chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right eyelid was swollen shut; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 02Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) in the left arm on 12Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not received any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient underwent Nasal swab test for COVID-19 and the result was found to be negative.  On 02Apr2021 at 23:00, the patient experienced right eyelid was swollen shut. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event right eyelid was swollen shut was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
I just had a lady infected by her sister and nephew; I just had a lady infected by her sister and nephew; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was infected by her sister and nephew who came down from withheld (both vaccinated with Pfizer). Family got sick with resp symptoms and infected her. She had her first shot couple weeks earlier and missed her second shot. She is hospitalized; they were not. The events resulted in hospitalization on an unknown date in 2021. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained.; Sender's Comments: Based on the information in the case report, A possible causal relationship between Covid-19 and suspect product BNT162B2 cannot be excluded.
This spontaneous report was received from a 62 year old male patient who was referring to himself. The patient's concurrent conditions were elevated white cell count, high blood pressure and high cholesterol. The patient's concomitant medications included unspecified high blood pressure medication and unspecified high cholesterol medication. The patient had no drug reactions and known allergies. On 03-APR-2015, the patient was vaccinated with ZOSTAVAX for prevention of shingles (dose, route of administration, lot number and expiration date were not reported). On approximately May 2015 (reported as about a month after vaccination), the patient experienced hives. The patient stated that they showed up on his body and were itchy and then were gone in a couple of hours (dates not provided). The patient also reported that the hives were worse in the winter than in the summer months. The patient was prescribed with triamcinolone cream as a treatment. There was no laboratory diagnostic studies performed. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided.
initial sx low grade fever, fleeting rash 10PM 24JUL became more quiet, refused to eat;seen by MD 25JUL;became more disoriented, neuro sx, refuses to eat 27JUL;adm to hosp 27JUL;remains in hosp sx persist 29JUL;
I exp pain  in my cheek and swelling of my face. On 12/27 I went to urgent care with  a rash and  diagnosed with Shingles. I had blisters with redness scalping which fell off on 1/8.
Pt recv vax on 10/16/98; on same day pt exp achy arm, swollen arm w/ rash, unable to move arm, fever (102); tx=Aspercreme
Follow Up information regarding vaccine administration, concomitant medications, medical history, and event outcome was received from a physician on 05/28/02. A physician reported that a 5 month old male received his first doses of Prevnar, Tripedia, IPOl and Comvax vaccines on 02/06/01 at 2 months of age On 04/27/01, the infant presented to an emergency room with a fever of 104.3 deg. F., a cough, a runny nose and a nose bleed. He was reportedly sluggish but arousable. "Mild" erythema of the oropharynx was noted.  A diagnosis of pneumococal bacteremia without focus was made. He was treated with saline bolus and IM ceftriaxone and was released on 04/28/01 He recovered. Pneumococal bacteremia was considered medically important.
Hypersensitive dermatitis where touched, swelling, hives. Created egg allergy causing hives still occurring.
Information has been received form a 69 year old female patient who in November 2009, was vaccinated with a dose of ZOSTAVAX (dose, route and Lot# unspecified). Patient reported that she "contracted shingles less than 2 years (in January 2011) after receiving the ZOSTAVAX". At the time of the report patient's outcome was not reported. Patient sought unspecified medical attention. Additional information is not expected.
vial undergo temperature excursions; Dose administered from vial undergo temperature excursions; administered expiry vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expiry vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered from vial undergo temperature excursions) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expiry vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered from vial undergo temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expiry vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered from vial undergo temperature excursions) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  It was reported that dose was administered from 3 vails after 30-day Use By Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator on 17-Jul-2022,and 18-Jul-2022 and vial undergo temperature excursions.   Maximum of 5.8°F temperatures was reached and excursion took place for 15 minutes  While visual inspection it was noticed that vaccine were still frozen  No proposed desired Use by Date was provided.  No treatment details were provided.   This case was linked to MOD-2022-611877 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow up received included non significant information (reporter's last name and email address updated).
Woke up with severe headache and vertigo.  Went back to sleep for a couple of hours, got up with same symptoms.  Called my family doctor at 8:30 a.m. and got appointment for 1:30 p.m.  Around 9:30 a.m. realized that I could not hear very well out of my left ear and a lot of ringing.  Went to see my family doctor and he got me in to see an ENT specialist that same afternoon.  Went thru a battery of hearing tests and found to have 85% hearing loss in my left ear and 25% in my right ear.  Put on high dosage of prednisone.  Went back a week later for more tests.  Hearing was at 65% loss in left ear and 20% in right ear.  Received a shot of prednisone to the ear canal.  Went back again 2 weeks later and the  hearing remains the same.  Tried on a hearing aid but decided to give it a couple more months.  Scheduled to go back to ENT doctor on March 20, 2014 for another test and will probably get the hearing aid as it has not gotten any better.  A lot of ringing in left ear and very hard to understand what is being said when in a room of more than 4 people for meetings, etc.
