chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hours following Immunizations, baby developed high fever T105 degrees, with Tylenol. Temp reduced to 102 degrees. Mom called her doctor office. No Dr. office visited. Within 48hours. After immunizations "baby was acting sick", fussy, wanted to be held constantly. Not taking as much food. Decreased appetite, runny nose, congestion, cough presented.
Mother of this child reports that her left arm is swollen ("Doubled in size") and her lymph nodes are swollen as well.
had the vaccine and still got it pretty bad/ Suspected vaccination failure; still got it pretty bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the vaccine and still got it pretty bad/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got it pretty bad). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that, he/she could not imagine what it would had been like without the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
10 day mark symptoms became heighten the red rash came back the size of a quarter in half, red and swollen  and itchy, raised and hand became swollen and a bad head ache and went into the urgent care 01/23/202 . .He gave antibiotics for a two weeks Cephalexin and elevate the sizes and symptoms and red mark faded away
After receiving second dose of COVID vaccine, patient began experiencing swelling of face and throat and was taken to ED. Patient reported having similar reactions to vaccines in the past. Patient received 20mg Pepcid PO BID, Loratadine 10mg PO once, and prednisone 50mg PO once in ED and had subsequent resolution of tongue pruritis and improvement in throat tightness. Was discharged with prescription of prednisone.
Fatigue, muscle aches, sore arm and headache 16 hours later. 48 hours later have a two inch circular red rash at injection site and painful armpit, just the blanket lying in my armpit was painful.
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Transverse Myelitis; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (medically significant), outcome "unknown"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse Myelitis".; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202200916772 Same drug and different event/patient;
Patient received PREVNAR-13 and FLUZONE HD. Patient claims a large rash appeared at injection site of PREVNAR-13, 5 days after injection.
Systemic: Fainting / Unresponsive-Severe, Additional Details: patient fainted and father said patient hit head on floor. so ambulance was called and paramedics took patient to hospital
left arm at injection sight 2" by 3" red,warm to touch, hard ,itchey area
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date since 13 JUL 2015, the patient was administered with VAQTA lot # K012457 with expiration date of 04 JUN 2017 (strength, dose and route unspecified) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
5/23 36y.o. female with history of lumbar DDD and disc herniations s/p right L4-L5 discectomy who presents with acute on chronic low back pain, associated with intermittent numbness in her L leg.
This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a consumer or other non health professional and concerns a 33 year old female; local ID: 0134. The subject's weight and medical history were unknown. The subject received typhoid vaccine oral ty21a (heat, Phenol inactivated) (capsule, hard) on an unspecified date in AUG-1993. Concomitant medications were not reported. On an unknown date in SEP-1993, the subject developed a twitching syndrome in the upper right and left extremeties with weakness and muscle atrophy. The subject was later diagnosed with a motor neuron disease described as 'of ALS nature'. Action taken with TYPHOID VACCINE ORAL TY21A was unknown. At the time of this report, the subject had not recovered from the event. This report was serious (medically significant).
Information has been received from a nurse concerning a patient who was vaccinated po with a dose of ROTATEQ (date and number of dose unspecified). The nurse reported that the patient developed rotavirus, confirmed by the office lab technician. It was reported that the patient sought medical attention, unspecified. The outcome was not reported.
first simple febrile sz 8 days p/vax;pt hospitalized & developed pharyngitis & viral exanthem; prob entervirus;
Case number PHHY2012US053744 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not reported). The patient was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On an unknown date after vaccination the patient died due to cardiomyopathy. The causality of the event cardiomyopathy was not reported. Authors stated that the adverse event profile after H1N1 in VAERS was consistent with that of seasonal influenza vaccines, although the reporting rate was higher after H1N1 than seasonal influenza vaccines, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after H1N1 vaccination were rare (each <2 per million doses administered).
Patient with extreme fatigue day after vaccine. Large red bump at site of injection, hot to touch, hard. Arm very sore to move.
In upper left arm with in 12 hrs of Hep B vaccination #1, pain started in muscle. Deep pain is very noticeable, also a "knot" in the muscle is present. Pain has remained consistent predictable since initial vaccination. Has not gotten worse or better.
visit note 11/18/2020: HISTORY: Patient is a 4 y.o. female, who presents with vaccine reaction.    A lot of pain in the left leg Left leg is very swollen, no give to the skin, skin is very taught and tight.  If anyone touches the leg she screaming.    Had quadracel in left thigh yesterday at well visit check up with Dr..    Second shot was given refused to walk, has done this before. When she has had leg pain in the past she has refused to walk.    Thought let might be swelling yesterday but was wearing pants so didn't notice.    Woke up with pain last night after going to bed, pain was in left leg.  Left leg is really swollen this morning.  Briefly had some red splotchiness over body while screaming, then resolved and is no longer present.   Having to bribe her to stop screaming.  Not drinking very much.    Ibuprofen about 6 hours ago.    Skin is warm to the touch but no fever.  Has decreased appetite.  Never had a vaccine reaction before   Exposures: no known sick contacts
pt recvd vax 17AUG95 & on 18AUG95 pt devel a urticarial rash, which persisted on & off;no further details were provided;
MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; FEELING UNWELL; JOINT PAIN; SORE ARM; FATIGUE; HEADACHE; This solicited pregnancy report received from a consumer concerned a 38 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 68.93 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the patient experienced maternal exposure during pregnancy. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced joint pain. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, headache, joint pain, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, feeling unwell, joint pain, sore arm, fatigue, and headache was related.  This report was non-serious.
