chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drooling; That night patient hadn't eaten and became acutely congested; felt like there were marbles in his mouth; This case was reported by a other health professional via call center representative and described the occurrence of drooling in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included PROQUAD for prophylaxis.   On 10th September 2020 16:30, the patient received the 1st dose of Kinrix .5 ml and PROQUAD. On 10th September 2020 18:00, 1 hr 30 min after receiving Kinrix, the patient experienced drooling, respiratory tract congestion and oral discomfort. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the drooling, respiratory tract congestion and oral discomfort were recovered/resolved.   It was unknown if the reporter considered the drooling, respiratory tract congestion and oral discomfort to be related to Kinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Kinrix and ProQuad in right thigh.  At 6pm that night patient hadn't eaten and became acutely congested, was drooling and felt like there were marbles in his mouth.  The patient's mom gave him Bendaryl and he seemed spaced out.  The symptoms subsided immediately after receiving Benadryl.  He had no issues in the past.  Consented to follow up.
After taking the 4th dose, I had a severe sore arm. The pain persisted and I spoke to my doctor on 10/05/2022. I have been diagnosed with frozen shoulder, which is also called adhesive capsulitis. I have been dealing with pain, tenderness, swelling, and limitation of movement in my arm and shoulder. I was prescribed VOLTAREN topical medication. I am in the process of looking for a physical therapist for the problem.
24 hours after injection........chills, fatigue, sore left arm that lasted 3 days.
This spontaneous report as received from a pharmacist refers to a 61 years old male patient. On 19-SEP-2012, the patient was vaccinated with ZOSTAVAX (Lot# H011333; exp. date: 08-SEP-2013) subcutaneously. The pharmacist noted that on 20-SEP-2012, the patient experienced itching on his hands, legs, and feet and that on 21-SEP-2012, he had a rash. The pharmacist noted she did not know the extent of the rash but did not there was no injection site reaction. No treatment was given. The patient's outcome for the event was not recovered. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
5 days after vaccine my skin got very hot, red, irritated and broke out in hives. It's been three days and my skin is still irritated.
Information has been received from a physician concerning a patient who was vaccinated at 4-month-old with a dose of rotavirus vaccine (human-bovine). Subsequently the patient experienced pseudomonas sepsis. The physician did not feel that the rotavirus vaccine (human-bovine) caused the infection. Additional information has been requested.
Ongoing fever spikes starting on Day 5 from 101-103 along with moderate to severe chills; Ongoing fever spikes starting on Day 5 from 101-103 along with moderate to severe chills; diarrhea; excess fatigue; This is a spontaneous report from a contactable physician.  A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 16Dec2020 12:30 as a single dose (dose 1) in the left arm for COVID-19 vaccination.  The facility where the most recent COVID-19 vaccine was administered was a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included type 2 diabetes mellitus and hyperlipidaemia. There were no allergies to medications, food, or other products. Concomitant medication included metformin, eicosapentaenoic acid ethyl ester (VASCEPA), and losartan.  The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient experienced ongoing fever spikes starting on Day 5 from 101-103 along with moderate to severe chills, diarrhea and excess fatigue. The adverse events' start date & time was reported as 21Dec2020 at 12:30. The events were reported as non-serious. "Today" (24Dec2020) was day 8 and none of these symptoms have improved. The patient underwent treatment for the adverse event which included paracetamol (TYLENOL) and fluids. The outcome of the events fever spikes, moderate to severe chills, diarrhea, and excess fatigue was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
24 hours after injection, experienced bad headache ; muscle aches throughout body, mostly back area; overall malaise and spent much of the day resting. Felt better after 48 hours. Felt fine on day 2 and 3 after injection. Next, on fourth day after injection experienced bad headache (current situation). I have not sought medical care as I feel it is not severe enough.
Patient reports a burning pain in her right leg from the hip to the knee area; not pinpoint pain, more radiating; initial swelling but reports no longer swollen. Patient following up with primary care provider to see if this is related to history of back issues and radiating pain or something  else.
Fever; Chills; Headache; Muscle aches; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 14Apr2021 at 12:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 12:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 07:00, the patient experienced fever, chills, headache, muscle aches and injection site soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, headache, muscle aches and injection site soreness were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I work as an EMT and have had anaphylactic rxns before (but never to vaccines, always mystery food items or environmental allergens). My worst anaphylactic rxns have always displayed more on the GI/cardiac side rather than respiratory (although environmental allergens do trigger asthma for me). Approximately two hours after receiving the vaccine I began experiencing positional syncope to the point that sitting even slightly upright in bed left me extremely light headed. Walking to the bathroom less than 20 feet away resulted in blurred vision and weakness and near collapse. I was nauseous and unable to eat or drink; no significant emesis. A mottled red rash was present near the vaccine site with approximately 4 inch margins and considerable swelling at site and axillary lymph nodes. Transient mild wheezing present. My known allergens were not present while I experienced these symptoms. The symptoms lasted in total approximately 36 hours. I was able to get up and look for benadryl on the second morning which completely resolved the remaining allergy-like symptoms. Admittedly, I am a stubborn patient and did not seek medical attention, and instead treated myself; however, I was too weak to properly document anything beyond what I have written. Prior to vaccine administration I was recovering from an asthmatic attack associated with a known allergen (rabbit dander), but the allergen was removed and I was not experiencing symptoms by the time I received the vaccine.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 2/8/2023RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
A few hours after pre exposure rabies vaccine, (second dose of series)complained of minor lymphatic pain, under arm injection was given in. 8 hours later had chills, felt like had the flu. Then fell asleep. 48 hours still has lymphatic discomfort.
10 hours after vaccine, became very uncomfortable and slept poorly which continued for 3 weeks. Very hard to comfort, even with nursing. 01/23/05, developed a hive like rash 25% of abdomen an 10% of back
patient received a .25ml dose when they should've received a .5ml dose.  I've worked with our state health department and will be contacting the patient to inform them and encourage another .5ml dose 8 weeks after the .25ml dose was given.
Was seen on 9/13/21 in office. Rash that is documented as scattered wheal like lesions with some targets on trunk and bilateral upper and lower extremities; also noticed around mouth , central clearing present, blanches with pressure, also has single blister to L foot.  4mg Decadron given IM. Rash greatly improved next day at office visit on 9/14/21
Narrative:  Patient received Moderna COVID-19 vaccine at store in May. At 8/9 follow up with psychiatry, she reported an allergic reaction after administration of the dose requiring EMS and multiple doses of epinephrine. Patient's mother was with her at the time of the reaction.
Janssen COVID-19 Vaccine EUA 4/5 - (from time of waking up in the AM) persistent migraine, joint pain, heart palpatations, soreness at injection site, nausea, dizziness, persistent lethargy and lack of appetite 4/6 - persistent headache, joint pain, light-headedness, lack of appetite. Noticed a red welt at injection site (bright red, hot to the touch, swollen) 4/7 - red welt inflamed, still hot, sore, became incredibly itchy, whole arm uncomfortable and hurting. All other symptoms gone 4/8 - Inflammation of welt partially faded but red irritation spread out like it was dispersing. Later became darker red, still itching, began to hurt so much that even light fabric brushing across the skin caused pain. Still very warm to the touch. Doctor diagnosed the welt as Cellulitis and immediately issued an antibiotic.
Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Sep-2022 at 11:47 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Sep-2022 at 11:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant information was reported. Injection site given as Deltoid. Dose/volume given as 0.5 There were excursions noted. No adverse reactions reported to reporters knowledge for patient. No treatment information was reported.
increased dose of venlaxafine, also, had shingrix shot  started medication with low blood pressure. now my blood pressure is elevated 130/84 taken on July 5th at urgent care. I took Shingrix shot first dose in March 2023 from Dr. I developed tinnitus in late June 2023.
For about a week after the shot, I felt like my mouth was filled with cat fur. Not cotton mouth, not thrush, but specifically cat fur. It would disappate if I drank a lot of water, but would come back in a few hours. Lasted about a week.
