chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Found today husband have it; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Found today husband have it) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced IMMUNISATION REACTION (Found today husband have it). At the time of the report, IMMUNISATION REACTION (Found today husband have it) was resolving.            No concomitant medications were reported.  It was reported that the reporter and their husband had been vaxxed and boosted. Reportedly, the patient was doing ok.  No treatment information was provided by the reporter.
Arm Pain 6pm, Headache the following 2 days all day long, brain fog the following day of vaccine, Diarrhea 4 days now, glands under arm (same with injection) swollen painful days 3 and 4 after vaccine, 2nd night had insomnia, days 3-4 had restless legs at bedtime.
Patient reported that a painful spot, approximately 6 x 3 inches, appeared on the inside of his vaccinated (left) upper arm later in the evening following vaccination.  He reported the spot was red, warm to the touch, and was sore and swollen when pressed upon.  He called the pharmacy to report as it was different than the usual response after having vaccines here previously (described the area as "more pronounced" than the usual small spot right at site of vaccination).  Patient reported having to take two Tylenol 500mg the Sunday night of vaccination, 2 tabs AM and 2 tabs PM on Monday, and 2 tabs AM on Tuesday (he called Tuesday afternoon).  At that point he described the spot as a mild sunburn and was getting somewhat better.  I counseled him to continue with the Tylenol regimen as it seemed to be helping and to ice the area in 15-minute intervals to help with further swelling and discomfort.  He was instructed to report any further reactions to his primary care physician and the pharmacy.
Patient received vaccine and 5 minutes later reported tingling/pins & needles feeling in left hand & up wrist.
Client called office 8/11/22 to review adverse reactions of vaccines received 8/9/22. Reports throat swelling 75 min after vaccine administration. Treated at home with benadryl and inhaler.  States there is improvement but throat still feels a little "funny" also reports low grade fever and achiness with reddness/tenderness at YF injection site. Encouraged to call PCP that day to let them know what happened so she could have a physical examination and see if they'd like to do anything else.  Discussed immune responses vs allergic reactions. Client speaking in complete sentences and doesn't sound to have any difficulty breathing over the phone. Called client to follow up 8/18/22, she did get into see PCP, monitoring at this time, slight inflammation noted per MD. No further inventions at this time as well. Will go back 8/19/22.
73 y/O female with hx of oxygen dependent COPD presents with cough and SOB. she was noted to be febrile in ER. She desaturated on room air however she has > 90% sat on 2 lit oxygen. She has Hx of COPD,HTN,HLD, GI bleeding, RA, VTE, Anxiety  8/11/2021 tested positive
lost 7 lbs; Diarrhea; Nausea; broken her ankle and cannot walk right now/ 8 broken bones in her legs and ankles/ patient in a cast; broken her ankle and cannot walk right now/ 8 broken bones in her legs and ankles/ patient in a cast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 01Jan2021, stop date: 14Jan2021, notes: nauseous and had diarrhea; lost 17 pounds and almost went to the emergency room for dehydration; "nauseous" (unspecified if ongoing); "diarrhea" (unspecified if ongoing); "dehydration" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANKLE FRACTURE (medically significant), LOWER LIMB FRACTURE (medically significant) all with onset 2021, outcome "recovering" and all described as "broken her ankle and cannot walk right now/ 8 broken bones in her legs and ankles/ patient in a cast"; DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "Nausea"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 7 lbs". The patient reported that the first shot gave her diarrhea for 24 hours. The patient took promethazine (PHENERGAN) as a treatment for nausea. She was in a cast due to the 8 broken bones in her legs and ankles. The patient does not want to receive the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Exposure to SARS-associated coronavirus Fever, unspecified fever cause  Loss of smell Loss of taste   Progress Notes     Signed Encounter Date:  8/6/2021     Signed        Hide copied text  Hover for details Patient here for Regeneron infusion. Patient tolerated infusion well and was monitored for 1 hour post. Upon discharge, patient was provided a pulse ox, thermometer, after visit summary and follow up instructions. No adverse events noted during this visit.
J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 9/5/2021 DM 2 WO COMPLICATIONS R57.0 CARDIOGENIC SHOCK 9/5/2021 DM 2 WO COMPLICATIONS
02/15/22 presents to ED for "abdominal pain". PMHx of "gastric adenocarcinoma status post resection(2018),prior G tube (5/2020,since removed), Hodgkin's lymphoma, hypertension, hyperlipidemia, borderline diabetes, GERD, hypothyroidism and sleep apnea"
Facial weakness, double vision, numbness tingling of extremities. Progressed to ophthalmoplegia, severe weakness, DX as Guillain Barre syndrome pt hospitalized.
