chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-JUN-2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, lot # and expiration date were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 16-JUN-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX and VICODIN for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, pain, suffering, and other damages. At the time of the report, the outcome of the events was unknown. Additionally, the causal assessment between the aforementioned events and vaccination with ZOSTAVAX was reported as related. Additional information has been requested.
pt recv vax JAN97 & several days p/vax pt exp tenderness @ the inj site & a nodule @ the inj site;pt devel 1 papular pustule on torso;
Initial report received from a health care professional on 25 October 2010. A 28-30 year old female (age not exact) received on 25 October 2010 a 0.5 millimeters right forearm intradermal injection of FLUZONE, lot number U3616CA. The patient had received a flu vaccine and an H1N1 vaccine in the past. On the 25 October 2010 the patient developed a large raised wheal that disappeared in 15 minutes and a quarter size red area that remained at injection site. The patient required an emergency room visit. No further information was available. The outcome was not reported. Follow-up information was received by a health care professional on 06 December 2010 reported that the patient was a 27-year-old female who received the FLUZONE on 25 October 2011 in the AM. The patient was monitored by the employee health office and photographs were taken. The patient had no illness at the time of vaccination. The outcome was reported as recovered. Documents held by sender: None.
a newborn was given an Adacell vaccine rather than the ordered hep B   No adverse reaction
Tachypnea, Angina, Tachycardia, Sore  Muscles Narrative: Started feeling ill on the 28th. Drove himself to get checked out at the hospital. Hospital sent him home. Called EMS at 12/30/2020 @ 0200 and was hospitalized for 1 day. He is more stable now but still has these symptoms at a moderate level.
hives all over face & neck, w/swelling & itchiness;eyes swollen shut for short period of time 1-2hr, then swelling went down but remained for several days;
Dizziness, Headache, Myalgia & Fever Narrative:  Reaction on 1/27-1/28 Sx: Chills, body aches, fever, headache, dizziness, sweating
Information has been received from a physician concerning a 17 year old female patient who on 26-MAY-2009 was vaccinated with the third 0.5 ml dose of GARDASIL (lot number not reported). On 30-JUN-2009 the patient experienced syncope after the vaccination. At the time of the report, the patient recovered. It was reported that the patient did not experience any adverse event from the first and second dose of GARDASIL. This is one of three reports from the same source. Additional information has been requested.
Congestion Runny nose Fatigue/lethargy Slower to recover/fight off illness
1 day after Varivax, developed 5 x 6cm redness, induration on left thigh, vaccine site.  Ice pack, Benadryl.
Within 30 seconds , chest became constricted and found it difficult to breathe. Felt immediate head rush and thought I was going to pass out or was having a heart attack. Additionally had a pang in the middle of my chest for the next few hours and was out of breath during short. leisurely walks. I have never had this feeling before nor have ever had a reaction to a vaccine.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly female patient who received Shingrix for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix. In July 2018, 1 day after receiving Shingrix, the patient experienced muscle pain, loss of energy and fever. On an unknown date, the outcome of the muscle pain and fever were recovered/resolved and the outcome of the loss of energy was unknown. It was unknown if the reporter considered the muscle pain, loss of energy and fever to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. Th patient received Shingrix sometime in July 2018, and received 2nd dose in September 2018 exact dates not known. She reported muscle aches, fever, and no energy. The symptoms began 1 day after 1st dose of Shingrix and lasted for 2 to 3 days. This case has been linked with the case US2018186348, reported by her husband.
outbreak of Shingles after the 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 15th November 2021) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 4 months after receiving Shingrix, the patient experienced shingles. In May 2020, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed an outbreak of Shingles after the 1st dose of Shingrix.  The patient had the symptoms for 3-4 weeks prior to 18thJune 2020. The reporter was consented to follow up. No additional details were provided.
pt has knot and skin finding at injection site that has persisted from 11/12 until current on left thigh at site of Hep A or typhoid. Initially started as a small pus filled bump which resolved. Has not seemed painful. Dad concerned about tight muscle at time of administration due to positioning of pt. No fever, gait issues, redness or pain. Left leg lesion at site of Hep A or typhoid administration on 11/12/21 that has persisted. Typhoid more likely to be causal agent. No sign of infection, myalgias, rash, pain, restrictions of movement. Not indicative of an allergy or contraindication to vax. Can massage area. Anticipate eventual spontan resolution. No restrictions on activity.
pt received the moderna COVID-19 vaccine. Approximately 10 minutes later she experienced dizziness and lightheadness and weakness. She was evaluated in urgent care, found to have severe hypertension 230/120 (no h/o htn). Hypertension remained present for 2 hours and troponin returned indeterminate. She was transferred to ED for further evaluation and management. See note for details of care.
