chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal, SARS-CoV-2 test, Streptococcus test
Clinical narrative: tested positive for strep throat; shocked she has strep throat; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:ELO142), via an unspecified route of administration on the left arm at the age of 62 years on 12Jan2021 10:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and asthma from an unknown date and unknown if ongoing. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) both for asthma. The patient had the first part of the Pfizer vaccine. Overall, she had no side effects, but in between getting the vaccine her asthma was bothering her. She went to an Urgent Care and was getting her asthma medicines changed and got tested for Covid and for Flu and both were negative. She was also tested for strep throat and that was positive. She didn't really have any symptoms of a sore throat or anything, she maybe felt some sinus drainage prior to it, but no symptoms. She was shocked she has strep throat and they gave her medication for it and she was almost done with that and wanted to make sure she is able to get the second part. It was clarified her asthma was bothering her prior to getting the vaccine and she was in the midst of getting her asthma medications changed because her asthma wasn't controlled and she was having something with the medications. She had the Covid, flu, and strep testing at her visit on 20Jan2021. She was being seen at the Urgent Care because of her asthma already, not about the vaccine and was given something for the strep. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. Asthma medication, Symbicort was changed because she felt like she was having side effects. Not sure when she stopped it, but started taking it she started taking it again right before she had testing and got the vaccine. May have stopped taking it about end of November, but tried it again around testing time. She mentioned taking regular medications and medication for high blood pressure and asthma medication. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Jan2021 and streptococcus test: positive on 20Jan2021. The outcome of the event was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Diarrhoea, Dysphonia, Fatigue
Clinical narrative: Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza like illness, Myalgia, Nausea
Clinical narrative: Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm; is real tired and she even slept 14 hours last night; is real tired and she even slept 14 hours last night; This is a spontaneous report from a contactable Consumer (patient's husband). A 94-year-old female patient received the first dose bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), via an unspecified route of administration (right arm) on 21Jan2021 at SINGLE DOSE (arm right) for covid-19 immunisation. Medical history included left shoulder pain (on medication for years) from an unspecified date, and elbow that she fell on two weeks before on Jan2021. Concomitant medication included hydrocodone for left shoulder pain. On 24Jan2021, the patient experienced real tired and she even slept 14 hours the night before. Reporter was wondering if tiredness is a side effect of the product. The patient also had an elbow that she fell on two weeks before on Jan2021, and three days after getting the vaccine (24Jan2021), that elbow started hurting more, and it was on the same arm as the side she got the injection on, the right arm. The reporter was unsure of the lot number reported as E13249 or EL3249 (unsure which lot number is his, and which is the one his wife received). The patient received no other vaccines on the same day as the COVID vaccine. Outcome of the event "elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm" was not recovered. Outcome of events "is real tired and she even slept 14 hours last night" was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Diagnosed as Angioedema; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL9265) via an unspecified route of administration on 28Jan2021 10:00 into left arm at a single dose for COVID-19 immunisation. The patient medical history included Hypersensitivity Pneumonitis (PF-ILD) Interstitial Lung Disease and the patient allergies to Lisinopril, meclizine, and Bactrim. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications within two weeks included nintedanib, atorvasatin, Vitamin D3, cyanocobalamin (VITAMIN B12) and acetylsalicylic acid (ASPRIN). The patient diagnosed as angioedema on 30Jan2021 and result in emergent room/department or urgent care. The patient awoke on 31Jan2021 with facial swelling, lip swollen right side of face. No swelling of throat. The patient received methylprednisolone (Solu-MEDROL) injection 125mg, tranexamic acid (CYKLOKAPRON) 1 g in sodium chloride 0.9% 100 ml IVPB (mini-bag plus) as treatment. The patient did not test COVID post vaccination. The outcome of the event was recovering.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Madarosis, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: Universal hair loss: scalp, eyelashes, eye brows, pubic hair; Universal hair loss: scalp, eyelashes, eye brows, pubic hair; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686A) at the age of 51 years-old via unspecified route of administration on 08Jan2021 in left arm at single dose for COVID-19 immunization in the hospital. Medical history included GERD (Gastroesophageal reflux disease). The patient had no allergies to medications, food, or other products. Concomitant medication included VITAMIN D NOS. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at the age of 51 years-old via unspecified route of administration on 20Dec2020 at 01:00 PM in left arm for COVID-19 immunization. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 15Jan2021 patient experienced universal hair loss: scalp, eyelashes, eyebrows, pubic hair. No treatment received for the adverse events. Since the vaccination, the patient has been tested for COVID-19. Post vaccination patient underwent labs and procedure on 19Jan2021 included PCR (Polymerase chain reaction): negative, Nasal swab: negative. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: back pain; bilateral leg pain; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 123302), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ergocalciferol (VIT D) and an unspecified vaccine (lot number: P 100242861) taken for an unspecified indication on 01Dec2020. The patient previously took the first dose of BNT162B2 (lot number: EL0140), at 50-years of age via intramuscular route, on 30Dec2020 at 03:30 pm on the left arm for COVID-19 immunization and four days after the injection, patient had severe low back pain, difficulty walking, standing, sitting. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, the patient experienced back pain along with bilateral leg pain. The patient did not receive any treatment for the reported events. The patient underwent lab test which included nasal swab test which showed negative result on 21Jan2021. The outcome of the events was recovering. The patient was not pregnant at the time of vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: pain to that area when lifting arm; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration, in Jan2021 (reported as "3 weeks ago"), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had complaints of pain to that area when lifting arm (pending clarification) in Jan2021. The patient was scheduled to have the second dose in the afternoon of 27Jan2021. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: pain to that area when lifting arm; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration, in Jan2021 (reported as "3 weeks ago"), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had complaints of pain to that area when lifting arm (pending clarification) in Jan2021. The patient was scheduled to have the second dose in the afternoon of 27Jan2021. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza like illness, Nausea
Clinical narrative: flu like symptoms; diarrhea; severe/bad headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL9261; expiry date: unknown) at the age of 75 years old, via an unspecified route of administration in the right arm, on 23Jan2021 09:00, at a single dose, for COVID -19 immunization. The patient had no relevant medical history and was not taking concomitant medications. Patient reported that she got the Pfizer Covid vaccine shot on 23Jan2021 at 9:00. On 24Jan2021, about 2:00, the next morning, she felt like she got hit by a bus further described as flu like symptoms including nausea, diarrhea, and a severe/ bad headache. The events were treated with Phenergan at home. These symptoms lasted about a day; patient completely recovered on 25Jan2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Pain, Pain in extremity
Clinical narrative: Headache; left arm and back pain; left arm and back pain; everything hurt; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4176; dose 1) via an unspecified route of administration on 23Jan2021 at 16:00 (at the age of 72-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included a dental appointment in Jan2021; the patient had no other conditions. Concomitant medications were not reported. The patient previously took penicillin and had a reaction when he was younger. The patient had not had adverse events from prior vaccinations. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 24Jan2021 the patient experienced headache, left arm and back pain, everything hurt. The patient said that "it" didn't bother him at all that day (23Jan2021) but on 24Jan2021 he had headaches, left arm and back pain and everything hurt. It was worse "yesterday" but "today" (on an unknown date) his arm and back still hurt. The events did not require a visit to the emergency room or physicians office. The patient underwent lab tests and procedures which included a new dental crown put on on 25Jan2021. The clinical outcome of headache was recovering. The outcome of left arm and back pain and everything hurt was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: hot flash sensation on right side body under her arms down side of her body; This is a spontaneous report from a contactable pharmacist (patient). This 45-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3302; dose 1) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced hot flash sensation on the right side of her body. The patient stated she got the vaccine "today" (26Jan2021) and wanted to find out if the kind of side effect she was having would resolve or if she needed to contact her physician. She had been experiencing a hot flash sensation on the right side of her body under her arms and down the side of her body on 26Jan2021. The outcome of hot flash sensation on the right side of her body was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, Chills, Headache, Myalgia
Clinical narrative: Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 13:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 26Mar2020, she tested positive for Covid. In the beginning of May2020, she went to get tested for antibodies, she did have them, that she received a report, number was 8.2 and knows that at 1.4 she would be considered to have antibodies so they told her it was good that her number was high, she asked them what it meant and they told her they did not know. Patient had chills, fever of 100.2, bad headache, and muscle aches on 20Jan2021. She took Tylenol to treat her symptoms and they went away, and states they would come back as Tylenol wore off. Her symptoms have completely resolved however she does not have the exact date. Outcome of the events was recovered on Jan2021.  Information about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 13:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 26Mar2020, she tested positive for Covid. In the beginning of May2020, she went to get tested for antibodies, she did have them, that she received a report, number was 8.2 and knows that at 1.4 she would be considered to have antibodies so they told her it was good that her number was high, she asked them what it meant and they told her they did not know. Patient had chills, fever of 100.2, bad headache, and muscle aches on 20Jan2021. She took Tylenol to treat her symptoms and they went away, and states they would come back as Tylenol wore off. Her symptoms have completely resolved however she does not have the exact date. Outcome of the events was recovered on Jan2021.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: 10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has a question about the COVID-19 vaccine. She stated that she thought she had a simple question, and she called the COVID hotline, and the CDC and they just keep bouncing her around. She said she had her first dose of the vaccine on 16Jan2021, and wasn't bothered by it, she had just a bit of soreness when she touched her arm (unspecified date in Jan2021), but 10 days later, on 26Jan2021, her arm got red, so she is wondering if this could be a delayed reaction. She stated that she is not having bad effects, she is just wondering why it would pop up after so many days. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lip swelling
Clinical narrative: Lip swelling; Extreme tiredness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on the left upper arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history seafood allergy. There were no family medical history and concomitant medications. The patient previously received flu shots in Sep2020 (Has had 100's of vaccines while in the army and never had a reaction to any of them). The patient experienced extreme tiredness on 25Jan2021; was noticed at 6pm when he fell asleep on the phone. Right now, he is fine, stating later he was just a little tired. Lip swelling- this was noticed about 11pm on 25Jan2021 the day he received the shot, when he woke to go to the bathroom. Both lips were swollen but he wasn't worried as he knew this was a possible side effect. He reported that he was back to normal other than being a little tired. He just slept. Patient reported that he couldn't stay awake for a more than 5 minutes but he is still very glad he got it. The second dose is due 15Feb2021. The events did not require a visit to physician office or emergency room. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. Outcome of the event lip swelling was recovered on 26Jan2021 while the event extreme tiredness was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Chest pain, Diarrhoea
Clinical narrative: Nausea; Fever; Diarrhea; Pain and stiffness in her chest; Pain and stiffness in her chest; can't seem to regulate her body temperature; Laboring to breathe; Immediate soreness in arm; couldn't really taste, things didn't really taste right; Muscle pain; Joint pain; Red rash; Hives; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This consumer reported for a patient (other health professional). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry 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 patient previously took the first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient was having the same symptoms with the caller except that it was after receiving the second dose. On an unspecified date, the patient experienced immediate soreness in arm, stated that she couldn't really taste, things didn't really taste right, muscle pain, joint pain, red rash, hives, nausea, fever, diarrhea, and pain and stiffness in her chest. She also can't seem to regulate her body temperature and was laboring to breathe on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076108 same reporter/drug, similar events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal stiffness, Myalgia, Nausea, Pain in extremity
Clinical narrative: Nausea; Fever; Diarrhea; Pain and stiffness in her chest; Pain and stiffness in her chest; can't seem to regulate her body temperature; Laboring to breathe; Immediate soreness in arm; couldn't really taste, things didn't really taste right; Muscle pain; Joint pain; Red rash; Hives; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This consumer reported for a patient (other health professional). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry 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 patient previously took the first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient was having the same symptoms with the caller except that it was after receiving the second dose. On an unspecified date, the patient experienced immediate soreness in arm, stated that she couldn't really taste, things didn't really taste right, muscle pain, joint pain, red rash, hives, nausea, fever, diarrhea, and pain and stiffness in her chest. She also can't seem to regulate her body temperature and was laboring to breathe on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076108 same reporter/drug, similar events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Taste disorder, Urticaria
Clinical narrative: Nausea; Fever; Diarrhea; Pain and stiffness in her chest; Pain and stiffness in her chest; can't seem to regulate her body temperature; Laboring to breathe; Immediate soreness in arm; couldn't really taste, things didn't really taste right; Muscle pain; Joint pain; Red rash; Hives; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This consumer reported for a patient (other health professional). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry 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 patient previously took the first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient was having the same symptoms with the caller except that it was after receiving the second dose. On an unspecified date, the patient experienced immediate soreness in arm, stated that she couldn't really taste, things didn't really taste right, muscle pain, joint pain, red rash, hives, nausea, fever, diarrhea, and pain and stiffness in her chest. She also can't seem to regulate her body temperature and was laboring to breathe on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076108 same reporter/drug, similar events, different patient
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache, Malaise, Nausea
Clinical narrative: Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This is a spontaneous report from a contactable consumer. A 78-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on her left arm, via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. It was reported that the patient got shot on Friday and last night she woke up with vertigo on 25Jan2021. This morning (26Jan2021), she could not eat breakfast because she was nauseous and sick to her stomach; stomach is upset. She is walking around now and just is not feeling great. She also has a headache and dizziness. The outcome of the event nausea was recovering while unknown for the other events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This is a spontaneous report from a contactable consumer. A 78-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on her left arm, via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. It was reported that the patient got shot on Friday and last night she woke up with vertigo on 25Jan2021. This morning (26Jan2021), she could not eat breakfast because she was nauseous and sick to her stomach; stomach is upset. She is walking around now and just is not feeling great. She also has a headache and dizziness. The outcome of the event nausea was recovering while unknown for the other events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Flushing, Nasal congestion
