chrisvoncsefalvay/vaers-outcomes huggingface dataset:
attempt to vaccinate ID in LFA no wheal with full dose leakage.  second attempt made 2 inches from first attempt in LFA. at least 1/2 vaccine leaked from ID attempt. SQ dose given in LA. Dose given successfully.
Initial unsolicited report received from pharmacist on 30-Aug-2018. This case involves five patients (reported as 18 years old and older) who were vaccinated with a 0.5 ml double dose of vaccine TENIVAC (Batch number, expiration date, route and site of administration was not reported) on 30-Aug-2018 which was expired and had a temperature excursion of 0 Celsius. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage, extra dose administered and expired vaccine used. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
CC: pain and swelling Physician assessment in emergency room: There is a 10 x 10 swelling of the right arm  above the elbow and there was local heat in the area. There  was no sign of infection. Patient was given 8mg Decadron IM and prescribed Decadron to use for the next 3 days
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild
Was given shot 2 days ago. Woke up this am with red rash on arm under the injection site. Rash is itchy and arm is sore. At this point I do not need medical treatment. I am not in any distress other than itchy at injection site.
09feb90 pt vax hepta B.  10feb90 pt ex joint pain esp. in neck, ankles, wrist, and fingers.  pt devel temp of 100 F.  sx remitted but still ex pain in neck.
Swelled up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelled up) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelled up). At the time of the report, VACCINATION SITE SWELLING (Swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNA TX, INC-MOD-2021-084890 (Patient Link).
debilitating pain in arm, unable to raise arm the morning after the vaccine 10/26.  Nausea and lack of appetite the second and third days 26th and 27th  temperature between 100.4 and 101.9 for 2 days after vaccine 26th and 27th and fatigue.  Still have some fatigue and soreness in the arm but no fever or nausea.
Client complaining of pain after injection, some mild redness immediately.  Ice pack applied.  Approximately 18 hours later - area with induration, red, warm to touch.  Ice applied, repeated.
Headache, body aches, fever to 100,5 I took 650 mg acetaminophen and slept for 12 hours. Symptoms worsened about 12 hrs after receiving vaccine and resolved 36 hrs after receiving vaccine.
Patient was given vaccine and had left the clinic. I went to put the shots that was given into my system that's when I notice the expiration day. I in formed my office manager and the doctor of what happen and apologized for it, then I tried reaching out to the parent's. But the number we have on file is not in service, so we though it would be good to mail a letter out.
Patient received a Pfizer dose 2 days after receiving  a Pfizer dose from another agency. Checked data and the previous vaccine wasn't in the registry. Health department gave a Pfizer dose on 4/28/2021, then entered it on 6/9/22021.
little red around the injection site; itching; tenderness in the spot; This spontaneous case was reported by a consumer and describes the occurrence of   in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment provided.  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.   Reporter did not allow further contact; 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.
one time only a fever on 1/9/2021 of 102.0 at 4:51 pm.
About 2 days after the vaccine he just had a cough, congestion, and trouble breathing at night when he slept. He was mildly lethargic and had dark circles under his eyes. It lasted about a week. During that time he had vitamins. I started with Dimetapp and by the end of the week I was giving him pseudoephedrine. I was also providing a humidifier when he would sleep and elevated his head. It took him about a week and he was better.
Triggered increased tachycardia plus arrhythmias beginning 20 minutes after 1st shot and getting worse over 24 hours. 3 weeks after 1st shot continue to have arrhythmias that are interfering with daily life. I have been advised medically to not take the 2nd Pfizer Covid 19 shot
3 days post vax, the mom observed "eyes rolling up into head:" occurs randomly, ongoing. No other changes with child.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/13/21 2nd dose04/03/21 Diagnosed covid positive:07/31/21 Symptom onset:07/27/21 Exposure: Symptoms:cough fatigue,muscle aches, sore hroat, runny nose, HA
Per mom child was not exibiting any signs other than a rash.  Mom opted not to recieve any doctor care until 07/29/2010.
