chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling at injection site; bruising at injection site; itchiness at injection site; swelling at injection site; bruising at injection site; itchiness at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In March 2019, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular). On 5th July 2019, the patient received Boostrix. In July 2019, not applicable after receiving Fluarix Quadrivalent 2018-2019 season and less than a week after receiving Boostrix, the patient experienced injection site swelling, injection site bruising and injection site itching. On an unknown date, the patient experienced injection site swelling, injection site bruising and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site bruising and injection site itching were recovered/resolved and the outcome of the injection site swelling, injection site bruising and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site bruising and injection site itching to be related to Fluarix Quadrivalent 2018-2019 season. It was unknown if the reporter considered the injection site swelling, injection site bruising and injection site itching to be related to Boostrix.   Additional details were provided as follows: The case was reported by patient who was a psychologist  The patient received Fluarix dose and experienced swelling, bruising and itchiness at the injection site that lasted for about 2 weeks and resolved. The patient reported that she had a tetanus booster shot on 5th July 2019 (unsure of the brand name) and less than a week after vaccination, she experienced the same reactions which had not yet resolved. As per narrative brand name of tetanus booster dose was unknown but in the source document boostrix was reported, hence captured as per source document.
Red circle around injection site about 3-4inches big with a lump.  It felt a little irritated lasted about a week.
strong chills, fever 101.2; pain in muscles and joints, burning pain in the lower back/kidneys  and lungs area - overnight. Ibuprofen taken, fever get lower and less pain. next day - fever 100.2 almost all day; pain in the lower back/kidney area; chills. weakness.
Reaction began about 2 minutes with receiving 3 vaccines. Began with itching and feeling warm. Given 25mg liquid BENADRYL and then vomited immediately. C/o tongue feeling swollen and itchy. Developed full body rash and was given EPIPEN Jr injection. Began to feel better within 10 minutes. Lungs were clear and never developed SOB. Given additional 25mg BENADRYL and started on prednisone next AM.
This spontaneous report was received from a pharmacist and refers to a 24-year-old male patient. The pertinent medical history, drug reactions or allergies were not reported. The concomitant therapies included: vitamin B12, gabapentin and capsaicin cream. On 30-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (lot #: N025428, expiration date: 19-JUN-2020, anatomical location, strength, dose and frequency were not provided) for prophylaxis (indication also reported as "what the doctor ordered"). On 03-APR-2018, the patient was vaccinated in right arm with second dose of GARDASIL 9 intramuscularly (lot #: N025428, expiration date: 19-JUN-2020, strength, dose, and frequency were not provided) for the same indication. On an unknown date, in approximately 2018, the patient developed numbness in his right arm, following the second dose of GARDASIL 9, where he was vaccinated with the second dose. The pharmacist did not specify where the patient was vaccinated with the first dose. The patient was seen in the emergency room and the patient was not admitted to the hospital. There were no lab diagnostics performed. There was unspecified treatment given for injection site numbness. The outcome of injection site numbness was reported as recovering. The relatedness between injection site numbness and GARDASIL 9 was not reported.
TWO TO THREE DAYS AFTER RECEIVING FIRST AND SECOND DOSES, I HAD SIGNIFICANT FOCAL MID-UPPER CHEST PAIN. I PRESENTED TO THE ER ON FRIDAY JANUARY 8TH FOR THIS REASON. I HAD NEVER BEFORE HAD ANY PAIN IN THIS AREA OF MY CHEST.
Can not eat beef, chicken, scallops since the second vaccine.   I can cook it for my husband, but have no desire to eat it and have no interest in it and cannot put it in my mouth .    Never been a fussy eater before.  Otherwise,  appetite is normanl
A nurse reported that a 16 year old male received an injection of TD Toxoids Adsorbed, Purogenated on 6/28/00. On 6/30/00, the child developed an injection site reaction characterized by swelling and erythema. On 7/1/00, he was seen by the physician. The reporter notes that the mother took the child to see another physician, who treated the child for "infection" at the site. The child recovered by 7/6/00.
Employee stated "Yesterday 2/3/22 in the morning it was hurting like burning pain first I thought it was common. When I came home at 2:30 pm I noticed a big ball swelling in my left arm pit. I took Tylenol but it does not help".
Pt recv vax on 3/24/98; on 4/7/98 pt exp "dark circles", lethargic, tingling sensation, headache; tx=Excedrin
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 11-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
pt recvd vax 18AUG94 1010AM & given APAP 1030AM napped 1PM fussy @ 225 began screaming; pt pale & shallow breathing; pt unresponsive for less than 1 min; t100.9;
Experienced extreme fatigue, nausea, muscle weakness, anorexic and slept for most of 36 hrs starting at night after receiveing the vaccines at 4:43pm. No treatment.
