chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy rash again in the same area as the second shot. At first it looked like welts and like mosquito bites. It was large but later flattened down.; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash again in the same area as the second shot. At first it looked like welts and like mosquito bites. It was large but later flattened down.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 028L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (itchy rash again in the same area as the second shot. At first it looked like welts and like mosquito bites. It was large but later flattened down.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itchy rash, at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash again in the same area as the second shot. At first it looked like welts and like mosquito bites. It was large but later flattened down.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-395629 (Patient Link).
Fever of 102.7 with chills and shaking that lasted for 5 hours and ringing in the ears (tinnitus) that has not yet resolved.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
spinning, a terrible vertigo; my head felt light, empy; very dizzy; my head "went away"; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (spinning, a terrible vertigo), DIZZINESS (my head felt light, empy), DIZZINESS (very dizzy) and HEADACHE (my head "went away") in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D), BITIONOL and ASCORBIC ACID (VITAMIN C) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (spinning, a terrible vertigo), DIZZINESS (my head felt light, empy), DIZZINESS (very dizzy) and HEADACHE (my head "went away"). At the time of the report, VERTIGO (spinning, a terrible vertigo), DIZZINESS (my head felt light, empy), DIZZINESS (very dizzy) and HEADACHE (my head "went away") outcome was unknown.            Concomitant medication reported as 5mg/day high blood pressure med. Treatment was recommended Dramamine, but patient haven't bought it yet.
Normal expected symptoms first 3 days:  sore arm, feeling tired.  Day 4th  (2/8/2021) I developed very itchy patches on my thighs, and recognized it as hives.  I took 1 Benadryl and felt better.  I went to bed and at 12:30 am, awoke with chills and very itchy.  I saw that the hives were back, and I took another Benadryl.  Day 5:  (2/9/2021), I woke to find the hives were up and down both my legs (inside and out), plus I had a rash on my face.  I took another Benadryl, and had some relief.   Night of Day 5:  I am covered with hives all over my body and find little relief with Benadryl.
Information has been received from a receptionist in a physician's office concerning a child (age noted to be between 6-12 weeks) who in March 2006, was vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live. The physician reported that in march 2006, the day after vaccination, the patient developed diarrhea which lasted 12 days. Unspecified medical attention was sought. The child was tested for rotavirus and the results were positive. At the time of this report, the outcome was unknown. Additional information has been requested.
Received flu and GARDASIL vaccine, 1-2 min after said "I have a headache", then reported being dizzy. 1 minute later, turned pale and limp (was sitting). Returned to supine position, check HR (HRR) and came to after 1-2 minutes. Laid down for 15-15 minutes, was able to tolerate and return to baseline.
irregular flat rash on the arms, the chest, and the back, with delineated borders in different shapes, mostly snake-like.
Patient reported dizziness, chest pain, bp readings were 176/98 and 161/99 15 minutes later. Symptoms resolved after about 45 minutes.
c/o irritability w. rt leg movement 2 hrs p/inject; screaming from pain per mom during noc; seen @ ER 10AM 11FEB93; rt leg sl limp, small hematoma w/sl induration @ inject site per MD:
Client received the COVID vaccine Janssen booster (Lot# 1855191 exp. 04/11/2022) at 4:41 PM. While reviewing the participant forms, RN noted the Janssen COVID vaccine was administered 41 minutes after beyond use date (time) of 4:00 PM. RN verified with the vaccine preparer the beyond use date (time) was 4:00PM.
ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE ACUTE PULMONARY EMBOLISM
Red Rash, itchy, felt hard, area by elbow painful for 5 days plus. Rash started receding on day 4.
I was given the PPV and the Flu shot on 12-1-2003 at 1:00pm. Within 18 hours after receiving the PPV, I noticed general muscle aches (12-2-2003). Within 36 hours(12-3-2003) I developed a fever that ranged from 99.1 to 100.0 which lasted for approximately 20 hours. Accompanying this I had severe muscle aches particularly on the side that I received the shot (right), lethargy and extreme sensitivity and pain at the point of where the shot was given.  Cold packs were used with little effect. Mild difficulty with breathing and coughing was also noted.  I took 2 alleve in the morning and 2 tylenol in the evening. I was unable to touch and move my right arm until this morning (12-4-2003).    Today I feel much better with just mild muscle aches and tenderness at the area of the shot. I do not believe this reaction was due to the flu shot because I have never reacted to the past four flu shots I received and because of the severe right sided arm pain I had.
This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (Received 1st dose in October 2018, for tolerance refer case US2019GSK062395). Concomitant products included simvastatin. On 26th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 26th March 2019, 9 hrs after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, pain in arm, general body pain, tremor, headache, neck pain and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site warmth, injection site erythema, pain in arm, general body pain, tremor and fever were recovering/resolving and the outcome of the headache and neck pain were not recovered/not resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema, pain in arm, general body pain, tremor, headache, neck pain and fever to be related to SHINGRIX. Additional details were reported as follows: The reporter consented to follow up. This case has been linked to case US2019GSK062395, reported by the same reporter for the same patient.
