chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/14/08 Patient is a 4 year old male. Complaint: worsening vaccine reaction on leg. HPI: Pt was seen 4/10/08 for 5 year WCC--received DTaP, IPV, MMR, and Varicella vaccines at that visit. Two days later pt was seen in Urgent Care for redness and swelling of L thigh at vaccine site (where Varicella and MMR were administered per report). I was asked by PA at Urgent Care to also examine pt that day. Pt was started on Keflex TID for possible cellulitis vs. adverse vaccine reaction. Pt returns today because L leg has increasing redness outside of the lines initially drawn on leg. Leg seems less painful, was itchy two nights ago in area of redness and was given dose of Benadryl. Otherwise is only taking Keflex, is not taking Ibuprofen or applying cool packs to leg No recent fevers, no lethargy. No wheezing, stridor, or increased WOB. No seizure activity. Pt is otherwise feeling well and is active, is playing and running around despite leg being red and swollen. Pt received first MMR in July 2004 but has not received Varicella prior to 4/10/08. Pertinent negatives: no fever, headache, vomiting or diarrhea. Fluid intake: normal, still eating well. PMHx: negative pertinent to this illness, no prior adverse reaction to vaccine. Pt does not take any chronic prescription medications PE: awake, alert, well hydrated and in no acute distress, looks well, talkative and playful. Skin: 11x13cm area of erythema over anterior/lateral L thigh region, erythema now extending a few cm beyond the initial lines drawn but initial central erythematous/indurated area less intensely erythematous, not as firm and indurated as with previous exam, mild warmth to touch, much less tender to touch today. Central area now with purplish hue and some scattered small patches of clearing. No vesicles, no surrounding urticaria.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Feb2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Sep2023 to 12Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called to report that after her first Moderna vaccine she has experienced a high pitched buzzing noise in her ear that has not stopped. She states this is very annoying. She has seen a doctor and has seen APNP. APNP told patient that it was a problem in her brain from the vaccine. She stated it is not a problem with patient's inner ear. Dr. referred patient to an ear nose and throat specialist which she has been reluctant to go to. This RN highly encouraged patient to go to specialist and continue to search for answers about this as it is interrupting her every day life and QOL. This RN states she will report to VAERS.
On 9/4/14 the patient's spouse reported that the patient began experiencing effects two days after the administration of the vaccine. The injection site returned black, the patient's face turned red a few days later for which she administered BENADRYL twice and it went away, and he experienced memory loss. The patient was evaluated by his primary care provider on 9/9 and he described difficulty recalling numbers. The Mental Status exam (MS) was completed and the patient scored 10/30, falling in the dementia range. On 9/15 the patient's wife mentioned the patient had been struggling with memory for a few months. On 11/14, the patient was evaluated in the memory clinic. Repeat MS was 27/30, suggestive of normal cognition. Other testing was consistent with mild cognitive testing. The patient reported abrupt memory loss after vaccination and gradually improving with time. The patient's spouse reported his memory and cognition are now back to baseline.
Red circle formation around injection site. Slightly warm and somewhat painful per patient. Formation began around 1 to 2 days after administration. Patient to f/u with PCP noted above.
tested positive for covid-19; tested positive for covid-19; mild, cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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 "tested positive for covid-19"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "mild, cold-like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical information: My cousin, a 27-year-old male, tested positive for covid-19 after having previously received a full course of PFEs covid-19 vaccine, learned of this yesterday, 13Jan. He has mild, cold-like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection location: Pain-discomfort, swelling . General symptoms: Chills, Fever, headaches, joint pains, muscle pains, fatigue, nausea, rash, swollen glands.  Narrative:
8 hrs after the vaccine i started feeling nausea and tired. about 12 hrs. i was freezing cold , high fever, muscle aches, lasted all through the night. next day i still had nausea, bad muscle ache. on sat i started to have soreness and large nymphonids, swelling, i was dizzy, light headed, cold and clamy. Continued to feel bad into Sunday. woozy dizzy, waves of nausea, indigestion, heart burn, right upper quadrant pain.  some degree of head ache everyday. yesterday my puffy arm started to go down .
headache; sore throat; fatigue; sore arm; This is a spontaneous report was received from a contactable consumer or other non-Health Care Professional. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 08Apr2021 10:15 at the age of 27-years-old as 2nd dose, single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC); cyanocobalamin (B12-VITAMIIN); loratadine (CLARITIN); guaifenesin (MUCINEX) taken for an unspecified indication. Patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on 18-MAR-2021 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient has not received any treatment and was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. On 08Apr2021, 21:30 the patient experienced headache, sore throat, fatigue, sore arm. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Patient received the Pfizer vaccine 7/2/21 and the moderna vaccine on 7/25/21
Patient states that about a week after receiving the Moderna she noticed a rash on her arms and L leg. Rash was red, painful and itchy.Patient states she had some prednisone at her house and she took that and some Benadryl at night. She called her primary care and was instructed to notify the Health Department.