Information has been received from a licensed practical nurse concerning a 21 year old female patient with no medical history and no known allergies who on 21-MAR-2007, was vaccinated IM into the left deltoid with a first 0.5ml dose of Gardasil (Lot# 658490/0802U). On 24-JUL-2007, the patient was vaccinated with a second dose of the vaccine. There was no concomitant medication. On 31-JUL-2007 one week later, the patient developed hives on her legs and arms. The patient was treated with over the counter BENADRYL. On 24-JUL-2007, a urine lab was taken and was negative for pregnancy. At the time of this report, the patient was recovering. It was reported that the patient was instructed to follow up with the doctor's office if any other symptoms arose, such as shortness of breath. No product quality complaint was involved. Additional information has been requested.
Pt suffered Cardiac Arrest and respiratory arrest on 2/9/21 and passed away at a local hospital. He had multiple health conditions likely contributing to this.  he arrested at home and CPR was attempted and unsuccessful. Pt received his Covid vaccine #1 on 1/27/21. No issues were noted after vaccine and was due for his 2nd dose next week. However, we were notified he passed away on 2/9/21.  Very likely death not at all related to vaccine but wanted to document as patient was in the middle of the covid vaccine series.
It started in the evening with my tongue starting to swell. By morning the next day my throat was swollen. I was having trouble breathing. I would've took my EpiPen but it was expired so I drove myself to the ER that morning at Hospital on 4/6/2021. The doctors gave me additional Benadryl but that wasn't working so they gave me a medication intravenously to stop the swelling in my throat.
Mom called in Friday afternoon 3/21/03-about 24 hrs after shots received to report pt had a fever of 101.8 even after Tylenol. She said he hasn't been sleeping and just crying all the time. He is eating OK. I rec. she continued with the Tylenol and fever was to be expected, the crying was not. Pt had thrush and she had planned to take him to MD so I encouraged her to do that. Called Mon. 3/24/03-he is fine. MD felt normal reaction to shots; OK to continue series.
This spontaneous report as received from a medical assistant refers to a patient of unkonwn age and gender. The patient's concurrent conditions and medical history were nnot reported. On 29-AUG-2015, the patient was vaccinated with the improperely stored VAQTA (lot number L009445 and expiration date 01-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional inofrmation has been requested.
Painful oral ulcers within 24 hours, ipsilateral painful tender enlarged axillary lymph node.
Angioedema, bilateral hand swelling, Urticarial rash.  Treated with DEPO MEDROL & PREDNISONE TAPER.
Vertigo; nausea. One hour later still not feeling well-school nurse sending home.
pt states w/in 30-40 min p/vax head, face, chest & neck became bright splochy red & swollen & stinging sensation & thraot itched;pt took DPH;
After my booster vaccine about ten minutes after the vaccine, I had a headache that had been almost immediately that was blinding and body aches as well. Serum Sickness Reaction. These symptoms occurred for approximately 3 months. I reached out to my primary and she gave me another shorter course of steroids. This prescription helped out extremely well however after the two weeks the symptoms came right back and I was dependent on Tylenol which did not help.  Eventually, they have only gone away after the beginning of February.
Rash developed on forehead.  Felt itch on other part of body. Felt hot and prickly.  Took diphenhydramine and subsided within 45 minutes.
Pt was given the regular Moderna booster shot rather than the bivalent booster shot.
flu like symptoms; The vaccine felt like it stayed in my right side (right arm and right leg specifically); Since I started eating and got a lot of sleep; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SENSATION OF FOREIGN BODY (The vaccine felt like it stayed in my right side (right arm and right leg specifically)), SOMNOLENCE (Since I started eating and got a lot of sleep) and CHILLS (Chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SENSATION OF FOREIGN BODY (The vaccine felt like it stayed in my right side (right arm and right leg specifically)), SOMNOLENCE (Since I started eating and got a lot of sleep) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), SENSATION OF FOREIGN BODY (The vaccine felt like it stayed in my right side (right arm and right leg specifically)), SOMNOLENCE (Since I started eating and got a lot of sleep) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. After the first dose the patient had flu like symptoms. Chills. The vaccine felt like it stayed in right side. Right arm and right leg specifically. Since the patient started eating and got a lot of sleep the effects got better. No treatment information provided.   This case was linked to MOD-2022-439232, MOD-2022-439261 (Patient Link).
