chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bleeding in stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (bleeding in stool) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (bleeding in stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (bleeding in stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. Treatment medication were not reported. The reported states that the patient experienced bleeding in stool after vaccination.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
3 days after vaccinations administered pt presented to the office with vomiting, decreased appetite, fever, coughing, Mother reported symptoms began after receiving vaccines
Expired fluzone high-dose quadrivalent, was administered to a patient with no reported adverse event; Initial information was received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68 years old female patient who was administered with  expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Feb-2023, the patient received total, 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ765AC and expiry 30-Jun-22) (expired product administered) (strength: unknown) via intramuscular route in deltoid (UNKNOWN IF RIGHT OR LEFT) for prophylactic vaccination.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event expired fluzone high-dose quadrivalent, was administered to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient was in to have Janssen vaccination at 12:30pm . She waited her appropriate time and felt fine. At 4:50 pm she developed a reaction of hives on the torso, legs and arms. She said she could not take the benadryl because it would be lock up her throat as has happed before.  She tried to contact md office, but they were closed and we suggested she go to ER and she proceeded to go to the ER.
Sharp abdominal pain, nausea, dizziness, headache and weakness. This has persisted throughout the day.
C/O itching (L) anterior arm below elbow. Approximately 1hr 15 minutes after receiving injection. No rash, swelling or discoloration noted. Redness not as signs of scratching at site. Ice pk applied with relief noted. Injection site no visible signs. Only slight redness where band aid was.
This spontaneous report was received from a health care worker referring to an unspecified number of patients' of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with inappropriately stored doses of PEDVAXHIB lot # I038502 (expiration date 16-AUG-2018) orally, (dose, dose number and frequency were not provided). Concomitant medications were not reported. The reporter stated that these unspecified number of doses of PEDVAXHIB were stored at 34 degrees Fahrenheit for 14 hours and the data logger was involved. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.
Twelve Moderna vaccines were given in office today. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. (Case #: MOD21-060693). Quality was also notified.   Patient notified with The Moderna Vaccine you received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. You have received your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
Scattered papules with erythema bilateral thigh. Mom reports child with increased fussiness. Received shots 9/7/04. Mom noted rash 9/10/04. No fever.
Patient within one minute after administration of Flu vaccine developed tonic motions (arched back, cllnched fist bilaterally, eyes rolled back) for approximately 10-15 seconds.  Then became diaphoretic, lethargic for next 15-20 minutes.
pt reported rash and swelling of arm at and around injection site, advised pt to follow up with md
Patient came back with antibiotic for KEFLEX 250 four times daily for 7 days due to cellulitis on her arm. Dr drew a circle around to monitor and pt seems to be doing ok.
Information has been received from a 26 year old female, through a pregnancy registry, with no medical history or drug allergies who on 7/19/04 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The patient reported that on 7/26/04, she found out she was pregnant and miscarried on that same day. The patient believed she was only a few weeks pregnant at the time of vaccination. Unspecified medical attention was sought, but no treatment was required. Additional information has been requested.
Soreness in injection site after 12 hours. After 18 hours, weezing , coughing, difficulty breathing. Deep breathing painful. Nauseous.   It is 5 am on the 18th, almost 3 days after injection.  Symptoms are getting better.  Still raspy when breathing. Will call My Doctor if continues
Extreme dizziness when I sat down in the couch. My head is spinning so hard. This is the first time I've experienced such a feeling. It is so severe. It is so scary. Then as the days progressed it mellowed down but this time the dizziness happens when I'm about to lay down in bed. When I raise or lower down my head from or to down position. After waking up in the morning to turn off the alarm clock my head will moderately spin. And when I get up, I will feel dizziness which I have never experienced in my life. I am a very healthy person and for the first time in my life I am experiencing this dizziness. I am very disappointed and sad if this dizziness will not leave me. It is like incapacitating. When I do stretch out in bed or I am in extreme sigh of relief, my head will spin. Its like when you are experiencing a sexual arousal my head will feel dizziness. It is triggered by head movement and feeling of arousal.
headache, dizziness, nausea and vomiting, fatigue, muscle aches
I cannot lift or barely move my right upper, arm since the vaccine I called the phone line  and they told me to fill this report ou
Rash all over the body associated w/ itchiness . Diffuse urticaria extended from head to abdomen, back & extremities Given benadryl Rx: prednisolone
mild case of Shingles on her face; This case was reported by a physician via sales rep and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received the 1st dose of Shingrix .5 ml. In November 2019, 1 month after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left deltoid and one month post vaccination the patient experienced a mild case of Shingles on her face.  The patient sought medical treatment at an urgent care and was given Valtrex.  The patient stated that the shingles were mild but went across her face.  The patient did not seek any other medical treatment after seeing the urgent care.  At the time of reporting she presented to primary care doctor for a regular appointment and mentioned what had happened after receiving the first dose of shingrix.
