chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional. Follow-up received on 18Mar2021, was processed together with initial information.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, patient experienced sore arm. Patient mentioned that their grandson hadn't had the vaccine yet and his mother was exposed to a COVID- 19 patient. Patient wanted to know if it was okay to bring their grandson into their home. Outcome of the events was recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: received the Pfizer covid vaccine on 05Mar2021. A few days later, she tested positive to the covid infection; This is a spontaneous report from a contactable consumer (Patient, Self-reported) via Medical information team.  An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration on 05Mar2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient reported that she received the Pfizer covid vaccine on 05Mar2021 and few days later she has tested positive to the covid-19 infection on an unspecified date in 2021. She further wanted to know when she can get the 2nd dose of the covid vaccine since she has tested positive for covid infection. She would like to know whether she will have to restart the vaccination series if she gets her 2nd dose of the covid vaccine 90 days later due to a current covid infection. The patient underwent lab tests and procedures which included Covid 19: positive on an unknown date in Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis
Clinical narrative: cold; slight dizziness; This is a spontaneous report from contactable consumer (patient) reported for herself. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number- EN6202), via intramuscular route of administration in the left arm on 25Feb2021 at 15:00 (at the age of 71-years-old) and previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number- EN5318), via intramuscular route of administration in the left arm on 25Jan2021 at 17:00 as a SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication reported as vitamin for wellness, Zyrtec for allergies and still ongoing. It was reported that, on 28Feb2021 at 16:00 patient experienced cold and slight dizzness. The patient didn't received treatment for events. The outcome of the events for cold and slight dizzness was recovered on 29Feb2021.   Information on the lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Other 2 people who got the vaccine the same day as me, tested positive too; This is a spontaneous report from a contactable consumer. This is 3rd of 3 reports. A 25-year-non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration in right arm on 16Mar2021 (Batch/Lot Number: EN6208) at single dose for covid-19 immunisation. There was no other vaccine in four weeks. No known allergies. No other medical history. The patient medical history and concomitant medications was not reported. Covid was not tested prior vaccination. Covid test type was Nasal Swab and test name was antigen. The patient tested positive for covid 9 days later from the day got the vaccine. The symptoms started 7 days later. Other 2 people who got the vaccine on the same day tested positive too. The events occurred on 22Mar2021 at 12:00 PM. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diplopia
Clinical narrative: Double vision for 6 hours; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 14Mar2021 at 16:00 (Batch/Lot Number: EN6208) at the age of 73-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included hiatal hernia. The patient had no allergies to medications, food, or other products. Concomitant medications included calcium and multiple vitamin; both taken for an unspecified indication, start and stop dates were not reported (received within 2 weeks of vaccination). The patient experienced double vision for 6 hours on 17Mar2021 at 10:00 AM. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT scan: unknown results on 2021. The patient received treatment for the event reported as patient had examination at PCP and ophthalmologist and CT scan. The outcome of the event was recovering.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: I had a severe anaphylactic reaction; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 10:30 as a single dose for COVID-19 immunisation. There was no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 23:15, the patient experienced a severe anaphylactic reaction, with swallowing difficult, hives, significant swelling of the face, very puffy and watery eyes, and significant swelling in the throat and uvula that made breathing and swallowing difficult. The patient went to the emergency room (ER) and received epinephrine, prednisone, and a large dose of intravenous (IV) diphenhydramine (BENADRYL). Clinical outcome of the event severe anaphylactic reaction was recovering.  Information on about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Angioedema, Ear swelling, Lip swelling, Peripheral swelling, Pruritus
