chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. On 21-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 504 hours, the lowest recorded temperature was 20 degrees F. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
pt recvd vax 3NOV93 & w/in 24 hrs devel pain in the arm & shoulder on the side of inject; also had severe lumbar/sacral pain, unrelieved by Advil or APAP, neck pain, joint pain, myalgia, a dull h/a & tiredness; 36 hrs later had a t102;
Pain in left shoulder/arm EVERY time I reach, stretch or twist my arm in certain motions, especially stretching. It does not hinder me from daily activities, but each time it causes wincing pain for 30 seconds to a minute. Pain started the day after first dose on 03/10/21, continued up through second dose on 3/31/21 and beyond. Still hurts today, 05/24/21, mostly in upper left arm, but also radiates down  lower arm.
No pain during the first day but onset of red, swollen hard, hot, painful lump that increase in size to a baseball sized lump over the next day, this lasted for about 5 days before it appeared to go away then 7 days from the vaccination a round, hard, tender, itchy, hot, swollen area appeared in the same place and lasted another 3 days, about 4 inches across.
p/ pt recv vax in 8/96 & in 7/98 pt lab tests revealed negative varicella antibody titers. pt has been taking fexofenadine (allegra) since 5/1/98.
pt recvd vax;was screaming x 3 hrs inconsolable; did cont over next 2-3 days; t 103-104; given acetaminophen;
On 1/22/2021 I noticed some red elevated bumps on my right hand.  They were itchy.  Over the weekend the rash spread to other areas including my back and elbow.  A few spots were also seen on my face.
The vaccine was given past it's refrigeration expiration date, the date on the vial was still within date. Antibody testing completed.
Jynneos was administered intramuscularly; Case reference number US-BN-2022-001863 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (fourth out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from Bavarian Nordic on 15-Aug-2022, included local BN case ID.  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001861, US-BN-2022-001862, US-BN-2022-001864, and US-BN-2022-001865 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. No associated adverse events were reported with the reported medication error. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. No associated adverse events were reported with the reported medication error. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Left upper arm, red, hot and swollen on 8/9/05. Seen 8/10/05, less swollen but itchy. Area 7x7.5cm red. Benadryl PO and Prelone syrup if not better 8/10/05.
Patient present mild redness to back of L arm measuring from 7" L x 3.5 " W.  Top point of measurement is dark in coloration till the last 1" of measurement if red and arm to touch.  Patient states she noticed the increase of redness and swelling on Friday night into Saturday morning and she thought maybe it is because it was from graduation and everyone hugging her.  Then she states it felt better on Sunday; still with some mild redness & swelling; reports feeling better today; instructed patient to take IBU as directed and apply ice to area for 15-20 min several times a day.  F/U if no improvement by 1-2 days is recommended, sooner if symptoms worsen.  to RTC Urgent care for re-evaluation.
the problem was a bloodclot; slight swelling of right foot; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 09Mar2021 13:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and allergy to tape. Concomitant medications included levothyroxine; olmesartan; metformin; all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 15:00, the patient noticed slight swelling of right foot and on 14Mar2021, the swelling increased so the patient texted the nurse who arranged appointment. The nurse said to contact the doctor and the patient spoke with registered nurse (RN) on duty who told the patient to go to the emergency room (ER) because the symptoms indicated the problem was a blood clot. The ER doctor examined and ordered an ultrasound and the results confirmed blood clot. The patient was given a prescription for blood thinner to take for 21 days (times/day, 15mg) and was told to make an appointment with the primary doctor. The patient's doctor was on spring break and she was walked in to see another doctor who said swelling looked improved and showed her where the clots were located. The patient saw her primary doctor today and she ordered a visit with a hematologist as soon as possible (ASAP) because of concerns about possible underlying issues. The outcome of events, slight swelling of right foot and the problem was a blood clot was recovering.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
w/in 15min of vax pt began to cry inconsolably;pt gagged, wretched & spit up mucus;HR, RR, calm all were good;no fever;pt cried cont for 30min;
Trigeminal neuralgia, tired,  nerve pain, facial numbness. Doctors have not found a reason or treatment. I?ve done MRI, bloodwork, X-rays, physical, EKG, CT scans. No resolution.
After second COVID vaccine on 4/12/21, I was sick from 4/13-15. I knew of the flu-like symptoms and had those--high, fever, chills, headache and body aches, but it was worse than the flu. Including: --heart rate consistently between 100-112 BPM for more than 24 hours after vaccine, even right after waking, not returning to normal rate for two days --exhaustion and weakness that I have never experienced before
Pt received PNEUMOVAX 23 on 8/16/10 in (L) arm and FLUVIRIN in (R) arm. She came in today 8/18 & showed immunizing RPh her redness in (L) arm (on the inner side) about 1 -1 & 1/2 inch from inj. site. The redness is warm to touch, pt did not have any fever but report increased soreness the day of inj. but pain decreased now. Pt was brought to ER by RPh & was diagnosed for possible allergic rxn but MD gave doxycycline & CLARITIN for discharge meds (in case of possible cellulitis, but MD was 80% sure of allergic rxn). Pt had pneumonia shot before & no problem (in Yr 2003). RPh called pt for f/u x 48 hrs & pt's reaction was decreased & went away by CLARITIN 8/20/10.
