chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 4-month-old patient received IPOL and PEDIARIX on the same day no AE; A patient received PEDIARIX in error instead of a stand alone DTap dose no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via nurse via consumer/non-health care professional via Medical Information (MI) (Reference number- 00809307) and transmitted to Sanofi on 12-Oct-2021.  This case involves a 4-month-old male patient who was received POLIOMYELITIS VACCINE (INACTIVATED) IPV (VERO) [IPOL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) on the same day (extra dose administered) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTap) (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and HIB VACCINE for Prophylactic vaccination.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot T1D481M, expiry: 25-Jul-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 12-Oct-2021, the patient received a 0.5 mL dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number and expiry not reported) via intramuscular route in unknown administration site for prophylactic vaccination instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  It was a case of an actual medication error due to extra dose administered and wrong vaccine administered (latency same day).  It was reported "A Nurse wanting to know how to proceed after a 4-month-old received two doses, on the same day, of Inactivated polio vaccine (IPV) in error described as getting the IPOL and the Pediarix vaccine that contains the IPV. The nurse reported that the consumer was ordered to get IPOL and a stand alone DTap dose but in error the Pediarix was given along with the IPOL and that the mother of the consumer wanted the vaccines to be given separately."  No other adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 7 days after receiving my 3rd dose I began breaking out in migrating rashes all over my body. This has been going on for weeks and doesn?t seem to be getting better.  I?ve had blood work done and also show swollen lymph nodes but no infection.  I?m having a punch biopsy this week to see if I?m allergic to PEG.  Not sure what is causing this but it all started after shot. All medications I listed I?ve been taking for the past 6months with no issues.
Patient reports shakiness, dizziness, nausea, abdominal cramping and ringing in ears. Patient was placed on exam table and ice packs placed for comfort. Patient was given vomit bag as a precaution Vitals taken at 2:25 PM BP: 122/85 P:65 - Sitting position Vitals taken at 2:50 PM BP: 110/63 P: 68 - Laying position with legs and head elevated
devel high pitched screaming cry from 1PM to 9PM day of vax; mom states pt was rigid & crying so hard it was difficult to catch breath; MD visit that day & next morning; pt returned to nl behavior 9PM which cont w/no relapse; MD said DT onl
Employee did not provide another date or time of onset to: "Started tripping at work and couldn't feel my feet."
swelling of eyes 10 minutes post vaccination, then tongue swelling and tingling lips. no shortness of breath, Given IM diphenhydramine.  Some improvement of swelling 20 minutes after diphenhydramine, swelling of tongue and lips totally resolved.
1) Elevated body temperature to 100-101 9 days after vaccine administration.  2) Rash macular, erythematous on face, trunk 12 days after vaccine administered.  3) Fatigue 4) White blood cell count 2.0.
Day after 2nd dose of Pfizer COVID vaccine right breast turned red, warm to touch and swollen. I was checked by OB 3 days after the 2nd dose and she also noted redness and irritation on the breast. She suggested to apply hydrocortisone cream and keep an eye on it. It took almost 2 weeks for all the breast symptoms to go away, Currently 24 weeks pregnant, EDD 1/6/22.
Left arm, shoulder pain shortly after receiving vaccine. Now diagnosed with abnormal echo poss, posterial cardiac wall dysfunction, left atrial dysfunction.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX. Concomitant products included atorvastatin. On 4th may 2018 03:00, the patient received the 2nd dose of SHINGRIX. On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, appetite lost, influenza-like symptoms and pain. On 4th May 2018 08:00, the patient experienced lethargy. In May 2018, the patient experienced injected limb mobility decreased. In May 2018, the outcome of the pain in arm, headache, lethargy, appetite lost, influenza-like symptoms, pain in injected limb mobility decreased were recovered/resolved. The reporter considered the pain in arm, headache, lethargy, appetite lost, influenza-like symptoms, pain and injected limb mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The reporter was a GlaxoSmithKline employee. The reporter was at a meeting last night before the late of reporting, where the patient at the meeting mentioned that she had the experienced sore arm that lasted for 2 days. The patient reported that, after receiving the second dose of SHINGRIX it was painful and that she had a hard time moving because of the pain that she had on the same side where she received her shot. The patient also stated that, the side effects were even more severe than that experienced after vaccination with the first dose. Five hours after the vaccination the patient experienced lethargy. The patient stated that she felt lethargic at the point when she went to bed at 8:00 pm, the same night after vaccination, she slept all night and felt flu like symptoms. This case was linked with case US2018081702, reported by the same reporter for the same patient.
No menstrual period for month of January after first period/Late Menstrual Period FEB2022; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (No menstrual period for month of January after first period/Late Menstrual Period FEB2022) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced MENSTRUATION DELAYED (No menstrual period for month of January after first period/Late Menstrual Period FEB2022). In February 2022, MENSTRUATION DELAYED (No menstrual period for month of January after first period/Late Menstrual Period FEB2022) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. After the first shot, patient had no  period for the month of JAN-2022. Her menstrual period came at the beginning of FEB-2022. No treatment medications were reported.   This case was linked to MOD-2022-492309 (Patient Link).
Upset stomach, wanted to vomit but couldn't, headache, loose bowels, fit-full sleep, sweating. Took 1000 mg of Tums. Did not take temperature, but it didn't seem to be very high.
This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Knots on hands that cause pain) and PAIN IN EXTREMITY (Pain in arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NODULE (Knots on hands that cause pain) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, NODULE (Knots on hands that cause pain) had not resolved and PAIN IN EXTREMITY (Pain in arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. No treatment information mentioned. Patient experienced knots on hands that cause pain and pain in arm. On an unknown date, pain in arm was resolved. The reporters causality for event knots on hands with Humira was no reasonably possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A non-serious spontaneous report of gave H1N1 LAIV to a 6 yr old child with asthma was received from a registered nurse concerning a 6-year-old  male. The patient had medical history of asthma. No concomitant medication was reported for this patient. On 17-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter's causality assessments are not applicable, and the event was considered resolved.
Pfizer COVID vaccine #3 given 10/1/21, lot # FF8841; 1/29/22 pt presents to hosp with generalized weakness, nausea and cough; found to be positive for COVID; given O2, remdesivir, baricitinib, dexamethasone; blood cultures positive for MRSA; multi-organ failure; pt conditioned to worsen; DNR; condition deteriorated; made comfort care only; pt passed away in the hospital; DC and med records sent.
arm pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2019, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR067485   Additional Information: GSK receipt date: 31 Mar 2023 This case was reported by a consumer via interactive digital media. The patient had the Shingrix vaccine in October 2019 and the only issue the patient had was a sore arm. Follow up would not be possible.; Sender's Comments:  US-GSK-US2023AMR067485:same patient US-GSK-US2023AMR067485:same patient
some type of bronchitis; felt like she had the flu; sinus infection; It's gradually getting worse; fever; Sore arm; It's getting hotter and bigger; Injection arm hot; Injection arm red; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse) and PYREXIA (fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Intestinal angioedema.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse), PYREXIA (fever), MYALGIA (Sore arm), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE PAIN (Injection arm hot) and VACCINATION SITE ERYTHEMA (Injection arm red). At the time of the report, BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse), PYREXIA (fever) and MYALGIA (Sore arm) outcome was unknown and VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE PAIN (Injection arm hot) and VACCINATION SITE ERYTHEMA (Injection arm red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  Patient stated that she takes pain medication regularly and medications for chronic angioedema of the intestine.   This case was linked to MOD-2021-269277 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-Significant Follow Up Appended On 04-Aug-2021: Follow up information included event outcome updated.
3 weeks after initial dose (4/23/2021), I started experiencing dizziness and a constant mild headache. With the dizziness, there was no visual perception of moving or spinning objects and no proprioception problems. The dizziness is more like a sense of being unsteady and an inability to maintain balance. The feeling has never gone away and persists in any position. On different occasions, many times per hour, there is a sweeping feeling that is never in a persistent direction. On the first day of symptoms, the headache was moderate with a feeling of facial puffiness with an elevated blood pressure near hypertensive crisis levels... which was on a Sunday. The following Wednesday morning, I visited the Emergency room at 0034 EST 5/19/2021 because the dizziness was not getting better. A review of systems was performed with no abnormal results. EKG was normal. Cranial CT scan showed no indications of stroke either although I have not looked at it myself yet.  Blood sugar level was at 90. Chem12 test was normal.  Well for more details, please contact me. Session is about to time out and I don't know how to extend it on my phone.  I have tried vestibular therapy motions. None improved the dizziness. I also have intermittent fog and below normal focus capacity.
Pt was given DTaP on 7/6/04. Mom brought him in c/o erythema to left deltoid s/p DTaP x 2 days. Evaluated by MD. Recommended ice to arm. Tylenol PRN, if Sx worsen return to clinic
Two days after the shot, large lumps on the back and sides of the head formed and cause throbbing pain. Headaches often occur throughout the day. Extreme burning and pain are present daily to this day (May 08, 2018).
BODY ACHES; EXTREME FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme fatigue and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210407180.
Within an hour of the vaccines, mother recalls her being fussy and shortly thereafter developing a fever.  She had a fever up to 103 and noticably stopped using her legs voluntarily.  She normally puts her feet in her mouth and she was not even flexing her hips much.
I experienced lips and throat swelled, shortness of breath, chest tightness, eyes turned red, became very hot, dizzy, nausea, headaches, diarrhea, and heart palpitations. I alerted the nurse at the location where the vaccine was administered and needed to use my inhaler (only helped my symptoms a little and I still felt like someone was choking me). I was given Benadryl and upon arriving home, my husband noticed that my jaw was trembling. I called urgent care the following day to see a doctor for treatment. My symptoms seems as though I was having a stroke. I am presently experiencing blurred vision (prescription glasses are not a year old yet). I am continuing to have symptoms that make me feel like someone is choking me and have scheduled a phone appointment with my doctor on 11/02/2021 because I am still having breathing issues. He prescribed flunisolide nasal spray .025% and clindamycin HCL 150mg; however, I'm still experiencing the same symptoms.
pt recv expired MMR vax on 10jan95;f/u in jan95 pt exp inguinal lymphadenitis, MD stated also pt had an allergy to Cefprozil which caused rash;also URI at time of 1st dose;subsequently recovered;
site pain, inc to the shoulder; 2 days later chest, arms & neck felt hot, a rash devel SOB, high pulse; MD dx poss vaccine react;
Injection site rash, noticed 3 days ago from PCV 13 - Recommended hydrocortisone 1% topical and OTC oral Claritin. Instructed to watch for worsening symptoms, increased redness, swelling, pain, and  anaphylaxis.