Clinical narrative: swollen upper and lower lips; horrendous itching; I broke out in large hives, (palm sized); had swollen earlobes; swollen palm on my right hand; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 18Feb2021, 12:00 pm at a single dose for covid-19 immunisation (age at vaccination was 70 years). The patient was not pregnant. Medical history included colon polyps and diverticulosis. Allergies to medications, food, or other products included premarin, ambien and many seasonal allergies. Co-suspect medication included amoxicillin sodium, clavulanate potassium (AUGMENTIN) for diverticulitis. Concomitant medication patient received within 2 weeks of vaccination included acebutolol hydrochloride (SECTRAL), allopurinol, rosuvastatin calcium (CRESTOR) and amitriptyline. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 28Jan2021, 13:00 pm at a single dose for covid-19 immunisation (age at vaccination was 70 years). No other vaccine was received within 4 weeks prior to the COVID vaccine. On 18 Mar2021, 4 weeks after second vaccine, the patient took Augmentin for recurring diverticulitis. For the last few years, the patient has taken the Augmentin once or twice a year to treat the problem (alternative to the flagyl/cipro regimine) and she have never had any problems. This time, on the 3rd day of the Augmentin, the patient broke out in large hives, (palm sized) and had swollen earlobes and a swollen palm on her right hand. The next day on 19Mar2021 she had swollen upper and lower lips. The patient took lots of Benadryl and Zyrtec, and by the 5th day her hives and horrendous itching went away. The patient does not know if the vaccine played any role in this at all. She just thought she should report since prior to the vaccine she never had a problem with Augmentin. The patient had absolutely no reaction at all to the Pfizer Covid vaccine itself after either of the doses. No covid prior vaccination and no covid tested post vaccination was reported. The outcome of all the events was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: pink eye; This is a spontaneous report received from a contactable consumer. This 63-year-old female contactable consumer (patient) reported for herself that she received second dose of BNT162B2 (BNT162B2, solution for injection, Lot no: unknown) on 26Mar2021 at 09:30 AM, via an unknown route of administration on left arm as single dose for covid-19 immunization. The patient relevant medical history included Thyroid issues. The patient previously received first dose on 05Mar2021 at 09:45PM on left arm via an unknown route of administration. In Public Health Clinic facility the most recent COVID-19 vaccine was administered. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. List of the medications the patient received concomitantly within 2 weeks of vaccination included Amoxicillin, Prilosec. The patient was not diagnosed with COVID-19. Since the vaccination, the patient has been not tested for COVID-19. The patient was unaware of allergies to medications, food, or other products. On 27Mar2021 (14 hours 30 min after the vaccination), the patient experienced pink eye. The treatment for the event included eye drops. The outcome of the event pink eye was not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperaesthesia, Pain
Clinical narrative: Headache; Major fatigue; Felt like going through Covid all over again; Body sensitivity and aches; Body sensitivity and aches; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 03.30 pm as a single dose for COVID-19 immunization. Medical history includes allergies and prior prostate CA. Prior to the vaccination, the patient was diagnosed with COVID-19. There was no COVID-19 test post vaccination. Patient was not had other vaccine in four weeks. Patient had no known allergies (medications, food, or other products). Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) and fluticasone furoate (ARNUITY ELLIPTA) 100mcg. On 27Mar2021 patient experienced headache, major fatigue, body sensitivity and aches. Felt like going through COVID-19 all over again. The patient did not receive any treatment for the events. The clinical outcomes of the events are unknown.   No follow-up attempts are needed.  No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Lymphadenopathy, Pyrexia, Retching
Clinical narrative: Dry heaving for 4 hours (2 am to 6 am) then fever chills and severe joint pain for next 13 hours. Swollen lymph nodes in arm pit area until day 5 after injection
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity
Clinical narrative: Tired, achey hands,feet,back.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Electrocardiogram normal, Urticaria
Clinical narrative: Hives beginning in upper torso (not at injection site) that initially subsided with Benadryl. Returned with more severity two days later. Plaque hives covering 95% of body and on face and mouth. Patient continued Benadryl but was eventually seen by a doctor who prescribed Zyrtec, Pepcid, and hydooxy
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Chills, body aches, temp of 101.5, fatigue,runny nose, throat hurt, coughing
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea
Clinical narrative: Chills, body aches, temp of 101.5, fatigue,runny nose, throat hurt, coughing
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I have itching problem on my body after the vaccination shot. It started 5 days after the shot and still didnt stop.; This is a spontaneous report received from a contactable consumer. A 39-years old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 14-MAR-2021 14:00 at single dose for COVID-19 immunisation. It was reported that the patient was Unable to locate or read the details. Medical history and concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine neither was tested for COVID. On 18 Mar 2021 12:00 PM, after 5 days of shot the patient had experienced itching problem on body after the vaccination shot. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient had not recovered from the event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Buzzing in ears began a week after 2nd dose.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Haemoptysis, Pulmonary embolism, Pulmonary thrombosis, Pyrexia
Clinical narrative: 4/9/21 before 8am -  coughed up large amounts of blood, went to ER at hospital several hours later. Admitted to the hospital for 4 days after finding blood clots in the lungs.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Ultrasound Doppler normal, X-ray normal
Clinical narrative: 4/9/21 before 8am -  coughed up large amounts of blood, went to ER at hospital several hours later. Admitted to the hospital for 4 days after finding blood clots in the lungs.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Large swollen itchy red rash at injection site along with pain and fever/nausea plus feeling weak and it?s been over a week of putting Benadryl cream on it and taking that and Tylenol
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash erythematous
Clinical narrative: Large swollen itchy red rash at injection site along with pain and fever/nausea plus feeling weak and it?s been over a week of putting Benadryl cream on it and taking that and Tylenol
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pyrexia
Clinical narrative: Headache, back soreness, fever, chills
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives over arms and leGs
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash at injection site 1 week after dose.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Insomnia, Laboratory test, Lymphadenopathy
Clinical narrative: Swollen face, rash on face, feeling very tired, insomnia for 4 days prior to developing rash, rash on hands 6 days after rash on face , joint pain  continuing still now comes and goes in ankle, knee and wrist joints. Swollen glands under arms and in neck for two weeks. Rash was peeling from face after one week.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin exfoliation, Swelling face
Clinical narrative: Swollen face, rash on face, feeling very tired, insomnia for 4 days prior to developing rash, rash on hands 6 days after rash on face , joint pain  continuing still now comes and goes in ankle, knee and wrist joints. Swollen glands under arms and in neck for two weeks. Rash was peeling from face after one week.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Dizziness, Dyspnoea
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient, self-reported). A 39-Year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER2613 and expiry date: not provided), via an unspecified route of administration, in Arm Left, on 24Mar2021 at 10:15 AM (at the age of 39 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Lot number; EN6199, expiry date; not provided, received in left arm on 10Mar2021 at 10:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient stated that she felt tired after her shot but at around 10 PM. She started getting a fever and chills that lasted for 6 hours. It was stated that she was shaking uncontrollably and soaked her clothes and sheets in sweat, several sets of clothes. She could not walk because she was dizzy and would almost faint. She was nauseous and the joints in her hands ached. Her fever finally broke after ibuprofen.  The patient also stated that the next day (25Mar2021), she had a rash all over her chest and back, and some of it was still there. However, she was not sure if it was a heat rash. The day after (25Mar2021), she had a hard time breathing my chest and back felt compressed. She was so tired to second day following the shot she couldn't take care of her kids and continued to have a fever for several days. She would have gone to the ER but could not leave her kids. The patient also stated that she was small person and carried twins over 7 lbs to term. She was super strong and healthy. She can't believe how severe my reaction was and she was trying to understand why. The patient did not receive any treatment for the events except for fever. Seriousness of the events was reported as non- serious. The outcome of the fever and chills was recovered in Mar 2021; for rash it was not recovered; for remaining events it was recovering. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Hyperhidrosis, Inappropriate schedule of product administration, Musculoskeletal discomfort
