chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Pain, Pruritus, Urticaria
Clinical narrative: Difficulty breathing; Legs have also itched; Hives painful to touch; Hives; Little nausea; A spontaneous report was received from a consumer, who was a 81-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch.   The patient's medical history included afib (atrial fibrillation). Products known to have been used by the patient, within two weeks prior to the event, included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported that he felt a little nausea for the first few days after vaccine administration.  On 25 Jan 2021, the patient woke up at 1:00 AM with hives on his right arm from the elbow to the shoulder. He stated the hives were painful to touch. The patient took diphenhydramine and the hives disappeared that morning. Later that day, the patient developed difficulty breathing and the hives appeared on his left arm from the elbow to shoulder.  The patient went to the emergency room and was hospitalized overnight due to breathing issues. He was given diphenhydramine and steroids and was released from the hospital on 26 Jan 2021.    On 27 Jan 2021, the hives reappeared from the patient's hands, spreading to the arms, shoulders, head, neck, and face. He described some of the hives as being nearly a quarter-inch high and he stated they looked like water blisters.  On 28 Jan 2021, the patient went to the emergency room again because he was having a lot of trouble breathing.   On an unknown date, the patient's legs had also itched but there were no spots.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch, was unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, with medical history of atrial fibrillation, who experienced serious unexpected event of dyspnoea, and non-serious unexpected events of urticaria, pruritus, pain, and non-serious expected event of nausea. The event of nausea occurred on day 1 after mRNA-1273 (Lot# Unknown). The event of dyspnoea, urticaria, and pain occurred 14 days after mRNA-1273 and the event of pruritus occurred on an unspecified date after mRNA-1273. Treatment included diphenhydramine and steroids. Concomitant medications included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Critical illness, Decreased appetite, Gait disturbance, Headache
Clinical narrative: he is near death; Some flu sickness; Could barely walk; Not eating; Soaked with his sweat; He just wants to sleep; Fever for 2 days; Bad headache; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some flu sickness, he is near death, could barely walk, fever for 2 days, not eating, soaked with his sweat, bad headache and he just wants to sleep.  The patient's medical history, as provided by the reporter, included positive nasal swab COVID test. No relevant concomitant medications were reported.   On 07 Dec 2020, the patient had a nasal swab that was positive for COVID at the emergency room and received hydrochloroquine.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. He experienced some flu sickness for a few days and then felt fine.  On 27 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. It was reported that the side effects were really bad and he was near death. The patient could barely walk and was not eating. He had a fever for two days with temperatures of 103 Fahrenheit (F), 101F, 98F, 100F and 99F. It was also reported that the patient was soaked with his sweat and soaked through his bedding and mattress. He also had a bad headache that was described as being worse than when he had COVID. The patient just wanted to sleep and was difficult to wake up. Treatment for the events included two acetaminophen or ibuprofen, zinc, vitamin C, vitamin D, sports drink and water while he is awake. The patient refused a protein shake and wanted nothing. Consent given for Safety to follow up.  Action taken with mRNA-1273 in response to the events is not applicable since the patient received two doses as scheduled.   The event, some flu sickness, was resolved on unknown date. The events, he is near death, could barely walk, fever for 2 days, not eating, soaked with his sweat, bad headache and he just wants to sleep, were not resolved at the time of this report.; Reporter's Comments: This case concerns a male patient , age unknown, with medical history of positive nasal swab COVID test, who experienced a serious unexpected event of Critical illness and NS events of Influenza like illness, Gait disturbance, Decreased appetite, Hyperhidrosis, Hypersomnia, Pyrexia and Headache. The event occurred 29 days after first dose of the study medication administration and on the same day after the last dose administration. Treatment for the events included two acetaminophen or ibuprofen, zinc, vitamin C, vitamin D, sports drink.   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.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Influenza like illness, Pyrexia
