chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia; Chills; This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (For tolerance of 1st dose, refer case US2022AMR144027).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the myalgia and chills were unknown.   It was unknown if the reporter considered the myalgia and chills to be related to Shingrix.  Linked case(s) involving the same patient:US2022AMR144027   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: The reporter mentioned that, she gave the Shingrix to a patient and he mentioned that, he had myalgia and chills.  Also stated that, he experienced less severe after the 2nd dose of Shingrix. The reporter stated that the side effects that the patient experienced were less severe after the 2nd dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR144027:Same reporter
Sluggish feeling; Headache; Chills; Not feeling well / unwell; Pain in my arm; Little bit tired; Head is little bit in a fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SLUGGISHNESS (non-serious), outcome "unknown", described as "Sluggish feeling"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well / unwell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in my arm"; FATIGUE (non-serious), outcome "unknown", described as "Little bit tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Head is little bit in a fog". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sluggishness, headache, chills, malaise, pain in extremity, fatigue, feeling abnormal.  Additional information: The patient took Ibuprofen as treatment of the events. The patient went to a doctor just to check the blood pressure and he was informed that he was totally fine. The patient was asking if how long does the symptoms or the adverse reactions will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated w/Pneumococcal developed diffuse swelling, redness & pain of rt arm within hrs of injection.
35 mm erythema -no inguinal adenopathy. Amoxicillin 250 mg/5 mL - take 6.2 mLs po BID.
Beginning four hours after injection, began developing rashes: initially left middle finger became itchy, raised erythematous, weeping, progressed to eventual desquamation down to dermal layer. Over several days to week developed facial rash appearing atopic, weeping. Bilateral nipple rashes: pruritic, lichenified, weeping. Bilateral thighs with annular erythematous pruritic, now lichenified lesions. Initially thought to be herpetic whitlow when just affecting finger--HSV culture sent, rxd antiviral. Ultimately was rx'd prednisone course (5d 40 mg) today, 5 weeks out.
09/07/2005 client started breaking out in raised red rash with white puss head in center, top of hands top of feet, fore head and near 1 eye on 09/04/05, 18 days after receiving chicken pox varicella vaccine. 50-60 spots on 9/08/2005 noted, afebrile, not itchy ore sick acting.
Pt developed generalized itching and erythema and hives on neck, arms, and upper torso after receiving vaccine. No respiratory distress. Was given 0.3cc Adrenalin 1:1000 SQ and benadryl 50mgmpo and observed for one hour. Symptoms subsided after treatment.
74-year-old presents from outside nursing home to this hospital's emergency room with shortness of breath and EMS transported the patient to hospital.  He was in respiratory distress upon arrival.  He was intubated by ER physician.  Patient was hospitalized at Hospital and  diagnosed with COVID-19 2 weeks ago.  He also has ischemic cardiomyopathy with very low ejection fraction. He became hypotensive after intubation.  Pt is now on IV pressors & has a central line in place.
rashes / welts on legs, stomach ulcer, arm pain, muscle fatigue, chills, dull pain under the injection arm's armpit
Discharge Provider: MD Primary Care Provider: PA-C Admission Date: 10/7/2022 Discharge Date:  10/08/2022  PRESENTING PROBLEM: Hypoxia  Altered mental status, unspecified altered mental status type  COVID-19 virus infection  COVID-19    HOSPITAL COURSE: Patient is an 83-year-old female with medical history of heart failure with preserved ejection fraction, type 2 diabetes mellitus, CKD stage 4 and obstructive sleep apnea.  Patient presented 1 day ago for altered mental status and COVID-19.  Patient stated that overnight she felt foggy and confused and when she woke up she was still experiencing this.  Patient does have history of sleep apnea but is insistent that she is using her CPAP correctly.  When patient came to ER was found that patient was positive for COVID-19.  Patient was originally hypoxic satting 86 on room air him briefly requiring 2 L nasal cannula.  Patient only required oxygen with exertion and was satting comfortably on room air in the mid 90s otherwise.  Because patient did not have true oxygen need, no steroids were prescribed.  Additionally patient's kidney function ruled her out for remdesivir.  Patient additionally was complaining of lower abdominal pain however CT abdomen did not reveal any acute processes.  When patient moved to floor patient was satting comfortably on room air.  Patient's confusion had completely resolved.  Patient's abdominal pain had completely resolved.  Patient did well overnight and use CPAP as prescribed.  Patient did fall asleep well CPAP was off and that did result in some confusion however this quickly resolved.  Patient passed her ambulatory pulse ox and continued to sat at 94.  Patient is stable for discharge home.
