chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with very swollen right shoulder, like twice the size of not larger of my left arm a few days ago. Then yesterday morning,6/9, I woke up and my right armpit hurt like swollen lymph node pain, armpit hurt all day. I can ignore the swollen shoulder it doesn't bother me just looks odd. But this morning,6/10, the armpit pain is duller but my shoulder is severely swollen, hard, hot and tingly, and very large defined red circle around the injection site.
the vaccine helped with his allergies; just a little fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 (Lot number: EW0170, Expiration Date: Aug2021) at the age of 52 years as dose 2, 0.3 ml single and administered in arm right, administration date 13Apr2021 (Lot number: ER8731, Expiration Date: Jul2021) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "severe latex allergy" (unspecified if ongoing), notes: He has a severe latex allergy; "Allergy to nickel" (unspecified if ongoing), notes: He also has a allergy to nickel; "Lymphoma" (unspecified if ongoing), notes: Diagnosed in 1984-1985.; "chicken pox virus" (unspecified if ongoing), notes: He could not finish his Senior year because the chicken pox virus came back and it attacked his legs and he was on crutches. He had chemo and radiation treatments.; "Blisters" (unspecified if ongoing), notes: did not get any blisters this summer for almost the first time in 30 years. Concomitant medication(s) included: DIPHENHYDRAMINE HCL taken for blister. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "the vaccine helped with his allergies"; FATIGUE (non-serious), outcome "unknown", described as "just a little fatigue".  Additional Information-Caller reported that he used to wear latex for his job but later on developed poisoning and allergy, had blisters and from contact. After receiving both doses of the Comirnaty he had no outbreak during this summer from the vaccine. Department called it an AE. Caller stated he wanted to give a heads up that the vaccine helped with his allergies. He said that this can be ironic that the first time in years his hands had not broken out during summer. He added that this even happened during winter but more during the summer because of the heat. Caller added that he called because this was something that Pfizer might want to look in to. Caller said that he'll be monitoring his condition because at this point, he had zero outbreaks. He added he thought there would be something from Pfizer because there are people who have latex allergy. He said that what he took when he does have outbreaks was diphenhydramine. He said that he would take 25mg tablets. He said that when he had a doctor and he needed to get his outbreaks under control, they would prescribe him 180mg prescription strength.  He said that he would buy it OTC and he would took 4 of them at a time. He said that they are basically tranquilizers. Patient did not had any other vaccinations within four weeks prior to the first  administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Possible heart inflammation; injection sight supposed to swell; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDITIS (Possible heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Possible heart inflammation) (seriousness criterion medically significant) and VACCINATION SITE SWELLING (injection sight supposed to swell). At the time of the report, MYOCARDITIS (Possible heart inflammation) and VACCINATION SITE SWELLING (injection sight supposed to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment history was reported.  Very limited information regarding the events has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Initial report received from a consumer (patient) on 23 Apr 2010: This patient was vaccinated with FLUVIRIN (batch no: unknown), intramuscular, on 13 Jan 2010. On 13 Jan 2010, the patient experienced soreness in arm (immediately after vaccination), feel like damage to the muscle where the vaccine was injected and lump at the injection site. The patient reported that events to treating physician (who is endocrinologist). The outcome of the event soreness in arm was reported as condition unchanged and outcome of the other events were not reported. Follow up report received from an endocrinologist on 03 May 2010: Batch number of FLUVIRIN was provided as 02147P1. The patient presented with persisting arm swelling and pain at the site of vaccination. The patient was advised to go to primary care doctor. Outcome of events were unknown. The reporter assessed the events as medically significant.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline. Pt reported 4 days post developed head congestion, coughing for several weeks. Arranged for Covid testing & is pending
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions and allergies were not reported. On 17-JUN-2016 the patient was inadvertently vaccinated with RECOMBIVAX HB lot # K008334 expiry date 09-JUN-2016. The patient experienced no adverse event. Additional information has been requested.
PATIENT CALLED PHARMACY TO REPORT ADVERSE EVENT WITH FIRST DOSE OF COVID VACCINE. PATIENT RECEIVED MODERNA. ADVERSE EVENT SYMPTOMS OF REDNESS AND SWELLING IN THE LEFT ARM. PATIENT ALSO REPORTS HIGH DEGREE OF ITCHING IN THE ARM. VERY LARGE RED SPOT SPREADING FROM THE NECK DOWN TO THE ELBOW.
Symptoms: Headache, chills, pain in joints  Time: 4:30 3/27/2021 - 12:30 3/28/2021 Treatment: OTC Naproxen (Aleve) as directed by manufacturer  Outcome: Complete Recovery
PATIENT REPORTED ITCHING AT INJECTION SITE THAT STARTED 1 HOUR POST IMZ INJECTION. PATIENT CAME TO PHARMACY WITH SMALL 3 INCH RED SPOT ON ARM AT INJECTION SITE. PATIENT STATED HER ARM ITCHED AND THAT BENADRYL WAS WORKING TO CONTROL THE SYMPTOMS. PT ALSO STATED THE RED SPOT WAS DIMINISHING OVER THE PAST 24 HOURS.
