chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As happened with my 2nd Moderna vaccine, I developed hives a little over a week after the shot. Last time it was on my torso and feet with intense itching usually around 7-8 pm (I thought that the timing thing was really strange). This time around it manifested on my head, forearms, buttocks and, now, clavicle area. The itching was even more intense and then came the swelling of my head. I woke on the second day of this with swelling around my head, from the temple area, behind the ears and around the back of my head. It felt like the reaction I get to a bee sting, like a thick pad of something forming beneath my skin. I had taken a Benadryl before bed, then a Zyrtec in the morning to keep the itching at bay (with varying results). I iced the swollen area and the swelling subsided after an hour, but the temple are remained swollen. The swelling was moving too close to my eye for comfort, so I went to the local clinic to be examined. I was prescribed a steroid, which seems to have helped. The only itching and hives are now around my neck/clavicle area.
Pt received vaccinations at Public Health Nursing on 11/05/2012. Three days after she noticed some redness and itching, and some bruising on the L upper arm where vaccinations were administered.  A month and a half ago a nodule appeared in the same place without redness or irritation.  Denies fever or chills or other s/s of infection.  2 cm bolus lesion with boggy/fluctuant exterior and underlying hard nodule no ecchymosis, erythema, not warm on palpation.
1/25, in morning, mom noticed swelling & erythema at site. Saw Dr. On 1/26, afebrile, erythema 6mm x 5mm w/5mm bullseye at site. Full ROM, afebrile, very playful.
This solicited report as received from a physician and another unspecified reporter as a part of a market research program refers to an approximately 12 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, the patient experienced a lot of pain at the injection site. The outcome of the event was reported as recovering/resolving. The reporting physician considered the event to be non-serious and related to the vaccination with GARDASIL. Additional information has been requested.
Accidentally vaccinated a child with the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidentally vaccinated a child with the Moderna vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidentally vaccinated a child with the Moderna vaccine). On 09-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidentally vaccinated a child with the Moderna vaccine) had resolved.        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.   Concomitant medication product use was not provided by the reporter. No treatment information was provided.
CHILLS; INJECTION SITE SORENESS; VOMITING; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 11-APR-2021 02:15, the subject experienced vomiting. On an unspecified date, the subject experienced chills, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, vomiting, chills and injection site soreness was not reported. This report was non-serious.
Swelling in the jaw and neck. At 30 min mark she had hives developing and numbness going down the side she had the injection. Benadryl administered and transported to hospital.
covid pfizer bivalent was given administered less than 48 hrs after best use date.  There was NO adverse reaction.
on 05/11/2021 16 y.o Client arrived at Health Dept vaccine for his second COVID vaccine. His vaccine card shows he recleced Moderna 04/02/2021. It was explained to clients mother disease control guidance that the second dose may be given as off-label. Clinets mother chose to have child receive second Moderna. Client denies known side effects and adverse reactions to first dose.  Moderna COVID # 2 given 05/11/2021 RD/IM Lot # 041B21A
December 2 I started getting very tired, next morning felt bad, headache, fever of 100.3 temp. Got tested on Friday 12/3 tested positive for COVID-19. Sunday night & Monday, nasal swab burned. Respiratory problems started. Trouble breathing and extremely congested. Contacted MD Mon AM. Went to Urgent Care, got evaluated car-side. For about a week trouble breathing and coughing, BP was up. Monoclonal antibodies administered on 12/9. Started feeling a lot better by Saturday. Also got Z-Pak. Codeine cough syrup was also prescribed. Didn't feel recovered until Sat 12/14.
