chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received ROTATEQ prior to receiving 6 month vaccines about 5:30pm. Patient is exclusively breastfed. Patient nursed as usual every 2-3 hours. Patient went to bed but seemed to be irritable by grunting, no fever. Projectile vomiting started at midnight 5 episodes of projectile-vomiting which turned bilious. Over the duration of 3 hours. Patient did not eat until 7:50am. Patient has spit up multiple times each day since 7/6/16.
1 Week after Varivax #2 erythema multiforme rash on trunk also has mild URI Rx Benadryl and observation
Rotarix reconstituted with sterile water; Rotarix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 5th January 2022, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 5th January 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional called regarding a patient of unknown age and gender and reported that the patient orally received Rotarix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. At the time of call, the reporter did not had any information of the patient's demographics available.
Site of injcetion became red that spreads from top of her shoulder to her biceps; Site of injection is itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Site of injcetion became red that spreads from top of her shoulder to her biceps) and VACCINATION SITE PRURITUS (Site of injection is itching) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ARNICA MONTANA (ARNICA (PLANTA TOTA) "WELEDA") for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Site of injcetion became red that spreads from top of her shoulder to her biceps) and VACCINATION SITE PRURITUS (Site of injection is itching). At the time of the report, VACCINATION SITE ERYTHEMA (Site of injcetion became red that spreads from top of her shoulder to her biceps) and VACCINATION SITE PRURITUS (Site of injection is itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used Benadryl and cortisone cream for treatment.
Information has been received from a physician concerning a female who in approximately July 2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot# not reported) and she was late getting her menstrual cycle. Subsequently the patient also gained 30 pounds since getting the vaccine. The patient sought medical attention since getting the vaccine. The patient sought medical attention on an unspecified date with an office visit, The patient's outcome was not reported. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning a 13 year old female who on 17-MAY-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 655619/1427F). On 17-JUL-2007 the patient was vaccinated intramuscularly in the left arm with her second dose of GARDASIL (lot# 656050/0245U) and she was late getting her menstrual cycle. Subsequently the patient also gained about 30 pounds since getting the vaccine. The patient's BMI before 1st vaccine was 26 and BMI after the 2nd vaccine is 30. The patient sought medical attention on an unspecified date with an office visit. The patient's outcome was not reported. Additional information has been requested.
PT HAD ITCHING AT 9PM  AND TOOK BENADRYL 15ML (37.5MG) EVERY 3-4 HOURS.  PT ALSO HAD BODY ACHE AND TIREDNESS.
(L) arm sore since receiving FLUZONE 10/28/08. Started getting sore the evening she got shot. No redness or swelling. Ultrasound negative for hematoma. Prednisone gave little relief. Ibuprofen takes edge off.
The injection site got swollen and red 2 days post administration of vaccine. Patient was instructed to put ice and take TYLENOL for mild to moderate pain.
Patient passed out for about 2 minutes upon receiving immunization. The patient was caught by her father and placed in a seated position.  As the pharmacist went to call for assistance, the patient's father realized that she was awake again. The whole incident occurred within a few minutes. We had the patient sit in observation for 30 minutes, and we gave her water.
Dose #1 on 12/21/20 Dose #2 on 1/11/21 On 1/12/221 He states over the last 24 hours he has developed shortness of breath, chills, extreme fatigue.  Patient states he went to sleep fine last night using his BiPAP which she always does for obstructive sleep apnea and woke up today around noon.  He states upon awakening he had extreme fatigue and chills and felt short of breath.  He states he was breathing "60 times a minute".  Patient has not had fever since.  Patient states he did have coronavirus in October and had pneumonia with this, states that his pneumonia improved and his symptoms resolved.    Patient initially requiring 2 L of supplemental oxygen.  Afebrile throughout admission.  Was able to be weaned to room air.  Patient symptomatically improved in terms of shortness of breath as well as myalgias.  Likely the symptoms were secondary to vaccine reaction. Patient stable to be discharged home. No changes made to home medications.
