chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US013228 is an initial spontaneous report received from a nurse on 14 Jan 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to a 12-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014), at a dose of 0.5 ml intramuscularly in the right on 11 Jun 2013. Reporter stated that the un-reconstituted MENVEO reached minus 1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from a nurse on 09 Jul 2013: Patient demographics (height and weight), site and date of vaccination updated.
9 days after receiving the Moderna Covid19 vaccine my are got red and itchy at the injection site. The redness is about 3 inches in diameter
09/06/22 presents to ED for "fatigue". PMHx of " AML (diagnosed in 2017), hepatitis C, HLD, HTN, RA and nephrolithiasis"
This spontaneous report as received from a register nurse refers to unspecified number of patient (age and gender were not reported), that on an unknown date were vaccinated with ROTATEQ oral (dose, strength and not number were not reported), which on an unknown date experience an incorrect product storage. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I started with a slight headache the day after; The second day I woke up and my eyes hurt, I looked in the mirror and they were bright red and painful. It called the doctor and they said it was allergies; The second day I woke up and my eyes hurt, I looked in the mirror and they were bright red and painful. It called the doctor and they said it was allergies; this has caused it to dilate for a day and then return to normal as well; My eyeballs themselves also seemed swollen.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EW0158) via an unspecified route of administration, administered in right arm on 25Jun2021 16:45 (at the age of 38 years) as dose 1, single dose for covid-19 immunization. No other vaccine administered in four weeks. No covid prior vaccination. The patient's medical history included hypoglycemia and uveitis from an unknown date and unknown if ongoing, known allergies included walnuts allergies from an unknown date and unknown if ongoing. It was reported that in one eye patient have a problem with from birth with dilation. The patient's concomitant medications included in two weeks included (plexus supplements) cisapride (PLEXUS [CISAPRIDE]) taken for an unspecified indication, start and stop date were not reported. On 27Jun2021 06:00 AM, the patient started with a slight headache the day after. the second day she woke up and her eyes hurt, she looked in the mirror and they were bright red and painful. It called the doctor and they said it was allergies, this has caused it to dilate for a day and then return to normal as well, her eyeballs themselves also seemed swollen. It was reported that doctor said it was allergies and gave me drops. It lasted about three days with treatment, but still hurt a little. One eye patient has a problem with from birth with dilation, this has caused it to dilate for a day and then return to normal as well. Patient not tested for covid post vaccination. Therapeutic measures were taken as a result of all the events. Treatment included eye drops. The outcome of the events was recovered on unspecified date in 2021.  Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.
Patient called to say she had a softball size swelling and redness at site of injection and bruising above, the night 1/21/10 of getting injection.  Called her friend who is a nurse and was told to take BENADRYL.  The next day spoke with a Pharmacist and was told to use BENADRYL cream on arm.  She did for 2 days.  Today 1/26/10 she said she still has redness and warmth & bruising.  She never spoke to a Doctor or reported to her Dr. the symptoms.  Notified Dr. 1-26-10.
Within 24 hours of the shot, my arm began to turn black. Within a week, it became completely black from mid-upper arm to mid-forearm. Arm was very sore. I went to Emergency. They didn't know what it was.I went to the cardiologist to see if it was the blood thinners. It wasn't.  A week later, I woke up and couldn't turn my head or move my neck at all. The pain was excruciating. I thought I had herniated a cervical disc. I could barely walk around my house. At the same time, I lost the use of my right arm and hand because of the pain. I couldn't move my arm in any direction. My right hand swelled up, turned red, and the pain was so bad I couldn't even touch the palm of my hand. The phlebotomist wouldn't draw blood from my right arm because she was afraid it was sepsis. Between my cervical spine and my arm, it was incapacitating. I went back to Emergency. They did a cervical CT scan and blood work, but only found severe arthritis. Shortly thereafter, the pain began in my leg. I thought I had re-ruptured my Achilles tendon and I couldn't put any weight at all on my knee or ankle. I was on crutches for more than a week. It was 4 months before I could completely turn my head again. The entire inflammatory episode took about 6 or 8 weeks.
The patient is 13 and was given the 5-11 COVID Pfizer vaccine but he should have had the 12-18 COVID Pfizer vaccine. He did not show any adverse effects while waiting in the clinic twenty minute after receiving the vaccine.
heart pounding, itching in throat, difficulty swallowing;ears itching;trembling;epi & ambulance to Er more epi;
Body aches - extreme - very low energy uncontrollable chills nauseas - sweating through night.