Clinical narrative: he is near death; Some flu sickness; Could barely walk; Not eating; Soaked with his sweat; He just wants to sleep; Fever for 2 days; Bad headache; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some flu sickness, he is near death, could barely walk, fever for 2 days, not eating, soaked with his sweat, bad headache and he just wants to sleep.  The patient's medical history, as provided by the reporter, included positive nasal swab COVID test. No relevant concomitant medications were reported.   On 07 Dec 2020, the patient had a nasal swab that was positive for COVID at the emergency room and received hydrochloroquine.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. He experienced some flu sickness for a few days and then felt fine.  On 27 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. It was reported that the side effects were really bad and he was near death. The patient could barely walk and was not eating. He had a fever for two days with temperatures of 103 Fahrenheit (F), 101F, 98F, 100F and 99F. It was also reported that the patient was soaked with his sweat and soaked through his bedding and mattress. He also had a bad headache that was described as being worse than when he had COVID. The patient just wanted to sleep and was difficult to wake up. Treatment for the events included two acetaminophen or ibuprofen, zinc, vitamin C, vitamin D, sports drink and water while he is awake. The patient refused a protein shake and wanted nothing. Consent given for Safety to follow up.  Action taken with mRNA-1273 in response to the events is not applicable since the patient received two doses as scheduled.   The event, some flu sickness, was resolved on unknown date. The events, he is near death, could barely walk, fever for 2 days, not eating, soaked with his sweat, bad headache and he just wants to sleep, were not resolved at the time of this report.; Reporter's Comments: This case concerns a male patient , age unknown, with medical history of positive nasal swab COVID test, who experienced a serious unexpected event of Critical illness and NS events of Influenza like illness, Gait disturbance, Decreased appetite, Hyperhidrosis, Hypersomnia, Pyrexia and Headache. The event occurred 29 days after first dose of the study medication administration and on the same day after the last dose administration. Treatment for the events included two acetaminophen or ibuprofen, zinc, vitamin C, vitamin D, sports drink.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram, Fatigue, Feeling cold, Full blood count
Clinical narrative: fatigue; fainted; shaking; arm cold (felt like ice); red spots on forehead; chills; A spontaneous report was received from a consumer's relative concerning a 21-years-old, female patient who received Moderna's COVID-19 Vaccine, and experienced fainting, shaking, cold arm, red spots on forehead, chills and fatigue.   The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 28 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 031L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 28 Jan 2021, the patient experienced fainting, shaking, cold arm, red spots on forehead, and chills. Reporter stated that no treatment drugs were prescribed for the events. A complete blood count and an electrocardiograph was performed (results not provided).  On 29 Jan 2021, the patient experienced fatigue.  Action taken with second dose of mRNA-1273 in response to the events was not provided.    The outcome of the events fainting, shaking, cold arm, red spots on forehead, chills and fatigue was not provided.; Reporter's Comments: This case concerns a 21-year-old female patient, who experienced a serious  event of syncope and non-serious events of tremor, feeling cold, rash macular, chills and fatigue. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Syncope, Tremor
Clinical narrative: fatigue; fainted; shaking; arm cold (felt like ice); red spots on forehead; chills; A spontaneous report was received from a consumer's relative concerning a 21-years-old, female patient who received Moderna's COVID-19 Vaccine, and experienced fainting, shaking, cold arm, red spots on forehead, chills and fatigue.   The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 28 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 031L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 28 Jan 2021, the patient experienced fainting, shaking, cold arm, red spots on forehead, and chills. Reporter stated that no treatment drugs were prescribed for the events. A complete blood count and an electrocardiograph was performed (results not provided).  On 29 Jan 2021, the patient experienced fatigue.  Action taken with second dose of mRNA-1273 in response to the events was not provided.    The outcome of the events fainting, shaking, cold arm, red spots on forehead, chills and fatigue was not provided.; Reporter's Comments: This case concerns a 21-year-old female patient, who experienced a serious  event of syncope and non-serious events of tremor, feeling cold, rash macular, chills and fatigue. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out after 1 day of having the vaccine; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out.  The patient's medical history as provided by the reporter included dementia. No concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient passed out after one day of having vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, passed out was unknown.; Reporter's Comments: This case concerns a 66-year-old female patient, who experienced a serious unexpected event of Loss of consciousness. The event occurred approximately one day after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident, Sneezing
Clinical narrative: No longer has vision in that eye; Stroke; Sneezing; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who experienced stroke, lost vision in one eye and Sneezing.    The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medicines.    On 31 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 039K20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient reported sneezing and had vision issues. He was told that it appeared he had a stroke. Treatment for the event included eye drops.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events stroke,  lost vision in one eye and Sneezing were unknown.; Reporter's Comments: This case concerns a 75 year old, male patient, who experienced a serious unexpected event of blindness and cerebrovascular accident. Concomitant medication included blood pressure medication. Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Gait disturbance, Paralysis, Pyrexia
Clinical narrative: Limp; Paralyzed (pain was so bad he couldn't move it); Low grade fever; Severe left hip pain; A spontaneous report was received from a consumer who was also a 85-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced left hip became paralyzed (pain was so bad he couldn't move it) (paralysis), low grade fever (pyrexia), limp (gait disturbance), and severe left hip pain (arthralgia).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, approximately 10 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient woke up at 10:00 pm with severe left hip pain. His left hip became paralyzed (pain was so bad he couldn't move it), and he took 2 ibuprofens then went to bed.   On 10 Jan 2021, he was still in pain with a low grade fever of 98.8 which is 1 to 2 degrees higher than normal for him. He reported using his wife's walker to ambulate and took 4 ibuprofens which helped his hip.   On 11 Jan 2021, the patient was still in pain, had a limp, and ran a low fever until the afternoon. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, low grade fever, was considered resolved on 11 Jan 2021. The outcome of the events, left hip became paralyzed (pain was so bad he couldn't move it), low grade fever and limp, was unknown.; Reporter's Comments: Based on the information provided, the events of low grade fever, gait disturbance and severe left hip pain are temporally associated with the administration of mRNA-1273 and a causal association cannot be excluded. Fever and arthralgia are consistent with the known safety profile of the product.  The event of paralysis is considered unlikely pending additional information.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Cerebral small vessel ischaemic disease, Computerised tomogram head, Dysarthria
Clinical narrative: chronic small vessel ischemic disease; Felt Bad; Arm pain; Headache; Body ache; Sweating; Cold Feet; Tremors; Slurred speech; Elevated blood pressure; Stuttering; A spontaneous report was received from a Healthcare professional concerning a 31 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced non-serious events of body pain, headache, arm pain, hyperhidrosis, peripheral coldness, tremor, dysarthria, elevated blood pressure, dysphonia and serious event of exacerbation of preexisting chronic small vessel ischemic disease after the 2nd dose of Moderna vaccine chronic .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-JAN-2021, prior to the onset of the events, the patient received their second dose of planned doses of mRNA-1273 batch no:028L20A  intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On the same day, The patient experienced arm pain, headache, sweating, body ache, cold feet, tremors, slurred speech, elevated blood pressure measured at 183/90., and sluttering.  On 21-JAN-2021, CT brain normal. MRI was abnormal and showed flare signal regions in the brain which signified early microvascular ischemic changes, a demyelinating process, vasculitis, or sequelae for migraines. The subject was treated with intravenously with lorazepam 2mg and Benadryl.  On 03-FEB-2021, the subject was referred to a neurologist and was improving.  On 05-FEB-2021, another MRI was performed and showed multiple scattered punctate foci of unenhancing white matter, signal alteration which were nonspecific but unchanged in comparison to previous MRI. Report suggested that findings were most likely to reflect an early onset chronic small vessel ischemic disease, other somewhat less likely considerations in a patient of this age would include migraine syndrome, various cerebral vasculopathies, or demyelinating conditions.  Action taken with mRNA-1273 in response to the events was not applicable as second dose had been administered.   The outcome of the event was resolving.; Reporter's Comments: The non-serious events of pain, headache, sweating, body ache, cold feet, tremors, slurred speech, elevated blood pressure, and sluttering are temporarily associated with the mRNA-1273 use and a causal association cannot be excluded.  The serious event of chronic small vessel ischemic disease is considered a pre-existing event based a diagnostic findings and thus assessed as unlikely associated with mRNA-1273 use.
