chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients administered Moderna vaccine while temperature excursion assessment was ongoing.; patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that because their facility was not been able to download the digital data logger, they have been put on hold by the local Health Authority at the movement and were not administering the Moderna COVID-19 vaccine to the patients until an assessment was made by the local Health Authority. The reporter also stated that there had been no power outages that would have impacted the Moderna vaccine. The reporter stated that however, because their facility was unable to download the digital data logger, they treated this issue as a temperature excursion. It was also reported that the data logger which was unable to download was for the months of Dec-2021, Jan-2022 and Feb-2022. Reporter stated that no adverse reactions were reported by any patients.  No concomitant medications were reported.  No treatment medications were reported.
76-year-old female patient comes in complaining of left neck pain that she first noted approximately 1 week ago.  Has been getting worse over the last several days.  Worse with palpation.  Worse when she moves her neck.  Patient has noticed a large mass at the base of her left neck that she states was previously not there 1 week ago.  Also has some mild edema in the left lower extremity. CT imaging suggestive of extensive cellulitis changes/infectious process.
On 11 Dec 2018, patient presented to ER for evaluation of midsternal, pleuritic chest pain characterized as a tightness, which began morning of 10 Dec, made worse with deep inspiration, and laying supine. Patient notes that the pain was intermittent throughout most the day (12/10/18), but after he awoke from sleep, the pain became constant. He was admitted x 24 hours. He was discharged on ASA 975 mg 3x/day until symptom free x 24 hours, then 2x/day x 1 week, then once daily x 1 week, with colchicine 0.6mg BID x 3 months. (Also, placed on Protonix daily) Activity restriction x 6 months.
Pt recvd vax in 1983 & exp arthralgia for nearly a yr following last vax; pt was also found to be non-responder in 1988; was subsequently administered a dose of Hep B in 1991; following exam on 21FEB93 MD felt pt poss have fibromyalgia;
"Quarter-sized" red, swollen, lump; painful x 5d, beginning 2d after admin lump decreased in size, still persists about "pea-sized."
RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 28 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was 211A21A expiry: unknown) 0.25 ml, 1 total, administered on 27-NOV-2021 for prophylactic vaccination (Dose number in series is 2). No concomitant medications were reported.  On 27-NOV-2021, the patient received half dose for their booster dose (coded as vaccine under dose and off label use). As described by reporter, HCP (health care provider) (from public health dept) stated that there were 33 patients who received half doses (0.25ml (milliliter) for their booster or 3rd dose a few days ago. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through VAERS. HCP thought that the vendor will file the report with VAERS, not public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated that Spartan is the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports.(Dose number in series is 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211200717, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871 and 20211220152.
started with a headache then slight nasue. Turned to dizzyness. Entered the ems room where vitals were taken and patient was evaluated. Patient drank some water and sat down. After 20min the patient began to feel better.
Information has been received from a 61 year old female patient concerning herself with no drug allergies. The patient's pertinent medical history included high blood pressure. On 10-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (strength, lot # and expiration date not reported) 1 shot, intramuscularly. Concomitant therapies included atorvastatin, losartan (manufacturer unknown), diazepam (manufacturer unknown), metformin and metitepine. In the evening of 10-DEC-2015, a rash under both her arms developed, that was black and "all of the hair went away". the rash was extremely painful to the touch. The rash then turned pink (date unspecified), then red (date unspecified). The patient had sought medical attention by having appointments with several doctors. Lab diagnostics studies were not performed. Her doctor had give her clotrimazole (manufacturer unknown) (MARRS#: 1605USA001588), betamethasone cream (manufacturer unknown) (MARRS#: 1605USA001592), triamcinolone, acetonide cream and BENADRYL as treatment for the events, but she had found all of them ineffective. The outcome of the events was reported as not recovered. The causal relationship between the events and ZOSTAVAX was unknown. This is one of several cases regarding the same patient. Additional information has been requested.
