chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional 18 October 2013. This case is cluster case of 58 patients and linked to case numbers 2013SA106326, 2013SA105996 and 2013SA106345. 58 patient had received an intradermal dose of FLUZONE ID vaccine (dose number and anatomical site of administration were not reported) on an unspecified date. The vaccination was given 13 October 2013 and on. On an unspecified date, the patients had developed site reactions such as wheal and urticaria at sites with warmth at the site. Laboratory investigation was and corrective treatments were not reported. At the time of this report, the patients had not recovered from events. Documents held by sender: none.
NO adverse effect; inadvertently administered one dose of expired rotateq; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 27-JUN-2019, the patient was inadvertently administered one dose of expired rotavirus vaccine, live, oral, Pentavalent (ROTATEQ) (lot # N030995 and expiration date: 17-JUN-2019) (dose number, frequency, strength were unspecified) via oral route for prophylaxis. No adverse events reported. No product quality complaint (PQC) involved.
Contracted Shingles; One dose long time ago, 2nd never received; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The reporter was a healthcare professional from vaccine facility. The reporter reported that the patient received first dose of Shingrix vaccine a long time ago and never received the second dose of Shingrix vaccine. The reporter stated that the patient experienced Shingles. The timing of the initial dose and the onset of the adverse event was not known. The reporter stated that it was not known whether the patient was planning to receive the 2nd dose of the Shingrix vaccine series. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Passed out for less than 30 seconds with persistent dizziness for about 5 minutes, vomited.
Vaccine given right arm - redness about 6" in length, raised as well - 1 1/2" cluster of blister - itching of raised, red area. Body aches x 1 day with HA.
I HAD A STOMACH ACHE AT FIRST THEN INFLAMTION IN MY SHOULDERS, CHEST AND BACK.
01/26/22 presents to ED for "back pain". PMHx of "chronic pain syndrome, anxiety, depression, fibromyalgia, chronic headaches, IBS/drug-induced constipation, neuropathic pain, OA, wheezing, and urinary retention"
Mild injection site soreness - start 02-Apr-2021, end 05-Apr-2021 Mild injection site redness - start 02-Apr-2021, end 11-Apr-2021
Muscle soreness starting in hand day after vaccination. Has now spread throughout the body.  Patient now complains of muscle pain all over.
Severe body aches. Fever 101 for 5 hours. Tylenol didn?t help. Dehydrated.  Could not get up by myself without help.  Very weak.
Hospitalized with fever, nausea and vomiting, also patient has Cholangitis acute with cholelithiasis.
Patient presented to the clinic with her husband. They both came in to receive their flu and covid vaccinations. Patient requested the high-dose flu vaccine because of her medical history. She received the high-dose flu vaccine even though she is under the age of 65. Patient was monitored for 10 minutes after the vaccine administration and had no adverse reaction. She then left the clinic with her husband after he received his vaccine.
Its affecting my mother and we got some big issue; my mother do not feel well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Its affecting my mother and we got some big issue; my mother do not feel well".  No follow-up attempts are possible. No further information is expected.
p/vax pt had fatigue, body aching, flu-like sx;3/94 neuro MD eval sx:lt eye blindness, numbness (arms/legs) /weakness/paralysis legs, unable to urinate, constipation,  tingling & numbness-trunk,dx: transverse myelitis, optic neuritis, MS
A few hours after receiving it, I started to feel these horrible aches and pains in my hands (both), arms and upper back. And has not subsided. I'm still having today. It almost feels like I'm having rheumatoid arthritis problems. I'm not swollen. Just pain and stiffness. The pain is in all of these areas and is not moving. I'm miserable. No treatment except Tylenol and sometimes it helps and sometimes it doesn't.
Covid positive on 29Aug2021. Test results (PCR) received 31Aug2021. Mild to-Moderate symptoms.; Covid positive on 29Aug2021. Test results (PCR) received 31Aug2021. Mild to-Moderate symptoms.; This is a spontaneous report from a contactable consumer.   A 43-year-old female patient received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3248), via intramuscular route of administration, administered in left arm, on 25Mar2021, as dose 2, single and 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6203), via intramuscular route of administration, administered in left arm, on 02Mar2021 as dose 1, single for covid-19 immunization at the age of 43-year-old. The patient was not a pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies. No other vaccines received within 4 weeks. The patient did not receive any treatment. The patient did not have covid prior vaccination and the patient had tested positive post vaccination. On 29Aug2021, the patient underwent nasal swab PCR test and resulted with covid positive. On 31Aug2021, the polymerase chain reaction test results were received. Mild-to-Moderate symptoms were noticed. The outcome of the event was not recovered.
I got burning like; my heart is off and on racing; feels like my skin and my brain dropped by; feels like my skin and my brain dropped by; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to Sulfonamide" (unspecified if ongoing), notes: sulfa allergy because I have an allergy to Sulfonamide (Unspecified Medication). The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "not recovered", described as "I got burning like"; PALPITATIONS (non-serious), outcome "not recovered", described as "my heart is off and on racing"; FEELING ABNORMAL (non-serious), SKIN DISCOMFORT (non-serious), outcome "not recovered" and all described as "feels like my skin and my brain dropped by". The events "my heart is off and on racing" and "feels like my skin and my brain dropped by" required emergency room visit. The event "i got burning like" required physician office visit and emergency room visit.  Additional Information: Patient got burning; Sulfa allergy; Patient had an allergy to Sulfonamide; the reaction to patient's body was saying yes, there is (Sulfonamides). The event was reported as heart was off and on racing; It feels like skin and my brain dropped by; It was becoming unbearable. Further stated, patient got burning like, the only thing that can be described with us it is sulfa allergy because patient has an allergy to Sulfonamide (Unspecified Medication) and asked this doctor if there is sulfonamides in it when patient was seeing a doctor or pharmacist. If there was sulfonamide in this vaccine and he said no but my reaction to patient's body was saying yes, there is (Sulfonamides). Enquired if there was Sulfonamides in this drug. When paraphrased the concern, reporter stated, "Yes and what I need to do to get it to stop because my heart is off and on racing and it is feels like my skin and my brain dropped by." Enquired if patient should go to emergency room, called us because it was becoming unbearable. Patient was informed in case of emergency dial 911 or contact nearby healthcare provider. Reporter stated, "What they all seem to the part of your organizations, product line and I am afraid that I am just going to get run around and not get the problem fixed." Further stated, "I am going to go in the ER because I need this to stop."  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.
Starting around 6pm - pain at injection site, severe chills, muscle pain, joint pain, and extreme fatigue. Symptoms continued through 1/27 and around 6am started to feel nausea.
Got vaccinated with MMR on 08/06/2019 one day later on 08/07/2019 started getting rashes or bumps on her face: neck, with low grade fever
Pt got severe amount of satellite lesions surrounding smallpox injection site. Roughly 20 sides. Pt's armpit also swollen around lymph nodes (smallpox).
swelling of the chin; This is a spontaneous report from a contactable consumer (patient's parent). A 19-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date, NDC and UPC number was unknown) via an unspecified route of administration on 26Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On Aug2021, patient experienced swelling of the chin and reporter was not quite sure what to do. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Severe headaches Cervical pain  Upper back pain  Nauseas  Vomiting  Finger on right hand was numbed  Chills Eye infection
Initial information received on 15-Jun-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves three patients (age and gender not reported) who experienced a large reddened area at the injection site which is hot to touch, after receiving DAPTACEL. No medical history or concomitant therapies were reported. On an unknown date one patient received first dose of DAPTACEL (lot C5180BA, expiry date not reported) via intramuscular route in unknown administration site. On an unknown date other two patients received fifth dose of the DAPTACEL (lot C5180BA, expiry date not reported) via intramuscular route in unknown administration site. On an unknown date (latency not reported) following vaccinations all three patients developed a large reddened area at the injection site which is hot to touch. The area is about the size of a baseball. No further information was provided. No lab data was reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for all three patients. List of document held by sender: none.
Approximately 5 minutes after the vaccine was administered, patient notified me that she felt  her throat tightening. I had her sit down. After 5 more minutes she condition had not improved. at that point I called 911 and the paamedics arrived at the pharmacy. Patient could speak and breath but reported that the tightening in her throat was still continuing. Her blood pressure was normal as well as her pulse-ox.  she was brought to the hospital by ambulance.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 05-JUN-2017, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route, and lot # not reported). Shortly after being administered ZOSTAVAX, the patient suffered rashes all over the left side of her body and was diagnosed with herpes zoster. On an unspecified date, the patient also suffered redness, swelling and pain on her leg and was diagnosed with cellulitis. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's 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 the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered/not resolved. The events were considered related to ZOSTAVAX. Herpes zoster and cellulitis were considered disabling. Upon internal review, cellulitis was considered to be a medically significant event. Additional information has been requested.
PATIENT TESTED POSITIVE ON A PCR TEST ON 3/26/2021 DUE TO REQUIRED UNIVERSAL TESTING. REMAINED ASYMTOMATIC THROUGHOUT
About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet.  Within about an hour of one tooth hurting, all of my upper molars and jaw hurt and had a nerve sensation.   It was like the roots of all the molars were irritated.  The nerve sensation also felt like it was in the upper jaw/face area.   My entire pallet became irritated.  This lasted for about two hours and then went away completely.
dizziness; felt she couldn't focus her eyes; super pale; This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced dizziness, difficulty focusing eyes and pallor. On an unknown date, the outcome of the dizziness, difficulty focusing eyes and pallor were recovered/resolved.   It was unknown if the reporter considered the dizziness, difficulty focusing eyes and pallor to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported dizziness after the first dose and felt she couldn't focus her eyes. The patient was super pale.  The patient felt ok after 24 hours. The reporter consent to follow up.
Pt with generalized convulsions and eyes rolling back for 45 seconds. Stopped breathing for 30 sec. Had fever at time of event.
