chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vials that had exceeded the 30 day refrigeration limit; Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) and PRODUCT STORAGE ERROR (Vials that had exceeded the 30 day refrigeration limit) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that had exceeded the 30 day refrigeration limit). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) and PRODUCT STORAGE ERROR (Vials that had exceeded the 30 day refrigeration limit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.
I have a big bump where I received my shot and it?s a little sore now and hot.
13AUG97 mom reported noticed pt face looked splotchy in car on way to school; principal said to take child home & watch;rash-splotchy red spread to abd, back, arms;went to MD office given DPh for 1hr;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2016 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was very weak the next morning; my lymphedema in my left axilla region increased; my right arm that received injection was very sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 17:30 (Lot number: 30145BA) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stage 2A cancer left breast" (unspecified if ongoing), notes: Other medical history: Stage 2A cancer left breast, in remission; "Lymphedema left axilla, arm, and scapula" (ongoing). Concomitant medication(s) included: EXEMESTANE; VITAMIN D NOS; FOLIC ACID. Vaccination history included: Bnt162b2 (Dose 1, single, administration time: 05:30 PM , lot number: FC3183, Vaccination site location: Right arm, ), administration date: 17Sep2021, when the patient was 51 years old, for COVID-19 immunization, reaction(s): "headache", "bilateral legs felt heavy", "chest pain", "lump at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Oct2021 20:00, outcome "recovering", described as "my right arm that received injection was very sore"; ASTHENIA (non-serious) with onset 09Oct2021, outcome "recovering", described as "I was very weak the next morning"; LYMPHOEDEMA (non-serious) with onset 08Oct2021 20:00, outcome "recovering", described as "my lymphedema in my left axilla region increased". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphoedema.  Additional information: The patient had no known allergies. patient did not receive other vaccine in four weeks. Prior vaccination, patient had not been tested for Covid-19. post vaccination, patient had tested for Covid-19. Patient received treatment for lymphedema used pump Increased no of times.  No follow-up attempts are possible. No further information is expected.
Double vision, droopy eyelids, fatigue, headache, cramps ( all within first 24 hours after shot)
Dizziness; Nauseas; Thrown up a couple of times; Can't get from here to there without holding on to something; Felt cold; Shaky; Temperature 99F; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can't get from here to there without holding on to something), FEELING COLD (Felt cold), TREMOR (Shaky), DIZZINESS (Dizziness) and NAUSEA (Nauseas) in an 80-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.     Previously administered products included for Product used for unknown indication: Johnson&Johnson on 11-Mar-2021 and Johnson&Johnson. Past adverse reactions to the above products included No adverse event with Johnson&Johnson and Johnson&Johnson. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced FEELING COLD (Felt cold), TREMOR (Shaky) and PYREXIA (Temperature 99F). On 08-Dec-2021, the patient experienced GAIT DISTURBANCE (Can't get from here to there without holding on to something), DIZZINESS (Dizziness), NAUSEA (Nauseas) and VOMITING (Thrown up a couple of times). On 07-Dec-2021, FEELING COLD (Felt cold), TREMOR (Shaky) and PYREXIA (Temperature 99F) had resolved. At the time of the report, GAIT DISTURBANCE (Can't get from here to there without holding on to something), DIZZINESS (Dizziness), NAUSEA (Nauseas) and VOMITING (Thrown up a couple of times) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, Body temperature: 99 (High) 99F.         No treatment medications were reported.
A report was received from a health care professional on 12/12/03 concerning a 3 year old male vaccinee who was inadvertently administered Fluvirin on an unknown date. On an unknown date, a vaccinee was inadvertently administered Fluvirin. No adverse events had occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 1/26/04: A follow up report received from a health care professional confirmed that the vaccinee received Fluvirin on 12/9/03. No follow up pending.
Information has been received from a physician's assistant, concerning a 4 year old female patient, who on 07-JUN-2011 was inadvertently administered intramuscularly a 0.5 ml dose GARDASIL (Lot #: 667165/1167Z, Exp: 08-DEC-2012). Physician's assistant reported that on an unknown date, the patient had a sore arm. It was unknown if patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
large local rxn that was raised, red lesion 2" diameter when seen 4 days p/vax;
30 min after receiving H1N1 vaccine - patient became dizzy, sweaty and R arm tingling with numbness. All symptoms resolved within 30 min of onset. No reactions to seasonal flu vaccine in the past.
