chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient received improperly stored vaccine; This spontaneous report was received from the administrator from the doctor's office, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 30-OCT-2020, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S027467, which have been verified to be valid, expiration date reported and validated as 02-MAR-2021) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 17.2 degrees Fahrenheit (F) for 1 hour and 30 minutes, as recorded by a data logger. The previous temperature excursion reported was 12.2 degrees F for 1 hour.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA013430: US-009507513-2011USA013420: US-009507513-2011USA013844:
Walked in office about 2-3 PM. Child with temp 103. CBC OK. Blood cultures negative.
Patient received vaccine on 6/5/14 at 3:13 pm. Woke up on 6/6/14 with injection site red and swollen. Patient applied ice and took oral antihistamines. Area measured 6 inches long by 2 inches wide. Redness and swelling improved with home treatment.
Describes left face, arm, leg felt numbness/tingling Had first COVID shot on 12/20/2020 19:36 then while driving home felt L face numbness at 20:37 Went to ED, BP 167/107 "...driving home she states that she developed a strange, difficult to describe sensation when she was swallowing in her car, this started around 8:37 p.m.. She states that her numbness generalized to involve the entire left side of her face on the left side of her body including her left upper and left lower extremity. She denies any weakness. She denies any dysarthria or noticeable facial droop, she does not feel like she is walking differently. She denies any headaches or visual changes, denies any dizziness, chest pain, shortness of breath, palpitations. She states she has never had anything like this before." ED notes had a normal neuro exam POCT glucose was normal at 83 resolved after minutes to hours in ED
Took PREVNAR 13 at 11:00 am and about 3:30 pm got excruciating pain in right leg, unable to walk normally. As of this date have to use cane to walk. MRI, Cat Scan, X-Ray have been taken.
A report was received from a health care professional on 01/06/03, concerning a 2 month old male vaccinee who was inadvertently administered 0.5ml of Fluvirin on 01/06/03. Patient was given the vaccine intramuscularly in his left vatus lateralis. The vaccinee had no previous exposure to influenza vaccinations. The patient will be monitored closely for adverse reactions. There was insufficient information to determine the reporter's causality assessment. Update (1) 01/21/03: A follow up report was received from a health care professional indicating that no adverse reaction was experienced by the vaccinee. The vaccinee's parent was advisted to watch the vaccinee for any serious reactions.
Swelling; Redness; Warmth; Tenderness; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 46-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site tenderness to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Flulaval Quadrivalent season 2019-2020 in left deltoid. The nurse stated that, the patient received vaccine from different vial of same batch number. The reporter did not link this case to product complaint. The reporter did not consent to follow up. This case was 1 of 5 linked cases reported by same reporter.
Narrative: 68yo male patient died of a cardiac arrest at outside community hospital. Pt had received 3 covid vaccines on 2/4/21, 3/5/21 & 11/13/21. This death is not related to covid vaccines.
My arm started hurting a few hours after having the shot. The next day I woke up sore all over and aching. Later that day I was very tired also. Then later I had nausea and a fever of 100 degrees F. It lasted for about 48 hours but my arm hurt for a week.
Patients developed rash 1 day after getting shot went to emergency room and was advised to take BENADRYL. Came to pharmacy on 11/14/11 - mentioning rash to pharmacist - said rash on trunk. Advised pt to take BENADRYL (he had not taken any yet). Patient's chiropractor called pharmacy 11/15/11 at approximately 14 hrs - said rash had spread & was very severe, over trunk, back and legs.
Side effects started the same day I received the vaccine, which were reported on the V-safe app.  Started with very sore arm, within 24 hours progressed to extreme fatigue, joint and body aches, loss of taste and headache. I also experienced some mild nausea. By Wednesday evening, I began to experience heart palpations which I listened to as a nurse which sounded like PVC's. I have never had this happen to me before. I assessed my vital signs and noted that as the arrhythmia progressed, my O2 sat level began to decrease and my pulse began to increase. I could hear a definite pause in my heart rhythm. Within an hour, I had chest pain in the area of my left chest over my heart which progressed into a feeling of pressure as if someone was standing with a foot on my chest. As time went on, this sensation radiated into my back at an angle from left to right. It was at this point that I had my father take me to the emergency room. When I got there, my pulse was in the low 100's and my blood pressure was 230/130. I have never had this happen to me before. I ended up on a nitroglycerin drip. My magnesium level was low and my sodium level was low normal.   I was kept in the emergency room until Thursday evening then transferred to Progressive Care Unit where I remained until early evening on Friday.I was sent home on 2 different cardiac medications, Coreg and Lisinopril. I am to follow up with my PCP and a cardiologist. Both are brand new to me. I am now feeling better, but I am very reluctant to have the second covid vaccine. Also, the Hospital does not know what happened to me. (Facility where I received my Covid vaccine.)
