chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site is nowswollen, red and warm; red; warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site is nowswollen, red and warm), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Drug allergy (Patient is allergic to statins) and Hypertension.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site is nowswollen, red and warm), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm).   At the time of the report, INJECTION SITE SWELLING (Injection site is nowswollen, red and warm), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (warm) had not resolved. Not Provided    Concomitant product use was not provided by the reporter. No treatment information was provided.
Redness, pain, warmth & swelling (hard to touch) about 2 days later. High fever (not measured about 102 degrees) - (aching muscle/joint ). Took ibuprofen. Local symptoms persisted. System rxn subsided in 72 hr.
Not being able to sleep; Swollen right jaw cannot bite down and hurts to open mouth; hurts to open.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 25Feb2021 at 08:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), etanercept (ENBREL), metoprolol (MANUFACTURER UNKNOWN) and telmisartan (MANUFACTURER UNKNOWN); all for an unknown indication and start date. The patient had no known allergies to medications, food, or other products. On 26Feb2021 at 12:00, the patient experienced swollen right jaw, could not bite down and hurt to open mouth. Patient further stated that she went to urgent care because of pain and not being able to sleep for the same. The events resulted in doctor/other health care professional office/clinic visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified antibiotics and naproxen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events not been able to sleep, swollen right jaw could not bite down and hurts to open mouth and pain in jaw were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events on three patients. This is the third of three reports. A patient of an unspecified age and gender received PREVNAR 13, (lot N47827, exp. date 01Nov2017, NDC number 0005-1971-01) on the right deltoid muscle at single dose on 11Nov2016 for immunization. Relevant medical history and concomitant medication were not specified. On an unknown date the patient experienced warm, red and swollen at administration site and they turned red like cellulitis. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016586398 same reporter, same events, different patients. US-PFIZER INC-2016586397 same reporter, same events, different patients.
Mild to moderate reaction post/vax #3. Had 3.5 x 5 cm red, raised & warm area at vaccine site, R/upper arm, 36 hrs after shot. Resolved with Ibuprofen/Allegra after 48 hrs.
I have pain on the right shoulder (where I got my first vaccine). It's aching like the dickens; This is a spontaneous report from a contactable consumer.   An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 23Feb2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 82 years old) for COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on 29Jan2021 (Batch/Lot number was not reported) for COVID-19 immunisation. He received the first dose on 29Jan2021. It was given in his right shoulder. He did not have any problems with the first vaccine. The patient stated, "I had my 2nd one this past Tuesday on 23Feb2021 on my left shoulder. I have pain on the right shoulder (where I got my first vaccine). It's aching like the dickens. It's unusual and surprised it would show up so late. I'll have to call him tomorrow. I'll call. And its possible over night the pain may go away." The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Information has been received from a NP and a physician concerning a 16 year old Caucasian female with no past medical history who on 10/13/03 at 11:30AM was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 646144/0469N)(IM)(0.5mL), in the left arm.  There was no illness at the time of vaccination.  On 10/13/03 at 7:00PM the pt developed "hives on her abdomen, soreness at the injection site and tiredness."  The mother described the hives as "approximately 3" in diameter on daughter's abdomen."  The pt also had complained of a sore arm on the day after vaccination.  It was also reported that she "developed a sore arm and extreme fatigue".  There were no other symptoms reported.  The pt was not hospitalized.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations.  The pt sought medical attention.  The pt was treated with diphenhydramine HC1 (Benadryl).  There was no product quality complaint involved.  The pt recovered on 10/14/03.  No further information is expected.
Resurgence of granuloma annulare and herpes which was controlled for several years, anxious, heart palpitations, buzzing head, dizzy, light headed, heavy head like very hung over, dilating right eye then lost vision temporarily, malaise, headaches, shaky, nauseous, itchy hot spots, inability to think or function.  Complete exhaustion - Just want to sleep. Then developed chronic diarrhea for one month-diagnosed w microscopic colitis started on budesonide. Inflammation of the knee diagnosed with prepatellar bursitis.  All testing was negative with the exception of the colonoscopy diagnosed with colitis and knee mri diagnosed with bursitis. NB 2 covid vaccines administered -4/6/21 5/4/21. Symptoms started after 2nd v
Itchy increase in need to swallow. Lungs clear P98 BP118/72 O2 99-100%  drank water and sat longer felt better and went home
patient has history of seizures, presented with a seizure to ED, she was nonverbal, diagnosed with unspecified convulsions and pseudoseizures.  Patient was intubated.  diagnosed with seizures and acute respiratory failure.
no vaccine adverse event, but patient presented to the ED on 9/27/23 complaining of cough, congestion, runny nose x 2 days.  Tested COVID + in the ED.  Upon ED discharge 9/27/23  he was informed that he was ineligible for Paxlovid due to his anticoagulant use.  Advised to return for remdesivir treatment if he chose.  Patient returned to the ED ~ 3 hours later for remedesivir infusion.  He was stable prior to the infusion, but during the infusion became tachypenic.  Patient admitted to the ICU for observation.
