chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother claimed after vaccines were given, rash appeared on child's left forearm immediately. Child stated "itching a little bit". On exam, 15-20 papular (small, raised, solid) rashes on child's left forearm, no rash anywhere else, no respiratory distress - child was active, no other complaints. BENADRYL liquid 25 mg given by mouth. After 20 minutes no other complaint of itching. Follow up call after 6 hrs, rash disappeared.
the muscle weakness getting progressively worse; muscle weakness to her arms and legs; paintfull; unable to walk a mile; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single and administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing). Concomitant medication(s) included: DYSPORT, start date: 26Mar2021; PROZAC taken for depression. Past drug history included: Botox. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 06Apr2021, outcome "not recovered", described as "muscle weakness to her arms and legs"; PAIN (non-serious) with onset 06Apr2021, outcome "not recovered", described as "paintfull"; GAIT DISTURBANCE (non-serious) with onset 06Apr2021, outcome "not recovered", described as "unable to walk a mile"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "the muscle weakness getting progressively worse".  Additional information: The patient was injected with 105 units of Dysport (45 units to glabella and 60 units to forehead/frontalis) on 26Mar2021. On 20Apr2021 she reported that she had really bad muscle weakness to her arms and legs that started 2 weeks ago (06Apr2021). Patient reported that the muscle weakness if getting progressively worse and had been especially worse in the past 2 days. She stated on 20Apr2021 that it was painful to lift her cellphone and she was unable to work out and would be unable to walk a mile if she had to. She contacted the HCP and was advised to go to the ER which she did not want to do. HCP advised her to go to the ER if she had any trouble breathing or any swelling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the vaccination around 5pm on Friday, as soon injection went in a felt a stinging down my arm. At 1230am I woke up from sleeping with horrible body aches, I had a fever, and I was shaking (like a tremor in both of my hands). I took 1000mg of Tylenol and took a warm shower but the shaking did not stop for 1-1.5 hours. I then woke up with muscle pain and sweating. The muscle pain, fatigue, and headache. I have bruising to my right arm near the injection site and pain in my arm. On Sunday I woke up with a red, blanching rash on my trunk and arms and continued have muscle pain and a headache. Monday continued having a headache and fatigue and keep getting a sharp pain in my left chest. Tuesday I have an intermittent sharp pain in the left side of my chest.
Headache - ibuprofen - hasn't dissipated as of today Arm soreness - ibuprofen - better by 2/1 Blurry vision (right worse than left) - no treatment - better by 2/2
Started as small rash on front neck then spread to right of ear then went to my back an then spread to left side of neck. The rash grew larger spot like a blisters. Very fatigued still, loss of appetite. 2 skittish to Dr office and Dr cannot verify what it is. Sending me to dermatologist now. Dr prescribed prednisone 20mg and steroid cream. This made the rash worse.
Patient received 3 dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO) and MENINGOCOCCAL B VACCINE (BEXSERO).   On 8th October 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 8th October 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date- 17-Aug-2022 Reporter's comment: The nurse reported a patient received third dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The patient received the third dose of Bexsero, which led to extra dose administered.
Warm sensation injection site which travelled down arm followed by mild chest tightness, anxiety symptoms. After 10 minutes of observation, 911 called and pt. evaluated by paramedics within 30 minutes.  Pt. evaluated and refused ER transport.  BP slightly elevated at 167/89.  Paramedics left and patient developed recurrent chest tightness, throat irritation, mild disorientation, no nose or eye symptoms.  Was given epipen and paramedics were called back to scene.  Transported via ambulance to ER.  En route developed more SOB, pain under right breast.  In ER treated with ASA and chest pain protocol.  Observed for 2 hours and released.  Returned to work and felt slightly lightheaded, better with lunch.  Rest of day felt "out of sorts".  All symptoms resolved completely and have not returned after night of sleep.  Evaluated by PCP day after event with no unusual findings.
Originally had COVID Feb 2020, mild case with only a cough for 4 weeks.   As a result of mandatory vaccination required for employment, and despite continued levels of antibodies, as confirm prior to first vaccination, I received my first dose of the Pfizer vaccine on Sept 29, 2021.   Post Vaccination, approx 10 days later, I noticed a significant change in Tinnitus; increase in sound and new onset of high pitched noises.   In addition, I identified a trend in onset of GI issues which I never had before.  Shortly after eating, I had GI upset which required OTC treatment to resolve (eg Chewable Tums).  This GI upset lasted approx 3 weeks and has since resolved. Approximately 2 weeks ago, I started with light sensitivity issues, blurred vision, and headaches reappeared.  Use of prescription sunglasses indoors appears to be helping with the sensitivity, blurriness, and headaches.  Eye issue spontaneously appear and disappear.  Tinnitus has not resolved to baseline and continues to be problematic.  None of the symptoms described here were experienced with initial COVID infection dating back to Feb 2020.
A few minutes after vaccination, the patient stated she was feeling dizzy and she looked pale. I instructed her to sit down and while she was walking to the bench, her vision went blank for a second and she tripped and fell. When I got to her after she fell, she was already awake. She said she didn't lose consciousness but just went blank for a second.
This is a serious observational study case, initially received from other health professional on 13-May-2019, concerning a 24-year-old adult female pregnant subject of weight 131.6 lbs, 67.5 inches height and body mass index (BMI) 20.3, enrolled in prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The current conditions of the subject included Rh D negative. The subject's obstetrical history was collected in which no previous pregnancies were reported. The concomitant medication of the subject included Prenatal Vitamins (unspecified) as a supplement. The subject's family history of major congenital malformation was collected, and the subject had no maternal/paternal history with major congenital malformations. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 05-Sep-2018. The type of pregnancy was singleton. On an unknown date, the pregnancy status of the subject was collected, and no pregnancy complications were noted. On 09-Nov-2018, at 9 weeks of gestation, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF42609, dose, route of administration, expiry date and anatomical location: not reported] for an unknown indication (explicitly coded as vaccine exposure during pregnancy). On the same day, the subject underwent ultrasound scan and no major congenital malformation was noted. On 06-Dec-2018, the subject underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and no major congenital malformation was detected. On 22-Feb-2019, 3 months and 13 days after vaccination, the subject experienced genital herpes simplex type 2. On 10-Apr-2019, 5 months and 1 day after vaccination, the subject experienced cholestasis. The subject was treated with Ursodiol (ursodeoxycholic acid) (dosage: 300mg, qd, orally, start date: 12-Apr-2019 and was ongoing) for cholestasis. The outcome of the events was not recovered. The subject's estimated date of delivery was reported as 12-Jun-2019 and corrected estimated date of delivery was reported as 18-Jun-2019.; Reporter's Comments: A 24-year-old pregnant subject experienced genital herpes simplex, 3 months 13 days after administration of study vaccine and cholestasis approximately 5 months post vaccination, at 9 weeks of gestation (coded to Exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported events and no evidence for a biological mechanism that could cause the events, the events were assessed as not related to the study vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed this case as serious (medically significant).
tingling lips; numb lips; continual clearing of throat; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling lips), HYPOAESTHESIA ORAL (numb lips) and OROPHARYNGEAL DISCOMFORT (continual clearing of throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling lips), HYPOAESTHESIA ORAL (numb lips) and OROPHARYNGEAL DISCOMFORT (continual clearing of throat). At the time of the report, PARAESTHESIA ORAL (tingling lips) and HYPOAESTHESIA ORAL (numb lips) had resolved and OROPHARYNGEAL DISCOMFORT (continual clearing of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Right after injection, patient felt pain in area of her arm. By the next morning her upper right arm was red and swollen.  It became hard red and painful. It continued to get more painful and area grew larger of "hard red swollen" area for the next 2 weeks until 11/15/20, when she took benedryl. It started to reduce in severity with taking the benedryl. (She went to urgent care 2x, they advised advil, ice or benedryl. ) When saw patient on 11/16/20 she had a large (8" wide by 15" long), red, swollen, hard and painful area of R upper arm that continued down past elbow on lateral side after shingles vaccine 2 weeks ago.
Pt received Moderna Covid dose IM in left deltoid approximately noon on 2/17/21. Pt contacted clinic on 2/18/21 around 1030am and c/o onset the evening of 2/17 (day of shot) of low grade fever and hot rash on face that consisted of purple dots. No other rash on body but endorsed itching at injection site. Pt reports feeling lightheaded/ dizzy and very nauseous. Answering (also reporting) provider was concerned for possible ITP, and advised pt to go to ED for labs including CBC and physical exam. At this time we have not heard further from the pt, they are expected to go to the ED today. Labs have not yet been performed/ reported. The outcome is not yet known in terms of what care will be needed.
Patient informed me last week that he was still experiencing pain in his arm and felt that I should know.
Having issues and she lost 2 decimals in her right ear where she cant hear. Went to the dr and was dx with an outer ear infection, and gave her meds and she still woke up in worse pain. She went to the ER and they dx her with having an inner ear infection and was given antibiotics.
2" sl raised reddened area; warm to touch burise 2" x 4" w/some swelling;
PULMONARY  EMBOLISM; This spontaneous report was received from a female patient of unspecified age, race and ethnicity not reported. The patient's weight, height, concurrent condition, or medical history were not reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number unknown) dose, start therapy date were not reported for prophylactic vaccination. The patient was taking XARELTO (rivaroxaban) (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient reported that she was taking XARELTO and developed a pulmonary embolism after taking J&J vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of pulmonary embolism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210457869-COVID-19 VACCINE Ad26.COV2.S-Pulmonary embolism. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
My symptoms started with a scratchy throat and a headache. Then my arms and legs felt very heavy. I called my doctor, and I was tested the next day. I got an antibody treatment the next day. I had symptoms for about two weeks and I was a little tired for a while. I was not hungry and I lost my sense of smell for a little while. I had loss of appetite for three days and I had some diarrhea for about one week on and off. It was three weeks before my energy returned. Covid-19 symptoms 07/28/2021; Testing 07/29/2021; 08/30/2021 Antibody infusion.
passed out, tonic-clonic activity w/incontinence of urine;treated w/2 ammonia capsules;skin pale, diaphoretic BP & HR nl;
Information has been received from a consumer concerning his 21 month old daughter with no known allergies who in the Spring of 2006, was vaccinated with MMRII. There was no concomitant medication. In approximately April 2006, the patient experienced elevated temperature rash all over her body and was "listless". Unspecified medical attention was sought. The patient had unspecified bloodwork completed (results not reported). Subsequently, the patient recovered from elevated temperature, rash all over her body and being "listless". No further information is available.
COVID vaccine breakthrough case. Moderna 3/9/21 029A21A, 4/6/21 045A21A, 12/10/21 058H21A and Pfizer bivalent 10/15/2022
I was awakened at 4 AM with severe pain in arm, along with redness, swelling and hot to the touch. I began applying ice packs and taking ibuprofen.
Pt had a huge red bump on left arm where KINRIX was given. Hot when felt.
Report 2001022393-1 describes allergic reaction (NOS) in a pt of unspecified age and gender who rec'd hepatitis B vaccine (Engerix-B). The pt's allergies, medical history and concomitant medications were unspecified. On an unspecified date, the pt rec'd the first dose of Engerix-B. Subsequently, the reporter thought that the pt was having an allergic reaction (NOS). As of 9/17/01, the outcome of the event was unknown.
DX: COVID infection:  This patient is a 57-year-old gentleman with past medical history of Parkinson, schizophrenia, GERD, diabetes, who is a resident at a skilled nursing home recently was diagnosed with COVID-19.  The patient presented to the hospital with a cough, fatigue and mild shortness of breath. T-max was 102.3,heart rate 92.  EKG, sinus rhythm, no ST elevation or T-wave inversion.  Chest x-ray, no evidence of suspicious pleural or parenchymal abnormalities.  Blood work was done and reviewed. Due to his presentation, the patient was seen and evaluated by Infectious Disease who reported that the patient has a COVID-19 infection, but no respiratory distress on room air.  To continue with a Lovenox and not a candidate for remdesivir.  The patient's culture was negative so far.  Also, the patient regarding mild hyponatremia was seen and evaluated by a nephrologist, which improved.  Followup with the patient showed improvement in his presentation.  Discharged in stable condition to subacute rehab. On 10/11/2021 Pt was unreponsive at the nursing home and brought to the ED.  Patient was brought in from nursing home with hypoxia and low blood pressure. Associated symptoms: fever and shortness of breath , tachycharia and repiratory distress.  Critical care was necessary to treat or prevent imminent or life-threatening deterioration of the following conditions:  Sepsis, respiratory failure and shock.Initially patient responded to the CPR. We got a pulse back. Fluid antibiotic was also started. Accu-Chek's was done.  Patient was coded again because he lost pulse. This time he did not respond. Patient was pronounced in emergency department.
here with c/o 8 days of headache, sore throat, cough, body aches, fever, chills, shortness of breath, , loss of taste, loss of smell, diarrhea, ear pain, eye pain, chest tightness, chest pain, sinus congestion, ear fullness, ear pain, vomiting~just last pm vomited mucous up, chest pain with inspriation starting 11/18/21
He was found dead in his home by friends who went looking for him after he didn't show up for work... possible suicide?
Initially started with nausea around min 5, shortly after then itching on arms. Around min 15 ?lump? sensation in throat. Around min 20 swelling of tongue, worsening feeling in throat, wheezing, itching around mouth.  Sent to ER, received IM Epi, IV: Steroids, Benadryl, Zofran, Pepcid, Albuterol inhaler.
had problem with her back(across her back) after 2nd dose; Rash on sisters back; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (had problem with her back(across her back) after 2nd dose) and RASH (Rash on sisters back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (had problem with her back(across her back) after 2nd dose) and RASH (Rash on sisters back). At the time of the report, MUSCULOSKELETAL DISCOMFORT (had problem with her back(across her back) after 2nd dose) and RASH (Rash on sisters back) had not resolved. Unknown          Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-039961 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: F/U received on 08 MAT 2021,New event was added.
Mom states that after 4 month immunization given, left thigh developed redness and swelling from upper thigh to ankle.
My last period prior to my first vaccine shot had been in June 2020.  All signs, including blood work, pointed to me having entered menopause.  My mom also went through menopause at age 45 when her periods suddenly stopped, so I figured I was following in her footsteps.  On Saturday, February 13, 2021, I received my first dose of the Moderna vaccine, and by Thursday morning, I was spotting.  This was very surprising since I had not had a period in several months.  Over the course of a couple of days, it turned into a full-blown period with the most severe cramping I've ever had in my life.  By Saturday, they felt like labor contractions, and I was releasing sizable blood clots.  I made an appointment at our health clinic, and all bloodwork again pointed to menopause.  After my 2nd Moderna vaccine, I again experienced just a tiny bit of brown spotting a few days after the vaccine.  However, it did not progress into a full-blown period that time.
extreme muscle/ body aches; extreme muscle/ body aches; loss of appetite; fatigue; fever (101); nausea; chills; headache; low energy; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 06Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or other non hcp.  A 65-yearsold patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) Dose 2 via an unspecified route of administration, administered in in the left arm on 04Feb2021 at 16:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included coeliac disease from 31Oct2016 and ongoing Pertinent details: Endoscopy done by GI doctor , biopsy from 2004 to an unknown date Verbatim: Excisional Biopsy  Pertinent details: L.Breast. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162b2 on 14Jan202 at 15:00 (Lot Number: EL1284)  via an unspecified route of administration in the left arm for COVID-19 immunisation. On 05Feb2021 at 15:30, the patient experienced extreme muscle/ body aches , loss of appetite, fatigue (in bed approx 36 hrs), some fever (101), some nausea (briefly), chills, headache (some), very low energy; all medically significant events. I guess the vaccine was working. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 05Feb2021 , sars-cov-2 test: negative on 29Jul2021 Same day testing. The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of all the events. The patient recovered from all the events in 2021. Follow-up attempts are completed. No further information is expected.
"Rash" on face, chest and back. Hand joint pn w/ slight finger swelling and slight redness on both hands and upper lip and cheeks.