chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experiencing really weird side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing really weird side effects) 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 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experiencing really weird side effects). At the time of the report, VACCINATION COMPLICATION (Experiencing really weird side effects) had not resolved.            No concomitant details was provided. Patient had second booster on Thursday March 31 and  experienced really weird side effects. it was reported that not really have much of a reaction to any of the others, may be patient didn't felt it on the first day, but it was is very different and it is the same thing for both husband and wife. No treatment information was provided.   This case was linked to MOD-2022-535485 (Patient Link).
received both doses of the Shingrix vaccine in January and since then have had 3 outbreaks / vaccine has made no difference in the recurrrence rate of my outbreaks/Suspected vaccination failure; 3 outbreaks; received both doses of the Shingrix vaccine in January; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (chronic shingles first  occurred in 20's.).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and drug dose administration interval too short. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reporter by the patient herself.  Additional details were provided as follows: The case was reporter by the patient herself. The age at vaccination was not reported. The patient received both doses of Shingrix in January and experienced vaccination failure and shingles. The patient received 2nd dose in less than recommended time frame, which led shortening to vaccination schedule. The patient stated that had 3 outbreaks, after vaccination. The patient inquired how common that was and if there were any data on patients who already had a history of shingles and the recurrence rate when vaccinated. The patient informed that, the vaccine had made no difference in the reoccurrence rate of outbreaks. This case was considered as suspected vaccination failure as details regarding, onset time and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-FEB-2010, the patient was vaccinated with a first dose of VAQTA for prophylaxis (dose, route of administration, lot # and exp date was not provided). On 19-MAY-2010, the patient received the second dose of VAQTA. No adverse effect was reported.
5 minutes after shot, patient passed out for 10-15 seconds. Nurse woke up patient. Patient reports vomiting about 1 minutes later. Patient states they had a migraine before getting the vaccine today. Patient reports a history of getting  anxious and passing out with shots or blood draws.
Rash at the injection site.  Circular red rash (4 inches in diameter), itches, and slight pain. Currently self-treating with a topical cream, Hydrocortisone cream 2.5%, twice daily.  Reduces itching, redness and pain.
Pt recvd DTP/HBOC/OPV & cried & turned very red; seemed unable to catch breath; pt became limp & pale; taken to ER pulse rapid;
Erythema, edema, warmth at injection site 2 days post (9/21) and surrounding (about baseball size). Reports muscle soreness, especially when moving arm. Warm compress and ADVIL provided; BENADRYL encouraged also.
Vaccines administered on 2/17/04. 3/5/04 febrile seizure with temp 102. Also developed lesions of chickenpox. Had febrile 2/02 also. Adverse onset rash 3/2/04 8 pm, seizure 3/4/04 6 pm per mom.
Large rectangular patch 4 1/2 inches wide and 5 1/4 inches long reddened area at the original injection site. I was ill from 1/15 to 1/17 with fever, severe headache, and severe body aches. Fever broke on the morning of 1/17 and patch or reddened skin at the original injection site. It itches and is warm and tender to the touch at this time 1/20 (Wed).
85 x 200 mm area of warm, red, hard c/o's pain to touch, recommendation to see personal doc.
Swelling/redness when he woke up. Next day swelling and redness wrapped around entire leg. Tuesday 4 September woke up with Hives all over body, swelling/redness wrapped around entire thigh at injection site.  Tuesday night 7:30PM fever (102.1). Wednesday 5 September Hives all over body, swelling/redness wrapped around entire thigh at injection site, no fever. Thursday 6 September, hives and swelling/redness started to fade. Friday 7 September, hives gone and most of swelling/redness gone.
Raised macules 0.3 - 0.5 on medial anterior aspect of lower legs and circumferencally around suprapubic line of body.  Itches where clothes are rubbing. Treated with topical ointment and Benadryl.
vaginal bleeding/a lot of bleeding; Anemic; Health is being affected; worsening headaches; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding/a lot of bleeding), ANAEMIA (Anemic), MALAISE (Health is being affected) and HEADACHE (worsening headaches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Started when patient was much younger), Drug allergy (Allergic to Benadryl) and Menopause (Patient went into menopause approximately two years ago).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 VAGINAL HAEMORRHAGE (vaginal bleeding/a lot of bleeding), ANAEMIA (Anemic), MALAISE (Health is being affected) and HEADACHE (worsening headaches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding/a lot of bleeding), ANAEMIA (Anemic), MALAISE (Health is being affected) and HEADACHE (worsening headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) never tested positive.         No concomitant medications were reported.  The date of administration for the Booster dose was two to three weeks ago from the time of report. The events started occurring a couple of days after she received the Moderna booster dose. Patient had gone into menopause approximately two years ago and the reporter stated that the Moderna booster dose brought the patient out of menopause and her health was being affected by the vaccine. The health was being affected and it was worsened after booster dose. Vaginal bleeding had not improved or worsened. Patient may have to undergo a surgery - hysterectomy. The patient has been exposed to COVID-19 in the past but never tested positive. It was reported that the patient was under duress when she received the Moderna COVID-19 vaccine and stated that she was made to get the Moderna vaccine by her employer or she would be at risk of losing her job.   Reporter did not allow further contact
felt faint; stomach was bothering him; nauseous; constipated; felt terrible; didn't sleep well; indigestion; fatigue; A spontaneous report was received from a Consumer concerning a 77 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, dyspepsia, abdominal discomfort, nausea, constipation, discomfort, poor quality sleep, dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A)  for prophylaxis of COVID-19 infection.  On 21-JAN-2021, The patient experienced fatigue, On 22-JAN-2021, patient experienced indigestion. on 24-JAN-2021, the patient experienced stomach bothering, stomach feeling tight, nausea, constipation, felt terrible, didnt sleep well  and felt faint.  Treated with Rolaids .   Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events were unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Dizziness, balance issues, concentration issues, forgetfulness, depth perception issues all started after the first dose of the vaccine but really ramped up in the month of June  about 2 months after the last dose. I went to 2 ENT doctors in the month of July, In hopes of possibly having  an inner infection but they found nothing.  I went to a physical therapist for 2 months  in June & July  to be treated for vertigo but that did not help much.  I went to a chiropractor in August - November.  I had my annual physical in September & Dr.  suggested a MRI since the  symptoms have lasted so long. This is scheduled for December 2 nd.
child had episode of prolonged atypical crying (exact time unknown) followed by breath holding spell of uncertain duration, during which time child turned dusky red-blue. Family treated child at home, child did well.
After vaccine I developed OAS (oral allergy syndrome). I got hives inside mouth, throat and lips. I also contracted COVID after being fully vaccinated.
My arm hurt; sleep alittle more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ptsd" (unspecified if ongoing), notes: Ptsd; "Known allergies: Metal allergy" (unspecified if ongoing), notes: Known allergies: Metal and latex; "Known allergies: Latex allergy" (unspecified if ongoing), notes: Known allergies: Metal and latex; "tendinitis" (unspecified if ongoing), notes: I had tendinitis in it from cleaning hoard houses for over 10 years. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Bc), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "My arm hurt"; SOMNOLENCE (non-serious), outcome "recovered", described as "sleep alittle more". Therapeutic measures were not taken as a result of pain in extremity, somnolence.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Also no other medications received within 2 weeks of vaccination. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My son had a low grade fever friday night with full blown pox marks all over his body by Sunday, hundreds of them 9/5/2010.
Severe chills and fever Severe fatigue swelling and discoloration of upper arm (6 inches x 3.5 inches)
Missed entire menstrual cycle and the had unusual bleeding.  Received first COVID vaccine dose on 7/31/2021, at end of menstruating.  Received second dose on 8/20/2021.  Missed an entire menstrual cycle, which should have started at about that time.  Circa 8/30/31 and 9/2/2021, took two pregnancy tests - both negative.   Then bled from 9/8/2021 to 9/13/2021.   Then had another week of bleeding from 9/25/2021 through 9/30/2021.  Prior to this I had never missed a menstrual cycle before in my life, and after the end of menstruation on 9/30/2021, all cycles have since been normal and consistent.
This spontaneous report was received from a nurse practitioner refers to a 46 year old female patient. No medical history or drug reactions were reported. On 29-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J003219, expiry: 15-MAR-2015) in the right arm subcutaneously as required vaccination for nursing school. On 08-SEP-2013, the patient experienced bumps on her right arm that was vaccinated. No treatment was given Patient sought medical attention. Nurse practitioner stated the patient called her today on 10-SEP-2013, to report this. Nurse practitioner stated the bumps were not blisters or pustules. The outcome of bumps on her right arm was reported as not recovered. Additional information has been requested.
Patient received second dose on day 21. Called patient but was not able to reach them. They currently have not stated that there were any side effects or issues.
Moderate level of fluid around heart ((baseline/all her life = minimal level of fluid); Temp 103, low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDIAL EFFUSION (Moderate level of fluid around heart ((baseline/all her life = minimal level of fluid)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERICARDIAL EFFUSION (Moderate level of fluid around heart ((baseline/all her life = minimal level of fluid)) (seriousness criterion medically significant) and PYREXIA (Temp 103, low grade fever). At the time of the report, PERICARDIAL EFFUSION (Moderate level of fluid around heart ((baseline/all her life = minimal level of fluid)) and PYREXIA (Temp 103, low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Electrocardiogram: abnormal had moderate level of fluid around heart (baseline/all her life = minimal level of fluid).         No relevant concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-033237; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
ED visit for MVA on 12/6. Treated and released. Hospital admission on 1/4/22 for severe sepsis; received IV fluids and stats improved with rest. Discharged home. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a registered nurse and refers to a 13 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # reported as M010476 with expiration date of 01-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 21 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Inflammatory reaction in various nerves in head and neck causing pain and numbness   myalgia in legs and arms numbness and tingling in hands and feet Lasting 5 days as of this report  Treated with nsaids, acetaminophen, flexeril
75 Y  male with history of HLD, GERD, sleep apena not on CPAP admitted for ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/2 COVID pneumonia. Received two doses of Moderna vaccine in March but not COVID positive after recent travel abroad. Patient returned on 10/2, developed symptoms on 10/6, and presented to the ED on 10/13. Note pt still in hospital on 10/28/21 AHRF // COVID PNA Hypoxemic respiratory failure due to COVID PNA. Interval CXR with improvement, CT chest b/l GGO, possible nodularity. Negative fungal culture, no sputum cultures. On admission, afebrile, WBC 15, no lactic acidosis, confirmed COVID swab, vaccinated (moderna), most c/w COVID pneumonia. S/p 1 x decadron, transitioned to solumedrol. S/p toci x 2. LFTs stable. BNP elevated initially, but downtrended. Leukocytosis still uptrending, most likely steroid-induced. Now s/p empiric CAP doxycycline and cefepime. Still with high oxygen requirements, but now off iNO. Inflammatory markers elevated, but stable. Continue to wean O2 as tolerated. Currently satting at 92% on 40L 40% FiO2.  - Bactrim ppx, d/c when prednisone at 10mg daily - Continue to monitor inflammatory labs - CRP, d-dimer, ferritin, LDH every other day - Prednisone 20mg x 2 days starting 10/28, then 10mg x 2 days. - Wean O2 as tolerated, maintain O2> 92% - Prone as tolerated at night - Lasix prn - Out of bed into chair.  - Bedside commode - Tessalon pearls - Codeine/guaifenesin   PREDIABETES Hx of pre-DM, glucose still elevated, likely due to steroids. A1c 6.6. Still with significant insulin requirements. CTM while weaning steroids. With prednisone taper, will adjust insulin regimen  - Hypoglycemic protocol - NPH 10U BID - Regular ISS   URINARY RETENTION Patient with >999mL in PM bladder scan. Foley replaced. Patient with urinary retention in ICU and had foley placed.  - Cont Tamulosin 0.4mg qd   HLD - Continue home atorvastatin 20mg daily   GERD - GI PPx: protonix PO - Bowel regimen: senna/miralax   DVT  Right popliteal DVT on lower extremity US (10/14/2021). Continue therapeutic dosing for lovenox.  - ASA 81mg qd - VTE: Lovenox 40mg q12h per pharmacy recs
Post vax, the pt developed a perianal rash consist with varicella zoster.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. The patient did not have any known allergies. On 19-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not reported). The dose of the vaccine given was reported as "expired 2 years ago", according to the nurse. No adverse effect was reported. Additional information has been requested.
This case was considered medically important (OMIC). Information regarding Tetramune vaccine (diphtheria and tetanus toxoids and pertussis vaccine adsorbed and haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a consumer regarding her son, who received a dose in 1997, and experienced grand mal seizures. Relevant medical history was not provided. Indication for Tetramune Vaccine was immunization. Product was administered in 1997. Dose regimen  was 1 dose. Additional vaccine administered on an unspecified date included Orimune vaccine (Poliovirus vaccine live oral trivalent solution). Concomitant medications were not reported. A consumer, the mother of a male child reported that her son received a dose of Tetramune in 1997 (date unspecified) and subsequently experienced "grand mal seizures". Additionally, the child received Orimune vaccine on an unspecified date and year. As of 06/23/04, the mother stated "the seizures were unresolved". No additional information was available at the time of this report.
Feels like she's going to pass out Pt. passed out then placed in wheelchair Pt.taken to ER via ambulance BP=89/43  Pulse= 82  Po2 =97%  FS=149 Recorded by: RN    and EMT
Very bad pain at injection site day of vaccine. Could hardly move arm. Day 2 redness started with swelling and fever spike up to 103. Controlled with TYLENOL, MOTRIN and BENADRYL. Feeling better by day 4.
dry mouth; joint pain; headaches; chills; very painful at the shot site; This spontaneous case was reported by an other and describes the occurrence of DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site). At the time of the report, DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Tenderness and swelling of the lymph node in left armpit. Same arm the vaccine was injected into.  There is also soreness at the injection site. Fatigue similar to when I had Covid in January 2021
10/23/22 parents noticed blistering at the site of injection.  Parents had left the bandaid on and thought maybe it was from the adhesive, but the blisters were only at the site, not extending out.  Parents were instructed to keep bandaids off and wash the area and keep it dry.  As of 10/25/22 blisters were beginning to diminish.  No treatment was necessary.
difficult in breathing, dizzy, shaky;pt went to ER dx was possible adverse reaction to rabies vaccine;MD recommended pt take DPH now & before 3rd dose of vax;
Redness on R deltoid 2" x 1 1/4" slightly raised.
This spontaneous report was received from a nurse, concerning a 71 year old female patient. The patient did not have any medical history or concurrent conditions to report. The patient's concomitant medications included supplements. On 11-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis, lot #N034525 and expiration date 13-SEP-2019 (strength, dose, frequency and route of administration were not reported). On the same date, after the patient was vaccinated, she had fever, chills, body aches, and injection site redness and tenderness. The patient was treated with cool compresses, ibuprofen and bedtime BENADRYL. At the time of reporting, the patient was better with no fever. The causal relationship between the vaccination with PNEUMOVAX 23 and the events was not provided by the reporting nurse.