chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse from a physician's office via a sales representative. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced local reaction on arm like a dermatitis on an unspecified date with outcome of unknown. Follow-up (24Feb2015): Follow up attempts completed. No further information expected.
Very Sore arm  lasting to this day 8/9/2021.  After a couple of days, small itchy bumps tat would come and go all over my body. Lasted almost 3 weeks.
pt recvd vax 13JUL95 & pt devel a generalized red rash that was raised w/white periphery;no vesicles were noted;also had a t103 & was irritable
Developed itchy red rash on arms and scalp 10 days after vaccine booster. Chronically fatigued. Developed into full-body hives (urticaria) within a few more days.  Saw ER physician and dermatologist on Jan 17 (one month after booster), and again March 8. Antihistamines taken since Jan 2-- Allegra (Jan 2-Jan 17), Zyrtec (Jan 18-Feb20), Claritin (Feb 21 to present). Antihistamines have caused drowsiness and been disruptive to my life, so trying different medications that work for me. Hives are controlled by the antihistamines, but dermatographia has developed and will not reduce with medicine. Redness and swelling around throat is chronic.  I HAVE NO HISTORY OF ALLERGY AND HAD NO LIFESTYLE CHANGES. The time correlation with the vaccine booster is STRONG.
Redness, severe pain at injection site, loss use of left arm. Could not use that arm nor could I raise that arm shoulder height.  painful to touch. Had a large golf ball size knot at injection site, under the armpit, and in the crease of left arm/elbow. This happened for both injections.
Patient was administered PROQUAD vaccine (MMRV) instead of MMR vaccine. No s/s or tx noted/given.
Left clavicle lymph node is tender and swollen, with swelling radiating to base of neck and up to left ear.
Fever, chills, headache that started within 8 hrs from the time of Covid shot.  From the next day the skin below the injection site  is red , swollen and hot
VOILENT HALLUCINATION; FULL BODY TREMORS; CONFUSION; ANXIETY; VIVID DREAMS; HEADACHE; This spontaneous report received from a health care professional (Nurse) concerned a male of an 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 (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown ) dose was not reported, 1 total administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 18-AUG-2021, 12 hours post vaccination, the patient experienced violent hallucination, confusion, vivid dreams, anxiety, full body tremors and headache. He went to physician office. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body tremors, violent hallucination, confusion, anxiety, vivid dreams and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210844101-COVID-19 VACCINE AD26.COV2.S - Violent hallucination. This event is considered unassessable. The event 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.
Headache for a few days; Body aches for a few days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for a few days) and MYALGIA (Body aches for a few days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced HEADACHE (Headache for a few days) and MYALGIA (Body aches for a few days). At the time of the report, HEADACHE (Headache for a few days) and MYALGIA (Body aches for a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2022-518808, MOD-2022-518813 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2022: Follow-up received contains no new information.
Persistent cough; Fever; Chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Persistent cough"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional information: Fever chills persistent cough-first shot, Nauseous and uncomfortable with second shot, Event took place after use of product. Reporter does not wish to be contacted for follow-up.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Presents for weakness; was found on floor, other sx include cough, diarrhea, and fever. Admit for sepsis due to COVID pneumonia. Tx: steroids, abx, remdesivir. DC to home.
Itchy red rash developed on multiple spots on the body.  Started gradually several hours after shot.    No rash on arm where I had the shot.  Affected areas were stomach, forehead, cheek, chin, inner thighs, legs, fingers.    Rash was similar to poison ivy rash in appearance and discomfort.   Peak of symptoms was 4-5 days after injection.  All symptoms were gone by about day 12 after injection.
Extra Dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31-OCT-2024) for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO) and MENINGOCOCCAL B VACCINE (BEXSERO).   On 01-MAY-2023, the patient received the 3rd dose of Bexsero. On 01-MAY-2023, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: Extra Dose). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-MAY-2023 Medical Assistant reported that she inadvertently administered a dose of Bexsero to a 16-year-old female patient that had already received two doses.  The patient was dosed on 01Feb2023 (lot number EN939, expiration date 31Oct2024), 29Mar2023 (lot number TP294, expiration date 31Oct2024). The patient received third dose.  The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. The patient received third dose of Bexsero, which led to Extra dose administered.
