chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At the time of this report, the physician did not have any other information.
expired ACT-HIB was administered to a patient 2 days past the expiration date, with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 19-month-old and unknown gender patient, expired HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient 2 days past the expiration date, 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 pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On 15-Aug-2023, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (lot: UJ803AA) via intramuscular route in unknown administration site for Immunization and expired act-hib was administered to a patient 2 days past the expiration date, with no reported adverse event (expired product administered) (latency: same day).  It was unknown if nay lab data/test results available.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was 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 authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium.
Arm became sore again 8-10 days after the vaccine. No other accompanying side effects, just a sore arm that hurts to raise.
Myalgia, Arthralgia, Fever, Rash, NauseaVomiting, arm swelling, fatigue.  onset of s/s on day of injection, resolved within 5 days.
Narrative:  COVID infections following completion of COVID vaccine series 03/19/21 COVID vaccine dose #1 04/09/21 COVID vaccine dose #2 07/20/21 Pt reports to ED c/o cough, diarrhea x6 days, body aches, general weakness, and congestion; denies nausea, vomiting, chest pain; admitted to hospital for IV antibiotics and further management; treated with acetaminophen, dexamethasone, azithromycin, ceftriaxone; COVID POSITIVE 07/24/21 Pt reports improving dyspnea 07/25/21 Pt reports loss of taste, temp 98.0 07/28/21 Pt reports improving dyspnea 07/25/21 Pt reports loss of taste, temp 98.0 07/28/21 Pt reports improving dry cough and fatigue 07/29/21 Pt is stable and improving; quarantine ended
NauseaVomiting Aggravation of POTS, dizziness, fever, nausea, muscle aches and pain Narrative:
VACCINE ADMINISTERED AT RANGE OF 1.6-2.0 CELSIUS FOR ABOUT 45 MINUTES; VACCINE STORED AT RANGE OF 1.6-2.0 CELSIUS FOR ABOUT 45 MINUTES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: 22-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced vaccine administered at range of 1.6-2.0 Celsius for about 45 minutes. On 09-JUN-2021, the subject experienced vaccine stored at range of 1.6-2.0 Celsius for about 45 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine administered at range of 1.6-2.0 Celsius for about 45 minutes, and the outcome of vaccine stored at range of 1.6-2.0 Celsius for about 45 minutes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210619366.
On 1/20/21 around 12 Pm, I noticed that my vaccination site was either a little swollen still or again unsure, to be honest). I massaged the area a bit and very shortly after and for approx. 24 hours, the swelling increased a little bit and the site became warm to the touch.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 40-year-old female.  Neither medical history nor concomitant medications were reported.  On 06-Feb-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.  Follow-up information was received on 12-May-2009:  Product Complaint Investigation results.
Accidently vaccinated a 17 year old because of miscommunication.;This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently vaccinated a 17 year old because of miscommunication.) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045D21A) for COVID-19 vaccination.  No medical history was provided by the reporter.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently vaccinated a 17 year old because of miscommunication.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently vaccinated a 17 year old because of miscommunication.) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications include birth control pills
This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site is blushed, pinkish-red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the arm), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site is blushed, pinkish-red). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown and VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site is blushed, pinkish-red) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Patient details, outcome of the events injection site swollen and blushed, pinkish-red were updated.; Sender's Comments: 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.
So much pain that she could not move her left arm; So much pain that she could not move her left arm (the arm that was injected)/ moved to her right arm; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9266), via an unspecified route of administration on the arm on 13Feb2021 at a SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  She had the shot on the 13Feb2021 and was fine, but reported that a week and 2 days later (22Feb2021) she was in so much pain that she could not move her left arm (the arm that was injected) and 2-3 days later this moved to her right arm. The patient spoke to her healthcare professional regarding this and was prescribed a muscle relaxant. Outcome of the events were unknown.
vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Symptoms: Rough rash started around inner bilateral wrists within an hour of received the 2nd dose of COVID-19 vaccine Pfizer. Rash turned into extreme redness and hives when taken a shower. 2 days later, the rash radiated to the outer wrists, abdomen, and groin area. On the third day, the rash radiated to under the left breast. Whole-body is itching including the scalp.  Treatment: On the third day, I was advised to go to employee health. I was advised to go to my physician. On the fourth day, I went to my physician. The treatment plan is: Zyrtec 10 mg daily for 2 weeks, Pepcid 20 mg for 2 weeks. I was advised to also use hydrocortisone cream twice a day for two weeks.  After two weeks, I have a follow-up visit with my physician.
Lightheaded about 10 minutes after had Hepatitis A. Then got nauseated about 1/2 hour after vaccine. Nausea continued presently 8/20/14. 8/17 thought she was going to throw up, but did not. 8/13 had diarrhea. Has had chills; states: like adrenalin chills not fever chills. Does not feel like eating normally. Not getting worse but still nauseated. These symptoms happened also with first Hepatitis A 9/4/14 but still having nausea. Patient did not report until 8/12/13 when for 2nd Hepatitis A.
This spontaneous report was received from a nurse and refers to four children patients of unknown age and gender. It was stated that they were under 15 years of age. No information was provided regarding the patient's medical history, concurrent conditions, drug history, allergies or concomitant medications. On an unspecified date in May 2017, reported as "about a year ago", the patients were vaccinated with first dose of GARDASIL 9 injection, (lot number N009173 with expiration date on 20-OCT-2019 for HPV vaccination) (strength, route of administration and anatomical location were not reported. On an unknown date, the patients fainted (syncope). It was reported that the patients did not seek for medical attention and it was unknown if the patients received any treatment. The patients recovered from the event on an unknown date. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the event. This is a corrected report. The correct initial aware date is 15-MAY-2018 and not 16-MAY-2018 as previously reported. Therefore, the safety report US-009507513-1805USA007240 is being deleted from our files and all the information is being captured in this new case US-009507513-1805USA008787.
Patient presented to the ED and was subsequently hospitalized for CVA, ischemic stroke within 6 weeks of receiving covid vaccination.
Patient reported feeling dizzy after vaccination during observation period.  Patient was placed in wheelchair and brought to a private observation area. During transport, patient seized and had syncopal episode in wheelchair twice. EMS was notified and arrived within one minute. Vitals were taken and patient regained consciousness. Initial blood pressure in supine potion was 92/62 with a heart rate of 58. Patient was alert and oriented times three, stable. Orthostatic blood pressure was taken. Patient was diaphoretic. Patient's wife was in  tent with patient. Patient's blood pressure on recheck was 122/73, 132/78 with heart rate 75, 76. Patient agreed to have wife drive patient home. Patient to follow up with PCM if patient has recurring symptoms. ER precautions given. Patient agreed with plan.
5-6 hours following Moderna, RT arm pain was severe. Couldn't lift arm above shoulder, due to pain. No local site reaction. Had difficulty sleeping that night. This progressed into full body aches. Also felt dizzy, weak and fatigued. Experienced sweats, unsure if an actual fever. Difficulty resting. These symptoms lasted 72 hours. "I was unable to take part in normal activity for the full weekend due to symptoms... Still experiencing arm pain."
headache; fever (101.5); fatigue; pain in TMJ left side; stomachache; nausea; back pain; limited motion; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever (101.5)), FATIGUE (fatigue), PAIN (pain in TMJ left side) and ABDOMINAL PAIN UPPER (stomachache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache), PYREXIA (fever (101.5)), FATIGUE (fatigue), PAIN (pain in TMJ left side), ABDOMINAL PAIN UPPER (stomachache), NAUSEA (nausea), BACK PAIN (back pain) and HYPOKINESIA (limited motion). At the time of the report, HEADACHE (headache), PYREXIA (fever (101.5)), FATIGUE (fatigue), PAIN (pain in TMJ left side), ABDOMINAL PAIN UPPER (stomachache), NAUSEA (nausea), BACK PAIN (back pain) and HYPOKINESIA (limited motion) outcome was unknown.            This case was linked to MOD-2021-015262 (Patient Link).
Pain in every tissue and bone  of my body. Cold to the bone. Shivering, often uncontrollable. Temperature of 101.6. Intense nausea - kept thinking I was going to vomit. Tummy felt like I was going to have diarrhea so kept running to the toilet, but nothing happened. Swollen throat glands. Intense back pain. Head feels like it?s in a vice. Congestion in sinuses. Intense fatigue.
Injury symptoms began on 10/5 - 3 days post injection with tingling in both feet and both hands and decreased ability to use hands.  Progressed, being masked by back pain/possible spinal compression he'd been having trouble with. He was brought to ER by ambulance 10/20/23 having lost ability to stand up. MRI showed severe compression, so Dr looked no further & did spine surgery 10/24. Woke with no feeling or movement in either leg, bilateral hands, which continued in days following - ascending up arms & trunk to diaphragm and swallowing resulting in emergency vent, then trach & g-tube. Countless tests, MRIs, spinal tap showed no physical reason. Dx is severe Guillain Barre. 11/15 sudden ITP, & platelet transfusions aren't helping. Currently in ICU with trach/vent and g-tube, and no functional movement in his body.
Patient received MMR intramuscular Right Deltoid and VARIVAX intramuscular Left Deltoid. They should have been administered SC. Age of patient at time of event: 30 and 6 months.
moderate fevers,, chills, moderate-severe muscle aches, moderate arm soreness for a little over 24 hrs
Patient received FLUZONE 2013-14 vaccine manufac Sanofi (L) UH926AB (Ex) 30/6/14 at 2:45 PM on 11/5/13. At 11:10 PM, pt's wife called and said he is hot and fainted. He is fine now.
gastronomic distress; dehydrated; renal failure; it could be something like a virus of some sort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "immune system definitely compromised" (ongoing), notes: antirejection therapy for organ transplant; "organ transplant" (unspecified if ongoing). The patient took concomitant medications (immunosuppressive drugs). The following information was reported: ABDOMINAL DISCOMFORT (hospitalization), outcome "unknown", described as "gastronomic distress"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydrated "; RENAL FAILURE (hospitalization), outcome "unknown"; VIRAL INFECTION (hospitalization), outcome "unknown", described as "it could be something like a virus of some sort". Clinical course: The patient took immunosuppressive drugs because of an organ transplant so his immune system is definitely compromised on purpose. His pulmonologist recommended Prevnar 20 and he got the vaccine. Shortly after the vaccine he became very ill with a gastro problem and wound up in the hospital with renal failure. The doctors couldn't find anything, they said it could be something like a virus of some sort. He did have side effects. He had gastronomic distress to the point where he got so dehydrated that his kidneys failed. The patient reported the events as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant and treatment medication was not reported. Event start date was reported as 2022. Patient was not enrolled in clinical trial. Company Comment: This is a spontaneous case concerning a 43-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately more than 9 months after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 43-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately more than 9 months after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Had runny nose/sneezing.  By 3:00pm developed fever.  At 5:30pm vomited. At 11:00 developed fever of 103.9 reported by EMS and had seizure.  Admitted to Emergency Department for febrile seizure.