chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt given vaccines and approx 5 min after vaccines given Pt stated that her right arm felt "tingly" and she felt very hot and then had an emesis. Pt states "I feel better now."
Client received second dose of Moderna  per Dr.  (Health Officer).  Error and Deviation/Off label error and off labile use. Along with administration and error documentation.
Severe swelling and pain in muscles in the area of the injection.  Lasted for more than three days.
A mother reported that her 6 year old daughter received a "flu shot" last year (2002), and "her arm was sore for days." No additional info was available at the time of this report.
Area of injection site swollen, erythematous, and hand, approximately 5 inch circular area to arm that DTAP given.  Injection given approximately 24 hours prior to exam, patient given single dose steroids and 24 hours follow up.
Patient received vaccine then fainted while sittting in the chair. Regained consciousness after a few seconds.
Dosing error given to an individual that did not meet the criteria for EUA by Moderna.  Patient was monitored post vaccination for 15 minutes with not adverse reaction to the vaccination. Dose was given at 12:42pm on the 13th of March 2021. Parent of the patient was contacted @ 18:30 and patient did not have any adverse reaction at that time.
headache; arm was sore; whole body was itchy all over; hives; This is a spontaneous report from a contactable consumer (patient) from sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache, arm was sore, she got 2 hives and whole body was itchy all over. The events were considered as non-serious. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Large, local reaction - induration, swelling measuring about 8" diameter. Pt given DTaP, IPV, Hep B and Prevnar on 5/27/03.
woke up 1/23/21 with redness at injection site; a rash on the arm of said injection, right arm; a rash on the arm of said injection, right arm; This is a spontaneous report from a contactable healthcare professional who is the patient.  A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), intramuscularly on 22Jan2021 at 08:45 (at the age of 32-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included AV node re-entrant phenomenon. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246) intramuscularly in the right arm on 31Dec2020 at 8:30 AM.  The patient is allergic to morphine and "Celcor." The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ivabradine hydrochloride (CORLANOR) 5 mg half tablet twice daily with food. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient woke up on 23Jan2021 at 08:00 with redness at the injection site and a rash on the arm of said injection site (right arm). The patient did not receive any treatment for the events. The clinical outcomes of the events injection site redness and rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Headache; Exhausted; Strange feeling for rest of the week up till today/wiped out; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EN6199) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; METHOTREXATE. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Exhausted"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "not recovered", described as "Strange feeling for rest of the week up till today/wiped out"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "achy". Therapeutic measures were taken as a result of headache, fatigue, feeling abnormal, pain.  Additional information included: Reporter stated, "I got the Pfizer vaccine on Monday and I didn't have much of it an arm soreness or anything that was pretty good but I have an headache and exhausted, strange feeling for rest of the week up till today. So I thought I will check and see about how long does it last?" Reporter confirmed the shot as first shot. Reporter confirmed treatment with Tylenol. Patient reported herself of Mixed ethnicity. She could not remember the rest of her medications. Reporter stated that she got the first dose last Monday and she was still feeling wiped out and achy until now. Caller was asking how long will it last.  No follow-up attempts are possible. No further information is expected.  Follow-up (11Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored program.  Updated information included: narrative was updated.
Started with rash and fever on 3 days after receiving the MMR/Varivax, fever of 101  Patient seen in the office ( 4-30-19 ) rash is slowly starting to get better
patient did receive a second dose for Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patient swho received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too long (Verbatim: patients did receive a second dose for Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The pharmacist called to report a late second dose of Shingrix The reporter stated that in pharmacy they receive various patients for a late second dose of Shingrix but did not had specific information to report. The reporter consented to follow up via email. This case was linked with US2023AMR043623 reported by the same reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2023043217:Same reporter
Patient complained of tachycardia about 15 to 20 Minutes after receiving the vaccine
Post vax, the patient developed redness and induration extending beyond the injection site. The patient reports a fever.
Pt describes feeling fever, chills, headache, nausea in the hours following Yellow Fever vaccination. Presented to medical provider 3/1/16 w complaint of fever, chills, nausea, productive cough with scant blood. 4.5 x 5 cm rash noted over injection site. Pt prescribed sudafed 30mg, Mucinex dm, Tylenol for symptoms, instruced to increase hydration and rest for 24 hrs, and return for reassessment 3/2/16.
This spontaneous report as received fro ma pharmacist refers to an unspecified number of patients of unknown age and gender. No concurrent conditions and medical history were reported. On an unspecified date, the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot number, expiration date, route and dose were not provided) as routine pre-employment vaccinations. Concomitant medication were not provided. On an unknown date, the patients experienced injection site redness and itching. The patients did not seek to medical attention. Therefore, no treatment was given for the events. The outcome of injection site redness and itching was reported as recovered on an unspecified date. The reporter did not assess the relatedness of (Oka/Merck) VARIVAX to the events. This is one of several reports from the same source. Additional information has been requested.
Burning sensation behind eyes approximately 1-2 hours after receiving immunization that lasted about 1 hour then went away.
SERIOUS JOINT PAIN IN HAND WRIST OF INOCULATED ARM; SERIOUS MUSCLE PAIN IN HAND WRIST OF INOCULATED ARM; MILD ACHINESS; This spontaneous report received from a patient concerned a 6 decade old male. The patient's weight was 205 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included type ii diabetes, and hypothyroidism, and other pre-existing medical conditions included no known drug allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included dulaglutide for type ii diabetes. On MAR-2021, the subject experienced mild achiness. On 14-MAR-2021, the subject experienced serious joint pain in hand wrist of inoculated arm. On 14-MAR-2021, the subject experienced serious muscle pain in hand wrist of inoculated arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild achiness on MAR-2021, and the outcome of serious joint pain in hand wrist of inoculated arm and serious muscle pain in hand wrist of inoculated arm was not reported. This report was non-serious.   Additional information was received on 23-MAR-2021: The following information was updated and incorporated into the case: Patient Demographic details (height ,weight) , reporters details (Address , zip code ,city ,state ) was updated .; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious
Body aches; Sore arm; Chills; Vomiting every 16 minutes for 6 hours; Very bad Headache; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine on 10-Mar-2021 and Pfizer COVID-19 vaccine on 05-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine; and Vomiting with Pfizer COVID-19 vaccine.    On 22-Nov-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021 at 4:30 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Nov-2021 at 2:30 AM, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency. On 22-Nov-2021 at 4:30 PM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 24-Nov-2021, PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VOMITING (Vomiting every 16 minutes for 6 hours) and HEADACHE (Very bad Headache) had resolved.            No concomitant medications were provided.
On 11/12/2021, Approximately 2 weeks after Pfizer booster ( 10/27/2021), I experienced intermittent "flutters" in my chest. I have not had this prior to the vaccine.  I have been a critical care RN for almost 37 years, so with my stethoscope I could hear the irregular "skipped" beats.  A week later I had an appt with my primary care doctor and brought this to her attention. The decision to follow and report increased symptoms was agreed on. I have continued to notice intermittent palpitations but on 02/12/2022 I began to notice a steady increase to multiple times daily.  On 2/24/2022 I again saw Primary care doctor regarding the palpitations. EKG/Echocardiogram done. On 3/18/2022 I again saw Primary care for follow up. I was referred to a Cardiologist.  On 3/30/2022 I had a 24 hr. Holter monitor placed that confirmed Premature ventricular contraction, Premature atrial contractions.
This case was reported by a physician via sales representative and described the occurrence of rotavirus infection in a 32-month-old female subject who was vaccinated with live ROTARIX (GlaxoSmithKline). On 27 August 2010 and 27 October 2010 the subject received 1st dose and 2nd dose of ROTARIX (oral). Years after vaccination with ROTARIX, the subject experienced rotavirus infection and vaccination failure. The physician reported a "confirmed case of Rotavirus in a patient that received vaccination with ROTARIX." No further details were available at the time of reporting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.
Approximately 10 min after immunizations were given, patient became light headed, diaphoretic, pallor. Patient was given oxygen via mask at 6lpm for approx. 5 minutes. Patient responded well. Patient did not lose consciousness at any time. Provider evaluated patient, vital signs were stable during the event. Patient left clinic after being observed for 30 minutes, in stable condition.
OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAY-2021 18:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738. Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into tracking system prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and data collection reconciliation o Training on how to enter information into data tracking when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Developed hives of face 10 minutes after administration of vaccines. Cried profusely. Vital signs taken - ADRENALIN & BENADRYL administered - after 10 minutes partial resolution after 20 minutes full resolution of hives.
No additional adverse event.; the patient was inadvertently administered a dose of PREVNAR 13 and PNEUMOVAX 23 concomitantly; This spontaneous report was received from a medical assistant and refers to a 42-year-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 22-JUL-2020, the patient was inadvertently vaccinated with dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial (lot# S036811 and expiration date: 02-AUG-2021) and dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (lot#CM1131 and expiration date 30-APR-2022) concomitantly, (dose, dose number, route of administration and anatomical location of aforementioned vaccines were not reported) both for prophylaxis. No additional adverse events were reported.
Received IZ's 4.29.09 -   5-1-09 pale, fever by evening was in Reno all day that day.  5-1-09 Fever increased- unknown temp as no thermometer.  Went to ER = sent home.  Flu + Strep negative.  5-2-09 checked with ER = Blister on tip of tongue from fever.  Ears neg.  5-4-09 Motrin decrease fever to 99.  Did better.  5-5-09 Low grade fever still-  Blisters going away.
Information has been received from a registered nurse concerning a 62 day old male patient who on 24-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667445/0993Z, expire date 05-JAN-2012), 0.5 ml, intramuscularly instead of PREVNAR. No adverse effect was reported. Additional information has been requested.
Right after the vaccine, I was minorly sick with tiredness and sore arm. A week later I took my blood pressure and it was elevated. My blood pressure is usually 120/77 and it now averages 137/85. I went to my doctor and added Amlodipine and the Lisinopril was raised to 40mg. I do have a follow up appt in June. In January and February my blood pressure reading were at the highest. In March it has been normally 130/81.
your covid 19 vaccine gave me a heart failure now I only have 15 years to live; I am sitting at home with covid now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: CARDIAC FAILURE (medically significant, life threatening), outcome "unknown", described as "your covid 19 vaccine gave me a heart failure now I only have 15 years to live"; SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "I am sitting at home with covid now".  Clinical course: The caller stated that your covid 19 vaccine gave me a heart failure now she only had 15 years to live, she send all the reports that you want and you ignore me now. She have a medical bills she was sitting at home with covid now and you ruined my life, wanted to know what Pfizer will do about it. How can you ask people to do booster when the two vaccines gave me heart failure. (Attempted to explain that Pfizer was a manufacture of the product but the treating HCP was in the best position to determine what's best for her specific situation) When attempted to clarify, exactly what information she was looking for, caller stated I spent (dollar) 9 mailing all the information to you and now you just ignore me since Jan and I am sitting here sick, what do you mean my doctor. it's your vaccine that was ruining peoples life, you are ruining peoples life and she want to know what you are going to do about it. Who was going to pay my medical bills who was going to care for 15 years that she have left, she was a healthy person, never had covid now she only had 15 years to live. Heart failure was 35% she was down to 25%, she was a dead person walking, you have my information how come you ignore me. she was gonna to call back (then caller said something inaudible and disconnected the call).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
it is unclear if 18 year old received PROQUAD.; it is unclear if 18 year old received PROQUAD.; No additional AE details; This spontaneous report was received from a consumer referring to an 18 years old patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    It was unclear if the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error). No additional AE details were reported.
pt recvd vax 22JUL92 had dry cracked lips & itchy rash; seen by MD; DPH prescribed; pt recovered; 21JUL92 pt exp swollen upper lip;
11JUL91 fever APAP given, 10JUL91 hives appearing on back of legs & arms; 11JUL91 hives head to toe x/belly; tx APAP given intermittently- Caladryl suggested;
No reaction at the time of immunizations. Went to doctor the next day with his right leg swollen, red and with increased warmth. This is contained above the knee. The leg does not appear tender. He has been running a low-grade fever. He has had a clear runny nose. Appetite is good, but fussier than usual. Dx'd with a reaction to shots. If the child worsens or develops fever, mother is to call. Mother called on Saturday morning and said child's fever spiked to 102F. She was going to bring him over so I could recheck him, but when I called back in the afternoon, father said the fever had resolved. It was down below 100F, he was much better, leg was less swollen and they felt he would do well.
PT SEEMED TO HAVE AN ANXIETY ATTACK POST VACCINATION ADMINISTRATION.  GOT A HEADACHE. FELT BLOOD WAS RUSHING TO HER HEAD.  CHECKED BLOOD PRESSURE AND PATIENTS PRESSURE WAS ELEVATED 157/108 WITH 70 HEART RATE.  CHECKED AGAIN AFTER 5 MINUTES AND IT WAS THE SAME.  PT WAS GIVEN A BOTTLE OF WATER TO INJEST AND AFTER 15 MINUTES, PT FELT FINE.  STATED SHE MAY HAVE HAD A PANIC ATTACK AND WAS NERVOUS ABOUT GETTING THE VACCINE.
No adverse event; patient that received an unknown varicella vaccine 3 weeks before becoming pregnant.; This spontaneous prospective pregnancy report has been received from a nurse practitioner, regarding a 19-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 12-JUL-2022, reported as 3 weeks before becoming pregnant (last menstrual period reported as 23-JUL-2022, with and estimated date of conception on 29-APR-2022 (conflicting information)), the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (caller did not know if this was the first or the second does) as prophylaxis (lot number: U029621, which was determined to be valid, with an expiration date on 22-SEP-2023) (dose, route and anatomical location of administration was not reported) (maternal exposure during pregnancy).  The pregnancy outcome was not reported at the time of the report therefore, the fetal outcome was unknown. No additional adverse event was reported.
Swollen lymph nodes, fever,chills, body aches, sore arm, headache, nausea