chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Headache; Fatigue; Sick to her stomach; Felt arm pain; Shortness of breath; Upper respiratory infection; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via intramuscular route, administered in left arm, on 08Jan2021 14:00 (Lot number was not reported), at the age of 56 years, as single dose for COVID-19 immunisation. The patient medical history included COVID-19 from 13Dec2020 to unknown date. The concomitant medications were not reported. On 08Jan2021, the patient experienced upper respiratory infection. After 26 hours on 09Jan2021 16:00, the patient experienced chills, headache, fatigue, sick to her stomach and Felt arm pain. On 09Jan2021, patient had shortness of breath. For upper respiratory infection patient was treated with IC-minicyclone 100 mg once daily from 09Jan2021 for 7 days. The outcome of the event upper respiratory infection was recovering. The events chills, headache, fatigue, sick to her stomach was recovered on 10Jan2021 16:00, after 24 hours. The event felt arm pain was recovered after 3 days on 12Jan2021. The outcome of the event shortness of breath was unknown.   Information on Lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
Moderna COVID-19 Vaccine Bivalent  Pain in injection arm, extreme muscle soreness in arm, neck, back and lower back, headache, stiff neck, restless legs Ibuprofen
Symptoms occurred off-site post-immunization.  Donor reported on 2/26/19 that he had been experiencing hives, a rash, and itching on bilateral arms, bilateral lower legs, and on entire front area of the abdomen/waist since 2/22/19. Donor reported using anti-itch hydrocortisone cream PRN, Benydryl  PO every night, and Loratidine PO every morning starting on the day symptoms started (2/22/19).
Injection arm sore; chills; fever of 101.3; lethargic; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (tested positive for covid in 2020 and did develop pneumonia).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache). At the time of the report, VACCINATION SITE PAIN (Injection arm sore), CHILLS (chills), PYREXIA (fever of 101.3), LETHARGY (lethargic) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-1 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
leg calf started hurting/getting worse and bothering; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg calf started hurting/getting worse and bothering) and INSOMNIA (can't sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg calf started hurting/getting worse and bothering) and INSOMNIA (can't sleep). The patient was treated with IBUPROFEN for Adverse event following immunization, at a dose of 800 mg. At the time of the report, PAIN IN EXTREMITY (leg calf started hurting/getting worse and bothering) and INSOMNIA (can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
presented 48hr p/vax hot swollen arm c/o local rxn vs cellulitis;treated w/med;
Extremely sore arm at injection site, potentially do to location of vaccine given. Patient has slowly improved.
sensitize teeth; diarrhea; nausea; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 15Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown) for covid-19 immunization on an unspecified date. The patient got her 2nd COVID19 Vaccine dose yesterday 15Jan2021 and, she asked if it was normal to have really sensitize teeth (started last night, 15Jan2021) and that, she also experienced diarrhea and nausea both in Jan2021. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Acute transverse myelitis; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Acute transverse myelitis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
10/24/02-sluggish. 10/25/02-weak, fever (Motrin). Headaches, chills, cold sweat, back ache, and sore throat, no energy.
Exposed to a co-workers daughter August 13, 2021 who became symptomatic and tested positive for Covid August 15. Tonsilitis from sinus drainage started the morning of August 16. Went for Covid rapid test that morning. Test was negative. Went back to the doctor that afternoon. They swabbed for strep, which was also negative. 10 day dose of Amoxicillin and step down pack of Methylprednisolone prescribed and started that evening. August 22, the coworker developed symptoms and tested positive. Tested with Ellume home test that day, also negative. Went for PCR to confirm the negative on August 23, received positive result on August 25. Covid symptoms remained extremely minor - skin rashes, some minor aches that resolved after an hour or so, chest pain that resolved after an hour or so. Fatigue lasting an entire day on September 4 was the worst symptom.
Itching on various areas of body with hives and welts, redness. Took 50 mg Benadryl, 12 mg methylprednisolone, and applied hydrocortisone. Had to reside after 4-5 hrs, and again the next morning. Went to urgent care clinic and received 60 mg depo-prednisolone and went home and took more Benadryl and applied more hydrocortisone cream. Rash all over the body.
posterior cervical and supraclavicular lymphadenopathy present 1 dy after vaccination and evaluated in clinic after 1 week and improving .  Plan for reevaluation in 1-2 wks
On 10/28/2018, Patient came to pharmacy concerning about redness, hot to touch and pain at injection site on right arm. She started to have this reaction started 5 days ago. Patient took Benadryl on 10/27/2018, I advised her to continue taking Benadryl, cold compress, acetaminophen if needed. I told her that we will follow up with her later on today and tomorrow as well as we will call her physician tomorrow as they are closed today.
Booster dose of 0.5ml instead of 0.25ml administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Booster dose of 0.5ml instead of 0.25ml administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Booster dose of 0.5ml instead of 0.25ml administered). At the time of the report, ACCIDENTAL OVERDOSE (Booster dose of 0.5ml instead of 0.25ml administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Hives first day  on chest and trunk  6 days later itching and redness at injection site began, intensify each day, no antihistamine Or hydrocortisone or Advil help
I received the flu vaccination in the am of 11/10/15.  By pm of that day I had a spotty rash (very itchy) to my chest area. Also had a headache. By Weds (11/11/15) Rash had thickened an I had body aches fever and runny nose.  Rash to progressively worsen the next couple of days. By Friday (11/13/2015) the rash had spread up onto my neck and up the left side of my face. My face and neck were swollen with the rash becoming very painful by this time (I had started taking Benadryl when the rash started also was taking Ibuprofen). By Saturday the rash took on a sunburn/chemical burn appearance, and had spread to both ac areas on my arms with the left side worse than the right.... .was extremely painful and itchy.... also had swelling in the throat and became hoarse.  (I work in the ER as RN so the ER doctor treated me as output with a IM injection of steroids (Kenalog and Decadron and also started me on a Medrol dose pack.  My face had sunburn type appearance by Sunday and felt very flushed.  Rash and symptoms are almost gone by today Tues (11/17/2015).  Still have some itching to the chest and a couple of areas that feel "burned". I reported all this to our employee health nurse and to my ER director.
similar cases encountered in other patients, mechanism of activation of mast cells after the administration of adjuvant.; This case was reported by a physician and described the occurrence of mast cell activation syndrome in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mast cell activation syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the mast cell activation syndrome was unknown.   It was unknown if the reporter considered the mast cell activation syndrome to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not applicable for this report.  The reporter wanted information about adjuvant metabolism, as cases were encountered in patients for activation of mast cells after the administration of adjuvant. This case has been linked with US2019184363, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019184363:same reporter
Patient reported adverse effect after receiving J&J vaccine on the 4/6/21. Pain inner elbow intermittently. Fever 103.2F on the evening of the date of vaccine, but has not had another fever since. Patient reported headache that comes and go.  Pt was scheduled for UC visit
Dizzy, lightheaded, visual changes...right eye- visual field appeared to be moving when still
No adverse events occurred.  Pt was administered both Pfizer Covid 19 vaccines under the age of 16 years.
This is a spontaneous report from a registered pharmacist referring to a male who received his 1st dose of Lymerix on 2/2/99 and his 2nd dose on 3/2/99, respectively. On 5/13/99, while jogging, the pt experienced arthritis-like pain of both knees. He could not drive his car. He was seen by a physician and was treated with ibuprofen. As of 8/24/99, his pain has slowly abated. He still has some discomfort. The most recent information, received on 8/24/99, reports the condition of the pt is ongoing. The most recent information received on 5/31/00 reports the condition of the pt as resolved.
Patient described that the night of her vaccination she had a bump under her left arm. The next morning it was swollen, red, hot, and a rash began to develop. Patient reported that the rash was located above her elbow. We recommended that she take ibuprofen, benadryl, and ice the area on her arm.
Started with a sore throat for a few days and progressively turned into shortness of breath and a cough. Went to Urgent care to get steroids and antibiotics. Been coughing and short of breath for 3 weeks.
99.9 Fever, headache, fatigued for 17 hours. Then painful arthritis in all joints especially old injuries (ankles, knees, back, shoulders, wrists). This was quite pronounced for two weeks then abated gradually over the week 3. Normal after 22 days.
Patient developed pain and a lump at the site of injection . The injection was administered below the deltoid. Patient has had pain for the past month and a bump. Physician has prescribed a 5 day steroid course of therapy and recommends an MRI if condition persists.
Vaccinated left deltoid 15JUL20040. Presented 23JUL04 complaining of hand trembling and numbness x qd, transient SOB (resolved). Self-medicated with Allegra and acetaminophen.
One week after the injection my arm began itching. It is red, elevated and warm.   Estimated date of delivery: August 22, 2021
Chills, low grade fever, pain in left arm, pain throughout left side, fatigue, numbness in left arm and hand, difficulty moving left arm, joint pain throughout body. Numbness began 30 minutes after injection and all other symptoms began the night of 2-2 and persists as of today 2/4/21
I received my J&J COVID-19 vaccine at around 1:45 p.m. on April 7, 2021. The shot itself was hardly painful, and I felt fine in the wake of the vaccine. That same evening, I had a fever of around 100 degrees , along with chills and fatigue. My most notable symptom was a severe, pounding headache throughout my forehead. It seemed to be localized above my eyes, in the front of my head. This was surprising to me, as I never get headaches. I took some acetaminophen and went to sleep, and the next day the headache had subsided slightly. The headache did not subside completely until 3 days after the vaccine and even now, nearly two weeks after the vaccine, I still get a slight headache in the same location (above my eyes, across my forehead) unexpectedly. Again, I never got headaches until receiving this vaccine.
booster dose given at 1/3 the full dose; immunocompromised patient given a booster dose for her 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given a booster dose for her 3rd dose) and EXTRA DOSE ADMINISTERED (booster dose given at 1/3 the full dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 022M20A and 042J21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation (she takes unspecified medications) and Immunodeficiency.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given a booster dose for her 3rd dose). On 04-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (booster dose given at 1/3 the full dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient given a booster dose for her 3rd dose) and EXTRA DOSE ADMINISTERED (booster dose given at 1/3 the full dose) outcome was unknown.            It was reported that the patient was immunodeficient and had MS (unspecified condition).  The patient did not have COVID-19 diagnosis prior to or after getting the vaccine.   The patient had no history of allergies.  Concomitant medications included unspecified medications.  Lot number for 1st booster dose was 088_21A (could not decipher the 4th character in the lot number).  The had her last flu vaccine in Sep-2021.  The reporter mentioned he would clarify with the pharmacy the dose that was administered to her on 08-Aug-2021 and 04-Feb-2022.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-529184 (Patient Link).
Patient requested her first dose of Moderna primary series. My technician typed up the vaccine correctly and vaccine was processed in the system without any need for verification by the pharmacist. Her consent form was lined up after a string of patients needing the new Moderna- Bivalent vaccines. There was no communication amongst the team that a different Moderna product was requested. I prepared the vaccine for the bivalent booster (which was already open) instead of her first primary doses. Prior to directing her to the consultation room, I asked her if she had her vaccine card to document her vaccine or if she needed a new one - she said she needed a new one. In the consultation room, I asked for her name, birthday, and whether she was expecting the new booster shot. She said yes. After I gave her the vaccine, she asked when she would need a next one and told her this is the only booster dose approved at this time. It was after she left that I took a second look at the consent form and realized the mistake. I immediately called her and let her know of the error and per CDC guidelines, I had the patient come back and gave her the primary dose of the Moderna series. Contributing factors to this error: it happened right as we reopened for lunch and it was very busy - this is uncontrollable. I asked my technicians moving forward to verbalize to me if a patient is needing a different formulation all together - especially if we have both vaccines happening given that the packaging to these vaccines are very similar looking. Patient's confusion to the process did not help with today's situation but shows the importance of verifying name, DOB, and what vaccine they are expecting. Today, was our first day offering this vaccine at a walk-in bases so there were many factors that were contributing to this mistake but a team huddle emphasizing how to mitigate this from happening again will happen tomorrow asap.  As this time, no adverse effects has been reported by the patient.
Stroke; She has went Dizzy and cozy; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age (Age 57; it: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced stroke. The patient had gone dizzy and cozy went to urgent care she wasn't hospitalized. She was in urgent care, that was in July2021. The outcomes of events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day After Injection: fever, chills, nausea, dizziness, light sensitivity, migraine, muscle aches, itchiness by injection Day two: swollen injection site, severe itchiness, muscle ache, dizziness Day three: 04/10/21 severe itchiness, redness size of golfball
Tinnitus. Sharp pains throughout body especially in fingers, hands, head, back of head, jaw, neck, Throat, ears, eyes, chest, upper and lower and sides of back, child and fever for 29 hours. Disability unable to move 36 hours in excruciating pain. Loss of right thumb use for 7-9 days thereafter. Continued joint swelling not recovered from.
IMMEDIATE Hives on both arms.  Left arm immediately felt very tight....felt like a tourniquet was tied around my elbow and fingers started tingling.  Within 5 minutes eyes, mouth, ears and vaginal area very itchy and  became dark pinkish/light red.   Advised pharmacist on duty.  Was advised to go home and take 2 Benadryl  every 4-6 hours.  Heart began racing within 30 minutes.  Heart racing lasted 5 days.  Hives are still in all the above areas.  Still taking Benadryl. Still itchy,  Fingers are still still tingly on left hand.  Left arm still feels weaker.  Left armpit is still sore.  Left breast is still having off and on pain and hives on nipples.
09May90 pt vax;  10May90 devel redness & tenderness w/ pain at inject site.  Tx w/ APAP.
Varicella - Information has been received from a registered nurse concerning a 4 year old male who on 25 Mar 1997 was vaccinated with one dose of varicella virus vaccine live.  In May 2000 the patient experienced full blown chickenpox with greater than 100 lesions.  Medical attention was sought.  The patients two siblings has a similar experienced following vaccination with varicella virus vaccine live (waes 00061175 the patients twin and weas 00061176.  No further information is available.
Hand weakness, swelling at injection site, large hematoma, spasm in arm, neck, and shoulder blade and radiating in head.  Loss of full range of motion in shoulder.
She had her apt at 3:20...at around 4:45 she said she felt "drugged" then, got a slight fever, got very shaking, light headed--lethargic, very dizzy, crying uncontrollably....I made her keep moving...kept her stimulated. made her drink extra water and eat. Gradually started to feel better, dizziness of and on all night--seemed okay in the morning. Did not take her into the ER..Dr office was closed at the time of reaction....Her FNP who gave and insisted on the shot, (I was never notified or asked about this shot prior to it's administration--I have withheld it previously, for precarious reasons) said she would have to have a Pap if she refused--so my kid opted for the shot--she is only 15). The FNP said there would be no adverse reations, said it was very safe--should not even worry about a fever...would not disclose to ME any the reations to look for...when this started going on, I asked my daughter for all the sheets the practitioner gave her regarding her visit...thats when I saw the reactions to be warned about. The dizziness was one of the serious reactions to look for.
Migraines and I had nausea, body aches, debilitating fatigue and dizziness. Sharp pain in right ear and on right side of skull.   I have adrenall insufficiency and take daily doses of hydrocortisone. I have had to triple my dose to control the dizziness, fatigue, and migraines and to be able to do laundry, clean my house, and prepare meals.  Will NOT be getting any more Covid jabs!