chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: body aches; chills; fever 100.4; headache; runny nose; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL0140; expiration date: not known), intramuscular on left arm on 07Jan2021 10:00 at single dose for COVID-19 immunization, administered in hospital. Medical history included COVID-19 (reported as "COVID prior vaccination: Yes"). The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to vaccine and no other medications received within 2 weeks of vaccination. The patient experienced body aches, chills, fever 100.4, headache, and runny nose on 07Jan2021 20:00. The reported events were non-serious. There were no treatment received for the reported events. The patient underwent lab tests and procedures which included nasal swab on 01Oct2020: negative; blood test and antibody test on 06Oct2020: unknown results and positive respectively. The outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Red, circular site reaction. No itching or burning at site.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Persistent nausea; headaches in the morning; She is extremely fatigued, zero energy she said; This is a spontaneous report from a contactable consumer (mom/caregiver). A 44-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient (daughter) works at a hospital as a Radiation Therapist. The patient got her first vaccination of the Pfizer vaccine a week ago (Jan2021). She was in bed unable to function for two days and was experiencing persistent nausea, headaches in the morning, and she was extremely fatigued, zero energy she said. The mom stated "This is so not like her. I think she may have gotten too big a dose of the vaccine. Please advise of what I can do to help her. I am a worried mom". The events were assessed as non-serious (reported as "Serious: No"). Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Feeling of body temperature change, Illness, Nausea
Clinical narrative: fevers of 101; getting worse; she is so sick; felt  'nausea, chilly and hot'/she is feeling hot; felt  'nausea, chilly and hot'/nauseous; arm been sore; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 09:30 at single dose for prevention.  Medical history included covid-19 from Jul2020, hair loss. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fevers of 101 on an unspecified date with outcome of unknown, felt  'nausea, chilly and hot'/nauseous on 08Jan2021 with outcome of not recovered, felt  'nausea, chilly and hot'/she was feeling hot on 08Jan2021 13:00 with outcome of not recovered, getting worse on an unspecified date with outcome of unknown, arm been sore on 06Jan2021 08:00 and on 08Jan2021 08:00 with outcome of not recovered, she was so sick on an unspecified date with outcome of unknown. Clinical course: She had it on Tuesday and arm been sore since then. now she gotten very nauseous. Her temperature is around 98 degrees Fahrenheit now and she is feeling hot. She does not have a temperature. After transfer caller stated ' I felt nauseous but now its gone, but also getting worse.' She was usually 96 or 97 degrees Fahrenheit. She was nauseous. Is this normal after 4 days. There was no prescriber. She was more sore on Wednesday than she is now. It is better yesterday and now than on Wednesday when it was real sore. She did something she should not have done. She went to a yoga class and had not eaten. Afterwards, she had a strawberry and did not feel like eating. Then she said she did not take her pills, which are mostly vitamins. The thought of taking pills made her sick. After she took them she ate something and has been nauseous ever since. She did not confirm if she needed glasses prior to getting the vaccine. She had COVID in Jul2020. She is taking a lot of vitamins. She had hair loss and is taking Biotin. She takes very few prescribed medications. Now she was so sick she would not think of taking them. No further details provided. The patient underwent lab tests and procedures which included body temperature: 98 degrees fahrenheit on unknown date. Information on the Lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fevers of 101; getting worse; she is so sick; felt  'nausea, chilly and hot'/she is feeling hot; felt  'nausea, chilly and hot'/nauseous; arm been sore; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 09:30 at single dose for prevention.  Medical history included covid-19 from Jul2020, hair loss. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fevers of 101 on an unspecified date with outcome of unknown, felt  'nausea, chilly and hot'/nauseous on 08Jan2021 with outcome of not recovered, felt  'nausea, chilly and hot'/she was feeling hot on 08Jan2021 13:00 with outcome of not recovered, getting worse on an unspecified date with outcome of unknown, arm been sore on 06Jan2021 08:00 and on 08Jan2021 08:00 with outcome of not recovered, she was so sick on an unspecified date with outcome of unknown. Clinical course: She had it on Tuesday and arm been sore since then. now she gotten very nauseous. Her temperature is around 98 degrees Fahrenheit now and she is feeling hot. She does not have a temperature. After transfer caller stated ' I felt nauseous but now its gone, but also getting worse.' She was usually 