chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph nodes which are painful; swollen lymph nodes which are painful; has difficulty eating and drinking due to the swelling; low grade fever on/off; has swollen lymph nodes and tonsils; experienced sleeplessness; This is a spontaneous report from a contactable consumer reported that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was unknown. The patient's concomitant medications were unknown. second dose (dose 2) of the Pfizer COVID-19 vaccine last Tuesday. On unspecified date She has been, experiencing symptoms ever since she got the second dose in the last 6 days, swollen lymph nodes which are painful and impacting her sleep, has difficulty eating and drinking due to the swelling, low grade fever on/off, has swollen lymph nodes and tonsils, experienced sleeplessness. Therapeutic measures were taken with Tylenol and Ibuprofen for, low grade fever on/off. She took another medication which reduced some of her symptoms. She wants to know if its normal for the adverse event to last this long. Caller heard symptoms only last 24-48 hours post vaccination. Outcome of the events were unknown.  Information on the Lot/Batch Number has been requested.
TUMMY TUCK; BREAST IMPLANT; FLU LIKE SYMPTOMS; SORE ARM; This spontaneous report received from a patient concerned a 38-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild asthma. Patient was non-alcoholic, and non-smoker. From an unknown date, the patient was taking birth control (unspecified). The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 22-MAR-2021 at 12:26 for prophylactic vaccination to left arm. No concomitant medications were reported.  On 23-MAR-2021, the next day after vaccination, she had Flu like symptoms like fever (not too high, body feels warm), chills, light cough, arm was sore and boy aches for the whole next day. On 23-MAR-2021, she had a COVID 19 test because she was travelling to other country and the test came back negative. On 16-APR-2021, about 3 weeks later, she had major surgeries including Tummy Tuck and Breast Implant. She thought she was taking a big risk especially after hearing on the news about blood clots. Her surgeries went well with no complications. She didn't have any symptoms of blood clots. She was now recovering from the surgeries and was doing great so far. She wanted her case to be useful for Janssen to help with research. She was willing to share the documents and reports from her surgeries if needed. Patient does not have a PCP (primary care physician) at that time. Laboratory data included: COVID-19 virus test (NR: not provided) as negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and sore arm on 24-MAR-2021, and was recovering from breast implant, and tummy tuck. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210506581-Covid 19 Vaccine- Tummy Tuck and Breast Implant. This event(s) is considered unassessable. 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).
Pt c/o lips feeling swollen, dizziness and lightheadedness within 15 minutes of vaccination. Over the next 45 minutes the pt c/o throat feeling tight, voice husky, chest heaviness. Pt had intermittent episodes of redness of upper torso, upper arms, chest and face; and itchy palate and throat. Pt reported runny nose and flu-like symptoms for about 10-12 hours. All symptoms, except for mild fatigue, resolved within 12 hours without any medical intervention.
IZ on 4/6/00 at 16:45. Pt presented at clinic on 4/8/00 at 12:45. Pt presented to HD complaining of erythema, induration (5" diameter) on left deltoid muscle. Afebrile and no acute distress. Prescribed Benadryl, Augmentin and hydrocortisone topical.
patient had his 1st dose of Shingrix on 3/10/2019 / has not had a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th March 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. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient received 1st dose of Shingrix at primary reporter's facility.
Fever, chills, body aches, fatigue,  headaches ? all lasted for 24hrs starting about 12 hours after the vaccine
This health care worker developed small patches of hives on her arm app 4 hrs after receiving the flu mist-the next day hives were on her chest, thighs, neck, back, face. Itching relieved with an anti-histamine-reddened areas remained.