Severe anxiety and panic attacks beginning approximately two months after the second dose of the Pfizer vaccine. Around February 21st, 2022, I started to experience severe anxiety (that I've never experienced before) with symptoms of excessive worry, sweating / hot all over, dizziness, heart racing, shakiness, and fear of not being able to go back to feeling "normal." On February 25th, 2022, the anxiety heightened almost escalating to a panic attack but did not, although severe anxiety was still experienced. On the night of February 27th, 2022, a panic attack struck with intense fear (sense of impending doom), sweating / hot all over, heart racing, dizziness, shakiness, nausea, and difficulty breathing. I did not seek medical attention at the moment of the panic attack but rather worked to calm myself down (panic attack lasted approximately 2 hours). I did, however, schedule an appointment with a psychiatrist the week prior to the panic attack due to the excessive anxiety. The appointment is scheduled for Tuesday, March 1st, 2022.
Patient describes pain in the left arm at the injection site x8 days. No erythema, swelling, warmth, or itching. No fever.
Initial report was received on 13 August 2008 from another manufacturer.  The initial reporter to this manufacturer had been a health care professional.  An unidentified patient received an injection of DTaP (manufacturer and lot number not reported).  The patient developed an allergic reaction like "protosis" after receiving the injection.  The patient's recovery status was not reported.  No additional information was provided.
L upper arm with tenderness, swelling and erythema for approx 10 days. S/S increased approx days 9 and 10. Client advised to seek medical at hospital.
patient presented to emergency department on 11/4/21 after falling patient tested positive for covid-19 after testing in the emergency room on 11/4/21 patient was admitted to hospital and received treatment for symptoms associated with covid-19 infection. treatment included dexamethasone, oxygen patient required intubation on 11/7/21 and was put on a covid-19 unit patient expired on 11/12/21 due to continuous renal replacement therapy hyperkalemia and bradyarrhythmia
got Covid once after receiving my [Pfizer] initial shots and once again after receiving a [Pfizer] booster.; got Covid once after receiving my [Pfizer] initial shots and once again after receiving a [Pfizer] booster.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: Covid once after receiving my [Pfizer] initial shots. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid once after receiving my [Pfizer] initial shots and once again after receiving a [Pfizer] booster.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: patient thought it was targeted towards everyone, which is sketchy to me because I think that only people at risk of serious illness should be getting boosted. I am a healthy person who got Covid once after receiving my [Pfizer] initial shots and once again after receiving a [Pfizer] booster. I would not have got the booster if I had not been required by my university. I think boosters are a scam by the  companies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received an IM injection at 4:40 pm at my place of work. I sat down as per our protocol after the injection. Within 5 minutes, I felt a flushing effect start from my head and travel down my body to my toes. I became light-headed and felt like I was floating in my chair. My legs, from my knees to my toes, felt very warm, numb and tingling. After the 15 minute period of monitoring ended, I walked back to my unit. While walking, I felt light on my feet and as if I were walking on a bunch of thick blankets. There was a numbness sensation to the soles of my feet. I informed the doctors and nurses that I work alongside with once in my unit. The light-headedness dissipated within approximately 30 minutes. The numbness, tingling and warm feeling from my knees to my toes lasted approximately for 2 hours (until 6:30 pm). I had no issues after that point.
pt recvd vax 18NOV93 & 27NOV93 7AM pt exp numbness & tingling sensation in both arms;weakness progressed throughout the day &  hardly able to move extremities;gen weakness-stinging sensation;HTN BP 197/123;urinary incontinence;paresthesia
Around 0500 after I got off work...I had the intense feeling of extreme fatigue , this was about 10 hours after recieving the injection. I was so tired that i didnt get out of bed for 15 hours the fatigue and extreme tiredness lasted untill about 7pm the night after recieving the vaccine. Did not experience anymore fatigue or any other symptoms after the tiredness/ fatigue resolved.
Suspect COVID breakthrough case Incidental COVID finding s/p fall and intracranial hemorrhage
This spontaneous report was received from a Licensed Practical Nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. It was reported that on 06-SEP-2018, the patient was vaccinated with an expired dose of VAQTA (dosage, route, and anatomical location were not provided) lot # N019924, expiration date on 02-SEP-2018, for prophylaxis. No adverse effect was reported.
Next day had nausea. The second day had diarrhea felt nauseous couldn?t eat anything or drink. That night vomiting alongside other symptoms from earlier. Next day still diarrhea no vomiting and can eat crackers and drink water. I had a headache the whole 3 days. I was fine after that.
pt devel scalp itching & lip edema 1hr post vax;pt instructed to take DPH;24hr post vax 16JAN96 pt devel gen hives & mild wheezing;pt went to hosp & was treated w/steroids & decadron;
itching doctor gave me cortisone cream to relieve itch i got a rash on my leg and foot. I went to PCP first.
Patient noted that she had immediate pain at injection site in left deltoid after vaccination. Pain  and tenderness continued in left deltoid and shoulder throughout the day and evening for a few weeks afterwards; then subsided during the day and was only in the evenings when laying in the bed. Patient described it as "achey." No associated numbness, tingling, weakness. No redness or swelling near injection site. Her pain resolved completely by 10/27/18. She did not seek any medical evaluation for symptoms during this time. I offered her examination now, however declined examination now, as symptoms resolved.
She came to the Occupational health Department shortly after receiving the Flu shot, complaining of dizziness, feeling lightheaded and cold. She was treated and released with no further signs and symptoms.
Had vaccine 9/24/02. Redness and swelling of R arm-cellulitis.
Information has been received from a registered nurse concerning a 25 year old male with no known allergies and no pre-existing medical conditions or illnesses who on 09/21/2001 was vaccinated on the left with a first dose of varicella vaccine. There were no illnesses at the time of vaccination. On 09/28/2001, the pt experienced a "prodromal syndrome" described as a headache, "achy all over," malaise and a slight temp of 100 deg F. On that same date, the pt developed approximately 30 tiny vesicles. No lab testing was performed. The pt recovered on 10/08/2001. No further info is available.
Information has been received from a physician concerning a 13 year old female with eczema and peanut allergy who, on 19-FEB-2007, was vaccinated with the first dose of Gardasil (Lot #655126/0087U). Concomitant therapy included triamcinolone. On an unspecified date, she was vaccinated with the second dose of Gardasil (Lot #654741/1208F). The patient, who had completed the Gardasil (Lot #657622/0388U) series on 17-AUG-2007 had developed Type I diabetes (diagnosed on 29-AUG-2007). When the patient was initially seen at the office on 19-FEB-2007, she weighed 166 lbs and was 5 feet 3 inches. She informed the office that she would try to lose some weight. She presented to the office on 29-AUG-2007 at 122 lbs with a random blood glucose (finger stick) of 479 mg/dl and an A1c >14. A urine test found sugar and ketones present. The patient was admitted to the hospital on 29-AUG-2007 where she remained as of 30-AUG-2007 (not recovered). The patient sought medical attention. The physician considered the Type I diabetes to be immediately life-threatening. Additional information has been requested.   9/18/07 Reviewed hospital medical records which reveal patient experienced abdominal pain intermittently x 2-3 months, diarrhea for 2-3 weeks & incidental finding of elevated BS & glycosuria.  Admitted 8/29-8/31/2007.   W/u for celiac disease was neg. FINAL DX: newly detected diabetes.
Patient presented to the ER with complaint of shortness of breath, cough and malaise. In the ER he was found to be saturating in the 70s on room air.  He required about 6 L O2 supplementation.Chest x-ray showed Right pleural effusion with adjacent atelectasis or infiltrate. He was admitted and started on levofloxacin IV for CAP and continued on oxygen supplementation + DuoNeb as needed. Lactic acidosis resolved on gentle hydration.  With continued improvement he was transitioned from IV to p.o. levofloxacin. He was weaned off O2 supplementation and remained HD stable through out his hospital stay. Patient was discharged home to f/u with his PCP. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Five or so hours after injection my arm became very sore and I had a slight headache.  The next day my arm remained sore and I could feel a bump and see redness at injection site.  It was sightly  itchy and I also had some neck pain and aches.   The third day my arm wasn?t sore to move only to touch.   The bump remained.  It was not as itchy. Day four no pain at all really. No aches or pains.  Felt normal.  On the 7th day post injection my arm became itchy again and red and warm to the touch and now feels like there are two small bumps.  My nurse friend it might be ?Covid Arm?.  I have asthma and allergies so am taking benedryl but from what I read this is harmless.
Broke out in extremely itchy burning welps on arms legs and started on trunk till I took benadryl. Looked like measles welps. Benadryl resolved welps by this morning although skin still slightly itchy
Pt. was administered H1N1 vaccine intranasal instead of intramuscular. No s & s of Flu noted as of 12/16/09. Thinking that this is protocol, no MD order in place.
This spontaneous report was received from patient's father refers to 13 year old male patient. No current condition was reported. The patient's medical history included SCT disease and Kawasaki disease which patient experienced on an unspecified date when he was younger. Approximately on 28-JUL-2014 (as reported that event occurred after two to three minutes after receiving the vaccine), the patient was vaccinated with GARDASIL dose 3 (as reported last dose) (route- injection, dose strength was not reported). Other suspect therapies included hepatitis A vaccine, inactivated (manufacturer unknown) dose 1, vaccinated on same day on 28-JUL-2014. No concomitant medication was reported. On 28-JUL-2014, after two to three minutes after receiving GARDASIL the patient was passed out (medically significant) and hit the counter as he was falling down, he hit his tooth and also scrape on his neck due to hitting the counter. Patient was passed out for about ten to twenty seconds and when the patient came to he was still dazed. Blood pressure was taken after the reaction and was reported to be normal. There was no treatment given for the events. The outcome of passed out (medically significant) and hit the counter as he was falling down, hit his tooth and scrape on his neck due to hitting the counter and still dazed was reported as resolving. The consumer reported that the patient was still recovering a half hour after receiving the GARDASIL. The event occurred in physician's office. No product quality complaint was reported. The causality between GARDASIL and other suspect therapy hepatitis A vaccine, inactivated (manufacturer unknown) and event was unknown. Upon internal review event passed out was considered medically significant. This case is related to 2 cases via same reporter link. Additional information has been requested.
Right arm redness, swelling, warm to touch from elbow to shoulder, Ice, Ibuprofen, Benadryl.
Felt flu-ish within 10 hours. Went to the bathroom after 16 hours and lost consciousness twice. Paramedics called--elevated BP and BS. Once seated, BP returned to normal.
Patient said she had a lymph node form in the left armpit 1 day after the first dose. Patient said it was painful and lasted 2 weeks.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 26-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Three days after I got a massive headache at the back of my head and a stiff neck. I do not get headaches. I went to the ER to be checked out and they couldn't find anything. They assumed it was a migraine and gave me migraine related drugs and fluids but they did not affect the headache and stiff neck.
Patient experienced dizziness, vomiting, diarrhea and chills after getting flu shot. Symptoms started 4 hours after shot.
contracted Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced COVID-19 (contracted Covid-19). At the time of the report, COVID-19 (contracted Covid-19) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
ABOUT ONE-FORTH OF THE DOSE LEAKED OUT OF THE SYRINGE WHETER THE NEEDLE ATTACHES WHILE BEING ADMINISTERED TO THE PT
First was a large 1.5 inch diameter, red welp at site. For the next 60 hours, experienced severe migraine and joint pain. Red welp at site eventually turned purple with a large 4inchx1 inchx0.5 inch deep indention into muscle tissue at vaccine site. Arm has a constant dull ache that worsens with use and on palpation at site with noted weakness.
Pulmonary embolism. Awoke Monday 11/7 with pain and difficulty breathing. Labwork done by doctor on 11/7 was abnormal. Extremely difficult to breathe the night of 11/7 with intense pain, admitted on 11/8 mid morning