chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023).    No concomitant medications were provided. It was reported that due to lost power in the middle of the day at 12:00 PM, had to place all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. No treatment medication was provided. This case contains information for the 4th out of 26 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Three days after vaccination, sight became red and itchy. Also, warm to the touch. Symptoms cleared in about 3 additional days. I had a slight headache the day of the vaccination but cleared the 2nd day. I did call to report these symptoms. Therefore, this reporting form is being filed.  I DID NOT have to contact a doctor.
Pt reported numbless and tingling in L shoulder/neck x 4 weeks since his injection
Pt stated that he had severe pain at vaccination site, said that it was so bad that he felt like he could not use his arm/drive. Took TYLENOL and would be calling md if it got worse. Started around 5pm when vaccine was around 2pm.
Pt. states rec. vaccine early morning of 10-23-09 and began having dizziness lasting about 15 minutes. These symptoms occurred daily off and on for about 5 days. No symptoms since 10/28/09.
a little sore arm; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious social media.  This case involves patient (unknown demographic) who experienced a little sore arm (pain in extremity), while he/she received INFLUENZA VACCINE.  The patient taken flu shot for at least 26 years, but never had flu that time. Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious a little sore arm (pain in extremity), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of event was not reported.  The shot does not kick in for immunity for two weeks after shot.  There will be no information available on the batch number for this case.
Within about 10 hours, I had severe chills, muscle/joint pain.  During the night I had night sweats, increased muscle/joint pain, and began to have a headache and nausea by early morning the next day.  I also had dizziness when standing and did feel like I was going to pass out when sitting on the toilet.  I went back to bed for another six hours and began to feel better.  The chills and sweats had subsided, though I still had some muscle/join pain.  I took 800 mg ibuprofen and the headache went away.  Within 36 hours of the Janssen  COVID booster shot I was feeling OK, and completely back to full capacity within 48 hours.  I had a similar reaction, though less severe after my initial Janssen COVID vaccine in April 2021 and did have to take a few hours of leave from work to go to bed.  I did not report that reaction, but this second reaction was more severe.
A non-serious, spontaneous report of "feel a bit little tired" has been received from a consumer concerning himself, a male patient, subsequent to receiving H1N1 vaccine. The patient's medical history and concomitant medications were not reported. The patient received H1N1 vaccine on 17-Oct-2009. On 21-Oct-2009, the patient reported feeling a little bit tired. The event outcome was not reported.
On 12/06/2022 client presented to the vaccination site and was vaccinated with a Covid Pfizer Bivalent Booster Lot# GJ6738 on left arm by vaccinator. At approximately 1728 while sitting in the observation area, client notified nurse that she was feeling ?Dizzy?. Nurse proceeded to take her vital signs; BP:122/78, HR:67, O2:98%, RR:13. Client was able to move to the gravity chair without assistance. Client denied itchiness on any part of the body, denied difficulty breathing, and denied pain. Client reported a history of high blood pressure (medication unknown) and no known allergies. Client stated she experienced dizziness about six months ago due to being stressed. She also denied dizziness or any adverse reaction with the previous Covid Vaccines; Janssen primary series (04/10/2021) and Janssen booster (11/23/2021). Client reported she ate lunch around 1500, ?Sandwich and french-fries with coffee and soda.? At approximately 1741 PHN offered client to have EMS activated for a follow up assessment, client declined. Client reported dizziness had subsided. Client was offered a water bottle. 1740 vital signs; BP: 122/68, HR:68, O2:98%, RR:14. Client rested for a few minutes. 1750 vital signs; BP: 118/76, HR:68, O2:98%, RR:16. Client denied itchiness, difficulty breathing and dizziness. Husband reported he would be driving back home.  PHN educated on possible side effects after vaccine, to seek emergency care if symptoms worsened and to follow up with her primary care provider. Client verbalized understanding. 1756 vital signs: BP:120/78, HR:73, O2:99%. Client denied dizziness and that she was feeling ?Fine.? Client was able to stand up without assistance from gravity chair. Client left the facility accompanied by husband with a steady gait at 1759.
