chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 2nd dose 25 days after 1st dose; Red swollen palms; Rash around neck, behind ears and in the chest; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose), PERIPHERAL SWELLING (Red swollen palms), RASH (Rash around neck, behind ears and in the chest), CHILLS (Chills) and FATIGUE (Tiredness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 0111J20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included CALCIUM and VITAMIN D3 for Osteoporosis.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). On 01-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash around neck, behind ears and in the chest). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose) and PERIPHERAL SWELLING (Red swollen palms). On 03-Feb-2021, RASH (Rash around neck, behind ears and in the chest), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose) had resolved and PERIPHERAL SWELLING (Red swollen palms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable  Treatment medicines were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No New Information On 16-Apr-2021: Updated Reporter Details, Patient medical history, Concomitant medicines, both Vaccines details, Updated outcome of the event from Unknown to Recovered On 10-May-2021: No NewInformation
rash on both his right and left thigh; This is a spontaneous report received from contactable reporter (healthcare professional). A 6-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 23Jan2023 as dose 3, single (Lot number: FP2144, Expiration Date: 30Sep2024) at the age of 6 months intramuscular, in left thigh for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Prevnar 13 (Dose 1; lot number: Unknown), for immunization; Prevnar 13 (Dose 2; lot number: Unknown), for immunization. The following information was reported: RASH (non-serious) with onset 25Jan2023, outcome "recovered" (27Jan2023), described as "rash on both his right and left thigh". Therapeutic measures were taken as a result of rash. Additional information: The reported NDC number is 00005-1971-02. The reporter stated that she has two affected patients. They cannot be sure that it was Prevnar 13 but the caller does not think so since they have been doing Prevnar vaccines for as long as she can remember. The reporter stated that the patient had no fever. The reporter stated that the patient was seen in the practice and given and unspecified ointment. The reporter also mentioned that the patient's rash was gone on 27Jan2023. Caller denies any other medications, medical conditions, labs, testing, or treatments for the patient relevant to these events.
Fever; chills; Restlessness; fatigue; constant headache; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; This is a spontaneous report from a contactable healthcare professional reporting for self. This 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL 3302) on 17Jan2021 08:45 AM (vaccine location= Left arm) at single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number= EL1284) on 27Dec2020 09:15 AM (vaccine location= Left arm) at single dose for Covid-19 immunisation. Patient did not have other vaccine in four weeks, and did not have other medications in two weeks. No known allergies. Patient was not pregnant. The patient experienced fever and chills approximately 11 hours after vaccine. Restlessness, fatigue and constant headache. Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back. Fever went away about 16 hours after fever onset and was coming back approximately 36 hours after vaccine dose. The events onset date was reported as 17Jan2021 08:00 PM. No treatment received. Patient did not have COVID prior vaccination, did not test COVID post vaccination. Outcome of events was recovering.
Patient is a 11y.o. female who arrived by car presented to the emergency department for possible seizure. Noncontributory past medical history. Patient presents with mother who provides a portion of the history via an interpreter. Reportedly, 1 hour ago the patient was getting her immunizations for school and after the third immunization the patient fainted and went stiff with some shaking movements for roughly 6 seconds and then regained consciousness following this. Mother reports that she was somewhat slow and ?not really herself? for roughly 20 minutes which gradually improved spontaneously. By the time of my evaluation, the patient states that outside of a headache and generalized fatigue she feels asymptomatic. Specifically denies any chest pain or cardiopulmonary complaints. No trauma or incontinence during the episode. No history of similar episodes previously.
The patient arrived at the pharmacy the day we were administering the Moderna vaccine. Previously he had administered the first dose against covid 19 from Pfizer on April 1, 2021. The patient entered the pharmacy on April 21, 2021 requiring his second dose since 21 days had passed. After the event, we watched the patient for a long period to confirm that he did not present any side effects. It was confirmed with the CDC and they reported that there were no contraindications. The next day we call the patient and he told us that he felt very well.
Pain and soreness at injection site (both thighs).  Fever ranging from 100 - 102.5 for approx. 2 days.  Fussiness for approx 3-4 days.
