chrisvoncsefalvay/vaers-outcomes huggingface dataset:
absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; Increasing fatigue and shortness of breath; Increasing fatigue and shortness of breath; absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells; This is a spontaneous report from a health care professional, the patient.  A 75-years-old non-pregnant female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration from in the right  arm on 29Jan2021 at 13:30 (at the age of 75-years-old) as a single dose, for COVID-19 vaccination.  Medical history included heart valve replacement (under the care of cardiologist for heart valve leakage  causing some shortness of breath &  fatigue, but was manageable), thyroid cancer, breast cancer female and tricuspid valve disease. Patient did receive concomitant medications in two weeks but details were not provided. The patient previously took penicilin and experienced drug hypersensitivity.. No other vaccines were given within 4 weeks.  Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 01Feb2021 at 12:00, The patient experienced  absolute neutropenia (medically significant)   and  relative lymphocytosis, normocytic anemia and a typical monocular cells, and increasing fatigue and shortness of breath (in 2 weeks since vaccine on 29Jan2021; almost debilitating). The patient underwent lab tests included Blood test 4 months earlier results were normal on an unspecified date, Blood Test during routine check-up on 02Jan2021, revealed absolute neutropenia, relative lymphocytosis, normocytic anemia and a typical monocular cells. . No treatment was given for the events. Consumer inquired if the  vaccine can contribute to increase in fatigue and shortness of breath and new blood work reading. The clinical outcome of the events absolute neutropenia, lymphocytosis, normocytic anemia and a typical monocular cells,  and increasing fatigue and shortness of breath was not recovered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 11Sep2022 at 12:00 as dose number unknown, single at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2023, outcome "recovering", COVID-19 (medically significant) with onset Jun2023, 9 months 21 days 12 hrs after the suspect product(s) administration, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered for COVID-19 treatment from 24Jun2023 to 28Jun2023. No follow-up attempts are possible. No further information is expected.
Sore arm; Stuffy nose; Cough; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffy nose), COUGH (Cough), MYALGIA (Body aches) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 096b21a and 032b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffy nose), COUGH (Cough), MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffy nose), COUGH (Cough), MYALGIA (Body aches) and FATIGUE (Fatigue) had not resolved.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information was not provided.
This spontaneous report received from a patient via other manufacturer concerned an adult female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number and expiry date  were not reported) 1 total, dose was not reported, administered on 2021 for covid-19 prophylaxis. On an unspecified date, the patient experienced grip strength decreased/cant grab things, covid-19, and painful hand (Dose number in series 1). The outcome of the painful hand, grip strength decreased/cant grab things and covid-19 was not reported. The patient received covid-19 vaccine ad26.cov2.s second dose (Dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown), third dose (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, both doses administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The product was associated with Off label use (off label dosing frequency) (Dose number in series 2). No concomitant medications were reported. The patient received non-company suspect drugs included: upadacitinib (Rinvoq) (form of admin unknown, oral, batch number was not reported) dose was not reported, therapy dates were not reported for moderate to severe rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220805946 (dose number in series 1).
Initial information and follow up has been received from a physician for the pregnancy registry for GARDASIL concerning a 24 year old female who on 21-May-2008, was vaccinated with her second dose of GARDASIL (lot# 659655/1486U) and found out on 27-May-2008 that she was pregnant. The patient's estimated LMP was 28-Apr-2008. Follow up information was received which reported that patient's concurrent medical condition included hypertension, and the patient smoked half a pack of cigarettes per day during pregnancy. Concomitant therapy included Tylenol and vitamins (unspecified). The  patient had ultrasounds (no results reported) and blood test positive for down's syndrome (however the baby was normal). During pregnancy she developed anemia, platelets decreased, vomiting and dehydration. On 27-Dec-2008, 35 weeks gestation, the patient gave birth to a female infant weighing 5 pounds and 5 ounces. The length was 19 inches. The infant was normal. There was no congenital anomaly. There were n complications during delivery. No further is available
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022 at 6:54 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Sep-2022 at 6:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    Concomitant product use was not provided by the reporter.  Dose 4 anatomical site was also reported as deltoid.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.  No adverse reactions were reported for patient at the time of the report.  Treatment information was not provided.
Due to COVID / second dose / 7 months and one week after the first; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: This case was reported by patient for herself/himself. The age at vaccination was not reported. The patient due to COVID had to took his/her second dose of Shingrix vaccine 7 months and one week after the first dose which led to social problem. The reporter asked whether his/her immunization good or do he/she need to restart the series.
Guillian-Barre Syndrome.  My mom was in ICU for 2 weeks with compromised respiratory system, fully intubated, blood pressure and full paralysis. Still not able to move her legs,.
Had an odd side effect after the Moderna vaccines/Phantosmia an odd smell no matter where I am; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Had an odd side effect after the Moderna vaccines/Phantosmia an odd smell no matter where I am) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Had an odd side effect after the Moderna vaccines/Phantosmia an odd smell no matter where I am). At the time of the report, PAROSMIA (Had an odd side effect after the Moderna vaccines/Phantosmia an odd smell no matter where I am) had resolved.            No concomitant medications were reported. No treatment information was provided.  The patient stated that after 2nd vaccine, the symptom took at least a month to go away.   This case was linked to MOD-2021-419291 (Patient Link).
After receiving the booster vaccine I had am pain. When I caught covid the first time I had a temperature of 100.1, chills, bad headache, and I was extremely tired. I lost 7 lbs. in a week from not eating much. I just felt out of it. I lost my smell for 3 months, and I lost my taste for 2 and a half months. The fatigue lasted a very long time as well. My heartbeat got so fast that I went to the ER. They said I had covid and it affected my heart. It also affected my hearing because I lost half of my hearing in my left ear. Then I went to Facility and found out that I caught covid for the second time. I had a bad headache, very tired,  sneezing a lot, my nose was running, fever, and my heart was skipping. I felt worn out. I'm still fatigued. I get tired very easily now. Then I started to urinate blood, and I have blood clots in my urine now. The doctors thought it was stones, but then they said I didn't have any. Then they thought that it was my bladder lining, but my bladder lining is okay. They had gave me antibiotic but then told me to stop taking that medication because I didn't have an infection. So now they are testing to see if I have cancer cells in my urine.
A male pt reported that he received a dose of Adenovirus Vaccine Live Oral Type 4, Adenovirus Vaccine Live Oral Type 7, Poliomyelitis virus and Influenza Bivalent vaccines on 2/4/75 when he was in the military. The pt noted that his medical records indicate that a "couple of days" after vaccination, he developed "nose bleeding and neck adenopathy". He also reported that he has been dx'd with chronic Hepatitis C. The reporter indicated that "his neck is swollen to this day". Additional information received on 7/11/00 included the pt's medical records which indicated that the pt had recurrent nose bleeds from his right nostril, his throat was inflammed and had neck adenopathy.
Vomiting and explosive diarrhoea for 4 hours; Vomiting and explosive diarrhoea for 4 hours; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hernia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 02:00, the patient experienced vomiting and explosive diarrhoea for 4 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events vomiting and explosive diarrhoea for 4 hours was resolving at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I26.99 ACUTE PULMONARY EMBOLISM 12/22/2021 COVID-19 PNEUMONIA I95.9 HYPOTENSION 12/22/2021 COVID-19 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/22/2021 COVID-19 PNEUMONIA
Headache; Tiredness; Nausea; Weakness; Dizziness; Pain; Stiffness; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 18:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, hypothyroidism, endometriosis, depression, anxiety and ADHD, penicillin allergy from an unknown date, COVID-19 on an unspecified datea. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), sertraline (MANUFACTURER UNKNOWN), and nitrofurantoin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 18:30 the patient experienced headache, tiredness, nausea, weakness, dizziness, pain and stiffness. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events headache, tiredness, nausea, weakness, dizziness, pain and stiffness was resolving at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling and erythema of left deltoid1 day after vax given. + pruritus. Cellulitis noted 20 after vax received.
Swelling from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Redness from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Pain from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; Tingling from the injection site (right arm) which radiates all the way to the customer's forearm and wrist; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 13th May 2022) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix. On 10th October 2020, 3 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities, pain in arm and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient had received vaccine at right deltoid and around 10th October 2020, the patient had reported swelling, redness, pain, tingling from the injection site (right arm) which radiated all the way to the patient's forearm and wrist. The swelling was more at the upper arm upto the elbow and only slight swelling was there below the elbow. The patient had also reported that she was in lot of pain a day before the reporting date, but  the pain had improved on the reporting date. The reporter consented to follow-up and fax details were provided.
Developed red rash on both wrists within 1 hour of vaccine.  Within 4 hours of vaccine, red rash developed on buttocks, upper thighs (front and back).  Not itchy or painful.
headache on right side of head; back went out from right side and cannot bend over; right leg hurts; right foot tingles; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (lot number: EK4176, administration time: 02:00 PM on left arm). The patient previously took levofloxacin (LEVAQUIN) and cefalexin (KEFLEX) and experienced allergies to medications. On 30Jan2021 10:00 PM, the patient experienced headache on right side of head, back went out from right side and cannot bend over, right leg hurts and right foot tingles. No fever. No treatment was received for the adverse events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
On day 9 I had a red bullseye circle around injection site that is itchy and painful.
hives; Swelling of eyes, face; Swelling of eyes, face; Mouth swelling; pressure on her throat with little interruption in her breathing; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, one week after the vaccination, the patient experienced hives. patient also had eye and mouth swelling, and pressure on her throat. She stated the patient had little interruption in her breathing with the pressure on her throat. Patient received 2 Advil as a treatment for events and was just managing her symptoms. Caller asked, should the patient get the second COVID-19 Vaccine shot based on the side effects the patient experienced after the first COVID-19 Vaccine dose. She said the patient's side effects just seemed like hives, and the patient had no difficulty breathing. She said she had read not to get the second COVID-19 Vaccine if there were severe side effects within 4 hours of receiving the first COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up: (29Jul2021): This follow-up is being submitted to notify that the new information is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.