chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vaccine more than 12 hours from required time injected to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine more than 12 hours from required time injected to patient) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine more than 12 hours from required time injected to patient). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine more than 12 hours from required time injected to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received and contain Non significant information.
Pain started slowly after shot and within a couple of hours the pain was in the entire arm, I could not lift my arm up. I also felt very tired and sleepy. I took some acetaminophen twice (650mg) and was much better within 24h. The next day, the pain in the arm went away pretty quickly and I wasn't feeling so tired anymore.
Pt received smallpox vaccination on June 6, 2009, a Saturday. On the following Tuesday, his right arm started to hurt and gradually worsened. On Friday June 12th, his arm was very sore and swollen and he went to an emergency room for treatment. He received anti-inflammatory and pain medication and was sent home a few hours later.
patient presented with a large red area on the arm where the shot was administered.  patient used ice and said it seems to be a little better the next day
The patient received Menactra and Adacel subcutaneously instead of intramuscularly, No AE; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves a 12 year old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] subcutaneously instead of intramuscularly.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 27-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once and a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported) via subcutaneous route in unknown administration site for prophylactic vaccination respectively.  It was a case of an actual medication error due to inappropriate route of vaccination.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number.
mom states pt recvd immun 9JUL93 said pt woke up crying w/pain in rt thigh; pt limping & has a hard spot; pt had fever & pain & heat in rt thigh, difficulty walking; advised to go to ER for evaluation;
feels like i had chills; reddened ring around injection site; felt feverish; slightly itchy; 2" round reddened spot; This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (2" round reddened spot), CHILLS (feels like i had chills), INJECTION SITE REACTION (reddened ring around injection site), PYREXIA (felt feverish) and RASH PRURITIC (slightly itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced RASH ERYTHEMATOUS (2" round reddened spot) and RASH PRURITIC (slightly itchy). On 17-Mar-2021, the patient experienced CHILLS (feels like i had chills), INJECTION SITE REACTION (reddened ring around injection site) and PYREXIA (felt feverish). On 18-Mar-2021, PYREXIA (felt feverish) had resolved. On 19-Mar-2021, INJECTION SITE REACTION (reddened ring around injection site) had resolved. At the time of the report, RASH ERYTHEMATOUS (2" round reddened spot), CHILLS (feels like i had chills) and RASH PRURITIC (slightly itchy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.    patient received Shingrix vaccine couple of years ago
Patient was present to have flu vaccine.  Approximately 10 minutes after shot patient complained of headaches, being nauseous and having difficulty hearing out of right ear.  Immediately, , MD notified .  MD observed patient experiencing swollen lips.  Benadryl was given. MD informed mom to take patient to Hospital
Severe allergic reaction - welts/hives/rash over entire body, ears and ear canals swelling - swelling of throat. Required EPIPEN shot and steroid shot and 12 days oral steroid Rx.
p/vax pt exp T99.7 (taken at home) & 100.9 (@ MD office), lt arm that was swollen, red & painful to touch (dx cellulitis);tx w/ATB;
mom called 16APR96 states pt lt leg swollen,red&cried,t102;mom stopped by clinic area redness hard 2cm x 1cm;advised to keep cold on are try ATB ointment&stop by MD office;17APR96 temp up to 103.8
Information has been received from a company representative concerning a 4 year old healthy female who on 04/05/99 was vaccinated with Varivax . In the first week of 02/02, the girl experienced varicella with more than 50 lesions. The physician indicated that it is a wild type varicella. The girl was treated with diphenhyramine hydrochloride (Benadryl), calamine (+) camphor (+) pramaoxine hydrochloride (Aveeno) and certirizine hydrochloride (Zyrtec). There were no complications and the varicella was reported to be "progressing well". The patient's brother (WAES0202USA01924) also experienced varicella following exposure  to Varivax. It was also reported that the third sibling is 1 year old and received Varivax from another lot on 11/07/01 and has not developed any symptoms . No further information us available.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the healthcare facility and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Information has been received from a licensed visiting nurse concerning a 13 month old male with a history of pneumonia and sinusitits and no known drug allergies who on 17 APR 2002 at approximately 4:30 pm was vaccinated with the first dose of varicella virus vaccine live subcutaneously in the right anterior thigh. Concomitant therapy at that time included the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live subcutaneously in the left anterior thigh. There were no other reported concomitant medications or illnesses at the time of vaccination. The nurse was told by the patient's mother that the child symptoms began with fever and lesions. On 26 APR 2002 the patient developed a temperature of 103 deg F, and a blistery rash on arms, legs, back and scrotum. On 30 APR 2002, the patient's scrotum had swelled and the patients temperature had continued to rise. The patient's rash spread, now with purplish lesions and the patient was taken to the ER. The child was diagnosed in the ER with varicella, epidymitis, and perineal cellulitis. The patient's rectum was explored and had an abscess drained, that was reported to be staphyloccal positive. The abscess was packed with medicated gauze and the child was treated with an intravenous antibiotic and sulfamethoxazole. It was reported that the patient was hospitalized for 7 days and recovered. It was also noted that the patient did not have any adverse events following previous vaccinations. No further information is expected. 60 Day follow up states that pt recovered from the immediate results of the adverse event, however, he continues to undergo test and evaluations to determine the extent of permanent damage.