Headache, nausea, chills, rigors, numbness and tingling body wide... HORRIBLE for about an hour, uncomfortable for another 12hrs, still present 20hrs from onset.  Hope it will be over by morning of 3/11.  Have had reactions to vaccinations in the past.  This was a bad one.  Glad I don't have to repeat the dose.
covid positive; covid positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller calling on behalf of the husband who was in a long term care facility. He was given 1st dose on 23Jan2021, thereafter tested covid positive in 2021. He was scheduled to receive the 2nd dose on 23Feb2021. He was advised not to have it because he tested positive. Wife wanted to know if it's true. The outcome of the events was unknown.  Information about lot/batch number has been requested.
I experienced after my vaccine, after a few days I had a runny nose, head cold and I thought it as hay fever.  At the end of my day it would clear up, my runny nose was back again. On the next morning I also experienced sore throat and a runny nose. This lasted about one week.  I went to my PCP, and they did a COVID test and I tested positive.  I can not taste anything, my nose is not runny and I have to blow up a few times a day. I have no fever 96.7F. I also get a minor phlegm when coughing.  At this time I can say my symptoms are a bit better when taking OTC Tylenol medication though I still can not taste anything.   I am taking fluids and taking Tylenol for my Covid symptoms.
Starting the following day after booster I felt periodic tightening and soreness in my chest, left side. I also had numbness in my feet and fingers (ends turned white periodically) Skin was sensitive to touch - slight burning sensation General malaise, headache, low fever, chills, nausea
p/vax pt exp chickenpox;pt seen by MD w/greater than 100 lesion;
Developed bad headache and upset stomach at 8:00pm, then went to sleep. Woke up at 12:00am and had a fever of 101 and felt very sick, vomited once. She went back to sleep after this. Felt better the next day.
Two days after vaccine was administered I noticed increasing blood pressure and headaches. Four days after vaccine my blood pressure elevated to 180/110 and had to go to the Emergency Room
No adverse event. Patient was given pediatric dose of Pfizer Covid vaccine and should have received regular dose. This was the booster.
Local reaction with blistering 9x9 cm area with multiple blisters measuring 2x2cm.
Very severe headache, loss of vision, and not able to concentrate or know what he was doing. He had a migraine like this over 2 years ago, but it occurred right after getting the vaccination. His headache was bad that morning but it just kept getting worse to where he couldn't even see. He developed a fever and was chilling and aching all over. He was in the bed and not moving for 2 full days. The migraine meds hardly touched the headache, and he did not even remember when we gave him his meds. He was talking out of his head.
He awoke at 3am for a bathroom trip and then woke again at 5am to go to bathroom, Felt very weak and lowered to the floor, ambulance was called and was taken to local Hospital ER and was admitted then discharged to home on 10/25/2021 Was given IV fluids and had a foley catheter found pneumonia on CXR, was treated with antibiotics Erythromycin, and Mucinex.
RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 22 year old male. 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: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious.
chest pain hyperventilation hypertension diaphoresis tremor - seizure-like symptoms; sent via ambulance to local ER
Upper lateral side of Left arm swollen and somewhat tender. No warmth or redness and elbow with FROM.
Flu like symptoms including fever and bodyaches for 36 hours after the second dose. Covid arm red and swollen for two weeks after the second dose. About two weeks later, dizziness started. It has continued on and off to the present, which is more than a month. Dizziness is not severe or hampering lifestyle. It is like the buzz after having a drink. It comes and goes and just makes me feel lightheaded.
I woke up with excruciating headaches; chills; everything except for a fever; body aches etc. They thought it was an autoimmune reaction. I called my doctor and she concurred. Those symptoms continued until next Wednesday- rapid test for COVID -10th of Feb and I tested positive on it. They thought it was autoimmune still and they had me get a PCP on the 11th and that came back positive also on Saturday the 13th. The symptoms lasted gave onset of COVID on 2/5/2021 (Health dept put my onset of symptoms) and they lasted until 2/15/2021. Tylenol but not other treatment. The fatigue stayed until about a month afterwards. And up until three months afterwards - it got a little better at three months and still at times presently I deal with brain fog. It hasn't completely gone away. Had telehealth doctor visit.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients. Initial information was processed along with the additional information received from central complaint vigilance Organization on 26-AUG-2021. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown)1 total dose was administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The consumer stated that at his work place, 25 people had tested positive for Covid-19. He stated that he was unsure who they all were due to privacy, and that he did not know if and what vaccine each of them got. However, he stated that some of those 25 individuals received the Janssen Covid-19 Vaccine and still got sick with covid- 19 (suspected covid-19 infection, suspected clinical vaccination failure). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000191131.; Sender's Comments: V0: 20210851777-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
inflammation in left knee and both elbows; joint pain went into knees; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation in left knee and both elbows) and ARTHRALGIA (joint pain went into knees) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation in left knee and both elbows) and ARTHRALGIA (joint pain went into knees). At the time of the report, INFLAMMATION (inflammation in left knee and both elbows) and ARTHRALGIA (joint pain went into knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided. Treatment included anti-inflammatory medication for the inflammation she had put ice on the area.
Moderna was past it's 30 day shelf life from being transferred from the freezer to the refrigerator and given to this patient. The manfacturer was contacted and given the scenario. The manufacturer stated that vaccine would be considered invalid and would need to be repeated. Patient declines a repeat dose at this time. Patient has been informed and did not report any physical reaction.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available.  It was unknown if the patient received any other vaccines prior to 4 weeks of COVID-19 vaccine.  Treatment details were not reported by the reporter.  This case was considered for 2nd adult patient out of 40 adult patients who were received expired bivalent dose of moderna.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
1.7 cm circular lesion (R) deltoid area described as "cellulitis", noted to have a crusted drainage of a yellow color with 1 plus erythema to 10-12 cm diameter periwound. Treated w/ cephalexin 500mg TID x 7 days.
Patient, received second Pfizer Covid vaccination on July 8th, 2021.  About August 1st, 2021, he started having symptoms of weakness, thirst and polyuria culminating in ICU hospitalization for Diabetic Ketoacidosis.  He had no history of Diabetes prior to the Covid vaccine.
Pt recvd 1st dose of Engerix-B vax on 7MAR91 & 16 hrs later on awakening tongue swollen way back to epiglottis; It was difficult for pt to swallow; Seen in ER; exp nausea, uvula edema;
Skin at the injection site looks like i had a small burn. About the size of a pin top.
First noticed small red spots under arms and lower abdomen which progressed to larger blotchy red spots (hives) all over body by monday 8/12/13, treated with Benadryl with not much if any change. Hives started fading on 8/16/13 to smaller red spots. To date still has a few red spots on lower abd, buttocks, and legs.
Rash noted to diaper area per mom. Child had been fussy with tantrums for the past 2 weeks (since father detained d/t incident-not involving this child but father was primary caregiver while mother went to work). No fevers. Was told had a diaper rash. On exam, erythematous patch to right ankle area and zoster lesion to right lower back area starting from midline and moving down buttock (dermatome T1).
3rd day after vaccination, cold sores along bottom lip, cluster of blisters along lower lip, clusters of 'bumps' on forehead, itchy spots on face.
I take birth control continuously and don't have to go off of it for five months but on 03/12/2021, I woke up with horrible cramping and heavy bleeding and I had taken my medication every day. I had my last period on 12/18/20. It was so bad that I thought I needed to take another break from medication, and I was cramping really badly. I took a week off of my medication and then went back on it and then on 04/05/2021 I was still taking the medication and had another episode of cramping, heavy bleeding, and clots. At that point I was considering seeing my gynecologist but had an annual visit coming up in June and I also wanted to wait and see if it happened again. It happened again on 05/06/2021 and I saw my Doctor on 06/26/2021 and she asked if it happened in June and it didn't, and she said several patients told her the same thing. I haven't experienced anything weird like that since then. I had weird periods in March, April, and May, and I've been fine since then. My continuous birth control was working just fine and I stopped in August and switched treatments.
This case was considered medically important (OMIC). Information regarding Hib-Titer vaccine was received from a healthcare professional regarding a patient who experienced developmental delay. The patient received Hib-Titer vaccine. Relevant medical history was not provided. Indication for Hib-Titer vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The patient experienced developmental delay on a date not specified. No additional information was available at the time of this report.
pt recv vax;devel fever, irritability and inject site rxn; pt dx w/ otitis med however pt thinks it was present at time of vax;
This spontaneous report was received from a registered nurse and refers to multiple patients of an unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored ROTATEQ lot # K020181 expiration date: 24-JUN-2016 (dose was not reported; orally). There were no adverse effects reported. This is one  of several reports received from the same source. Additional information has been requested.
Described local reaction as "red, raised, and itchy." Treated with "steroidal cream."
This spontaneous report was received from a registered nurse referring to a 7 week old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 14-DEC-2017, the patient was vaccinated with an improperly stored doses of ROTATEQ orally, lot # M018958, expiration date on 03-MAR-2018, lot #N004815, expiration date on 07-OCT-2018 or lot #M045546, expiration date on 12-JUN-2018, for prophylaxis (strength and dose were not reported) and with LIQUID PEDVAXHIB lot #N004632, expiration date on 02-NOV-2019, for prophylaxis (strength, dose and route of administration were not reported). The vaccines were stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccines were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1712USA010085: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514: