chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of chest congestion, fever and cough has been received from a consumer concerning a 36-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 05-Oct-2011, the patient received FLUMIST. After receiving FLUMIST, the patient had chest congestion with cough. The patient first had fever but not anymore. The symptoms lasted for 20 days. The outcome of the event fever was recovered and the events chest congestion and cough was not recovered.
Dizziness, Headache, Sedation, Myalgia, Arthralgia, site redness X 2 days Narrative:  Other Relevant History:
About a baseball size redness and about a golf ball sized lump. Red and warm to touch.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Palpitations, Redness,swelling, ithching, @ injection site, Sore Throat Narrative:
Patient had a minor cold for 2-3 days prior to the vaccines.  She had a runny nose, sniffle, and mild fever one night.  She was on the mend and doing better prior to the vaccines.  The doctor told me that it would be fine if her fever was more than 24 hours prior.  It was but she was still slightly stuffy.  She got the vaccines and within 24 hours afterward was not sleeping through the night like she had been for months prior.  She was screaming nearly non-stop.  She proceeded to regress into her cold again but this time worse.  She developed an ear infection.  She received an antibiotic.  This gave her diarrhea, a topical yeast infection on her vulva and groin and did not help the infection.  She then received another antibiotic from a different pediatrician for a double ear infection and a topical nystatin for her yeast infection on her vulva/groin.  This slowly improved over 14+ days.  She now has muscle spasms in her face (eyebrows and jaw) and has ongoing diarrhea and constipation alternating since this episode.
Information has been received from a physician concerning a 16 year old female with anxiety issues with vaccines who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not reported) and on 21-AUG-2009 was vaccinated with the second dose of GARDASIL (lot # not reported). The physician reported that the patient had anxiety issues about receiving vaccines (names and manufacturer unspecified) and in response to that she usually had vasovagal issues. The physician indicated that on 21-AUG-2009, the patient received her second dose of GARDASIL lying down and about 5 minutes later, she experienced tingling on her skull and the back of her neck like she did after the first dose of GARDASIL. The patient had laid at the office for another half hour and at one point the patient was going to get up and leave when she should up she started to faint, so the patient laid back down. Then later on the patient was alright to leave and had recovered. Additional information has been requested.
B/L armpit swelling, L side of neck tender and sore for over a month.
Patient had two ED visits on 3/14/21 and 3/18/21, and two ED to admission visits on 3/21/21 and 3/27/21. These visits are within 6 weeks of receiving COVID vaccination.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (chronic fatigue), VERTIGO (vertigo) and FEELING ABNORMAL (brain fog) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 23-Jan-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (chronic fatigue) and VERTIGO (vertigo). On an unknown date, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, HEADACHE (headache), FATIGUE (chronic fatigue) and VERTIGO (vertigo) had not resolved and FEELING ABNORMAL (brain fog) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated he had several symptoms such as brain fog, headache, chronic fatigue, and vertigo. They started immediately after the second dose.  No concomitant medication were reported. No treatment medication were reported.
Information has been received from a registered nurse concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not reported. The unspecified patient received two doses of pneumonia vaccine, PNEUMOVAX 23 could not be ruled out, strength, dose, route and lot number not provided within one week. Additional information has been requested.
Severe pain in my left shoulder that continues one month after second vaccine dose. Constant pain of around 5 - 6 (1 - 10 pain scale) and pain level of 8-9 when moving arm/doing PT exercises. Pain medication and OTC drugs (ibuprofen. Tylenol)  have no affect on pain level
hives approximately 15 hours later-at first on abdomen and back then chest then tops of legs and inside of arms; Itching badly; This is a spontaneous report from a contactable consumer (Patient). A 22-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 24Aug2021 11:15 AM (at the age of 22-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medication of the patient included paracetamol (TYNELOL). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown) via unspecified route of administration on 03Aug2021 as a dose 1, single for COVID-19 immunization. The patient had no known allergies and no other medical history. Patient had no COVID prior to vaccination. The patient was tested for COVID post vaccination (negative). On 25Aug2021 02:00 AM the patient experienced hives approximately 15 hours later-at first on abdomen and back then chest then tops of legs and inside of arms. Itching badly. Patient reported that hives were worse on arm that didn't receive the injection. Patient received the treatment of Benadryl and Benadryl topical cream for the reported events. Outcome of the reported events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt had high pitch shrill cry for 30 to 45mins 2 1/2 hr p/vax; also had inconsolable cry for 2 hr; APAP given every 4 hr for 36 hr post vax;
The patient was administered with an expired PENTACEL vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via consumer/non-health care professional via Medical Information (Reference number- 00752586) and transmitted to Sanofi on 02-Sep-2021.  This case involves a 3-month-old patient (gender unspecified) who was administered an expired DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] [Expired product administered].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for prophylactic vaccination.  On 02-Sep-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] (lot UJ215AAA, expiry: 30-Apr-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  No adverse event was reported.  It was reported, "Stated that they injected an expired Pentacel and want to know what to do. Lot UJ215AAA Exp 04/30/2021. Call transferred from Manufacturing Authorization (MIA). Physician Assistant (PA) states that a patient was injected with Pentacel on 02Sep2021 that expired on 4/30/2021. The PA asks if the expired Pentacel dose is valid and needs to reinjected. The PA reports an AE. The patient did not experience any adverse events as a result of this.   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 guidelines. 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.
Pt got vaccine in afternoon. Awakened next morning unable to move the arm in extreme pain.  Examined in office and even with max OTC meds on board (Ibuprofen and Acetaminophen) she was incredibly tender to the touch, mildly swollen and unable to abduct the arm at the shoulder. No nerve symptoms. Pain has persisted and now the patient has shoulder pain on that side and very enlarged nodes under the arm.
Febrile seizure - given anti-pyretics. On exam- oropharynx lesions seen - vesicular, consistent with coxsackie virus.
Erythema, pain, induration at left upper arm. Started 24 hours after vaccines.
A couple days after getting the vaccine I started breaking out in a rash. It started on my ankle, in the course of a week it went from my feet to the top of my head. It was raised bumps that were red and fluid filled. It presented itself differently on different parts of my body. It showed up in patches, I was itchy, it felt like sandpaper. Some areas dried up and flaked off like dandruff others the skin peeled off. I went to my PCP who ran blood test, thyroid test, skin biopsy. The test only showed that I had a rash. I was treated for a general rash. I have seen my PCP, an Endocrinologist and an Allergist who have all come to the same conclusion that I have had a viral infection reaction. I was taking prednisone for a while it helped with the itching. The rash came back after the three week treatment. I was given a cortisone shot and this completely wiped out the rash. I was given betamethasone ointment to put on the rash. It is helping with my hands as we are nearing the five week period of when the shots normally wear off.
arm soreness began, mom tried rubbing alcohol at home. 11/7/23 pt's arm began to itch, it felt warm and was swollen, ice tried at home. Today mom received a call from school, pt was crying saying her arm was hurting and mom picked her up. Still itchy and warm today. Pt has been scratching arm.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
2 days following vaccination with DTAP, arm swollen, warm and itchy.  Swollen from shoulder to elbow-circumference of arm was 8 1.4 inch ("normal" arm 6.5 inches).  Child was afebrile and acting fine otherwise.
Had the shot just before 11 am Tuesday and within a few hours had nausea, by evening had headache, chills, low-grade fever (under 100). Did not take anything for it. Awakened at 3 am by pain at injection area. Wednesday, all day on couch with nausea, pain in arm, chills, low-grade fever. Took 1 Advil around noon and another before bed (temp just over 100). Woke Thursday morning in a pool of sweat, no more fever. Brain slow and foggy all day, shot area red and hot, but not painful. Friday, all good except lingering soreness in arm (to touch).
Fussiness and irritability, tactile temp at home, wouldn't take / spit out Tylenol so brought to ER.  ER physician documented fever with no other signs or symptoms, normal exam.  No labs or imaging done. Temp recorded in ER as 102.3 at 3am. Both acetaminophen and ibuprofen suppositories were given in ER, defervesced, and then he tolerated PO before being discharge.
Red swollen area at site of flu shot. Complained of arm pain. 4x4" swollen area. Local reaction. Temp 97
Patient received the Pfizer vaccination in his left deltoid.  After approximately five minutes, while sitting in our chair in the waiting area, patient complained of dizziness.  He kept closing his eyes saying he was dizzy and vision was blurring.  He slumped over and passed out for approximately 3-5 seconds.  He came back to a little, was diaphoretic and breathing shallowly.  Mom was worried and we called the paramedics.  Mother said he hadn't been out of the house in about 3 years and had anxiety about the shot.  Paramedics asked if he wanted to go to the hospital with them and he refused.  Mother informed us he doesn't have a PCP.
Administered Kinrix vaccine on 3/29/22. Expiration date 1/15/22. No adverse reactions noted. No symptoms
patient did not receive more than half of the dose, maybe got a fraction of it; faulty syringe; A spontaneous report ) was received from a nurse concerning a 38-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) had a faulty syringe and did not receive more than half of the dose, maybe got a fraction of it.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number not provided).   On 04 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) on her right arm, intramuscularly for prophylaxis of Covid-19 infection.  The patient was administered the mRNA-1273 vaccine with a faulty syringe and therefore, she did not receive more than half of the dose, maybe got a fraction of it. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with mRNA-1273 in response to the events were considered not applicable.  The events did not receive more than half of the dose, maybe got a fraction of it and faulty syringe use, were considered resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 38-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot# 007M20A), reporting Underdose and Syringe issue.
