chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Infantile spasms-seizures. Treated with ACTH for 6 weeks. Seizures started one week after vaccinations. Pt did have a temperature of 102 deg (by ear) following vaccines-same day. Treated with Tylenol.  03/10/2008 MR received for DOS 11/22-12/04/2008 with DX: Infantile Spasms. Child presented to ER after several seizure-like episodes with increasing frequency over the past week. Pt stiffens up, then becomes limp for 10-15 seconds. these are occuring in clusters. PE WNL except pt is sleepy following several seizure episodes. EEG shows the presence of an epileptic encephalopathy with clinical infantile spasms correlating with a progressive tendency toward hypsarrhythmia. Tx with B6 and ACTH.
nose bleed; fatigue; injection site tenderness; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On 1st July 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 1st July 2019, less than a day after receiving Bexsero, the patient experienced injection site tenderness. On 9th July 2019, the patient experienced epistaxis and fatigue. On 4th July 2019, the outcome of the injection site tenderness was recovered/resolved. On 10th July 2019, the outcome of the epistaxis and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, epistaxis and fatigue to be related to Bexsero.  Additional details were provided as follows: This case was reported by the patient's mother. The reporter did not have the vaccine information for this adverse event (AE). The patient received a dose of Bexsero in his left arm and developed injection site tenderness that lasted for 3 days. 8 days after vaccination, the patient had nose bleed and fatigue, that lasted for 1 day. The reporter did not consent to follow-up and also did not consent to Health care professional (HCP) follow up for this case.
11/17/2004: fever temp 100.4 degrees f; sore arm Tylenol given.
Received immunizations on 9/25/03. Noticed rash or tiny bumps to immunization site on arms (both) 9/29/03. Child has no allergies; notified health district. Thinks maybe a reaction to DTaP.  Will complete form and discuss with doctor. Suggested giving child Benadryl. Notified parent; track child very behind on immunizations.
Scalp lesions which had appeared after second dose, but which had healed and all but disappeared reactivated with a vengeance. Extreme discomfort, itchiness, burning. Finally was advised to use hydrocortisone ointment which calmed them. Four months post vaccine all are healed and most are gone (about four remain). Though eligible for a second booster, am very hesitant about getting another MRNA dose. I would prefer the new traditional vaccine that is 90% effective vs. the 93% of Pfizer. Darkening of skin at base of neck and surrounding left armpit (underarm).
rash on injection site; Arm soreness; Pregnant patient received the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the Moderna vaccine) and VACCINATION SITE RASH (rash on injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Jul-2020 and the estimated date of delivery was 26-Apr-2021. On 26-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the Moderna vaccine). On 27-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 02-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 26-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the Moderna vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE RASH (rash on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.   This case was linked to MOD-2021-076246 (Patient Link).
1 episode of Vomiting 10 minutes post vaccination,  Pt laid onto side for several minutes. Stated he was feeling much better.  He denied all other symptoms.
Information has been received from a pharmacy tech concerning a female patient in her late 60's who on approximately 01-Jan-2009, "approximately two weeks ago" was vaccinated with ZOSTAVAX (Oka/Mereck) (Lot# not provided). After vaccination, patient experienced excessive pain at injection site. Ibuprofen and ice were suggested as treatment. This is one of several reports from the same source. Additional information has been requested.
27 weeks pregnant. Received Tdap vaccination. A few days later started with severe shoulder pain, decreased range of motion, and unable to put any pressure on that side.
Per mom pt with 101 temp, crops of pox developing and crusting over within 24 hr time frames. Varicella administered at other office in town per mom.
9-10 hours after 1st dose my left arm tingled like it was asleep. Then my hands and feet started tingling as well. My arm tingling stopped after a few minutes but I have tingling in my fee quite often.  12 hours after 2nd dose I got a fever, 17 hours after I threw up and had a the worst headache, 21 hours after I still had a fever headache nausea and I passed out. I started to feel a little better 30 hours after my 2nd dose, but was sluggish for another 2 days. Then 2 days after the tingling in my feet came back and is almost constant.
Patient was sitting down on the phone talking with his wife after his vaccination with Janssen at 11:47am. Another patient heard his phone drop and saw the patient fall back in his chair. The patient later stated that he suddenly felt as though someone were trying to kill him. Staff were alerted and responded immediately.  It was then about 11:53,  five minutes after vaccination. The patient did not fall out of his chair. A code was called. Patient appeared to be unconscious, seizing in his chair. This lasted until about 11:54 when the patient was able to sit up again, was hyperalert, and muttering to himself. He asked for water and appeared diaphoretic and frightened.  He soon calmed down enough for his vital signs to be checked at 11:57 [BP119/69, HR: 53] He said he felt better and was given water.  Patient reported that he had taken no medications that morning and that he had no history of seizures, although he stated that his mother told him he had seizures as a child. He had eaten some bread and milk that morning. Patient drank two juice packets and one and a half water bottles. He stated that he had been feeling nervous about the vaccine,  but was feeling better. Patient's vitals were checked again at 12:03pm [BP:123/72 HR:56]. Patient called his wife to update her. Patient was kept another 30 minutes with his blood pressure (BP) and heart rate (HR) checked periodically; at 12:12pm [BP:118/75 HR:58], 12:17pm [BP:112/61 HR: 64], 12:22pm [BP:117/68 HR:60], 12:28 [BP:110/69 HR:65], 12:32 [BP:110/67 HR:59 Temperature:97.3 degrees F and O2 saturation:99%]. Patient stated he was feeling well and was permitted to leave.
Confirmed Breakthrough Case   COVID-19 (Janssen) 1  03/12/2021  Janssen 1802068   COVID-19 (Janssen) 2  12/17/2021  Janssen 211D21A
Improperly stored vaccine involved in a temperature excursion was administered to a patient.; No additional AE reported; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, which was improperly stored and involved in a temperature excursion (Product storage error). The patient received 1 unspecified dose, lot # W006595, with an expiration date on 10-OCT-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  The dose of b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to a temperature excursion of 57.49 degrees Fahrenheit (°F) during a time frame of for 1 hour 45 minutes. No adverse events were reported.
Headache and fatigue 24 hours later. Continued extreme fatigue/brain fog through present (13 days later). Red ?rash like? irritated skin on face and neck which is exacerbated by touching/rubbing, this appeared suddenly at day 10 and is still present. Sore throat, chills starting day 11 thru present.
Initial report received on 20 October 2009 from a consumer who is a health care professional. A 47-year-old female patient, who has allergy to Codeine, had received a dose of FLUZONE (lot number unknown) two weeks prior to 20 October 2009; and subsequently received a right deltoid dose of H1N1 (lot number unknown) on 16 October 2009. Concomitant medications included IMITREX; "Amitryptyline", and SYNTHROID. The following day after receiving the H1N1, the patient experienced pain in both legs from her hips to feet, which persists. The patient required medical attention; however no relevant diagnostic tests or laboratory data were performed. It was not reported whether the patient received any treatment. It is worthy to note the patient indicated that she experienced the "same" type of adverse events with prior flu vaccinations; however the dates of administration, trade names, manufacturer names, lot numbers, routes and sites of administration were not reported for those vaccines. At the time of this report, the patient had not recovered. Documents held by sender: None.
One hour after receiving influenza injection client described a dull ache that radiated down to her elbow with occasional shooting pain to the 5th finger. Denies shoulder pain. Encouraged follow up with primary care if symptoms do not resolve. Client has been taking anti inflammatory medications, icing, and using topical ICY/HOT. Spoke with client 10/4/18 and 10/8/18. Client states slow improvement with good range of motion but states it is weak. Client states she will make appt. for exam this week if pain does not improve/resolve.
doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022; No Adverse event; Administered 3 doses that experienced the excursions; Patient received 0.25 ml as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No Adverse event) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Aug-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 22-Aug-2022 at 10:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions) and UNDERDOSE (Patient received 0.25 ml as a first dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022) and UNDERDOSE (Patient received 0.25 ml as a first dose).    No concomitant medications were reported.  Vaccine was stored in fridge at the time of excursion. The maximum temperature reached was 52.8 Fahrenheit and the excursion duration was 8 days, 16 hours, and 30 minutes. on 22-Aug-2022 the vial was moved from freezer to refrigerator and vaccine was stored in fridge as of now. Total 3 doses were impacted from the vial. A total of 3 doses were administered with no previous excursions. On 05-Sep-2022 fridge died, ever since the fridge went out of range that past weekend and no doses was administered. The temperature went up to 70 degree and the vaccine in that fridge were moved to another fridge.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Follow Up received included- Case became valid. Patient information, Dosage information updated. On 15-Sep-2022: Non Significant follow up appended
one day of fever found to have elevated inflammatory markers, LV dysfunction (now resolved), elevated troponin and ST elevation in EKG concerning for myopericarditis. Admitted to hospital.  No documented fever in hospital, no rash, no GI symptoms, no other criteria met for MIS-C. Unclear etiology of myopericaraditis.
0935 Employee is taken into the back to receive Pfizer booster. Employee is asked if she is currently having any Covid symptoms. Her answer is "No".  Employee is asked if she has had any reaction to her previous two Pfizer shots she said yes. Employee does have a history Asthma. Her reactions are SOB, lightheadedness, rash to her face and neck. Per her PCP she is cleared to receive the Pfizer booster. At 0935, employee was given Pfizer gray cap booster shot Lot#FK9893 to her left deltoid. At 0952 employee starts to feel lightheaded, with mild redness to face and is having chills. Employee is still alert oriented x3 with mild distress but as able to drink water with no issues.  Per protocol Epi Pen is nearby to administer. Vital signs are taken and they are 142/90 with HR of 116bpm. At 0953 transport is called to pick up patient to help transfer to the ER.  Rapid Response is called at 0953. Rapid response team arrives at 0958 with report given to RN  and is taken down alert and oriented with mild distress at 1005.
Narrative: COVID infection following COVID vaccine series 07/15 Janssen, dose #1 12/30 COVID swab, result: detected 12/28 pt cc: Itchy, dry throat exposure: unknown 12/30 pt admit to ED cc: Itchy, dry throat dx: COVID 19 LOS: 1 day
I felt warm feeling in left arm at injection site. minor pain in arm just after injection. pain in arm increased later in the evening. The following morning no pain felt in arm . Moderate pain felt at top of left shoulder to neck.  Decreased ability to  fully  raise left arm  and decreased range of motion in left shoulder.
An extensive,  very itchy, burning rash rash on my back, abdomen and hips. some scalp involvement.  Lasted several weeks, still not totally gone.  Treated with two rounds of cortisone...Punch biopsy indicated a reaction to a drug.  No new drugs in several years other than the vaccine.
Pt's mother reported diffuse rash and edema in pt's L thigh on 8/17/21, approx. 1 day post-vaccination. Pt's mother had given pt Children's Benadryl, topical Hydrocortisone 1%, and iced the area twice before being seen in office. Per pictures taken by mother of injection site, pt's thigh was grossly swollen and erythematic prior to bring seen in office. Minor pinkish-red hue of skin on exam and pt reported some minor itching and painful to touch.
Information has been received from a registered medical assistant concerning a 13 year old female with no pertinent medical history, who on 30-JAN-2007 at 3:00 pm, was vaccinated in the left arm with a first dose of Gardasil (lot # 654389/0961F). On 30-JAN-2007 at 3:00 pm, the patient experienced a brief syncopal episode. The patient was monitored in the office for 10 to 15 minutes vital signs were reported as normal. Subsequently, the patient recovered from a brief syncopal episode and patient was left with her mother who is a registered nurse. Additional information is not expected.
Information has been received from an RN concerning a 65 year old white male pt who was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent IM in the right arm and  also a 2nd dose of influenza virus vaccine IM in the left arm. Later that same day, the pt presented with a reaction at the injection site where pneumococcal vaccine 23 was administered that consisted of "a little redness, swelling and tenderness." The pt was advised to take Tylenol and apply ice to the involved area. Follow-up information from an RN reported that subsequently the pt recovered.
Arm swollen; Arm red; Injection site hot to the touch; redness is growing; Itching at the injection site; Arm hard; Pain at the injection site; A red bump; A spontaneous report  (was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little pain at the injection site and had a red bump. The patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch.  The patient had no medical history and was taking Calcium, Vitamin E, Zirtec, Glucosamine, Turmeric as concomitant medications.  On 15-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:027L2A) in the left arm for prophylaxis of COVID-19 infection.  On 15-JAN-2021, the patient experienced little pain at the injection site and had a red bump. This symptoms subsided in two days. On 22-JAN-2021, a week after vaccination, the patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch. The symptoms are not ongoing, but the redness was growing.  Laboratory tests were not provided. The patient applied cool pads and a cream with Mometasone 0.1% to the zone. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of most of the events was resolving, but the redness was growing . The reporter assessed the events (little pain at the injection site and had a red bump. The patient felt an itching at the injection site, swollen arm; hard and red and the injection site was hot to touch) as related to the study drug.
