chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 30-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
3/4 Inch round mild swelling locally to site of injection - painfull to touch. Was not hard or spread beyond initial 3/4 inch lump
Knee pain in both knees approx. 3 months after last shot of series. Pain is an arthritis-like feeling in knees. (Series of 3 shots) 2nd on 5/19/99 and 3rd on 5/16/00.
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. No current condition, medical history or drug/allergies were reported. On 13-MAR-2015 the patient was vaccinated with first dose of GARDASIL injection (strength, dose number, route, lot number and expiry date unknown). No concomitant therapy was reported. On 20-MAR-2015 (also reported as today), the patient was vaccinated with second dose of GARDASIL. No adverse effect was reported. The outcome of event was unknown. No further information was provided. Additional information is not expected.
lymph nodes under my arm and by my collar bone gets inflamed and is painful/swelling and pain in my lymph nodes; lymph nodes under my arm and by my collar bone gets inflamed and is painful/swelling and pain in my lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 14:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization Complete, Unknown Manufacturer), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 3 (Booster), Single, Unknown Manufacturer), for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 04Oct2023 at 06:00, outcome "not recovered" and all described as "lymph nodes under my arm and by my collar bone gets inflamed and is painful/swelling and pain in my lymph nodes". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy. Additional information: The patient had no Covid prior vaccination and had not tested post vaccination. The patient has no known allergies. The patient had received her 4th dose and reported that, each dose, her lymph nodes under her arm and by her collar bone gets inflamed and is painful. This occurs about 10 hours after the dose. She received her 4th dose the day prior (03Oct) at the Pfizer clinic at 2PM. She woke up that morning with swelling and pain in her lymph nodes.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200016214 same reporter/patient; different dose number/event;
This non-serious medically confirmed report (initial receipt 18-Jun-2014) concerns a 49 years old female patient who was on unspecified concomitant medications. The patient had drug reaction/allergies to flu vaccine and no known other allergies. On the 19-Oct-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). On the 20-Oct-2012, one day after the influenza vaccination, the patient had a reaction to influenza vaccine. The patient complained of hives, rash, swelling, nausea, flushing. The patient did not have shortness of breath. Treatment included diphenhydramine and prednisolone. Outcome was reported as recovered.
Urticaria on bilateral extremities, chest, torso, and neck   No shortness of breath, closed airway, or any other signs of a severe allergic reaction
Pt vaccinated with OPV/DTP/MMR/HIBV rash started last night.
I am just trying to find out why I have pain in my calves and taste problems - food doesn't taste good and I have a bad taste in my mouth all the time. Could this be side effects of Hep b antibodies or vaccine? Or Truvada/Tivicay? Or some other drugs I may have been given in the hospital. I had my gallbladder removed and one piece of equipment hadn't been cauterized so I was put on a protocol for HIV/Hep. Ever since then I have had these issues.
pt recvd vax; to ofc w/ inject site rxn of erythema,tenderness, swelling 3-4" in diam;apap & ice packs used;
Pfizer vaccine was administered outside of Facility- reported by patient  G62.9 PERIPHERAL NEUROPATHY 1/3/2022 ABDOMINAL PAIN I26.99 ACUTE PULMONARY EMBOLISM 3/13/2022 ABDOMINAL PAIN G62.9 PERIPHERAL NEUROPATHY 1/3/2022 ABDOMINAL PAIN I26.99 ACUTE PULMONARY EMBOLISM 3/13/2022 ABDOMINAL PAIN G62.9 PERIPHERAL NEUROPATHY 1/3/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION I26.99 ACUTE PULMONARY EMBOLISM 3/13/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION G62.9 PERIPHERAL NEUROPATHY 1/3/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA I26.99 ACUTE PULMONARY EMBOLISM 3/13/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA G62.9 PERIPHERAL NEUROPATHY 1/3/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA I26.99 ACUTE PULMONARY EMBOLISM 3/13/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA
Our office was informed 3/14/08 of patients demise - no side effects in office. 5/15/08-records received-Cause of death:Sudden Infant Death Syndrome (SIDS). Manner of death:natural.
