chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm turned really red; Arm turned really / swelled up; This case was reported by a nurse via other manufacturer and described the occurrence of erythema of extremities in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were reported as follows: The patient was a retired residential nurse. The patient had no medical history (including any illness) and no family medical history relevant to adverse events. The patient stated that she got her 1st dose of Shingrix and her arm turned really red and swelled up, so her physician told her not to take the 2nd dose. In 2019, the patient had a spinal fusion and had been doing great. The reporter consented to follow-up but did not consent to follow-up with prescribing healthcare professional.
The patient's mother states the patient had "welts all over her body" 3 hours after receiving the vaccines. The patient's mother then gave the patient BENADRYL. She states the welts went away. Then, in the morning, the patient's mother noticed that the patient's right leg "is swollen and has a big, red bump". The patient's mother has been applying ice and has been alternating in between TYLENOL and MOTRIN. She states the patient had a "low-grade" fever. She states she also called her child's PCP, and they informed her that she likely has a viral infection. She is also scheduled to see her allergist.
The arm that received the vaccine shot was very sore and I experienced fatigue day of vaccination and the following day.
20 min febrile seizure with drooling, eye deviation, tonic clonic activity admitted overnight to hospital. ED report and short stay H&P (includes DC summary) received from Allegheny Memorial Hospital. ED report documented temperature 101.5 (R), pulse 194, arrived in full seizure 20 minute in duration, began with drooling, eye deviation and tonic-clonic movement. Treated with Valium IV and Tylenol, seizure activity stopped and she had a postictal phase of about an hour. Initial O2 sat 85%, improved after seizure activity. Hospital course restless, vomited x1, tolerated breakfast. Temp 100.5, DC to home. PMH 37 weeks at delivery, RSV at 2 months, rotavirus, diarrhea 4 months ago. She is behind on her immunization. Little behind in speech development compared to 4 year old sister. Motor skills age appropriate. Chief complaint: febrile seizure.
HCP reported that ROTATEQ was expired on 16-SEP-2020 and was administered to a 2 month old baby on 06-OCT-2020; This spontaneous report was received from a physician concerning a 2-months-old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies, historical drug and concomitant therapies were not provided.  On 06-OCT-2020, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1660148 expiration date 16-SEP-2020 (expired vaccine administered), for prophylaxis. The physician inquired if the patient need it a re-vaccination.
After 15 hours, fever,  body aches, and headache began. These got progressively worse to a peak at 7am. I had a fever of 102, severe headache, and severe body aches. Now, 48 hours after the dose, my symptoms have subsided.
Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.Patient had the first dose of the Moderna vaccine a month ago and going for the second dose tomorrow. Caller does not think the headache is related to the vaccine as it was a month ago and does not provide additional information. Does not consent to safety follow up.  On 26 Mar 2021, the patient experienced the event headache.  Treatment details included Unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, headache was unknown.
Day later with fever, chills, fatigue, nausea, diarrhea, left axillary lymphadenopathy, description of absence seizure
Pt received pneumococcal vaccine at Dr's office in AM of 3/13/2008 in Tricep area. Pt experienced reaction and went to emergency room at Hospital approx 7pm (1900 hrs) later that day.
I woke up with like an obstruction in my throat, it was painful to talk and swallow, I got a covid test and was negative and also tested for Strep A& B and they both came out negative. it was painful for about 4 days and i was able to go back to work on the 6th day.
Night of second dose got VERY dizzy lost balance and fainted. From that day on (has been 5 days now) have felt very dizzy and off balance with some nausea here and there (especially in a car) and loss of appetite.
Information has been received from a physician concerning a patient who in 1996 was vaccinated with one dose of varicella virus vaccine live. In approximately May, 2000 the patient developed a mild case of chicken pox. The patient sought unspecified medical treatment. Additionally it was noted that 2 other patients also developed similar reactions. Additional information has been requested.
Patient developed swelling at site of injection, developed a fever and remained agitated and febrile for several days. 104.2 F rectal temperature noted on 01/07/2011.  Parents administered ibuprofen to lower temperature.  High temperatures abated but fever continued for several days.
Dizzy, cold and clammy, nausea, difficulty walking (legs where shaky).
12 hrs p/vax pt c/o itching, rash on face, redness & aching joints; pt reported to clinic;
I had increased symptoms - pain, stiffness and swelling has increased since I took the vaccination. I was pretty much symptom-free before that. But I did change medicine right before that on March 17th, 2021 - it was the Cimzia that was new to me. I have had increased pain requiring additional medications like Methylprednisolone - starting that in May 2021. I am continuing to have the pain, stiffness and swelling. I am on low doses of Methylprednisolone - because it's not good to be on a lot.
Pt recv vax on 9/30/98; on 10/1/98 pt exp swollen hands w/ funny feeling, funny feeling in legs & arms; tx=Benadryl PO
Pt developed rash on neck and torso 48 hours after receiving 2nd dose of COVID vaccine. She did not seek medical care until 4 days following onset of rash. Unclear if COVID vaccine triggered rash. She was treated with oral Benadryl with no improvement. She was seen again by medical provider one week later and diagnosed with likely pityriasis rosea. She is currently being treated with topical steroid and continued oral Benadryl as needed.
Fever 101.7, boby aches,chills, unable to work, injection site soreness and feverish. Everything on my body hurt.
Mom called took child to ER on 09/19/2005 child had high temp, hives and incoherent, given Benadryl and Steroids in ER. Mom states child still has slow speech. Mom to bring child into our office for follow up. Child was given MMR 09/07/2005. Rash on body (hive like) fever 4 days. sore throat, no appetite today plus erythema.
Starting 05/10/2022, I started getting red streaking and lumps in my lower leg. I went in to see my doctor on 05/11/2022. He told me I had superficial thrombolysis and that I needed to elevated it and put moist compresses on it. He told me they should resolve on their own. He thought it was coming from inside the right knee and that it would resolve but it didn't. On 05/17/2022, I saw another dr. and at that time I had a rope on the inside of my thigh. He measured it at 27cm and lumps in the front of the top part of my thigh and I was getting pain up into my groin area. He said if it was 5 cm or more that he needed to treat it so he started me on Lovenox shots x 5 days and ordered an ultrasound (but wasn't able to get in for a few days after I saw him). The ultrasound tech said he was glad I had gotten started on treatment because he said I had a serious of clots throughout my leg but primarily in the rope region (where there were numerous clots). The doctor called me once he got the results of the ultrasound and we discussed options. Some of the clots were in the deep veins so he started me on Pradaxa. I am going back in today to see a third dr. to answer some questions I had. On 05/17/2022 when I saw the doctor he told me I was the 2nd person that day to have clots following the vaccine, so he feels it was likely related to the Moderna booster vaccine. He filed a complaint with the FDA regarding the vaccine.
Post vax, the patient lost work due to a stiff neck, neck pain and enlarged lymph nodes. The patient was diagnosed with reactive adenopathy and myalgias secondary to vaccine reaction.
Extremely itchy scalp. Raised itchy hives, dermographia, or dermatographic urticaria on arms, chest, back, buttocks, randomly on upper part of body. Itching on face, feeling heat on itchy red areas.  I did also get red itchy rash/hives on my legs and ankles, sometimes on my left knee.
He tested positive for COVID 8/12/21 after he developed shortness of breath.  He was found to be afebrile in the  emergency room at 101.5.  He was placed on nasal cannula.  He is satting at  95% on 4 L.  He is in no obvious distress.  Chest x-ray does show atypical  pneumonia consistent with viral infection.  He does take Xarelto for history  of pulmonary emboli.  He has been compliant.  He is agreeable to admission at  this time for acute hypoxic respiratory failure secondary to COVID pneumonia.   ABG did show a PO2 of 75, pH of 7.45, pCO2 of 31.  He was picked up by EMS  and by report his oxygen saturation was in the 70s. Patient was treated with supportive care, supplemental oxygen, remdesivir, Decadron.  During the course of hospitalization patient started to feel better and was not requiring oxygen at rest or with 6 minute ambulation test. Discharged on 8/18/21.
About three weeks after second dose, got hives/ urticaria. It travels around body (arms, legs, back, head, face, neck, lips, etc.; BNT162B2 was administered at left leg; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), administered in left leg, administration date 14Apr2021 at 10:30 (Lot number: ER8729) at the age of 64 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Allergy to antibiotic" (unspecified if ongoing), notes: Known allergies: No, except may be allergic to certain antibiotics. Concomitant medications included: LOSARTIN and LEVOTHYROXINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP7534, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 09:00), administration date: 24Mar2021, when the patient was 64 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 14Apr2021 at 10:30, outcome "unknown", described as "BNT162B2 was administered at left leg"; URTICARIA (non-serious) with onset an unknown date in May2021, outcome "not recovered", described as "About three weeks after second dose, got hives/ urticaria. It travels around body (arms, legs, back, head, face, neck, lips, etc". The event "About three weeks after second dose, got hives/ urticaria. It travels around body (arms, legs, back, head, face, neck, lips, etc." was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the event urticaria had not stopped since occurrence and patient never had it before vaccine. The event was still there as of 27Jan2022 (reported as today). The patient tried to control it with ZYRTEC as per family doctor and dermatologist. Treatment included ZYRTEC and ZYZOL for urticaria.
muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Apr-2021, the patient experienced MYALGIA (muscle pain). On 18-Apr-2021, MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided by the reporter
Patient reported feelings of nausea, dizziness, and shaking. Patient was given area to rest on the floor and vomited a few times. Patient reported lessening of dizziness and shaking and is currently resting under the watch of the pharmacist.
diarrhea; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 02Mar2021 17:30 (Lot number: EN6205) at the age of 60 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medications included: METFORMIN; LIPITOR; PREDNISONE. The following information was reported: DIARRHOEA (non-serious) with onset 03Mar2021 11:00, outcome "recovered" (06Mar2021 11:00), described as "diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: It was reported that the event lasted for 3 days, but the outcome was also reported as recovering. Additional concomitant medication included Q-NOL. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 3NOV94 @ 1130 & 230PM didn't feel well-throat started to close so pt took allerest; BP 160/104-nl 136/80; eyesight blurred; 4 days later eyesight ok; 3 1/2 wks later BP ok; no fever;
No adverse effects reported; improperly stored doses of VARIVAX was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.   On 11-APR-2019, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R027993 and expiration date 01-OCT-2020)  (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010085: US-009507513-1905USA010082: US-009507513-1905USA010081: US-009507513-1905USA010080: US-009507513-1905USA010084: US-009507513-1905USA006081:
fever of 100 +; This is a spontaneous report from a contactable consumer via medical information team. A 68 (units unknown) female patient received bnt162b2 (BNT162B2, solution for injection, lot/batch number unknown) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the first dose of vaccine and was now experiencing a fever of 100 +. The reporter would like to know what they should do for patient and if she should get the second dose. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
Soreness in left arm. Pain traveled down left arm to left wrist and hand. Two days later after putting ice on left hand, my hand swelled up.
Symptoms started 11/07/2001 with fatigue, malaise. On 11/08/2001 joint aches, stiff neck and lower back ache. Will contact PMD 11/13/2001 regarding symptoms which she is currently experiencing.
This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 75-year-old female patient who received SHINGRIX (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis. On 20th July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 20th July 2018, the patient experienced wrong injection technique. In July 2018, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that, the patient received the SHINGRIX, high on the deltoid and might have hit the bone, which led to wrong injection technique. The patient could not move her hand for 2 to 3 days after vaccination.
she has "a little flu" ("Gripilla").; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (she has "a little flu" ("Gripilla").) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The patient's past medical history included Catheterisation cardiac and Surgery.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFLUENZA (she has "a little flu" ("Gripilla").). At the time of the report, INFLUENZA (she has "a little flu" ("Gripilla").) outcome was unknown.            Patient was still on antibiotics, but she doesn't have a diagnosis.  Treatment medication was unknown. Lot number couldn't be gathered appropriately, it was said 7D21A or 7021A.    This case was linked to MOD-2021-435613 (Patient Link).
right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; right deltoid where the injection site has a local redness. Its warm touch and appears swollen. It appears to be getting bigger everyday.; This is a spontaneous report from a contactable Nurse. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL0142, intramuscular on 18Jan2021 14:45 at SINGLE DOSE second dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The first dose of vaccine bnt162b2 was administered on 28Dec2020 lot number=EJ1685 vaccine location left arm. The patient reported that "right deltoid where the injection site has a local redness, it is warm touch and appears swollen and is getting bigger everyday" on 18Jan2021 16:00 with outcome of not recovered.  The action taken was not applicable.
This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Shoulder sore) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives and Angioedema. Concurrent medical conditions included Food allergy (Has had hives, angioedema in lips and tongue; and cheers swollen in the past) and Environmental allergy (Has had hives, angioedema in lips and tongue; and cheers swollen in the past).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced ARTHRALGIA (Shoulder sore). At the time of the report, ARTHRALGIA (Shoulder sore) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Case comment: Based on the current available information and temporal association between the use of the product and the onset date of the event of arthralgia, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of arthralgia, a causal relationship cannot be excluded.
fever; This is a spontaneous report received from a non-contactable consumer (the patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second Pfizer COVID vaccine shot and had a fever since. He took ibuprofen for it when it went up to 101. He asked if he could continue to take it. The outcome of fever was not recovered.   No follow up attempts are possible; information about lot number cannot be obtained.
pt recv vax 28MAY96 & 18JUN96 pt devel a fever of 99.3 & itchy, round, raised varicella-like rash w/2 spots on neck by 21JUN96;approx 30 spots appeared on arms, legs, head, chest, groin, back & abd;pt to ER;