chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm redness; Arm swollen; Arm was warm and hot; pain at the injection side (left arm); A spontaneous report () was received from a consumer who was also a 36-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at injection side. arm was warm and hot, arm redness and arm swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A or 011J708) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, in the 24 hours after the administration, the patient experienced pain at the injection side (left arm).  On 05 Jan 2021, the patient woke up with pain in her arm and it was warm, hot, had redness and was swollen. Treatment included antihistamine (not specified). Symptoms were still ongoing at the time of this report.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, pain at injection side (left arm), arm was warm and hot, arm redness and arm swollen, were unknown at the time of this report.; Reporter'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.
Pt began experiencing dizziness 2 days after vaccination. It has been getting progressively worse since that time. He is currently being evaluated in the ER for dizziness
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 20-year-old female patient who received BEXSERO (batch number 151401, expiry date unknown). On 23rd June 2016, the patient received BEXSERO. On 23rd June 2016, several hours after receiving BEXSERO, the patient experienced fever, local swelling and facial swelling. In June 2016, the outcome of the fever, local swelling and facial swelling were recovered/resolved. It was unknown if the reporter considered the fever, local swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: On 23rd June 2016, at 11:30 am, the patient received a dose of BEXSERO and in the evening the patient began to experience a fever of 100.3 degrees F, swelling in the face mostly under her eyes and red bumps on her legs, hand and abdomen, which lasted for 3 to 4 days. At the time of the reporting, no additional information was available but might be available upon follow up.
Vaccine given in early afternoon. Pt. went home and laid down.  Reported rigors and extreme muscle tremors all night.  Currently complaining of joint aches and "locked knees."  Fiancee administered tylenol and benedryl.
patient recieved vaccine in left arm. 2 days later Nov 2,  had fever and intense pain and numbness in both arms, decrease ability of motor function in arms and hands bilat.  Concurrently patient experienced intensive itching over the upper 1/2 of body, and ringing in both ears,  denies rash, welts or swelling.    Most symptoms have inproved but states he still has a decrease range of motion and loss of movement in right arm, partial paralysis.
QUADRACEL being administered to a patient 2 years of age with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received from via health professional. GMI number: 01523514.  This case involves 2 months old female patient who was administered vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] 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) for Immunization; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunization.  On 02-Dec-2022, the 2 years patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Suspension for injection at dose 0.5 ml once (lot: C5862BA, Expiration: 01-Apr-2023) via intramuscular route in the left thigh for Immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Recovered on an unknown date for the event product administered to patient of inappropriate age.    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.
1 day after Migraine; Fatigue and Activity intolerance days 1-3; Rash diffuse on arms, stomach, back, and on legs starting Day 5
1st dose year ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received more than a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 05-Dec-2022 The Patient said she received her first shingrix shot more than a year ago and had not received the second shingrix shot. No further information was reported.  The reporter did not consent to follow up.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Clinic nurse accidentally administered the adult dose  (12 y/o and up) of Moderna Spikevax XBB 1.5 monovalent to the pediatric patient. Patient guardian reported as expected side effects (very sore arm, fatigue x 2 days and patient was able to return to "school" per guardian and is doing well.  Advised guardian to follow up with pediatrician.
pt presented to hospital after mechanical fall with fracture, and tested positive for covid. Pt presented with dehydreation, and AKI. Pt went to OR for ORIF. Pt went into cardiac arrest after surgery, rosc was achieved and was mad a DNR. Despite medical treatment She then went into vtach and had a sudden drop in blood pressur and lost her pulse. Pt expired 07/16/2022
developed swelling  redness and pain at injection site one day after injection.  Swelling and redness increased for five days after injection. Pateint was started on antibiotic for possible cellulitis.
Patient reported having felt tingling nerve pains up from vaccination to placement to the shoulder which dissipated after 1 or 2 hours. The following day she developed a warm, red rash at the injection site. The rash was still present 2 days after injection when she reported to the pharmacy.
THROAT SWELLING, THROAT FEELING SCRATCHY. BENADRYL 25MG IM GIVEN. SYMPTOMS RESOLVED BY 10:40AM.
Given at .  Patient presents to office 4/20/2021.  Rash which is similar to others noted in A reactivation of shingles over the upper chest arm and back.  Started five days after vaccine, with five small patches of raise clusters of small blisters.  Has spread to neck , top of shoulder and back.  Symptoms include pain to touch and itching.
Left arm did not hurt and no symptoms until on day 9, left arm got mildly painful at injection site and tingling radiating to the fingertips. Feeling of weakness in the arm. Not constant but fairly frequent. Received 2nd dose on 4/1/21 (Pfizer ER8732) and arm is more painful and tingling and weakness have increased.