Patient currently inpatient  at (5) days admission on 11/21/21.  Patient is a 68 y.o. male who presents today with significant worsening dyspnea, shortness of breath, hypoxemia, and pain from previous rib fractures.   Patient fell last Tuesday on November 18th in presented to emergency department is noted to have rib fractures to 8th and 9th rib on the right side.  Patient has history of chronic obstructive pulmonary disease and severe emphysema.  He was sent home with narcotic pain management including oxycodone Zanaflex.  Apparently states this was not helping.   Patient presented back to the emergency department today with worsening rib pain worsening shortness of breath.  At home he usually takes 2 L of home oxygen only at night.  He arrived without oxygen with his saturations at 70%.  He was placed on high-flow nasal cannula at that time.  It was noted he had elevated BNP, procalcitonin, and lactic acid.  He was given IV fluid bolus of 2 L. COVID test was noted to be positive.  Patient has been vaccinated.  Chest x-ray revealed interstitial changes with possible pneumonia versus emphysematous change.  He was given IV Levaquin in the emergency department as well as Dilaudid for pain.  Also given Tylenol for low-grade temperature blood cultures were taken.  Blood pressure was somewhat low so he was started on Levophed at that time.  Attempt was made to transfer patient due to the acuity of care but they were unable to transfer due to no bed availability.   Patient's chronic medical issues include the following hypertension, diet-controlled diabetes, history of pulmonary fibrosis, rheumatoid arthritis, obesity, coronary artery disease, chronic obstructive pulmonary disease with home oxygen 2 L, progressively worsening rib pain and progressive shortness of breath.   Patient admitted to intensive care unit with severe sepsis, bacterial pneumonia, acute respiratory failure with hypoxemia, and hypotension.  Currently on norepinephrine will wean down as appropriate.
Initially, I had no soreness or redness. My arm swole up c. 28 hours post-injection. The swollen area was roughly rectangular and 2"x3". It wasn't painful and didn't itch - but the area felt very weird for five days. It took ten days for the swelling to begin to abate; the remaining lump finally disappeared this past weekend. I received a full dose of Bavarian Nordic JYNNEOS.
Immediate I felt like an electrical current for a few minutes. Then someone asked if I felt well because my face was flushing and my arm were red and any exposed skin was red and when pressed it blanched white. All resolved within a few mins.  No issues since.  Went to ER for the vaccine not for the reaction.
11-9-16 Patient seen at ED with seizure; described as localized/staring about 3 minutes; (L) gaze deviation, (R) upper extremity jerking; gagging per ED note believed to be related to DTAP.
vomiting / She has vomited five times since then; Chills; Really sick; Started feeling tired; This is a spontaneous report from two contactable consumers (patient included). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EM9809; Expiration date was not reported), via an unspecified route of administration on 25Feb2021 13:30 as dose 2, single for COVID-19 immunisation. The patient was okay for about four hours after receiving the second Pfizer shot and then experienced started feeling tired and went to bed on 25Feb2021. The patient woke up at about 12:00 AM, 26Feb2021 and experienced vomiting, she has vomited five times since then. The patient was experiencing vomiting and chills, was very tired and was really sick (reported that she doesn't known what to do) on 26Feb2021. The reporter wanted to know if this was normal. The outcome of the events was unknown.
I was sitting out in my sun porch with my dogs in my lap, it started as a trembling and it just got worse and worse. I tried putting a blanket and jacket on and I could barely speak because I was trembling. I went to closest Hospital. We had a good 45 minute wait. The physician came in did vitals and i was getting exhausted from the shaking. They put heated blankets on and i was still shaking and then they gave me Tylenol and Motrin. I was told to follow up with my primary care doctor.
Child developed a very erythematous rash on head trunk & extremities. Confluent on face thighs & leg. "Measly" looking. No other sx. Exam nl except for skin. Had Epi & BENADRYL with altering the rash.
