chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hands got cold immediately; Scratchy throat; Nasal congestion; Chills; Low grade fever; Upper arm pain at the site of injection; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills) and PYREXIA (Low grade fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020, Chills in April 2020, Pyrexia in April 2020, Nasal congestion in April 2020, Fatigue in April 2020, Throat irritation in April 2020 and Peripheral coldness in April 2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills), PYREXIA (Low grade fever), VACCINATION SITE PAIN (Upper arm pain at the site of injection) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills), PYREXIA (Low grade fever), VACCINATION SITE PAIN (Upper arm pain at the site of injection) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Approximately 10 minutes after injection my ears got hit and my face flushed. At about 25 minutes after injection I started to feel my heart race. Medical staff took my pulse and it was extremely high. My blood pressure even on all of my meds was 205/112. My resting pulse topped a little over 140 during monitoring. After about an hour my pulse was 110 and my BP was 190/95 and I went home to rest.  Called my physician a couple days after and alerted him. Monitored BP at home that day and it continued to go back to my normal. By that evening I was back to my baseline.  Other symptoms following day extremely painful arm cold sweats and feeling of unwell all which I know are common side effect. My pulse racing was extremely scary in that I have a hard time raising my pulse when I exercise due to my medication.
Initial report received from a healthcare professional who is also the patient on 23 October 2012. A 54-year-old female patient with medical history of hypertension, high cholesterol and hysterectomy; had received intradermal (ID) ADACEL vaccine (Lot number C4023AA) in left forearm 22 October 2012. The patient also received Tubersol intradermal in right forearm (Lot number not reported) on 23 October 2012. The patient had no illness at the time of vaccination. The patient received ADACEL intradermal instead of intramuscular. Thus ADACEL was adminsitered through wrong route. After 12 hours, the patient had half dollar sized red area with hard lump at injection site. The patient was treated with ice compresses and ibuprofen every 4 hours. Corrective treatment and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: None. Follow-up information received from a healthcare professional who is also a patient on 11 March 2013. It was reported that on 24 October 2012, patient visited his personal physician and physician given him Prednisone dose pack to take. It was reported that small knot was remained, patient applied Aloe Vera plant to area, spot the reduced. 1/2 CM circle of discoloration remains. On an unspecified date, the patient had recovered from the event.
2/5/15 patient noticed area looked bruised and sore. 2/6/15 patient reports area bruised look, sore, tender to touch, warm to touch, raised area and hard to touch. Area approx size (4 x 6 inches).
Pt vaccinated with Imovax Rabies developed pain in feet accompanied by small erythematous lesions on soles of feet 18 days after last in series of 5 doses & RIG.
Patient received 1st dose of Pfizer vaccine at about 15:15 and after about 15 minutes, she started complaining of tingling and numbness in her throat. Patient denied shortness of breath or trouble breathing. No rash, hives, dizziness or other symptoms. After 30 minutes patient continued to have symptoms and was clearing her throat. Patient brought to ED for evaluation.
Pt received vaccine 07/17. She did not notice any immediate reaction. She presented to ER on 07/26 c/o dizziness that began 07/25. At the ER she told them she recently had a vaccination and noticed a rash at the injection site on 07/22. Rash still present on 07/26 (mild, erythematous-LUE, 4x4 cm). Pt given prednisone and ANTIVERT and told to f/u with PCP, which she did on 07/31. Rash/symptoms resolved.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; No adverse event; doses administered after excursion;     This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not reported any adverse event.  No treatment medications were provided.
This is a 57 year old F with PMH HTN, depression anxiety, who was exposed by her son who tested positive and was admitted here at hospital. She started having cough, tested positive for COVID 11/26 along with her husband. Has been vaccinated x 2 for covid. No history of COVID infection in the past. She was in the ED to receive MCA infusion. Has been complaining of cough with productive sputum yellow, subjective fevers at home. Also endorsing erythematous rash on face, chest and back that started yesterday and has bene getting worse today as per patient.
Soreness never abated. Now, months later, I have limited mobility in my right arm. I can't sleep on my right side due to shoulder/arm pain. I have significant limited  mobility in the arm and pain when I try to force typical motion.
Pt recvd 2 doses of Engerix-B & exp severe arthralgia following both injects;
1/11/22 28 yr/o at 38w5d.  presents for planned induction for chronic hypertension at term. 28-year-old gravida 5 para 4 admitted at 39 - weeks gestation for induction with chronic hypertension.  The patient goes through a 6-hour labor and delivery to deliver spontaneously a 7 pound male infant with Apgars of 8 and 9.  General Appearance:    Alert, cooperative, no distress, appears stated age Head:    Normocephalic, without obvious abnormality, atraumatic Eyes:    PERRL, conjunctiva/corneas clear, EOM's intact, fundi    benign, both eyes Ears:    Normal TM's and external ear canals, both ears Nose:   Nares normal, septum midline, mucosa normal, no drainage    or sinus tenderness
Tested positive for Covid on 4/9. Experienced body aches, congestion, heavy cough, fatigue
patient complained of nausea and dizziness after injection. states that she fell and hit head earlier. encouraged her to go to ed. refused medical assistance. observed for additional 45 minutes. patient wanted to leave.