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Feeling abnormal, Headache, Hyperhidrosis, Magnetic resonance imaging
Clinical narrative: chronic small vessel ischemic disease; Felt Bad; Arm pain; Headache; Body ache; Sweating; Cold Feet; Tremors; Slurred speech; Elevated blood pressure; Stuttering; A spontaneous report was received from a Healthcare professional concerning a 31 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced non-serious events of body pain, headache, arm pain, hyperhidrosis, peripheral coldness, tremor, dysarthria, elevated blood pressure, dysphonia and serious event of exacerbation of preexisting chronic small vessel ischemic disease after the 2nd dose of Moderna vaccine chronic .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-JAN-2021, prior to the onset of the events, the patient received their second dose of planned doses of mRNA-1273 batch no:028L20A  intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On the same day, The patient experienced arm pain, headache, sweating, body ache, cold feet, tremors, slurred speech, elevated blood pressure measured at 183/90., and sluttering.  On 21-JAN-2021, CT brain normal. MRI was abnormal and showed flare signal regions in the brain which signified early microvascular ischemic changes, a demyelinating process, vasculitis, or sequelae for migraines. The subject was treated with intravenously with lorazepam 2mg and Benadryl.  On 03-FEB-2021, the subject was referred to a neurologist and was improving.  On 05-FEB-2021, another MRI was performed and showed multiple scattered punctate foci of unenhancing white matter, signal alteration which were nonspecific but unchanged in comparison to previous MRI. Report suggested that findings were most likely to reflect an early onset chronic small vessel ischemic disease, other somewhat less likely considerations in a patient of this age would include migraine syndrome, various cerebral vasculopathies, or demyelinating conditions.  Action taken with mRNA-1273 in response to the events was not applicable as second dose had been administered.   The outcome of the event was resolving.; Reporter's Comments: The non-serious events of pain, headache, sweating, body ache, cold feet, tremors, slurred speech, elevated blood pressure, and sluttering are temporarily associated with the mRNA-1273 use and a causal association cannot be excluded.  The serious event of chronic small vessel ischemic disease is considered a pre-existing event based a diagnostic findings and thus assessed as unlikely associated with mRNA-1273 use.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral coldness, Tremor
Clinical narrative: chronic small vessel ischemic disease; Felt Bad; Arm pain; Headache; Body ache; Sweating; Cold Feet; Tremors; Slurred speech; Elevated blood pressure; Stuttering; A spontaneous report was received from a Healthcare professional concerning a 31 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced non-serious events of body pain, headache, arm pain, hyperhidrosis, peripheral coldness, tremor, dysarthria, elevated blood pressure, dysphonia and serious event of exacerbation of preexisting chronic small vessel ischemic disease after the 2nd dose of Moderna vaccine chronic .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-JAN-2021, prior to the onset of the events, the patient received their second dose of planned doses of mRNA-1273 batch no:028L20A  intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On the same day, The patient experienced arm pain, headache, sweating, body ache, cold feet, tremors, slurred speech, elevated blood pressure measured at 183/90., and sluttering.  On 21-JAN-2021, CT brain normal. MRI was abnormal and showed flare signal regions in the brain which signified early microvascular ischemic changes, a demyelinating process, vasculitis, or sequelae for migraines. The subject was treated with intravenously with lorazepam 2mg and Benadryl.  On 03-FEB-2021, the subject was referred to a neurologist and was improving.  On 05-FEB-2021, another MRI was performed and showed multiple scattered punctate foci of unenhancing white matter, signal alteration which were nonspecific but unchanged in comparison to previous MRI. Report suggested that findings were most likely to reflect an early onset chronic small vessel ischemic disease, other somewhat less likely considerations in a patient of this age would include migraine syndrome, various cerebral vasculopathies, or demyelinating conditions.  Action taken with mRNA-1273 in response to the events was not applicable as second dose had been administered.   The outcome of the event was resolving.; Reporter's Comments: The non-serious events of pain, headache, sweating, body ache, cold feet, tremors, slurred speech, elevated blood pressure, and sluttering are temporarily associated with the mRNA-1273 use and a causal association cannot be excluded.  The serious event of chronic small vessel ischemic disease is considered a pre-existing event based a diagnostic findings and thus assessed as unlikely associated with mRNA-1273 use.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration, Magnetic resonance imaging head, SARS-CoV-2 test
