chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day I had diareahha and had Jul8 to 22, Symptoms lasted four days. Nasal congestion, coughing, no fever.
Patient verbalized "scratchy" dry throat, feeling of swelling to lips, throat, tongue. Bilateral arm soreness. Headache. Vitals taken and stable. 10mg Zyrtec given. Patient feeling less swelling to lips, and throat. Vitals before discharge BP 132/73, HR 87%, O2 99%. Discharged home ambulating and stable.
an extra dose of PENTACEL was inadvertently administered with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old male patient who was administered an extra dose of pentacel was inadvertently with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and HEPATITIS A VACCINE INACT (VAQTA).  On 28-Oct-2022, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation, strength not reported; lot UJ674AA and expiry date: 04-Jun-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 28-Oct-2022, (latency: same day) the patient developed a non-serious an extra dose of pentacel was inadvertently administered with no reported adverse event (extra dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01347468:
Fever, chills, area of slight swelling but very tender and red at vaccine site. As of 12/12/2001 oval with 5" diameter of erythema, heat and tenderness.
about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided wheezes. I self treated with albuterol (2 puffs) inhaler that I have on hand in case of environmental allergy triggers (I rarely have to use it- last use 3 years ago). The wheezing resolved and chest pain improved but the hoarseness remained. Over the next 2-3 hours I developed headache, malaise, mild dizziness, arthralgia, myalgia, and eventually fevers and chills (by 13 hours after vaccine administration). When fever reached 101 I self treated with naproxen 250mg. I slept for 4 hours and awoke diaphoretic, but the fever had resolved and I felt much better. However, I developed urticaria that started on my flexor surfaces of the elbows, hips, and knees, and spread to my adbomen, thighs, and face, with swelling about my right eye. I self treated with 25mg benadryl and itching and urticaria improved to the point that I was able to sleep. When I awoke the next morning my symptoms had largely resolved with the exception of mild headache, body aches, hoarseness, slight chest tightness, and mild residual swelling of the right eyelid.
Injection site red, swollen and sore 2 days after 2 weeks after injection, onset axillary lymph node swelling, pustule over injecton sites, puffy and sore.  Evaluation by primary MD.
Significant arm redness, edema above and below vaccine site. Increased wheezing (Hx asthma).
Moderna COVID-19 Vaccine EUA - Second Dose Arm/shoulder soreness at site of injection Fever/Chills Body/Muscle aches Headache Fatigue
About 12hours after the vaccination  I  had a 101.3  fever (normally 98.1) Body aches; when I got up about 9am the next morning I was dizzy and then fainted. The fever persisted until mid afternoon that day, as did the body aches, and a headache. I spent the day dozing or sleeping.  I did eat some oatmeal and have a cup of black coffee about noon. That helped the headache.  That evening I was more tired than usual, but no fever or aches. The next day I was also very tired, but I did go to work. The rest of the week I  had no energy, but that was the only other side  effect.   After the first shot, I had only had an achy arm at the injection site that persisted for 2 or 3 days.
High pitched cry 1 1/2 hrs p/vax; slept, then awoke and cried for 2 hrs following fussy next day;
Initial and follow up information has been received from a  health professional concerning a 7 year old health female with seasonal allergies who 03/14/96 was vaccinated with the first dose of varicella virus vaccine live. there was no concomitant medication and no history of adverse reactions to prior vaccinations. On 11/08/01, the pt presented with chicken pox and cold symptoms (rhinitis) it was reported that the pt had less than 12 pox and was not febrile the child's mother stated that the child was cranky over the past few days. Medical attention was sought. At the time of this report, the outcome of the events was unknown. No further information is available
Ct left flu clinic heading for physical therapy.  10 min prior to arrival ct became cold, teeth were shattering uncontrollably, physical therapists assessed ct pulse to be > 100/min.  After a warm blanket was placed over client, she warmed up and was fine.  No problems afterwards.
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling  Started within 20-30 minutes of receiving the vaccine  Received 25mg of Benadryl with improvement
pt recv vax;exp HA & malaise immediately;also devel fever & v;sx devel into serum sickness-like synd;
Severe sweating and chills, vomiting, raging headache, muscle aches, total weakness,  for 24-30 hours. no appetite for 48 hours and still weak.  I was unable to do anything but writhe in discomfort
Felt feverish, then had cold chills and felt rough for a few hours; patient feel bad after a flu shot; Felt feverish, then had cold chills; Felt feverish, then had cold chills; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a unknown demographics patient feel bad after a flu shot (feeling abnormal), felt feverish, then had cold chills and felt rough for a few hours (pyrexia), (chills), (discomfort), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient feel bad after a flu shot (feeling abnormal), felt feverish, then had cold chills and felt rough for a few hours (pyrexia), (chills), (discomfort) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was patient was feeling abnormal, pyrexia, chills, discomfort.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
10 days later have a swollen arm, severe headaches for 2 days and started having intense ringing in my ears (which I have never had before)
Pt had a hospital admission and was found to be positive for COVID, acute on chronic hypoxic respiratory flow, severe sepsis, UTI, pneumonia; 8/21/22 dc'd to home with caregivers; continued to have a productive cough at home with SOB; on oxygen supplementation via NC; back to hospital; dc'd back to home 9/27/22 where he passed away on 10/13/22
Two days post vax, the mother stated the pt awoke her complaining of the room spinning, headache, and fever of 104. She was given acetaminophen and her temperature decreased to 99 but she continued to complain of the room spinning. She slept some and she went back to school. Awoke again on 9/3/00 complaining of the room spinning but no fever.
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included sepsis (sepsis infection requiring 23 days of hospitalization 6 months before the time of reporting).   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in early November 2019 and had arm soreness which lasted 2 days. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2020AMR003593, reported by the same reporter.
Injection site was raised; Injection site was hard; Injection site was hot; Injection site was red; Left armpit was very tender; Chills; Overall not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), VACCINATION COMPLICATION (Overall not feeling well), AXILLARY PAIN (Left armpit was very tender), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was raised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (Chills) and VACCINATION COMPLICATION (Overall not feeling well). On 15-Jan-2021, the patient experienced AXILLARY PAIN (Left armpit was very tender). On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red). On 17-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site was raised), VACCINATION SITE INDURATION (Injection site was hard) and INJECTION SITE WARMTH (Injection site was hot). On 07-Jan-2021, CHILLS (Chills) and VACCINATION COMPLICATION (Overall not feeling well) had resolved. At the time of the report, AXILLARY PAIN (Left armpit was very tender), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was raised), VACCINATION SITE INDURATION (Injection site was hard) and INJECTION SITE WARMTH (Injection site was hot) outcome was unknown.
Mother called fRi 1/31/03 stating child's L arm swollen, and deep red from shoulder to elbow; painful to touch. Parent not sure if running temp. Said noticed swollen arm Thurs pm. have been giving child Tylenol.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around October 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not presented prior the used of zoster vaccine live (ZOSTAVAX). The patient was also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient's condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, 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 result of zoster vaccine live (ZOSTAVAX) conduct, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
flu like symptoms; headaches; nausea; body aches; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced flu like symptoms including headaches, nausea and body aches that lasted for 4 days on an unspecified date in 2021. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating). At the time of the report, HYPERHIDROSIS (sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  Concomitant medications were provided. No Treatment medications were provided.
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 30-NOV-2012 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On 06-JUN-2015 the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
No reaction to first dose beyond sore injection site; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 10:00 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 05Apr2021 08:00, outcome "not recovered", described as "No reaction to first dose beyond sore injection site". Therapeutic measures were not taken as a result of injection site pain.  Additional information: Blisters on tongue following second dose only. First dose 01Apr2021 Second dose 22Apr2021. No reaction to first dose beyond sore injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination since vaccination patient not tested for covid-19. Nonchronic, no surgeries  No follow-up attempts are possible. No further information is expected.
Expired Vaccine given 04/06/2023.  Moderna notified and will instruct on if there is a need to revaccinate.
Severe joint and body aches, chills, headache, sweating, fever, nausea, no appetite, fatigue. Everything hurt so bad it felt like I was hit by a car. I felt like I had a horrible flu. I am starting to feel better, still have a headache.  I was completely bed ridden for the entire day after my injection. I had Covid in December 2020, so I am wondering if my body is hyper sensitive to the vaccine because it is primed with antibodies already.
Chills; Body aches; Nausea; Numb arm; Temp 103.2 (fever); Headache; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 08:15(at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 03Apr2021 at 20:30, the patient experienced nausea, temp 103.2 (fever), chills, headache, body aches and numb arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if patient received any treatment for the events. On 03Apr2021, the patient underwent tests and procedures which include body temperature and the result was 103.2 (units unspecified) .The clinical outcome of the events nausea, fever, chills, headache, general body pain and numb arm was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
very fast hair loss; Burning scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose number unknwon, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "very fast hair loss"; TRICHODYNIA (non-serious), outcome "unknown", described as "Burning scalp". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The patient reported side effects after receiving the Pfizer Covid vaccine in May. The patient reported that the side effects began last week but he has not taken any other vaccines and has not changed his lifestyle in any other way. The patient reported since his son also experienced the same side effects he figured he should report in case they are related to the vaccine.   Follow-up (03Nov2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (son) that on an unspecified age his son got exact same symptoms; Burning scalp and very fast hair loss. The patient reported that his side effects started last week. He did not know if they can add the notes to this report. The patient reported that his side son had the same vaccine in different state same date in May and he got exact same symptoms in August. Exactly same symptoms but in August. When he got the symptoms last week, he was very concerned because definitely it aligns up. The patient reported that they both are not on any medications (Further clarifications unknown), and they both are very healthy. The patient wanted to notify that his son got exact same symptoms. The patient wanted to know if anybody else will had same symptoms. It's very sad. The patient wanted to know is there a way for him to find out if anybody else reported this kind of side effect.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (06Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101504259 similar report from same reporter
A non-serious report of nosebleed was received from a physician concerning a male child over five years of age. The patient had a history of nosebleeds. No concomitant medications were reported. The patient received FLUMIST on an unknown date between 03 Dec 2007 and 07 Dec 2007. The patient experienced nosebleed after FLUMIST administration. No outcome for the event was provided by the reporter. Action taken was not provided. The reporter provided no causality assessment for the event. The pharmaceutical company physician conservatively assessed causality for the event as possibly related to FLUMIST therapy.
After administering the vaccine, the patient fainted. He regained consciousness after laying him down. We monitored his blood pressure for 30 minutes