chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned an 82 year old male. Initial information was processed along with additional information on 15-NOV-2021. 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: 1820095 expiry: Unknown) dose was not reported, 1 total, administered on 06-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.   The patient had no side effects after vaccination. On 10-SEP-2021, the patient was tested positive for COVID-19 (confirmed clinical vaccination failure and confirmed covid-19 infection). The patient did not have a severe case and thought it was because he received the jnj vaccine was reported. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000201562. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211125378- COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient report L eye not blinking.  1-2 hours after getting above immunizations in clinic. Reports L sided facial droop and numbness.
1 day after: fever and tiredness. 2nd day after: Swollen armpit on side of injection
Prior to administering vaccine, nurse discussed anaphylactic reactions to mango and bee stings.  Not a component in vaccine but will monitor for 30 minutes after. discussed risk vs benefit.  Answered pt questions and administered vaccine.  11:23am pt reported to nurse tingling sensation around mouth and lump in back of throat.  breathing WNL.  Administered benadryl at 11:23am with consent of pt. Continued to monitor.  11:45am pulse 85, BP 168/98, respirations 16.  Denies SOB.  Pt feels sensation in back of neck going up to head.  Tightness in throat and compares it to her previous anaphylactic reactions.  Notices vision changes. 11:50am pulse 82, strong and steady, BP 158/90. respirations WNL.  Discussed epinephrine with pt.  pt agreed.  administered 0.3 mg 11:52am, called EMS.  Continued to monitor pt.  11:59am pulse 88, BP 160/100, respirations WNL denies SOB.  Normal pallor.  Responding appropriately.  Pt stated feeling tired and wants to just close her eyes, "feeling my body react".  Continues to complain of lump in throat, itchy eyes.  12:03pm discussed, consented and administered second dose of Epinephrine 0.3mg. EMS arrived, pt still responding appropriately.  Pt left via stretcher to ER.
Patient states that she is experiencing a radiating nerve pain from her neck down to her elbow. The pain starting the day after the vaccination.  Patient said she tried stretching, Ibuprofen, Tylenol and she is not getting any relief.
Patient missed the 2nd dose beyond recommended window; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose beyond recommended window) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose beyond recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose beyond recommended window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
45 hours after vaccine admin, woke up Sunday AM, and upon eating and hydrating, got vertigo-- dizziness and vomiting. Unable to keep food or fluids down. (Patient is 68 yrs, and has never ever thrown up.) Elevated heart rate and BP, stress reaction. These symptoms continued for 8 hours. Wound up at ER. Doctors suspect vaccine as cause of vertigo reaction. Received IV to restore fluids. Had an MRI to rule out stroke or heart attack. Released from Hospital Sunday 10:30PM
This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (I only had a a sore shoulder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (I only had a a sore shoulder). At the time of the report, ARTHRALGIA (I only had a a sore shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up information includes No New Information
Flushing, chest tightening, SOB, feeling of impending doom, anaphylaxis tx. Benadryl, Epi, Decadron, Pepcid, Solumedrol, O2, cardiac monitoring. Information received from medical records states anxiety, dizziness. msv
Extended interval in vaccine schedule; Extended interval in vaccine schedule; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Extended interval in vaccine schedule) and PRODUCT AVAILABILITY ISSUE (Extended interval in vaccine schedule) in a 23-year-old male patient who received mRNA-1273 (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Extended interval in vaccine schedule) and PRODUCT AVAILABILITY ISSUE (Extended interval in vaccine schedule). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Extended interval in vaccine schedule) and PRODUCT AVAILABILITY ISSUE (Extended interval in vaccine schedule) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
First began tingling on left side of forehead,  then 4 hours later left temple then 6 hours later left side of lower lip and 1-2 hours later top of left cheek. [left side of jaw/ear lobe/half of cheek decreased sensation from prior surgery to remove parotid tumor since Nov. 1992] By 30 hours after vaccination I had received solu medrol and valtrex for early s/s of Bell's palsy by hospitalist at hospital. All symptoms resolved by 1/9/21 pm.
Fluzone Quadrivalent was administered to a patient which was was unstable, plus it took a long time before delivery, no AE; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with 2019SA270664 (same reporter).  This case involves a 21 years old female patient who received 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT6654KA, expiry date: 13-Jun-2020) via intramuscular route in the left deltoid on 17-Sep-2019, which was incorrectly stored.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual mediation error due to incorrect product storage. It was reported that vaccine was unstable, plus it took a long time before delivery. Shipment come and it took 3-4 days to be delivered. Vaccine was out of range and unstable.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
pt recvd vax & devel localized erythema, swelling of L arm 6x4cm;
Patient was given  Tdap and MMR immunization. Patient tolerated Tdap well. After giving  patient MMR immunization patient had a vasovagal response and fell off of exam table. Provider was unable to stop patient from falling off of exam table. During fall patient obtained laceration about right eye from glasses breaking. Patient woke up and was alert and oriented x4. She denied being light headed or dizzy. She did state that her head hurt where she obtained laceration. Patient was able to sit in exam room and wait for her sister to pick her up and take her to ER. Patients daughter was in the room during incident as well. Other staff came to help during incident.
Severe nausea and vomiting, shaking, fever, chest redness, burning sensation on chest, throat "like the worst sunburn I every had"  elevated lactic acid.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included zostavax with an associated reaction of herpes zoster (received in 2013). On 11th September 2018, the patient received SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 17th September 2018, the patient experienced nerve pain, ear pain, neck pain and jaw pain. The patient was treated with gabapentin. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the nerve pain was resolved with sequelae and the outcome of the ear pain, neck pain and jaw pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, nerve pain, ear pain, neck pain and jaw pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient had experienced shingles 2 weeks following the ZOSTAVAX vaccine in 2013. The shingles presented on her left ear and down the left side of her neck. On the next day of SHINGRIX vaccination, the patient experienced a red, swollen area measuring 2 square inches at the injection site. The symptoms lasted 6 days. On 17th September 2018 (Monday morning), 6 days after receiving SHINGRIX vaccine, she woke up with ear, jaw and neck pain on the left side. She was examined by her dentist and he did not find any tooth issues. She was then examined by her physician who believed she experienced a flare up of nerve pain from the previous case of shingles. The pain comes and goes. The last time it presented was a couple of weeks ago. The patient took gabapentin to help control the pain. The reporter consented to follow up.
No adverse event took place. It was caught upon entering data and checking inventory that the individual received a monovalent vaccine instead of the bivalent booster. Local Department of Health was notified on 10/17/22 and they advised to contact the manufacturer (done on 10/19/22) and submit a VAERs report. No further guidance was provided at this time by the Pfizer manufacturer other than that the pt. may receive a bivalent vaccine 2 months after their last dose.
Onset fever 103.0-103.6 F (orally) 6 hours post injection chills, mild headache, mild pain at injection site. Resolved by 12 hours, except for mild pain at injection site.
Patient had shot of DTAP on left deltoid last week Friday and had redness reaction on the shot area. Notified attending physician.
About 10 minutes after vaccine patient complained of headache & chest pain, advised patient to seek immediate medical attention.
Patient with 4 COVID vaccines who admitted with COVID detected PCR.  Provider d/c note: "Hospital Course: No notes on file  These were his acute medical issues addressed:   1. Intractable N/V. -- may have been a viral gastroenteritis vs COVID infection. -- resolved with supportive care. -- tolerating a full diet at discharge.   2. COVID-19 patient; Vaccinated x 2 (Moderna); NOT boosted. -- No fever, cough, SOB or hypoxia.   3. CKD-3 baseline GFR in the 20's. -- sl decreased GFR into the teens after presenting symptoms. -- needs repeat BMP next week.  -- did resume ARB at discharge.   4. AKI due to #1 -- ARB held this hospitalization, but continued at discharge as BP was rising.   5. Kidney transplant patient (Cadaveric- 2004). 6. Chronically immunosuppressed from #5 (Prednisone/ Cellcept/ Tacrolimus). -- Tacrolimus levels WNL.   7. HTN -- ARB resumed at discharge.   8. PVD   DC home in stable condition.   To return to ED is +fever/ SOB/ difficulty breathing, or any untoward symptom.
This spontaneous report was received from a registered nurse refers to a 3 year old female patient. The nurse reported that on 15-FEB-2013, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, intradermally because it was mistake for TB MANTAUX injection (manufacturer unknown). MANTAUX injection had not been given at the time of the call. The VARIVAX (Merck) was indicated for the patient at that visit, and the patient was still in the office. The vaccine was injected under the sin and formed a small bubble and was red around the injection site. the outcome of the events was unknown. The relatedness between the events and VARIVAX (Merck) was unknown. Additional information has been requested.
Diagnosed with episodic cluster headaches by general practitioner. Provided with care instructions and advised to report to VAERS by general practitioner.
Pt developed increased swelling and redness in left arm from shoulder to elbow the day after TD vaccine. She was unable to move her arm due to soreness. She took Benadryl. She still has a hard knot at injection site but swelling has decreased, after 6 days.
Site of injection got swollen, warm to touch the next day 8/26/17. Patient was taken to the ER on 8/27/17. Diagnosed to have Cellulitis and was prescribed Clindamycin and BENADRYL.
After the second shot (4/21/21) I had a common reaction, fever, aches and felt really unwell the day after. The next day the only symptom I had remaining was lung/chest pain. The discomfort as not subsided any since the day after I got the shot (it had been over a week and a half), if any it has worsened slightly. It hurt most when I exhale and relax. It is a tight feeling in my mid chest.
Information has been received from a nurse practitioner concerning a 53 year old male hospital employee electrician with no pre-existing medical conditions or drug allergies who on 25-JUL-2007 at 10:20 was vaccinated IM with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. Suspect vaccination administered on 23-JUL-2007 at 10:25 was vaccinated IM with a dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot# AHBVB431BA) in the left deltoid. On 08-AUG-2007 (also reported as 12-AUG-2007) the patient developed muscle pain that started with knee and ankle pain. The patient also developed swollen knees and ankles and hand pain thereafter. Pain was also noted in the arms which increased in intensity and duration and the patient would awaken at night. On 08-AUG-2007, the patient also experienced numbness and tingling in both hands. The patient sought medical attention via the nurse practitioner's office. No labs or diagnostic studies were performed. The patient was treat with NAPROSYN every 12 hours since 20-AUG-2007 with some relief. Subsequently, the patient was not recovered. There was no product quality complaint. Additional information has been requested.
fever ( 101.7); sever headache, neck pain, nausea/vomiting, diarrhea, rib,spine, hip pain
administered YF-VAX to a patient but a different diluent was used instead of the diluent supplied with the vaccine with no reported adverse event; Initial information received on 28-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered yellow fever vaccine [YF-VAX] but a different diluent was used instead of the diluent supplied with the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a total dose of suspect yellow fever vaccine once (formulation, strength and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, the YF-VAX was administered to a patient but a different diluent was used instead of the diluent supplied with the vaccine with no reported adverse event (product preparation error) (latency: same day).  It was reported, they have administered YF-VAX to a patient but a different diluent was used instead of the diluent supplied with the vaccine.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
felt a little bad; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient felt bad but was otherwise asymptomatic. For tolerance of 2nd dose, refer case US2020079532. The reporter did not consent to follow up.
Pain at injection site, constant, began ~2 hours after vaccine administration-time of VAERS submission  Chills,  duration from 3 AM-5 AM on 1/11/2020 ~14 hours after vaccine administration   Generalized muscle aches,  constant, began at 6 AM on 1/11/2020 - time of VAERS submission, ~ 17 hours after vaccine administration
I contracted COVID-19 and received a confirmed diagnosis on 8/30/2021 at 32 weeks of my pregnancy.
Pt c/o dizziness and chest pressure following administration of second dose of vaccine. Pt used her inhaler at 1402 and started to feel better but after using the restroom she reported feeling like her throat was closing and it was hard to swallow. Pt also began coughing, dry heaving and vomiting. Pt was given Epinephrine  at 1452 after a second assessment by the provider and EMS was called. Pt was transferred to the hospital.
Patient reported that both eyes dilated after the 15 minute wait period and that one returned to normal in about 5 hours and the other returned to normal by the next day. He also stated that her has noticed "irregular heart beats" since his vaccination and has an upcoming appt. with his cardiologist.
Exhaustion/ Felt more exhausted; Lightheadedness/ Light headed; Nausea/ Nauseous; Sore throat/ Throat is really sore too/ there is pressure there; Injection site soreness; Loss of appetite; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL324) via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 in Oct2020 and she had a mild case. The patient had no other medical history. There were no concomitant medications. The patient got the vaccine yesterday (reported as 18Jan2021, clarification pending) at work in the afternoon. Yesterday, she felt fine, except for the normal injection site soreness. Today on 18Jan2021, she felt more exhausted. At work started feeling kind of lightheaded. She was kind of nauseous and stuff. Over all, she was not feeling well. She didn't have a prescribing doctor. She got it done at her place of work. This morning when she woke up she noticed the exhaustion. Being light head started about an hour or half or so, maybe 2 hours ago. The nausea, she first noticed about 1 hour to 2 hours ago. Her throat was really sore too. She first noticed that this morning, and it had persisted. It was like a sore throat but there was pressure there. She took Ibuprofen for the injection site soreness. She had experienced a loss of appetite. She ate this morning and didn't have much to eat. She was also usually hungry by now, and she hadn't ate. All she ate was some protein bar because she was nauseous, but the symptoms hadn't subsided from eating. She got the vaccine because she was an essential worker. She worked with people with disabilities. She was looking at symptoms and figured she should call and see if this throat issue she was having would make it severe. She wasn't having trouble breathing or face swelling or anything. She just couldn't tell if her throat was just sore or swollen too. There was no investigation assessment. The outcome of event normal injection site soreness was recovering, outcome of event not feeling well was unknown, outcome of other events was not recovered.
RIGHT LEG WHERE DTaP WAS GIVEN BECAME VERY RED AND SWOLLEN, WARM TO THE TOUCH, AFEBRILE.  TO BE TREATED WITH MOTRIN AND BENADRYL, RTC IF SX DO NOT RESOLVE.