Patient was administered 0.5 mL of air intramuscularly, instead of 0.5 mL of vaccine. Since he did not get the dose during the first injection, had to do the vaccine again. He did not seem bothered at all, so administered the vaccine again. This time vaccine was administered correctly. He stayed around the pharmacy to be observed for 15 minutes after the 2nd injection and then went home.
Information has been received from a healthcare work referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 24-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling, redness to elbow; numbness in fingers, some itching, swelling under armpit
Developed a brief headache/ Tested negative with a rapid antigen test. PCR came back the following day positive.; Developed a brief headache/ Tested negative with a rapid antigen test. PCR came back the following day positive.; Booster; This is a spontaneous report received from a contactable reporter (consumer).  A 40-year-old male patient received BNT162B2 (COMIRNATY), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, described as "Booster"; DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "Developed a brief headache/ Tested negative with a rapid antigen test. PCR came back the following day positive." The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: positive and negative. Clinical course: The patient was fully vaccinated with COMIRNATY and received a booster dose, and in less than 24 hours, he developed a brief headache on 26Dec2021. He then tested negative for COVID-19 with rapid antigen test and his PCR test came back positive the following day. The remainder of his family was tested of which all members were fully vaccinated and were all asymptomatic. Of the remaining 4 family members tested, all were antigen negative. At the time of the report, PCR results were available for 3 of the 4 family members of which one was positive (fully vaccinated with COMIRNATY- 10-years-old) and 2 negative (10-years and 8-years-old).  The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200009294 same reporter and drug, similar events, different patient
constant runny nose; a bad head cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Feb2021 15:45 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (unspecified if ongoing), notes: Hypothyroidism due to total thyroidectomy; "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism due to total thyroidectomy. Concomitant medication(s) included: ARMOUR THYROID.  The following information was reported: RHINORRHOEA (non-serious) with onset 26Feb2021 14:00, outcome "recovered with sequelae" (2021), described as "constant runny nose"; NASOPHARYNGITIS (non-serious) with onset 26Feb2021 14:00, outcome "recovered with sequelae" (2021), described as "a bad head cold". Therapeutic measures were not taken as a result of rhinorrhoea, nasopharyngitis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 at 14:00, the patient experienced constant runny nose similar to a bad head cold for two days. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of runny nose and head cold was recovering with sequalae at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The same adverse reaction that happened with the first dose happened again with the second dose. The only difference was instead of being the following day, this time the increased menstrual bleeding and clotting began 3 days following the vaccine. I received the vaccine this time on 5/14/21 and today, 5/17/21 I suddenly began bleeding mid-day with noticeable clotting that is not normal for me. I was again at the end of a period cycle much like last time, and not bleeding prior to this event.
Child developed fever early morning of Monday 11/7/06, then status epilepticus. Was brought to ER, was intubated and ventilated. Suffered hypoxic insult. Died 11/8/06. 7/6/06 Received medical records & autopsy report from hospital which reveal COD as status epilepticus with subsequent severe hypoxic/ischemic encephalopathy; cerebral edema with bilateral cerebellar tonsillar herniation; subdural hematoma, small, right lateral cerebellum & asthma (by clinical history).  Stated that status epilepticus possibly related to URI (MRSA).  Temp max 105.8
61 year-old-male with a PMH significant for HTN, DM, squizophrenia, mental retardation, Barretts esophagus, cellulitis, GIB, vaccinated x2 w Moderna who was sent to the ER due to syncope. He is a poor historian, hx collected from records and caregiver. Reportedly, while at Behavioral day program he was found "unresponsive for several minutes", Caregiver was told by the facility "he was sleeping in the chair and fell off the chair".   In the ER, he arrived awake and alert with VS 97.5F, BP 125/77, RR 18, pulse ox 95% on RA. CXR w pending read. CT head without acute abnormalities. EKG with NSR at 73 bpm, no ST changes. Lab significant for leukopenia with 23% bands. He is admitted to cardiac telemetry with a cardiology, neurology and ID consultations.
Slight headache; Soreness at the injection site; Out of date vaccine given; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (Slight headache), VACCINATION SITE PAIN (Soreness at the injection site) and EXPIRED PRODUCT ADMINISTERED (Out of date vaccine given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Out of date vaccine given). On an unknown date, the patient experienced HEADACHE (Slight headache) and VACCINATION SITE PAIN (Soreness at the injection site). On 29-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Out of date vaccine given) had resolved. At the time of the report, HEADACHE (Slight headache) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-Jun-2021, events were added, slight headache and soreness at the injection site.
Did not reconstitute the vaccine; Administering only Shingrix adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 19th April 2022, the patient received the 1st dose of Shingrix. On 19th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Apr-2022 Reporter's comment: The registered nurse reported that an employee administering only Shingrix adjuvant and did not reconstituted the vaccine. The reporter consented to follow-up. Additional Supportive Information: The patient was administered only Shingrix adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Fever, body aches, fatigue, redness in arm, and arm pain, all lasting 48 hrs.. Localized "lump" at injection site lasting 5 days.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 59 year old male of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805020 expiry: unknown) dose was not reported, 1 total administered at right arm on 07-MAR-2021 10:00 for covid-19 prophylaxis. Age at time of vaccination 57 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received second dose of Non-company suspect vaccine included: tozinameran (Pfizer BioNTech covid-19 vaccine) (dose number in series 2) (form of admin and route of admin were not reported, batch number: unknown, expiry: Unknown) dose was not reported, administered to left arm on 28-OCT-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of tozinameran (Pfizer BioNTech covid-19 vaccine) (dose number in series 2).  The patient received third dose of Non-company suspect vaccine included: tozinameran (Pfizer BioNTech covid-19 vaccine) (dose number in series 3) (form of admin and route of admin were not reported, batch number: unknown, expiry: Unknown) dose was not reported, administered to left arm on 20-JUL-2022 at 18:30 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 3). On an unspecified date in APR-2023, the patient experienced suspected covid-19 infection (dose number in series 3) for which the patient received treatment with Non-company suspect drugs included: nirmatrelvir/ritonavir (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 07-APR-2023 to 12-APR-2023 for covid-19 treatment. On 22-APR-2023, patient's covid symptoms were returned. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (dose number in series 2), and tozinameran (dose number in series 3) was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Seizures, right sided brain lesion, memory lapses, fatigue, bone-joint pain, started September 28, 2000, 2 stereotactic-guided brain biopsies, MRI, CAT scans, EEGs, no answer to anything. Many hospitalizations.  6/26/07 Received 2nd hosp med recs which reveal patient experienced new onset gen tonic-clonic seizure on 9/29/00 followed by repeated partial seizures 11/25/00.  Admitted 11/25-11/28/00.  Right frontal mass had been biopsied in 9/00 at 1st hospital revealed reactive gliosis w/increased benign appearing oligodendroglia cells.  Cytology was neg.  After biopsy, patient had paresis of LUE & face which resolved w/steroids but returned in 10/00 & tx w/steroids again.  Had been seizure free on Dilantin prior to the 11/00 admit.  Repeat CT scan revealed known lesions w/significant vasogenic edema & 5 mm midline shift, felt to be malignant.  Meds adjusted & additional anti seizure med added. No further seizure activity noted for this admission. FINAL DX: Focal motor seizures & right frontal mass.  7/20/07 Received medical records from NMC which reveal patient initially admitted 9/29-10/6/00 for Seizure disorder & right frontal cystic brain lesion.  Craniotomy for evacuation of the cyst & brain biopsy done at that time.  Prior to admit patient had 3 days of focal seizures which progressed to generalized seizure on day of admit.  Loaded w/anticonvulsant & steroids meds.  Progressed well & d/c to home on multiple meds. Returned to ERat outlying hospital over holidays(see above notes) Admitted to NMC  11/30-12/3/00 for status epilepticus.   Craniotomy & biopsy was repeated & revealed gliosis.  Had mild left facial weakness post op.  D/C to home on continued steroids & anticonvulsants. 12/14/00 Evaluated by oncology for unresectable low-grade astrocytoma of right frontal lobe.  Felt to be good canididate for rad & chemo tx; however, patient was reluctant to receive chemo tx. 1/5/01 Had appendectomy w/o complication. 2/5-2/8/01 Readmitted to hospital due to neurocystosarcoma & suspected neurocysticercpsos fpr ID drug treatment.  Responded well.  No seizure activity noted during admission.  D/C to home to f/u w/ID & neurosurgery.
