chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Muscle pain; Joint pain; Fever up to a 100.2; Nausea; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK9231, via an unspecified route of administration on 01Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I had the COVID shot today (01Jan2021). This morning I had the first shot of the medicine Covid-19 Vaccine Pfizer. This is what is happening. I had the shot around may be 10-10:30. I felt great all the day and after 7 O?clock I started getting injection site pain, muscle pain, joint pain, and fever up to a 100.2, nausea on 01Jan2021. Is there anything that I can do home for the fever especially? Let me give you the number that I got on my vaccination record card. It is Pfizer EK9231 (not clarified)." The patient further stated, "I wanted someone to tell me if I can take Tylenol. Do I have a situation like to go to the hospital?." The patient was advised to visit the nearest emergency room or can contact the physician as the department is closed. The patient further stated, "I will probably go to the hospital if I threw or some temperature if it is higher. I got to do something. I got so many symptoms. I had probably 19 in Nov, in Nov I spent three days on bed in Hospital. It is fine now and I was in hospital. I do not know what is happening now. It was good all the day but then at night these things." The patient underwent lab tests and procedures which included body temperature: 100.2 on 01Jan2020. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: had the vaccine and later tested positive for COVID-19; had the vaccine and later tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunisation.  Medical history included that the patient previously was positive from the virus COVID-19.  The patient's concomitant medications were not reported.  The patient that had the vaccine and later tested positive for COVID-19. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231, Expiration Date: 30Apr2021), via an unspecified route of administration in left arm, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure. The patient had unspecified concomitant medications. The patient took this shot on 31Dec2020 at her job at medical center (EDF, environmental service; it's housekeeping). The patient was fine during the daytime. The patient made it to her home and now she got the chills and was shaking on an unspecified date. When the patient was asleep, that is when she started feeling chills and the shake. The patient was bad and cold, and she got a bad chill. The patient wanted to report and asked if it was going to go away. No treatment was administered for the events. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Feeling hot, Heart rate, Palpitations
Clinical narrative: Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had fever and felt like kind of warmish; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0140), via an unspecified route of administration, on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergy, brain aneurysm, psoriasis, diabetic, blood pressure, immunosuppressant, cholesterol, and stent in brain. The patient's concomitant medications included metformin, semaglutide (RYBELSUS), valsartan for blood pressure, acetylsalicylic acid (ASPIRIN), ustekinumab (STELARA) as immunosuppressant for psoriasis, and an unspecified statin for cholesterol. The patient took the COVID vaccine yesterday morning (30Dec2020) at the hospital and she had like a pounding heart rate, it is faster than normal, but it is pounding. The patient can hear her heartbeat in her ears. The patient took her blood pressure and it is normal at 123/78 something like that. Heart rate is an over - little 72, 75, little bit fast but not tachycardia. The patient felt like she had fever and felt like kind of warmish, but her temperature is 98.2. As treatment, the patient took an over-the-counter medication, paracetamol (TYLENOL). The outcome of the events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Sharp pain and it's going down his neck; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELI1284 or ELI284 [pending clarification], Expiration Date: Apr2021), intramuscular, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included hypertension. The patient's concomitant medication included losartan for hypertension. On 31Dec2020, the patient had the COVID vaccine and he kept getting a sharp pain and it's going down his neck; it is at the opposite side where the shot was injected. The patient didn't know if it's a side effect. No treatment was administered for the event. The outcome of the event was unknown.    Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: Ankle Joint Pain; This is a spontaneous report from a contactable physician (patient).  A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 26Dec2020 14:00 to 26Dec2020 14:00 as SINGLE DOSE for COVID-19 immunization.  Medical history included hypertension and allergies.  The patient's concomitant medications were not reported.  On 28Dec2020, the patient experienced ankle joint pain.  On 31Dec2020, the patient was tested for COVID-19 post vaccination via nasal swab and tested negative. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site.; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the first of 2 reports.   A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at 12:00 pm at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the "usual reaction", soreness at the injection site on an unspecified date with outcome of unknown. This report is assessed as non-serious. Patient asked if this was normal and if was ok to use paracetamol (TYLENOL) or ibuprofen (MOTRIN) after getting the vaccine. Outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021004657 same reporter/drug, similar event, different patient
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Pyrexia
Clinical narrative: I felt kind of cold; had a little bit of fever; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The consumer stated, she works at university hospital and she got the Covid 19 shot. The side effect, she felt kind of cold and had a little bit of fever, on an unspecified date. The consumer stated, 'I am warm now. When I was at work there, I was in a room and it just got cold to me.' She stated that she is supposed to take the next shot, the date 23Dec2020. Outcome of the events was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Cervical and clavicular lymphadenopathy on the left side; Some tenderness in neck; This is a spontaneous report from a contactable physician (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 17Dec2020 at 11:45, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 27Dec2020, the patient experienced cervical and clavicular lymphadenopathy on the left side (same side as the vaccine shot was received). The patient first noticed some tenderness in neck about 10 days after vaccine was administered. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.   Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Joint range of motion decreased, Myalgia, Neck pain
Clinical narrative: Severe muscle pain and soreness on opposite side of vaccine.; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Range of motion highly affected not responding to self treatments or other meds; This is a spontaneous report from a contactable nurse reporting on herself. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Dec2020 at 11:00 AM (at the age of 34 years old) as a single dose for COVID-19 vaccination. Relevant medical history included anxiety. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. 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. On 30Dec2020, the patient experienced severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected. not responding to self treatments or other meds. The events resulted in a physician's office visit. The patient did not receive any treatment for the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back. The patient received treatment for the event range of motion highly affected but it was not responding to self-treatments or other medications. The outcome of the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe muscle pain and soreness on opposite side of vaccine.; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Range of motion highly affected not responding to self treatments or other meds; This is a spontaneous report from a contactable nurse reporting on herself. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Dec2020 at 11:00 AM (at the age of 34 years old) as a single dose for COVID-19 vaccination. Relevant medical history included anxiety. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. 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. On 30Dec2020, the patient experienced severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected. not responding to self treatments or other meds. The events resulted in a physician's office visit. The patient did not receive any treatment for the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back. The patient received treatment for the event range of motion highly affected but it was not responding to self-treatments or other medications. The outcome of the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: menstrual pain has been magnified; her period came one week early; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age (age: 45; unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 21Dec2020 to 21Dec2020 as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The reporter/patient is an RN that got vaccinated with the first dose of the COVID vaccine in the 21Dec2020. According to her she had nothing different aside that and her period came one week early, and the menstrual pain has been magnified. She wonders if the vaccine could have caused this. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Muscle twitching
Clinical narrative: Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown.  No follow-up activities are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Tinnitus
Clinical narrative: Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown.  No follow-up activities are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient herself).  A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unknown route, on 30Dec2020 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included hypothyroidism, osteoporosis and COVID-19 (prior to vaccination). No known allergies. Relevant concomitant medications included levothyroxine and alendronate sodium (FOSAMAX). The patient was vaccinated at Workplace Clinic, age at vaccination was 57-year-old. No other vaccine was received in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient developed nausea 20 minutes after vaccine (on 30Dec2020, at 09:05), then headache, dizzy, fever started about 2 hours after (on 30Dec2020, at 10:45). The patient was not treated for the events. The outcome from the events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Left arm (site of injection) soreness/pain Left underarm; Swollen lymph nodes; This is a spontaneous report from a contactable Nurse (patient herself).  This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142X-31-21), via an unknown route, on 29Dec2020 at 21:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant.  Relevant medical history included hypothyroidism, hypertension and COVID-19 (prior to vaccination). Relevant concomitant medications included amlodipine. The patient was vaccinated at hospital, age at vaccination was 43-year-old. No other vaccine was received in four weeks. On 30Dec2020 at 12:30 the patient developed 'left arm (site of injection) soreness/pain left underarm' and 'swollen lymph nodes'. Post-vaccination COVID test was not performed. The patient was not treated for the events. She was recovering from the events.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; headache; body aches; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular in Dec2020 (reported as mid-Dec) at single dose for Covid-19 immunization. Medical history included Covid-19 on an unspecified date in 2020 (before vaccination). The patient's concomitant medications were not reported. It was reported that the patient had been ill with COVID earlier in the year and was glad she could receive the vaccination. The patient reported that she had her first shot in mid-Dec and would soon be getting her second. She wasn't sure if she'd have side effects but indicated the 24hours the hospital gave them after vaccination was adequate for her flu like symptoms mainly headache and body aches to pass. She took some Tylenol and felt fine the following day. The outcome of events was recovered on an unspecified date. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was also unknown if the patient received other medications the patient received within 2 weeks of vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphagia, Fatigue, Oropharyngeal pain, Vaccination site pain
Clinical narrative: fatigue; Severe throat pain, it's hard to swallow any liquid right now; It really hurts to talk; Severe throat pain, it's hard to swallow any liquid right now; It really hurts to talk; Diarrhea; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 30Dec2020 15:20 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the vaccine two days ago on Wednesday at about 3:20 PM and have been feeling like very fatigue. The patient added "like I know injection site pain is normal but I have been having diarrhea as well and severe throat pain, it's hard to swallow any liquid right now". The patient further stated that it started this morning with the throat pain and can't swallow anything and really hurts to talk. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: feeling some tingling again where she had shingles awhile back; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history included shingles from an unknown date and unknown if ongoing she (had shingles awhile back). The patient's concomitant medications were not reported. The patient previously took Valtrex which she had to stopped taking a day and half before the vaccine. On an unknown date, the patient felt some tingling again where she had shingles awhile back and would like to known if she could go back to Valtrex or would it interfere with the vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization.  Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol.  The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy.   The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I am having the most wicked head pains, headache; This is a spontaneous report from a contactable other healthcare professional (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration from 31Dec2020 to 31Dec2020 as single dose for COVID-19 immunization. The patient's medical and concomitant medications were not reported. The patient stated "I didn't know what I am experiencing is normal or not but I am having the most wicked and I have high pain tolerance, but I am having the most wicked head pains, headache. Is that normal?". The outcome of the event was unknown.   Information regarding the batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Nausea; Diarrhea; Mild headache; This is a spontaneous report from a contactable consumer (patient herself).  This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 30Dec2020 at single dose for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included sertraline, levothyroxine and furosemide. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. Age at vaccination was 81-year-old. No other vaccine was received in four weeks. On 01Jan2021 at 12:00 AM, the patient had nausea, diarrhea and mild headache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash occurred on a recent surgical wound/rash developed on the back crease of her legs and neck/severe rash that got worse/general practitioner got steroids to help with itching; This is a spontaneous report from a contactable consumer.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3246, via an unspecified route of administration to left arm from 02Jan2021 to 02Jan2021 as SINGLE DOSE for COVID-19 immunization.  Medical history included spinal surgery and surgical wound, a 7 inch scar along her back/she had spinal surgery and has a 7 inch scar, she had no problems.  There were no concomitant medications. The patient reported a rash that developed after receiving vaccine on 02Jan2021.  On 03Jan2021, her rash occurred on a recent surgical wound, a 7 inch scar along her back.  The rash also developed on the back crease of her legs and neck.  She has been managing her symptoms with Benadryl. The patient was asking is others has reported this side effect. The patient is also asking if she can get the second dose of the vaccine. Her surgeon suggested perhaps not receiving second vaccine. It was further reported as, "got Pfizer COVID-19 Vaccine on Saturday. Next day had a severe rash that got worse. Saw her general practitioner this morning and got steroids to help with itching. No further details provided, wants to know if she should forgo the second shot. The patient stated she was fortunate to get the Pfizer vaccine, later clarified as Pfizer COVID vaccine, Saturday in the early am, then on Sunday, developed a rash over part of her body, she can control with Benadryl, the itching, but the weird part, is a month ago, she had spinal surgery and has a 7 inch scar, she had no problems, like no reaction to glue, but the rash is concentrated down both sides of the scar. She had an appointment with her surgeon today, and showed it to him, since she thought it was unusual, and he said she may not want to take the second dose, it was not a terrible rash all over her body, mainly concentrated to the area of her back, and it is like a little bit on the back of her neck, not even anything she would notice, but it is there. The patient stated she can't get through to the Health Department, and she has a card to say to have the second dose on 23Jan2020, but she can't get through. States thanks so much, this is a miracle event and in a year's time, even if she did get a rash. The rash is a little more pronounced, but she has been rubbing it trying to not scratch, but it doesn't seem to be spreading any at all. States she is healthy. Seeking more information about getting the second dose after experiencing a rash. The outcome of the event was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: dizziness; muscle aches; chills; fatigue; subjective fever; sore throat; headache; congestion; This is a spontaneous report from a non-contactable consumer, the patient. This 52-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration from 30Dec2020 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included depression from an unknown date and unknown if ongoing and dyslipidaemia from an unknown date and unknown if ongoing. 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram (CITALOPRAM) and atorvastatin (ATORVASTATIN). On 30Dec2020, the patient experienced dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat. The adverse events resulted in a doctor or clinic visit. Therapeutic measures included Tylenol and Nyquil. The clinical outcome of dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat was not resolved. It was also reported that since the vaccination, the patient was tested for COVID-19 on 04Jan2021 via nasal swab, results pending.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: dizziness; muscle aches; chills; fatigue; subjective fever; sore throat; headache; congestion; This is a spontaneous report from a non-contactable consumer, the patient. This 52-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration from 30Dec2020 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included depression from an unknown date and unknown if ongoing and dyslipidaemia from an unknown date and unknown if ongoing. 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram (CITALOPRAM) and atorvastatin (ATORVASTATIN). On 30Dec2020, the patient experienced dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat. The adverse events resulted in a doctor or clinic visit. Therapeutic measures included Tylenol and Nyquil. The clinical outcome of dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat was not resolved. It was also reported that since the vaccination, the patient was tested for COVID-19 on 04Jan2021 via nasal swab, results pending.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: face was kind of swollen/swelling in her cheek and her face on the left side; swelling in her eye; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1284, via an unspecified route of administration from 31Dec2020 to 31Dec2020 as single dose for COVID-19 immunization.  The patient has no medical history.  The patient's concomitant medications were not reported.  On 01Jan2021, the patient experienced face was kind of swollen, have some swelling in her eye and her cheek and her face on the left side. The outcome of the event was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Swelling