pt recvd vax; next day, exp a pruritic rash which was tx w/ dph; subsided;
Patient received second dose of Moderna vaccine at event.  Immediately he experienced nausea and vomiting.  He was very anxious about getting the vaccine.  Vitals were monitored and were stable.  He was observed for 30 minutes and did well with no further adverse reactions.  He contacted a family member to come and drive him home.
felt sensitivity in her arm as if she first got the shot; warm to the touch; tender; upraised irregular bordered red spot in the area where the vaccine was injected.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (felt sensitivity in her arm as if she first got the shot), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (tender) and VACCINATION SITE ERYTHEMA (upraised irregular bordered red spot in the area where the vaccine was injected.) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (felt sensitivity in her arm as if she first got the shot), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (tender) and VACCINATION SITE ERYTHEMA (upraised irregular bordered red spot in the area where the vaccine was injected.). At the time of the report, VACCINATION SITE DYSAESTHESIA (felt sensitivity in her arm as if she first got the shot), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (tender) and VACCINATION SITE ERYTHEMA (upraised irregular bordered red spot in the area where the vaccine was injected.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. No pertinent history, drug reactions or allergies were reported. On 27-AUG-2014 (Oka/Merck) PROQUAD (dose, dose number, route, anatomical location lot number and expiration date were unspecified) and (Oka/Merck) VARIVAX (dose, dose number, route,anatomical location lot number and expiration date were unspecified) were administered concomitantly to the patient. No adverse effect reported. No other concomitant therapies were reported. The outcome of the event was unknown. Additional information has been requested.
This is a spontaneous report from a contactable pediatrician communicated to a Pfizer sales representative. A female patient of an unspecified age and race/ethnicity (the grandparent of one of the reporter's patients) received PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced heightened immunologic reaction, like rheumatoid arthritis symptoms. The patient was being managed by a rheumatologist. The event had not yet resolved at the time of report. No follow-up attempts possible. No further information expected.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concurrent medical conditions and concomitant medications.  However, a contributory role of PREVENAR 13 might not be completely ruled out towards the occurrence of the serious event heightened immunologic reaction like rheumatoid arthritis symptoms considering the time association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt recv vax 27OCT97 & rt arm edematous, painful, hot to touch, reddened 9blotchy) by next morning;presented @ clinic s/s confirmed by nurse;states advised warm packs, cortisone, no further pneumovax;
Patient was anxious. After 15 minutes of administration, patient vomited. He waited 15 more minutes. Given water and cold pack; felt better. Told by parents he had a pizza right before vaccine administration.
A physician reported the occurrence of an injection site reaction in a child of unspecified age and gender who was vaccinated with DTAP (Infanrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. In April 2003, the subject received the fifth injection of Infanrix. "Within hours" post-immunization, the subject developed an injection site reaction characterized by redness, swelling and induration. The injection site reaction "was still present almost four weeks after administration".
This spontaneous report as received from a certified medical assistant refers to a multiple patients of unknown age and gender. No pertinent medical history or concomitant medications were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VAQTA pediatric, lot #L028666 with expiration date 04-NOV-2016 and lot #L042486 with expiration date 12-DEC-2016 (dose and route of administration not provided), and improperly stored VAQTA adult, lot #L048460 with expiration date 14-JAN-2017 and lot #M009786 with expiration date 26-MAY-2017 (dose and route of administration not provided). The vaccine products were exposed to the following conditions: temperature 0.3 degrees Celsius for 8 hours. There were no previous temperature excursion. The temperature excursion was captured via a Digital Data Logger. This is one of several reports received from the same reporter. Additional information has been requested.
Pain in my arm/ pain in the injection arm; 99.8 fever/ had fever about 100°F; Chills; pain in the injection arm like it was numb; This is a spontaneous report from a contactable consumer(patient). A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Mar2021 (Lot Number: EN6206, At the age of 51-year-old) as single dose for COVID -19 immunization. Medical history included Arthritis, sjogren's syndrome from an unknown date. Concomitant medication included methotrexate taken for an unspecified indication, start and stop date were not reported. Last Thursday, the patient got her first vaccine (Covid Vaccine) and she just have pain in her arm like they said and Friday, patient got a 99.8 fever and chills. One more thing, Yesterday, patient got chills again and it was just 99.8 fever but patient do not know if this thing is because of the vaccine, she do not know. The patient mentions that she need to get the second dose of the Pfizer covid vaccine and she would like to know which medication she can take since her physician told her that she cannot use Tylenol and she uses a lot of medications currently. She comments that after getting the first dose she had pain in the injection arm like it was numb and it went away next day. Next day she had fever about 100°F and it went away as well but this one came back 3 different occasions at the same time of the day after 3 days. She mentions that when she had this side effects she call Pfizer to report her experience and she had to talk with an agent but she doubts that everything she wanted to say was understood. Possible AE duplicate. The patient underwent lab tests and procedures which included Fever: 99.8/100 Fahrenheit on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Nova Nordisk Inc. (manufacturer control number: 0221504). A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient stated that her sugars have been higher since receiving vaccination and that it had caused her to gain 10 pounds. On an unknown date, the patient also had injection site swelling. The clinical outcome of the events, blood glucose increased, vaccination site swelling, and weight gain, was unknown.
