss
Clinical narrative: loss of muscle tone of my cheek and inability to smile on the left side; Loss of sensation of my left cheek from under my eye to my mouth; loss of muscle tone of my cheek and inability to smile on the left side; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration in the left arm, on 29Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. Medical history included hypertension, diabetes, increased cholesterol and COVID-19 prior to vaccination. The patent has no allergies to medications, food, or other products. Concomitant medication included enalapril, hydrochlorothiazide, atorvastatin (LIPITOR), and metformin. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient was not tested for COVID-19 since the vaccination. The patient experienced "loss of sensation of my left cheek from under my eye to my mouth.  My wife noted loss of muscle tone of my cheek and inability to smile on the left side" on 29Jan2021 at 08:30. Symptoms started about one hour after the injection and resolved after 3 hours. No treatment was received for the events. The outcome of the events was resolved on 29Jan2021 at 11:30. The reporter assessed the events as non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypotonia, Sensory loss
Clinical narrative: loss of muscle tone of my cheek and inability to smile on the left side; Loss of sensation of my left cheek from under my eye to my mouth; loss of muscle tone of my cheek and inability to smile on the left side; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration in the left arm, on 29Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. Medical history included hypertension, diabetes, increased cholesterol and COVID-19 prior to vaccination. The patent has no allergies to medications, food, or other products. Concomitant medication included enalapril, hydrochlorothiazide, atorvastatin (LIPITOR), and metformin. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient was not tested for COVID-19 since the vaccination. The patient experienced "loss of sensation of my left cheek from under my eye to my mouth.  My wife noted loss of muscle tone of my cheek and inability to smile on the left side" on 29Jan2021 at 08:30. Symptoms started about one hour after the injection and resolved after 3 hours. No treatment was received for the events. The outcome of the events was resolved on 29Jan2021 at 11:30. The reporter assessed the events as non-serious.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Gout, Malaise, Parkinson's disease
Clinical narrative: not feeling well; tremors (symptom of Parkinson's which he has but they had been under control with medicine); Gout which has flared occasionally but had not caused problems recently; tremors (symptom of Parkinson's but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently; This is a spontaneous report from a non-contactable consumer. An 84-year-old male patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included Parkinson's and gout. The patient didn't have COVID prior to vaccination. Concomitant medications were not reported. The patient with other health problems got vaccinated. Next day was not feeling well and the day after was admitted to the hospital complaining of tremors (symptom of Parkinson's which he had but they had been under control with medicine), and gout which had flared occasionally but had not caused problems recently. Adverse events started from 30Jan2021. The events resulted in emergency room/department or urgent care and hospitalization for 1 day. Treatment received included medication for tremors. The outcome of the events was recovering. COVID was not tested post vaccination.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: hearing loss/Cannot hear in right ear very well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration in left arm on 24Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included levamlodipine besilate for blood pressure high. On 27Jan2021, the patient experienced hearing loss in the right ear, she started to feel like she could not hear very well in her right ear. It was like she was underwater or something. Patient went to see the family doctor on 31Jan2021 because of her ear and the doctor looked in ear and did not see anything wrong. The doctor prescribed an allergy medication, something basic that could be picked up over the counter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic varicella syndrome
Clinical narrative: hemorrhagic shingles on opposite arm 4 days after vaccine; This is a spontaneous report from a contactable consumer reported for herself. An 86-year-old female patient (not pregnant at the time of vaccination) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 15Jan2021 09:00 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, diabetes type 2, depression, no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient received some other medications within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hemorrhagic shingles on opposite arm 4 days after vaccine on 20Jan2021. The event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included valtrex and medrol pack. The outcome of the event was recovered with lasting effects. The reporter considered the case as non-serious.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Colitis, Hypersensitivity
Clinical narrative: colitis flare up/soft stools and abdominal pains; my joints were aching: ankles, hips, elbows, shoulders, wrist.; Also my allergies seemed to be bothering me more; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EJ1686), via an unspecified route of administration into the right arm on 11Jan2021 08:30 at a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoporosis, ulcerative colitis, ongoing colitis and ongoing allergies to mites, mold, pollen, environmental and rubber. Patient was not pregnant. Concomitant medication included venlafaxine (VENLAFAXINE), zolpidem (ZOLPIDEM) and levothyroxine (LEVOTHYROXINE). The patient was previously administered with first dose of zoster vaccine recombinant, adjuvanted (SHINGRIX) via an unspecified route of administration into the right arm on 04Dec2020 for immunization. On 12Jan2021, the patient's allergies seemed to be bothering her more. On 13Jan2021 09:00, patient woke up with her joints aching: ankles, hips, elbows, shoulders and wrist. On 14Jan2021, patient experienced colitis flare up with soft stools and abdominal pains. The patient did not receive treatment for the events reported. Outcome of events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.