Pt did not have a negative reaction.  The wrong patient was vaccinated.  Staff brought us 4 patients the vaccinate.  We confirmed name and date of birth on all 4 patients with the patients.  After injecting the first patient, a nurse came in and notified us that this patient was not the patient we were there for.  The patient did confirm the name and date of birth (even though it was incorrect) prior to injecting.  We stayed for 30 min to monitor the patient.  The patient that was injected had already received 2 doses of Pfizer with the second dose being on 2/5/2021
pt recvd vax 31OCT95 & given APAP;630PM mom heard a high pitched weak cry;pt color was pale ashen&bubbles of saliva noted @ mouth;grunty resp;lethargic & unresponsive requiring stimulation & 02;to ER adm to apnea diagnostic ctr;sl mottled
when moving my left shoulder in a downward motion there is a tight pulling sensation that radiates from the base of my neck to my head.  It feels similar to a muscle strain.  I have not been performing any activities beyond my normal baseline and have not been lifting weights of any kind.
Sweating, stomach upset, chills, headache, slight dizziness and multiple vomiting.
felt dizzy, became pale...was given water, VSS, school nurse aware and patient mother was called to make aware she felt better after water and color returned, she left the clinic on own within a  hour
Pt. states that after receiving the 1st dose of Moderna 02/17/2021, started experiencing symptoms 02/18/2021 of muscle aches, nausea, fatigue, weakness, and "nerve" pain.  Continuing to experience symptoms, Primary communications/ no recommendations. Received 2nd dose of 03/17/2021/ similar symptoms occurred. Booster received 12/03/2021 reoccurring symptoms.
Approx. 5 min. spell of extreme pallor- "white skin & lips" /w out cyanosis.  Infant was hypotonic, /w unresponsiveness. No seizure. Episode resolved /w stimulation. Infant sleepy for another 30-60 min. Occurred 4 hrs /p vaccine.
While patient was being given the vaccine, the MA that was administering the vaccine, noticed that some of the medication squirted out as she was injecting, it was less than 50%.
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 21-JAN-2015. Patients received expired FLUMIST Quadrivalent on 21-JAN-2015. The outcome of the event of expired FLUMIST Quadrivalent was unknown. The report was considered to be non-serious.
11:30:  163/85, 83HR, o2 sat 100%. 11:44:  142/103, HR 74, o2 sat 99%. 11:47:  173/99, HR 81, o2 sat 99%. 11:51:  143/73, HR 79, r 18, o2 sat 99%. 11:58:  138/96, HR 69, rr16, o2 Sat 99%. 12:03:  137/100, HR 67, rr16, o2 Sat 100%. 12:20:  153/107. Still flushed/warm. Fatigue, felt weak, slept 4 hours. Light snack. Slept 16 hours. Following day remained very fatigued. Sunday: symptoms resolving. CRITERIA: Grade 3 Fatigue.
Pt came to ER c/o cough and SOB, tested positive for Covid 7/28.
We received the following literature report on 15 JUN 2009.  15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007.  The children received a total of two doses (fully vaccinated).  Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness.  Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group.  This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA20091717 and MA2009-1719 to MA2009-1722).  Laboratory-confirmed influenza was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
Day two or three, I got similar skin symptoms as the first one. Dry skin, rash, headache, congestion. But then, throughout that week, escalating on day 10 I had to go to ER. I felt like I was going to pass out- headache, light headedness, chest tightness, shortness of breath. I started getting tingling in my arms and legs, my blood pressure was getting really low whenever I checked it with my husband's monitor. I went to ER on February 20th, advised by pcp to go to ER, because blood pressure was 75/45 that day. They did a complete cardiac workup, chest x-ray, ekg, complete blood panel, gave me a few IVs to get my blood pressure up. They said the only thing that was slightly abnormal was a slight electrolyte imbalance. Advised me to hydrate and take electrolytes. On February 22nd, I took a herbal formula tablet that I normally advise for my clients for allergic reactions, and my symptoms cleared up after a few days of that.
