chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Do not know the time or day that the symptoms first occurred. Patient was fine when she left after being vaccinated, other than that she jerked free from parents hold and kicked her leg when the injection was in her leg but I instructed them about a cool washcloth or covered ice pack if needed. Several days later, my supervisor informed me that the Grandmother (who was not at the visit) had called and spoke to the Health Department, and stated that the limb in which the Dtap was given (the left, which would have been the same leg she kicked during the injection) was entirely swollen and that there was a knot in both limbs. She took her to the Emergency room, where the physician said her lymph nodes were swollen, which happens when the vaccinations are working and building antibodies. My supervisor told me that patient has recovered. I do not know any other details as I was not the person contacted.
Zero symptoms after the first dose aside from a sore arm for 24 hours. Almost no immediate symptoms after second dose aside form a sore arm again for 24 hours. However, a few days after the second dose, I noticed a very slight metallic sort of buzzing or ringing in my ears. After consulting a week later with my family doctor, he mentioned the possibility of tinnitus and we have an appointment set with an ear/nose/throat specialist on May 3rd.
Fever, body aches, joint pain, stomach cramps, diarrhea, fatigue.
Slightly dizzy "spacey"  b/p 148/78 pulse72 Respirations18 right after seeing vaccine.  Client refused medical treatment.
STINGING AND TINGLING DOWN ARM AFTER INJECTION; STINGING  AND VERYSORE UPPER LEFT ARM; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number -unknown), in the left arm via an unspecified route of administration on 18Mar2021 as single dose (at the age of 61-years-old) for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma and Immune deficiency. The patient had history of drug allergy to penicillin, biaxin, bactrim, levoquin, codine, opioids and doxycycline. The concomitant medication included XOLAIR since an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she was not tested positive for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced stinging and tingling down arm after the injection(paraesthesia) and had very sore upper left arm (pain in extremity). The clinical outcome of the events paraesthesia and pain in extremity was not resolved at the time of the report.  Information about lot number cannot be obtained. No further information is expected.
Hives-lips, face and itching 6 hours after having Gardasil #2 Patient had eaten sushi with that 6 hr period
very hot; really sick; red; arm is still swollen; itching; chills/freezing; horrible body aches on legs; pretty high fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), ILLNESS (really sick), PERIPHERAL SWELLING (arm is still swollen), PRURITUS (itching) and CHILLS (chills/freezing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 95?905, 010M20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FEELING HOT (very hot), ILLNESS (really sick), PERIPHERAL SWELLING (arm is still swollen), PRURITUS (itching), CHILLS (chills/freezing), MYALGIA (horrible body aches on legs), PYREXIA (pretty high fever) and ERYTHEMA (red). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (very hot), ILLNESS (really sick), PRURITUS (itching), CHILLS (chills/freezing), MYALGIA (horrible body aches on legs), PYREXIA (pretty high fever) and ERYTHEMA (red) outcome was unknown and PERIPHERAL SWELLING (arm is still swollen) had not resolved.            no concomitant medications are provided by the reporter. Patient took Advil and it did not bring the fever down and Tylenol.   This case was linked to MOD-2021-375561 (Patient Link).
patient saw some vaccine drip on her arm, about the size of a quarter; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (patient saw some vaccine drip on her arm, about the size of a quarter) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (patient saw some vaccine drip on her arm, about the size of a quarter). On 02-Mar-2021, PRODUCT ADMINISTRATION ERROR (patient saw some vaccine drip on her arm, about the size of a quarter) 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 medications are not provided. No treatment information was provided.; Sender's Comments: This report refers to a case of accidental underdose  and product administration error for mRNA-1273 (lot/batch: 027A21A) with no associated AEs reported.
I had the first dose of the Pfizer COVID Vaccine on Friday, April 2nd. I had a headache a few hours after, which still hasn't subsided. I woke up at 4 am on the 5th itching all over, hives all over my abdomen, calves and arms. Nausea followed soon after. I went to my doctor today and was given steroids, allegra and Zofran for the nausea.
