chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Like an allergy; Little welts; Itchyaround the injection site; Red around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Like an allergy), VACCINATION SITE URTICARIA (Little welts), VACCINATION SITE PRURITUS (Itchyaround the injection site) and VACCINATION SITE ERYTHEMA (Red around the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ALLERGY TO VACCINE (Like an allergy), VACCINATION SITE URTICARIA (Little welts), VACCINATION SITE PRURITUS (Itchyaround the injection site) and VACCINATION SITE ERYTHEMA (Red around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Like an allergy), VACCINATION SITE URTICARIA (Little welts), VACCINATION SITE PRURITUS (Itchyaround the injection site) and VACCINATION SITE ERYTHEMA (Red around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Additional information received
lightheadedness; rash; itching; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), RASH (rash) and PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lightheadedness), RASH (rash) and PRURITUS (itching). At the time of the report, DIZZINESS (lightheadedness), RASH (rash) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
She got her vaccine, she got a swollen gland under her armpit.  With the first vaccines it swelled up on this arm and stayed swelled up.  At around 10:45 she started to feel sunburn sensation with sharp needles all over, which triggered her fibromyalgia reaction/skin reaction. She had a headache over her right ear and behind her eyes.  She had a pain at the base of her head like where the atlas and axis connect, bad pain in that area.  Really bad pain anywhere she had an injury and everything that could possibly hurt did.  She has a hemangioma between her shoulders, her foot curled and cramped, hips, tightness across her chest.  It wasn't like a heart attack, but really tight as if the muscles were all tight and she had trouble getting a breath in.  It kind of felt like an asthma attack, but nothing to go to the ER for.  Her lungs also decided to do the asthmatic thing, but not a bad attack and not needing to use the inhaler as it keeps her up all night, and she has improved lung wise.   She also has been having to urinate a lot.  The weirdest past is that she has had menstrual cramps, and other cramping in her internal organs.  She has had worse pain in the throws of fibromyalgia and arthritis 8 years ago and was not that bad, but was wanting to know if she was going to be a long-hauler and hurting everywhere.  Her hands are still hurting, her foot is hurting as well.  Every place that she has had an injury to her skin in her past, scars, etc. turned bright red.  She has had a spider bite in the paste 26 times, it showed up red,  and where ever she had had some type of injury had a red appearance. This did disappear by the morning. This also happened with the 1st vaccines as well. She said she knew instantly that was what killed people with the virus, that it goes into where you have inflammation or ever had inflammation and attacks it and affects it. Her fibromyalgia and arthritis are pretty much under control this caused a lot of pain in those areas. The interesting thing is that she is noticing that she has a better range of motion with her thumb since the vaccine.  She has some bone change, but her thumb she could not get it to go back out spreading her fingers, it was really tight but it seems to be able to have a normal range of motion. She had muscle weakness last night, and took an Epsom salt bath (Ginger clay), had her soak and tried to get out and could not.
Fine maculopapular rash covering upper arm; few excoriations; no calor; no drainage.
Post vax pt developed swelling at the injection site. No further info was available at the date of this report.
The patient is a 85 y.o. female with pmhx relevant for paroxysmal atrial flutter fibrillation on Eliquis, obstructive sleep apnea adherent with home CPAP, carotid stenosis, hypertension, hyperlipidemia, endometrial cancer, GERD admitted for sepsis and acute respiratory failure with hypoxia. She was found to be COVID+ and treated with steroids and remdesivir. Imaging suspicious for RML pneumonia and completed five day course of antibiotics for CAP. Did well and improved to room air prior to discharge. SLP did evaluate due to concerns for dysphagia and has recommended outpatient VFSS. She did have mild transaminase elevation on admission and statin was held. Other chronic conditions were stable.  Crestor temporarily held with AST of 69 and ALT of 77.     New to this MD today 5/29/2022  She is awake and alert, pleasant . Denies SOB, admits to very mild just bothersome pleuritic pain R ant axillary line. O2 sat at rest and on ambulation are normal. Lowest on ambulation was 92.   BP of 149/96 at rest was without her usual cozaar, her creatinine is normal and cozaar resumed with this BP on discharge.