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient, self-reported). A 39-Year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER2613 and expiry date: not provided), via an unspecified route of administration, in Arm Left, on 24Mar2021 at 10:15 AM (at the age of 39 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Lot number; EN6199, expiry date; not provided, received in left arm on 10Mar2021 at 10:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient stated that she felt tired after her shot but at around 10 PM. She started getting a fever and chills that lasted for 6 hours. It was stated that she was shaking uncontrollably and soaked her clothes and sheets in sweat, several sets of clothes. She could not walk because she was dizzy and would almost faint. She was nauseous and the joints in her hands ached. Her fever finally broke after ibuprofen.  The patient also stated that the next day (25Mar2021), she had a rash all over her chest and back, and some of it was still there. However, she was not sure if it was a heat rash. The day after (25Mar2021), she had a hard time breathing my chest and back felt compressed. She was so tired to second day following the shot she couldn't take care of her kids and continued to have a fever for several days. She would have gone to the ER but could not leave her kids. The patient also stated that she was small person and carried twins over 7 lbs to term. She was super strong and healthy. She can't believe how severe my reaction was and she was trying to understand why. The patient did not receive any treatment for the events except for fever. Seriousness of the events was reported as non- serious. The outcome of the fever and chills was recovered in Mar 2021; for rash it was not recovered; for remaining events it was recovering. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Presyncope, Pyrexia, Rash, Tremor
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient, self-reported). A 39-Year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER2613 and expiry date: not provided), via an unspecified route of administration, in Arm Left, on 24Mar2021 at 10:15 AM (at the age of 39 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Lot number; EN6199, expiry date; not provided, received in left arm on 10Mar2021 at 10:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient stated that she felt tired after her shot but at around 10 PM. She started getting a fever and chills that lasted for 6 hours. It was stated that she was shaking uncontrollably and soaked her clothes and sheets in sweat, several sets of clothes. She could not walk because she was dizzy and would almost faint. She was nauseous and the joints in her hands ached. Her fever finally broke after ibuprofen.  The patient also stated that the next day (25Mar2021), she had a rash all over her chest and back, and some of it was still there. However, she was not sure if it was a heat rash. The day after (25Mar2021), she had a hard time breathing my chest and back felt compressed. She was so tired to second day following the shot she couldn't take care of her kids and continued to have a fever for several days. She would have gone to the ER but could not leave her kids. The patient also stated that she was small person and carried twins over 7 lbs to term. She was super strong and healthy. She can't believe how severe my reaction was and she was trying to understand why. The patient did not receive any treatment for the events except for fever. Seriousness of the events was reported as non- serious. The outcome of the fever and chills was recovered in Mar 2021; for rash it was not recovered; for remaining events it was recovering. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Pruritus, Swelling face
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Facial/lip swelling (felt not observed externally) and tingling. Better after benadryl. Follow up called in 4 hours
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy started within week after 1st covid vaccine.  This has required medical treatment
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial spasm, Rash pruritic
