chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incomplete dose administered/25 percent of vaccine slipped out without being administered to the patient; had an issue where the syringe failed; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Incomplete dose administered/25 percent of vaccine slipped out without being administered to the patient) and SYRINGE ISSUE (had an issue where the syringe failed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Incomplete dose administered/25 percent of vaccine slipped out without being administered to the patient) and SYRINGE ISSUE (had an issue where the syringe failed). At the time of the report, INCORRECT DOSE ADMINISTERED (Incomplete dose administered/25 percent of vaccine slipped out without being administered to the patient) and SYRINGE ISSUE (had an issue where the syringe failed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. The administering facility had previously called and reported this dosing administration error.
Normal labor and delivery on 11/19/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
Rash all over arm, hand, and neck only on the side of the shot. Swelling around injection sight. Fever and sick day after shot.
There was a hole in the oral dosing tubeProduct packaging issue; ROTATEQ squirt into her eye; This spontaneous report was received from a medical assistant concerning a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 29-APR-2019, the patient's child was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R028189, expiration date 06-JUN-2020 but, because there was a hole in the oral dosing tube (product packaging issue), the vaccine squirt into the patient's eye.  The reporter stated that the patient recovered from product packaging issue on 29-APR-2019.  The causality between product packaging issue and vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Received vaccine 8/5. Next day had erythema at injection site and arm his upper arm, placed ice on it and it improved when he was seen 8/9/16.
pt. recvd. vax & developed T-103.Later pt. developed rash& palpable postauricular & cervical adenopathy.
pt recvd vax;c/o feeling light headed & queazy shortly p/ vax;couple of days later,devel joint aching/pain;2mar95 says all sxs resolved completely p/ about 2 wks;
9/9/21 - SADDLE PULMONARY EMBOLISM -  9/21/21 - ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN -
Just not feeling well; Nausea; fluttering in stomach (butterflies instomach feeling); This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 07Sep2021 at 18:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included colecalciferol (VITAMIN D3), acetylsalicylic acid (ASPIRIN), curcuma longa rhizome (TURMERIC) and unspecified multivitamin; all from an unknown date for an unknown indication and unknown if ongoing. On 07Sep2021 at 18:45, the patient was not feeling well, nausea and fluttering in stomach (butterflies in stomach feeling). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events just not feeling well, nausea and fluttering in stomach (butterflies in stomach feeling) was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
fever 102.5-103.1 for three days, fever 101-101.8 for 2 more days. (five straight days of 101+). terrible headache 1 day; chills, moderate headache, muscle aches, joint pain -i am on the sixth day of these. extreme fatigue.  did not get out bed for three days other than bathroom.  moved from bed to couch and sitting up on day 4.  on day 5 got swollen lymph nodes in neck. have overall felt very unwell.  much more extreme side effects than i could have imagined. six days in.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-JUL-2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-AUG-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed methyl-prednisone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Strong headache for 1 day; extreme fatigue, sleepiness and mental confusion for 3 days; itchiness for 1 day
Breakthrough case admission after 2 vaccines: Moderna 2/5/2021 batch/lot# 026L20A; Moderna 3/5/2021 batch/lot# 015M20A.
Within minutes after receiving the vaccine the patient experienced numbness and parasthesias in the left arm (the vaccine was given in the left arm).  Within an hour the numbness and parasthesias progressed to both of the patients feet/legs/and right arm.  She also experienced Chills, severe Headache, and shivers withing a few hours of the Fluvirin Vaccine. The next day dizziness was added to the list of symptoms. The numbness and parasthesias progressed over the next few days to the torso, face, and head. The patient also had a fever within hours of the vaccine.  The patient saw both her primary physician and a neurologist the 1st week the symptoms began.  The neuro exam revealed dysthesias and the absence of achilles tendon reflexes.  No treatment was offered until muscles weakness occurs per Neurologist.  The numbness, parasthesias, dysthesias, and headache are still evident at 21 days post vaccination.   11/17 and 11/18/09:  Primary care record received for date of service 10/23/09 and Nuerology Consultation received for 10/27/09.  Dx:  Parasthesias and numbness/tingling after seasonal flu vaccine.     Assessment:  Presented with paraesthesias, numbness, dizziness that started immediately after H1N1 vaccine. Noted numbness and tingling of L arm at injection site.  Within an hour she developed similar sx. in her left toes which spread to the right foot.  Then, discomfort and head pain, teeth chattering and chills.  Difficulty sleeping.  Sx. increased to severe HA and dysesthesias spread to calves and thighs.  Dysesthesias in cheek spreading to torso.  Discomfort on tops of feet, right more than left.  Also shaky.  Soreness upon standing.  Occasional muscle twitching.  Denies weakness.   She also notes some fatigue.  F/U with PA at Neurology office in 2 wks.
Immunization administered was expired when given. Immunization expired on 9/30/22 and was administered on 11/7/22.
Pt was incorrectly given a Pfizer pediatric dose instead of the adolescent/ adult Pfizer dose. MA did not realized that wrong covid vaccine was given until documentation. MA informed clinic manager and informed of next steps. Pt's guardian was informed that wrong vaccine was given and the per CDC guidelines, pt will need to get second adult Pfizer vaccine after 21 days.
