chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. On an unknown date, the patient experienced redness and swelling on the arm, at the injection site after receiving ZOSTAVAX. The outcome of redness and swelling on the arm, at the injection site after receiving ZOSTAVAX was not reported. Additional information is not expected.
looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; looks like a cold, dizzy, slight fever, feels weakness; I feel not so good; cough; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for himself.   A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EK9231 on 11Jan2021 at single dose for COVID-19 immunization. The second dose of vaccine was scheduled on 02Feb2021. The patient had no medical history. Concomitant medications were not reported.  Beginning on Friday, 22Jan2021, he started having symptoms that "looks like a cold, dizzy, slight fever, feels weakness", "I feel not so good" and cough. On unknown date in Jan2021 the patient was positive to SARS-CoV-2 test. The outcome of the events was recovering.
12 hours of low grade fever - 24-48 hours of body aches, chills & fatigue
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: patient experienced syncope about 15 minutes after vaccine given...lasted around 30 minutes
About 6 hours post vac had moderate pain in Rt. shoulder. This continued for several days. Both shoulders and neck sore at times. Now 2 months post vacc shoulders are still sore especially Rt side. Hard to do normal activities with Rt. arm. Have seen doctors 3 or 4 times PT 3 times and do exercises regularly. Never any fever. Injection site was never swollen or sore. Have taken oral steroids and they are effective for a short time. Slow pain returned in about 5-7 days after steroid treatment finished. 4 mg Dexameth prior to oral surgery Nov. 29th and prednisone tapered treatment starting 12-22.
headache, neck pain and stiffness, upper back pain, (right side), tingling and numb hands and feet.  Face, bilateral, mouth and tongue numbness and tingling. Droopy face.
Information has been received from a nurse, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M046373 with expiration date on 04-NOV-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 47 Fahrenheit (F) to 77 F during 240 hours, it was also confirmed that the vaccines did not have previous temperature excursions or a digital data logger involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA005516: US-009507513-1706USA007411:
upper part of my stomach decided hurting, excruciating pain; I can hardly move; fatigue; terrible headache; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (upper part of my stomach decided hurting, excruciating pain), HYPOKINESIA (I can hardly move), FATIGUE (fatigue) and HEADACHE (terrible headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (upper part of my stomach decided hurting, excruciating pain), HYPOKINESIA (I can hardly move), FATIGUE (fatigue) and HEADACHE (terrible headache). At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (upper part of my stomach decided hurting, excruciating pain), HYPOKINESIA (I can hardly move), FATIGUE (fatigue) and HEADACHE (terrible headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment for the event includes drank some of that pink stuff.
Initially was having some significantly elevated BP after the 1st Pfizer vaccine dose in January 2021.  Was getting under control on Lisinopril 5mg medication.  Had bloodwork all performed that was negative to rule out other underlying causes for HTN.  Was getting ready to wean off the medication, when within 24 hours after the 2nd Pfizer vaccine dose on 2/22/21, my BP significantly elevated again.   Continued to follow up with my PCP, trying increased medication dosage (Lisinopril 10mg).  BP was not fully stabilizing, and started having significant headaches, which was then attributed potentially to Lisinopril.  Changed to Metoprolol Succinate 25mg on 4/5/21, and my PCP  performed another EKG, and then referred me for an echo cardio stress test, and to see a cardiologist, as  BP had continued to be elevated, and was now also have PVCs.
Called to obs area ~25 minutes after receiving injection, patient stayed longer due to an issue after first injection where she felt a little light-headed when she was driving to her office afterwards.  Patient stated that she had started to feel that her neck was weak, no ShOB, throat tightness, N/V, diaphoresis. BP 164/92, HR 82, O2 98%, HRRR no murmur, CTAB. No palpable abnormality in the neck. Patient took fexofenadine last night, I did give her diphenhydramine 25 mg to take and provided water to take that with as well. Patient requested to use the restroom and I walked her in to the office building, she did not appear to have any issues with ambulation, though she did state she felt less steady than normal. Extended her observation time for 10 minutes after my exam (total 40 minutes obs time) and patient had no further issues.
Patient reported her age as 18 (caregiver) but she actually didn't turn 18 for one more month, she will be 18 at the time of dose number two in the series
Numbness and weakness in legs progressed to arms, face about 1 week before presenting to physician 12/27/05. Tx: IVIG. Diagnosed GBS. Discharge summary states decreased reflexes, hypertension, chest pain, gout. msv Annual follow up information indicates patient has not recovered, since injection patient has had electric shock type feelings throughtout his body. Admitted to hospital 5/30/06 with right side weakness & numbness. MRI showed moderate cerebral atrophy with associated periventricule ischemic demyelinization. Admission to hosptial 12-27-05 with extremity numbness & weakness. Per 60 day follow up: GUILLAIN BARRE has resolved except for occassional parethesias.
