chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a GI illness associated with nausea, vomiting, and diarrhea after a Tdap vaccination.  The patient is also having trouble ambulating and has a mildly ataxic gait.  She has no sensory symptoms but only motor and coordination symptoms.
Muscle pain; tremor; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration on the left arm on 24Mar2021 at 10:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of receiving the second dose COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient experienced muscle pain and tremor on 24Mar2021 at 22:00. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event muscle pain and tremor was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
Patient was given a dose of vaccine that had not been diluted properly. It was diluted with 1 mL of sterile diluent and not the 1.3 mL of saline that it was supposed to have been diluted with.
Patient presented to Clinic after receiving flu vaccine at a pharmacy 3 days prior. Patient developed swelling, tenderness and itching at injection site. No signs of infection.
2nd Day Pain and swelling under Left armpit where Lymph Nodes are.  Home Treatment Heat on area, Over the counter Pain Medicine.
I26.92 SADDLE PULMONARY EMBOLISM 3/28/2023 PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 3/22/2023 PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 3/22/2023 PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED
Within (4) hours mom noted that he had pain, resistance to walking and swelling of his right thigh. No fever. Later that evening thigh had become red and felt warm to the touch. He was evaluated in the ER on 06/05/2018,diagnosed with cellulitis and given one dose of KEFLEX. He was walking well. No fever. He was seen here in clinic on 06/06/2018 for a follow up. Dr. determined the quickness of development and resolution was not consistent with cellulitis, it is more likely a large local reaction to a vaccine known as hemihypetrophy.
Patient received 0.5mL, but the dose should have been 0.25mL.
pt recvd vax 30APR93 & 4MAY93 pt devel generalized 2x2mm papules w/clear irregular borders surrounded by red borders; papules were concentrated in folds like neck & arms & very pruritic when popped;
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 17-OCT-2012 14:00, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a physician referring to a 4 month old male patient. The patient did not have any known pertinent medical history, allergies or reactions. Information regarding concomitant therapies was not provided. On 01-MAR-2017, the patient was vaccinated with ROTATEQ lot # M029251 with expiration date of 14-MAR-2018 (strength, dose, frequency, were not provided) orally to prevent rotavirus infection. Then on 01-MAY-2017, the patient became irritable and lethargic, and developed vomiting and blood in the stools. On 02-MAY-2017, the patient was admitted to the hospital and diagnosed with intussusception. The following laboratory studies were performed: complete blood count (CBC), electrolyte levels, basic metabolic panel, x-ray, ultrasound, fluoroscopy with no results provided. An unspecified "emergency life-saving surgical procedure" was performed on the patient on 02-MAY-2017. However, no new medications were started for this patient. The patient was discharged from the hospital on an unknown date in 2017. The patient recovered from the events on an unknown date.  No further information provided. The reporter did not assess the causality between the events and ROTATEQ. The reporter considered the events serious to be life threatening and medically significant as there was an "emergency life-saving surgical procedure" to prevent another serious criteria. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (lot # K016966, expiration date 10-MAY-2017) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Cellulitis; Intense itching; Redness; Swelling; Arm soreness; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of arm soreness, intense itching, redness, swelling and cellulitis.  The patient's medical history included allergy to several drug allergies. No concomitant medications were reported.  On an unknown date of Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced arm soreness.   On an unknown date of Jan 2021, the patient experienced intense itching, redness and swelling. The patient reported that she went to her doctor and was diagnosed with cellulitis. The treatment information for the events included clindamycin.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, arm soreness, intense itching, redness, swelling and cellulitis was unknown.; Reporter's Comments: This case concerns a female patient with medical history of several drug allergies, who experienced events of arm  soreness, intense itching, redness, swelling and cellulitis.  The events of arm soreness, intense itching, redness, swelling  occurred on the same day after the first and last dose of mRNA-1273 vaccine administration. The event of cellulitis was reported approximately 10 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
The patient felt woozy and fainted 5 minutes after administration of the vaccine. It was around 12:55 pm.  We lay down the patient giving some air while the paramedic was called. She was responding to all the questions she was asked.  After her vital signs were checked, which turned out to be normal, the patient declared of feeling good and even left the premises by walking on her own.
Very irritable; Severe shooting back pain/ lower back and upper back pain; Neck pain; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 11Sep2021 at 17:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included no thyroid due to thyroid cancer, sulfa (sulfonamide) allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The concomitant medications included lorazepam (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from an unknown date, for unknown indications and unknown if ongoing . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Sep2021, the patient experienced severe shooting back pain with in one hour and for the next 3 days, with lower and upper back pain and on an unknown date in Sep2021 experienced neck pain which would not subside. Also, on 17Sep2021 at 18:30, the patient was very irritable. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe shooting back pain, lower and upper back pain and neck pain and very irritable were not resolved at the time of this report.
Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Mar-2023 A technician called in to report the administration of an expired Havrix dose to 2 patients. The reporter asked if she had to call back the patients in order to re-vaccinate them. Both patients had same initials. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used. The case was linked with case US2023036775, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023036775:Same reporter
This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (Lot # L010596, expiration date 06-APR-2017) doses. routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Pt came to pharmacy complaining of sore and bruised (R) upper arm (site of injection). Pt is in pain over a week.
(L) arm pain, weakness, rash on truck about 48 hours (ibuprofen). Persisten arm pain.
About a week after his booster dose he started to break out in a full body rash. It has progressively gotten worse. He called today to ask what to do. I referred him to a physician and stated I would send the report.
pt lives in a Long term care facility and Rehab Center; had a positive COVID test in facility; was treated with zinc, Vitamins C and D3; azithromycin, dexamethasone, Lovenox; pt found in his bed deceased in Long Term Care Facility
First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21.
Soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the injected arm) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in the injected arm). At the time of the report, VACCINATION SITE PAIN (Soreness in the injected arm) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
13 year old patient was accidentally administered Flublok, no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old patient who received a 0.5 mL dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1914, expiry date: 30-Jun-2020,  via intramuscular route in the left deltoid on 21-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Documents held by sender: none.
A report has been received from a Health Professional concerning a female patient, who had received FLUMIST quadrivalent (intranasal), 0.1 mL in each nostril, once/single administration. FLUMIST quadrivalent started on an unknown date. The patient experienced patient number five given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1mL was given in each nostril. FLUMIST quadrivalent was continued. The outcome of the event of patient number five given FLUMSIT that underwent a temperature excursion and it is unknown if the dose of 0.1mL was given in each nostril was unknown. The report was considered to be non-serious by company physician.
I received the 2nd dose of the Moderna vaccine on Monday. After working a 10hr shift on Tuesday evening around 7pm I started getting chills and having muscle aches. I took my temperature and it was 101.1 at 8:40pm. I took some tylenol at 9pm and it started to lower after about an hour and a half. Wednesday morning I no longer had a fever but was still fatigued and having muscle aches.
Within one day of dose, pt developed psychiatric symptoms (disorganized thoughts, speech, etc.) and ended up admitted 5 days after dose to psychiatric inpatient facility for 12 days. 8/23/07-records received for DOS 7/3-7/16/07- DC DX: Axis IBipolar affective disorder, manic; alcohol abuse; alcohol induced mood disorder.Axis II and III none. Axis IV:alcohol abuse, genetic predisposition to a mood disorder; social and family issues. Axis V 60 to 65. Admitted with bizarre behavior. She had gone away a week for a program. When she came back she appeared to be responding to internal stimuli. She was reporting she talks to a person which apparently the family was not aware of. She was found in a closet talking to herself and laughing. Not sleeping well at night and very disorganized. Very labile, from agitated to crying to being very hyper. Reports auditory hallucinations Patient using significant amount of alcohol. Drinks to point that she loses her memory. Denied suicidal or homicidal ideation. Insight and judgement grossly impaired Follow-up: It is still felt that the psychiatric symptoms represented a psychotic break, temporarily related but causally unrelated to the vaccine.
3? round red hive at injection site ,hard X 2days.  Itching on lower arm day after then stopped by end of day
Fever 102-103F; chills; headache; pain on joints; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3245), via an unspecified route of administration at arm left on 11Feb2021 at 12:45 as single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at arm left on 21Jan2021 02:15 as single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril (LISINOPRIL) for an unspecified indication. On 12Feb2021 the patient experienced fever 102-103f 12:30, chills, headache, pain on joints and dizziness. The patient underwent lab tests and procedures which included body temperature was 102-103 Fahrenheit. The outcome of the events was recovering.
This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 79-year-old subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
lower back pain; possible swelling in her arm that received the injection; fever; Indication: "Worried about Coronavirus"; soreness in her arm; she does not feel well; light headache; This spontaneous report was received from a 50-year-old female patient, who was referring to herself. Her had seasonal allergies. She had no pertinent medical history and concomitant medications. In approximately 2015 (reported as approximately 5 years ago), she received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to raise immune system and did not report any symptoms after receiving the vaccine.  On 20-AUG-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in the right arm (lot# was reported as T-010293, however, after validation was established as non-valid; expiration date was reported as 30-AUG-2021) as she was worried about coronavirus. On the same day, approximately 1 hour after the vaccination, she did not feel well, had soreness in her arm and experienced light headache. On 21-AUG-2020, the patient had fever that went from 99.1 degrees Fahrenheit (F), to 100.4 F, lower back, soreness and possible swelling in her arm that received the injection. The patient reported that she thought she should get the vaccine again because of "everything going on with novel coronavirus disease of 2019 (COVID)". She reported that a doctor in the office she visited said it that revaccination would not hurt to do it again. She reached out to the physician's office and was instructed to go to the emergency room if her symptoms worsen over the weekend. No treatment was given for the events and no lab diagnostic tests were performed.  At the reporting time, the patient did not recover from the events. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
4Dec91-Lt arm red & swollen size of 2 eggs called PMD, advised Advil, T< or = 101. 5Dec & 6Dec-unable to reach mom by phone.9Dec91-no further problems
I will breakout in itching whelps that are either on parts or all of my body. When I take a Benadryl the symptoms will go away. This is a continous problem whether I am outside or inside, it does not matter what I am doing. Sometimes I will be in a place for 3-4 hours before I breakout or I will breakout within 5 minutes of being there. At one time I had to go to the emergency room it was so bad. I have never been allergic to anything, and this problem did not start until I had the flu vaccine.
All of my food tastes like plastic now; Also I have a headache; diahhrea; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 18-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 07Apr2021 at 15:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included mental health issues and chronic urinary reflux. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and ethinylestradiol and norethisterone acetate (JUNEL) both for an unknown indication from an unknown date. The patient took BACTRIM on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 08Apr2021, the patient experienced all of her food tasted like plastic and also had headache, diarrhea and nausea. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events food tasted like plastic, headache, diarrhea and nausea were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Muscle twitching and numb feelings in left arm (site of vaccine); eventually in left thumb. Has had intermittent fasciculations in arms, legs since then. Usually not while active.
Error in vaccine administration. Td administered to a 5 year old rather than DTaP. Telephone call to CDC medical consultant, who recommended child be given the correct DTaP dose at same visit as Td given.  DTaP given. No adverse events observed at the clinic visit.