Pt experienced moderate reaction to the yellow fever vaccination. Pt c/o dizziness, weakness, numbness around neck, and reddening of facial skin. Pt was immediately referred to physician for observation. Pt was monitored in the clinic for 30 minutes and prescribed benedryl, 20mg of prednisone, and given an epipen. Shortly thereafter pt was released due to normal vitals/blood pressure 108/60.
Vaccine Administered:  1344hrs    Reported Reaction:  1355hrs While in post-vaccination area, pt suddenly stood up and complained of feeling light headed and had some tightness in her chest. Ambulated outside of classroom for fresh air.  Stated she felt better with fresh air.  Chair made available for pt but would sit and then stand.  She did this twice until just standing. Vital signs taken - stable.  Water offered but refused.  Chair offered but sat only for a little due to wanting to stand.  Monitored until symptoms resolved.   Discharged at 1413hrs.
3-hours post-injection: pain at injection site. 12-hours post injection: generalized fatigue, pain and stiffness in hip and shoulder joints, reduced appetite. 24-hours post-injection: continued fatigue and joint pain, generalized body aches (including skin sensitivity and mouth pain) and headache. 36-hours post injection: continued tiredness and joint pain, slight weakness in legs, alternating episodes of feeling too hot/too cold (but no actual fever), no headache. 48-hours post injection: lessening of both the fatigue and joint discomfort, return of mild headache. No further temperature episodes, appetite returning. 72-hours post injection: lingering slight fatigue, slight pain at injection site, minor joint discomfort, mild headache. All side-effect symptoms are improving.
Patient hospitalized from 4/18/21-4/23/21  4/18 Hospital Day 1: Patient (pt) presented to the ER via EMS for aphasia/altered mental status that began that AM. Pt had received his 2nd COVID19 vaccine (Moderna) x3 days prior. Pt had generalized body aches/fever and was taking acetaminophen for his symptoms with mild relief per wife. Per ER notes, patient had clear speech but was not making sense and easily agitated.   4/19-4/21 Hospital Day 2-4: Patient with altered mental status. Was non-verbal and easily agitated. There was concern for encephalitis, infectious vs autoimmune. On 4/19, antibiotics were discontinued and patient was being treated with steroids for possible autoimmune encephalitis.  4/22 Hospital Day 5: Patient was doing better and more talkative. Patient was able to have a limited conversation, appeared alert and oriented with some slow speech. Per medical chart, family reported patient was at "50% back to baseline."   4/23 Hospital Day 6: Patient was back at baseline and completed 3 days of IV steroids. Patient reported not being able to recall anything from "Saturday 4/17 to Wednesday 4/21". Patient was discharged on 4/23 and recommended to follow up with neurology and was not discharged with any steroids.   Treatments:  Fever: APAP 1 IVPB x1 (4/18-4/19), APAP 650 mg PO x1 (4/20-4/21) Encephalitis: Methylprednisolone 125 mg IVPB x1 (4/18); Methylprednisolone 500 mg IVPB BID (4/19-4/23) ID: Acyclovir 700 mg IVPB q8h (HSV infection) [4/18-4/19]; Cefepime 2 g IVPB x1 (Sepsis) [4/18]; Ceftriaxone 2 g IVPB q12h (CNS infection) [4/18-4/19]; Vancomycin 2.25 g IVPB x1, 1.5 g IVPB q12h (CNS infection) [4/18-4/19]