2 days after immunizations, had 2 days of high fevers "105 -106" per parents, a few sores with vesicles at site of VARICELLA vaccine.
Swelling, redness, quickly turning into blisters then into one giant massive blister, massive swelling all in arm of shot site, headache, shoulder pain, fever, severe pain. Continued swelling, pain, itching and redness going down arm past elbow.
sore legs,fever 103,glands sore/swollen,muscles sore,feels weak,cough,congestion x 4-5 days called MD;
Presented from home for N/V/D. CXR showed opacities, COVID PNA. Tx w/ supplemental O2, abx, steroids, remdesivir. Hx HTN, Type II DM. At time of DC stable on 2.5L. DCd to SNF.
Red circle appeared 2-3 days after vaccine administration on Left Deltoid where vaccine was given.  Skin changes noted and still evident 6 weeks later.  Skin is rough and scaly, no masses or thickening noted at site. No enlarged L axillary nodes.  Patient c/o feeling weak for last month.
10 minutes after the injection my right arm was very heavy and tingle-y and my thumb throbbed. Almost 5 hours later, the sharp pain in my right arm has only intensified, though mostly concentrated about the injection site.  3.5 hours after the injection I felt a sharp pain radiate through my right hip to my inner right pelvic area. This sharp pain began pulsating, localized to the right inner pelvic area, nearly 6 times over the next 5 minutes and then dissipated. This same sensation was repeated about 1.5 hours later. That was when I decided to report my reaction thus far to the Moderna dose #1 COVID-19 vaccination.
Pt c/o redness and warmth to injection site one day post vaccine.  No treatment was needed.
Pt states that his arm immediately hurt after the injection.  It was given high on the arm so I suspect the vaccine was injected into his left bursa.  The pain was described as an 11/10 and that he could not lift or move his arm.  2 days later he called the pharmacy to report his side effect that he is still having pain not managed by acetaminophen and while the pain is better it is still present and he still has difficulty moving his arm.
Six days after TD shot, I had a delayed reaction to my right upper arm with severe pain. Treatment was naproxen and cephalexin.
11:57am C/O difficulty breathing. Vital signs:  118/68  101  16;  12:10pm  112/68  74  16;  12:25pm  112/70  71  16;    Disposition:  Patient left with Mother.  No signs of distress. Full ambulatory.
Patients daughter reported she was in extreme pain not controlled with Hydrocodone.  She could not lift her arm. (it was not red or inflamed) She was feeling awful. Her whole body hurt.
Cold like symptoms  such as runny nose,  stuffy nose,  sneezing,,,,, severe back pain. Cold symptoms were done morning of the 26th and back pain lessened by that afternoon.
Developed tender, subcutaneous nodules both thighs where he had been given vaccines. Pt's twin received the same vaccines but had no reaction.
Dizzy/woozy; Heavy head pressure; Headache; High pitched ringing in right ear, off and on; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW969) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), oenothera biennis oil (PRIMROSE OIL), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 10:00, the patient experienced dizzy, woozy, heavy head pressure, headache, constant high-pitched ringing in right ear (on and off) and extreme fatigue began the day after first vaccine and had continued ever since, the ear ringing had become more constant. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, dizzy, woozy, heavy head pressure, headache, constant high-pitched ringing in right ear (on and off) and extreme fatigue began the day after first vaccine and had continued ever since, the ear ringing had become more constant were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Received Moderna vaccines on 12/31/20, 1/28/21; Pfizer vaccine on 12/17/21; tested positive COVID home test on 5/17/22, positive COVID PCR on 5/18/22; admitted to hospital on 5/18/22 d/t SOB, COVID infection. Underlying morbid obesity, sleep apnea, asthma, Type II DM
I became symptomatic with chills, fever, and cold symptoms. I had a runny nose, watery eyes. I treated myself with DAYQUIL and NYQUIL as well as extra strength TYLENOL. After Midnight on Wednesday the 28th, I had fever and chills. I took NYQUIL for those symptoms and took a test that morning for COVID-19 which was positive. I then had a virtual visit with my physicians assistant who prescribed PAXLOVID. I have been taking it for 1 day. My symptoms improved and I feel like I completely recovered but I am still isolating.
Fever from 2am to 2pm the next day, body aches continue past 2pm and after fever is gone
N17.9 - Acute renal failure (ARF) (CMS/HCC) GROIN SWELLING URINARY PROBLEM CONSTIPATION