chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain in jaw, Pharyngeal swelling
Clinical narrative: throat was swelling; pain in jaw to ear; tongue was numb; could not feel her swallow reflex; blood pressure was elevated to 185/Unknown; pulse was 131bpm; aching and pain in throat area; shortness of breath; felt like the lymph nodes in her throat were achy; felt like the lymph nodes in her throat were swelling; chills; tiredness; This spontaneous case was reported by a consumer, who is a 62 year old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced throat was swelling, felt like the lymph nodes in her throat were swelling,felt like the lymph nodes in her throat were achy (Lymph node pain), pain in jaw to ear (Pain in jaw), tongue was numb (Hypoaesthesia oral), could not feel her swallow reflex (Hyporeflexia), blood pressure was elevated to 185/ unknown (Blood pressure increased), pulse was 131 bpm (Heart rate increased), aching and pain in throat area (Oropharyngeal pain), shortness of breath (Dyspnoea), chills (Chills) and tiredness (Fatigue).     The patient's past medical history included No adverse event (No medical history reported).    On 17 Mar 2021, 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 047A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 17 Mar 2021, the patient experienced felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, and chills. The patient went to the emergency room. While there, the patient's tongue was numb and she could not feel her swallow reflex, her blood pressure was elevated to 185/ unknown, pulse was 131 bpm. The patient was at the emergency room for 4 hours before the symptoms subsided. Treatment medications included prednisone for 3 days and Benadryl 50 mg every 6 hours. Since then, the patient was feeling shortness of breath and tiredness.     The outcome of the events of felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, chills, tongue was numb, could not feel her swallow reflex, blood pressure was elevated to 185/ unknown and pulse was 131 bpm was resolved on 17 Mar 2021. The outcome of shortness of breath and tiredness was unknown.   Action taken with mRNA-1273 in response to the events was unknown.; Sender's Comments: This case concerns a 62 Y/O F with serious unexpected pharyngeal swelling and NS unexpected oropharyngeal pain, jaw pain, hypoaesthesia oral, hyporeflexia, blood pressure increased, heart rate increased, dyspnea, and expected lymphadenopathy, lymph node pain, chills, fatigue. Event onset day 1 after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Feeling abnormal, Loss of consciousness
Clinical narrative: Looked awful; Almost passed out; Vision was gone; Ringing in the ears; Clammy; Dizziness; Severe fatigue; Low grade fever; A spontaneous report was received from a consumer concerning for herself, a 30-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced almost passed out/ Loss of consciousness, low grade fever/ Pyrexia, severe fatigue, dizziness, vision was gone/ Visual impairment, ringing in years/ Tinnitus, clammy/Cold sweat, Looked awful/ Feeling abnormal.  The patient's medical history included she had undergone 2 open heart surgery and was on blood thinners. Concomitant medications include blood thinners.   On 18Mar2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch/Lot number: 037A21B) via an unknown route for prophylaxis of COVID-19 infection.   On 18Mar2021, patient felt low grade fever. On 19Mar2021, patient had severe fatigue, dizziness and both were ongoing. On 20Mar2021 the patient stated that she almost passed out, my vision was gone, ringing in the ears and clammy (lasted 20 mins). On 22MAR2021 the patient was sent home from work because she looked awful. The event almost passed out was considered as medically significant. Treatment for the events was unknown.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of the event low grade fever was resolved on 18Mar2021.The outcome of the events, almost passed out, vision was gone, ringing in years and clammy, were resolved on 20Mar2021. The outcome of events severe fatigue, dizziness was not recovered. The outcome of the event Looked awful was unknown, at the time of this report.; Reporter's Comments: This case concerns a 30 Y/O F with PMH cardiac surgery, had a serious unexpected event of loss of consciousness and nonserious unexpected dizziness, feeling abnormal, tinnitus, cold sweat, visual impairment and expected pyrexia and fatigue. Event onset Day 5 after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus, Visual impairment
Clinical narrative: Looked awful; Almost passed out; Vision was gone; Ringing in the ears; Clammy; Dizziness; Severe fatigue; Low grade fever; A spontaneous report was received from a consumer concerning for herself, a 30-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced almost passed out/ Loss of consciousness, low grade fever/ Pyrexia, severe fatigue, dizziness, vision was gone/ Visual impairment, ringing in years/ Tinnitus, clammy/Cold sweat, Looked awful/ Feeling abnormal.  The patient's medical history included she had undergone 2 open heart surgery and was on blood thinners. Concomitant medications include blood thinners.   On 18Mar2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch/Lot number: 037A21B) via an unknown route for prophylaxis of COVID-19 infection.   On 18Mar2021, patient felt low grade fever. On 19Mar2021, patient had severe fatigue, dizziness and both were ongoing. On 20Mar2021 the patient stated that she almost passed out, my vision was gone, ringing in the ears and clammy (lasted 20 mins). On 22MAR2021 the patient was sent home from work because she looked awful. The event almost passed out was considered as medically significant. Treatment for the events was unknown.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of the event low grade fever was resolved on 18Mar2021.The outcome of the events, almost passed out, vision was gone, ringing in years and clammy, were resolved on 20Mar2021. The outcome of events severe fatigue, dizziness was not recovered. The outcome of the event Looked awful was unknown, at the time of this report.; Reporter's Comments: This case concerns a 30 Y/O F with PMH cardiac surgery, had a serious unexpected event of loss of consciousness and nonserious unexpected dizziness, feeling abnormal, tinnitus, cold sweat, visual impairment and expected pyrexia and fatigue. Event onset Day 5 after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Gait disturbance, Muscular weakness, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: muscle weakness in her legs; oxygen level was low; could not get up or walk; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (oxygen level was low), GAIT DISTURBANCE (could not get up or walk) and MUSCULAR WEAKNESS (muscle weakness in her legs) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Mar-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen level was low) (seriousness criterion hospitalization) and GAIT DISTURBANCE (could not get up or walk) (seriousness criterion hospitalization). On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness in her legs) (seriousness criterion hospitalization). The patient was hospitalized from 14-Mar-2021 to 17-Mar-2021 due to GAIT DISTURBANCE, MUSCULAR WEAKNESS and OXYGEN SATURATION DECREASED. The patient was treated with Rehabilitation therapy for Gait disturbance. At the time of the report, OXYGEN SATURATION DECREASED (oxygen level was low), GAIT DISTURBANCE (could not get up or walk) and MUSCULAR WEAKNESS (muscle weakness in her legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood test: normal (normal) Normal. On 13-Mar-2021, Oxygen saturation: low (Low) Low.         No concomitant medications were reported.  The treatment information included oxygen for 2-3 days.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint pain, Vaccination site pain
Clinical narrative: arm where she received the injection is really hurting bad to the elbow/felt sore on her arm where the first dose was placed in and it is like on side and right on her elbow; arm where she received the injection is really hurting bad to the elbow/felt sore on her arm where the first dose was placed in and it is like on side and right on her elbow; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248), first dose via an unspecified route of administration, administered in Arm on 29Jan2021, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, Sjogren's, Lung problems, from an unknown date. The patient had a flu shot and experienced sore on her arm. Concomitant medications included mycophenolate mofetil hydrochloride (CELLCEPT); insulin (INSULIN); sitagliptin phosphate (JANUVIA). Patient experienced her arm where she received the injection is really hurting bad to the elbow, she took Tylenol and she would like to know if she can put heat on the site to decrease the pain. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site irritation
Clinical narrative: local site irritation; the injection received may have been subcutaneously and not intramuscularly; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the BNT162B2 (BNT162B2, Solution for injection, lot number and expiry date not reported), subcutaneously, on an unspecified date at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The pharmacist reported that concerns were raised if a health care provider was given vaccine SQ (subcutaneous) versus IM (intramuscular). They were investigating if needle went deep enough. The person in question seems ok other than local site irritation and was concerned that they may not have full immunity. One of their physicians, the  medical officer reported that the injection received may have been subcutaneously and not intramuscularly. They stated the administration wasn't deep enough. Outcome of the event local site irritation was unknown.  Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Swelling of eyelid
Clinical narrative: There's a tiny bit of irritation in the outside corner of my left eye; eyelid is swollen; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 29Jan2021 10:00 (lot number: EL9261) as single dose (at the age of 66-years-old) for covid-19 immunization, administered in public health department. Medical history included seasonal allergies. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX, GlaxoSmithKline) on 08Jan2021, lot number: GM2Y4, second dose in the left arm taken for immunization; rhodiola rosea (RHODIOLA) taken for an unspecified indication, start and stop date were not reported; loratadine (LORATADINE) taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; fluticasone (FLUTICASONE) taken for an unspecified indication, start and stop date were not reported.  The patient previously took lanolin and experienced rash. The patient was not diagnosed with COVID-19 prior to vaccination. On 29Jan2021 at 22:00, the patient experienced a "tiny bit of irritation in the outside corner of my left eye and the eyelid was swollen". The patient has seasonal allergies, so this could be releted to that. Although, the patient has never had swollen eyelid issue before. The patient has not been tested for COVID-19 since the vaccination. The events were considered non-serious by the reporter. The event did not result in death, not life-threatening, did not require hospitalization, was not disabling and did not contribute to a congenital anomaly/birth defect. No treatment was received for the events. The patient has not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient herself).   A 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the left arm  on 28Jan2021 08:15 (at the age of 85-years-old) at a single dose for COVID-19 immunisation. Medical history included sinus disorder. Concomitant medications included mirtazapine (manufacturer unknown), montelukast (manufacturer unknown); and atorvastatin (manufacturer unknown) all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced nausea and vomiting on 28Jan2021 12:15 and the whole evening. Patient was okay in the morning. Events were assessed as non-serious. Treatment was not received for the events. The outcome of events reported was recovered on 29Jan2021. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Oropharyngeal pain, Vomiting
Clinical narrative: diarrhea; throwing up; sore throat; This is a spontaneous report from a contactable consumer (patient) via the 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, on 26Jan2021, at a single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of Covid vaccine on Tuesday, 26Jan2021. She called in to report that last night on 29Jan2021 she had diarrhea, was throwing up and, has a sore throat. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up this morning (unspecified date) with body aches and chills after receiving COVID-19 vaccine wanted to know if these are normal side effects. The outcome of the events was unknown. No follow-up attempts are completed. No further information is expected. Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo, Vision blurred
Clinical narrative: vertigo; dizziness; blurred vision; This is a follow up spontaneous report from a contactable consumer (Patient). A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation. Medical history included none. No concomitant drugs were reported. On 05Feb2021 16:35, The patient experienced vertigo, dizziness and blurred vision on unspecified time. Consumer says she just had her first dose of the Pfizer COVID-19 vaccine around 03:00-03:15PM today, and then about 20 minutes ago she had vertigo, or a dizzy spell then bad blurred vision. She says she feels normal or feels ok now, but it took like 5 minutes to get better, maybe 10-15 minutes. Consumer says she would like to know if this is normal, or if she should seek medical attention. she has had no recent vaccinations and is on two meds but they are not new, she has taken them 6 months already. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event was recovered.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 30Jan2021 08:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 01Feb2021 07:00 AM patient experienced rash and welts mostly on right arm. Some on other parts of body. Patient did not have COVID-19 prior vaccination, Patient did not COVID-19 tested post vaccination. Outcome of the event was not recovered. Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: she was diagnosed with COVID-19 by rapid test; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 3 patients. This is 1st of 3 reports. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264, Expiration date: 31May2021), via an unspecified route of administration on left arm on 28Jan2021 09:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, on 31Jan2021, she was diagnosed with COVID and went for monoclonal infusion. She asked if she can still get her second dose of the Pfizer COVID-19 Vaccine as scheduled on 18Feb2021. Results of tests and procedures for investigation of the patient on 25Jan2021 by COVID-19 Rapid test was negative, on 25Jan2021 by COVID-19 PCR test was negative, on 26Jan2021 by COVID-19 Rapid test was negative, on 26Jan2021 by COVID-19 PCR test was negative, and on 31Jan2021 by COVID-19 Rapid test was positive. The patient was not hospitalized but was in emergency room/Physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021133627 same reporter/ vaccine, different patient, similar AE
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 30Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the BNT162B2 on 30Jan2021. He was scheduled for the second dose in a couple of weeks and he found out today he has tested positive for COVID 19. It was questioned that can he get the second dose as scheduled. Outcome of the events were unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: malaise; severe arm pain at the injection site; severe right shoulder pain near the point of injection, to the point he cant move the arm and it is very stiff; severe right shoulder pain near the point of injection, to the point he cant move the arm and it is very stiff; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 04Feb2021 11:30 (Batch/Lot Number: EL9262) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus Had this for 7-8 years. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. The event reported was severe right shoulder pain near the point of injection, to the point he cant move the arm and it is very stiff. Caller states his pain level was a 9-10 but then corrected this to say it was actually an 8 out of 10 or maybe a little better. The arm pain started on the day he got the injection, 04Feb2021, around 6pm and was noticed to be severe the next day, 05Feb2021. At this point, the pain is about the same since getting severe. He had been taking ibuprofen which he had taken 5 times and acetaminophen which he had taken once. The patient had also used ice and heat for the pain. He also experienced malaise which was very minor. This started the after the shot and he just didn't feel good that day. It resolved that a same day. The caller's wife explained that the pain was so intense it was causing him to be close to screaming because he cant use it, and that is not like him. He explained that he is hoping it will get better soon. It was worse at night, it started out ok in the morning but as the day progresses it build up. Caller asked how long will this last. Caller received the Pfizer-BioNTech COVID-19 Vaccine Dose 1 last Thursday, 4FEB2021 and is scheduled for their Dose 2 on 25FEB2021. Caller reported to have experienced severe arm pain at the injection site. They wanted to know how long does this side effect usually last and what he should do about the side effects, whether he could proceed with the 2nd shot. AE(s) did not require a visit to Emergency Room/Physician Office. Relevant Tests was none. No Investigation Assessment. Outcome of the event malaise was recovered on 05Feb2021 and other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: pain around her neck; This is a spontaneous report from a contactable physician. A female patient of a age 34, unit was unknown received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. was not reported), dose 1st subcutaneous on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced a lot of pain around her neck. Reporter would like to verify if there's a concern getting the second dose of the vaccine. Reporter like to know if there's updated information on the duration of protection after receiving the Pfizer-BioNtech Covid-19 vaccine, if there's information on the other data on transmissibility of the virus in people who has been vaccinated. Also, if there's any updated information from the Phase 3 trials population who tested positive for Covid-19. The number of individuals who have tested positive since the vaccine and the quantity of virus detected, and also if if there's updated information on the transmissibility of the virus in people who has been vaccinated with the Pfizer-BioNtech Covid-19 vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lipase, Lipase increased, Myalgia, Platelet count
Clinical narrative: her blood platelet count was lower; Lipase count was up; she has muscle, pain joint; she has muscle, pain joint; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included osteoarthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that she took the Pfizer COVID vaccine and her blood platelet count was lower than usual. Lipase count was up and she has muscle, pain joint. Outcome of events was unknown. Events reported as non-serious.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: her blood platelet count was lower; Lipase count was up; she has muscle, pain joint; she has muscle, pain joint; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included osteoarthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that she took the Pfizer COVID vaccine and her blood platelet count was lower than usual. Lipase count was up and she has muscle, pain joint. Outcome of events was unknown. Events reported as non-serious.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: feeling itching and redness on the same arm as injection was given; feeling itching and redness on the same arm as injection was given; feeling itching and redness on the same arm as injection was given; feeling itching and redness on the same arm as injection was given; This is a spontaneous report from a contactable 86-year-old female consumer reported that she received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EN5318), via an unspecified route of administration on 30Jan2021 at single dose in deltoid left for covid-19 immunization. The patient medical history and concomitant medications were reported. On 07Feb2021, she experienced feeling itching and redness on the same arm as injection was given and the injection was on the left side in the shoulder area. The patient took an allergy tablet and it put her to sleep and she took Benadryl, and it helped the itching, but it put her to sleep too. The outcome of the events was resolving.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lethargy, Pain in extremity
Clinical narrative: Skin bright red from neck down to below buttocks back and front; Down both arms; Very lethargic the entire day; This is a spontaneous report from a contactable consumer or other health care professional (patient herself) of 79-years-old female non pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, Expiration number: not reported) via an unspecified route of administration on 04Feb2021 14:45 (at the age of 79-years) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not known to allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, patient experienced skin bright red from neck down to below buttocks back and front, down both arms and patient felt very lethargic entire the day. No therapeutic measures were taken for the events occurred. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Pustule
Clinical narrative: itching; Little red pustules would swell into a whitehead, burst & scab over; Pretty soon my whole body was covered in these red marks; This is a spontaneous report from a contactable consumer. A 69-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection via unspecified route of administration on Left arm on 22Jan2021 14.30 at single dose for covid-19 immunization. other medical history includes Asthmatic, anemic, HBP, osteoarthritis, hypothyroidism, reflux, and allergic to Demerol. Other medications received in two weeks are acetaminophen 650 tablets. Calan SR, losartan, Si. It was reported that the day after the injection, I started itching - terribly! Little red pustules would swell into a whitehead, burst & scab over. Pretty soon my whole body was covered in these red marks & I was itching constantly!!!!! I had to take, plus get up in the middle of night, to take a Benadryl tablet each time to help me. It has been 2 ½ weeks now, and I am still itching constantly. Red Pustule development has lessened - finally. I'm actually hesitant to get the next inj scheduled in 5 days. I'm afraid these symptoms are going to magnify greatly. On 22Jan2021 14.30 adverse event was started and did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Not recovered".
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer. A 64-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration in arm right on 8Feb2021 at 19:00 as single dose for covid-19 immunisation. Medical history included diabetes mellitus, palpitations, hyperlipidaemia and diverticulum. Concomitant medications included metformin, aspirin [acetylsalicylic acid] (Aspirin [Acetylsalicylic Acid]), atorvastatin, diltiazem and cinnamomum verum (Cinnamon). Patient did not receive other vaccine in four weeks.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 08Feb2021 at 20:00, heart palpitations but I get those frequently. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Extreme fatigue; dizziness; This is a spontaneous report from a contactable consumer (patient reported herself). A 54-year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EN9581) via an unspecified route of administration on 05Feb2021 10:45 AM at single dose to her left arm for Covid-19 immunization. The patient's medical history included asthma. No known allergies were reported. Other medications in two weeks reported as yes. Historical vaccine included first dose of (COVID 19, Pfizer, Lot number: EL8982) on 15Jan2021 10:45 AM at single dose to her left arm for Covid-19 immunization. Facility type Vaccine: Workplace clinic. On 06Feb2021 10:00 AM, the patient experienced extreme fatigue and dizziness starting day after vaccine and still had four days later. Covid was not tested prior or post vaccination. The patient did not take any treatment in response to the events. Outcome of the events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hot flush, Nausea, Oropharyngeal pain, Vaccination site pain
Clinical narrative: nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in my left arm; This is a spontaneous report from a contactable consumer or other non hcp.  A 76-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9264; Expiration Date: unknown), dose 1 via an unspecified route of administration in Arm Left on 04Feb2021 09:00 as SINGLE DOSE for COVID-19 immunization.  Medical history was unknown. There were no concomitant medications. The patient experienced slight soreness at injection site in my left arm (vaccination site pain) on 04Feb2021 with outcome of recovered, feel a little punk on 08Feb2021 with outcome of unknown, nausea, hot flashes, slight sore throat on 09Feb2021 with outcome of not recovered. The patient is scheduled for the second dose on 25Feb2021.  No follow-up attempts are possible. No information is required.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: following tested positive for SARs-COV-2; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reported herself) reported that a 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EK4176) via an unspecified route of administration on 20Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "received first dose 20Jan2021, 3 days following tested positive for SARs-COV-2. Looking for guidance on second dose. Potential duplicate AE". She tested positive after she took the first dose of vaccine. It was said that, on 20Jan2021 she got the first dose of the vaccine and then after three days she tested positive for COVID 19. She spent 14 days in quarantine, and she was asking if she could take the second dose tomorrow. She said she was totally fine. Agent said the caller got disconnected three times trying to get to DSU. The caller confirms the details provided by the transfer agent. Caller confirmed product is Pfizer COVID 19 vaccine. Her primary care was not who tested her she went to an urgent care to get tested. She consulted her doctor office once when some things were happening, she went to a nurse practitioner. She did not know her weight. She confirmed her first dose of the vaccine was 20Jan2021 and she clarified it was 24Jan2021 that she tested positive for COVID 19. She needed to find her card she had it in one spot and she moved it because she took it with her when she went to get her test done. She just thought that she was just having side effects she had a little headache, she was tired and that went on Friday and Saturday and then on Sunday she was just beyond exhausted, she could not get out of bed and while eating dinner she completely lost her sense of taste and smell and that is what prompted her to go get tested. Product details included she did not see an expiration date or NDC number on the card. Outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Right arm pit is swollen. Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is; Lymph nodes are sore and puffed up. Big noticeable bubble where armpit is; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9264), via an unspecified route of administration on Right arm on 08Feb2021 12:00 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included back disorder and Chronic back problems. Concomitant medications within 2 weeks of vaccination were not reported. No Allergies to medications, food, or other products was reported. The patient experienced right arm pit is swollen, lymph nodes are sore and puffed up and big noticeable bubble where armpit is on 09Feb2021 05:00. The patient did not receive any treatment for the event. 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. The outcome of events were not recovered.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal enanthema, Throat irritation
Clinical narrative: Have a rash on my throat, just on the front part of my throat; It itches; Have a rash on my throat, just on the front part of my throat; It itches; This is a spontaneous report from a contactable consumer (patient). A 85-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9261), via an unspecified route of administration on 21Jan2021 (at 85-year-old) as single dose for COVID-19 immunization. Medical history included rashes. The patient's concomitant medications were not reported. The patient got vaccinated on 21Jan2021 and last, within a week, about a week, still she was having some rash on her throat (Jan2021). She had the vaccine on 21Jan2021, she thought and from last few days she was having rash on her throat. She just wanted to report that, she don't know, it has been better sometimes but she have been having it from three or four days now and she just wondered if they might want to know or Pfizer might want to know that she does have a rash on her throat, just on the front part of her throat. The patient got some topical itch medicine as it itches (treatment). Weight was reported as about 112 or 114 pounds. The outcome of the events was unknown. When probed if there is a relationship between consumer experiencing rash and Covid vaccine, consumer stated that she was not sure because she have had some rashes on other places and that was before this. So, she was not sure.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Chills, Feeling abnormal, Pyrexia
Clinical narrative: I just feel it is like had a weigh on my entire body/ I am feeling like I got run over; Chills; Fever; This is a spontaneous report from a contactable nurse (patient). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Jan2021 16:00 at single dose for COVID-19 immunisation. The patient had no medical history and no concomitant medications. On 30Jan2021, when he woke up in the morning, he felt like had a weigh on his entire body and got up and he just instantly started having chills, and fever usual (statement incomplete). He looked at all the symptoms of getting the vaccine and he had like 98 percent of them that was just normal, just like a flu. But he was travelling tomorrow morning at 5am and he don't want to travel right now. He still have a fever on and off. He doesn't know if it was safe enough to go on a plane after getting my first dose and how long the symptoms will last. The patient felt like he got run over. His wife got her second dose a couple of days ago and had really bad reactions like flu and could not move all day and that was a Moderna one. Patient stated that he was 6 ft; however, not appropriately paraphrased and clarified. The patient received unspecified treatment for the events. The patient considered a causality between the event because of the vaccine. Outcome of event fever was not recovered; outcome of the rest of events was unknown.  Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hot flush, Nausea, Throat tightness
Clinical narrative: Lastly my throat got really tight; Face, neck, and chest got flashed; nauseous; fussy; This is a spontaneous report from contactable consumer (patient) communicated to Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection, lot number: unknown, expiration date; unknown), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced face, neck, and chest got flashed, nauseous, fussy, lastly throat got really tight on unspecified date. HCP said wait 15 mins, the symptoms will go away. The patient waited for 15 mins and then symptoms disappeared after 1.5 hrs. The patient called because she had an adverse event to the vaccine, but call was disconnected will Fax. The outcome of event was not recovered.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy
Clinical narrative: she felt lethargic; had a terrible headache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patients second dose scheduled on 11Feb2021 and was asking if she can take the vaccine earlier. On an unspecified date, the patient felt lethargic and had a terrible headache. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Body temperature increased, Dizziness, Injection site warmth
Clinical narrative: Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; arm swollen; back hurts; hot where she got the injection; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0142), via an unspecified route of administration on Left arm on 08Feb2021 at single dose for covid-19 immunisation. Medical history included Flu on an unspecified date. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), at single dose for covid-19 immunisation. The patient reports, she received her second shot yesterday and her arm hurt like any shot would. She says today she feels really sick, after being fine yesterday. She says today she is dizzy and lightheaded. She says she took Advil, her temperature was 101 degrees Fahrenheit even with Advil, and every time she gets up she feels lightheaded and shaky. She says her back hurts when the Advil wears off, it is ok now because she is laying down, and she also feels a little nauseous. She says that her arm is swollen and hot where she got the shot, and this started today. She says that yesterday it just hurt like she got the flu shot. She says that she took Advil 200mg, she took two of them this morning at 06:00AM or 07:00AM, and then two more at 01:00PM. LOT: DY3057, EXP: May2023. She says by 11:00AM her fever was 101 degrees Fahrenheit, and now with the Advil it is 100.7 degrees Fahrenheit. Caller says that her lightheadedness and shakiness feel about the same. The seriousness was reported as non-serious. The outcome of the events unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; arm swollen; back hurts; hot where she got the injection; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0142), via an unspecified route of administration on Left arm on 08Feb2021 at single dose for covid-19 immunisation. Medical history included Flu on an unspecified date. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), at single dose for covid-19 immunisation. The patient reports, she received her second shot yesterday and her arm hurt like any shot would. She says today she feels really sick, after being fine yesterday. She says today she is dizzy and lightheaded. She says she took Advil, her temperature was 101 degrees Fahrenheit even with Advil, and every time she gets up she feels lightheaded and shaky. She says her back hurts when the Advil wears off, it is ok now because she is laying down, and she also feels a little nauseous. She says that her arm is swollen and hot where she got the shot, and this started today. She says that yesterday it just hurt like she got the flu shot. She says that she took Advil 200mg, she took two of them this morning at 06:00AM or 07:00AM, and then two more at 01:00PM. LOT: DY3057, EXP: May2023. She says by 11:00AM her fever was 101 degrees Fahrenheit, and now with the Advil it is 100.7 degrees Fahrenheit. Caller says that her lightheadedness and shakiness feel about the same. The seriousness was reported as non-serious. The outcome of the events unknown.  Information on the lot/batch number has been requested.