chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse, concerning an unspecified number of patients (patient's demographics not provided). Registered nurse first, requested temperature stability data for several vaccines. Then, stated that she believed that an unspecified number of patients may have received improperly stored M-M-R II (lot #, expiration date, route and dose were not reported). No symptoms reported. This is one of two reports from the same source (MARRS: 1401USA014578). Additional information has been requested.
Pre- Anaphylaxis, Severe prolonged Asthmatic episodes, Fever (103) Severe diarrhea
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD rHA, lot # R002937, expiration date 29-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393.
This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported) (total daily dose not specified). The patient stated she had pain at the site of insertion, after receiving the ZOSTAVAX vaccine. The patient did not seek medical attention. The outcome of pain at the site of insertion was unknown. Additional information is not expected.
Moderna COVID Vaccine given on 8/13/2021, due to data entry error, we gave Pfizer Vaccine for second shot on 9/10/2021.  Patient did not have vaccine card with her.  Pharmacist reported to physician and is waiting for response.  Patient noticed the discrepancy when she returned home and looked at her card.  Pharmacist will follow up with patient next week.   No side effects noted as of yet.
no significant past medical history who presented to the emergency room with complaints of shortness of breath and positive COVID-19 test.  Symptoms started on 12/20/2021 and per ER note tested positive for COVID-19 on 12/22/2021.  He has been having fevers, chills, shortness of breath and worsening dyspnea on exertion, no nausea or vomiting, some diarrhea, poor appetite, no lightheadedness or dizziness, nonproductive cough.  Patient came into the emergency room today because his symptoms had worsened to the point where he was more short of breath than he has been before. 12/30/21  He was found to be hypoxic and initiated on supplemental oxygen.  His chest x-ray showed fairly extensive patchy and groundglass infiltrates throughout both lungs.  He was initiated on IV steroids.  Procalcitonin was checked and this was negative.  No indication for antibiotics.  His inflammatory markers were followed.  COVID POSITIVE 1/3/2021 He was advised proning and incentive spirometer use.  On initial admission since he was within the 10-day window, he was also advised tocilizumab treatment which he declined.  Slowly his oxygen needs improved.  He was able to be completely weaned off of oxygen.  He was discharged in stable condition with recommendations for continued isolation and follow-up as outpatient. DISCHARGE DIAGNOSES: Acute hypoxemic respiratory failure due to COVID-19 viral infection Hyponatremia Mild thrombocytosis
This report was received from a physician reporting that the patient was a female of an unknown age, who in September 2012 (a few weeks of each other patients) was vaccinated with subcutaneously with a 0.65 ml dose of ZOSTAVAX. It was confirmed that the lot number was HO11333. No other co-suspects therapies were reported. No concomitant medications were reported. It was reported that in September 2012, the patient experienced injection site reaction and pain. The physician suggested treat the injection site reaction by applying cold compresses and to take TYLENOL for pain. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for injection site reaction and pain was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a nurse concerning a12 year old female with no allergies who in 2007 was vaccinated with GARDASIL (lot # not reported). In September 2007, 11 months ago, the patient experienced headaches. The patient's headaches persisted. The patient sought medical attention seen by the physician. Additional information has been requested.
Paralyzed soft palate for 26 days and paralyzed right vocal chord for 2 1/2 months and counting
Localized Rash, Redness, sore, knot, warm to touch.
Bourse after injection the site became red, sore, hot to the touch, itchy, tender, and painful. The redness and soreness continued to spread up to my armpit and down to the elbow. The entire area was all of the above descriptions. The pain is a stinging and burning sensation with constant itching and some dull pain. I was also very fatigued, having headaches, body aches, joint pain,  nausea, and fever of 101. I visited the emergency room Sunday morning to be evaluated. They performed an ultra sound and found liquid buildup and prompted them to administer an injected antibiotic and take-home antibiotic medication.  It has now been over 24 hours since ER visit with minor improvement of symptoms.
