chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 49.88.  Concomitant products were not provided.  On 15-Apr-2021, excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration at 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from a registered nurse concerning a 5 year old female with asthma who on 10-APR-21002 was vaccinated SC with a 0.5 ml dose of Varivax (638931/1144L). Concomitant therapy included ADVAIR and montelukast sodium. On 01-FEB-2007 the patient experienced 20 lesions on her back and 2 lesions on her face with a temperature of 100F. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 02/11/2010 Follow up information has been received from the physical who reported that the patient presentd to the office on 01-FEB-2007 with a low grade temp of 100 degrees and varicella rash. The physician reported that patient received symptomatic treatment icluding calamine and baking soda. Additional information is not expected.
Injected patient with a Moderna Covid 19 3 rd dose that was prepared +12 hrs prior to administration
3PM t103 APAP given; 5PM t105.3 taken to ER;
My first symptom was a sinus infection, a pressure on my nasal and cheek. Started on Dec 16, on Dec 17th I tested positive with a home COVID-19 test. On Monday I had a call with my doctor and prescribed medication to start taking, I took the medication, my symptoms start to get better, but by the first of the year, I was coughing, kind of felt like bronchitis & breathing problems. On January I scheduled a visit about my breathing and coughing. He prescribed more medication and antibiotics. After the 2nd round of medication, I was feeling normal, but a couple of times a week I do inhaler to help with my breathing, up to this point. I never had a fever above 99.5. The first time I did not take all the medication (PAXLOVID) because when I was reading the description it had a problem with my other medications. I had other home COVID-19 tests.
Chills - Onset 10 hours - on and off for 24 hours Low-grade Fever - Onset 14 hours - on and off for 24 hours Headache - Onset 14 hours - stabbing headache on and off for 48 hours Neck ache - Onset 14 hours - stabbing headache on and off for 72 hours Body aches - Onset 14 hours - on and off for 36 hours Fatigue - Onset 8 hours- lasted 72 hours Diarrhea - Onset 36 hours - lasted on and off for 18 hours Dizziness/Lightheadedness - Onset 68 hours - Lasted 1 hour Period/Heavy Bleeding - Onset 24 hours - continued with normal cycle
Woke up with a very sore arm.  About 10 am Migraine started  11 am  Tired "feeling out of it" Noon - Short of breath  Currently 12:30 Muscle soreness in shoulders, migraine worse, heavy chest
Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023; No adverse event; Dose administered after 30 day BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day BUD.), PRODUCT STORAGE ERROR (Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2023, 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 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day BUD.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day BUD.), PRODUCT STORAGE ERROR (Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day BUD.) and PRODUCT STORAGE ERROR (Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023).    No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No symptoms were reported. No treatment information was provided.
Patient called to pharmacy and stated that after 2 week she was still having difficulties moving the arm that she got the vaccination in.  She has tried taking ibuprofen, applying heat and anagelsic rubs but still has difficulties with activities of daily living like dressing.
The patient report dizziness (spinning),  lemon size lump at the injection size, fever, and "hot joints".  She called for an ambulance around 3 in the morning and was taken to the hospital.  There, they ran tests including an Xray and CT scan.  Patient reports that it was determined she had a reaction to the vaccine.
I went in and had a confirmed appointment for a COVID -19 Updated Booster Pfizer, and instead was accidentally given Boostrix. This booster was for work, and my deadline was 1st of December. Now that I have been given the wrong vaccination, I am not sure if I can mix it with the covid booster. This pharmacy seemed to be understaffed.
Flu shot sit swollen approx. 2hrs after administered, however subsided w/massage of area. Several hours after that, lip started to itch, followed by swelling of (R) cheek and bottom lip. Went to urgent care, Re'd steroid dose pack.
Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradually better over 45?. Tried to leave didn?t get out of bldg, collapsed in chair bad chest pain felt really bad. Ambulance called, gradually progresses to weak r side hi b/p slurred stammering speech inability to swallow tongue thrusting to Uc health ct w contrast ok. Gradually  improved discharged at 1700. Saw doctor following Monday. Cardiac work up scheduled 4/5/21 She does not want 2nd vaccine until cleared by cardiologist. I have had bouts of chest pain. Hospital tadmitted me as Jane doe. Severe fatigue sleeping 12-14 h/ d for 5-6 d no fever flu sx. Low energy. Hospital never took he from me once better discharged as migraine but I don?t have migraines
Site: Redness at Injection Site-Mild, Additional Details: Pt got the Moderna booster shot 0.25ml on 12/20/21.  Pt was suppose to get Pfizer booster shot 0.3ml.   Pt received 2 COVID SHIELD vaccines.  The 2nd covid shot was on 7/17/21.   Pt was scheduled to have a Moderna booster shot at Pharmacy.  There was a miscommunication from Pharmacy side to store side on what vaccine to give patients.   *Pt did not have any side effects at injection sites. * Only side effects listed above.
