chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Bedridden, Erythema
Clinical narrative: right leg had been paralyzed; nerve sensation in leg was gone; leg pain; leg was stiff; unable to walk; was in bed for three days unable to get up; lost muscle ability of leg; lower leg looked purplish; right quad was reddened and inflamed; did not have strength in legs; felt weak; right quad was reddened and inflamed; knee was swollen, warm to touch and looked inflamed; sharp electrical shocks in knee; A spontaneous report was received from a consumer concerning a 76-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced right leg had been paralyzed, sharp electrical shocks in knee, right quad was reddened, right quad was inflamed, knee was swollen, knee was warm to touch, knee was inflamed, leg looked purplish, did not have strength in legs, felt weak, lost muscle ability of leg, leg pain, was unable to walk, leg was stiff, was in bed for three days unable to get up and nerve sensation in leg was gone.  The patient's medical history was not provided. Concomitant medications reported included valsartan, amlodipine, simvastatin, acetylsalicylic acid, potassium and gabapentin.  On 29 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient complained of sharp electrical shocks in her knee.   On 01 Feb 2021, her knee was swollen, warm to the touch and looked inflamed. She also reported what looked like an infection under her right thigh as the whole quad was reddened and inflamed.   On 03 Feb 2021, the patient reported her lower leg looked purplish, did not have strength in her legs, felt weak, and her leg flopped to side of car as she reported losing muscle ability.  On 04 Feb 2021, she experienced leg pain, was unable to walk, leg stiffness, was in bed for 3 days unable to get up and lost nerve sensation in her leg. Treatment for the event included unspecified therapy.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, right leg had been paralyzed, sharp electrical shocks in knee, right quad was reddened, right quad was inflamed, knee was swollen, knee was warm to touch, knee was inflamed, leg looked purplish, did not have strength in legs, felt weak, lost muscle ability of leg, leg pain, was unable to walk, leg was stiff, was in bed for three days unable to get up and nerve sensation in leg was gone, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Arthralgia is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Inflammation, Monoplegia, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: right leg had been paralyzed; nerve sensation in leg was gone; leg pain; leg was stiff; unable to walk; was in bed for three days unable to get up; lost muscle ability of leg; lower leg looked purplish; right quad was reddened and inflamed; did not have strength in legs; felt weak; right quad was reddened and inflamed; knee was swollen, warm to touch and looked inflamed; sharp electrical shocks in knee; A spontaneous report was received from a consumer concerning a 76-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced right leg had been paralyzed, sharp electrical shocks in knee, right quad was reddened, right quad was inflamed, knee was swollen, knee was warm to touch, knee was inflamed, leg looked purplish, did not have strength in legs, felt weak, lost muscle ability of leg, leg pain, was unable to walk, leg was stiff, was in bed for three days unable to get up and nerve sensation in leg was gone.  The patient's medical history was not provided. Concomitant medications reported included valsartan, amlodipine, simvastatin, acetylsalicylic acid, potassium and gabapentin.  On 29 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient complained of sharp electrical shocks in her knee.   On 01 Feb 2021, her knee was swollen, warm to the touch and looked inflamed. She also reported what looked like an infection under her right thigh as the whole quad was reddened and inflamed.   On 03 Feb 2021, the patient reported her lower leg looked purplish, did not have strength in her legs, felt weak, and her leg flopped to side of car as she reported losing muscle ability.  On 04 Feb 2021, she experienced leg pain, was unable to walk, leg stiffness, was in bed for 3 days unable to get up and lost nerve sensation in her leg. Treatment for the event included unspecified therapy.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, right leg had been paralyzed, sharp electrical shocks in knee, right quad was reddened, right quad was inflamed, knee was swollen, knee was warm to touch, knee was inflamed, leg looked purplish, did not have strength in legs, felt weak, lost muscle ability of leg, leg pain, was unable to walk, leg was stiff, was in bed for three days unable to get up and nerve sensation in leg was gone, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Arthralgia is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sensory loss
Clinical narrative: right leg had been paralyzed; nerve sensation in leg was gone; leg pain; leg was stiff; unable to walk; was in bed for three days unable to get up; lost muscle ability of leg; lower leg looked purplish; right quad was reddened and inflamed; did not have strength in legs; felt weak; right quad was reddened and inflamed; knee was swollen, warm to touch and looked inflamed; sharp electrical shocks in knee; A spontaneous report was received from a consumer concerning a 76-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced right leg had been paralyzed, sharp electrical shocks in knee, right quad was reddened, right quad was inflamed, knee was swollen, knee was warm to touch, knee was inflamed, leg looked purplish, did not have strength in legs, felt weak, lost muscle ability of leg, leg pain, was unable to walk, leg was stiff, was in bed for three days unable to get up and nerve sensation in leg was gone.  The patient's medical history was not provided. Concomitant medications reported included valsartan, amlodipine, simvastatin, acetylsalicylic acid, potassium and gabapentin.  On 29 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient complained of sharp electrical shocks in her knee.   On 01 Feb 2021, her knee was swollen, warm to the touch and looked inflamed. She also reported what looked like an infection under her right thigh as the whole quad was reddened and inflamed.   On 03 Feb 2021, the patient reported her lower leg looked purplish, did not have strength in her legs, felt weak, and her leg flopped to side of car as she reported losing muscle ability.  On 04 Feb 2021, she experienced leg pain, was unable to walk, leg stiffness, was in bed for 3 days unable to get up and lost nerve sensation in her leg. Treatment for the event included unspecified therapy.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, right leg had been paralyzed, sharp electrical shocks in knee, right quad was reddened, right quad was inflamed, knee was swollen, knee was warm to touch, knee was inflamed, leg looked purplish, did not have strength in legs, felt weak, lost muscle ability of leg, leg pain, was unable to walk, leg was stiff, was in bed for three days unable to get up and nerve sensation in leg was gone, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Arthralgia is consistent with the known safety profile of the vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure increased, Discomfort, Dysarthria, Fatigue
Clinical narrative: heart rate was low; pupils looked tiny; no color on face, pale; speech was completely slurred; afraid she was going to die; head and hands felt heavy; extremely tired, could barely lift a glass; Blood pressure went way up; felt groggy; back pain; back spasms alternating with throbbing in her back that was quite significant; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a  Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced   back pain, back spasms alternating with throbbing in her back that was quite significant, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired, very motionless all night, thought she was in a coma, pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 10:12 am 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left upper arm for prophylaxis for COVID-19 infection.  On 6/Feb/2021, The patient experienced back pain, back spasms alternating with throbbing in her back that was quite significant. On 7/Feb/2021,The patient experienced, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired. On 8/Feb/2021,The patient experienced very motionless all night, thought she was in a coma,  pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy. Treated with Baclofen, IV with morphine, Tylenol, Motrin, back patch with lidocaine.  Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events were  unknown.; Reporter's Comments: This case concerns a 67-year-old female who had a serious unexpected event of Heart rate decreased with NS unexpected blood pressure increased, pallor, miosis, dysarthria, back pain, muscle spasms, discomfort, somnolence, fear of death and NS expected fatigue. Event onset 1 day after first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fear of death, Heart rate decreased, Miosis, Muscle spasms, Pallor
Clinical narrative: heart rate was low; pupils looked tiny; no color on face, pale; speech was completely slurred; afraid she was going to die; head and hands felt heavy; extremely tired, could barely lift a glass; Blood pressure went way up; felt groggy; back pain; back spasms alternating with throbbing in her back that was quite significant; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a  Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced   back pain, back spasms alternating with throbbing in her back that was quite significant, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired, very motionless all night, thought she was in a coma, pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 10:12 am 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left upper arm for prophylaxis for COVID-19 infection.  On 6/Feb/2021, The patient experienced back pain, back spasms alternating with throbbing in her back that was quite significant. On 7/Feb/2021,The patient experienced, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired. On 8/Feb/2021,The patient experienced very motionless all night, thought she was in a coma,  pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy. Treated with Baclofen, IV with morphine, Tylenol, Motrin, back patch with lidocaine.  Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events were  unknown.; Reporter's Comments: This case concerns a 67-year-old female who had a serious unexpected event of Heart rate decreased with NS unexpected blood pressure increased, pallor, miosis, dysarthria, back pain, muscle spasms, discomfort, somnolence, fear of death and NS expected fatigue. Event onset 1 day after first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: heart rate was low; pupils looked tiny; no color on face, pale; speech was completely slurred; afraid she was going to die; head and hands felt heavy; extremely tired, could barely lift a glass; Blood pressure went way up; felt groggy; back pain; back spasms alternating with throbbing in her back that was quite significant; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a  Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced   back pain, back spasms alternating with throbbing in her back that was quite significant, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired, very motionless all night, thought she was in a coma, pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 10:12 am 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left upper arm for prophylaxis for COVID-19 infection.  On 6/Feb/2021, The patient experienced back pain, back spasms alternating with throbbing in her back that was quite significant. On 7/Feb/2021,The patient experienced, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired. On 8/Feb/2021,The patient experienced very motionless all night, thought she was in a coma,  pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy. Treated with Baclofen, IV with morphine, Tylenol, Motrin, back patch with lidocaine.  Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events were  unknown.; Reporter's Comments: This case concerns a 67-year-old female who had a serious unexpected event of Heart rate decreased with NS unexpected blood pressure increased, pallor, miosis, dysarthria, back pain, muscle spasms, discomfort, somnolence, fear of death and NS expected fatigue. Event onset 1 day after first dose of mRNA-1273. Based on 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.
Sex: U
Vaccine: COVID19
Symptoms: Out of specification product use
Clinical narrative: Partially Frozen Vaccine Administered to 3 Patients; A spontaneous report was received from a HCP concerning three patients who received Moderna's COVID-19 vaccine (mRNA-1273) and 3 doses of vaccine were administered from a vial which was then observed to contain partially frozen vaccine.   The patients' medical history was not provided. No relevant concomitant medications were reported.     On unknown date, three patients  received their first of two planned doses of mRNA-1273 (lot/batch: unknown)  for prophylaxis of COVID-19 infection.   On unknown date, 3 doses of vaccine were administered from a vial which was then observed to contain partially frozen vaccine. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events were  resolved.; Reporter's Comments: This report refers to a case of Out of Specification Product Use for mRNA-1273 (lot# not provided) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patients who is 17 years of age got Moderna Vaccine; A spontaneous report was received from a healthcare professional concerning a 17-year-old patient, of unknown gender, who was administered Moderna's COVID-19 vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of Covid-19 infection.  It was reported that one of their patients who is 17 years of age, got Moderna Vaccine, and it was already reported to VAERS. No further information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not applicable.  The event of "Product administration to patient of inappropriate age" (patient who is 17 years of age and got Moderna Vaccine), was considered resolved.; Reporter's Comments: This report refers to a case of "Product administration to patient of inappropriate age" of  mRNA-1273, (lot # is unknown),  with no associated AEs reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Seizure
Clinical narrative: seizure; hospital staff "couldn't wake him up"; A spontaneous report was received from a consumer who was also a 77-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a seizure. He was hospitalized for one night and the staff had a difficult time waking him up.   The patient's medical history included prostate cancer last year. Patient provided that he takes 8 or 10 different medications daily but did not list them out. No other medical history was shared and patient has no known drug or food allergies.   On 30-Jan-2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 31-Jan-2021, the day after the mRNA-1273 vaccine was given, the patient had a seizure and was hospitalized for one night. He stated that the hospital staff had a hard time waking him up. He spent one night in the hospital and was released on 01-Feb-2021. It was not reported what caused the seizure and the patient was unsure if the hospital knew that he had the vaccination the day prior. He was discharged with Keppra.  Consent to contact was given by the patient to contact him and the hospital.  No further treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The events, seizure and depressed consciousness level, were considered resolved on 01 Feb 2021.; Reporter's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: He can barely see/he cannot see/his vision is getting worse and worse/visions problems; This is spontaneous report from a contactable consumer who reported for her father.  An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 (at the age of 86-year-old) as a single dose for COVID-19 immunization. Medical history included two ongoing autoimmune diseases from unspecified dates and an ongoing pacemaker from an unspecified date. Concomitant medications included ongoing blood thinners from an unspecified date. The patient experienced he can barely see/he cannot see/his vision is getting worse and worse and vision problems, both on unspecified dates. The patient's child called and stated that "my father is on blood thinner. He has two autoimmune diseases and has a pacemaker. He developed visons problems within a few days after receiving the first dose of Pfizer COVID-19. Now he cannot take care of his dog. He will not be able to take care of himself. His vision has gotten progressively worse, he can barely see. I spoke to the specialist and other doctors, but they have no information. He will be seeing the doctor in 2 weeks only. I reported the side effects online. It was hard to get medical help because not many people are informed about what might go on with the vaccine. To get him diagnosed has been difficult. They can't do an MRI on him because he has a pacemaker. He is also 2 weeks out to see a specialist. In the meantime, he cannot see. His vision is getting worse and worse. His next vaccine is coming up too." The reporter had called and spoke with the director of immunization at the health department. She had also called and talked to VAERS as well. No one could point her to any help. The reporter believed this was probably related to the autoimmune diseases. The patient had no consultation not take the vaccine. The reporter had answered some information on the website while she had been waiting. The rest of the family also had autoimmune issues, and now they were all wondering if it was safe for them to take (the vaccine). The reporter wanted to know if we could provide any recommendations and if her father could get the second dose of the COVID-19 vaccine. The clinical outcome of the event was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: diverticulitis; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program. A 72-year-old male patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Jan2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient developed diverticulitis and was on 2 antibiotics (not specified). It was reported that it was not a bad or severe bout. The clinical outcome of the event diverticulitis was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chest injury, Contusion, Fall, Magnetic resonance imaging