Very red and swollen-hot to touch at injection site. Given Benadryl and Keflex x 10 days.
Shortness of breath, pain on left side when taking deep breath, blood clots both lungs
headache, dizziness, no energy, insomnia since 04/13/2021
Provider prescribed 400 mg  Ibuprofen, 1 tablet by oral every 4-6 hours as needed
pt had a neg titer for mumps following vax w/MMR; f/u info revealed that the test performed was for complement-fixation rather than an IGG antibody test for mumps; No further details were provided;
Hospitalized DVT and PE probably related to COVID 19 infection, no respiratory symptoms at this time.   Boosted with Moderna 11/22/2021  Lot 0091D21A Intramuscular LD
EXPIRED PRODUCT ADMINISTERED; OFF LABEL USE; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced expired product administered. On 28-APR-2021, the subject experienced off label use. On 28-APR-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired product administered, off label use and medication error was not reported. This report was non-serious.
Severe headache, lost of taste, bronchitis reaction, joint pain, cough,  and congestion.
This spontaneous report was received from an approximately 68 year old female patient, reporting on herself. The patient was taking at the moment of this report several unspecified concomitant medications. There were no pertinent medical history, drug reactions or allergies. On an unspecified date in 2008, the patient was vaccinated with a dose of PNEUMOVAX 23 Injection, for prophylaxis (reported as "to prevent pneumonia")(strength, dose, dose number, route, anatomical location, lot # and expiration date not reported). On an unspecified date in 2008, after the patient was vaccinated with PNEUMOVAX 23, she experienced swelling at the injection site, which she described as "a little bit of an allergic reaction". She did not receive any treatment for this event, and she did not seek medical attention; also, no laboratory diagnostics or studies were performed. The patient recovered from the event on an unknown date, and she did not provide a causality assessment between the Injection site hypersensitivity and vaccination with PNEUMOVAX 23. The patient also reported an adverse event with losartan potassium (manufacturer unknown) (captured in MARRS # 1801USA003516).; Sender's Comments: US-009507513-1801USA003516:
Hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Menveo.  Additional details was provided as follows: The age at vaccination was not reported. The patient developed hives after receiving Menveo. No further information was provided.
Kept pt. for 30 minutes  as precaution because of her previous history of allergic reactions to Morphine and Flagyl.  At 30 minutes patient c/o being hot, feeling dizzy and having a HA.  b/p was 140/90, HR 110, SaO2 96%.  Did hear few upper airway expiratory wheezed.  Called Doctor and she came and assesessed pt and ordered Benadryl 50 mg IM.  Given at 3:10.  Pt was also given 1000 mg Tylenol for fever of 100.6.  Pt. was monitored and returned to baseline in 50 minutes.
body and joint aches all over body. pain/swelling/hardness in left shoulder (continues into next day--injection site). cold hands and feet, chills, low-grade fever of 100.4., headache, sinus pressure, diarrhea. thirsty.
This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the ROTATEQ (lot number K016966, expiration date 16-JUN-2017) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients.  From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported.   Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007375: US-009507513-1703USA001520: US-009507513-1703USA007374: US-009507513-1703USA007371: US-009507513-1703USA007372:
Felt burning pain and inflammation at injection site.  Area evaluated and Benadryl offered in ED.  Area of inflammation turned into erythematous area one day later.  No systemic symptoms.
p/vax pt exp a fever of 102-103, erythema & arm swelling from the top of the shoulder to elbow, malaise, gen aches, nausea, vomiting, myalgia, asthenia & severe h/a;seen by MD;pt reported was basically bed ridden throughout the weekend;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose02/12/2021 2nd dose03/05/2021 Diagnosed covid positive:08/19/21 Symptom onset:08/21/21 Exposure:Home Symptoms:Cough, muscle aches, sore throat,runny nose, HA.
Arm was tingly at time of injection, though that seemed normal. However, the the shoulder became strangely sore.  The shoulder soreness continued and worsened into the next day and onward and is still very problematic 5 days later. Arm is still tingly, but worse, shoulder movement is impeded by a dull pain and I am woken by throbbing pain during the night, even though I am not lying on that shoulder.  I was surprised at the location of the injection, which was very high on my arm, and have since read that can cause this very problem...SIRVA.  I am an extremely active and fit 50-year-old and this is a terrible consequence of a simple flu shot!!!  I am beside myself with fear that it will not resolve on its own and will interfere terribly with an active lifestyle which includes lots of tennis and exercise. I've not yet visited a doctor but will certainly do so in the upcoming week if improvement is not significant. I've never, ever had any weird medical issue, and this is incredibly upsetting.
Onset of rash (red bumpy, itchy) on right and left forearms and right and left lower legs about 4 days after administration of vaccine dose #1.  Rash continue to expand became bumpy and skin was red on both arms beyond elbows and on legs.  Rash started to appear on left side of stomach.  Saw physician on Monday 2/1/2021 was was prescribed course of 10 mg Prednisone and 10 mgHydroxyzine HCL.  After 5 days, not much improvement, then saw physician on Friday 2/5/2021 and was prescribed MethyPrednisolone 4mg dosepk tablets and 25 mg Hydroxyzine HCL.  Started dosepk on Friday 2/5/2021 but after 3 days on dosepk, rash has lessened on arms and legs but has spread across torso and some on upper arms.
fever; had slight arm pain; headache; This is a spontaneous report from a contactable consumer (patient himself). A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP7534; Expiration date: unknown) via an unspecified route of administration on 09Mar2021 (at the age of 68-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 16Feb2021 (at the age of 68-years-old) as DOSE 1, SINGLE for COVID-19 immunization and had no reactions. Caller reported that, after receiving his second vaccination on this past Tuesday, 09Mar2021, caller stated he experienced a fever for the first on last night, 10Mar2021. Caller stated his fever started at 100.1, went up to 100.8, 100.5 and a 100.4, dropped down to 99.8. Caller stated he felt "feverish" and had a headache. Caller asked was this something to worry about or not. Patient also experienced head hurt and had slight arm pain on an unspecified date in Mar2021. This report was not serious. The patient underwent lab tests and procedures which included body temperature: 100.1, 100.8, 100.5, 100.4 and 99.8 on an unspecified date. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 29-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that, there had been no power outages that would have impacted the Moderna vaccine. It was also reported that, they would need to treat this issue as a temperature excursion. The reporter stated that no adverse reactions were reported by any patients. No treatment medications were reported.
Erythematous, Edematous rash extending from right shoulder down to right elbow. Tender to touch Benadryl, ice to site, ibuprofen Pt noted discomfort to arm within 1-2 hours after admission Required Medrol dose pak to alleviate symptoms.
Fever (99.9-101.9), chills, body aches, joint and muscle pain, nausea and vomiting, headache, fatigue, pain and swelling at injection site.  Symptoms began approximately 6 hours post-injection and fully resolved 45 hours later.
A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning an 18 year old female who received FLUMIST. Medical history and concomitant medications were not reported. On 29-Dec-2008, this child was administered FLUMIST which expired on 28-Dec-2008. There was no adverse events associated with this error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 13-Jan-2009 confirmed the patient did not experience any adverse events after administration of expired product. Additional information received on 09-Apr-2009: product complaint investigation results.
started having asthma attacks (chest pain and Shortness of breath  with wheezing) on friday  01/15/2021 Didnt get any better over weekend.  was taking inhaler every 3-4 hours.  Monday was tested for covid which was negative.  body aches and fatigue began over weekend.  asthma progressively got worse.  On 01/20 had to visit dr office, my neck was swollen on both sides, injection site had a raised large area that extended from my shoulder to my elbow.  Up until yesterday, you could not even tell where I had the shot.  Now there is still a raised area and you can tell exactly where i recieved it.
PATIENT WAS ADMINISTERED  SECOND HEP A VACCINE ON 12/28/2021 AT HEALTH DEPARTMENT. THIS DOSE WAS ADMINISTERED TO SOON  BECAUSE DOSE WAS GIVEN BASED ON DOSE THAT WAS GIVEN ON 02/16/2017, WHICH WAS AN INVALID DOSE DUE TO BEING GIVEN TO SOON AS WELL., THIS DOSE WAS GIVEN AT ANOTHER FACILITY. FIRST VALID DOSE WAS ADMINISTERED ON 11/29/2021 AT HEALTH DEPARTMENT, BUT WAS OVER LOOKED  ON 12/28/2021 AND THE DOSE GIVEN ON 02/16/2021 WAS THE BASIS FOR ADMINISTERING THE VACCINE ON 12/28/2021., WHICH MADE THIS DOSE INVALID AS WELL. WHEN ERROR WAS NOTED , SUPERVISOR WAS INFORMED OF THE OCCURENCE. THE FATHER WAS NOTIFIED OF THE OCCURENCE AS WELL AND WAS ADVISED TO MONITOR CHILD FOR ANY SIGNS AND SYMPTOMS OF REACTION FROM HAND OUT SHEET GIVEN AT TIME OF VISIT. FATHER  RPORTED NO REACTIONS DURING TIME OF CALL  AND REPORTS THAT HE WILL CONTINUE TO MONITOR AND WILL CALL IF ANYTHING HAPPENED. HAS NOT RECEIVED CALL FROM FATHER SINCE OCCURANCE HAPPENED REPORTING ANY REACTIONS OR OTHER PROBLEMS.
Severe abdominal pain & vomiting. 10/27/09 ED records received service date 10/22/09. Assessment: Possible reaction to immunization. Patient c/o periumbilical abdominal pain, nausea, vomiting.