3 weeks after vaccination patient developed Mild molluscum contagiosum-type rash on lower abdomen and penile shaft, mild, persisting until now and requiring cryotherapy at this time. Cryotherapy was not available at the deployed location. He states he had sexual contact only prior to the vaccination/deployment and that partner is unaware of any similar condition.
Within 24 hours severe headache, followed by inner war pain, then on Morning of 6/13/2021 awoke with left sided facial paralysis inability to close eye or lift smile.
It was reported that a 69 year old male received Fluzone SV '99-'00 on 10/12/99. The pt experienced "local immediate swelling, hardness and redness". No further information is available at this time.
Started to complain of pain in right deltoid -site of injection; HPV #2, 2 hrs after injection - felt stiff - difficulty sleeping ; Next a.m. very pale dizzy, nausea. went to ER that night 1/14
Received vaccine at 1:50pm. Began to have site soreness and swelling that radiated to right shoulder and down to rt. elbow. Experienced redness associated with area of swelling. She began to experience fatigue, shivers and had night sweats Friday night (1-13-12). She states began to have a "metallic" taste in mouth beginning at approx 5:00pm on 1-12-12. Still has faint metallic taste today 1/16/12.
Patient passed away; Found him non-responsive; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unresponsiveness to stimulus. The event was followed by his death.  The patient's medical history included Covid-19 and experienced dehydration prior to testing positive for Covid-19. Concomitant product use was not provided by the reporter.  The patient was diagnosed with COVID-19 at the skilled facility after becoming dehydrated. He was transported to Hospital on 23 Dec 2020 then discharged to skilled facility on 03 Jan 2021 for physical therapy.  On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The anatomical location were not reported.  On 03 Mar 2021, the patient was found non-responsive and the staff at skilled rehabilitation tried to resuscitate. Death was the outcome. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not applicable.  The outcome of the event non responsive to stimuli was fatal. The patient died-on 03 Mar 2021 and the cause of death was not provided. It is not known whether autopsy done on this individual. No results were provided.; Reporter's Comments: This is a case of death in an unknown aged male subject with unknown medical history of recently recovered covid-19 infection before first dose, who died one day after receiving second dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Head bobbling; Questionable seizure episodes 8 days after 6 month vaccines administered on 2/5/2009. 3/23/09-records received for DOS 3/2-3/4/09 DC DX: encephalopathy. Discharged on VEEG. Presented with 2 weeks of ongoing pattern of what appears to be baby's head falls forward.
Expired Boostrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 575HC, expiry date 28-FEB-2023) for prophylaxis.   On 14-APR-2023, the patient received Boostrix. On 14-APR-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Boostrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter called to report an expired dose of Boostrix was administered to a patient. The reporter consented to follow up via email. The reporter called to report an expired dose of Boostrix was administered to a patient, which led to expired vaccine used.
During cardiovascular exercise experienced SOB, Dyspnea, Chest pain, during and for 1-2hrs post cardio exercise. this continued for 2-3 days. with fatigue, sob,. Pt. had EKG performed which showed 1st degree AV block w RBBB. Pt. was then referred to cardiology where she was seen and diagnosed on 27Jan with pericarditis. Pt has since started NSAID therapy with mild symptoms persisting. Pt. will have Cardiology follow-up at 4weeks time.
Really really hot; Arm started itching; It's been extremely extremely sore; Actual size it's about an orange, Red; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Really really hot), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE PAIN (It's been extremely extremely sore), VACCINATION SITE ERYTHEMA (Actual size it's about an orange, Red) and PYREXIA (Slight fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Blood pressure, METFORMIN for Diabetes, CHOLESTEROL and OMEPRAZOLE for an unknown indication.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Really really hot), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE PAIN (It's been extremely extremely sore), VACCINATION SITE ERYTHEMA (Actual size it's about an orange, Red) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Really really hot), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE PAIN (It's been extremely extremely sore), VACCINATION SITE ERYTHEMA (Actual size it's about an orange, Red) and PYREXIA (Slight fever) outcome was unknown.            Relevant concomitant medications included Blood thinner.   This case was linked to MOD-2021-364084, MOD-2021-364075 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Non-significant follow up (Contact info. updated)
Information was received from a male consumer concerning his wife. On 17-OCT-2013, she was vaccinated with ZOSTAVAX. It was reported that after she and her husband (MARRS# 1310USA014844) they both experienced "a little redness and itching at the injection site". It was reported that she experienced these symptoms "a little more" than he did. It was reported that the symptoms lasted about three days and the injection site was sore after that. Additional information is requested.
