chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Pneumonia on both lungs; A report was received from a consumer who was an 87 year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the serious adverse event pneumonia on both lungs.   The patient's medical history was not provided. Concomitant medications reported included carvedilol, digoxin, furosemide, lisinopril, simvastatin, codeine phosphate hemihydrate/paracetamol, testosterone, acetylsalicylic acid, and multivitamins.    On 02 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported receiving the first dose of Moderna Covid-19 vaccine on 02 Jan 2021. On 04 Jan 2021, he was having a very difficult time breathing. He went to the doctor on 06 Jan 2021 and found out he had pneumonia on both lungs and was positive for COVID-19. He was treated by the doctor. Treatment for the event included antibiotics, 1 week of steroids, and a bamlanivimab injection on 11 Jan 2021.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, pneumonia on both lungs, was unknown/not reported.; Reporter's Comments: This spontaneous report concerns an 87-year-old male patient serious adverse event pneumonia on both lungs.  The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 025L20A, expiration date-unknown). Treatment administered included antibiotics, steroids and bamlanivimab injection, and outcome was unknown. Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported event and mRNA-1273 vaccine administration.  Critical details such as diagnostic test for COVID infection prior to vaccination was not established or ascertained.  Causality is also confounded by the patient's advanced age.  Main field defaults to possibly related'
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Skin discolouration, Vomiting
Clinical narrative: Systemic: Other- patient had blueness in one hand, states she had problems breathing, and vomiting, epipen was given and paramedics were called, she was taken to the hospital, not believed to be anaphylaxis
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dysarthria, Facial pain, Gait inability, Hemiplegia
Clinical narrative: Paralyzed on the right side down to her foot; Numbness in her hands and feet; Slurred speech; Felt really heavy in her face area, hurt really bad; Shooting pain; Feels tingly; Felt really heavy in her neck, hurt really bad; unable to walk; A spontaneous report was received from a consumer who was also a 25-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings.   The patient's medical history was not provided. Concomitant product use was not provided.  On 21 Jan 2021, approximately two hours prior to the start of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Approximately two hours after receiving the vaccine at 12:30 pm, the patient experienced heavy feeling in her neck and face area that hurt really bad. Later, she noticed numbness in her hands and feet. Slurred speech was reported from a bystander. By 3:30pm, the patient was completely paralyzed on her right side. She was taken to the hospital, and a code stroke was initiated; however, all labs were normal.   On 26 Jan 2021, the patient was still paralyzed on her right side, unable to walk, had shooting pain feeling, and two fingers on her right hand were able to move but still felt tingly. The doctors planned to discharge her on the next day to a rehab center because she could not function alone.  Treatment for the event included pain medication and hospitalization.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings were considered unknown.; Reporter's Comments: A spontaneous report concerns a 25-year-old, female, patient, who experienced heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly and shooting pain feelings. The events of heavy feeling in her neck and face area, numbness in her hands and feet, slurred speech, completely paralyzed on her right side occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 032L20A, expiration date unknown). The events of inability to walk, had shooting pain feeling and two fingers on her right hand were able to move but still felt tingly occurred the following day after the vaccine administration. Treatment included pain medication and outcome is unknown. Based on the information provided, which indicates a strong temporal association between the reported events and administration of mRNA-1273 vaccine (onset latency of 2 hours), a causal association cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test normal, Neck pain, Pain, Paraesthesia
Clinical narrative: Paralyzed on the right side down to her foot; Numbness in her hands and feet; Slurred speech; Felt really heavy in her face area, hurt really bad; Shooting pain; Feels tingly; Felt really heavy in her neck, hurt really bad; unable to walk; A spontaneous report was received from a consumer who was also a 25-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings.   The patient's medical history was not provided. Concomitant product use was not provided.  On 21 Jan 2021, approximately two hours prior to the start of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Approximately two hours after receiving the vaccine at 12:30 pm, the patient experienced heavy feeling in her neck and face area that hurt really bad. Later, she noticed numbness in her hands and feet. Slurred speech was reported from a bystander. By 3:30pm, the patient was completely paralyzed on her right side. She was taken to the hospital, and a code stroke was initiated; however, all labs were normal.   On 26 Jan 2021, the patient was still paralyzed on her right side, unable to walk, had shooting pain feeling, and two fingers on her right hand were able to move but still felt tingly. The doctors planned to discharge her on the next day to a rehab center because she could not function alone.  Treatment for the event included pain medication and hospitalization.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings were considered unknown.; Reporter's Comments: A spontaneous report concerns a 25-year-old, female, patient, who experienced heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly and shooting pain feelings. The events of heavy feeling in her neck and face area, numbness in her hands and feet, slurred speech, completely paralyzed on her right side occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 032L20A, expiration date unknown). The events of inability to walk, had shooting pain feeling and two fingers on her right hand were able to move but still felt tingly occurred the following day after the vaccine administration. Treatment included pain medication and outcome is unknown. Based on the information provided, which indicates a strong temporal association between the reported events and administration of mRNA-1273 vaccine (onset latency of 2 hours), a causal association cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Leukopenia, Myalgia, Pyrexia, Rash
Clinical narrative: Severe arm rash the size of a baseball welt; Muscle pain; Had a fever for five days; Severe leukopenia; Could not walk; A spontaneous report was received from a pharmacist who was a 35-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt.    The patient's medical history was not provided. No concomitant medication use was reported.  On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Jan 2021, the patient's white blood cell count decreased which was considered severe leukopenia. Additionally, she experienced a fever for five days that would not decrease with paracetamol or ibuprofen, had muscle pain, and could not walk.  On 25 Jan 2021, the patient had a severe arm rash the size of a baseball welt. Treatment for the arm rash included diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt, was unknown.; Reporter's Comments: This case concerns a 35-years-old female patient, who experienced a serious unexpected event of leukopenia, a non-serious unexpected event of gait disturbance, rash and non-serious expected event of myalgia, and pyrexia. The event of rash occurred on day 4 after first dose of mRNA-1273, lot # unknown. Remaining events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown.  Laboratory tests revealed severe leukopenia (details not provided). Treatment included Tylenol, Ibuprofen and Benadryl. 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, White blood cell count decreased
Clinical narrative: Severe arm rash the size of a baseball welt; Muscle pain; Had a fever for five days; Severe leukopenia; Could not walk; A spontaneous report was received from a pharmacist who was a 35-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt.    The patient's medical history was not provided. No concomitant medication use was reported.  On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Jan 2021, the patient's white blood cell count decreased which was considered severe leukopenia. Additionally, she experienced a fever for five days that would not decrease with paracetamol or ibuprofen, had muscle pain, and could not walk.  On 25 Jan 2021, the patient had a severe arm rash the size of a baseball welt. Treatment for the arm rash included diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, severe leukopenia, had a fever for five days, muscle pain, could not walk, and severe arm rash the size of a baseball welt, was unknown.; Reporter's Comments: This case concerns a 35-years-old female patient, who experienced a serious unexpected event of leukopenia, a non-serious unexpected event of gait disturbance, rash and non-serious expected event of myalgia, and pyrexia. The event of rash occurred on day 4 after first dose of mRNA-1273, lot # unknown. Remaining events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown.  Laboratory tests revealed severe leukopenia (details not provided). Treatment included Tylenol, Ibuprofen and Benadryl. 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pruritus
Clinical narrative: full body itching
Sex: U
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Fainted; Had a seizure; A spontaneous report  was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and had a seizure.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, after vaccine administration, the patient fainted and had a seizure. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, fainted and seizure, were unknown.; Reporter's Comments: This case concerns a patient, who experienced events of fainted and seizure. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Syncope
Clinical narrative: fainted; body aches; fever; Chills; A spontaneous report was received from a consumer who is a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainting, body aches, fever and chills.  The patient's medical history was not provided. Concomitant medications were not reported.   On 26 Jan 2021, the patient received their second dose of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced body aches, fever and chills and she got up in the middle of the night and fainted.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events fainting, body aches, fever and chills, were considered not resolved.~; Reporter's Comments: This case concerns a female patient, who experienced events of fainting, body aches, fever and chills. The events occurred the same day after the second and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Headache, Infusion, Malaise
Clinical narrative: Difficulty breathing/ shortness of breath; Tested positive for COVID-19; Pain; Not feeling well / very sick; Vaccine is defective; Bad headache; Fever; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 14 Jan 2021, approximately two to three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 04L20) intramuscularly for COVID-19 infection.   On unknown date, the patient experienced a bad headache, pain, fever and was still not feeling well. Patient went to emergency room and had difficulty breathing, shortness of breath and ended up receiving an infusion of casirivimab  imdevimab. Patient tested positive for COVID-19 as well. Treatment for the event included casirivimab/ imdevimab.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19, was unknown.; Reporter's Comments: A spontaneous report concerns a 65-years-old, male patient who experienced the unexpected serious event difficulty breathing/ shortness of breath bad and non-serious events of headache, pain, fever, not feeling well and tested positive for COVID-19. The events occurred approximately two to three days after administration of mRNA-1273 vaccine (Lot number 04L20). Treatment provided included casirivimab/imdevimab and outcome of the events is unknown.  Based on the known information about COVID and duration to diagnosis, it is very unlikely to be associated with the vaccine administration. The other events are temporally associated with the administration of mRNA-1273, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Difficulty breathing/ shortness of breath; Tested positive for COVID-19; Pain; Not feeling well / very sick; Vaccine is defective; Bad headache; Fever; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 14 Jan 2021, approximately two to three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 04L20) intramuscularly for COVID-19 infection.   On unknown date, the patient experienced a bad headache, pain, fever and was still not feeling well. Patient went to emergency room and had difficulty breathing, shortness of breath and ended up receiving an infusion of casirivimab  imdevimab. Patient tested positive for COVID-19 as well. Treatment for the event included casirivimab/ imdevimab.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19, was unknown.; Reporter's Comments: A spontaneous report concerns a 65-years-old, male patient who experienced the unexpected serious event difficulty breathing/ shortness of breath bad and non-serious events of headache, pain, fever, not feeling well and tested positive for COVID-19. The events occurred approximately two to three days after administration of mRNA-1273 vaccine (Lot number 04L20). Treatment provided included casirivimab/imdevimab and outcome of the events is unknown.  Based on the known information about COVID and duration to diagnosis, it is very unlikely to be associated with the vaccine administration. The other events are temporally associated with the administration of mRNA-1273, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of the vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Started itching mu upper arm where I had gotten the Moderna shot and it felt like a mosquito bite.  Later when I looked at my arm is was very red and swollen the size of a grapefruit.  I used topical Benadryl cream on it, but it continued to get worse and spread out.  I took 2 Benadryl tablets before bedtime and it was much improved the next morning.  The redness was still there, but the swelling had gone down.  By the next day it was mostly back to normal without taking any more Benadryl.   Now a week later on 02/08/2021 I developed bumps or hives in the exact same area.  I again took 2 Benadryl before going to bed and this morning  the hives have lessened, but the redness is still there  and itches.  Prescriptions  I take are 10 mg tablet atorvastatin once a day and 60mg capsule of duloxetine once a day.  I take Calcium tablets 630mg a day.  I just started on vitamin D capsules 125 mcg two days ago.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Haemoptysis, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: Pneumonia; coughing up blood; A spontaneous report was received from a consumer who was also a 71-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pneumonia and coughing up blood.  The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.  On 19 Jan 2021, approximately 1 day 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.  On 20 Jan 2021, the patient began to cough up blood and was seen and treated by a healthcare professional. A chest x-ray was done and revealed pneumonia. Treatment for the event included doxycycline, prednisone and an inhaler.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, pneumonia and coughing up blood, were unknown.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious unexpected event of Hemoptysis. The events occurred one day after the first dose of the mRNA-1273 administration. Treatment for the event included doxycycline, prednisone and an inhaler. Since Pneumonia has insidious onset rather than acute onset, the event was possibly related to underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Hemoptysis, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA Fever starting night of shot lasting 4 days fever as high as 103.2 Chills, fatigue,body aches, sores in mouth and one outside of bottom lip, ringing in ears Felt just like I had Covid-19 all over again!!!!! Called Doctor and was told I was probably having a allergic reaction  to the shot and should feel better in a couple days. It took 4. Also asked if I should get the 2nd shot and was told yes, and I probably would have adverse side effects from that one as well.  I am supposed to receive that on March 4th 2021. I cant wait LOL
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis, Tinnitus
Clinical narrative: Moderna COVID-19 Vaccine EUA Fever starting night of shot lasting 4 days fever as high as 103.2 Chills, fatigue,body aches, sores in mouth and one outside of bottom lip, ringing in ears Felt just like I had Covid-19 all over again!!!!! Called Doctor and was told I was probably having a allergic reaction  to the shot and should feel better in a couple days. It took 4. Also asked if I should get the 2nd shot and was told yes, and I probably would have adverse side effects from that one as well.  I am supposed to receive that on March 4th 2021. I cant wait LOL
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Client was observed for 15 min. after vaccination with no issues and left Clinic.  Client returned to Clinic approx. 5 min. later. She complained of feeling her lips swollen and a little tingling.  Client observed in Clinic. Benadryl 50 mg was given.  Vitals remained stable.   Client reported no tingling to lips and less swollen 1/2 hour after Benadryl.  Client remained in Clinic for 1 hr. and 40 min. after Benadryl given as she was waiting for husband to pick her up. Upon leaving Clinic Client stated felt better, Lips feeling normal.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia - ongoing for last two days
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Throat irritation
Clinical narrative: lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 22Jan2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, morbid obesity, anemia, arthritis, allergic to fish (shell & fin) and all nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but it was reported that the patient took other medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Jan2021, at 16:15 (also reported as after 15 minutes), the patient's lips became numb and the throat started to sound very scratchy and itchy. This resulted in a doctor or other healthcare professional visit. Treatment for the events included the patient taking her own diphenhydramine (BENADRYL), epinephrine (EPIPEN) and albuterol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of lips became numb and the throat started to sound very scratchy and itchy was resolved with sequel on Jan2021.   Information on the batch/lot number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria
Clinical narrative: Developed a large hive around the injection site 2 weeks after the first dose
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Blood test, Chest X-ray normal, Chills, Headache
Clinical narrative: started with headache and sore throat, then high fever (103) a few hours after first symptoms. body aches, chills and vomiting.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: started with headache and sore throat, then high fever (103) a few hours after first symptoms. body aches, chills and vomiting.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative, Vomiting, White blood cell count increased
Clinical narrative: started with headache and sore throat, then high fever (103) a few hours after first symptoms. body aches, chills and vomiting.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Muscle spasms, Nausea, Seizure
Clinical narrative: severe shaking convulsive; chills; nausea; leg cramps; difficulty breathing; vomitting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received single dose of BNT162B2 (PFIZER, Solution for injection, batch/lot number and exp date not reported ), via an unspecified route of administration (vaccine location: left arm) on 22Jan2021 10:45 for COVID-19 immunization. Medical history included diabetes and high cholesterol. The patient did not have Covid prior vaccination. The patient had no known allergies. Concomitant medication/other medications within two weeks included rosuvastatin calcium (CRESTOR), telmisartan, empagliflozin, metformin hydrochloride (SYNJARDY), and atenolol. There was no other vaccine within four weeks. On 24Jan2021 02:00, the patient experienced severe shaking convulsive, chills, nausea, leg cramps, difficulty breathing, and vomiting. No treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: severe shaking convulsive; chills; nausea; leg cramps; difficulty breathing; vomitting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received single dose of BNT162B2 (PFIZER, Solution for injection, batch/lot number and exp date not reported ), via an unspecified route of administration (vaccine location: left arm) on 22Jan2021 10:45 for COVID-19 immunization. Medical history included diabetes and high cholesterol. The patient did not have Covid prior vaccination. The patient had no known allergies. Concomitant medication/other medications within two weeks included rosuvastatin calcium (CRESTOR), telmisartan, empagliflozin, metformin hydrochloride (SYNJARDY), and atenolol. There was no other vaccine within four weeks. On 24Jan2021 02:00, the patient experienced severe shaking convulsive, chills, nausea, leg cramps, difficulty breathing, and vomiting. No treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depression, Fatigue, Feeling abnormal