Acute appendicitis; Appendix had small rupture; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm left, on 08Mar2021 at 12:00 (Lot Number: EN6199), as single dose, for COVID-19 immunisation. Medical history included hypothyroidism and COVID-19. The patient had not known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced acute appendicitis (caused hospitalization for 1 day, life threatening) on 12Mar2021 at 10:45 with outcome of recovering and appendix had small rupture (caused hospitalization for 1 day, life threatening) on 12Mar2021 at 10:45 with outcome of recovering. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up information has been requested.
Patient is seen for recurrent outbreak of a rash on her buttock.  It is painful, raw.  She is here fairly early in the course.  Stays in the same spot.  Hasn't spread. No associated fevers.  She had Zostavax in November.  Left buttock shows a papular eruption with some superficial crusting.  No distinct vesicle formation. There is no surrounding erythema or induration. A couple of whiteheads are noted.  Assess: 1) Buttock rash, folliculitis vs. zoster.
No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022; Dose 1 administered on 7-Apr-2021, dose 2 administered on 17-Jun-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 7-Apr-2021, dose 2 administered on 17-Jun-2021) and NO ADVERSE EVENT (No Adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 038B21A, 0148C21A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 7-Apr-2021, dose 2 administered on 17-Jun-2021). On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 7-Apr-2021, dose 2 administered on 17-Jun-2021) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 7-Apr-2021, dose 2 administered on 17-Jun-2021).    No concomitant drug was reported. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case
On 07/18/02, pt came to unit for scheduled dialysis with c/o "rash all over and soles of feet and palms of Hands itch". She states the itching on her feet started on 07/11/02 and that the rash started on 07/16/02she denies going to the hospital of physician's office. The responsible physicians was notified on 07/17/02.
Pain, warmth, erythema and tenderness over site of injection (lateral aspect of left deltoid), fever of 102.5, area of redness is not quite cirucular but approximately 5 to 6 inches in size around site of injection.  Also complained of severe back pain onset concurrent with fever and left deltoid pain and redness.
Breakthrough case admission after 3 vaccines Moderna 2/2/21 Lot# 011L20A ; Moderna 3/2/21 Lot# 012L20A;  Moderna 1/14/22 Lot# 060H21A
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild
Patient received second dose of Jynneos before the 28 days due date. He received it 20 days after the first dose. Nurse attempted to call patient to discuss further guidelines, however patient did not answer. Voicemails were left on unidentified voicemail box.
numbness of tongue, lip swelling, itching around eyes, chest heaviness, tacchycardia c rrr@100bpm
Developed tingling in arm. The tingling was not in the arm that the vaccine was administered.  Patient stayed in monitoring center for an hour and symptoms resolved.
Minor to light pain to the touch at the injection site approximately 30 minutes after injection, accompanied by minor to light soreness in the left arm. Symptoms gradually intensified throughout the day. I started to feel generally fatigued a couple hours following injection. Approximately eight to ten hours post-injection, injection site had fair pain to the touch, but no redness or other discoloration was noted. Moderate soreness in the left arm. I felt very fatigued. No pain medication was taken, I just slept for approximately nine hours. When I woke up before 0700, the arm soreness and pain at the injection site had lessened to mild soreness and minor to light pain at the injection site, but I still felt fatigued. I decided to power through and go to work, and the fatigue had subsided in hours. No further issues.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with unspecified number of improperly stored (Oka/Merck) VARIVAX (dose and route not reported). Lot information of (Oka/Merck) VARIVAX was provided as lot# J014131, expiration date: 07-NOV-2015 and/or lot# K016132, expiration date: 24-SEP-2016. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
About 24 hours after receiving the vaccine I noticed shortness of breath and cardiac arrhythmia as determined by repeated radial pulse checks. This lasted fro 6 to 8 hours, then I seemed to return to normal. the effects were notably more severe while lying down on my side back or stomach. sitting up felt the best.
patient received one improperly stored dose of PROQUAD; no adverse effects; This spontaneous report was received from a medical assistant concerning to an patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  Since 12-JUL-2019, vaccines had a temperature excursion.  On 14-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot number S008570 with expiration date on 16-SEP-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of 5 degrees Celsius (C)  for more than 30 days. The excursion ended on 05-SEP-2019. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
6 hours after vaccination, chills and chest "tightness". Felt like reactive airways. Tight x 3 days with slow development of cough, continues to progress, feels like pneumonia. Unrelenting cough, frequent use of rescue inhaler. On day 6 full exam in ER. Chest x ray clear, covid negative, ekg normal. Day 9 back in ER. Unable to sleep. Constant cough so violent I am wrenching.
Vertigo every day since having injection. Multiple times a day. Doesn't matter if laying down or upright.
