chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 103. Hives. Adverse event started: fever-after injections, hives-2 days after immunization. This 7 month old male presents to Clinic today for an ER follow-up. He is brought today by the patient's mother. Current medication allergies include No Known Drug Allergies. The historian denies travel outside of the country during the past four weeks. Aside from the patient's current illness, since his last visit, has had an emergency room/Urgent Care visit. He was seen in the emergency room 2 days ago for an ear infection. Records of the visit will be reviewed. He was seen in the ER and diagnosed with fever. ER notes are available for review. The patient had a maximum temperature of 103-104 F, several days ago and lasted until now. Other than the temperature as noted, the patient's symptoms include the following: fussiness, diarrhea, a rash, and restless at night. He has had several episodes of diarrhea in the past 1 day. The rash involves the generalized and developed 3 days ago. Symptoms denied: pulling at the ears, nasal congestion, nasal discharge, coughing, hair changes, enlarged lymph nodes, and new medication allergies.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On an unknown date the patient experienced an adverse event (no further details provided). The outcome of adverse event was not reported. Causality assessment was not provided. Additional information has been requested.
New swelling at site of injection, started with discomfort and then visible swelling was noticed.
48 yo female with PMHx Churg-Strauss and allergy to rituximab, now with vaccine reaction.  Pt with remote h/o rituximab reaction p/w throat swelling, itching, wheezing.  Infusion d/c'ed and pt given medication.  Since then, has been treated with nucala w/o issue.   Has h/o multiple food reactions, suspected sulfite sensitivity.  Pt was seen by her allergist, who cleared her for the COVID vaccine as she tolerates nucala (which has polysorbate 80 as well).   Today, pt was given the Pfizer vaccine at 5:30 PM, and within 15 minutes felt LH and vague throat discomfort.  Denies throat closing or itching.   +LH but does not feel like she will pass out.  No vertigo.     No face/tongue/lip swelling/itching, stridor, wheezing, SOB. No CP, palp, diaphoresis, N/V, abd pain, diarrhea. Pt given benadryl 50 at 6:05 PM with some mild improvement.   Pt also on chronic daily steroids, which she took this AM.      VS: T 98.2, HR 80s, R 16, BP 150s/90s, SaO2 99% RA.  Gen: WDWN HEENT: NCAT, sclera anicteric and w/o injection, MMM, OP clear.   Neck: supple, good ROM CV: RRR, S1, S2. No m/r/g Pulm: CTAB.  No wheezes or crackles.  No stridor Abd: S, NT, ND. NABS.  No rebound or guarding Extr: no c/c/e Skin: no rashes Neuro: A&Ox3.  No focal deficits   A/P: 48 yo female with PMHx Churg-Strauss and allergy to rituximab, now with vaccine reaction, p/w vague throat discomfort and LH. No e/o anaphylaxis, however as sxs persist despite benadryl (and pt on baseline steroids), feel that pt warrants prolonged observation that cannot be done in clinic.  Monitor for s/sx anaphylaxis, epipen if develops. EMS called and pt transported to the ED. While in ER, pt given dex IM, monitored for a few hours and discharged with instructions to f/u with her allergist.
My arm was so sore the night of the shot that I had to drag my left arm with my right hand to reposition it. I also had my right pointing finger lock up a couple of times in the curled position, which has never happened to me before. Was scary. Right now my shoulder is hurting and it seems to get worse, especially at night. During the day it only hurts when I move it a certain way.
Previous medical history of regular menses and 2 pregnancies. No fibroids. 13 years with IUD without problems. Within 7 days after 2nd vaccine profuse menstrual bleeding and large clots leading to ejecting IUD. Replaced IUD (standard to help with heavy bleeding), but ejected that IUD. Had D&C and bleeding stopped for a few weeks then started bleeding heavily again (meaning having to change an overnight pad every 30 minutes to 1 hour) leading to only solution of hysterectomy.  Hysterectomy lead to an open incision and extended healing.
Information has been received from a 68 year old male consumer who on 19-NOV-2006 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included influenza on 16-NOV-2006. On 20-NOV-2006 (also reported as "later that evening" after receiving Pneumovax 23) the patient felt delirious and stated that his wife called life support for assistance. The patient was admitted to the hospital "while the physician operated on his right shoulder." According to the patient's chart, on 29-NOV-2006 the patient had surgery due to a fractured humerus. The patient stated that he was unconscious throughout the whole process and only knew what his wife had informed him. The consumer also stated that the treating physicians at the hospital could not determine why the Pneumovax 23 and influenza affected him in this way. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
was administrated three doses; first dose 02DEC2020, second 13DEC2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 295s7, expiry date 9th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number xn4fp, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd December 2020).   On 11th February 2022, the patient received the 3rd dose of Shingrix. On 13th December 2021, the patient received the 2nd dose of Shingrix. On 13th December 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 11th February 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. After receiving first dose of Shingrix the patient received 2nd dose one year later, which led to lengthening of the recommended interval between vaccine doses. The patient received 3rd dose of Shingrix, which led to extra dose administered. No further events were reported. The vaccine administration facility was the same as primary reporter. Consent for follow up was granted
pt had rapid onset high fever 104 (but no sz); lt OM also clinically apparent @ time ER visit early AM 9DEC94;
Injection given Friday, 3/27 around 10AM - Saturday, 3/28 around 10AM started having a low grade fever 99.8 to 101.4 most of the day - took tylenol Sunday, 3/29 noticed a few small blisters near the injection site on the back of the right upper arm.
Acute respiratory failure with hypoxia  Pneumonia due to COVID-19 COVID 19 virus infection  Symptom onset ~ 9/8 (chills, cough, fever, shortness of breath)  Detected 9/13 Vaccination status: vaccinated J&J 6/26 CXR Patchy multifocal bilateral pulmonary infiltrates Oxygen requirements on admission: 2L NC Current oxygen requirements: 96% RA  Medical therapy: remdesivir and steroids Stable for DC to home with Dexamethasone to complete 10 day course and PRN Albuterol inhaler
titers negative hepatitis B antibodies; This spontaneous report as received from a registered nurse refers to a five unspecified patient between the ages of 13  15 years old. The patients' concurrent conditions, medical history and concomitant therapies were not reported.   On unspecified date, the unspecified patients were vaccinated for prophylaxis with the full series of hepatitis b vaccine (recombinant)(manufacturer unknown) (dosage regimen, route of administration, lot number and expiration date were not reported). On unknown date, the unspecified patients had titers negative for hepatitis B antibodies (Hepatitis B antibody negative). At the time of this report the patients had not recovered from the adverse event of Hepatitis B antibody negative.  The causal relationship between hepatitis B antibody negative and hepatitis b vaccine (recombinant) (manufacturer unknown) was not provided.
PATIENT RECEIVED PFIZER AS A SECOND DOSE BUT SHOULD HAVE RECEIVED MODERNA. PATIENT DID NOT REPORT ANY SIDE EFFECTS DURING OBSERVATION PERIOD POST VACCINATION.
On 10/4/21 patient complained of numbness and tingling in his extremities which progressed rapidly. By 10/06/21 he was unable to stand on his own and was rushed to the ER. After many tests it was determined that the cause of his sudden paralysis was due to GBS. He received treatment but his condition worsened and had to be transferred to Medical Center. He was there until 10/26/21 and is currently at  Rehabilitation for an undetermined time
Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB
Reporting second dose prior to recommended time frame.  First Dose was documented as 12/29/2020, second dose was 01/21/2021, indicating early second dose.
I had flu feelings and a very bad scratchy throat. My nieces had it and that is how it started. That is what tipped me off. The next morning, 11/14/2022, I was full flu sick. I had a fever and tested with a COVID-19 home test and it was positive. That day I had fever, bad headache, very, very tired. I had low oxygen. On 11/15/2022, I had a telehealth with my physician, and she prescribed PAXLOVID for a 5 day regime and she sent me down for a chest x-ray. I have not received that chest x-ray result. My doctor asked me to purchase an oximeter. The first couple of days it wavered between 86 percent to about 91 percent. I was taking breathing treatments with a machine using albuterol treatments every 4 hours. Then after the treatment my oxygen would go up to 96 percent. The treatments were definitely working. I had fever up till yesterday morning. Fever ranged from, 102.5, 100.3, and 3 days of 99.5 and 99.9 and that let up yesterday morning, 11/20/2022. I am almost fully recovered. I don't have a fever; I just have a cough.
Localized redness 3" X 4" with soreness and hot to touch lasting over 4 days.
Pt. became pale and then had a seizure. He was staring and tremors in his legs and hands. Seizure symptoms lasted less than 5 min. We took the baby to ER for eval.
Fever and Chills approx 6 hours post shot and headaches/fatigue the following day.
terribly dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (terribly dizzy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced DIZZINESS (terribly dizzy). On 24-Feb-2021, DIZZINESS (terribly dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications includes allergies medicines- claridrem (nose, eyes) No treatment medications provided
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 12/30/2008 for COPD exacerbation. Vaccination took place on 12/11/2008.  According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  2/13/09 MR received for DOS 12/30/2008-1/3/2009 with D/C DX:  Acute COPD exacerbation. Pt presented with c/o SOB and pain all over. CO2 narcosis seen on ABGs. Increasing difficulty with breathing and intubated. Tx with steroids and abx. Hypotensive- tx with fluids. Extubated next day and returned to baseline by 1/3/09.
Redness on left arm, a 6lx 1cm, pruritus. (Noted 3 days after vaccine administered).
This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 2 January 2014 the subject received a dose of BOOSTRIX (unknown details). In January 2014, within a month of vaccination with BOOSTRIX, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
pt state has difficulty breathing same evening as vaccine not fully cleared by normal breathing treatments,  went to er on 3 days later and symptoms relieved with therapy there
Shot received on 10/15/08.  Patient noticed increased pain in left upper arm in the PM of 10/15/08.  On 10/16/08 patient noticed increased redness and swelling of upper arm.  She also had generalized symptoms - nausea and light headed.  Patient took Tylenol and went to bed - general symptoms subsided.  Started ice pack to left upper arm.
CHILLS; FEELING COLD; FEELING TIRED; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced feeling cold. On 25-JUN-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling cold, and feeling tired. This report was non-serious. This case, from the same reporter is linked to
Patient complains of a "lump" on her arm after administration of the flu vaccine - distal to the deltoid where the vaccine was confirmed to be administered. Called the manufacturer, common "induration" site reaction, although may not be related because of the location. Video footage shows proper administration.
got his flu shot but was still afflicted by covid; Initial information regarding an unsolicited valid non-serious social media case was received from a consumer (patient) on 14-Dec-2020.  This case involved male patient with unknown age, who got his flu shot but was still afflicted by covid (coronavirus disease 2019) (COVID-19), while he received vaccine Influenza Vaccine.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got his flu shot but was still afflicted by covid (coronavirus disease 2019) (COVID-19) was reported.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
pt recv vax 14SEP98 & seen in clinic on 16SEP98 w/ c/o swelling, redness & pain @ inj site;instructed to use DPH cream;18SEP98 w/cont sx;also c/o cold sx;T99.2, redness noted 4x4 w/inc heat & tenderness;
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients had been administered GARDASIL (dose, frequency, route, lot # and expired date were not reported) that fell to refrigerator temperatures outside the prescribing information, despite being supported. No adverse effects reported. This is one of several received from the same source. Additional information has been requested.
Woke up around 1:30am with chills (cold, shaking uncontrollably, teeth chattering), slight nausea and muscle aches. Gradually alleviated with a dose of ibuprofen. The next day I was tired but felt ok. Large 3x4 cm of arythema  on arm at injection site.
This 50 yo female dependant received her ZOSTAVAX vaccine subq to her left tricep area on 8/20/2013. On day 2 (8/22/2013) evening, she noted her left tricep region was red, itchy, hot, swollen and had a large knot at the vaccination site. She denied any fever, headache or other systemic symptoms, trauma, or any injury to vaccination site. The next day the vaccine site area was more inflamed with a single white pimple like spot with secondary ring of redness surrounding the initial red site. She presented on 8/23/2013 (day 3) with a 12 cm x 8 cm pale red indurated region that extended down and around posterior region left upper arm that had a 4cmx3cm oval shaped warm indurated redden center at injection site area. She had 1 white fatty tissue like skin macule to upper outer edge of central reddened area. She was afebrile (98.7) and had no systemic symptoms. She had full ROM to her left shoulder, elbow, wrist and fingers. Her grip was equal to right. She had no axillary or cervical lymphadenopathy. There were no other skin rashes, nodules or macules noted. On 8/26/213 the hive like red area has resolved with use of Ibuprofen and topical steroid cream leaving a paler red central region. The itching is also better. She continues to deny any fever or other systemic symptoms (headache, malaise, fatigue, joint pain, etc).
Left arm cellulitis, fever, placed on Keflex. Bactrim added, then IV infusions (ceftriaxone) X-ray done, ultrasound done (12/5) neg. swelling, erythema improved. Arm pain still present 12/9/19.
Patient was administered the wrong covid bivalent booster based on her age, Patient was administered the Pfizer 12+ bivalent booster and patient is only 9 years old.
This initial spontaneous case, was received from consumer on 10-Oct-2017, concerning a 20-year-old adult female pregnant patient. The patient had no medical history and had no previous pregnancy. The patient did not receive any concomitant medications prior and during the pregnancy and no medications received by the father prior to conception. The patient had no maternal medical history relevant to pregnancy and paternal medical history for hereditary disease. The patient had not use any contraceptive method. The patient's last menstrual period date was 20-Jan-2017 and had first pregnancy. There was no evidence of any defect/adverse finding from a prenatal test and no birth defect or congenital anomaly, during pregnancy. The gestational period of the fetus was 37 weeks (third trimester) and gender of the fetus was female. The patient gave the permission to enroll in the pregnancy registry. On 09-Oct-2017, at 37 weeks of gestation period (third trimester), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number, route of administration, anatomical location: not reported). On 10-Oct-2017, after 2 days of vaccination, the patient experienced the soreness in arm and no adverse event was reported in the fetus. On the same day, the patient recovered from the event. The estimated date of delivery was reported as 27-Oct-2017. The reporter assessed the events as non-serious. Significant case correction received with IRD 10-Oct-2017: narrative was amended.
First covid arm Then serious hives that I never experienced before and are still appearing until today. Abdominal pain that comes and goes Chest pain that comes and goes Some dizziness when standing up
severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terrible like hit by a truck; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 19Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration at the left arm on 31Dec2020 for Covid-19 Immunization and experienced had small joint pain on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 16:45 (within 3 hours of getting the 2nd shot), the patient experienced severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck. The patient has not been tested for COVID-19 since the vaccination. The patient took Tylenol and didn't work. The outcome of the events severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck was not recovered. The events were considered non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.
developed herpes like cold sores within hours of both the first and second vaccine; Is light sensitive; 6X4inch bump on her left arm; feels a lot of pressure in the back of her eyes; extreme tiredness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (developed herpes like cold sores within hours of both the first and second vaccine), PHOTOPHOBIA (Is light sensitive), VACCINATION SITE MASS (6X4inch bump on her left arm), INTRAOCULAR PRESSURE TEST (feels a lot of pressure in the back of her eyes) and FATIGUE (extreme tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20 and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced HERPES VIRUS INFECTION (developed herpes like cold sores within hours of both the first and second vaccine), PHOTOPHOBIA (Is light sensitive), VACCINATION SITE MASS (6X4inch bump on her left arm), INTRAOCULAR PRESSURE TEST (feels a lot of pressure in the back of her eyes), FATIGUE (extreme tiredness) and CHILLS (Chills). At the time of the report, HERPES VIRUS INFECTION (developed herpes like cold sores within hours of both the first and second vaccine), PHOTOPHOBIA (Is light sensitive), VACCINATION SITE MASS (6X4inch bump on her left arm), INTRAOCULAR PRESSURE TEST (feels a lot of pressure in the back of her eyes), FATIGUE (extreme tiredness) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: no new information.
Patient husband advised patient has been experiencing chest pain on her right side beginning the day after receiving booster vaccine.