I had sharp pain in my arm and shoulder.  These lasted for about 4 days.  No other symptoms other than that.
GBS paralyze short or long term side effects/GBS which acquired through the flu shot; GBS from the vaccination which can paralyze short or long term side effects; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced guillain barre syndrome (Verbatim: GBS paralyze short or long term side effects/GBS which acquired through the flu shot) (serious criteria GSK medically significant) and paralysis (Verbatim: GBS from the vaccination which can paralyze short or long term side effects) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were unknown.   The reporter considered the guillain barre syndrome to be possibly related to Flu vaccine. It was unknown if the reporter considered the paralysis to be related to Flu vaccine.   The company considered the guillain barre syndrome to be possibly related to Flu vaccine. It was unknown if the company considered the paralysis to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that just remember you could be one of the few that got GBS (Guillain Barre syndrome) from the vaccination which could paralyze you for short or long term and leaves side effects that would hang with you for a very long time.  The GBS (Guillain Barre syndrome) could be acquired through various vaccinations including the shingle shot and after getting it the patient wished, just had the flu rather than the GBS which he/she acquired through the flu shot. Additional Supportive Information: The follow up would not possible as no contact detail were available. The event paralysis was captured conservatively because as per description it seemed that the reporter himself/herself had experienced it.; Sender's Comments:  US-GSK-US2023AMR037296:same reporter
Patient complained of continued muscle soreness and pain in left deltoid area 8 days after receipt of Hepatitis A/B vaccine.  Physician examined.  No redness, warmth, edema or cellulitis.  Patient without fever.  Patient was prescribed Erythromycin 500mg 1 PO BID x 7 days and Advil recommended for pain.
Intense shakes, teeth chattering, stiff neck, locked jaw, then body would stiffen rigidly, then back to curled up and shaking uncontrollably...lasted several hours...next day, flu-like symptoms, sore joints, sore muscles, lack of appetite, exhausted (but it was a rough night.) It took four days for the malaise to lift.
The patient requested to be vaccinated while inpatient (swing bed) at hospital. He stated at the time he had not been vaccinated, but upon reporting the vaccine given to a facility that would be accepting the patient as a transfer/ admit they informed hospital staff he was previously vaccinated 4 month earlier.   Patient has no side effects or other adverse symptoms, this is being reported as a vaccine error.
My hair began to fall out a week after my second dose of the vaccine. It may be unrelated, but I wanted to report it just in case.  I had a fever from the night of 03/31/21 to 01/02/21 that was managed well with tylenol. I had hot flashes, chills, and joint pain during this time as well. Aside from my hair falling out, I feel completely fine now. As I said, the hair may be a coincidence as I have an unrelated autoimmune disease.
This happened exactly 6 months after the vx and wasn't sure if it's related. The ceiling was being repaired at work, and the fumes were so strong that the employee's were taking a lot of breaks to avoid the fumes. About 4 hours after this construction her heart rate was raised to 150 BPM, when it's normally about 60 BPM. She couldn't bring it back down and started using her inhaler about 4 times a day. She had a nuclear stress test performed and she was diagnosed with tachycardia. Then went to her Endocrinologist where she's treated for hyperthyroidism and found out that her hyperthyroidism progressed to hypothyroidism.
I the pharmacist was not there for the care of the patient. The clinics  directed all of the care and I was not tol dabout it until 2 hours post event. Patient presume dbetween 20 minutes to 2 hours post vaccination (undetermined as ressources mixed) had a pulse ox decompensation in the 70s.
Patient became clamy and lightheaded and sweaty.  Eye had significant dilation and he said he couldn't see well.  We determined he just passed out due to anxiety about getting a shot.  911 was called and an ambulance crew allowed him to leave and go home with his mother after the symptoms resolved.
PATIENT RECEIVED SECOND DOSE OF PFIZER COVID-19 VACCINE TOO SOON AFTER THE FIRST DOSE.
Patient was sitting down while receiving Influenza vaccine. After the vaccine was administered patient stood up and was looking at some stickers while suddenly the knees bended and the patient fainted. The parent was able to catch the patient before the patient reached the floor. Patient was unconscious for a few seconds (aprox.10 sec), but was breathing and had a pulse. Patient recovered consciousness on her own. Patient was checked by onsite physician who determined patient was oriented and stable.
After getting the shot pt became light headed and passed out.  We laid him down and elevated his feet and he came back immediately.  We had him rest on the ground for about 5 minutes then sat him in a chair for about 20 more minutes at which time pt said he felt fine and wished to go home.  We advised for him to have a driver take him but he declined.  Pt was very sure he was fine.  Prior to the shot he expressed anxiety and hesitation about the shot but wanted to proceed.  The adverse effect was most likely anxiety related.  We followed up with him at home approx 1 hour later and he was fine.  We advised he discuss reaction with MD.