Clinical narrative: Stroke; Dose Number 1 on 08Jan2021/Dose Number 2 on 25Jan2021; This is a spontaneous report from a contactable nurse. A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiry date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Patient has no medical history. Concomitant medication included tamsulosin hydrochloride (FLOMAX). Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on 08Jan2021 on the left arm. The most recent COVID-19 vaccine was administered at the hospital. On 18Jan2021 06:00, the patient experienced right foot drop. Spine MRI on 18Jan2021 was negative. Stroke confirmed on brain MRI on 28Jan2021. Patient was sent to the ED at the hospital immediately after and was admitted from the ED to the hospital. Number of days of hospitalization was 2. Adverse event result: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient has not recovered from the event stroke. Event was reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has been tested for COVID-19 with test type: nasal swab on 28Jan2021 with result negative. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based on current information available, the event stroke mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment.   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.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Neuralgia, Neuropathy peripheral, Pruritus
Clinical narrative: He also mentioned having neuropathy in both ankles and feet; After getting the shot, the itchiness on the back and chest is so severe; he can hardly walk due to the excruciating pain; excruciating pain; dizziness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose for COVID-19 immunization. Medical history included he is experiencing headache and sinus infection (from unknown date and ongoing) that has been going on for about 6 months and was not managed despite getting scanned. He added that he was a smoker for over 60 years, and that when his oncologist discovered he has cancer he was given 2-6 months, but that was back in 2017. Concomitant medication was not reported. Caller would like to report his experience with the Pfizer covid vaccine he received yesterday. He stated that a callback may be given in case more information is needed. Caller mentioned taking chemotherapy every two weeks for his cancer, and one of the expected side effects is itching. After getting the shot, the itchiness on the back and chest is so severe that he only managed to sleep for 45 minutes (Jan2021). He also mentioned having neuropathy in both ankles and feet, the shot may have messed with his nerves and he can hardly walk due to the excruciating pain. Additionally, he experienced dizziness, described as "drinking a 12-pack and standing too quick". Outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: kidney infection; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Other medical history and concomitant medications were not reported. The patient received her second dose of the vaccine yesterday. After the vaccination she was diagnosed with a kidney infection (in Jan2021) and was prescribed nitrofurantoin. The event was reported as non-serious. The patient asked if she may take nitrofurantoin a day after receiving the Pfizer-BioNTech COVID-19 vaccine, asks if the antibiotic may impact the effectiveness of her vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Urethral haemorrhage
Clinical narrative: brownish blood spot in his underwear, it looked like mixed blood to the urethra; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for self. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got first dose of covid-19 vaccine on 21Jan2021 and on an unspecified date he noticed brownish blood spot in his underwear, it looked like mixed blood to the urethra. He took Plavix and Tamsulosin. His provider does not think it is from those medications. The event outcome was unknown.   Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Influenza, Presyncope
Clinical narrative: thought she would pass out and it went downhill from there; flu symptoms; she got hot; This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E18982), via an unspecified route of administration on 21Jan2021 13:00 by injection once to left arm at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included apixaban (ELIQUIS) as blood thinner. Patient was calling about COVID 19 vaccine. She had the first shot 21Jan2021, and had had flu symptoms ever since on 21Jan2021 and when they gave the shot they didn't ask for her allergies or anything, and she read on a letter given after, she was taking blood thinners, she was not sure what they do to the vaccine, that wasn't asked of her either, before she decided whether to take second or not, she needed some answers, she hadn't had the flu for 40 years. Her shot was at 1PM, and about 6 or 7PM that night, she got hot and thought she would pass out and it went downhill from there. Patient did not have some medical problems that she checked off when she registered, none of that came through either. Patient was thinking about not taking the second shot if she didn't get some medical information. The outcome of event flu symptoms was resolving, outcome of other events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Intestinal obstruction, Paraesthesia, Peripheral coldness, Vaccination site coldness
