chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After getting the 2nd shot they felt like they do after they get the flu shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After getting the 2nd shot they felt like they do after they get the flu shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant. Concurrent medical conditions included Cancer (Former cancer patient).   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (After getting the 2nd shot they felt like they do after they get the flu shot). At the time of the report, VACCINATION COMPLICATION (After getting the 2nd shot they felt like they do after they get the flu shot) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was not sure whether or not patient considered to be immunocompromised.
Cellulitis on right upper arm. Sx's: erythema, warmth, tenderness at injection site, one week after injection - treated with Doxycycline 100mg BID x 10days.
Fell UNCONSCIOUS, stopped breathing,  wife revived me with CPR. when falling,  sprained left ankle and leg and left foot Went to hospital by ambulance,  diagnoses:  suspected blood clots in left leg and ankle and foot..  D Dimer reading very elevated.
STIFF LEFT ARM, HOARSENESS, GENERAL BODY PAIN AND SORE THROAT. PATIENT WAS ADVISED TO TAKE BENADRYL TO HELP WITH ALLERGIC REACTION AND TYLENOL TO HELP WITH PAIN AND WAS ADVISED TO GET MEDICAL ATTENTION IF THEY HAVE ANY TROUBLE BREATHING.
Severe headache started second day after vaccination. Treated with OTC pain medication.  Headache subsided on 6th day.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-APR-2017, the patient was vaccinated with the expired dose of PROQUAD (lot # L032759, expiration date 24-FEB-2017; dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Severe burning chest pains extending to arms and upper body on days 2 and 3. Body aches, low grade fever on days 3 and 4.
Pain and swelling at the point of injection. There were 2 small red spots that was encapsulated what appeared to be a blister. For a couple of days I was unable to keep a grip on anything I held with my left hand. I could grab an item and hold it for a while, but would loose hold of it and drop it.
Fever 102°F lasting over 16 hours. Fever 99°F+ lasting over 48 hours. Chills and body-wide muscle aches the first overnight. Rest and fluids was treatment.
fatigue; congestion; runny nose; cough; headache; temp 100; PCR test positive for COVID; PCR test positive for COVID; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: EW0187) at the age of 58 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and administration date 25Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogrens syndrome" (unspecified if ongoing); "history of breast cancer with lumpectomy" (unspecified if ongoing); "bilateral spinal fusion" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing); "rhinoplasty" (unspecified if ongoing); "Epstein Barr" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "bee stings" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; ATORVASTATIN; CALCIUM. Past drug history included: Erythromycin, reaction(s): "Allergy: erythromycin", notes: erythromycin, bee stings. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "recovering" and all described as "PCR test positive for COVID"; IMMUNISATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 28Dec2021, outcome "recovering", described as "fatigue"; NASAL CONGESTION (non-serious) with onset 28Dec2021, outcome "recovering", described as "congestion"; RHINORRHOEA (non-serious) with onset 28Dec2021, outcome "recovering", described as "runny nose"; COUGH (non-serious) with onset 28Dec2021, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 28Dec2021, outcome "recovering", described as "headache"; BODY TEMPERATURE INCREASED (non-serious) with onset 28Dec2021, outcome "recovering", described as "temp 100". The events "pcr test positive for covid", "pcr test positive for covid", "fatigue", "congestion", "runny nose", "cough", "headache" and "temp 100" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (28Dec2021) 100; sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue, nasal congestion, rhinorrhoea, cough, headache, body temperature increased.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19. Prior to vaccination and Since the vaccination, has been tested for COVID-19. Treatment received for adverse events are Prednisone, doxycycline and promethazine DM.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events  cannot be completely excluded.
received dose from vial expired 5 days before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician concerning an 18 year old female who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) and she had no reaction after her initial GARDASIL vaccine (yeast). On 03-SEP-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). Four days post vaccination, on 07-SEP-2008, the patient developed what she described as a "hives". At the time of the report, the patient was "still itching with the hive/rash covering for whole body". She had been prescribed unspecified steroids to treat the reaction. Additional information has been requested.
Patient endorses diffuse migratory muscle and joint pain and difficulty with bilateral grip strength since receiving Shingrix and Pneumovax vaccines on 11/27/2020. Has had difficulty making fist with hands despite OT sessions. At one point, pain was so debilitating that she couldn't get out of  bed for days. Pain has improved somewhat but still having difficulty making a  fist and having intermittent swelling of the joints of her hands.
