chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day after PNEUMOVAX and FLUZONE, developed arm pain bilaterally. When coughed pain went up arm and in chest. Developed fever of 101.4 degrees. 2 days after shots, felt dizzy and dyspneic, with rapid heart rate. Did not receive medical attention. Had had flu shot for past 9 years without incident.
PHARMACIST WHO PERFORMS CLINIC IN , ADMINISTER JANSSEN SHOT TO 16 YEARS OLD.  NO ADVERSE REACTION HAS BEEN REPORTED YET.
joint pain, body aches, chills, fever, a little nausea,  painful, silver dollar size swelling and redness at injection site
Felt awful - sneezing, headache, runny nose, tired, all moderate in severity. Sore throat started 12/10 (severe). Symptoms lasted until 12/13. Took Excedrin, Sudafed.  Also had migraine 12/13 - took Maxalt.
received half dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (received half dose of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced UNDERDOSE (received half dose of Moderna). At the time of the report, UNDERDOSE (received half dose of Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were reported by the reporter. It was reported as on 30-DEC-2021 patient received half dose of Moderna.   This case was linked to MOD-2022-608716 (Patient Link).
On 8/19/2012 patient received an Intradermal injection of FLUZONE vaccine. Patient came back to the pharmacy on 9/20/2012 complaining of pain in the left arm since receiving the vaccine.
Received Rotarix 2nd dose at 3 weeks; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Rota (Rotarix lyophilized formulation) (batch number 322CM, expiry date 15th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX).   On 21st October 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 21st October 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 5 Dec 2022 Reporter's comment: Licensed practical nurse called to inquired that the dose need to be repeated. The reporter was unable to provide any patient details. Did not consent to follow-up. Additional supportive information: The patient received second dose of Rotarix at 3 weeks instead of the series recommended 4 weeks in the reporter's facility, which led to shortening of vaccine schedule.
Patient experienced Hashimoto Thyroiditis. Patient developed a rash on their upper chest and left arm.
The patient developed an itchy rash 2 days after being vaccinated on his chest and stomach, then it was completely gone after about a week.
Day 2 - Soreness to arm area; Day 7 - Severe headaches; Day 9 - Rash and itching on site area, redness and swelling, hot to touch, headaches; Day 10 - Redness has spread to a bigger area, itching, hot to touch, headaches
This case reported by a physician and described the occurrence of anaphylactic reaction in a 5 year old male subject who was vaccinated with Havrix for prophylaxis. There was no relevant medical history or concurrent medications. concurrent vaccination included Varivax given on 27 January 2007. On 27 January 2007 at 12:54 PM, the subject received 1st dose of Havrix (720 Elisa unit, left gluteal). Within one hour of receiving the vaccinations with Havrix and Varivax the subject experienced puffiness on face, eyes almost closed, wheezing, coughing, and said he could not breath. The subject experienced an anaphylactic reaction. In addition, the Havrix was administered at an inappropriate site of administration. Medical attention was required at the subject's doctor's office. The physician considered the events were disabling and life threatening. The subject was treated with adrenaline (Epinephrine) and breathing treatments. The physician prescribed steroids and diphenhydramine hydrochloride (Benadryl) for the subject. At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with Havrix.
Local reaction of 3" x 3" erythema at site of PREVNAR injection ((R) thigh) and 1" x 2" on (R) ankle. Also very fussy and had diffuse erythematous spots on trunk, face and legs. Erythema around PENTACEL inj site of 1" x 15". 3/4 tsp BENADRYL administered and cool compress applied to (R) thigh. Erythema started to resolve after approx. 15 min and almost completely resolved by 45 min.
pt became faint after injection, sat in waiting area, cold compress applied, pt ok to leave after 15 minutes
PATIENT CAME BACK AFTER 14 DAY TO PEORT PAIN AND MUSCLE WEAKNESS IN THE SAME ARM AS VACCINE. PATIENT REPORTED NUMBNESS, WEAKMESS AND THROBBING PAIN IN THE ARM ALL DAY LONG. PATIENT IS SEEN BY PRIMARY CARE DOCTOR.
area very swollen, red, warm to touch; face swelled, t100 w/APAP;
2/17 @ 2000- hives on torso and upper body 2/17 @ 2200 shortness of breath  2/18 @ 1100-1400-  angioedema (lip and facial swelling)
Chills, Fever, Fatigue, Aches, Headache, Nausea, Very Sore Arm at shot site, stuffy nose
Initial unsolicited case received from a nurse (FNP) on 31 Jul 2017. This case involves a female patient (age not reported) who was vaccinated with two doses of HIB (PRP/T) VACCINE (HIB PRP-T) (Batch numbers: UH768AA, UH639AB, expiry date, dose, dose in series, route, and site of administration were not reported) on an unknown dates in Feb, and Apr 2013 respectively. The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccinations, the patient developed nodule at vaccine site that itched x 2 years. The patient relevant lab tests and corrective treatment was not reported. The outcome of the event was reported. List of documents held by sender: none.
pt recvd vax; cried/screamed for several hrs; returned to clinic; examined by MD,napped several hrs; stopped crying but remained irritable; no tx;
Pt complained of great swelling in left shoulder after receiving the shot. The next day (24 hours later) noted the swelling had progressed down the arm to the elbow area.
