chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE/ BODY ACHE; NECK ACHE; DIARRHEA; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore/ body ache, neck ache, diarrhea, low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore/ body ache, diarrhea, headache, neck ache and low grade fever was not reported. This report was non-serious.
Hospitalized sepsis due to recurrent lower extremity cellulitis.  Note patients first vaccine was Moderna on 3/5/2021 her second dose was Pfizer on 5/7/2021 and her third dose was 6/3/2021 of Pfizer.
papulo-vesicular grouped red hypereresthetic rash; papulo-vesicular grouped red hypereresthetic rash; right scapular pain begins; burning right scapular pain begins; This case was reported by a other health professional via sales rep and described the occurrence of scapula pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. On 17th September 2020, 16 days after receiving Shingrix, the patient experienced scapula pain and burning sensation. On 22nd September 2020, the patient experienced papular rash and erythema. On an unknown date, the outcome of the scapula pain, burning sensation, papular rash and erythema were unknown.   It was unknown if the reporter considered the scapula pain, burning sensation, papular rash and erythema to be related to Shingrix.  Additional details were provided as follows: The over 50th years old patient received Shingrix and experienced burning right scapular, right scapular pain, papulo-vesicular grouped red hyperarithmetic rash on left scapula and papulo-vesicular grouped red hyperarithmetic rash on left lateral breast. The patient asks about 2nd dose of Shingrix. The reporter consented to follow up.
Acute on chronic respiratory failure with hypoxia. ED Visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Saw pt. Arm was red, hot and swollen around injection site. Sore arm.
Rash & UrticariaPruritus Narrative:  ~2x2 inch rash inferior to injection site developed the same day and lasted for approximately 2 weeks. Described as pruritic, erythematous, indurated. No associated warmth or sloughing. No hives or other affected areas, adverse effects noted.
17cm X 18cm area of erythema and inflammation around site of vaccination, no induration or tenderness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing); "Known allergies: pencillins" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive. Therapeutic measures were taken as a result of covid-19. Patient had Paxlovid start date: 06Aug2022, stop date: 11Aug2022 for the indication treatment of COVID-19.  Clinical information: Within 2 weeks of the vaccination patient had Albuterol inhaler.   No follow-up attempts are Possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded.
Client reported severe arm pain starting several hours after injection. Describes pain as a 9/10. Client continues to have arm pain one month after vaccination.
Information has been received from the healthcare worker who reported that on 07-MAY-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0.5 (units not provided) of M-M-R II (lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Patient had uncomplicated pregnancy,did not have covid during pregnancy. Overall healthy adult. All prior labs were normal as well. Patient came in laboring. Delivered full-term vaginally, AGA weight, placenta delivered fully intact. After delivery patient began to hemorrhage. Could not stop the bleeding
Swollen lymph node in left arm pit; extreme fatigue; dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 13:00 (Lot number: Fj1620) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8727, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 24Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6205, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 04Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 13:00, outcome "unknown", described as "dose_number=3"; LYMPHADENOPATHY (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "Swollen lymph node in left arm pit"; FATIGUE (non-serious) with onset 09Dec2021 01:00, outcome "recovering", described as "extreme fatigue". It was unknown if therapeutic measures were taken as a result of lymphadenopathy, fatigue.  Additional information: 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, patient has not been tested for COVID-19. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Within minutes after 1st shot Pt. lost her voice, c/o tickle in throat, SOB, fatigue, dizziness.   She was given 50 mg. Benadryl.  VS were normal during her observation.  States she had nausea/vomiting/ diarrhea and myalgias for 3 days after 1st and 2nd covid vaccines.  States she still feels a little lightheaded at times, but otherwise feels has recovered from the vaccine effects.  In July 2020 had series of 4 hospitalizations for ARDS and gastroparesis.  States 4 covid tests were negative throughout that time.  Has chronic headaches from Chiari Type 1 diagnosed 12 years ago.  Had meningitis as a child with lifelong headaches.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient was dehydrated. Once she drank a bottle of water, she was fine
RIGHT EAR FEELS/ SOUNDS CLOGGED. FEEL LIKE WATER IS CONSTANTLY IN RIGHT EAR. BELIEVED TO BE TINNITUS.
Joint Pain, Cold Chills, Fever of 101.3 Symptoms started roughly 28 hours after injection.  Took extra strength Tylenol x2 and drank powerade. Symptoms were resolved by morning.
Duration - 5 days - c/o fatigue, excessive sleepiness, gait abnormalities, dizziness, LLE weakness, HA.
Began having joint pain and body aches along with sweating as if breaking a fever the morning following the vaccination as he did with the first dose. Currently still having but it is not worse than that after his first vaccine. Symptoms from the first vaccine resided after approximately two weeks.
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment.  Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
On 1/8/2023, it was very late at night, my hands were shaking very bad, I could not take a test. I had chills, no appetite, sore throat, earache, sinus pressure filled with mucus. I had a terrible headache and a lot of nausea, body aches, and a lingering and painful cough. I tested positive on the next day. I was sleeping in the extra bedroom, my left foot was having severe pain, I could not walk for 4 days. I would take ADVIL to relieve the pain. It was really extreme. I called my doctor and got prescribed PAXLOVID and promethazine. I also had a fever.  My sense of smell was great, I still cough in the morning with congestion. I don't need to take my cough medicine until I go to bed.
Pt got Moderna 048F21A COVID vaccine 9/20/21.  Ever since, chest hurt for 1 week after.  Since then, when sneezes has chest pain and feels like chest is going to collapse.  Denies shortness of breath, cough.  Also since Covid vaccine, Stomach feels weird, as if lining is inflamed.   Due to these uncomfortable symptoms, has not gotten the second Moderna vaccine. Denies pain with eating, drinking. Denies diarrhea, constipation, nausea, vomiting.
Stabbing pains in both kidneys every time I would inhale, stabbing pains in stomach every time I would exhale; lasted approximately 1 hour. Intense throbbing pain in the head. Sporadic pain and ringing in both ears. Stabbing pain in left armpit. Fever dreams / delirium. Chills, fever. Sensitivity to cold. Spasms of abdominal muscles. Spasms and ?tics? of neck and shoulder muscles. Spasms of leg muscles. Nausea. Extreme weakness of upper body.
4-24-07 9:10 am PC from client, states she felt nauseated about 1 hr after receiving Gardasil. Today she states she continues to feel very weak-advised to see PMD or ER. 12:30pm PC from client states she cancelled DR appt because she felt better after lunch
sore arm; felt sick; rash; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On 19th July 2022, less than a month after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the patient experienced pain in arm and feeling unwell. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the pain in arm and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, feeling unwell and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments:  The patient reported case for herself.  The patient received 1st dose of Shingrix one month ago from reporting.  She stated that she initially had a sore arm and felt sick. Both symptoms had resolved.  She also stated that she developed a rash a day before reporting which was diagnosed as Shingles on the day of reporting by her dermatologist.  The patient had started Valtrex for her Shingles.  The reporter did not consent to follow-up.
Pain on the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on the injection site) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain on the injection site) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Pain on the injection site) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Information has been received from a physician concerning her 18 year old daughter who on approximately 24-MAY-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included appetite depressant (unspecified) and Meningococcal (unspecified). On approximately 25-MAY-2007 the patient experienced tenderness at injection site 6 to 12 hours after vaccination. Twent-four hours after vaccination the patient experienced flu like symptoms of joint aches, high fever of 102 degrees F, sore throat and shortness of breath. Unspecified medical attention was sought. The patient was monitored for the shortness of breath with a pulse oximetry reported normal. The mother reported that two days after the onset of the symptoms the symptoms resolved spontaneously. The physician examined the patient on 12-JUN-2007 and the patient had no symptoms. Subsequently, the patient recovered from the flu like symptoms. Additional information has been requested.  Additional infromation is not expected.
About 3:45pm that day, I started feeling really tired, weird tiredness never felt before. When I was walking out of the OR, I felt my legs weak and wobbly and very tired. I went home and to came up the stairs my legs still felt very heavy. About 10:40pm, I felt very thirsty and I felt warm and checked my temperature and it was 103.5F. I drank water and called in to work for the next day to tell them how I was feeling. I was sweating and did have some chills. Around 2:00pm on Wednesday, my fever was not going down and was taking naproxen and Tylenol and also taking showers but my fever would not go down. I was told to continue taking my medication. My fever did not break through until yesterday. After that I did not have the fever and I am still continue taking the medication.
pt states she had headache, chills, muscle pain.  she developed red rash all over her body with some spots that are swollen.   She went to her PCP  on 3/8/2021.  He told her she was allergic to the vaccine and told her take Benadryl.  She has FU appt on 3/12/2021.  Pt states the rash is still present, still spreading, itchy and swollen.  The rash has been from head to toe.
I palpated a cylindrical mass in my right abdomen about 5.5 months after my 2nd vaccination dosage
Pt had sudden onset of hives with pruritus and vomiting with increased HR and decreased O2 sats. Max HR 188, lowest Sats 93% RA.
Case number PHEH2014US015458 is an initial spontaneous report from the health care professional received on 01 Aug 2014. This report refers to a 11 year old male patient. The patient received an expired MENVEO (batch number: M12013) vaccine on 30 Jul 2014, intramuscularly. No adverse event reported following this medication error.
Bell's Palsy- pt presented on 2/1/10 with a watery R eye, felt like R side of face was swollen, eyes felt dry.  Treated with prednisone taper and valacyclovir.
tiredness; This is a spontaneous report from a contactable consumer (patient). This consumer reported for 3 patients (Reporter self, Mother and Husband). This is for Reporter self. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient stated she and her husband also received the Pfizer covid vaccine and experienced tiredness but no major side effects. Patient and her husband got theirs almost 3 weeks ago and are due for the second one next week. The only thing they felt was tired but no major aches and pains. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
fever @ 1630 temp not taken, delirous gave APAP; 12APR91 convuls; given 02 by fire dept t105f; treated for OM;
This spontaneous report as received from a consumer refers to a 50 years old male patient with routine vaccination. The patient was vaccinated with, 1 DF ZOSTAVAX on 29-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient developed a very severe pain after receiving ZOSTAVAX. On an unknown date the pain occurred on the left side of his neck and jaw. He stated that he received the vaccine on 29NOV2012, and the next day he started getting sharp pain on the left side of his throat area. The pain is not in his throat, not as a sore throat would be, but rather on the outside of the throat area of his neck. The patient explained that he also developed a medium hard lump under his jaw. No treatment information was reported. The outcome of developed a severe pain and developed a medium lump under his jaw is unknown. The relatedness for developed a severe pain and developed a medium hard lump under his neck is unknown for ZOSTAVAX. No further AE information was provided.
no further information provided; Caller is a pharmacy technician (listed as technician in additional case contacts, as pharmacy technician is not listed) who is reporting that a dose of PROQUAD was administered with VARIVAX for 8 different patients; This spontaneous report was received from a registered nurse via a pharmacy technician from same facility clinic and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided.  On 07-APR-2022, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U024221, expiration date was provided and also validated as 04-AUG-2023; and also with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U028179, expiration date was reported and also validated as 08-MAR-2023; for prophylaxis (exact doses, route of administration and anatomical location were not provided for both vaccines) (overdose). It was unknown to caller if any product confusion occurred that might had contributed to the error. No further information was provided (no adverse event).  This is one of several linked reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA005095: US-009507513-2204USA004906: US-009507513-2204USA004990: US-009507513-2204USA005079: US-009507513-2204USA005733:
After the first vaccination, I was tired for 24 hours. However, with the second vaccination, I began experiencing more serious symptoms or reactions. Serious shortness of breath, as if unable to get sufficient oxygen. Extremely tired. Headaches behind my eyes. It is normally very unusual for me to get headaches. Dizziness and loss of balance. Weak and impaired vision. Eyes very sensitive to sunlight. Changes in ability to taste foods and sometimes foods taste very different. Pain spikes - various muscle and joint pain spikes. These symptoms have lasted for the past 8 weeks. I feel like most of the symptoms are gradually subsiding, but the time period is too short to be sure (as some symptoms come and go). I am anxiously expecting them to subside in the near future. I am sending this information to you for the purposes of records and statistics. I really do not have a choice in accepting the vaccinations because I am in my 70s. My son developed cancer; so, I had to make sure I do not expose him.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot# reported as L008660, expiration date 10-NOV-2016, dose, frequency and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Hives and itching 2 weeks after vaccine.  I have been to my primary doctor and was given prednisone with no results. I went back a week later and was referred to discussed the problems. I was given a shot of Kenalog and put on Zyrtec. The shot was effective but wore off in 2 weeks.  I went back after a month on May 3. I will now be doubling my dosage of Zyrtec and ad dont another pill twice a day.  I have been sent for blood work looking for alfa-gal.