Clinical narrative: fall; bruised rib; bruised hip; This is a spontaneous report from a contactable consumer (reporting for his father). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration into the left arm on 12Jan2021 at a single dose for COVID-19 immunisation (COVID prevention). The patient's medical history included Alzheimer's disease and stroke. There were no concomitant medications. The reporter was calling regarding his father who was an 87-year-old combat veteran. The reporter stated that the patient received the first dose of the Pfizer COVID Vaccine on 12Jan2021. The patient was scheduled for his second dose on 02Feb2021, but they had to cancel that appointment because the patient was in the hospital from a fall he had on 29Jan2021 where he bruised his hip and bruised his rib. The patient was hospitalized from 30Jan2021 and was released from the hospital on 05Feb2021. The reporter stated that the clinic said they are not able to make any more appointments right now. The reporter was wondering if there were consequences of, or a danger in, getting the second dose outside of the recommended timeframe. The patient is now on a waiting list to get the second dose and he would like to know how far past the recommended 21 days can he go and still have the vaccine be effective. The patient received no other vaccines on the same day as the COVID vaccine. The patient has had an MRI before where it was indicated that there were some spots from a past stroke. The reporter stated that no paralysis has been identified. The outcome of the events was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Headache
Clinical narrative: dementia is getting worse; headaches; This is a spontaneous report from a contactable consumer (patient's child). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Jan2021 (at the age of 81 years old) at a single dose for covid-19 immunization. Medical history included dialysis from 2015 and ongoing and ongoing dementia. The patient's concomitant medications were not reported. On unspecified date in Jan2021, the patient started getting headaches and that her dementia is getting worse. Therapeutic measures were taken as a result of headaches which included BC powder and acetaminophen (TYLENOL). Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Deafness, Decreased appetite
Clinical narrative: hard on hearing/lost his hearing; pain in his right ear; Chills; headache; Fever; Weakness; lacking appetite; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810, expiration date was not reported) (at 86 years of age), via an unspecified route of administration in the left arm on 03Feb2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia, ongoing blood pressure abnormal and ongoing thyroid disorder. Concomitant medication included hydrochlorothiazide which he was taking for years, ibrutinib which he was taking for 7 years, levothyroxine which he was taking for 10 years and losartan which he was taking for 8 years. The patient had no any other vaccine prior to covid vaccine. It was reported that the patient received the Pfizer covid vaccine on 03Feb2021. 24 hours later (04Feb2021), he experienced pain in the ears, headache, chills, and fever up to 101.5 for almost a week now, and currently is hard on hearing and had been feeling weak and lacking appetite. It was added that a week ago he received the first dose of the Pfizer COVID 19 vaccine on 03Feb2021 at 1500PM in the left arm. Within 24 hours the side effects started. He had a pain in his right ear and a headache. Since then he has gradually lost his hearing in that ear and they are following up with an ear nose and throat doctor. On 04Feb2021, he got a fever of 101.5, chills, weakness and no appetite. Since then in the evening he had been having kind of a fever of 100 to 100.5 and she has treated with TYLENOL. The fever comes and goes. In the morning he was normal. Adds his appetite was better but he still has to force himself to eat. She queried if should the patient get the second dose of the vaccine. Patient is scheduled to receive the second dose on 04Mar2021. The patient did not visit the ER. The patient underwent lab tests and procedures which included body temperature: up to 101.5, fever of 100 to 100.5, and 101.5 on 04Feb2021.  The outcome of the event loss of hearing, fever, weakness, and pain in his right ear was not recovered; headache and chills are recovered on 05Feb2021; while recovering for lacking appetite. The loss of hearing was reported as worsened. Therapeutic measures were taken as a result of fever (pyrexia).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Headache, Pyrexia
