chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist (R. Ph.) concerning a 60 year old male with no medical history and no drug allergies who on 07-DEC-2010 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. The reporter stated that on 10-JAN-2011 the patient complained of a sensation he described as "1000 pins being pushed into his back, starting at the bottom, and rising to the top, accompanied by a tingling and sweating sensation, that required me to take my coat off." At the time of reporting, the outcome of the patient was unknown. No lab diagnostics studies were performed. The patient sought medical attention by returning to pharmacy. Additional information has been requested.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.            No concomitants were reported. No treatment was reported.
Felt pain running down my arm at time of booster injection, hour later felt dizzy, arm of shot the arm pit swelled and is still swelled 4 days later, intense lymph node pain in the arm pit, day 2 hives on my upper body, I went to bed my throat swelled and could not unplug my ear for 8 hours
light fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (light fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PYREXIA (light fever). At the time of the report, PYREXIA (light fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported , No treatment medication was reported .   Reporter did not allow further contact
chills/fever, stomach upset, nausea, headache after dose of Shingrix given at 9:23 in morning and symptoms started at 9:30pm and resolved in morning
Lips immediately started tingling. After about 25 lip tingling started to subside and then cheeks mouth and tongue feel funny. Top of mouth burns.  I feel like when I have an allergic reaction to a cat
mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (mild symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (mild symptoms). At the time of the report, ADVERSE REACTION (mild symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
I tested positive for COVID-19 on 6/26/22. I had a really stuffy head, stuffy nose, general congestion, and an achy back. I decided to take an at-home test and it turned up positive. I was prescribed PAXLOVID.
Patient has discrete rash through out extremities mild tenderness and swelling at the injection site large 5 x 5.5 cm round spot on left forearm with darker coloration - Erythema Multiforme.
began seeing hallucinations; A spontaneous report was received from a consumer concerning a 89-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and began seeing hallucinations.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Feb 2021, about 4 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 Feb 2021, about 4 hours after receiving the vaccine, the patient began seeing hallucinations. She was seeing moss grow on the walls and real bright turquoise colors that turn pink.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event began seeing hallucinations was unknown.; Reporter's Comments: This case concerns a 89 year-old, female patient, who experienced event of hallucinations. The event occurred 4 hours after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Patient sent to ED 2/4/2015 for evaluation of fever of unknown origin with abnormal posturing involving back and neck, concern for meningitis, adverse reaction to vaccine. Fever max 104F 2/3/15.
He died unexpectedly early in the morning. He woke up suddenly, said he needed help, and then was gone.
Redness, itching, swelling to insertion site 9/21. Area of redness has gotten larger and more tender since then. Area is warm to touch. Patient prescribed a round of steroids and will return for re-check.
powder component of Menveo was mixed with Menactra and administered to patient; powder component of Menveo was mixed with Menactra and administered to patient; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA928A) for prophylaxis.   Concomitant products included MENACTRA.   On 14-SEP-2023, the patient received Menveo. On 14-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: powder component of Menveo was mixed with Menactra and administered to patient) and inappropriate dose of vaccine administered (Verbatim: powder component of Menveo was mixed with Menactra and administered to patient).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-Sep-2023 A Medical Doctor called to inform that the powder component of Menveo was mixed with Menactra, and then administered to a patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX  23 lot # L010598, expiry date 16-AUG-2016, lot # L019836, expiry date 24-MAR-2017, lot # L014458, expiry date 11-FEB-2017 and lot # reported as K101522, expiry date 25-FEB-2016 (strength, dose, route and site of administration were not reported). No adverse effects were reported. All vaccines were administered after being stored improperly but prior to their labeled expiration dates. This is one of several cases received from the same reporter. Lot number K101522 is an invalid lot number of PNEUMOVAX 23. Additional information has been requested.
Information has been received from a pharmacist concerning a male patient who "About four months ago" in approximately November 2010, was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck) (lot number not reported), SQ. Pharmacist stated that the patient "About four months ago" in approximately November 2010, experienced musculoskeletal pain. At the time of the report the patient's musculoskeletal pain persisted. The patient did not seek medical attention. Additional information has been requested.
Patient reported walking to restroom, feeling dizzy and had pre-syncopal episode witnessed by staff and brought to floor Patient stated symptoms improved Patient seen by medical team and ambulance was called and patient sent to hospital
Subsequently pt developed an injection site reaction characterized by redness extending from the shoulder to the elbow, swelling and warmth. The patient recovered. This is 6 patients from facility who developed an injection site reaction.
Runny nose, cough and congestion no fever. (had indicated at time of vaccination that she was getting over cold or allergy).
