chrisvoncsefalvay/vaers-outcomes huggingface dataset:
only gave one component; only gave one component; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 3rd November 2021, the patient received Menveo. On 3rd November 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, medical assistant (MA) only gave one component that is liquid portion of Menveo was administered without being reconstituted with the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No information provided regarding patient, date of administration of Menveo/date of onset of adverse event.  The reporter reported that, she was calling on behalf of the nurse (data listed under HCP details) and had no additional details about the adverse event. The reporter did not have patient permission to provide additional details and she did not have the lot number available. She did consent to follow up from safety via email.
This spontaneous report was received from a pharmacist and refers to a 66 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2017, the patient was inadvertently administered an expired dose of VARIVAX lot # L013068 with expiration date of 14-APR-2017, subcutaneouslly, for prophylaxis (strength, dose and frequency were not reported) instead of the intended dose of ZOSTAVAX (strength, frequency, lot/batch # and expiration date were not reported). The VARIVAX was diluted in sterile diluent (DILUENT MRK). There was not a temperature excursion. No adverse effects were reported.
tingling in tongue, felt that throat was closing. Given Benadryl 50 mg po, Solu Medrol 125 mg IV and observed for 2 hours in the ED.
On April 6th at 8:30am, wife noticed her husband had facial drooping and slurring of speech, and left hand weakness. He was taken to Hospital. Upon arrival a CT was performed, in which it was confirmed a right middle cerebral infarction. He was then transfered priority to a Hospital for a thrombectomy by Dr. This was successful in removing the clot. He spent 3 days in ICU and then moved to progressive care. Pt is on his 13 day in the hospital where he is no longer able to care for himself.  He now has behavioral disturbances, aggitation,  confusion, delium, halluciantions. He is under Psychiatric care, physical, occupational, and speech therapy.
1. Chills, low grade fever, light-headed: duration approximately one hour. 2. Headache: duration one day. 3. Redness, warmth and lump with extreme soreness started on 07/15/2014 and lasted 5 days with daily improvement. 4. Pins and needles feeling on very small area of back behind right shoulder started on 07/18/2014 and is still there but improved and currently very slight--noticed while taking a shower--felt when water touched area--very strange sensation but no break out.
My arm was sore on the night I was vaccinated. The next day I woke up with a migraine and I was nauseous. I started running a fever and had tightness in my chest. I also had issues focusing which caused me to not be able to drive. I had to use my inhaler as a result of the tightness in my chest. My arm was so sore I couldn't lift it. This lasted for 24 hours I was feeling really run down. The next day I felt better but I still couldn't lift my arm  it was really sore underneath. This lasted for a few days so I called my doctor and she stated my lymph nodes were swollen. It hurt to wear a bra. I didn't start to feel better until a week after.
Headache, shivers, and shakes for the entire evening of Aug 1. Upon awakening the next day the shivers and shakes subsided. Headache finally went away in the afternoon on Aug 2.
delayed transit of Fluzone Quad 0.5mL pre-filled syringes and administered to a patient, no AE; delayed transit of Fluzone Quad 0.5mL pre-filled syringes and administered to a patient, no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA287365, 2019SA287366 and 2019SA287333 (same reporter).  This case involves a 47 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe, lot: UT6686JA, expiry date: 30-Jun-2020), via intramuscular route in the right arm on 14-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to the incorrect product storage and Product shipment delay.  It was reported that there was delayed transit of Fluzone Quad 0.5mL pre-filled syringes and shipment was to be delivered on 10-Oct-2019 and was not received until 14-Oct-2019 and inadvertently administered to 1 patient prior to being aware of delayed shipment.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
She got her vaccine, was told it would hurt a little, which it did.  When she got home she looked to see where she had gotten.  Just below it she had a lump come out on her arm about a 3" diameter, it was red as a beet.  It stayed there for about 4 days.  On Friday night she felt something coming on her forehead, and on Saturday she thought she had gotten bit by a spider or mosquito and went to the doctor on Sunday morning.  Went to urgent care and the doctor there saw her and she said that she had shingles.  She asked how could she get shingles when she just got her vaccine.  She was told that the vaccine possibly could have caused it, but didn't see how.  She was then sent to Hospital to have an Ophthalmologist see her eye as it was coming on her forehead, down into her eyebrow, down on the left side of her nose, down around eye, underneath her eyes and in her temple area.  She can tell it's part of the shingles, and is trying not to touch her face.  She did have shingles back in 1990 and asked if she should take the vaccine due to that.  She was given Valacyclovir to take 1 by mouth every 8 hours for 7 days, and picked it up at the drug store and has been taking it ever since.  The symptoms are not getting any worse, and they are not opening up, feel like it's under the skin and one area on her nose is trying to open up and hoping that it does not.
About 24 hours post vax, the pt complained of fever, myalgias, arthralgias, pain and rash at injection site. No wheezing, no throat irritation, no shortness of breath. Fever of 101, erythema, confluent elevated rash at injection site, no fluctuance. Treated with NSAIDS and Benadryl.
A few hours after immunizations nausea, Temp 101. Some tingling in hands and feet. Pain Rt. arm and tender to touch. Slight swelling. Fever, tingling resolved by 6/15/17. 6/16/17 still not feeling well, appetite improving. Fever resolved 6/16/17, still fatigued. Couldn't move Rt. arm for days. Warm to touch, not red. Headache resolved 6/19/17.
Patient became hypertensive and developed rash on chest up her neck. no oropharynx swelling or SOB. Benadryl 50 po.
Have edema in his throat/Have swelling his throat; Have edema in his esophagus/Have swelling esophagus; he has not been able to eat or drink normally; Not been able to eat or drink normally has lost 40 pound; Developed a welt at the injection site the size of a baseball; Feeling very nauseous; Feeling sick; This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   Concurrent medical conditions included tooth infection. Concomitant products included amoxicillin + clavulanic acid (Augmentin).   On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2021, immediately after receiving Shingrix, the patient experienced injection site wheal, nausea and feeling unwell. In August 2021, the patient experienced throat edema, esophageal edema, swallowing difficult and weight loss. On an unknown date, the outcome of the injection site wheal, nausea and feeling unwell were recovered/resolved and the outcome of the throat edema and esophageal edema were not recovered/not resolved and the outcome of the swallowing difficult and weight loss were unknown.   It was unknown if the reporter considered the injection site wheal, nausea, feeling unwell, throat edema, esophageal edema, swallowing difficult and weight loss to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient received Shingrix in his left arm.  Soon after receiving the injection, he reported feeling very nauseous and sick, and he developed a welt at the injection site the size of a baseball. These symptoms last 3 days before resolving.  The reporter then stated that about one week after the vaccine, he began to had swelling and edema in his throat and esophagus and described his throat as a riverbed of rocks. He stated he had not been able to eat or drink normally since then and has lost 40 pounds.  The patient had an appointment for a GI (gastro-intestinal) exam later this week.  The reporter stated at the time of the Shingrix vaccine he was also suffering from a tooth infection and was being treated with the antibiotic Augmentin.  The patient reported the swelling of his throat and esophagus were the worst from the months of October through December and are still unresolved.  The patient stated that he would not be taking the second dose of Shingrix due to the adverse events experienced. The reporter consented to follow up.
Extreme tiredness and disorientation. Went to sleep early and slept for 15 hours. On the night of 11/14/2012 I woke up at 2:00 AM in extreme pain in my jaw and gums and teeth. It hurt to eat, drink or talk. I made an emergency appt with a dentist who sent me to another specialist to get a root canal. The specialist said that I didn't show any need for a root canal. He gave me a prescription for Aspirin and sent me away. The pain did not respond to the Aspirin. I was unable to eat for 3 days. I saw my doctor on 11/17/2012 who noticed that I had the HEP B vaccine the day before the symptoms appeared. My doctor prescribed pain medications and recommended that I report my adverse experience.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted for a few seconds while sitting in observation for 15 minutes. almost 15 minutes had lapsed and fell to the floor. bumped head mildly on the groud. immediate response. a little disorientated. gave water and granola bar. pt did not drink or eat anything all day . sat for 30 extra minutes and felt better. advised to check with md.
PATIENT STATES THAT HER ARM HAS BEEN HURTING EVER SINCE SHE RECEIVED VACCINE AND IT IS NOT GETTING BETTER.  PATIENT FELT LIKE IT WAS ADMINISTERED HIGH ON THE ARM.
Lymph node swelling on the side of her face on right side; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling on the side of her face on right side) and TENDERNESS (Tenderness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 28-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling on the side of her face on right side) and TENDERNESS (Tenderness). At the time of the report, LYMPHADENOPATHY (Lymph node swelling on the side of her face on right side) and TENDERNESS (Tenderness) outcome was unknown.            Concomitant medications were not reported. Treatment information were not provided.