Few hours after shots evening time/bedtime work up with severe pain and some fever and had seizure-like symptoms had to call 9-1-1.
Shortly after receiving my second dose of the Pfizer vaccine on 30 Mar 2021, there was insidious and unilateral onset of pain of the left shoulder that quickly amplified in severity and intensity.  This pain was subsequently replaced over the ensuing days and weeks with progressive weakness, reflex changes, and sensory abnormalities in shoulder girdle musculature and proximal upper limb. The progressive neurologic deficits of motor weakness, dysesthesias, and numbness have persisted.  Subsequent tests (MRIs and EMGs) have been ordered to confirm and/or rule out possible causes of the event.
As I was leaving the hospital I started feeling VERY cold. My husband got a blanket from the back of the car, put quickly got MUCH worse. I was moaning uncontrollably. My mouth and throat got very dry. Vomited at least 3-4 times. After a 15 minute ride home, I got under a few blankets, and fell asleep for about 2 hrs. I felt like none of it happened when I woke up.
Ony July 29th contracted Covid-19. Currently isolating at home for 5 days.
Flu shot 11-17-16, pain continued and became severe, examined by family physician, referred to ortho specialist, anti inflammatories did not help, MRI, steroid shot, temporary relief, pain returned. Loss of sleep, work, surgery 3-2-17, 9 weeks of physical therapy.
Patient had Janssen COVID vaccine on 5/11/2021, and was hospitalized with COVID acute respiratory failure on 12/11/2021
The patient was due for her updated bivalent vaccine. They received the monovalent vaccine after the FDA and CDC discontinued the administration of this vaccine. The vaccine was also expired as of 12/31/22.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (lot number and expiry date unknown) (dosing regimen and frequency unknown) that was stored correctly. No concomitant medications were reported. No adverse events were reported. No product quality issue was reported. This case is related to case number 1405USA007252 and 1405USA008990 via same reporter link. Additional information has been requested.
Sore arm, red spot the size of a half dollar at injection site, body aches, chills, fever, nausea, headache.
MUSCLE PAIN THROUGHOUT THE BODY; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced muscle pain throughout the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain throughout the body. This report was non-serious.
Two days after injection she noted a red, swollen spot at injection site on left deltoid. Hot to touch. Applying ice and taking IBU, states today it looks and feels better.
we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist reporting that 12 doses were given within the 12 hour time limit from time of first puncture from 3 refrigerated vials, but the 3 vials had been refrigerated for 31 & 32 days.  Concomitant product use was not provided.  Treatment product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant Follow-up received on 07-Sep-2021. Reporter's Salutation, fax number and phone number were updated. Patient Initials, Patient's notes were changed. Batch/lot number for suspect product was added. Action taken, Re-challenge and De-challenge of suspect product were updated. Outcome of event was updated. Product event details were updated. Narrative from the source was added
Rash started on May 13 after second dose of Pfizer Covid Vaccine.     Irregular Menstrual Cycle started on May 16
Extreme arm & shoulder pain (unable to move arm & shoulder, unable to bear weight on arm or shoulder while sleeping, redness from shoulder down to elbow, fever of 102 degrees, anxiety & insomnia due to pain.
slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight headache). At the time of the report, HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
Bell's Palsy; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Bell's Palsy.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09 Feb 2021 he patient received their first of two planned doses of mRNA-1273 (BATCH # 042C20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   Consumer was a 70-year-old male that received the first dose of the Moderna COVID-19 vaccine on 09 Feb 2021, in the left upper arm. The patient experienced Bell's Palsy after the first dose on 09 Feb 2021.  No further information was reported.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the event Bell's Palsy was unknown.  The reporter did not provide an assessment for the event, Bell's Palsy.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Tdap and MENACTRA given in left deltoid area and warmth, swelling, erythema at and around injection site after 2 days. No fever, KEFLEX given on 10/1/15. Also told to give BENADRYL and apply cool compresses.
