chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible stomach cramp from taking VIVOTIF, unable to sleep the pain is so intense, comes in waves and seems to be linked to what I eat, any dairy and the pain is intense. I've been avoiding dairy but I'm having an attack now that I can't explain.
pt recvd vax  on 23dec93 & exp tingling of fingers, toes, gingiva & tongue; progressed to bell palsy w/ loss of 30-40% muscle tone; hosp 28dec93, transfer to rehab facility of ot/at;
Patient reports that with her first dose of Pfizer Covid-19 vaccine she developed leg numbness 45 min after her dose.  She could feel her leg if she touched it but if she stepped down to stand she couldn't feel the floor.  She also developed confusion by the time she drove home and son had to help get her out of the car. She states confusion lasted 1.5 days, the leg numbness lasted 2-3 days after first vaccination.  After her second dose she felt leg numbness within 20 minutes of getting the injection. and had7-8 days of leg weakness where she felt she would fall when walking and had 4 days of confusion with second dose.
3/24 headache about 2 hours after vaccine.  3/25 around 11:30am I started having numbness and tingling in my lower(bottom) lips. Throughout the morning and currently the sensations are going back and forth from numbness to tingling -- i also have a little swelling.
Patient called back the day after immunization to report injection site was swollen, red and painful. She scheduled for a follow up visit the next day after calling back again and reporting subjective fever, continued pain, and continued redness and nodule. She was seen in clinic on 8/3/23 where she was noted to have a 10 cm erythematous patch over left lateral thigh/glute region with tender central subcutaneous nodule approx 1.5 cm .
This spontaneous report has been received from a Nurse referring to a patient of unknown gender and age. No concurrent or clinical history was reported. On 25-JUN-2015 the patient was vaccinated with an expired dose of M-M-R II (Lot # J003004) 0.5 ml intramuscular (incorrect route of drug administration). No adverse events were reported. Additional information has been requested.
Developed fever, vomited X 1, weak, aching all over with swelling on left arm 4" X 5" area and very sore. Doctor seen and he felt it was infected. Red streaks on arm. Was placed on antibiotics. Improving.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 11-MAR-2016 the patient was vaccinated with an expired dose of GARDASIL (lot # J013324, expiration date: 12-FEB-2016, dose and route were not reported). Concomitant drug was not reported. No adverse effects were reported. Additional information is not expected as there was no consent for follow up.
Arm hurt a little bit; A spontaneous report () was received from a consumer concerning a 86-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt a little bit.  The patient's medical history was not provided. Concomitant medications reported were Thyroid meds, Blood pressure meds, Vitamins, Ibuprofen for drug use for unknown indication.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event arm hurt a little bit.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, arm hurt a little bit was unknown.
Itchiness, redness, swelling of hands, knees, and feet claims he is feeling like there is a ball in his throat but no difficulty swallowing and breathing. Treatment to be sent out to ER.
A 10 month old was given first shot of Rotarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K2fm7, expiry date 4th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th May 2022, the patient received the 1st dose of Rotarix lyophilized formulation (oral) 1 ml and Rotarix Oral Applicator Device. On 4th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Nurse practitioner stated that a 10 month old was given their first shot of Rotarix on the day of reporting. The reporter consented to follow up. Additional Supportive Information: The 10 month old patient received Rotarix, which led to inappropriate age at vaccine administration.
Invalid Dose; noticed that a little amount of vaccine dripped/Caller mentioned that almost 0.45ml was administration; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Invalid Dose) and DEVICE CONNECTION ISSUE (noticed that a little amount of vaccine dripped/Caller mentioned that almost 0.45ml was administration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021 at 4:30 PM, the patient experienced UNDERDOSE (Invalid Dose) and DEVICE CONNECTION ISSUE (noticed that a little amount of vaccine dripped/Caller mentioned that almost 0.45ml was administration). On 25-Apr-2021 at 4:30 PM, UNDERDOSE (Invalid Dose) and DEVICE CONNECTION ISSUE (noticed that a little amount of vaccine dripped/Caller mentioned that almost 0.45ml was administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. No treatment information was provided by reporter.
Swelling of lymph nodes in both sides of neck, high fever, screaming. Tylenol was administered. Called doctor to report.
Pt got HAVRIX 9-30-08- called office 12-2-08 asking when to get booster as she still has very achy and sore arm at times. Is now improving - will call office if does not completely resolve.
Facial numbness in cheeks, chin and around eyes; Facial numbness in cheeks, chin and around eyes; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old adult non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EP6955) via an unspecified route of administration on 20Mar2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included birth control on an unknown date. It was unknown whether the patient had any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021, patient experienced facial numbness in cheeks, chin and around eyes. Lasted 2-3 hours. Felt like face does after dentist numbing wears off. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of the event's facial numbness in cheeks, chin and around eyes was recovered on 20Mar2021.   No follow-up attempts are needed. No further information is expected
pt recv vax 28OCT98 lt deltoid area returned today 29OCT w/a local rxn red raised area size of silver dollar, warm to touch;
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.
Hives - both arms. Mom gave pt BENADRYL. Occurred about 4 hrs. after vaccine.
can't move it very well / can not lift arm above shoulders / can't put arm behind back to touch back; Left arm has been sore; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number B4527, expiry date 2nd May 2022) and (batch number 954K5, expiry date 2nd May 2022) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. On 5th October 2020, the dose was an unknown dose. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were unknown.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient's left arm had been sore and she could not move it very well. She could not lift arm above shoulders and could put arm behind back to touch back.  The reporter stated that the patient was due for second dose of Shingrix. The reporter did not consent to follow-up.
This spontaneous report as received from a medical assistant refers to a 52-year-old female patient with hypothyroidism (reported as "hypothyroid") and penicillin allergy. On 08-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX, injection, subcutaneous, (dose, dose number, injection site, lot number and expiration date were not provided) for the prevention of shingles. There were no concomitant medications reported. The reporter stated that the patient's "sub-cu tissue became red, hot, swollen and painful to the touch" after receiving ZOSTAVAX (on 08-SEP-2017). It was also reported that the patient experienced lymphadenopathy which lasted until the next day. According to the reporting medical assistant, the patient saw a nurse practitioner as a precaution, however, no treatment was given for the adverse events. The outcome of erythema, pain of skin, skin swelling and skin warm was unknown. The relatedness between the adverse events and suspect therapy was not provided. Additional information is not expected as no permission has been granted to contact the reporter.
This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Tested positive for Covid) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Hypothyroidism.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
About a month afterwards on 4/23/2021, I developed shingles infection. I have not had my shingles vaccine. I had a terrible back ache on the 4/15/2021 and was diagnosed with shingles on 4/23/2021. I had a rash and some blisters on my back and a few on my groin area. On 6/18/2021, I had an aortic aneurysm. I had a very sharp pain across my lower back and I got very winded and called 911 and the fire department and ambulance came. I was taken to hospital in state. They ran a lot of tests and blood work and I was transported to another hospital in city, state which is more specialized and I had to have triple A surgery. The aortic artery had burst.
A few days after the vaccine I noticed a swollen lymph node above my right clavicle which is about 2 cm in diameter.  After about 2 weeks of it not leaving, I reached out to my PCP who did bloodwork and saw my WBC was a little elevated. I have an Ultrasound scheduled within the next week or so, but the lymph node still is swollen and has not gone away.
Pt received VARIVAX vaccine (2nd dose) on 11-6-2009: according to the pt's mother "she swelled up @ injection site 3 hours later. Pt was taken to the MD who prescribed warm compress & pt to stay away from VARIVAX vaccine.
Patient received both vaccines and then reported about 2 hours later he lost vision in his left eye.  He called pharmacy and we told him to go to the doctor to not take any chances and after investigating this could be a possible adverse reaction from the Shingrix Vaccine.  Patient went to the hospital and they did test because at first they thought it could of been a stroke or diabetic complication.  After test they realized that it was from the Shingrix vaccine attacking the optic nerve.  The patient had to have surgery on the left eye.  They had to do laser surgery on the left eye optical nerve.  The patient was given antibiotic/steroid eye drop to use after surgery and reports back to the doctor in a week.
3/6/08 Thousands of reds dots - bilat legs thigh (upper) to ankles. Also less severe rash on back, hips, flanks, bilat arms. Dots not painful, not itchy, denies fever, or malaise. States she feels fine. Patient recently showered and shaved legs, but rash is on more areas of body. No other changes in soaps, detergents, lotions. Complained of right arm very sore, claims shot was in bone.  4/1/08 Reviewed hematology outpatient clinic note of 3/7/08. FINAL DX: severe idiopathic thrombocytopenia. Records reveal patient experienced petechiae all over LEs that spread to abdomen & arms, nosebleeds, gums bleeding, bloody vaginal discharge, intermittent HA.  Exam also revealed mucosal petechiae & purpura.  Rubbery lymph nodes at jaw.  Spleen questionably palpable.  Tx w/WinRho & was to f/u w/her pcp.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: pt was itching away fromt the site but on the same arm and also rash on the chest...pt was otherwise fine no other symptoms
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included: something with her leg to which she was hospitalized (it was 2 years age), and concurrent conditions included: allergies (something with some sort of pain medication she could not had), blood pressure abnormal (she took blood pressure pills), smoker, and alcohol use, and other pre-existing medical conditions included: The patient had not drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 01-APR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUL-2022, patient was in the hospital and the doctors told her she had COVID-19 (confirmed covid-19 infection), she went to the hospital because she felt unwell and they did a test for her and it was positive (confirmed clinical vaccination failure), She was in the hospital since 05-JUL-2022 because she was 82 years old they kept her there. She was coughing. The number of days hospitalized was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint number: 90000241394.; Sender's Comments: V0. 20220715152-covid-19 vaccine ad26.cov2.s -confirmed covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.   20220715152-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report as received from a nurse practitioner via company representative, refers to a 13 year old female patient. The patient's medical history included asthma. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (dose, route not reported) (lot# reported as L040459, expiration date was reported as 06-APR-2017). Concomitant therapies included albuterol sulfate (manufacturer unknown) and generic montelukast sodium (manufacturer unknown). On an unknown date, the patient slept a lot the following 2 days after getting the vaccination. On an unknown date, she experienced nausea, vomiting and headaches. The patient "became very "giddy", she was "laughing at the clouds". On an unknown date, the patient decided to discontinued series of the GARDASIL 9 due to events. The outcome of patient was reported as recovered (dates not provided). The relatedness between the events and vaccination of GARDASIL 9 was not reported. Additional information has been requested.
Pt recvd 3 doses of Engerix-B vax 30OCT90, 27NOV90, & 11MAY91 & 14SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B vax;
postherpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding concomitant medication, historical condition or current condition was unknown. On or about 02-MAR-2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, Plaintiff was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of post herpetic neuralgia and herpes zoster was considered as not recovered. The reporter considered herpes zoster and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).   Herpes zoster and postherpetic neuralgia were considered as disabling.
For 6 days there was a lot of redness & swelling the entire length of my underarm down to elbow. Also several pox erupted on chest.
Tip of tongue tingling; Tip of tongue burning; This is a spontaneous report from a non-contactable other healthcare professional. A 58-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on an unknown date (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, during 15 minutes waiting period after the vaccination, the patient began to experience tip of tongue tingling and burning. The patient reported that, she might have burned the tip of the tongue after eating hot oatmeal. The patient wanted to be evaluated to be sure if that was the issue and not an allergic reaction. Therapeutic measures were taken as a result of events and included treatment with water. It was reported that the patient's response to treatment was good. The patient was discharged and stable to go home and was asked to follow up with primary care physician (PCP). The clinical outcome of the events tip of tongue tingling/burning was unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
NOTE: Vaccine listed was given to patient's father(Says he kept site covered with bandage or long sleeves)*Suspected inadvertant inoculation in son. On 5/12/03, parents noted a small pimple-like lesion on son's L) cheek, which later had a 2-3cm area of erythematous plaque around it. Took to the doctor a few days later, when there were several facial lesions on R)cheek, around R)ear, nose, and chin. No vessicles or pustules. Over week-end of 5/17 and 5/18, many of lesions resolved, but some new lesions appeared. Asymptomatic except for mild pruritis.
Administrative deviation only; no adverse event resulted from this deviation. The patient received a mixed series of COVID-19 vaccine (one dose of MODERNA and one dose PFIZER-box #4 reflects the second dose).The decision to administer a mixed series to the patient was due to an exceptional circumstance "  stemming from the the unavailability of the first vaccine product (MODERNA) at the time the second dose was due.We understand tat although CDC provides considerations for a mixed series in exceptional circumstances (such as a vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires VAERS reporting.Note second vaccination date is listed.
Patient came with husband to Vaccine clinic today 3/5 for 2nd dose of vaccine. Did well during and immediately after vaccine. Husband states patient has c/o severe chest pressure and pain for several weeks but has refused to come to ER for evaluation. Today, after getting vaccine dose and going to local bank, patient was in passenger side of truck when chest pain started again. Husband begged patient to let him take her to the ER but she said no, I?m fine and I don?t want to go. She then went unresponsive. At a stop light, he was next to a couple of cops who he was able to wave down and proceed to escort them in to ER. Upon arrival to the ER, patient was unresponsive and pulseless. CPR was initiated, 1 defib, and 1mg of epi was given. Return of pulse was obtained, but husband asked for no life support and only comfort measures. Patient was admitted for comfort measures.  I do NOT think this was related to her vaccine, but rather the unfortunately end to a sub-acute chest pain patient that declined multiple urgings to seek care.  Patient then expired on 3/5/21 at 2037.
home by parents for symptom control. Chest pain started on 6/13, fever 103, vomiting continued. Sought treatment in the ED. See attached ED provider note for more detail