chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 11APR96 & pt devel an edema (elbow to shoulder) on the inj arm;pt also exp chills, fever, h/z & gen malaise which was treated symptomatically @ home;pt recovered as of the date of this report;
This spontaneous report was received from healthcare professional refers to a patient of unknown age and gender. On 21-APR-2015 the patient was vaccinated with RECOMBIVAX HB (dose, route of administration and lot # were not reported). It was reported that this vaccine had been improperly stored. No adverse effects reported. Additional information has been requested.
45 min after influenza vaccination client returned to clinic stating she felt nauseated and hot. Pale, moist skin warm to touch, Client weak. B/P 154/90, Pulse 76/min, resp normal. Within 30 minutes (2pm) client felt better, but start to itch, call 911 and sent to ER. Given epinephrine, Benadryl, Prednisone sent home after 2.5 hours.
Diagnosed with COVID; Diagnosed with COVID; lost about 12 pounds; pneumonia; lungs were aching; Interchange of the vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: G52524) at the age of 81 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: Blood pressure diagnosed about 2 or 3 years ago, on BP medication for years. The patient took concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Interchange of the vaccine products"; PULMONARY PAIN (medically significant) with onset Jan2023, outcome "not recovered", described as "lungs were aching"; PNEUMONIA (medically significant) with onset 15Jan2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "lost about 12 pounds". The event "pneumonia" required emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19 screening: Negative; Weight decreased: lost about 12 pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: On15Jan2023, she was in the ER because she thought she had pneumonia because her lungs were aching her, the ER visit was prior to Paxlovid. Reports her lungs are still aching.She has been taking her regular medication for years, such as blood pressure medication. She does not think its relevant. Has nothing to do with the way she feels. Testing: She did COVID at home testing, and all the tests showed negative. Even the day after being diagnosed she still showed negative.
COVID test result: Positive; COVID test result: Positive; ST; Low O2 sat; High fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 04Mar2021 as dose 2, single (Lot number: EL3247) and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 01Apr2022, outcome "recovering", described as "High fever"; OXYGEN SATURATION DECREASED (non-serious) with onset 01Apr2022, outcome "recovering", described as "Low O2 sat"; ELECTROCARDIOGRAM ST SEGMENT ABNORMAL (non-serious) with onset 01Apr2022 at 18:00, outcome "recovering", described as "ST"; VACCINATION FAILURE (medically significant) with onset 02Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 02Apr2022, outcome "recovering" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: Body temperature: (01Apr2022) High; Oxygen saturation: (01Apr2022) Low; SARS-CoV-2 test: (01Apr2022) Negative, notes: COVID test name post vaccination: Home Ag; (02Apr2022) Positive, notes: COVID test name post vaccination: Home Ag. Therapeutic measures were taken as a result of covid-19, pyrexia, electrocardiogram st segment abnormal, oxygen saturation decreased. Clinical information reported as patient exposed at an athletic event 31Mar pm then ST 01Apr 6pm and went on to have high fever and low O2 sat got positive home Ag on 02Apr and started Paxlovid (PCP) same time. Ae resulted in: None of the above. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Complained of hives developing on face around eyes about 2-4 hours after Influenza vaccination. Parent called in report but didn't want to bring patient into clinic for evaluation.
The symptoms started after the second shot.Fatigue, muscle aches, chills, headache were the  most debilitating symptoms started at  8am the morning after administration of shot. Fatigue and chills have continued into the next day and evening.
day p/vax pt devel fever, c/o vomiting, rash h/a which lasted x2day, nausea persisted through 6/19-6/20.
Patient received 5th dose of DTaP and started coughing and slight wheezing within 10 minutes. Seemed irritable and started itching intensely within 20 min. Upon arriving home had hives on body and face. Returned to office and BENADRYL & prednisone given.
Information has been received from a medical assistant concerning a 23 year old female patient with no pertinent medical history and no drug reactions/allergies who on 19-MAR-2010 was vaccinated on the buttocks with the second dose of GARDASIL. On 25-MAR-2010 the patient developed short of breath and lump at the injection site. The patient sought unknown medical attention. There were no lab diagnostic tests performed. At the time of report the patient's status was recovering. Additional information has been requested.
No additional AE details are available; ROTATEQ and PEDVAX HIB which were administered after improper storage; ROTATEQ Dose/Frequency: 0.5 mL; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 01-FEB-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # 1742461 with expiry date 17-NOV-2021, 0.5 milliliter (underdose) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, 0.5 milliliter, lot # T026959 with expiry date 11-MAR-2023 (route of administration and vaccination site were not specified), both for prophylaxis. The vaccines underwent a temperature excursion at 9.9 Celsius degrees for 35 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse event was reported.
Lymph edema; This is a spontaneous report from a contactable health care professional nurse, the patient.  A 50-years-old non-pregnant female patient (nurse) received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE;  on 06Jan2021 as a single dose, for COVID-19 vaccination.  Medical history included asthma, hypothyroidism and known allergy to penicillin. There were no concomitant medications.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 08Jan2021, The patient experienced lymph edema. No treatment was  given for the event. The clinical outcome of lymph edema  was not recovering.    Information regarding lot number  has been requested.
pt recv vax 26JUN98 & 29JUN98 pt devel rt shoulder pain (inj site);6JUL98 the entire rt arm was red, warm & swollen (inj site);dx cellulitis;
Lower back pain; cannot bent over or get out of the car without feeling pain.; experiencing joint pain mainly in his shoulders, hips and lower back. He states the his knees hurt both not as much as the joints; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), MOBILITY DECREASED (cannot bent over or get out of the car without feeling pain.) and ARTHRALGIA (experiencing joint pain mainly in his shoulders, hips and lower back. He states the his knees hurt both not as much as the joints) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A221A, 039F21A, 029120A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, the patient experienced BACK PAIN (Lower back pain), MOBILITY DECREASED (cannot bent over or get out of the car without feeling pain.) and ARTHRALGIA (experiencing joint pain mainly in his shoulders, hips and lower back. He states the his knees hurt both not as much as the joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Lower back pain) and ARTHRALGIA (experiencing joint pain mainly in his shoulders, hips and lower back. He states the his knees hurt both not as much as the joints) had not resolved and MOBILITY DECREASED (cannot bent over or get out of the car without feeling pain.) outcome was unknown.            The patient stated that he takes concomitant medication, but does not specify what type of concomitant medication. Patient also stated that he has no allergies to food or medication.patient stated that the joint pain has not subsist.
Fever Rigors Narrative:  Reaction occurred from 1/27-1/28.
Prolonged heavy menstral bleeding...I had a full heavy period which started on 14 May and lasted til mid-July. I had no blood for 10 days, then had a full heavy (bleeding in large clots) period for a week, then a week break, then a week period, etc. I continue in this one week on one week off cycle.
Pt states that he experienced flu symptoms 6 days post vax. Pt is experiencing soreness in shoulders, down arms, hands and feet. Pain in right upper arm when gripping object with right hand.
Heavy fatigue.  Little arm soreness, note a major issue.  The extreme fatigue was different than the first shot.
5 days after vaccine, husband noticed non-painful large bright pink/red area with bumps right popliteal area and small red area with bumps on rt. achilles tendon. (redness could have occurred earlier but not noticed) Next day red with bumps area upper, inner posterior right thigh, then couple of days later a red area with bumps lower buttocks.  All rash areas in line up leg.  5 days after rash appeared the redness decreased and there was burning especially popliteal area that would be for a day or two then return every couple of days.  There still is mild burning off and on.  I have thalamic pain syndrome with burning in various areas so didn't realize this burning was at the rash area.  No treatment as pain not severe and way past the 48 hours for medication when realized and I was on a trip across the country.
Shortly after the vaccination my arm began to hurt, in my opinion, above average for this vaccination which I've had before. Then within a few hours I began to feel sick and got hives on my face, head and chest. I itched alot. No shortness of breath was noted or breathing problems.  Some dizziness the next day (today).
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX lot # M027342, expiration date 01-JUN-2018, and lot# M031970 (expiration date not reported) (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003935: US-009507513-1708USA004392: US-009507513-1708USA004393: US-009507513-1708USA004394: US-009507513-1708USA004395: US-009507513-1708USA004408.
Complained of feeling "flushed," dizzy, sweating, chills, nausea.
patient definitely get sick if patient take the flu shot; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA328865.  This case involves a unknown demographics patient who definitely get sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who definitely get sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was patient was illness.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Vaccine may have been stored under conditions that departed from the manufacturer's recommended specifications. Pharmacy consulted with the vaccine manufacturer regarding this issue.  In such a circumstance, the manufacturer deems the vaccine not to be viable.  Additionally, the CDC recommends that patient repeat 1 dose of the same COVID-19 vaccine immediately (no minimum interval). Patient may not have received the full benefits of the vaccine. The additional dose is provided at no cost. Patient will call back when she can return to get additional dose.
Information has been received from a physician concerning a female patient who on an unknown date, was vaccinated with her first dose of GARDASIL and after vaccination had to go to the hospital (duration not specified).  On an unknown date, was vaccinated with her second dose of GARDASIL and became sick.  The patient sought unspecified medical attention.  No further information is available.
Within 1 hour site if injection began to turn red and swell. Swelling continued for 24 hours. Red, warm to the touch, pain and itchiness.
There was an opened unlabeled vial of Moderna in the fridge. There had not been any mentions on the group chat of an open Moderna vial (as when we open each vial we let everyone in the chat know) . I grabbed the open vial along with an unopened vial of Moderna and proceeded to the Covid clinic. There were 7 doses of this vaccine given to patients. As of 9/27 we were off on our counts and now realize that the vial that was used on 9/24 to those 7 patients was an expired vial. The vial had originally been opened on 9/23 by RN. These 7 patients have been located and will be contacted once recommendations from CDC are reviewed.
Fluid accumulation in lungs, shortness of breath, pressure on chest, weight gain, fever, body aches, chills, lymphs had inflammation, markings on lungs, increase in myocarditis.
Patient presented to the ED and was subsequently hospitalized for cellulitis of right lower leg within 6 weeks of receiving COVID vaccination.
Patient developed fever after second COVID-19 vaccine and over the next two weeks became increasing encephalopathic before presenting on 4/18 and being admitted for encephalopathy and persistent fever. He was found to have mediastinal lymphadenopathy There has been no cause for fever through infectious, rheumatologic, and hematologic evaluations.
Stiff left arm; jerking movement in left arm; This case was reported by a pharmacist via call center representative and described the occurrence of limbs stiffness in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 44DX9, expiry date 28th October 2022) for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Shingrix. On 14th July 2021, less than a day after receiving Shingrix, the patient experienced limbs stiffness and jerkiness. On 17th November 2021, the outcome of the limbs stiffness and jerkiness were recovered/resolved.   It was unknown if the reporter considered the limbs stiffness and jerkiness to be related to Shingrix.   Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported patient experienced stiff and jerking movements in left arm after administration of Shingrix vaccine that resolved once patient went to bed. The reporter consented to follow up.
muscle pain; bone pain but only in the right side of her body; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle pain and bone pain but only in the right side of her body on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
first dose of Shingrix a year ago and have not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the second dose yet, which led to incomplete course of vaccination.  Pharmacist did not provide date of birth of the patients nor lot number or expiration date of the vaccines administered. The reporter consented to follow up. This case was linked with case US2020037873, reported by the same reporter.
Rash itchy; Rash at injection site size of a half dollar; The rash is raised and swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash itchy), VACCINATION SITE RASH (Rash at injection site size of a half dollar) and VACCINATION SITE SWELLING (The rash is raised and swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a01a) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH PRURITIC (Rash itchy), VACCINATION SITE RASH (Rash at injection site size of a half dollar) and VACCINATION SITE SWELLING (The rash is raised and swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Rash itchy), VACCINATION SITE RASH (Rash at injection site size of a half dollar) and VACCINATION SITE SWELLING (The rash is raised and swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Benadryl was used as treatment medication.
Sore arm - like a tetanus shot (right after injectio, lasting 2 days), feverish with chills (started about an hour afterward), intense sweating that night, fever of 102° (started the next morning)