chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml).    This case contains information about the 19th patient out of 27 patients as described by the reporter.  All the patients were over the age of 65 years.  No concomitant medications were reported.  The first booster dose of vaccine was administered in the deltoid site.  On 10-May-2023, 27 patients received 0.25 ml booster dose of the Moderna bivalent vaccine instead of 0.5 ml dose.  On 11-May-2023, 26 patients were contacted, and on 12-May-2023, 18 patients received an additional 0.25 ml booster dose, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25 ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be contacted by phone.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Patient claim right arm & shoulder pain occurred right after (ie within 24 hours) Tetanus injection. Patient developed RDS of arm and was found to have Brachial plexus syndrome that was not causing any symptoms UNTIL after injection. 06/09/2005:  Patient has not recovered.  Residual symptoms include chronic pain syndrome, thoracic outlet syndrom with right lower trunk pelsxopathy causing right arm pain and hand weakness.
took 2nd capsule & about 1 hr later exp nausea; then had vomiting & diarrhea & stomache cramping; felt this way for about 5 hrs; then abdo pain for about 1 hr; feels tired;
Delayed cutaneous hypersensitivity (COVID Arm), redness, swelling, itchiness in a two to three inch area around the injection site.
The Bi-Valent Pfizer Covid booster with the Orange Cap, for ages 5-11 was put in the Mono-valent Orange Cap 5-11 spot and used, and the Bi-valent was used instead of the Mono-valent for the first in the series. The parents were contacted immediately and the incident was recorded and discussed with the providers at the time.
Upon administration, patient states that the injection site hurt and occasionally pain shot down her arm. In the first 2 weeks, she was unable to lift her arm above shoulder level. In our first post-admin conversation, we discussed injection site and I determined that the vaccine admin was not in the bursa, which was primary concern. Patient stated that things seemed to be improving, so we decided to watch and wait.      12/26- When patient lifts her arm over her head for more than 20-30 minutes, she cannot pull it down on her own, she has to use her other arm to pull it down. She saw her Dr and asked about it, and he wonders if the nerve was hit and causing these issues (per patient, the Dr's wife had a similar problem that resolved in about 6 weeks). Patient also states today that she has had some arm pain that moves around. Initially at the injection site, then at the front of her shoulder (near the joint), then the back of her shoulder (near the joint), and then again at the injection site.
First shot: within 2 hours-headache, joint achiness, dry cough. Symptoms lasted 6 hours Second shot; after 18 hours: dry hacking cough-turned productive with phlegm, body aches, fever-100.1, lethargy. Resolved after 12 hours.
This spontaneous retrospective pregnancy report was received from a registered nurse refers to an approximately 17-year-old female patient. On an unknown date in December 2011 the patient was vaccinated with a dose of 0.5 milliliter (ml) live (Merck) VARIVAX (lot# 0711AA, expiration date 09-JAN-2011) subcutaneously. Other suspect therapies included M-M-R II (lot#, expiration date and route not reported) on 09-JAN-2012 and GARDASIL (lot#, expiration date and route not reported) on 09-JAN-2012. The patient became pregnant on an unknown date, The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) is not known. Patient was vaccinated before realizing she was pregnant. The patient gave birth on an unspecified date after carrying the baby full term. Nurse reported that the baby was healthy and suffered no known complications. No further information available. Additional information has been requested.
Clinical Summary Patient is a 84 y.o. male with a history of T2DM, HTN, dementia who presented to hospital 12/31/2022 with fall, cough and congestion. Found to have COVID-19 pneumonia and acute respiratory failure. Hospital course complicated by placement; however he improved and was discharged home with HHC.    1. COVID 19 pneumonia: partially vaccinated. Symptom onset 12/25/22, COVID-19 test positive on 12/31/22. Completed 5 days of Remdesivir 1/7/23. Stopped Decadron 1/5/23 due to insomnia.  2. Acute hypoxic respiratory failure: no baseline needs, required 4L on admit. Admit CXR with bilateral lower lobe consolidations. Due to COVID infection, weaned to room-air since 1/3/23.  3. Acute Metabolic Acidosis: likely 2/2 minimal PO intake. Given IVFs with bicarb with improvement.  4. Fall: with head trauma. CT head and CT C spine nonacute on admit. Trauma-Surgery signed off.  5. Acute Metabolic Encephalopathy with Chronic Dementia: mild symptoms with recall difficulties at baseline. Worsening due to infection, hospital associated delirium with known dementia. Delirium precautions, supportive care.  6. AKI on CKD2: baseline Cr 0.9--1.1, Cr 1.3 on admit. Held ARB. Resolved since 1/5/23.  7. HTN: Held home ARB due to AKI. Resume as needed.
41 yo F with asthma, hypothyroidism, and epilepsy and history of anaphylactic reaction to Janssen Covid19 vaccine on 4/9/21 (lot # 043A21A) presented to Clinic on 1/14/22 for vaccination with Pfizer Covid19 vaccine.  Vaccination (lot # FL3198) was given in left deltoid at ~0800 1/14/22 and within 2 minutes patient was reporting difficulty breathing.  Face was erythematous.  Patient was holding her throat.  Emergency epinephrine given IM in left thigh at 0826 and patient was transported to ED via EMS.  Patient treated with famotidine, epinephrine SC and methylprednisolone and has required IV fluids and start of epinephrine drip for low BP.  Admitted to ICU due to shock, initially thought to be anaphylactic in setting of COVID vaccination.  Normal tryptase.  Patient had refractory hypotension and bradycardia, newly reduced EF on point of care concerning for dilated cardiomyopathy of uncertain etiology and acute HFrEF.s   Patient is still in ICU as of 1/18/22 with some hypotension.  Prior to admission, last documented HR and BP from 1/3/22 were 96/59 and HR 64.
Patient is experiencing fever, swelling, chills, irritation/redness, lots of soreness.
Patient is an 85-year-old man with past medical history significant for non O2 dependent chronic obstructive pulmonary disease though he had previous COVID-19 pneumonia requiring supplemental oxygen at discharge in 2020. Patient presenting with increased shortness of breath and cough.  Found to be hypoxic requiring 4 L by nasal cannula on admission.  Chest x-ray demonstrating stable diffuse bilateral interstitial lung disease.  Started on Decadron and DuoNebs.  Patient had a quick response to treatment and was weaned down to 1 L. Evaluated by pulmonary rehab who recommended 1 liter/minute at rest and 2 liters/minutes with activity.  PT and OT evaluated patient and recommended home with assist but no needs identified as far as equipment at the time of discharge.  Patient was discharged to complete 10 days total of oral Decadron.  Discharged home in medically stable condition.
Fever - 101 degrees. Achy legs. Sore throat. Fatigue.
Starting July 24th through the 29th I had decreased range of motion of my left arm. On the 29th I went to Orthopedic Clinic and they x-rayed me. I got a cortisone shot in my left shoulder. I was out of work after that for four weeks. The x-ray showed calcific tendinitis in the exact spot that I received the first and second shot of the vaccine. I attended physical therapy for three weeks as well.
Patient developed a rash all over arms and chest the morning after receiving the shot.  He took 2 doses of Benadryl and the rash subsided.
About 4 hours after the second dose I began the most intense headache I have ever had.  I kept expecting it to go away.  After 10 days of enduring this I went to the ER.  I was admitted with blood clots and bleeding from the face. (but probably more wrong)  I was initially treated for a PE and meds to try to stop the headache.  Nothing seemed to work.  About 3 days into the hospital stay, my pre-existing Stills disorder began to show.  I was then treated with 60mg of prednisone daily to control the Stills.  About the same time, we discovered that a standard migraine medicine would control the extreme headache, morphine would not.  My CRP results were off the charts and almost 4 months later it is still high.  My treating doc says 2 more months of prednisone treatment.  I had an immediate weight loss of 25 pounds in the hospital.  I am struggling to this day to put the weight back on.  I have lost hearing in my left ear as a result.
Headache, Fever, Nausea, and Pain in Arm lasting about 2 days.
Pt vaccinated w/DTP/MMR/OPV/HIB developed intermittent rash beginning 22DEC90. Rash on buttocks & back. Red & blotchy. Slighly raised. Rash is less pronounced but still present 10JAN91.
Father noted little redness at site of injection on 9/30/14 after taking off bandaide. 10/1/14 noted more redness around the injection site and was speading by 10/2/14. Took child to ED in the am on 10/2/14 and follow up here this afternoon at the clinic. ED gave a prescription of Keflex and provider advised to give Benadryl as needed.
The pt arrived on 8/7/12. He received multiple vaccinations on 8/8/12 at which time he was in his normal state of good health. He reported that he had no local reactions (erythema, pain, swelling or tenderness). Additionally he denied any systemic reactions (headache, body aches, fever, chills, N, V, diarrhea). The pt noted a "pins and needles" sensation in his toes and fingers on 8/17/12 which progressed to his hands and feet the same day. He reported to medical on 8/20/12. At that time he was afebrile and his neurological exam was normal. The pt was started on Prednisone 60mg/day for inflammation. On 8/21/12 the pt noted "chest tightness" which he described as "difficulty taking an adequate breath" and no change in the tingling in his hands and feet--his neuro exam was normal and the pt was placed on 48 hours SIQ. On 8/23/12 the pt complained of left shoulder pain (6/10) with numbness and tingling in his arms and legs and difficulty walking due to "weakness". On PE grip weakness (L>R), left shoulder weakness, an abnormal wide gait and decreased reflexes of L4 were noted. The pt was referred to Neurology and was subsequently admitted to Hospital with the diagnosis of Guillain-Barre Syndrome. On admission to the hospital the pt reported new onset of: difficulty swallowing; pain in his left deltoid, mid back and neck; and a mild cough and nasal congestion. He was noted to have decreased BUE/BLE reflexes and motor strength, bilateral weak grip strength and impaired coordination on exam. A NCS and Swallow test were performed (both were abnormal: see results below); the pt was admitted to ICU and started on IVIG 500mg/kg/day for 4 days. He denied incontinence (bowel or bladder) but he did state that he was no longer experiencing morning or night time erections. The pt also reports that his cough worsened and from 8/24-8/26 his cough was productive with thick yellow secretions. He denied rhinorrhea, sneezing, fever, chills, N, V, diarrhea. The pt was NPO and self suctioned to manage his secretions (he was able to move his right forearm). When the pt was transferred to the acute rehab center on 8/28/12 he was able to move all four extremities although with difficulty. His strength was 4/5 in all four extremities and he was areflexic. A repeat swallow test showed improvement. Intensive speech, physical and occupational therapy were initiated. A review of medical records of 9/26/12 indicate that the pt is able to ambulate without assistance; his strength and endurance continue to improve although the pt requires rest breaks during therapy secondary to fatigue; the pt performed lower than expected on standard balance testing. The pt remains at the acute rehab center.
After receiving the vaccine it resulted in an adverse reaction. Pain and unable to lift my arm over the course of multiple days. It?s Friday and still unable to use it without intense level of pain and discomfort. I?ve never had a reaction to a flu shot ever before and the first time I get this one after asking if it was a traditional vaccine and told it was, I get it and have a reaction like I?ve never had and have been experiencing greater than normal pain, discomfort and unable to use my arm as doing so results in tremendous pain.
Pt recv vax on 11/17/98; 5 hr post vax pt exp malaise, fever, headache, unable to bend arm LA (2 day), burning sensation; 11/18 red, hot, raised area of LA
Ringing in ears.  I started getting ringing in ears over a year ago.  I had previous Moderna vaccines.  I did not associate it until this time.  This time the ringing got much stronger right after the vaccine.  It is constant.
Headache Narrative: CHILLS, fever, body ache, fatigue  Other Relevant History:
Information has been received from a physician concerning a 12 month old male who was vaccinated with a first dose of PROQUAD. It was reported that the patient developed light vesicles around injection site. The patient was advised by the physician to apply hydrocortisone cream at the injection site. A product quality complaint was not involved. Additional information has been requested.
rash lasted for 6 days;mom said 35-45 bumps on body;MD dx ;fever for 2 days, max T101;APAP given;
1 day after vaccination, heart rate increased to 152 bpm, both arms went numb, and contracted thereafter, numbness became generalized throughout the body with muscle jerks in extremities. Unable to stand and walk without assistance with tachycardia. Went to ED 3 days post-vaccine regained the ability to walk without assistance and no further muscle numbness or jerks, tachycardia subsided. The onset of persistent diarrhea 3 days post-vaccine.
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion.; No additional AE; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W025274, expirtion date 10-AUG-2024, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The vaccine underwent temperature excursion before administration for 5 hours 51 minutes in 24.4 degree Fahrenheit (F) (Product storage error). No other adverse events were reported.  Lot number #W025274 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck).
Loss of muscular use to left side of face. Dx with Bells Palsy per Dr. in ER. DOS 11/16/06- DX Bells Palsy. Left sided facial numbness onset 11/15/26 evening. Left eye felt funny, then numbness started. Unable to wrinkle forehead. Eye will not close. Left facial droop. RX wtih prednisone, acyclovir.
Been having headaches in the afternoon, a lot of stiffness in the back of the head.
Severe itching and hives including on scalp and bottom of feet for up to a week after receiving shot.
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff). This case involves a 54 years old male patient who received a 0.5 ml dose of FLUZONE QUADRIVALENT intramuscularly in left deltoid on 16-Nov-2018 (lot number: QFAA1835, expiry date: 30-Jun-2019). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy reported. It was actual medication error (Incorrect product storage) because it was reported that vaccine refrigerator experienced a temperature excursion, which reached a low temperature of -0.78 degrees celsius and was out of range for 1 hour, the patient was administered fluzone quad only, as well as potential medication error as other vaccines ADACEL, MENACTRA, FLUBLOK QIV, FLUZONE HIGH DOSE and FLUZONE QUADRIVALENT and TUBERSOL were exposed to temperature excursion only and not administered. It was not reported if the patient experienced any 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 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. List of document held: none.
