chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red raised bumps noted on face, chest and back by moth on 4/27/16. Called office on 4/29/16 to report rash at 0920am. No fevers recorded. Dr's office notified. Call placed 5/10/16 to follow up. Pediatrician diagnosed as dermatitis not related to vaccines.
We got a call from Doctor from ER to inform us that this patient came to the ER today & got swollen arm @ the injection site (left arm). They did the ultra sound & found there's a clot in brachial vein on the opposite arm (right arm). Doctor said they'll give pt Eliquist today.
I started without getting my minstrel cycle. From there I started having other symptoms...not using the bathroom.... forgetting things...trouble swallowing...trouble sleeping. I went to doctor finally advising that it slowly started after my first shot and worsened after my 2nd. They tested me. I came back with hypo thyroid and enlarged thyroid and enlarged left ovary.  I went to the dr the october before and was perfectly healthy with nothing. Now I have thyroid issues ...still have problems sleeping...still have one had one cycle since the shots.....put on 20pds!! and have occasional pain in the arm still.
Pt experienced flu like symptoms, severe body pain with joint pain. After second injection in June, 99, pt experienced more pain throughout body for the past year, was unable to walk for a short period. 60 day follow-up dated 10/03/00 provided no additional data. The annual follow-up states pain; extreme fatigue; paralysis; autoimmune; lyme WB -.
Employee was given 2 IM shots in Left deltoid flu shot & tdap vaccine. Employee came in on 10/24/2008 stating that 2days after the vaccine was given to her,she experienced nausea, headache & dizziness. She was then referred to Dr. for evaluation.
Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed and I had to go to the emergency room where I was given doxycycline b.i.d. for seven days.
Information has been received from a healthcare facility concerning an unidentified pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced shoulder and elbow pain. The pt sough unspecified medical attention. An additional pt (WAES 00062102) had a similar experience following exposure to this same vaccine. Additional information has been requested.
diarrhea qd, & mole like bumps-(rash) on chest, stomach, arm areas (permanently) still come to this day;numbness in feet, can barely walk- occurs when running; seeing objects move in peripheral vision sometimes, abd pain;
I had mild thinking and numbness on my lips and tongue with my 1st dose of Moderna gotten on 3/5/21.  This was 1/2 hour after being vaccinated.  The symptoms last about 2-3 hours and then disappeared.  With my second dos the symptoms start about 1/2 after being vaccinated.   This time I felt bit dizzy, and I felt thinking and numbness on my chin, nose, both cheeks, lips and mouth.  It lasted until evening but the symptoms seem to lessen as the hours went by. Today 4/1/2021 I have just typical side effects. Mild tiredness and light headache , and soreness/swelling on the vaccination site.  I also had a reaction to MRNA vaccine that I received about 5 years ago from .  I had t take it for work related services.  I Had fever and body aches about 5 days which took place about 2 weeks after being vaccinated.  I assume  reported that one.
Stevens-Johnson syndrome; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Pharmacist stated that she had a patient who received the 1st dose of Pfizer vaccine and developed Stevens-Johnson syndrome. The patient wanted to receive moderna vaccine. Pharmacist wanted to know can the patient receive the moderna vaccine and does the moderna also can cause the same side effect, if causes what is the percentage. Pharmacist did not have the patient details. Outcome of the event was unknown.  Information about lot/batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Stevens-Johnson syndrome due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
VARIVAX was given 06-21-16. Patient's Mom called 7-05-16 for an appointment. Pt. had rash all over body indicating adverse reaction.
Patient with complaints of tightness of throat, but could breathe very well, she stated. Vitals initially were B/P 170/100, HR 61,, R 20. O2 saturation 99%.  Offered rest period. Offered EMS transport for further evaluation at the Emergency Room and Patient declined. After rest, patient drank water and tolerated this well. Second set of vitals after rest and water were: B/P 124/89,  HR 60, R 20, O2 saturation 99%. Patient stated she felt better, and was transported to her vehicle per wheelchair for release.
Marked vertigo with inability to walk unassisted. Symptoms gradually faded over 4 days and resolved.
