chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age and gender. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Pain in shoulders and elbows have persisted for over 2 months now.  Range of motion of the right arm in particular is limited significantly die to pain.  There is dull to throbbing pain during certain times of the day even when arms are not being used.  Pain becomes more intense if arms are moved in certain ways like reaching back  or quick movements.  Pain emanates from joints but seem to affect muscles of the upper arm as well.
Headache, Myalgia, low grade fever Narrative: missed a day of work following second dose due to flu-like symptoms
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received 3 months prior to the 2nd dose, refer case US2019GSK001214). In November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In November 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced mobility decreased and muscle pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the mobility decreased and muscle pain were unknown. It was unknown if the reporter considered the pain in arm, mobility decreased and muscle pain to be related to SHINGRIX. Additional details were provided as follows: After vaccination, the patient experienced severe pain in her arm but it was still continuing and had not improved. The patient was unable to raise her arm, could not lift anything and it was painful to lay on that side. The patient did not have any redness or swelling, it was just internal muscular pain. The patient had not yet seen her healthcare professional. The reporter stated it was related to patient. The reporter did not consent to follow-up.
Adverse Reaction-right deltoid 8x8cm area of erythema, warmth, induration and pain in right shoulder and neck area.
Fever, muscle aches, upper respiratory symptoms within 24 hours after dose administered. Symptoms have continued 6 days.
Fever of 3+ degrees F, body aches, 10lbs+ water weight gained in one day, severe left arm pain to the point of tears if arm needed to be moved (carried in a sling for 24 hours). Extreme fatigue, unable to attempt normal ADLs, dizziness, brain fog, joint pain (worst in wrists, ankles, knees, hips and neck).
Dizziness, weakness, light headed, loss of balance. Lasted 48 hours and then got some better. No treatment. It is now 4 days later and I still feel the same symptoms slightly.
1st dose:  chills, felt very bad on couch first day after.  extreme muscle aches the second day and was debilitating. 2nd dose:  same symptoms & timings.  However; 2nd day my left eye lid started twitching uncontrollably and constantly.  I mentioned this to many people.  It slowly diminished over two weeks and went totally away. 3rd Booster shot:  30 hrs after got the muscle aches again.  36hrs my eyeballs started moving from center to the right @ 5% or so constantly and uncontrollably.  It made me dizzy, sick & had vertigo.  I went to bed at 6:30pm because I felt like I was hit by a bus.  Next morning I am still very sick & eyes still warbling bad.   muscles aches diminished by 3pm and warbling is not as bad but still a problem.  Monday morning I feel great but I still have some eye warbling issues.  It's the afternoon and I have to report this.
Patient was vaccinated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAV (Havrix) (batch number T035721, expiry date 15th April 2022) for prophylaxis.   On 18th May 2022, the patient received Havrix. On 18th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: The HCP (health care professional) reported that a dose of Havrix was given indivertibly to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Havrix dose which was already expired on 15th April 2022, which led to expired vaccine used.
Client received her 1st dose of Moderna COVID vaccine lot # 021C21A at 1852 by agency.  At 1901, ancillary stayed with client as Medic came to Lead office to alert Co-Lead RN that the client was complaining of dizziness and shortness of breath. 15 seconds later, Co-lead arrived in vaccination room #10 and visualized the client sitting in a chair, drinking a bottle of water.  Client stated "I feel a little warm" and asked "can I lay down?" Zero-gravity chair was retrieved as well as an EMT at 1904.  We then assisted client to the zero-gravity chair and placed her in trandelenberg position with her feet elevated. Client denied headache, nausea, and chest pain.  She stated that the dizziness had passed, she was no longer short of breath and she was feeling better.  She stated she had eaten and drank fluids within the past couple of hours before her vaccination. Client explained that "this happens sometimes with medical stuff", "I'm sometimes anxious" and "just last week I almost passed out when I donated blood".  Client denied any medical hx, current conditions, medications, or allergies.  Preliminary vital signs were taken at 1906 and were: BP 110/86, HR 58 (her normal, she stated she is a runner), O2 Sat 100%, and RR 18.  Client was then asked if she felt well enough to walk, and when she responded yes and was then escorted to the Observation Room which she ambulated to with a normal, steady gait.  Client denied needing a ride home, and stated she lived 7 minutes away and would have no problem driving as she felt fine.  Co-lead RN consulted Clinical Care Coordinator who advised IR but no VERP as this was a near syncopal episode with client's history of anxiety with medical procedures. Client was educated by Co-lead RN to stay for 30 minutes and to call 911 or go to the ED if she experienced any signs or symptoms of a vaccine reaction after she left the vaccination site with examples provided such as SOB, hives, tachycardia, and chest pain.  Co-lead also advised client to f/up with her PCP for further evaluation if needed.   EMT took a final set of vitals at 1930: BP 116/82, HR 68, O2 Sat 99%, and RR 16.  Co-lead observed client with an improved color and no complaints as she departed the Observation Room independently with a normal, steady gait at 1933.
