chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu symptoms; Broke foot; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FOOT FRACTURE (Broke foot), INFLUENZA (Flu symptoms) and HEADACHE (Headache) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 13-May-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced HEADACHE (Headache). In March 2022, the patient experienced FOOT FRACTURE (Broke foot). On an unknown date, the patient experienced INFLUENZA (Flu symptoms). In 2021, HEADACHE (Headache) had resolved. At the time of the report, FOOT FRACTURE (Broke foot) and INFLUENZA (Flu symptoms) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant product use was reported.  The patient received 1st, 2nd and booster vaccine dose one in once. Humira was citrate free.   No treatment information was provided.  The reporter's causality with humira for the events of broke foot, flu symptoms and headache were not reported.  The reporter's causality with Janssen covid-19 vaccine for the events of broke foot and flu symptoms were not reported. The reporter's causality with Janssen covid-19 vaccine for event headache was reported as probable.
Headache, Myalgia, Fever, pain at injection site, left deltoid. Narrative:
Pt fully vaccinated as of 1/8/2021 then was diagnosed with PCR positive (UK variant) COVID 3/18/2021.
13Nov90 pt vax w/ hepta B; 15Nov90 exp respiratory infection, soreness in the arms, fever 100F, pharyngitis.  As of 16Nov90 sx persisted.  MD attrib. exp to vax.
DIARRHEA; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a male 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: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, diarrhea and fatigue was not reported. This report was non-serious.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-MAR-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Upper and Lower GI issues that included abdominal pain and discomfort, felt like something was "stuck in his throat",  and constimation
chills; fever; headache; This is a spontaneous report from a contactable consumer(patient) reported that. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), dose 2 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as DOSE 2 SINGLE for covid-19 immunization. The patient medical history was and concomitant medications were not reported. On an unspecified date the patient experienced chills, fever, and headache. Asking if can pass Sars-COV-2 to immunosuppressed roommate. The event outcome was Unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
pre syncope; difficulty breathing; dizzy - after 20 minutes of monitoring patient refused emt
stiff leg;unable to bend knee day p/vax;MD advised warm bath;1wk p/vax;pt had no residual sz;using leg;fully recovered;local redness;
COVID(+) Narrative:  Patient developed COVID-19 symptoms on 1/16, approximately 2 days after receiving dose #1 COVID vaccine. He was admitted on 1/30 with worsening symptoms of fatigue, low grade fever, myalgias, dyspnea, and productive cough and found to be COVID(+) via Cepheid test. Patient was treated with supplemental oxygen and oral dexamethasone therapy.
Infection at site of injection. Arm was swollen and hot to touch. Caused limited mobility pt received indirect attention.
Patient presented to the ED on 5/4/2021. Patient presented to the ED and was subsequently hospitalized on 5/17/2021 with COPD exacerbation. These visits are within 6 weeks of receiving COVID vaccination.
LEFT SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION SUSPECTED.  SYMPTOMS LEFT SHOULDER PAIN AND DECREASED RANDGE OF MOTION OVER THE LAST MONTH.
Patient presented with fever the evening of 10/29/2108. Fever lasted approximately 24 hours. Patient c/o right leg pain, is limping and cannot walk up stairs. At time of exam, patient holding right leg with knee bent, avoiding weight bearing. Right leg uncomfortable with with palpation around injection site on Right thigh, pain with knee flexion and extension.
Arm soreness at site of injection; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, also reported as "COVID vaccine," Solution for injection; lot/batch number and expiration date were not provided), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after use of the product, the patient experienced arm soreness at site of injection. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient advised receiving 1st dose Pfizer vaccine and started feeling extremely sick with fever, headache, body aches, congestion, chills and sweats that lasted for several days from day of vaccine received.
Site: Pain at Injection Site-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: pt is afraif of shots had a little panic and was lightheaded. pt felt better and left pharmacy
Patient received second dose of Pfizer COVID-19 vaccine and experienced symptoms of difficulty swallowing while waiting in-store for 15 minutes afterwards. Patient initially reported feeling warm and a slight tingling sensation in her arm, after an additional 5 minutes (20 minutes total post-injection), reported feeling a throat tightening sensation and difficulty swallowing. Patient was not short of breath, was able to speak without difficulty, and reported to be able to breathe normally. No epinephrine was administered and EMS was called for evaluation. EMS assessed that the patient was stable, had no signs of swelling in or around the throat area, and did not suspect an allergic reaction. Patient was released home with parent shortly after assessment.
Case number PHHY2011US65527 is an initial spontaneous report received from a consumer on 20 Jul 2011. This report refers to a patient of unknown age group and gender. This patient was given only the MenCYW lyophilized liquid component of MENVEO (batch number: unknown) intramuscularly on an unspecified date. No other adverse reaction was reported.
Right side facial numbness and tingling immediately after vaccine injection. Tops of hands and feet burning with raw sensation. Months later still experiencing numbness and tingling but in both arms and both legs from knees down to toes. Also, still have the burning and raw sensation on tops of hands and feet
Two days after receiving MMR vaccine family noticed patient was not using the left side of his mouth when he talks.  Mother showed video to provider who confirmed he was able to use his mouth to eat/drink without difficulty or drooling and could close both eyes. He also developed fever 8 days after receiving the vaccine. Today (01/16/2020), mother contacted my office again as symptoms had not resolved.  Mother provided me with two videos that show depression of the orbicularis oris when face is at rest.
Cellulitis reaction at the injection site was warm, firm, red, and getting bigger; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis reaction at the injection site was warm, firm, red, and getting bigger) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis reaction at the injection site was warm, firm, red, and getting bigger). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site cellulitis, at a dose of UNK dosage form; IBUPROFEN for Vaccination site cellulitis, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site cellulitis, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis reaction at the injection site was warm, firm, red, and getting bigger) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The cellulitis was is warm, firm, red, and getting bigger despite taking Tylenol, ibuprofen, and Benadryl.; Sender's Comments: This case concerns a patient of unknown age and gender with nonserious unexpected vaccination site cellulitis.  Event onset with unknown latency after first dose mRNA-1273. Treatment with paracetamol, ibuprofen and diphenhydramine. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
From initial information received on 5/19/05 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a female patient, now age 9, received a DTP vaccination, a Hepatitis B vaccination, a Polio vaccination, and a HIB vaccination when she was two months old, exact date of vaccination unknown. No information regarding the manufacturers, the lot numbers, the route and sites were provided. Reportedly, three days post vaccination the patient developed cold symptoms, her eyes started to cross and she began wheezing. The patient was hospitalized and diagnosed with bronchiolitis. After the patient was discharged from the hospital, she developed drooling and her eye began turning inward. At eight months old the patient still could not roll over. The patient was seen by a neurologist and began therapy. The drooling continued until the patient was two years old. She needs braces to walk which started when she was 22 months old. The patient's recovery status is listed as not recovered. From additional information received on 5/24/05 from a nurse, this child was diagnosed with Cerebral Palsy as per mother. Also, the mother thinks the polio vaccine given was an injection.
24JAN96 spots noted on abd, mostly raised;25JAN96 eyelids, toes, entire body had rash;low grade fever 2 days ago 22JAN96;pt fussy but taking fluids, eating well 25JAN96;MD stated rxn from MMR
I wake on Saturday I okay. I eat oatmeal. I felt like I was having a heart attack. I had really bad heart burn. I went to the ER. They did EKG. Thought it was acid reflux. I did not help. So, they did another EKG, which showed that there was something going on with my heart. They decide to do a heart cath and two stents in.
Patient said his arm started to hurt and believed that the needle hit his bone. He visited his primary Dr.  Has now retained a lawyer for damages.
21NOV94 530PM rt arm & rt leg started twitching p/starring for 10-15seconds-did not respond to voice-twitching duration about 1min; not eve happened before; T105.5R
Patient's flu shot was administered in the left deltoid muscle on 11/17/16. The patient called on 11/21/16 to complain of bruising after receiving vaccine. Bruise was 2" x 2" square with clots at bottom. Was painful the first day but not anymore as of 11/23/16. Patient still has bruise as of 11/23/16.
Patient seemed slightly nervous prior to vaccination. Shortly after we checked on the patient while he was in the post-vaccination observation area, the patient abruptly experienced syncope 5-10 minutes after receiving J&J vaccine while he was seated in the waiting area. The patient slid and/or flopped sideways out of the chair before we could stop his fall, and his head struck the floor, resulting in a 1" laceration on his right forehead.  Bleeding controlled with direct pressure and gauze. Patient quickly regained consciousness while in position he fell to, later brought to supine, with knees and feet elevated, and was A&O and PERRLA with BP 90/60 with radial pulse and HR in mid 50s, pale and diaphoretic, minimal nausea, no breathing issues, and mild pain and discomfort. Patient felt warm, wrapped ice pack applied and seemed to help.  NKA. Patient stated he had history of type 2 diabetes, regularly took metformin and may not have taken it earlier that day (later said he had taken it after all), and that he had in the past been hospitalized for 4 days for DKA. Patient stated that he had a history of syncope after injections, blood draws, and medical procedures or settings and that in the past he and his healthcare providers had chosen to have him lay down while getting vaccines or possibly certain other treatments. Patient stated he has recently been experiencing extremely stressful events in his life and that he had recently felt more difficulty concentrating or thinking.  Patient condition began to improve, with improvement in skin signs and vivaciousness in his conversation with us. FD arrived, patient symptoms and vitals continued to improve, the patient was moved by FD to a seated position, and FD applied steri-strips. Patient stated he did not want to go to a medical facility, in part because of medical anxiety, stating he felt he would likely have syncope again just from going to an ER or urgent care. Patient seemed well enough that with all factors considered emergency transport to the hospital did not seem to medical personnel present like it would be the best option for him. Arranged for patient to be driven home and monitored by family. Patient felt very sad and stressed for a moment.  We cleaned up his wound area while leaving the steri-strips in place, and recommended urgent care and PCP follow-up, and talked with him about caring for the laceration. We advised him he may have a concussion injury from his head impacting the ground. We advised him to follow up with a medical provider, and to have 911 called if any concerning signs or symptoms developed. We talked with his family and friends about how they should help him rest while monitoring for any complications and ensuring his safety. The patient remarked he felt much better than he had expected as we walked him to waiting vehicle, patient departed from scene in care of family to be driven home and monitored by family.
ADMINISTRATION OF A DOSE OF THE VACCINE 6 HOURS AND 20 MINUTES AFTER FIRST PUNCTURE OF THE VIAL; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191,expiry: UNKNOWN) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 06-JAN-2022, the patient experienced administration of a dose of the vaccine 6 hours and 20 minutes after first puncture of the vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of a dose of the vaccine 6 hours and 20 minutes after first puncture of the vial was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 18:22, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
A non-serious spontaneous report of administration of H1N1 to 18 month old, low grade fever and a little sleepy and napped has been received from a registered nurse/health professional concerning 18-month-old male, subsequent to H1N1, Intranasal. There was no medical history and the patient was healthy at the time of vaccination. The patient was not on any concomitant medications. On 18-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. After receiving H1N1 vaccine, the child felt a little sleepy and napped most of the afternoon and it was resolved on 19-Nov-2009. Twenty four hours after vaccination, the patient experienced low grade fever which resolved on its own 24-hours later. The outcome of the events was resolved. Additional information was received on 01-Dec-2009 and incorporated into the narrative: Event of low grade fever and the outcome of the event was resolved. Additional information was received on 03-Dec-2009 and incorporated into the narrative: Event of a little sleepy and napped most of the afternoon. The outcome of the event was resolved.
Fever Headache and Chills started, body aching did not start until the next day 02/03 and lasted through 2/4 Headache has not gone away it goes from dull to throbbing depending on amount of Ibuprofen and last time taken. Narrative:  Other Relevant History:
Hives on both legs within 24 hours of shot. 3rd and 4th day - hives up back and elbows.
got the flu; Initial information received on 13-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who got the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Initial report was received 04 November 2010 from a health care professional. An 83-year-old male patient had received FLUZONE HIGH-DOSE "maybe three weeks ago" (lot number, route, site and the actual date of administration were unknown) and an unspecified amount of time later, the patient was hospitalized for joint pain and immobility. Corrective treatments consisted of unspecified pain medications. No further information was provided at the time of the report. Documents held by sender: None.
Pt had swelling the size of quarter or a little bigger.  Injection site had some fever & was sore to touch and was increasing in size.  This shot was given on 12/10/07 & child was seen for swelling on 12/12/07.  Pt was treated with Amoxicillin for cellulitis.
Died of covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Died of covid) in an 81-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Died of covid) (seriousness criterion death). The patient died on 16-Jul-2021. It is unknown if an autopsy was performed.            No concomitant medications were reported. No treatment information was reported. Very limited information regarding this event has been provided at this time. Further information has been requested. Further information is not expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Further information is not expected.
Patient was very upset after her booster shot that she had itching in the site. She felt we needed to report this. Patient has difficulty hearing and to make sure we followed through on her request, we told her we would submit her concerns. Her armed itched for 3 days. Patient has COPD and did not want to submit the form herself due to age and hearing.
For 24 hours had a fever of 101 degrees and body aches.  Treated the symptoms with rest and fluids.  The symptoms have not returned.
Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose in OCT-2022).   In SEP-2023, the patient received the 2nd dose of Twinrix adult. In SEP-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine).  The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2023 Pharmacist requested guidance on Twinrix series. Exact dates of vaccines unknown as patient received at a different pharmacy. Pharmacist disconnected call prior to confirming Safety team follow-up. The patient received the 2nd dose later than recommended interval, which led to lengthening of vaccination schedule.
RASH ON UPPER ARM OF INJECTION SITE.  ON FOURTH DAY OF RASH GETTING REDDER AND BIGGER EACH DAY.  DOES NOT ITCH OR HURT.