chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling cold with chills, stuffy head, slight headache 2/2, 5p (day of injection), woke up 2/3 9a, with stuffy head , slight headache, and black eye (allergic shiners?)
Woke up this morning, a week after vaccination. Localized reaction at injection site, itchy, blotchy, swollen and firm slightly larger than the size of a baseball.  Also running low grade fever of 100.2. Had been feeling completely normal for the 48 hours prior.
Violent muscle spasms/Muscle spams that were like convulsions; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Violent muscle spasms/Muscle spams that were like convulsions) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS74OC) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced MUSCLE SPASMS (Violent muscle spasms/Muscle spams that were like convulsions). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In September 2022, MUSCLE SPASMS (Violent muscle spasms/Muscle spams that were like convulsions) had resolved.            Patient took first dose of Moderna, batch no 024M204 on Feb-2021, second dose on 19Oct2021 with batch no. 004C21A, first booster dose on 12-JAN-2021 with batch no. 01LA21-2A, second booster dose on 22-FEB-2022 with unknown batch no. No concomitant information were reported by the reporter.
Redness of the left thigh, extending 22 cm by 14.5 cm.
11/17 Patient received her influenza vaccination (FLULAVAL) on the afternoon of 11/15. She reported today that her lymph node under the arm she received the shot began to swell the night of receiving the vaccination. She described to appearance of the lymph node to be about the size of an egg but flatter. She reported that the swelling has been consistent since then. Patient reported that the reaction is limited to only the side that the vaccination was given. She reports no fever or trouble moving muscles. She stated the area is not hot to the touch. Patient reports that she hasn't had a flu shot in 5 years and stated there were no issues when she received her last one. Patient stated that she has a PCP visit scheduled for Monday and will get the situation evaluated at that time. After being recommended to be seen by her provider sooner, she stated that she doesn't plan to be seen sooner than Monday unless her symptoms get much worse.
On Friday my left arm was swollen twice the normal size. Then on Saturday morning  started around my left arm pit on left arm was swollen (described as small orange). The injection site was hot and had fever of 100.2. I stayed in bed all day Saturday and most of day on Sunday. My joint was aching and left arm was sore to touch. On Monday I stayed home from work due to the swelling contacted my doctor. I went to see my doctor on Tuesday he stated might was a draining from my lymph node advised me to take Aleve and apply cold compress. The swelling has gone down to normal.
injection Location: Pain-discomfort. General symptoms: headache, joint pains, dizziness.  Narrative:
3 1/2 weeks after getting the vaccine my  side effects returned when I started taking an antibiotics for a skin infection (minocycline).  The first time the side effects lasted 36 hours, the second time 24 hours.  Side effects included fever, dizziness, nausea, skin hurt, eye hurt (I had to wear sunglasses inside),  and I heard swishing sounds everytime I moved my eyes.
Swelling with redness, itchiness over 3/4 of entire surface upper left arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: go3277) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Lot number: eh9899), in left arm, on 31Jan2021 as dose 2, single (Lot number: el9269), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: ff2589), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: fm0173), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2022, stop date: 18Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253665 same patient, different drug, different event;
Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1686) via an unspecified route of administration on 06Jan2021 11:00 AM at a single dose in the left arm for Covid vaccine. Medical history included GERD. Concomitant medication included omeprazole (received within 2 weeks of vaccination). The patient had known allergies to erythromycin and hydrocodone bitartrate/paracetamol (VICODIN). The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. On 06Jan2021 16:00 (04:00 PM), the patient experienced extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours), it started 5 hours after injection and lasted 48 hours. Treatment was not received for the events. The events were non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination (post vaccination). The outcome of the events was recovered on 08Jan2021 16:00.
Patient had pain from injection sites on the eve of the shots, then awoke next morning with erythema & edema of (R) proximal lateral arm & ecchymosis of (L) proximal lateral arm.