Clinical narrative: hard on hearing/lost his hearing; pain in his right ear; Chills; headache; Fever; Weakness; lacking appetite; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810, expiration date was not reported) (at 86 years of age), via an unspecified route of administration in the left arm on 03Feb2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia, ongoing blood pressure abnormal and ongoing thyroid disorder. Concomitant medication included hydrochlorothiazide which he was taking for years, ibrutinib which he was taking for 7 years, levothyroxine which he was taking for 10 years and losartan which he was taking for 8 years. The patient had no any other vaccine prior to covid vaccine. It was reported that the patient received the Pfizer covid vaccine on 03Feb2021. 24 hours later (04Feb2021), he experienced pain in the ears, headache, chills, and fever up to 101.5 for almost a week now, and currently is hard on hearing and had been feeling weak and lacking appetite. It was added that a week ago he received the first dose of the Pfizer COVID 19 vaccine on 03Feb2021 at 1500PM in the left arm. Within 24 hours the side effects started. He had a pain in his right ear and a headache. Since then he has gradually lost his hearing in that ear and they are following up with an ear nose and throat doctor. On 04Feb2021, he got a fever of 101.5, chills, weakness and no appetite. Since then in the evening he had been having kind of a fever of 100 to 100.5 and she has treated with TYLENOL. The fever comes and goes. In the morning he was normal. Adds his appetite was better but he still has to force himself to eat. She queried if should the patient get the second dose of the vaccine. Patient is scheduled to receive the second dose on 04Mar2021. The patient did not visit the ER. The patient underwent lab tests and procedures which included body temperature: up to 101.5, fever of 100 to 100.5, and 101.5 on 04Feb2021.  The outcome of the event loss of hearing, fever, weakness, and pain in his right ear was not recovered; headache and chills are recovered on 05Feb2021; while recovering for lacking appetite. The loss of hearing was reported as worsened. Therapeutic measures were taken as a result of fever (pyrexia).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from a contactable consumer. A 6-decade-old female patient (in her 50's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. It was noted that one of the reporter's co-worker developed a blood clot after receiving the first dose of the Pfizer vaccine on an unspecified date. Any information or data on someone developing blood clots? The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block left, Echocardiogram, Fatigue, Headache, Hypertension
Clinical narrative: Thyroid cancer; paraganglioma; headache; constant fatigue; nausea; pump in blood pressure/hypertension; 3-day pain in the chest, his pain in the chest turned out to be an LBBB or left bundle branch block; This is a spontaneous report from a contactable consumer (patient).  An 86-year-old male patient received first single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 27Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the first dose (onset date: 2021), he experienced AEs like constant fatigue, nausea, pump in blood pressure/ jumping blood pressure, and 3-day pain in the chest. He had a cardiogram and his pain in the chest turned out to be an LBBB or left bundle branch block. On an unspecified date, the patient had been diagnosed with thyroid cancer and was now with remission; paraganglioma, hypertension, 0left bundle branch block, and headache. The pain in the chest subsided after 3 days but nausea, headache and fatigue were still being experienced a few days after. He said that he has read that most of the side effects of the vaccine manifests on the second dose. Because he had bad AEs with the first dose, he was seeking the company for recommendations for having the second dose of the vaccine. The outcome of fatigue, nausea and headache was not recovered while unknown for the other events.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paraganglion neoplasm, Thyroid cancer
Clinical narrative: Thyroid cancer; paraganglioma; headache; constant fatigue; nausea; pump in blood pressure/hypertension; 3-day pain in the chest, his pain in the chest turned out to be an LBBB or left bundle branch block; This is a spontaneous report from a contactable consumer (patient).  An 86-year-old male patient received first single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 27Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the first dose (onset date: 2021), he experienced AEs like constant fatigue, nausea, pump in blood pressure/ jumping blood pressure, and 3-day pain in the chest. He had a cardiogram and his pain in the chest turned out to be an LBBB or left bundle branch block. On an unspecified date, the patient had been diagnosed with thyroid cancer and was now with remission; paraganglioma, hypertension, 0left bundle branch block, and headache. The pain in the chest subsided after 3 days but nausea, headache and fatigue were still being experienced a few days after. He said that he has read that most of the side effects of the vaccine manifests on the second dose. Because he had bad AEs with the first dose, he was seeking the company for recommendations for having the second dose of the vaccine. The outcome of fatigue, nausea and headache was not recovered while unknown for the other events.  Information on lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Dyspnoea, Feeling cold