2 days after vacc. pt. had bilat. shoulder and arm pain for a few days. Then his arms were ok and he developed bilat. hip pain severe enough that he was unable lie on either side while in bed. The pain then migrated to his knees and lower legs. It was so bad today that he was unable to get out of bed so he came to the ER.
pt recv vax; had achy feeling all over; joints ached;had missed 7 days work;seen in urgent care ctr;on anti inflammatories;saw internist on the 16th;Sed rate wnl;x-rays to r/o neck injury;no problems;to cont on anti inflammatories
Upper abdominal cramps and pain. Cramps occur every 5-10 minutes and last for 1-2 minutes each.
Monday 3-15-21: developed scratchy throat, followed by coughing. The cough became congested, like when you have bronchitis. Considered going to ER, but the coughing gradually eased up.  Tuesday 3-16-21: felt better so I didn?t contact anyone. Wednesday 3-17-21: scratchy throat and coughing returned in the morning. Called my MD for appt but no appts until Monday, 3-22-21. Made apt for 1:30 PM.
Area around inj site became hard and sore, got home hardness area expended.  No redness but forearm & shoulder hurts.  Also pt felt some what dizzy.  Cellulitis 5-2-08 Rocephin one gam IM given and Rx for Augmentin bid 875 mg.
rash at the injection site; felt ill for a day; This case was reported by a consumer and described the occurrence of injection site rash in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (1st dose, refer case US2020AMR042554).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site rash was unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site rash and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt ill for a day and had a rash at the injection site. This case has been linked to US2020AMR042554 and US2020AMR042566, reported by the same reporter.
HAD COVID VACCINE 4 DAYS PRIOR, DIFFUSE HIVE OVER ABDOMEN, TRUNK, BILATERAL UPPER AND LOWER EXTREMITIES.  NO OTHER KNOWN NEW PRECIPITANTS
Severe pain in right hip. Unable to lay down or sit for periods of time. Hard to walk without assistance. Felt like hip was under attack. Took both Tylenol and Flexeril with no relief.  The pain lasted for almost 8 hours, then disappeared. Previous hip replacements to both right and left hips in 2016. This pain was only in the right hip.
Patient was administered incorrect dosage of Pfizer COVID vaccine. 17 year old received 10 mcg dose instead of 30 mcg dose. No adverse event to vaccine administration. After consulting with CDC, patient was advised to complete her COVID series in 21 days with 30 mcg dose.
Patient up to date on COVID vaccinations who admitted with COVID detected test.  Provider d/c note below:  "35-year-old male history of intractable complex partial seizures tonic-clonic epilepsy hydrocephalus S/P with VPS, cerebral venous sinus thrombosis, SAH, PE/DVT who presented to the emergency department with complaints altered mental status.  Patient was brought in via EMS which reported he had multiple frequent falls prior to admittance.  Patient reported that he did hit his head and had been more altered.  Patient was recently seen at hospital prior to emergency department visit for a seizure and fall.  Patient was initially altered.  His history was limited due to his mental state.  Patient was initially febrile tachycardic and tachypneic.  He had extensive workup including labs for sepsis and toxicology.  Patient had a CT exam which was significant for acute hemorrhage, acute intraparenchymal hemorrhage, subarachnoid hemorrhage, extensive chronic changes. Patient was also suspected to have sepsis likely encephalitis with VP shunt infection. In the emergency department patients coumadin was held and he was given vitamin K and Kcentra, Neurosurgery, Dr, was consulted, Infectious disease, Dr was consulted, repeat ct scans and labwork were ordered,  given fluids 2L LR and started on empiric Vanco, Acyclovir, and cefepime. Patient tested positive and transferred to the ICU with isolation protocols for admission for evaluation and monitoring. For his acute brain hemorrhages, patient neuro surgery was consulted and indicated he did not require surgery but needed blood pressure and Coumadin reversal. They held anticoagulation, antiplatelets, and NSAIDs. Patient was continued to be followed by neurosurgery during the duration of his admittance, no changes were made to his treatment. Patient was also followed by Infectious disease with recommendations to tapping the shunt or LP to r/o shunt infection/meningitis.and to continue vancomycin and cefepime, stop Rocephin and stop acyclovir. Shunt was tapped and no clear evidence of infection was indicated. CSF fluid was significant for 79 glucose, 600+ protein, 41 nucleated cells, 88,500 RBC. Patients empiric antibiotics were stopped. Patient was covid positive and continued to remain with isolation parameters during his hospital stay. Neurology was also consulted and endorsed possible CNS infection would be secondary to COVID, considered MRI, EEG and continued his home epilepsy medications. Patient was transferred to Gen med once sepsis was ruled out. On Gen medicine floors, patient was monitored until he was fluid resuscitated and cultures were processed. Patient was discharged following evaluation and consideration of holding anticoagulation for 2 weeks as per neurosurgery. "
Information has been received from a physician concerning an 8 year old female who in 1996 was vaccinated with a dose of varicella virus vaccine live. The physician reported that in Sept 2004, the pt developed breakthrough characterized by more than 50 lesions and a low grade fever. Unspecified medical attention was sought. In Sept 2004, the pt fully recovered. Additional information has been requested.