Chills and body aches approximately 8 hours vision changes approximately 30 minutes, headache ongoing for several days now, fatigue
on 2/1/21 had extreme body aches, headache, fatigue, around 1:30 pm body chills and fever developed, i went to sleep and at 8 pm woke up with fever 101.2,
every bone in her body was aching after booster dose; arm aches after booster dose; ongoing headache after booster dose; temperature of 99.6°F after booster dose; leg aches after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose), VACCINATION SITE PAIN (arm aches after booster dose), HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose), VACCINATION SITE PAIN (arm aches after booster dose), HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose). At the time of the report, PAIN IN EXTREMITY (leg aches after booster dose), BONE PAIN (every bone in her body was aching after booster dose) and VACCINATION SITE PAIN (arm aches after booster dose) outcome was unknown and HEADACHE (ongoing headache after booster dose) and PYREXIA (temperature of 99.6°F after booster dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (High) 99.6 Degree F.         Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient took  the booster dose; at 2-3am, the symptoms are started.   This case was linked to MOD-2021-367247 (Patient Link).
Pateint received H1N1 nasal vaccine and she was pregnant at the time.  No adverse reactions noted at time of event report.  12/23/09 OB notes received for DOS 12/01/09 and 12/16/09. Although, pt did not report any adverse event during OB visits, Pt had H1N1 vaccine during early pregnancy. Pt reported h/o vaginal spotting 1x 2wks ago and fever. Pt was taking Tamiflu, but stopped when found out pregnancy.
Patient received his yearly influenza vaccine at one of our school based clinics. His reaction started about 2 hours after receiving the vaccine. He started with a rash around the injection site area which grew to his legs, arms, abdomen, neck and face. He also had welts that were very itchy.
After about a month after her COVID vaccinations ending April 5, 2021, Moderna, she developed increased excessive abdominal pain and she started passing bloody clots through her rectum. Within a few days of this, she became unresponsive at home and was taken by EMS to the hospital. She was found to be in a severe shock and was treated with Levophed. She was hospitalized for 4 to 5 days and diagnosed with "sepsis" and severe diverticulitis with bloody stools. She was treated with IV antibiotics and discharged on Cipro and Flagyl. . Post this event, she is having overwhelming fatigue and generalized neuropathic pain, muscle pain, and bone pain. She is also having chronic gut dysbiosis
Patient was faint, clammy, tired about 45 minutes after vaccination (patient works at store). Patient was sitting in chair when pharmacist arrived to where patient was working. Patient's blood pressure and pulse were taken (in normal range). Patient was moved to the floor carefully. 911 had already been called. Patient was monitored until EMTs arrived and took over the scene. Patient was given fluids in the ER and sent home. Patient does have a history of dehydration per patient report.
4/11/2021 830PM  I NOTICED MOISTURE IN MY UNDERWEAR.  WENT INTO BATHROOM , PANTIES BLOODIED, BRIGHT RED  AND  A QUARTER SIZED CLOT WAS INTHE TOILET. I SUFFERED NO PAIN. HOWEVER I HAD A TOTAL HYSTERECTOMY IN 1997, AND SHOULD NOT HAVE ANY BLEEDING WHATSO EVER.   TOOK A SHOWER, ADVISED MY HUSBAND OF THE  INCIDENT.  WENT TO BED , 230AM 4/12/2021 SAME THING  HAPPENS, ONLY NOW  I AM WIPING BRIGHT RED BLOOD  AND I FELT A LARGER SIZED CLOT LEAVE MY BODY.  I WENT TO THE ER IMMEDIATELY.
Reported sore arm and mild fatigue 24hr after, redness started 24-36hrs after and continues to spread.  She notes mild warmth, no fever, chills, feeling ill.  Denies any shortness of breath, CP, angioedema or airway compromise.  Today, mostly feels back to baseline x rash.
Woke up with swelling of upper lip  and  hives on bilateral forearms, later in the day upper lip swelling resolved and lower lip swelling noted. No treatment required. 2 days later- swelling in lower lip nearly resolved, hives on forearms resolving, itching persists.
On injection patient stated area around injection site numb, I received message from ER and when I returned called could not get through & left message so I called patient who said has neurology visit tomorrow & c/(L) eye & (L) face & left arm & part of (L) breast numbness, states can use arm normally.
Pt. diagnosed with bursitis due to flu vaccine. Going into joint spur and not muscle. Required multiple MD visits and physical therapy due to illness.
Patient presented to the ED and was subsequently admitted for NSTEMI within 6 weeks of receiving COVID vaccination.
03/18/22 presents to Birth Center Triage for "ctx since yesterday" "40w1d". PMHx of "Hypothyroid"
About 5 minutes after vaccination with Gardasil and Menactra he fainted and hit head on the door and then fell on his face.  Sustained a concussion and a broken nose. Had some retrograde amnesia which improved over about an hour but still not back at baseline so he was sent to the ER for imaging.
FULL BODY PARALYSIS FOR TWO MONTHS (FACE IS STILL PARTIALLY PARALYZED); This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, reporter stated that patient experienced full body paralysis for two months and his face was still partially paralyzed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from full body paralysis for two months (face is still partially paralyzed). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211246280- COVID-19 VACCINE AD26.COV2.S- full body paralysis for two months (face is still partially paralyzed). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).