chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and soreness in my right arm at the injection site; This spontaneous report has been received from a pharmacist referring to a male patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 13-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S005857 in the right arm (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that since the vaccination, the patient had pain and soreness in my right arm at the injection site (vaccination site pain). The outcome of vaccination site pain was unknown. The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S005857; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
This spontaneous report as received from a physician refers to three female (also reported as male) patients of unknown age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 lot # M000386, expiration date 17-AUG-2017 (dose, route of administration were not reported. On unknown dates, within 24 hours after PNEUMOVAX 23 administration, the patients experienced severe swelling and redness in their arms, neck stiffness and muscle pain in their shoulders. On unknown dates, the patients came back to physician's office and were treated. The physician reported that it took 5-7 days for all the symptoms to go away. The patients did not need to go to the hospital or seek further treatment. The outcome of the adverse events was reported as recovered (on unknown dates). The relatedness between the adverse events and the PNEUMOVAX 23 was not provided. Additional information has been requested.
inflamed/infected subaceous cyst in left breast cleavage - doctor office visit on May 31; given antibiotic follow-up doctor office visit on June 3; sent to emergency room for draining; referral to surgeon for removal of cyst hospital er visit - cyst drained and antibiotics prescribed surgeon removed cyst and cyst pocket July 28 developed cyst on underside of right breast - Sept 18 became inflamed/infected - Oct 15 doctor office visit on Oct 16 - referral to surgeon for removal, I have had the sebacious cyst on my left breast for years and have never had any problems until now.
POST VACCINE PT BECAME DIZZY, DIAPHORETIC, HOT. TRANSFERRED TO OBS VIA W.C. PT REPORTS FEELING BETTER ONCE PLACED IN TRENDELENBERG ON STRETCHER. VS MONITORED THROUGHOUT OBSERVATION. HX OF HTN, TAKES BP MEDS QHS. ONCE SYMPTOMS RESOLVED, PATIENT AND SPOUSE ESCORTED TO EXIT WITHOUT ISSUES AT 1200, INSTRUCTED TO MONITOR BP AND SEEK FURTHER EVAL/TREATMENT IF UNRESOLVED OR WORSENS. PER ON-SITE MD, PT EXPERIENCED CLASSIC NON SYNCOPAL VASOVAGAL REACTION-RESOLVED. 1120 INITIAL BP 193/100 HR 70 SATS 99% RA 1125 BP 185/94 HR 75 SATS 100% RA 1135 BP 186/105 HR 65 SATS 99% 1155 STANDING BP 175/98 HR 59 SATS 98%
Constant and debilitating headaches lasted for 2 weeks since symptoms first appeared. Constant meaning daily with little to no pause in headache. Tylenol offered some and brief relief. Debilitating at times in which the pain alternates between the right and left side of the head as well as travels from the lower back of head to the top. During pain sessions, lymph nodes at back of head feel tender and swollen with heat and throbbing sensation traveling throughout the head.
After last dose in 2013, I was 22. My period changed to twice a month, painful. I went in for routine pap and was diagnosed with ?unexplained infertility? and ?possible endometriosis? at age 24.
Patient is 65 years of age and given the incorrect medication. She was given the ped/adol dose 10 mcg
Telephone call 6/1/10 from client stating had MMR 5/27/10 and began with R ankle, R calf, R knee pain (3-4 pain level) on 5/28/10 pm progressing 5/29, 5/30, 5/31 including L elbow, L ankle, L knee, R hand numbness - Pain increased to 10 out of 10 5/31/10 difficult to ambulate - Pain increased at rest - No swelling noted but pain localized to joint areas - c/o sore throat x 24h 5/28-5/29. Some rash, fever, n/v, positive chills, 5/29, 5/30 and 5/31.
C/O feeling dizzy and hot 10 min. after receipt of vaccine.  At 15 min post vaccine, c/o headache as if a migraine were beginning.  Person left with spouse.   12/7/09:  Prenatal records received for dates of service 9/21/09 to 12/7/09. Gravida 3, Para 1 EDC 5/13/10, shows normal course of pregnancy with no AE noted.
On 1-5-02, patient "bumped" area in evening. On 1-6-02, patient woke up and noticed left arm had 1-2 inch area that was red, bumpy and itchy. Area "improved" between 1-7-02 and 1-10-02. On 1-10-02, patient reports "bumping" area again and area is "red, slightly bumpy, and some itching on 1-11-02. No treatment.
