chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient did not take the 2nd dose; Rash generalized; Tongue swelling; Hot flashes; Not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), HOT FLUSH (Hot flashes), ASTHENIA (Not feeling well), RASH (Rash generalized) and PRODUCT DOSE OMISSION ISSUE (Patient did not take the 2nd dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue swelling), HOT FLUSH (Hot flashes), ASTHENIA (Not feeling well) and RASH (Rash generalized). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not take the 2nd dose). At the time of the report, SWOLLEN TONGUE (Tongue swelling), HOT FLUSH (Hot flashes), ASTHENIA (Not feeling well), RASH (Rash generalized) and PRODUCT DOSE OMISSION ISSUE (Patient did not take the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No Treatment History was provided.  Follow up Description: The patient went to get the 2nd dose and  was not given the vaccine but instead asked to go see an Allergist. The Allergist said that not to take the 2nd dose absolutely. So, the patient did not take the 2nd dose.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Added event Patient did not take the 2nd dose
Headache, Myalgia, CoughWheeze, Short of Breath, fatigue Narrative:
Erythema on Cheeks; Generalized Itching; Facial Edema; Symptoms started 8:30am 1/12/10 and ended 1/13/10 10:30pm
Patient given combo vaccine Pentacel. Patient is to young for Pentacel due to Polio vaccine being in the combo.  Spoke to mother, 4/25/2019 who states baby seems fine
Received prevnar 6/15/2005 developed urticaria following day resolved with benydryl with 24 hours
After administration of PNEUMOVAX, within 1 to 2 minutes patient became weak and shortness of breath. Patient was helped to the floor and monitored by vaccine provider (pharmacist) while other staff called 911. Emergency response team arrived in approx. 5 minutes.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 01/28/2021, 02/17/2021, and 09/28/2021. The first doses were administered at the facility specified above. The third dose was administered at the Clinic. It is not known if the individual had a specific symptom onset, but tested positive for COVID-19 on 01/28/2022. They were also admitted to hospital on 01/28/2022. They experienced complications of pneumonia and respiratory failure. They were transitioned to comfort care only and died on 02/05/2022.
Pt exp temp 104 ax noc of DTP 13MAY91 t103 next day t105 r 15MAY; Seen by MD 14MAY91 checked for dehydrated-no; Use APAP, fluids; 15MAY91 when temp inc hosp x 3d for observation devel n,v,d, lg intestine enlarged, OM, conjunctivitis, rash;
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: NP returned patient's call regarding vaccine reaction concern from flu vaccine given on 10/31/22. Patient stated "I feel that the nurse who gave me the vaccine gave it to me too close to the bone and did not feel the muscle before giving it". Pt also stated "I am very disappointed that I did not know Clinic was not a part of Pharmacy and am very disappointed in Clinic" Patient states "I am having bruising in my arm as well as neck pain and swelling and also arm pain and swelling"
Two days post vax, the patient returned with localized redness. The patient's right deltoid had an area of red induration 4 x 2 inches. The patient's left arm had an area of red induration 2 x 2 inches.
heart problems; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (heart problems) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (heart problems). At the time of the report, CARDIAC DISORDER (heart problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
13 year old male received  Intramuscular Pfizer vaccination (Lot# EW0191) in right deltoid on June 9th 2021 at 12:44pm . At approximately 1:00pm  the client complained of headache and dizziness to his guardian. (Name) who has her BSN in nursing and her interim permit at observation went over to assess the patient with other onsite staff. The patient denied difficulty breathing. Patient was oriented x 3 with stable vital signs. Vital Signs were taken at approximately 1:00 pm Pulse 58; RR: 12; B/P: 113/67; O2: 100%. Second B/P was taken at 1:19 pm and was 129/79. Client stated he ate breakfast today. No medication was given. Denied having difficulty swallowing. Water was provided. The client stated he was feeling better and after waiting an additional 20 minutes left home with his guardian.
Sudden onset nausea, body aches, fever 101 day after Tdap.  Nasal congestion, cough, right arm sore.  Exposed to viral septis 2 days ago in emergency room.  Medicated with Tylenol and Ibuprofen for relief.
This initial spontaneous case, was received from other non-health professional on 12-Oct-2017, concerning a 53-year-old adult female patient. The patient current conditions included HTN (hypertension) and hot flashes since an unspecified date. The patient's concomitant medications included lisinopril, EFFEXOR SR and PRILOSEC for an unknown indication. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number, expiry date, manufacturer and trade name: not reported). On 30-Sep-2017, after 2 days of vaccination, the patient had sore arm, flu like symptoms and fatigue. It was reported that, the patient was recovered within 24 hours. The reporter assessed the events as non-serious. Follow-up received on 20-Oct-2017: Non-significant information received (no new information). Significant case correction received with IRD 12-Oct-2017: Causality was changed from 'not reported to related'.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient called on the evening of 11/11/2021 in regards to having pain and arm armpit swelling after having the 3rd covid vaccine on Tuesday night. I was not the one who gave the vaccination but proceeded to talk to him about what otc and therapy things he could do to help. I also advised for him to see his provider as his md could provide him with further assistance. He was thankful for my help and taking the time to have conversation with him.
king size belly ache; pooped all over herself; weak and too through; severe diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 82-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262, expiry dates not provided, NDC#; unknown), via an unspecified route of administration, in arm left, on 27Jan2021 14: 00, as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were none. It was reported that the patient experienced severe diarrhea on an unknown date in 2021, also reported that She got a king size belly ache the following Saturday and pooped all over herself. She is weak and too through; all events on 30Jan2021. The outcome of the event diarrhea was unknown and other events were recovering.