1/5- I woke at 11:00 p.m. with a horrible headache, nauseous, and could not go back to sleep.  1/6- I had horrible migraine like headache, nauseous, felt sluggish, weak, hot. That night I was having sever night sweats, running fever, headache, nauseous. Could not sleep.  1/7- I could not go to work same symptoms continued. Migraine type headache, nauseous, weak, overall feeling horrible.  1/8- Still had headache but other symptoms were getting better.  1/9- Started feeling back to normal.
Patient stated that he had not received any other vaccines since June 2, 2022 however patient had received a Pfizer bivalent booster dose on 9/20/2022 and did not disclose;  upon checking vaccine website, another nurse had discovered patient had received the September 2022 dose however the nurse had already administered it
(L) thigh, welt 3 1/2 x 4 1/2 wide red, hot to touch, swollen. Cold packs Ibuprofen and TYLENOL, Heat packs, trouble breathing x 4 days treated w/antibiotic.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L002867, expiration date 11-NOV-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot #651401/0619F). Subsequently the patient experienced a local reaction including redness, soreness and swelling. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This case was reported in a literature article and described the occurrence of ataxia in a 4-year-old subject of unspecified gender who was vaccinated with DTaP-IPV (manufacturer unspecified). Concurrent medical conditions included fever and otitis media 2 days prior vaccination. The subject may have received other vaccines the same day. On an unspecified date, the subject received unspecified dose of DTaP-IPV (unknown route, injection site and batch number). Four days after vaccination with DTaP-IPV, the subject experienced upper and lower extremity weakness. The subject was hospitalised. The next day the weakness was substantially improved, the child was discharged with the diagnosis of post-viral ataxia. Guillain Barre syndrome was ruled out. Article summary: In 2008, a DTaP-IPV was licensed for use in children 4 through 6 years of age. While pre-licensure studies did not demonstrate significant safety concerns, the number vaccinated in these studies was not sufficient to examine the risk of uncommon but serious adverse events. The objective was to assess the risk of serious adverse events following DTaP-IPV vaccination. The study was conducted from January 2009 to September 2012 in the project. In the project, electronic vaccination and encounter data were updated and aggregated weekly as part of ongoing surveillance activities. Based on previous reports and biologic plausibility, eight potential adverse events were monitored: meningitis/encephalitis; seizures; stroke; Guillain-Barre syndrome; Stevens-Johnson syndrome; anaphylaxis; serious allergic reactions other than anaphylaxis and serious local reactions. Adverse event rates in DTaP-IPV recipients were compared to historical incidence rates in the project population prior to 2009. Sequential probability ratio testing was used to analyze the data on a weekly basis. During the study period, 201,116 children received DTaP-IPV vaccine. ninety-seven percent of DTaP-IPV recipients also received other vaccines on the same day, typically MMR and varicella vaccines. There was no statistically significant increased risk of any of the eight pre-specified adverse events among DTaP-IPV recipients when compared to historical incidence rates. In conclusions, this safety surveillance study of more than 200,000 DTaP-IPV vaccine recipients, there was no evidence of increased risk for any of the pre-specified adverse events monitored. Continued surveillance of DTaP-IPV vaccine safety may be warranted to monitor for rare adverse events, such as Guillain-Barre syndrome. This case was part of the diagnosis code for Guillain-Barre syndrome. This case is one of the 2 cases described in the literature article.
