chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood work showed some number of rheumatoid arthritis markers/Rheumatoid factor quantitative; Drug side effect/side effects from covid vaccine; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Blood work showed some number of rheumatoid arthritis markers/Rheumatoid factor quantitative) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe ).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Blood work showed some number of rheumatoid arthritis markers/Rheumatoid factor quantitative) (seriousness criterion medically significant), IMMUNISATION REACTION (Drug side effect/side effects from covid vaccine) and INFLAMMATION (Inflammation). At the time of the report, RHEUMATOID ARTHRITIS (Blood work showed some number of rheumatoid arthritis markers/Rheumatoid factor quantitative) and INFLAMMATION (Inflammation) outcome was unknown and IMMUNISATION REACTION (Drug side effect/side effects from covid vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Showed that she had some number RA markers. On an unknown date, Rheumatoid factor quantitative: Rheumatoid factor quantitative. On an unknown date, Scan: Body scan showed inflammation.         No concomitant medications were reported.  No treatment details were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for Humira(adalimumab) for the event(s) of blood work showed some number of rheumatoid arthritis markers andside effects from covid vaccine with humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of inflamation was not provided.  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.   Reporter did not allow further contact
Pt received 3 immunizations/vaccines in left deltoid on same date 9/13/16. Came to office on 9/20/16 with chills, malaise and fatigue. Treated for cellulitis of arm with cephalexin and prednisone. (13.2 x 9.5 cm).
painful tender lymphadenopathy of R axilla, R biceps, R inguinal beginning day of 2nd vaccine and worsening over the week prior to ED visit.  pt received steroids for outpt treatment.
Service member reported the following symptoms temporally-related to receipt of anthrax vaccine given in Feb 2007, which she says was her 2nd annual booster (previously she had received a total of 7 AVA doses).  Severe throbbing headache-'migraine', associated with nausea (no vomiting), onset 2-3 hrs following AVA, lasting 72 hrs, unrelleved with Ibuprofen, but necessitated bed rest.  Tactile fever/chills, onset 2-3 hrs following AVA, treated with Ibuprofen, resolved in 48 hrs.  Generalized muscle and joint pain, onset 2-3 hrs following AVA, treated with Ibuprofen, resolved in 72 hrs.  Loss of appetite, onset 2-3 hrs following AVA, resolved in 72 hrs.  Injection site 'lump' onset 3 hrs following AVA, resolved within 2 weeks (no large local swelling).
Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt her legs shaking and tingling on her top lip. She came back to the vaccine clinic and asked to be monitored. Vital  signs taken 138/90, HR 109 POX 100 RA. Continued to have tingling upper lip and brought to ED for further observation. Warm hand off to ED RN
about 18 hours Later I experienced symptoms that have been reported as quite typical following the 2nd shot of moderna or pfizer. these included:  Chills (but no objective fever) Severe headache Tiredness.
Bone pain; Nausea; Fatigue; Headache; joint pain and muscle aches; joint pain and muscle aches; chills and sweating off and on; chills and sweating off and on; Diarrhea; she was bleeding after the person injected her; This is a spontaneous report from a contactable consumer (patient reported for herself). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269), dose 1 via an intramuscular route of administration, administered in Arm Left on 02Feb2021 at 16:45 (at the age of 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation and prophylaxis. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Medical history included She did have a baby last February and covid-19 from an unknown date to Mar2020. Family medical history was none. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was none. On 03Feb2021, the patient experienced bone pain, nausea, fatigue, headache, joint pain, muscle aches, chills, sweating off and on, diarrhea and she was bleeding after the person injected her. The clinical details of the events as follows: she received the first dose and would like to report some adverse events. She had all the side effects listed and also had bone pain. She called her doctor and reported the symptoms to her. She was unable to confirm if it was given in the muscle but did note that she was bleeding after the person injected her. Injected in left shoulder unable to confirm if given in muscle. It was reported that Bone pain progressively worse with every hour. After 24 hours, she was taking Ibuprofen for symptom relief, but did not take anything prior to receiving the vaccine. ER or physician office required: tele-visit with doctor on 05Feb2021 and it was not her usual doctor and medical treatment provided. Relevant tests were none. She did have a baby last February and recently read where people had children had worse side effects. It was just an online article. She did not have any information on those people to provide. No Investigation Assessment was provided. She was very hesitant to get second dose and would like some guidance about that. The patient outcome of the events Nausea, Headache, and Diarrhea was resolving, the outcome of the events Bone pain, Fatigue, joint pain, muscle aches, chills, sweating off and on and the outcome of the event bleeding after the person injected was unknown at the time of this report.  Follow-up attempts completed. No further information expected.
Mom called on 3/3/2023 to report that patient developed projectile vomiting that would not stop. She was taken to ER and after 3 hrs wait and no further vomiting, she was taken home without further evaluation. Mom called to inform us that she did not want patient to receive any further combo vaccines and wanted to only give single vaccines one at a time.
12 days after vaccination, my arm began hurting again near injection site. shortly after, it began to itch, feel warm to touch, and a red rash began to form.  i am currently experiencing all of those symptoms today,
pt recvd vax in AM that evening had c/o red raised area @ site of inject; also fever, lethargy; fever 104 x 2 days; sore arm x 5 days;
Vestibular Neuritis, dizziness, vomiting, nausea, balance, unable to walk
Youth complains of a headache and pain at injection site. Redness to upper arm and shoulder. Warm to touch. No swelling noted.
Pt received vaccine on 7/21/10.  Returns to clinic 7/23/10 with 3" red, raised area over injection site.  Reports positive fatigue, headache, nausea and pain at site.  Examined by MD.  Treated with ice to area and BENADRYL.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 17-MAY-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JAN-2015 (dose and route unknown). The Healthcare worker reported that VAQTA had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
First dose was administered into gluteal region; Case reference number US-BN-2021-000281 is a spontaneous case report initially received from consumer on 22-Mar-2021, and concerns a female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 17--Mar-2021, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered into gluteal region (Product administered at inappropriate site).  On 20--Mar-2021, patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack was administered in thigh region.  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.  This case is linked with cases US-BN-2021-000280 and US-BN-2021-000281 (same reporter).; Reporter's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert into gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.; Sender's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert into gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.
A non-serious spontaneous report of administration of expired FLUMIST was received from a pharmacist concerning an 11-year-old female. The patient's medical history included twin birth. No concomitant medications have been reported for this patient. The product expired on 27-Nov-2011. On 04-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
several min p/vax pt threw head back & was unconscious for a few seconds, jerked body became sweaty & woke up crying oriented & nl;neuro eval looked like a vasovagal rxn w/ tonic clonic episode
Red - hot, swelling at injection site.  Rt delt. BENADRYL and LORATADINE given.
Information has been received from a physician concerning a patient who on unspecified dates was vaccinated with the two doses of VARIVAX (Merck).  The physician reported that the patient experienced injection site reaction such as swelling, pain and erythema.  The reporting physician stated that it was from their private and public stock (Vaccines for Children stock).  The patent sought medical attention.   This is one of two reports received from the same source.  Attempts are being made to obtain additional identifying information to distinguish the individual patients.  Additional information has been requested.
This was my booster shot, my second dose I did get covid arm but it was not as severe, this time I got extremely sick and got everything that is listed as a symptom. Even my covid arm, however, my rash appeared on 11/19, grew larger on 11/20, it however is now wrapping around my arm into the inside part of the arm. This is all surrounding the injection site. As of today it comes and goes. It is hot to the touch and itchy, which I assume is normal for a covid arm rash. But, it grew in size and has a purple tint occasionally.
pt states lt arm was sore w/sl redness @ site of inj & whole lt side maintly lt had muscle soreness;
Patient called the pharmacy on 11/19/18 and spoke with Associate. The patient complained of ongoing pain in his arm including sharp pains, also with difficulty lifting heavy objects. Patient states he has not see an physician at this point and will follow up within a week.
Runny nose; Soar throat; Cough; Arm extremely sore; Arm Swollen; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm extremely sore, arm swollen, runny nose, soar throat, and cough.  The patient's medical history was not provided. No relevant concomitant medications were reported. No relevant lab data was provided by the reporter.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the events arm extremely sore and arm swollen . On 24 Jan 2021, the patient experienced the events runny nose, soar throat and cough. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, arm extremely sore, arm swollen, runny nose, soar throat and cough was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Bell's palsy . ON PREDNISONE. NUMBNESS IN THE FACE AND LEFT SIE OF FACE DROOPY.
administration of Shingrix 41 y/o patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 41-year-old female patient who received Herpes zoster (Shingrix) (batch number 2737P, expiry date 22nd January 2022) for prophylaxis.   On 1st September 2021, the patient received Shingrix. On 1st September 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: This case was reported by the registered nurse. The reporter stated that, an immunocompetent 41 year old patient was administered with Shingrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
tested positive for Covid-19 after receiving the first dose; This is a spontaneous report from a sponsored program. A contactable consumer reported that, A female patient of an unspecified age received first dose of BNT162B2 (solution for injection) via an unspecified route of administration on 08Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid -19 positive after receiving the first dose on 11Feb2021 with outcome of unknown. The patient underwent lab tests which included sars-cov-2 test: tested positive for covid-19 on 11Feb2021 after her second dose. The patient was supposed to get the second dose on 01Mar2021. she enquired if she should get the second dose or wait? Will it hurt her The outcome of the event was unknown.  Follow-up information was received on 15-Feb-2021: follow-up information was received from a contactable consumer. No new medically significant information was received.  Information on the lot/batch number has been requested.
NECK PAIN; DIZZINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 06-MAR-2021, and had not recovered from neck pain. This report was non-serious.
explosive diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (explosive diarrhea) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Back pain, ACICLOVIR (ZOVIRAX [ACICLOVIR]), SIMVASTATIN, METFORMIN, DOXEPIN and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (explosive diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) for Adverse event, at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event, at an unspecified dose and frequency; FIBRE, DIETARY (BENEFIBRE) for Adverse event, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (explosive diarrhea) outcome was unknown.
at 12 hours post vaccine I had Headeaches and Body Aches for the next 20 hours
Patient was vaccinated on 1/22/09 (fluid was noted in both ears at the time). His ears became inflamed and he was given amoxicillin (has previously had with no adverse reactions) on 1/26/09. He woke up (7am) with spots on 2/3/09. Went to see Dr. on 2/5/09 and was given the diagnosis of erythema multiforme minor. Started giving him ZYRTEC before bedtime to control itching. Spots are currently clearing up, with no new ones developing since 2/7/09.
4 days of fever averaging 100-101° without medication, given Tylenol or Motrin with it just coming right back.
Patient reported having a "scratchy throat" and feeling flushed after receiving the shot, was taken to AR RN area monitored by an RN and MD for 30 minutes. Symptoms improved, patient sent home with ED precautions
PATIENT CAME TO THE CLINIC TWO DAYS AFTER RECEIVING IMMUNIZATIONS.  THE RIGHT ARM WAS RED, SWOLLEN, AND WARM TO THE TOUCH.
After second dose, spiked fever and had a fainting spell about 10 hours after the dose. Since second dose, have experienced heart palpitations and have recently completed a Holter cardiac monitor to determine next steps for treatment.
During the administration of the vaccine, the syringe separated from the needle and the vaccine was wasted.   After discussion with on call Dr. it was decided that very little vaccine was administered and a second injection was administered.
Information has been received from a physician concerning a patient who was vaccinated with third dose of  Rotateq. Subsequently, the patient received the last dose of Rotateq beyond the 32 week mark after receiving the first dose. Additional information has been requested.
patient complained of redness and swelling at the injection site, also swollen lymph nodes in the armpit of the injection
SHARP PAIN UPON DEEP INHALATION; This spontaneous report received from a health care professional concerned a 6 decade old female. 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: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced sharp pain upon deep inhalation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain upon deep inhalation. This report was non-serious.
Describe Event, Problem, or Product Use Error: Johnson & Johnson vaccine use for COVID-19 under Emergency Use Authorization (EUA):T/C from pt stating that she infused Hizentra on 4/6, then received J&J COVID vaccine on 4/7. Pt stated she was not feeling well and spoke to MD; MD advised her to infuse another Hizentra dose on 4/9. Pt now c/o large welts and fatigue. Advised pt to contact MD.
Dtap (Infanrix) is generally given in our clinic at 12-15 months of age. It was inadvertently given today at the 6 month well visit instead of Pediarix. (Dtap,IPV,HBV) combination .  No adverse reaction or outcome occurred.  Patient will be given Pediarix combination at one year well appointment to catch up with scheduled vaccines.   Mom was notified by phone and voiced understanding of change in  vaccine schedule.
My heart raced to 165 20 hours after receiving the vaccine. For the next 3 months my heart would race intermittently . I was back in Afib and I had it fixed in 2002. It came back right after the first Moderna vaccine and I had ablation done on July 2nd 2021 by a doctor. I had Covid back in January of 2021. I am still not feeling right and it was recommended by my doctor not to take the 2nd vaccine.
flu like symptoms; nausea; fever; shivering; headache; muscle pain; tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix. On 3rd November 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness. On an unknown date, the outcome of the influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter. The reporter stated that the patient experienced influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness. The daughter of the patient stated that her mother planned to follow up with her physician on an unknown date. The reporter consented to follow up.
Local erythema 4 x 5 cm at site of injection. No systemic sx.
Pt received the full Moderna Vaccine on 06/06/2021, 07/28/2021 and came to the vaccine site claiming this is his first dose. An Employee looked pt up in system and overlooked the two doses. She gave the vaccinator (me) the green light to vaccinate pt. After the pt was vaccinated and looked up the system to add his shot information it was discovered he had received two prior shots and pt was counceled and observed for possible adverse reactions.
The JANSSEN COVID-19 vaccine. Fever of 38.5 degrees C. Strong pain in ovaries. Shaking chills. Muscle pain in lower limbs. Sweats. Headache.
Almost immediate pain in arm which grew more intense incapacitating me within less than an hour. For one week the arm was useless. Now, three weeks later my arm still hurts inside, like something has been fundamentally injured. Can't sleep it. Can not move it without intense pain. Can't sleep; pain wakes me up.
Chills, sweats, vomiting, diarrhea, fatigue, flu-like symptoms, fever over 102 degrees. Symptoms lasted about 48 hours.