Presented to the ED c/o generalized weakness onset 3 days ago; admitted for severe sepsis; COVID test positive 1/7, pt developed COVID-19 pna w/acute resp failure; tx w/O2 therapy, remdesivir, abx; pt weaned to RA, dc'd home
After receiving Pentacel #4 and MMR #1 patient was screaming as nurse stepped out of exam room to get Varivax.  Mother called out to nurse saying patient seemed to go limp and his eyes rolled back.  He was in his mothers arms at the time.  When nurse returned to the room patient was staring straight ahead and was unresponsive.  His respiratory status was good.  The event lasted approximately 1 1/2 minutes.  Dr. was called and examined patient.  Patient continued to have a glazed appearance and then started crying.  A EEG was scheduled due to the seizure event.
cold chills; Cold chills; fever of 102.1; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1). On 27-Feb-2021, NASOPHARYNGITIS (cold chills), CHILLS (Cold chills) and PYREXIA (fever of 102.1) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102.1 High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient called 911 for the symptoms but was not taken to the hospital.   This case was linked to MOD-2021-059479 (Patient Link).
This spontaneous report as received from a pharmacist via Novartis and was assigned manufacturer report number S2012US04359 refers to a female patient of unknown age. The patient was vaccinated with M-M-R II lot number not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced adverse event (unspecified) while on M-M-R II. The outcome of adverse event (unspecified) was unknown. It was unspecified if the patient had sought medical attention. This was originally reported by an unspecified source working in a pharmacy. Additional information has been requested.
I felt like I had a UTI; This is a spontaneous report from a contactable Retired Nurse (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL1283), via an unspecified route of administration on 28Jan2021, as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the Nurse (patient) felt like to have an UTI (urinary tract infection). The Nurse got the Pfizer Covid vaccine yesterday and had the issue hence went to the Gynaecologist on Tuesday because nurse felt like to have an UTI. However, the Gynaecologist said it did not look like it was an UTI and investigated for urine which looked negative. The nurse's urine was sent out for a culture which came positive. Therefore, the gynaecologist wanted to treat the nurse with Cipro for 3 days, but the nurse had a question if Cipro could be taken after just taking the vaccine. Nurse was informed about role Pfizer Drug Safety department and asked for the permission to probe further question to which the Nurse denied hence further probing could not be done. On an unspecified date, the patient underwent laboratory investigations included urine investigation which looked negative and urine culture showed positive. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
PNEUMOVAX 23 dose administered to a paitent in a shorter interval than recommended; This spontaneous report was received from a vaccine administrator and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.          On 22-NOV-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for prophylaxis. It was reported that this dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was administered in a shorter interval than recommended.
A 12 years old female patient accompanied by mother to receive firs dose of Pfizer.   When the pharmacist tried to administer the vaccine, she noticed the arm muscle was tensed and experienced a bit of difficulty to penetrate the needle in to the arm.  Once the needle inside,  the pharmacist tried to inject the vaccine in and noticed the plunger moved a bit and then stopped.  She tried to use a bit of force to push the vaccine in further but it did not work.  So the pharmacist pulled the injection out and attempt to administer again.  She did inform patient's mother that she has to try again.  This time the injection went well and as precaution,  the pharmacist did not inject all the vaccine in since she knew the patient got a bit of the vaccine in on the first time.   Mother was advised to give patient a dose of Tylenol or Ibuprofen that night (if patient is not allergic to those meds) to help out with the soreness.  Mother came back to store the next day to ask more questions but there was another pharmacist on duty.  That pharmacist did explain to patient's mother the mechanism of vanish point syringe and how it is supposed to work.  He relayed the message with the administering pharmacist to follow up.   The administering pharmacist called on Friday (May 21) but could not leave the message.  She tried again on Saturday (May 22) and was able to explain in detail what happened that day.  Her concern is the possibility of her daughter getting double dose and the long term effect of the vaccine.  Pharmacist did ask how the patient doing  and exhibits  any noticeable or  severe side effects beside soreness.  Mother said so far she is ok besides sore arm.   Pharmacist advised mother to monitor the child for a few more days to be safe and call the pharmacist or even her pediatrician if there is further concern.  Pharmacist also will follow up with mother to check on how the patient is doing
Itching over 3 days, rash and pain of shingles after that. Still current with shingles at this time.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: redness around the injection site-Mild
Information has been received from a nurse concerning a 6 or 7 years old male who was vaccinated with at least two doses of VARIVAX (Merck). The nurse reported that the patient had chicken pox every time when he was exposed to it in the community. The physician believed that it was not breakthrough, but rather an exposure to the wild type. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
COVID-19; COVID-19; Exposure to communicable disease; Fluid in middle ear; Diarrhea; Vertigo; Back pain; Gastric infection; dose 2  subcutaneous, administration; Flu like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4153593-00.  A 85 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single and subcutaneous, administration date 07May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; EXPOSURE TO COMMUNICABLE DISEASE (non-serious), outcome "recovered" (2021), described as "Exposure to communicable disease"; MIDDLE EAR EFFUSION (non-serious), outcome "unknown", described as "Fluid in middle ear"; DIARRHOEA (non-serious), outcome "recovering", described as "Diarrhea"; VERTIGO (non-serious), outcome "recovering", described as "Vertigo"; BACK PAIN (non-serious), outcome "not recovered", described as "Back pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset May2021, outcome "recovered" (2021), described as "Flu like symptoms"; GASTRIC INFECTION (non-serious), outcome "recovered" (2021), described as "Gastric infection"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 07May2021, outcome "unknown", described as "dose 2  subcutaneous, administration". The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of VERTIGO, EXTRA FLUID IN EAR, DIARRHEA, COVID TWICE, BACK PAIN, FLU LIKE REACTION, CAUGHT A BUG FROM GRANDCHILDREN/IT WAS STOMACH VIRUS unknown onset and CAUGHT A BUG FROM GRANDCHILDREN/IT WAS STOMACH VIRUS unknown onset was not provided. reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available in narrative the reported  events of  VERTIGO, EXTRA FLUID IN EAR, EXPOSURE TO COMMUNICABLE DISEASE  ,DIARRHEA, LOE, BACK PAIN, FLU LIKE REACTION, assessed as related to suspected vaccine BNT162B2. However the event of gastric infection is assessed as unrelated to suspected vaccine.
