chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Face and body got very hot, she was sweating, said it felt like there was something in her stomach.  Lasted about 2 minutes after shot was given
(R) VL influenza (FLUZONE), (L) VL SQ MMR/V (PROQUAD), (R) VL DtaP/IPV (KINRIX).
4 mm flesh-colored papular lesion anterior proximal left thigh. Not currently vesicular on upper left thigh.
24 hrs after experienced fatigue a headache. 48 hrs later fatigue and headache increased. Ibuprofen was taken with no results.
Patient was kept for 15 minutes after the vaccine and on the way to work the patient called and said her face is blotchy red, swollen and her throat is swollen and weak voice patient took BENADRYL and advised her to go to ER.
3/29 Onset at 1400, left anterior chest pain. SOB. Dizzy. Afebrile 3/29 Treatment in ER:  GI Cocktail 3/31 left chest discomfort continues-pain under left breast. 4/3 Having less chest discomfort now.
pt recv vax DEC95&pt devel a fever of 104-105;fever abated w/in 48hrs;this adverse event may have been previously reported to the FDA on a medwatch form by the reporter
Nasal irritation, watery eyes, then lots of sneezing. Low grade fever and achiness.
Nausea, chills, fever, headache, severe muscle aches, stomach distress, followed by diarrhea the next morning.
Zoster vaccine Aug 2019 and Oct 2019, had shingles last week/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Herpes Zoster vaccine) for prophylaxis.   In October 2019, the patient received the 2nd dose of Herpes Zoster vaccine. In August 2019, the patient received the 1st dose of Herpes Zoster vaccine. On 25th February 2022, more than 2 years after receiving Herpes Zoster vaccine and Herpes Zoster vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine and Herpes Zoster vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Zoster vaccine in August 2019 and October 2019 but his/her physician told him/her that he/she had shingles last week Friday.  The reporter asked that how long did the vaccine last. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 03Mar2021 at 11:40 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced soreness at the injection site and no other symptoms. The outcome of the event was unknown.  Information on the batch and lot number has been requested.
Initial consumer report received on 11 Jan 2010: This patient with an unknown medical history was vaccinated with influenza virus vaccine (unknown manufacturer) on 09 Nov 2009. On 09 Nov 2009, he experienced blurred vision, short breath and disorientation. The patient outcome was not reported.
16 yo F received Dose 1 of Moderna vaccine in left arm on 3/26/21 @ 1052. Patient was observed for 15 minutes as per protocol; no adverse events were noted.  Due to inadvertent administration outside of EUA age range, event is being reported as per Moderna COVID-19 Vaccine EUA.
Nausea within two hours of injection, Soreness  at injection site within two hours, Enlarged redness around injection site within 24 hrs.- 48 hrs, Vomiting within 48 hrs and continued gastro intestinal  disturbance at 72 hrs.
Blood clots.  After long car trip on April 18th; returning on April 22nd, noticed shortness of breathe when walking.  Made appointment with cardiologist with complete cardiology work up. Everything OK.  Then saw doctor, my regular doctor, because shortness of breathe continued. She ordered  CT scan which showed multiple blood clots.  Doctor immediately prescribed Eliquis for six months. Of note, I also have varicose veins with leg swelling after 8 to 10+ hours riding in car, but I have never had blood clots.  Shortness of breathe seems to have been resolved.
Reporter stated that patient got real ill and new symptoms arrived everyday from the day she reviewed the vaccine.. loose stool, fatigue nausea and pain in her spine and headaches. . A few  days after the vaccine patient went to the hospital and tested positive for COVID. Patient went to the Hospital on June3rd around 5pm. Test was perform and said she was filled with inflammation of the spine. Patient was release from hospital on June 4th with pain killers and steroids. Patient was pronounced dead on June 6th.
Vaccine that was administered was 5 days past expiration date. No adverse reaction was noted.
h/o COVID (12/2020) c/b post-COVID long hauler syndrome follows with Dr. who p/w fevers, dyspnea & cough being admitted for sepsis & acute hypoxic respiratory failure 2/2 multifocal pneumonia. tx: Maxipime, rocephin, singulair; maintained on Ceftriaxone and Azithromycin during hospitalization as per ID. O2 was weaned and walking oximetry test was 94% on room air.