Patient had vasovagal episode, losing consciousness for a few seconds. Patient became conscious quickly but remained uncommunicative for an extended period. It took over 30 minutes for patient to feel better. Did walk out of office with mom and sister
Nausea, abdominal pain, vomiting, severe headache, chills, shivering, shaking, profuse sweating, dizzy, crying I hurt so bad. It is now the 24th of April at Noon. I am feeling somewhat better. Mild chills, nausea not quite as bad, dizzy, moderate to severe headache, sweating and shivering off and on, but not as bad as last night. I am taking 1 g of acetaminophen every 4-6 hours. Attempting to drink water. Sleeping off and on. No vomiting as of yet/that stopped around 1 a.m.
Temperature that started low grade in afternoon then increased to 102 then 104 degrees. Cough, rhinorrhea and increase in respirations reported to nurse upon arrival to office. Patient was diagnosed with an Otitis Media.
Localized warmth, palm-sized redness at injection site, significantly painful to the touch which only began at 7:00 PM the day after injection (prior to this was "normal" vaccine symptoms, small red spot and normal site tenderness)
Severe arm pain; Fatigue; Fever 38.6C; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain), FATIGUE (Fatigue) and PYREXIA (Fever 38.6C) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe arm pain), FATIGUE (Fatigue) and PYREXIA (Fever 38.6C). At the time of the report, PAIN IN EXTREMITY (Severe arm pain), FATIGUE (Fatigue) and PYREXIA (Fever 38.6C) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38.6 degree Celsius. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. This case was linked to US-MODERNATX, INC.-MOD-2022-623795 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-623795:Case 1 of family's 3rd - Moderna(same reporter).
4/11/2021: chills, fever  4/12/2021: Lipschütz ulcer; vaginal ulcerations that lasted for ~2 weeks. Noticed discomfort on 4/12. First saw nurse practitioner on 4/15 and saw ob/gyn on 4/20. Never experienced before.
Severe arthralgia, myalgias, headache, fatigue, severe pain at injection site diarrhea, nasal congestion, hyaline rhinorrhea, dysphonia, anosmia, ageusia, dry cough 4 day evolution.
Swelling, redness, induration, warmth in posterior upper arm (triceps area);  occurred one mo. after vaccine.
pt recvd vax;lt upper arm lateral aspect shows 1cm size area of dried crust, surronded by border of redness; pt c/o tenderness to area;father reported pt has been febrile off & on since vax;
Female developed tremors in legs about 1/2 hour after receiving influenza vaccine. Mother recommended school personnel to administer Benadryl 50mg capsule as this adverse event occurred after starting on an antibiotic series.  Benadryl was given by school personnel.  Instructed child to lay down.  Tremors lasted about 20 minutes.  Child was assisted to a private room to lay down and rest.  Checked her every 1/2 hour.  Complained of being tired but tremors did not occur again.
Positive Covid test on 22Apr2022; Positive Covid test on 22Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "Positive Covid test on 22Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Apr2022) Positive; (28Apr2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: There was no other medication in 2 weeks. Reported Event: After a positive COVID test on 22Apr2022 I took Paxlovid for the 5 day treatment. I took another COVID test on 28Apr2022 and tested negative (PCR). On Day 13, I started experiencing COVID symptoms again and took another COVID test and it came up positive again. There was no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Right ear hearing loss - 2 days since vaccination until present (4 days since vaccination) Right ear ringing - 2 days since vaccination until present (4 days since vaccination) Right wrist joint ache - 1 day since vaccination until 2 days since vaccination
Received flu shot 10/30/15 at 4:30p: Between 7:30p and 9p  - c/o coughing sensation, blurred vision, bloodshot eyes and itching, nasal congestion. By morning recovered.
Originally, I had a sore throat on the first day. A few days later it did not improve, and I noticed an infection starting on my tonsils, so I decided to go to the urgent care. The doctor decided not to provide antibiotics. I decided to continue to gargle with salt water for a couple days and the infection went away.
Patient received her 1st dose on Jul 27th 2021, Patient was scheduled to receive her 2nd dose on Aug 21st 2021 but she missed her appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose on Jul 27th 2021, Patient was scheduled to receive her 2nd dose on Aug 21st 2021 but she missed her appointment) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose on Jul 27th 2021, Patient was scheduled to receive her 2nd dose on Aug 21st 2021 but she missed her appointment). On 21-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose on Jul 27th 2021, Patient was scheduled to receive her 2nd dose on Aug 21st 2021 but she missed her appointment) had resolved.            concomitant medicines was not reported by reporter Treatment information was not provided
Migraines with cyclic vomiting. Started the day after vaccine was given. Placed on tramadol, Phenergan, and Ativan for immediate action. Started on propranolol for migraine presentation. At this time, still unable to come off propranolol.
Hospitalized with weakness and fatigue multifactorial with chemotherapy and positive COVID Remdesivir started due to increased risk for severe illness
Two days after receiving shot I started to feel a lot of pain where I received the shot. The pain radiates around and under the area as well as up to shoulder. I have trouble moving arm up and certain ways without pain. I also feel a burning sensation off and on in the area. Have trouble sleeping because of pain. I have never had any issues with my arm and I did not do anything in that time period for it to cause the pain.
pt recv vax 7/17/98, exposed to cousin who had varicella, presented in m.d. ofc w/rash under arms & spreading, dx: probable varicella
Pt recvd vax 08OCT90 subcutaneously & subsequently devel erythema & swelling @ inject site.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site hives in a 59-year-old male patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, 3 days after receiving SHINGRIX, the patient experienced injection site hives, injection site itching and hives. The patient was treated with BENADRYL. In January 2019, the outcome of the injection site hives, injection site itching and hives were recovered/resolved. It was unknown if the reporter considered the injection site hives, injection site itching and hives to be related to SHINGRIX. Additional details were provided as follows: The batch number was not reported. The pharmacist stated that the patient received SHINGRIX in the first week of January, she believed that it could be on 6th January 2019, but was not sure of the exact date as she was not in office at the time of reporting. The hives then spread to his body and legs. The patient was given oral BENADRYL and itching and hives resolved after approximately one week.
This spontaneous report was received from a nurse prescriber concerning  to a male patient of unknown age. The patient's had not concurrent conditions, medical history nor drug allergies/reactions. Concomitant therapies included AMBIEN and PRINIVIL. On 23-NOV-2016, the patient was vaccinated with the first dose ZOSTAVAX for prophylaxis (the lot #, expiration date, route, and dose were not provided). On approximately 25-NOV-2016, reported as around 2 days after the administration of the vaccine, the patient got a rash on his forehead. The patient was treated with VALTREX. On an unspecified date, the rash was resolved. The causal relationship between the event and the vaccine was unknown. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013216.
Pt called an stated that she had chills 2 hrs after getting flu shot and had aching in her hip replacement. Today, 11/15/14, the patient has a fever of 100.4 degrees and will be going to a health clinic to determine if she has the flu.
flu like symptoms; feeling like sick/malaise; lack of energy; felt dizzy; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (feeling like sick/malaise), ASTHENIA (lack of energy) and DIZZINESS (felt dizzy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 048F21A, 043B21A and 007B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: shingrix (Dose 1) on 24-Oct-2019, shingrix (Dose 2) on 20-Jan-2020, pneumococcal on 12-Oct-2021 and flu vaccine (at 65 years). Past adverse reactions to the above products included No adverse event with flu vaccine, pneumococcal, shingrix and shingrix. Concurrent medical conditions included Seasonal allergy and Allergy to antibiotic (Augmentin).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (feeling like sick/malaise), ASTHENIA (lack of energy) and DIZZINESS (felt dizzy). On 27-Apr-2022, INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (feeling like sick/malaise), ASTHENIA (lack of energy) and DIZZINESS (felt dizzy) had resolved.            No concomitant medication information reported Patient reports that patient had had flu like symptoms, felling like sick, malaise, lack of energy, felt dizzy a day after (23Apr2022) getting the 2nd booster dose of the Moderna Covid- 19 vaccine. Patient never had COVID positive test or diagnosis. Patient not had experienced a similar events in the past. Outcome of all events reported as recovered after 4 days No treatment information reported.
shingles blisters; severe pain on her back; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 15-DEC-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered shingles blisters (herpes zoster) and severe pain on her back (back pain). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. She sustained severe and permanent personal injuries. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, she has not recovered from herpes zoster and back pain. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster and back pain were considered disabling events by the reporter.
bruise at the injection site, about the size of a nickel, it has been there for a couple days not brownish in color; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at the injection site, about the size of a nickel, it has been there for a couple days not brownish in color) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions were reported.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE BRUISING (bruise at the injection site, about the size of a nickel, it has been there for a couple days not brownish in color). At the time of the report, VACCINATION SITE BRUISING (bruise at the injection site, about the size of a nickel, it has been there for a couple days not brownish in color) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact