chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles on the Right side of the Neck; Hard Lymph Nodes around the Neck; Raised Red Bumps on the Right side of the Neck; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles on the Right side of the Neck), LYMPHADENOPATHY (Hard Lymph Nodes around the Neck) and SWELLING (Raised Red Bumps on the Right side of the Neck) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HERPES ZOSTER (Shingles on the Right side of the Neck), LYMPHADENOPATHY (Hard Lymph Nodes around the Neck) and SWELLING (Raised Red Bumps on the Right side of the Neck). At the time of the report, HERPES ZOSTER (Shingles on the Right side of the Neck), LYMPHADENOPATHY (Hard Lymph Nodes around the Neck) and SWELLING (Raised Red Bumps on the Right side of the Neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  concomitant medications reported.  No treatment information was provided.
myocarditis; Initial information received on 23-May-2022 via healthcare professional regarding an unsolicited valid serious case issued from a literature article.  This case involves a 58-year-old male patient who experienced myocarditis while receiving rabies vaccine (latency: few weeks).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect rabies vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  Few weeks later after 14 injections, the patient developed a serious myocarditis.  Action taken: not applicable. Corrective treatment: vitamin B complex and trihexyphenidyl hydrochloride (Sedrena) extract. Outcome: recovered  Seriousness criteria: medically significant Reporter causality: related Based upon the reported information, the role of a vaccine cannot be assessed.; Sender's Comments: Sanofi company comment dated 31-May-2022:  This case involves a 58-year-old male patient who experienced myocarditis while receiving rabies vaccine. Based upon the information the role of suspect drugs cannot be denied however the lack of information related to past drugs, medical history and concomitant drugs precludes better case assessment.
Pt. experienced chest pain starting Monday morning (03/15/21). Went to the emergency room and found out he was having a heart attack. He underwent a heart cath procedure and while having the heart cath he ha a stroke (around 9pm). Pt is currently in recovery.
next day after being vaccinated, I had pain all over my body with joint pain. 2 days after getting the vaccine, i had to go to urgent care as i developped a rash on my right shoulder in the front and back. I was told it is Shingles and prescribed Valtrex. I still feel the shingles today and rashes are almost all gone.
When the provider first tried to inject, I felt a sudden and intense pain. I'm not sure what the provider felt or saw, but they removed the needle and injected the content of the same syringe lower in the same arm. The actual injection was fine. The provider denied any wrongdoing. During the 30 minutes I waited after the injection, I felt quite light headed and my arm was feeling weird down to my hand. Almost 5 hours later, my hand feels extremely cold and is still not feeling like the other one. I'm not sure about the rest of the arm, but the left hand is definitely not feeling normal, with a light tingling.
Facial swelling and extreme flushing of the face neck and arms.  Headache turned to migraine with in two days.
Chills/pus/redness at injection site; Left arm; Started 7/30/08; treatment: Keflex 500mg tid x 7d
Left arm weakness for over 1 month each shot. Severe neck pain on left side to present day. Headaches till present day. Sharp stabbing pains running up from both ankles to mid calf.
headache, increased salivation, swollen mandibular gland, pain in neck radiating to ear
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 at 11:00 as dose 2, single (Lot number: EN6203) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course: Patient did not receive any other medication in 2weeks. Patient had no allergies. Patient received Paxlovid for the treatment of COVID-19 from 01May2022 to 06May2022. After taking paxlovid, patient seem to have a recurrence of Covid about 10 days after completing the dosage. He have much milder symptoms the second time.
Blurry vision, dizzy, pallor, head ache, "Felt like I got tazed" (like electric shock).  Hypotension that took about 30 minutes to resolve.
Pt exp h/a the next day following dose of Engerix-B then exp flu like sx, shingles on lt leg, arthralgia & intermittent fever; pt seen in ER where shingles was dx;
Fever to 101 and 6 brief seizures with twitching and disorientation over about half hour.
Student developed hives 3-4 hours after getting the injectable vaccine.  Hives were gone by 3:00 the next day.  Was given BENADRYL every 4-5 hours and CORTISONE cream applied.
8/30/06 12:30PM jerking body movements, staring. 9/1/06 1:30AM-2:30AM, crying, staring, would not respond to mom.
this is 1 of 3 pt from this site to devel a rash @ the inj site following vax;rash resolved spontaneously p/3 days;
Joint pain, fatigue, muscle pain, started 2 weeks after first dose, lasting for 3 days and still currently experiencing symptoms
Suffered a stroke on May 9, 2021.   Rushed to the ER and administered TPA, then surgery was performed to get out the rest of the clot.  Symptoms: Fainting, Right side paralysis, slurred speech
11-15-15 right facial droop dx with Bell's palsy. Started on amox and steroids pending Lyme titer. Titer negative abx stopped.
LEFT CHEST PAIN; FELT VERY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced felt very tired. On 09-APR-2021 02:00, the subject experienced left chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left chest pain, and felt very tired. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
This spontaneous report as received from a Pharmacy Student refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 14-NOV-2012, which expired on 20-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL Lot # L004601; expiration date: 04-NOV-2016, Lot # K006960; expiration date: 19-FEB-2017 and Lot# K007828; expiration date: 02-MAR-2017. No adverse experiences reported for any patients. This is one of several reports received from the same source. Additional information has been requested.
The afternoon on the date of vaccine administration, 10/28/11, she started experiencing a temporal headache. On 10/29/11 during the day, she felt like she had a fever (not measured) and chills with body aches. She reported frontal headache and head pressure on 10/29/11. On 10/30/11, she reported continued headache and nausea. On 10/31/11, she reports continued nausea. On morning of 10/31/11 afebrile and vitals within normal limits. No local reaction or soreness to site of injection noted.
Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional (Office person med asst.). This case involves a child patient (gender and age not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique as patient received only DTaP/IPV component of PENTACEL. No adverse event reported. 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 Directive 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. Documents held by sender: none.
Myocarditis: On 10/7/2023 around 11:00pm (a little over 1 day after the injection), I started getting chest pain on the left side of my chest below my pectoral muscle. It felt like a sharp pain in my heart; I felt squeezing or spazzing in my heart if I tried to move, but then the pain would relieve if I kept still.  The pain was intense (4 on a 1-5 scale) if I took a deep breath. I went to sleep and the next morning I did not notice it. Then on 10/8/2023, the next day around 4:30pm I felt the pain again. I felt it most intensely around 10pm when it woke me up from sleeping. It was always on my left at my heart. It continued through the night. It got intense if I moved or tried to take a deep breath, but with shallow breathing I was able to fall asleep. It is now 10/9/23 at 11am and I still notice some pain, but it is less intense.  This was after my third COVID 19 shot, the booster. I believe a similar pain occurred after my second dose of the COVID Moderna vaccine in December 2021, but I did not make the mental connection to my shot until now. Last time the pain subsided after 3-5 days.
Rash (hive like) at site of injection.  Left upper extremity, radiating to distal upper arm.
Day 1: nausea, headache, chills, fever, severe pain and swelling at injection, heat at injection, redness at injection (probably 3"x4"). Day two, same as day 1 plus jaw pain, pain in dental implant, feeling like I had a very bad case of the flu. Unable to eat from breakfast at 9 until 7 when I ate toast. Day 3: slightly better but still small headache. Then migraine with aura mid afternoon which responded to Rizatriptan. Day 4: Okay upon awakening. Then serious migraine which did not respond to medication.  Arm only hurts a little on day 4.
that evening I have 100 fevers to 101. My whole-body aches, I had headache all night. I have to change clothes several times I was wet. It last 48 hrs. I had tenderness in my arm. I had fatigue and brain fog. No need to see a doctor. Everything was fine by the next day.
Thrombocytopenia-Full Left leg. Leg swelled up 3x normal. Pain and difficulty walking. Treatment Xarelto. Still on it. Took 3 months to feel normal.
About 7 hours after patient received the vaccine, he complained of nausea. He didn't finish all of his dinner. Throughout the evening dizziness & nausea increased. He vomited a few times. In the middle of the night he fell while he was on his way to the bathroom. The following day he stayed home as he was still experiencing lightheadedness. He reports that it has been gradually improving over the course of the day. I instructed patient that if he is not improving tomorrow, he may want to go to the doctor to be examined to rule out other issues.
marked erythema & induration w/inc heat & pain @ site which started evening p/vax w/good response to Cox Z inhibitor; much improved w/dec pain in 24hr;
Patient felt palpitations after taking vaccine, states she did not take her metoprolol this morning, HR stayed between 80s-90s
This spontaneous report as received from a consumer via Clinic refers to a currently 69 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
COUGH; GROIN PAIN; PELVIC PAIN; HIP PAIN; BODY PAIN; MUSCLE ACHES; FEVER; FEELING BAD; COLD/FREEZING; SHIVERING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included crohn's disease, and immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 08:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 16:30, the subject experienced feeling bad.  On 06-MAR-2021 16:30, the subject experienced cold/freezing. On 06-MAR-2021 16:30, the subject experienced shivering. On 06-MAR-2021 17:30, the subject experienced body pain. On 06-MAR-2021 17:30, the subject experienced muscle aches. On 06-MAR-2021 17:30, the subject experienced fever. On 06-MAR-2021 18:00, Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). On 06-MAR-2021 19:00, the subject experienced cough. On 06-MAR-2021 19:00, the subject experienced groin pain. On 06-MAR-2021 19:00, the subject experienced pelvic pain. On 06-MAR-2021 19:00, the subject experienced hip pain. On 06-MAR-2021 21:00, Laboratory data included: Body temperature (NR: not provided) 103.2 (units unspecified). On 06-MAR-2021 21:31, Laboratory data included: Body temperature (NR: not provided) 101.4 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from cold/freezing, feeling bad, muscle aches, body pain, cough, shivering, hip pain, groin pain, and pelvic pain. This report was non-serious.