Narrative:  Patient died from septic shock secondary to perforated appendicitis on 4/3/2021
Patient experienced two syncopal episodes in short succession while in the observation lot following vaccination. He was evaluated by EMTs and found to be bradycardic. He vomited after the second episode. He was transported to Hospital for evaluation in the ER.
On 8/22/00, received call from pt, stating in 4/00 she received travel vaccines of Hep-A, HBV and IPV. Pt was hospitalized in 5/00 for back surgery at which time she received Medrol 6 pk during hospital stay (5/1/00 to 5/19/00) and states she took a 2nd course of Medrol 6 pk and completed this course on 5/25/00. On 6/15/00, pt returned to travel clinic for more travel vaccines of Meningococcal, TD, Typhoid and YF. Pt states she is now having alopecia since mid-July/00. Discussed and investigated and alopecia is not a reported side effect of YF vaccine. Therefore, we recommend that the pt consult with a good dermatologist to see if something other than that vaccine has caused the reaction.
PT C/O BURNING FROM CHEST UP, TACHYCARDIC, AND HYPERTENSIVE. SENSATION RELIEVED W/ BENEDRYL
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from a physician concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K003408, expiration date 16-MAR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
severe headache; nausea; on top of a migraine; room was spinning-never happened to me before.; Bowels emptied; could not tolerate food or water; could not tolerate to light; Could not tolerate noise; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included lower back pain. The patient did not have any allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), plantago ovata seed husk (PSYLLIUM SEED HUSK CAPSULES) and multivitamin (MANUFACTURER UNKNOWN) for unknown indication and unknown date within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ENI0206) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021  at 03:00 two nights after the vaccination, the patient experienced that the room was spinning, which never happened to her before. On 09Apr2021 at 20:00 after seventeen hours, experienced with severe headache and nausea, which was like a sinus headache on top of a migraine. On an unknown date in Apr 2021, the patient experienced emptied bowels, could not tolerate to food or water or light or to noise. No therapeutic measures were taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events spinning sensation, headache, nausea, migraine, emptied bowels, could not tolerate to food or water or light or to noise were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 1/27/22 I started having a pain in my left side on mid back area, and also a dull pain ache in my left sided rib cage area. It bothered me all day on 1/28/22 and while I was driving home on 1/28/22 at 8:49 pm, I started having chest pain, and a sharp shooting pain in my neck and left shoulder blade, going down to my left arm. I got out of the car and my wife drove me straight to the emergency room. I was diagnosed with a Pulmonary Embolism. The doctor in the ER listened to my symptoms and ordered a CT scan and found the PE and transferred me to another hospital for a higher level of care. I DID not have COVID-19, I was tested and my test was negative.
We dispensed 28 doses of expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We dispensed 28 doses of expired Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We dispensed 28 doses of expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We dispensed 28 doses of expired Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient had no known allergies at the time of vaccination. Patient reported no adverse events after vaccination. The vial did not undergo any temperature excursions. On unknown date the vial was initially stored in the refrigerator. Patient had never been diagnosed with or tested positive for COVID-19. The result of stability study shows full activity against COVID-19. No treatment medication was reported.
Within 5 minutes of shot had rapid heart beat and trouble breathing.  Removed face mask and heart rate and breathing returned to normal within 5 minutes
Moderna COVID-19 Vaccine EUA Extreme tiredness: sleeping 12+ hours and still feeling like I have not slept Migraine: I do get chronic migraines so I am unsure 100% if the migraine is related to the vaccine or not Fever: under 100.0°F Night sweats Chills
6/13/13 7pm fever - 100.2, headache, fatigue, abdominal pain, nausea, and vomiting (2am, fever 102). 6/14/13 10am vomited once, no headache. 1:30pm seen in our office, normal exam. Normal vital signs, no headache feeling better.
anaphylatic react, not described; to ER 20 mins p/inject on 8OCT93 w/tightness of chest, sensation of throat closing; tx w/DPH, Solu Medrol, Proventil inhaler; referred to allergist;
Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Start Date/Time: 08Jan2021 12:45 PM/ Start Date/Time: 21Dec2020 10:15 AM; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date not reported), intramuscular in the right arm on 08Jan2021 12:45 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the right arm on 21Dec2020 10:15 at single dose for COVID-19 immunisation. The patient experienced significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
Information has been received from a Registered Nurse (R.N.) concerning a 13 year old female patient who on 19-FEB-2007 was vaccinated IM a first dose of with Gardasil lot #653736/0689F and on 24-APR-2007 she was vaccinated IM with a second dose of Gardasil lot # 655849/0263U. She became dizzy and flushed with sweating within minutes after her second injection was given. She quickly recovered. Additional information has been requested.  Additional information is not exepcted.