Clinical narrative: small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: she forgets her own address; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 18Jan2021 17:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she was fine and wanted to inform that she had her Covid vaccine shot on 18Jan2021 at 17:00. She has not been sick and does not have fever. She was now waiting on the date for the second dose. She then mentioned that she forgets her own address on Jan2021. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Neck pain, Pain in extremity
Clinical narrative: Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck, its an aching pain, a nuisance type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left deltoid on 28Dec2020 (07:15) at a single dose for COVID-19 immunization at the hospital. The had no relevant medical history and concomitant medications. On an unspecified date, after the first dose of vaccination, the patient had sore arm; pain in chest to her upper sternal border area (under the collar bone); and pain in the neck (further described as "an aching pain, a nuisance type of pain"). The patient had chest x-ray on 25Jan2021 (results were not provided). The patient had received paracetamol (TYLENOL), naproxen sodium (ALEVE) and ibuprofen as treatment for the reported events. The outcome of the events was not recovered for 'pain in chest to her upper sternal border area (under the collar bone)'; and was unknown for 'sore arm' and 'pain in the neck'. The patient had received the second dose of vaccination on 14Jan2021. The reporter believed that it was "highly coincidental" (pertaining to causality) considering the events happened with both vaccine doses.  No further information was provided or obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Pain
Clinical narrative: Temperature of 103; Had severe body aches; Weakness; This is a spontaneous report from a non-contactable consumer reporting for a patient. A female patient in her 60's received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE for preventative for Covid 19. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on an unspecified date for covid-19 immunisation. The patient experienced temperature of 103, had severe body aches, and weakness on an unspecified date which lasted for two days and then recovered on an unspecified date.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: after getting the vaccine, her taste and smell came back which has been gone since Oct2017 when she had shingles in her mouth and right side of face; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 lot number: EK9231, expiry date: 30Apr2021), via an unspecified route of administration on the left arm, on 24Jan2021 15:30, at 0.3 mL, single, to protect her husband and her neighbor/COVID-19 immunization. Medical history included shingles in her mouth and right side of her face in Oct2017; and has not been able to taste or smell since 2017. There were no concomitant medications. The patient had shingles in her mouth and right side of her face on Oct2017 and she lost her taste and smell from it. She has not been able to taste or smell since 2017. The patient called to report a positive thing that happened after she got the COVID-19 vaccine on 24Jan2021 15:30. By the morning of 25Jan2021, the patient fixed her coffee and when she drank her coffee, she tasted it. She was like, 'wait a minute'. So, she took another sip. She can taste and smell. She smelled and tasted everything. After the coffee, she fixed an egg and put extra salt and pepper and she could taste it. After getting the vaccine, her taste and smell came back which has been gone since Oct2017 when she had shingles in her mouth and right side of face. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives from his knee to his chest, and from his chest to his arm and to his neck area, hives had little red bumps and were itchy; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on the left arm, at the age of 75 years, on 21Jan2021 10:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient said he had red hives develop on Saturday, 23Jan2021. He went to an Urgent Care for treatment. He said the doctor at the Urgent Care looked at his hives, and told him the hives were likely related to the COVID-19 Vaccine, but the doctor was not positive of that. The patient said he hadn't had any recent changes in his health, or issues before he received the COVID-19 Vaccine, so that was why the doctor thought the hives were from the COVID-19 Vaccine. He clarified he has hives from his knee to his chest, and from his chest to his arm and to his neck area. He clarified the hives have been moving around his body. He said the hives had little red bumps, saying the hives were itchy. Therapeutic measures (Zyrtec and Hydrocortisone Cream) were taken as a result of hives from his knee to his chest, and from his chest to his arm and to his neck area, hives had little red bumps and were itchy (urticaria). The outcome of the event was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain
Clinical narrative: I'm currently 20 hours post administration of my 2nd dose and feel lousy; light nausea approx 2 hours after adminstration; dull headache and intense body aches approx 8 hours after administration; dull headache and intense body aches approx 8 hours after administration; This is a spontaneous report from a contactable other hcp. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on the left arm at the age of 36 years, on 26Jan2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included anaphylactic reaction, drug hypersensitivity to penicillin, food allergy to pistachios. The patient's concomitant medications were not reported. The patient had the first dose on an unspecified date in Jan2021. On 26Jan2021, the patient experienced light nausea approx 2 hours after administration. Then developed a dull headache and intense body aches approx 8 hours after administration. The patient was currently 20 hours post administration of 2nd dose (27Jan2021) and feels lousy. There was no treatment received for the adverse events. The outcome of the event feel lousy was unknown while other events were recovered on an unspecified date in Jan2021.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for different patient. This is the first of two reports.  A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included egg allergy, bladder cancer and surgery.  There were no concomitant medications. It was reported that the patient had a sore arm after getting the shot. The outcome of the event was recovered on an unspecified date in Jan2021.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106756 same drug, same event and different patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Fatigue, Muscle spasms
Clinical narrative: arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.