chrisvoncsefalvay/vaers-outcomes huggingface dataset:
REDNESS - 3";  RAISED - 1 1/4". COOL COMPRESS APPLIED. REDDENED AND RAISED AREA BECAME SMALLER AND MORE LOCALIZED. CLIENT JUMPED DURING MMR INJECTION.
Swelling and redness of left thigh around site of vaccine injection with 24 hours from injection.
Fever of 101 -102, body aches, and fatique x 4 days.
Fever or Chills  Muscle or body aches Headache  Congestion or running nose
Hepislav-B, approved for people 18 years and older, was given incorrectly to a 13 year old. no adverse reaction was noted, and clinic will be looking into systems level changes to prevent future vaccination errors like this. Client has been informed.
12 hours after fever, chills, headache. Next day very tired and couldn't get out of bed and vomiting.  4 days later got very red arm on sane side as vaccination "Covid Arm". It went away in 3 days
dizziness; soreness in Left arm,muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and MYALGIA (soreness in Left arm,muscle pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced DIZZINESS (dizziness) and MYALGIA (soreness in Left arm,muscle pain). At the time of the report, DIZZINESS (dizziness) and MYALGIA (soreness in Left arm,muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter. No treatment medication provided by reporter.
unable to get the second dose due to the pandemic; feeling a little off; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the malaise and social problem were recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received 1st dose on an unknown arm. The reporter stated that, after 1st dose felt a little off, that way the day received the vaccine but it quickly went away the next day. The reporter stated that, the patient did not receive dose 2 due to the pandemic, which led to social problem. The reporter consented to follow up.
Patient received second dose of GARDASIL-9 44 days after the first dose.; This spontaneous report was received from a registered pharmacist and refers to a female patient of an unknown age. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 10-JUL-2020 (reported as 44 days ago), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot#, expiration date, route and site of administration were not provided) for prophylaxis. On 23-AUG-2020, she received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, once (lot#, expiration date, route and site of administration were not provided) for prophylaxis.  On that day, the patient received second of the vaccine, 44 days after the first dose, rather than the recommended 2 months.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/8/2022 ASCITES
Admitted 9/27 due to multi-focal pneumonia, +COVID, No supplemental oxygen needed . Treated for bacterial superimposed infection with omnicef and azythromycin. Requested discharge home on 9/28. Returned to hospital ED on 10/1 with worsening Shortness of breath, O2 saturation 75% on room air and altered mental status. O2 given with saturation up to 95%. Respiratory status continued to decline and intubated on 10/3. Treated for candida with eraxis x 7 days. Due to hx of staph epi bacteremia, porta cath and dialysis tunnel catheter removed 10/5. Pt. in septic shock due to pneumonia. on CRRT due to renal failure. Developed pneumothorax and pneumomediastinum with subsequent chest tube placement x 2. Bronchoscopy on 10/9 due to elevated peak airway pressures. Failed ventilator weaning. Required pressors for each dialysis session. Discussion with family for trach and peg tube placement. Family requested comfort care on 10/14.
Sore throat, fever, ears clogged, general malaise; to continue w/ASA, fluids, rest-sx not severe enough to require office visit;
Swollen Left Armpit, lasting 2 days.  Starting to subside on third day.
pt recv vax & that evening pt devel an inj site rxn characterized by redness & hardness;the rxn has improved;this is one of ten patients from the site who exp above rxn p/vax;
Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "Sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Patient got one and two [Pfizer COVID vaccinations] but was not going to pollute her body with any more boosters. One and two let the flu get her sick. It's best to rely on the immune system.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-PV202200125797 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
2 weeks ago she tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry: not reported), via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunisation (at the age of 60 years). The patient medical history and concomitant medications were not reported. She was scheduled to receive her second dose tomorrow (15Apr2021). However, on an unspecified date in 2021 (2 weeks ago) she tested positive for Covid with las test SARS-COV-2 test, and on 10Apr2021 (last Saturday) was still positive with lab test SARS-COV-2 test. She no longer had symptoms and had finished her quarantine. The concern was if she can receive her second dose of vaccine tomorrow. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 03/10/2021. Presented to ED 1/23/22 w/Covid sxs. Admitted 1/24/22 w/acute hypoxic respiratory failure secondary to COVID-19 PNA, UTI, and AKI of neurogenic bladder. He had been progressively worsening without any improvement. Pt had worsening confusion and increasing shortness of breath, desaturating to 70s% while talking despite being on high flow O2. Transitioned to comfort care.  Tx'd with decadron, ceftriaxone, rocephin. Expired 02/08/22.
folliculitis; follicular acne; sniffly/runny nose; sniffly/runny nose; slightly congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing), notes: individual has a heart condition that I believe is associated with Marfan's; "Marfan syndrome" (unspecified if ongoing), notes: individual has a heart condition that I believe is associated with Marfan's. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 Immunization. The following information was reported: FOLLICULITIS (non-serious), outcome "unknown", described as "folliculitis"; ACNE (non-serious), outcome "unknown", described as "follicular acne"; RHINORRHOEA (non-serious), RHINORRHOEA (non-serious) all with onset 04Feb2022, outcome "unknown" and all described as "sniffly/runny nose"; NASAL CONGESTION (non-serious) with onset 04Feb2022, outcome "recovered" (Feb2022), described as "slightly congestion".  Additional information: Patient developed a sniffly/runny nose in the afternoon. Patient had folliculitis or follicular acne or something like these previously.  Follow-up attempts completed. No further information is expected.
fever, chills, hallucinations, severe shaking, severe diarrhea, abdominal pain and rectal bleeding.   I was hospitalized in April for the side effects. it destroyed my colon and increased my inflammation. my immune system went completely haywire.
Patient called pharmacy on 10/12 to report ongoing headache that started the morning of 10/8, on the left side of her head and stated that is has not subsided since. She stated taking TYLENOL helps a little, but the headache comes back. Patient states she received the flu shot in her left arm and has had a headache ever since and the flu shot definitely caused her headache. I advised her to please follow up with her primary care physician and that I would report this as an adverse event
POST VACCINATION- IN OBSERVATION AREA--- APPROXIMATELY 10 MIN LATER- FELL OUT OF CHAIR LANDING PRONE BESIDE CHAIR.  UNCONSCIOUS 1-2 MINUTES.  INCONTINENT OF URINE.  DISORIENTED TO TIME.  ASKED" HAVE I RECEIVED MY VACCINATION YET?"  STATES HAS HISTORY OF "PASSING OUT FOLLOWING MEDICAL PROCEDURES"  BUT DENIED SEIZURE DISORDER.  EMS ATTENDED WITH TRANSPORT TO HOSPITAL FOR ASSESSMENT.
mom states on 17DEC95 pt had t103 high & down to 100-hallucinations-screaming on 17DEC95 & 18DEC95 AM;pt seen in clinic pt had 98.9 temp & state of mind was nl-no hallucinations noted;
Diarrhea; Nausea; Fatigue; Swollen Neck Glands; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen Neck Glands) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen Neck Glands) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen Neck Glands) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Febrile seizure x3, no medications given, patient admitted to PICU for observation
Heart palpitations,. Irregular heartbeat. Shortness of breath. Dizziness. Tightness in chest
Swelling, erythema bi-lateral feet and ankles resulting in pitting edema and veinous stasis
Lightheaded, Nausea, Seen by onsite EMT,BP: 127/82 , Pulse: 76, 02: 98ed, Patient discharged at 9:45 am to home. Recorded by EMT.
Woke up with chills, fever of 100.8, moderate headache, and body aches. I took 1000 mg of Tylenol which brought the fever down to 98.2, however, headache and body ache remained. I took Tylenol in 1000 mg doses around the clock every six hours for 24 hours, and 24 hours later felt no more symptoms.
Swollen, painful lymph nodes under both arms. Worse in right arm (injection arm), but still painful and swollen under both arms. Sore lymph nodes on right side of neck. Body aches all over
Abdomen pain; Headache; Tiredness; Drowsy; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 13 year old non pregnant female patient received the first dose of bnt162b2 (BNT162B2) intramuscular on 22May2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if was the patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced abdomen pain, headache, tiredness and drowsiness on 22May2021 few hours after vaccine shot. The patient did not receive any treatment for the events. The clinical outcome for the events was recovered.  Upon Follow-up (24May2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: that the adverse events were not directly reported by them.  No follow-up attempts are possible. No further information is expected.
Fever Fatigue Narrative:  Fever 100.7  Other Relevant History:
My daughter had welts and hives from head to toe, front and back.  Some difficulty breathing and a low grade fever and swollen eyes.  She was taken to the emergency room at 10pm and given vistarel and decadron IM.  She took the flu shot at about 10:00 am.  I picked her up from the daycare at 5pm and she was itching.  I noticed the welts at 6pm when I changed her diaper and placed some benadryl cream on her and gave her some tylenol.  Then at 10pm everything became worst.
Information has been received from a certified medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#649914/0578P).  Subsequently, the patient developed a reaction at the injection site with redness with discoloration, swelling, hardness, and pain.  The patient's outcome was not reported.  No product quality was involved.  Additional information has been requested.
No other adverse events reported.; Caller reports that a patient was administered an expired MMR II; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 26-AUG-2022 (also reported as today), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), lot number: T018635, expiration date: 29-MAY-2022 (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The reporter confirmed that the dose was properly stored up through the time of administration. No other adverse events were reported (no adverse event).
This case was reported by a healthcare professional and described the occurrence of burning in a male subject of unspecified age who was vaccinated with TWINRIX, manufacturer unspecified. On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified amount of time following injection tingling. The burning and tingling worked it's way down the arm. The reporter stated that the events only last 2 to 5 minutes and then seem to be fine. Resolution was not specifically stated. The reporter felt that this was not occurring say 6 months ago. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases include A0732540A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A73252BA, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
PATIENT/EMPLOYEE TESTED POSITIVE TO COVID ON 7/20/21 AND 7/25/21
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, numerous patients have reported soreness at the injection site which resolved after a couple of days. This case has been linked to the case US2018140164, reported by the same reporter.
Joint and muscle pain, feeling unwell, nausea, weakness, dizziness, shaky, fast heartbeat, tiredness, headache. chills, injection site pain and swelling
Injection site tenderness started about 6 after injection. 24 hours later feeling tired, fatigued, soreness in arm increased, decreased appetite, feeling cold. 1900 fever of 100.4, nauseated, weak, achy, light headed, bounding heart rate. Temp started to decrease 1 hour after Tylenol.Temp was 98.6 at 2200. Nausea improved after Zofran.  Day 2 after injection- no fever. Still feeling queezy, decreased appetite and weak. Not able to do daily exercise. Not chilling or feeling aches. Right arm - injection site has swelling, flat red linear patches. Tenderness improving. I did have some of these sx with first dose, but this was more severe. Hope this helps.
Pt presented in office a couple of weeks after injection of PROQUAD with a large bump and redness and irritation at the sight of the injection.
After expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (After expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (After expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.
Excruciating all over body nerve pain from 3:00am to 8:00Pm the following day. Not effected by medications- Tylenol and ibuprofen. I visited a walk in clinic as I was unable to lay down, sit, stand or walk as the pain was so excruciating. The ER would have been my first choice but unsafe due to COVID. I was given an injection of Torodal without effect. They recommended ibuprofen which I explained was ineffective. I called my physician who also recommended Ibuprofen. The pain was unbearable.
COVID 3 TIMES; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid 3 times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 3 times was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000261983. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this report states the patient was vaccinated and had covid. There was no product quality issue described in the report and there was insufficient information to determine vaccination failure as there was no timeline for date of vaccination to contracting covid and no confirmatory test or symptoms reported) based on the PQC evaluation/investigation performed.
Within 1-2 minutes of receiving Tdap vaccine and a blood draw, patient had a vasovagal reaction lasting about 30 seconds.  Came out of it and talked for a couple of minutes and then said that he did not feel well and had another vasovagal reactions lasting 1 minute.  Was diaphoretic.  States B/P and pulse are normally low.  Was 78/42 and pulse was 48.  Got him into reclining position and had him drink 2 liters of fluid.  Watched him for 30 minutes.  No injuries.  B/P was 86/64 with pulse 56 on discharge.
Firm Swelling and redness at injection site with itching just noticed on 2/26/21.
Client received flu vaccine at 12:47 PM. Patient stated she was feeling s/e from injection that was raised and hot.  Patient, arrived for assessment at 2:00 PM, left arm red and swollen at injection site. Vital Signs stable, no signs and symptoms of sever reaction. Local reaction only.  Client advised to contact primary care physician for follow up.
Received Flumist and 12 minutes later c/o facial flushing, red, throat felt strange. Rec'd Epipen and diphenhydramine
This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a child male patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 305 days after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to dTpa vaccine. Additional details were provided as follows: The reporting physician stated that, her son received Tdap vaccine at 10 years of age. Ten months after receiving Tdap vaccine, the patient experienced pertussis. There was an outbreak at the patient's school and 1 out of 3 of the children were impacted. This case was considered as suspected vaccination failure since the completion status of primary immunization schedule and laboratory confirmation for the disease were unknown. The reporter did not agree to be followed up.
She got the vaccine, and had no effect, woke up on 3/27/21 with a huge rash on her chest, terribly itchy and red.   It spreads across the whole chest and towards her neck.  She put calamine lotion all over it, was using ice packs, and then went to the drug store over the weekend, and they gave her 1% Hydrocortisone cream which did not work.  Then on Monday she called her dermatologist and was seen by her and she said that it was an allergic reaction to something, and she prescribed Hyroxyzine HCI 10 mg, Atarax., Avene spring water to use after showering and Xera lotion .  Was also given Triamcinolone .1% to use for 2 weeks.  After using this it has become much better.