FLUZONE HIGH-DOSE QUADRIVALENT administered to a 3 year old with no reported AE; FLUZONE HIGH-DOSE QUADRIVALENT administered to a 3 year old with no reported AE; Initial information was received on 19-Oct-2021 regarding an unsolicited valid  non-serious case from a nurse.  This case involves a three-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (overdose, product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 19-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (0.7mL, lot UJ751AA, expiry date 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to overdose and Inappropriate age at vaccine administration (latency: same day).  At time of reporting, the outcome was unknown for the 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 the 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.; Sender's Comments:  00819055:
Patient presented to pharmacy today complaining that her right arm was swollen, warm to the touch and painful for the last 3 days. She also had a headache and dizziness as well. Patient also stated that she had a similar reaction with her first injection of PNEUMOVAX 23. She received this injection at a different pharmacy. Patient is feeling better today and stated that her arm feels better. Upon examination patients arm looked normal.
Information has been received from a consumer concerning her 12 year old daughter who on 25-SEP-2007 was vaccinated intramuscularly with GARDASIL vaccine (yeast). There was no concomitant medication. On 04-OCT-2007 the patient experienced recurring low fevers and nausea. The patient's fever and nausea persisted. No other symptoms were noted. A similar adverse experience was reported for the consumer's other daughter, refer to WAES#0711USA00230. Additional information has been requested.
Headache Narrative: : Continuous severe headache started 1/2 hour after receiving the 2nd COVID vaccination.
In August 2000, the pt was reportedly dx with autism. The reporter indicated that she believes that the development of autism is related to the thimerosal in the shots her son received as part of his routine IZ series.
She woke up vomiting uncontrollably and shaking. Each time I tried to clean her up she would vomit and have to start over. She continued vomiting/dry heaving till 5am the next morning, the entire time she was very pale and cried a lot, only sleeping in small intervals. I took her back to the doctor the next day for them to check her and they said she might have caught a stomach bug. She perked up and did ok on the day of 03/06/2015 so I thought that she was on the mend. But the next morning 03/07/2015 when I woke up I realized that she was still sleeping in exactly the same position that I had put her in the night before. She was hard to wake up and very pale. I got her up and changed her diaper and then all she would do is lay her head over on me and try to go back to sleep. This is HIGHLY unusual for my daughter who is VERY active. She offered to drink a small amount and then is now continuing to sleep 5 hours later. She is fever free and has some color returning but is lethargic to the point that I felt it was necessary to report her reaction. Her doctor's office still seems to think that she may have been coming down with a virus when she was vaccinated. She received the Hep A booster. That is the ONLY vaccine she received on her visit that day.
Fatigue occurring 18 hours post injection. Nausea, fever occurring 24 hours post. Hives occurring Thursday morning 4/15/21.
Information has been received from a registered nurse concerning a male who was vaccinated with a dose of varicella virus vaccine live. The reporter is unsure if the patient was vaccinated with the vaccine or not. Subsequently the patient developed a chicken pox break out. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Pt having reaction in left arm, suspected to be bacterial in nature, will treat with abx, has only gotten worse since date of event.
Patient received second Moderna COVID-19 vaccine on 4/7/21 . She had issues starting on day 2 and developed fever of 102F for two days. Whole body swelling - hands, feet, arms, legs and trunk  associated with fever, body aches and severe headaches following the Moderna vaccine #2.
Patient developed itchiness redness systemic  with "phlem" feeling  in throat patient  sent to the ED
reported itching to mom evening of 8/5/99;redness & swelling began 8/6/99;reported to ER of on 8/7/99 w/ dx of cellulitis;rx given for keflex suspension & instructed to f/u if worsened or cont past 7 days;
patients arm became swollen and red at injection site.  Patient went to the doctors office and the doctor stated it was an infection and prescribed keflex
This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K020181, expiration date: 24-JUN-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Body Rash.  Both upper arms, lower back, back of legs, mouth. Significant itching and discomfort. Right upper arm developed Cellulitis. Treatment - Cephalexin 500mg, Triamcinolone acetonide 0.025% cream, hydrOXYzine 50mg.
Information has been received from a physician concerning a 5-week-old male who on 06-JUN-2007 was vaccinated with a dose of Rotateq. There was no product quality complaint. No additional information is expected.
