chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tremor; decreased appetite; Inflammation; Chills; Pyrexia; Headache; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills) and PYREXIA (Pyrexia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) for Atopic dermatitis and METOPROLOL for an unknown indication.    The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Weight gain.   On 23-Apr-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and METOPROLOL (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills), PYREXIA (Pyrexia), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, TREMOR (Tremor), DECREASED APPETITE (decreased appetite), INFLAMMATION (Inflammation), CHILLS (Chills), PYREXIA (Pyrexia), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.         Treatment product details not provided.  Concomitant product details not provided.   This case was linked to MOD-2021-215355, MOD-2021-215355 (Patient Link).
Patient presented to the ED and was subsequently hospitalized on 2/11/21, 3/6/21, 3/12/21. These visits are within 6 weeks of receiving COVID vaccination.
Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   On 21st December 2022, the patient received Engerix B. On 21st December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
After immunization patient had brief episode of syncope. Resolved completely; Fell to floor but no head injury
Patient given 1st dose covid-19 vaccine (Pfizer) on 4/17/2021 at Walgreens. 2nd dose covid-19 vaccine (Moderna) given 5/18/2021 at La Palmera Mall
missed the 2-6 month return window; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as he/she had missed the return window of 2 to 6 months, as per the vaccination schedule, which led to incomplete course of vaccination. The reporter asked if they could give the 2nd dose outside of the window or did they need to restart the series. The follow-up would not possible as no contact details were available.
Arm had red welt the size of a half dollar - noticed within 1/2 hour of injection.  Warm and tender to the touch.   One week later it started to itch.  As of 3/4/21 it is still itching and has a rash  (many small welts) within the same area.    Redness has diminished, but still warm to the touch.   Not significant enough to go to doctor, but felt it should be reported.
Registration noticed a dose on 9/15/2022 and it was logged as a Bivalent Booster.   The patient was questioned if her dose on 9/15/2022 was a Bivalent Booster and she advised no it was not.  Registration proceeded to move forward with the paperwork for Pfizer Bivalent Booster.  When data entry was logging the dose in immunization registry they noticed a Bivalent dose already logged and brought it to management's attention.   After reviewing, patient did in fact receive a 2nd Bivalent dose, first dose on 9/15/2022 LOT # GH9702.  All staff present today were reminded to triple check doses administered after 9/7/2022 and to ask management if any questions.
At the injection site, she had a quarter sized welt that is hot to the touch; At the injection site, she had a quarter sized welt that is hot to the touch; She said that it hurts to the fingers, arm, and shoulder; She said that it hurts to the fingers, arm, and shoulder; The injection site is red and swollen; The injection site is red and swollen; She also has a 103F fever; This is a spontaneous report from a non-contactable nurse (patient). This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. At the injection site, she had a quarter sized welt that was hot to the touch. She said that it hurts to the fingers, arm, and shoulder. The injection site was red and swollen. She also had a 103F fever. She asked if this was expected from the vaccine. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd 3 doses of Engerix-B & titer report dated 20JAN92 indicated pt did not respond;
This shot was very painful and seemed to be given much higher in my arm than previous shot I had received in the past.  The arm pain continued and has gotten worse over the next few weeks  and now going on  almost 3 months.  I have had X-rays and an  MR I of the shoulder because it is so difficult to raise my arm.  I have had a cortisone injection for getting back the range of motion in the shoulder and hopefully decrease the pain in the shoulder and arm.  This helped but only for about 4-5 days.  I have also been on oral medication, prednisone, but only minimal relief the first day or two with that medication.  I?m scheduled to see another Doctor on Wednesday to discuss other options at this point.  In addition to the arm pain, I?ve also had a reaction to the  booster shot itself, and  I have swollen lymph nodes on the left arm side, chest  Area etc which is also been very painful.
Dizziness, Fatigue and low grade fever(max 100.0) starting within hours of vaccination, lasting 48hours. Motrin was taken which helped symptoms.