This spontaneous report was received from a medical assistant referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. It was reported that, on unknown dates since 17-JAN-2017, the unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot# M034187 expiration date 17-MAY-2019, lot# M014925 expiration date 16-FEB-2019; strength, dose, and route were not reported) for prophylaxis. The vaccines were exposed to a temperature excursion between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 2 hours 20 minutes. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse experiences had been reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA009073.
This spontaneous report as received from a nurse via field representative refers to a female patient of unknown age. Patient received the ZOSTAVAX (strength, formulation, lot#, dose/frequency, route and duration were unspecified) 2-3 years ago(about in 2010 or 2011) and developed the Shingles 3-6 months ago(in 2013). Patient had sought medical attention via going back to HCP. The outcome of shingles was unknown. Additional information is not expected.
A day after the second shot I got a fever of 101.3 that lasted two more days.  My lymph nodes on my left side under my arm and my neck were swollen.  The ones under the arm hurt.  I knew swelling of nodes was common so I waited for them to go down.  They did not, and the one on the left side of my neck got bigger.  After 3 months I went to my doctor's PA and she was concerned that my nodes were so large.  She ordered several tests, I was cleared for breast cancer after several diagnostic tests.  but when I went to an ENT specialist he had me get a sonogram of the neck.  The node was larger than a quarter (25 cent piece) and since it was so large and had been there for so long, he recommended having it surgically removed., which I did.  The pathology reported the results were consistent with reactive changes, and not diagnostic for malignancy.   Basically, this very stressful and terrifying situation was all due to the vaccine.  I wish I never got it.  I should have relied on my own very good immune system
The events which precipitated this report were a shingles vaccine administered on September 30, 2013 followed by the 2013 flu vaccine administered 10 days later on Friday October 11, 2013. The shingles vaccine resulted in absolutely no immediate after effects, as was also true of the flu shot. However, on the evening three days after the flu shot, I became seriously itchy, primarily around the beltline, not like the typical shingle symptoms which I understand are generally on one side of the body. Resorted to hydrocortisone ointment which I had on hand which calmed the itch down enough to enable sleep. The itch persisted from Sunday evening until Tuesday morning and on Monday evening there was a distinct rash on front of the upper right thigh. I continued with the hydrocortisone through this roughly 36 hour period. To my amazement and relief, upon awakening Tuesday morning, the itch and the rash were gone and there have been no further problems to date. Was the itch and rash following the flu shot caused by an interaction between and should a longer period of time been allowed to pass between to the two vaccinations?
Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was stored in refrigerator on 06 Dec 2021.  No concomitant medications were reported. No treatment information were reported.
30MAY92 fine rash began on face, t100; 31MAY92 continued w/rash, mom states sl worse than day a/-cont w/t100-101; 1JUN92 rash large blotchy wheals; took pt to MD believed was vax related & wanted rxn reported;
Started with fever, rash, and feeling very tired.  Then skin started to itch constantly, and feelings of pin pricks all over.  Then my skin started getting bumps and my skin felt like it had been sun burned.  Skin started to slough off in sheets on my hands, arms and face leaving raw pink skin exposed.  Very painful and lasted for 6 months.
SHOCK, UNSPECIFIED 6/1/2022 DYSPNEA  SHOCK, UNSPECIFIED 6/1/2022 SHOCK, UNSPECIFIED
Congestion, ear-ache due to sinus, headache, fever, sore throat, cough, all symptoms continuing for at least 24 hours after first appeared
Fever; Arm had a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Arm had a rash) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised (compromised immune system with leukemia). Concurrent medical conditions included Leukemia.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-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 RASH (Arm had a rash) and PYREXIA (Fever). At the time of the report, RASH (Arm had a rash) and PYREXIA (Fever) had resolved.            No concomitant products was provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-294291 (Patient Link).
Had Moderna vaccines for the last three vaccines and was only sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Had Moderna vaccines for the last three vaccines and was only sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Had Moderna vaccines for the last three vaccines and was only sick). At the time of the report, ILLNESS (Had Moderna vaccines for the last three vaccines and was only sick) had resolved.            Concomitant medication list was not provided. It was reported that the patient got Pfizer Covid-19 booster on Friday and she had been very sick since then. Its the fourth day since getting it. Last night, she had trouble breathing. Tested herself with an at home Covid test and she was negative, but she was sick. The patient had lung pain, coughing, and extreme exhaustion, muscle pain, and jaw pain in particular. Treatment information was not provided.
Employee states on the same day as the injection left arm began to ache. By the evening, broke out in hives and arm pain. Continue to C/O pain and was sent to Occupational Health Clinic on 10/22/18.
12/30/20 at 7am as soon as I woke up I was in sever pain and had fever and chills.  I was not able to leave the bed at all the day unless to use the bathroom to which I would be out of breath from that. I slept most of the day as I was so very weak. This lasted all that day. On 12/31/20 I was still weak and tired but able to get out of bed with bad headaches and pain in my bones all over. I would still loose my breath walking anywhere in my home. Sharp pains would come and go throughout the day at least once and hour if not more. Sleeping was next to impossible due to the pain. On 1/1/21 which is my current day my headaches are still here along with slight pain and weakness. I can breath better but the injection site on my left arm is still sore but not as bad as the last few days where it was on fire and very sensitive.
Hospitalized 5/2/22-5/4/22 Weakness of left arm and leg, COVID +, elevated troponin, dis-coordination,
Became sick with COVID 19; Became sick with COVID 19; Became sick with COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date May2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single and administered in arm right, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered with sequelae" and all described as "Became sick with COVID 19"; ILLNESS (non-serious) with onset 08Jan2022 23:00, outcome "recovered with sequelae", described as "Became sick with COVID 19". The event "became sick with covid 19", "became sick with covid 19" and "became sick with covid 19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of covid-19, illness.  Clinical course was reported as: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not any other medications the patient received within 2 weeks of vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient had received treatment for the adverse event with inhaler. Prior to vaccination, was the patient was diagnosed with COVID-19, Since the vaccination, has the patient been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Petechiae and purpura first noted on arms and legs. Felt tired, weak, lightheaded. Throbbing in head. Hospitalized X2. Is currently in hospital receiving 2nd round of IVIG. Also treated with prednisone and WinRho anti-D. ITP - per pt's private physician.  Follow up 05/22/2003: "Update 05/21/2003:  Patient remains hospitalized.  He has undergone splenectomy and continues to receive platelet and infusions.  Due to resulting neuropathy he has limitatives in use of right hand and both legs and will require rehabilitation."  The 60 day follow up states pt hospitalized 2/15-2/18/03. Hospitalized 3/8/03-present. Pt has chronic ITP because of vaccine. Pt's hospitalization includes splenotomy. Pt not expected to recover. Discharge summary states anemia, hematuria GI bleed, tachycardia.
Caller states she is calling about the Pfizer Covid 19 vaccine, Booster; Headache; Left arm hurt; Arm swollen, upper left arm; Lump, in upper part of left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Batch/Lot number: unknown) at the age of 66 years as booster dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1, NDC/Expiration: Unknown, Lot:EN6205, Site: Unknown), administration date: 04Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, NDC/Expiration: Unknown, Lot: ER8733, Site: Unknown), administration date: 31Mar2021, when the patient was 66 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Caller states she is calling about the Pfizer Covid 19 vaccine, Booster"; HEADACHE (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Left arm hurt"; PERIPHERAL SWELLING (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Arm swollen, upper left arm"; LIMB MASS (non-serious) with onset 11Nov2021, outcome "not recovered", described as "Lump, in upper part of left arm".  Additional information: it was reported that patient was not received any other vaccine, but stated that she gets a B12 shot once a month but was unsure what the date was.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient presented to office on 11/17/20  with complaints of an itchy rash on posterior right leg since 11/14/20. Assessment from doctor included the following documentation: Skin Rt posterior thigh patches of papular/blistery rash with mild erythema along S1-S2 dermatome. Diagnosed as Herpes zoster without complication  during office visit Treatment plan includes Valtrex 1 g tid x 7 days.     A/p Shingles -classic 5 days out from receiving Shingrix, mild symptoms Will contact manufacturer Very unusual Valtrex 1 g tid x 7 days
pt devel eczema flare rash w/itching & coughing 1 hr p/vax; vomited x 1;
Extremely heavy periods after completion of the series.  Periods were similar to after birth menstruations.  I was using super tampons and pads and having to change tampons every 30 min and pads every hour for several days.  These periods have continued to be heavy since completion of the shots 10 months later.
