chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left underarm was hurting; There was a pear size lump that is very tender there. It feels fluid filled to her; There was a pear size lump that is very tender there. It feels fluid filled to her; This is a spontaneous report from a contactable nurse.  A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3302,via an unspecified route of administration in the left arm, on 12Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization. Medical history sleep apnea, GERD, TMJ and depression. Historical vaccine included first dose of  BNT162B2 on 22Dec2020 for COVID-19 immunization. Concomitant medication included cefixime (FLEXERIL), fluoxetine hydrochloride (PROZAC), omeprazole (PRILOSEC) and trazodone. on 13Jan2021 12:00, 24 hrs post vaccination, patient noticed that her left underarm was hurting, and she touched it. There was a pear size lump that is very tender there. It feels fluid filled to her. Therapeutic measures were taken as a result of events included an unspecified treatment and will be receiving an ultrasound. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Rashes started on 01/09/2021. I went to the emergency room on 01/10/2021, diagnosed with shingles, started treatment with Valacyclovir.
MD called 19JUL91 1030PM leg swollen & benn crying for 4 hrs straight; MD ordered APAP & warm bath;
no adverse effect reported; A dose of PNEUMOVAX 23 which expired on 16-FEB-2019, was inadvertently administered to the patient on 26-MAR-2019.; This spontaneous report has been received from a medical assistant regarding to a patient of unknown gender and age. The patient's concurrent condition, medical history, drug allergies and concomitant medication was not reported.  On 26-MAR-2019, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and anatomical location of vaccine were not provided) lot # N019838 which expired on 16-FEB-2019, for prophylaxis. No adverse effects were reported.  This case was considered as non-valid since not patient identifier were reported.
Approx 5 min after receiving vaccines, pt was standing in hallway doing vision test where she suddenly fainted, fell forward & hit face on the ground. Top braces slipped off of teeth, minor lip lac.
pt recv vax 18APR97 & devel high fever on 20APR97 104;1 grand mal sz that lasted for 5min;pt taken to ER dx febrile sz, OM;
Mother states child was seen yesterday for physical and received two shots.  One of the injections was administered in the back of child's arm and has swollen to the size of a quarter.  Affected area is warm to touch and itchy.  No significant pain, no bruising, no drainage.  Told mother most likely is vaccine reaction and reviewed s/s of infection. Mother will monitor her closely and anticipates improvement in the next 48 hrs or so. She states plan to give her Zyrtec and suggested to apply cool compress which may help with reaction.  Mother to call with any increase in swelling or tenderness, or any new symptoms.
approx 3hrs p/vax had h/a & fever felt completely better 15hrs later;
Pt developed a low temperature and broke out in flat red rash on chest and abdomen. Pt not itching or irritable.
Headache, Sedation, Myalgia, Pain @ injection site Narrative:  Other Relevant History:
When I woke at 8:30am the day after the vaccination, I had a fever and was weak. I fainted four times in succession, resulting in multiple bruises, three bumps on my head and a cut above my eye. I called pharmacy but they seemed unconcerned. I started feeling better in a few hours so I did not seek medical treatment.
Patient may have been administered an expired dose for the 2nd booster; Patient may have been administered an expired dose for the 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have been administered an expired dose for the 2nd booster) and EXPIRED PRODUCT ADMINISTERED (Patient may have been administered an expired dose for the 2nd booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have been administered an expired dose for the 2nd booster) and EXPIRED PRODUCT ADMINISTERED (Patient may have been administered an expired dose for the 2nd booster). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have been administered an expired dose for the 2nd booster) and EXPIRED PRODUCT ADMINISTERED (Patient may have been administered an expired dose for the 2nd booster) outcome was unknown.            No concomitant medication was provided.  It was reported that on 21-Apr-2022, the patient received the 2nd booster, and when patient's wife entered the Lot number in the online tool, the message was that the vaccine was expired, Lot number was read from the vaccination card: 017S21A, Expiration date: 27-Mar-2022, patient stated that this lot number was typed in computer like a medicine prescription. Then she mentioned that there was another Lot number written in ink: 056A22A Expiration date 07-Sep-2022.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up includes no new information.
Muscle pain; Joint pain; Headache; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included HIV disease (positive) since an unknown date. Concomitant products included TRIMETAZIDINE HYDROCHLORIDE (TRIMET [TRIMETAZIDINE HYDROCHLORIDE]), VALACYCLOVIR [VALACICLOVIR], HYOSCYAMINE and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). On an unknown date, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication taken for the reported events is Advil.
Narrative:  Chest pain started last few days ago (around 4/10/21). She thinks she may be anxious from the news of the SE of the vaccine. Her BP is 130-70s. She has been working in the yard. She is not sure what actually is causing the pain. She is taking Vit C. One of MDs told her to take Vit C. Drinking a lot of water. Taking an ASA and it helps. Nurse talked with patient and she agrees to go to the ER for further assessment.