2 days after first vaccine I have large areas on my body that are red hives and intense itching. Areas on my trunk, abdomen and legs.  Feeling fatigue
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's current conditions, medical history, drug history and concomitant medications were not reported. On 21-JUN-2017, the patient was vaccinated with ZOSTAVAX of lot/batch #N012492, expiration date:17-MAR-2017 (strength, dose and route of administration were not reported) for routine vaccination at a time that may have corresponded with a temperature excursion (incorrect product storage). Other suspect therapies included sterile diluent(STERILE DILUENT) (ZOSTAVAX Diluent) of lot/batch#M047667, expiration date: 25-JUL-2017 used for the dilution of ZOSTAVAX. The pharmacist reported that per pharmacy policy, the patient was observed for 15 minutes and did not experience an adverse reaction. The reporter declined to provide relevant laboratory data. It was reported that the patient might have also received prevnar during that visit. As of 21-JUN-2017, it was unknown if the patient continued to receive ZOSTAVAX. The outcome of incorrect product storage and no adverse event was unknown. Additional information has been requested.
DID NOT TAKE SECOND DOSE ON TIME; This spontaneous case report (PVX2019-2935) was received from a consumer on 27-Nov-2019. It described a female consumer who "did not take second dose on time" (PT: Product dose omission), while being on oral Vivotif (lot number: 3003297) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-Nov-2019 and then she left Vivotif unrefrigerated for 2 days after taking the first dose. She did not take the second dose which was due on 26-Nov-2019 as the vaccine was no longer good to use.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: It was reported that a consumer did not take the second dose of Vivotif on due date (missed dose) as she left the Vivotif unrefrigerated for two days after taking the first dose. Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.; Sender's Comments: It was reported that a consumer did not take the second dose of Vivotif on due date (missed dose) as she left the Vivotif unrefrigerated for two days after taking the first dose. Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.
APPARENT HEART ATTACK; MYOPERICARDITIS AND INFLAMED HEART; CORONARY TEAR; GYNECOLOGICAL PROBLEMS; This spontaneous report received from a Company representative concerned a 34 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient had no pre-existing conditions. The patient never had coronavirus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case.  No concomitant medications were reported.  The patient did not notice complications until three months later on 09-JUL-2021 the pain started with what felt like heartburn or indigestion, but three days later on 12-JUL-2021 pain intensified to the point that she was breathing into a paper bag for relief and body aches kept her up at night. After three days on 12-JUL-2021, the patient experienced apparent heart attack. By the time patient went to an emergency room, where the amount of troponin in her blood was 7.3 nanograms per milliliter (normal range between 0 to 0.04.), which indicates heart injury. They asked her to get done cardiac catheterization. They sent her by ambulance to hospital for treatment. Catheterization was done and they did not find any blockages and it was normal. The patient also experienced inflamed heart (myopericarditis and inflamed heart) and a coronary tear that will take six to eight months to heal. She met the next day with an infectious diseases team, which recommended additional testing before noting on her admissions paperwork. In addition to continuing to heal, she said she has also developed gynecological problems and her doctors have mentioned the potential for a hysterectomy. On an unspecified date patient was hospitalized. Number of days hospitalized was unknown.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myopericarditis and inflamed heart and coronary tear and the outcome of apparent heart attack, gynecological problems was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210953564.; Sender's Comments: V0: 20210953105 -COVID-19 VACCINE AD26.COV2.S-Apparant Heart attack, Myopericarditis and inflamed heart ,Coronary tear. This event(s) is considered unassessable. 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).
Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA658A, expiry date 31st January 2023) for prophylaxis.   On 16th February 2023, the patient received Menveo. On 16th February 2023, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received an expired dose of Menveo vaccine. The reporter did consent to follow up via email. Additional supportive information: The patient received a Menveo which was already expired, which led to expired vaccine used.
