chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently administered an expired dose of adacel prefilled syringe with no reported adverse event; Initial information received on 21-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 years old female patient who was administered an expired dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] prefilled syringe with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W Conj (Crm197) (Menveo) for Prophylactic vaccination.  On 20-Mar-2023, the patient received 0.5 ml Total (1X) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: U6923AA, Expiry date: 21-Jan-2023) (with an unknown strength) via intramuscular route in the left deltoid for immunization.  On 20-Mar-2023, the patient was administered an expired dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine prefilled syringe with no reported adverse event (expired product administered) (Latency: same day).  It was reported, Caller stated that they administered a dose to a patient, but the dose expired 21Jan2023. Caller is asking for efficacy information or any possible side effects they should watch out for.  Action taken: not applicable.  Outcome: Unknown   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 guidelines. 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.
My first vaccine was administered on 2/26/2021. It was Moderna, 025A21A. It was given by injection in the left arm. My second vaccine was given on 3/26/2021. It was Pfizer, er8730. It was given by injection in the right arm. I have called the pharm and the CDC and no one really knows how this is a problem. The CDC website says that the vaccines should not be mixed.  So far, I have not had any adverse reactions but I do not know what the future holds.
Major headache resulting in dizziness, nausea, vomiting, weakness, itching all over body, redness around injection site larger than a quarter.
This spontaneous report was received from a physician regarding unspecified number of patients of unknown demographics. There was information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored MMR II lot # K014833, Expiration Date-14-SEP-2016 (dose strength and route was unknown). No concomitant medication was reported. No adverse event reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date (reported as when the patient was a baby) the patient was vaccinated with a dose of VARIVAX, for prophylaxis. On an unknown date (reported as when the patient was a first-grader) the patient developed chickenpox. The outcome of chickenpox is unknown. The causality assessment was unknown.
Day of immunization developed erythema induration pain anterior to (R) triceps immunization site. Pain, itching (+) fever/chills no SOB, CXP, hives, LAD.
Diarrhea; Swelling on the lower Lip and left facial area; Swelling on the lower Lip and left facial area; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 13Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included asthma, sinus and sensitive to egg white and milk. Concomitant medication included simvastatin, losartan and syzygium jambolanum. The patient experienced diarrhea, swelling on the lower lip and left facial area on 14Jan2021 09:00. Outcome of the events was recovering. No treatment was received for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
This spontaneous report was received from an office manager via company representative referring to a 67 year old female patient. The patient's concurrent and historical conditions, as well as the concomitant medications, were not reported. On 21-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N025384, expiration date 19-APR-2019,(unknown strength, route of administration) for prophylaxis. On the same day, after the vaccination was received,  the patient experienced swelling and pain in her left arm (peripheral swelling and pain in extremity). The patient was hospitalized from 28-FEB-2018 to 01-MAR-2018. The outcome and the causality of the events in regards the therapy PNEUMOVAX 23 was not reported.
This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received in 2018).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got two shots of Shingrix which he/she forgot about and got another Shingrix shot recently, which led to extra dose administered.  The reporter asked if this was a problem. No contact details were available.