Left thigh redness/swelling/discomfort in region of his DTaP vaccine received on Wednesday, 10/21/12. Pt can still walk and has had no fever or bruising. Pt. to try ice pack, ibuprofen, and a little BENADRYL to treat swelling. Pt to return to clinic if fever/red streaking occurs.
patient reported that he first had flu like symptoms and his injection site looked like it may have had bruising. He then said after flu symptoms faded away he kept noticing his injection site first looked like a pea sized bruising it then kept increasing in size and is now about the size of Ping-Pong ball.  He said its painful if he lays on it otherwise does not hurt but still keeps increasing in size with time and is not shrinking.
This spontaneous prospective pregnancy report was received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) while she was pregnant. No concomitant medications were reported. Last menstrual period (LMP) and estimated Date of Delivery (EDD) were unknown). The pregnancy outcome was pending. No adverse effect was reported. Additional information has been requested.
A few days after getting a second dose of COVID-19 vaccine, Patient began to feel generally unwell. He experienced numbness in his legs, dizziness and heart palpitations. We took him to the doctor a few times, but his Flu, COVID and Mono tests were all negative.  Over the course of the month, his symptoms became worse, causing him to miss school and sports. In October, Patient's primary care doctor, Dr., referred Patient to Hospital Cardiology after an EKG reveals his resting heart rate was 31. We followed up with Dr. at Hospital. Another EKG showed his heart rate in the 30s. Patient underwent an echo and then wore a 24-hour holter monitor a few different times. After it was discovered the electrical system in his heart wasn't working properly, he was referred to Dr. who subsequently diagnosed Patient with sinus node dysfunction and heart block. Dr. continued to monitor Patient's symptoms, which did not significantly improve. In October of 2022, his symptoms again became worse. It was decide Patient would best benefit with a dual chamber pacemaker implant. A pacemaker was implanted on Nov. 7, 2022, and a lead revision was performed Nov. 22, 2022.
"COVID arm" - large half-moon shaped redness at injection site.  Itchy, tender, and warm
Systemic myalgia, headache, dizziness, extreme drowsiness, injection site pain.
My 12 year old daughter was vaccinated on 04/06/2021 by Dr. clinic at the Airport. We were told they were vaccinating ages 12 and up at that time. We received an email to return for our 2nd dose but when we returned they told us she was not allowed to have her 2nd dose due to age. There were multiple children her age in our area that have received the 1st dose through this clinic but are being refused the 2nd dose.
Extreme go.lying and nausea, dehydration,  couldn't keep down medicines, went into altered state, kidney failure heart and was in Hospital for March 31 - April 7, was not conscious until.April 5th.  Some dr blamed it on the morphine but have had past unconscious hospitalization when sudden withdrawal from gabapentin which resulted from vomiting.  Have never had problem with heart kidneys or lungs before this.   Was given (medication) three times but it didn't bring me back to normal.  As for level of morphine sudden stoppage of gabapetin CA  affect the levels in blood. I was told not to get the second vaccine but not one dr in hospital seemed to want to report this and I don't think its right. I am going to have bill from being in intensive care and who knows what this will cost me.
LOCALIZED SWELLING AT INJECTION SITE. ASSESSED BY PHYSICIAN, INSTRUCTED TO GO TO ER IF SHORTNESS OF BREATH, CHEST PAINS, OR RASH OCCUR.
Redness and swelling to left bicep area. Pt received a PNEUMOVAX injection on 1/16/13, pt stated tenderness and pain that evening. Bag ice in cloth ML every day.
The morning after receiving immunization, patient's verbalizations changed to less verbal sounds, more "mmms" with a closed mouth. He was much more muted and nonverbal beginning Day 1 after receiving PEDIARIX. He clearly spoke 7 words prior to immunization at 10 months. His speech began deteriorating by Day 4: his pronunciation of the words "dog" and "book" which he already spoke clearly deteriorated. Eventually he stopped speaking these words altogether. Over the course of the next 4 weeks, he lost all words that he had previously produced except for one: "ball," but no longer pronounces the word fully. About 4-5 weeks later, he did produce one new word, "mama," which he has retained. Now at 4 months after the immunization, he has not produced any other new words or recovered any of the words that he spoke previously (bird, book, dog, etc.). He gets visibly frustrated not being able to communicate what he wants and says "da" a lot. Sometimes he shapes his lips like he's trying to pronounce a word, but no sound comes out. He does not repeat words after us if we try to prompt him to speak. He has also reverted to mouthing things and picking up tiny objects from the floor and eating them, which he had previously stopped doing at 8 or 9 months. He continues to do this at 14 months.  Patient's walking/gait also deteriorated. He was taking about 6 steps at a time prior to the immunization, but the day afterwards, he tried to take steps but kept rolling his ankles and falling - this never happened before. This progressed to the point where de didn't even try to walk. After about 1 month, he started taking steps but his gait has been different and he trips and falls often, doesn't have the same balance that he did before when he was taking steps. He is very bowlegged and pigeon-toed.  His behavior and personality has also changed. He gets frustrated often and almost seems irritable, throwing a fit if he isn't allowed to do what he wants. He used to be a much happier baby. He also is a much pickier eater now, where he used to eat anything we fed him.