This spontaneous report was received from a healthcare worker refers to a 7 month old patient. The patient's concurrent conditions and medical history were not reported. On 26-AUG-2015, the infant was vaccinated with VARIVAX (lot # L009205, expiry date 17-MAR-2017) and MMR II (lot # K020189, expiry date 11-SEP-2016) in error. The patient did not demonstrate an adverse experience. Additional information has been requested.
Patient completed Janseen one dose COVID-19 series on 4/2/21. Patient was admitted to reporting hospital on 10/11/21 with 10 days of on-going symptoms with persistent diarrhea, fatigue, cough, and poor oxygenation. Patient continues to be hospitalized on day 4 and has been treated with dexamethasone and remdesivir. Original positive test was at pharmacy on 10/4.
no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 02-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U014992 was confirmed to be valid, expiration date: 29-OCT-2023) (dose, dose number, site and route of administration were not provided) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccine were improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005825: US-009507513-2204USA005827: US-009507513-2204USA005828: US-009507513-2204USA005829:
Spiting up white flem ,when getting up in the morning and during the day !pain left side !Lung?
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:11 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses 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.   Age of patient was reported as 63.21 for dose administered on 27-Feb-2021 and 63.28 for dose administered on 27-Mar-2021. No concomitant product reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Patient received vaccine on 27-Feb-2022 at 09 AM and received other dose on 27-Mar-2021 at 09:11 AM. Batch number 014M20A underwent multiple temperature excursion on 27-Feb-2021 from 33 to 35 degrees Fahrenheit from 09AM to 05 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09AM to 10 PM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. No treatment medication were provided.
weak, is sleeping all the time; weak, is sleeping all the time; has to use a cane to walk, which he didn't used to before.; dizzy, which is not normal for him; started experiencing tiredness and went to lie down; He has fallen 4 times since receiving the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time), FALL (He has fallen 4 times since receiving the booster dose), GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.) and DIZZINESS (dizzy, which is not normal for him) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included TIA (He was hospitalized 3 times in 2019 due to the TIAs) in July 2019. Concurrent medical conditions included Grand mal seizure since July 2020. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, COLECALCIFEROL (VITAMIN D3), DOCUSATE SODIUM (COLACE), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), PHENYTOIN (DILANTIN [PHENYTOIN]) and POTASSIUM CHLORIDE for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced FALL (He has fallen 4 times since receiving the booster dose), DIZZINESS (dizzy, which is not normal for him) and FATIGUE (started experiencing tiredness and went to lie down). On an unknown date, the patient experienced ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time) and GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.). At the time of the report, ASTHENIA (weak, is sleeping all the time), SOMNOLENCE (weak, is sleeping all the time), FALL (He has fallen 4 times since receiving the booster dose), GAIT DISTURBANCE (has to use a cane to walk, which he didn't used to before.), DIZZINESS (dizzy, which is not normal for him) and FATIGUE (started experiencing tiredness and went to lie down) outcome was unknown.            No treatment medications were reported.
Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient.; Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient.) and inappropriate dose of vaccine administered (Verbatim: Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Oct-2023 Registered nurse gave permission for follow-up for patient demographics, lot and expiration date of Menveo and administration dates. Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient, which led to wrong vaccine used in drug reconstitution and inappropriate dose of vaccine administered.
Patient experiened redness and itching especially on both arms.  Patient called and we recommended for her to take some Benadryl right away.
Information has been received from a 63 year old male consumer with no medical history an/or drug/allergic reactions, who on 16-APR-2007 was vaccinated intramuscularly with a 0.65 mL dose of Zostavax (Merck). Concomitantly therapy included Diovan and Lipitor. On 18-APR-2007 the patient developed a "hard knot like configuration" at the injection site. No diagnostic laboratory tests were performed. Medical attention was not sought. The patient's status was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
A wrong dosage of Hep B was given to an infant. After the injection, the child was not experiencing any symptoms, discomfort etc. A supervisor, Medical director, and parent were informed of the incident.
I developed cold like symptoms:  headache, congestion and cough.  No fever.  Received positive covid test result on 2/18/2022
7 days post injection patient developed redness/hives at injection site with some itching and pain as well as warmth to the touch. Lasted for 2 days, has since resolved. Scheduled for dose #2 01/28/2021.
I received my first Pfizer vaccine when they were first available to the public (April 7,2021). My shoulder was in pain soreness at the injection site. I got the shot in my nondominated arm because I knew it was going to be some discomfort. On April 28 I went to get the second dose and I asked the nurse was it weird that my arm was still in sooo much pain 3 weeks later. The nurses didn't think that there was any correlation to the pain in that arm, so I received the second dose in left arm as well. The pain was nonstop and in July I noticed that the weird arm discomfort hadn't resolved. And I had a hard time doing daily activities driving's. Picking things up or even opening doors. I really find it strange because I am young to have issues with range of motion and baring weight. I have let this go on for a while because I thought that over time it would just go away but it hasn't. In December my arm was showing some improvement I was able to move my arm parallel to my shoulder like above my head without pain. My arm was better with the range of motion. I met with my PCP (April 12,2022) and she refereed me to an Ortho doctor. I saw the Ortho doctor on May 2,2022, he referred me to physical therapy which starts on Tue May 31,2022. I was also given a shot of cortisone. Rotator cuff and bursa was in flamed and mad as my Orto doctor described which is why I was limited with range of motion and having so much discomfort.
After she took the vaccine on her left leg her knee joint started hurting. It stopped her from walking it also swole up. It was very painful and it kept her up at night.  Then her hair started coming out. When she comb it it started coming out by the hand full.
body ache; Headache; soreness in his arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reported for himself. A 52-year-old male patient intramuscularly received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), first dose on 15Dec2020 21:00 and second dose on 05Jan2021 09:00 at single dose at deltoid left for preventative. Medical history and concomitant medications were reported as none. The patient experienced body ache on 06Jan2021 with outcome of unknown, soreness in his arm on 05Jan2021 with outcome of recovering, headache on 06Jan2021 with outcome of not recovered.  He was asking if he can take paracetamol (TYLENOL) for body ache and soreness in his arm following administration.
pt recv vax; 31jul started itching, swelling,blotchy rashes that spread up to legs, to the arms,neck & shoulders;1aug spread from neck to face;
an expired dose of PENTACEL was inadvertently administered today with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was inadvertently administered an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 20v (crm197) (prevnar 20) for immunisation; hepatitis b vaccine (hepatitis b [hepatitis b vaccine]) for immunisation; and rotavirus vaccine (rotavirus vaccine) for immunisation.  On 23-Oct-2023, the patient received 0.5 ml (Dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ786AA, Expiry date: 12-Oct-2023) (Strength: Standard) (Frequency: once) via intramuscular route in the left thigh immunization.  On 23-Oct-2023, the patient was inadvertently administered an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] today with no reported adverse event (expired product administered) (latency: same day).  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
large local reaction to right thigh - enlarged to almost full thigh  no systemic symptoms  treated with Motrin and Benadryl
JOINT PAIN; FEVER; NECK PAIN; ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced arm pain. On an unspecified date, the subject experienced joint pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, neck pain, fever and joint pain was not reported. This report was non-serious.
Headache; Tiredness/ the general feeling of tiredness; Muscle pain; Chills; Night sweats; Joint pain; Low-grade fever; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included triamcinolone acetonide (NASACORT) from an unknown date for an unspecified indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the right arm on 16Mar2021 at 19:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 07:00, the patient experienced headache, tiredness, muscle pain, chills, night sweats, joint pain, low-grade fever, dizziness, and the general feeling of tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event headache, tiredness, muscle pain, chills, night sweats, joint pain, low-grade fever, dizziness, and the general feeling of tiredness were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
The first dose was given on 12/30/20 with site soreness and slight redness.  Redness was gone in about three days and the soreness was gone after two weeks. The second dose was given 1/27/21. About 12 hours after given the 2nd vaccine, I woke up from a sleep with chills, temp of 99.2, muscle and joint aches, breast tenderness, site soreness, slight redness.  These symptoms were expected and my temperature was normal after taking a shower and drinking some water.  The chills persisted and I checked my temp a few times to make sure I didn't have a temperature.
Appeared well when immun given; Was found by babysitter w/out respiration & pulse; Paramedics called - vomitus in nares & throat; Pronounced DOA @ Hosp Fr Death Certificate: cause of death-SIDS;