chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects after a week of getting vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after a week of getting vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after a week of getting vaccinated). At the time of the report, VACCINATION COMPLICATION (Side effects after a week of getting vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on concomitant medications were reported. No information on treatment medications were reported.
Fever: Tmax 102.8. Varried in temperature x 2days. Ended on 11/04/09 @ 5pm
REDNESS AND FEELS HOT TO TOUCH, ITCHING. PT STARTED BENADRYL AND ACETAMINOPHEN TODAY.
Virtually no symptoms from first vaccine or in first 72 hours after 2nd injection.  Approximately 74 hours after 2nd injection I noticed some slight nausea and body aches. Within a few hours I was severely tired, weak stomach, had short, shallow breathing, tight chest and body aches. This has gone on continuously until this morning, 5 days after vaccine.
Numbness in lower half of body; inability to move legs. Panic attack; rapid heart beat. Debilitating migraines without aura occurring every day since vaccine administered.
Patient had a rash after 1st dose. Fever,chills and chest pain after dose 2. Diagnosed with costochondritis on 5/24 and EKG was normal. Side pain on 7/12 and continued chest pain went to ER. Sent home.  Went to primary for side pain and on 7/21 had surgery to remove appendix. Md found abdominal inflammation and scar tissue in gut without a known source. Suspected systemic inflammation from vaccine. 7/27 chest pain continues 2 EKGs done and both were now abnormal. Patient sent immediately to ER with tachycardia and arrythmia and tested for blood clots.  Blood test was positive but no clots found. 8/16 went to md had 4 bug bites on leg and whole leg was swollen. She was put on antibiotics (keflex).  8/27 went to md for stomach pain. They found colon block/inflammation and did a colon prep.
Not sure flushot name. Within 3 hours my bottom lip began to tingle like a cold sore (but I don?t get cold sores) and the bottom lip began to swell. I took 50mg of Benedryl and was fine within a few hours.
This spontaneous report as received from a registered pharmacist refers to two patients of unknown age. On an unknown date, "over the last couple years", the patients were vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously. The pharmacist reported that on an unknown date, "over the last couple years", the patients experienced bruising around the injection site. The patients did not receive treatment for the adverse event. The outcome of bruising around the injection site was reported as recovered/resolved. This is one of several reports received from the same source. Additional information is not expected.
Patient received 0.5 ml instead of 0.3 ml.  No adverse reaction occurred.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare office consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Resident has had residual temperatures of unto 103 with shaking. Treatment with acetaminophen has been effective to fevers. Provider will be updated.
Fatigue, fever of 101, chills, headache, vomiting. As a note, I had Covid in December. The symptoms were very similar, although only lasted one day.
RespDepression & CoughWheeze Narrative:  within 1 hr post vaccine-uneasy feeling;throat swelling;bronchospasm;chest pressure and tightness; soa ; swallowing difficulty. symptoms improved the next day. currently still experiences soreness in her esophagus r/t swelling. she did not receive any treatment.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 24-MAR-2014, the patient was inadvertently administered a dose of ROTATEQ, (Lot # reported as H015715) oral route that had expired on 15-MAR-2014. No adverse effects reported. No PQC involved. Additional information has been requested.
pt recvd vax; cough w/ tightness, wheezing, fussy, poor appetite; adm to hosp;tx w/ atb,meds for resp; T 100.1; WBC 15.8;
Pt developed Graves Disease an autoimmune disorder (rare for pt's age group) that was not diagnosed officially until Spring of 2009.  9/28/09 PCP medical records received DOS 5/18/09 to 9/2/09. Assessment: Graves Disease.  Patient presents for headache behind eyes and across forehead. Nausea. Feels like something is moving in head. Fatigue. Tachycardia, enlarged thyroid gland. Weight loss. Palpitations. Slight tremor. Hyperthyroid.
This spontaneous report as received from a nurse refers to a 12 year old male patient without any pertinent medical history and drug reactions or allergies. On an unknown date in 2004, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX 0.5 ml, subcutaneous (lot number was not reported). On an unknown date in 2007, the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (dose, strength frequency, route and lot number were not reported). On 22-AUG-2014, the patient was vaccinated with the third dose of (Oka/Merck) VARIVAX (vial 1350 U) lot # J013905, expiration date 30-OCT-2015 in the arm (dose, strength and route were not reported). The nurse reported that the patient received a third dose of (Oka/Merck) VARIVAX due to lack of documentation of the second dose of (Oka/Merck) VARIVAX at the time of the office visit. Patient developed a blister or vesicle on his arm at the injection site after receiving the dose of (Oka/Merck) VARIVAX ON 22-AUG-2014. The outcome of blister or vesicle at the injection site was not reported. No treatment was given for the adverse event. No lab diagnostics studies were performed. It was reported that the patient seek medical attention by an unspecified method. This is one of two reports received from the same source. Additional information has been requested.
pt recvd vax & exp mild case of chickenpox 5 days p/vax; pt was exposed to natural varicella 10 days prior to vax; No further details were provided;
Mild facial and tongue swelling - possible angioedema. No airway restriction. Jaw and body/joint aches. Took 1 capsule of diphenhydramine 25mg at 5:30, then another at 6:30, and one more at 11:00.
Shortness of breath, worsening fatigue, difficulty sleeping, exertional shortness of breath, diarrhea, occasional vomiting, and cough productive of white sputum
1st dose on 10/3/2020 and 2nd on 4/12/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd October 2020).   On 12th April 2022, the patient received the 2nd dose of Shingrix. On 12th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comments: The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of the vaccination schedule.
nausea, throwing up for 20 hours, high temp on 3rd day 3 hrs of strong painful chest pain with shortness of breath, ( heart spasms )went to ER at 10:30 am was released at 3:15 pm to follow up w/primary care Dr. w/in one week.
Extremely bitter taste creating strong desire to stop medication; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Extremely bitter taste creating strong desire to stop medication) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced COVID-19 (Extremely bitter taste creating strong desire to stop medication). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Extremely bitter taste creating strong desire to stop medication) had not resolved.            Concomitant medications were not reported.  Company Comment: This spontaneous case concerns a 42-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 6 months and 22 days after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccine.  Patient developed COVID-19 and was treated with Nirmatrelvir, Ritonavir (Paxlovid). He also experienced bitter taste after taking the medication. The clinical course, diagnostic investigations, and further treatment details of COVID-19 were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 6 months and 22 days after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccine.  Patient developed COVID-19 and was treated with Nirmatrelvir, Ritonavir (Paxlovid). He also experienced bitter taste after taking the medication. The clinical course, diagnostic investigations, and further treatment details of COVID-19 were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
80 y.o. 9/29/1941   Admit Date:  6/29/2022   Discharge Date:   7/1/2022   Discharge Diagnosis:  Principal Problem:   Pneumonia due to COVID-19 virus Active Problems:   COPD exacerbation   Pulmonary emphysema     Hospital Course:  80 year old female was admitted for COPD exacerbation and Covid-19 infection. She was treated with Remdesivir, steroids and antibiotics. She has improved and will be discharged home today on oral medications. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.9 °F (36.6 °C) Pulse: 83 BP: 115/61 Respirations: 18 SpO2: 98 % O2 Flow Rate (l/min): 2 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert, normal strength and tone    Consults:  IP CONSULT TO SEPSIS NURSE NAVIGATOR   Significant Diagnostic Studies:   CXR   Operations: none   Disposition:  Home    Discharge Condition:  Fair
2hr p/vax devel a sore throat & flu sx (weakness, dizziness, aches ect) which lasted about 12hr;mouth, gums & inter nose devel a burning sensation which lasted for 1 day;eyes teared up for about 4 to 6 hr;
2130 on 10JUL pt noted to have tactile temp given APAP; c/o tenderness @ inj site (thigh) & was limping; @ 2330 was noted to have eyes rolled back in head & stiff extremities; taken to ER by family initially drowsy w/altered sensonume; sz
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6200; expiration date: Jun 30, 2021), at the age of 63, via an unspecified route of administration, right arm, on Feb 16, 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history: none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Feb 16, 2021, at 19:20, patient experienced low-grade fever, stuffy nose, chills and stomach near where the ribs separate right under the breastbone was kind of tender. She received her injection in the right arm. It is still hurting and was reported as worsened. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative on an unspecified date, SARS-CoV-2 test: negative on an unspecified date in 2020. The events did not result in emergency room or physician office visit. Therapeutic measures taken as a result of stuffy nose included Zyrtec. The outcome of she received her injection in the right arm and is still hurting: not recovered; and outcome of all other events: unknown. No follow-up attempts possible. No further information expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of the patients who received SHINGRIX. On 10th April 2018, the patient received SHINGRIX. On 10th April 2018, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. In April 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was a client service manager with a pharmacy and covers 16 stores. The age at vaccination was not reported. SHINGRIX was inadvertently reconstituted with ZOSTAVAX diluent and administered to the patient, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. The reporter that reported the incident was a regional manager and did not have any information on the patient or vaccine and administration. An update (not further specified) after call escalation was received. The healthcare professional reported that he was heard from other pharmacists that the patients have complained about pain, more so than with TDaP (did not specify BOOSTRIX), at the injection site day after vaccination. This case has been linked with case US2018GSK068224, reported by same reporter.
Possible adverse reaction the day following vaccine injection. 1 episode of diarrhea/nausea with flushing of left side of face which lasted 30 minutes. Redness and swelling at the injection site app. 3 inches induration. Warm to touch. Checked today still warm, red, swollen. No systemic symptoms noted.
My left shoulder feels weak and unstable as if it could become dislocated.  I have pain/soreness when lifting my left arm.  It has never felt this way before in my life.
Pt developed fever of 102.5F. Went to ER. Vomited X1 about 15:00. Site of injection tender to touch and inconsolable until about 17:30. Dx'd with vaccine reaction at ER.
Information has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in 2016 (reported as "since August 2016"), the patients were vaccinated with doses improperly stored GARDASIL 9 (lot #, expiration date, dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 14-year-old male patient received TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced acute flu-like syndrome for 24hours on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.
Redness, Swelling, Raised at injection site about 3cm in diameter, warm to the touch and throbbing. Bump on arm popped and wartery blood and pus came out.
Arm swelling, red spots on arms, stomach and face. Onset after shot. Went away - came back with nausea, fever. Pt received rx VALTREX 1 gm TID x 7d. 12/8/14. Prednisone 20 mg taper down.
fever 104, h/a, varicella rash requiring office visit & tx starting day 6, seen day 8 p/1st dose of vax
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA PERIPHERAL NEUROPATHY
I still have pain in that arm where injection was given. Whole area is still hurting; I still have pain in that arm where injection was given. Whole area is still hurting; 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 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 13:30 (Lot number: EP7534) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heartburn" (ongoing); "Depression" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM] taken for dyspepsia, start date: 2006 (ongoing); EFFEXOR taken for depression, start date: 2006 (ongoing); LIPITOR [ATORVASTATIN] taken for blood cholesterol abnormal, start date: 2006 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Mar2021, outcome "recovering" and all described as "I still have pain in that arm where injection was given. Whole area is still hurting". Therapeutic measures were taken as a result of vaccination site pain, pain in extremity.  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated pain in arm began probably within 30 minutes after the shot. She treated the pain with ibuprofen by mouth and has reported that it has improved but still hurts.   No follow-up attempts are possible. No further information is expected.
"Covid-arm"  7 days after my vaccine the injection site started itching, when I woke up the next morning it was swollen and warm to the touch. 3 inches in diameter.
This was for Occ health. The employee reported feeling as though she had the flu the evening before, she developed several irregular fluid filled blisters on her L deltoid muscle along with mild redness in the morning and these gradually increased, there were more developing on her L wrist  as she spoke with me. The employee was referred to Occupational Health. I also contacted GSK and reported this event.
When I started taking Humira again after my Moderna vaccine for my psoriasis I started having terrible itching on my legs, back and arms.  Wake up in the middle of the night with horrible itchiness on back and legs. Could be coincidence. But terrible itching has diminished over time.
"Seizure" - pt. stiffened in his sleep (co-sleeps with parent) - not arousable approximately 5 min. T 100.2 - 10/07/15 and 10/8/15.
None. Patient was given the adult dosage of Havrix, Hep A, instead of the right dosage. He denied adverse symptoms appr. 45 minutes later. I phoned him today. He denies any adverse symptoms since receiving the dose.
Beginning 9/15/09 at 6 or 7 PM EST patient reported hurting in her back and stomach. Chills and a fever (100 degrees F), vomiting, diarrhea at 5AM 9/16. Headache and aching all over. Patient reported being dehydrated, vomiting yellow bile. Diarrhea was "grass green" and watery.
Mom and baby came in 6/26/18. Baby received MMR, Varicella Vacc and Hep A vacc 6/25/18. Mom stated baby actually seemed ok, but woke during night and cried for 2-2 1/2 hrs with high pitched cry inconsolable. Noted per Mom child had poor eye contact, was not able to be comforted by holding or soothing, felt clammy. Baby eventually went to sleep just before midnight, am not after a few hours seemed back to her "normal" self. At visit baby was happy, smiling, interactive, with good eye contact and no obvious difference from her precious edam.
By 11-18-2021, injection site swelling with red, raised bump. Increased muscle soreness, area of injection very warm to touch, tingling in tongue and floor of mouth, aching joints and skin, low-grade temperature of 99.4, dizziness, fatigue. Itchiness over the night - dreaming of hives all over face.
H/A started late afternoon on day of injection (11/19/2009). Lasted x4 days-pain level 8 (1-10 scale).
After second shot, pain, redness, swelling, warm to touch, feels like a big hard lump in arm of injection.  It's been 4 days and symptoms have not gone away or minimized.  Redness has expanded a little.  Swollen lymph nodes in armpit of arm of injection appeared on day 2 after injection and has not gone away.  Had fever for the first 2 days but has gone away.  After 1st shot, a week later I had pain, redness swelling, warm to touch, big hard lump in left arm of injection.  This only occurred for 2 days only.  This was not previously reported.
Herpes Zoster  C34 dermatoma    Greater than 20 vesicles
58 year old with history of Hyperlipidemia falty level osteopenia. On 04/22/2005 received on dose (1st dose) of Hepatitis A, Hepatitis B vaccine. Three to four days later developed multi joint and muscle pain. Seen by rheumatologist placed on Prednisone so pain improved.
mom called hlth dept & informed us that approx 10 mins p/vax; pt broke out in hives w/o fever; mom took pt to MD;
I went on vacation and I started to feel really sick. I tested positive for COVID-19 on 6/26/22. I had a headache, body aches, fever, cough, and fatigue. I was prescribed Paxlovid by the doctor. I didn't start feeling better until 7/2/22, after we returned from vacation home from vacation.
Employee states onset of bilateral ear ringing began about 2 days after receiving influenza vaccine.  Tinnitis has persisted since onset.  Seen by ENT specialist and exams included AVR and ECOG testing.  Given diagnosis of high frequency hearing loss, possible Meniere's disease.