Had the vx and have them right now/Suspected vaccination failure; Have them right now; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was unknown.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had Shingles right now. The patient stated that he/she had the vaccination but it had not stopped them. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I got the shot in my left arm and shortly after right above my right eye I could feel a reaction going on. Almost like something effected the muscle, I didn't say anything and went to the wait room I mentioned it before I left and they said it sounded like a migraine and I went home.  When I raise my face on the right side of my eyebrow area feels like I have spasms. When I got home it moved to my cheek area as well and felt strange.  I got a rash on my right cheek that evening and a super bad headache. I took a Benadryl and went to sleep. I didn't have a fever.  By the morning the rash was gone, the only thing that bothered me was my eyebrow area ( muscle area) I went to the Dr the following day and she said it sounded like it was my sinuses. Prior to this I was having allergy / sinus issues.
Patient with known CAD. Per member, has had NTG 5x in last 6 months. Patient states unable to do anything but medical therapy " all 6 grafts clogged".  c/o precordial and right sided chest pressure, took ntg with improvement , recurrent pain and member  took second dose of ntg .Pain started to return and 911 called.
1 of 2 pts who exp pain, redness & swelling @ inject site; No further clinical details available;
Initially admitted for hip fracture and tested + for Covid.  His admission was prolonged due to worsening COVID-19 pneumonia. Given his underlying COPD and requirement for supplemental O2, he was started on Dexamethasone 6mg daily for a 10 day course on admission, which is to be continued after discharge. He had Remdesivir added for 5 days as well as CAP coverage with Ceftriaxone and Azithromycin for 5 day course. His oxygen requirements increased from 3L to 6LCT
joint pain; tiredness; headaches; muscle pain; chills; fever; felt bad; migraine; This is spontaneous report from a contactable consumer reported for female patient (reporter's wife). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 03Apr2021 at 3:08 PM EST via voicemail verbatim, patient queried how long these shot effects last, the tiredness, the headaches, muscle pain, chills, joint pain, fever. Reporter stated his wife received the Pfizer COVID-19 vaccine on Wednesday (he did not specify if it was the first or second dose). Reporter was very rushed during the phone call and stated, they just need to know how long these side effects were going to last. This agent clarified what was said on the voicemail and he confirmed, then his wife spoke up in the background and said, she got the shot on Wednesday, felt bad on Thursday and Friday but today she had a migraine because of all of this. Reporter stated that they were really busy and had to get off the phone. Unable to offer transfer to speak with a different department. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received Pfizer dose #1 12/21/20 (at 12 weeks of pregnancy), dose #2 1/9/21 (15 weeks).  I was diagnosed with pre-eclampsia with severe features at 39 weeks 1 day on 6/25/21 and required hospital admission for induction of labor. I had a normal vaginal delivery of a healthy infant (date of delivery 6/27/21, birthweight 7 lb 10 oz), and I was discharged from the hospital 6/29/21. No other complications during this pregnancy.  I am also a participant in the VAERS pregnancy registry and have previously answered questionnaires regarding my pregnancy from the VAERS team. I am filing this VAERS report per v-safe team request.
Hives on  abdomen, back, and ankles; associate reports taking loratadine 10 mg PO from personal stock
Directly from online message to MD from patient on 9/13/16 -  No reaction for 24 hours except for a headache which lasted 2-3 days. Day two I started to get a reaction at the site which spread as far as my collar bone. There were about 6 or more red splotches (I don't believe they were hives) and they were hot and itchy. I also got a mild rash on my legs and chest but that only lasted about 12 hours. I spoke with the advice nurse and she recommended I use ice on the red splotches-I did that and within 24 hours they had diminished significantly. I did not have a fever.
Tested positive for COVID-19 at assisted living facility on 8/18/21, got progressively weak and fell in his bathroom. Patient is still receiving hospital treatment.
Lt thigh with erythematous, warm induration over 1 3/4" wide, 3 1/4" long. Tender to touch over needle site. Surrounded by white edema. No lymphadenopathy, no pus, no drainage-normal mobility.