chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion involving a punctured IPOL with no reported adverse event; patient received the punctured IPOL post excursion with no reported adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA119943, 2023SA120330, 2023SA119961 and 2023SA119126.  This case involves a 2 months old male patient who received the punctured IPOL post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13), Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP), HIB VACCINE (HIB) and Rotavirus vaccine for Immunisation.  On 30-Mar-2023, the patient received 0.5 ml dose (1x) (dose 1) of suspect IPV (VERO) Suspension for injection (strength: standard) of lot V1B901M and expiry date: 02-Jun-2024 via intramuscular route in unknown administration site for immunization.  On an unknown date, a punctured IPOL underwent temperature excursion with no reported adverse event (product storage error) (unknown latency).  On 30-Mar-2023, the patient developed a non-serious event of patient received the punctured IPV (VERO) post excursion with no reported adverse event (poor quality product administered).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.   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 the guidelines. 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.; Sender's Comments:  US-SA-2023SA119943: US-SA-2023SA119943:
Sudden death due to heart event while at the beach at 7:00 am in the morning. CPR performed for an hour. Heart could not be restarted as my husband had the event in the water.
Minutes after the vaccine, C/o throat feeling dry and SOB. NO Diaphoresis. Breathing does not appear to be labored. Iv was started as a precaution.  Pulse oxygen was 100%. NO meds given on scene. Taken to ED to be evaluated.  Believed to be anxiety related.
Information regarding Prevnar ( pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a nurse regarding a 4 month old female pt who received possibly improperly stored Prevnar and developed hives all over the body. The pt received the 2nd dose on 12/06/04.  Event Details: On 12/09/2004, 72 hours post immunization, the pt developed a rash, described as hives all over the body. The hives were reported to be "not raised". The nurse stated that Prevnar vaccine that was administered "arrived later than expected and was stored at unknown temperatures before  it was received on ice". The patient was prescribed Benadryl as needed for the symptoms. As on 12/13/2004, the condition of the pt was "unknown". Information regarding this event has been forwarded to Merck and Aventis, manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report.
Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 06/17/2021. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be revaccinated.
5 days after receiving 2nd dose of vaccine,  sudden onset vertigo, nausea, "pulsing sensation" through body, sensation of increased heat without fever and  muffled hearing . Lasted approximately 12 hours then subsided completely.  I was unable to function at my work (evening and overnight shift)
Patient was given two separate injections of 0.3 ml of Pfizer covid vaccine in the same arm.   Date: March 27,2021   Time: around 1315
Delayed localized reaction at injection site.  Started feeling a slight itch at the injection site exactly 7 days after receiving vaccine. By the 8th day(today) it is red and swollen, with a burning sensation. At this time the redness and swelling is 4 inches in height and 2 inches in width.  l had no  previous reaction at the site of injection besides the usual pain after the first and 2nd day.  I am applying  hydrocortisone  3-4/daily.
I got a big red rash by the injection site that stretched to about my elbow. It was red, raised, hot and very sore.  I also had a low grade fever about 100 degrees.
"Full blown seizure" preceeded by hives, dizzness, chest tightness within 20 min. of inject. Was admitted to hospital /w supportive IV therapy. Pt states to have 2 more seizures since then, most recent 09Sep90 /w unconsciousess, twitching
patient c/o dizziness, nausea, chills, congestion. denies stomach pain. states recieved J&J vaccine this morning symptoms started after receiving shot.
At 9:00 pm, I started feeling light headed. I went to bed. Friday at 5:00 am  I had a headache, chills, and fever of 101.4. Shortly after this, I vomited. Had to miss work. Slept most of the day. Still had fever Friday pm. Vomiting multiple times on Friday. Saturday am no fever, but still had a headache and body aches. Sunday still have headache on and off.
This case was reported by a nurse via call center representative and described the occurrence of Guillain-Barre syndrome in a patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced Guillain-Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain-Barre syndrome was unknown. It was unknown if the reporter considered the Guillain-Barre syndrome to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had a history of Guillain-Barre syndrome after receiving an unknown flu vaccine. No additional information could be obtained.
We had spent a weekend with a friend. On Tuesday, 12/13/2022 they said they tested positive. My husband was positive but I was not. I tested positive the next day on 12/14/2022. I had aches and pains and congestion. I was given PAXLOVID and have taken 2 doses now.
Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a health professional. This case involves a patient of unknown demographics who received an expired dose of MENACTRA (lot number not reported via unknown route in unknown administration site) which was expired one month before. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if patient experienced 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. List of documents held by sender: none.
Patient is a 21 y.o. male with no past medical history who got his second dose of COVID (Pfizer) vaccine on Saturday presented with chest pain since Sunday. Patient says that he was in his USOH until yesterday when he started having substernal chest pain which was getting worse with inspiration but also with specific movements. He does have pain even at rest sometimes but he thinks that it's exacerbating by breathing. Had some nausea/vomiting as well. Denies other symptoms. Not really sob or leg swelling.    In the ER, his Trop I was 10.7 and his WBC was 12.2. His EKG was NSR with short PR and STE I, II, III, AVF, V4-V6  Patient is a 21 y.o. male with no past medical history who got his second dose of COVID (Pfizer) vaccine on Saturday presented with chest pain since Sunday with some pleuritic characteristics. He was found to have a very elevated trop I to 10.7, leukocytosis to 12.2 and STE in I, II, III, AVF, V4-V6. His POCUS in the ER was without significant pericardial effusion and probably normal EF. Differential at this point includes pericarditis vs myopericarditis (there are some myocarditis cases reported in Israel post Pfizer vaccination, predominantly in young male patients) vs less likely ACS. Will need admission and further work up and treatment        -Admission to Cardiology -NPO in case team tomorrow decides to proceed to LHC  -Full echo and cardiac MRI tomorrow  -Telemetry monitoring  -Repeat EKG q4h overnight  -send CRP, ESR -trend Trop to peak  -would not start heparin gtt at this point  -Please start tonight ASA 650 TID + Colchicine 0.6 mg BID   21-year-old man admitted with signs and symptoms of acute myo-pericarditis or in the setting of recent COVID-19 vaccination.  He apparently had the findings are vaccine 2 days ago and developed pleuritic chest pain.  His ECG shows pathognomonic changes for pericarditis in the is a small troponin elevation.  He has no past medical history or exertional symptoms to suggest CAD.  Bedside echocardiogram showed preserved left ventricular systolic function.  He was admitted and placed on aspirin and colchicine.  A cardiac MRI today showed evidence of myopericarditis.  He had 3 beats of nonsustained VT on tele.
MMR SHOT High fever for 3 days on May 12, 13, and 14 (104  degrees), very tired, fussy, and irritable
This spontaneous report was received from a medical assistant concerning an adult female patient on unknown age. There was no information about the patient's current conditions, medical history or concomitant medications. On an unknown date the reporter states that a possible intramuscular injection of VARIVAX (lot# N017699 exp 09-JUN-2019) into the deltoid muscle was performed (indication and dose was not reported). No adverse reactions were reported. No further information was received.
The post-injection inflammation made my spinal arthritis go nuts, causing muscle spasms, severe nerve pain, and numbness in my hands. Prescription anti-inflammatory helped.
Redness; Arm was sore; Allergic reaction; Bruise; Burning sensation,irritated,bigger red blotchy rim; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), ERYTHEMA (Redness), SKIN BURNING SENSATION (Burning sensation,irritated,bigger red blotchy rim), CONTUSION (Bruise) and PAIN IN EXTREMITY (Arm was sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced SKIN BURNING SENSATION (Burning sensation,irritated,bigger red blotchy rim). On 26-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction) and CONTUSION (Bruise). On an unknown date, the patient experienced ERYTHEMA (Redness) and PAIN IN EXTREMITY (Arm was sore). At the time of the report, HYPERSENSITIVITY (Allergic reaction), ERYTHEMA (Redness), SKIN BURNING SENSATION (Burning sensation,irritated,bigger red blotchy rim), CONTUSION (Bruise) and PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: An additional document received on 16 Apr 2021 has updated reporter information
administering FLUBLOK to under 18 years of age, instead of FLUZONE with no reported adverse event; Initial information received on 19-Jul-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves Adolescent under 18 years of age and unknown gender patient to whom administering flublok instead of fluzone with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 19-Jul-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, frequency, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On 19-JUL-2022 the patient developed a non-serious  event of administering flublok to under 18 years of age, instead of fluzone with no reported adverse event (wrong product administered) (latency:  1 day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  Outcome: Unknown  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 the 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.
