chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Developed a cold sore; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EY1685, or EJ1685) at single dose in the left arm on 21Dec2020 for covid-19 immunisation, through her work as workings in a high risk area.  Medical history included oral herpes (It is in the same spot as she has previous had other cold sores).  There were no concomitant medications.  The patient experienced developed a cold sore (oral herpes) on 22Dec2020 since receiving the vaccine. She started to notice on 22Dec2020 night. She was unsure that night if it was a cold sore, but she was sure on 23Dec2020. She thought it was a chapped lip, but it was not a chapped lip this morning. It was painful. It was in the same spot as she has previous had other cold sores. The cold sore was the 3rd one of her entire life. The vaccine outcome of cold sore was not recovered and worsened. Reporter assessed the event cold sore as not serious. She is wondering if she can take Valtrex, an anti-viral, to help with it, asking if Valtrex will interact with her vaccination. She was also scheduled out 17 days for her 2nd dose, and wants to make sure that is okay and this interval appropriate.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: he is feeling tired, saying his joints feel weak; joints feel weak; persisting feeling of having to throw up; Feverish; Chills; Headache; sweating; This is a spontaneous report from a contactable consumer reporting for himself. This 56-year-old male consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot FH9899) on 21Dec2020 at around 12:40 PM, in left upper arm, for COVID-19 immunisation. Additional vaccines administered on the same date or within 4 weeks before: none. Medical history included seasonal allergies. Concomitant medications included fluticasone propionate (FLONASE) for seasonal allergies. On 21Dec2020 the patient was feverish, had chills, headache. These symptoms went away the following morning but started again around 10-11 AM. He reported his chills came on in the evening and then he will be sweating. Feeling feverish and having headaches came and went. On 22Dec2020 he was feeling tired saying his joints felt weak and had a mild, persisting feeling of having to throw up. Treatment: he took 2 naproxen sodium (ALEVE) last night. Relevant tests: none. The events did not require a physician office visit or emergency room visit. Sweating outcome was unknown. The other events had not yet resolved at the time of report. He reported his next COVID-19 vaccine dose is scheduled for 11Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: he is feeling tired, saying his joints feel weak; joints feel weak; persisting feeling of having to throw up; Feverish; Chills; Headache; sweating; This is a spontaneous report from a contactable consumer reporting for himself. This 56-year-old male consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot FH9899) on 21Dec2020 at around 12:40 PM, in left upper arm, for COVID-19 immunisation. Additional vaccines administered on the same date or within 4 weeks before: none. Medical history included seasonal allergies. Concomitant medications included fluticasone propionate (FLONASE) for seasonal allergies. On 21Dec2020 the patient was feverish, had chills, headache. These symptoms went away the following morning but started again around 10-11 AM. He reported his chills came on in the evening and then he will be sweating. Feeling feverish and having headaches came and went. On 22Dec2020 he was feeling tired saying his joints felt weak and had a mild, persisting feeling of having to throw up. Treatment: he took 2 naproxen sodium (ALEVE) last night. Relevant tests: none. The events did not require a physician office visit or emergency room visit. Sweating outcome was unknown. The other events had not yet resolved at the time of report. He reported his next COVID-19 vaccine dose is scheduled for 11Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Hypertensive emergency
Clinical narrative: Patient had dizziness when she got down to the emergency department.; transient ischemia attack (TIA); Hypertensive emergency; This is a spontaneous report from a contactable pharmacist reporting for two patients. This is the second of two reports.   A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EH9899), intramuscular at 0.3 mL, single in the arm on 23Dec2020 for Covid-19 immunisation. Medical history included hypertension, allergies to sulfa, morphine and cipro.   There were no concomitant medications. The patient experienced hypertensive emergency on 23Dec2020 with outcome of unknown, patient was getting her blood pressure checked and the patient was in the 170s systolic on an unspecified date with outcome of unknown, patient had dizziness when she got down to the emergency department on an unspecified date with outcome of unknown.   The events were described as follows: Patient was getting her blood pressure checked and the patient was in the 170s systolic. She was taken down to the emergency department. She had a blood pressure of 191/105 in the emergency department. Patient had dizziness when she got down to the emergency department. She does not have further details to provide since the patient is being worked up right now to see if she experienced a transient ischemia attack (TIA). Patient has a history of hypertension.  The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: While the patient is a known hypertensive and events may be intercurrent events, the causal relationship between BNT162B2 and the events hypertensive emergency, dizziness and transient ischaemic attack cannot be completely excluded due to temporal association. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020510735 Same reporter/different patient/similar events
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: low-grade temperature: 99 degrees; Chills; General malaise; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient (not pregnant) received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (right arm) on 20Dec2020 15:15 at single for COVID-19 immunization. There was no medical history. No known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low-grade temperature: 99 degrees, chills, and general malaise on 21Dec2020 (13:00). There was no treatment received for the adverse events. The patient has been tested for COVID-19 post vaccination. COVID test post vaccination: Nasal Swab on 15Dec2020, Result: Negative. The outcome of events was recovered on an unspecified date in Dec2020. This case is non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Severe chills; left arm ache, severely sore/'arm is really tender'; sleepy; Muscle weakness; low grade headache; something weird: she could smell bleach but she is not using bleach; This is a spontaneous report from a contactable Nurse (patient).  A 64-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via an unspecified route of administration on 22Dec2020 15:40 at single dose (Anatomical Location: left arm) for covid-19 Vaccination. Medical history included hypothyroidism, muscle pain, legs hurt, Covid 19 infection/COVID-19 virus from Nov2020 to 10Dec2020 (recovered, duration: 39 days). Concomitant medication included levothyroxine sodium (SYNTHROID) for Hypothyroidism, ibuprofen (MOTRIN [IBUPROFEN]) for legs hurt and muscle pain.  The patient had previous diagnosis of Covid 19 infection that resolved 10Dec2020. She received 1st dose of vaccine yesterday (22Dec2020) and experiencing the following symptoms: "arm is really tender", severe chills ("i Gotta go lay under covers, like I'm freezing to death", low grade temp ("98.8F")."  "I feel like I have the virus again", "the chills are new" (when caller comparing symptoms to covid 19 infection experience). The patient stated, "I already know this is possible side effects from vaccine".  This Nurse reported she was administered her first dose of Pfizer COVID-19 Vaccine at work on 22Dec2020. She reported before she was administered that first dose of COVID-19 Vaccine she had COVID-19 virus from approximately the Saturday or Tuesday before Thanksgiving in Nov2020 and had reached point of recovered completely by date she returned to work on 10Dec2020. Starting this morning: 23Dec2020 she had onset of: left arm ache, severely sore; severe chills; she had to go back to bed she was so sleepy; muscle weakness; low grade headache; and something weird: she could smell bleach but she is not using bleach; she is definitely having COVID like symptoms.  She initially reported during call that she feels warm now; but that the chills were really bad like she could not get warm. She reported she started getting the chills again during this report. She reported seriousness criteria is not serious because she can now get warm but she cannot believe the severity of the chills Seriousness criteria as not serious because she can not use this arm because she was off of work for 2 days. COVID-19 virus causality not provided, not applicable. The patient verified yes for causality of all other reported events, with additional statement that she was feeling so well before these events started. She took her body temperature during this report (23Dec2020) with result of 98.8 degrees Fahrenheit. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered. The reporter reported all events were non-serious and related to the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Parosmia, Somnolence
Clinical narrative: Severe chills; left arm ache, severely sore/'arm is really tender'; sleepy; Muscle weakness; low grade headache; something weird: she could smell bleach but she is not using bleach; This is a spontaneous report from a contactable Nurse (patient).  A 64-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via an unspecified route of administration on 22Dec2020 15:40 at single dose (Anatomical Location: left arm) for covid-19 Vaccination. Medical history included hypothyroidism, muscle pain, legs hurt, Covid 19 infection/COVID-19 virus from Nov2020 to 10Dec2020 (recovered, duration: 39 days). Concomitant medication included levothyroxine sodium (SYNTHROID) for Hypothyroidism, ibuprofen (MOTRIN [IBUPROFEN]) for legs hurt and muscle pain.  The patient had previous diagnosis of Covid 19 infection that resolved 10Dec2020. She received 1st dose of vaccine yesterday (22Dec2020) and experiencing the following symptoms: "arm is really tender", severe chills ("i Gotta go lay under covers, like I'm freezing to death", low grade temp ("98.8F")."  "I feel like I have the virus again", "the chills are new" (when caller comparing symptoms to covid 19 infection experience). The patient stated, "I already know this is possible side effects from vaccine".  This Nurse reported she was administered her first dose of Pfizer COVID-19 Vaccine at work on 22Dec2020. She reported before she was administered that first dose of COVID-19 Vaccine she had COVID-19 virus from approximately the Saturday or Tuesday before Thanksgiving in Nov2020 and had reached point of recovered completely by date she returned to work on 10Dec2020. Starting this morning: 23Dec2020 she had onset of: left arm ache, severely sore; severe chills; she had to go back to bed she was so sleepy; muscle weakness; low grade headache; and something weird: she could smell bleach but she is not using bleach; she is definitely having COVID like symptoms.  