Patient never took her second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient never took her second dose of vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient never took her second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient never took her second dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not experience any side effects after her first dose.  Concomitant medications were not reported.  Treatment information was not provided.  This report refers to a case of Product dose omission, for mRNA-1273, lot #  037K20A, with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product dose omission, for mRNA-1273, lot #  037K20A, with no associated AEs.
by 8pm the night of my injection I was developing symptoms. I had pain, swelling, redness and rash at the injection site.  I had swelling at the injection site the size of a tennis ball. It was hot to touch. I had a rash about 2 inches wide that went 5inches down my arm from the injection site.  I had a severe headache, I felt like my head was going to explode. I was taking large amounts of tylenol and ibuprofen but they had very little effect on the headache. My right eye was painful, it hurt. I had chills, shivering, sweats. Fever of 101.2 to 101.5 that would come and go. I was dizzy. My entire body hurt. It felt like someone had just beat the crap out of my from head to toe. My legs were weak. My stomach was on fire. I had nausea, sometimes tried to vomit but didn't. Gagging I guess.  I spent the next 3 days in bed after getting this shot. I spent the next 4 days after that still getting over the effects of it before I actually started to feel better from all of this. If I had know this would happen I would have never gotten this shot.
swollen arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.
5x7cm area of erythema, swelling & warmth then devel fever resolved by 8MAY97;
Approximately 5-10 minutes from injection; felt a metallic  flavor in my mouth. No other side effects as of this time , 4 hours after the  vaccination.
Local reaction upper left thigh with erythema and induration without tenderness. 8 inches in ovular redness, + pruritis.
The morning after vaccination I started experiencing vertigo - it was several episodes thought the day during standing, moving, seating and reading. Vertigo reoccurred in lighter less inconvenient form days later. Have not experienced it in the last week. About a day later I stated experiencing nausea that lasted for  about a week. Due to the resemblance with morning sickness I used 2 pregnancy tests with both were negative. On December 6th menstruation period stated and lasted for 2 weeks, which was very unusual. After the first few days it was a light form until December 20th-21st. Normally my periods are no longer than 5 days (heavier flow the first 2-3 days). The only other occasion that I had a prolonged period was after receiving a 3month contraceptive hormonal shot. There were no changes in supplements or exercise routine, no unusual stress. Furthermore, a friend told me she has a similar prolonged period after her vaccination. So in the absence of other possible causes/connections, I believe it is linked to the vaccine. It?s to early to tell if the changes in menstruation will continue. I have delayed taking the second dose so far.
Information has been received from a physician concerning a 5 year old female who on 25-JUL-2007 was vaccinated with Varivax. On 27-JUL-2007, the patient was brought to the emergency room with a fever of 101-102 degrees fahrenheit associated with a headache and pain in both legs below the knees. A complete blood count was done. At the time of this report, the patient was not recovered. No product quality complaint was involved. No further information was available. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
No additional AEs reported/ What was the patient's response? NO ADVERSE REACTION/ NOTIFIED EXCURSION; GARDASIL 9 was administered to a patient after experiencing a temperature excursion/ Temperature: 31.0 F/ Previous temperature excursion? Yes; 68°F/ Fridge temp went out of range/ Got as low as -0.28 for 30 minutes; This spontaneous report was received from a private doctor's office/hospital site manager regarding a 20-year-old male patient. The patient did not have any pre-existing physician-diagnosed allergies, birth defects, and medical conditions. Neither he had any illness at the time of vaccination.   On 19-JAN-2021, the patient was vaccinated with the first dose (reported as "# of previous doses 0") of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe of 0.5 milliliters (ml), in the left arm, intramuscularly, as prophylaxis, after it had experienced a temperature excursion (product storage error) (vaccination scheme was not reported; lot number 1687291 and expiration date 11-SEP-2022 were verified to be valid).   A healthcare professional operated the single-use vaccine and used it according to the instruction leaflet; however, the fridge temperature went out of range and got as low as -0.28 (units not provided) for 30 minutes as read from a Digital Data Logger (also reported as a temperature of 31.0 Fahrenheits (F) for a time frame of 1 hour and 15 minutes). A previous temperature excursion of 68 degrees F for 17 hours and 30 minutes was reported.   Regarding the patient's response, he was notified of the excursion, and there was no adverse reaction (no adverse event). The vaccines were quarantined, the probe was readjusted and secured better, the fridge was monitored for one week with stable results, and other monitoring devices were also adjusted. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
mouth (lips) swelling canker type sores in mouth overall unwell feeling anti allergy medication prescribed by physician
Approximately 5 hours I started with a alight itch and later that night i itched more and I call the pharmacy and was told to it would go away after a few hours nevertheless it didn't with me being a medical professional I have been haling benedrayl and oatmeal baths and this is the. 3rd day and in still have this body itch .... Im subject to go to the emergency room but I don't have insurance its bad and I mean really bad
24hr after vaccine I was so tired I could barely function and ended up falling asleep on the floor of my office. When I woke up two hours later I was freezing cold and my body was very achy. I ended up sleeping the rest of the day and night. On Friday I felt fine most of the day until about 10pm at night when I started having diarrhea. Throughout the night it got worse and my body got very hot to the point where I had to sleep naked with fans on me. I?m lightly short of breath, exhausted, and am still having diarrhea now (Sat).