In November 2021, I was initially diagnosed with Bullous Pemphigoid, 10 days after receiving a Pfizer COVID vaccine. I was treated and achieved complete remission in Spring 2022. On 11/10/2023, I received the Pfizer bivalent vaccine, and on 11/13, I had a recurrence of my Bullous Pemphigoid requiring additional treatment.
Client was vaccinated on March 12 and April 10, 2021 with Moderna vaccines for Covid. Symptoms started on 9/26 chills, nasal congestion, headache, and myalgia. Client tested positive for Covid with rapid test on 9/30. Client had treatment of antibodies via infusion on 9/29. Symptoms significantly better on 10/1, approximately 24 hours after infusion. Reported as a case of breakthrough Covid illness in a person who is fully vaccinated.
This spontaneous report as received from a medical assistant refers to four patients of unknown demographics. On an unknown date in August 2017, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M043308 with expiration date on 24-APR-2018; lot # N010247 with expiration date on 25-SEP-2018, reconstituted with properly stored sterile diluent (manufacturer unknown). Additional information has been requested.; Sender's Comments:  US-009507513-1709USA000870:
I got the flu vaccine on 9/24/09 (Thursday) at about 5 p.m. I felt OK at that time and had no problems.  Within an hour, I was seeing floaters in my right eye. Also see flashes of light like a shooting star to right of eye when it is dark.  Went to Hospital Saturday but they didn't have equipment to check it so was sent to another Hospital and got there Sunday morning at about 2 a.m.  Was examined about 6 a.m., dilated etc.  They said vitreous fluid was detatched and was causing the floaters in my eye but my retina was not detatched.  Released with instructions to follow up with an eye specialist within 2 weeks.  They didn't connect it with the flu vaccine but I had no eye injury or other event that was known to cause it so thought I should report in case it was a side effect.  I still have the floaters and light flashes on Monday 9/28/09.
Headache; she really isn't feeling well; BP has been going up; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the 2nd dose on 28Jan2021 and woke up with a headache since and BP has been going up on an unspecified date in 2021. They tried transferring the patient, but the patient reported she really wasn't feeling well and didn't want to wait long so they tried disconnecting due to long hold times and transfer the patient but accidently disconnected on the patient. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Pt called complaining of chills & hands shaking. Suggested he go to ER & he didn't want to. Suggested he take Tylenol, he had no fever or soreness or swelling at injection site. He finally decided to try to go to the ER.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003724, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
The person who administered the vaccine said that I may get a "bruise" as I was bleeding after the vaccine.  I drove out of the vaccine clinic warehouse and sat in the parking lot for the 7 minutes.  I started to feel "off" and a little dizzy.  The nurse came over and my BP was 109 systolic and HR was 72 - both are/have never been that low.  Her pulse ox wasn't working at the time.  I told her I instantly got an intense left neck pain and headache...she said that some people get that.  I had to immediately go poop and used the portapotty in the parking lot.  I went back to my car and still felt sick.  I sat there for prob about 10 more mins and then just left as my bladder literally felt like it was on fire.  It hurt SO badly....right above my pelvic bone.  It was awful.  I was in the fetal position as I was driving home and got numbness/tingling down my right arm.  I got home and immediately went to the toilet to go poop again.  I was shaking from being so cold and having the chills and had a puke bucket in front of me, which I never used, while I was sitting on the toilet.  Nothing was helping my bladder from that intense burning sensation.  I just went to bed because I felt so off.  The next day (and following days), I just felt very weak and foggy/off.  I report this to my PCP and discussed with him at my annual exam on 11.16.21.
The night after patient had his shots, his wife reports that he felt unwell, and had a temperature of 104 degrees as of the next day (10-1-18)...his arm was described as being red and swollen from shoulder to elbow, with "welps" and red streaks extending to areas on chest and down his arm below elbow....I advised them to seek medical attention ...the temperature continued the next day and the patient's wife called and said he was shivering and tired, patient was not wanting to go to the hospital at that time...pt was advised to try taking diphendyramine orally and ibuprofen/acetaminophen to lower fever but that seeing a dr was optimal....on Oct 3, the patient's temp dropped to 98.8 degrees and he saw his cardiologist as scheduled. His arm remained red and swollen but the fever abated...The cardiologist expressed the opinion that the cause of the reaction was getting 2 shots in the same arm, but based on the patient's history of severe allergic reactions, an allergic reaction cannot be ruled out (please note the cardiologist was an already scheduled visit, there was not a visit scheduled for this issue specifically).
sore throat that has progressively gotten worse; low grade fever; cough; congestion; phlegm from cough; body aches; fatigue; chills; initially had sore arm at injection site but when away; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (phlegm from cough) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (initially had sore arm at injection site but when away). On 17-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion), PRODUCTIVE COUGH (phlegm from cough), MYALGIA (body aches), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (sore throat that has progressively gotten worse), PYREXIA (low grade fever), COUGH (cough), NASAL CONGESTION (congestion), PRODUCTIVE COUGH (phlegm from cough), MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (initially had sore arm at injection site but when away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
A couple spots began to appear on belly.  The following day a rash spread over belly, arms, back and legs.  Rash continued to spread mildly for the next 3 days and we took our son to the D. where the doctor said he had a viral rash similar to that of chicken pox.  Could be a reaction to the vaccination but he was not sure or some kind of allergic reaction.
Patient reported needing a bivalent booster when seeing a provider in our office. Provider handed off to MA, who reviewed the chart and did not note any previous bivalent administrations. Vaccine was given. When trying to document, MA noticed bivalent vaccine had been pulled into chart (perhaps from local registry information) and noticed error. Provider informed patient of the error and that no harm was likely to occur. Event discussed with affected staff for prevention in future.
Pt found by (paramedic) at 1027 leaning forward in chair in vaccine observation area. C/o nausea, dizziness. Pt ambulated self to recliner chair. Clt leaned back in chair, head to the side, then leaned forward feeling like was going to throw up, exhibiting vasovagal like symptoms. Vitals taken at 1032: BP 160/90, HR 110, RR 16, pupils sluggish, AxO x4. 9-1-1 activated at 1143, vitals recheck at 1145: BP 160/92, HR 90, RR 16, pupils sluggish, A x Ox4. Pt transported by ambulance, hospital unknown.
Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side of face; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 13:00 (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health clinic facility. No other vaccine in four weeks. The patient received the first dose of bnt162b2 (lot not reported) in left arm on 24Feb2021 at 14:00 (at the age of 46-years-old) for COVID-19 immunization. Medical history included known allergies: Sulfa. The patient's concomitant medications were not reported. The patient did not have covid prior vaccination and was covid tested post vaccination by nasal swab on 03Mar2021 with result of negative. The adverse events were swelling in head, headache, dizzy, sore arm, numbness left side of face and Bells palsy, all on 19Mar2021 at 01:00. On day 4, went to hospital no stroke or heart attack was told swelling from vaccine. The events were reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. Treatment for the events included pain meds, nausea meds. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I have been vaxed and 3 boosters . I took paxlovid for five day; I have been vaxed and 3 boosters . I took paxlovid for five day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have been vaxed and 3 boosters . I took paxlovid for five day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took paxlovid for five day; Positive, notes: tested positive for four days; Negative, notes: I am now negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient read there was only a two percent relapse which the patient think was miss leading. The patient was 75. The event awareness date was on 06Aug2022. The CEP Number: CEP 005570  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.