96 or 97 degrees Fahrenheit. She was nauseous. Is this normal after 4 days. There was no prescriber. She was more sore on Wednesday than she is now. It is better yesterday and now than on Wednesday when it was real sore. She did something she should not have done. She went to a yoga class and had not eaten. Afterwards, she had a strawberry and did not feel like eating. Then she said she did not take her pills, which are mostly vitamins. The thought of taking pills made her sick. After she took them she ate something and has been nauseous ever since. She did not confirm if she needed glasses prior to getting the vaccine. She had COVID in Jul2020. She is taking a lot of vitamins. She had hair loss and is taking Biotin. She takes very few prescribed medications. Now she was so sick she would not think of taking them. No further details provided. The patient underwent lab tests and procedures which included body temperature: 98 degrees fahrenheit on unknown date. Information on the Lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Got chills when tired; Got chills when tired; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date: Mar2021) on 22Dec2020 (11:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital (not at a facility). The patient had no relevant medical history and concomitant medications. On 04Jan2021, the patient got chills when tired; further described as very minor chills in the evening or on and off in the day. The outcome of the events, chills when tired, was recovering. The patient was planning to receive the second dose on 12Jan2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Roughly 36 hours after the injection I experienced external swelling of my nose. Swelling went down, though not entirely, after I woke up and went about my day. Sent a photo of my nose with notes to my general practitioner who suspected it was a delayed reaction to the vaccine and instructed me to take an antihistamine that evening.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Dyspnoea
Clinical narrative: Severe allergic reaction; injection site pain/It hurt way more than the first one; her arm still hurts/Hurt way more than the first one; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; Difficulty breathing; Fast heartbeat; Dizziness; Weakness; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was a healthcare worker and she got the second round of the Pfizer Covid-19 vaccine on 07Jan2021 (reported as yesterday). The patient had a severe allergic reaction in Jan2021. It hurt way more than the first one in Jan2021. It's been over 24 hours and her arm still hurts in Jan2021. The patient experienced: tiredness, headache, muscle pain, chills, joint pain, feeling unwell, difficulty breathing, fast heartbeat, dizziness, weakness in Jan2021. It happened once she was home, 5 hours after she had received the second dose of the vaccine in Jan2021 and these symptoms lasted 3 to 4 hours. She still had some weakness and kind of feeling unwell, injection site pain and tiredness. The patient was a patient care tech and work directly with Covid patients. The outcome of events Weakness, Feeling unwell, injection site pain and tiredness was not recovered. The outcome of the other events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Hypersensitivity, Malaise
Clinical narrative: Severe allergic reaction; injection site pain/It hurt way more than the first one; her arm still hurts/Hurt way more than the first one; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; Difficulty breathing; Fast heartbeat; Dizziness; Weakness; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was a healthcare worker and she got the second round of the Pfizer Covid-19 vaccine on 07Jan2021 (reported as yesterday). The patient had a severe allergic reaction in Jan2021. It hurt way more than the first one in Jan2021. It's been over 24 hours and her arm still hurts in Jan2021. The patient experienced: tiredness, headache, muscle pain, chills, joint pain, feeling unwell, difficulty breathing, fast heartbeat, dizziness, weakness in Jan2021. It happened once she was home, 5 hours after she had received the second dose of the vaccine in Jan2021 and these symptoms lasted 3 to 4 hours. She still had some weakness and kind of feeling unwell, injection site pain and tiredness. The patient was a patient care tech and work directly with Covid patients. The outcome of events Weakness, Feeling unwell, injection site pain and tiredness was not recovered. The outcome of the other events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Severe allergic reaction; injection site pain/It hurt way more than the first one; her arm still hurts/Hurt way more than the first one; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; Difficulty breathing; Fast heartbeat; Dizziness; Weakness; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was a healthcare worker and she got the second round of the Pfizer Covid-19 vaccine on 07Jan2021 (reported as yesterday). The patient had a severe allergic reaction in Jan2021. It hurt way more than the first one in Jan2021. It's been over 24 hours and her arm still hurts in Jan2021. The patient experienced: tiredness, headache, muscle pain, chills, joint pain, feeling unwell, difficulty breathing, fast heartbeat, dizziness, weakness in Jan2021. It happened once she was home, 5 hours after she had received the second dose of the vaccine in Jan2021 and these symptoms lasted 3 to 4 hours. She still had some weakness and kind of feeling unwell, injection site pain and tiredness. The patient was a patient care tech and work directly with Covid patients. The outcome of events Weakness, Feeling unwell, injection site pain and tiredness was not recovered. The outcome of the other events was unknown.  Information about lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, SARS-CoV-2 test positive