Patient reports having significant swelling and pain in the right arm after receiving the injection. The swelling went from deltoid down to forearm. Patient applied ice pack and since the time of the injection arm has improved daily. Patient was not seen by a doctor and was not evaluated in an emergency room.
DVT with severe edema, pruritus, erythema, pain on walking, and malaise.  Treatment = Xarelto
Erythema multiforme rash on hands, arms, right knee, feet and gluteal cleft. PT taken off the military ship and seen by Dermatology at a medical center. Punch biopsy done. Atarax prescribed.
Elevated ST's on EKG.  Mild chest pain 4 wks post immunization, worried, but had personalized level for next 3 conceal months.  Recurrent pain NDV/CE when he tired to run.  11/25/08 Reviewed hospital medical records of 11/11-11/12/2008. FINAL DX:probable post-vaccinal smallpox immunization myopericarditis; atypical chest pain secondary to #1; possible GERD. Records reveal patient experienced retrosternal chest pain while running w/radiation to left shoulder & slight dizziness.  Pain resolved w/rest.  Reported he had similar chest pain in past.  Became fatigued w/insomnia, generally weak, dyspneic, increased thirst, nasal stuffiness, anorexia, heartburn.  Admitted to ICU for monitoring.  Tx w/NSAIDS & antacids.  Responded well & d/c to be medevaced stateside for recovery.
Information has been received from a pharmacist concerning an 86 year old female patient with hypoactive thyroid. On unspecified date many years ago, the patient received unspecified Flu shot and Pneumonia shot (manufacturer unknown) which caused her lymph nodes to swell resulting in the removal of some of lymph nodes (MARRS# 1504USA014504). The patient had no drug reactions and allergies. The patient's other medical history included arrythmia and thyroid disorder. On 30-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, strength and frequency were not reported, lot # L000450, expiration date: 09-MAR-2016, subcutaneous). Concomitant therapies included digoxin, levothyroxine sodium (manufacturer unknown) and metoprolol. On 31-MAR-2015, the patient called the pharmacy and complained of a red, warm, painful area (the size of a quarter) at the injection site of the ZOSTAVAX. On 01-APR-2015, the patient came to the pharmacy and the pharmacist noted that the size of the reaction had gotten bigger and was about 2 inches by 1.5 inches in diameter at the time of reporting. There was no treatment given for the events. There was no lab diagnostics performed. The patient had sought medical attention via calling and visiting the pharmacy. The outcome of the events was reported as not recovered. Causality between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 71-year-old female patient who received ENGERIX B adult (batch number 35G7C, expiry date 1st February 2019). Previously administered products included ENGERIX B adult (1st dose with no adverse event) and ENGERIX B adult (2nd dose with no adverse event). On 6th April 2017, the patient received the 3rd dose of ENGERIX B adult. In April 2017, less than a week after receiving ENGERIX B adult, the patient experienced influenza, cold, fever, vomiting, chills, headache and general body pain. On an unknown date, the outcome of the influenza, cold, fever, vomiting, chills, headache and general body pain were recovering/resolving. It was unknown if the reporter considered the influenza, cold, fever, vomiting, chills, headache and general body pain to be related to ENGERIX B adult. Additional details were reported as follows: The pharmacist reported that the patient received a dose in series of ENGERIX-B the day before reporting date and called back to report the symptoms of vomiting, fever, chills, headaches and body aches. The patient and pharmacist stated that the symptoms might be the result of a flu or cold. No further information was reported regarding the event.
Client states that the injection site became red and warm to touch after receiving vaccine. He states that is has progressively gotten worse over the course of 4 days.
Injection site reaction of redness and swelling. "Splotchy" per patient. Also feeling dizzy/lightheaded and sweating. Time course unknown.
Patient returned to the pharmacy three days after receiving ZOSTAVAX vaccine with an obvious and classical shingles infection. The infection followed a dermatome from the right side of her neck down her arm to the palms of her right hand. There were several painful lesions and patient has had cold chills. The patient was told she needs to be seen by a doctor for the infection.
Pt flushed and had trouble breathing. Paramedics administered oxygen and pt took albuterol inhaler she had for COPD.
