chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after the administration of both vaccines patient started to get lightheaded. She stated that she sometimes gets like this after vaccines. She laid down on the floor, drank some water and was able to eat some fruit snacks. Her symptoms resolved in 15 minutes.
This spontaneous report was received from a registered nurse concerning a patient of an unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 18-AUG-2014, the patient received VARIVAX (Merck) lot number J014400, expiration date: 13-NOV-2015 (dose and route were not provided), which was improperly stored on 05-AUG-2014 at 11:18 am for 3 hours 10 minutes. Other suspect and concomitant therapies were not reported. No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
On 9/2/08 Pt and his mother presented to our regular clinic services at 11:15am.  Was given #2MMR, #4IPV, #2Varicella and #5Dtap without incident and left the clinic and Health Dept. at 11:50 am.  After leaving Mother states while taking older brother back to school with pt sitting in the back seat, he suddenly began to cry and when she turned to look back at him she noticed both his eyes red and very swollen.  Because he had just had his shots less than an hour before she brought him back to the Health Dept.  At 12:40pm at the Health Dept. the Clinic Coordinator observed him crying with both eyes red and very swollen (Rt almost completely shut and Lt swollen slightly less), large amount of mucous draining from his nose, slight cough and audible wheeze.  911 emergency service called and taken to exam room.  Vitals AP100, R28 easy, B/P96/52.  On auscultation bil wheezes in all lobes.  Questioned Mom if he ever had any reaction (ie runny nose, cough etc) after any of his shots which she denied.  Respirations remained unlabored and other than redness of eyes, skin color remained good.  Paramedics arrived at 12:45 assessed briefly and tranported per cart to Ambulance then on to another hospital.  At 2:50pm, Mother returned to the Health Dept to report that he was home resting and stated the ER had said he probably had a reaction to one of the vaccines he had received earlier.  He was given Benadryl in the ER and discharge to home with 2 prescriptions, Orapred 20mg. po x 5 days and Benadryl 12.5mg/5ml 1/2 tsp po QID prn.  He was to follow up with his PCP in 3-5 days.
On the night of Saturday May 1 I fainted in the street (injuring my face and breaking a front tooth) and was transported to  ER.
Erythema, induration, and tenderness to R thigh (DTaP injection site) about 16 hours after immunization; treatment includes ibuprofen and heat packs to area.
Pfizer-BioNTech Covid 19 Vaccine EUA  Rash     Elevated blood pressure        Elevated heart beat      Dizziness and weakness  Observed on site by EMS and nurses for approximately 1 hour
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reaction/allergy was not provided.      On 27-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (lot # S030093, expiration date 24-MAR-2021; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Previous temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. Data logger was involved.
pt vax hepta B. pt ex flu-like illness which resolved. pt vax 2nd hepta B.  pt ex no adverse affects.  It was felt that sx were result of flu epidemic.
Left arm swelling and red from shoulder to elbow. Pain from shot lasted about 2 days. Dr visit 12/08/06 gave 2 tab each day for 2 days Prednisone 10 mg. Got much better after taking for 2 days + 5 Clarinex 1 a day.
Information has been received from a registered nurse concerning a 36 year old female with drug reaction to NORGESIC FORTE which causes nausea. The nurse mentioned the patient received MMR II as a child and titers were found to be negative on 30-JUL-2008. The lot number of this MMR II dose is unknown. It is unknown if the patient received a second dose of MMR II as a child. On 04-AUG-2008, the patient was given a subcutaneous dose of 0.5 mL MMR II (rHA) (Lot # 658582/0043X) and another subcutaneous dose of 0.5 mL MMR II (rHA) (Lot # 658582/0043X) on 26-AUG-2008. The patient was not experiencing any known symptoms from receiving the dose on 26-AUG-2008 early. The patient sought medical attention and had an office visit. There was no product quality complaint. Additional information has been requested.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 648 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Fever and malaise 03/22/2005 followed by outbreak of lesions on neck and torso 03/23/2005
This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Lightheadedness/dizziness; Weak leg; Muscle pain in legs; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Aug2021 (Lot number: EW0175) at the age of 59 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE; ATORVASTATIN; GABAPENTIN; SERTRALINE; TRELEGY; VENTOLINE [SALBUTAMOL]; LISINOPRIL; FUROSEMIDE; ALBUTEROL [SALBUTAMOL]; ASPIRIN [ACETYLSALICYLIC ACID]; JANUMET; FARXIGA; NOVOLOG. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: BioNTech, Lot number: EW0175, Dose number: 1, Vaccine location: Right arm), administration date: 05Aug2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Lightheadedness/dizziness"; MUSCULAR WEAKNESS (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Weak leg"; MYALGIA (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Muscle pain in legs"; DYSPNOEA (non-serious) with onset 09Sep2021, outcome "not recovered", described as "Shortness of breath". It was unknown if therapeutic measures were taken as a result of dizziness, muscular weakness, myalgia, Dyspnoea.  Additional information: It was unknown if the received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether patient was diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
I developed weak, rapid, irregular heartbeat indicative of atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: ER2613) via an unspecified route of administration in left arm on 19Mar2021 at 11:00 am (at the age of 64-year-old) for COVID-19 immunisation. Medical history included persistent atrial fibrillation, allergies to sulfa. Patient was not pregnant at the time of vaccination. Heart in regular sinus rhythm for several months prior to vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included dofetilide (TIKOSYN) 250mcgtwice daily, loratadine and ibuprofen, (all received within 2 weeks of vaccination). The patient previously took dofetilide (TIKOSYN) for atrial fibrillation (persistent atrial fibrillation was controlled with 250mcg twice daily); also took erythromycin and had allergies. Patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 17:15, the patient developed weak, rapid, irregular heartbeat indicative of atrial fibrillation. This last 8 hours. The patient did not receive any treatment for the events. Patient noted regular heartbeat on 21Mar2021 at 1:15am. Patient visited to physician office for events. The outcome for the event was recovered on 21Mar2021 at 1:15am.  Follow up attempts needed. Further information is expected.