This spontaneous report as received from a registered nurse refers to a 3 years old patient of unknown gender. On 11-JUL-2014 the patient was vaccinated with M-M-R II (therapy type: rha, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 ws exposed to at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
In mid-May 2021 I stubbed my left toe walking down the stairs which triggered a minor gout incident that last a few weeks. After the gout went away I had cold feeling and tingling sensation in my feet which has not gone away in these last 6 weeks. The only relief I get from this is by going  jogging for about 5 minutes followed by a 10 minute walk. I try to do this every day. If I miss two days my feet get very cold and the tingling becomes very painful.
Patient received vaccine at 1100, placed in 30 minute observation area.  1105 alerted observer of sensation of numbness and swelling of tongue.  Assessment of patients mouth shows tongue reddened to right side, no visible swelling, pt reports recently having a red cough drop.  Covering attending present to take brief hx of patient and ordered patient to receive 12.5mg of Benadryl PO. Patient given Benadryl at 1110.  Patient appears in NAD, hx of recent concussion after a fall.  Resides in rehab center.  After medication received patient monitored for additional 30 minutes and discharged back to rehab facility.
Severe hives starting 10 days after shot.  No known allergies. Going on now for a week and still severe. 13 days after shot eyes, head, feet, and hands swelled up, went to ER. Prescribed me steroids and antihistamines which don?t seem to help much
Child received 2 vaccines, MENACTRA and GARDASIL # #3, in opposite deltoids. Within 5 seconds after receiving the 2nd shot child had a seizure which lasted about 10-15 seconds. Seizure included loss of consciousness, tonic clonic movements of arms and urinating on self.
mom stated pt c/o eyes swollen becoming red approx 2 hrs p/vax; approx 2 hrs p/that a red rash started & itching; pt c/o being stuffed up; mom states did not have fever but was hot to touch;
Left upper arm - redness and swelling, mild rash redness used Benadryl 2t sp Q60 until redness gone.
pain in arm; 2nd dose was delayed due to not feeling well; pain in her arm/whole body starting aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed due to not feeling well) and MYALGIA (pain in her arm/whole body starting aching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed due to not feeling well) and MYALGIA (pain in her arm/whole body starting aching). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 800 mg. At the time of the report, PAIN IN EXTREMITY (pain in arm) and MYALGIA (pain in her arm/whole body starting aching) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed due to not feeling well) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. The patient was treated with heating pad. The patient stated that she was scheduled for a procedure on her left arm soon.   This case was linked to MOD-2021-200406 (Patient Link).
Eight days following my booster shot, (the evening of Tuesday, December 20) I experienced a break out of hives and rashes in various spots around my body. These breakouts itched badly. Since that evening, I have experienced continual breakouts of rashes and/or hives that itch and/or burn. They appear in large patches or as streaks across my skin. They can appear anywhere, but mostly appear around my scalp, ears, neck, shoulders, and back. I've also experienced them on my arms, hands, legs, stomach, and face. I can tell when a new rash will appear because I feel a slight burning that increases as time goes on. Since they've appeared, I have been using Zyrtec or Benadryl to keep symptoms at bay. These help but do not fully relieve symptoms. I am also using anti-itch lotion and ice to help control the uncomfortable symptoms. I have been in contact with my doctor via e-mail and she has prescribed me hydroxyzine and prednisone, but I have yet to take them.
Pt reported that at 2pm she woke from a nap with headache, chills, body aches, nausea with vomiting, and a recorded fever of 102.2.  Pt reports taking a home zofran SL with some improvement in the nausea and was able to take 600mg of ibuprofen prior to coming to urgent care.  She was diaphoretic and pale upon arrival with continued head pain and nausea.  She was given IV normal saline 1000ml, benadryl 25mg IV, zofran 4mg IV, and dexamethasone 4mg IV with mild improvement in her headache and nausea.  Pts temperature started to increase again while here in clinic and additional tyelnol 1g was given.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients may have received doses of GARDASIL (dose and lot #s were not reported) that were improperly stored. No adverse events reported. Additional information has been requested.
while administering the Fluzone Quadrivalent to an 11 year old receiving a partial dose with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 years old to whom while administering the Fluzone Quadrivalent to an 11 year old receiving a partial dose with no AE [Underdose], INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past medical treatment was unknown.  On 12-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT6647KA; Exp. Date unknown] via intramuscular route in the left deltoid for immunization.  It was a case of actual medication error due to vaccine Underdose.  It was unknown if any adverse event occurred.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
This spontaneous report was received from the patient's wife refers to her husband a 69 year old male patient. The patient's medical history included prior cases of shingles occurred during 1997 and another unspecified year after that. No drug/allergies were reported. On 26-JAN-2008 the patient was vaccinated with a single 0.65 ml dose/once of ZOSTAVAX, (lot number and expiration date not reported) subcutaneous injection to treat the pain caused by shingles. Concomitant therapies included a shot of influenza virus vaccine (unspecified). On 12-OCT-2014 the patient experienced shingles rash. Reporter stated that the shingles rash stretched from the back of his neck going up over his ear, up to his face, and onto the eyelid. Reporter also stated that her husband was experiencing nerve pain. The patient sought for medical attention on an unspecified date on an unspecified date in October 2014 and unspecified prescription medication and eye drop medication were given as treatment for the events. The outcome of the events was not recovered. Additional information is not expected due to no permission to contact the physician was given.
Information has been received from a 51 year old female nursing student who on 01/16/04 was vaccinated with a dose of MMRII (Lot # not reported). About one week later, on approximately 01/23/04, the pt began feeling rundown and sick. She later broke out in a rash and, at the time of this report, had a rash all over her body and even in her mouth. Her doctor diagnosed her as having a vaccine related measles rash. The pt was also experiencing fever, chills, and swollen glands. She was negative for a strep infection. The pt's outcome was not reported. Additional information is not expected.
No additional adverse events; the patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 16-JAN-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S006018, expiration date 27-FEB-2021 (strength, dose, route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) on the same day. It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 9 hours and 49 minutes in the temperature range between 15 degrees Fahrenheit and 46 degrees Fahrenheit on unknown date prior to administration. There was also previous temperature excursion reported with the time frame of 1 hour and 30 minutes in the temperature range between 15 degrees Fahrenheit and 46 degrees Fahrenheit on unknown date. No adverse event was reported.
15NOV95 induration rt upper arm around inj site;4" diameter;pain from rt shoulder down to lt fore arm; no redness noted;
Information has been received from an RN concerning 53 year old female who on 21OCT2003 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Within 24 hours of vaccination, the pt developed an injection site rxn that was hot to touch. On 23OCT2003, she developed a rash that extended from the shoulder to the injection site. Unspecified medical attention was sought A complete blood work up was done. It was reported that after two days the pt recovered. There was no product quality complaint involved. It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No further information is expected.
This spontaneous report was received from a registered nurse (also reported as medical assistant) referring to an unspecified number of unspecified patients. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ lot # M016238, expiration date 07-DEC-2017 (dose was not reported) orally for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 53 degrees Fahrenheit for 2 hours. Data logger was involved. It was reported a previous temperature of excursion of 34 degrees Fahrenheit for 1 hour 15 minutes. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012603.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years 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) all with onset 26Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive, notes: (23 days after confirmed infection); (17Aug2022) Positive, notes: Tested positive for Covid again 17 days after completing paxlovid (23 days after confirmed infection). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report was about covid treatment. Patient received vaccine. Anti viral details were product covid 19 Treatment, brand reported Paxlovid, treatment start date was 26Jul2022 and stop date 31Jul2022. Vaccine lot unknown reason was provided as not available/provided to reporter at the time of report completion. Adverse event description provided as tested positive for covid again 17 days after completing paxlovid (23 days after confirmed infection). Adverse event start date was18Aug2022. No treatment taken for adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The nurse on the unit was to give a PPD skin test SC but mistook the PPD box for the TD vaccine box. The pt was given the TD vaccine SC. The pt required treatment of cellulitis due to the error. Permanent scarring may occur.
pt recv vax 8JUL97 & 25JUL97 pt devel a varicella like rash on trunk;some of the lesions were scabbed & some were vesicular;
Pt cried after the shot, was quiet for less than a minute, then had tonic clonic seizure with eye deviation to the left.  Did not appear to be a breath holding spell.  Occurred less than a minute after the vaccines.
Patient was infected with shingles.  Occured twice 02/24/2010 and 06/01/2010 prescriptions filled for va
CDC reports: 4 mo infant developed fever to 105.6. lump (half-dollar size) at inject site, wheezing, pain & inflammation in joints following DTP/OPV immunization. Duration of illness 5 days.