One day after vaccination, pt had sore arm, nausea, headache, extreme weakness, diarrhea - dizziness - no symptomatology pt felt better but not normal after 2 days.
Pt is a 33 year old male who received anthrax (AVA) # 2 on 24 Oct 03. He stated that 18 hours later he noticed a rash on arms and chest that looked like little red spots that were close together. He said that there were mounds of them. He did not notice any fluid and said that they were itchy. He denied scabbing and was treated with Atarax and prednisone. He stated that the rash lasted 1 month and that it gradually decreased with the medication. He stated he took the steroids for 1 week and was also given some antibiotics. He has been doing extensive traveling at this time. No other traveling companions developed this rash. 10 Nov 03 he received AVA # 3 and he did not develop any new skin lesions. He said that he had residual dry spots from the previous outbreak and that everything had cleared except for a small area on his left palmer surface of his forearm. This area would have intermittent breakouts not associated with anything in particular and he would sometimes treat with an anti-fungal. 12 Apr 04 he received AVA # 4 with no outbreak noted.  In regards to patch on his arm, he reports intermittent itching and occasionally uses Lidex cream on his arm only. He reported that the area on his arm would ease but would never clear completely. He stated that his torso cleared completely and he did not have any increase in the rash after AVA # 3& 4.  He reports that approximately 6 weeks ago he noticed that the rash on his left arm began to flare again and it spread to his both the inside and outside of his elbow. He stated that both of his elbows were affected. In mid June he noticed an area on his right nipple area. Stated the area was dry, red, raised and scaling. During the past 2 wks he has noticed orange watery discharge with nipple area turning white with some squishiness. Went to MD in on July 21 and was given Keflex with slight improvement.  Pt presented to Allergy Immunology today for evaluation. 30 Sep 04: pt reports that the rash may have been a reaction to ibuprofen. Rash has now cleared and he had a follow-up last week. He said now it is " just wait and see".
Arm soreness and fatigue first two days. Several hours after the vaccine, experienced some paresthesia in left arm/hand (same arm as shot). After 3 days the tingling/paraesthesia was more widespread to arm, fingers, and feet, mostly still on left side of body. No pain or burning as of day 4 but feeling of "pins and needles" continues.
Rash; Vesicular cluster of eruptions on left mid axillary line and near the epigastrium on the left in a dermatomal fashion; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via intramuscular route of administration in the right arm on 01Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to sulfa drugs. Concomitant medications included Multi Vitamin Injection (MVI) (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC), both taken for unspecified indications from unknown dates. The patient previously took clarithromycin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 28Dec2020, the patient underwent COVID-19 test Polymerase Chain Reaction (PCR) and the result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced rash, vesicular cluster of eruptions on left mid axillary line and near the epigastrium on the left in a dermatomal fashion. She denied any pain prior to the eruption. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the  event and included treatment with valacyclovir and Hydrocortisone (HC) cream. The clinical outcome of the event rash and vesicular cluster of eruptions on left mid axillary line and near the epigastrium on the left in a dermatomal fashion was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Itchy rash throughout entire body that does not resolve with steroids, flu-like symptoms, upset stomach, pain at injection site
1 minute after vaccine injection throat closed, feeling difficulty breathing and swollen throat for a few hours. Palpitations for 3 hours after injection.
Crohn's aggravated; Chills; Aching joints; This is a solicited report based on the information received by Pfizer from Manufacturer (Mfr. control no.: 21K-163-3936556-00). A contactable 82-year-old male consumer (patient) and a non-contactable consumer (Patient's wife):  A 82-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on 03Feb2021 as dose 2, single for COVID-19 immunization and adalimumab (HUMIRA), subcutaneous from 2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg, 1 in 2 wk) for crohn's disease.The patient previously received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) vial intramuscular route of administration on 13Jan2021 as dose 1, single for COVID-19 immunization.The patient medical history include hypersensitivity, Crohn's disease, Anxiety, pain, Supplementation therapy. Patient's wife stated that the patient was allergic to two medications to improve his bone density but could not recall the specific medication, bone density abnormal, Abstains from alcohol, Sesame Seeds and Oil allergy manifested by red face and throat swelling and Sulfa Drugs Allergy. The patient was non-tobacco user.Concomitant medication included ciprofloxacin (CIPROFLOXACIN) for crohn's disease, azathioprine (AZATHIOPRINE) for crohn's disease, lisinopril (LISINOPRIL) for crohn's disease, balsalazide (BALSALAZIDE) for crohn's disease, venlafaxine (VENLAFAXINE) for anxiety, oxycodone (OXYCODONE) for pain, betacarotene;calcium carbonate;cyanocobalamin;folic acid;nicotinic acid;pyridoxine hydrochloride;riboflavin;sodium ascorbate;thiamine hydrochloride;tocopheryl acetate taken for supplementation therapy, hyoscyamine for crohn's disease and valsartan taken for an unspecified indication. On 04Feb2021, the patient experienced Chills, Aching joints and Crohn's aggravated.On an unknown date, the patient underwent lab tests which included computerized tomogram: unknown results. The action taken in response to the event(s), for adalimumab was unknown. On 07Feb2021, the patient recovered from chills and Aching joints and had not yet recovered from Crohn's aggravated.  Causality as per reporter for event chills and aching joints as probable and for Crohn's aggravated not reportable    No follow-up attempts are needed, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in narrative, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the reported events of Crohn's aggravated ,chills and arthralgia cannot be excluded.. 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.
Pt began experiencing a slight cough, followed by stating she was producing mucus and that that is what generally happens before she has an asthma attack. Pt was observed and her friend went to the car to bring her inhaler inside just in case. Pt later C/O itching and provider ordered Benadryl via IM injection.
Flumist given in error, was not age appropriate.  Child is 1yrs old, minimum age for vaccine is 2yrs old.   When mom was contacted approx 2 hrs after event, she indicated child was fine.  Mom called back 24hrs later to notify nurse of diarrhea, fever of 99.9 and rash to chest and face.  Informed mom this RN would consult with MD and call her back.  After consulting with MD,  message was left for mom for a call back.
Got sick for 3 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick for 3 days after first dose) in a 72-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick for 3 days after first dose). At the time of the report, ILLNESS (Got sick for 3 days after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.  The patient received first dose of vaccine 3 weeks ago from tomorrow and was scheduled for his second dose after 1 week from tomorrow.
Menomune given on 8/9/02. On 8/10/02, had sore and red arm. On 8/14/02, the mother reports no strength in arm, achy all over, headache, scratchy throat and tired. No fever. Treat with Tylenol and monitor for fever. On 8/15/02, better, fine and no further complaints.
1:00PM Pt. left after 15 plus minutes and came back to parking lot. RN notified at 1:07pm.  S&S numbness and tingling of left hand. Heaviness in left arm.   Sitting: at 1:15pm B/P 150/95, Pulse 118,  O2 sat at 100%.  1:20pm Clear lungs and heart sounds, RR 20, B/P 150/70, Pulse 117, O2 sat 100%.  1:30pm B/P 146/70, Pulse 99, O2 sat100%.  1:40 pm  RR 18, B/P 148/74, Pulse 104, O2 sat 99%.  1:55 pm B/P 150/70 Pulse 110, O2 sat ( too cold to read). Left hand tingling resolved;  Left lower arm felt heavy still.  No dizziness with standing upon repeat exam. 2:05pm  Felt comfortable driving home - 10 minutes away.  Advised calling EMS immediately if symptom progress or any additional  S&S  occur.
I did not have an adverse reaction to the vaccine. I tested positive with a home test for COVID-19 on 07/29/2022. I had  a telehealth visit with my doctor and was prescribed PAXLOVID. On 08/07/2022 I tested positive for COVID-19 again. I'm now treating my symptoms with over the counter medication.
Dizziness, nausea, bruising, swelling in the arm and 2 large lumps in the left arm as well.
Patient given a booster dose of expired Pfizer COVID-19 vaccine. No adverse symptoms reported.