chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of ROTATEQ orally, lot # M03180 (doses and expiration date were not reported). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion between -1 degree Celsius to -2 degree Celsius which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.; Sender's Comments: US-009507513-1703USA012983: US-009507513-1703USA014122: US-009507513-1703USA014120:
Fluzone Quadrivalent was administered to a 2 month old, no AE; Initial information received on 31-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2 months old male patient was vaccinated with a 0.5 ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA, expiry date: 30-Jun-2020) via intramuscular route in the right vastus lateralis on 31-Dec-2019.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation on 31-Dec-2019.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, the patient had no adverse event.  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.
Pt received Pediarix combo vaccine (Diptheria, Tetanus Toxoid and Acellular Pertussis, Hep B, and Polio) on 7/30/2020;  On 7/31/2020, we discovered the patient was given a Pediarix vaccine that expired on 7/3/2020; no known problems related to the expired vaccine to our knowledge
Pretty immediate  skin rash , cheek tingling, lip tingling, warmth over body and one day of feeling achy, cold &  tired
Bulging fontanel (anterior) x 1 day. Clinically stable. Observed and by 48 hrs and was back to flat/normal. Infant was fussy with sl. fever but never in acute distress.
Patient has some tachycardia and dizziness on the day of vaccination. Developed rash at injection site 4 days later, which is itchy, tender, and inflamed.
severe pain from her waist down to her thigh; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy). At the time of the report, PAIN IN EXTREMITY (severe pain from her waist down to her thigh) and DIZZINESS (dizzy) outcome was unknown.            After the third dose patient was in severe pain from her waist down to her thigh and felt dizzy. No concomitant and treatment medication were provided.   This case was linked to MOD-2021-338542, MOD-2021-338524.
Reconstituted with saline water; Reconstituted with saline water; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31-MAY-2023) for prophylaxis.   On 23-FEB-2023, the patient received the 2nd dose of Menveo. On 23-FEB-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Reconstituted with saline water) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with saline water). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-MAR-2023 The nurse reported that a Menveo dose was reconstituted with saline water and administered.  The reporter did not consent to follow-up.  Permission to create an HCP´s account declined. The patient received Menveo which was reconstituted with saline water, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
patient experienced body aches, shivers, headache, diarrhea, vomiting and reddness/swelling  in the left arm  the first day. symptoms improved day 2 but still wasnt feeling well with continued swelling of the left arm and slight body aches and headache.
admitted to the hospital Feb 2nd with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (admitted to the hospital Feb 2nd with shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HERPES ZOSTER (admitted to the hospital Feb 2nd with shingles). At the time of the report, HERPES ZOSTER (admitted to the hospital Feb 2nd with shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Per the patient herself: She received the flu shot at pharmacy no sooner she walked out of the building her throat started to swell. Her husband took her to the ER where they would not treat her. She went to the local Urgent Care where her lips and feet started turning blue. Urgent Care in turn called the ambulance. The ambulance arrived and the EMT administered Epinephrine, Benadryl and Sodium Chloride. Patient states within minutes she was feeling better and her throat loosened. She also stated that she has gotten the flu shot every year for years with no reaction.
Numbness in extremities (hands, feet, and legs), inability to pee (day after 2nd dose) and erectile dysfunction.
extreme Muscle pain, joint pain, neuropathic pain, hypersensitivity to normal touch (pain), tooth pain/sensitivity, Raynaud's reaction, fatigue  and weakness,  chills with severe shaking/shivering,  swelling and redness at injection site, inability to use arm that was injected, reddening  of SLE rash
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 2nd July 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and extremities hot feeling of. On an unknown date, the outcome of the pain in arm and extremities hot feeling of were unchanged. It was unknown if the reporter considered the pain in arm and extremities hot feeling of to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's girlfriend. The patient received SHINGRIX vaccine on the left arm. The patient experienced sore arm, pain and heat radiating down the arm. On the day of reporting, his arm was also tender. His symptoms had gotten worse from the vaccination day (a day before reporting). The patient was in the same room in the background while the reporter reported this event, and he had denied permission to contact their physician. No further details were provided.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Diagnosed for prostrate cancer 7 years ago and recently got the treatment as "took out small spot on vertebrate". Also reported to finish 5 radiation 2 weeks ago on 19-Feb-2021.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included basic vitamin. The patient also took acupuncture. No treatment was reported.
Severe joint pain in left hand.  Treated with CBD oil and exercise.  Severe pain subsided within two hours.
Headache; Nausea; Malaise; Chills; Fever; Fatigue; Myalgia; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Apr2021 (at the age of 23-year-old) (Lot Number: 204A21A) as single dose (unknown if first or second dose) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced myalgia on 10Apr2021 with outcome of not recovered, headache on 11Apr2021 with outcome of not recovered, nausea on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 15 hours), malaise on 11Apr2021 with outcome of recovering, chills on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 2 hours), fever on 11Apr2021 with outcome of recovering and fatigue on 11Apr2021 with outcome of not recovered. The events were considered as non-serious. The patient underwent lab tests and procedures which included body temperature: fever, temperature not measured on an unspecified date.    No follow-up attempts are needed. No further information is expected.
pt received DTaP (infanrix) shot on thursday 5/25 with redness to L thigh injection site. - 5x5cm area of erythema with rash per provider note. lot 7HM5J
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated.
I had a fever of 102 degrees almost the entire day after receiving the second shot (the fever went away after a day) with a very painful headache that continued in a milder manner for a few days after the fever was gone. I was also dizzy when my fever was worst and had trouble Standing/walking straight.
About 12 hours after injection, was woken up with sever sweating. Enough sweat to drench clothing. Temperature was aprox. 102.4 F. Later I started to have body aches, headache, nausea, loss of appetite. Later in the evening I began to experience dizzy spells that would come and go. I continued to experience the fluctuating temperature but did not exceed a temperature of 102.6. After going to bed at around 1:00am on April 14, I continued to have severe sweating. The sweating continued until 12:30pm this afternoon. I was unable to get out of bed and felt like I was paralyzed. I was able to hear my family awake around me but could not respond. I also started to feel a sharp pain that started u set my right breast and radiated into my chest. After the pain started, I became short of breath. After waking up, again drenched in sweat, I showered and felt better. I am still experiencing a headache, dizzy spells and a tightness in my chest that makes it difficult to breath. My head feels like it gets flushes of pressure that causes me to be dizzy. Then I have a headache for an hour. I am taking 15mg meloxicam because of my hip surgery so I can?t take any aspirin. I have taken Tylenol but it does not relieve my symptoms.
Lump developed under right arm in lymph node. Hot flashes followed by periods of chills. Dr told her if it didn't go away a couple of days to come back and she would take antibiotic.
h/a, vomited eve p/inject; day p/inject-fever 100 or so vomited nausea;
Reporting is for a vaccine administration error where an adult patient was administered the Pfizer-BioTech vaccine  5-11 years   formulation(Orange cap),resulting in a lower than authorized dose for a booster. There is currently no symptoms or adverse event. Patient has been called and correct age appropriate dose of Pfizer-Biotech vaccine has been given on 11/24/21, as per CDC and vaccine manufacturer guidelines.
When I caught COVID-19 I experienced symptoms of a headache, cold, and congestion for the first 5 days after testing positive. I also had joint pain in one of my shoulder, knee, hip, and ankle that lasted for 3 or 4 days. Then I was experiencing fatigue. It was really bad for 2 or 3 days. I'm still feeling it, but it has improved. I took some TYLENOL.
2 weeks post vaccine. I was first thinking I was tired because I work too much. So one day I picked up some reading glasses and they helped me see better. I don't pay too much attention to my vision because I am always busy. Before the vaccine I did not have any problems with my vision. I was not able to see well for a month after the vaccine. 11/08/2021- Now my vision has improved. I still use the reading glasses, but not as much. I have recovered from my vision. Not 100%, but it is a lot better now.
Information has been received from a 20 year old female with anatryptaline allergy and a history of eating disorder, acid reflux and pelvic inflammation (physician found " low recessive cells for cervical"; after treatment and another PAP test the physician suggested getting HVP vaccine) who on 03-SEP-2008 was vaccinated in the upper arm with the first dose of GARDASIL.  On 13-SEP-2008 she found out she was pregnant.  On an unknown date she received a flue shot and prenatal vitamins.  On the day of vaccination the patient experienced "burning pain at the time the shot was given, and after the injection she had a little red dot for a couple of days that eventually turned into a swelled up knot that was very painful to the touch".  The consumer recovered "2 and a half weeks after getting the vaccine".  The consumer sought unspecified medical attention.
1-10-22 hospitalized for shortness of breath and chest pain. Died 1-11-22.
