chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age. Concomitant medications, medical history, drug reactions and allergies were not reported. On unspecified dates between 15-SEP-2014 and 24-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J013555 expiry date 02-MAY-2015, intramuscular (dose was not reported). On the day in September 2014, following to the vaccination with PNEUMOVAX 23 injection, the patient experienced hot area, red and painful at the site of injection. The patient sought medical attention went to see the physician. There were no laboratory diagnostic studies performed. On an unknown day, the patient received an unspecified antibiotic. The outcome of painful red and hot area at the site of injection was reported as recovering. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. Approximately on 04-SEP-2016 (reported as "5 days ago"), the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose, strength, dose number, vaccination site, route not provided). It was reported that, approximately in September 2016, the patient was prescribed with unspecified antibiotics and unspecified steroids after vaccination of ZOSTAVAX for an unknown reason (Adverse event). The outcome of adverse event was unknown. Causality assessment was not provided. Additional information has been requested.
pt recv vax 12AUG98 & 5min later had crushing chest pressure & nausea;pt went to ER & Bp 152/70;10min later BP 124/64;cardiac enzymes performed WNL;pt hosp 12AUG98 for cardiac workup;
Patient reported very red, swollen, and hot all the way down left arm and into lymph nodes in underarm. Also experienced upset stomach, fever, and headache.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old female. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
a little pain while the GARDASIL 9 was being administered in his right arm, but the pain went away after the administration was complete.; administered an expired dose of GARDASIL 9; Information has been received from a nurse, referring to a 25 years old male patient. The patient had no medical history, concurrent condition or concomitant medications.      On 04-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, lot # R024264, expiration date 29-OCT-2019) intramuscularly in the right arm as his second dose in the series for routine vaccination (expired product administered).         On 04-NOV-2019, the patient experienced a little pain while the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was being administered, but the pain went away after the administration was completed. The patient did not seek for medical attention. No treatment was given for the events. No lab diagnostics/studies were performed. The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and pain was not provided by the reporter.
Headaches for 4 months, brain fog, sensitivity to loud noises at times, tingling in tongue. 2 weeks after the vaccine I had 2 rapidly growing tumors on my head. One was biopsyed and revealed to be cancer.
Pt stated her arm was very warm, swollen and red with streaks from injection site down to elbow.  She experienced fever, chills and night sweats. She also reported muscle aches and balance problems.  She went to the MD and he gave her antibiotics for cellulitis on 10/13/2014.  She went back and received a steroid injection on 10/14/2014 and reported feeling better on 10/15/2014.
A non-serious spontaneous report of administration of extra dose was received from a physician concerning a 10-year-old male who received FLUMIST. The patient received two doses of FLUMIST five months apart. No medical history was reported. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
11 year old female received the HPV, TDaP, and Meningococcal vaccines. The patient became pale and complained of nausea. The Corpsmen and Nurse sat the patient in a chair with the patient's knew raised. The patient was given a cold pack and some water, while vitals were taken every few minutes. The vitals were as follows: B/P- 87/56, 90/58, 86/49: Pulse- 60bpm, 82bpm, 83bpm. The patient was allowed to leave with their guardian once they exhibited signs of improvement.
Severe headache started on date of vaccine administration at 7PM, "felt like my head was going to implode", took tylenol and ibuprofen at some point and headache subsided during the night. Also had body aches, chills, fatigue that went away on 04/02/2021. From 04/06/2021-04/11/2021, patient had bloody noses on and off which was very unusual for her. Patient went to her PCP on 04/14/2021 for evaluation and he ordered lab work, scheduled repeat  lab work and appointment on 04/28/2021.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 adolescent patients. This is the 4th of 4 reports. An adolescent patient of an unspecified ethnicity and gender received TRUMENBA (Lot# F26962), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache, redness, pain radiating down arm to hand, fever of 103 and swelling all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103. Sender's Comments: Linked Report(s): US-PFIZER INC-2017256820 Same reporter/drug/event, different patient.
Monday morning--extreme tiredness, chills, body aches, headache, muscle aches Tuesday afternoon--hives on chest, neck, back, stomach, thighs, arms Wednesday--hives continue Thursday--hives continue
Pt given expired vaccine. No s/s. Contacted Moderna. Followed up with patient.
pain; swelling; bump at injection site; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), SWELLING (swelling), INJECTION SITE MASS (bump at injection site) and ARTHRALGIA (Joint pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), SWELLING (swelling), INJECTION SITE MASS (bump at injection site) and ARTHRALGIA (Joint pain). At the time of the report, PAIN (pain), SWELLING (swelling), INJECTION SITE MASS (bump at injection site) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Breakthrough case admission after 2 vaccines  Pfizer 3/31/21 Lot# Ew0150;  Pfizer 4/21/21 Lot# Ew0170
Information has been received from a nurse practitioner concerning a female who in approximately 1997 was vaccinated with varicella virus vaccine live. In approximately 1997 post vaccination, the patient experienced a "huge hive" at the injection site. Additional information has been requested.
Headache; Tiredness; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia, Diabetes and Thyroid disorder. Concomitant products included INSULIN GLARGINE (LANTUS) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 24-Feb-2021, HEADACHE (Headache) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) patient did not have any antibodies to the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient got her 1st dose of the Moderna vaccine on 22Feb2021 and her 2nd dose on 27Mar2021, both in her left, non-dominant arm in the deltoid region. For both vaccinations, experienced tiredness and headache, both started the day of their vaccines and lasted for 2 days. No medications were taken for these symptoms. Patient called as she got an antibody test done and it showed that did not have any antibodies to the vaccine and wanted to inquire about this.  Treatment information was not provided   This case was linked to MOD-2021-222249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received on 28-JUL-2021 and does not contain any new information.
Information has been received from a 76 years old female patient with allergy to "Sippro", "Codine", ibuprofen (reported as ibuprohen) and "Pene". The patient's medical history included minor case of shingles approximately in 2007 (about 5 years ago). On 27-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant medications included: BENADRYL. On 28-SEP-2012, the patient experienced 5 red, very itchy bumps around the site of injection. Unspecified treatment was given for the events. The outcome of the events was unknown. The patient sought unspecified medical attention. The relatedness was unknown for ZOSTAVAX. Additional information is not expected.
8/26/10 Rec'd DTaP, HIB, HBV, PCV, IPV; 8/30/10 developed fever, rash, runny nose, irritability; 9/1/10 Seen in our office with rash - dx chickenpox; 9/3/10 went to urgent care facility because rash still present - told it was a vaccine reaction & no treatment given.
This is a spontaneous report from a contactable unspecified Healthcare professional. A female patient of unknown age and race/ethnicity received first single dose of TRUMENBA and influenza vaccine (manufacturer unknown), both for immunization. Medical history and concomitant medications were not reported. The patient had a fever of 105.0 degrees F on an unknown date. Outcome was unknown.
Developed a 3" by one inch height raised area surrounding pinpoint needle entry. Developed on 10/15/11 about 24 hrs. after injection. The area was red, warm and sore to touch. She notified her PMD who advised her to go to a walk in clinic. Dr gave her 10 days AUGMENTIN.
28JUL97 started getting hives about 1hr p/vax no fever-took pt to PMD & was given DPH hives were gone by 330PM;
Epstein-Barr virus (mononucleosis); achy/ sore arm; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFECTIOUS MONONUCLEOSIS (Epstein-Barr virus (mononucleosis)), PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTIOUS MONONUCLEOSIS (Epstein-Barr virus (mononucleosis)), PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFECTIOUS MONONUCLEOSIS (Epstein-Barr virus (mononucleosis)) outcome was unknown and PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Epstein-Barr virus test: positive had Epstein-Barr virus (mononucleosis).         No Concomitant product use was reported.  The patient stated that they received the Moderna primary two dose series approximately one month part and stated the patient had no untoward reaction after the first two doses in 2021. The patient however reported that the patient experienced the normal side effects, including an achy, sore arm and flu like symptoms that lasted for about one day. The vaccine administration dates, and lot numbers were not provided by the patient. The reporter mentioned that one must eat and hydrate well before they get their Moderna vaccines to lessen the side effects.   The patient stated the patient had Epstein-Barr virus (mononucleosis) and their resistance became low. The exact date of Epstein-Barr virus was unknown but appeared to have occurred sometime after receiving the Moderna primary series vaccinations. The patient stated the Moderna vaccines worked, and the patient had never gotten COVID-19 infection. Reportedly, the patient regularly wore mask and practiced social distancing.   No treatment information was provided.   This case was linked to MOD-2022-531820, MOD-2022-531834 (Patient Link).   Reporter did not allow further contact
patient has been having new dizziness with changing from the laying to sitting position.  She has been cleared by ct head, cardiology and has not improved in 4 months.
First period following vaccine was heavy, clumpy, and bright red. Period lasted for seven days. Normal period lasts 2-3 days and is quite light. I was using a new pad every hour and was asked to come into the doctors office for an exam. I was told my vitals were normal, but the exam was conducted at the first available appointment, two days after symptoms ended.
?Pfizer-BioNTech COVID-19 Vaccine EUA?  Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer. (This VAERS writer assigned to form completion was not the administrator of this vaccine.)   Outcome: Vaccine recipient was contacted by staff.
Tdap given at 19 weeks of pregnancy instead of 28 weeks, when i  looked up on CDC website it stated it's recommended at 28 weeks of pregnancy however it can be given earlier and should not be repeated during the same pregnancy. No physical reaction to patient she tolerated well. EDD 02/01/2023 She has past history of pre-eclampsia in third trimester in pervious pregnancy.
Sudden onset of severe pain in left lower back, left flank, and left labia. Called my PCP and was directed to the ED for imaging and pain f/u. Had CT scan of the abdomen and a stone was noted. Given IV toradol with relief. Sent home with a appt to see Dr. on 12/30/21.
The patient experienced swelling, a red knot, bruising and pain in the left thigh. The left thigh feels warm to the touch.
1:30 pm vaccine given R deltoid, 1:40pm pt became diaphoretic pale, pupils dilated and rolled back up, became rigid with posturing noted, nonresponsive to verbal and tactile stimuli 1 minute responded ammonia inhalent, speech slurred, no resp.  distress, no RAGH, BLP 96/62 P84 Reg.  R 20 (9-1-1 activated) Pt. transfer E.R.
pt to ED unconscious and unresponsive; required intubation; found to be positive for COVID; CXR with multifocal PNA; Head CT showed acute bleed; CT of abdomen and pelvis showed cirrhosis and portal HTN; pt had fever; transferred to ICU; given Decadron, ABX, Remdesivir; extubation a success; sudden change in mentation; code called; cardiac arrest; ACLS, chest compressions, rescue  meds, shocked several times without success; pt passed away in the hospital
Pt complained of dizziness, nausea and vomitted x1, 10 mins after vaccination.  Clear content.  Patient is oriented x 4. V/S is in normal range, no SOB, legs elevated. Advised parent to extend observation for 30 mins. Pt feeling better at 5:16 pm. Pt states ? I feel regular? and symptoms fully resolved. Pt educated to go to urgent care if symptoms persist. Pt left in stable condition, accompanied by Mother and siblings.
Within 30 minutes of injection patient experiences hives on both arms. Hives spread over the mid section and legs over the next 24 hours. Reaction was treated with Prednisone, Benadryl, and Zyrtec. Hives reduced, but persisted for 8 days.
She administered the vaccine very close to my shoulder. That night I had severe pain in my arm and shoulder. It's 6/13 and my pain in my shoulder is severe, I  still can't use my arm. I have a rash on my arm that just appeared today, I had a fever last night. The night of getting the vaccine I almost threw up , was dizzy, and nauseated. What concerns me is that it's been 5 days and my shoulder pain is getting worse/still very severe.  I've tried ice and to reduce inflammation...I'm not noticing much change. I spoke to a nurse on the phone and was told this isn't normal and it shouldn't have been administered near my shoulder. It appears I have SIRVA.
Patient had 2 dose of SHINGRIX at 11pm, stated feeling dizzy wake up at night. She fell down and got bruise.
Sudden circular patches of hair falling out - left side of head.  Appears to be sudden Alopecia Areata with no family history of such.
Viral syndrome; Vomiting; Fatigue; fever; cough; Chest pain; Shortness of breath; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VIRAL INFECTION (Viral syndrome) and VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vaccination site erythema (delayed effects) and Induration (induration at vaccination site( delayed effects)).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (fever). On an unknown date, the patient experienced VIRAL INFECTION (Viral syndrome). At the time of the report, COUGH (cough), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VIRAL INFECTION (Viral syndrome), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Negative) Negative. On an unknown date, Exercise electrocardiogram: (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Patient date of birth has been updated.
Patient was asked by provider if she wanted her 3 rd vaccine  of  Covid. Pt agreed.  At the time her 3 rd covid hadn't been entered in  EMR.    After giving  the vaccine, I asked patient for her Covid card and  patient  said her son out in the waiting room had it.  I proceeding to get from son, at that time  is when he informed me  his mom  had just gotten her 3 rd covid vaccine a week or so ago.  Patient and son and providers, office manager were all informed.
Red and swollen for a few days after injection, mother applied ice. On 5/9/18 (20 days later) came back to office, persistent 1cm subcutaneous nontender nodule at left deltoid injection site with slight grayish discoloration of skin.
Migraine, fever, chills. Nausea, vomiting. Dehydration, diarrhea, swelling at the injection site ?tomato sized? per ER doctor, extreme pain, dizziness. Body aches And a white blood cell count of 23.
10 mins of getting the pfizer vaccine patient stated she was having heart palpation, chills, pain in the left shoulder. Blood pressure 130/74 at 1:10 patient walked to restoom after being observed.
Subsequent to receiving varicella virus vaccine live the pt developed a disseminated vesicular rash on trunk, chest, back and hands. Redness and vesicles at the injection site were also noted.
The patient reported feeling dizziness shortly after (~2 minutes) receiving the pfizer covid-19 vaccine.  The pharmacist approached the patient.  She appeared sweaty and slightly disoriented.  The patient then passed out ~3 minutes after vaccination.  She regained consciousness briefly, but passed out again.  The patient was then laid on the floor where she regained consciousness within a minute.  The patient was fully recovered within 5 minutes of initially reporting symptoms.
pt presented to hospital with generalized weakness, confusion and flank pain; mildly hypoxic, started on O2 supplementation; ABX, dexamethasone, Lovenox; positive test for COVID; COVID pneumonia; AHRF; CHF; pt did not improve, condition worsened and he was admitted to hospice; DNR; comfort measures; pt died in the hospital.
Moderna vaccine was administered outside of office - reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------- I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/9/2021 ATRIAL FIBRILLATION, UNSPECIFIED I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/17/2021 ATRIAL FIBRILLATION, UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/9/2021 RIGHT LEG CELLULITIS I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/17/2021 RIGHT LEG CELLULITIS I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/9/2021 ATRIAL FIBRILLATION, PAROXYSMAL W PROTHROMBOTIC STATE I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/17/2021 ATRIAL FIBRILLATION, PAROXYSMAL W PROTHROMBOTIC STATE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/9/2021 ATRIAL FIBRILLATION, UNSPECIFIED I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/17/2021 ATRIAL FIBRILLATION, UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/9/2021 ATRIAL FIBRILLATION, PAROXYSMAL W PROTHROMBOTIC STATE I82.409 ACUTE DVT, UNSPECIFIED VEIN 3/17/2021 ATRIAL FIBRILLATION, PAROXYSMAL W PROTHROMBOTIC STATE