experiencing pain on his right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EV6207) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovering", described as "experiencing pain on his right arm".  Additional information: He reported that he was experiencing soreness in right arm where he had the vaccine in his left arm which started about a week and a half ago. Injected in left arm in the shoulder. Received this one on left arm in the shoulder as well. Unable to confirm if given intramuscularly. No of previous doses was none. Event did not require a visit to Emergency Room or Physician Office. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Relevant tests was none. Patient wanted to know if this right arm pain was normal, how soon will it go away and if it will go away or will he be stuck with it. Report is related to a study or programme.  Follow-up attempts are completed. No further information is expected.
Debilitating body pain starting roughly 24hours after 2nd dose of moderna shot. This all over pain subsided 16 hours after onset. Currently experiening ongoing symptoms of aphasia, brain fog. Word substitutions are becoming more frequent such as saying slide vs swing or colors wanting to say black but saying pink in addition to forgetting names of common items, and frequent use of talking around words I want to say example a definition or alternative word due to word searching.
PENTACEL given right leg without difficulty - pt. cried hard then held breath. PREVNAR given left leg without diff. Pt. noted to be still holding breath and lips turned blue. Eyes rolled back and no response for 20-30 secs. Pt. opened eyes and was arousable but subdued. Monitored x 15 mins. and then was up moving around room and talking. Spoke with MD office and child sent there for further evaluation.
pityriasis rosea, no tx, still have rash. abdomen, left upper arm and upper right thigh
Fever. A physician reported via a territory representative that a child received Prevnar and subsequently developed a fever of 104.3F. No further information was available at the date of this report. This is 1 of 2 pt's from this facility who developed a fever following receipt of Prevnar.
for a few days after receiving immunization, site was very sore. no redness or swelling reported. pain faded but was still present. upon waking at 5am on 10/23/2020, injection site felt hot to the touch to to patient, but not to someone else (boyfriend) who tried to note a difference. Patient did a telehealth visit with an urgent care, who, upon looking at the site and hearing description of events, prescribed a z-pak. at the time of this form being completed, patient has taken 3 out of 5 days of this zpak and has 2 days remaining.  on day 1, seemed like site was getting better (no longer hot, pain decreased) but on evening of 24th, pain returned in a new and more painful way.
experienced a metallic taste in her mouth; This is a spontaneous report received from contactable reporter (Physician) from a sales representative. The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Lack of food cravings" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "experienced a metallic taste in her mouth".  Additional Information: The patient experienced a metallic taste in her mouth almost immediately. She did not mention if this was after the first dose, the second dose, or both. She also experienced a lack of food cravings that she used to have prior to being vaccinated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
With vasculitis; Extremely painful; Leg was completely red; This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (With vasculitis), PAIN IN EXTREMITY (Extremely painful) and ERYTHEMA (Leg was completely red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis, Open heart surgery and Blood transfusion (3 blood transfusion in the past). Previously administered products included for an unreported indication: PREDNISONE (For vasculitis (allergy caused by Forteo injection).) in 2001. Concurrent medical conditions included Cryoglobulinemia (She had a mix essential type 2 cryoglobulinemia. She has been in remission for some time.) and Drug allergy (She took Forteo injection for osteoporosis 10 years ago and had a reaction.At that time, she had her waist down covered with vasculitis, and they gave her prednisone to treat.) in 2001.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VASCULITIS (With vasculitis), PAIN IN EXTREMITY (Extremely painful) and ERYTHEMA (Leg was completely red). At the time of the report, VASCULITIS (With vasculitis), PAIN IN EXTREMITY (Extremely painful) and ERYTHEMA (Leg was completely red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included 1 dose of 20mg prednisone on 18 Feb 2021.
Three days of fever 102, loss of appetite, fussiness, ear infection, cold/flu like symptoms.
Flu shot 2010 - (L) arm very painful to move for 5 mos., still has some residual tenderness. Flu shot 2011 - 2 days after shot pt had tingling (L) side of face, blurred vision (L) eye, constant rhinitis (L) nostril still has sx 1 yr. later. Saw opt and ophth. (L) vision had decreased from 20/20 to 20/60.
Patient felt faint a couple minutes after vaccine.  Given apple juice and felt better after lying down.  BP , VS normal.  After 20 minutes observation he ambulated and was deemed ready to be discharged.
Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676, MOD-2022-438675 (Patient Link).
CERVARIX #1 given on Rt arm - 7" by 7" area of swelling and erythema, warmth.