Clinical narrative: little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient received the first dose on the left arm on 19Dec2020 10:30 (lot number: EL0140). Medical history included hypertension. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no side effects after the first vaccine except for a little tenderness which went away. On 11Jan2021, after receiving the second dose, she felt really tired but which went away. On 20Jan2021 (last Wednesday), she started to feel tired, weak, and not feeling like herself. On 22Jan2021, the patient was a little depressed. She did not have a headache. Her blood pressure was fine and she never had a fever. She had an X-ray back in Sep2020. Her vision is good. She is not hurting anywhere. She doesn't feel as strong. She doesn't understand the tiredness, weakness, and depression. Outcome of the event tired was recovered on 11Jan2021, of the events doesn't feel like herself and weak was not recovered, and of the event depression was recovering. The reporter assessed all the events as related to the bnt162b2. The events depression and doesn't feel like herself were reported as serious: medically significant while the other events were reported as non-serious.; Sender's Comments: A possible contributory role of bnt162b2 in triggering the onset depression and doesn't feel like herself cannot be excluded, considering 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Rash
Clinical narrative: swollen eyes; a rash on her forehead , around her eyes and both cheeks; very itchy eyes; This is a spontaneous report from a contactable Nurse (patient's mother).  A 22-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 06Jan2021 17:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Nurse stated her daughter received her first Pfizer vaccine on 06Jan2021 around 5:30 pm. The patient's signs and symptoms began shortly after receiving the shot. That evening at 19:00, she had very itchy eyes, the next morning (07Jan2021) she woke up with swollen eyes, a rash on her forehead, around her eyes and both cheeks. She took benedryl and zyrtec on 07Jan2021. The symptoms clear up by 10Jan2021, following a visit to her HCP, on 08Jan2021. She received a steroid shot, a prednisone dose pack her HCP. Her HCP recommended she not take dose 2 and instructed her mother to call Pfizer for recommendations. The outcome of the events was recovered on 10Jan2021.  The  reporting nurse considered the case as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: The reported events of swollen eyes, itching eyes and rash on face were likely related to first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), due to 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: patient became sweaty and flushed
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Paraesthesia, SARS-CoV-2 test
Clinical narrative: tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 21Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included "Celtics disease", allergies to gluten and negative COVID-19 test nasal swab on 10Oct2020. Concomitant medication included birth control and prenatal vitamin. Patient did not have COVID prior to vaccination and was not pregnant. Vaccination was received in the hospital and no other vaccine was received four weeks prior. On 21Jan2021 16:00, the patient reported nausea, dizziness sight and chills were normal then she had tingling with pins and needles feeling all through arms, legs, face. She still had prickling feeling in arms and her left foot was tingling and it had been four days later. The adverse events pins and needles reportedly resulted in disability or permanent damage. Patient has been tested for COVID post-vaccination on an unspecified date with unknown results. Treatment was received for the events. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of prickling feeling in arms and her left foot tingling cannot be excluded, considering 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Eructation, Gastrooesophageal reflux disease, Hallucination, visual
Clinical narrative: pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awake all night; had strange visions flashing in my head while trying to sleep; acid reflux/burping up acid; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: TL9261, expiration date not provided), via an unspecified route of administration on 25Jan2021 16:30 at a single dose for COVID-19 immunization. The patient has no medical history and there were no concomitant medications. On 25Jan2021, the patient experienced having acid reflux, pain in her chest/stomach that lasted all night last night and was worse when lying down. When she burped, it relieved some pressure. She had strange visions flashing in her head while trying to sleep on 25Jan2021. The patient was wondering if she was having a reaction from the vaccine. On 25Jan2021, after over an hour after the vaccine, she started having severe pain in the chest and stomach area and she couldn't sleep last night at all. She was awake all night, burping up acid. She was wondering if those were reaction to the vaccine, should she go see her doctor or what should she do about that. She got her first dose on 25Jan2021 and she started having chest and stomach pain the same day at about 6 PM. She was burping acid all night and early in the morning of 26Jan2021 and she was having these strange things like pictures going to her head that were weird. She was not sleeping but they were strange images, they were strange, they weren't normal. She says with that added in it sounds crazy. She has her vaccine card that says she should get the next one 15Feb2021. She wanted to avoid catching the corona. She had drank acid yesterday and she was wondering if that was causing her to have acid reflux. She clarified that she drank a lot of acidic liquids on 25Jan2021 and she was wondering if that might have had something to do with it, like orange juice and cranberry juice so she is wondering did that have anything to do with it, the acidity maybe made her stomach have acid reflux because she has had that in the past. She asked if she should go to the doctor. The outcome of the events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awake all night; had strange visions flashing in my head while trying to sleep; acid reflux/burping up acid; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: TL9261, expiration date not provided), via an unspecified route of administration on 25Jan2021 16:30 at a single dose for COVID-19 immunization. The patient has no medical history and there were no concomitant medications. On 25Jan2021, the patient experienced having acid reflux, pain in her chest/stomach that lasted all night last night and was worse when lying down. When she burped, it relieved some pressure. She had strange visions flashing in her head while trying to sleep on 25Jan2021. The patient was wondering if she was having a reaction from the vaccine. On 25Jan2021, after over an hour after the vaccine, she started having severe pain in the chest and stomach area and she couldn't sleep last night at all. She was awake all night, burping up acid. She was wondering if those were reaction to the vaccine, should she go see her doctor or what should she do about that. She got her first dose on 25Jan2021 and she started having chest and stomach pain the same day at about 6 PM. She was burping acid all night and early in the morning of 26Jan2021 and she was having these strange things like pictures going to her head that were weird. She was not sleeping but they were strange images, they were strange, they weren't normal. She says with that added in it sounds crazy. She has her vaccine card that says she should get the next one 15Feb2021. She wanted to avoid catching the corona. She had drank acid yesterday and she was wondering if that was causing her to have acid reflux. She clarified that she drank a lot of acidic liquids on 25Jan2021 and she was wondering if that might have had something to do with it, like orange juice and cranberry juice so she is wondering did that have anything to do with it, the acidity maybe made her stomach have acid reflux because she has had that in the past. She asked if she should go to the doctor. The outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Very sore and swollen upper left arm  I could barely raise my arm half way up for two days. There was  stiffness in the back of my neck,.  I also had a headache,  runny nose and was very tired  and sleepy the next day.   Additionally, I  could taste the vaccine which was coming from the back of my throat and my menstrual cycle started one day late.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rhinorrhoea, Somnolence
Clinical narrative: Very sore and swollen upper left arm  I could barely raise my arm half way up for two days. There was  stiffness in the back of my neck,.  I also had a headache,  runny nose and was very tired  and sleepy the next day.   Additionally, I  could taste the vaccine which was coming from the back of my throat and my menstrual cycle started one day late.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Dizziness, Illness, Laryngeal oedema
Clinical narrative: Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering.    No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pharyngeal swelling
Clinical narrative: Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering.    No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Eyeglasses therapy, VIth nerve paralysis
Clinical narrative: Diplopia due to left 6th (abducen) cranial nerve palsy; Diplopia due to left 6th (abducen) cranial nerve palsy; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscular, in the left arm, on 05Jan2021 07:30 at a single dose for covid-19 immunization. Medical history included type 2 diabetes. Concomitant medications were unspecified. The patient took unspecified medications in two weeks. The patient did not have any other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 07Jan2021, the patient experienced diplopia due to left 6th (abducen) cranial nerve palsy. The event resulted in doctor office/clinic visit, and emergency room visit. Therapeutic measure was taken as a result of the event which included fresnel prism on current glasses to alleviate diplopia. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported diplopia due to left 6th (abducen) cranial nerve palsy and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: 02/04 - chills and headache all day; 02/05 - headache, fatigue, nausea; 02/06 - headache (partial day), nausea (am); fatigue all day;  02/07 - minor fatigue most of day
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, Swollen tongue
Clinical narrative: Tip of tongue feels slightly enlarged; Salty taste in mouth; Tingle sensation on tip tongue; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3302), via an unspecified route of administration on 22Jan2021 08:00 at single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure and COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications included amlodipine and ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 12:00, the patient experienced salty taste in mouth for over 2days. Tingle sensation on tip tongue. Tip of tongue feels slightly enlarged. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered.