chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC STEATOSIS (FATTY LIVER), BLOOD TRIGLYCERIDES INCREASED (HIGH TRIGLYCERIDES) and MALAISE (FEELING UNWELL AFTER COVID VACCINE with HUMIRA) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriasis. The patient's past medical history included Defibrillator/pacemaker insertion in 2012. Concurrent medical conditions included Psoriasis. On 18-Jan-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2022, the patient experienced MALAISE (FEELING UNWELL AFTER COVID VACCINE with HUMIRA). In June 2022, the patient experienced HEPATIC STEATOSIS (FATTY LIVER) and BLOOD TRIGLYCERIDES INCREASED (HIGH TRIGLYCERIDES). In 2022, MALAISE (FEELING UNWELL AFTER COVID VACCINE with HUMIRA) had resolved. At the time of the report, HEPATIC STEATOSIS (FATTY LIVER) and BLOOD TRIGLYCERIDES INCREASED (HIGH TRIGLYCERIDES) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The reporter did not have the lot number information, because the packaging was discarded. The reporter causality for the events of FATTY LIVER, HIGH TRIGLYCERIDES and FEELING UNWELL AFTER COVID VACCINE with HUMIRA was no reasonable possibility. Treatment information was not provided.
Pt complained of soreness in right arm, swelling and redness from site of injection to elbow.
Post vax the patient experienced redness and swelling from the elbow down and a fever. The mother applied ice and elevated his arm. The doctor said it was a local reaction, and treated it with a steroid injection. The doctor advisede all future shots to be given in the hip.
Case number PHEH2015US020518 is an initial spontaneous report from a pharmacist received on 09 Oct 2015. This report refers to a 65-year-old male patient. He was vaccinated with FLUCELVAX (batch number: 174271, expiry date: May 2016) on an unknown date. On 05 Oct 2015, after vaccination he experienced cellulitis at the injection site. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of the event cellulitis at the injection site upgraded based on the NVS-IME list.
Patient had received the flu vaccine and had gone to waiting room to wait 15 before leaving. Patient had not been sitting one minute when she reported to her friend she was dizzy and had a syncopal event. She fell to the left hitting her head on the wall. Patient was unconscious for approximately one minute. Vitals were stable. Patient remained pale and lightheaded for approximately 20 + minutes until EMS took her in for further evaluation.
2 days p/vax pt noted itching in chest/abd-then devel Herpes Zoster in T11 distribution;
This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (For tolerance to 1st dose please refer case US2018183733). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 days after receiving SHINGRIX, the patient experienced fever and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the fever and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; it could be around 64 or 65 years. The patient had 2nd dose and the side effects were not as bad, just low grade fever the next day. Less than a year after receiving SHINGRIX, the patient experienced sore arm for about 5 days.
Information has been received from a physician who "heard from a patient that someone related to her friend", a female, who was vaccinated with her second dose GARDASIL on an unspecified date. Subsequently the patient required assistance in walking. The patient might have been treated at a hospital. At the time of the report, the patient's status was unknown. Follow up information on 25-SEP-2009 has been received through a phone call from a physician. The physician stated that she did not know any information of the patient. She would ask the person who report the case to get the patient's adverse experience. Required assistance in walking was considered to be disabling. The Health Care Professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number, date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information. No further information is available at this time. Additional information has been requested.
L arm of injection warm to touch; pain on L arm of injection; Headache mild in intesity; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (L arm of injection warm to touch), VACCINATION SITE PAIN (pain on L arm of injection) and HEADACHE (Headache mild in intesity) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 630B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN (INSULIN HUMULIN-N) and GLIPIZIDE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (L arm of injection warm to touch), VACCINATION SITE PAIN (pain on L arm of injection) and HEADACHE (Headache mild in intesity). At the time of the report, VACCINATION SITE WARMTH (L arm of injection warm to touch), VACCINATION SITE PAIN (pain on L arm of injection) and HEADACHE (Headache mild in intesity) had resolved.            Treatment details included two ibuprofen  and application of ice. Action taken with mRNA-1273 in response to events were not applicable.
Gave full doses (0.5ml) for boosters instead of half doses (0.25ml); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave full doses (0.5ml) for boosters instead of half doses (0.25ml)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave full doses (0.5ml) for boosters instead of half doses (0.25ml)). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Gave full doses (0.5ml) for boosters instead of half doses (0.25ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 years old male patient who received an expired dose of MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 22-Feb-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5823AB (expiry date: 22-Feb-2019),via intramuscular route in the left deltoid. It was unknown whether adverse event was received. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning a patient who was vaccinated with ROTATEQ (lot number not reported) oral. Subsequently the patient's heart stopped. The patient was resuscitated in the office. The patient recovered from heart stopped. The patient's heart stopped was considered as an other important event by the physician since resuscitation was required. Additional information has been requested.
3/19/13 A.M. Mom noticed fine red rash to arms, legs, and trunk with a little bit on cheeks. After he had his batch that evening, it was more red. Denies fever or any signs of distress, stating "He doesn't even act like he feels bad." Mom contacted Health Dept. on 3/20/13. Suggested she notify child's physician. He told her to bring him in if it seemed to get worse, if it went away don't worry about it. It has been going away on it's own.
24 hours after vaccine,  I developed severe Vertigo.  I couldn't lift my head off the pillow.  My eyes darted horizontal and would not stop.  I waited 3 days and contacted my Dr.  She made arrangements for me to see a Physical Therapist the next day. He made an evaluation and said it was the crystals in my ears were out of line.  He worked on me that day.  The vertigo is now down to just one side of my head if I turn it at the wrong time.  It is worse when I am lying down.  At this time (2 weeks) I feel the PT will be  able to work.  I feel tired thru all of this but every week I'm getting better.
Became sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Became sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GAMMA GLOBULIN from 12-Jan-2021 to an unknown date for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Became sick) (seriousness criterion hospitalization). The patient was hospitalized from 19-Feb-2021 to 03-Mar-2021 due to ILLNESS. At the time of the report, ILLNESS (Became sick) outcome was unknown. Not Provided          Patient  was going to get the second Gama globulin infusion 4 days after the second dose. Treatment included oxygen since hospitalization (19 Feb 2021). Reporter  wanted to know about the interaction between the Gama globulin infusion affects and the Moderna shot.
Patient received Janssen Covid-19 vaccine 4/12/21 and requested Pfizer Covid-19 vaccine 7/24/21 after discussion with PCP. Patient worried about Delta varient.
Pt had KINRIX imm (L) deltoid on Wednesday yest. Today has large 3x3 inch localized red and warm area on inner aspect of (L) deltoid region.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (Chills). On 21-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Client called health department on 8/20/21 to report "several hours" after receiving his first dose of COVID-19 vaccine (Pfizer), he noticed drooping of his right eye. On 8/20/21 he reported the drooping has persisted. Denies drooping of mouth/cheek. Denies any other side effects of the vaccine. Client stated he called his doctor (client's PCP) and he was going to see the Dr. for a steroid injection that should improve symptoms.
Scratchy throat,  congestion with runny nose,  hoarseness and mild headache  beginning 05/11/2022.  Home test positive that night. AM of 05/12/2022 Urgent Care rapid molecular NAAT test was positive.  Began quarantine for 5 days. 05/13/2022 got monoclonal antibody slow push IV at local Hospital 05/14/2022 Started Paxlovid.   All symptoms except hoarseness had abated by 05/15/2022.  Hoarseness almost gone by today 05/17/2022.
Unable to focus eyes, dizzy, faint, falling over started 2 hrs after injection. Extreme tiredness 3 hrs after injection so bad couldn?t get up. Symptoms lasted 24 hrs. Soreness in arm, shoulder then neck of left side injection prohibiting sleep 48 hrs after injection.
mom reports 1 hrs p/immun given pt started having shrill cry that lasted for 6 hrs, fever up to 103 & lethargic; APAP given & notified their pediatrician;
Right arm extremely sore unable to lift for almost two weeks and constant ache and pain.  Sleep interrupted.  Using heating pad and taking ibuprofen.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from non-health professional. This case involves 82 years old patient of an unknown gender who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ004AA via intramuscular route in the left deltoid (frequency-once, expiry date not reported) on 25-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to underdose. It was also case of syringe issue. It was reported that RN was giving the vaccine to a patient and liquid leaked out the compartment between the needle and the part of the syringe where the vaccine is and patient received the majority of dose. It was unknown whether the patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient with complaint of left shoulder pain day after receiving vaccination.  C/O sharp pain, not being able to move arm forward above the chest without much pain.  Bruised area noted at top of left arm.  Patient states has Physical Therapist look at home, believe pain is consistent with SIRVA.
his arms and hands became very itchy; started to swell up; eczema; lead to open sores, scabs, and puss; create rashes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (his arms and hands became very itchy), PERIPHERAL SWELLING (started to swell up), ECZEMA (eczema), SCAB (lead to open sores, scabs, and puss) and RASH (create rashes) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRURITUS (his arms and hands became very itchy), PERIPHERAL SWELLING (started to swell up), ECZEMA (eczema), SCAB (lead to open sores, scabs, and puss) and RASH (create rashes). At the time of the report, PRURITUS (his arms and hands became very itchy), PERIPHERAL SWELLING (started to swell up), ECZEMA (eczema), SCAB (lead to open sores, scabs, and puss) and RASH (create rashes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided. The patient was in his 30s. Patient had received the Moderna dose last year. No changes were noticed immediately after the administration of vaccine. However, after 3 weeks to a month, he started to experience the adverse events. It was almost a year by the time of reporting, and patient was still dealing with the complicated effects of having this vaccine.  Patient was given cream for his eczema which was healing for some time but whenever it healed, the itchiness would come back and cause his scabs to reopen or create puss again. It was further reported that the patient's hands and arms seriously looked painful and almost rotten in certain areas. Patient was completely healthy, and he doesn't get as sick either.
patient received flu shot at pharmacy and 2 days later developed redness, pain, and swelling of L upper arm where she received the shot..  by the time I saw her on 9/28/20 her arm was much better.  redness had resolved, swelling was much improved.  pain resolved.
Noon: chills, body aches 3:00 PM: extreme tiredness, dizziness, ringing in ears, torso/neck rash, heavy bodied feeling, heaviness in chest
Patient had a cellulitis type reaction at injection site. Sought medical care and was prescribed an antibiotic for cellulitis by physician assistant. Patient presented to pharmacy 3 days after injection with prescription for the antibiotic.
Patient was participating as a volunteer plasma donor for anthrax immune globulin given. The patient's last anthrax immunization was 18 Dec 2006. April 4th -- Symptoms began with palms itching.  Donor used topical and parenteral Benadryl, getting some relief. After a few days feet started to swell.  Saw internist who gave her a diuretic.  Symptoms expanded to aching feet, hands, arms and shoulders.  Donor developed chest pain which felt "like severe heartburn".  A rash developed -- big circles on the arms.  Made 2 to 3 visits to doctor.  Physician removed all routine medication and prescribed prednisone.  The patient seemed better and doctor said to resume her medications(Synthroid, Evista, Wellbutrin).  The rash returned in two days.  Rash developed into "itchy hives".  May 18 -- Rash was all over patient's body.  Donor saw an allergist.  Donor began taking Zyrtek, Singular, Alavert, and Ranitidine.  July 18 -- Rash and aches are kept under control with one Ranitidine and two Zyrtek daily.  If 2 doses are missed, the patient experiences itching over entire body and aching in her arms and chest.
Skin really hot to the touch, still warm, hot today; Was pretty bad, felt like he needed to stretch; Ears are burning; This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2023, the patient received the 2nd dose of Shingrix (intramuscular). In February 2023, less than a day after receiving Shingrix, the patient experienced skin warm, feeling bad and burning sensation. The patient was treated with ibuprofen. On an unknown date, the outcome of the skin warm, feeling bad and burning sensation were recovering/resolving.   The reporter considered the skin warm, feeling bad and burning sensation to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The case was self reported by the patient but there were two reporters. The patient and his fiancee were both on the line.  The patient received second dose of Shingrix yesterday (the day before reporting) into right deltoid and his skin got really hot to touch and it was still warm now and last night it was pretty bad and the patient felt like he needed to stretch. They did not take his temperature to see if he had a fever but he did take Ibuprofen and warm skin involved his whole body and he was still hot today but not like last night and his ears were burning because they were hot and the patient was getting better today. The reporter did not have the lot number of the administered vaccine. The reporter consented to follow up. Additional Supportive Information: Event outcome for all event was captured as recovering conservatively as per the last sentence from the narrative and event causality captured as yes.
Site pain; tiredness; mild headache; muscle pain; chills; fever; not well; swollen lymph nodes; swollen face; aching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 08Mar2021 15:00 (at the age of 58-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination) and Penicillin allergy; both from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) and vitamins (taken by the patient every day); both taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient was not tested for COVID post vaccination. On 09Mar2021 12:00 PM, the patient experienced site pain, tiredness, mild headache, muscle pain, chills, fever, not well, swollen lymph nodes, swollen face and aching. No treatment was taken for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccinator had previously been giving Pfizer vaccine, and switched to Moderna for this patient. Drew up and injected only 0.3ml of Moderna vaccine. Error was immediately realized and patient was informed. Patient gave consent and received an additional injection of 0.2ml to make up total 0.5ml Moderna dose.
Constipation; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8724) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergy to penicillins. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date, the patient experienced constipation. The event constipation did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constipation was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.