Covid 19 Infection diagnosed with positive home test on 9/26/2022, symptoms included fever, myalgias, sore throat, extreme fatigue, rhinorrhea, cough x 3 days, started Paxlovid on 9/26/2022 which improved symptoms slowly but fatigue, rhinorrhea and cough are persistent and still present today 10/24/2022.
pt states that she had a red itchy rash that developed on the left arm.  She says the rash is 2x6' that covered her entire arm.  The rash is painful, warm to the touch and swollen. Pt has started taking Benadryl 25mg x 3 doses. She says the swelling has gone down but it is still itching and the rash is still present.
Rash; itching all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2021 15:15 (Lot number: EL3248) at the age of 91 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). Concomitant medication(s) included: COUMADIN; LOSARTAN; BISOPRIL, stop date: 2021; HCTZ. The following information was reported: PRURITUS (non-serious) with onset 20Jan2021 20:00, outcome "not recovered", described as "itching all over"; RASH (non-serious) with onset Feb2021, outcome "not recovered", described as "Rash". The events "itching all over" and "rash" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: The patient started itching all over with no rash. The patient's itching has kept her up at night (it's the worse at night) but the patient had itch all day. After a couple of weeks, the patient got a rash; thinking it was where she would scratch. The patient went to several dermatologist and nothing. The patient got off the bisoprl; thinking that was it. The patient got the second shot and then she got the pfizer booster and the patient's daughter gave her a print out saying itching and rash were side effects of the shots. if the patient had known that; she wouldn't have taken it. The patient was so miserable. The patient tried creams from dermatologist that doesn't work. The patient was treated with creams. The patient did not receive any other vaccine within 4 weeks. The patient had the most recent COVID-19 vaccine was administered in a hospital. The adverse event resulted in Doctor or other healthcare professional office or clinic visit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 17Sep2021.  Follow-up attempts are completed. No further information is expected.
HPI: Seen at her doctor's office, and given a flu shot but states she has not take it was because she had a reaction when she went home causing what sounds like neck tightness and she stood over the commode and copious amounts of liquid emanated from her mouth but she will describe that she was vomiting, nauseated, drooling, etc.  She states she was not drooling no abdominal pain or diarrhea.  No prior reactions to flu shots.  She is somewhat nontangential related to her concern of having had a collapsed lung in the past, she thinks she might have pneumonia now but is not coughing, short of breath or having any fevers.   Her muscular function and neck spasms have returned to normal  Personally saw her 7 days ago for dyspnea/asthma diagnosis and she has been emergency room twice since then
Pt complaining of shoulder pain and decrease range of motion starting one day after vaccination and continuing over next week. Pain and range of motion has improved since then but pt continues to complain of soreness.
Pt got the shot and called the pharmacy about an hour later to report of rash and itching symptoms. Pt was advised to seek a medical care as soon as possible. Pt went to urgent care and got treated and recovered.
Information has been received from a certified medical assistant concerning a 4 year old female with seasonal allergies, congestion, pyloric stenosis (diagnosed in January 2003), a cefdinir (OMNICEF) hypersensitivity and a history of tubes (in 2004), who on 18-NOV-2003 was vaccinated SC with a 0.5 ml dose of Varivax (lot # 646140/0539N). Concomitant vaccination included a first dose of ProQuad (lot # 640788/1180M) given SC. Concomitant therapy included cetirizine hydrochloride (ZYRTEC). There was no illness at the time of vaccination. On 10-JAN-2007 the patient experienced an unspecified amount of lesions and red papules on the trunk. The patient was afebrile. Medical attention was sought, the patient was seen in the office on 11-JAN-2007 and was diagnosed with chickenpox. There were no lab studies performed. The patient was treated with oral diphenhydramine hydrochloride (BENADRYL) capsules and calamine (+) zinc oxide (CALAMINE LOTION) topically as needed. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided.  The patient's vaccination history also included a second dose of MMR (lot # 655063/0861F) given SC on 18-NOV-2006. Additional information is not expected.
Fever, chills, headache the night of injection, fatigue every day and then fever, chills, and sore throat again on Thursday night
This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a adult female patient who received FLUARIX QUADRIVALENT (batch number 45ER7, expiry date unknown). On 18th December 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced erythematous rash and itchy rash. On an unknown date, the outcome of the erythematous rash and itchy rash were recovered/resolved. It was unknown if the reporter considered the erythematous rash and itchy rash to be related to FLUARIX QUADRIVALENT. Additional details provided as follows: This case was reported by the patient's mother. The patient experienced a reaction after receiving the FLUARIX QUADRIVALENT. The reaction was further described as a bright fiery red rash with small little itchy bumps all over. The rash resolved within a few days.
This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose) and VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose), VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose), VACCINATION SITE SWELLING (Injection site swollen after 1st dose) and VACCINATION SITE PAIN (Injection site tender after 1st dose). At the time of the report, TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose), VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose), VACCINATION SITE SWELLING (Injection site swollen after 1st dose) and VACCINATION SITE PAIN (Injection site tender after 1st dose) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information not provided. List of concomitant medication were not given.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
Information has been received from a health professional concerning a 14 month old pt who at 12 months of age, in approximately July 2003, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. On approximately 09/29/03 the pt has "now" developed less than 50 lesions all over the body with no fever. The lot # was not reported. The child was given some type of cream to treat the chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
heart palpitations, chest tightening and pressure beginning 08/2021  no confirmed relation to the covid vaccine.