Had pain at the injection site for about 2 months; This is a spontaneous report from a contactable pharmacist via Pfizer Sales Representative, who reported events for two patients. This is one of the two reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single dose for immunisation .The patient medical history and concomitant medications were not reported. On an unspecified date the patient had pain at the injection site for about 2 months; event is non-serious and recovered on an unknown date. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020076440 same reporter/drug, different patient
Lump under armpit, red rash, swollen and itching.  Began Sunday night (1/26/21) with pain under arm, rash began Tuesday.  Went to Dr's office on Wednesday (1/27/21) morning.  Began taking Claratin and using cortizone cream for itching.
pt recvd vax & was screaming; head was wobbly; 1 wk later sxs repeated; pt had sz & was shaking; had difficulty breathing; duration 5 min; went to MD;
Fever Chills tired sleeping all day pain in the arm unable to lift arm    Very bad heartburn - painful burning feeling in your chest  12 hours apart
Child was given a 2nd dose of FluMist and only should have received 1 dose, due to age. Child is 9 years of age. No treatment. Per mother, no signs or symptoms noted after adverse event. Adverse event was reported to MDH.
pt brought to ED for c/o worsening SOB, confusion, generalized weakness, diarrhea; O2 supplementation ;admitted;  given steroids, remdesivir, baricitinib; pt's condition worsened; family decided upon comfort measures for pt; BiPAP removed and pt expired in the hospital
This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 19-year-old male subject who was vaccinated with FLULAVAL, (GlaxoSmithKline).  There were no concurrent medications.  On 7 January 2009 at 13:30 the subject received a dose of FLULAVAL at 0.01 ml, intradermally, in the right arm.  This was the wrong route of administration and an inappropriate dose of drug administered.  The nurse administering FLULAVAL was thinking about how purified protein derivative is given instead of the way flu vaccine should be given.  Following administration of FLULAVAL, the subject developed a local reaction immediately, which was defined as within one hour.  The reaction consisted of a 2cm by 2cm area of redness and swelling.  The area was also inflamed.  The events were not resolved at the time of reporting and were being monitored and measured.  No treatment was required.  In the reporter's opinion, the local reaction and redness were probably related to treatment with FLULAVAL.  The invalid FLULAVAL dose was repeated at the full 0.5 ml dose and was given via the appropriate intramuscular route.  The repeat dose was given in an unknown deltoid muscle and there were no reactions reported.  The reporter did not know if the repeat dose of FLULAVAL was administered in the same arm as the invalid dose or the opposite arm.
Patient received his second COVID shot and waited the 15 minutes with no issues.  He went out to his car and was about to drive off when he informed his wife that the side of his face felt a little numb.  He had no other symptoms.  His wife suggested he come back inside and ask what to do. Based on his symptoms, I asked him to have a seat for another 15 minutes to see how he felt.  He was completely coherent.  After checking on him again, he reported no change in symptoms.  A few minutes later, around 12;45 pm, his wife said they would contact his doctor from the car.  He left and I tried calling him around 4pm to ask how he was doing.  I had informed him to contact his doctor, go to the ER if his symptoms worsened or stayed the same after a little while.