Wife called and stated that her husband received the Pfizer vaccine on 01/06/2021 at 4pm and since receiving vaccine has been experiencing possible side effects. Wife states that patient has been excessively throwing up and having diarrhea. Wife has been encouraging husband to go to E.R. or seek medical attention, but he is refusing.
pt states that p/vax noted painless swelling of lt elbow;says swelling was not present prev;inj was given lt deltoid;swelling was noted to be olecranca bursa, non tender relationship to vax unk;
Pt presented to ER three days after Hepatitis A/B vaccination.  Vaccination was given for admit to EMT school and clinical rotation.  Pt was not ill with any sx until three days post vaccine.  Upon presentation to the ED he was nauseated, vomiting, lightheaded, confused and feeling "off balanced".  CT scan was negative other than what the physician described as posterior reversible leukoencephalopathy.  Lab values showed an HGB of 19 with a corresponding HCT of 56, and increased AST 33, ALT 70.  Pt was discharged on 4/1/2014 after treatment with steriods, antibiotics and IV fluids.
Patient called the pharmacy today to report numbness/tingling and cold feeling in lower extremities. Symptoms began after vaccine was administered and have not abated since.
SARS-CoV-2 test positive; Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) and COVID-19 (Covid-19) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) (seriousness criteria hospitalization and life threatening) and COVID-19 (Covid-19) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 25-Mar-2021 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) was resolving and COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not reported/ unknown.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of SARS-CoV-2 test positive and COVID-19 disease after vaccination, these events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of SARS-CoV-2 test positive and COVID-19 disease after vaccination, these events are assessed as unlikely related to mRNA-1273.
Patient received the Janssen COVID-19 vaccine (batch/lot# 1855191 and expiration date:  04/11/2021), at 10:48 pm in error. He was due for second dose Moderna COVID-19 vaccine. Patient verbalized his request to receive the Janssen dose. The RN/vaccinator gave him the Janssen COVID-19 vaccine. The immunization registry staff brought this to the attention of the lead RN vaccinator after the dose was given. They did not disclose problem until after incident had occurred. Lead RN vaccinator provided education on the importance of verifying doses before administration occurs. Everyone verbalized understanding. Earlier in the day the resource nurse provided a list of clients that needed the COVID-19 vaccine, however this patient was placed on the Janssen COVID-19 vaccine list rather than the Moderna COVID-19 vaccine list. Lead RN vaccinator discussed error with the nurse. During the discussion there was no other evidence of a second dose of Moderna COVID-19 vaccine given prior to today's Janssen COVID-19 vaccine. Resource nurse verbalized understanding of error displayed on the list given. Lead RN made supervisors aware of incident, no further direction needed at this time. Observation period done. No complaints from patient or via staff.
severe eczema all over the body 2 days after vaccines of 2 months visit. The baby also started loosing his hair and now currently almost 6 months and bold. still suffering from serious skin problems. His face and scalp are red itchy dry and flaky every day and every night no matter how much cream or moisture I put on. Before the vaccines his face were perfect no eczema whatsoever.
Pt presented to the ER due to ground-level fall.  He has a history of DM and afib and a previous submassive PE.  He had shortness of breath and a cough and was COVID positive.
pt recvd vax; swelling, hot,  induration of lt deltoid area; ? inject abscess;also c/o some tremors after inject;
some of the vaccine got into the medical assistant's eye while giving IPOL, no AE; some of the vaccine got into the medical assistant's eye while giving IPOL, no AE; Initial information received on 30-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown demographics who was exposed to IPV (VERO) [IPOL] (lot number and expiry date not reported) in her eye while giving it to the patient.  Medical history, medical treatment, vaccination and family history were not provided.  This was a case of actual medication error due to accidental occupational exposure to product and Exposure via eye contact.   It was also a case of exposure via eye contact. It was reported that CMA (certified medical assistant) was giving patient Ipol vaccine when some of the vaccine got into the CMAs eye.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
who sponsored the Vaccine site.  Adverse event: Was starting to drive and was kind of lethargic and was slow reacting. My wife was asking  questions but I was  having slow responses. She said I had  glazed stare  and  I was a little off balanced and the ambulance was called but the symptoms had subsided by the time the ambulance got there: Blood pressure - a little elevated; Blood Sugar was fine . At that time could follow finger across eyes (before when symptoms were still there, had not been able . Ambulance left and just said to keep an eye on him at home when I refused to go to hospital. We called the family doctor and she said to go to ER immediately. No return of symptoms since that episode.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient came in 01/08/23 and described a rash that had developed after admsinstartion of the 1st shingrix dose which lasted for 4 days and went away.
After first dose, given on 11/5/2021,  I had weakness, fatigue, pain in left arm/ muscle/body aches, hot flashes/chills that started the next day. Muscle aches went pretty much away after 2 weeks but weakness and fatigue never subsided and had to get second dose on 11/26/2021. After second dose weakness, fatigue, muscle/body aches and spasms, hot flashes, occasional mild tingling/numbness in legs/one arm(usually right)  are still present.
Seven days after vaccination, I developed a large, itchy rash above and below the injection site.   The area measured 6" x 4 ".   Rash lasted 5 days.   A wide yellow circular discoloration  also appeared at the point where the vaccine was administered.
Pruritic, maculopapular, generalized rash noted 4 days, post vax. Fever occurred on day 9.
pt is 27 weeks pregnant, 122.90 pounds at date the vaccine was administered. estimated due date March 8th
This spontaneous report was received from a nurse and refers to a 12 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient received a previous dose treatment with M-M-R II (dose, route, lot number and expiration date unknown) for prophylaxis. On 20-AUG-2016, the patient was vaccinated with M-M-R II I026553 (invalid), dose 2, intramuscularly in the right deltoid (dose and expiry date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). Concomitant therapies included TDAP and VARIVAX. This is one of several reports from the same reporter and also has been linked to case# 1702USA009066 via same patient link. Additional information has been requested. Sender's Comments: US-009507513-1701USA005376: US-009507513-1702USA009066.
Patient reported thinking he had a blood clot in both legs. Patient stated Saturday night he experienced severe leg pain in both of his legs lasting 30 minutes later.  Patient stated that he felt as if he had pain in every muscle in both of his legs; patient stated that he could not stand for quite some time once pain began.  Patient stated that pain caused him to wake up.  Patient stated that he did not have any other problems afterwards.
Patient developed s/s shingles (R) 10th rib after shingle vaccine was administered 08/03/12.
I had diarrhea, headaches, vomiting, and fever that lasted for 2 weeks. My arm was also sore at the injection site that was hot to touch. I am now having seizures that I am not for sure if it related to the vaccine or not. I am waiting to see a neurologist which is a long waiting period. I have had hallucinations and vivid dream that I was put in a hospital in August which I do feel was due to the vaccine. The hospital told me that it could be due to the vaccine as well too. I was in the hospital for 16 days in the psychiatric ward. I have had medication changes as well.
Narrative: COVID infection following completion of COVID vaccine series: 02/19/2021 COVID vaccine dose #1 03/12/2021 COVID vaccine dose #2 07/06/2021 Pt reported onset of productive cough, fever, and myalgia, 07/08/2021 Pt reported to ED c/o worsening symptoms. 07/08/2021 COVID positive per nasopharyngeal swab. CXR showed opacities. CT recommended but not performed. 07/08/2021 Pt discharged with self-care instructions and medications (Z-pak, vitamin D, meloxicam, and melatonin). 07/12/2021 Pt reported vis spouse of continued cough, fever, and myalgia. Onset of fatigue. Denied CP or dyspnea. 07/12/2021 Pt prescribed vitamin C, albuterol, and Robitussin DM. Meds mailed to pt. 07/13/2021 Pt reported via spouse of mild desaturation episode (O2sat of 90) after walking to bathroom. 07/13/2021 Pt attended telehealth appointment with PCP. Prescribed 2-week therapy of zinc sulfate. Med mailed to pt. F/u scheduled for one week if needed.
Tingling Narrative: The symptoms was mild. No necessary to take any medication. After he took some juice, he felt fine to leave.
100+ Fever & Headache for 6 days. Fatigue & Aches for 8 days and continuing.
First was weakness, dizzy, exhausted, I thought I had UTI because I needed to urinate, it was a little painful, then needed to again within an hour. That went away. My arm swelled, got hard and red and painful, then the cold/bronchial symptoms started. Coughing constantly, (painful) headache, terrible conjestion, hard phlegm in my throat that I cannot clear, some fever. Today is November 5. I went to the doctor  esterday, got a bunch of prescriptions and some over the counter. It is still going on!
Vaccine administration error. Patient reported to staff that he needed his second Janssen COVID-19 vaccine. Patient did not have vaccine card available. Pharmacist administered vaccine. Patient came back to pharmacy with vaccination card where the pharmacist noticed the patient had already received two Janssen vaccines. Patient should have received either Pfizer or Moderna.
The injection site is circled with ink and is one finger breadth below the acromion. Patient presents with pain and poor range of shoulder motion. Suspect vaccine was injected into her subacromial bursa, or possibly shoulder joint, resulting in injury (SIRVA)