19July95 recv 1 dose vax. 17Jan98 Pt exp "breakthrough rash", well over 100 lesions. All over mouth, eyes, everywhere.
Patient was inadvertently administered the Moderna Vaccine Patient is only 16. Patients fathered signed the consent
4 weeks after getting the second shot, I am Covid positive again with pneumonia this time. I first had Covid Dec 2020
had pneumonia; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 14Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization; Pneumonia shot (when I have the Pneumonia shot before, I had my flu shot on one arm and pneumonia on the other arm.), for Immunization; Flu shot (when I have the Pneumonia shot before, I had my flu shot on one arm and pneumonia on the other arm.), for Immunization. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "had pneumonia"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "sick". Clinical course: Consumer stated that she got the 2nd dose of the Pfizer Biontech Covid-19 Vaccine on 14Aug2021. Consumer also stated that " she had pneumonia bef.. she did not have pneumonia, when she had the Pneumonia shot before, she had her flu shot on one arm and pneumonia on the other arm. Both of those were due now. She could not go in Nov because she was sick but they were due now." Caller says that she did not think that she had contacted the right department and she doesn't know which one was the one she was supposed to do but she has had the 2 shots already and she was due for the booster shot and she was wondering if she could get that now. She had her last dose on 14Aug2021. Product clarified to be the Pfizer COVID 19 vaccine. She had already had dose one and dose two. Also she was close to the time for her regular doctor appointment, it was a month away, 21Feb2022. She usually had her pneumonia and flu shot together in the month of Nov every year she couldn't come out at that time because she was too sick, she was 85 years old, and she wanted to know when she get her booster could she gets those 2 with it. Other Products were not provided.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient received vaccine with her siblings. No history of dizziness or fainting previously. She went to join her siblings while mother asked about how long they should wait, and while we spoke child passed-out and fell into a fixture. Mother indicated she herself has a history of dizziness, fainting with needles but had not indicated child ever experienced this though she said she had been nervous earlier about getting vaccine. Pharmacist examined child because child hit her leg and head on a fixture as she fell, but no cuts or anything are visible. No medical attention has been sought as of this point in time.
pt recvd vax 28JAN93 & devel a yeast infect; No further details were provided;
It was discovered after Janssen dose was administered that Patient had received 2 doses of Pfizer (4/25/21 & 5/16/21) and 1 dose of Moderna on 1/27/21 prior to receiving this dose. Patient did not experience signs or symptoms and was monitored for a longer than 30 min prior to leaving facility.
We had a student that was vaccinated on Friday the 23rd and immediately became ill, signs when she left were extreme hot feeling and heavy limbs which she reported but was told that was fine and could leave.   She went directly home and symptoms continued - very hot, sweaty, heavy feeling,  literally slept for 12 hours and woke to total body heaviness and all around not feeling well
Respiratory alway clearing her nose, in the hot weather she get sexual acting. Can learn but do it very slow. Shrinking eyes.
A report has been received fr om a Physician concerning an 11 month old, Female subject who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that FLUMIST was administered to 11 month old which started on 28-NOV-2012. The outcome of the event of FLUMIST ADMINISTERED TO 11 MONTH OLD is unknown. The report was considered to be non-serious.
Information has been received on 12-JUL-2017 from consumer via a company representative regarding a female patient of unknown age, reported as over 65 years old. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, reported as two weeks ago, the patient was vaccinated with ZOSTAVAX (lot number and expiration unknown), subcutaneous for the prevention of shingles. The patient reported that when she returned to work "shortly" after being administered the ZOSTAVAX injection "two weeks ago" at a pharmacy, she noticed that the injection site was very red and warm to the touch. The redness and warmth lasted for about one week. The patient applied ice to the injection site. The patient also reported a little itching at the injection site, but "nothing uncontrollable". The patient took no medication for the adverse event. No further information provided. The outcome of application site warmth, injection site pruritus and injection site erythema is unknown. The causality was not reported. Additional information is not expected. No consent to contact the physician.
BRONCHITIS; VOMITING; NAUSEA; SORE LEFT ARM; BODY ACHES; POSSIBLE UTI; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hidradenitis suppurativa, penicillin allergy, latex allergy, and overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total was administered on 12-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, the patient experienced body aches, chest pain, intermittent dyspnea, and sore left arm, which resulted in hospitalization. Patient was hospitalized on 13-APR-2021. The patient was discharged on an unspecified date. Patient went to another hospital as patient's symptoms did not subside. On APR-2021, the patient was diagnosed with bronchitis. Patient was not able to provide admission and discharge date. On 25-APR-2021, the patient experienced vomiting and nausea. Patient was additionally in contact with her health care professional regarding a possible urinary tract infection and/or yeast infection. Patient was not having any problem before the vaccine, even though patient can't say the Janssen Covid-19 vaccine caused her issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and sore left arm on APR-2021, and vomiting, and nausea on 26-APR-2021, had not recovered from intermittent dyspnea, and the outcome of bronchitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210413562- covid-19 vaccine ad26.cov2.s-Bronchitis,bodyaches. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I am hurting in between my breast like a type of soreness but yet sometimes I feel little pain is going between my two breasts; I am hurting in between my breast like a type of soreness but yet sometimes I feel little pain is going between my two breasts; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2) formulation solution for injection, unknown dose, via an unspecified route of administration on 14Mar2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, she got the COVID Vaccine (reporting before day) yesterday and it may be about an hour and half she been having, they are not actual chest pain, but she was hurting in between her breast like a type of soreness but yet sometimes she feels little pain was going between her two breasts. She doesn't know that was why she called you. In response to further probing, consumer stated, "You know what never mind. She just holds it out." And hung up abruptly. Consumer hung up the call abruptly, hence, product details (LOT#, expiration date, NDC# and UPC#) reporter type and other details were unknown. Limited information was available over the call. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot been obtained.
Resident had the COVID vaccine 12/30/2020. 12/31/20,  resident has been in bed all shift. Staff became concerned when resident was not easily aroused. Resident displayed signs of tremors, twitching, confusion, in and out of consciousness, low O2 sats, elevated pulse and fever, fatigue and weakness. Writer called NP. NP stated this is most likely a reaction d/t the COVID vaccine. She gave orders for Benadryl 25mg IM x1 now and Tylenol 1000 mg now. NP also stated resident will not be getting the second dose of vaccine. Will continue to monitor and update NP if worsening symptoms.   After receiving Benadryl and Tylenol at 145pm, resident began to appear as though she was feeling better and was talking to talk, fever had gone down. Tonight resident is not easily aroused, lethargic, continues to have tremors and twitches, almost appearing as convulsions. When asked if she knows where she is or what day it is, resident can properly answer. Resident denies SOB but staff has noted loud squeals while breathing. NP was updated and gave new orders to give Benadryl 25 mg IM x1 if needed and Ok to send resident to ED. Resident currently refuses to go to the hospital. Will continue to monitor. BP 152/112, P 116, T 99.1, O2 87-91. Resident's O2 at 1205am was 80% on 3LPM. Resident unable to be aroused from sleep by writer. NAR called to assist. NAR could not arouse resident. Writer and NAR attempted to reposition resident and resident's breathing became more labored. Resident turned back to previous position and writer called on call MD at approx. 1220am. MD returned call approx. 1235am with orders to send resident to ED. 911 called and ambulance arrived about 1245am. History of present condition given to EMTs and they stated resident would be going to Hospital. Writer has attempted to contact Hospital ED x3 but have been unable to get through. An EMT did just call to clarify when vaccine was given, what symptoms have been present and when they started. She said she has everything she should need and she will let Hospital ED staff know to call if they need anything else. Writer will again attempt to contact them though.  Resident's temp was 97.5 and BG 128. When EMTs arrived they got an O2 reading of 60%. Resident did open her eyes a couple times during transfer from bed to stretcher and while stretcher was going outside but no responses from resident were made.
The day after I got a shingles vaccination, a red, swollen area developed. By the next day it was a 3in by 4in, oblong area that was red/hot /tender. I saw an MD 9/16/215 who told me that it was a reaction to the vaccination, and not cellulitis. I was told to apply cold compresses, return if not gone in 2-3 days.
Pt experienced left arm, jaw and chest pain  x4 days.  Pain moderate to severe in  severity. Pt treated the pain with OTC Tylenol.
Narrative: Patient is a 76 yo MALE with PMHx significant for HTN, Afib, neck pain (2015 C SPINE MRI c/w multilevel cervical spondylosis) , and tobacco dependence. Patient received the Pfizer COVID vaccine dose #1 and #2 on 2/3/21 and 2/24/21 respectively. Per 2/24/21 COVID-19 vaccine administration note, pt reported a headache after first vaccination; felt at forehead and worse tension in his neck, which radiated to upper back (worsened with head movement). Pt works at a warehouse and does some lifting up to 40-50 lbs. He stated taking OTC acetaminophen provided mild help. Pt's PCP recently increased losartan dose to 100mg daily in 1/2021 for uncontrolled HTN. Per clinic provider's evaluation, afebrile, BP = 149-87, HR 80, O2 Sat RA 98-99%; recheck BP = 143/83/ HR 70 then 132/75 after 10 min. Noted L lateral neck tenderness and upper back tenderness w/ worsening reported neck pain with lateral ROM's. Per provider's assessment, suspected tension headache/ cervicogenic headache likely due to exacerbation of pt's chronic neck pain and less likely d/t first COVID vaccination. Provider instructed pt to take acetaminophen 500mg tab 1 to 2 tabs every 8 to 12 hours as needed (LFTs WNL). Also discussed strict ER precautions and avoidance of heavy lifting. Pt declined topical lidocaine in lieu of f/u w/chiropractor; consult placed.
Vomiting after every feed since vaccines were given. Emesis is NBNB but is projectile at times and is usually at least 1/4 to 1/2 of her feed. Also having loose, watery stools. Fussy. No fevers.
redness at injection; swollen injecyion site; itchiness at injection site; Round ring at injection; Sore arm; A spontaneous report was received from a 58-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, and developed a red, swollen, itchy injection site that had a round ring.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving the vaccine, the patient's arm was sore for two days. On 7 Jan 2021, the injection site became red, swollen, itchy and had a round ring. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, sore arm, was considered resolved on 2 Jan 2021.The outcome of the events, developed a red, swollen, itchy injection site that had a round ring, were considered unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
States he woke up with hives on his chest and back the next morning after receiving the vaccine.
Severe case of hives all over her body; Itchy hives all over body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URTICARIA (Severe case of hives all over her body) and PRURITUS (Itchy hives all over body) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CYCLIZINE HYDROCHLORIDE (TRIAZINE), APIXABAN (ELIQUIS), POTASSIUM CHLORIDE (KLOR CON M20), ATORVASTATIN, BUMETANIDE, LETROZOLE (FEMARA), VENLAFAXINE, CALCIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS] and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced URTICARIA (Severe case of hives all over her body) and PRURITUS (Itchy hives all over body). At the time of the report, URTICARIA (Severe case of hives all over her body) and PRURITUS (Itchy hives all over body) had not resolved. Not Provided          The patient called her doctor who prescribed Prednisone for five days and Diphenhydramine for itchiness. The symptoms improved but did not resolve completely so the doctor prescribed Prednisone again for 15 days with decreasing five days of two tablets of 0.5mg a day. The patient also visited her dermatologist who prescribed Fluocinonide 0.5% cream and it did not work. Other concomitant medication included Apulia injection for an unknown indication every six months.