Third cranial nerve palsy; A spontaneous report was received from a 63-year-old male pharmacist who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed third cranial nerve palsy.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, approximately 5 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient began to have blurred vision which progressed into double vision. He then experienced a headache that felt similar to when you have the wrong prescription glasses or cross-eyed. On 06 Jan 2021, he was seen by his ophthalmologist who ordered a CT scan which was negative. His eyelids were drooping and he wore an eye patch on the right eye because his right eye is completely shut. The patient reports that the muscle that keeps the pupil in focus in the middle is paralyzed, so his pupil is turned to the right and down, which is what was causing the double vision.The treatment of the event include eye patch.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, third cranial nerve palsy, was considered unknown.; Reporter's Comments: This case concerns a 63 year old male patient, who experienced a serious unexpected event of IIIrd nerve paralysis. The events of IIIrd nerve paralysis occurred 6 days after first dose of mRNA-1273, lot # 037K20A. Diagnostics included a CT scan, which revealed no abnormality. Treatment for the event include eye patch and no other details were provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Patient reports soreness to the arm, she has a lymph nodes  are the size of a "golf ball". This is on the right side. No other findings
Blurred vision, numbness in the mouth and high blood pressure.  Benadryl 25 mg PO was administered approximately 1 hour post vaccination.  Employee was instructed to see primary attending physician.
expired dose of Adacel was administered with no reported adverse event; Initial information received on 23-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who received expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Immunisation.  On 23-Mar-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (frequency - total (1x), strength - standard, lot - U6984AA, expiry date - 18-Mar-2023) via intramuscular route in right deltoid for prophylactic vaccination (immunization) that was expired with no adverse event  (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
Red Rash at injection sight, pt was kept 20 min after injection by Primary Care Physician and released without any cmoplications
THIS IS THE SECOND DOSE, THE PATIENT REFERS THAT SHE HAD ALMOST THE SAME REACTION FOR THE FIRST DOSIS BUT DID NOT SAY ANYTHING. SHE REFERS THAT SHE THE LEFT ARM BECAME HOT TO THE TOUCH AND SWOLLEN, IT STARTED OUT AS A BUMP AND THEN THE CELULITIS WAS FORMED, IT LASTED 3 WEEKS AND SHE VISITED THE EMERGENCY ROOM AND WAS GIVEN ANTIBIOTICS, SHE REFERS THAT SHE DID NOT REPORT THE REACTION BECAUSE SHE THOUGHT THAT IT WAS NORMAL. SHE DID NOT HAVE FEVER OR RASH AND DID NOT APPLY AND COMPRESSES ON HER ARM.
Patient received the Covid Vaccine then sat at the observation area for15 min. for monitoring with no s/s of adverse effects. Patient proceeded to go back to work at the factory. Nurse was flagged down by staff stating patient came back because complaint of vomiting in the restroom, slight dizziness. Patient was offered to lay down. Ice pack was placed on the back of patients neck. Nurse encouraged fluids, took VS and noted to be stable. Patient was monitored for 30 mins before departure.  Patient took the rest of the day off and nurse instructed patient  on  signs, Symptoms of Severe Adverse Reactions to report to health care provider or to go to the emergency room. Patient verbalized understanding.
Husband came into Health Department on 12/29/2011 at 11:00 AM to report his wife experienced SOB, throat pain and "Heaviness" in tongue 5 hours after receiving the fluzone vaccine. symptoms resolved in 15 minutes and she remained asymptomatic for the rest of the day and feels "normal" this morning. She did not take any medication or seek medical attention during or after epidsode. I advised him to report episode to his wife's family physican and told him that I will report this event to VAERS. At 1:00 PM Husband telephoned Health Department to report that his wife experienced the same symptoms again approximately 1 hour ago. He states that the symptoms again lasted about 15 minutes and were self limiting and she is presently asymptomatic. I advised him to take his wife for immediate medical evaluation.
SCALE/RASH AT SITE OF INJECTION; UPSET STOMACH; FELT LIKE CRAP; TENDER AND SORE ARM.; FEELS WIPED OUT; MUSCLE PAIN; RECURRENCE OF SIDE EFFECTS; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included bone spur, and disc problem, and concurrent conditions included hypersensitivity to medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm. No concomitant medications were reported. On 06-MAR-2021, the subject experienced flu-like symptoms. On 24-MAR-2021 04:15, the subject experienced recurrence of side effects. On an unspecified date, the subject experienced scale/rash at site of injection, upset stomach, felt like crap, tender and sore arm., feels wiped out, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tender and sore arm., scale/rash at site of injection, flu-like symptoms, feels wiped out, upset stomach, recurrence of side effects, felt like crap and muscle pain was not reported. This report was non-serious.