Client was fully vaccinated with Pfizer Covid vaccines on 4/2 and 4/23/2021.  Developed Covid symptoms on 8/9 and tested positive with rapid test on 8/10.  Symptoms mild.  Reported as a breakthrough Covid case in a fully vaccinated person.
Before the vaccinations, patient showed no signs of seizures. Approximately two weeks after vaccinations, she experienced seizures involving severe jerking of head and limbs and crying. CRNP prescribed KEPPRA 100 mg/ml. She continues to experience at least four seizures a day. This limits her ability to progress in normal development because the seizures tire her out.
pt recv vax & w/in 8hr post vax pt exp fever;pt exp n/v & shaking which were intermittent;anti-nausea med was recv in ER; sx resolved in 48hr;
Information has been received from a physician concerning a 25 year old female patient with no medical history or allergies, who on 25-APR-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included Zovia 1/50E. It was noted the patient received the vaccine at another practice. On 18-MAY-2007, the patient experienced numbness in the left leg which spread to the left foot. The numbness has since spread to all of her extremities. The numbness was sporadic and there was no pattern to the numbness. The patient was examined by an internist (name unspecified) who has ordered blood tests (unspecified). At the time of this report the patient has not recovered. No product quality complaint was involved. The internist suspected that Gardasil may be responsible for the numbness. Additional information has been requested.
5-6 hours after Td, developed fevers and right arm swelling, erythema and pain at injection site. Arthus-type reaction.
Minor arm pain, stomach pain, ears feeling full, throat feeling scratchy, neck pain, pink rash on neck, arms, trunk, inner thighs, feeling clammy, hot and cold sweats, foggy feeling in head.
Feeling a bit woozy, not quite dizzy, but like i am on some heavy medication or my blood pressure fell suddenly and too much. My blood pressure that i just measured is 100/67 with puls 65 - which is not unusual for me, (my standard blood pressure is about 96/65), but this is after a coffee too and a 32oz water.  I can't focus easily if i am turning head from side to the other, takes like a second or so to stabilize gaze.  The same thing happened with the first doze of vaccine i got. It got better the next day.
Bumps or red round blister all over his forehead and left side of the face; Bumps or red round blister all over his forehead and left side of the face; Been running a fever around 101.5; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 16th March 2020, 10 days after receiving Shingrix, the patient experienced fever. On 23rd March 2020, the patient experienced blister and erythema. On 22nd March 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the blister and erythema were not recovered/not resolved.   It was unknown if the reporter considered the fever, blister and erythema to be related to Shingrix.  Additional details were provided as follows: The patient had been running a fever around 101.5 degree F; Yesterday (22nd March 2020) was the last day with the fever. Today (23rd March 2020) he started noticing bumps or red round blister all over his forehead and left side of the face. He's been tested for coronavirus as well. Patient said all tests came out negative. Consented to follow up.
Started running, body aches, chills and experiencing extreme fatigue about 11 hours after injection.  Took Tylenol and drink plenty of fluids.  Reports being sick for about 48 hours.
Patient was administered 0.25 cc of the 6-11 yo Moderna vaccine, this resulted in the patient receiving less than the intended dose
The patient showed several signs of a dairy allergy immediately following his second DTaP vaccine (Brand used was Sanofi Pasteur).  His first bowel movement following his second DTaP vaccine was drastically different than normal.  He had been exclusively breastfed, and up until this day his bowel movements were completely normal.  Immediately following the vaccine, he had diarrhea that was green, had mucous in it, and smelled extremely bad.  Normal breastfeed bowel movements are yellow-ish, don't have much of a smell and don't have a mucous consistency to them.  Before this DTaP vaccine, his skin was completely clear of any eczema, rash, or redness.  Immediately following this injection, his skin broke out in a red, bumpy rash.  His face was the portion of his skin that was the most red and bumpy.  The rest of his body was covered in these small bumps, but weren't as red as his face. Each time he would nurse, his face would get more red.  He also began spitting up an excessive amount following this vaccine.  He spit up before hand, but after the second DTaP vaccine, his spit up increased in frequency and volume.  His spitting up would continue from one feeding to the next (three hours lapsed between daytime feedings).  After two weeks of these symptoms showing no signs of dissipating, I consulted patient's physician and he suggested taking dairy products out of my diet to see if he had a dairy allergy. I stopped eating all dairy products and after about a month, I saw cessation of all of the above listed symptoms in patient.  I re-introduced dairy into my diet to see if the symptoms would return, and they did immediately.  After discontinuing dairy products again in my diet, his symptoms again stopped.  He has not had any blood work done to test for a dairy allergy, but I believe it has been confirmed from this trial and error of removing and reintroducing dairy into my diet.  My suspicion is that the casamino acid in the Sanofi Pasteur DTaP vaccine is what caused his dairy allergy.  There is no history of dairy allergies in his immediate or extended family.
Expected systemic immune response with fever, chills, skin sensitivity starting 12 hours post-vaccination and fully resolved by 48 hours after (this is not the adverse event). at 72 hours after vaccination, development of Lipschutz vulvar ulcers. Pt has a remote history of this but not since adolescence. She had no other ongoing symptoms post-vaccination aside from the ulcers. These are still present at the time of reporting (1 week post vaccination).  Unlikely to be a vaccine adverse event per se, but a result of the intense immune response mounted as an expected response to the vaccine.
Sore swollen arm, edema to left armpit, swollen supraclavlicular lymph node onset 2 days post vaccine
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages and genders. On an unknown dates the patients were vaccinated with GARDASIL (route, dose number, dosage and lot number unknown) that was improperly stored. No adverse effects were reported. The physician also reported that improperly stored PEDVAXHIB (MARRS no. 1410USA006928) and VAQTA (MARRS no. 1410USA006929) were also administered. This is one of three reports on the same reporter. Additional information has been requested.
At 1:35 pm on 11/17/00, this patient arrived to the health dept complaining of hives and itching of the upper torso. Symptoms progressed. The itching intensified, restless. Complains of throat discomfort. Wheezing noted. The patient was transported to the ER via rescue unit. She received Epinephrine, Benadryl, breathing treatment, and Prednisone.
Stomach pain  diarrhea  unstable heart rate.  Low blood pressure  extreme body sweats  loss of consciousness
achy; feverish; headache; fatigue; warm body; soreness in the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received either the 10th or the 15th of March 2020, please refer the case US2020AMR140069).   On 21st July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 12 hrs after receiving Shingrix, the patient experienced pain, fever, headache, fatigue, feeling of warmth and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, fever, headache, fatigue, feeling of warmth and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pain, fever, headache, fatigue, feeling of warmth and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received the 2nd dose at 4:00 pm. The patient experienced same soreness in the arm. All symptoms presented approximately 12 hours following the administration of that dose. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR140069:1st dose
Case number PHEH2012US007900 is an initial spontaneous report received from a nurse on 06 Apr 2012. This case refers to a patient of unspecified age and gender. This patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on an unspecified date. The reporter stated that they recently discovered an extra MENVEO MenCWY liquid conjugate component vial in the fridge and suspected that this patient was only administered a 0.5ml intramuscular dose of MenA reconstituted with an unknown diluent. The patient information and date of administration were not known, since they were investigating who received this dose. No adverse events have been reported since vaccination. No other information was available.
The patient was administered an undiluted dose of the Pfizer pediatric vaccine in the left deltoid at 11:24 AM. The patient was then monitored for 15 minutes after administration of the vaccine. During the 15 minutes, the patient showed no signs of distress and continued to do so upon leaving.  At departure, the patient showed no signs of distress and was alert and oriented x 4.
Information has been received from a physician referring to a 2 to 3 weeks old male patient. The patient had no medical history or drug reactions/allergies. On an unspecified date in 1999, the patient was vaccinated with his first dose of RECOMBIVAX HB (dose, frequency and lot# were not reported). Then, on an unspecified date in "February of 1999", he received his second dose of RECOMBIVAX HB (dose, frequency and lot# were not reported). There was no concomitant medication. Then, on an unspecified date "3 to 5 days later", the patient developed erythema multiforme. Then, on an unspecified date "a couple weeks later," the patient recovered. The patient also developed respiratory syncytial virus on an unspecified date "at 2 to 3 weeks of age". The patient recovered on an unspecified date. The patient sought medical attention via seeing a physician. No lab diagnostics studies were performed. Causality was not reported. Action taken with RECOMBIVAX HB was not applicable. Additional information has been requested.