Severe chills and shaking for 4-6 hours between 2 a.m. and 8 a.m. Feb. 27, 2021.  Fever of 100.2 after taking tylenol and Advil.  Some nausea.  Body aches and joint pain.  Extreme tiredness.
Began feeling itchy across front trunk and bilat upper arms and back of knees while in a meeting about 4h after receiving flu vaccine. Noticed she had developed a rash at the sites she was itching.
Pain throughout upper arm started within the hour. Chills and low grade fever started at 2am and lasted for about 4hrs. Felt fatigued throughout the day and slightly dizzy, but felt much better. At 4pm, the fatigue increased and the chills/fever/aches returned. Fever went up to 102.5 and came down slightly with ibuprofen. As of 8:30pm, still feverish, achy, and cold.
Client was sitting in chair-fell out of chair. Pale, shallow respirations. Lasted about 15 sec. Client had not eaten since breakfast. Was feeling better at 5:10pm. No longer pale respirations were normal.
PATIENT DIDN'T HAVE AN ADVERSE EVENT BUT POTENTIALLY RECEIVED A DOSE FROM A LOT THAT EXPIRED ON 9/30/22.  DATA HAS ACTUALLY SHOWN THAT THE VACCINE IS STABLE UP TO 10/19/22
The morning after I received the injection, I was sitting at the table on our back porch tending to an injured bird that had hit one of our windows.  Only a minute or two after having sat down, I became extremely hot, light-headed, and nauseous.  I sat the bird down on the table, stood up, and began walking toward the patio door.  As I approached the door, my left arm (the same arm in which I received the injection) began twitching uncontrollably.  I had to reach across my body to open the door with my right hand.  Upon entering our house, I collapsed to my knees and fell forward.  I was able to catch myself from completely collapsing, but then my upper body began to convulse forward and I was unable to stop myself from slamming my head against the floor.  I was completely aware of what was happening, but I just couldn?t control my body.  After multiple convulsions, perhaps 10 ? 12, the convulsions stopped.  During the repetitive impacts with the floor, my nose was cut rather severely, and my forehead suffered a significant abrasion.  Roughly a minute after the convulsions stopped, I began to feel extremely hot and nauseous once again and then vomited.
14Aug07 4:30 P.M. Shots administered at clinic.  15Aug07 6:30 A.M. Patient awoke with 101.6 degree temperature, and localized mild swelling at injection site.  Began alernating schedule of ibuprofen and acetiminophen every three hours (or so).  5:00 P.M. Patient's fever rises to 104.0 degrees, swelling increased to moderate with acute pain at injection site.  16Aug07 6:00 A.M. Patient's fever has dropped to 103.0 degrees.  10:45 A.M. Patient's fever reduced to 88.8 degrees.  Treatment continues.
one eye is swollen shut; swelling around breast implant area; sensitive to the touch; swelling face; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (one eye is swollen shut), SWELLING FACE (swelling face), IMPLANT SITE SWELLING (swelling around breast implant area) and VACCINATION SITE PAIN (sensitive to the touch) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy bilateral. Concurrent medical conditions included Breast cancer.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced SWELLING FACE (swelling face) and VACCINATION SITE PAIN (sensitive to the touch). On 08-Feb-2021, the patient experienced EYE SWELLING (one eye is swollen shut) and IMPLANT SITE SWELLING (swelling around breast implant area). The patient was treated with FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (one eye is swollen shut), SWELLING FACE (swelling face), IMPLANT SITE SWELLING (swelling around breast implant area) and VACCINATION SITE PAIN (sensitive to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given.  Additional treatment includes steroids.