Became sick one day after the vaccine with COVID-like symptoms.  Approximately one-week severe heart palpitations and chest pains began.  Still having heart palpitations and chest pain almost daily since May 2021.  A physician has now placed me on 2-3 times a day Atenolol to assist with heart palpitations.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history included: "DM2" (unspecified if ongoing), notes: Other medical history: DM2 (diabetes mellitus 2); "HTN" (unspecified if ongoing), notes: Other medical history: HTN (Hypertension); "HLD" (unspecified if ongoing), notes: Other medical history: HLD (hyperlipidemia); "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; LEVOTHYROXINE; OZEMPIC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) positive, notes: tested positive on 18Jul2022; (01Aug2022) positive, notes: She tested positive again on 01Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. She received Losartan, levothyroxine, Ozempic medication in 2weeks. Her Symptoms started 15Jul2022 and she tested positive on 18Jul2022. She took Paxlovid and she felt better for the time she was on it. Then her symptoms started coming back again. She tested positive again on 01Aug2022. She received Paxlovid as treatment for COVID 19 Treatment and Treatment started on 18Jul2022 and stopped on 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
pt recv vax 7APR97 & that same day pt exp a severe cellulitis of the entire arm where administered;
COVID Vaccine Breakthrough Case  Moderna Dose 1 2/10/21 (057G20A) Moderna Dose 2 3/10/21 (010A21A) COVID Positive 10/30/21  10/30/21: Patient is a 70 year old female who presented to ED with complaints of shortness of breath. She has had increased shortness of breath and cough for the past four days. She lost her husband one week ago, he pasted in his sleep after battling a long illness. She has not been out of bed for the past week, except to use the rest room. She becomes dizzy and lightheaded upon standing. She has not been eating or drinking. She has no appetite. She does have a history of depression and anxiety, she is on medications but has not been taking them since her husband passed. She denies any suicidal ideation, no homicidal ideations. Denies visual or auditory hallucinations. She denies any recent fevers. No chest pain. No nausea, vomiting or diarrhea. She has a past medical history of IBS, CKD, and tobacco use. She has been fully vaccinated for Covid-19.   Arrival to ED the patient was hypotensive 98/56 and hypoxic on room air at 89%, 2 L supplemental oxygen was applied with improvement in oxygenation saturation. Laboratory findings were significant for severe hypokalemia 2.5.  Acute on chronic kidney injury BUN 43 and creatinine 2.70.  Lipase 98. Chest x-ray showed patchy bilateral infiltrates, viral pneumonitis could have this appearance. Ceftriaxone and azithromycin initiated in ED.  Potassium 40 mEq IV rider given in ED.  IV hydration given with NS 3 L bolus.  11/3/21: She is a 70-year-old female who recently lost her husband after a protracted illness presented to the emergency room with a complaint of SOB, dizziness and lightheadedness.  At the emergency room she was mildly hypoxic requiring 1-2 L of oxygen.  Chest x-ray showed a patchy infiltrates and subsequent COVID-19 screen came back positive.  She was admitted to hospital commenced on IV remdesivir, IV dexamethasone, IV antibiotics in addition to other supportive management.  Patient oxygen requirement has remain fairly stable at 1 to 2 L over the past few days.  She had an oxygen walk for home determination this morning and will require 1-2 L with physical exertion. Have other vital signs remains normal.  She will be discharged home will be enrolled in COVID safe at home program.  I gave a prescription of azithromycin for a few more days and will continue with pre-admission oral medications.
Patient developed chest pain, shortness of breath and fatigue.  Chest pain was worse with laying down. Went to Urgent Care and EKG revealed abnormal changes and was sent to ER for evaluation.  Found to have minimally elevated troponin, WBC, Sed Rate, CRP and D-dimer.  CXR and CT scan were normal with only small L axillary lymph node identified. Diagnosed with pericarditis and discharged home with Ketorolac for 5 days. Symptoms resolved.
48 hours post injection I began to experience hives everywhere on my body. Treatment included prescription steroid creams, Zyrtec and Pepcid during the day and Benadryl at night. The reaction lasted approximately 10 days.
pt recv vax & w/in 11 days of  vax pt exp lesions & inc temp;
This spontaneous report was referring to a 16 year old patient of unknown age received from the patient's mother. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot number, route and anatomical location was not reported). One week later, the patient developed swollen lymph nodes. Field employee reports that the patient was seen by an unspecified physician, was given antibiotics (it was also reported that no treatment was given) and within "about a week" the swollen lymph nodes resolved. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
in bed 3 days, extreme bone pain 4-5 days on left side, fever 4 days, itching at injection site,
Swelling and soreness at injection site starting 12 hours or so after vaccination. Patient will apply ice and take OTC Anti-inflammatory.
Wrong Vaccine Administered; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong Vaccine Administered) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong Vaccine Administered). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong Vaccine Administered) had resolved.            No concomitant medications were provided.  No treatment information provided.
(L) upper arm with 7 cm area of erythema and edema; no other sx.
Friday 6/29/2018 Right upper arm became, red, swollen, hot & arm became difficult to move. Later in the evening running a temperature of 100. Took ibuprofen for pain, swelling & temperature. Symptoms decreased. Slept over 12 hours. 6/30/2018 Swelling, redness, heat & difficulty moving arm increased. Temperature now 102. Headache, nausea, inability to eat or drink, body aches, chills, numbness & tingling in fingers, hands & around mouth. Difficulty concentrating. Went to ER at local hospital. Treated with TORADOL for pain, REGLAN for nausea & TYLENOL for fever. After treatment BP 90/66, Temp, 100.7. Sent home with REGLAN Rx. Able to eat & drink very little at home. Started taking 400mg ibuprofen QID. Slept 18+ hours 7/1/2018 Swelling, redness, heat & difficulty moving arm decreased. Horrible body aches & head ache upon waking. Continued taking 400mg ibuprofen QID. Decreased pain for 2 hours & then increased. Temperature fluctuated between 97.0 and 100.0 throughout the day. Still confused. Slept 14+ hours 7/2/2018 Worked 4 hours as pre-op nurse. After shift given 1000 NS via IV Lt AC via 22 gauge IV set. Easily confused & dehydrated 7/3/2018 Continue with ibuprofen as above. Temperatures still fluctuating. Easily confused & dehydrated.
Narrative: Patient passed away due to COVID-19. He was hospitalized and had received the COVID-19 vaccine.
This spontaneous report was received from a health care worker refers to an unspecified number of patients of unknown age and gender. Between July and August 2014 the patients were vaccinated with an improperly stored dose of GARDASIL Lot # K004204, expiration date: 12-JAN-2017 (dose and route of administration was not reported). No adverse effects were reported. It was reported that sterile water diluent (Lot # J015953, expiration date: 30-SEP-2016, Lot # K01010820, expiration date: 13-MAY-2017 and lot # K006954, expiration date: 28-FEB-2017) were exposed to 83F for 12 hours and to 28F for 36 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report was received from a health care professional on 10 Dec 2009: This patient received FLUVIRIN intramuscular in to deltoid on an unspecified date. It was reported that patient called her pharmacy that she developed rash on her face on an unknown date. The outcome of the event was not reported.
Information has been received from a health professional concerning a female who was IM vaccinated with her first dose of Gardasil (lot number unspecified) and experienced a mild unspecified pain.  The patient received her second dose of Gardasil (lot number unspecified) intramuscularly and experienced a more severe pain in her pelvic area which intensified when she walked.  The caller was not able to provide the lots numbers for the vaccinations.  The patient sought medical care by calling the office.  Additional information has been requested.
Narrative: Per ID physician note: "7 y/o man with h/o CAD, COPD, HFpEF, IgG4 pulmonary/renal disease (CrCl 45), and recent retinal detachment who was admitted yesterday for ophthalmologic surgical repair. He was incidentally found to be COVID+ last Friday 7/23 (viral load <100 copies at the time), and the decision was made to proceed with surgery yesterday. The procedure was uncomplicated, but post-op he desaturated to the mid-80s. He had been on varying levels of supplemental oxygen since (2-5L), but he is currently stable on 2L O2. He has fever last night to 100.8. Per the patient's primary team, he is currently complaining of cough with sputum production. - Start IV remdesivir 200mg x 1, followed by 100mg daily starting tomorrow x 4 doses - Given that his oxygen requirements have stabilized around 2L, I do not recommend starting dexamethasone at this time, but should his respiratory status worsen, we could consider adding steroids while in-house."
Insomnia (severe) lasting several weeks. Doctor prescribed sleeping and allergy meds to alleviate symptoms. Insomnia alleviated with meds within three-four weeks and without meds within eight-ten weeks.  Menstrual changes. Period arrived immediately after second shot and was not due. Period was very heavy and unusually painful. Did not have period after that for another two cycles( months.) Both incidents are out of the ordinary for me as period is usually on time and not heavy. Menstrual timing resolved itself within four-five cycles however heaviness and painfulness of periods is still an issue I did not have before this vaccine.
Patient fainted after receiving 3 of 5 vaccines. She recovered quickly and then received her final 2 vaccines without further incident.
This case was reported by a other health professional via call center representative and described the occurrence of constipation in a 2-year-old female patient who received BOOSTRIX for prophylaxis. On 5th May 2018, the patient received BOOSTRIX. On 5th May 2018, unknown after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information was reported as follows: The healthcare professional did not have the lot number or expiry date for BOOSTRIX. The healthcare professional reported that they inadvertently administered a 2 year old patient with BOOSTRIX, which led to inappropriate age at vaccine administration. Follow-up information reported by the other healthcare professional on 11th July 2018 was as follows: On the date of reporting the healthcare professional called the representative and updated with information provided to them by the patient's mother. All the information provided by the healthcare professional in this call was documented. The reporter details were updated. The reporter also stated that the healthcare professional was a supervisor at a chain of urgent care facilities, not the child's pediatrician. The case was upgraded to serious for the event constipation with seriousness criteria as other serious (as per reporter). On 24th May 2018, the patient was vaccinated with BOOSTRIX. Eleven and a half weeks after the vaccination, the patient was diagnosed with high formaldehyde level by her pediatrician, constipation, hemorrhoids and behavioral changes of agitation and hitting. The patient was treated with by the pediatrician with probiotics and a detox soup. The outcome of the events constipation, hemorrhoids and behavioral changes was recovered. The VAERS details were updated. Healthcare professional also stated they were available via email for follow up questions if needed. Lab Comments: On an unknown date, the patient carried out formaldehyde test that showed high formaldehyde level.
9/23 1:30 Pain / small lump size of a quarter at site. 9/23 7:30 increased pain / larger lump / redness (used ice). 9/24 6 am increasing pain / lump about the size of a baseball / hot to touch / red / slight fever / blood pressure elevated  145/90 (ice compresses regularly). 9/24 3 PM same symptoms / fever 100.4. 9/24 2 am same symptoms / fever 102.9 / BP 170/110. 9/24 same symptoms / diagnosed with cellulitis at injection site / blood cultures drawn at 2 sites / Vancomycin IV started. 9/26 or 9/27 blood cultures came back positive for staph and elevated WBC (14000), diagnosed with Sepsis, switched to Augmentin.
ITP, petechiae, bruising, low platelets, had to have two rounds of dexamethasone and it took 6 months for my platelets to stabilize.
Itch Rash on chest and head. Patient still states having hives and itchiness flair ups has been sent to allergist.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 07-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 07-DEC-2012 the patient experienced drug dose omission, 1 day after onset of therapy and syringe leakage. No treatment information was reported. The outcome of drug dose omission and syringe leakage is unknown. The relatedness for drug dose omission and syringe leakage is unknown for ZOSTAVAX. No adverse effect reported. No further information is available. This pharmacist was transferred from a member of the PQC team who had already confirmed that there was no PQC with ZOSTAVAX in the case; therefore no PQC filed. Additional information is not expected.
Coughing, trouble breathing, runny nose, fever, diarrhea, nasal congestion, decreased appetite. Diagnosed with pertussis. Discharge Summary received on 9/10/2003 states pertussis and GERD.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On 01-JUN-2012, the patient was vaccinated with improperly stored dose of VARIVAX dose 1, lot#: 671861/1907AA. On 29-JUN-2012, the patient was vaccinated with the second improperly stored dose of VARIVAX, lot#: 671861/1907AA. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
The patient came in to receive a flu shot to Pharmacy. The initial flu shot did not take well into the patient's deltoid causing the vaccine to squirt back out. A new vaccine was prepared for readministration. The patient fainted immediately after receiving the vaccination. Her eyes rolled back and pupils became dilated. 911 was immediately called. Her head was supported and she began to seize slightly. Epipen was immediately administered after and the patient quickly woke up again. The patient felt sick and vomited. The patient was instructed to lie supine on the floor and was closely monitored for 10 minutes until paramedics arrived. The paramedics checked the patient's vital signs and offered to take her to the hospital.  The patient declined a visit to the hospital and was cleared by the paramedics.
pt recvd vax & devel hives in lt antecubital space,to ER for eval; tx DPH & Solumedrol;
This is a 90 y.o. with hx of HTN, GERD, dementia who presented with the above complaints.  Husband at bedside.  Pt has been having tremors with generalized weakness since yesterday.  She has been having urinary frequency with pain.  No fever or chills noted.  She has not had a cough or congestion. No sob,chest pain, abdominal pain, nausea, vomiting, or diarrhea. Remained on room air. Initially no anti viral indicated per ID ; however started on Remdesvir and low dose steroid  per ID on 2/13 for worsening inflammatory markers  Completed IV Remdesivir x 5 days  Complete steroid po outpatient