Headache, Fever, Nausea Vomiting,  @ 1500 falling asleep, 2000fever, hand pain; mid night fever of 102.  Narrative:  Employee taking OTC tylenol. Highest fever @ midnight 102.0, symptoms of fever and left hand pain, h/a present but improving. Advised these are normal symptoms. Seek medical attention for worsening or persisting symptoms >48 hours, rest and hydrate. Update EH and Supervisor
This spontaneous report was received from an immunization coordinator referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of ZOSTAVAX Lot#: L011529, expiration date on 03-JUL-2016, lot# L024999, expiration date on 06-OCT-2016 and lot# M001746, expiration date on 07-APR-2017 (strength, dose number, route of administration and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were previous excursions reported as 13.1 degrees Fahrenheit for 3 hours 10 minutes and 7 degrees Fahrenheit for 2 hours, 50 minutes. It was reported total cumulative time out of range 6 hours 30 minutes. This is one of several reports received from the same source. Additional information has been requested.
Fever/achy/severe headache/nausea. Severe headache started in back of head ended up on top and eyeballs. Ibuprofen Tylenol and prescribed pain medication. Had shot on 7/21/06 by 7/22/06 very sick, lasted 1 week.
exhaustion; my arm became red and swollen; my arm became red and swollen; chills; muscle ache; headache; racing heart; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left on 10Apr2021 as dose 2, single for covid-19 immunization. Patient relevant medical history includes high blood pressure and bee sting allergies. The patient known allergies hydrocodone and levequin. The patient concomitant medications includes Hydrochlorothiazide (Hctz 25mg). The patient was not pregnant at the time of vaccination. Patient receive other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: Er8727), dose 1, administered in arm left on 03Mar2021 11.00 Am for covid-19 immunization. The first dose the patient had only a sore arm but a couple of weeks later, was severely fatigued. With the 2nd dose, her arm became red and swollen the next day on 11Apr2021 and on 11Apr2021, the patient also experienced chills, muscle ache, headache, racing heart and total exhaustion. After 4 days, arm was still red, swollen and itchy. Still exhausted with racing heartrate. The patient did not received any treatment for adverse event. The patient did not had covid prior to vaccination. The patient did not tested for covid post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pt developed tingling around mouth and cheeks as well as itching in on the right Shin.  Treatment: Cetirizine 10 mg PO and an addition 30 minute observation.  The pt felt better after the additional wait time, vitals signs stable  She was released home.
I had an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had an adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had an adverse reaction). At the time of the report, VACCINATION COMPLICATION (I had an adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
rapid COVID-19 antigen test Positive; Soreness of the left arm/extreme pain on the left arm; drained out; Fever 99.5-99.7 F; Body aches; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), COVID-19 (rapid COVID-19 antigen test Positive), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm) and FATIGUE (drained out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm), FATIGUE (drained out) and PYREXIA (Fever 99.5-99.7 F). On 11-May-2021, the patient experienced COVID-19 (rapid COVID-19 antigen test Positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-May-2021, PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm), FATIGUE (drained out) and PYREXIA (Fever 99.5-99.7 F) had resolved. At the time of the report, COVID-19 (rapid COVID-19 antigen test Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter.
within 7 days of the vaccine pt broke out in whole body hives, fever, cough, n/v/d, loss of smell, loss of taste, total fatigue as her symptoms kept worsening and she felt horrible she came into my office (PCM) at the time of the appointment SOB with minimal exertion, fever, tachycardia, tachypnea and hypoxia noted, upon assessment diminished lungs sounds bilat lower lobes, tachycardia regular, febrile, tachypnea, lethargic. She appeared to be very ill and distressed. temp 101.8, R22, HR 110, bp 110/62, sats 96% after sitting for 10minutes. During exam she repeatedly had dry cough and got very winded while speaking.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 22-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC Found.  This is one of several reports received from the same reporter.
minor fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (minor fever) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (minor fever). At the time of the report, PYREXIA (minor fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2022-437875 (Patient Link).
Patients were given the incorrect formulation of COVID booster.  They were given the original formulation and should have received the bivalent booster dose.  Patients were contacted and made aware of the error.
4 1/2 m/o female dx with Kawasaki Disease.  Symptoms began 1/4/08 - fever x5d, rash, scleral injection change in mucous membrane.  Labs consistent with Kawasaki disease.  Increased ESR-67, increased plat 445, negative blood, urine, CSF cultures, rapid Strep, echo with diffuse dilation of coronary arteries.  Hospitalized 1/11-1/15 then another hospital 1/18-1/19.  Received IVIG, aspirin.  Cardiology consult. 4/11/08-records received -admitting DX Incomplete Kawasaki. Presented to PCP 7 days prior to admission with C/O red rash on extremities, torso and temperature of 103. Admitted for 5 days. LP, blood and urine culture negative. Injected sclerae. Beefy red tongue and lips. Irritable. Seen in follow-up 1/18/08- irritable. Exam normal except for fissuring of lips and puffiness of feet. No fever.
ACHY EVERYWHERE; COULDN'T SLEEP; FEELS HORRIBLE; FEVER; NAUSEA; This spontaneous report received from a parent concerned a 22 year old male. 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, administered on 03-AUG-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the subject experienced achy everywhere. On 03-AUG-2021, the subject experienced couldn't sleep. On 03-AUG-2021, the subject experienced feels horrible. On 03-AUG-2021, the subject experienced fever. On 03-AUG-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, achy everywhere, and feels horrible, and the outcome of couldn't sleep was not reported. This report was non-serious.
Pt recv vax on 11/9/98; on same day pt exp tachycardia, high blood pressure, tingling hands, stuffy ears, tight throat
T78.40XA ALLERGIC REACTION, INIT 11/18/2022 ATYPICAL LIPOMA, SOFT TISSUE
Pain in left shoulder, left clavicular area, and left neck. Still experiencing 5 days after injection. No pain at injection site.
Redness and bruising appearance at injection site reported by patient, gradually improving over 10 days. Patient reported 10-11-2013.
Pain and swelling in the injection area after injection, and lasted 3 days. Fever at the night of injection and subsided next morning.  I considered these normal and did not worry. However, pain in the injection area came back after 10 days of injection and continued to date (over a month), with no signs of stopping. No redness or swelling in the area, but the pain is constant and sometimes radiates to my shoulder and elbow.
infant's mom recv vax 4 days prior to conception;pt was born w/anencephaly & died @ birth;
Sudden onset of unmeasured fever in early AM of 03-10-06, accompanied by one vomit in AM. Parent feels that injection site in the right thigh is warm, red and tender. Incidental hyperemic enlarged tonsills on physical exam 3-10-06.
Pt. called stating arm, red, swollen & hot to touch: Advised pt. to put ice over areas. No more than 10-15 min at a time.
Fever; chills; joint pain; back pain; nausea; This is a spontaneous report from a contactable other health professional (patient reported for herself). A 70-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in left arm on 02Feb2021 at 03:45 PM (at the age of 70-year-old), as unknown dose, single for COVID-19 immunisation. The patient medical history included COVID prior to vaccination. The patient other medical history included hypothyroid and diabetes metabolic syndrome. The patient had non known allergies. The patient concomitant medications were not reported. The patient did not receive other vaccine in four weeks. On 03Feb2021, after the vaccination, the patient experienced fever, chills, joint pain, back pain, and nausea. The patient was not tested for COVID post vaccination. The patient had a visit to physician office for the events. The patient did not receive any treatment to treat the events. On an unspecified date in Feb2021, the patient was resolved from all the events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Hypotension; light-headedness; mild headache; unsteadiness; dose number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "CKD" (unspecified if ongoing); "OA" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 29Aug2022 as dose number unknown, single; LIPITOR; BENICAR; SYNTHROID; GLUCOPHAGE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL1283, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: EL9265, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FC3184, Anatomical Location : Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot Number: FP4554, Anatomical Location : Left Arm), for Covid-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Sep2022 at 09:30, outcome "unknown", described as "dose number: 5"; HYPOTENSION (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered"; DIZZINESS (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "light-headedness"; HEADACHE (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "mild headache"; BALANCE DISORDER (non-serious) with onset 23Sep2022 at 07:30, outcome "not recovered", described as "unsteadiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypotension, dizziness, headache, balance disorder.  Additional information: The patient had no known allergies. Prior to vaccination, the patient had not have COVID. Post vaccination, the patient had not been tested for COVID.  Follow-up attempts are completed. No further information is expected.
07/15/2022 I tested  positive for COVID-19. I had sore throat; stuffy nose; and low grade fever. Same day I did a tele heath with my doctor who prescribed with PAXLOVID  for 5 days.
11:45 PM c/o SOB, 10/10 chest pain, diminished bilateral breath sounds    T 101, HR 120, 20  O2Sat 88-89% RA.  3L O2 applied, sat went up to 95%.  BP 160/80  Tylenol given transferred to ER.  CXR done patchy infiltrates seen ,  CT of chest showed Cardiomegaly, Cardiac Troponin and EKG were negative.  DX on admission was Acute Respiratory Failure with hypoxia.  Sinus Tach.  Suspected due to Covid Vaccine Booster.   FYI  Resident was Covid + in March of 2020.