On Tuesday, 6/18/2019 began to feel soreness and stiffness in right shoulder and neck area. I felt like it was flu symptoms. On Wednesday 6/19/2019 feeling tired, sore , began to research symptoms for Lyme's disease, inasmuch as ticks are often pulled from my body. On Friday, 6/21/2019 feeling very tired and sore, I then had a very painful earache and the feeling as if it was full of water, as a swimmers ear symptom, and within 3 hours had a migraine, something  I have had but a few in my lifetime.  Friday evening, I noticed a rash on my right shoulder and neck area, yet no itch or inflammation as I normally experience with the urticaria experienced with allergies.  Saturday 6/22/2019 and Sunday 6/23/2019, the rash began to spread down my spinal column on neck and right ear , scapular, entire right shoulder and right pectoral , and becoming very sensitive to touch and painful .My right scalp felt as if it was sunburned and sporadically a severe pain would penetrate deep inside my right ear and temporal area. A very painful area developed along the right side of my neck at the hairline, yet not the same time as ear or temporal pains.   Monday, 6/24/2019 I called my family practice and was seen by Dr. and she determined it to be shingles.  She prescribed medications and the symptoms continue.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Influenza vaccine (the patient had never experienced any reaction in the past after vaccination with flu shots). Concurrent medical conditions included knee arthritis. Concomitant products included ALDACTONE, SINGULAIR, progesterone, estradiol and ADVAIR DISKUS. On 22nd September 2015, the patient received FLULAVAL QUADRIVALENT. On 24th September 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain, stiffness, arthralgia, stiff joint and joint range of motion decreased. On 25th September 2015, the patient experienced pain in hand. On 27th September 2015, the patient experienced shoulder pain. The patient was treated with CELEBREX. On 29th September 2015, the outcome of the injection site pain, stiffness, arthralgia, stiff joint, pain in hand, shoulder pain and joint range of motion decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, stiffness, arthralgia, stiff joint, pain in hand, shoulder pain and joint range of motion decreased to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient was a employee. The reported injection site was right arm. The patient did not experience any adverse reaction following previous vaccination. On 24th September 2015, 2 days after receiving FLULAVAL QIV, the patient experienced pain and stiffness in her right hand and wrist. The pain and stiffness really resulted in a decrease range of motion when performing certain activities. The decreased range of motion was similar to someone who suffered from chronic arthritis. After one day the symptoms started to dissipate with little residual pain. On 25th September 2015, 3 days after vaccination, the patient experienced pain in the left hand and wrist. The pain and stiffness lessened after one day but with residual pain. After almost complete resolution, the pain and stiffness returned to both hands and wrists on 27th September 2015. On 27th September 2015, 5 days after the vaccination, the patient also experienced quite significant pain and stiffness in her left shoulder and was very painful that she was unable to sleep that following night. Throughout the entire course of pain, the patient was taken CELEBREX 200 mg with little relief. She normally takes this medication. The patient also added that she experienced pain in right and left knees, but has a history of arthritis. She noted that pain was more severe than it normally is with just her arthritis. The pain was particularly in the left knee. The patient could not recall when the pain started following the vaccination. The batch number and expiry date of the vaccine were unknown. Medical attention was not required. The patient did not consult a physician regarding the events. The patient was not hospitalised because of the reaction.
Pt reported vax w/ Hep B vax in 1984, @ that time hepatitis B surface Ab was pos, but was unaware if any other Ab's or Ag were tested.Mar91 test showed pos for HBCAb & HBSAb & neg for HBSAg.Pt recovered.
Parent of child contacted clinic 11/15/2018 reporting that child had muscle soreness since vaccination 11/14/2018. Child reported feeling dizzy and tired after leaving the clinic yesterday. He says that he went home and fell asleep and felt weak when he woke up. He stayed home from school today because he continued to feel dizzy, weak, and tired, and still has muscle soreness. He reports more pain in right arm than left arm.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 19-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Patient received vaccine and was standing behind me while I administered a vaccine to her mother.  The patient then fainted while my back was turned, falling on the floor and hitting her head.  This resulted in a bump on her forehead, but no blood.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On unknown dates, the patients were late to receive second and third doses of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported. This is one of several reports from the same reporter. Additional information has been requested.
Day of next day after vaccine administration-only had mild headache, thirst and fatigued.   I did have a hematoma and bruising, No fever On Jan 1st, I started feeling fatigued again and noticed round reddening approximately 2 inch in diameter appear about a inch under vaccination location which is still bruised.  There is no pain or itching at reddened site. Jan 2, 3 and 4th-Fatigue worsened and developed low grade temp never surpassing 100. My throat developed allergy reaction feeling, same reaction I get with nuts.  Throat did not swell and benedryl managed the reaction on Jan 3rd.  My eyes began swelling and I could not stop sneezing.  Developed laryngitis from the post nasal drainage.   I was up whole night but still went into work as normal on Jan 4th.  Struggled through the days but swelling and itching subsided.    I experienced the muscle aches on the 3rd and 4th. On Jan 5th, started feeling better and rested.  Still have reddened reaction on arm but is fading.  It is faintly visible today on Jan 6th, I feel better, just have the sneezing currently and a mild headache.  Benedryl is the only medication besides daily meds I took during the past several days.  I did not want to interrupt the immune system's work.