an adult patient was given a pediatric dose of Engerix-B; an adult patient was given a pediatric dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 42-year-old male patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 05-APR-2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: an adult patient was given a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: an adult patient was given a pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 01-AUG-2023 The reporter was a medical assistant. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional was not sure of patient exact age and did not have initials at time of call. The reporter consented to follow up.  The reporter reported that an adult patient was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
2nd maderna vaccine was given to my dad on 02/26/2021 and on 03/15/2021 my dad was visiting me all day and he acted fine and normal. At the end of our visit between 8 & 9 pm we went to the store where he started to gasp for breath. He had to keep stopping and said he couldn't breath. I had him sit several times because I didn't know how bad it was. By the time we reached the doors to leave after a short trip  he almost fell over and he became confused and said he couldn't breath. I had another customer get my dad a wheel chair close by while I called 911. The ambulance came quickly but at the hospital my dad went into cardiac arrest and his heart stopped 2 or 3 times and it had to be restarted. When I was able to get to the hospital my dad was on a ventilator and sedated. They had put him on medicine to blast the blood clots they had found. They said he had 2 very large blood clots with one on each lung. Later his kidneys started failing him and they said he would need to go on dialysis as soon as the next day. Later that night they told me my dads heart was shutting down and he had developed pneumonia. My dad died that night and I had to watch him take his last breath. If you want further information please contact Medical center would be the ones to contact for all information and my dad was in the critical care unit.
After 2 weeks from date of administration of DTAP vaccination, patient began to stare at her fist in a non-purposeful way. Patient repeatedly stared at her fist for sensory stemming. 3/15/19 Pt presented with severe and ongoing to this day constipation with no previous stooling difficulties. The action was not normal developmental exploration of her hand. Beginning 4/13/19, patient's symptoms worsened to hand flapping, non-communicable humming, rocking in long sitting position, and twirling of ankles. Pt began abnormal staring and rapid blinking spells. The beginning of June 2019, patient began stages of crawling. However, patient exhibited insidious left leg weakness/hemiplegia with upper extremities not affected. Patient continues to have left leg weakness and gastrointestinal difficulties.
Shortly after receiving vaccines I started to have heavier bleeding. Irregular periods. I became very anemic and low iron. Blood work dropped drastically. Became fatigued. Also had biopsy done on a mass found in my ovary luckily benign. Hard not to think its related
This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patients were vaccinated with improperly stored GARDASIL (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
1) itchy arms and legs starting a few minutes after injection, resolving within the half hour 2) allergic dermatitis (id reaction) on my fingers about 30 hours after the injection (presumed type 4 hypersensitivity reaction to PEG)
Since feb 09 2021, i have had moderate to severe GI related illness. Bloating, gas, slow digestion. Belching, abnormal stool color and frequency, decreased food intake, vomiting, pain discomfort, weight loss.
I usually never feel the flu shot being administered and usually have no reaction.  This time it was uncomfortable going in, had slight sore shoulder until going to sleep at night then had a headache all of the following day.  The headache was not very bad, but it was letting me know it was there.  Never had these issues with a flu shot before.  Do NOT want a double dose next year!
Information has been received from a mother concerning her son with a history of coeliac disease who in March 1997, was vaccinated SC with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Ten days after the vaccination the patient's physician said the patient experienced measles. The patient broke out in red and swollen hives all over his body. The patient had a fever of 105 degrees Fahrenheit and the face of the patient swelled. The patient was taken to the emergency room and was given a shot of diphenhydramine hydrochloride. The patient was not admitted to the hospital and he recovered completed within 4 weeks. Upon internal review, fever of 105 degrees was considered to be an important medical event. Additional information has been requested (OMIC)
Patient reports a lack of energy, body aches, fever, soreness, and a knot at the injection site.  The effects started the evening of the shot 3/31 and have continued this week.  She has missed work and is reaching out to her primary care provider today 4/8/2021
I developed tinnitus in my left ears several hours after getting my Moderna COVID booster. I saw my ENT about a week later who confirmed it was likely caused by the vaccine I?d received. I tried taking a course of oral Prednisone (60mg x 1 week, 1 week taper) but it did not help. I am about three weeks out from the booster snd still experiencing symptoms.
Pt vax Sep90; blood drawn & abnorm results obtained.  Determined that vax had hepta B outcome:  asymptomatic.
Seizures.  New medication added - Tegretol - which was not tolerated.   Seizures increased after the second dose of Pfizer Covid vaccine to almost every night.   The seizures stopped about a month after the second vaccine.   Continued on the same original dose of Keppra  with no further seizures since then.
Patient had body aches and low energy the day after the shot.  On Nov 21, 2021 patient had significant difficulty walking up steps due to leg pain.  This was highly unusual since she regularly walks for exercise and has never had a problem like this with her legs.  It was clearly a sudden, unusual event.  She continued to have low energy through the rest of Nov, 2021.  Patient had significant leg swelling and inflammation by Dec 24th and went to the Emergency Room.  She underwent an ultrasound and an x-ray.  She was diagnosed with superficial thrombophlebitis.    (continued below) Patient subsequently visited her ARNP on Jan 10, 2022 and was directed to use compression hose and heat to treat her issues.  She continues self treatment.  The blood clots were a highly unusual, sudden event with no prior similar symptoms.
Headache LEFT SWOLLEN LYMPH NODE ONE WEEK AFTER INJECTION. RESOLVED IN 5 DAYS. NO HEAD ACHE Narrative:
WENT TO SLEEP ON 1/6/21 WITHOUT ANY ADVERSE EVENTS. WHEN AWOKE ON 1/7/21 AT 07:00AM, HAD A RASH ON ARMS AND BELLY. RASH IS NOT ITCHY.
she had pre cancerous symptoms after receiving the GARDASIL vaccine.; This spontaneous report was received from a consumer referring to herself as a female patient of unknown age. The patient's pertinent medical history, concomitant therapies, previous drug reactions, or allergies were not reported.     On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).   On an unspecified date (reported as "after receiving the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine"), the patient experienced pre-cancerous symptoms (precancerous condition). As a result, she had surgery (unspecified) for the symptoms. The outcome of the event was not reported.  The causality assessment between quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) and the event precancerous condition was not provided.  Upon internal review, the event precancerous condition was determined to be medically significant.
Pt diagnosed with COVID infection and hospitalized for new oxygen requirement along with community acquired pneumonia on 6/18/21
Two days post vaccination, he started to get some chest pain when he was laying down. Three days after, he went to the emergency department and was admitted to the hospital. He was diagnosed with perimyocarditis.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Temp 102.5 degrees F. Fatigues less than 18 hours. Two hour episode of hand tingling, pale fingers, blue fingernails. After 2 hours now resolved.
Headache starting approximately 24 hrs. after vaccine administered - moderate severity. Gone upon waking next morning. Swollen glands. Unable to swallow vitamins - started 48 hrs. after vaccine, alleviated after 72 hrs.
Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 16:55 (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Nausea".  Additional information: There was no history of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines was Administered on Same Date of the Pfizer Suspect. There was no Prior Vaccinations (within 4 weeks).Patient did not experience any AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Five minutes after injection child was leaving and started coughing, felt like she couldn't breathe, face turned red, and eyes began to water.  Coughing subsided, but child reported that it felt like something was in throat.  Face was still red and eyes tearing.  Vital signs obtained BP 114/72. HR 86, SpO2 97%.  Lung sounds clear bilaterally and no wheezing heard on auscultation.  Reaction seemed to subside and child was no longer coughing or reporting feeling like something was in throat.  Redness in face resolved with tearing.  15 minutes post injection redness noted at injection site in oval shape extending approximately 3 inches.  20 minutes post injection MD to see patient.  Child showing no more signs of reaction.  All symptoms resolved.  No redness at injection site 25 min post injection.
A patient was administered an expired dose of Quadracel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00313615) and transmitted to Sanofi on 13-Oct-2020.  This case involves a 4 years old female patient who was administered an expired dose of 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA, expiry date: 09-Oct-2020, Single dose vial) once via intramuscular route in the right arm for prophylactic vaccination on 13-Oct-2020 (expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) (given in separate arm) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse 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 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.
loss of vision in left eye began on 9/28/21.  Went to ophthalmologist on 9/28/21 .  He sent me to a retinal specialist on on 9/29/21. returned to retinal specialist on 10/05/21.  waiting for blood to clear from left eye. Until blood clears will not know if it is an artery, vein, blood clot, or a tear.
other zoster other zosterrelated; shingles; Information has been received from a lawyer regarding a case in litigation and  refers to a patient of unknown age and gender. On or about September 2016, the patient  was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiry date were not reported), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician in an eye center for shingles and other zoster related conditions. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine the patient has and will continue suffer 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. The outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
mom states p/2nd set of shots pt screamed in high pitched from 12PM until the next morning;PMD states to cont w/DT;
Pt broke out in hives 10-15 min after shots were administered. They moved all over his entire body. He was given BENADRYL & parents were counseled about what to watch for. I attempted to call them the next day & check on child but could not get an answer.