devel diffuse urticaria 5 mins p/receiving vax; given DPH urticaria cleared;
I developed Dermatographia on November 13 (two weeks after booster dose of Moderna). I have full body hives with itching and redness.  The hives would appear, linger for around 30 minutes, disappear, and then start somewhere else. I began taking Benadryl regularly for itching. I went to a local urgent care on November 15 and was prescribed  a 6 day pack of Methylprednisolone, once daily Pepcid, and Triamcinolone Acetonide topical cream. I was also told to continue Bendaryl use. The itching and hives continue unabated with momentary relief from Benadryl. The topical cream helped a little. I saw my primary care doctor on November 18 and she suggested Allegra instead of Benadryl. I tried that for one day but the itching was unbearable so I switched back to Benadryl. On November 23 I went to urgent care again and was given a steroid shot in the bum and told to try liquid Benadryl. At this point the slightest touch made me break out in hives within 2-3 mins. The hives and red marks continued to dissipate after 30 mins. On November 29 I saw a dermatologist and was diagnosed with Dermatographia. The prescribed regime at the moment is 2x daily Claritin - once in the morning and once in the evening. I'm still getting the hives but they are much less itchy.  If the itching gets worse the dermatologist recommended x3 daily Claritin - two in the am and one in the evening.
Experienced angina; She felt like her brain was swollen; Severe nerve pain (sciatic); felt like she was dying; Soreness; Fever; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Experienced angina) and BRAIN OEDEMA (She felt like her brain was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatica (on and off for 30years), Penicillin allergy (Penicillin) and Latex allergy (Latex). Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Experienced angina) (seriousness criterion medically significant), BRAIN OEDEMA (She felt like her brain was swollen) (seriousness criterion medically significant), NEURALGIA (Severe nerve pain (sciatic)), FEELING ABNORMAL (felt like she was dying), MYALGIA (Soreness), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ANGINA PECTORIS (Experienced angina), BRAIN OEDEMA (She felt like her brain was swollen), NEURALGIA (Severe nerve pain (sciatic)), FEELING ABNORMAL (felt like she was dying), MYALGIA (Soreness), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No laboratory provided by the reporter Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information included : Additional events were added. On 24-Jun-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.
Fever over 103, swollen face, throat, hands and feet.Hard to swallow. Body aches.
Severe joint pain in left shoulder with burning/ electrical pain radiating down tricep to my elbow. I?ve used ibuprofen, heat, ice, rest and it still hurts a week later. I?ve missed three days of work now.
R arm pain at time of administration reported as too high and posterior than usual. Still with pain 3 weeks later.
Tinnitus in ear, I hadn't seen how this could be related to vaccine until now, so just now reporting possible adverse affects. Ringing in ears comes and gos and somedays it is so loud that I can't hear much, today is one of the bad days. It never goes away.
child was crying & irritable for hours p/vax;inc fluid intake & redness & swelling of lt thigh reported to clinic by phone per mom;rt outer thigh w/sl purplish bruising all 3 sites smooth w/o swelling or hardness;
Medium-size green bruises appeared on legs for no reasons on first week after 2nd Pfizer COVID-19 mRNA vaccine. New smaller green bruises formed on week 4 after the shot (again for no obvious reasons); Medium-size green bruises appeared on legs for no reasons on first week after 2nd Pfizer COVID-19 mRNA vaccine. New smaller green bruises formed on week 4 after the shot (again for no obvious reasons); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Sep2021 16:00 (Lot number: FC3184) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing); "Allergy: Latex" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 15:30), administration date: 14Aug2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: CONTUSION (non-serious) with onset 08Sep2021, outcome "recovered" (2021), CONTUSION (non-serious) with onset Oct2021, outcome "unknown" and all described as "Medium-size green bruises appeared on legs for no reasons on first week after 2nd Pfizer COVID-19 mRNA vaccine. New smaller green bruises formed on week 4 after the shot (again for no obvious reasons)". The event "medium-size green bruises appeared on legs for no reasons on first week after 2nd pfizer covid-19 mrna vaccine. new smaller green bruises formed on week 4 after the shot (again for no obvious reasons)" and "medium-size green bruises appeared on legs for no reasons on first week after 2nd pfizer covid-19 mrna vaccine. new smaller green bruises formed on week 4 after the shot (again for no obvious reasons)" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of contusion, contusion.  Additional information: It was reported that, medium-size green bruises appeared on legs for no reasons on first week after 2nd Pfizer COVID-19 mRNA vaccine. New smaller green bruises formed on week 4 after the shot (again for no obvious reasons), though old ones dissolved. Patient received vaccine at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Parents state that an hour after receiving vaccines and PPD, that she started developing a rash on buttocks and legs.  I saw her for same rash on 1/21/14 and diagnosed her with Henoch-Schoenlein Purpura (HSP).  Her rash is classic for this.
Information has been received from a physician concerning a "15 or 16 year old" female who on approximately 25 Oct 2006 or 26 Oct 2006 was vaccinated intramuscularly in the deltoid with Gardisil. On approximately 27 Oct 2006, the patient developed a low grade fever of about 99 and dizziness. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
This is in follow-up to report (s) previously submitted on 4/15/1998, 5/4/1999. Information has been received from a physician concerning a 24-month-old male with sickle cell trait ("HMG PAC THAL") who on 08-JAN-1998 was vaccianted with on dose of VARIVAX vaccube (lot # 623647/0802E) in his left arm. On 10-JAN-1998 the patient experienced a fever of 104 degrees F and had a febrile seizure. The patient was taken to an emergency room. It was noted that the patient's brother had been diagnosed with strep throat so a throat culture was obtained. The patient was released from the emergency room that same day. On 12-JAN-1998 the patient's throat culture was negative for strep throat. On 23-JAN-1998 the patient's mother calle the physicians' office to report that her son had experienced tremors while sleeping. The patient was scheduled for and EEg and was referred to a neurologist. "Within several weeks" after the initial experience, the patient again experienced another ferile seizure while in daycare. The patient was noted to have recovered. Additionally it was noted that the patient's mother did not follow through with the neurologist or the EEG appointments because "she believed the child's seizures were probably not related to the vaccine and that the child had probably caught a virus from his sibling. It was noted that the mother has since left the physician's practice. It was noted that another patient (WAES # 98011537) experienced a similar reaction after vaccination with VARIVAX vaccine. No further information is expected.
Patient who is 4 months short of 18  years old received Moderna Covid Vaccine indicated for 18 years and older. After administration of vaccine, realised while data entry of the age. Rph immediately contacted the Clinical Team and Pharmacy District Manager and notified them. Right after that, Rph also called the Patient's mom and left a message to call back. Mother called in approximately 30 minutes. I sincerely apologised and told her upfront what had happened and enquired how patient was doing and reasured her that i will contact their Dr first thing monday morning when they opened and keep her updated. She said patient was doing well and asked if she needs to keep their second appointment. I told her i will check with their Dr and our Clinical team and get back to her promptly.Followed up with their Dr and RN on behalf of the Dr and our Clinical team said as per CDC guidelines to give her the second moderna covid shot as scheduled for 5/30/21. Left 2 messages for mom to call us. Will follow up tomorrow.
Periorbital itching followed by erythematous, itching and burning exanthem on neck and anterior chest.
Cried alot with pain then both legs turn red, swollen and hot to touch. Lasts for 25-30 minutes. Cried whole time and became everything normal after 30 minutes.