3-5 min /p vax pt fell to floor and had flailing movements of arms and head per mother, bp 118/82
It started with sensitivity to smells and then having my first anaphylactic reaction was in July to spray paint and I had to use my EPI-PEN. 911 was called and I had to go to the ER. The sensitivity to smells increased. The next time I had to use the EPIPEN was in October and the reaction was to cologne, and the next reaction was to cologne as well in November. The sensitivity is continually increasing and disrupting my life. Anytime I start having a reaction I have to stay home and use my inhaler or breathing machine and rest. It will also give me a cough and irritated throat, physical exhaustion, and it effects my breathing and asthma. I have had to call off work numerous times for reactions, more than the 3x listed. My life has drastically changed, I only go to church and home because I try to limit my interactions with things. I am a triage nurse and frequently have to call out because sometimes I lose my voice, or a bad cough and am unable to speak on the phone. This is happening at least twice a week that I encounter things that cause me to react. I am frequently using my albuterol inhaler and BENADRYL. The main triggers that have the biggest reactions are cologne, spray paint and cigarette smoke. I've purchased a ventilator and a particle safe mask to help lessen the smaller attacks. I went to see my pulmonologist and my asthma has been ruled out as primary factor. I have an appointment with an allergist in March.
Severe abdominal cramps.  thought to be appendicitis. Severe nausea, heart burn, dizziness, loss of appetite. The only thing that has subsided is the severe abdominal cramps. Diarrhea at first then constipation.  Continued nausea and dizziness.
Three phfizer covid vaccine shots, this is my first with Moderna, on the morning about 1130 am after shot - feeling suddenly queasy intestinally, stomach hurting, feeling very ill - as if more and more to faint (as if circularly going down a drain).  I made it to the clinic, asked to be let down, after sitting, to lay on the floor with my knees up.  Was very very close to fainting.  BP was low 101/69, and so on as per nurse, sugar at 115.  I was sent to the hospital via ambulance.  Was tested, saline solution in arm.  Was sweating as per nurse and looked grayish.  The night of 04NOV22 was urinating almost every ten minutes all night long.  On day 07NOV22 (return to work), BP was found somewhat high.  150 over 79?.  This is not normal BP for me.
Fever, rash all over body, cries all day and has symptoms about 1 week.
We had a nurse here giving vaccines and despite us processing the rx for flublok he gave the patient fluzone HD by mistake. He mixed up her vaccine with her husband's vaccine (who was over 65). He caught his mistake after and husband received correct vaccine. No adverse events have been reported by patient and she was notified of the mistake.
I was given a shot very high on my upper arm near the shoulder bone. Left upper arm became very sore, as with most flu shots. This is the most sore I ever felt however; and it did not go away after several days. This pain has lasted for over 7 weeks. It is much greater at night, with stiffness setting in during my sleep. Pain at waking up is extremely great. I cannot move it or lift anything at first; gradually I am able to move it and do weight-bearing activity as I keep moving it. Soreness diminishes with heat and movement but does not go away completely. It is worse with extension-type ROM movement; e.g. moving left art across to right side of body.
2/12/09 - tiredness from 14:00pm - 14:30pm. 2/17/2009 headache @ 15:00pm, took two TYLENOL gel capsules @ 15:00 pm, Sx resolved by 15:15 pm or 15:20 pm on 2/17/09.
patient became dizzy, nauseas and developed a migraine. She had similar reaction with prednisone. Admits to episode of vomiting
Patient received flu vaccine. Was with husband. Left and did not state any issues at that time. Her and her husband came back to the pharmacy stating she passed out. She did not fall, her husband caught her. She urinated herself while passed out. She stated she has a fear of needles but has never passed out. She was sweating. Gave her a cold cloth for face. Sat with patient for about 10-15 minutes. Offered twice to call abulance, husband and patient refused. Husband was going to take her home and monitor. Called husand 1 hour later and patient was home, showered and doing well.
I26.99 ACUTE PULMONARY EMBOLISM 5/22/2022 HYPOTENSION I95.9 HYPOTENSION 5/22/2022 HYPOTENSION R57.1 HYPOVOLEMIC SHOCK 5/22/2022 HYPOTENSION