Began 08/22/03 with general aches, joint discomfort worse at night. Symptoms continue through day of this report.
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; PATIENT RECEIVED 0.15 ML DOSE OF VACCINE (INCOMPLETE DOSE); OFF LABEL USE; This spontaneous report received from a physician concerned a 13 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) .15 ml, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced product administered to subject of inappropriate age. On 28-JUN-2021, the subject experienced subject received 0.15 ml dose of vaccine (incomplete dose). On 28-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age, off label use and patient received 0.15 ml dose of vaccine (incomplete dose) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210735433 and 20210663915.
This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported as Flu started on 07-Oct-2022.   Pfizer bivalent vaccine was administered on 25-OCT-2022 12:00 PM. On 11/21/22, patient had developed an acute onset of shingles and have never before and see that there have been several reported cases of shingles with this booster.  Treatment received included NSAID, calamine lotion, analgesics.
Case number PHEH2013US025514 is an initial spontaneous report received from a health care professional on 09 DEC 2013. This report refers to a 1-year old male patient. he was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309601; expiry date: APR 2014) 0.5 ml intramuscularly on 04 DEC 2013. No adverse event was reported following this medication error (inappropriate age at vaccine administration). No other information was available.
About a week after the second dose of the vaccine I started to have fasciculations in my left forearm. The fascinations then started occurring at random places throughout my body such as my toes, legs, pectorals muscles, shoulders, and triceps. These tend to occur more when at rest and are brief. They normally go away when I move or contract the muscle affected.  Some days they are less frequent, but others they increase in frequency and duration. They continue to occur daily.
Rash reported as starting 7/2/15 6-8 red raised bumps in a row on right thigh. Crusty but no weepy this AM. Mom to monitor for varicella rash.
Generalized maculopapular rash (hypersensitivity not disseminated vaccinia). Onset on day 10 after vaccination. No exanthem. No constitutional symptoms. Improving at time of exam.
Received DTAP, Polio and varicella vaccines in left arm on 6-6-11. There is swelling, redness approx. 7 cm x 7 cm.
Anaphylaxis - after leaving clinic where vaccine was administered, pt developed swelling of eye and difficulty breathing.  Brought to ED, given epinephrine, albuterol, and benadryl.
Patient develop sore throat on 7/27/2021, tested positive for COVID on 7/31/2021.
Narrative: Dizziness, Myalgia, NauseaVomiting, dry mouth
Symptoms clarified as body aches and pains like her bones aching; Symptoms clarified as body aches and pains like her bones aching; This is a spontaneous report from two contactable consumers (one was patient herself). A 54-year-old female patient received the first dose of NT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# EJ1685), via an unspecified route of administration on 21Dec2020 in right arm at single dose for vaccination. Medical history included hypertension. Concomitant medication included lisinopril from 2017 and ongoing for hypertension. This Medical Assistant called to report on behalf of herself, not a healthcare professional. She had her first dose of Pfizer COVID-19 Vaccine on 21Dec2020. She reported she developed symptoms which she clarified to be body aches and pains like her bones aching. Symptoms clarified as body aches and pains like her bones aching: onset 22Dec2020 around 10:00am. By around 8:00pm on 22Dec2020 this event pretty much went away, but she can still feel the body aches and pains like her bones aching on and off; event had improved now. She was taking paracetamol (TYLENOL) 1000mg every 6 hours for this event. She was scared she was gonna not be alive after getting this vaccine; because she was very sensitive with flu shots. She clarified that she got flu shot on 30Oct2020 at the institution where she worked and did not get sick with that flu shot. Second dose in series scheduled for 11Jan2020-she did not plan to change dose at this time. Outcome of events were recovering.
I was exposed to COVID-19 on March 17, 2023. My symptoms include scratchy throat, sniffles, and an earache. My symptoms got worse. I took a COVID-19 test at home on March 21, 2023. The result was positive. I called my doctor. I was seen that morning. My doctor prescribed Paxlovid. I took the 5-day pill regimen. They symptoms eased on day three, and I tested negative for COVID-19 on the sixth day. I've felt fine ever since.
Information has been received from a physician concerning a 39 year old female patient who on an unspecified date, was seen by an allergist in an allergy clinic and was vaccinated with a dose of PNEUMOVAX 23 (Lot #, dose and route not reported). The physician reported that on an unspecified date, the patient developed cellulitis and was hospitalized for sepsis. It was unspecified if laboratory tests were performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Reports soreness and discomfort at injection site.  Returned to clinic several days later with complaint of "my arm feels like it is going to fall off," and "feels like something is torn."
Patient developed a pinpoint, papular rash on the trunk 4 days post vaccine, atypical in appearance when compared to other rashes normally seen post MMR/varicella vaccination.
This is a spontaneous report from a contactable consumer, reporting on behalf of her husband. A 77-year-old male patient received PREVNAR 13 on 15Dec2015 at 4:30 PM in the left shoulder at 0.5 ml single. The patient's medical history was not reported. Concomitant medications included vitamin B intramuscularly in the right hip and other medications (patient was on a lot of medications). On 15Dec2015, the patient experienced pain which began almost right away and into the next day across his shoulders and down his back; the pain stopped after he quit throwing up. On an unknown date in Dec2015, two and a half days after the vaccine, the patient experienced vomiting. On an unknown date, the patient felt sick from it, like his body was trying to reject it, with urinating and bowel movements, dehydration, lost weight, weakness all the time, tiredness and nausea. In Jan2016 the patient experienced thrush in mouth and nose, chest pain on 16Dec2015, stomach pain on 16Dec2015, high blood pressure on an unknown date. The patient was 77-years-old at the time of the onset for his adverse reactions, and turned 78-years-old a few days later. The patient was treated for nausea, vomiting, thrush in mouth and nose, chest pain, stomach pain, high blood pressure. The patient was not hospitalized. The patient visited the emergency room for the events of vomiting and lost weight. He was currently 139 pounds, he weighed 148 pounds when he received the vaccine. He lost about 10 pounds. The patient underwent blood tests taken twice on unknown dates after vaccination. Pain resolved on an unknown date. Dehydration resolved with sequelae on an unknown date. Weakness was resolving. Vomiting, nausea, high blood pressure, thrush in mouth and nose, chest pain, stomach pain and tiredness had not yet been resolved. Mouth and nose remained raw and red. Vomiting stopped after at least a week, but the patient continued to have dry vomiting or regular vomiting every morning for another week. Outcome of the events of felt sick from it, like his body was trying to reject it, with urinating, bowel movements, and lost weight was unknown. Follow-up (17Feb2016): New information from the same contactable consumer includes: previously reported events details, additional events with relative details, treatment received, events outcomes.
Information has been received regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 04-FEB-2016, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered a sudden and rapid decrease in hearing, sudden and constant ringing in ears, and ear pressure. Patient was diagnosed with sensorineural hearing loss and tinnitus. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, loss of accumulations, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, sensorineural hearing loss was determined to be medically significant. Sensorineural hearing loss and tinnitus were considered to be disabling. Additional information has been requested.
little blisters at the injection site; swelling at the injection site; redness at the injection site; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th May 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site pain. On 8th May 2019, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and injection site blisters were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. Two days after vaccination, the patient expereinced blisters at injection site. The reporter consented to follow up.
Pt c/o redness approx 5in x 3 inches on left delt. +tenderness. very sore/tender to the touch. some stiffness/decreased ROM r/t soreness. Symptoms began a few hours after injection and worsened gradually. Seen in urgent care office 1/8/22. Pt was given an injection of 10 mg dexamethasone in office on 1/8/22.  Of note, area of bruising in center of redness is in an appropriate place on deltoid, do not suspect that improper (too high) injection technique is the cause.
sore arms; moderately restrict activity; mild headache; Received COVID bivalent booster and flu shot on 13Sep2022; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 13Sep2022, outcome "unknown", described as "Received COVID bivalent booster and flu shot on 13Sep2022"; HEADACHE (non-serious) with onset 14Sep2022, outcome "unknown", described as "mild headache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 14Sep2022, outcome "unknown", described as "moderately restrict activity"; PAIN IN EXTREMITY (non-serious) with onset 14Sep2022, outcome "unknown", described as "sore arms".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I had a very severe headache on March 23.  Tylenol did not help. I ended up in bed most of the day from it.    I had a mild headache  on and off after it.   I do not normally get headaches, this was very unusual for me.
Patient received varicella vaccine on 10/30/02. On 11/18/02 started with 3 red, itchy bumps. Then on 11/19/02 had 4-5 more and 11/20/02 3-4 more red bumps with yellow fluid filled centers. No fever.
Diffuse 1/2 circle red rash below injection site. Hard and warm to the touch.
First Injection: Severe pain in knees approximately 24 hours after injection. No pervious joint issues. Difficulty standing and walking for approximately 48 hours after the onset of this symptom. Soreness in knees persisted for approximately 7 days.   Second Injection: Less severe but present pain in the knees. Feeling of rapid heart beating approximately 24 hours after injection with flue like symptoms. Ability to perform sustained aerobic exercises impacted. Easily exhausted on bike rides that were previously casual.