Started to ache all over body and back and legs. Lungs feel congested; some shortness of breath and was advised to go to ER immediately or call 911. At 10:15, pharmacy called, not usual adverse reaction. 24 hours adverse effect called in ER. No long term effects. Given pain Rx of Darvacet.
2/18 received shot, 2/19 onset of swelling, hardness, redness, tenderness, soreness,hot to the touch which increased to greater than palm sized by 2/20. I also experienced fatigue. By 2/23 it had faded to dime sized, but was still hot, red, and hurt to touch. By 2/25 it was almost gone, but on 2/26 all symptoms started to return and increase. Itchiness and pain were the first symptoms.  By 2/28, there was a large red ring around the swollen injection area that spread across the arm (where it had not in the initial days following the injection), was larger (hand-sized), and accompanied by a sore throat, cough, and runny nose. I applied cortizone cream and took Benadryl until 3/2 when the reaction began to subside again. There is still a red mark on my arm, but the swelling, itchiness, heat, soreness are gone.
Pt reports rcvd vax on10/19/99.  On 11/7/99 c/o fatigue, terrible pains in legs, upper back, lost 10 pounds and was put on prednisone.
Sore injection site, lump and warm; Sore injection site, lump and warm; Sore injection site, lump and warm; This is a spontaneous report from a contactable Other-HCP. A 65-year-old female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL12F3), at single dose into the right arm on 14Jan2021 at 01:15 PM for COVID-19 immunization. Medical history was none. The patient had no history of allergies to medications, food, or other products. The patient had a negative Covid test Nasal Swab on 20Nov2020. Concomitant medications included Omeprazole, Atorvastatin, Buspirone, Lisinopril. On 15Jan2021 at 9:00 AM the patient experienced sore injection site, lump and warm. No treatment was received. The events were considered non-serious. The outcome of the events was not recovered.
pain in the muscle area where she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the muscle area where she got the vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included BUSPIRONE, DULOXETINE, LAMOTRIGINE, TOPIRAMATE, c-Dextro HBR, IBUPROFEN, METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN), GABAPENTIN, METOLAZONE, BUMETANIDE (BUMEX), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), L-METHYLFOLATE, LURASIDONE, LEVOTHYROXINE, SPIRONOLACTONE, SUVOREXANT (BELSOMRA), TRIAMCINOLONE ACETONIDE (NASACORT), MACROGOL 3350 (DULCOLAX BALANCE), GUAIFENESIN (MUCINEX) and MECOBALAMIN (B12 SHOT) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (pain in the muscle area where she got the vaccine). At the time of the report, MYALGIA (pain in the muscle area where she got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment given
HEALTHCARE WORKER IN PROXIMITY OF TWO-THREE OTHER INDIVIDUALS WHO WERE GIVEN THE SMALL POX VACCINE.  ABOVE PERSON DID NOT TOUCH VAIL, CHANGE DRESSING, OR COME INTO ANY KNOWN DIRECT CONTACT WITH VACCINE.  PRESENTED TO LOCAL ER SUNDAY 4/6/03 WITH POX-LIKE RASH DISTRIBUTED MAINLY ON TRUNK--OTHERWISE TOTALLY ASYMPTOMATIC--NO FEVER, NO MALAISE, NO PAIN, NO ITCHING.  INSTRUCTED TO KEEP "RASH" COVERED AND BE CAUTIOUS.  PRIMARY CARE PROVIDER WILL BE SEEING CLIENT SOMETIME TODAY TO EVALUATE.
Respiratory disorder. A nsg reported a pt with medical history of possible latex allergy, received his 1st doses of Prevnar, Hib-TITER, IPOL and DTaP vaccines on 1/21/01. On 3/19/01, when he was 5 months old the infant's mother reported to the pediatrician that the infant developed respiratory difficulty, wheezing and oral thrush. A copy of this report has been forwarded to Aventis Pasteur.
Arms, legs, hands & feet broke out in hives - dime to quarter size which lasted until approximately 4/8/16. Then small red dots with small white centers appeared on extremities until 4/26/16. I treated the hives with over the counter antihistamine and when they continued I went to the doctor and was given a prescription antihistamine and a steroid injection. Although this helped relieve the itching somewhat it did not keep the hives and spots from continuing. On 4/18/16 I went to a allergist to determine if it was a food allergy - he could not determine if the reaction was from the shot but the test indicated I was allergic to eggs which I have never been allergic to before and seldom eat.
Very sore arm morning of, could hardly move it. Headache and body aches. Chills and sweats. Drowsiness.