Injection needle was not inserted completely into the patient's arm and consequently there was a moderate amount of vaccine leakage
Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician.   The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233) (Temperature excursion case)  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004233, MCM-004325 and MCM-004327.  Further information is expected.  FOLLOW-UP INFORMATION was received on 12-DEC-2022, from a HCP. The case is maintained as non-serious.   The HCP confirmed that there were no adverse events following Vaxelis administration..  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA" and Vaxelis remained not applicable.  Further information is expected..
Patient received booster dose, previous 2 doses of Pfizer, booster dose of Moderna provided.  Within one minute had redness, pruritis, and hives at injection site. After 7 minutes had more hives down her arm and across chest. To partner, patient started seeming more somnolent. At this time partner notes patient was tachycardic at 150. Not hypoxic. He thinks she sounded wheezy. BP 90/70. At this point, patient was given 0.3 epi at the vaccine site by EMT and then transported to the Emergency Department.  Upon arrival to ED, hives and pruritus had resolved and there were no breathing troubles or signs of swelling. Patient was treated with  benadryl, steriods and pepcid, observed with steady improvement and then discharged.
117/70 PULSE 97 C/O SHARP CHEST PAIN UPPER RIGHT CHEST AND DOWN RIGHT ARM AT 15MIN MARK. LAID DOWN ON COT AND 911 CALLED. ADMITTED TO HAVING ANXIETY ABOUT THE SHOT. ABLE TO MOVE FINGER ON RIGHT ARM BUT STATES SHE CANNOT FEEL HER FINGERS. DENIES SOB. BP AFTER 5 MINUTES BP 116/71 PULSE 94. RIGHT ARM AND HAND WARM TO TOUCH AND STATED SHE FELT ME TOUCH HER. RADIAL PULSE RIGHT WRIST GOOD. C/O DIZZINESS. PATIENT IS DEVELOPMENTALLY DISABLED. CAREGIVER STATES PATIENT AGREES TO ALL QUESTIONS. C/O STOMACH PAIN, DENIES NAUSEA. B/P AFTER 10 MINUTES 115/72 P 92 DENIES SOB. RATES CHEST PAIN ON A 0-10 AT A 10. STATES STILL CANNNOT FEEL FINGERS. PARAMEDICS ARRIVED AND HOOKED PATIENT UP TO A 12 LEAD YIELDING NORMAL RESULTS. PATIENT DID NOT GO TO THE HOSPITAL WITH PARAMEDICS.
PT STATES HE GOT HOT AND FELT LIKE HE WAS HAVING A DREAM AND WOKE UP.  PT DID VASO VAGAL AND WAS ONLY OUT ABOUT 20 SECONDS.  PT WAS IN A RECLINING BLOOD DRAWING CHAIR, HE WAS RECLINED AND PT BECAME ALERT.  THIS WAS SECOND TIME PT HAD THIS REACTION WITH ANTHRAX.
took the flu shot on a Tuesday and dead on Saturday; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 4 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The reporter mentioned that, the patient had received a flu shot on tuesday and was dead on saturday. The reporter was warning people to not take any vaccines in order to be alive. The case is linked with the case- US2020AMR225462, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225462:same reporter; Reported Cause(s) of Death: Unknown cause of death
coughing up a lot mucus/ keeps coughing and coughing; spitting up a lot of mucus; This is a spontaneous report from a contactable consumer, caregiver of the patient. A 88-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6200) via an unspecified route of administration, administered in left arm on 03Mar2021 at 12:35 as dose 2, single (age at the time of vaccination: 88 years) for covid-19 immunisation. The patient had stroke last Mar2020 and that 25% of his heart was working. The stroke was in the front lobe, it was small. Then 20-25% of his heart, he had a watchman, clarified, watchmen filters blood clots so they can get the patient off warfarin, the blood thinning medicine. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EM9810) via an unspecified route of administration at dose 1, single. The patient previously received flu shot on an unspecified date and experienced sore arm. There were no concomitant medications. His follow up check ups have been fine. The patient was spitting up a lot of mucus/ spitting up all kinds of mucus in the trash can and was coughing and coughing on 03Mar2021 at 16:00. It was reported that the patient was still coughing even at 8:00 PM when the reporter's shift changed. The patient took Tylenol at 8 hour interval at a dose of 225 mg. No vaccines were administered on same date with the suspect product. The reporter was giving him 2 tablets by mouth and he was feeling better. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. The reporter considered the fever to be almost certainly related to SHINGRIX. Additional information was received as follows: The patient experienced low-grade fever following administration of SHINGRIX. Additional information was not provided. The reporter stated that these incidents occurred a month before the time of reporting and he had forgotten the details at the time of reporting. The reporter did not report GSK initially, as he read in the package insert that low-grade fever was a known adverse event following SHINGRIX administration. This case has been linked to the case US2018052279, reported by same reporter.
Woke up in the morning with severe chest pain.  Went to ED and diagnosed with pericarditis. After second shot had same symptoms starting and started taking colchecine which I was prescribed after the first incident
Rash that appeared to be urticaria on arms/legs and trunk that appeared around 50hrs post injection and worsened at 72hrs. I am a physician and have seen similar rashes in kids and mine appeared to be consistent with urticaria multiforme. Responsive to Benadryl. I am now day #5 with itching of my palms and faint rash on arms and legs.
Child developed fever and bulging anterior fontanel within 6 hours of getting DTAP, HIB, IPV and Prevnar. Also had chills. Work-up is negative for an infecting process.
Patient took first shot of vaccine 4 months ago and is yet to take the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient took first shot of vaccine 4 months ago and is yet to take the 2nd dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient took first shot of vaccine 4 months ago and is yet to take the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient took first shot of vaccine 4 months ago and is yet to take the 2nd dose) had resolved.            Patient is unable to go for the second dose due to an unrelated tooth infection and swollen gum. No concomitant medication details was reported. No treatment medication details was reported.
Patient states she noticed redness and swelling on left arm and pain to touch 1 day after receiving Varicella vaccine. It has doubled in size and feels hot.
High fever, chills, lethargy, malaise, body aches, and baseball size swollen lymph nodes on head (behind ear) and in armpit of left arm.  All symptoms lasted 36 hours. This is Tuesday after the shot on Thursday and I am still very tired and weak and I still have swollen lymph nodes, but not as big.
Patient was administered 1st dose of Moderna covid 19 vaccine. However in April 2021 she was also administered 1 dose of the Janssen covid vaccine. She stated no ill effects or issues after either dose
Vaccine recipient reported that 10 hours post vaccination they experienced fevers, chills, confusion, body aches, headaches, nausea, GI distress, generalized weakness and blunted cognitive processing. On a follow-up call on 1/11/2021, the vaccine recipient reported that their symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.
Rash starting around injection site, diffuse raised red bumps the size of pimples.  Still present.  Applying topical steroid cream hoping to avoid oral steroids as he just had oral steroids less than 45 days ago for another contact dermatitis but different in appearance.  My son has also complained of headache since rash began.
On 09/13/2022 I received my covid-19 vaccine. On 12/07/2022 I started experiencing a low-grade fever, sore throat, coughing, and headache. After reaching out to doctor I tested positive for Covid-19. I was prescribed PAXLOVID. After taking the medication I started experiencing extreme diarrhea. I also developed a post viral bronchial cough that lasted  approx. 6 weeks.