nurse administered the DTAP-IPV component to the patient without reconstituting the HIB component with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 18 months old female patient who experienced nurse administered the diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] component to the patient without reconstituting the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot UJ849AA via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (poor quality product administered) (latency- same day).  Reportedly, only the DTAP-IPV component was given and not the HIB component. As per caller one of their nurses was rushing and did not realize there is a 2nd vial. The nurse administered the DTAP-IPV component to the patient without reconstituting the HIB component  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
On Nov. 1, the day after the vaccine, I noticed a 1" x 2" raised red wheal that was hot, hard and very sore. I contacted the doctor on Nov 2, and they advised warm moist heat 20 minutes, 4 times a day. They were going to add prednisone, but I was already on prednisone, so we added BENADRYL. Today, November 5, the injection site is pink, no heat, not raised, but still sore. The doctor did offer to see me on Friday Nov 2, but I wanted to try the heat and BENADRYL first and see them only if it didn't improve (or if it worsened).
Information has been received from a nurse practitioner concerning a 7 year old male patient with upper respiratory tract infection, and no medical history who on 5/29/96 was vaccinated by SC injection in the arm with a first dose of varicella virus vacine live (lot # 609287/0393B). Concomitant medication administered on the same day, 5/29/96 via SC injection in the right arm included a first dose of MMR (lot # 616874/0104D). The reporter indicated the patient broke out in a varicella rash, described as pruritic, maculopapular vesicular lesions, approximately 50 lesions on 3/23/03, (also reported by the health professional as began 3/24/03). It was noted no laboratory tests were done. The reporter noted the patient recovered.
6 days after the injection I suffered a massive heart attack of the Left Anterior Descending Artery with no prior heart history, less than a month earlier I had a physical with bloodwork and all cholesterol levels were normal, the doctors have not been able to give a real reason as to why this happen except I had a blockage but no explanation of why as my cholesterol levels are normal.
Sudden onset of diplopia, blurred vision  on April 21, 2021 with frequent headaches and right orbital and eye pain.
PATIENT STATES SHE STARTING EXPERIENCING TINGLING IN HER ARMS (LASTING 15MINS-1HOUR) THAT COMES AND GOES, PAIN, FATIGUE, AND A FLUID-LIKE POCKET THAT IS WARM TO THE TOUCH. HER SYMPTOMS BEGAN ABOUT A WEEK AFTER RECEIVING THE SHOT AND ARE STILL ON-GOING 2 WEEKS LATER.
6/10/2022 mild congestion, mild consistent cough as of pm; 6/12 sinus, ear, head congestion, moderate consistent cough, constant cough when laying down, positive test for COVID, Advil sinus 2x/day; 6/13 sinus, ear, head congestion, constant serious cough, hoarse voice, Paxlovid, Advil sinus every4 hours daytime, Guaifenesin/Codeine 100-10mg/5ml Sol at night; 6/14 - 6/16 all previous symptoms + moderate fatigue, medication same as prior days; 6/18 mild congestion, mild cough, hoarse voice, finish Paxlovid, continue Advil sinus every 6 hours, negative test Covid; 6/21 - 7/4 easily fatigued, mild congestion in ears & head, periodic coughing, hoarse voice, Advil sinus 2x/day; 7/5 to present same symptoms, no drugs
Revaccination with different Covid-19 vaccine; interchange of vaccine products; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    The patient's past medical history included Bariatric surgery in December 2020. Concurrent medical conditions included Hidradenitis suppurativa. Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   On 20-Aug-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FATIGUE (Fatigue). On 20-Sep-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, FATIGUE (Fatigue), COVID-19 IMMUNISATION (Revaccination with different Covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication were not reported.
expired dose of Pentacel was inadvertently administered to a patient, no AE; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who inadvertently administered with 0.5 ml dose of expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: C5466AB, Expiry Date: 05-Sep-2019) via intramuscular route in the right thigh on 16-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no adverse event.  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 Directive and Module VI of the practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.