This spontaneous report as received from a physician via company representative regarding a patient of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an unknown date the patient experienced shingles. The outcomes of herpes zoster was unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
This spontaneous report was received from a physician via field representative referring to a 12 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was administered GARDASIL 9 intramuscularly (lot and expiry date not reported) as a prophylaxis. After administration of GARDASIL 9, the patient experienced syncope and fainted to the floor. The patient did not suffer any injuries as a result of the fall. Patient recovered from the events syncope and fall within the same office visit. It was unknown if the patient received any treatment. Causality assessment was not reported for the events.
The day after the injection, she developed chills and severe fatigue, had to stay in bed for 2 days.  Injection in arm but had some leg pain too.  Then developed local reaction with (by her report) 4 in diameter erythema, tender, with some nonpurulent drainage
Night terror begun approximately 10pm. Lasted about 5 minutes. Daughter's eyes were opened, but her speech wasn't making sense, she was repeating things, her body was shaking, and she had startled look in her eyes. I held her, quietly shushed her, said "Mommy's here, etc." until she went back to sleep. She expressed no memory of event the next morning.
Narrative: 91yo male died on 11/12/2021 of unknown cause, unknown place, & unknown circumstances. Pt did have a previous hospitalization at a non-community hospital - Per MD note: "Date of Service" 10/24/2021 - 10/29/2021 Name of Facility: Inpatient Admitted for Chest pain and diagnosed with sepsis, acute respiratory failure with hypoxia, bilateral lower lobe pneumonia, bacteremia from Klebsiella pneumoniae, and acute on chronic systolic heart failure. This is the second episode of bacteremia in the past month. CT abdomen and RUQ U/S showed gallbladder wall thickening. ID consulted and recommended 2 weeks of IV antibiotics, last day 11/9/2021. They state if bacteremia occurs again, that gallbladder could be likely source and would need removal. Hypoxia improved after hypertonic saline treatment and IV diuresis." Problem list: PROBLEM LAST MOD PROVIDER Chronic combined systolic and diastolic heart 10/21/2021 failure Paroxysmal atrial fibrillation, 10/21/2021 Cardiac pacemaker in situ 07/20/2021 Dementia 07/20/2021 Heart failure 04/20/2020 Hearing loss 04/20/2020 Benign prostatic hyperplasia 04/20/2020 Callosity under metatarsal head 06/01/2018 Asthma 01/14/2016 Hyperlipidemia 01/14/2016 Diabetes mellitus type 2 without retinopathy 01/14/2016 Hypothyroidism 01/14/2016 Trigger finger 02/17/2010 Osteoarthrosis, unspecified whether generalized 12/01/2009 or localized, involving unspecif hypertension 01/14/2016 Coronary Artery Disease 01/14/2016 Pt had received covid vaccines from non-facility site on 01/27/21 & 2/17/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Vertigo; pounding heart (sinus tach); overheated; extreme anxiety; very dehydrated; nausea; vomiting; anxiety still prevelant.
fever, chills, headache, nausea, muslce, joint aches, fatiue
pt had fever of 103 & persistant crying several hrs p/receiving vax;  pt's fever went to 105; pt seen @ ER on 22JAN93, 23JAN93 & 24JAN93 because of persistant crying & elevated temp;
Patient has malaise and general fatigue for 48 hours after dose. Patient also had significant swelling at the injection site and red-patchy rash that lasted 5 days. Patient experienced significant soreness at injection site that also lasted about 5 days.
Red rash, warm, slight swelling at injection site R deltoid meas-5 1/2cm x 7cm, oval.  No wheeze.  Tx: Medrol dose pack & Vistaril po.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/1733AA, expiration date 04-FEB-2013, dose not reported) on 11-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073. Additional information is not expected.
I had nausea, fatigue, weight loss, heart palpitations, increased heart rate, tremors, muscle loss, hair loss and occasional vomiting. I underwent radioactive iodine treatment. I had to take a radioactive pill i131. I had to isolate for 3 days. I was also prescribed beta-blockers for my heart and tremors. I couldn't take them during my radioactive treatment.