10 minutes after receiving vaccine, patient felt nausea and a "body rush." Assisted patient to treatment room, layed down and took VS.  Patient given water to drink, discharged from clinic 15 minutes later, NAD
Right arm with rash, burning, pain, numbing sensation per patient. Topical and oral medication provided to relieve symptoms.
Had a 15 minute stint of Alice in Wonderland Syndrome.  Limbs felt extremely large, depth perception felt like room was closing in/then expanding away.  Time felt slowed and incorrect.  It lasted 15 minutes and then disappated.  I have experienced similar feelings as a child when I had a high fever.  There was no fever this time.  It only occured once, the evening of receiving the vaccine.
I broke out in hives about an hour after being vaccinated. This lasted for about 4 or 5 weeks. I had them everywhere!
Itchy rash, lips swelling, fingers and hands swelling, chest heaviness. Symptoms started 12 after vaccination and continued for 12 hours.
Admitted to hospital 11/15 with increased shortness of breath, found to be COVID ++
GARDASIL #1 11/3/10 - shortly after seen by multi. providers w/dx sinusitis, mycoplasma. Seen in Dec 10 for fatigue, myalgias, chest pain, cough. GARDASIL #2 1/17/11 Pt reported fatigue much worse again in weeks following HPV #2. Also c/o chest pain, arthralgias. Referred to rheum.
pt recv vax 11/12/97 & became preg LMP 12/20/97, EDC 9/26/98;preg was confirmed by ultrasound;10/98 pt delivered nl live female child exp jaundice;
Three to four years after vaccines, the first case / the second was / 5 months after the first/suspected Vaccination failure; First case was near my tail bone / second was / 5 months after the first; First case was near my tail bone, I could barely walk for several weeks; The second / less painful, but lingered longer; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, walking difficulty and pain. On an unknown date, the outcome of the vaccination failure, shingles, walking difficulty and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, walking difficulty and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. Three to four years after vaccines, the first case of shingles was near tail bone and the patient could barely walk for several weeks. The second case of shingles was a mere 5 months after the first, less painful, but lingered longer. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
pt recv vax 9MAY97 & 17MAY97 pt devel a fever & hives all over entire body;some welts & some were red dots;allergist had dx as hives but skin test failed to ID allergy;
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 544 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is a 97-year-old lady who lives independently with history of atrial fibrillation, coronary artery disease with remote stent, hypertension, and dyslipidemia who came to emergency room after she was feeling dizzy and passed out.  According to the emergency room report, after she passed out she woke up and was able to call EMS herself.  She complained of palpitations upon presentation to the emergency room and her heart rate was found to be in the 140s-150s range atrial fibrillation with rapid ventricular rate.  She was given Cardizem 10 mg IV push x1 but this did not work, so a drip was started. According to the patient's son, she had not been taking her medications regularly (specifically her metoprolol which she takes for atrial fibrillation) because both he and his wife have been unavailable to help her due to their own COVID-19 illness.
pt recv vax summer 1995 & exp inj site redness;this is one of ten pt from this site who exp the above rxn;
After shot, pain was abnormally high. Unable to make fist. Arm was sore. Pain went up through next. Pain in arm for 3 days. From Hep C shot, first round.
Woke up complaining of severe itching, burning at nect, hives noted. 50mg Benadryl adm by mother. Patient complaining of chills, "can't breath" wheezing, swelling of hands and wrists. Take to local emergency department. Treated and released.
Not adverse event, vaccine booster was given too early. Patient did not have any side effects. He is not immune compromised but dose on 8/23/21 then  9/13/2021 for primary series. Booster given on 12/8/2021
Partial dose administered due to syringe malfunction.  No adverse event.  Client stable.
A strange feeling with his chest; Muscle ache on his abdomen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "A strange feeling with his chest"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache on his abdomen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with abdominal pain 1/20/16 RLQ pain. Had U/S and CT which showed large cystic mass. Had diagnostic laparoscopy which showed (R) paratubal cyst and fallopian tube torsion. Had detorsion of fallopian tube and excision of cyst.
Fever 100.2 at 12:30 AM, gave Tylenol. At 6 AM fever went up to 101.1, gave Tylenol. At 10 AM fever rose to 103.7, gave Tylenol. Also dressed infant in only diaper and onesie with a cool cloth on head/neck. Very sleepy. Other side affects included stuffy nose and injection area warm to touch. Still treating infant for fever today.
Felt weak, achey, dizzy, hot, cold, chills, overall ill on evening of shot, 12/22/2021. Next morning 12/23/2021, got up around 6:30AM, and felt the same symptoms. felt very dizzy, sat down. Got up then fainted and fell on stone floor, hit back of head, major bleeding and concussion.
Pt developed increased temperature of 102F; local cellulitis approx. 2" X 2". Treated with ceftriaxone 600mg X 2 and given Augmentin X 8 days.
A rash started by armpits, went to under breasts, then stomach, then crotch, then knees. The rash seemed to travel down my body over a period of 1 day. Severe itching. Swelling with heat. Extremely uncomfortable.
9 days after receiving smallpox vaccine, patient noticed red spots on abdomen and trunk. Pt was seen by MD in the clinic on 12/11/2018. Sparse number of macular rash with raised areas on trunk, in axilla and on arms; without ulceration or exudate expression observed by provider slightly erythematous, not pruritic or expressing fluid. Pt was instructed to monitor for spread or changes in rash. Also was given strict precautions for emergent follow up. Educated patient on continued care of inoculation site.
This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX. Co-suspect products included ROTARIX, PEDIARIX, KINRIX, HAVRIX, INFANRIX, and CERVARIX. On an unknown date, the patient received BOOSTRIX at an unknown dose, ROTARIX, PEDIARIX, KINRIX, HAVRIX at an unknown dose and INFANRIX at an unknown date. On 10 August 2014, the patient received CERVARIX. On an unknown date, an unknown time after receiving BOOSTRIX, ROTARIX, PEDIARIX, KINRIX, HAVRIX, INFANRIX and CERVARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Multiple GSK vaccines were exposed to 23.5F for 340hrs between 10 August 2014 to 25 January 2015 and have been administered.
arm soreness; chills; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 11:00 (Lot number: EW1096) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 11:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "arm soreness"; CHILLS (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain in extremity, chills, fatigue.  additional information: the patient had no known allergies. other medical history none. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not receive any other medication within 2 weeks of COVID vaccination. The patient did not diagnose with covid-19 prior to the vaccination. The patient did not test for Covid post vaccination. facility type vaccine: Workplace clinic.  Follow-up attempts are completed. No further information
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "59-year-old female with past medical history of GERD, sleep disorder, depression, hypothyroid, OSA and former tobacco use.  She presents for chief complaint of shortness of breath.  Patient states she has had upper respiratory infection type symptoms for roughly 9-10 days ago she is uncertain on exact onset.  She notes shortness of breath, productive cough but is unsure of sputum quality.  She states she had fevers up to 104.8 earlier in the week.  Notes associated back pain, chest pain with coughing, headaches and myalgias.  Patient presented to the emergency department 2 days ago and was tested positive for COVID-19.  At the time she was noted to have transient hypoxia while sleeping patient opted for discharge home.  She received symptomatic management with steroids, albuterol, Toradol.  Patient statin states her shortness of breath continued to worsen.  She feels she is able to take a full breath secondary to the pain in her back.  Upon repeat presentation patient was satting 84% on room air per emergency department reporting.  Labs are notable for hypokalemia, hypo magnesemia and lymphopenia.  An x-ray was obtained showing mild patchiness, bilateral lower atelectasis and questionable effusions bilaterally.  Dimer is negative, BNP was elevated in the 200s, troponins were negative patient received steroids, p.r.n. pain medications, and was placed on oxygen.  She received electrolyte replacement has been transferred to hospital for admission."
fever around injection Site; Redness 2" around injection site; Case reference number MOD-2021-011252 is a spontaneous case report sent by a Non-Health Professional on 21-JAN-2021 00:00:00 , which refers to a Female aged 77 Years. At the time of the event the patient had Blood pressure. The following drugs are known to have been taken by the patient prior to the event: METOPROLOL and LOSARTAN.  On  09-JAN-2021, the patient received Moderna COVID-19 Vaccine  in the upper left arm  for COVID-19 vaccination. On 20-JAN-2021,  the patient developed Injection site redness and  and fever around injection Site .    The action taken for Moderna COVID-19 Vaccine was  Unknown on.The Non-Health Professional did not declare any relatedness between Redness 2 injection site and Moderna COVID-19 Vaccine.   The outcome of the event(s) was unknownot reported.
Grandmother reports runny nose, hoarseness, fever the same night as vaccinations (5/5/08). Had otitis media also. She reports "welts" on bilat LE and face 1 wk later. Taken to doctor for follow up on 5/16/08 - no "welts" noted by MD, but otitis media remained - antibiotic changed. Report from patient's grandmother/guardian.
Moderna COVID-19 Vaccine EUA.  Upper arm sore and Flu like symptoms for 3 days PLUS pain under arm for 5 days. All symptoms gone on day 6
Vaccine given at 12pm on Friday 3/12. 8 hrs after vaccine shot on 3/12 i experienced chills, aches, weak, fever of 100.5 with slightly increased resting heartrate of 107.  By next morning 3/13 my fever gone but still had  aches , sore arm,, headache, and extremely tired and dizzy.. Low grade fever returned that following afternoon 3/13 but subsiding by next morning 3/14 with a slight dizzy feeling and feeling sore and tired on Sunday.
Information has been received from a physician concerning a 6 day old male patient who on an unspecified date was vaccinated with a dose of ROTATEQ. No adverse effect was reported. At the time of the report, the patient's outcome was unknown. Additional information has been requested.