Was stuck 3 times, first two times hit bone and third was injected intramuscularly.  Is now having "nerve pain" in left forearm that started 12/31/2020.
Stomach flu symptoms; diarrhea; body aches, headache, chills and fatigue. Those lasted four days. OTC anti-diarrheal and Tylenol and Ibuprofen
PResented on 1/23 with progressive dyspnea and productive cough requiring 2-4 L O2. Admitted and treated for COPD exacerbation and CHF with evidence of fluid overload. COVID +. Placed on dexamtheasone, remdesivir, diuretics and doxycycline for COPD. CT revealed large bilateral pleural effusions. Pulmonary consutled and thoracentesis done. Nephrology consulted for continued poor renal function. Vas cath placed and hemodialysis started.  talked with family about sever debilitated state. Changed to DNR/ DNI by family. Had episode of sever hypotension with worsening respiratory status reuqiring 15 L high flow O2. Was given comfort care.
pt recvd vax 7APR93 & approx 2 hrs following vax pt devel swelling of eyes & face; presented immed to MD office; tx Epi & Pred & DPH; 17APR93 devel t103.5, genl sz; adm to hosp;
Received Moderna vaccine, just stinging sensation after first vaccine.  A few days later arm still hurt, and I noticed a large red square patch on my arm and it was very itchy and the vaccine spot was sore to touch. this lasted about a week but has since stopped
C/O stinging sensation at site of flu shot. Has hard lump at site. Not warm to touch, no fever. Able to move arm without difficulty.
Pt recvd immun @ approx 9-10AM; Awoke @ noon w/fever & rash; onset of rash on lt leg & spread to other leg, trunk, upper extremities; Pt given APAP; To clinic w/hives & t103.2 R;
Felt fine that day the 24th , felt sick on the 25th and collapsed at work on the 26th. I was taken to the hospital by ambulance. I was "out of it" for 5 days. Was discharged along with a lot of other pts because the hospital had to take a bunch of pt from another hospital. I couldn't walk or balance. It was months before I could walk steadily again. Indeterminate cause. Ended up with atrial fibrillation and I have a Waxman patch put in. 2 Weeks later my PCP tried to give me another shot and I said no.
presented to hosp 25OCT92 w/extremity numbness & weakness; could not stand unassisted; MD dx GBS;
Patient received the first dose of the Moderna vaccine on 1.8.2021. Reported to urgent care visit on 1.18 complaining of rash, redness, and swelling extending to her wrist and fingers beginning 1.15.2021. Patient treated with benadryl and cortisone cream with some improvement. Patient also reports tingling and weakness to the left arm yesterday.
Received vaccine 10/20/07 in AM. Approx 8 hours later child experienced a generalized seizure for which he received benzodiazprim therapy and was hospitalized for observation and EEG.  12/04/2007 MR received for DOS 10/20-21/2007 with D/C DX: Seizure. While driving in the car, mother noted child vomited, then was having a "tic" with eye deviation to the L. Child was not responding, and was still seizing upon arrival to the ED. Seizure lasted ~ 10-15 min. ER MD noted generalized seizure activity with incontinence. PE (+) for somnolence, L TM erythema, mild L ant lymphadenopathy, mild rhonchi in LLL, tachycardia. Observed o/n and D/cd the next day.
This spontaneous report was received from a Healthcare worker regarding a 2 month old patient of unknown gender. There was no information about concurrent condition and historical medication. ON an unknown date, the patient was vaccinated with PEDVAXHIB. Other suspect therapies included oral, ROTATEQ vaccinated at the age of 2 months (inappropriate schedule of drug administration) and PEDIARIX. No concomitant medication was reported. On an unknown date the patient developed uncontrollable crying that lasted for a couple of days. Also it was stated that two month old patient received all vaccinations required for a two month old. No product quality complaint (PQC) was involved. The outcome of crying was reported as resolved (as reported fully recovered). The outcome of oral, ROTATEQ vaccinated at the age of 2 months was unknown. The causality between uncontrollable crying and oral, ROTATEQ and PEDVAXHIB was unknown. Additional information is not expected because physician does not want to get contacted.
Pt recv vax on 10/7/98; 5 min later pt became pale, fell down, exp seizure >1 min, dizzy, sweaty.  On 10/8/98 pt exp headache.
Muscular Weakness, starting from lower extremity and spreading upwards. Patient reported difficulty climbing stairs when previously there was no problem. Suspicious of Guillain-Barre Syndrome. Hospitalized, decreased tendon reflexes and decreased facial muscle strength noted as well on admission. Given 5-day IVIG treatment with significant symptom improvement.
arm was red; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (arm was red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     The patient's past medical history included Hypertension and Cholesterol. Concomitant products included high blood pressure medication and cholesterol medication for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm was red). At the time of the report, ERYTHEMA (arm was red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.