No adverse event. Patient aged 15 was vaccinated with FLUCELVAX: approved for 18 + y/o.
tested positive for Covid; Case reference number MOD-2021-014581 is a case report which refers to a 70 Years old Female patient.  The patient experienced tested positive for Covid which resulted in .  This occurred while participating in   The patients started Moderna COVID-19 Vaccine on  .  Some  8 days  later, the patient developed tested positive for Covid.'  Relevant laboratory results included   and relevant physical signs were  The patient experienced the following serious criteria:   The eventual diagnosis made was COVID-19 .  The patient was treated for the event with   The action taken for Moderna COVID-19 Vaccine was    .  The investigator considered the tested positive for Covid  did not declare related to the study drug/placebo.  In the investigators opinion other possible factors included and the patients age/history or other factors
This nurse gave pt shots when she turned to throw needles away in sharps container. Pt fainted and fell off examine table to the ground. Pt was rushed to by this nurse, Dr. , and pt mom. Pt was given a cool cloth for forehead, ice pack for head, vs taken, and blood sugar taken. All vs within normal ranges. Pt given time to rest and monitored by physician.
Pt was normal before the injection. After the shot he developed rash in groin area which started to spread. Tried treatment but didn't work and the symptom is still visible.
Immediately after vaccine was administered, complained of pain at the site. The area was hard and became ecchymotic immediately.
Monday, July 4, I began running a fever and got up to take home COVID-19 test and it was positive. My symptoms were mostly sinus head pain and just really tired. Post nasal drip caused me to cough. I had a tickle in my throat that caused me to cough. Fever only lasted one day.
Patient with history of COVID vaccination admitted to hospital with COVID detected PCR test. Per provider discharge notes, "Patient is a 87 YO male with HTN, essential tremor, hypothyroidism, Afib with controlled ventricular rate,OSA on CPAP at home, HFpEF presents from ER for evaluation of SOB, increased WOB and dry cough for 2-3 days. Admitted for acute hypoxic respiratory failure secondary to COVID infection.    Hospital Course: SIRS 1/2 for tachypnea, did not meet criteria for sepsis. CXR: Normal pulmonary vascularity. No pulmonary consolidation, pneumothorax, or evident pleural effusion. Procal 0.03, afebrile, no leukocytosis, CRP 3.35, lactic acid 1.2, blood culture NGTD x 2 d. Antibiotics held, as no sign of bacterial co infection.    Patient was weaned off oxygen. Upon exam this morning, patient feeling overall better.  Patient was medically optimized. Vital signs were stable for discharge."
COVID (+) WITH SYMPTOMS SORE THROAT LOSS OF SMELL CHILLS COUGH AND NASAL CONGESTION Narrative:
Feel very achy; Feel tired; Fell just not up to par; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th September 2019, the patient received the 1st dose of Shingles vaccine. In September 2019, less than a week after receiving Shingles vaccine, the patient experienced pain, tiredness and feeling abnormal. On an unknown date, the outcome of the pain, tiredness and feeling abnormal were unknown.   It was unknown if the reporter considered the pain, tiredness and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt very achy, tired, and just not up to par after receiving vaccine. The patient realized that these are common side-effects of the drug. The patient asked when they go away and when should I worry.
Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Very tired, chills, rash near injection site. The tiredness and chills lasted about a day. The rash started the second day after my vaccination
Left inner upper arm and forearm, redness, swelling and constant pain for 2 days.  Received 3rd shot 3 days ago.  Previous 2 shots-local swelling.  Last shot-bigger local swelling.
headache next day, swollen tonsils starting two days and lasting 4 days, fatigue, malaise.
I received the GARDASIL shot on Wednesday 5/23/2018 and on 5/25/2018 I noticed rash (raised bumps) area on my stomach on the right hand side. As of 5/26/2018 it has gotten worse.
Information has been received from a pharmacist concerning a 60 year old female patient with iodine allergy. No medical history was reported. On 08-APR-2016 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # L028282, Expiration Date 28-OCT-2016) subcutaneous in the left deltoid. Concomitant therapies included progesterone (manufacturer unknown) and estrogens (unspecified). On 10-APR-2016, the patient called the pharmacy back to report that she developed pain in her right leg and right hip on 10-APR-2016. The pharmacist stated that she advised the patient to "take TYLENOL and ice the affected area." No lab diagnostics studies were performed. At the time of reporting, the patient had not recovered from adverse events. The causality between adverse events and the vaccine was not provided. Additional information has been requested.