A 13-year-old boy was scheduled for his first COVID-19 vaccine at one of our COVID-19 clinics aimed at 5-11 years old. Even though we had a plan to identify anyone who showed up >11 years old and vaccinate them appropriately, our catches missed this patient. He was immunized with a 10mcg dose instead of a 30mcg dose. This was not caught until a few days later during an audit. We contacted his family and explained that it is recommended he not repeat dose 1 but make sure he gets 30mcg of dose 2. Our team met internally to do a quality improvement causal analysis and  put additional safe guards in to make sure appropriate doses are delivered to patients.
4/28/21: numbness in left arm  4/29/21: fever, nausea, fatigue, heart palpitations, chest pressure, shortness of breath, numbness in limbs, panic attacks, black spot in vision  6/9/2021: stomach ulcers, burning/ nerve pain in pelvis and hands  7/24/2021: severe nerve pain (sharp, burning, prickling, shooting) in hands, feet, pelvis, spreading to chest, mouth, and eyes, bladder pain, urinary retention, weakness in left leg, limping
Patient reported numbness and ringing in ears after recieving vaccine. She stated she felt like she was going to pass out. Onsite HR 53 BP 116/67 Patient stated she was a runner, she recovered fully and was free to go home.
die of Men B; die of Men B, hurt her; This case was reported by a consumer via interactive digital media and described the occurrence of death in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced death (serious criteria death and GSK medically significant) and pain. On an unknown date, the outcome of the death was fatal and the outcome of the pain was unknown. The reported cause of death was unknown cause of death.   The reporter considered the death to be related to Meningococcal B vaccine. It was unknown if the reporter considered the pain to be related to Meningococcal B vaccine.  Additional details provided were as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The reporter reported that he/she hate what the vaccine did to his/her daughter. The reporter reported that the patient was more likely to get hit by lighting more than once than die of Men B, but they hurt her and they did not care. The reporter stated that they trick people into thinking that all meningitis was the same, but it was not, but they would not benefit if they knew that. Follow-up would not be possible as no contact details provided. Note: The event death was conservatively captured as the information received was not clear as the patient was died from receiving Men B vaccine.; Reported Cause(s) of Death: unknown cause of death
3 miscarriages since vaccination; now positive for anticardiolipin antibodies and anti thyroid antibodies (anti TPO)  No issues prior to vaccination
At 4:00 pm on 10/24 I noticed my throat was sore  As day progressed my throat got red and  swollen and it hurt to swallow.  At 6 pm I took an allergy pill - cetirizine and within the hour my symptoms started to go away.  Very scary as I did not want to go to emergency room but I would have if the symptoms got worse.
Mother stated pt was extremely tired, red cheeks and C/O pain at the injection site. At 8:30pm mom noticed child scratching leg and found welts that continued to spread. Child then C/O throat hurting, No difficulty breathing. Child was taken to the ER and diagnosed with Local Reaction, Generalized Allergic Reaction.
Pt called in for triage stating rash below injection site that appeared Monday 5/2/22. Pt reports improvement of rash but also c/o itching. Pt advised to apply Hydrocortisone cream OTC and apply ice x3/day.
Extremely heavy period. On Nexplanon and hardly get periods, if I do they are light and last maybe three days. The Sunday after my vaccination (on a Tuesday) I started a period which was normal until the next Tuesday when it got extremely heavy and I had to leave work. Days 2 and 3 of my period had always been the worst before I was on birth control and would last 6-7 days petering out at the end, and I am now on day 6 with as heavy a period as day 2. I've also noticed a lot of blood clots in my menstrual fluid which I have never had before. I have had to take days off of work and hope this doesn't last too much longer.
adolescent patient was administered adult formulation of Vaqta, need to know what to do next; adolescent patient was administered adult formulation of Vaqta, need to know what to do next; This spontaneous report was received from a office manager and refers to an adolescent patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The patient was administered adult formulation of hepatitis a vaccine, inactivated (VAQTA) (inappropriate formulation of drug administered), (inappropriate dose of drug administered).
no adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2023, 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 24-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug information was provided. The vial was initially thawed on 10Jun2023. No treatment drug information was provided.  The case corresponds to 22nd out of 30 patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up received, updated suspect drug administration date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case
Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 had a Shingles rash for which I consulted a dr and was treated
patient received flu shot was fine for a second tried to stand up and stated that she felt dizzy and then sat back down. upon sitting back down patient passed out but still breathing. she was non responsive for about 2-3mins and came too feeling just fine. during her unresponsiveness i moved her to the floor in case i had to preform CPR and did also yelled for my intern to call 911. paramedics arrived and checked the patient out and he BP and heart rate was normal. Patient stated she felt fine and that she did not want to be taken to the hospital.