Tired, Chills, Joint Pain  All day super tired Chills so bad my teeth chattered - lasted a couple of hours Joint pain started a couple of hours after shot and continued for 24 hours
Patient had a possible seizure within seconds of receiving the flu vaccine. He started to slump down, eyes rolled back, and convulsed. Seizure lasted approximately 10 seconds and then he came to. We gave him water, a candy bar and told him to rest. He left w/his dad after 30 min.
No adverse effect/event observed nor did pt. voice any concerns during and after administration or during observation and time spent here in the clinic. However, pt. received Janssen 0.5 ml as second booster instead of MRNA vaccine.
Severe and constant pain in left arm at injection sight. Unable to move arm without significant pain. Also chills at 9:00PM (no fever).
Patient received dose 1 of the COVID vaccine (lot EW0150, exp 7/2021) at 1420. At 1425, patient approached EMT reporting he felt dizzy, nauseous, sweaty, and anxious. The patient reported having a similar reaction when getting previous injections due to a fear of needles and blood. PHN approached to assist. Vital signs: blood pressure 90/48, O2 97%, pulse 56, respirations 18. Patient denied allergies, medical conditions, or current medications. Patient reported not eating breakfast. At 1427, EMT offered patient water. PHN offered patient Benadryl but patient declined, also advised to contact provider and when to call 911. Patient reported he did not have a medical provider, PHN advised patient to contact 211 for assistance. At 1430, vital signs: blood pressure 102/58, pulse 74, O2 94%, respirations 18. Patient reported symptoms had resolved and he felt back to baseline. At 1445, vital signs: blood pressure 104/52, O2 94%, pulse 71, respirations 18. Patient denied anxiety at this point. At 1455, vital signs: blood pressure 98/58, pulse 74, O2 94%, respirations 16. Patient left walking with steady gait.
Pt stated her hand felt numb, she was sitting up and her face went pale then she folded forward passing out. We sat her up and she convulsed slightly and turned red before stating she was very confused and became pale again. We had her sit for 15 minutes, gave her water and snacks (chips and candy for salt and sugar). She stated she was feeling better after sitting and the color returned to her face.
A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated that patient inadvertently administered expired FLUMIST QUADRIVALENT to a patient which started on 06-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT to a patient is unknown. The report was considered to be non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 74-year-old female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown. It was unknown if the reporter considered the localized erythema and local swelling to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient experienced a localized reaction of redness and swelling. No further details were provided regarding the patient's experience.
Red rash which was spreading down to the left hand; Itchy rash which was spreading down to the left hand; Soreness; Headaches; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash which was spreading down to the left hand), RASH PRURITIC (Itchy rash which was spreading down to the left hand), PAIN (Soreness), HEADACHE (Headaches) and MYALGIA (Muscle aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Scleroderma (Diagnosed in 2018).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash which was spreading down to the left hand), RASH PRURITIC (Itchy rash which was spreading down to the left hand), PAIN (Soreness), HEADACHE (Headaches) and MYALGIA (Muscle aches). At the time of the report, RASH ERYTHEMATOUS (Red rash which was spreading down to the left hand), RASH PRURITIC (Itchy rash which was spreading down to the left hand), PAIN (Soreness), HEADACHE (Headaches) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included immunosuppressive drugs for scleroderma.   Treatment information was not provided.
16JAN99 pt deltoid area started to swell, turn red & become painful;18JAN99 redness & swelling;22JAN99 swelling in lt hand & fingers;lt arm weakness & tiredness;25JAN99 hardness @ site, tingling lt fingers;sore thumb;
Pt received Janssen vaccine on May 4, 2021 then received a 2nd Janssen vaccine on July 20, 2021.    No adverse reaction or side effects have been reported at this time.
Patient woke up the 11/28/18 with ataxia, inability to engage in eye contact, and increased fussiness. Parents called our office and were advised to go to the ER. They went to ER where they suspected an ear infection and labyrinthitis. They treated her with amoxicillin and sent her home. They followed up with me 11/29/18, where she was observed in the waiting room to have upper extremity tremors, and poor eye contact. She would not walk during clinic visit and was sent back to ER. They did a head CT and MRI. The attending physician suspects she had brain swelling when her symptoms started, but the swelling may have resolved spontaneously by the time the imaging studies were done.
52-year-old female receiving Fluzone Quadrivalent High-Dose, with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 52-year-old female patient who was receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2022, the patient received 0.7ml dose total of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation: unknown) (lot number: UJ895AC and expiry date: 30-Jun-2023) via intramuscular route in the left arm for Immunization and 52-year-old female was receiving fluzone quadrivalent high-dose, with no reported adverse event (off label use; latency: same day).  It was reported, the Nurse reported that the error was due to the order was given verbally; that the provider misspoke thinking the consumer was over 65-years; and the age of the patient was not checked prior to administration.   Action taken was not applicable.  At time of reporting, the outcome was Unknown.
Information has been received from a pharmacist referring to a 63 year old female patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 16-OCT-2014, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not available to the pharmacist at this time, strength, dosage and frequency unspecified). On 13-NOV-2015 the patient was vaccinated with ZOSTAVAX (lot # L028281 with expiration date of October 2016; strength and dosage unspecified) (extra dose administered). The patient had not reported an adverse experience. Additional information has been requested.
Left forearm red, swollen Stinging/burning pain in the entire arm. Intense itching feeling in forearm.
Patient came in on 9/29/21 and requested to get a vaccine for moderna. she didn't provide us a card that she had already gotten the Janssen vaccine on 3/2021 and did not mention it to the immunizing pharmacist. the pharmacist gave her the moderna vaccine knowing that its her fist covid vaccine. she then came in 10/27/21 wanting second moderna shot and provided us with the vaccine card we had given to her for her first dose of moderna. then while waiting for the technician to process the shot she mentioned that she had the janssen vaccine in past as well. the technician asked for the vaccine card for the janssen which she provided. I explained to the patient that we cannot give her the second moderna vaccine since she already got 1 full dose of moderna and the current CDC guidelines only recommend one booster dose of 0.25ml of moderna at least 2 months from janssen vaccine. patient was upset and left the pharmacy.
Patient's parents supplied us with the wrong DOB for the patient in order to qualify for booster shot. At that point we were only authorized to administer Pfizer booster shots for patients 16+. They supplied us with a birth year .  No side effects has been reported by patient at this point yet.
Chills, sever body aches, mostly in the legs. Heart racing but only lasted a few hours, fatigue
patient was unconscious; patient was unconscious; UTI; Bedridden; Patient began to vomit; This case was received via FDA VAERS (Reference number: 0967119) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (patient was unconscious) and SYNCOPE (patient was unconscious) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Syncope (granddaughter states patient has episodes of syncope) and Wheelchair user.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (patient was unconscious) (seriousness criterion medically significant) and SYNCOPE (patient was unconscious) (seriousness criterion medically significant). 22-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI), BEDRIDDEN (Bedridden) and VOMITING (Patient began to vomit). At the time of the report, LOSS OF CONSCIOUSNESS (patient was unconscious) and SYNCOPE (patient was unconscious) had resolved and URINARY TRACT INFECTION (UTI), BEDRIDDEN (Bedridden) and VOMITING (Patient began to vomit) outcome was unknown.        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.   After administration, the patient remained in waiting area for the recommended 15 minutes observation time. Approximately 20 minutes after vaccination, patient was unconscious and appeared not to be breathing, but pulse was palpable. Pharmacist administered 1 dose of 0.3mg epinephrine via epi-pen into patient's left thigh. The patient quickly regained consciousness, spoke to family, said she did not feel well. Emergency medical services (ems) arrived. The patient began to vomit, was placed on stretcher and left with ems. A few hours later the granddaughter reported that the patient had a urinary tract infection (UTI) and physical exam by emergency room (ER) attributed her experience to untreated infection.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Vomiting is consistent with event safety profile.
I noticed that I was hearing sounds kind of like a white noise in both ears. I usually only hear it when I'm in a quiet room. I experienced this for months before I decided to see a doctor. On 04/08/2022 I decided to see a doctor about it. He checked my ears and said there was no obstruction or damage. He stated I had subjective Tinnitus. He referred me to see an audiologist. I have an appointment with the audiologist on 05/18/2022.
On of diarrhea, emesis, decrease appetite to all foods and liquids about 6 hours after the vaccines. No rashes, no new wheezing and no blood in stool. No seizures.
Had minor back issue prior to vaccine.  Within 24 hours, lower back muscles began to severely spasm as well as the tops and bottoms of the feet.  Muscle relaxants were not effective until two days later when spasms began to subside.
My son missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (My son missed second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (My son missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (My son missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant informations were reported.  No Treatment informations were reported
Fatigue; nausea; mild joint soreness; diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for herself). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in left arm on 26Mar2021 at 15:15 (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation at workplace clinic. No medical history and concomitant medications were reported. No known allergies were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021 at 20:00, the patient experienced fatigue, nausea, mild joint soreness, diarrhea. No treatment was received for the events. The outcome of the events was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA PATIENT DEVELOPED HIVES ON INCISION SCARS ON HER RIGHT FOREARM AND CHEST AT 15 MINUTES POST VACCINATION.  AT 24 HOURS POST VACCINATION, PATIENT DEVELOPED PETECHIAE ON INCISION SCAR ON CHEST AND LEFT COLLAR BONE.
Pt received a first dose of Moderna vaccine on 05/22/21 at 1:00pm while being in an unauthorized age group per the CDC. The pt was scheduled on 06/25/21 to receive their 2nd dose of Moderna vaccine at 2:30pm. The clinic manager called the parent to notify them of the situation. The pt visit was cancelled until further information was given from the CDC. The CDC was called at 1430 on 06/25/21 by clinic manager. According to the CDC, ?If the patient is age 12 to 17 years and Moderna vaccine was inadvertently administered as the first dose instead of Pfizer-BioNTech vaccine, administer Moderna vaccine as the second dose (as off-label use, because Moderna vaccine is not authorized in this age group). Report this to VAERS as a vaccine administration error.? This information was relayed to the parent, and sent via email with the CDC information. The parent stated they would let us know if they decide to get the 2nd dose of the Moderna vaccine. Patient currently does not have any known adverse events or outcomes.
This spontaneous report was received from a Registered Nurse concerning a 18 year old female patient. The patient's concurrent conditions, medical history or allergy/drug reactions were reported as none. On 18-SEP-2015, the patient was vaccinated with GARDASIL 9 injection, 0.5 ml/once, intramuscular route, lot # L013429, exp.:21-JUL-2017. Concomitant therapy was not reported. On 19-SEP-2015, the, patient experienced severe stomach pain that lasted 2 to 3 months, "weird fluttery feeling in her head, blurry vision and feeling light headed". No treatment was give for the symptoms and no laboratory tests were performed. At the time of this report, the outcome of severe stomach pain, weird fluttery feeling in her head, blurry vision and feeling light headed was not informed. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Hard, swollen, tender lymph node below left collar bone. First noticed 1/28/2021 but also had minor full body achiness for 2 days prior.
Per patient following injections R deltoid injection site pain, increasing in severity , fever, R upper extremity numbness, severe abdominal pain. Urgent care visit, ER visit, blood work, imaging studies & IV catheter with IV narcotic pain redness & IV antihistamine follows.
pt recv vax 27FEB97 & w/in a few days of vax pt devel a few bumps on one thigh, leg, & face;It was reported that bumps look like pimples or a blisters-like an ant bite;