Vaccination given 05/07/07. Patient reports dizziness and nausea starting 5/09/07 et continues. 5/14/07 redness et hardness noted at injection site. Injection site s/s worsened 5/15/07. On 5/16/07 site less red with 1.2 cm hardened area noted with slight tenderness.
Parents report on Monday night 04/22/02 baby developed a fever and vomiting. Fever got as high as 104.5. Parents treated fever with Tylenol, but baby vomitted it up frequently. On 04/24/2002 they notified health department on 04/25/2002. They took him to physician. Physician feels illness is unrelated to immunization.
PATIENT STATED ARM VERY SORE AND COULD NOT LIFT IT UP REDNESS AT SITE OF INJECTION AND SWOLLEN.
Patient had syncopal episode for about 10 seconds. Patient woke up and stated she needed fresh air .Patient taken outside. Blood pressure 132/80,82,  At present time patient is  alert and oriented x3 and does not want to go to hospital. Patient signed refusal form
Symptoms began about 35-37 minutes, post vax. She began to feel "funny"; legs felt weak and then passed out. She does not recall anything until waking on the ambulance. She was sent to hospital ER and kept X 5 hours. She became stable and all labs were ok. Bed rest X 48 hours.
Temperature Excursion (10.5 hours) Product Administered; Initial Report Received on 29-NOV-2022  This is a spontaneous report received from a registered nurse in the regarding a 32-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 29-NOV-2022, dose 1 of HEPLISAV B (Lot #937783, expiration date 29-SEP-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.   The dose had undergone a temperature excursion of 18.9°C for 10 hours and 30 minutes.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a pharmacist concerning a currently 84 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU, lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014127: US-009507513-1611USA014128.
Multiple hives, increase fever >104 degrees, irritable, no resp. difficult, good PO intake.
This was my 2nd covid vaccine.  I received my first one on March 2, 2021 and was extremely tired and fatigued up until the day I went to receive the 2nd vaccine.  I received the vaccine around 12:45pm on 3/23/21, around 6:30pm. I started to get an intense headache, fatigue, mild arm soreness, slight chills and nausea..  Chills and nausea subsided next day., but the headache has persisted since Mar 23, 2021 until today April 6, 2021.  I have had to take Advils 400mg to 600mg per day to help eleviate the headache.  It has helped but the headache returns.  It is a little better today, April 6th but I did take 600mg advil today.  Along with the headache is fatigue and tiredness, which has required daily naps, and not feeling refreshed after the naps.  Also a feeling in my head as "brain fog". I did not see my doctor nor did I alert her.    Today it has been 2 wks since the 2nd vaccine, I am just starting to feel somewhat better , but hope the headache does not return.
Child developed superficial erythema (L) mid arm approximately 30 hours after vaccines administered. Erythema distal to deltoid; erythema near raised papule. Unclear if 2 hour infection from infect bite or vaccine related LRN docs. Not typically administer vaccines in that area. Started on KEFLEX PO x 10days.
In order of occurrence: Itching  Soreness  Rash in shape of Little Dipper at injection site  Mental/cognitive problems (couldn?t text without numerous and repeated errors  Shivering  Diarrhea
This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. The reporter considered the fever to be almost certainly related to SHINGRIX. Additional information was received as follows: The patient experienced low-grade fever following administration of SHINGRIX. Additional information was not provided. The reporter stated that these incidents occurred a month before the time of reporting and he had forgotten the details at this time of reporting. The reporter did not report to GSK initially, as he read in the package insert that low-grade fever was a known adverse event following SHINGRIX administration. This case has been linked to the case US2018052280, reported by the same reporter.
Patient called on 7/12 to report chickenpox-like (itchy red blisters that scab over) cutaneous skin reaction with localized mostly to his legs and feet. Reaction still ongoing, onset noticed by patient a few days after vaccine administration.
This spontaneous report as received from a certified medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-MAR-2014 the patient was vaccinated with M-M-R II lot # 0496AE expiration date 07-MAR-2014, 0.5 ml, subcutaneous (dose unspecified). Co-suspect and concomitant therapies were not reported. Medical assistant stated that on 10-MAR-2014, that a patient was administered an expired dose of properly stored M-M-R II. No adverse effects were reported. Additional information has been requested.
I developed symptoms and have them for 2 days before testing positive, but before I went to the local health center and I got prescription for PAXLOVID due my lung condition; I took it for 5 days, I had fever, and took a fever reducer, I had congestion, sore throat. I felt better by Monday of the following week. That Wednesday night I started with congestion, headache, I took another test, and it was positive again. I was pretty congested and had slight fever of 101, lasted the following until Saturday and after that I feel much better. I tested negative the Monday after being sick the first and second time.