Day Of: 3:30 pm-Loss of taste sensation and feeling left side of tongue.  10/07/2015: Continued loss of taste and feeling left side of tongue, followed by weakening of forehead and lip muscles left side of face. Went to ER at 11:00 PM and diagnosed w/ Bell's Palsy.
Patient given Pfizer for 5 to 11-year-old, instead of Pfizer 12 and older. Patient is 15 years old. She declined any symptoms or any allergic reaction.
Pt came to ER on 10/26/09 with complaints of numbness & tingling to left foot & later to right foot and then both upper extremities. Spinal tap done-negative. Placed on inpatient unit, started on ASA 81mg & neuro consult ordered. Normal EMG 10/26/09.   10/29/09 and 10/30/09 Hospital Records and Discharge Summary received for hospital dates of service 10/26/09 to 10/29/09.  Final diagnosis:  Left leg weakness. Assessment:  Presented with numbness and tingling in the LLE extending from the ankle to the knee as well as slight parasthesia in the R foot.  Two days later noted parasthesia in both hands.  No weakness, slurred speech, disarthria, sx. in hands improved somewhat.  EMG and nerve conduction studies were normal.  DTR's in UE's and LE's 2+, MRI brain normal, head CT normal.  Discharged improved on 10/27-09 with no evidence of GBS, but subsequently returned to the hospital with a spinal headache from the LP with a pain scale of 8/10 and had a blood patch performed.  10/30/2009 Neuro progress notes received, also anesthesia note regarding patient with c/o's headache post LP that did not respond to conservative tx, patient elected to have epidural blood patch which alleviated the headache
Before the COVID vaccine, I had a very mild case of tinnitus in the left ear. There was no discernible ringing, except occasionally at night in bed when it was quiet. One hour after the 1st COVID vaccine shot on March 2nd, there was extremely loud ringing in the left ear, which scared me terribly. It lasted about a minute. Whille the ringing is not as loud, there is constant ringing which overcomes everyday sound. For instance, when talking to people or watching television, the ringing is still heard. In addition, the ringing is often pulsating, which is a new experience for me.   Clearly, my tinnitus has gotten much worse as a result of the event.   I AM CONCERNED THE 2ND DOSE WILL MAKE THE RINGING WORSE.
Another reports increase swelling , hardness, itching to injection site; increase temperature x 2 days also; entire LT red, swollen.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # N003997, expiry date unknown) for an unknown indication. No concomitant medications were reported.  On an unknown date the patient experienced an infection at the injection site. The action taken and outcome of the event was unknown. The relatedness of the event to the therapy with PNEUMOVAX 23 was unknown. Additional information has been requested.
Had flu shot by CSL preservative free, two days later developed what is now chronic urticaria.
PATIENT BEGAN TO FEEL FAINT AND NAUSEOUS AND CALLED FOR HELP AFTER 5 MINUTES FROM INJECTION (12:02 PM). PATIENT LAID ON THE FLOOR TO CALM DOWN FOR 15 ABOUT MINUTES. SAID HE WAS ABLE TO BREATHE BUT VERY FAINT. GAVE PATIENT COOL RAG OVER HEAD AND ELEVATED FEET. WE CONTINUTED TO WATCH PATIENT FOR ANY OTHER SIGNS, PATIENT WAS STILL ABLE TO BREATHE. AFTER ABOUT 15 MINUTES PATIENT WAS ABLE TO SIT UPRIGHT IN CHAIR. PATIENT WAS ABLE TO WALK OUT OF THE STORE ATFER 10 MINNUTES (12:28 PM).