She initially reported during call that she feels warm now; but that the chills were really bad like she could not get warm. She reported she started getting the chills again during this report. She reported seriousness criteria is not serious because she can now get warm but she cannot believe the severity of the chills Seriousness criteria as not serious because she can not use this arm because she was off of work for 2 days. COVID-19 virus causality not provided, not applicable. The patient verified yes for causality of all other reported events, with additional statement that she was feeling so well before these events started. She took her body temperature during this report (23Dec2020) with result of 98.8 degrees Fahrenheit. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered. The reporter reported all events were non-serious and related to the vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Extreme dizziness; nausea; headache; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; This is a spontaneous report from a non contactable other HCP. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on right arm on 18Dec2020 15:30 at first single dose for covid-19 immunization. Medical history included Type II diabetes, migraines, solitary kidney status post (s/p) left nephrectomy in 2006. Concomitant medication included metformin, amitriptyline, propranolol. Known allergies included morphine, septra. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme dizziness, nausea, headache as well as injection site reaction to include red, hot to touch, itchy welt, all on 21Dec2020 05:00. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Extreme dizziness; nausea; headache; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; injection site reaction to include red, hot to touch, itchy welt; This is a spontaneous report from a non contactable other HCP. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on right arm on 18Dec2020 15:30 at first single dose for covid-19 immunization. Medical history included Type II diabetes, migraines, solitary kidney status post (s/p) left nephrectomy in 2006. Concomitant medication included metformin, amitriptyline, propranolol. Known allergies included morphine, septra. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme dizziness, nausea, headache as well as injection site reaction to include red, hot to touch, itchy welt, all on 21Dec2020 05:00. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Feeling hot
Clinical narrative: feeling lightheaded and warm; dizziness; This is a spontaneous report from a Non-contactable Other HCP. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on right arm (deltoid muscle) on 22Dec2020 17:00 at first single dose for COVID-19 immunization. Patient had history of (h/o) hypothyroidism on LT4- last lab a few months ago, vasovagal episodes with shots, mammograms, etc. Concomitant medication was not reported. The patient denied any history of previous adverse reactions to vaccines. The patient started feeling lightheaded and warm. The patient was doing a temp check. 135/94- repeat blood pressure (BP) check. Pulse between 72-90s on rechecked. Blood sugar was just checked and normal at 76-repeat also normal at 86. She was eating a snack and having some water. During her 15 minute waiting period after the injection, the patient began to experience dizziness. The events were non-serious. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable other HCP. A 93-year-old male patient received fist dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose by injection at arm for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient was not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient, nursing home had turned positive after the getting the vaccine. The patient was tested negative for COVID 19 before getting the vaccine on 18Dec2020, then took his first dose of COVID vaccine. The patient had no reaction to the vaccine. The patient got on the plane on 19Dec2020 and tested positive on 22Dec2020. PCR test for COVID 19 was done on 22Dec2020 and received the results on 23Dec2020 and it was detected(PCR test was positive). Event reported as non-serious. The patient still had had no symptoms before the test and none after the test came back detected. He was pretty healthy. It was unknown if patient would receive the second dose but he was scheduled to receive it. Patient was not admitted to an Intensive Care Unit. Patient did not display clinical signs at rest indicative of severe systemic illness. Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient had no any new or worsened symptoms/signs during the COVID-19 illness experienced (including date of onset/worsening). The patient did not receive any additional therapies for COVID-19. The event did not require the initiation of new medication or other treatment or procedure. Patient's outcome with COVID-19 reported as not currently ill. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: The patient received BNT162B2 on 18Dec2020 and took plane on 19Dec2020.  The patient was tested positive for COVID-19 on 22Dec2020.  The event occurred only 4 days after first vaccination and therefore the patient was not under full protection by vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia
Clinical narrative: neck pain for the past 3 days and wont go away; felt febrile; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FA9899, expiration date: Mar2021), via an unspecified route of administration (given in the left side of her upper arm) on 19Dec2020 at single dose for COVID-19 immunization. The relevant medical history included diabetic from an unspecified date and ongoing, and allergic to NSAIDS. Concomitant medications included another unknown medication but the patient didn't know the name of the medication. The patient previously took metformin for diabetic (take metformin when it is high. when it is under control she does not take metformin); took motrin and experienced allergies (she says Motrin or well any NSAIDS make her tummy irritated when she takes them). The patient previously received flu vaccine for immunization and experienced fever. The patient received the vaccine at her hospital, took it last Saturday morning on 19Dec2020. She didn't feel anything after, she was fine. The next day she reported she was feeling pain in her neck on the side she got the shot. She took Tylenol for the pain. This had gone on for 3 days and it was not going down. She was wondering what to do about this, should she go to the emergency room or what should she do. The patient reported she had taken pain and muscle relaxer. She felt febrile, that was also why she took the Tylenol. The fever went down after taking the medication. Her fever was 99.8 but that was high as she was usually 97.0. This started Sunday, and she took the liquid Tylenol and it brought it down to 98.2. After that she was ok and only needed to take the one dose. She reported that she took another unknown medication but she didn't know the name of the medication. The medications she took, the pain medication and muscle relaxers helped a little bit but as soon as they wear off the pain was back and so bad. The shot was given in the left side of her upper arm. The neck pain started on 20Dec2020 and was ongoing and seemed worse. She thought the pain medication and muscle relaxer should be helping. She knew that this was a side effect so she wasn't worried when she started feeling the neck pain but it was taking too long, it should have been gone by the time of the report. She had had a fever after the flu vaccine and therefore she was not worried about having a fever with this vaccine. She had to take medication just once and then she felt ok. She hadn't taken the flu this year because she wanted to get the COVID vaccine. She has had no vaccines this year. The outcome of the event neck pain was not recovered, while the event felt febrile was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Feeling hot, Peripheral swelling
Clinical narrative: Arm got red and swollen; Arm got red and swollen; Feeling very hot; Dizzy; Tired and exhausted; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age (Age: 36; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient's arm got red and swollen and she experienced feeling very hot, dizzy, tired and exhausted on an unspecified date in Dec2020. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Palpitations
Clinical narrative: Extreme soreness at injection site/upper left arm x 48 hrs; Heart racing; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female (not pregnant) patient received BNT162B2 (lot number: EK5730) first dose on 21Dec2020 05:30 PM on left arm at single dose for COVID-19 immunization. Medical history included allergies to PCN. Concomitant medications in two weeks: sertraline hydrochloride (ZOLOFT), meloxicam (MOBIL) and calcium supplements. No other vaccine in four weeks was No. Facility type vaccine was Hospital. Patient experienced Heart racing on 21Dec2020 05:45 PM. Patient had Extreme soreness at injection site/upper left arm x 48 hrs on 21Dec2020 06:30 PM. No covid prior vaccination and no covid tested post vaccination. No treatment received for the events. The outcome of event Heart racing was recovered. The outcome of the event Extreme soreness at injection site/upper left arm x 48 hrs was recovering. The seriousness was reported as no.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for COVID 19 the same day; patient tested positive for COVID 19 the same day; This is a spontaneous report from a non-contactable Nurse. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The COVID 19 vaccine was administered to the patient and the patient tested positive for COVID 19 the same day. Patient did not have a fever and reported feeling tired. The nurse wanted to know if the immune response would be affected by having COVID 19 at the time of vaccination and will the symptoms be exacerbated because of receiving the vaccine. The outcome of the events was unknown.  No follow up attempts are possible. Information on Lot/Batch could not be requested. No further information is expected.; Sender's Comments: The patient tested positive for COVID-19 on the same day when receiving BNT162B2 vaccine.  And therefore there is not a reasonable possibility that reported "tested positive for COVID 19" is related to vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Sinus congestion
Clinical narrative: Spike in temperature/ low grade fever; feels sick; sinus congestion; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration in the left deltoid on 22Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient said she got her first shot of the COVID vaccine on 22Dec2020 the day prior to the report. At the time of the report, she had a spike in temperature. This morning at 6 AM it was 99.7 and then just now at 4 PM it was 102.9. She received the shot at her place of employment at the hospital. She just felt sick, like she had a normal fever. She knew there would be side effects. The patient was wondering side effects just like a low grade fever and some sinus congestion. The outcome of the event "Spike in temperature/ low grade fever" was not recovered, while the other events were unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Head discomfort, Heart rate increased, Vertigo
Clinical narrative: Dizzy in her head; Heart rate increased to around 130; Blood pressure shot up to around 140; head was heavy; If she sat down she would feel it spinning; her adrenaline is really high; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left deltoid on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history included underweight (she was underweight prior to receiving the vaccine/ She thought based on her BMI she should be 104 pounds at least). Concomitant medications were reported as none. On 21Dec2020, 10 minutes after the patient received the vaccine she felt a little dizzy in her head. Her head was heavy and if she stood up it kind of lessened it. If she sat down she would feel it spinning. Her heart rate also increased to around 130. She had never had issues with vitals. Her blood pressure also shot up to around 140. After she got the vaccine, the doctor there mentioned that her adrenaline was really high. What helped her out was she helped her was walk and pace around for 0.5 hours after she had the symptoms. That helped. Moving around helped. It was almost like she was ready to do a marathon or something like that. She wanted to do something. She could not sit down. When she sat down she would start spinning after walking. Her rate and her blood pressure were not as high the second day. They re-checked her vitals Monday evening and they were still high before she left work. Not as high as right after, but her heart rate was still around 120 and her blood pressure was about 130/80. The outcome of the events "Dizzy in her head", "Heart rate increased to around 130" and "Blood pressure shot up to around 140" was recovered on 22Dec2020, while other events were unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a mild full body rash/rash on body; received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a mild full body rash/rash on body on 20Dec2020 and took diphenhydramine hydrochloride (BENADRYL) and rash went away, seemed to be a mild reaction and came to work and had nothing to do with work environment. The outcome of event was recovering.   Information on the Lot/Batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Heart rate increased, Hot flush
Clinical narrative: felt flush; hands sweating; lightheaded; heart rate increased; chest tightness; blood pressure measurement: 141/101; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient (not pregnant) received first dose of BNT162B2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 23Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included allergies: Bees, penicillin, hypertension, all from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR), escitalopram oxalate (LEXAPRO), propranolol, colecalciferol (VITAMIN D). The patient experienced felt flush, hands sweating, lightheaded, heart rate increased, chest tightness all on 23Dec2020 13:45. 10 min post dose felt flush, hands sweating, lightheaded, heart rate increased, chest tightness all on 23Dec2020 01:45 PM. Given cetirizine hydrochloride (ZYRTEC). Subsided after 5-10 min. The patient underwent lab tests and procedures which included blood pressure measurement: 141/101, heart rate: increased, pulse: 85, Sats (oxygen saturation): 99 all on 23Dec2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of events was resolved on 23Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: felt flush; hands sweating; lightheaded; heart rate increased; chest tightness; blood pressure measurement: 141/101; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient (not pregnant) received first dose of BNT162B2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 23Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included allergies: Bees, penicillin, hypertension, all from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR), escitalopram oxalate (LEXAPRO), propranolol, colecalciferol (VITAMIN D). The patient experienced felt flush, hands sweating, lightheaded, heart rate increased, chest tightness all on 23Dec2020 13:45. 10 min post dose felt flush, hands sweating, lightheaded, heart rate increased, chest tightness all on 23Dec2020 01:45 PM. Given cetirizine hydrochloride (ZYRTEC). Subsided after 5-10 min. The patient underwent lab tests and procedures which included blood pressure measurement: 141/101, heart rate: increased, pulse: 85, Sats (oxygen saturation): 99 all on 23Dec2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of events was resolved on 23Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Limb discomfort, Nervousness, Palpitations