Patient had a seizure about 5-6 minutes after receiving immunization. They were unconscious for about 1-2 minutes. They regained consciousness and were taken by E,M.T. to be evaluated further.
pt recv vax & some oozed out @ time of inj;cont to ooze clear fluid;area tender to touch, sl swollen & red;cont to ooze for 24hr;(small amount clear fluid)seen by MD';
6NOV97 by 5PM pt had severe h/a; a little gen achiness but not much;h/a persisted until Friday & was not relieved by APAP until p/3 separate doses over 18hr;more achiness devel w/chills, low grade fever & nausea;no appetite;diarrhea;
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 71-year-old, elderly patient of unspecified gender. it was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 02-Nov-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805547 was crossed linked to original case 201804863 due to same reporter.
I had a scratchy throat, tired, I lost my taste and smell. I did an at home test that came back negative. I called my doctor, made an appointment to have a test run to see if my at home COVID-19 test may have been wrong. The COVID-19 test at the doctor's office came back negative. The next day I was still feeling bad, I went to an Urgent Care to have a PCR Rapid COVID-19 test, this time it came back positive. I was prescribed Paxlovid that I was able to start on March 9, 2023. I am feeling much better from COVID-19, my allergies are now bothering me.
Facial swelling along the left side of the face along jawline leading up to ear. Pain when closing mouth resulting in some drooling from keeping mouth open.  Also some nasal drainage and feeling of unwell.  Telehealth appointment occurred on 1/8/21. Both corners of his mouth would raise when smiling so a stroke was ruled out.  Could possibly be a coincidence with the vaccine timing but healthcare professional advised us to report it here.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on the deltoid, on 04May2018 at a single dose; and MENACTRA, via an unspecified route of administration on the same arm as meningococcal group b rlp2086, on 04May2018 at an unspecified dose, both for immunization. The patient had no underlying conditions. The patient's concomitant medications were not reported. In May2018, after the patient left the office, the patient fainted and was taken to the ER. It was reported that the event took place after use of the product. In May2018, the lab results were normal - no issues. The outcome of the event was unknown. Information on the batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
ON THE ABOVE DATE AND TIME, THE ABOVE NAMED GUEST FELT WEAK AND DIZZY AFTER RECEIVING HER VACCINATION.  GUEST WAS ASHEN IN COLOR.  HER VITALS WERE TAKEN HR:79/SPO2:99%RA/BP: 68\44/RESP:18-NON LABORED.  GUEST WAS ALSO CHECKED BY ON-SCENE PARAMEDIC.   THE GUESTS' MOTHER OF SAME ADDRESS MENTIONED ABOVE, STATED THAT THIS IS A COMMON OCCURANCE FOR THE GUEST AFTER RECEIVING INOCULATIONS.  AFTER A FEW MINUTES, THE GUEST WAS FEELING BETTER STATING SHE WAS NO LONGER DIZZY.  SHE WAS WARM, PINK , DRY, EYES WERE EQUAL AND RESPONSIVE.   PATIENT REFUSED FURTHER TREATMENT OR TRANSPORT FOR HER DUAGHTER TO THE HOSPITAL.  GUEST WAS ESCORTED TO HER VEHICLE WITHOUT FURTHER ISSUE OR INCIDENT.
Local induration, tenderness, redness and itching at vaccination site (shingles) (R) triceps administered at local pharmacy.
Myalgia chills, rhinorrhea Narrative: Per nursing report: "c/o took 2nd Moderna vaccine on yesterday [3/23]. C/o muscle soreness and achy muscles, with chills, runny nose."
PATIENT HAD NO PROBLEMS AT TIME OF IMMUNIZATION. LATER IN THE EVENING, SHE DEVELOPED FLU LIKE SYMPTOMS, NAUSEA, DIZZINESS AND HOT FLASHES. THIS LASTED ALMOST 2 DAYS
I went for the pneumonia vaccine and by mistake they gave me the four of covi19, the modern one already had 3 Pfizer's, and they still gave me pneumonia, I almost died.
Elevated temperature--103 degrees Farenheit 24 hours after.  Increased restlessness.
Seen in ER 10/3 with c/o confusion, increased temp, chills, nausea and vomiting and large ecchymosis around vaccination site. Pt has had flu vaccine in past with no adverse reaction. 12/10/07-records received for DOS 10/3-10/4/07-DC DX: post influenza vaccination fever. Delirium secondary to medication, antihistamine. Presented to ED with confusion and fever. Temp 39.4. Appeared flushed. Large ecchymosis around vaccination site. Episodes of vomiting, nausea, chills rigors. Removed clothing, fell. CXR:low lung volumes no acute findings.
Pneumovax given 9/20. Pt c/o 9/21 AM, site discomfort/low-grade temp 9/22. Rx by MD. Cellulitis; Rocephin, IM, Augmentin PO?9/24. Rx by MD, Rocephin IM/continue Augmentin. 9/25 follow-up office visit.
After receiving the flu vaccine, I experienced a lapse in memory. I was conscious, and actively working at my desk while at work, however I do not recall from around 10:30am-1pm. No medical attention was sought, and there are no accompanying symptoms. No history of any similar past episodes. No underlying health conditions.
6NOV95 reported taken to MD for tremors 1 1/2-2 hrs p/vax 8SEP95; TC to MD 15NOV w/no mention of rxn to vax in office chart
Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle pain, knots in large muscles, diarrhea.
Diarrhea, fever, redness, induration, pain in right thigh 4 hr later. Worsened over 48 hrs, seen in ER on 8/11/05. Given Benadryl, Prednisone, Tylenol. Seen by the office on 8/12/05 doing better.
4 & 1/2 hrs /p recving immun.Mom went to check on infant.Infant grey,clammy,listless"dazed".Mom picked pt up & stimulated color returned immediately pt responded.
Rash at site of vaccine was discovered at 5am on 1/22/2021.  As the day progressed, rash became warm to the touch and itchy.
large (4cm) wheal reaction rt arm w/t103 w/uncontrolled shaking, chills, & limb spasms;
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unspecified dates, the unspecified patient were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M001579 and expiry date 05-OCT-2018) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature of 30 Fahrenheit for 12 hours. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
1. Day 1- (same day) didn't feel anything until later that night, I felt a lump at site with a quarter size area around the direct shot red and sore. 2. Day 2- Sore arm, felt a bit restricted to move arm around, minor weakness, still red quarter size and lump at site. 3. Day 3- Arm same as day 2, but by the evening I was extremely tired. Joint pains, body aches, and random chills all severe. 4. Day 4- Arm issues gone but continued with the body aches, weakness, extremely tired, and chills. A bit cloudy, and a bit forgetful. 5. Day 5- Same as day 4, but worse. Completely unable to accomplish daily activities, had to call in to work, weakness at one point as bad as struggling to lift and open a water bottle. 6. Day 6- I am here, slightly better than the day before. Still severe joint pains, body aches, and body chills.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to an unspecified group of patients of unknown age and gender. Patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of ROTATEQ (doses, frequencies and lot numbers were not provided, orally) which were improperly exposed to 9.7 Celsius degree (C) for 1.25 hours on 09-DEC-2014. Concomitant medications were not reported. No adverse effects were known. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report was received 27 September 2011 from a health care professional. A child patient (age, sex and date of birth not reported) had received an injection of FLUZONE (unspecified) a "few years ago" (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the child experienced an allergic reaction. The reporter inquired about the source of the gelatin in the vaccine and stated the physician was testing a child who had an allergic reaction to FLUZONE years ago. Per the reporter, they would encourage the doctor to complete a VAERS form if it had not already been completed; but declined to provide any additional information at the time of the report. Outcome was not reported. Documents held by sender: None.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Anaphylaxis-Mild; symptoms lasted 8 days
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 30-NOV-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Developed a bumpy rash at injection site that spread down arm to back with other spots where skin was sensitive and extremely itchy and with various shades of red.  A lump also developed and lasted one for on day at that time at injection site.  Area warm.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: patient was instructed to wait 15 minutes after receiving injection for monitoring. patient left after approx 7 minutes, walked out to the parking lot and "passed out" hitting his chin on the concrete. patient became responsive shortly after fall (exact time un-known) non-pharmacy staff attended to him at first but patient left before ambulance could be called
Menactra was put on the wrong encounter tray and given. wanted to give hepatitis b vaccine/ no AE; Menactra was given to a 2 day old in error/ no AE; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 2 days old female patient who was vaccinated with a 0.5 ml  dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number: U6207AB and expiry date: 25-May-2020) in right thigh on 11-Apr-2019, instead of HEPATITIS B VACCINE.   The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines was received.   It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was reported that patient was supposed to get a Hep B vaccine but 2 nurses were drawing up vaccines and the Menactra was put on the wrong encounter tray and given.  The patient followed up in office for a weight check and no reaction symptoms was reported, healthy baby.  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.   Follow up information was received on 15-May-2019 received from a nurse.   As reported updated, no AE added.  Documents held by the sender: none.
Patient received second Pfizer vaccine on 5/5/21.  First shot went okay, but symptoms occurred after second shot and are still occurring.  Symptoms include itching in the scalp and arm without rash.  Patient's ankle also has intense bone pain which can keep her awake at night.  She also has sinus issues (stuffiness and drainage).
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) and (batch number NR4Z4, expiry date unknown) for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 8th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and shoulder pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right deltoid. The pharmacy intern notes the patient reported pain in her arm and shoulder after receiving SHINGRIX series. The pain was described as consistent pain that radiates from injection site to the entire arm, pain continues. The healthcare professional provides lot numbers for both lyophilized powder and diluent. The lot number listed in report was for lyophilized powder. The healthcare professional provides NR424 for diluent but notes the '2' could also be a 'Z', he could not specify which.
Have all had break-thru cases; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Have all had break-thru cases) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Have all had break-thru cases). At the time of the report, INFECTION (Have all had break-thru cases) outcome was unknown. Not Provided          Concomitant product was not provided by the reporter. Treatment information was not provided.