I?m now 2.5 weeks out from my second dose and the side effects: fever, chills, muscle aches, night sweats are still occurring and still very bad. No end in sight.
lt arm swelling & redness w/soreness started 1wk p/inj;ice, advil, hismanal x 7 days;
Fly like symptoms, fatigue, chills, fluid cough more than usual,  left side pain under navel
Subsequent to receiving one dose of varicella virus vaccine live on 7/24/96 and on 4/15/99, the pt developed a little itchy rash in her peroneal area and small erythematous bump and a few other dotty type lesions. The following day, the pt had other lesions at different stages maculopapular and vesicular. The one in her peroneal region was fluid filled. A total of 25 lesions were reported. Pt was seen by a physician and dx'd with varicella on 4/16/99 and treated with Benadryl for itching and Tylenol for the fever. On an unspecified date the pt recovered from episodes. No further details were provided.
Very painful for 4 months stilll have a lot of pain, putting on clothes, reaching, pulling up pants. Also, can't sleep on side of flu shot. I didn't go to my dr. I knew it was from the flu shot. Take ALEVE at night.
Bodyaches; low-grade temp; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2021, the patient received the 2nd dose of Shingrix. In December 2021, 1 week after receiving Shingrix, the patient experienced general body pain and slight temperature. On an unknown date, the outcome of the general body pain and slight temperature were unknown.   It was unknown if the reporter considered the general body pain and slight temperature to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter asked if it was possible to had side effects a week after getting a second shingles shot. The reporter asked if it was possible to have body aches and a low-grade temperature from the shingles shot a week after receiving the shot. The reporter came to know that safety team like to be informed of any side effects from GlaxoSmithKline vaccination. The reporter was not sure that the thing he/she was not sure if it was a side effect or a cold or exposure to covid, could be anything but he/she thought to check.
Both legs became swollen; Skin on legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both legs became swollen) and PAIN OF SKIN (Skin on legs hurt) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced PERIPHERAL SWELLING (Both legs became swollen) and PAIN OF SKIN (Skin on legs hurt). The patient was treated with SODIUM CHLORIDE for Swelling of legs, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Both legs became swollen) was resolving and PAIN OF SKIN (Skin on legs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   Treatment included sodium chloride, for the adverse event and then the patient was feeling better.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow-up included treatment medication sodium chloride and Event swelling of legs outcome  were updated
pt recv vax 2OCT96 & 22OCT96 pt exp extreme dryness in mouth;woke up two to three times during the noc to moisten dry mouth w/water;
Got the flu shot, got the flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the flu shot, got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch number, expiry date: unknown) via unknown route in unknown administration site for Flu Vaccination. Information on batch number and expiry date was requested.  On an unknown date the patient had a non-serious event of got the flu shot, got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown.
Information has been received from a physician concerning a 16 female who tested negative for High Risk HPV on 06-Jan-2007. On 16-JAN-2007, the patient was IM vaccinated with her first dose of Gardasil (Lot # 653736/0868F). The patient received her second intramuscular dose of Gardasil (Lot # 653736/0014U) on 13-Mar-2007. The third dose of Gardasil (Lot # 653736/0014U) was IM administered on 08-May-2007. A fourth dose of Gardasil (Lot # 653736/0014U) is reported to have been given to the patient on 10-Jul-2007. Concomitant therapy included hormonal contraceptives (unspecified). On 15-JAN-2008 the patient tested positive for High Risk HPV. Subsequently, the patient is not recovered. The patient sought unspecified medical treatment. Additional information has been requested.
Immediately after the vaccination the patient reported not feeling well, a little dizzy, but said it was normal for her. She was instructed to sit in the waiting room for about 15 minutes with her boyfriend. About five minutes after sitting out in the waiting room, the patient almost passed out and had some convulsive like movements. 911 was called. The patient did not loose consciousness, but was extremely pale. She was nausea and almost vomited three times. She reported feeling shaky, and said her throat felt funny. EMS arrived and took over the care of the patient.
Pt admitted 1/18.       Chief Complaint   Generalized weakness x 2 days   History of Present Illness        This is a very pleasant 42yo male with a recent history of new onset DM, diagnosed in  August 2021. Recently, the patient passed out in his work cafeteria and found to have a glucose 700 (1/12/22) and presented to the ER. Found to be in mild DKA and did not want to be admitted. Signed out against medical advice. COVID negative. Represents today with generalized weakness and fatigue. Polydipsia and polyuria. States he is "so thirsty." Found to be in DKA. Given 2L IVF and started on an insulin gtt. Also COVID positive. The patient is on room air and denies any current respiratory complaints. The patient is fully vaccinated.     Unknown covid vaccine date, manufacturer, and location given.
Vaccine given IM in (L) UE. (L) arm became very swollen, warm to touch, painful. She went to the doctor. The doctor gave her steroids (prednisone). Monday morning arm is without swelling & redness.
Patient woke up 10/3 at 730 am feeling really tired. Later had chills, body ache and temperature 101.  Arm swollen golf ball size at injection site.  Saw FNP associated with her work place and sent home 1/2 day from work.  Feeling better 10/4 and 10/5 but not 100%.
Information has been requested from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced fainting. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
patient was given an expired vaccine, lot expired on 10/01. Patient was given vaccine on 10/11 and then patient was contacted on 10/12 to advise patient, patient reported no side effect or unusual reaction. Consulted with patients NP in regards to situation, NP shared guidance on how to proceed with error.
p/vax, pt TDY in Honduras & got sick; pt returned to U.S., seen at FSO-cold symptoms; dx with otitis media,vertigo.
17AUG97 rash began between legs, progressed to all limbs then on 18AUG97 trunk;rash was wheals, raised-pale in center no bluish tinge;dx in ER by MD erythema mult;
On Feb. 9th I got my 2nd shot. After that my left arm was sore. I didn't think anything of it at first. This pain went on for about 3 weeks. I was having shooting and radiating pain down my arm. I am a nurse I do patient care and lift people. I could not lift people up, and now I can't lift my keys, put my hair up. It is very difficult. I scheduled a video interview with my primary care doctor who referred me to the orthopedic doctor. Dr. would not give a MRI, but gave me a X-ray instead and it showed I did not show any broken bones. The ortho doctor referred me to a physical therapist. After not being able to get in with the therapist my arm pain eased a bit. But now the pain has come back. I can't take my shirts off without pain. I do have a little range of motion. I can't put my seat belt on. And at work I have to modify what I do. It has not gotten better it is just kind of here now. Lately the cold has really been bothering me. When I saw Doctor, he gave me a hydrocortisone shot, because it was so inflamed. This was before I started seeing the physical therapist. It helped a lot but, my arm is nowhere near back to normal. I have taken off of work, because at times I cannot function.
Allergic reactions; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reactions). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Allergic reaction, at a dose of 10 mg. At the time of the report, ALLERGY TO VACCINE (Allergic reactions) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-048496 (Patient Link).
Cellulitis diagnosed by the ER but review of chart by me along with other reports of acute cellulitis diagnosed in ER in post vaccinees makes me think most likely scenario is vigorous local reaction.  Clindamycin prescribed.  Swelling started one day after vaccine and extended above shoulder and below arm