The patient is not responsive on March 4, 2021 around 8:30 pm. He is not breathing, preformed CPR and call 911 right away. Then the police and ambulance came. The paramedics tried to save him by electrical cardioversion. However, he died. Later the coroner came and she made a call to funeral service. At the end, the funeral service people came and took his body away.
I started vertigo on 1/27/2021 that lasted about 6 days even after physical therapy. Bilateral and horizontal vertigo. It's been about 4 weeks as of today since I have experienced vertigo
Medical assistant was completing vaccination when patient ''jerked then pulled away and the vaccine sprayed in a mist onto (medical assistant's) hands, face, possibly eyes".; Medical assistant was completing vaccination when patient ''jerked then pulled away and the vaccine sprayed in a mist onto (medical assistant's) hands, face, possibly eyes".; Medical assistant was completing vaccination when patient ''jerked then pulled away and the vaccine sprayed in a mist onto (medical assistant's) hands, face, possibly eyes".; Medical assistant was completing vaccination when patient ''jerked then pulled away and the vaccine sprayed in a mist onto (medical assistant's) hands, face, possibly eyes".; Medical assistant mostly experiencing anxiety; This spontaneous report was received from a medical assistant referring to herself as a female patient of unknown age. The patient allergy to sulfa, azithromycin, clindamycin, amoxicillin and unspecified antibiotics. The patient had medical history of rash and stomach upset to unspecified antibiotics. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).     On 09-JAN-2020, the patient (medical assistant) was completing vaccination with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA)) (lot # S017244, expiration date 01-DEC-2020), the vaccine sprayed in a mist onto the patient's (medical assistant) hands, face, possibly eyes (occupational exposure to product, accidental exposure to product, exposure via eye contact and exposure via skin contact). The patient mostly experiencing anxiety. The patient did not sought medical attention and there was no laboratory tests were performed for the event. The outcome of anxiety was reported as recovering. Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA003657:
Pt experienced immediate pain at injection site. Pain continued and progressively-worsened, extending up and down arm and into shoulder and eventually into right arm and shoulder. Several weeks post injection patient began to experience muscular weakness and tremor in left arm, also eventually extending into right arm and shoulder. At which time diagnosis of brachial neuritis made.
patient received second Moderna vaccine at 5 pm; that evening started to feel itchy. next morning woke up with a fever (unsure of how high) and chills with full body rash that has worsened since then it has become warm to touch, itchy and a deeper red from bilateral cheeks/ears to tops of feel; Rash has spared the bottoms of feet and scalp; No rash at the eczema site of anterior elbow
On 07/2022 around 1:00-2:00PM I went to my doctor's office for a vein test. Everything was normal in my vein but my doctor noticed that I had 2 nodes on both on my thyroids. I had clusters of lymph node on the left side of my thyroid. I had infection on my right thyroid which wasn't  cancerous. My doctor did Ultrasound he said my lymph node on the right side was growing but both nodes on the thyroids are stable. My doctor did biopsy on 11/28/2022 and I received results on 11/30/2022. I also went to the ear, nose, and throat doctor he said it's not cancer but it's infections. He told me to get a CT scan but nothing is set up yet. I have diabetics but my doctor isn't sure what can cause the inflammation on my left side my thyroid. I feel good not knowing that something was happing in my body till the day I went for a normal vein test.
load-grade dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003907 (Novavax).  A female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Jan2021, outcome "unknown", described as "load-grade dizziness". Additional Information: It was reported on 13Oct2022, a patient started treatment on an unspecified date in Jan2021 with Pfizer BioNTech COVID-19 Vaccine dose 1 for an unspecified indication. It was reported the patient experienced load-grade dizziness after 1st vaccine Jan2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8 days post 2nd covid vaccine (given on 4/6/21), patient awoke with stroke like symptoms. Evaluated in the ER and diagnosed with Bell's Palsy.
This report was received from manufacturer for Augmentin Suspension and was assigned manufacturer report number (A0392300A) concerning a 12 month old male pt who was vaccinated on an unspecified date with a dose of MMR II. Additional suspect therapy included amoxicillin trihydrate (+) clavulanate potassium initiated on 1/3/03 for sinusitis. On 1/12/03, the pt's mother reported that her son had developed a "really bad rash from head to toe." It was noted that hte ? was a raised rash that the pt scratched occasionally. He was treated with Benadryl on the advice of the physician and therapy with amoxicillin/clavulanate potassium was discontinued on 1/12/03. According to the pt's mother, the physician felt that the rash was due to the MMR II that the child had recently received and not the amoxicillin trihydrate/clavulanate potassium. "The outcome of the event was reported as unresolved." A consumer, the pt's mother, was the initial reporter. Additional info is not expected.
patient states that 2 weeks ago she developed a flare; This is a spontaneous report from two contactable Other healthcare professionals (HCPs) via Pfizer-sponsored program Optum Xeljanz Program.   A 61-year-old female patient received tofacitinib citrate (XELJANZ, 5 mg), via an unspecified route of administration from 20Apr2021 at 5 mg unknown frequency for an unspecified indication and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 20Apr2021 (at 61 years) at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient stated that 2 weeks prior, in Apr2021, she developed a flare but believed it was related to getting vaccinated for Covid. The final outcome of the event was unknown.  Tofacitinib was prescribed until 08May2021, however action taken for tofacitinib citrate in response to the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
26-year-old female who received her influenza vaccine in Oct 2002 and the following day felt fatigued and developed a rash on her knees. Stated she never had anything like this before and within one week the rash started to spread up to her abdomen, chest and down to feet. Stated the rash was not hives and described as small red bumps with white tops. Stated the itching was severe and was a "deep itch". She denied any respiratory problems, problems swallowing or speaking, nausea, vomiting, diarrhea, or eye swelling.   She went to the medical clinic and received topical ointments, unknown name or type, with no relief. She returned to the clinic several days later and was then given a steroid dose pack. Within one week of taking the steroid dose pack her rash cleared.  Patient (pt) reports a history of eczema during her childhood. Did have a dermatology evaluation and was given steroid creams, which helped. Pt denied any aggravation of eczema by foods. States her eczema was primarily on her face. Reports that her eczema has not bothered her. She reports occasional breakouts on her hands, especially the area around her rings. Breakouts described as small red hard bumps and notices it more if she does not dry her hands well, or if she is in contact with harsh chemicals. Has a rare outbreak on her face. States her face will feel dry around her mouth. Currently she applies a natural progesterone cream to the outbreak areas with relief.   When comparing the rash following her immunization with that of her eczema she replied that it was similar but different. Her eczema does not have white tops, only involves face and hands and not as itchy. The rash following her immunization had white tops, involved a greater portion of her body, spread quickly and was itchy.  She denies any new foods, soaps, detergents, or creams. Reports no problems when she eats eggs or gelatin based products.
Achy for 24 hours after receiving 2nd dose; This is a spontaneous report from a contactable consumer. A male patient in his 40s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced achy for 24 hours after receiving 2nd dose of BNT162B2. Therapeutic measures were taken as a result of the event included intake of paracetamol (TYLENOL) and ibuprofen, alternating for 24 hours following vaccination to manage achy symptoms. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated she received her first Covid 19 vaccine at 9:45am. She felt a "dry throat" while sitting in observation. She never had trouble breathing. She left observation after 15 minutes and still felt like her throat was dry and had trouble swallowing. She stopped to get a soda to see if that would help. Her throat continued to feel as if it were closing. She drove herself to the ER. She stated they monitored her for 2.5 hours . She was not given any medications in the ER. They took her vitals, looked in her throat every 20-30 minutes. She was not given Epineprine. Denied any wheezing.
This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 31-MAR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
About 9 hours after receiving vaccine (she was feeling well at the time of vaccination).  Patient developed body aches, fever (to 101), nausea, vomiting.  Unable to keep any liquids down became dehydrated.  Hospitalized overnight 10/22-23/2003 and anticipated to send home 10/23/2003.  Improving well now. The medical records received on 1/12/04 states abdominal pain. The medical records received on 1/28/04 states headache, lightheaded and cramping in legs.