Intussusception, s/p surgical reduction.  4/28/09 MR received for DOS 4/16-19/2009 with D/C dx: Intussusception.  Pt presented with vomiting, fussiness and reduced po x 12-18 hrs. IS dx by abd US and reduced by BE.  2 subsequent episodes again IS confirmed by US, so pt taken to OR for surgical reduction and appy. Diet advanced post-op without difficulty and d/c 4/19/09.  4/28/08 Vax rec received from PCP.  Rotateq given 12/16/2008 Merck 0469X.
Mottled rash appeared around area of injection.  Mother speculated his sensitive skin reacted to the alcohol wipe (redness did encompass this area).  I administered 2 tsp Benadryl to the patient and then asked the mother to wait in the waiting area for an additional 10-15  minutes and would re-assess. She returned 10 minutes later (12N) and the redness had improved.  She went home and I provided instructions to go the ER if there was any worsening, swelling of the face or neck, shortness of breath or vomiting.  She returned to this clinic at 3:40 to have me assess the patient's arm which was erythematous and edematous and tender to touch.  Otherwise with no symptoms.  I instructed her to administer ibuprofen, apply an ice pack to the arm and give Benadryl again at 6PM.  I re-iterated my previous instructions regarding additional signs and symptoms to look for and advised she go to the ER with any of the above or worsening symptoms.  She verbalized understanding.
She was vaccinated on 5/5. Symptoms started with headache, malaise, anorexia, and fatigue on 5/17. Then developed into nausea, vomiting, and diarrhea. Presented to ER on 5/29 and found to have splenomegaly with splenic infacts and small splenic artery aneurysm on CT abdomen/pelvis.
itchy palms of hands & soles of feet, rash on belly, hives on back w/in 45 mins of injection. tx /w epi & resolved.
Breakthrough infection; Breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: if covid tested post vaccination: Yes. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Saturday,  Feb 20th, I lost hearing in my right ear. It continued for 10 days. On the day that I was going to make an appointment with an ENT, I could suddenly hear again. It has been almost a week now & I can still hear.
Bell's Palsy; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date not reported), via an unspecified route of administration on 2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bell's palsy on 09Feb2021, still going on today 02Mar2021. She was wondering if she should still get the second dose and when. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
No additional AE information provided; the patient was administered an improperly stored dose of PEDVAX HIB; This spontaneous report was received from a vaccine coordinator 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 05-DEC-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R021077, expiration date 11-JUN-2021, (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33.2 degrees Fahrenheit for 15 hours and 35 minutes. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion.
Noticed 11:30 a.m. when grasped child's left arm that it felt tight and warm, Child stated "ouch" but had not c/o pain. Now 4:00PM and presents with mom. Left arm from top of shoulder to 1" above elbow, reddened, warm to touch, swollen left more than right, feels hard- distal. Strong GI sounds and pulses. Denies pain except to touch. Temp 97.3 degrees Fahrenheit. Recommended supportive care- hot or cold packs, Tylenol or Motrin, Benadryl. May get worse x1D. Return if worse in 2D PRN.
Immediately after receiving vaccines - her L arm began swelling blotchy appearing hive-like reaction appeared on upper L arm from shoulder to elbow.  DTaP & varicella were given in L arm.  Ice pack applied & swelling & hives began to decrease.
Client was to receive 9 injections. Received 5 in RUA then went to LUA. Received 3 there and then fainted.
Within one minute of vaccine administration, patient complained of faintness/lightheadedness, tightness in chest and dry mouth/throat. 911 was called and patient was released after 10-15 min. as ok. Patient reported several days later that she still had a headache/lightheadedness.
Pt recvd 1 dose of Engerix-B & 2 hrs later devel shoulder pain in inject arm; tx motrin; pain has persisted;
I received my second dose of the moderna vaccine on a Sunday at 10:30 am in my left deltoid.   Symptoms started with chills and swollen supraclavicular lymph nodes around 10:30 that night, and progressed to body aches,  joint pain, muscle pain,  and a low grade fever.   I was unable to sleep due to chills and pain.   The muscle pain would radiate down my arms and legs, and I would sometimes have a pinpoint sharp pain in the bottom of my left foot.  Symptoms persisted the next day, and also included extreme fatigue, nausea, and enlarged and painful axillary and supraclavicular lymph nodes.  The  supraclavicular lymph nodes were large enough to visibly see.   A round rash/redness started around the injection site started on Monday as well.   This also occurred with the first vaccine, but is much larger this time.   Most symptoms had resolved as of Tuesday, except for fatigue and the rash which are still on going.
FACE PARALYZED; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnicity. 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: Unknown, expiry date: Unknown) dose, start therapy date were not reported (dose number in series 1),1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot number. No concomitant medications were reported.  On an unspecified date, the reporter stated that "your vaccine paralyzed my brothers face". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of face paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211163834-COVID-19 VACCINE AD26.COV2.S- Face paralyzed. This event is considered unassessable. The event 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.
Information has been received from a certified nurse midwife via pediatric medical records concerning an infant who was born from a 25 year old female with no pertinent medical history and no drug reactions or allergies who on 09-JAN-2009 was vaccinated with a first dose of GARDASIL (Lot # 660616/0570X) 0.5mL, intramuscularly. On 14-APR-2009 she received second dose of GARDASIL (Lot # 661678/0904X, which was valid for MMR II) 0.5ml, intramuscularly. Concomitant medication included vitamins. The patient's mother became pregnant. The patient's mother last menstrual period was on 17-APR-2009. Estimated date of delivery was 22-JAN-2010. It was reported that the patient's baby was born on 18-JAN-2010 at 7:41, weighing 3042g. The patient's mother was 39 weeks from her LMP. It was reported that the baby had a normal development and the review of systems was within normal limits, except for a newborn rash and a tongue tie. The baby's circumcision was healing well. It was also reported that the baby was tongue tied. The plan was to give ambulatory guidance. Laboratory tests performed were normal. Tongue tie was considered to be a congenital anomaly. The mother's experience is captured in WAES 0905USA03365. No further information is available. All available medical records will be provided upon request.
Patient states that on the day receiving her second Moderna vaccine, the injection site became red, warm to the touch, a bit swollen, and a spreading redness across her arm. She has no pain and can move her arm, no fever, and no other symptoms. She reported this to her physician, Dr. , who advised her to contact us to report the event.
Pt was brought to the ER by mother after pt had hours of vomiting and diarrhea. Pt was admitted for dehydration.
"COVID Arm" - redness (about 3" diameter) and swelling at injection site; and itching From the day after the injection until day 6, mild redness, swelling, and tenderness had progressively decreased each day. On day 7, redness and swelling increased and itching began. On day 8 (today), redness, swelling, and itching are worse.
NUMBNESS ON THE FACE; TINGLES ON THE FACE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hbp, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 in the right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced numbness on the face. On 12-MAR-2021, the subject experienced tingles on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the face, and tingles on the face. This report was non-serious.
8 month old breastfeeding baby developed fever and fatigue about 36 hours after mother received 2nd dose of Moderna vaccine. Fever of 101-102 degrees lasted around 48 hours and presented with no other symptoms. Infant was unaffected by first dose.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 68.71. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021 vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
patient had shoulder pain on vaccinated arm for a couple months. also had with the moderna vaccine (as a booster) on 11/1/21
He felt a little bit off, but did not have anything specific; Sore arm after both doses; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (He felt a little bit off, but did not have anything specific) and VACCINATION SITE PAIN (Sore arm after both doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (He felt a little bit off, but did not have anything specific) and VACCINATION SITE PAIN (Sore arm after both doses). At the time of the report, FEELING ABNORMAL (He felt a little bit off, but did not have anything specific) and VACCINATION SITE PAIN (Sore arm after both doses) outcome was unknown.      Concomitant medications include medicines for diabetes and blood pressure. No treatment medications provided.   This case was linked to MOD-2021-392116, MOD-2021-392113 (Patient Link).
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the, unspecified number of patients were vaccinated with GARDASIL (Lot # J013324 and expiry date: 12-FEB-2016) which was improperly stored. No product quality complaint was reported for GARDASIL. Reporter provided that there have been no reported adverse events following administration of the vaccinations. There has been no need for revaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Case number PHEH2015US022999, is an initial spontaneous report from a health care professional on 06 Nov 2015. This report refers to an 11-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient (under 18 years) was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly on 05 Nov 2015. No adverse event was reported.
Break through COVID after being  fully vaccinated when young children became COVID (+) after exposure at their daycare. Patient tested (+) on 8/30 with minimal to no symptoms but did get more symptoms day or two later.  Second sample obtained on 8/31/21 to send to facility.
Case number PHEH2015US026957, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 56 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 13 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.