Red swollen non-tender lump on right arm at site on DTaP, had fever x 2 days then afebrile.
T to > 102 within 4 hours, cellulitis picture 48 hours later.
02/01/22 presents to ED for "Biloma". PMHx of "primary hyperparathyroidism s/p parathyroid ectomy 9/2014, GERD, HLD, and symptomatic cholelithiasis s/p robotic cholecystectomy 1/7/22"
Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Medium, Additional Details: Patient appeared sleepy a few minutes after administration. Patient says she felt extreme drowsiness almost immediately after injection.  Several minutes later, patient reported nausea.  Symptoms continued for 30 minutes under observation. As patient did not report dizziness or symptoms of anaphylaxis, I let her go home with her husband who was in store.  Directed him to assist her in walking out so she did not fall. Discussed to contact PCP if symptoms got worse or did not get better within hou
Information has been received from a physician concerning a female in her 30's with penicillin allergy and sulfonamide allergy and a history of splenectomy who on 7/17/06 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651356/0089F) (0.5ml), subcutaneously in the right arm. Concomitant therapy that day included Hib conj vaccine OMPC manufacturer unknown and pertussis vaccine unspecified, administered in the left arm. On 7/19/2006 the patient presented to office with injection site reaction with right arm pain, approximately 3 inch swelling and redness at the injection site. The patient was treated with prednisone pack. On 7/20/06 the patient presented for a follow up visit and swelling at injection site had increased to approximately 5 inches. The physician stated that the patient had been vaccinated with Pneumococcal 23v polysaccharide vaccine 16 months ago. At the time of the report, the patient was reported to be not recovered. The reporter considered right arm pain, swelling and redness at injection site to be disabling and to be other medical events (OMIC). Additional information has been requested.
Patient was given both doses of the vaccine in the wrong location; A spontaneous report was received from a consumer concerning a female patient of an unknown age who was administered Moderna's COVID-19 vaccine (mRNA-1273) and reported that patient was given both doses of the vaccine in the wrong location/inappropriate route of vaccination.  The patient's medical history and concomitant medications were not reported.  The patient received (dates not provided) her both first and second of two planned doses of mRNA-1273 (batch number: unknown) for the prophylaxis of COVID-19 infection.  The patient was given both doses of the vaccine in the wrong location. One was administered too high and the other too low. The patient thought it was not as effective and may need to restart the vaccination series.  Action taken with mRNA-1273 in response to the event was not applicable.; Reporter's Comments: This report refers to a case of Inappropriate route of vaccination for mRNA-1273, lot# unknown, with no associated adverse events.
A 58 year old female pt was given RabAvert approx two years ago for a dog bite. Past medical history was significant for allergy to antibiotics. The pt had asked her physician if the RabAvert contained antibiotics. The pt also stated that she told the doctor she had a history of allergy to all antibiotics. After the first immunization on 10Apr02, she did not feel right. After the second injection, she developed an anaphylactic reaction and was seen by an immunologist who told her to discontinue the series. At some point after that, the pt developed immune symptoms which have continued to the present, including headache, abnormal liver function tests, and open sores that wont heal. She was being followed by an immunologist at the time of the report.
Mother reported large red lump on L) thigh & fever on 1/14/2021. Lump remains on thigh when reassessed on 1/18/2021
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose number, route, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: >46°F (fahrenheit degrees) but < 77°F (fahrenheit degrees) during 16 hours. There were no previous temperature excursion. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided.; Sender's Comments: US-009507513-1701USA004139:
This spontaneous prospective pregnancy report was received from a 32 year old consumer regarding herself. The patient's current conditions included type 1 diabetes mellitus. The patient was on treatment with unspecified diabetes treatment. The patient did not had any drug allergies/reactions. Information on medical history was unknown. On 13-MAR-2019, from the physician's office, the patient was inadvertently vaccinated with GARDASIL 9 injection for prophylaxis (strength, dose, frequency, lot#, expiry date not reported). The patient became pregnant with last menstrual period (LMP) of 14-AUG-2018 and estimated date of delivery (EDD) of 21-MAY-2019. Initial exposure to GARDASIL 9 was at 30 week(s). The pregnancy outcome was unknown. On an unknown date, the patient sought medical attention by contacting the physician's office. The patient did not receive any treatment neither underwent any lab tests. The patient did not report about any ill effects experienced with GARDASIL 9. There was no product quality complaint associated with this report.
patient had redness and swelling from shoulder down to elbow. area was warm to the touch. advised patient to contact primary provider and see if they feel he should be seen.
all over body rash; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: Six weeks before the time of reporting, the patient received 1st dose of Shingrix and since then he has sustained an all over body rash. They have looked at possible allergens, such as food allergies or detergents, but had not been able to find a culprit. The responsible physician or any details regarding vaccine were not reported. The reporter consented to follow up.
