chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient passed out, (syncopoe), resulting in fall, 5-10 minutes later vomiting.  Called 911 and patient was evaluated on site, and refused any additional treatment
The expired product was store; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (The expired product was store) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The expired product was store). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (The expired product was store) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, there was a confusion between the expiration date printed in the carton the expiration date when the code was scanned.   The vial was initially refrigerated on 26-Oct-2021, the vial did not undergo any temperature excursion and patient did not experience any adverse events.  No treatment medications were reported.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ 2 ML, 10 unit dose tube, which had the lot # K022995, with expiration date 22-JUL-2016, orally (dose and dosage number were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursion of 24 hours. The highest recorded temperature was 47 F (8.333333333 Celsius degrees), the lowest temperature was not reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Redness, heat, knot, and swelling at injection site. Hives on other parts of the body.
Pt recvd 3 doses Engerix-B vax 7MAY91, 26JUL91, & 10JAN92 & 1/2 hr later exp pain in rt hand (in ganglia); the ganglia became swollen 1/2 inc to about 1 in in diam; 11JAN92 exp tiredness, nausea, lightheadedness;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Concomitant products included gabapentin, lorazepam, sodium chloride, Tamsulosin, AMITIZA and trazodone. On 9th June 2018 11:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received SHINGRIX in the left deltoid. At the time of vaccination, the patient commented that the injection was painful. The patient had not reported anything else to the pharmacy.
hotness at injection site; itching at the injection site; covid arm; swelling at the injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hotness at injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (covid arm), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (pain at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hotness at injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (covid arm), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE WARMTH (hotness at injection site), VACCINATION SITE RASH (covid arm), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (pain at injection site) had resolved and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.
I had mild fatigue; Fever; Chills; Fluzone High-Dose Quadrivalent Syringe shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Sep2021 16:00 (Lot number: FF2589) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), administration date 25Sep2021 (Batch/Lot number: unknown) as unk, single. Relevant medical history included: "BPH" (ongoing); "Inflammation" (ongoing); "Anxiety" (unspecified if ongoing); "Shoulder Occusion", start date: 02Jan2005 (unspecified if ongoing), notes: Pertinent details: Fixed; "Shoulder RCT", start date: 02Jan2006 (unspecified if ongoing), notes: Pertinent details: Repaired; "Kidney Stone", start date: 02Jan2017 (unspecified if ongoing), notes: Pertinent details: Removed; "Lymes", start date: 01Aug2020 (unspecified if ongoing), notes: Treated with antibiotics. Concomitant medication(s) included: TERAZOSIN taken for benign prostatic hyperplasia, start date: Jan2016 (ongoing); MELOXICAM taken for inflammation, start date: Jan2018 (ongoing); BUSPIRONE taken for anxiety, start date: Jan2017 (ongoing); IBUPROFEN taken for inflammation, start date: Jan2000 (ongoing). Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "I had mild fatigue"; PYREXIA (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "Fever"; CHILLS (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "Chills"; OFF LABEL USE (non-serious) with onset 25Sep2021, outcome "unknown", described as "Fluzone High-Dose Quadrivalent Syringe shoulder". Relevant laboratory tests and procedures are available in the appropriate section.Therapeutic measures were not taken as a result of fatigue, pyrexia, chills.I had mild fatigue, fever, chills, I did not treat with NSAIDS, wanting the vaccine to take full effect before or after. No follow-up attempts are possible. No further information is expected.
PATIENT SAID THAT SHE HAD A SORE ARM, AND THERE WAS A SMALL, HOT CIRCLE AT THE INJECTION SITE.  WHEN SHE NOTIFIED US ON 3/15/17, THE CIRCLE WAS NOW APPROXIMATELY 6 INCHES IN DIAMETER.
I have had a rapid heart rate and it only happens when I am sleeping or lying down. I also have a covid arm that has not went down.
It started on 20Sep2022. My head was stuffy had sore throat and crappy, chills and a low grade. I got a home test and tested positive. I left. I was working from home, I didn't feel well, I couldn't take a breath and ended up calling my doctor and was told to go to urgent care and they asked me to go the ER to check for pulmonary embolism. That episode went away and I feel had like the flu and COVID-19 Symptoms, congestion, cough, low grade fever and loss of appetite and fatigue. I am better but not fully recovered.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; NO APPETITE; NOT ABLE TO EAT; This spontaneous report received from a health care professional concerned a 48 year old male of white race and unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: 1 or 2 coronary stents, non-alcohol user, non-smoker and the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-AUG-2021, the patient began having symptoms of aching, congestion, generalized malaise, temperature ranging from 100-102 Fahrenheit, no appetite and not able to eat and also experienced the event of suspected clinical vaccine failure. Laboratory data included: Body temperature (NR: not provided) 100-102 Fahrenheit. On 17-AUG-2021, after receiving vaccine about 2-3 months ago, the patient was found positive to covid-19 infection (suspected covid-19 infection), however reporter was not certain on the type of test performed (nasal or throat swab, or PCR vs rapid). The reporter stated that the patient's health care professional was aware of the symptoms and positive test result. The patient's symptoms abated when the patient was given a steroid injection and anti-emetic, and that the patient commented that nausea he was experiencing (date of onset unknown) had improved and was able to eat solid food and drink soup and green tea.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from no appetite, and not able to eat, and had not recovered from suspected covid-19 infection, and suspected clinical vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190135.; Sender's Comments: V0: 20210837634-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a medical assistant and refers to a 17 year old patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 19-NOV-2018, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot # N034410 with expiration date on 01-FEB-2020 for prophylaxis (route of administration were not reported) instead of an unspecified meningococcal vaccine (unspecified). However, no adverse effects were reported.
1 of 4 pts exp an inject site reaction @ the DTP site only, approx 6 hrs p/immun; reaction consisted of swelling, redness, hot to touch & myalgia; required ER MD visit; treated w/Advil;
Fever 101 - 102 degrees fahrenheit, severe body aches, severe headache, weakness in joints Onset approximately 12 hours after injection with increasing severity until 24 hours after injection.  All symptoms tapered off by 48 hours after injection except for injection site soreness, which lasted 72 hours post-injection.
10-20-09 After lunch - school called to report redness at injection site, slight warmth and itchy. Denies fever or chills. Instructed mom to apply ice to area and may take BENADRYL for age and to contact MD or go to ER and that Dr. available for MD visit if needed.
back was hurting; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration from an unknown date to an unknown date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, it was reported that the patient was calling because the patient must schedule to get the second shot and do not know what to do, missed appointment because the patient didn't wake up early and didn't realize until woke up and missed appointment which was 12:20 today and want to know what will happen, what can be done to get second shot and do not know. The patient wants to know how to go back and reschedule, didn't know what to do, and missed schedule appointment for today. It was missed today because the patient's back was hurting, so did not realize after woke up. The patient added, "So there will be no harm to me if I get that after the schedule date, everything should be fine with me." When inquired about lot number, the patient stated, "Do you mean ER number because I do not see any other number, the ER number is 8733." The outcome of the event was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in the left deltoid.  Per mother, patient's arm was red and swollen for 3 days but is now fine.
positive experience; feeling better with NO joint pain; hips and shoulders NO longer hurting; Used to be in a lot of pain but so much better and definitely not as painful as it had bee; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION (positive experience), ARTHRALGIA (feeling better with NO joint pain), PAIN (hips and shoulders NO longer hurting) and PAIN (Used to be in a lot of pain but so much better and definitely not as painful as it had bee) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Mar-2021, the patient experienced FEELING OF RELAXATION (positive experience), ARTHRALGIA (feeling better with NO joint pain), PAIN (hips and shoulders NO longer hurting) and PAIN (Used to be in a lot of pain but so much better and definitely not as painful as it had bee). At the time of the report, FEELING OF RELAXATION (positive experience) and PAIN (Used to be in a lot of pain but so much better and definitely not as painful as it had bee) outcome was unknown and ARTHRALGIA (feeling better with NO joint pain) and PAIN (hips and shoulders NO longer hurting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Information has been received from a registered nurse concerning a 4 year old female with no known medical history and drugs allergies, who on 08-SEP-2005 was vaccinated with a dose of VARIVAX (Merck), subcutaneous. There was no concomitant medication. The patient was exposed to a person who had shingles two weeks ago. On 04-FEB-2009 the patient developed chicken pox. The patient had a fever from 04-FEB-2009 to 05-FEB-2009. The patient was seen on 05-FEB-2009 and it was reported that the patient had about 30 chicken pox lesions scattered on her face and upper torso. The patient was seen again on 06-FEB-2009 for follow up and the nurse mentioned that the patient had more lesions. No laboratories studies performed. The patient sought medical attention through an office visit. At the time of this report that patient had not recovered. Additional information has been requested. Follow up information received on 26-MAR-2009 from the registered nurse stated that it was a student patient with no known medical history and illness at the time of vaccination. The patient received a second dose of VARIVAX (lot # 647958/0068R), subcutaneoulsy into the left arm on 08-SEP-2005. On 04-FEB-2009 at 09:00 the patient developed more than 30 viscles and fever but the reporter stated that this was not an adverse event since the patient was exposed to shingles 2 weeks priot the vaccination. No laboratorties studies performed. The patient required emergency room visit/doctor visit. The patient recovered on 09-FEB-2009. No further information is available.
patient received a 2nd Bivalent booster after receiving booster on 10/25/22 that was not documented at the time it was given.  Pts PCP advised. Member did not have any reactions.
A physician reported that a 83 year old female sustained an injury to her lower leg on 5/4/00. Because she could not recall ever being immunized against tetanus, the physician initiated the primary immunization series, she received her second dose on 6/6/00. That day, she developed an injection site reaction characterized by an area of swelling, redness and pain measuring 4" by 4". By the time she was evaluated by the physician, the reaction had resolved.
Fever & pain x 2 days. Right arm swollen to elbow. Large area of rash.
The patient is a 62 year old female who presents with a complaint of a skin rash. The onset of the rash has been acute and has been occurring in a persistent pattern for 1 day. The course has been constant. The rash is characterized as red, pustular and raised above the skin. The rash was first seen on the back. It spread to the upper extremity (right side). There has been associated itching and pain, while there has been no chills. Overall examination of the patient's skin reveals - Skin is warm and dry. Note: she has rash consistent with shingles on right upper back...three patchy areas of vesicles. FAMCLOVIR 500MG; LORTAB 5 5-500MG. Follow up if no improvement or if symptoms worsen.
Pt experienced swelling in her left arm (about 1+1/2 inch in diameter) at injection site and still has it currently; she experienced fever and said she had fatigue for 3 days.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 4-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the first dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 13-JAN-2014 at 11:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Hives, itchiness on all over the body which occurred roughly 10 days after the booster. The symptom persists until now, but milder than the first encounter.
Delayed cutaneous hypersensitivity (Covid arm).  Red rash, warm to the touch at injection site.  No treatment required.  Occurred 8 days after injection.
Vaccine was administered in the right arm not centered in the deltoid muscle.  Patient came back after vaccine was administered with numbness and pain radiating down the arm.  Patient was assessed by NP and advised to use an ice pack.  NP will followup with patient.  Nurse that administered vaccine was educated on correct site to administer vaccines in the deltoid.
NOT A LISTED ADVERSE EVENT BUT PATIENT GOT THE SHINGLES APPROXIMATELY 1 MONTH INTO GETTING THE VACCINE. PATIENT WAS TOLD THIS IS NOT A LIVE VACCINE AND SHOULD NOT GIVE HER SHINGLES BUT WILL REPORT IT.
Patient received her vaccination from local Pharmacy. The first shot was given on 11/25. The second shot was administered on 12/15. By 12/18 patients jaw was so swollen she couldn't open her mouth. She was on a liquid diet for two days. After two days the swelling/pain moved into her throat. She developed a sore throat and fever. We had her tested for Covid-19 to double-check she hadn't contracted the virus. Her fever continued. She missed two days of school. She started to feel better about 7 days after the 12/15 shot.
My period came the day of vaccination around 6:00pm. Started with a clot and stopped, 2 days later it came again. I had my period 5 days before vaccination.; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:15 AM (Lot Number: EW0150) at single dose for covid-19 immunization. Medical history included hypertension, generalized anxiety and Gel nail enamel allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included propranolol (PROPANOLOL) taken for an unspecified indication, start and stop date were not reported; alprazolam taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (CETRIZINE) taken for an unspecified indication, start and stop date were not reported; fish oil taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced her period came the day of vaccination around 6:00pm. Started with a clot and stopped, 2 days later it came again. She had her period 5 days before vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse event. Outcome of event was not recovered. COVID-19 test post vaccination included nasal swab, Negative.  Follow-up attempts are completed. No further information is expected.
Day of vaccine, I felt tunnel vision as soon as she pushed the plunger, thereafter I got intermittent hot and cold sweats, headache, terrible shakes, then she was trying to take my BP which was so low she could not get a reading, after multiple attempts she did get a very low reading, my pulse was very low as well and barely felt. She went into the back and said she was going to get a EpiPen. Ambulance came, nurse did not get the chance to inject me with the EpiPen. they put a fan on me and had a pallet laid out for me to lay on. The made sure I was hydrated. I was impressed with how quickly and thoroughly they cared for me.  I was finally up and responding after a few minutes and doing well by the time the EMT's showed. I walked home and by the time I arrived I was exhausted and drained. I laid down and the next day I had aches and pains throughout my body, like shooting nerve pain. In my right arm I had pain so bad I could not hold the phone, extremely electric, like shocks, lasted for 10 minutes. The day after this I was fine, I do have numbness every once in a while in my left arm.