Clinical narrative: at 1845 patient began to complain of itchy rash on right shoulder, rash spread to her back, I gave 25mg capsule of diphenhydramine that I had in my purse.   At 1906 patient began to have facial spasms on the left side of the face with inability to move right side of face with rash spreading to left shoulder then eventually to chest, neck and face.  I took the patient to the local ER and they administered 25mg IV diphenhydramine and 125mg IV methylprednisolone at 1948 and monitored her til discharge from ER at approximately 2200.  Diphenhydramine and prednisone prescribed with follow up if symptoms returned.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial spasm, Rash
Clinical narrative: at 1845 patient began to complain of itchy rash on right shoulder, rash spread to her back, I gave 25mg capsule of diphenhydramine that I had in my purse.   At 1906 patient began to have facial spasms on the left side of the face with inability to move right side of face with rash spreading to left shoulder then eventually to chest, neck and face.  I took the patient to the local ER and they administered 25mg IV diphenhydramine and 125mg IV methylprednisolone at 1948 and monitored her til discharge from ER at approximately 2200.  Diphenhydramine and prednisone prescribed with follow up if symptoms returned.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pain, Paraesthesia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: extremely idzzy/ligh headed tingling sensation all over body, weakness
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Circular spot of red on left arm where I got the vaccine, hot tender and itchy. It also has a bumby red ring around area. And a tiny hole on spot of injection.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Perforation
Clinical narrative: Circular spot of red on left arm where I got the vaccine, hot tender and itchy. It also has a bumby red ring around area. And a tiny hole on spot of injection.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Pulmonary embolism
Clinical narrative: Pt with a pulmonary embolism 4 days post vaccine.  Diagnosed in our ED.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Livedo reticularis, Pain
Clinical narrative: Flu like symptoms- Fever (102 degrees) started ~ 10 hours post shot lasted 48 hours, chills, body aches, headache  Rash resembling Livedo, or blood clots of the skin first notices 2 days after shot was received but may have started earlier. Condition has not worsened but livedo is still present as of 4/17/2021. Went to doctor about it and was told as long as it does not get worse not to worry.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin discolouration
Clinical narrative: Flu like symptoms- Fever (102 degrees) started ~ 10 hours post shot lasted 48 hours, chills, body aches, headache  Rash resembling Livedo, or blood clots of the skin first notices 2 days after shot was received but may have started earlier. Condition has not worsened but livedo is still present as of 4/17/2021. Went to doctor about it and was told as long as it does not get worse not to worry.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Vision blurred, Visual impairment
Clinical narrative: Vision impairment after about 60 minutes of receiving the shot that lasted for 6 hours; Blurred vision, unable to read.; soreness; light headedness; I had the expected symptoms of headache; This is a spontaneous report received from a contactable consumer (patient). A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8732), at right arm via an unspecified route of administra-tion on 27Mar2021 10:30, as SINGLE DOSE for COVID-19 immunisation. Medical history included low iron and anemia. Concomitant medications included montelukast sodium (SINGULAIR) and omepra-zole (PRILOSEC [OMEPRAZOLE]), patient received these medications within 2 weeks of vaccination. Patient was allergic to IV contrast dye and salicylates. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. After about 60minutes of receiving the shot (27Mar2021 11:30) the patient had vision impairment lasted for approximately 6 hours. Patient had blurred vision and unable to read. Patient had the expected symptoms of headache, soreness, light headedness, etc. But was not expecting vision to be decreased. Patient not received treatment for the adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the event visual impairment was recovered and for the other events its recovering.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: He appeared to have an allergic reaction.  He had itchiness on multiple parts of his body with a rash on multiple extremities.  He had shortness of breath, but throat did not start to close.  He was observed for around an hour and 2 diphenhydramine 25 mg tablets were given to him.  His vitals were monitored and they were okay.  A nurse from the minute clinic came to observe him as well as a pharmacist.  He was sent home later and told to go to the ER if his symptoms did not lessen.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain
Clinical narrative: Small pain under left arm pit when pressure applied.  Lymph node side effect?