Case number PHEH2013US020558 is an initial spontaneous report received from a physician on 01 OCT 2013. This report refers to a 24-year-old pregnant female patient. She was 23 weeks pregnant when she was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308701) intramuscularly on 01 OCT 2013. After administration, she experienced slight swelling and numbness in the fingers. No medical care was provided till the time of reporting. No further information was available.  01 MAY 2014: Multiple attempts have been made to obtain follow-up information and outcome of pregnancy event without success. This case is considered lost to follow-up.
Febrile seizure with temp to 102.7 without other source for infection, normal CBC, U/A.
I would get dizzy, nausea at times, break out in sweats. I would have to sit down. Once the vaccine was in my system the symptoms would than fade away. I experience heart pain & had to see a cardiologist. In about a couple weeks to a month later; I started to feel awful & went to the emergency room 4 times. Local emergency room.
Patient presented at a mobile clinic for her flu vaccination. When our billing team was processing the claim, we were informed she had already received a flu vaccination for the 22-23 season on 9/6/22. Patient did not require this vaccination. On 2/1/23, s/w the head nurse for the facility. She states patient is doing well and has had no issues or side effects.
Information has been received from a LPN concerning a female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646156/80287N). The LPN reported that the pt subsequently developed cellulitis of the injection site characterized by inflammation of the injection site. Unspecified medical attention was sought and the pt was treated with an unspecified antibiotic. At the time of this report, the outcome was unknown. Lot check results are as followed: The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The LPN also reported that two males also developed cellulitis of the injection site and inflammation of the injection site after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0311USA02604).  Additional information has been requested.
Patient had already received an Influenza vaccination 9/27/2022. She did not require the dose given 11/21/2022. No adverse reaction.
Mom called HD 6/28/07 And reported "bumps all over her body" this am. Denies fever. States child is eating and taking fluids well.  Mother was advised to have the child evaluated by her physcian.  Mother phoned later and state the physcian told her it was a"possible reaction to Hepatitis A since that was the only new vaccine that she had received". She was instructed by MD to use Benadryl lotion on rash and "to keep and eye on her". She was to go back to MD if rash increased.
Information received from healthcare professional on 30 April 2013. This is an invalid case as individual patient identifiers were missing. Cluster of 3 patients (demographics not reported) whose medical history and concomitant medications were not reported; received ADACEL vaccine lot number C4365AA (dose number, route and site of vaccination was not reported) on 15 April 2013, 16 April 2013 and 20 April 2013. On an unspecified date, the patient had experienced swelling at injection site, jaw pain and fever. Corrective treatment and laboratory details were not reported. The patient's outcome was unknown. Documents held by sender: None. Follow up information received from a healthcare professional on 03 June 2013. The patients had recovered from the events on unspecified date.
Right eye inflamed and itchy and painful. Unknown if symptoms are related to vaccine.  Pt only received seasonal flu.  Galyna did not get the H1N1 F/U.
Initial misuse report received from a healthcare professional on 17 April 2013. A second dose of ADACEL was administered to a 4 month old patient. No adverse event was reported. List of documents held by sender: none.
Seeing colors History of reacting poorly to vaccines Mild headache at 11:00am BP 106/80 P 100 Resp 18 O2 97%
Pfizer Bivalent (5-11 y.o.) ordered, accidentally administered Pfizer Monovalent (5-11 y.o.). No symptoms or reactions.
Light-headed, vertigo, fast pulse, high blood pressure over 2 days.  EKG was negative.  Holter heard monitor results pending
Patient arrived to observation room and shortly after called observation RN over to him and reported that throat "feels funny, sore and tight, but not  having difficulty breathing."  RN administered 25 mg benadryl to patient and gave him water to make sure he could swallow.  Patient had no difficulty swallowing benadryl.  At 1240, patient reported no changes. At 1250, patient reported that he was "feeling better."  At 1303, patient left with mom and reported feeling much better- no residual issues.