Pt states he has developed a red, itchy rash on parts of his back, mostly on the left side. Rash appeared 8/24/21; 1 day after receiving his 3rd dose of Modern COVID-19 vaccine.
pt recvd vax & 4hrs p/vax exp itching rash on chest, neck, & hands;seen by MD & treated w/DPH;
Right arm red area on 03/15/2002 at 16:00 until Saturday-applied heat. Hives appeared at 03:00 on 03/18/2002.
pain in the back of the knee going down to the calf; bump in the mouth; painful to touch; dull, sharp pain like a nerve thing; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISORDER (bump in the mouth), PAIN (painful to touch), NEURALGIA (dull, sharp pain like a nerve thing) and ARTHRALGIA (pain in the back of the knee going down to the calf) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-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 ORAL DISORDER (bump in the mouth), PAIN (painful to touch) and NEURALGIA (dull, sharp pain like a nerve thing). On 22-Mar-2021, the patient experienced ARTHRALGIA (pain in the back of the knee going down to the calf). At the time of the report, ORAL DISORDER (bump in the mouth), PAIN (painful to touch), NEURALGIA (dull, sharp pain like a nerve thing) and ARTHRALGIA (pain in the back of the knee going down to the calf) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient presented for a flu vaccination at our mobile clinic. Upon billing the claim, we discovered patient had already received their flu vaccine on 10/20/22. On 2/2/23, s/w caregiver at care home. Caregiver states they were not aware she had received a flu vaccine at another facility. Patient is doing okay, no issues.
Not sure if this is related to the Vaccine Shot I received since it was around 2 months later, but I am reporting it anyway.  Developed a Blood Clot and it traveled to my left lung.
redness, swelling, heat, knot feeling, tenderness at injection site and area approx 6x6; body aches; run down feeling; nausea began evening of shot and has gotten worse over last 3 days treated with tylenol/ibuprofen with little to no results
SLIGHT LEFT SIDE CHEST PAIN BELOW NIPPLE; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced slight left side chest pain below nipple. On 19-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from slight left side chest pain below nipple, and sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Friday : soreness at injection site,3 hours later severe migraines; fatigue Saturday - severe migraines, fatigue Sunday,- -Vomiting, severe migraines, joint aches Monday - awoke with swollen face - centered around eyes and cheeks area,  achy headaches, fatigue - went to ER and received Steroid shot.
Mom states that a few hours after the immunization she noticed an area of redness on the inner aspect of patient?s left thigh. She reports that patient did not seem particularly bothered by the area of redness. Mom states that over the last 24 hours after receiving the immunizations, the area has became brownish, like a bruise.The area on the leg appeared to be a bruise with the presence of a hematoma just under the bruise. The bruise is medial to the injection site. although doubt given the pressure that would need to be applied to this area to cause a hematoma of that size. The vaccine administration was performed by a novice medical assistant, under the supervision of an experienced medical assistant--The technique for vaccination was reviewed with both medical assistants, none of whom reported any unusual nor forceful application of pressure to the leg during vaccine administration. Medial aspect of the left thigh noted to have an irregular shaped brownish bruise measuring between 12 mm to 20mm (horizontally) X 25 mm (vertically). There is a palpable 5 mm to 7 mm mobile lump under the bruise.
The arm where the vaccine was applied was broken out with itchy rash that spread over entire arm. It took about 3 weeks to clear up. I used Benadryl and it helped a little with the itch and discomfort.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding concomitant medications, concurrent conditions and medical history was not reported. On unspecified dates in April 2015, reported as since 03-APR-2015, unspecified patients were vaccinated with PROQUAD (dose, frequency, lot number, expiration date were not reported). The PROQUAD was exposed to temperatures outside of the recommended range. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
5/18/2016 1545: Pt presents in office with her father. Reports wheezing, shallow breathing, sore throat, and laryngitis last night as well hives, redness and soreness at the MENACTRA injection site on her right upper arm. Dad reports he had her do a nebulizer treatment and do an albuterol nebulizer treatment and the symptoms. Wheezing, shallow breathing, sore throat, laryngitis and hives resolved. I noted redness, swelling and slight warmth around the Menactra injection site on her upper right arm. O2 Sat 97% on room air, P 71, respirations are even and unlabored. 1400: Patient's PCP, PA-C, advised of above. No further treatment advised, reports patient has these symptoms routinely regardless of proximity to immunization. Ok to continue both HV and MENACTRA immunizations.