chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came into the pharmacy approximately 48 hours after receiving her vaccinations and reported pain, redness, swelling, and some warmth at the injection site of the Moderna Bivalent COVID-19 Booster.   I asked the patient if I could take a look at her arm and she complied.  There is not appear to be redness but there was some swelling to the area.  The patient stated that the soreness in the arm was what she expected but she did not anticipate the swelling, warmness, and redness at the injection site. She stated the pain started around bedtime the day of the vaccination, but the other symptoms started the morning after the injection. She also stated that the pain, redness, and warmth had gone away today (11/11/2022), but the swelling seemed to be worse in the morning. She did not report any limited range of motion.  I told the patient that she could keep an eye on the symptoms over the weekend but if anything got worse to contact her physician.
No adverse events reported. VAERS being filled out since patient previously received Janssen COVID vaccine on 3/22/21 (confirmed with pharmacy provider), and patient received this first Pfizer COVID vaccine outside of ACIP recommendation. Patient had indicated on her vaccine consent form and verbally that she had not previously received a COVID vaccine.
Case number PHEH2013US021669 is an initial spontaneous report from nurse received on 16 OCT 2013, with a follow-up received on 11 NOV 2013. This case refers to a 55-year-old female patient. She received FLUVIRIN 2013/2014 (batch number: 13395P) at a dose of 0.5 ml intramuscularly into left deltoid on 16 OCT 2013. The nurse stated that patient received FLUVIRIN from pre filled syringes that had temperature excursion of 54 F for 8 hours (refrigerator had been out of range). No adverse event was reported following medication error. The seriousness and causality of event was not reported.  Follow-up received was received on 11 NOV 2013: Batch number, vaccination site, other clinical information and information that patient had no adverse event was updated.
Developed lesions on left arm (mid upper arm to wrist). Initally blistered, fluid filled followed by scabbing followed by absence of scabs leaving pale brown-pink to pink flat lesions on skin. Was seen in ED on 4/17/2012.
Diarrhea since 03/06/2021.   Pain-sensitivity-TMJ/lockjaw type symptoms in the right side of face from temple & ear-cheek-jaw, down to right side of neck. Area that's worse is upper right jaw, aligned with ear & running down & underneath jaw bone. Entire right side face feels swollen and jaw is tightening up.
Five minutes after injection, felt nauseated, face went cold and tingly, started rapid breathing, blood pressure elevated, felt very parched, hands tingly, thought I was going to pass out.  This happened with the first Covid vaccine shot as well, so I lied down immediately after this shot, but it didn't help.  I've never had this reaction to any other vaccine.  Symptoms improved after 10-15 minutes, but I had to move very slowly.  Felt very parched the rest of the evening and now as well (the next day).  Had hallucinations of bright lights in my right peripheral vision that evening (which I've never had).
sick; arm feels tender due to flu shot; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and pain in arm. On an unknown date, the outcome of the sickness and pain in arm were unknown.   It was unknown if the reporter considered the sickness and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine and was sick and arm feels tender.
Heavy vaginal bleeding with clots, cramping in uterus and tenderness in this area prior to onset of bleeding. Vaginal bleeding lasted for 6 days.  Please note that this was not like a regular menstrual period and I was not due for my period. I also bled after my first Pfizer vaccine but it was not alarmingly heavy like it was after this second dose. I was fatigued during the bleeding and after. The fatigue was resolved two weeks after I received the vaccine. One other strange side effect was that three days after I received the second vaccine my left hand was slow to respond when I needed to type on the computer. This lasted for several days.
no adverse event; expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    Patient's age was reported 60 years 3 months.  No concomitant medications were reported.  The reporter informed that, the expired Moderna vaccine was administered to the patient between 08-Apr-2022 to 15-Dec-2022.  No treatment medications were reported.
HA with light sensitivity and body aches since yesterday after getting J&J vaccine yesterday; Denies taking any meds; denies any noise sensitivity or any vision changes at this time. CC: headache and malaise  HPI: 24-year-old active-duty male received Johnson & Johnson COVID vaccine yesterday and is having headache and generalized malaise today.  He has no focal subjective neurologic deficits, headache is not first/worst/maximum at onset.  He has no fever no other complaints.
Pt. became lethargic with loss of appetite followed by a full body rash on 04/14/22.  Rash first appeared on the chest.  Fever of 103 and cough onset on 04/16/22.  Fever resolved after one day.  Pt.was seen first by an urgent care clinic and diagnosed with fifth's disease and put on steroid medication.  Pt. was seen again in the emergency room and reported to local public health for concern for suspect measles.  Testing was done on 4/22/22 in order to rule out wild type measles virus.  Pt. tested positive for vaccine virus strain.
Child developed fever 100.x when mom called in on 18th after vaccinations given.At this time child was almost recovered from an episode of bronchiolitis with otitis media and pharyngitis diagnosed on 01/03/2007. Still taking albuterol and pulmicort nebs, tylenol and dimetapp as he had developed a new cold. Upon exam it was noted that the ear infection was not completely resolved and child had a cough. Did not appear ill and was in good spirits. Received a call from mom on 01/19/2007 that the child had had a tonic clonic seizure and had been transported to ER where a full sepsis workup was performed. Child was being referred to hospital for admission and observation. Current status is not exactly known yet.  2/5/07 Received medical records from 2nd hospital which reveal patient experienced apparent life threatening event & possible onset seizure disorder vs GERD.  Neuro & GI consults obtained.  Temp in ER was 101.5.  Neuro felt was febrile seizure vx s/p vax provoked seizure. FINAL DX: Apparent life threatening evelt; febrile seizure vs s/p vax provoked seizure.
Joint pain, both ankles experience pain. I could walk but pain increased the longer I walked / ran.  I still have pain in my left ankle. The pain level is lower than it was months ago but it's still there and I've never had this issue before the vaccination.  I'm still able to do activities but later in the day my left ankle will experience soreness and at times, clicking.
This case was reported by a physician via sales rep and described the occurrence of stiff neck in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced stiff neck and tiredness. On an unknown date, the outcome of the stiff neck and tiredness were unknown. It was unknown if the reporter considered the stiff neck and tiredness to be related to BEXSERO. Additional details were provided as follows: The age at the vaccination was not reported. The reporter stated that the patient told that he was tired and also complained about a stiff neck.
Received Pfizer vaccines on 1/4, 1/27, 8/26/21 Tested positive for COVID by PCR on 12/14/21 Hospitalized at a local Hospital from 12/13-12/17/21 d/t lumbar vertebra fracture, underlying lung cancer. Per dismissal summary: After admission she unfortunately tested positive for COVID. She had a goals of care conversation with her primary oncologist and family. They agreed to pursue home hospice. In line with those wishes, she underwent palliative radiation to her back, thoracentesis to relieve a known pleural effusion and monoclonal antibodies for her COVID
This case was reported by a consumer via call center representative and described the occurrence of tingling in a male patient who received SHINGRIX for prophylaxis. On 5th April 2018, the patient received the 2nd dose of SHINGRIX. In February 2018, less than a year after receiving SHINGRIX, the patient experienced tingling, rash, welts and pruritus. The patient was treated with SHINGRIX and BENADRYL. On an unknown date, the outcome of the tingling, rash, welts and pruritus were recovering/resolving. It was unknown if the reporter considered the tingling, rash, welts and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received both doses of the SHINGRIX and after 1st dose the patient experienced some side effects including tingling neck, bumps, spots or welts on her upper arms and back and tremendous itching. The patient had the same side effects and she had a concern that her symptoms from the SHINGRIX. The patient husband took BENADRYL and his symptoms are improving but he still has a slightly itchy feeling. He experienced was only above the waist and it was related to an area that follows a nerve. This case linked with US2019GSK032767, reported by same reporter for the different patient (wife's case).
Chills, headache, fatigue, loss of appetite, muscle aches Rest, Tylenol,fluids Fine the next day
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive; Negative, notes: negative antigen test on days 10 & 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid on day 2, symptom free on day 6, negative antigen test on days 10 & 11, and was symptom free through day 13. On day 14, I felt fatigued with nasal congestion and had a positive antigen test. My symptoms which continued for about another week were worse than my symptoms during days 1-6. Anti-viral details include, Product- COVID 19 Treatment, Treatment start date- 03May2022, Treatment start date- 08May2022. Indication- Treatment of COVID-19.
Pt admitted to medical facility 8-17-21 with fever, HTN, local shot site reaction, chest pain, and vomiting; elevated liver enymes, troponins, and D-dimer.  Dx: covid vax related myocarditis in obese, anxious teen with liver disease.  Treated with steroids, IVIG, clonidine, zofran, and benadryl.  Four normal EKGs, Echo with ejection fraction 64%, BP stablized, patient improved, discharged home 8-20-21.
Extreme fatigue; chills; sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 09:45 (Lot number: 3248) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "pacemaker" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CARVEDILOL. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer BioNTech,, lot number=EL3248,, lot unknown=False,, administration date=02Mar2021,, administration time=09:45 AM,, vaccine location=Left arm,, dose number=1), administration date: 02Mar2021, when the patient was 71 years old, for Covid-19 immunisation.  The following information was reported: FATIGUE (non-serious) with onset 23Mar2021 19:00, outcome "recovered" (24Mar2021), described as "Extreme fatigue"; CHILLS (non-serious) with onset 23Mar2021 19:00, outcome "recovered" (24Mar2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 23Mar2021 19:00, outcome "recovered" (24Mar2021), described as "sweats". Therapeutic measures were not taken as a result of fatigue, chills, hyperhidrosis.  Additional information: The patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. It was reported that side effects from the vaccine started the day of the second vaccination: 23Mar2021 and lasted about 24 hours.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax & 1 day later tested HBSAG pos;
Local reaction, no secondary infection. Provider ibuprofen for inflammation and warm compresses to affected area.
general malaise  achy joints and muscles also tested positive for COVID-19 on 03-10-2021
No additional AE reported.; Caller reports that a dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured.; This spontaneous report has been received from a medical assitant, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 01-JUN-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml), subcutaneous injection (valid lot number U029496 [expiration date 21-SEP-2023]) for prophylaxis, after a temperature excursion of 7.7 degrees Fahrenheits (F) for 30 minutes (product storage error) (vaccination scheme, and frequency were not provided). Additionally, a previous temperature excursion was reported.  No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007717: US-009507513-2206USA007710: US-009507513-2206USA007693: US-009507513-2206USA007675: US-009507513-2206USA007547: US-009507513-2206USA007910: US-009507513-2206USA007894: US-009507513-2206USA007855: US-009507513-2206USA007845: US-009507513-2206USA007706: US-009507513-2206USA007527:
The following is the abstract from the article: A 32-year-old man with recurrent idiopathic pericarditis was admitted with persistent hypotension. Workup revealed elevated ACTH, low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. Maintenance hydrocortisone, 20 mg in the morning and 5 mg at night, as well as fludrocortisone 0.05 mg daily, were started. He was counseled on the use of emergency dexamethasone injection pens. One month after discharge, he had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. This case involves a 32-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Lot number, expiry date, route and site of administration were not reported), also received DIPHTHERIA AND TETANUS TOXOIDS and PNEUMOCOCCAL VACCINE (Lot number, expiry date, route and site of administration were not reported), on an unknown date. The patient had a medical history of autoimmune Addison disease. Concomitant medications included 20 mg of hydrocortisone in the morning and 5 mg at night and 0.05 mg fludrocortisone daily. On an unknown date, 6 hours following the vaccination, the patient experienced fever, myalgias, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 Celsius and hypotension of 88/54, with hyponatraemia and hyperkalaemia, that resulted in adrenal crisis and the existing disorder aggravated. Upon admission to the intensive care unit for adrenal crisis, the patient received 4 L of normal saline and stress-dose IV hydrocortisone for 24 h. Patient was discharged on his home steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient's laboratory data included renin level of 3.0 ng/ml/h. The patient was treated with 4 L of normal saline and stress-dose iv hydrocortisone for 24 h for adrenal crisis. It was reported that, the patient's gastrointestinal symptoms, Abdominal pain, Vomiting, hypotension of 88/54, hyponatraemia, hyperkalaemia, quickly resolved after steroid administration and his sodium and potassium normalized. The outcome of adrenal crisis, myalgia, aggravation of existing disorder and fever of 39.5 Celsius was unknown. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient with pre-existing adrenal insufficiency disease who developed an aggravation of his disorder after vaccination with Influenza, Tdap and Pneumococcal vaccines. The time to onset is compatible with the role of vaccines. However, the disease aggravation is clinically judged to be due to a stressful situation (simultaneous vaccination), concurrent stoppage of steroid therapy temporarily or a possible co-incidental infection. Based upon the reported information, the direct role of the vaccine components is unlikely.