Large raised hematoma on my right forearmAnd small raised hematoma on my left forearm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 09:30 (Lot number: EL9266) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MEN II A Multiple endocrine neoplasia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; BUPROPION. Past drug history included: Peniclilin, notes: Penicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EL9265   , Anatomical Location: Arm right at 09:30 AM), administration date: 02Feb2021. The following information was reported: HAEMATOMA (non-serious) with onset 23Feb2021 16:00, outcome "recovered" (2021), described as "Large raised hematoma on my right forearmAnd small raised hematoma on my left forearm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of haematoma.   Additional information:The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included: Levothyroxine,  Bupropion and The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination.  No follow-up attempts are possible. No further information is expected.
1. Headache - for 24 hours. Treated with acetaminophen & naproxen. 2. Nausea  when standing - duration 24 hrs 3. Dizziness when standing - duration 24 hrs 4. Fever up to 103 F - duration 18-24 hrs. Unknown due to taking acetaminophen & naproxen.
The last day of my period was March 1st, and I got bleeding just like the period one day after the vaccine (March 6)   I usually have my period 3 weeks after last day.
sweating; couldn't sleep one night; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included Heart murmur, Skin cancer, Brain neoplasm benign and Depression. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches). At the time of the report, HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported by the reporter.
11 (total)-pox marks on extremities and face. (Broke out with varicella).
All over body rash that has yet to resolve on 1/2/2015. Was seen by provider who deemed it allergic rx to nasal vaccine. Extreme itching.
GAVE PATIENT A VACCINE WITH IPV IN IT, THEN A SEPARATE IPV BY MISTAKE.
Less than 5 minutes after immunization, while grandmother was changing child, child began screeching, not crying. Face became flushed and unconsolable screech continued. Restless with intermittent screeching. R36 AP 86-90. Grandmother reported facial swelling and swallowing between screeching. 10 minutes later still. Awaiting ambulance  given Epinephrine 1:1000, 0.15ml IM left thigh, other physician consulted. Grandmother holding over shoulder, responds when spoken to and intermittenly restless. Ambulance carried to emergency room.
Patient states rash and pain at injection site. Physician states to patient it is "shingles." Treating pain as needed per patient.
PT RECEIVED A SECOND COVID VAX OF MODERNA. UPON ENTERING, IT WAS NOTED THAT THE FIRST DOSE HAD BEEN PFIZER. PT HAD BEEN ASKED WHICH VAX SHE HAD PREVIOUSLY AND SHE STATED MODERNA.
Menveo given with an alternate diluent (sterile water); This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The nurse stated that while completing reconciliation of the vaccines, it was noted that the clinic had two remaining vials of Menveo liquid portions, with one remaining vial of powder.  One dose of the powder given out of the nine doses administered was given with an alternate diluent, likely sterile water. The reporter stated they could not determine which patient was given a partial dose.  No further details were available, investigation was ongoing and the reporter intended to follow up with disease control for recommendations. The reporter consented to follow-up.  Additional supportive information: The patient received powder of Menveo with alternate diluent, which led to wrong solution used in drug reconstitution.
This spontaneous report was received from a consumer via Pfizer and refers to a patient of unknown age with a history of lymphoma. On an unknown date in 2003, the patient was vaccinated with a dose of PNEUMOVAX 23 injection. On an unknown date, the patient experienced an unspecified adverse event, reported as "a bad reaction" after the second dose. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported.
This spontaneous report has been received from a nurse practitioner via a company representative and refers to a 16 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-SEP-2017, the patient was vaccinated with GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported). On the same day, directly afterwards, the patient had chronic seizure-like symptoms. The outcome of the event was not reported. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of chronic seizure-like symptoms was considered to be medically significant.
Mother states pt developed rash/hives all over body approximately 1 wk after 12mo. shots.
Janssen COVID-19 vaccine EUA  Vaccine administered 9:20am 3/18. By 4:30 pm same day onset of chills, followed by fever of 102.6 measured at 7:00pm. Took Tylenol, fever unchanged an hour later. Also experienced joint aches. Symptoms started to subside around 12 midnight that night. Fever completely gone and had no other symptoms by 7am next morning 3/19.
Site: Pain at Injection Site-Mild, Systemic: Loss of taste-Mild, Additional Details: 1 day after 1st shot, patient lost sense of taste for 3 days. It slowly came back and it's back to normal. Patient doesn't know if he had COVID before or not. Patient is healthy with no preexisting conditions. This reaction never happened before due to vaccine or otherwise.
Pt was given Vaccines at 11:44am was left in the room with mother for 15 minutes to see if pt had any adverse reaction, Pt had fainted and vitals were taken and were normal pt was diagnosed with Vasovagal syncope was monitored and ok to go once provider seen her.
Fever (103.8); Chills; Bodyaches relieved with over the counter pain/fever reducer medication.
47-year-old female complained of allergic type reaction. On-site team responded. vital below. She refused additional evaluation and care.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 29-JAN-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot #: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.