Clinical narrative: nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered.   Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available.  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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myocardial infarction, Nausea, Pallor
Clinical narrative: nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered.   Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available.  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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blindness, Fall, Feeling abnormal, Gait disturbance
Clinical narrative: sinus infection; cannot see out of her right eye; sick; terrible terrible splitting headache on her right temple; can't sleep; pressure behind her right eye; head is all fuzzy; mind isn't good; throat hurts; jaw hurts; little off balance; she walks she falls into things; she walks she falls into things; can't see things hardly in her right eye; pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history was not reported.  Concomitant medication included atenolol for blood thinner.  The patient previously took first dose of bnt162b2 for Covid-19 immunization and experienced no adverse event. The patient stated that she received the second dose of the vaccine on 04Feb2021 and has been sick ever since. She has a terrible terrible splitting headache on her right temple and can't sleep and was having so much pressure behind her right eye. She stated she can't even lay her head on a pillow. She stated she had no reaction to the first shot but this time her head is all fuzzy, her mind wasn't good and when she sets things down she can't remember where they are. The second shot was really giving her a fit. Her throat hurts, jaw hurts, head hurts, and feels like she is running a temperature. She is a little off balance, when she walks she falls into things because she can't see things hardly in her right eye. She stated she can't put up with the pain any longer, it is terrible behind her temple and eye. She thought it was a sinus infection but now she thinks it was from the shot. She stated she almost had a wreck today because she cannot see out of her right eye because of the shot. She hit a telephone thing and almost wrecked 3 or 4 times. She tried to get tested for Covid but she didn't have an appointment and she cannot go to work until she finds out about the virus. She was going to get tested tomorrow but was going to have to call the rescue squad because she can't drive and she was not putting her son through this if she has the virus. The patient asked if she was allergic to the second shot or if these were normal symptoms. She asked what she should do. She stated she takes Atenolol, a blood thinner, and thyroid medicine. She stated she was taking Tylenol but it doesn't help any and nothing seems to help. All the events occurred on Feb2021. Outcome of all the events was unknown.   Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Memory impairment, Ocular discomfort
Clinical narrative: sinus infection; cannot see out of her right eye; sick; terrible terrible splitting headache on her right temple; can't sleep; pressure behind her right eye; head is all fuzzy; mind isn't good; throat hurts; jaw hurts; little off balance; she walks she falls into things; she walks she falls into things; can't see things hardly in her right eye; pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history was not reported.  Concomitant medication included atenolol for blood thinner.  The patient previously took first dose of bnt162b2 for Covid-19 immunization and experienced no adverse event. The patient stated that she received the second dose of the vaccine on 04Feb2021 and has been sick ever since. She has a terrible terrible splitting headache on her right temple and can't sleep and was having so much pressure behind her right eye. She stated she can't even lay her head on a pillow. She stated she had no reaction to the first shot but this time her head is all fuzzy, her mind wasn't good and when she sets things down she can't remember where they are. The second shot was really giving her a fit. Her throat hurts, jaw hurts, head hurts, and feels like she is running a temperature. She is a little off balance, when she walks she falls into things because she can't see things hardly in her right eye. She stated she can't put up with the pain any longer, it is terrible behind her temple and eye. She thought it was a sinus infection but now she thinks it was from the shot. She stated she almost had a wreck today because she cannot see out of her right eye because of the shot. She hit a telephone thing and almost wrecked 3 or 4 times. She tried to get tested for Covid but she didn't have an appointment and she cannot go to work until she finds out about the virus. She was going to get tested tomorrow but was going to have to call the rescue squad because she can't drive and she was not putting her son through this if she has the virus. The patient asked if she was allergic to the second shot or if these were normal symptoms. She asked what she should do. She stated she takes Atenolol, a blood thinner, and thyroid medicine. She stated she was taking Tylenol but it doesn't help any and nothing seems to help. All the events occurred on Feb2021. Outcome of all the events was unknown.   Information on the lot/batch number has been requested.