Sxs started 4-5 days prior to admission with mild headache, malaise, fever (max T 104.1), followed by onset of seizures. Admitted to medical center: 9/17/15. Discharged 3/1/16. Primary dx, epilepsy, unspecified secondary dx, encephalitis. Discharge dx includes seizure disorder, impaired ADL, cognitive deficits, muscular deconditioning.
I tested positive for Covid on an in-home antigen rapid test on 5/9/2022.  I was experiencing symptoms of scratchy throat, headache and fatigue.  The symptoms were gone within 72 hours.  My doctor prescribed Paxlovid and I started the 5 day course on the afternoon of 5/10/2022.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild
L arm soreness; very slight tiredness; only slightly placed needle in upper arm when injected; When I received this dose the nurse expired some serum down my arm right before injection/I have always wondered if I really received a full 2 dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (L arm soreness), FATIGUE (very slight tiredness), DEVICE CONNECTION ISSUE (only slightly placed needle in upper arm when injected) and ACCIDENTAL UNDERDOSE (When I received this dose the nurse expired some serum down my arm right before injection/I have always wondered if I really received a full 2 dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism (Hypothyroid Disease). Concurrent medical conditions included Asthma, Seasonal allergy (spring seasonal), Dust allergy and Allergy to chemicals (some solvents). Concomitant products included ALBUTEROL [SALBUTAMOL] from 1998 to an unknown date, LEVOTHYROXINE from 1997 to an unknown date, COLECALCIFEROL (VIT D [COLECALCIFEROL]) from 2004 to an unknown date and TOCOPHEROL (VIT E [TOCOPHEROL]) from 1998 to an unknown date for an unknown indication.   On 23-Jan-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021 at 9:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021 at 9:45 AM, the patient experienced DEVICE CONNECTION ISSUE (only slightly placed needle in upper arm when injected) and ACCIDENTAL UNDERDOSE (When I received this dose the nurse expired some serum down my arm right before injection/I have always wondered if I really received a full 2 dose). On 20-Feb-2021 at 1:45 PM, the patient experienced PAIN IN EXTREMITY (L arm soreness) and FATIGUE (very slight tiredness). On 20-Feb-2021 at 9:45 AM, DEVICE CONNECTION ISSUE (only slightly placed needle in upper arm when injected) and ACCIDENTAL UNDERDOSE (When I received this dose the nurse expired some serum down my arm right before injection/I have always wondered if I really received a full 2 dose) had resolved. At the time of the report, PAIN IN EXTREMITY (L arm soreness) and FATIGUE (very slight tiredness) had resolved.            There were no other potential causes. It was reported that the previously the patient experienced slight soreness at injection site. The patient would like to thank Moderna for the vaccination.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-437638 (Patient Link).
pt recv vax & exp thrombocytopenia, petechiae, & aseptic meningitis; pt was seen in ER & hospitalized; addtl info is being sought;
he patient received an improperly stored; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. The patient's concomitant therapies included a sterile diluent.   On 30-DEC-2019, the patient received an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for prophylaxis, lot number S021327 with an expiration date on 05-JAN-2021 (strength and dose were not reported).   The vaccine was stored at a temperature range between -9° Celsius degrees (C) to 8°C (-3°C) for the time frame of 30 minutes. There was no previous temperature excursion and the call was because of a data logger.
Approximately 4-5 hours after the injection, my right elbow began hurting.    There is no swelling or injury.   The elbow is a burning pain.   It hurts to even touch my elbow!
pt recv vax 13JUN96 & 3hr later pt irritable & cried as if were in a lot of pain;pt was almost doubled over;pt cried 30 to 40min;mom called MD & tried to give APAP but pt would not take it;pt taken to MD ofc tx of fever & pain;pt thirsty;
Around midnight u noticed I was scratching my arm in the same area that my shot was...its raised like a but bite and warm to the touch. I actually took a pic and outlined it in case it was something else. Very itchy.
Moderate to severe joint pain.  Headache.  2 ibuprofen and water. Slept for 2-3 hours . Pain gone within 8 hours
Trembling 2 1/2 days. Fever 103.1 1 day and TYLENOL 102 degrees 1 day. 101 degrees 1 day. Loss of appetite - 4 days. Severe diarrhea 1-3 days after. Fatigue, tired - continuous.
METTALIC TASTE IN MOUTH; ITCHING, RASHES, CHEST PRESSURE,HOT FLUSHES
Mild headache, soreness at site of injection, redness about the size of a quarter at site of injection, swelling at site of injection equivalent to about a quarter of a golf ball sliced long ways , hotness at site of injection, lower back pain, slight muscle twitching in upper arm - all relatively mild.
4/11 got vaccinated around10:10am. Few hours later arm started to get sore.5 hrs. later body started to feel sore and stiff as well.  By 8pm whole body, all joins and some muscles were very sore and head felt very heavy. Could not sleep, felt as if I had a high fever, hands were very hot but forehead was not. Every inch of my body was in pain and head felt heavy. 4/12 early hours felt nauseous. Symptoms lessened but continue to suffer the whole day. Couldn't eat. Now is 4/13 before 11 am?vaccination site is hardly in pain but feel dizzy. Head continues to feel heavy even though much much less than before. Can function but will not drive.
Within several hours of the Flumist, she developed chills and aches followed by nausea and sweating.  The symptoms were more severe on the following day with a temperature of 103.  She continued to have some fever for approximately 48 hours.  On day #3 post vaccine, she felt very tired and was back to normal on day #4.
This spontaneous report was received from a health care worker refers to multiple unspecified patients of unknown demographics. No medical history was reported. On an unspecified dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and frequency unknown) (Lot no: L015049, Expiry date: 29-APR-2017; Lot no: L013068, Expiry date: 14-APR-2017; Lot no: K021485, Expiry date: 3-NOV-2016; Lot no: L020004, Expiry date: 2-JUN-2017; Lot no: L021214, Expiry date: 10-JUN-2017; Lot no: K010437, Expiry date: 2-JUL-2016. No concomitant therapy was reported. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
The patient was inadvertently given a fourth dose of ROTATEQ; fever; vomiting; Diarrhea; This spontaneous report has been received from a nurse regarding to a 12-month-old male patient. The patient's concurrent conditions included asthma, ear infection and gastroesophageal reflux disease. The patient's medical history included gastroesophageal reflux disease. Concomitant therapies included albuterol, omeprazole and cefdinir. The patient had not drug reaction or allergies.   On 25-OCT-2018, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # N034400, expiration date 10-MAY-2019; on 22-JAN-2019, he received the second dose of the vaccine, lot # N030150, expiration date 29-AUG-2019, and on 07-MAR-2019, the patient received the third dose of the vaccine, lot # N030150, expiration date 29-AUG-2019; all doses were administered orally for prophylaxis.  On 22-AUG-2019, the patient was prescribed with antibiotic such as cefdinir as treatment for an ear infection. On 16-SEP-201,9 the patient at his 1 year well check exam, he was inadvertently given a fourth dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R030924, expiration date 10-JUL-2020, Orally for immunizations. On 17-SEP-2019, the patient's mother called to the office to report that he presented fever, vomiting and diarrhea but, it was stated that he had been ill prior to receiving the fourth dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). However, respiratory film panel were done but not results were reported; additionally, treatment as comfort measures and monitor were provided. At the reporting time, the outcome for fever, diarrhea and vomiting was reported as not recovered.   The causality assessment between fever, diarrhea, vomiting and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown.
p/vax c/o severe pain in shoulder area & arm; burning sensation in arm; pain on abduction, & internal & external rotation; severe tenderness over rt antecubital joint & bicipital groove; T97.7; tx: Voltaren XR, flexeril & heat;
Received Temperature Excursion HEPLISAV-B; Initial Report Received on 20-Jun-2023  A registered pharmacist reported that a 22-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion.   Medical history and medications at the time of vaccination were not reported. The patient had no known allergies.   On 13-Jun-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 941579, expiration date 04-Jan-2025, and NDC # 43528-003-05) intramuscularly (injection site not reported). The HEPLISAV B vaccine underwent a temperature excursion, described as being higher than the recommended temperature for 15 hours. No adverse reactions were reported.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.