Phone call from father: fever 99, cranky, Recom. monitor temp if > 11 Axillary use acetaminophen 50mgm, prn , c/b if any thing different, 12/5/2011 4PM baby cranky, not nursing well,  12/06/2011 recommend supplemental formula, Dad called back refusing bottle,  Mom kept trying breast feeding,  R evaluated 12/10/2011 w/ feeding problem, poor wt gain, No BM for 3 days, rectal stimulation paint consistency stool with odor, and flatus, baby calmed down after passing stool, nursed better, recommended q4 feeding schedule, pedialyte in between, baby started crying more and more, re-evaluated 12/11/2011, 4PM, cry uncosolable, with arching, abd distention, increased BS, passed stool again with rectal stimulation, greer psy, baby felt better, nursed afterwards, but cried within 15 min after eating, RX levsin. 060 po, helped, still waking up crying w/ pain
I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt nauseated and hot. I closed my eyes for a few minutes and when I hope Ed the the intense dizziness subsided.  I still feel a little dizzy, very tired and switch from feeling hot to very cold.
pt found to be COVID+ on 4/21/22 s/p 3 doses of Pfizer vax (3/11/21, 4/1/21, 11/4/21). pt symptomatic & remdesivir started
I felt wonderful prior to getting vaccine. About 12 hours later I experienced some kind of paralysis of all body muscles. I would simply attempt to reach for a soda and my arm would not respond! It did'nt do anything. This continued off and on for at least 10 hours.  This started the same day as I got the vaccine.    Also now two days later the paralysis is gone, but I have been having some sharp chest pains most of the day. I believe the vaccine has caused me some unusual heart problems.
Red raised area below injection site, no itching, no evidence of bug bite, not warm or painful. Located in the exact same place as primary post-injection pain was located. No treatment given 8/27/21 was about 1 inch diameter, 8/28/21 is 2 inches by 1 inch Currently 32 weeks pregnant, due 10/21/21, no complications with pregnancy
About an hour and a half after the vaccine the patient started having itching, with raised bumps on their neck and back that continue to this time when Benadryl is not taken. They had welts that formed on their face that only lasted the evening of the vaccine. They now have a sensation of raised rough areas on the inside of their lips.
While administering the influenza vaccine, the syringe leaked and vaccine sprayed out onto the patient's leg, so that the patient did not receive the full dose of the influenza vaccine. Therefore, another influenza dose was readministered during the same encounter.
my husband and I got the Shingrix shots last year / he came down with Shingles 2 days ago/ Suspected vaccination failure; he came down with Shingles 2 days ago; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had when patient was child).   On an unknown date, the patient received Shingrix at an unknown dose. In May 2020, less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but could be 70 or 71 years old. The patient received vaccine before a year of reporting and experienced shingles 2 days before from date of reporting. Thephysician said he was the first person they had treated that had the vaccine. The reporter wanted to know did this happen often. This case was considered as suspected vaccination failure as details regarding vaccination schedule was unknown at the time of reporting.  The reporter consented to follow up.
could not sleep felt aches all over chills vomiting felt really hot, 12 hours later got fever about 99.7 then took tylenoll and fever went to down then started again around 3pm and was about 100.7 still achey and weak, fever went down slightly after taking tylenol, arm upper part soar and tender at all times
Headache, Diarrhea, arm soreness and swollen lymph node under where vaccine was given arm vaccine was given, chest discomfort, insomnia Narrative:  Employee contacted our Occ. Health provider and was recommended to take ibuprofen, increase hydration, rest
loss of muscle tone; collapsed, hyporesponsive for about 3 to 5 minutes; pt recovered; t97.9, R24, AP118, BP 96/60;
PATIENT WAS GIVEN THE PFIZER BIVALENT BOOSTER INSTEAD OF THE PFIZER MONOVALENT VACCINE
We have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 06-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Event happened 6 months ago. No concomitant medication were given. No treatment information were given.   This case was linked to MOD-2021-392126 (Patient Link).
Resident was diagnosed with COVID-19 on 8/19/2021. Code status DNR with comfort measures. Began taking Recephin due to cough and crackles in lung bases on 8/20/2021. On 8/21/2021, resident began purse lip breathing and O2 sat dropped to low 80s. Continued to decline and passed away morning of 8/22/2021.
4:44 Pm 5/23/2012 - C/o coughing, itchy to neck and ear with red rash, throat tightness, cough is productive - 110/80 (L) arm bp, pulse 72. 4:50 PM - BENADRYL - 50 mg/ml (R) D IM give Lot # 07035D exp 7/2012 - 112/80 (L) arm bp, pulse 6B - A/Ox3, lungs clear.
Information has been received from a consumer with sulfamethoxazole, MICROBID allergy and without pertinent medical history referring to her 23 year old sone. On 01-JUL-2015, the consumer was vaccinated with a dose of ZOSTAVAX (dose, lot number and route not provided). The consumer's concomitant therapy included LASIX, hydrochlorothiazide, baby aspirin and AMBIEN. The consumer suspected that she might have transmitted the vaccine virus to her son because the patient developed shingles-like rash on 10-JUL-2015 (secondary transmission). He sought medical case on an unspecified date at an urgent care facility and was diagnosed with shingles by physician who also reported as he did not see a primary care physician. The consumer reported no adverse experience on herself as the patient after receiving ZOSTAVAX. No treatment was given for adverse event and no lab diagnostics studies were performed. Additional information has been requested.