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report from a contactable healthcare professional (patient).  A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date unknown), via an unspecified route of administration in right deltoid, on 18Dec2020 07:15 at a single dose for Covid-19 immunization.  Medical history included ongoing hypothyroidism and hysterectomy. Concomitant medications included estradiol (taking after hysterectomy) and levothyroxine for hypothyroidism, both ongoing. The patient has no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated that she received the Covid vaccine mid- Dec2020. She stated she was supposed to receive the 2nd dose 2 days ago, 06Jan2021. On 03Jan2021, she started feeling bad the day before testing positive, went to urgent care to be tested, thought she had the flu.  She tested positive for Covid on Monday 04Jan2021, so she has been in quarantine. She was unable to receive her 2nd dose because she was in quarantine. She wanted to know if it's ok to delay the second dose or if she needs to re-start the series. The reporter assessed the event relatedness was unknown, patient stated that she doesn't know the causality, she has not been in contact with anyone that was known to be positive, but she is a healthcare worker who sees multiple patients a day, so one of them could have been asymptomatic. Outcome of the events was not recovered.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site warmth, Peripheral coldness
Clinical narrative: Patient reports, "Received COVID-19 Moderna Vaccine yesterday in my right arm. About 10 minutes after the shot my arm became hot, then numb, and my fingers went cold. Eventually the whole arm numbness resided and only from my elbow up was still numb. However, the numbness radiated to the front of my right chest and back of my right shoulder. I called the Associate health number as instructed by the pharmacy team who then told me to go to the ER for further evaluation. "
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation error, Vaccination site reaction
Clinical narrative: administered an undiluted dose of the Pfizer-BioNTech Covid-19 Vaccine to a patient; administered an undiluted dose of the Pfizer-BioNTech Covid-19 Vaccine to a patient; local reaction; This is a spontaneous report from a contactable nurse. A female patient of unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The nurse reported that one of their healthcare facilities administered an undiluted dose of the Pfizer-BioNTech Covid-19 Vaccine to a patient. She said she wants to know if there is going to be any more of an issue to the patient other than a local reaction. Outcome of the event local reaction was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Fever at 103.1; Chills; Body aches; Fatigue; Headache; First dose administered on 19Dec2020; second dose administered on 07Jan2021; This is a spontaneous report from a non-contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (12:00) (Lot number: EL0140; Expiration date was not reported), and then the second dose on 07Jan2021 (06:00) (Lot number: EK9231; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient's first vaccine dose was received on 19Dec2020, and the second dose was received on 07Jan2021 (06:00). On 07Jan2021 (23:00), the patient had fever at 103.1 (unit was not reported); chills; body aches; fatigue; and headache. The patient did not receive any treatment for the reported adverse events. The outcome of the events was recovering for 'fever at 103.1 (unit was not reported)', 'chills', 'body aches', 'fatigue' and 'headache'; and was unknown for 'first vaccine dose was received on 19Dec2020, and the second dose was received on 07Jan2021'. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever at 103.1; Chills; Body aches; Fatigue; Headache; First dose administered on 19Dec2020; second dose administered on 07Jan2021; This is a spontaneous report from a non-contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (12:00) (Lot number: EL0140; Expiration date was not reported), and then the second dose on 07Jan2021 (06:00) (Lot number: EK9231; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient's first vaccine dose was received on 19Dec2020, and the second dose was received on 07Jan2021 (06:00). On 07Jan2021 (23:00), the patient had fever at 103.1 (unit was not reported); chills; body aches; fatigue; and headache. The patient did not receive any treatment for the reported adverse events. The outcome of the events was recovering for 'fever at 103.1 (unit was not reported)', 'chills', 'body aches', 'fatigue' and 'headache'; and was unknown for 'first vaccine dose was received on 19Dec2020, and the second dose was received on 07Jan2021'. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Malaise, Somnolence, Vaccination site pain
Clinical narrative: Injection site pain; General malaise; Sleepy; Chest tightness; This is a spontaneous report from a contactable physician, the patient. A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL0140), via an unspecified route of administration in the left arm on 08Jan2021 08:00 AM (at the age of 34 years) as a single dose for Covid-19 immunization. The patient's medical history was not reported. 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. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Historical Vaccine included the first dose of BNT162B2 on 18Dec2020 11:45 AM (at the age of 34 years) in the left arm for Covid-19 immunization (Lot Number EL0140). On 08Jan2021 11:00 AM the patient experienced injection site pain, general malaise, sleepy, chest tightness. The patient was treated for the injection site pain, general malaise, sleepy, chest tightness with acetaminophen (Manufacturer Unknown) 500mg oral every 6 hours. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events, injection site pain, general malaise, sleepy, chest tightness, was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache; muscle aches; fatigue; chills; 102.2 fever; This is a spontaneous report from a contactable healthcare professional (patient).  A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), intramuscular on the left arm on 08Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included hypertension (HBP).  Concomitant medications included irbesartan (IRBESARTAN), ibuprofen (ADVIL 12 HOUR), and sumatriptan succinate (SUMATRIPTAN SUCCINATE). On 08Jan2021 12:00, the patient had headache, muscle aches, fatigue, chills, and 102.2 fever and was recovering from these events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; muscle aches; fatigue; chills; 102.2 fever; This is a spontaneous report from a contactable healthcare professional (patient).  A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), intramuscular on the left arm on 08Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included hypertension (HBP).  Concomitant medications included irbesartan (IRBESARTAN), ibuprofen (ADVIL 12 HOUR), and sumatriptan succinate (SUMATRIPTAN SUCCINATE). On 08Jan2021 12:00, the patient had headache, muscle aches, fatigue, chills, and 102.2 fever and was recovering from these events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test positive
Clinical narrative: received first dose of bnt162b2/by the 3rd (03Jan2021), he was diagnosed as covid positive; received first dose of bnt162b2/by the 3rd (03Jan2021), he was diagnosed as covid positive; patient lost his sense of smell and taste; patient lost his sense of smell and taste; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient reported he needs advice on the second dose of the vaccine. Patient stated he is an ER nurse and received the first dose of the vaccine on 17Dec2020. On 31Dec2020, patient lost his sense of smell and taste and by the 3rd (03Jan2021), he was diagnosed as covid positive. The patient underwent lab tests and procedures which included Covid test: positive on 03Jan2021. The patient is asking how safe it is to get the second dose now and if there's a time period that he should wait so that he can get the second dose. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.  Further information like diagnostic detection of virus genetic material or virus protein antigen needed for meaningful medical assessment.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: 0.5 mL dose drawn into syringe for administration. Nurse and patient report that on slow IM injection, some of the vaccine 'spurted' out, felt by both administering nurse and patient. Just a few small dots (nurses writs, patient's arm and forehead). Administering nurse subsequently inspected syringe and saw that it had a crack in it, allowing some of the vaccine to expel.  Estimate that patient received 0.4 ml.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site lymphadenopathy
Clinical narrative: swollen lymph nodes under her armpits from the side where she got the shot; swollen lymph nodes under her armpits from the side where she got the shot; This is a spontaneous report from a non-contactable nurse (patient herself) via Medical Information team. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 vaccine on an unspecified date for COVID-19 immunization. On an unspecified date in Jan2021, the patient experienced swollen lymph nodes under her armpits from the side where she got the shot, which was assessed as non-serious. She said she wanted to know if there were any recommendations on what she should do about this. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable nurse (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 23Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her 1st dose of COVID vaccine last 23Dec2020 and she was doing fine. On an unspecified date, she woke up with fever and chills. She wanted to take Xofluza medication to shorten symptoms of flu and she would like to know if there would be an interaction if she takes it with COVID vaccine. She also wanted to know if it is ok to get her 2nd dose of the vaccine which is due next week, 13Jan2020. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye oedema