The patient had redness and itching at the injection site starting the day after injection and lasting for 1 week. It resolved on its own with no treatment.
No additional adverse effect reported; dose of pediatric VAQTA (lot S009562 & expiration date 7/26/2020 was administered on 7/30/2020 to a pediatric patient; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported. On 30-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) syringe, lot # S009562 was confirmed to be valid, expiration date reported as 26-JUL-2020, but upon internal validation, it was established as 05-MAY-2019 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse effects were reported. There was no temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S009562; expirationdate: 05-MAY-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I felt fine that day, even did a 2 mile run after work.  I slept poorly and the next day was sore all over and very tired.  I came to work but was dragging the entire day.  Wednesday morning, after a good sleep, soreness was gone, but I was tired early the next afternoon.  I was fine Thursday but continued to have sore lymph nodes in the armpit of the arm that got the shot for several days after.
Patient became very pale after his immunization. Briefly fainted with some twitching. Came back around within a couple of seconds. Alert and oriented to person, place, and time. Said his head hurt a little and he had a little ringing in one ear. Did not require an Epi-pen. Mom declined calling an ambulance and had a phone consultation with the pediatrician. No hospital visit required.
This spontaneous report was received from a registered nurse referring to a neonate of unknown age and gender. On an unspecified date in February 2016 (reported as "a year and a half ago"), the grandfather was vaccinated with ZOSTAVAX for prophylaxis. On an unspecified date in 2016 (reported as "shortly after received the vaccine"), he visited his newborn grandchild and the newborn developed chicken pox. The nurse reported that the grandfather stated "his grandchild was quite sick at the time". The outcome of secondary transmission, varicella and malaise was reported as resolved.
A spontaneous report was received from a consumer concerning a 79-years-old ,female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  vomiting, diarrhea, terrible nightmares(nightmare), tired(fatigue).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, at 9.15am,prior to the onset of the events ,the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M204)  in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021,at 11.00 am, the patient experienced vomiting. She took medication for nausea and at 10.30 pm she vomited the medication.She decided to use a suppository for nausea instead and her vomiting stopped.She started diarrhea as well,that lasted four days.She had  terrible nightmares for two nights.She was tired for about a week.  Treatment details included medication for nausea  and suppository for nausea.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event ,vomiting was considered resolved on 5 Feb 2021.The outcome of event, diarrhea was considered resolved on 9 Feb 2021.The outcome of event, terrible nightmares was considered resolved on 7 Feb 2021.The outcome of event, tired was considered resolved on 12 Feb 2021.
13 Hours After Dose: Chills set in, which caused back spasming and back muscle seizing in addition to shaking for approximately 20 minutes (it may have been convulsions). Also had a fever, nausea, dizziness, and injection site pain.  24-70 hours later: Fatigue and a headache  70 hours later: Woke up with major chest pains and went to ER. Testing eventually determined it to be myocarditis. Hospital stay was approximately 54 hours.
This spontaneous report was received from a registered nurse referring to a patient of currently 4 years ago and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The dose of PROQUAD (Merck) underwent temperature excursion: 14.47F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient were vaccinated with RECOMBIVAX HB (dose, route and lot# were not reported) which was exposed to -1C for 22 days. The nurse stated that she was not sure doses may had been administered to patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of allergic reaction in a 23 year old male subject who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic and allergy to pencilling. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 18 October 2006, the subject received unspecified dose of Fluarix. On 19 October 2006, one day after vaccination with Fluarix, the subject experienced allergic reaction and hive. The subject was seen in an emergency room and was treated with Benadryl. The events resolved on an unspecified date. On 20 November 2006, the subject again experienced hives. The outcome of the second episode of hives was not reported. The pharmacist considered the events to not be related to vaccination with Fluarix.
p/being administered vax pt devel brain damage, loss of motor control, neurologic damage;
patient received the prevnar 13 vaccine to her left deltoid on 10/9/19. She sent a message on 10/11 reporting flu like symptoms and she was told to go to the urgent care.  On 10/14 patient stopped in to the office and Dr. looked at her arm.  She reported that she went to the urgent care and was diagnosed with cellulitis of her left arm and was placed on keflex.   However, Dr. is one of our supervising physicians and he does not think it was cellulitis.
What if it has been more than 6 months after my first Shingrix vaccine?; This case was reported by a consumer via interactive digital media  and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  The reporter enquired what if it was more than 6 months after his or her first Shingrix vaccine. The follow up was not required.