chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from authors of a published literature article concerning an 11 year old male patient who was vaccinated with PNEUMOVAX. An 11-year-old male with Hemoglobin sickle C disease (HbSC) disease was admitted to the hospital with 3 day history of fever and left wrist pain. At admission he had significant pain and tenderness at the base of the first left metacarpal bone. He was up to date on his immunizations for Streptococcus pneumoniae (two doses of PNEUMOVAX at 2 and 5 years of age). He had stopped taking penicillin prophylaxis since he was 6 years old and had not received the PREVNAR vaccine. S. pneumoniae was isolated on blood culture and he was treated with Penicillin G. MRI of the left hand showed diffuse edema and mild heterogeneous enhancement of the left first metacarpal bone likely representing osteomyelitis. On the third day of admission he complained of pain in his right eye with excessive tearing and photophobia and he was treated symptomatically. His eye symptoms persisted and an ophthalmology consultation revealed a diagnosis of pneumococcal endogeneous endophthalmitis of the right eye based on his ocular signs and symptoms (2+ flare in AC, chemosis, vitreitis, vitreous opacities, visual acuity R=20/25; L=20/20, ocular culture negative). He was treated with topical antibiotics, mydriatic and intravenous Penicillin G for a total of 6 weeks. He had normal visual acuity in both eyes at discharge and was doing well at 1 year follow up (visual acuity R=20/25 L=20/20). Endogenous endophthalmitis (EE) is a rare, often misdiagnosed disorder characterized by poor visual outcome despite aggressive therapy. Pneumococcal EE has been reported in patients who are immuno-compromised, asplenic or both. The clinical findings of intra-ocular inflammation in the context of S. pneumoniae septicemia in a patient with possible splenic dysfunction made EE the most likely diagnosis in our patient. Blood cultures are the most reliable way of establishing the diagnosis of EE. The initial diagnosis in our case was conjunctivitis, probably of infectious etiology. The increased incidence of proliferative retinopathy associated with HbSC disease may act as a nidus for localization of infection in the eye during episodes of bacteremia and could explain the high incidence of EE in HbSC disease. Systemic antibiotics are the mainstay of therapy in EE, while invasive procedures like vitreal biopsy and intravitreal antibiotics along with vitrectomy are recommended for treatment of traumatic and post-operative endophthalmitis. Our case demonstrates that although rare, EE must be considered in any child with hemoglobinopathy with eye symptoms, especially with a positive blood culture. A high index of suspicion along with early diagnosis and prompt administration of systemic and topical antibiotics may help in complete recovery. Additional information has been requested.
On third day after receiving the first Pfiser vaccination I started experiencing extreme pain in my joints.  The pain has been increasingly getting worse over the last three weeks.  I was not experiencing this pain prior to getting the vaccine.
Pt with swelling to right thigh 3"x3". No fever, has immunization 9/29/04 was given Keflex 250/5ml 7.5PO x 10 days has F/U visit 10/4/04.
Muscle pain; Shoulder pain; All body tired; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), ARTHRALGIA (Shoulder pain), FATIGUE (All body tired), HEADACHE (Headache) and PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (Shoulder pain), FATIGUE (All body tired), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain) and ARTHRALGIA (Shoulder pain) had not resolved and FATIGUE (All body tired), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Patient took every day 2-3 Advil and Tylenol to ease
Sore left injection site arm; Very tired after his second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Very tired after his second dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-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 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Very tired after his second dose). On 17-Feb-2021, VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Very tired after his second dose) had resolved.            No Concomitant product use was reported.  The patient received their second Moderna Covid-19 vaccine on 16-Feb-2021 and had a sore left injection site arm. The patient was very tired after their second dose. The patient went to bed at 6 pm on 17-Feb-2021 and when the patient woke up it was all over.  No treatment information was provided.   This case was linked to MOD-2022-455008, MOD-2022-455275 (Patient Link).
A 52 year old female patient experienced tremors in the upper extremities while being treated with RabAvert following a bite from a feral cat. Patient was treated with RabAvert on days 0, 3, 7, 14, and 28 (which was 11/12/04). Past medical history and concomitant medications were not specified. The patient was bitten on the thenar aspect of one hand by a feral cat in an unprovoked situation on an unspecified date. She was treated with human rabies immune globulin (HRIG) into the wound and post exposure treatment was started with RabAvert. One week prior to the last rabies vaccine she developed tremors of both upper extremities. No other symptoms were reported. The event continued at the time of the report. Follow up information received on 12/6/04 revealed that the patient experienced bilateral hand tremors from 10/10/04 to 11/10/04. The first dose of RabAvert was administered IM on 10/8/04 and the fifth and last dose was on 11/5/04. Concomitant medications included Nadolol and Lipitor. At the time of this report, the patient had completely recovered. The reporter assessed the event as medically significant (OMIC).
Exhausting 24 hours; Off label use; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Exhausting 24 hours) and OFF LABEL USE (Off label use) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history information was provided.  Concomitant products included GABAPENTIN for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced FATIGUE (Exhausting 24 hours) and OFF LABEL USE (Off label use). On 31-Aug-2021, OFF LABEL USE (Off label use) had resolved. On 01-Sep-2021, FATIGUE (Exhausting 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications also include steroids injections in the knee due to plane crash injuries in 2016.  No treatment medications were provided.   This case was linked to MOD-2021-312037 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received contains additional, patient demographics was added, event fatigue was added, event outcome and updated narrative accordingly.
This case was reported by a healthcare professional and described the occurrence of pimple-like rash in a 35-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no relevant medical history and had experienced no adverse events following prior vaccinations. The subject had not previously received any influenza vaccination. Concurrent vaccination included HAVRIX (GlaxoSmithKline) given on 5 June 2009; BOOSTRIX (GlaxoSmithKline) given on 5 June 2009; TYPHIM VI (non-gsk) (Sanofi Pasteur MSD) given on 5 June 2009. On 5 June 2009 (mid-morning) the subject received 1st dose of ENGERIX B (1 ml, unknown route, right arm). On 10 June 2009 (evening), 5 days after vaccination with ENGERIX B, the subject experienced pimple-like rash on his knees that spread up to his hands and face. The pimples were described as "massive" on his thighs with smaller ones on his wrist. The subject was treated with BENADRYL and CORTIZONE. At the time of reporting the event was worse. Follow-up information was received by nurse via Merck on 25 June 2009. The nurse reported the subject was administered his 1st dose of ENGERIX B on 05 June 2009 and then developed an itchy, red rash on both knees on 10 June 2009. The has subsequently spread up to his groin, as well as both wrists and his face. No further information was provided. Follow-up information was received from the reporting nurse on 17 July 2009. The subject went to an urgent care facility on 15 June 2009. The subject's chief complaint at the urgent care was allergic reaction, June 2009 vaccines, itchy/burning rash. Concomitant medications included prednisone and XYZAL. The subject had no known drug allergies. The physician diagnosed severe contact dermatitis and decided the rash was unrelated to vaccines. The series was continued without further incident. When the subject came in to continue his hepatitis B series, the rash had resolved.
Erythema nodosum, myalgia, arthralgias started 48 hours after immunization.
Pt has fever 100.2 degrees, jerking motion. Pt given IPV 1/24/13 24hrs later sx have started.
Flu like symptoms; Had to stay in bed and keep drinking fluids; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and BED REST (Had to stay in bed and keep drinking fluids) in an 80-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and BED REST (Had to stay in bed and keep drinking fluids). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and BED REST (Had to stay in bed and keep drinking fluids) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient also felt under the weather and had flu-like symptoms. No treatment information was reported.   Reporter did not allow further contact
Facial swelling & redness, angioedema, tachypnea; given diphenhydramine 50mg IM and methylprednisolone 125mg IM. EMS called, pt transported to ER for further eval and treatment.
Moderna COVI 19 Vaccine EUA  I woke up Sunday March 7,2021- feeling fatigue(more than usual).  By 11:00 AM- headache, muscle pain, chills, nausea and vomiting. watery frequent stools.  Vomiting in morning .  Stated vomiting again at 9:00 PM and then stopped by 10:00PM. Remained nausea most of night. No sense of smell or taste on Sunday or Monday. Starting to feel alittle hungry at 8:50 PM Monday. The other symptoms lasted all day on Sunday and  Monday 3/8/2021. Fever ranged from 99.2-101.4. My normal temp is around 97. Super exhausted and slept most of Monday 3/7/2021. At 8:50 PM Monday  3/8 no vomiting, no fever, muscles aches still present but improving, still feeling very tired.
Fever of 102F; Vaccine administered to a 7 month-old-child by mistake; This is a spontaneous case, initially received from other health professional (nurse) via Med Communications (reference number: SEQ19-04421) on 10-Oct-2019, concerning a 7-month-old female patient.  The patient's medical history and concomitant medications were not provided.  On 09-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261198 (also reported as 261199), expiration date: 18-Jun-2020 (also reported as 19-Jun-2020)] (explicitly coded as Inappropriate age at vaccine administration') for an influenza prophylaxis.  On 10-Oct-2019, one day after vaccination, the patient developed fever of 102F. As reported, the patient did not receive any treatment.  At the time of initial reporting, event of fever was not resolved.  The reporter assessed the case as non-serious and did not provide causality assessment.  Non-significant follow-up reported by Med Communications (reference number: SEQ19-05258) on 22-Oct-2019: Additional Med Communications reference number added. No changes in narrative.; Sender's Comments: The patient experienced pyrexia after administration of the suspect product Flucelvax QIV to patient of inappropriate age. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Causal relationship between the suspect product and product administered to patient of inappropriate age is assessed as not related per company conventions. For the event pyrexia, causal role of the suspect product is assessed as related.
This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (wrist on that same side seems very swollen) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (wrist on that same side seems very swollen). At the time of the report, JOINT SWELLING (wrist on that same side seems very swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by the reporter. No information on treatment is provided by the reporter.
A report has been received from a Health Professional concerning a 49 year old, male patient, who had been receiving nasal FLUMIST. The patient's medical history included liver transplant. Concomitant medications included immunosuppressants. FLUMIST started on 04-SEP-2013. It was reported that the doctor inadvertently gave FLUMIST QUAD to former liver transplant employee. It was further reported that consumer was fine the date after receiving FMQ. FLUMIST was discontinued on 04-SEP-2013. The outcome of the event of inadvertently gave FLUMIST QUAD to former liver transplant employee is unknown. The report was considered to be non-serious.
Initial misuse report received from a healthcare professional on 29 October 2013. The cases were received on 21 March 2014 at the agency. A patient had received an expired dose of YF-VAX on an unspecified date. No adverse events were reported. List of documents held by sender: none.
"COVID Arm",  9 days after the shot,  a red, raised, tender, circular rash appeared. The rash's diameter was the size of a clementine.  It's current, so it hasn't resolved yet. We have not sought medical intervention.  Online it speaks of this event as" COVID Arm", or a delayed cutaneous hypersensitivity.  Some think it's an allergic reaction.
fatigue (24 hours)  muscle weakness (1 day) headache intermittent (2 days)  sore arm (3 days) muscle aches - lower back right scapula
This case was reported by a pharmacist and described the occurrence of did not feel well in a 50-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Approximately five to six years ago in 2006, the subject received 1st dose of FLUARIX (unknown). Five to six years ago in 2006, within hours of vaccination with FLUARIX, the subject experienced didn't feel well for an hour after vaccination and had to lay down for an hour after the vaccination [all consumer wanted was to lie down] and then had to leave work for the day [inability to perform daily activities]. At the time of reporting the events were resolved. Follow-up information as received on 07 November 2012 via healthcare professional who reported the events resolved on an unspecified date. It was also reported that the subject "received the vaccination this year with no complications! She took a diphenhydramine prior to injection". No other information was provided.
Initial report was received from a health care professional on 10 January 2012. This reporter also reported another adverse event in case 2011-00349. This case involved the same patient. A four-year-old female patient had received a first dose intramuscular injection in the left deltoid of FLUZONE, sanofi pasteur Inc., lot number U4147BA on 06 January 2012. On 06 January 2012, the patient experienced a 10 centimeter (cm) by 7cm red, hot, itchy area at the injection site. The patient had no illness at the time of vaccination and took no concomitant medications. The patient had an allergy to sulfa and previously experienced a 9 centimeter (cm) by 12cm site reaction after receiving the fifth dose injection of DAPTACEL. The patient had no previous FLUZONE vaccinations. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Dyspnea approximately 8 hours after Tdap injection.  Treated with Benadryl & albuterol MDI.  Chart marked allergic to Tdap.
By 6 PM my arm was sore, by 8 PM it was hurting, and by 9 PM I couldn't lift my arm and that's about the time I was feeling flushed, like a hot flash feeling. I went to bed and during the night I woke up really hot and I took my temperature at midnight and it was about 101. I took an extra strength Tylenol and I was able to get back to sleep. This morning 05/13/22, I woke up at 8 AM and I'm hurting all over and aching all over and I'm really tired. The pain in the arm is gone but it is still sore. My temperature after taking another Tylenol was 100.8 and I just have fatigue and I've just been really tired and flushed and hot and I'm still running fever. I am achy all over, and I don't feel like doing anything. It has been 17 hours now. I still have a headache but it's not a big deal.
Cellulitis at injection site with swelling, pain and warmth.   Antibiotics started on 12/24/20  (keflex 500mg po every 6 hours for 7 days)
Pause in menstrual cycle, 2 months, followed by extremely heavy/irregular menstrual cycles for approximately a year; golf-ball sized swelling in arm, bruising, rash, 2-3 weeks
About 6 hours after receiving shot, patient broke out in blisters on his hands and feet.  Pt self-treated with diforasone diacetate, which resolved symptoms in two days.
Patient is a 14 yo male c/o intermittent upper left chest pain for >20 min after Pfzier vaccine. Reported pain 3/10, described as sharp and non-radiating. Denied previous episode w/ similar symptoms. Reported feeling some anxiety but denied being diagnosed or treated with anxiety. Upon assessment no acute distress noted. Alert and orientedx4, verbal and able to make needs known. Respiration even and unlabored. Skin pink, warm, dry and intact. No sx of allergic reaction. Chest non-tender, heart rate WNL, noted irregular rhythm, no murmur or extra sounds noted. No loss or altered level of consciousness noted. Mother present with patient and reports having HX of elevated BP which physician recommended increased activity and weight loss, denied medication treatment. No HX of allergies per mother.  Past medical HX obtained from patient and physical assessment completed simultaneously. Pt assessed while sitting in chair. VS 160/81, HR 62, O2 97% RR 20, sponataneous resolution on symptoms after 2-3 minutes, patient observed additional 30 minutes, no acute distress noted, pt denied pain or symptoms. Advised mother to have patient evaluated by PCP for irregular heart rhythm ASAP. Advised mother to take patient immediately to ER if symptoms return or develop new symptoms. Advised mother to call 911 if patient develops chest pain, SOB, altered or loss of consciousness. Mother verbalized understanding of all advice and education. Patient went home with mother
Arm numbness when raises arm; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain). At the time of the report, HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.            No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Patient reported feeling tingling in the tongue and around her mouth for approximately three hours after receiving the COVID vaccine then subsided without any further intervention.
I had chills, weakness and then fever; weakness; sore arm and soreness under armpit
Chest pain lasting 4 days, treated with colchicine and ibuprofen and resolved within two days of treatment
: 52 Years old female presenting to the ED with complaints of a vaccine reaction after the she received her Tdap, zoster and pneumonia vaccine on 7/7. Endorses pain, edema and erythema to right shoulder with fever. Denies any nausea/vomiting, diarrhea, abdominal pain or burning/hot sensations to the area.
Mom called office on 04-08-16 regarding (L) deltoid area - red, hot, swollen (3 inch diameter). Advised mom to use ibuprofen for pain and ice/cool packs QID. Mom to call if Sx persist. 5pm called mom. Swelling decreasing in size.