Information has been received from a nurse practitioner (N.P.) concerning a 1 year old female who was inadvertently vaccinated with a first dose of GARDASIL (658554/0928U).  Subsequently the patient experienced inappropriate age and inappropriate schedule of vaccine administered.  No other information as available.  Follow-up information was received on 26-DEC-2008 from the N.P. indicating that the patient is a 2 (previously reported as 1) year old female child with no pre-existing allergies, birth defects or medical conditions.  On an unspecified date the patient was vaccinated with a dose of GARDASIL instead of a dose of POLIOVIRUS vaccine inactivated (unspecified).  On the same day she also received a dose of VARIVAX virus vaccine live (Oka/Merck) (MSD), DTaP/Hib (manufacturer unknown), MMR II and VAQTA (manufacturer unknown).  There was no illness at time of vaccination.  It was reported that there was no adverse event.
discomfort to her her chest; pain to her face; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date, patient experienced discomfort to her chest and pain to her face after the first dose. Patient was scheduled for the second dose but cancelled it. Patient asked if still she can take the second dose of the vaccine as 7 weeks have passed since she received the first dose. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT WAS EXPERIENCING CHILLS, SWEATS, LIGHTHEADED, AND DIZZINESS. SWOLLEN, RED & BRUISED IN THE AREA OF SHOT. PAIN IN ARM. SPOKE WITH PHYSICIAN, HE ADVISED PT TO TAKE MOTRIN OR TYLENOL, AND TO ICE SITE. IF GETS WORSE GO TO ER OR URGENT CARE.
Pt stated her feet felt numb and felt overall high. Doctor  addressed pt and advised pt to eat crackers as well as wait 15 minutes after. Pts vitals were stable.
2 days after receiving Shingrix patient's HR went up to 118.. went to ER and was admitted, HR continued to climb. Unsure if related to vaccine but patient didn't have any other events/pre-events that week. Could be coincidental timing?
Phone call 8/4/16, in the morning from Mom who reports patients arm is red, has a "half dollar size" lump, swollen and very itchy. Nurse advised to give BENADRYL, MOTRIN and apply ice to arm.
chills, body aches:  started next day and lasted for a couple of hours.  headaches=started day after and lasted until Monday.
non responder; IgM and IgG (S1/S2 assay) were both negative; A spontaneous report was received from a physician concerning himself, a 69-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and was a non responder who had IgM and IgG (S1/S2 assay) were both negative.   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 04 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Jan 2021, the patient checked his antibody level; he reported that the test was from Abbott. He reported that he was a non responder and that his IgM and IgG (S1/S2 assay) were both negative. He stated that "perhaps the antibody tests from the trials were different from the one he took because there are different amino acids." No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events non responder and IgM and IgG (S1/S2 assay) were both negative were not reported.; Reporter's Comments: This case concerns a 69 year old male patient who received his  first of two planned doses of mRNA-1273 (lot number 011J20A) intramuscularly for prophylaxis of COVID-19 infection and reported that he was a non responder and that his IgM and IgG (S1/S2 assay) were both negative. There were no reported adverse events after the vaccine was administered. Based on the current available information, a causal relationship cannot be excluded.
Pain and stiffness in joints (knees, back, elbows) followed by edema in ankles and wrists 7/22: pain in right knee started out of the blue, started giving out and could not straighten or bend fully (went to doctor on 7/27 because I could not walk and was told it was probably a sprain) 7/28: back pain and stiffness in the mornings 8/7: same pain as right knee started in left knee, right ankle swelled up like a balloon 8/9: left ankle swelled up, wrists swelled, pain in right elbow started, went to urgent care and was told it was likely an autoimmune disease, referred to rheumatology. sed rate normal, crp elevated. x-rays taken showed fluid around ankles and knees. 8/11: ankles, wrists returned to normal size; pain in both knees, back, and right elbow remained 8/13: saw rheumatologist, did blood work
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 03-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). The specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source.  Additional information has been requested.
localized inflammation in the arm where injection was administered; This spontaneous report was received from a consumer, via Pfizer, referring to herself, a 69-year-old female patient. Her medical history, concurrent conditions, diagnosed allergies and concomitant therapies were reported as none.    On approximately February 2016 (reported as "about 5 years ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) as prophylaxis (strength, dose, frequency, route of administration, lot number, and expiration date were not provided).    Afterwards, on an unspecified date in 2016, she experienced localized inflammation on the arm where injection was administered (peripheral swelling), which was reported as lasting a couple of days. However, the specific outcome of the event was not reported.  At the reporting time, the causality assessment between the suspect vaccine and the event was unknown.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recoded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
12/6/02 at 3:15pm presented to window left arm red and swollen. Child denied pain. Advised to go to ER dept.
1 one headaches and sore arm. Body aches. 2 one headache loss of site a while on right side heavy ness in chest hard swallowing ached all over my knees feet hurt really bad. And where giving away when I was walking. Rashes on feet and legs that itched and burned. Called Dr about it. Very sick