chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a female (consumer's wife) 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, batch number: Unknown) dose, start therapy date were not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a female patient of unspecified age, who developed a blood clot an unspecified time after receiving the Janssen COVID-19 vaccine. No medical history or concomitant medications were provided.  There is insufficient information to make a meaningful medical assessment.  Additional information is being sought.
Lower Jaw and lower Lip Swelled up overnight. Took 50Mg of benedryl and iced the area. Symptoms subsided 75%  within 6 hours, but still active on lower left jaw and lower lip. Took 50Mg. more of Benedryl and iced again. Results are pending.
Redness left arm, fever, "racking" chills, "flu-like" symptoms.
ARM SORENESS, SEVERE NAUSEA AND VOMITING12-24 HOURS AFTER VACCINE, CHILL 12-36 HOURS
Swelling and itching surrounding area immediately after vaccine was given.  Swelling, increased redness, pain, itching days later.   Noticed that injection site from Trulicity (stomach, subQ) is substantially more swollen and itchy, red, painful, for an extended period of time.  This happens post COVID vaccine.  No relief from Benadryl or other measures.
From initial information received on 5/12/04 from the patient regarding an adverse event occurring in the USA, it was reported that the female patient (age not reported) received her first dose of pre-exposure IMOVAX RABIES, lot number not reported, route and site of administration not reported, on 4/1/04 in preparation for a stay abroad. The patient also received four additional doses of IMOVAX RABIES (a total of five doses) as well as a dose of IMMUNOGLOBULIN HUMAN ANTIRABIES on unspecified dates. Lot numbers, routes and sites of administration of these vaccines were not reported. An unspecified amount of time after receipt of each dose, the patient experienced chills and fatigue. Reportedly, the first dose of the vaccine was the first injection out of a series of three, which was given from a re-called lot. Because of this, the patient was given four additional shots. The patient stated that with each time she received the shot, she was unable to study and learn at her usual pace and was unable to engage in any moderate physical activities for the rest of the day after the shot was given. The patient's recovery status was not reported.
Fever; arm was sore from shoulder to elbow; arm was sore from shoulder to elbow; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, pain in arm and shoulder pain. On an unknown date, the outcome of the fever, pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the fever, pain in arm and shoulder pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received shingles vaccine and had a fever, sore arm from shoulder to elbow. The patient could deal with this pain as he/she did not want shingles. The case has been linked to US2022AMR013188, reported for other patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR013188:Response to same comment
Fatigue, swelling/sore/redness at injection site, mild sore throat,  mild nausea, mild headache
Immediate bruising on arm for more than a week. Breastfed 10 month old developed measles-like rash 3 days after I was vaccinated that lasted about 24 hours.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored of ZOSTAVAX (lot # L029482 with expired date 06-NOV-2016, dose and route were unknown). No concomitant therapy was reported. No adverse effects were reported. This is one of two reports received from the same reporter (1512USA008203). Additional information has been requested.
On the 29th of January, I woke at the middle of the night, with 99 1/2 fever, I did not feel so good, it was Sunday, the whole day I did not feel good, I had 100.5 fever at the most, the following Monday on the 30th, I called and made an appointment with my doctor. On the afternoon I still had a fever 0f 100.5, no sore throat, very mild symptoms, stuffy nose, I took the Covid-19 test Monday and it was positive. The doctor wanted to wait to see how I was doing before prescribed PAXLOVID, two days later I was doing better. I only experience fatigue, feeling tired, but after 10 days it was gone, and it was fine.
Arm red at shot area, arm hot, welt on arm, dizzy, not hungry, diarrhea, stomach issues (upset).
Patient came into health department and stated that she talked to her doctor and that the reaction she had was a reaction to the covid vaccine. Patient stated that she had swollen eyes and hands, she felt like she had a sunburn on her forehead, and she like she was in some kind of fog.
PATIENT STARTED WAVERING IN HER CHAIR AFTER I ADMINISTERED THE SECOND SHOT (FLU SHOT). I NOTICED HER EYES WERE CLOSED.  I GRABBED HER SHOULDERS AND CALLED HER NAME. SHE NEVER FELL AND AFTER A FEW MINUTES WAS AWAKE. I HAD HER LAY DOWN AND TOOK HER BLOOD PRESSURE. IT WAS NORMAL. PULSE WAS VERY WEAK AND HER LIPS WERE PALE. SHE FELT BETTER AFTER LYING DOWN AND SHE ASKED FOR SOME WATER. SHE WAS ABLE TO LEAVE ON HER OWN ABOUT 10-15MINS LATER.
A Pharmacist was supposed to give a 14 years old patient Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; A Pharmacist was supposed to give a 14 years old patient Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; A Pharmacist was supposed to give a 14 years old patient Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from the other health care professional via Pharmacy manager via phone via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323899, 2020SA323872, 2020SA324116 and 2020SA323616.  This case involves a 14 years old male patient who's pharmacist was supposed to give FLUARIX, however pharmacist accidentally grabbed and administered a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Prefilled Syringe lot number: UJ552AA via intramuscular route in the left arm on 05-Nov-2020 for prophylactic vaccination (wrong product administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines given.  It was an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and it was also a case of overdose (latency: same day).  No Adverse Events were noted and no treatments were administered to the patient.  Product used : Used.  Still using product : Yes.  Was Device Used : Yes.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
4 days after administration, patient still has a red wheel the size of a quarter at injection site. Advised patient to take Benadryl and use Hydrocortisone Cr.
This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. No current condition, medical history or drug/allergies were reported. On 19-MAR-2015 the patient was vaccinated with PNEUMOVAX23 injection (strength, dose number and route unknown) lot # K005957 which was expired on 08-MAR-2015. No adverse effect was reported. The outcome of event was unknown. No further information was provided. Additional information is not expected.
Swelling, redness/bruising, very warm to touch - prescribed Bactrim DS in case of infection
Patient jerked his leg while the vaccine was being administered. Patient only got about one fourth of the vaccine. Patient's mom wanted to do the vaccine again, so the patient received the full dose of the MMRV successfully the second time. This nurse explained to the patient's parent  of the side effects that could happen from being  given the second dose of the MMRV today.
Information has been received from a Medical Assistant concerning a 16 week old female patient who on 21-NOV-2008 was vaccinated with first dose of ROTATEQ (Lot # not provided). On 05-DEC-2008 the patient received second dose of ROTATEQ (Lot # not provided). The child experienced diarrhea and vomiting. The patient also received (PREVNAR) on 05-DEC-2008. At the time on the report on 08-DEC-2008 the patient not recovered. The patient sought medical attention office visit. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009.  Follow-up information has been received from a physician who reported that a patient had not adverse events.  Two doses of vaccine were given 2 weeks apart.  On 21-NOV-2008 patient received first dose of ROTATEQ (Lot # not provided).  On 05-DEC-2008, at 14:30, the patient received second dose of ROTATEQ (Lot # 662603/1271X) orally.  Additional information is not expected.
Palpations of the Heart; Sleepy; Headache until to date; Chills; Nausea, no vomiting; Soreness of Upper Left Arm where the Shot was given; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), CHILLS (Chills) and NAUSEA (Nausea, no vomiting) in a 73-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.     Concurrent medical conditions included Heart disorder.   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, 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 experienced PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), CHILLS (Chills), NAUSEA (Nausea, no vomiting) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given). At the time of the report, PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), CHILLS (Chills), NAUSEA (Nausea, no vomiting) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given) outcome was unknown and HEADACHE (Headache until to date) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant and Treatment medication were reported.  The patient had two shots of the Moderna Vaccine of which during the same night and awoke to reaction.   This case was linked to MOD-2021-354466 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 07-MAR-2007, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On 02-SEP-2015, the patient was treated by a healthcare provider for shingles.   The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Vaccine administered 12/04/2001. Student claims injection site became reddened and intensely itchy the evening of 12/04/2001. Presented with area right upper arm 2 inches in diameter red, raised, warm to touch. Diffuse red area around this also complained of itching.
No adverse event; The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 002F21A and 021B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 12-Apr-2021 and second dose on 31-Aug-2021).    Concomitant medication information was not provided. The dosage details of first, second and third doses was reported as 0.5. Treatment information was not reported.   This case was linked to MOD-2023-722207 (Patient Link).
Left thigh cellulitis. Area where injection given - red, warm, swollen, slightly indurated.
Strong headache, in the left arm and all over the body. Nauseas Chills Dizziness
Red, hot rash on upper arm that the shot was given in for 2 days that is self resolving.
Guest  received the first dose of the Pfizer vaccine. Following this administration, the guest revealed that he had already received two complete doses of the Moderna vaccine last month. Stated that he wanted to make sure he was "really protected" from the variants. Guest stated that he felt good and was ready to go home following his 15 minute wait in observation.
Itching at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Pt broke out in rash on 07/02/2007.  More vesicles were appearing over body.  Advised to come in.  Diagnosed with varicella.  No fever.  No cellulitis.  Advised to monitor and treat symptoms.
Red, hot, tingly spot appeared 2 days after injection. Went away after a couple of days and then re-appeared Exactly a week after injection as a larger, puffy, red spot. Has spread larger every day. Hot to the touch and causes arm to be weak and tender
Per Dr.: "HPV vaccine administered on 7/12/22 and patient reports left arm pain. Per patient the local injection site pain resolved for approximately one day. Afterward he started with similar muscle ache pain(feels like a pulled muscle) for last ten days. Better when arm is at rest, but worse with movement/abduction of shoulder.  pain 2 out of 10 at rest, 7 out of 10 with movement.  Using icy hot, tramadol and ice pack for pain.  Denies fever, chills or anaphylaxis after injection. Some initial nausea but none currently.  Denies history of adverse vaccine reaction."
inflammatory response on her arms; autoimmune response like swelling to lymph nodes; The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting- Medical Information. There is no indication that the consumer experienced an event under Product BNT162B2, BNT162B2 OMI BA.4-5. Upon receipt of follow-up information on (10Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A female patient in her 70's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammatory response on her arms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "autoimmune response like swelling to lymph nodes".  Additional information: Patient wanted to know if she had an inflammatory response on her arms after getting the COVID-19 vaccine in the past, and she enquired can she get another vaccine in her buttocks. Reporter stated that she would have to have the patient provide verbal consent for her to do the report, which patient had disconnected to talk to her provider and is no longer on the call. Reporter said she had already explained to the patient the inflammatory and autoimmune response like swelling to lymph nodes would resolve in a few weeks and to follow up with her doctor if they hadn't, and patient had the question of getting the injection in her buttocks. Reporter said their triage manual explains that it I intramuscular, but it didn't have anything about alternative injection sites, which she was assuming they would be able to, to provide vaccines to people with physical limitations such as amputees with limb removal or due to their anatomy. Reporter said she doesn't have NDC/LOT/EXP or cap color to provide for the patient's COVID-19 vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dose received: 3; Sore swollen lymph nodes in armpit, neck, clavical on side of vaccine injection; Swollen lymph nodes in armpit, neck, clavical on side of vaccine injection; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 33 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: graves disease and "Blood pressure high" (unspecified if ongoing), notes: high blood pressure. Concomitant medications were not reported. Past drug history included: Bactrim, reaction: "Drug allergy", notes: Known allergies: bactrim. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose received: 3"; LYMPH NODE PAIN (non-serious), outcome "recovering", described as "Sore swollen lymph nodes in armpit, neck, clavical on side of vaccine injection"; LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Swollen lymph nodes in armpit, neck, clavical on side of vaccine injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain and lymphadenopathy.  Additional Information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date the patient under went Covid 19 virus test via nasal swab and the result found to be negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body aches and joint pain all over, headache, nausea, fatigue, muscle pain through out my body, lack of appetite. All of these lasted for 3 days after injection of vaccine.
Severe Headache - 1.5 days Fever - 100 degrees F - 1.5 days Fatigue, cramps in hands, soreness at injection site, chills and sweats  Treatment: 500 mg acetaminophen every 6 hours for first day
Patient presented to the ED and was subsequently hospitalized for acute hepatic encephalopathy within 6 weeks of receiving COVID vaccination.