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: COVID arm rash
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: After receiving my second Pfizer vaccine I have been having headaches. Several times a week I wake up with bad headaches. I also get them at night and during the days sometimes. Note, I do not have a history of headaches before the vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Headache, Musculoskeletal stiffness
Clinical narrative: After receiving my second Pfizer vaccine I have been having headaches. Several times a week I wake up with bad headaches. I also get them at night and during the days sometimes. Note, I do not have a history of headaches before the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia, Vertigo
Clinical narrative: Dizzy; Vertigo; Sore everywhere; Fever; Chills; This is a spontaneous report received from a contactable consumer (Patient). A 54-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 27Mar2021 10:45 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included breast cancer 4 years ago. The patient was allergic to dairy and tape. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizzy, fever, vertigo, sore everywhere and chills on 27Mar2021 16:00. The treatment was not received for the adverse events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Hypoaesthesia, Nervousness, Pain in extremity
Clinical narrative: It started with a sorr arm and fatigue. The problem began after I was lying down in bed for 1 hr and 1/2. I laid down at 3:30am, but at 5am I was still awake and my left arm felt like it had fallen asleep. The problem was, I could not seem to wake it up. When I turned on my flashlight, I found that nearly all of the veins in my left hand were invisible, actually everything past the elbow on that side. I tried for about 10 mins while lying down to get blood flow back, but nothing was working. My face.felt very warm and the rest of my body felt very cold. When I finally got up to turn on my bedroom light, I found that all of my veins from my chest down were almost entirely invisible as well. I normally have very visible and easy to get blood from veins (except sometimes in my right arm), so this was very worrying to me. I got up and paced a little around my room to try and get blood flowing again, and I felt pretty shaky while doing this. My hands and feet would shake when I held them up. After about 5 minutes, I sat down on my bed because I did not feel well standing anymore, and I waited. Maybe 10 minutes later and things seem to be returning back to normal. I am still very tired but my whole body seems to have blood again. I am also currently on day 3 of my monthly cycle, but this has never happened in relation to that either.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: It started with a sorr arm and fatigue. The problem began after I was lying down in bed for 1 hr and 1/2. I laid down at 3:30am, but at 5am I was still awake and my left arm felt like it had fallen asleep. The problem was, I could not seem to wake it up. When I turned on my flashlight, I found that nearly all of the veins in my left hand were invisible, actually everything past the elbow on that side. I tried for about 10 mins while lying down to get blood flow back, but nothing was working. My face.felt very warm and the rest of my body felt very cold. When I finally got up to turn on my bedroom light, I found that all of my veins from my chest down were almost entirely invisible as well. I normally have very visible and easy to get blood from veins (except sometimes in my right arm), so this was very worrying to me. I got up and paced a little around my room to try and get blood flowing again, and I felt pretty shaky while doing this. My hands and feet would shake when I held them up. After about 5 minutes, I sat down on my bed because I did not feel well standing anymore, and I waited. Maybe 10 minutes later and things seem to be returning back to normal. I am still very tired but my whole body seems to have blood again. I am also currently on day 3 of my monthly cycle, but this has never happened in relation to that either.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pain, Lymph node pain
Clinical narrative: I have developed a hard very sore lump starting on day 5 after my vaccine. The lump is below the injection site to the right of my bicep and it is about the size of a large grape and very sore. I have heard of others developing a lump in the area of their lymph notdes under their arms but my lump is not in that area.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Vaccination site pain
Clinical narrative: Soreness in injection site shoulder; slight body aches; headache; Felt like a cold coming on.; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 65-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on arm left on 27Mar2021 at 11:30 am as single dose for COVID-19 immunisation. Medical history included hypertension, depression and attention deficit hyperactivity disorder (ADD). Concomitant medications the patient received within 2 weeks of vaccination included venlafaxine; losartan; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and hydrochlorothiazide. Previously, he had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, in arm left on 06Mar2021 at 02:00 pm as single dose for COVID-19 immunisation. On 27Mar2021, he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 11:30. The patient experienced soreness in injection site shoulder on, slight body aches, headache and felt like a cold coming on at 03:00 pm on 27Mar2021. No treatment was received for the reported events. Outcome of all events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Pain, Pyrexia, Rash