Aches in head and injection site, stomach cramps, slight nausea, subsiding slowly after a day and a half. I took 1 TYLENOL capsule, which was not effective.
injection site got red; injection site got hard; injection site got hurt; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site got red), VACCINATION SITE INDURATION (injection site got hard) and VACCINATION SITE PAIN (injection site got hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure abnormal. Concomitant products included LOSARTAN for Blood pressure abnormal, METFORMIN and GLIPIZIDE for Diabetes.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site got red), VACCINATION SITE INDURATION (injection site got hard) and VACCINATION SITE PAIN (injection site got hurt). On 15-Jan-2021, VACCINATION SITE PAIN (injection site got hurt) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site got red) had not resolved and VACCINATION SITE INDURATION (injection site got hard) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender'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.
Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already". The date and cause of death for the patient were un-known. It was not reported if an autopsy was performed. It was reported that, as reporter was not willing to provide further details and abruptly hung up the call. Hence product details (LOT#, expiration date, NDC# and UPC#), purchased details and further probing could not be done. Limited information was available over the call and appropriate response could not be provided.  QR comment:- AE Filed conservatively.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Impacts negatively, should haven't died from this Pfizer crap/ whenever one is dead already
pt recvd vax 13DEC95 & 10 days p/vax pt exp broad based ataxia & was hospitalized x 2 days;pt is currently being evaluated by neurologist & is receiving physical therapy;No further details are available @ this time;
I got the shingles shot on Wednesday 2/27  and started severe itching all over on Sunday 3/3.  It was awful and a Sunday (no doctor hours)  so  I started taking 1 then 2 tablets of Allergy pills. and that finally helped get rid of the itching.
COVID-19; COVID-19; Moderna-Dose 1, Dose 2, Dose 4/Pfizer/BioNTech-Dose 3, Dose 5; Moderna-Dose 1, Dose 2, Dose 4/Pfizer/BioNTech-Dose 3, Dose 5; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Jul2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Mar2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly low IGg's" (unspecified if ongoing); "Known allergies: iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Jul2021 at 13:00, outcome "unknown", INCORRECT DOSE ADMINISTERED (non-serious) with onset Oct2022, outcome "unknown" and all described as "Moderna-Dose 1, Dose 2, Dose 4/Pfizer/BioNTech-Dose 3, Dose 5"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19, which included Paxlovid from 06Oct2022 to 11Oct2022. Clinical course: The patient never had nasal symptoms or fever before and during her treatment with Paxlovid. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment (Paxlovid), which included Mobic, Bystolic, Gabapentin, Baby aspirin, an unspecified medication from Bayer, multiple unspecified vitamins, Zinc, and D3.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was administered first dose Moderna Covid-19 Vaccine on 5/20/21 at Pharmacy .  Returning for second dose on 7/9/21.  This goes beyond the recommended time period between vaccinations and so it is being considered an adverse event.
Hardened, red area (the size of a quarter) at injection site. Described as painful and warm to the touch. Appeared approx. 12 days after injection.
Patient has hives on her right upper arm abd right kneee, and on the vaccine site.
No additional AE; MMR II and VARIVAX were stored improperly and administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, at a dose of 0.5 milliliter (ml) (lot number S022753, expiration date: 22-JUL-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 ml (lot number S033539, which has been verified to be valid, expiration date reported and validated as 22-OCT-2021), both therapies administered as prophylaxis (strengths, vaccination schemes, anatomical sites of injection and routes of administration were not reported) (product storage error). No additional adverse event (AE).  On an unknown date, the vaccines experienced a temperature excursion of 27.44 degrees Fahrenheit (F) for 5 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.
Headache, nausea, vomiting started on 10/30/09. MRI Brain wo on 11/7/09 showed multifocal T2 hyperactivity in thalamus, basal ganglia, and white matter c/w DA EM. Pt. had R-sided focal SZ on 11/7.  11/13/09 DS received for DOS 11/04/09  11/05/09 and DOS 11/07/09 -  11/12/09 Final DX: Acute disseminated encephalomyelitis (ADEM).  The Pt was admitted initially to the hospital on 11/04/09 after 1 HX week of intermittent headaches and vomiting, neck pain, lethargic and only responsive to painful stimuli.  Pt was discharged on 11/05/09 after his symptoms improved.  After the discharge, Pt's headache and emesis returned and new symptoms appeared of discoordinated movement, left lower extremity weakness, foot dragging and seizures. Upon readmission to the hospital on 11/07/09, Pt experienced 45 mins of tonic-clonic seizure affecting R and L upper and lower extremities, R facial movements, and non responsive to verbal stimuli.  Neck was supple. Pt lethargic. PERRL. Neuro assessment: spontaneous movement, but weak muscle strength, positive Babinski, generalized hyperreflexia with deep tendon reflexes 3+ throughout. Pt was irritable, but no fever. Pt was treated with Ativan and steroids and his neurologic function improved.