3 days of right jaw swelling and 2 days of chest/back pain/tightness. Reported feeling as if a "rope was tied around him".
45 minutes after dose I got hot flashes and itchy across chest and arm. Upon inspection arm was swollen. Area roughly 2 inches from injection sir was the size of a quarter. It was hot, red and itchy with a small rash above. Two hours later it increased in redness but itching went down. Still hot and red. The next morning small rash still present with hot, red ?lump?. Extremely tender to the touch. Progressively increased in size to the size of a half dollar. Continued to increase in size over the next 72 hours. 6 days later site is back to the size of a half dollar, red and itchy tender site. Has since reduced from a ?lump? to more flat. Took 599mg Tylenol 1/5/2021 and again 1/6/2021. Unable to take Benadryl due to sensitivity (over sedation) with household and family responsibilities. Sore throat also present for first 72 hours but went away.
Sweaty, dizzy, dry heaves, tired, experienced nausea, site tenderness, swollen and redness about golf ball size and warm to the touch.
Got 3 vaccines on Tues. 11/12 (MMR, Hep B, and Varicella) c/o swelling, redness at injection site apprx. 6-7 cm. c/o itching. Advised cold packs, and Benadryl for itching, Tylenol for pain. RTZ if symptoms or to ER if anapriglaxic symptoms occur. 11/18/2002 Attempted to call pt regarding complaint of red, itchy extremity after receiving immunizations on 11/12/2002. No answer: left message to have pt call me. No response. 11/19/2002 Spoke with pt's mom today. States that pt was not in today, was at work. Mom did however, state that her daughter's arm was better after cold packs and Benadryl p.o. and she didn't go to see an MD. Mom states that her daughter does not usually get home until after 8 pm most evenings if I needed to speak with her directly. No further action taken. Sincerely RN
5/18/21 Assessment: Retinal hemorrhage, left eye. Small preretinal hemorrhage visible over the fovea. Nevus of choroid of left eye. FA shows no evidence of retinal vasculopathy. Most likely due to rupture of a normal macular capillary. Patient has no history of valsalva maneuver or injury. The central macula is obscured by a small transmission defect. No leakage around the hemorrhage. 6/8/21 Assessment: Retinal hemorrhage, left eye. Small preretinal hemorrhage over the fovea seems to be resolving (thin residual reflective opacity at fovea). Monitor again in 4-5 weeks.
injection site pain; pimple at injection site; itching shoulder up to head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching shoulder up to head), INJECTION SITE PAIN (injection site pain) and VACCINATION SITE PAPULE (pimple at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression and Anxiety.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PRURITUS (itching shoulder up to head). On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain) and VACCINATION SITE PAPULE (pimple at injection site). On 09-Jan-2021, INJECTION SITE PAIN (injection site pain) and VACCINATION SITE PAPULE (pimple at injection site) had resolved. In January 2021, PRURITUS (itching shoulder up to head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treatment includes Silver facemask treatment, Cortisone applied QID and Benadryl as treatment medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever 103.5, itching, entire body swollen & red; Seen in Er; MD stated was allergy to DTP; Has since had DT w/o problems & 2nd dose of HIB w/o problems;
Seen by doctor 6-22-07. First noticed swelling 6-21-07 9pm. Arm swollen, hot, painful to touch located around injection site. Given shot of Prednisone on 6/22/07.
This case was reported by a healthcare professional and described the occurrence of nodule injection site in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 8 December 2009 the subject received unspecified dose of ENGERIX B (.1 ml, subcutaneous, right arm). On 8 December 2009, at the time of vaccination with vaccination with ENGERIX B, the subject experienced wrong vaccine administered. Less than one month after vaccination with ENGERIX B, the subject experienced nodule injection site. This is the first of three cases in which a nurse reported the subjects inadvertently received ENGERIX B instead of PPD. ENGERIX B was administered subcutaneously on 08 December 2009. Two subjects returned on 24 December 2009 and one subject returned on 28 December 2009 reporting a reaction of "knots at the site". At the time of reporting the outcome of the injection site nodule was unspecified. Please see cases A0836975A and A0836976A for the additional two reports with ENGERIX B.
This spontaneous report as received from a registered nurse refers to 4 patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Oka-Merck) PROQUAD (dose number, dose, lot # was not reported) which had been exposed to temperature as high as 8.5 F. No adverse effects were reported. This is one of several reports from the same source. 1405USA007382. Additional information has been requested.