77 yo female with multiple medical issues significant for Addison's disease, h/o CVA with mild right side weakness, markedly decrease her executive functions, vascular dementia (at baseline, she is alert and oriented, ambulates with assistance from other person, cannot safely uses a cane or walker) who presented with weakness and confusion.  Patient is living at home with her husband and son.  She is fully vaccinated for COVID with 3 doses of Pfizer.  Her son developed flu like symptoms around Christmas time.  Husband noted patient was having dry cough on Monday.  On Tuesday, patient was extremely weak; husband could not get her up.  He gave patient extra dose of Hydrocortisone then brought her to our ER however it was extremely busy.  Patient was confused, kept taking off her mask and it was cold.  He decided to bring her home.  After getting home, patient slept for 13 hours straight.  This morning, her son took her temp and noted it was 103 therefore they call EMS and brought patient back to the hospital.  EMS noted patient was hypoxic 88%; placed on oxygen.  Husband did not noted any diarrhea, nausea/vomiting.  No sob.  Patient did not complaints of chest pain.  She has urinary incontinent.     Patient was alert and oriented x 1 when I saw her.  Patient was able to follow directions.  She felt fine, denied of having chest pain, sob.  abd pain, nausea/vomiting.  No dysuria.    In ER, tmax 102.5, 99% on 4L NC.  sbp 104-160, HR 64-83.  cxr without infiltrate.  Labs without leucocytosis.  Urine analysis with + Nitrate, 4+ bacteria, 5 wbc.  COVID swab is positive.  She was given hydrocortisone 100 mg IV.  1.75L NS and Cipro."   Work up was consistent with sepsis due to COVID infection and possible UTI.     Sepsis:  Secondary to COVID infection and possible UTI.  She was noted to be hypoxic by EMS to 88%, patient was initially placed on 3L oxygen but then down to room air.     Covid symptom onset on 12/28. COVID positive on 12/29. Last fever on 12/29. - Was on supplemental oxygen via NC initially but has been on room air since 12/30.  - 5 day steroid course completed. - 5 day Remdesivir course completed as well. - No respiratory symptoms and not hypoxic. - continue isolation for 10 days total, through 1/7/22.   - Completed 5 day course of Cipro for UTI.  Urine Cx grew E Coli susceptible to cipro.     Weakness and confusion:  Are likely from acute infection in the setting of dementia.  Confusion is stable but she is still weak.  Working with PT who still recommends SNF. Addison disease:  On Hydrocortisone 20 mg qam/10 mg qm, florinef 0.1 mg.  Will hold Hydrocortisone while on Decadron 6.   Dementia:  Patient is continues to be calm and appropriate.  However delirium risk continues to be high.  D/wed husband who understands.  Unfortunately with active covid infection, family cannot visit.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The pharmacist informed that on 14-AUG-2014 the patient was inadvertently vaccinated with an expired PNEUMOVAX 23 injection 25, 0.5 ml, lot # J009827, expiration date; 10-AUG-2014 (route was not reported). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
PATIENT GOT PFIZER 1 ST DOSE THEN REQUESTED MODERNA FOR 2 ND DOSE
Pfizer-BioNTech COVID-10 Vaccine EUA.  Patient received his 2nd covid vaccine and felt like the middle of his tongue was swollen.  Zyrtec and pepcid administered.  10 minutes later patient reports some improvement.  No difficulty swallowing or shortness of air. After 25 minutes patient reports no swelling and mild tingling, which continues to improve.
Case number PHEH2014US004175 is an initial spontaneous report from the nurse received on 26 Feb 2014. This report refers to an 11-years-old male child. Past medical history and concomitant medications were not reported. On 11 Feb 2014, the child was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO (batch number: M13013) and did not receive Men A lyophilized conjugate. It was reported that the child did not experience any adverse event following this administration error (inappropriate preparation of medication).
Redness, rash  under chin, swollen white spots by lymph nodes under chin, some neck rash Took Benadryl and went away
Chills, shivers, extreme fatigue, nausea, vomiting, diarrhea, abdominal pain, headache. Ibuprofen and Tylenol had little effect. Zofran helped nausea a tiny bit but causes constipation. Side effects lasted 8 days....could not work/care for grandson and family five of those days
Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021   In a retrospective chart review that was conducted, Patient 8, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA undetectable, CD 4 count 663 cells/uL, CD 4 35%, positive for anti-HBc and negative HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Painless red dime-size lesion on l clavical, appeared on day 4 post vaccination. Mild itching, never became pustular, faded by day 11 post vaccination.  No other systemic symptoms.  Vaccination lesion WNL.  Vaccinated for post exposure to monkey pox.
pt recvd vax lt deltoid 18OCT93 site aching p/vax; 19OCT993 aching, sore throat, lt side neck 730AM by 8PM chills, vomiting, h/a 20OCT93; chills alternating w/sweating; weak couldn't stand up; unability to focus x 3 days;
Dose #2 on Sunday 8/1/2021, decedent expressed no medical complaints at that time. However, on 8/2/2021, decedent told his wife that he "wasn't feeling good" but went to work as a landscaper anyway. On 8/2/2021 at the end of the work day, the decedent had a witnessed collapse and CPR was initiated by bystanders.  Paramedics found decedent to be in vfib and defibrillated and subsequently intubated.  Epi given every four minutes, Amiodarone between epi.  Decedent was found to be in asystole and back to vfib and shocked again.  Second dose of Amiodarone was given and Narcan and decedent went into PEA.  When bicarbonate was given, decedent back into vfib, shocked and back into PEA until pronounced at 1805 hours.
High fever 103-104 x3 days, pt state it states 12hour post to H1N1 Vaccine
temperature excursion that exceeded the stability data with no reported adverse event; administered to patient after excursion with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 24 years old and unknown gender patient to whom administered influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose] after excursion with no adverse event and temperature excursion that exceeded the stability data with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 22-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED at an unknown dose (lot UJ899AA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On 22-Sep-2022 there was temperature excursion that exceeded the stability data with no reported adverse event (product storage error) and administered to patient after excursion with no adverse event (poor quality product administered) same day following the administration of influenza quadrival A-B multidose vaccine preserved.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
Pt reports diarrhea, nasal congestion, cough with green phlegm since Friday 4/9/21.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-MAY-2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-SEP-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
got very ill; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.   This case involves female patient (unknown age) who got very ill (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got very ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, she stopped taking flu shots and did much better without getting them. No one could ever explain why she got so ill after getting a flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Pain, redness, induration and heat > 2" at site - afebrile, temp 98 degrees (2.25 inches diameter) - BP 138/98, subjective c/o fatigue, "feels chilled" generalized "not feeling well" treated for possible cellulitis w/ BACTRIM DS.
Nausea beginning Sun Dec 20, in the late afternoon. Vomiting around 6:00 PM. Nausea a bit relieved then, but persisted until Mon Dec 21 evening.  Headaches noticed daily until Dec 27. Soreness in arm for only a few days.
After my 2nd dose I got all covid symptoms which lasted for 3 days; After my 2nd dose I got all covid symptoms which lasted for 3 days/cough lasted for a month and I still have no got my taste back. My lymph nodes were swollen under my right arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 2021 (Batch/Lot number was not reported) as 2nd dose, single dose, dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021, after my 2nd dose I got all covid symptoms which lasted for 3 days. They cough lasted for a month and I still have no got my taste back. My lymph nodes were swollen under my right arm. It's been 3 months and I can't taste. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event for the past 3 weeks. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
At time of vaccine administration and per the completed CDC pre-vaccination checklist, family states that patient had only 2 prior doses of Pfizer COVID-19 vaccine. After vaccine administration it was discovered that per our vaccine registry that patients record showed 3 prior doses (last dose on 12/30/21). Family is adamant that this vaccine dose was not received as patient left prior to vaccine admin, but after following up with vaccinating facility this pharmacy stated that it is not possible for them to have this documentation if the patient didn't receive the vaccine.
Systemic: Allergic: Itch Generalized-Severe, Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tachycardia-Mild, Additional Details: AT 6:09 BP WAS 120/64, O2 WAS 98%, AND HR WAS 86, TAKEN AGAIN AT 6:16 BP WAS 12/70, O2 WAS 100 AND HR WAS 89.\r\n\r\nPT SAYS NO REACTIONS TO VACCINES BEFORE, SAYS HER LIPS ARE ITCHY, THEN HER BODY BECAME ITCHY, FELT NAUSEAS, GAVE HER LIQUID BENADRYL 20ML (50 MG), CALLED 911 AT 6:15, THEY CAME AND WE STAYED WITH HER UNTIL THEY TOOK HER.
1. Limited/painful range of motion of arm; 2. Following day, fever, chills, body aches; arm quite swollen/red/aching/unable to lift/carry. 3: By day 3, general flu-like symptoms lessened, but arm remained red/swollen/achy. 4. Day 4 (Monday) sought medical dx--adverse reaction with cellulitis.
This non serious was extracted from the VAERS database via QScan on 11 March 2009 (reference number 297137). A 57 year old female patient received an intramuscular injection of Fluzone SV 2007-2008 (lot number U2511AA) on 15 January 2007. At 6:00 PM on 15 November 2007 (corrected on 16 April 2009) the patient developed a dry cough with a tickle in her throat and swollen glands in her neck. At 6:30 PM her eye became bloodshot, swollen, itchy, breathing was shallow and rapid. At 8:30 PM the patient developed headache and felt chilled. At 2:00 AM the patient complained of a headache. She did not seek medical care. The patient was reported as recovered.
After the initial injection site pain, two to three days later my wife developed tinnitus for three days, and continuing arthralgia and neuropathy in her shoulder with nerve pain radiating to her neck, elbow and fingertips.  It is now eleven days after the vaccine administration, and my wife continues to have arthralgia, myalgia, and nerve pain in her left arm where the vaccine was administered. Today she has an appointment with her primary care physician.
PT HUSBAND STOP BY THE PHARMACY TODAY AND SAID THAT AFTER 3 MONTHS SINCE THE VACINATION, PT ARM IS STILL SORE/PAIN. PT IS TAKING ASPIRIN FOR THE SORENESS BUT THE SYMPTOM DOES NOT GO AWAY.