Pt was erroneously given MMR, VARIVAX and PROQUAD at well exam on 6/8/16. One week later had fever 103.7 was seen in office and dx with fever, unspecified. On 6/18/16 was seen in office for a "measles-like rash"; afebrile, no other symptoms.
Pain, swelling, tenderness, warmth and redness worsening s/p injection.
Nausea-vomiting-EXTREME fatigue, chills-fever 100.6-all symptoms lasted 24 hours-sleepiness for 24 hours-headache.
Narrative: Patient received two doses of Pfizer COVID 19 Vaccine in March 2021. The patient tested positive for COVID 19 on 5 February 2022. The patient presented to the ED on with general malaise and weakness, dry cough, headache, and shortness of breath. The patient was admitted with a diagnosis of COVID/hypoxia. The patient was treated with remdesivir and dexamethasone. The patient's conditioned worsened with acute pneumonia and sepsis. The patient died on 12 February 2022 due to COVID pneumonia and sepsis. Reported per EUA
pt recv vax approx 6PM & around 10PM rt leg started to swell, w/temp raising @ 230AM;pt fever was 104;pt was given a cool bath, temp dropped to 101;
Infant became hypotonic and hyporesponsive immediately after vaccines administered. No seizure activity. Transported to ER via rescue and by arrival in ER, had returned to normal, but had developed a single clear fluid filled vesicle on one hand.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced full blown chickenpox with greater than 100 lesions and a mild fever. Follow up information indicated that the pt was exposed to shingles prior to chickenpox onset.
Involuntary movement of arm after needle injection extreme pain radiating from injection site down to hand. Tingling, numbness, inability to lift arm. Present symptoms still exist.
My arms were itching before I left the pharmacy.  Within one hour I had hives on both arms and a few blotches in other spots on my legs.  My throat tightened and I started to wheeze on the exhale.  I called the advice nurse who suggested I go to the ER.  I did not want to do that on a Friday night.  I took 2 Benadryl and the wheezing stopped.  Throat loosened, but still didn't feel quite normal.  The hives have lightened, but I am still itchy.  I am now 6 hours post vaccine with hives.
Severe headache for 17 days and is still present, left pain in left side of head, and pain in left arm in elbow.
I was very ill over the entire weekend after getting the J & J vaccine on Friday, 6.4.21 pm through Monday. It affected my hearing in both ears, foggy, muffled hearing in both ears, swollen glands.  I went to an appointment with a Chiropractor as a new patient on July 6 and he was assessing me, and noticed a bump on my throat that wasn't seen before by me or noticed, or felt. Since then, the bump has enlarged-thyroid area. I have appointments with Drs in 2 weeks, and just got labs for thyroid/parathyroid done.
Got vaccine at 5:36 pm and during waiting time afterward, she reported around 5;53 pm having generalized tingling then followed by generalized pruritis. Denied and did not exhibit signs of urticaria, angioedema, cough, dyspnea, wheezing, CP, abdominal pain, nausea, vomiting, abdominal pain, lightheadedness, weakness, pallor, tachycardia. Discussed giving her diphenhydramine and she agreed stating she had no previous adverse reaction to this treatment. At 5:56 pm, I gave diphenhydramine HCL 50 mg/ml 1 ml IM in her right deltoid muscle. Around the time of the injection (approximately 5:59 pm, pulse was 76, oxygen saturation 97%, BP 138/90, lungs clear, heart RRR. Within 20 minutes (6:22 pm) of diphenhydramine injection, she reported that the tingling had largely subsided (only remaining in lower legs) and her pruritis was improving. Her pulse was 77, oxygen saturation 96%, and BP 126/82 at that time. She also reported she had not developed any new symptoms (see above). By 6:28 pm, she reported no further tingling nor pruritis and feeling well. We released her at that time as we deemed her recovered from the symptoms. We advised her to call 9-1-1 if the symptoms returned especially with one or more of the above symptoms she had twice denied experiencing. 3/9/21 11:47 a.m. Called to check on status. No answer. Left message.
Pneumonia; Arthritis; Back pain; Productive cough; Knee and shoulder pain; Ache body; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rotator cuff tear in 2011, Spinal stenosis in 2018 and Reverse shoulder replacement in 2014. Concurrent medical conditions included Seasonal allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRITIS (Arthritis), BACK PAIN (Back pain), PRODUCTIVE COUGH (Productive cough), ARTHRALGIA (Knee and shoulder pain) and MYALGIA (Ache body). On 08-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) and PRODUCTIVE COUGH (Productive cough) was resolving and ARTHRITIS (Arthritis), BACK PAIN (Back pain), ARTHRALGIA (Knee and shoulder pain) and MYALGIA (Ache body) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, COVID-19: negative (normal) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events included unspecified antibiotics, voltaren gel and ibuprofen.  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.; Sender'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.
pt recvd vax;3 days later exp severe HA;4-5 days p/ vax exp abd cramping & a few hives on upper body;6 days post vax she exp joint pain,fever & was covered w/ hives;seen by MD who prescribed corticosteroids on 6apr95;all sx resolved;
Patient Covid + on 10/09/2021. Patient received Pfizer vaccine with 1st dose on 03/15/2021 and second dose 04/05/2021.  Per ED note: History of Present Illness  The patient presents emergency department multiple ongoing complaints that have been an issue over the past 2 to 3 months.  He reports subjective fevers and chills, generalized weakness, shortness of breath with ambulation stating that his legs will get weak.  He is also complaining of chest pain feeling as if he cannot take deep enough breaths.  He is complaining of cramping in his bilateral lower extremities episodically.  With regard to the back pain he is not actively having back pain there is been no loss of bowel or bladder function no saddle paresthesias and he is able to feel stool passing his rectum, there is no loss of sensation, no history of IV drug abuse no recent trauma no unexplained weight loss.  The weakness that he describes in his legs comes after has been ambulating and is also feeling short of breath.  He states his roommate tested positive for Covid a week ago but then tested  negative within the last couple of days.  He has not had any significant coughing no pleuritic chest pain.  He has had decreased oral intake due to both nausea and shortness of breath while eating.  He states he was in Dr. office on the fourth and had extensive pulmonary function testing done but he does not have the results yet.
This spontaneous report as received from a pharmacist refers to a 71 year old male patient with congestive cardiac failure. The patient had no drug reactions nor allergies. On 17-JAN-2015, he was vaccinated with a dose of PNEUMOVAX23 intramuscularly 0.5 ml, once, in his arm (lot # K009876, expiration date: 19-MAR-2016). Concomitant therapies included ZANTAC, XANAX, TOPROL, CYMBALTA, LIPITOR, NITROSTAT, DIOVAN, allopurinol, ZYLOTAN and LOMOTIL. On the same day, the patient experienced arm pain and soreness in the muscle at the injection site. It was unspecified by the reporter whether any treatment was given for adverse event. No laboratory test was perform. The patient sought medical attention by visiting the pharmacist (date was unknown). No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 23-NOV-2012, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-SEP-2013, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Swelling behand the ear; Swelling of the neck; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck). At the time of the report, EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck) had not resolved.            No concomitant medication details were provided. No Treatment Medication was available.  The action taken with mRNA-1273 in response to the event was not applicable.