Red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No specified medical history has been reported.     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, the patient experienced VACCINATION SITE RASH (Red rash at injection site). At the time of the report, VACCINATION SITE RASH (Red rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD-2021-187577 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: NNI FU - No new information was provided
Got her vaccine, no immediate reaction and then about 2 weeks later she had no strength in her hand, cannot do anything with it.  She went to her doctor in March, as her PCP was not taking any APTs.   She sent her for an APT with a neurologist that is in May.  She had x-rays this past Friday, but believes it is nerve damage.  It feels like it is from her elbow down to her fingertips.   She does not have any pain, but not not able to use the hand.   Feels that is getting weaker than stronger.  Her doctor did not feel anything on her right arm and not able to exert any pressure, but could with the other hand.
received the first dose / on 18 Jun 2019 and did not receive any further doses; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The medical assistant reported that, till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
pt. stated the felt light headed, had lie down took their blood pressure, obeserved for 30 minutes, called his mother to pick him up.
she noticed swelling in her upper lip; exposed to Covid; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). This report was received via Pfizer sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. After her second vaccine she noticed swelling in her upper lip. Symptoms lasted 24-36 hours. She states now she was having the same symptoms, duration was about the same on an unspecified date. She wonders if she was exposed to Covid and was having an immune response that was causing the same swelling in her upper lip on an unspecified date. She received cosmetic filler for swelling in her upper lip as treatment. The outcome of event she noticed swelling in her upper lip was not recovered while other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 symptoms started on 07/18/22; tested positive the same day. I had woke up with a terrible sore throat and then my head felt like I had a bad sinus infection. I felt lousy in like my muscles but I didn't have fever that I know of. It's mostly upper respiratory and I've had worse things in my life. I called my doctor and he sent me a Z-PAK to help with the body not overreacting so I am taking that. My pulse ox level is fine and I'm not feeling worse or better but yesterday I felt better than I did Monday and today is about the same. The sore throat went away.
At 10:58 patient came in for her booster she was very nervous after speaking with the MA's she decided she was more comfortable with staff. However as the patient was still very tense and nervous it caused her to tense up her arm so once MA staff went in to vaccinate the needle completely bounced back and squirted into the MA's eyes. The Provider instructed staff to wash out her eyes with saline and water. Before checking the patient. The patient still wanted to receive the vaccine so the provider advised her to try with the other arm and waited until she was relaxed. Staff was able to successfully vaccinate her. Staff also stated that after speaking to the provider as well as her personal provider that she was good and the saline and water helped and she was feeling better. It was the red cap needles that are known to bed easily especially on tensed arms.
1 week after varicella pt developed itch with multiple lesions on trunk, arms and legs a few on face.  Lesions seen today are completely healed with multiple dark spots.
Diarrhea     "shes been really weak, diarrhea, she lives with someone who tested positive or covid"        HPI:   This is a 78y.o. female with significant past medical history of HTN, CVA, and hyperlipidemia that presented to the hospital with chief complaint of generalized weakness. She reports a known exposure to COVID-19. She admits to worsening fatigue, weakness, and diarrhea for the past couple of days. She presented to the ED for further evaluation.    In the ED, patient febrile, normotensive, stable SPO2 on room air. COVID detected on swab. CXR with multifocal airspace disease. She has been admitted for further evaluation and management with ID consultation.    Patient seen and examined only by the attending physician; NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.
Patient was injected in his left arm - medial location in front of elbow; Redness at injection site; A spontaneous report was received from a health care professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of received vaccine on medial location of left arm two fingers above the elbow and experienced redness at the site of injection.  The patient's medical history was not provided. Concomitant medications were not reported.  On 12-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 12-Jan-2021, the patient received vaccine on medial location of left arm two fingers above the elbowand experienced redness at the site of injection.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The event patient was injected in his left arm - medial location in front of elbow was resolved. The outcome of the event redness at the site of injection was unknown.  The reporter did not provide a causality assessment of the events.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273 and concerns a male patient (age unknown), who experienced the event of injection site erythema. The event occurred approximately the same day after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
A few hours after receiving the second dose of Shingrix, I experienced involuntary leg tremors.  Thankfully, they did not last long-probably less than an hour.  According to what I looked up online, this is an unusual side effect.  So, I just wanted to be sure to report it.  I also battled a fever and a very sore arm for a few days after the shot.  However, these symptoms are apparently more common.  I had a very good experience receiving the shot at the Pharmacy.  The pharmacists were kind and helpful, and the woman who gave the shot did a great job.
Information has been received from a physician and a registered nurse concerning a 25 year old female who on 01-SEP-2006 was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 08-SEP-2006, one week after vaccination, the patient developed "small bumps under her skin" at the injection site. The patient sought unspecified medical attention. Subsequently, the patient fully recovered. Additional information has been requested.
allergic react 8 inch area (band almost around arm); hot, itchy, swollen hard;
pt recvd vax;high fever;too disoriented to measure;unable to control motion;fell into bed;unable to use phone; staggered to bathroom; cont incompetent through night; about 9am mostly recovered on 9NOV
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 25-JUL-2013 (lot # H011350, exp.: 21-FEB-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
Generalized urticarial rash; itchy all over the body; swollen lower lip; pallor.
a variety of different things are hurting/He hurts in a lot of places he never hurt before; Both shoulders are taking turns hurting noticeably/hip is hurting; It's kind of slowing him down a bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a variety of different things are hurting/He hurts in a lot of places he never hurt before), ARTHRALGIA (Both shoulders are taking turns hurting noticeably/hip is hurting) and BRADYKINESIA (It's kind of slowing him down a bit) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Hip replacement.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (a variety of different things are hurting/He hurts in a lot of places he never hurt before), ARTHRALGIA (Both shoulders are taking turns hurting noticeably/hip is hurting) and BRADYKINESIA (It's kind of slowing him down a bit). At the time of the report, PAIN (a variety of different things are hurting/He hurts in a lot of places he never hurt before), ARTHRALGIA (Both shoulders are taking turns hurting noticeably/hip is hurting) and BRADYKINESIA (It's kind of slowing him down a bit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
25 min after pt rec'd vaccine she came back to exam room stating she felt dizzy- she wasn't sure if it was blood sugar related since she had not eaten breakfast prior to coming in or if it was the vaccine.  Took pt in exam room and gave a bottle of water and some candy.  15 min later she still had slight dizziness but was feeling better.  10 min later, she c/o substernal chest pain, like something intermittently stinging her.  No SOB or symptoms associated with this, no radiating pain.  Patient seen and although symptoms not severe, it was determined patient needed to go to ER for evaluation.
Reports a reaction after the 1st shot. States she had itching, rash, and hives.
pt spike temp 103 4 hrs p/vax had sz taken to ER; spinal tap done; MD felt this was afeb sz-had rxn to DTP since this; pt has had t103 & had no szs;
pt was not 18 at time of vaccine dose 1 caught when pt returned for dose 2 -
Stomach pain; Dehydrated, after first vaccine; Fever, after first vaccine; Tired, after first vaccine; Numbness in legs, from knee all the way down to the feet, after the first vaccine; Nausea, after first vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8730, Expiry date: Unknown via an unspecified route of administration on 23Mar2021 10:30 (at the age of 63-year-old) as dose 1, single for COVID-19 immunization. Medical history included chronic kidney failure ongoing from an unknown date, patient stated at least 8 years ago. Reported 5 stages of kidney failure, with the most severe stage as 5, and he reported he was in Stage 4 and Covid virus in Dec2020 unknown if ongoing and had some type of infusion, clarified as a monoclonal infusion while he had Covid, because if not, he would not have had a good outcome. Patient stated he was told that he had to wait 90 days, before getting the first vaccine, in Mar2021, and he hated it. Concomitant medications were not reported. It was reported that on 23Mar2021 15:00 patient experienced Dehydrated after first vaccine, on 23Mar2021 Nausea, after first vaccine, Numbness in legs, from knee all the way down to the feet, after the first vaccine ,23Mar2021 12:00 Fever after first vaccine and Tired after first vaccine and on 23Mar2021 21:00 Stomach pain. Patient visited emergency room for the event because of concerns of his history of kidney failure. Patient stated he was glad he went, to the emergency room, and he was assured that any symptoms or side effects were normal with the covid vaccine. Patient stated the doctor in the emergency room, reclarified, that his symptoms were in keeping with the side effects of the vaccine, however, that because he has chronic kidney failure, that was the reason why he was dehydrated. Patient stated he had called his Internist, and he did not want to take the second vaccine. Lab test and procedures included on 21Apr2021 Fever100degree, MRI brain-Normal. Therapeutic measures were taken as a result of the events included saline solution, anti-nausea medication and two Tylenol on 24th.Outcome of the event Nausea, after first vaccine resolved on 24Mar2021, Fever, after first vaccine: resolved on 25Mar2021, Tired, after first vaccine resolved: 26Mar2021, Numbness in legs, from knee all the way down to the feet, after the first vaccine, Stomach pain resolved on an unspecified date in 2021. Outcome of other event was unknown.  No follow up attempts are needed. No further information is expected.
Approx. 8 mins after receiving VARIVAX, pt. reported redness & itching around shot site. Area 2" x 3" on (L) upper arm. Denies SOB, lip and/or tongue swelling, hoarseness. Given 2 tsp. BENEDRYL p.o..
She got her vaccine, about 15 minutes after receiving it she started having a racing heart, which lasted for about 48 hours. She also felt like she had a pulled muscle in her chest. She felt woozy, hot behind her eyes like she had a temp but did not have one, which lasted for about 48 hours. After that she thought was good, and then her arm started to hurt and ache really bad, and when she looked at it she had a round red mark about 4" in diameter and it was hot to the touch. It was approximately 3-4" below the vaccination and ice did not improve that, this she had for 3 days. She felt like her throat was closing up and she took one of her pills which helped it. She had a slight fever that lasted for a little while which lasted for about 36 hours. She had swelling of her arm, a little warm and is itching intensely. The three days that she had the muscle pain in her arm has gone away, now just itching and the red spot is less red, but is a still a little bit warm on that spot.