chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sense of smell has diminished greatly/not gotten back her sense of smell; Smells smoke; This case was reported by a consumer via call center representative and described the occurrence of loss of smell in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G33K, expiry date 10th July 2023) for prophylaxis.   Previously administered products included CHICKEN POX VACCINE (received on an unknown date) and COVID 19 BOOSTER (received on an unknown date). Concurrent medical conditions included covid-19.   On 13th June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2022, less than 3 weeks after receiving Shingrix, the patient experienced loss of smell and smell alteration. On an unknown date, the outcome of the loss of smell and smell alteration were not recovered/not resolved.   It was unknown if the reporter considered the loss of smell and smell alteration to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-Jun-2022. Reporters comment: The patient self-reported this case. The patient received Shingrix vaccine on right deltoid. The patient stated ever since she received her first dose of shingrix, she began smelling smoke, like someone was blowing cigarette smoke in her face.  The smell would wake her up at night because she could not breathe. The patient stated the smell of smoke has subsided, but not totally resolved. The patient also stated that since she received the shingrix vaccine, her sense of smell has diminished greatly. She stated that she used to have a great sense of smell, that she could pick up on odors well in advance of anyone else. At the time of the call, the patient has not gotten back her sense of smell. The reporter consented to follow up with HCP. Additional Supportive Information: This case has been linked with US2022100577, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022100577:Same reporter
Patient had flu vaccine in Right deltoid. After vaccine noted black and blue bruising from the top of deltoid down to the elbow. PT's PT/INR was critically high that day.
A few seconds after receiving the injections, pt complained she couldn't see and passed out. She hit her head on a chair. We picked her up and laid her on exam table. Gave her an ice pack. Checked her BP and pulse. Patient went for labs and EKG.
Got full dose instead of half dose; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Got full dose instead of half dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product SUNITINIB MALATE (SUTENT) for Secondary malignant neoplasm of kidney.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and SUNITINIB MALATE (SUTENT) (unknown route) 37.5 milligram. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Got full dose instead of half dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Got full dose instead of half dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Got full dose instead of half dose).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  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.
Late 1980s: neck pain, stiff neck; symptoms increased to tightness in right inguinal area in August 1997 and continued to get worse. 1997: Spasms in back on spine and radiating around to each side of back. Startle response to unexpected noise and touch. 2001: diagnosed with stiff person syndrome. Follow up 02/15/05: Patient sent address update. And states she was about 23 years old at the time of vaccination. She has siff peron syndrome, weakness in legs, pain in low back, stiffness in neck, trouble with walking, which includes balance, and fatigue. Stress related problems. I had a misscarriage after having 2 health boys (at the time were 4 and 10). I have to have IVIG (Gamma Globulin).$8000 per month approximately in medical cost. I have to take a lot of prescription medications. Due to all this I can no longer work. I was a medical technologist. This has caused a lot of stress and social problems for me.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
fatigue, body aches, swelling on left side from her neck down to her feet. She reported with these symptoms on Monday 4/12/21, we gave her  benedryl to take and some extra to have and recommended she follow up with her primary care phycisian.  Symptoms are still ongoing as of 4/14/21.
CLIENT BECAME DIZZY, DIAPHORETC-POST VACCINE 5 MINUTES.  ESCORTED TO EXAM ROOM-PRONE WITH LEGS ELEVATED.  CONTINUES TO C/O DIZZINESS, FLUSHING AND WEAKNESS.  UNABLE TO SIT UPRIGHT WITHOUT INCREASE IN SYMPTOMS.  C/O WEAKNESS.  RAPID RESPIRATIONS BUT DENIES DIFFICULTY BREATHING.   EMS CONTACTED.  TRANSPORTED TO HOSPITAL.
throat is swollen and closing up; throat is swollen and closing up; they have a faster heart bit; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat is swollen and closing up), THROAT TIGHTNESS (throat is swollen and closing up) and HEART RATE INCREASED (they have a faster heart bit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PHARYNGEAL SWELLING (throat is swollen and closing up), THROAT TIGHTNESS (throat is swollen and closing up) and HEART RATE INCREASED (they have a faster heart bit). At the time of the report, PHARYNGEAL SWELLING (throat is swollen and closing up), THROAT TIGHTNESS (throat is swollen and closing up) and HEART RATE INCREASED (they have a faster heart bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter. Patient got a Moderna vaccine and they feel their throat is swollen and closing up and that they have a faster heart bit. They wonder if this may be related to the vaccine.   Company Comment: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious, unexpected, events of pharyngeal swelling, throat tightness and heart rate increased. The events occurred  1 day after unspecified dose of mRNA 1273 vaccine. The patient felt throat swelling and closing up and heart beat was faster, no information regarding treatment given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious, unexpected, events of pharyngeal swelling, throat tightness and heart rate increased. The events occurred  1 day after unspecified dose of mRNA 1273 vaccine. The patient felt throat swelling and closing up and heart beat was faster, no information regarding treatment given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
lt arm neck went numb & aching; whole lt side of upper body just to below waist went numb; pt felt nauseated, light headed; about 5PM took 2 APAP & called clinic; soreness of lt deltoid;
cleft pallet; sinus; ear infections; Muscle spasms in the upper right cheek; Left eye is hurting inside the eye; Left eye is swollen; Muscle spams under the right eye; This spontaneous case was reported by a consumer and describes the occurrence of CLEFT PALATE (cleft pallet) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (diagnosed with cancer in 2017). Concurrent medical conditions included Diabetes, Hypertension and Reflux esophagitis.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Muscle spams under the right eye). On 05-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle spasms in the upper right cheek), EYE DISORDER (Left eye is hurting inside the eye) and EYE SWELLING (Left eye is swollen). On an unknown date, the patient experienced CLEFT PALATE (cleft pallet) (seriousness criterion medically significant), SINUSITIS (sinus) and EAR INFECTION (ear infections). At the time of the report, MUSCLE SPASMS (Muscle spams under the right eye) had resolved and MUSCLE SPASMS (Muscle spasms in the upper right cheek), EYE DISORDER (Left eye is hurting inside the eye), EYE SWELLING (Left eye is swollen), CLEFT PALATE (cleft pallet), SINUSITIS (sinus) and EAR INFECTION (ear infections) outcome was unknown.            No concomitant medications were reported. Treatment medication include ciprofloxacin (500 mg) and doxycycline to treat sinus infection.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  She stated that it would be okay if the safety department contacts her if additional information is needed.   This case was linked to MOD-2021-036432 (Patient Link).
Hep B titers low; This spontaneous report as received from a family nurse practitioner via a company representative refers to a 18-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) for prophylaxis (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported).        On an unknown date, the patient's hepatitis b titers came back from analysis as being low. It was unknown if the patient received any treatment for the event.  The outcome of the event was unknown. Relatedness between the event and suspect therapy was not provided.
arm pain day 1-2, day 2 fatigue and migraine, day 3-4 migraines and fatigue and joint pain, day 8 itching and swelling on arm around injection site and difficulty breathing, day 9 to present arm injection site swelling continues to grow in size on arm continues to be itchy and breathing is more difficult as day progresses. Right back of knee swelling and pain also beginning day 8, which gets worse as the day progresses.
Pt received 2nd round of vaccines at 4 month check 2/28/07 (Rotateq, DTaP, Hib, Prevnar, IPV). That night began having intermittent vomiting which persisted x 1 week, worsening significantly 3/6/07-3/7/07 to every hour. On 3/7/07, presented in circulatory shock and had lost 20% of body weight. Resuscitated and sent to hospital. Diagnosed with Congenital Intestinal malformation with acute volvulus. Recovered well after surgical correction. No bowel loss.  3/30/07 Received medical records from PCP which included partial hospital records & reveal patient experienced normal growth & development & had a well child vs on day of vax.  Next vs 3/7 was for vomiting since 2/28 now appearing severely ill w/dehydration, lethargy, fever, eyes rolling back & scant urine output.  Fontelle & abdomen were very sunken.  She had lost 20% of her weight.  Sent to ER for IVF & labs.  Had nasal congestion & cough x 2 days.  Admitted 3/7/07-3/13/07.  After exam, x-ray & IVF, surgical consult done.  Patient to OR for Ladds procedure, inversion appendectomy & extensive lysis of adhesions.  Findings at surgery were that extensive Ladds bands had caused nearly complete obstruction of the duodenum.  Surgery clinic f/u on 3/19 revealed patient had several episodes of vomiting that day which resolved spontaneously & upon exam, patient found to be doing well. FINAL DX: Malrotation w/midgut (duodenal)volvulus, dehydration & vomiting. 6/25/07 Received hospital med recs which reveal patient experienced persistent emesis x 1 week.  Admitted 3/7-3/13/07.  Progressed slowly & d/c to home w/o complication. FINAL DX: malrotation w/midgut volvulus, s/p Ladds procudure.
PT REPORTS ARM RED AND INFLAME RASH ON HER UPPER LEFT ARM; APPROXIMATELY 6" AROUND HER UPPER LEFT ARM.  STARTED ON 9/19/2017.
late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose with batch number 5P9DR, expiry date 20th March 2023, on 21st September 2021 at a different pharmacy location).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 27-MAR-2023 The reporter consent to follow up either through mail or email. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
fever 100- 102, shivering during night and couldn't get warm, very bad headache, very sore muscles throughout body, one hours episode of phantosmia (fourth one in three years) four hours after fever broke, 38 hours of reaction
Initial report received on 21 August 2008 from a healthcare professional.  A 26 year old female patient, with allergies to penicillin and prednisone and no other medical history, received on 10 July 2008 a left forearm intradermal injection of ADACEL (lot number C2927AA) and a left deltoid intramuscular injection of APLISOL (Parke-Davis, lot number 62418).  The reporter stated that the syringes were used incorrectly and that the doses were given by incorrect route.  The doses of each vaccine were not reported.  The patient had no illness at the time of vaccination and no other vaccines had been given within four weeks prior.  On 11 July 2008, one day post-vaccination, the patient's left forearm showed a large area of redness, soreness, and had an itchy feeling.  Six weeks later, the patient had an itchy 2 cm lump in the injection area.  The patient's recovery status was reported as unknown.  Follow up information was received on 29 September 2008 from a health care professional.  The patient received a first time dose of 0.5 ml of ADACEL and APLISOL 0.01 ml.  The patient had received many doses of APLISOL in the past without reaction.  On 15 July 2008 the patient received another dose of APLISOL without any reaction.  On 27 August 2008 the patient developed itchiness and a small lump approximately 1/4 of an inch.  VALAZONE cream 1% was administered without relief.  On 17 September 2008 the lump was removed.  Based upon new information received, this case was upgraded to serious.
worsening muscle aches; pains; joint site symptoms; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included muscle aches. Concomitant medications were not reported. He usually takes an anti inflammatory for muscle aches but decided to hold it prior to receiving the first dose of the vaccine. After getting the vaccine, he started to experience worsening muscle aches, pains, and joint site symptoms. He thinks nothing was out of the ordinary. He get these symptoms any time he receive a vaccine. Outcome of the events was unknown.  The following information on the batch number has been requested.
This spontaneous report as received from a healthcare worker refers to two female patient of college student age. The patients had three doses of RECOMBIVAX HB (lot number, does, route and injection site were not reported) and their titers had come back non reactive on an unknown date. Healthcare worker stated for college admissions they wanted titers drawn at the time of report, even if they had 3 doses of the vaccine. The outcome and action taken were not provided. The patients had contacted physician for medical attention. This is one of several reports received from the same source. Additional information is not expected.
Patient received 2 doses of Pfizer covid vaccine. She then received the Moderna vaccine for 3rd dose
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had shingles shot and still got the shingles. The patient's physician said that the patient could transmit them to another person, because it was a virus. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
24 hrs p/inject devel fever to 102.5, shaking, chills, neck stiffness, h/a, disorientation seen in hosp ER & had nl CBC, CXR;
pt recv vax;examiner's ofc called 26jun95 to report that pt was found dead in crib 22jun95; infant had no sx of illness prior to death; no sx of illness prior to death; no sz activity; no fever;
Felt discomfort on my left lymph node right away, 1 hour later I was light headed, hot and sweaty one minute and freezing the next, could not taste food for 10-12 hours but could smell everything and last developed a splitting headache that lasted a few days.
ITCHING, SWELLING, PATCHY PINK RASH. VACCINES GIVEN APRIL 30, 2003. NO TREATMENT GIVEN.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: n/a
Right arm (varicella vaccine) - Dime size swelling at site with itching. Advised to take BENADRYL and put ice on it.
tightness in chest 1 day p/inject; used Ventolin x 3; had swelling about the size of twenty cents lasted 3 days; uses Ventolin PRN; no dx of asthma;
Left 4th Nerve Palsy; This is a spontaneous report from a contactable physician. A 75-year-old non-pregnant female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: PfEL9Ue2), intramuscularly on 08Feb2021 12:30 at age of 75 years old no pregnant at time of vaccination at single dose in right arm for COVID-19 immunisation. Medical history included diabetes, hypertension, allergies to Penicillin, Sulfa drugs. The patient did not have COVID prior vaccination also not had COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication (other medications in two weeks) included Metoprolol, Metformin, Vitamins. It was reported 6 days after vaccine developed severe diplopia on 14Feb2021 10:00. Exam on 16Feb2021 revealed, Left 4th Nerve Palsy. Left Hypertropia, Esotropia and Torsional strabismus. Events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. No treatment received.; Sender's Comments: Based on the information provided, a causal association between BNT162B2 and IVth nerve palsy cannot be completely excluded in the basis of temporal relation. Note however, that patient has history of diabetes and hypertension which may have contributed to the event. Note also that the event is resolving without treatment received. 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 RAs, Ethics Committees, and Investigators, as appropriate.
States 5 days after vaccines noticed a couple of hives on face and on Wednesday one more. By Thursday no new hives, no treatment needed. No other symptoms.
Pt was brought into ER on 31JAN92 very sick, inc temp; spinal tap was done; H-flu meningitis was dx; pt was transferred to another facility;
it was inadvertently administered intramuscularly with no reported adverse event; Initial information received on 15-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and gender patient to whom experienced yellow fever vaccine - US [YF-VAX] was inadvertently administered intramuscularly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient  inadvertently administered unknown dose of suspect yellow fever vaccine, Solution for injection ( lot number, dose, strength and expiry date not reported) via intramuscularly in unknown administration site for Immunization with no reported adverse event (incorrect route of product administration) (latency: on same day).  Information on the batch number was requested.  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 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.
The first day 12/7/21 I felt good after the shot with tenderness. The following morning I had inflammation in my shoulder and on my lymph nodes under my armpit on the side of the vaccination which continued throughout the day. This morning I am light headed have worse pain in my arm and my lymph node is swollen close to the size of a baseball. I also have an upset stomach.