symptom: redness approx. 8 cm (in a shape similar to that of the United Kingdom) around site of injection; tenderness and slight pain around injection site time: redness starting about 24 hours after time and date of injection, continuing through April 2, 2021; tenderness and pain dissipated by end of fourth day treatment: none
This spontaneous report was received from a nurse and a physician via company representative referring to 7 patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies of the patients were not reported. On an unknown date, the patients were vaccinated with doses of M-M-R II injection (lot #, Expiry date and dose were not reported) subcutaneously. On an unknown day with in 3 minutes after receiving the vaccine doses, the patients experienced "a welt about the size of a nickel and redness about the size of a 50 cent piece" at the injection site. The patients did not receive any treatment for the events. The outcome of the events were reported as unknown. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Client states the next day her arm was swollen, red and very sore. Around 10/2/18 it became itchy and she did itch it. The area around the vaccine became very red. Today it is light pink and just slightly itchy.
extreme pain and large hard nodule on l deltoid for 2-3 weeks, nodule about the size between a quarter and silver dollar. Extreme fatigue and added muscle pain ever since vaccine 3 months ago.
HYPOAESTHESIA; NEURALGIA; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority [VAERS FDA Inbound Unit] concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and illness at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 265AZ1A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced hypoaesthesia. On 30-APR-2021, the subject experienced neuralgia. On 30-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, hypoaesthesia, and neuralgia. This report was non-serious.
Itchy hives throughout the body. Swollen lips/tongue and throat tightness.   Medication given at ED: Epinephrine IM shot and IV Solumedrol
Small reddish area about 1.5 inches in diameter around injection site forming around 8 days after injection.
Pt developed an immediate cutaneous reaction, a large area of erythema 3 x 5 inches, and swelling to back of left arm. Pt given 3/4 tsp of Benadryl.
After the patient's 15 minute wait, she left the facility, only to feel like her legs were "weak."  She was brought back to the facility to sit down and recover.  After several minutes, the patient stated that he throat felt itchy, and she began to cough and described dyspnea.  She also developed nausea.  She denied cutaneous symptoms, but with her multiple symptoms that were consistent with anaphylaxis, the patient was administered an EpiPen.  Her symptoms did not improve, and 16 minutes later she was administered another EpiPen (as well as 25 mg of diphenhydramine).  She was transported via EMS to the base ER for further treatment and evaluation.
Onset today, hard erythematous warm area surrounding both immunizations sites. Left leg redness measures approximately 3" across and right leg redness measures approximately 1" across.
Pt recvd 1st Engerix-B vax on 15JUL91 & later that day pt exp "arm hurt a lot & achy; treated w/APAP;
COVID19 infection (Omicron likely) tested positive 09/04/22 at 8PM called physician emergency number and had Paxlovid called to pharmacy. Have had multiple secondary bacterial infections since the Paxlovid series was completed, Strep, then Prevotella, and currently dealing with Acute Bacterial Sinusitis.
PNEUMOVAX vaccine to (L) arm IM - swelled up arm & painful - went to ER.
Itchy hands; Private area red; Flu like symptoms; Achy; Tired; red (hands); (Private area) Itchy; A spontaneous report was received from a (Consumer) concerning a 85 years - old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itchy hands, Private area red, Flu like symptoms, Achy, Tired, Red (hands), (Private area) Itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 13 Feb 2021,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown)in the left Arm for prophylaxis of COVID-19 infection.  On  an unknown date, The patient  experienced Itchy hands, Private area red, Flu like symptoms, Achy, Tired, Red (hands), (Private area) Itchy.     No treatment received was provided.  Action taken with mRNA-1273 in response to the events was not reported.    At this time of the report, the outcome of the event(s) Itchy hands, Private area red, Flu like symptoms, Achy, Tired, Red (hands), (Private area) Itchy were not reported.
SOB stated about a few weeks after injection, no relief from 12/21/21 Flovent was prescribed and prednisone and f/u on 12/23/21 with a steroid injection. SOB was so bad I could not eat or talk. Chest X-ray, Pulmonary function test, mild emphysema. Medication was changed again to Symbicort. Now being referred to a pulmonologist. All COVID tests have been negative.