Clinical narrative: Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection arm.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 28Dec2020 at single dose for COVID-19 immunization. The vaccine was administered at workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced axillary swelling, neck and hand pain in the injection arm on 29Dec2020. No treatment was given for the events. The outcome of the events was not recovered.   Information on the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the second of six reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis on an unspecified date. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 6 patients. This is 5th of 6th reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe anaphylaxis; This is a spontaneous report from a non-contactable Consumer. This Consumer reported similar event for six patient. This is 6th of sixth reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients
Sex: U
Vaccine: COVID19
Symptoms: Hypotonia
Clinical narrative: My whole, that really my back, it is not my side, it's like a muscle, all muscle don't tighten up; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just got a shot on Wednesday at the patient's job and over maybe two hours ago, the whole, that really the back, it was not the side, it's like a muscle, all muscle don't tighten up like, so was that, can be one of the side effects, like the joint was (sentence Incomplete). The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via intramuscular route of administration, on 22Dec2020 at 03:00 PM (at the age of 23 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Dec2020, at 03:00 PM, the patient developed chills, headache, fatigue 24 hours after the 1st dose. Treatment was received for the events chills, headache, fatigue 24 hours after the 1st dose included one Advil standard dose with relief. The outcome of the events chills, headache, fatigue 24 hours after the 1st dose was recovered on unknown date. Since the vaccination, the patient had been tested for COVID-19 (via saliva COVID test) on 30Dec2020 with negative result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Vaccination site pain
Clinical narrative: Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (patient herself).  This 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. She was working as a receptionist in a nursing home. Age at vaccination was 53-year-old. No relevant medical history and concomitant medications were provided. On unknown date after vaccination, the patient developed headache, sore arm, and swelling of the feet. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient).  A 41-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 02Jan2021 08:00 to 02Jan2021 08:00 as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 03Jan2021 03:30, the patient experienced fever, chills, vomiting, and diarrhea. The patient underwent lab tests and procedures which included Sars-cov-2 (Nasal Swab) test on Jan2021: with negative result post vaccination.   The outcome of the events was recovering. No treatment was given for the events.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Soreness in arms; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine for COVID. Medical history included did have COVID early on. Concomitant medications were not reported. The patient experienced fever, soreness in arms on unspecified dates. She had a vaccine on Wednesday, and she did have a typical side effect- two days of fever and soreness in arms, the typical. Her question was, "Now, if you have the side effects, the first go around. When I am going to get the second go round, well, how did they go out on the study? Did most people that got them on the first go around get them both?" She had COVID early on; one would think her body would already have what it needed to, that's why she was surprised that she was getting side effects. The outcome of the events was recovered.    Information on the Lot/Batch Number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 2 swollen lymph nodes appeared 10 days after vaccination; This is a spontaneous report from a contactable other healthcare professional (hcp). A 32-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date not reported), via an unspecified route of administration on 22Dec2020 14:30 at a single dose in the left arm for Covid-19 immunization. The patient had no medical history. Patient had no covid prior to vaccination. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks. The patient had birth control as other medication in two weeks prior to vaccination. Patient 2 swollen lymph nodes on 30Dec2020 20:30, which was also reported as appeared 10 days after vaccination in the hospital. They were located above left clavicle half way from middle of chest to arm, and easily palpable. No treatment received in response to the event and it resulted to emergency room/department or urgent care. The patient was not tested for COVID post vaccination. The outcome of the event 2 swollen lymph nodes was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: sick; Cold; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received BNT162B2 via an unspecified route of administration on 30Dec2020 at a single dose as Covid vaccine. Medical history included did have Covid on unspecified date. There were no concomitant medications. It was reported that the patient got her vaccine Covid shot on the Wednesday (30Dec2020) and now she's sick again on 02Jan2021; she could still smell everything (still smell it again) and could still taste everything, so none of that has gone away. She thought she came up with the cold on 02Jan2021. She was not sure if it was just cold. She had already been and had that her full shot. She had not been tested for Covid again. She asked if she should go tested again. The reason for no lot number was because she didn't know that. That's from work, they could provide the lot. No treatment was received for the events. Lab data included tested for Covid: did have Covid on unspecified date. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.