I am a pregnant patient. Dose 2  of Pfizer was injected too high,  ?pop? heard by nurse and myself.  Based on location this was likely into bursa .
devel urticaria rash on face & edematous eyelids;tx w/epi & DPH;225PM rash on face resolving;left clinic 310PM DPH given;
Two weeks after second Pfizer Covid, I developed a ITCHY RASH, legs,arms,back,hands 3/24/21   Rash is much worse,  terrible itching.  Never had any type dermatological events.
injection arm "blew up" down to her hand; face swollen; almost fell in the middle of the night because of balance; vertigo; uncontrollable diarrhea; fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 016M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: STEROIDS (2012 patient was given too much steroid, an amount that should have been taken once a month was taken everyday for three years and and it affected her immune system. Nowthe patient has a compromised immune system.) from 2012 to 2015. Concurrent medical conditions included AFib. Concomitant products included DIMENHYDRINATE (DRAMAMINE) for Vertigo.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5). At the time of the report, PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) high fever of 102.5.           Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received on 25 May 2021 included no newinformation.
Adult dose given. No adverse effects were noted. Parent was informed of incorrect dose given and instructed to watch for systemic or local symptoms.
Information has been received from a pharmacist concerning a 79 year old female patient who on 10-SEP-2009 inadvertently received a dose of VARIVAX (Merck) (subcutaneous injection, lot# 664327/0778Y) instead of ZOSTAVAX (Merck). No adverse effects reported. The patient did not seek medical attention. Follow-up information has been received from a pharmacist who explained that the patient received a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). It was a case of human error as the pharmacist was rushing and was distracted just prior to administering the vaccine. The pharmacist had no suggestions to improve packaging, labeling, storage, etc. The pharmacist could not confirm the lot number at the time of the report. The pharmacist did confirm that the patient had no adverse experiences as a result of the mistake and was due back in for vaccination with a dose of ZOSTAVAX (Merck) in 4 weeks. Additional information is not expected.
I experienced an intense pain in my joints. I went to bed and was shivering. I got a fever and had bloating in my stomach. This lasted 1 day. I called my doctor and ask if I should get second vaccine and they approved.
pt devel a fine point rash over arm, itching; Epi given BP of 112/60 & pulse 102; itching relieved for approx 10mins then returned; MD contacted w/advise to take to ER;
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter.   This case was linked to MOD-2021-361706 (Patient Link).
patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).; No adverse event; patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023), PRODUCT STORAGE ERROR (patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 057A22A and 074B22A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.   On 12-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Feb-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023), PRODUCT STORAGE ERROR (patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received Expired 2nd primary dose Moderna COVID-19 vaccine on 10FEB2023) and PRODUCT STORAGE ERROR (patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 10FEB2023 2:47PM Pharmacist was called to report that patient received Expired Second primary dose Moderna COVID-19 vaccine on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023). Case was related to Excursion Case MI-0001322. First Primary monovalent dose on 12JAN2023 (Lot number 074B22A& Exp. Date:11MAR2023) and FLU shot.  Second Primary monovalent dose on 10FEB2023 (Lot number 057A22A & Exp. Date: 06FEB2023).   Dose administered after manufacturer date of expiry Product(s) Monovalent Lot number(s) Lot number 057A22A & Exp. Date: 06FEB2023  intact cartons were used. Vial size was reported as 5.5 ml. On 10-Feb-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Started the next morning slight headache. Later morning aches starting in ankles, moved up to rest of the body.  About 1:00 pm chills, fever of 103.  Lasted until the next morning.
Raynaud Phenomenon, Cold-induced vasospasm (hands and feet), COVID-Toe
103 temp. mom called could not get the temp to break even with Tylenol-no other symptoms
Fever of 101.8; diarhea; lymph nodes under arm swollen and very sore; weak and exhausted.  Aches all over. Dizziness
No additional AEs were reported; The physician reported that a patient received improperly stored vaccine.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 08-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U024221, expiration date: 04-AUG-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (product storage error). Administered dose of vaccine underwent temperature excursion: -12.5 Celsius degrees for 1 hour. No previous temperature excursion was noted. No additional adverse event was report (no adverse event).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-APR-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-JUN-2012, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
On 02/10/21 I started to have shingle symptoms on my face; pain, shooting sharp pains in right temple area, slight itching, all the symptoms of a shingles breakout, though I never got the blisters, just internally.  Have had shingles symptoms of some sort since then, also fever blister breakouts on my mouth.  Shingles blisters across bra band on back in the last few months.  Weird instance where I couldn't move my left leg.  Then got symptoms of migraine headache, eye issues, headache.
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 58-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.   No concomitant medication was reported. The reporter was an internal medicine manager. It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the agency at this time. It was reported that, no adverse reactions were reported by the patient. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment medication was reported.
Case number PHEH2012US024845 is an initial spontaneous report received from a medical assistant on 14 Dec 2012: This case refers to an unspecified age and gender patient. This patient was inadvertently received only Men A lyophilized conjugate component of MENVEO (batch number: unknown) reconstituted with sterile water intramuscularly on 11 Dec 2012. No adverse reaction reported following this administration error.
Throwing up, chills going from warm to cold and so forth, terrible headache, body aches
Received vaccine on 9/15/05 developed urticarial rash and hand/foot swelling beginning 9/17/05. Seen in clinic 9/19/05 urticarial rash.