Clinical narrative: 20 minutes after vaccination I began to taste a medicine like taste on my tongue; my heart started racing; my blood pressure went up/It went to 168/91.; felt very heavy and shaky/ I have been feeling very shaky; I feel a lot of pressure at the left chest area; This is a spontaneous report from a contactable Other healthcare professional (patient). A 44-year-old female (not pregnant) patient received received BNT162B2 (lot number: EH9899) first dose on 21Dec2020 04:00 PM intramuscularly on Left arm at single dose for COVID-19 immunization. Medical history included allergies: Some aerosol sprays and chili pepper flakes. Concomitant medication included influenza vaccine (FLU VACCINE VII) on 07Dec2020 on Left arm. Facility type vaccine was Hospital. About "20 minutes" after vaccination she began to taste a medicine like taste on her tongue (21Dec2020 4:15 PM). Then her heart started racing and her blood pressure went up. She have never had high blood pressure. It went to 168/91. She left the facility about 45 minutes later and felt very heavy and shaky. She waited another hour and checked her blood pressure which was still high. The next two days she have been feeling very shaky and she feel a lot of pressure at the left chest area. She have been monitoring her blood pressure and it is normal now. No covid prior vaccination and no covid tested post vaccination. No treatment for the events. The outcome of event blood pressure increased was recovered. The outcome of other events was recovering. The seriousness was reported as no.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: 20 minutes after vaccination I began to taste a medicine like taste on my tongue; my heart started racing; my blood pressure went up/It went to 168/91.; felt very heavy and shaky/ I have been feeling very shaky; I feel a lot of pressure at the left chest area; This is a spontaneous report from a contactable Other healthcare professional (patient). A 44-year-old female (not pregnant) patient received received BNT162B2 (lot number: EH9899) first dose on 21Dec2020 04:00 PM intramuscularly on Left arm at single dose for COVID-19 immunization. Medical history included allergies: Some aerosol sprays and chili pepper flakes. Concomitant medication included influenza vaccine (FLU VACCINE VII) on 07Dec2020 on Left arm. Facility type vaccine was Hospital. About "20 minutes" after vaccination she began to taste a medicine like taste on her tongue (21Dec2020 4:15 PM). Then her heart started racing and her blood pressure went up. She have never had high blood pressure. It went to 168/91. She left the facility about 45 minutes later and felt very heavy and shaky. She waited another hour and checked her blood pressure which was still high. The next two days she have been feeling very shaky and she feel a lot of pressure at the left chest area. She have been monitoring her blood pressure and it is normal now. No covid prior vaccination and no covid tested post vaccination. No treatment for the events. The outcome of event blood pressure increased was recovered. The outcome of other events was recovering. The seriousness was reported as no.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: profoundly exhausted; This is a spontaneous report from a contactable nurse (care coordinator, not patient). A 52-year-old female patient (health worker under EUA) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 22Dec2020 06:00 at single dose for COVID-19 immunization. The patient had no medical history reported. Concomitant medications included unspecified medications. The patient experienced profoundly exhausted on an unspecified date with outcome of not recovered.  Investigation Assessment: No. It was reported that the patient was vaccinated with Pfizer's Covid vaccine on 22Dec2020 morning around 6am Mountain Time and she was profoundly exhausted and thought that it was from the vaccine. Seriousness and causality were not provided. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Infantile spitting up, Insomnia, Maternal exposure during breast feeding
Clinical narrative: The mother was lactating; had an upset stomach; had trouble sleeping; spit up a few times which is abnormal for her; This is a spontaneous report from a contactable other health professional (mother). This other health professional reported information for both mother and baby. This is a baby report. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), transmammary (parent route: intramuscular) on 16Dec2020 10:00 at single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS), colecalciferol (VITAMIN D) and calcium. The patient's mother was vaccinated in hospital. On 18Dec2020, the mother was lactating and her baby seemed to have had an upset stomach.  She had trouble sleeping and spit up a few times which is abnormal for her.  This occurred two days after the vaccination. The mother took her to her pediatrician for this. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020509869 mother case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Body aches all over from neck to legs; severe back pain; headaches; sore ribs; a little out of breath; a little chest pain; very tired; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: elo140), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included COPD, emphysema, type 2 diabetic, arthritis in hands and knees from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced body aches all over from neck to legs, severe back pain, sore ribs, headaches, a little out of breath, a little chest pain and very tired on 22Dec2020 with outcome of unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain
Clinical narrative: Body aches all over from neck to legs; severe back pain; headaches; sore ribs; a little out of breath; a little chest pain; very tired; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: elo140), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included COPD, emphysema, type 2 diabetic, arthritis in hands and knees from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced body aches all over from neck to legs, severe back pain, sore ribs, headaches, a little out of breath, a little chest pain and very tired on 22Dec2020 with outcome of unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: he wants to know how long he is supposed to feel like sleeping all day; Lymph nodes swollen; Sore throat; loss appetite; achy; Tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient receive first dose of BNT162B2 (Batch/lot number: EL0140, Expiry Date: Mar2021), via an unspecified route of administration on 22Dec2020 10:58 at single dose (injection in to left arm) for COVID-19 immunization. Medical history included asthma from 2013 and ongoing (Started seven years ago). The patient's concomitant medications included ongoing fluticasone propionate, salmeterol xinafoate (ADVAIR) powder inhalation, 550, one puff by mouth every 12 hours for asthma. The patient experienced lymph nodes swollen, sore throat, loss appetite, achy, tired, all on 22Dec2020, feel like sleeping all day on an unspecified date. He stated he is a firefighter and received the vaccine yesterday. He initially stated he wants to know how long he is supposed to feel like sleeping all day. He later stated after getting the vaccine he had side effects. His lymph nodes were swollen, he feels achy, and tired. His lymph nodes started swelling around 4 yesterday afternoons. He started to feel better last night and today since he started moving around. He would say comparing to last night the outcome of lymph nodes swelling is about the same. He also started to experience a touch of sore throat. When he touched his lymph nodes he can tell it was swollen. He also had a loss of appetite. He stated he just did not feel like eating. He did not have lunch. He ate some little pieces of an orange and ice cream to make his throat comfortable. When he woke up this morning he is not feeling as bad as he was yesterday. He has been more active throughout the day and does not know if that had anything to do with it. Feeling tired started around 2 yesterday afternoon. The outcome of events for lymph nodes swollen, feel like sleeping all day was unknown, for sore throat, loss appetite was resolving, for other events was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Irritability
Clinical narrative: I am currently breastfeeding my 3 month old baby; Since receiving the vaccine, he has been much fussier than he normally is; This is a spontaneous report from a contactable nurse. This nurse reported information for both mother and baby. This is a baby report.   A 3-months-old male patient started to receive bnt162b2 transmammary. The 28-year-old mother received BNT162B2 (Lot Number: EK5730) dose number: 1 on Left arm at single dose on 20Dec2020 04:00PM for COVID-19 immunisation. The mother had hashimoto's and previously used Amoxicillin, had known allergies: Amoxicillin. Concomitant medication included levothyroxine sodium (SYNTHROID) and ibuprofen. The mother was currently breastfeeding my 3 month old baby, since receiving the vaccine, he had been much fussier than he normally was. This could be completely unrelated. The event onset data was provided as 21Dec2020. The events were reported as non-serious. The event outcome was unknown. No treatment received for the adverse event. Prior to vaccination, the mother was not diagnosed with COVID-19. Since the vaccination, the mother had no been tested for COVID-19.; Sender's Comments: Based on the temporal relationship and lack of an alternative etiology, the association between the reported events with BNt162b2 can not be completely excluded.,Linked Report(s) : US-PFIZER INC-2020511430 mother case
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: After my vaccine I had to sit and wait for 15 minutes. During this time my face felt tingly. I did not have any swelling or any other symptoms. Just tingling in my face around my mouth and cheeks. My; My arm was very sore for about 24 hours.; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that the 34-year-old female patient who received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer, Pfizer-BioNTech, lot: Paa156051), via an unspecified route of administration on right arm on 22Dec2020 08:00 AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history was none. Concomitant medications were none. Facility type vaccine was Hospital. No other vaccine in fourweeks. No other medications in two weeks. The nurse reported that "After my vaccine I had to sit and wait for 15 minutes. During this time my face felt tingly. I did not have any swelling or any other symptoms. Just tingling in my face around my mouth and cheeks. My arm was very sore for about 24 hours". The event started from 22Dec2020 08:15 AM. The patient recovered in Dec2020. No treatment received. No covid prior vaccination. No covid tested post vaccination. Known allergies: Not that I am aware of. The case was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Somnolence
Clinical narrative: sleepiness; dizziness; exhaustion; joint pain; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for self that the 68-year-old female patient who received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer, Pfizer-BioNTech, lot: EK5730), via Intramuscular on left Arm on 18Dec2020 08:00 AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included known allergies to medications, food, or other products: Kenalog, Omnicef. Concomitant medications were unknown. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced dizziness, exhaustion, joint pain, sleepiness from 18Dec2020 08:00 AM and outcome of recovered in Dec2020. No treatment received. No covid prior vaccination. No covid tested post vaccination. The case was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. 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. Since the vaccination, the patient has not been tested for COVID-19.