Two weeks after my vaccine, side effects began to return: swollen, painful lymph nodes and breast pain on my vaccine side, fever, and fatigue. Over the course of a week (beginning May 18), they worsened and began to include chest pains and pins and needles in my left hand, arm, shoulder, neck, and face.  I sought emergency care on April 25.  The following day, I developed vomiting, diarrhea, and rash on my right side.  The following week, I developed balance issues and dizziness. My symptoms have never resolved, despite multiple follow ups with oncology, gynecology, infectious disease, neurology, and immunology/allergy across three hospital systems. I still have painful swelling on my vaccine side, intense fatigue, dizziness, balance issues, low fevers, elevated ALT levels (45-60), and bouts of nausea, diarrhea, and retching. I developed severe anxiety and depression in the summer of 2021. In November 2021, I began to develop neck pain and cardiac issues (chest pain, heart palpitations, racing heart, high blood pressure). I am currently being evaluated for late stage myocarditis.
This child was given DTaP on 05/11/01 in the left upper thigh. A rash developed at the injection site on 05/13/01. Seen at the office on 05/14/01. 5 cm x 5 cm circular erythematous rash with central clearing, (+) warmth, (-) tenderness, (-) firmness, pruritic.
p/vax pt started having convuls (shaking real bad), throat started to swell up, felt like fainting & had fever & flu like sx;pt was brought back to clinic & sx resolved in 1hr;no tx given;
Headache started AM of 12/23/20; Body aches started 1100 12/23/20; lymph node discomfort, same arm as vaccine, early AM 12/24/20;  Alternating Tylenol, naproxyn and rest helps. Once meds wear off, symptoms return.
A few days after second vaccine developed moderate occasional dizziness.  Today I woke with full blown vertigo.  I never had vertigo before but given that it?s a month since vaccine I wasn?t sure if this is due to the vaccine.
Soreness of arm that lasted 1 week, redness and swelling at the time that lasted 4 days, felt cold for 2 days after the shot, achy and tired for the first day afterwards, swollen glands under the armpit, which was followed by swelling of glands in the neck/chin area.  Broke out with 5 cold sores on the lips.
Entire body was shaking super bad/he had body trembling; Awake all night; Felt like somebody electrocuted him; Uncontrollable diarrhea; Sweating real bad; Back is tight; Whole body hurt; Upper body fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea) and HYPERHIDROSIS (Sweating real bad) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea), HYPERHIDROSIS (Sweating real bad), MUSCLE TIGHTNESS (Back is tight), MYALGIA (Whole body hurt) and FATIGUE (Upper body fatigue). At the time of the report, TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea), HYPERHIDROSIS (Sweating real bad), MUSCLE TIGHTNESS (Back is tight), MYALGIA (Whole body hurt) and FATIGUE (Upper body fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient wife thought he was having a seizure,which kept him awake all night.  No Concomitant and Treatment medication were reported.
Patient vaccine was part of mass vaccination event.  received vaccine, initially right after injection noted palps but hr when checked by rn  hr was normal.  patient noted she then went to have coffeecake and coffee. 2 hours after vaccine developed throat fullness and tongue swelling.  no wheeze no syncope no respiratory arrest
Menstrual period with significant bleeding lasting almost 8 weeks. Started off irregular for a few days, stopped and came back with an exorbitant amount of blood - needed a super tampon and pad every hour. Lasted about 7.5 weeks in total by using progesterone to stop the bleeding. Also significant cramping and pain. Both the heavy bleeding and pain with cramps are out of the norm for me.
got second one/ 8 months later.; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date, 8 months before 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details provided were as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient was expected to receive the 2nd shot 2 to 6 months after, but he/she did not really followed through and received 2nd dose 8 months later which led to lengthening of vaccination schedule and asked to start over again as in next year it would be 3 years. The follow-up would not possible as no contact details were available.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a 15-year-old male. Neither the patient's past medical nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Stinging when entering the arm; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (office staff).  This case involves Adult female patient who experienced stinging when entering the arm, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included Pain with Stinging when entering the arm more than in previous years. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1915 via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious stinging when entering the arm (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was stinging when entering the arm.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for stinging when entering the arm.  Information on the batch number was requested.  List of documents held by sender: none.
Heavy period; I have kidney pain in my other upper left kidney where the injection site that side of the body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Jul2021 (lot number and expiry date: unknown) as dose number unknown, single for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified contraceptives. The patient stated that she just had the Pfizer Vaccine on 27Jul2021 and then beginning 04Aug2021, she started having heavy period which she never had for years because she was on contraceptives. It was lot of blood and she was kind of shock because she never had periods for long time. On unspecified date in 2021, the patient also had kidney pain in the other upper left kidney where the injection site was/ side of the body. Outcome of the events was unknown.  Information on lot/batch number has been requested.