Clinical narrative: Eye puffiness; This is a spontaneous report from a non-contactable other healthcare professional. A 34-year-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (arm right), on 08Jan2021 at 11:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) intramuscular (arm left), on 22Dec2020, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021 at 13:00, the patient experienced eye puffiness. It was unknown if the patient received treatment for the event. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Local reaction, Urticaria
Clinical narrative: Patient received vaccine on 01/07/21. The evening of 01/13 experienced itching at the injection site. The morning of 01/14 noticed a welt, appeared to be a hive.  Saw her physician on 01/15. Per vaccine recipient, provider diagnosed local reaction and no infection. Able to proceed with second dose.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Polymerase chain reaction, Pyrexia, SARS-CoV-2 test
Clinical narrative: body ache; mild fever; This is a spontaneous report from a contactable other healthcare professional reported for himself. A 24-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration (Arm Left, dose number 1) on 29Dec2020 19:00 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date prior vaccination. The patient was vaccinated in hospital. No other vaccine in four weeks was received. There were no concomitant medications. The patient experienced body ache, and mild fever on 30Dec2020. Treatment was not received. The patient underwent lab tests and procedures which included Nasal Swab/PCR: negative on 07Jan2021. Outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbing; This is a spontaneous report from a contactable consume reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE (dose 1) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient just got her first COVID vaccine shot. She experienced facial numbing and wanted to know if it is normal to experience this side effect. Event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Inappropriate schedule of product administration, Pain of skin
Clinical narrative: Inflammation and tenderness of dermal filler which was placed in Dec2019.; Inflammation and tenderness of dermal filler which was placed in Dec2019.; first dose 20Dec2020/second dose 06Jan2021; This is a spontaneous report from a contactable physician (patient) reported that a 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) on 20Dec2020 11:45 then received the second dose on 06Jan2021 14:30, via an unspecified route of administration on the right arm at single dose for COVID-19 immunization. Medical history included allergic rhinitis, depression and gastrooesophageal reflux disease (GERD); all from unknown dates. On Dec2019, patient was placed with dermal filler. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) and omeprazole. On 08Jan2021 07:00, the patient experienced inflammation and tenderness of dermal filler which was placed in Dec2019. No therapeutic measures were taken as a result of the reported events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Inappropriate schedule of product administration, Off label use
Clinical narrative: repeated bouts of sharp stabbing pains to my mid/upper right abdomen; first dose of BNT162B2 on 18Dec2020/ second dose on 06Jan2021; first dose of BNT162B2 on 18Dec2020/ second dose on 06Jan2021; This is a spontaneous report from a contactable nurse (patient). A 32-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 06Jan2021 17:45 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took oxycodone and experienced allergy (known allergy). The historical vaccine included the first dose of BNT162B2 on 18Dec2020 06:00 PM (32-years-old) at right arm for COVID-19 immunization. The patient experienced side effects had been expected ones, severe, but known/expected. And what was unexpected were the repeated bouts of sharp stabbing pains to her mid/upper right abdomen on 07Jan2021 23:00 with outcome of recovering. No treatment received for the adverse event.  No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  Information on the batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: After getting the shot my arm started swelling up around the injection/Second day swelled more around the arm /On the 8th day after injection my arm swelled up around the injection again; It got extremley red and it hurt and itched; It got extremley red and it hurt and itched; It got extremley red and it hurt and itched; was hot to the touch; hard hot to the touch; This is a spontaneous report from a contactable Other-HCP (patient). A 25-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at arm right on 31Dec2020 13:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included Asthma allergies attention deficit hyperactivity disorder. There were no concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "After getting the shot my arm started swelling up around the injection. It got extremely red and it hurt and itched. Second day swelled more around the arm and was hot to the touch. 