chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of erythromacular rash in a 71-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 21st June 2018, 7 days after receiving SHINGRIX, the patient experienced erythromacular rash, pruritus and tingling sensation. On an unknown date, the outcome of the erythromacular rash, pruritus and tingling sensation were not recovered/not resolved. It was unknown if the reporter considered the erythromacular rash, pruritus and tingling sensation to be related to SHINGRIX. Additional information was received as follows: This case was previously reported to the doctor. The case was reported by the certified medical assistant. The patient received SHINGRIX on the left arm. One week after receiving SHINGRIX, the patient experienced red spots on her forearm, she felt like needles pricking her and itching. The same events then spread to the abdomen on 22nd June 2018. The events resolved, and then returned after an unspecified time. The events then resolved again. At the time of reporting, the events were not present. The timeframe was not communicated by the patient, only that the event was periodic.
Headache, facial flushing, ears red/hot, nausea, diarrhea, chills, body aches, fatigue, arm pain
Pain swelling tenderness redness rash itchy warm to the touch At injection site. Much worse today than yesterday. Icing and Tylenol
12/11/2021, The day receiving my booster vaccine. I was feeling body aches for about 24 hours being very intense. On the same day, my hearing was at best cloudy and it felt like I was underwater. There were days that I couldn't hear very well at all. Very muffled sounds as well. I was taking a Benadryl to see if it would release any liquid however it was not successful. I went to urgent care to get a examination, they did not see any inflammation or physical issues with the ear and so I then was sent to the ENT the week of Christmas. After the ENT examined the ear and there was no issues present physically, the audiologist stated that higher pitches were seeming to be going out. I went to get an MRI and the MRI showed no inflammation or physical issues with my ear. He suggested to see a rheumatologist and see if steroids may help. Tinnitus was still getting worse. My word recognition and hearing was improving however I still suffered from loss of frequency and tones stated the audiologist. Once every two weeks I would have my hearing checked. I was then given hearing aids and have set up a rheumatologist appointment which led to inconclusive results. 3 weeks ago I was told I have no autoimmune issues or anything surrounding them structurally. Tinnitus is still present, and hearing improves at times where I do not need the hearing aids and then intermittently need to use them when my hearing decreases.
Pt recvd vax 330PM on 2JUL91; Had intermittant high-pitched scream for 6 hrs longest interval of crying was 30min;
9/28/16 - Evening - Patient noticed her arm was itching, lifted her sleeve and arm was bright red. Very sore worse than a normal vaccine warm to the touch.
I had fever, chills, and ache all over. I was in the bed a couple of days and could get up. My doctor prescribed PAXLOVID and steroids', which we lost our appetite.
Admitted for acute on chronic hypoxic respiratory failure, tested positive for COVID-19 , also was noted to be encephalopathic initially attributed to hypercapnia.  Tx w/abx, steroids & pulm support w/noninvasive ventilation but  hypercapnia and encephalopathy did not improve hence patient was intubated. Due to lack of improvement family decided to withdraw care, patient was extubated, placed on comfort measures and expired on 01/27.
Right hand fingers tingling, now feels numb, right foot tingling a day after my hand. The sensation to both is similar when it falls asleep and prickly. My right leg keeps having sharp type of shocking sensation first started on the bottom and now more towards calf. I can?t shake the tingling sensation in my right hand or my right foot and it?s been 3 days now.
Fever started within 2 hours of vaccine to 100-101 degrees.  Lasted 3 months.  Tapered off slowly at the end.  No other symptoms.
Pt presents with c/o swelling and pain to LUE. Moderate amt of swelling to L deltoid with area of in 40 x 30mm thats radiating heat. Reports a constant pain. When movement attempted to raise arm limited ROM. Afebrile, Reports onset 2/21/01 pain easing of. Referred to OHS.
Shot was received in my left arm.  Within 10 minutes of shot, had severe pain in arm.  Nerve pain, pins and needles, ran up and down my arm and hand.  Hand and pinky finger had numb areas.  Nurse came to waiting area and I asked if this was normal.  She said some pain was ok.  This was a lot of pain.  Pain continued for a couple of days straight and then off and on.  Pins and needles in hand never fully stopped.  Also had facial numbness on left side of my face, chin and lower lip.  Upset stomach continued for a couple of weeks.  When I went for the second shot on May 27th, same nurse was there and asked about my pain.  She was going to report it.  The second shot was worse.  The pain started again within 10 minutes.  Within 30 minutes was unable to lift my arm to open the car door.  Tried to go back to work but needed to take some time off to lay down and immobilize my arm.  Pain was excruciating for hours.  Still have pain as of today.
After the first dose (end of March), I had a large red rash at the injection site which lasted almost two weeks.  After my second dose (April 20), I had an intense reaction. I was up most of the night freezing cold, leg hair standing on end, and body aching. Had to take a hot shower to cope with the chills. I finally fell asleep for two hours and woke up in hot sweats and an intense headache. I was fine by the afternoon, but developed a new and unusual symptom around 1pm -- sharp localized pains that would intermittently shoot through random parts of my body (mostly legs, but also arms and midsection). They were so bad I would keel over while standing and gasp. Each day since, they have lessened in intensity, but are still somewhat present (it is 11pm on April 26, one week later). Now, I have what I would describe as subtle, localized cramps (?) in random areas (calves, thigh, tricep, back) that come and go -- more of an ache-y sensation but widespread across my body. It is nothing I have experienced before, and only started after the vaccination.
Severe muscle pain in hamstring  and confined to area to rear of left knee extending to center of buttocks. Similar to cramp but not constant, only when using that muscle.  This was the same side that vaccine was given ( in left arm)  symptoms appeared approximately 28  hours after receiving the the injection.  Symptom persist 48 hours post injection, with only moderate improvement.
Redness, swelling and pain of injection site within 24 hours of vaccine of left deltoid after receiving Td. Last TD given over 10 years ago. 3 days after vaccine, site had mild erythema swelling and tenderness.  No induration.
Patient states her face swelled and she sought medical treatment from her PCP and was given prednisone.  She stated she would not be taking the second dose.
numbness on nose, cheek, upper left lip and gums; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (numbness on nose, cheek, upper left lip and gums) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Injected Lyft on left cheek.) on 30-Mar-2021. Previously administered products included for an unreported indication: INFLUENZA in September 2020. Concomitant products included HYALURONIC ACID (RESTYLANE) from 30-Mar-2021 to an unknown date for Dermal filler injection.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, 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 experienced HYPOAESTHESIA (numbness on nose, cheek, upper left lip and gums). At the time of the report, HYPOAESTHESIA (numbness on nose, cheek, upper left lip and gums) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   It was reported by the reported that patient has had numerous fillers in the past to her facial area. It was reported by the reporter the patient concomitant medications includes various vitamins and hormone pellets. Treatment information was not provided by the reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a male patient who received SHINGRIX. Concurrent medical conditions included convulsion disorder (well controlled, therapeutic drug level). On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the seizure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter wanted to know if any information could be provided specifically regarding SHINGRIX and seizures. The patient had a witnessed 2.5 minute seizure after receiving SHINGRIX. The reporter had submitted the report to VAERS. The reporter wanted to know if there was any information correlating SHINGRIX to seizure and wanted recommendation on whether the patient should receive the second dose of the series. If the patient did not receive the 2nd dose, what was the efficacy if only one dose was received. No further information (patient or vaccine information) was available at the reporting time.
itchiness all over; red dots on her face; break out with hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (break out with hives), PRURITUS (itchiness all over) and RASH MACULAR (red dots on her face) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced URTICARIA (break out with hives). On 02-Feb-2021, the patient experienced PRURITUS (itchiness all over) and RASH MACULAR (red dots on her face). At the time of the report, URTICARIA (break out with hives) had not resolved and PRURITUS (itchiness all over) and RASH MACULAR (red dots on her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Mom reports to Triage-1 1/2 hr after received shots. Pt. became pale, lethargic, sleeping a lot, did not check temp-could not find thermometer.
Varicella Information has been received from a physician and a school nurse concerning an 10 year old female who on 22-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 09-AUG-1996 and 17-MAY-2000. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. It was also noted that the patient's brother developed chickenpox after vaccination with varicella virus vaccine live (Oka/Merck) (WASE0510USA08935). No additional information is expected.
Pt went to a HCF for SOA today, found to have ruptured hernia, initial GCS 15. PT declined in CT at the HCF and was intubated. Pt found to be COVID positive.  Of note, facility information not available in notes, no provider info and no hospital name info.   Patient reportedly presented to the outside hospital for shortness of breath.  During his stay in the emergency department, he also was complaining of abdominal pain, which has been present and progressively worsening for the past 3 days.  He then had a sudden changes mental status following CT imaging and was intubated for hypoxia and altered mental status.  CT imaging demonstrated pneumoperitoneum with concern for perforation, likely from his large right-sided abdominal hernia.  Patient received a L fluid at the outside hospital as well as IV vancomycin, Zosyn, and was then transferred to our facility for further workup and management.  Patient also tested positive for COVID at the outside facility prior to transfer.  Was unable to conduct review of systems, other history with the patient secondary to intubation and mental status.    . He was taken to OR 1/17 for ex-lap, adhesolysis, partial colectomy, repair of duodenal perforation, vascular omental pedicle flap, intraabdominal abscess evacuation and wound vac placement with temporary abdominal closure.   On the night of 1/17-1/18,  he returned from OR on 0.04 levo and 0.03 vaso. Increasing levo requirement to 0.26. 1L bolus given. Shortly after return from OR, nursing staff noticed unequal pupils. Right pupil pinpoint and left dilated, non-reactive bilaterally. Stroke alert called. Reversed with sugammadex. CT scans were performed to rule out herniation. The team spoke with wife who did not believe that he carried a diagnosis of CHF and has never had an MI. He also has a history of detatched retina on the L and has a known history of anisocoria with a dilated L pupil. He had been having upper respiratory symptoms at home.    Overnight 1/18-1/19, he was given amp of bicarb and 1L albumin, started on bicarb gtt. Beta hydroxybutyrate was noted to be elevated 1.95. Acidosis was persistent despite bicarb, and nephrology consulted. Their recommendations were to begin insulin gtt and switch bicarb gtt from 100mEq in 1/2NS to 150mEq in free water. Levo was weaned down and vaso was turned off. EKG obtained due to episodes of tachycardia w/ concern for ventricular rhythm, shows atrial flutter.  Discharge Disposition/Condition Disposition: Morgue Condition: Expired (specify if autopsy was granted)
Severe pain/crying constipation stiffness in leg by 7=21 unable to walk and swelling in left leg.
given bivalent Pfizer booster instead of monovalent vaccine approved for 5-11 years of age
91 y.o. male patient of an MD with history of HFrEF, CKDIV, aortic stenosis, T2DM, HTN, CVA, and benign prostatic hyperplasia. Presents with shortness of breath.   Acute Hypoxic Hypercapnic Respiratory Failure Requiring 2-3L NC initially, down to RA at present  Due to pneumonia, covid, volume overload  No baseline 02 requirement - was steel worker with chronic CT changes  Stable on RA   COVID-19 With cough, hypoxemia Vaccinated, boosted  Positive 3/30 Cont decadron to finish 10d course while requiring supplemental O2/RA <94% No remdesivir due to AKI  Appreciate pulm Nebulizer on discharge with prn duonebs   Hypothermia - resolved Recurrent, requiring bair hugger rewarming No other VS abnormality Suspect related to CHF and recent infection, excessive beta blockade Decreased metop dose, with improved HR and temp Check TSH, AM cortisol; cortisol mildly low but on dex Pyuria noted, no LUTS, Ucx <10k normal flora on cefepime Off bair hugger, monitor   Multifocal PNA Sepsis Secondary to Multifocal, Gram Negative, PNA Dyspnea, cough, hypoxia and hypothermia  Repeat CT Chest w/ multifocal PNA, ? Masslike consolidation in RUL and LLL  Finished Cefepime for 7d course through 4/5 Micro unrevealing. MRSA neg   HFrEF, in acute exacerbation Aortic Stenosis NT-proBNP 13k Echo 3/16/23: EF 30-35%, grade II diastolic dysfunction, severe aortic leaflet calcification and aortic valve stenosis CXR: bilateral infiltrates - PNA vs edema Home toprol ordered; dose reduced to 12.5mg BID 4/7, hold parameters in place. 25mg succinate daily on discharge Nephrology consulted for assistance in diuresis management Still some peripheral edema, Cr climbing to 3.1 Lasix held 4/4, resume PO lasix 4/5 and continue on discharge   Chronic Kidney Disease IV Creatinine 2.55 on admission, baseline ~ 2.1-2.4 Nephrology followed, tolerating azotemia; Cr up to 3.18 with IV diuresis, down to 3.0 after transitioning back to PO lasix Renal signed off, follow up with Dr. outpatient   Elevated Troponin Likely due to HFrEF, demand ischemia 57, repeat 56 EKG non-ischemic   Lactic Acidosis LA 2.5, repeat 2.6 No SIRS criteria met on admit Monitor   T2DM Most recent A1c of 6.4 SSI Changed lantus to NPH with steroid given daytime hyperglycemia Hyperglycemia will improve off steroid, continue diet control
mild soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness in the injection site) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (mild soreness in the injection site) 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 22-Apr-2021: No specific follow-up information.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient presented with a round scab on upper arm in vaccination area. He said at first there was a raised spot where needle was injected, then it went away. A couple weeks later it felt like there was something under the skin surface in the area , so he picked at it and it bled and formed a scab. There is no pain at all, scab is healing.
4/16/2022 I have seasonal allergies, but this day I had a phlegmy cough, which is different from my allergy symptoms.  I took a home COVID test, it did not show positive. I had the PCR test, and it was positive for COVID. My symptoms were stuffy nose, minor headache, congestion and the phlegmy cough.
Developed life threatening pulmonary and leg blood clots, lung nodule - 8 mm (?)
Initial report received from healthcare professional on 07 NOVEMBER 2013. A female patient, whose age, medical history and concomitant medications were not reported, received ADACEL (lot number and expiration date unknown) intramuscularly and in left deltoid on 02 NOVEMBER 2013. On 07 NOVEMBER 2013, the patient had swollen, very sore arm, nausea, and lightheadedness. Stated can barely move arm since it is so painful. Laboratory investigation and corrective treatment were not reported. As of this report, outcome of the event was unknown. Documents held by sender: none
9 hemodialysis pts who recvd a complete course of Engerix-B failed to seroconvert; details pertaining to these pts were not available;
Patient received PNEUMOVAX in right upper arm on 1 Oct 2015 due to being told he needed PNEUMOVAX prior to receiving ZOSTAVAX. Patient said by Friday night he started having a fever, started shivering, and joints began aching. He said at 04:00 on 2 Oct 2015 his temperature reached 102 degrees F. Patient developed a significant rash around the injection site along with swelling, redness, and pain. He said by 3 Oct 2015 his flu-like symptoms dissipated. He dosed ADVIL and TYLENOL around the clock on Friday, Saturday, and Sunday. He presented in clinic on 5 Oct 2015 and had an office temperature less than 100 degrees F.
Patient reached out to PCP on 11/15/21 following his third shot on 11/11/21. Pt reports very severe pain and intense itching along arm, arm was swollen and red. Also reports headache, fatigue and shortness of breath. By 11/15 the shortness of breath was no longer occuring but states his arm is still itchy and red. Was advised to go to the ED if he had chest pain or ongoing shortness of breath. Otherwise advices to place ice wrapped in a towel intermittently on his arm to soothe the area.
Received flu shot about 8am. One hour later, R hand shaking, tingling, sharp pain at site. Went home from work, called MD on the way home-he told her that her ?. Take Motrin 3x/day, ice over R arm. She was bettter on Sunday. 11/10 except for bruised arm.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C211A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Pain. Concomitant products included ENALAPRIL MALEATE (ENALAPRIL [ENALAPRIL MALEATE]), HYDROCHLOROTHIAZIDE and CARVEDILOL for Hypertension, METHADONE and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Pain, ASPIRIN [ACETYLSALICYLIC ACID], ESTRADIOL, MIRTAZAPINE (REMERON), ALPRAZOLAM, ZOLPIDEM TARTRATE (AMBIEN) and SALBUTAMOL SULFATE (VENTOLIN HFA) for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced MYALGIA (Body aches). On 13-May-2021, MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced body aches three days after vaccination and which lasted for two weeks.No treatment information was provided.    This case was linked to MOD-2021-213295 (Patient Link).
A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis; A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An 18-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (hospitalization, medically significant), MYOCARDITIS (hospitalization, medically significant), outcome "recovered" and all described as "A 14 year old and An 18 year old were hospitalized for myocarditis/pericarditis".  Additional information: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate