chrisvoncsefalvay/vaers-outcomes huggingface dataset:
made an error and administered IPOL for the ppd test with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 16-year-old female patient for whom, made an error and administered IPV (VERO) [IPOL] for the ppd test 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 B; MENINGOCOCCAL VACCINE A/C/Y/W; and INFLUENZA VACCINE for Prophylactic vaccination.  In the mid to late afternoon on 28-Mar-2023, the patient received a dose of suspect IPV (VERO) Suspension for injection (strength: unknown) (lot number: V1A024M, expiry date: 17-Feb-2024) via subcutaneous route in the left forearm for TB skin test (Tuberculin test) and on the same day a new medical assistant made an error and administered ipol for the ppd test with no reported adverse event (wrong product administered).  It was reported, Nurse practitioner states that yesterday she ordered a ppd test for a patient. Do you have any information that I can tell them about Ipol given subcutaneously or intradermally? Is there any information to indicate that it could be harmful or a problem for the patient?. It is unknown what volume of Ipol was administered. The caller just found out about the error when the office called her, as she is off work and at home today. The error was discovered when the medical assistant (MA) asked the head nurse, how to document the administration. When the head nurse looked at the numbers, she knew it was Ipol instead of ppd that was given. The exact reason for the error was unknown. The caller stated, "we are thinking the MA just didn't look. It was poor attention to detail. The dose was administered by a Medical Assistant.   Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was 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.
Approximately 4 hours after my 4th dose vaccination I experienced pain in my left arm (vaccinated arm). It was excruciating and made it difficult to drive - for the next couple of hours it got worse than usual and I really couldn't lift my left arm. When I was lying in bed and trying to sleep it got more painful that it is. The next day, I couldn't use my arm at all - I tried cold and hot compress but nothing really worked. I also took Naproxen and Tylenol to suppress the pain - it was able to help me temporarily but it would eventually come back. I went to an Urgent Care a week ago because the pain never went away - and the physician who examined it said there was no sign of infection and said it might've been an injection site reaction. I was advised to see a sports medicine doctor who I'm going to see today.
Instantly hurt and never stopped hurting at the injection site. My entire shoulder, joint and next are in extreme pain where I can not do my job properly without over the counter pain medication.
No adverse effects reported; Pharmacist reported the patient inadvertently received an expired dose of VARIVAX (N017700, expiration 6/9/2019) on 7/3/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-JUL-2019, the patient was vaccinated with a dose of expired varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot # N017700 has been verified to be a valid lot number, expiration date was reported as 09-JUN-2019 and was confirmed to be valid; exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a sterile diluent (lot # S008565 and expiry date 09-SEP-2021). No adverse effects reported.
pt recv vax in 1972 & 1992 pt failed to seroconvert & approx 6yr ago devel measles;
This spontaneous report as received from a medical assistant concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX (does, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported that unspecified patients received improperly stored RECOMBIVAX HB exposed to 49F for 35 minutes, on an unknown date. No adverse effects were reported.  This is one (1) of four (4) reports from the same source (MARRS1408USA016198, 1409USA006389, 1409USA00638 and 1409USA006390). Additional information has been requested.
can not sleep, when adverts reaction happened up to today I have had 26.5 hrs of sleep
Stroke; Can't walk; This is a spontaneous report from a contactable consumer. A 4-decade-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization.The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date, the patient experienced Stroke and was unable to walk. The reporter stated she was told, from the group of employees, that they know a woman, who was in her 30's and healthy, that had a stroke, and can't walk after the Pfizer vaccine. Reporter stated she was at a pharmacy and was told by the pharmacist that the BioNTech vaccine was the one that was not FDA approved, and the vaccine that was approved, was not in stock. Reporter stated she was told that some employees are sick with Covid right now, after having the Pfizer vaccine. Reporter stated that her personal surgeon, told her, not to get the Pfizer vaccine, and to wait for other vaccines, such as Novovax. Reporter stated her surgeon is not recommending the Pfizer vaccine to his employees. Reporter stated telling their employees that Pfizer is only 35% effective, not 95% effective. Reporter stated the employees were told that only the vaccinated employees got Covid, not the unvaccinated employees. Reporter does not provide any specific details. Reporter stated her surgeon was not recommending the Pfizer vaccine to his employees. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed thigh swelling and redness 10-15min prior to mommy pager call. No treatments to date as mother on way home from MGM's house and father just arrived home from work. He had only seen a photo sent to his phone. Recommended Tylenol and cold compresses and evaluating leg to see if good color to leg, ensure he is moving it and monitor for changes in redness or swelling. If erythema spreads upward, worsening pain or swelling, increased fussiness or any other concerns, recommended bringing him into the ED to have a provider look at his leg. Father indicated his understanding.
urinary side effects; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT DISORDER (urinary 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT DISORDER (urinary side effects). At the time of the report, URINARY TRACT DISORDER (urinary side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment information was not provided.
Redness and heat at injection site and down arm - started 3 days after immunization.
On July 2nd she got her 2nd vaccine (should have been given on June 30th);; Case reference number US-BN-2021-002109 is a spontaneous case report initially received on 20-Jul-2021 from a health care professional via Agency (reference number: USBAV21-0367) and concerns a 33-year-old female patient.  The patient's current medical conditions included bipolar disorder and schizophrenia. The patient was a smoker.   The patient's concomitant medications included HRIG (immunoglobulin human anti-rabies).  On 27-Jun-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine, batch number was not provided) at a dose reported as one injection, administered intramuscularly, for post-exposure prophylaxis.  On 30-Jun-2021, the patient was supposed to receive the second dose, but the patient did not show up. On 02-Jul-2021, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine, batch number was not provided) at a dose reported as one injection, administered intramuscularly, for post-exposure prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').    The day 7 shot should have been on 4-Jul-2021, but since the patient was vaccinated with the second dose two days earlier, no vaccine was administered on that day.  At the time of this report, it was unknown whether the patient developed any adverse event.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed for RabAvert per convention. Reportedly, the patient did not show up when second dose of vaccine was scheduled and received it two days after, what bis considered as inappropriate schedule of product administration. No adverse event was reported. Inappropriate schedule of product administration is not related to pharmacological properties of suspect product, but to human action. Case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed for RabAvert per convention. Reportedly, the patient did not show up when second dose of vaccine was scheduled and received it two days after, what bis considered as inappropriate schedule of product administration. No adverse event was reported. Inappropriate schedule of product administration is not related to pharmacological properties of suspect product, but to human action. Case is considered as non-serious.
Vomiting; fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 10:30 (Lot number: Fk5618) at the age of 7 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 24Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 24Nov2021 12:00, outcome "recovered" (Nov2021), described as "Vomiting"; PYREXIA (non-serious) with onset 24Nov2021 12:00, outcome "recovered" (Nov2021), described as "fever". Therapeutic measures were taken as a result of vomiting, pyrexia.  Additional information: Patient was not tested covid post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Pain in shoulder when using arm. Numbness, extending down to my finger tips - steadily getting worse several weeks after shot
shingles; sores in mouth; mouth felt weird; eyelids felt heavy; felt tired; Headache; chills; fever and chills; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6199) via an unspecified route of administration, administered in Arm Left on 08Mar2021 as DOSE 2, SINGLE (at the age of 72-year-old) for covid-19 immunisation. Medical history included hypertension, blood pressure abnormal, blood potassium decreased. Concomitant medications included triamterene taken for blood pressure abnormal; potassium chloride taken for blood potassium decreased. Patient received the first dose of the Covid-19 vaccine on 15Feb2021. Lot: EM9809, NDC and Expiry not provided.On 09Mar2021, patient had the normal fever and chills, headache and all that stuff for a day or two. On 11Mar2021, patient developed sores in her mouth. The patient thought she had a canker sore. The patient went to the dentist. The dentist was able to see the sores and thought it was shingles. On an unspecified date patient had the shingles vaccine. On 10Mar2021, her mouth felt weird two days after she received the Covid-19 vaccine. Patient didn't relate this to the sores. Patient rinsed her mouth with Listerine 3-4 times day. It was sore when patient rinsed her mouth. Patient dentist appointment was previously scheduled. Patient kept rinsing with Listerine and it improved. The dentist took a picture of the sores and send it off to get another opinion. Patient added that her eyelids felt heavy and felt tired. After she got home remembered she had the vaccine and the dentist probably didn't know that she had it. The outcome of sores in mouth and mouth felt weird was resolving and other events was resolved on 10Mar2021.   No follow-up attempts are possible. No further information is expected.
Patient reported 4 days later a rash broke out on his left trunk of body (Waist to the left shoulder level) and continued down his left to the elbow. Had blotchy connected rash over the area. The rash had a burning sensation or burning pain. Patient DID NOT seek treatment from his family doctor. He treated it with over the counter hydrocortisone 1% cream for 4 to 7 days after rash appeared. Reported the adverse reaction to the pharmacy on 3/29/19.
Patient is being seen today due to a rash that developed after receiving first dose of her Pfizer vaccine 2/18/21. Rash appeared on 2/22/21, mostly on the tops of her feet and her face. A few very mild patches on her body. She has been taking Benadryl and has used Cortisone 10 on the itchy areas. She says what alarmed her was that her eyes felt dry and tight. Nose was also puffed up and felt a slight sensation in her ears and teeth. No tightness in throat or difficulty breathing. No swelling in lips or tongue or throat. She has no redness at the injection site.
bruse from the point of injectin 2-3in wide down to elbow (about 6in)
Sick for just one day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for just one day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 ILLNESS (Sick for just one day). At the time of the report, ILLNESS (Sick for just one day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was reported that patients daughter was ok. This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID vaccine on Wednesday this week (23Dec2020) and she tested positive for COVID yesterday (25Dec2020). She wanted to know if she should take the second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a healthcare worker refers to a 18 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. Approximately in April 2018, reported as 2 months ago, the patient was vaccinated with one dose GARDASIL 9 by an intramuscular route of administration (dose, lot # and expiration date were not provided) for prevention of HPV. It was reported that, on the same date, the patient fainted (syncope) shortly after receiving the vaccine. The reporter stated that the patient recovered the same day the vaccine was administered while in the office. The causality between the event and GARDASIL 9 was not reported.
Dermal fillers in check became swollen and tender. I took Benadryl the following day and swelling was completely gone within 36 hours after.
Patient developed swelling of right jaw, and right side of neck; hives and splotches on right arm, left arm, right leg, and back.
Received 3rd booster dose of Pfizer vaccine on 8/23/2021. My husband had a laboratory-confirmed breakthrough case of COVID-19 on 8/31/2021, and I was exposed. I limited my exposure to him but developed symptoms on 9/9/2021. I took a home test that was positive on 9/92021. I was not tested any further and am confident in my testing ability due to my licensure as Medical Laboratory Scientist. I have worked in many medical labs that provided this type of testing. I had brain fog, fatigue, chills, sweating, headache, body aches, coughing, sinus pressure, and loss of taste and smell. I received IV Regeneron monoclonal antibody therapy in the early hours of 9/11/2021. My illness lasted from 9/9/2021 to 9/14/2021.
arm hurt; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and FATIGUE (tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Perinatal stroke (Patient had a massive stroke on birth and lost a part of the brain.). Concurrent medical conditions included Penicillin allergy, Palsy and Disability (Handicapped).    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (arm hurt) had resolved and FATIGUE (tired) outcome was unknown.            Concomitant medications was not provided. Treatment details were not provided.
G62.9 PERIPHERAL NEUROPATHY 4/26/2023 AORTIC VALVE STENOSIS
Patient received third shot on November 13, 2002. On night of November 14, patient noticed his right arm was irritated and he had to keep rubbing it. On November 15, when released from night shift he noticed reddening to skin on right upper arm, hot to touch and swollen. The measurement of rash/red area is 8.75 by 9.5in. Patient states pain due to swelling in his arm.
On 8/24/2021 I had a tickle feeling in my throat. I couldn't clear my throat. On 8/26-8/27 I had chills and a fever. Those symptoms lasted through 8/30/2021. On 8/30/2021 I had congestion and ringing in my left ear that lasted up to 9/15/2021. On 9/15/2021 I saw the doctor for the ringing in my left ear. I was diagnosed with hearing loss in my left ear. I was prescribed triamterene 25mg 1xday for it. On 9/29/2021 my right eardrum clogged and popped. On 10/1/2021 I went back to the doctor. The doctor recognized hearing loss in my right ear as well and started me a prescription for prednisone 9xday for 4 days, then 6xday for 4 days, then 3xday for 4 days, then 1xday over a period of 2 weeks. On 10/13/2021 I went to see the doctor again and my hearing loss has improved in both ears since the last visit.
Loose projectile stools about 3-4 hours after injection. This also happened with the first dose which was recently reported because I did not link or to think it was related to the vaccine until the same symptom of upset stomach followed by shooting, watery, stools. The last episode ended over a week. If like before with the first vaccine shot, the diarrhea will occur every evening for about 9 days; however, unable to predict this course/cycle with this second vaccine. I mentioned to my PCP. Meanwhile I just tolerate symptoms with Imodium, hydration, and rest.
This spontaneous report was received from a Pharmacist, referring to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with 12 doses of improperly stored VARIVAX (which had a lot # L037561 and an expiration date of 29-SEP-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of VARIVAX (which had a lot # L013066 and an expiration date of 14-APR-2017) had also been improperly stored and had been administered. The vaccines experienced the following temperature excursions on the following dates: 21 F for 5 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
I got a rash at the injection site. The rash was rather large and accompanied by warmth and itchiness at the injection site. It began a few days after the injection site but became large and noticeable about 1 week after vaccination. It resolved about two days ago but still have mild itchiness intermittently.
Patient had second Moderna COVID shot yesterday and he can tell that he is in atrial fibrillation.   He remembers having palpitations on august 24 so they told him to wait to get the second shot. He was feeling fine yesterday just prior to getting the shot.   He admits to palpitations today and feels the "pounding".  He was seeing cardiology through telehealth. The PT just got a new one and he was going to establish with them in person, but has not yet done so.   mild shortness of breath  fatigue, brain fog shakiness headache this am no chest pain, pressure tightness of discomfort  dizzy and lightheaded   EKG in office showed he was in atrial fibrillation with rapid ventricular response. He is not on any blood thinners or anticoagulants and he was brought to ER for hospital admission.
Pt accidentally given Moderna Monovalent for 6m-5yr instead of Moderna Monovalent age 6-11 yr. No adverse reaction noted.
Client states he experienced pain in left deltoid  several hours after injection site near the Tdap site and for several weeks following vaccine injection. Pain reportedly occurred mostly during flexion and exertion of left deltoid. During the first month after  vaccines were given he reported pain I left deltoid when performing moderate to heavy lifting . Pain has gradually decreased since returning from trip abroad  at the beginning of June but continues with activities such as heavy weight lifting. Dr.'s  assessment today was noted and decision was made to monitor symptoms for 1 month then consider plan of action if pain continues.