Two hours after receiving vaccine she developed throat swelling, ear and sinus drainage, headache, tightness of chest, voice became hoarse and her eyes became itchy and drained mucus. She went to the local ER and was observed and given Benadryl. Rosacea intensified as well
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
"In my office all morning, started having shortness of breath around lunch time. I then made an appt for employee health and they suggested I leave and get tested"
Loud screeching sounds both ears Tinnitus! Started after 2nd vaccine approximately March 30,2021
Booster for COVID19 Vaccine.  The evening after receiving the vaccine, I began to feel some of the common side effects such as arm soreness, aches, headache, fatigue, slightly elevated temperature (100.3).   I also felt very confused, almost delirium like symptoms.  I was conscious, but felt very similar to the sensations of being drunk.   (Dizzy, walking a little off, very difficult to focus, forgetting where I was although I was home, forgetting who was in the room with me).  I went to sleep after checking in with my roommate and woke up this morning feeling okay, but throughout the day there have been times that I felt off with similar confusion to yesterday.
p/vax pt rt arm swollen; warm & tender to touch at inj site & under arm; can't move arm; pt to MD; cellulitis; tx: keflex; & tylenol;pt was suppose to return for f/u in 1wk; NKDA; attempted to contact
Received flu vaccine 9-22-10 in right deltoid. 1 week later on 10-01-10, noticed rash under right arm, then 1 day later rash under left arm. 1-2 days later rash spread from neck down to calves. Described rash as "little red bumps that are beet red and itches."
metallic taste; tingling up to the eldbows on both arms, chin, back of both legs, mouth; tingling up to the eldbows on both arms, chin, back of both legs, mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste), PARAESTHESIA (tingling up to the eldbows on both arms, chin, back of both legs, mouth) and PARAESTHESIA ORAL (tingling up to the eldbows on both arms, chin, back of both legs, mouth) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DYSGEUSIA (metallic taste), PARAESTHESIA (tingling up to the eldbows on both arms, chin, back of both legs, mouth) and PARAESTHESIA ORAL (tingling up to the eldbows on both arms, chin, back of both legs, mouth). At the time of the report, DYSGEUSIA (metallic taste), PARAESTHESIA (tingling up to the eldbows on both arms, chin, back of both legs, mouth) and PARAESTHESIA ORAL (tingling up to the eldbows on both arms, chin, back of both legs, mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatments were reported.
This 78-year-old female has a history of allergic reactions to ciprofloxacin and latex. She received a COVID-19 vaccine this morning at approximately 11 AM. In a matter of minutes after receiving the vaccine she developed tingling to the left side of her lower lip as well as some pressure in her tongue and behind her eyes.  She reported a sensation like her face was swelling.  She denies difficulty breathing, difficulty swallowing.  There is been no nausea or vomiting.  She was observed in the vaccine area, and then ultimately referred to the emergency department after approximately 40 minutes of symptoms. No chest pain or chest pressure. No rash.
Information has been received from a physician concerning a 22 year old female with anxiety who on 24-SEP-2008 was administered the second dose of GARDASIL, 0.5 mL, IM (Lot# 659184/0843X). On 25-SEP-2008, the patient developed redness at the injection site, blotchiness and red streaks down her entire arm. Subsequently, the patient recovered from the symptoms on 25-SEP-2008. Additional information has been requested.
Rash on trunk feels like like little bursts and then intense itching, burning soreness with red irritations
Pt complained of runny nose, itching and rashes, presented to ER with erythema rashes on the chest, lung clear, no swelling of tongue or neck. Pt treated with Benadryl, Solumedrol, Epinephrine and Tylenol.
This spontaneous case was initially received on 15-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 15-Oct-2015, Batch no:.U59208, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 15-Oct-2015, after starting treatment with AFLURIA the patient experienced Received an IM dose of AFLURIA on 15Oct2015 that was exposed to temperatures up to 48 degrees F for 12 hours/Administered vaccine exposed outside of recommended storage conditions/Medication error, AFLURIA exposed to temperatures up to 48 degree F for 12 hours/Vaccine exposed outside of recommended storage conditions. For relevant test results see appropriate report section. Reporter's assessment. Additional information received on 19-Nov-2015. The patient was 56 years old and female. VAERS ID: 638325.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 01-NOV-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
In the night, pt was whining and had a fever. The next morning, she stopped breathing and turned blue. CPR and was rushed to a nearby doctor's office. She has epilepsy.
Left thigh became very big with redness from "hip joint to knee" per mom-warm to touch.
Pfizer-BioNTech COVID-19 Vaccine  Starting about 3 days after first shot, I began having what felt like severe menstrual cramps--something that I've not experienced ever this far from the beginning of my cycle, as well as severe digestive cramping and upset stomach.
This is a 73 yo male with a history of follicular lymphoma with progressive disease most recently on treatment with Revlimid/Gazyva. He started having fevers at home on 6/11 and tested positive for COVID-19 on 6/15/21. He then presented to SH BWH ER on 6/17/21 with worsening fever, fatigue, congestion, and cough. In the ED he was found to be hypoxic at 80% on room air so he was started on supplemental oxygen. CXR showed hazy opacity along the periphery of the right mid-lung zone suggestive of pneumonia.
Days 1-3: fatigue, aches, night sweats, chills, mild headache, nausea. Continuing for another week, started to have left ear and face pain, left nostril burning, insomnia, anxiety, 12/28 developed shingle or herpes leisons in l nostril! Saw primary care physician on 12/28, prescribed Valacyclclonir 1 gram every 8 hours. Only 2 doses, bad side effects. 12/30 lesions  healing but other effects still present! Developed vertigo on 1/5/2020, lasted 24 hours, headache, night sweats, fatigue, insomnia. Have not had elevated temp or cold symptoms. Just these others, very concerned about this! I have never had shingles before this vaccine!
Patient came into office for 2nd dose of COVID-19 vaccine. Patient had the first dose of Pfizer on 6/25/2022. Patient due for the 2nd Pfizer today 7/25/2022, unfortunately patient given a 0.25mL Moderna dose. No adverse events occurred. Family notified and scheduled for the second dose of Moderna vaccine on 8/22/2022.
A FEW HOURS AFTER VACCINES HE TENSED UP, TURNED RED, ARMS AND LEGS EXTENDED. LASTED 5-10 SECONDS. HE THEN WENT LIMP, PALE, UNRESPONSIVE, THEN STOPPED BREATHING ABOUT 20 SECONDS. BACK BLOWS GIVEN BUT NO CPR. BREATHING WAS THEN SHALLOW. WAS SEEN IN ER AND ADMITTED. LABS NORMAL. NO EKG CHANGES. CARDIOLOGY FELT IT WAS NOT HEART RELATED. VIDEO EEG WAS NORMAL. WAS DIAGNOSED WITH ALTERED MENTAL STATUS + B.R.U.E.
light headed, sore throat, swollen throat, body and muscle aches and fatigue, encouraged to seek medical attention.
axillary lymphadenopathy Narrative: Per pt. report: "After my first shot, I began to develop a swollen lymph node in my armpit. It was extremely painful" As of 1/21/21: "I took the vaccine on 1/8 and it is still sore under my arm pit."
Other than my firstly reported vision issues, I have no developed tinnitus, constant ringing of the ears
Pt experienced nausea/vomiting approximately 10 minutes after vaccination, and again upon arrival at his home.
A non-serious spontaneous report of FLUMIST was administered to a pregnant female in her first trimester was received from a pharmacist concerning a female of unknown age. The patient's medical history, obstetrical history and concomitant medication have not been reported. The patient was in her first trimester at the time of vaccination. On an unknown date in 2010, the patient received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of event vaccine exposure during pregnancy was considered to be resolved.