Information has been received from a 23 year old female patient for GARDASIL, a Pregnancy Registry product, concerning herself. The patient had no pertinent medical history and no drug reactions or allergies. On an unknown date in December 2011 the patient was vaccinated with the first dose of GARDASIL (lot number 0626AA) (dose, route and injection site were not reported) to prevent HPV. On 28-FEB-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, dose, route and injection site were not reported). On 11-APR-2013 the patient was vaccinated with the third dose of GARDASIL (lot number, dose, route and injection site were not reported). There was no concomitant medication. On 23-MAR-2012 the patient found she was pregnant. On 26-NOV-2012 the patient delivered an infant. No side effects have been reported. The outcome was not provided at the time of report. There was no treatment given for adverse event. There was no lab diagnostics studies performed. The patient had seen healthcare professional for medical attention. The baby's information was captured in MARRS # 1304USA006581 (Parent-Child Link). Additional information is not expected.
COVID 19; COVID 19; Moderna dose 1, 2, booster/ Pfizer bivalent; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: GH9693) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2021 as dose 1, single (Lot number: 041B21A), on 11May2021 as dose 2, single (Lot number: 023C21A) and on 27Nov2021 as dose 3 (booster), single (Lot number: 939903) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Oct2022, outcome "unknown", described as "Moderna dose 1, 2, booster/ Pfizer bivalent"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Negative, notes: negative for the prior 3 consecutive days; (01Mar2023) Negative, notes: negative for the prior 3 consecutive days; (02Mar2023) Negative, notes: negative for the prior 3 consecutive days; (2023) Positive, notes: Rapid antigen positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Feb2023 to 26Feb2023. The patient experienced COVID rebound; symptoms returned the evening of 03Mar2023 after most symptoms except for the fatigue having disappeared and negative for the prior 3 consecutive days (28Feb, 01Mar, 02Mar) via home rapid antigen test. Sore throat returned and upon re-test, rapid antigen was positive.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 31 year old female with no pertinent medical history or drug allergies who on 19-MAR-2007 and 15-APR-2007 was vaccinated SC with the first and second 0.5 ml doses of varicella virus vaccine live (Oka/Merck) (lot# 656078/0169U). There was no concomitant medication. On 06-DEC-2007 the patient experienced a negative titer result from labs at the physician's office. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Vaccine given on 02/02/2010. Mom called next morning stating arm red and swollen, told to give Benadryl and warm compress.  Patient seen in office on 02/05/2010 with complaint of reaction to vaccine. Patient seen by Dr. and treated with Prednisone 20mg po  b.i.d x 3 days and Atarax 25mg po q6hrs. Follow up as needed. Prednisone was given only two doses per Mom b/c pt c/o heart beating fast and dizziness and nausea. Mom stated pt is better reaction cleared.
presented to the ED on 8/27/21 for evaluation of weakness, cough and SOB since 8/22/21.  Pt tested positive for COVID 19 on 8/25/21.   Pt has received both doses of Moderna vaccine.  While in the ED, pt with SpO2 of 93-94% on RA.  ABG showed a pO2 of 74.2.  D-dimer elevated at 1.63.  CT angio chest done showed no PE, but changes consistent with combination of CHF and COVID-19 pneumonia.  Pt had crackles and rhonchi on exam.  She was started on IV Lasix.  Pt admitted for CHF exacerbation.  She was started on Azithromycin as well.  She had been started on 2 L oxygen because of slightly low PO2 on ABG. Pt with Fever of 101.9 on 8/28.  No fever for the last 48 hours.  Ordered Urinalysis, Sputum and blood cultures.  Blood cultures without growth so far.  U/A not suggestive of UTI.  No report of sputum culture.  IV Azithromycin switched to PO on 8/29.  Will discharge with PO Azithromycin; per nurse she has been off of oxygen for over 24 hours and doing well.  Cardiology was consulted on admission given elevated troponin.  Troponin initially trended up from 0.048 to 0.076, but went down to 0.066.  Pt denies any chest pain.  Elevation of troponin thought to be likely related to CHF and COVID infection.  Troponin has been elevated since March.  ECHO showed EF of 30-35% and pseudonormal pattern of LV diastolic filling; no changes from ECHO in June.  Nurse reported that pt had new onset Afib on 8/28, so Cardiology has started Xarelto. Discharged 8/30/21