Vaccine administered at approximately 2pm.  Patient returned at 3pm, complaining of shaking, chills, subjective shortness of breath. Also complained of severe pain at injection site.  Pulse was 90-110.  O2 sat 95%, BP 130/80.  Patient shaking, shivering.  No airway edema visualized on oral pharynx exam.  Heart:  fast rate but regular.  Lungs clear.  No cyanosis.  Injection site slightly red but otherwise unremarkable.  Patient given epinephrine 1:1000 0.25cc SC, Visitaril 100mg IM (no IM Benadryl available), and ativan 1mg PO.  Also received Tylenol 975mg PO.  After 30-45 minutes, patient felt well enough to go home.  Telephone check next day showed she was doing well.
Patient developed a high pitched cry, became unresponsive and was taken to the ER. She arrested at the ER. Was intubated and admitted to the ICU with multiple organ dysfunction.
Patient  said , she developed shaking , dizziness, weakness next day after she had  vaccine
Left arm soreness, stiffness. It lasted about 12 hours. I was achy all over my body, though that could be due to the rain storm we had overnight. The rain has passed and I am no longer achy in my arm or elsewhere.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 10-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Vaxs received on 02/08/2000. Around 11 PM that evening, he awoke with vomiting, diarrhea, dizziness, lots of sweating and felt hot The symptoms lasted for about 5 days. Pt continued to have dizzy spells , but were not severe enough to restrict his activity. On 03/12, he developed syncopal episode and consequently, he had several episodes lasting for 3-30 minutes. He underwent complete neurological and cardiac work-up, which was negative. He was seen by an endocrinologist, and a diagnosis of orthostatic hypotension with tachycardia secondary to post-inflammatory neuronitis was made. Since the onset of febrile illness and shot preceded the symptoms, it is likely that this was due to one of the vaxs he received on 02/08. He has improved with volume load and Florinef and has not had any more syncopal attacks. The follow up states, "info is not available, the vaccines were given at a different facility, they did not record the lot numbers.
Parents complained that after a dose of the Rotateq was administered orally, the Patient had 5 bloody diarrhea diapers.
Pt went to sleep and woke up the following morning with chills, fever, fatigue, muscle aches, pain, redness, swelling for 2-3 days. Symptoms fully resolved. Patient did not have any of the above reaction to the second dose.
This spontaneous report was received from a pharmacist via a company representative, and refers to a patient of unknown age and gender. No information about patient's medical history, concurrent conditions and drug reactions/allergies was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). No concomitant medications were reported. It was reported that, on an unknown date (reported as "two years later"), the patient developed shingles. No product quality complaint was involved. At the time of reporting, the outcome of shingles was unknown. Additionally, the relatedness between the event and ZOSTAVAX was not provided by the reporter. Additional information has been requested.
Immunizations followed about 4-5 hours by fever and febrile sz witnessed lasting about 10 10 min. Pt also with (L) otitis media. No sequelae.  10/20/09:  Hospital records and discharge summary received for dates of service 7/09/09 to 7/12/09. Dx:  Febrile seizure, cleared, left otitis media, improved. Assessment:  Presented to ER after 10 to 15 minute seizure with rhythmic clenching and relaxing in left arm and leg, initially alert then became lethargic and unresponsive.  Eyes jerked and jerking motions were noted in both arms and both legs.  Febrile upon admission to ER with left otitis media and leukocytosis.  Started on IV Rocephin, Tylenol and Motrin then switched to oral Omnicef. Child has had mild cough and runny nose over last 2-3 days.  Chest X-Ray clear, CT of head was normal.  At the time of discharge patient was active, alert, taking feedings and medications well and was afebrile.
severe Itchy throat which lasted 2 to 3 hours; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (severe Itchy throat which lasted 2 to 3 hours) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for an unknown indication.     Concurrent medical conditions included Seasonal allergy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT IRRITATION (severe Itchy throat which lasted 2 to 3 hours). On 03-Mar-2021, THROAT IRRITATION (severe Itchy throat which lasted 2 to 3 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes antihistamines.
pt recv vax 1MAY97 devel erythema type rash head to foot w/urticaria dx as allergic rxn;placed on pred course 6 days