4-5 days after vaccine I noticed I had elevated heart rate and it felt like I was having a heart attack. My normal heart rate is 70 BPM but it was about 100 at resting and it was very concerning to me. I was always rushing to the ER or calling 911. On one hand I was experiencing the heart rate increase but it also increased my anxiety. At resting it felt uncomfortable and when going into palpitations it felt like I could hear my heart in my head and it lasted a long time, like a month or two. I bought a pulse ox machine to keep track and at resting it was always in the 95-100s. I went to the ER 3-4 times and they did an EKG and said it was elevated and not normal and they ran other tests and didn't find anything wrong. They checked for blood clots in lungs and all sorts of other tests but didn't see anything abnormal and said it could be an adverse reaction from the vaccine. I seen a doctor and they said it could be a reaction from Pfizer as well. My heart rate was at 110 when paramedics came one time and said they went to an older man's house and his heart rate was at 130/140 after vaccine. ENT told me to just wait it out. I just remember hearing my heartbeat in my ear and in my head. The doctors could feel my heart from the back to front and said it was beating harder than normal and could feel the palpitations. It was 6-7 months before I felt normal again.
Patient administered dose before recommended scheduled vaccine date; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received and does not contain any new information.
Pt vax w/3rd hepta B; exp severe joint pain, fatigue, myalgia, still having problems, & inc lymphadenopathy on 20SEP90;
Severe swelling on side of injection up into throat unable to move arm for two days due to swelling, severe headache severe nausea diarrhea abdominal pain ,  leg & arm pain,  significant overall  muscle cramping, tightness when I breathe, cough, fatigue
Fatigue (up to 36 hours after) headache (started about an hour after and slowly faded over 24 hours), neck/shoulder ache (still), rise in bp (still occasionally only), heart pounding and fluttering causing shortness of breath which feels like my panic attacks too so I?m not sure if they are related. Arm soreness immediately after up until now.
Received Pfizer vaccines on  2/25, 3/18/21 COVID-19 positive by PCR on  1/21/22 admitted to Hospital on 1/31/22 d/t COVID pneumonia, ARDS currently in ICU, intubated. underlying CAD, HTN
Site: Swelling at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.)-, Additional Details: Patient is a RN states she thinks it might be SQ insted of IM due to no systemic reactions and due to swelling and hardness of deltoid area post vaccination. Informed her to have MD check it out. Will reassess with her in a couple days after speaking to MD.
Very strong unbearable pain on the left lower back side; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 5W0150) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient was in good shape and workout daily. Concomitant medications included levothyroxine 137 mcg (MANUFACTURER UNKNOWN) and atorvastatin 40 mg (MANUFACTURER UNKNOWN); both were taken for unspecified indication since unspecified dates. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 11:30, exactly 24 hours after the vaccination, the patient experienced very strong unbearable pain on the left lower back side. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of unbearable pain on the left lower back side and included treating with 02 doses of Advil in 04 hr intervals, three times in a day. On 02Apr2021, next morning the patient felt better but during the day still had pain in the same area but able to tolerate with no medicine. The clinical outcome of the event very strong unbearable pain on the left lower back side was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax late 1995 & tested positive for hepatitis C on a routine blood donation screen;MD has repeated the test for hepatitis C & it is positive;
This client received a moderna vaccine from an LPN and walked over to the observation area and then complained of vision changes, sweating, tingling of extremities, vision problems and swelling of the throat. EMS was called. Client was talking and drinking water until EMS arrived (with in 3 minutes) and stated that symptoms were improving.
trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient experienced itching on legs arms and face along with hives; Headache getting severe by the minute; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received 2nd dose of bnt162b2 (BNT162B2; lot number EN5318) on 25Jan2021 intramuscular at right arm for COVID-19 immunization. Medical history was not reported. The patient had no COVID prior to vaccination. Historical vaccine include BNT162B2 for COVID-19 immunization. The patient had no other vaccine in weeks, concomitant drugs was none. The patient experienced headache getting severe by the minute. Patient experienced itching on legs arms and face along with hives and trouble breathing. Event start date was 25Jan2021. One epinephrine was received. Patient was taken to the hospital. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events headache, dyspnea, urticaria and pruritus are possibly related to suspect vaccine BNT162B2 administration. 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.