tightness of chest; asthma; Today she felt weird/she does not feel right; she has a sore throat; she also doesn't feel appetite; she felt dizzy; weird taste in her mouth; headache; This is a spontaneous report received from a contactable consumer (patient, reported for self). A female patient of an unspecified age (40-units not mentioned) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history included, Rheumatoid arthritis, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took metotrexate for 15 years for rheumatoid arthritis. On 10Apr2021, the patient experienced, immediately after receiving the injection she felt dizzy, and weird taste in her mouth only the first day along with headache. On 15Apr2021, she started experiencing tightness of chest, she has asthma and used her inhalator but it did not help, she also experienced felt weird, sore throat, headache, does not feel appetite (she also doesn't feel appetite) and she did not feel right. She has been only working from home in her computer. She would like to know if this was a regular side-effect even if it happened 5 days after she received the vaccine. The patient stated she has taken Methotrexate for 15 years for rheumatoid arthritis, she did not take it 2 weeks before the shot and has not taken it this week because she was told that it is not recommended to receive immunosuppressants a week before or a week after the vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Onset 8-11-08 of diarrhea after 2 month immunizations that persisted - patient seen in clinic 8-18-08 for diarrhea 10-12 x day.  (Formula fed).
The patient was administered a volume of 0.25mL instead on 9-7-22 of the intended volume of 0.5mL. The error was recognized the next day and action was immediately taken to reach out to Moderna and CDC for clinical recommendations on the appropriate steps forward. On 9-16-22 responses were received, with the direction to have the patient come back as soon as possible to repeat the dose to receive the full dose of 0.5mL.  No adverse effects were reported. The patient returned and received the full dose on 9-19-22.
3/26/21 4 hours after injection she started feeling sore, took Motrin.  The next morning she was unable to lift arm, took Motrin several times over the course of the day and when she couldn?t take the pain any longer she decided to go to the ER. 3/27/21 Went to the hospital after she had no relief from the Motrin. .   3/29/21 Went to the ER today, due to cold hands and feet, numbness and tingling, could barely stand, she stated she felt like she was going to die. Examined, states she had no deficits with vision or neurological.  It lasted about an hour and then states she was fine.  Dr. states she had a vasovagal response.
This nurse removed opened vial of Moderna from storage, 2-8 C. Placed in cooler with ice packs along with two other unopened vials of Moderna. This nurse then transported and gave the three vials to the agency nurse. Agency nurse administered open vial of Moderna to persons who had signed up for the Booster vaccination of the Moderna Vaccination 0.25ml. Once completed updated Manager that the bottle given to her was open and was going to open another vial. This nurse confirmed with the manager that the bottle had been opened previously, 1/19/2022. This nurse had mis read the storage information regarding Moderna to be stored unopened and unused for 30 days. This nurse made telephone call to each person affected by this opened vial. Per Medical Director  offered everyone a dose of 0.25ml out of the new unopened vial.
I would like to join the v-safe health checker and provide and receive information, however I DO NOT HAVE AND WILL PROBABLY NEVER HAVE A SMART PHONE. I have been working with computers since 1958 and presently have a computer that is probably faster and better then anything you have ever use--it works better and can do more things then any smart phone and its email works  VERY WELL. My present cell phone cost me $15 and costs $8/month and I see no reason to jump up to a $1200 phone that costs $150/month. Presently the folks who are getting the vaccine are in an age group that probably has a lower percentage of smartphone users then the younger folks who will be vaccinated later. Finally you are going to send the info by text. I have told all of my children, friends and associates that I REFUSE TO EVER TEXT SINCE IT IS A TOTAL WASTE OF TIME!!! So please learn to email info.
itchy; red; swelling/raised; Since receiving the booster dose of the vaccine, this has been worse/Hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives), PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In January 2022, the patient experienced URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives). On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Since receiving the booster dose of the vaccine, this has been worse/Hives), PRURITUS (itchy), ERYTHEMA (red) and SWELLING (swelling/raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not provided results not provided. On an unknown date, Skin test: results not provided results not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has no history of prior allergies. The patient reported that after receiving the first 2 shots started to develop hives that have continued up until today (07-Feb-2022). In addition those occurred all over body, itchy, red, raised, and occur with swelling. The  primary care doctor, and an allergist who conducted blood, and skin testing for allergies. Since receiving the booster dose of the vaccine, that had been worse and occurring every day despite the OTC medications which helped. The patient went to the emergency room for her symptoms on Saturday where they gave prednisone. The patient had an upcoming appointment with an allergist on 07-MAR-2022. No concomitant medications were reported.   This case was linked to MOD-2022-474585 (Patient Link).