14y/o M received his 2nd dose of Pfizer COVID vaccine on 7/28 and started to complain of chest pain on 7/30.  Pain worsened to 8/10 and he was seen in the ED that evening with an ECG suggestive of acute myopericarditis and positive troponin of 7.81.  He was admitted for likely post-covid vaccine myopericarditis.  His was initially treated with ibuprofen overnight with no complains of chest pain the following morning 7/31, and continued to be asymptomatic throughout the rest of his hospital course.  Troponin on 7/31 AM was up to 15.81. An echo was completed and showed normal cardiac size and function without pericardial effusion.  He was acutely treated with IVIG continuously for for 9 hours, and Ibuprofen q8 hour for a total of 4 days. Troponin was trended daily with gradual improvement to 1.36 on morning of discharge. A repeat echo was performed that was normal. Given that a repeat troponin level on 8/3 PM was 0.76, he was deemed to be stable for discharge by Pediatric Cardiology. He will need to be restricted from strenuous activities with no competitive sports or physical education for 3 months per cardiology. Pediatric Cardiology will continue to follow him as an outpatient, monitoring him 2-day post-discharge troponin level and will perform an exercise stress test in 3 months. Discharged on 7 more days of Motrin TID w meals
ABDOMINAL CRAMPS LOSS OF SENSITIVITY (LOWER AND UPPER LIMBS) NO COORDINATION TO WALK AND WEAKNESS ALL OVER THE BODY
arm very sore; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced arm very sore (pain in extremity), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route in unknown administration site prophylactic vaccination.  On an unknown date, the patient 's  arm was very sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.  There will be no information available on the batch number for this case.
Vaccine expired on 09/30/2022 was administered today 10/03/2022
febrile sz for 30 seconds (gen tonic clonic 30 sec);t104 R;
pt recvd vax 12APR93 & 19APR93 pt woke up crying w/t102.4 was seen by MD:
Evening of flu shot patient describes: Migraine, sinus inflammation, neck stiffness, joint pain
It was a very odd thing that happened, I was at work and dog that I was chasing pulled me over. I started bruising and knew something was off. I went to the ER and tests were run. My doctor determined that I have ITP and what it is that my immune system is killing off palates quickly and cannot clot. I'm going through Chemo Therapy and Steroids (don't have cancer) it has not been successful yet (resulted in a 4 day hospitalization). I have been having blood tests two to three times per week now and it's become a part of my life right now.
Patient is a 70-year-old female that presents to the ER with complaint of chest pressure and palpitations.  Patient states this morning she received her second Covid 19 vaccination at 0711.  She states about 5-10 minutes after receiving that she started having palpitations, became dizzy and pale.  She states staff did check her blood pressure which was elevated.  She states her symptoms lasted about 5 minutes and improved.  She states at 0726 she started having palpitations again, dizziness and substernal chest pressure/heaviness.  She states the dizziness and palpitations have improved but not resolved. pt states she had no reactions with her first dose. Patient denies nausea/vomiting, shortness of breath or recent surgery/travel, fever, cough.  Patient states she did take a 81 mg aspirin this morning. 0853- pt resting in the er, nad. vital signs improved. resp equal and non-labored. pt states she feels much better, symptoms resolved. labs / imaging reviewed along with obtaining repeat trop. pt verbalized agreement. 1143- pt resting in the er, nad. vss, pt non-toxic. second trop negative. pt states no further symptoms while in er. denies chest pain, soa, dizziness or palpitations. pt states she feels good to go home. discussed strict return precautions and importance of close f/u with pcp / cardiology. pt verbalized agreement. aware to return to er if concerns or change in symptoms. pt ambulatory out of er with steady gait wo difficulty.
Nasal Congestion Cough Weakness Dizziness Sore throat (1st day only)
10 mins post vax developed localized redness and 1 hive at site. Benadryl given.
I had the muscle and joint pain and stiffness, and headaches that most report. Slight fever. Just a general feeling of being unwell. However, I have had two swollen painful lymph nodes pop out at my collar bone on the left side (same side as injection site).
Patient reported spreading left upper swelling and redness, joint pains, headache, nausea, dyspepsia since the day after injection was given. Revealed very tender 8.25inx4.5in redness and swelling over the left deltoid extending to the distal aspect of the left tricep area.
Provider d/c note:  "Presented to the Emergency Department complaining of generalized pain for a week which was similar in nature to previous sickle cell pain.  Only other complaint per admission history and physical was chronic constipation. Initial hemoglobin was 5.9.    Hospital Course:   ? Was found to be Covid positive but had no indication for prednisone or remdesivir. ? Received 2 units of PRBCs during hospitalization; did not complete first unit initiated in the ED because she developed a rash and urticaria.  ? Pain was treated with IV Dilaudid and Benadryl.   ? At time of discharge patient indicated her pain was well controlled and she was ready to go home. ? Hemoglobin at time of discharge was 7.1."
Fever; Cold chills; Weakness; Loss of appetite, lasting 2 days and nights.
5 days after 1st shot had shortness of breath,fever 101  had hot & cold chills and body wetness when sleep  for the next 5 to 6 days took nasal test days after temperature occurred its was negative. Went back to work on 15th Had 2nd shot on  1/23/21 with no reaction