Clinical narrative: Swelling of nose and upper lip; rash on face, arms, chest, legs, feet.; Headache; general aching all over body; Swelling of nose and upper lip; low grade fever; This is spontaneous report received from a contactable consumer (patient). A 70-years-old female non- pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6207) via an unspecified route of administration on 18Mar2021 at 10:00 am on left arm as a single dose for COVID-19 immunization. Medical history included diabetes. Patient had no allergies to medications, food, or other products. Concomitant medications were not reported.  Patient received other medications within 2 weeks of vaccination. Previously, she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810) via an unspecified route of administration on 15Feb2021 at 02:00 pm on left arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 18Mar2021 patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Doctor's office/urgent care. On 18Mar2021 at 04:00 pm, patient experienced swelling of nose and upper lip, headache, low grade fever, general aching all over body and rash on face, arms, chest, legs and feet. Treatment was received for the adverse event. Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling of nose and upper lip; rash on face, arms, chest, legs, feet.; Headache; general aching all over body; Swelling of nose and upper lip; low grade fever; This is spontaneous report received from a contactable consumer (patient). A 70-years-old female non- pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6207) via an unspecified route of administration on 18Mar2021 at 10:00 am on left arm as a single dose for COVID-19 immunization. Medical history included diabetes. Patient had no allergies to medications, food, or other products. Concomitant medications were not reported.  Patient received other medications within 2 weeks of vaccination. Previously, she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810) via an unspecified route of administration on 15Feb2021 at 02:00 pm on left arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 18Mar2021 patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Doctor's office/urgent care. On 18Mar2021 at 04:00 pm, patient experienced swelling of nose and upper lip, headache, low grade fever, general aching all over body and rash on face, arms, chest, legs and feet. Treatment was received for the adverse event. Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise
Clinical narrative: Chills - the day after the 1st vaccine shot; Fatigue- the evening of the 1st vaccine shot and through the following day; General feeling of not feeling well; This is a spontaneous report from a contactable consumer.  A 67-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 07mar2021 16:00 as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported.The patient had hypersensitivity (Environmental/seasonal; e.g. dust, mold, trees, grass, cats, dogs). The Concomitant medication's included multivitamins and minerals taken for an unspecified indication, start and stop date were not reported. On 07Mar2021 at 04:30 PM, the patient experienced fatigue at the evening of the 1st vaccine shot and the next day the patient has general feeling of not feeling well and chills. Since after the vaccination, the patient was not tested for COVID-19. No treatment was received for the adverse events. The outcome of the events were recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I am experiencing tingling on my scalp, around my eyes, and on my nose; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 16Mar2021 16:30 as single dose for COVID-19 immunization. Vaccination facility type: Pharmacy/Drug Store. The patient medical history included myasthenia gravis from an unknown date and unknown if ongoing , autoimmune disorder from an unknown date and unknown if ongoing. The patient concomitant medications included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. The patient received Metformin, Lisinopril, Dietary Sup., Herbal Rem within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 16Mar2021 16:30, the patient experienced: tingling on my scalp, around my eyes, and on my nose (paraesthesia) (non-serious). This events has been ongoing since the date of the vaccination. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Product storage error, Pyrexia
Clinical narrative: Fever 102+, 12-hour duration, used Tylenol.  Soreness from 24-48 hrs, felt better after 2-days.  I was notified that the second dose was not temperature controlled, will need a 3rd dose next week.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Lymph node pain, Nausea
Clinical narrative: Severe headache, nausea, dizziness, fever and sore lymph nodes started less than 24 hours after 1st dose and have continued since. On day 7 at the time of reporting this and still having side effects
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Severe headache, nausea, dizziness, fever and sore lymph nodes started less than 24 hours after 1st dose and have continued since. On day 7 at the time of reporting this and still having side effects
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Heart rate increased, Pruritus, Rash erythematous
Clinical narrative: Lightheaded, pulse rose from 72 bmp to 100 bmp 10 minutes after vaccine. Hives and red rash on face, right arm, back, scalp, lips, inner lips/gum line, and back. Rash got worse the day after the second dose and caused an itchiness/ tightness of the chest and throat. Did not feel like my life was threatened so I nursed it at home with antihistamine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: Lightheaded, pulse rose from 72 bmp to 100 bmp 10 minutes after vaccine. Hives and red rash on face, right arm, back, scalp, lips, inner lips/gum line, and back. Rash got worse the day after the second dose and caused an itchiness/ tightness of the chest and throat. Did not feel like my life was threatened so I nursed it at home with antihistamine.