PT was administered a Moderna Covid vaccine with expiry date 10/15/2021.  PT was monitored for 15 min after injection and no complications or adverse effects were noted.
Initial misuse report received from a non-healthcare professional (patient's parent) on 11 June 2013. A 03-month-old baby was given MENACTRA vaccine in error. No adverse event was reported. List of documents held by sender: none.
reporter state 100 dose of vax given & an inc #  of pts were cranky & fussy following vax;many of the children exp elevated temp ranging form 99-104;all of the pts recovered w/in 2-3 days following vax;
grater than 35 days between Moderna Covid-19 vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (grater than 35 days between Moderna Covid-19 vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in 2021.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (grater than 35 days between Moderna Covid-19 vaccines). At the time of the report, PRODUCT DOSE OMISSION ISSUE (grater than 35 days between Moderna Covid-19 vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment information was not provided.
4/09/21 6:00pm Site pain and swelling 4/10/21 1:00pm  Fever 101.5, site swelling, facial flushing, weakness 4/10/21 4:00pm Fever 102.2, site swelling, joints pain, increase heart rate (124 heart rate) 4/10/21 7:00pm Fever 102.0 site swelling, joints pain, lower back, hip & wrist pain/sore, lung congested, increase heart rate (98 heart rate) - took tylenol 4/10/21 11:00pm fever 99.1 heart rate 89, site pain & arm weak, thrifty 4/11/21 1:00pm arm sore, weak and numbness with use, site swelling 4/12/21 10:00a  arm sore, weak and numbness, site swelling 4/13/21 1:00a  arm  pain  with extended numbness 4/13/21 11:00p arm soreness, arm weakness and numbness
Paralysis of Left arm -- could not move arm.  Pain in arm -- could not sleep at all during nite. Lasted  a bit over 12 hours.    Low grade fever lasted two days 99.8 F
Headache since 11-1-08; headache is occipital radiating to frontal, bilateral; rates pain 4-5/10; is somewhat relieved with Ibuprofen; less relief from Tylenol.
pt w episode of amnesia 3 days after Tdap vaccine given at local pharmacy CVA work up negative to include head CT, MRI, echocardiogram and labs Concern for possible Tdap Reaction
Lost muscle function; Fell; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 2nd dose of Shingrix. In NOV-2022, less than a day after receiving Shingrix, the patient experienced muscle weakness (Verbatim: Lost muscle function) and fall (Verbatim: Fell). The outcome of the muscle weakness and fall were resolved.   It was unknown if the reporter considered the muscle weakness and fall to be related to Shingrix.     It was unknown if the company considered the muscle weakness and fall to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The patient received shot and on the same day she lost muscle function and fell. The event lasted minutes and recovered. No other information provided. The reporter consented to follow up. This case is linked with US2023062750, for the same reporter.; Sender's Comments:  US-GSK-US2023062750:Same reporter.
Breakthrough case admission after 2 vaccines Janssen 4/7/21 lot# 041A;  MOderna 12/15/21 lot# 067H21A
Swelling, redness, heat, and pain at the injection site and radiating down to elbow starting shorty after injection and got progressively worse until then next day. Dr prescribed Keflex.
Temp up to 100, lethargic 8/16/16. Cellulitis, itching, redness, swelling to (R) deltoid. MENVEO injection site. 8/17/16
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term  prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA304677. This case involves a 7 years old female patient who had expired dose, while she received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included TYPHIM VI on the same day in right arm. On 30-Oct-2018, the patient received a 0.5 ml once dose of suspect IMOVAX RABIES lot M13911M via intramuscular route, expiry date- 24-Jul-2018 in left arm. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient received a corrective treatment. 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 Directive and Module VI of the 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.