3 day it went away. On the 8th day after injection my arm swelled up around the injection again. Itches and hard hot to the touch". Adverse event start date provided as 01Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was unknown.  Information on Lot/Batch has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: After getting the shot my arm started swelling up around the injection/Second day swelled more around the arm /On the 8th day after injection my arm swelled up around the injection again; It got extremley red and it hurt and itched; It got extremley red and it hurt and itched; It got extremley red and it hurt and itched; was hot to the touch; hard hot to the touch; This is a spontaneous report from a contactable Other-HCP (patient). A 25-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at arm right on 31Dec2020 13:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included Asthma allergies attention deficit hyperactivity disorder. There were no concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "After getting the shot my arm started swelling up around the injection. It got extremely red and it hurt and itched. Second day swelled more around the arm and was hot to the touch. 3 day it went away. On the 8th day after injection my arm swelled up around the injection again. Itches and hard hot to the touch". Adverse event start date provided as 01Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was unknown.  Information on Lot/Batch has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: 13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (patient).  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: El3246, via an unspecified route of administration on Left arm from 07Jan2021 10:00 to 07Jan2021 10:00 as SINGLE DOSE (first dose) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medication includes prenatal vitamins. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient experienced 13-hour migraine the day after the vaccine on 08Jan2021.  The outcome of the event was recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: 2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
Clinical narrative: 2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: 2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Inappropriate schedule of product administration
Clinical narrative: Chest tightness. On the inside , felt like I needed to exhale; administration date=07Jan2021, administration time=02:00 PM, dose number=2/administration date=18Dec2020, administration time=11:00 AM, dose number=1; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 14:00 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to penicillin. Concomitant medication included acyclovir (ACYCLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 0140; expiry date: unknown) in the right arm on 18Dec2020 at 11:00 AM, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 21:00, the patient experienced chest tightness. On the inside, she felt like she needed to exhale. The patient did not receive treatment for the event. Outcome of the event chest tightness was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Chills; Nausea; This is a spontaneous report from a contactable physician reporting for himself. A male patient of unspecified age received bnt162b2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient indicated the he was experiencing "all listed side effects e.g. chills, nausea" on an unspecified date. He asked if he can take Advil. Outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: about a half hour after the vaccine was given my mouth and tongue were numb for about an hour then it went away but came back for another hour or so and went away again and stayed gone.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test positive, SARS-CoV-2 test, Vaccination site discomfort, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: experienced arm discomfort, redness at the site and itching; experienced arm discomfort, redness at the site and itching; experienced arm discomfort, redness at the site and itching; rapid test IgG line came up faint pink; This is a spontaneous report from a contactable nurse reporting for herself. A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021 at a single dose on the Arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The nurse reported that she received the 2nd vaccination this week (Jan2021), which was "uneventfully after 2nd dose experienced arm discomfort, redness at the site and itching". She took a home rapid test IgG line came up faint pink. She asked if this confirm it's because she had the vaccine. She stated that she had been negative all along, so I can't see having the prior infection. Outcome of the events was unknown. The nurse assessed the events as non-serious.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine on 06Jan2021 and is feeling nauseous on an unspecified date in Jan2021 up to now. They were asking how long this usually last. The outcome of the event was not recovered.     Information on the Lot/Batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Rash erythematous
Clinical narrative: Large red rash on arm, approximately 12 inches.  Ran fever of 102.5. Neck ache