Chills for 3 hours followed by fever up to 101.9 for a couple of hours   Tylenol brought it down to normal   lasted abouth 14 hours total
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. Vaccine expiration date was mentioned as 07-NOV-2021
Can?t say if it?s related or not but I?ve been sick for almost a month now so I?m really starting to wonder. Developed cellulitis on my lower right leg on Thursday, was put on Keflex on Friday, then switched to Bactrum on Saturday. By Sunday, the abscess was large and my leg was swollen double the size, red and hot to the touch. I spiked a fever and felt very ill. I went to the ER Sunday night. Was told I was septic and was admitted. Transferred to another hospital on Tuesday. On Thursday, I had surgery to cut out the abscess (I&D). The following Sunday, my right foot and ankle became so swollen and red, another surgery was considered. Miraculously the swelling and redness went down through the night. I was sent home with a PICC line and IV antibiotics - Vancomycin. My Vanco trough kept showing low levels and I?m now on a dose of 1500mg 2x day. I am fatigued, nauseous, constant headache, spiking fevers 1-2 times a day for the last 7 days, my WBC and RBC is very low, I?m considered anemic now, waking up with night sweats when I do finally fall asleep...feels like no end in sight.
Extreme soreness at site of administration the same evening of administration 11/22/19. On 11/23/19 woke up with fatigue, joint pain all over body that limited her movement. Did not take her temperature but felt like she had a fever.
Shortly following vaccination, employee reported tongue tingling.  She had no difficulty swallowing or breathing.  She was evaluated by the physician present at the clinic who felt it might be angioedema.  She was observed for an extended time and cleared to return to work at the hospital.  No treatment was given.
I was told by someone who is monitoring the vaccines to fill out a report using the website on the back of my vaccination card because I had a breakthrough Covid infection even after being boosted. My series was the Pfizer vaccine and my injections were on 4/4/21 and  5/2/21. I did J&J as my booster on 12/9/21. Day 0 of my Covid sx was on the evening of 1/8/22 and my diagnosis was confirmed through PCR testing at a doctor's office. I had not previously had Covid (to my knowledge). My first symptoms were a sore throat before going to bed. The next day, my throat was more sore. I also had a runny nose and then hot/cold flashes, before developing a barking cough which was similar to the chronic bronchitis I had during childhood. The cough lasted for about 2 weeks, even with a steroid inhaler added on, which required me to quarantine for the full 10 days. It also caused worsening urinary incontinence. I had fatigue and additional brain fog, as well, which have lingered and became long Covid (with some shortness of breath when walking, on occasion, but especially up inclines). I recently went through a semi-experimental treatment for the long Covid. Interestingly, I did not infect any of my 4 housemates or any of the 4 other people with whom I had been in close proximity all day, unmasked, on Day 0.
Patient developed COVID -19 about 2 weeks after his first dose.  He is currently at the hospital.  His outlook is grim.  His sister called me today and said they put him on a ventilator yesterday and only giving him 14 days to turn around.
Patient began experiencing tingling and itching of the tongue and mouth roughly 15 minutes following 2nd Moderna vaccine. No issues with 1st dose aside from fatigue and arm soreness. Reported the tingling began on the tip of her tongue, migrating to the base. No throat involvement, full breath was drawn with no issues. Benadryl 25 mg was given orally and patient waited an additional 20 minutes. Swelling and itching of lips as well as tongue began to subside and pt left with intent for husband to drive her home; instructed to seek emergent medical attention if s/sx worsened or returned.
This spontaneous report as received from a physician via a field representative on 06-NOV-2014 refers to a 13 months old patient of unknown gender. On 06-OCT-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K003423, expiration date: 06-MAR-2016) 1 shot, injection in the left thigh for vaccine. Other suspect therapies included VAQTA (strength, dose, route and lot# were unknown) started on 06-OCT-2014 (also reported as on the same date). On an unknown date of October 2014 the patient developed a varicella-like blister at injection site after receiving (Oka/Merck) VARIVAX. No treatment given for adverse event. The outcome of the event was not provided. The reaction was reported to the office of the physician on 17-OCT-2014. Additional information has been requested.
Patient said within 6 hours of receiving shot she had flu like symptoms and a fever over 100 degrees.  Also, stated swollen lymph nodes in her neck.  Patient said fever, aches, and chills lasted about a week.
Continued swollen injection site - redness expanding on 2nd day.   Using ice and Tylenol for pain