Presented on the afternoon of the day of the shots with a hive reaction and vomiting.  Child received phenergan suppositories and did well.
Patient complained of worsening left lateral shoulder pain after receiving it the same day on 6/14/18 after 5pm. He states the pain continued to worsen. He was seen over time by different doctors regarding shoulder pain. He was seen on 6/26/18 by a primary care doctor, then went to urgent care on 6/28/18 and 7/2/18, he saw an ortho doctor on another day and received a steroid injection, which temporarily help with the pain, then he followed up with his PCP on 7/17/18. Patient given TORADOL injection, steroid injection, and NORCO as needed. He has had X-rays done, which came back normal. He is currently awaiting to complete an MRI.
pt was vaxed w/1st dose of HIB vax on 5AUG92 &  prior vax on 3AUG92 included Hep B vax; approx 2 hrs following vax 5AUG92 pt devel hivees primarily on trunk & legs;
Case number PHEH2015US003408, is an initial spontaneous report received from the nurse on 16 Feb 2015. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with partial dose of Men A component of MENVEO (batch number: M14089) reconstituted with sterile water intramuscularly on 12 Feb 2015. No adverse events reported after the maladministration (wrong solution used in drug reconstitution).
Headache, Myalgia, Fever,  mild pain and myalgia with first dose 48 hrs, injection site pain, headache, myalgia, low grade fever , shills fatigue for 72 hrs with second dose  Narrative:
Pt vax 3 doses; exp enlarged spleen.  Recommended that spleen be removed.
two Pfizer and two Moderna COVID-19 vaccine; she has been diagnosed with Covid-19; she has been diagnosed with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient reported vaccine lot numbers (039TC20A and the second vaccination number as 006M20A) but she was not sure if it belongs to Pfizer COVID-19 Vaccine or the Moderna COVID-19 Vaccine. The patient's relevant medical history included: "Colds" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for osteoporosis. Past drug history included: Vicks nyquil for colds. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "two Pfizer and two Moderna COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has been diagnosed with Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant concerning a patient of unknown gender who was currently 1 year old. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was not reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA 25/0.5, lot # N020689, expiry date: 22-OCT-2018 intramuscularly for prophylaxis (dosing details, anatomical location was not reported) (product storage error). The vaccine underwent temperature excursion of 10.47 degree Celsius for the time frame of 4 hours. There was no previous temperature excursion reported. Data logger involved. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA008623:
Information has been received from the mother of a 17 year old female with no known drug allergies and no pertinent medical history, who in February 2008 was vaccinated with the second dose of GARDASIL (lot # not provided), 0.5 mL intramuscularly.  There was no concomitant therapy.  The mother reported that on 14-JUL-2008, her daughter fainted and convulsed after receiving GARDASIL.  The patient sought unspecified medical attention.  No lab diagnostics studies were performed.  The patient recovered on 14-JUL-2008.  Upon internal review, convulsions was considered to be an other important medical event.  No further information is available as the mother declined to give her physician's information.