Clinical narrative: blocked colon; shot arm to go icy cold; cold sensation through her arm, "icy veins"/shot arm to go icy cold and travel down to thumb and hand and stay cold; tingling in her arms and legs; gastrointestinal issues; This is a spontaneous report from a contactable Other HCP (patient). This 48-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose, and second dose on 23Jan2021 at single dose in arm for COVID-19 immunization. The patient medical history included severe reactions to some things. The patient's concomitant medications were not reported. Patient wanted to ask if some of her symptoms were an effect of the vaccines. She was having problems locally being able to differentiate problems. In her case, since she had a history of severe reactions to some things, she was observed for both for 40 minutes. Patient reported to have experienced a cold sensation through her arm; "icy veins", tingling in her arms and, reported having a "blocked colon". Mentioned that the gastrointestinal issues may have been caused by the diphenhydramine hydrochloride (BENADRYL). Her problems worsened even after diphenhydramine hydrochloride and she wound up at the ER on Wednesday when she woke up. She did not want someone to think later that her symptoms were related to it if they are not. Maybe some would be related. The doctor told her if her symptoms don't get better in two weeks, then she needs to see the Immunologist.  She then described tingling in her arms and legs. She did not want to wait until then. If it is expected, she can live with it. She wanted to know if it was common for shot arm to go icy cold and travel down to thumb and hand and stay cold. That was what they were ignoring.  She also said she wound up with a blocked colon. Outcome of the events was unknown. The reporter considered the events as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the limitedly available information and drug's safety profile, the blocked colon is unlikely related to suspect vaccine BNT162B2 administration. The detailed clinical course would be helpful for further assessment.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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Loss of consciousness, Lymphadenopathy, Pain
Clinical narrative: fever/temperature reached 101 degrees; Chills; Swollen lymph node in left armpit/swollen lymph node under her left arm, which is the same side that she received her vaccine; Passed out; Body aches; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283, Expiry Date: Apr2021), via an unspecified route of administration on 27Jan2021 09:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were none. No family history. The patient previously took first dose of BNT162B2 (Lot# EL1283) on 07Jan2021 for COVID-19 immunization. Vaccination facility type was nursing home patient was employed at; administered by pharmacy. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations received within 4 weeks. No adverse events follow prior vaccinations. Patient had fever: temperature reached 101 degrees, early morning on 28Jan2021; chills on 28Jan2021; body aches: at night of 27Jan2021; passed out: later on day of 27Jan2021, didn't get out of bed, didn't remember passing out. Remembers waking up on the floor; swollen lymph node: under her left armpit/left arm noticed on 28Jan2021, which was the same side that she received her vaccine. Hurts less when she puts her arm down. Really was sore to the point where she had to keep her arm open. She can rest her arm now, but it is still sore. Everything has subsided except for the swollen lymph node. Her energy was back. No relevant tests. Relatedness of bnt162b2 to events for Fever/Chills/Body aches/Passed out/Swollen lymph node in left armpit: Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Event relatedness between COVID-19 Vaccine and fever/Body aches/Swollen lymph node in left armpit was Related. Outcome of the event was swollen lymph node was not recovered, outcome of other events was recovering. No investigation assessment.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever/temperature reached 101 degrees; Chills; Swollen lymph node in left armpit/swollen lymph node under her left arm, which is the same side that she received her vaccine; Passed out; Body aches; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283, Expiry Date: Apr2021), via an unspecified route of administration on 27Jan2021 09:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were none. No family history. The patient previously took first dose of BNT162B2 (Lot# EL1283) on 07Jan2021 for COVID-19 immunization. Vaccination facility type was nursing home patient was employed at; administered by pharmacy. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations received within 4 weeks. No adverse events follow prior vaccinations. Patient had fever: temperature reached 101 degrees, early morning on 28Jan2021; chills on 28Jan2021; body aches: at night of 27Jan2021; passed out: later on day of 27Jan2021, didn't get out of bed, didn't remember passing out. Remembers waking up on the floor; swollen lymph node: under her left armpit/left arm noticed on 28Jan2021, which was the same side that she received her vaccine. Hurts less when she puts her arm down. Really was sore to the point where she had to keep her arm open. She can rest her arm now, but it is still sore. Everything has subsided except for the swollen lymph node. Her energy was back. No relevant tests. Relatedness of bnt162b2 to events for Fever/Chills/Body aches/Passed out/Swollen lymph node in left armpit: Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Event relatedness between COVID-19 Vaccine and fever/Body aches/Swollen lymph node in left armpit was Related. Outcome of the event was swollen lymph node was not recovered, outcome of other events was recovering. No investigation assessment.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship.  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.
Sex: F
Vaccine: COVID19
Symptoms: Spinal cord disorder
Clinical narrative: pressing on her spinal cord; This is a spontaneous report from a contactable consumer reported for herself. This female patient of unspecified age (age:67; unit: unknown) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient stated she had the first dose of the vaccine and scheduled the second dose for 3 weeks later, but apparently 3 weeks, her cervical spine surgery fell on that day; (it's pressing on her spinal cord. She was fighting becoming paralyzed). The patient asked if any window, flexibility. The nurse told her there's a 3 day before and 5 day window after, but no one believed that's correct. If she missed and she couldn't have the vaccine (second dose), the patient asked whether she would have to start over. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Chills, Discomfort, Dyspnoea
Clinical narrative: Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activated all that discomfort; she thought she was having a heart attack; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 20Jan2021 12:30 at single dose in right arm to prevent covid. Vaccination Facility Type was Health department. Medical history included rotator cuff challenge. There were no concomitant medications. No other vaccine was administered on the same date. There were no prior vaccinations within 4 weeks and no adverse events were following prior vaccinations. Patient was calling about Pfizer Covid vaccine. She had the first shot on 20Jan2021. She did not have a reaction. She went to go get her monthly massage on Saturday (23Jan2021). On Sunday morning (24Jan2021) she started to feel ill and she had to go the hospital. She confirmed she was not admitted to the hospital. She had chills, aches and pains, it felt like an elephant was on her chest, she had chest spasms, a fever a little shy of 101. She went to hospital and the doctor there told her she had covid since she had all the symptoms. She confirmed she did not have covid and had a negative covid test. She had chest x-ray and an EKG since she thought she was having a heart attack. Reported her massage was primarily on her left shoulder, it was a deep massage on that area since she had a rotator cuff challenge, massage was focused on that shoulder. She was thinking that the vaccine activated all that discomfort since she felt it from the left part of shoulder, went down to her chest like a v, and back up to her right shoulder. Every time she took a breath she had a chest spasm and it was hard to breathe. The events required a visit to emergency room. For treatment, they gave her medication to take called robaxin, it was an anti-spasm, and 800mg of ibuprofen. She took robaxin Sunday night, Monday, and she took one on Tuesday since she was feeling better. She was sensitive to medication. She felt dizzy and nausea from Robaxin. The patient had recovered from the events completely by Wednesday on 27Jan2021. She had a reminder to return for the second dose on 10Feb2021. She was asking if she should get the second dose.   Information about Batch/Lot number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Malaise, Muscle spasms, Myocardial infarction, Pain
Clinical narrative: Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activated all that discomfort; she thought she was having a heart attack; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 20Jan2021 12:30 at single dose in right arm to prevent covid. Vaccination Facility Type was Health department. Medical history included rotator cuff challenge. There were no concomitant medications. No other vaccine was administered on the same date. There were no prior vaccinations within 4 weeks and no adverse events were following prior vaccinations. Patient was calling about Pfizer Covid vaccine. She had the first shot on 20Jan2021. She did not have a reaction. She went to go get her monthly massage on Saturday (23Jan2021). On Sunday morning (24Jan2021) she started to feel ill and she had to go the hospital. She confirmed she was not admitted to the hospital. She had chills, aches and pains, it felt like an elephant was on her chest, she had chest spasms, a fever a little shy of 101. She went to hospital and the doctor there told her she had covid since she had all the symptoms. She confirmed she did not have covid and had a negative covid test. She had chest x-ray and an EKG since she thought she was having a heart attack. Reported her massage was primarily on her left shoulder, it was a deep massage on that area since she had a rotator cuff challenge, massage was focused on that shoulder. She was thinking that the vaccine activated all that discomfort since she felt it from the left part of shoulder, went down to her chest like a v, and back up to her right shoulder. Every time she took a breath she had a chest spasm and it was hard to breathe. The events required a visit to emergency room. For treatment, they gave her medication to take called robaxin, it was an anti-spasm, and 800mg of ibuprofen. She took robaxin Sunday night, Monday, and she took one on Tuesday since she was feeling better. She was sensitive to medication. She felt dizzy and nausea from Robaxin. The patient had recovered from the events completely by Wednesday on 27Jan2021. She had a reminder to return for the second dose on 10Feb2021. She was asking if she should get the second dose.   Information about Batch/Lot number has been requested.