Woke up in a bed of sweat, had to go to the bathroom, I urinated, pooped and shook all at the same time. I was freezing cold. Not th runs solid poop, back to bed fell right back to sleep, only to wake about 2 hours later for a second bout of sweating out in the bed, shaking cold as I urinated and again pooped. This continuesd for about every 2 hours, When I did finally get up, I was not hungry, no appetite, no strength, basically worthless. Saturday 2 days later I felt almost normal. My husband had the same shot, same day and he just felt achy.
Fatigue; Nausea; Headache; High fever; This is a spontaneous report received from a contactable patient. A 64-year-old adult non pregnant female patient received  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration on left arm on 18Mar2021 at 0100 (at the age of 64 year) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not provided. The patient previously received treatment with codeine (MANUFACTURER UNKNOWN) from an unspecified date and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On the next day of vaccination, on 19Mar2021, the patient experienced fatigue, nausea, headache and high fever. The patient received treatment with paracetamol (TYLENOL) in response to the events. The clinical outcome of the events fatigue, nausea, headache and high fever was not recovered at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Heart palpitations that brought me to my knees felt like I was having a mini heart attack. I could feel my heartbeat through my entire body
Face and ears began feeling flush/face and ears hot to the Touch/face is flush and still splotchy red; Face and ears began feeling flush/face and ears hot to the Touch/face is flush and still splotchy red; intense itchiness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in the left arm on 19Feb2021 12:00 (at the age of 40-year-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have a covid prior to vaccination and has no known allergies. There were no other vaccines in four weeks before vaccination. It was reported that patient was taking regular unspecified vitamins and supplements. The patient previously took first dose of bnt162b2 on 28Jan2021 12:00 pm (lot number: EN6200) in the left arm for covid-19 immunisation. It was reported that on 01Mar2021 at approximately 11:15am, the patient's face and ears began feeling flush, which quickly proceeded into a very hot feeling. Face and ears were hot to the touch. After a few minutes turned into Intense itchiness. Then her elbows began to feel the same way, both elbows deep red color and hot to the touch. After 10 minutes hot/itchiness subsided but face still flushed. Thirty minutes later face was flush and still splotchy red. No treatment was given in response to the events. The patient was not tested for covid post vaccination. The patient was recovering from all the events at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
all at injection site after receiving 2 vaccines:  redness, swelling, warm to touch, blisters - took a while to heal as of may 2021 - still pain in his right shoulder, painful to touch the injection site. steroid shot did not help
w/in 10min p/vax began vomiting;vomited 5 or 6 times;lethargic, pale;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Approximately on 16-SEP-2014 (reported as "probably yesterday") the patient was vaccinated intramuscularly with an expired dose of PNEUMOVAX 23 (0.5 ml, lot # H022172, expiration date 16-AUG-2014). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nursing assistant in a private doctor's office concerning an eight-year-old female. The patient's medical history and concomitant medications were not reported. The product expired in Dec-2008. On 24-Aug-2009, the patient received expired FLUMIST. On 11-Sep-2009, the reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. The customer reported that they thought all expired FLUMIST was removed from inventory at the end of the 2008-2009 season. The product was missed and inadvertently used. Additional information was received on 11-Sep-2009 and 16-Sep-2009 and incorporated into the narrative: included confirmation from reporter that no adverse events were associated with this medication error and product complaint information. Additional information was received on 14-Oct-2009: included patient's date of birth.
Rash that started at the site of the injection and moved down into underarm area. It lasted 1 week.
Patient received VARIVAX #2 per School requirements on 07/12/2017 at 1437. Patient started noticing a localized reaction 07/13/2017 afternoon/evening. Patient arrived to clinic 07/14/2017 at 0815 for reaction to be assessed. Site was red, circular, slightly raised and warm to the touch with intermittent itchiness. There were no signs or symptoms of respiratory or cardiac distress and Patient had no other complaints. Patient was directed to Primary Care Clinic to be further assessed by Primary Care Physician.
6/24/03 Developed "chicken pox like" spots with 101 degrees (Ax) fever. 6/26/03 Generalized rash, worse on 6/29. Beginning to subside 6/30. Afebrile 6/30. Seen by MD 6/30. 7/3 Much improved.
Patient developed itching of arms, scalp 15 minutes after vaccine; no shortness of breath; VSS. This is a frequent reaction after antibiotics and takes benadryl with resolution.  Gave 25 mg benadryl po; monitored in ED for an hour; symptoms improved/near resolution. Reminded to not receive second dose per Pfizer recommendation; to discuss with provider.
came on 1/23/2021 to vaccinate at Facility. She vaccinated patient. This patient was very apprehensive about receiving the Pfizer vaccine. She held her hand to calm down. gave her the vaccination and 5 mins later the patient said she has a headache, was upset, and started crying. She covered her eyes with her hands and started to shake. She also went to her bed and was rolling in it. The facility called 911 and they came within 5 mins. They did confirm that the patient wasn't having a seizure. Patient was calmed down but still went with the paramedics to be checked out. When I followed up with the facility, they said it was an anxiety event and the patient is back at the facility doing well. Let me know if you have any additional questions.
This spontaneous report was received from a healthcare professional and refers to a currently 14 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
On 10/11/2021 awoke in morning with discomfort in left leg with swelling and feverish in lower leg.With no previous problems not sure for the cause. When awoke again on 10/12/2021 experiencing same symptoms so contacted doctor to schedule appointment. Able to schedule appointment for on 10/14/2021 at which time symptoms were noted by doctor and in addition to examining leg doctor felt it necessary to send me to obtain a doppler/mri of left leg where a blood clot was found in the lower leg area. After imagining completed was immediately sent back to doctor offices where it was verified the results of test was positive for a blood clot. Was started on blood thinners for blood clot, steroid pak for swelling  and antibiotics for fever in leg.
pt began running fever approx 6 hrs p/inject; mom was told should have no rxn to these; mom gave pt APAP; by 1130PM t103 & then broke out in hives; hives were all over body; MD felt was a virus & a coincidence that appeared just hrs p/vax;
Began with severe screaming and flailing of arms & legs 2 hrs. after receiving vaccines.  Acted like he had abdominal pain, wouldn't drink bottle, gagging & dry heaving, febrile x10-12 hrs.  Tyl given q 4 hrs & ibuprofen q 6 hrs x24 hrs.
Day of vaccine - Throat felt like someone was pushing on either side, numbness in sinuses (nose, cheeks, upper jaw, tongue), bad headache (almost immediately) Next day - congestion, bad headache, body aches, chills, coughing, more throat symptoms, numbness in sinuses
1 pain severe, 2 nausea, 3 vomiting, 4 headache, 5 fever 101.
Tuesday, September 19, 2017 3:43pm patient immediately felt woozy, dizzy, lightheaded and sat in the waiting room before being able to leave the pediatrician's office. Her throat felt tight and her head began to hurt. Her arms and legs hurt. By the time she drove herself home she was feeling very tired and went to sleep. 9:00 pm patient was running a low grade fever, complaining of a headache, that her arms and legs hurt, and of a very sore throat so I gave her TYLENOL, a cup of tea with honey, and a bottle of water to keep by her bed. Wednesday, September 20, 2017 6:30 am patient didn't go to school. She was feeling dizzy, nauseous, and still complaining of headache, arm and leg pain, sore and tight throat, vision changes, felt feverish all day. 3:00 pm She became very dizzy trying to shower and move around the house. She called her grandmother to come over to help her when she couldn't get a hold of me at work. Grandma is a nurse so she pushed fluids and stayed with patient until I got home. 8:30 pm A rash broke out on patient's inner right thigh. The skin was very red and there were dark purplish marks, a fine red rash and a section that was raised a bit more than the rest. I gave her 18ml of children's BENADRYL. Within an hour she was back asleep for the night. Thursday, September 21, 2017 patient didn't go to school. Still feverish and the same complaints. So I called to get an appointment with the pediatrician.