chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of fever in a male patient who received Shingles vaccine. Previously administered products included shingles vaccine (received couple of years ago and it was about 50 percent effective). On 9th March 2018, the patient received Shingles vaccine. On 10th March, 1 days after receiving Shingles vaccine, the patient experienced unable to walk. On an unknown date, the patient experienced fever, chills, lower extremities weakness of, sickness and sweating. On an unknown date, the patient experienced fever, chills, lower extremities weakness of, sickness and sweating. On an unknown date, the outcome of the fever, chills, lower extremities weakness of, sickness, sweating and unable to walk were unknown. The reporter considered the fever, chills, lower extremities weakness of, sickness, sweating and unable to walk to be related to Shingles vaccine. Additional details were provided as follows: This report was taken from the radio conversation. The age at vaccination was not reported. On 9th March 2018 at 15:00, a healthy patient received Shingles vaccine. Less than a week after vaccination, the patient experienced high fever, chills, legs were weak like rubber, sweating and sick. The body temperature was not measured. On whole weekend, the patient was so sick. Whole weekend the patient was lying on bed. The patient stated that he needed to go to bed. That was what he did and it was disgusting. The patient was discussing about the possible treatment drug (Aspirin), but patient did not take it. The patient stated it was like you sweat through about 20 t-shirts.
I felt like a burning and itchy underneath my skin all over my body, broke out in hives, lips started tingling, itchy then went to top surface of my skin. This lasted for 6 weeks. Skin irritation, dry skin, and peeling.
Patient had initial vaccine with lip swelling and purple coloring (did not witness this). With 3rd vaccine, had fever to 102, headache, bodyaches and vomiting 2 hours after vaccine and into 48th hour.
Patient Mother informed clinic that her child's WBC count drops after having COVID vaccine.  Stated happened first July 2021 after first series one year ago.  Patient received COVID booster 11 July and WBC count was low right after, but returned to normal 2 weeks later.
Itching at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) and MYALGIA (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced MYALGIA (Sore arm). On 20-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking other medication. HCP was not aware of the symptoms. Treatment information was not reported.
Patient recieved vaccine and went back to work (in the same building). Approx. 1 hour after recieving vaccine, she reported feeling hot/sweaty, itchy with rash, nausea (did not vomit), and dizzy. Other than being hot and sweaty while working, patient states she was not experiencing these symptoms prior to recieving the vaccine. She did not report symptoms until 01/03/2014 when she was preparing for her 3rd vaccine. However, the third vaccine was not given because of her reporting reaction to previous dose.
Feel like got the flu; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Feel like got the flu) 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 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 INFLUENZA (Feel like got the flu). At the time of the report, INFLUENZA (Feel like got the flu) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
Within 10 minutes of the shot I had a severe headache, numbness in my lips, feet and hands and was weak and unable to walk without fear of falling. These symptoms continues for an hour, and while still weak I returned to work. I awoke the next day with a fever, body aches and fatigue that lasted 3 days. I have had 3 more bought s of severe fatigue since the shot and on Monday 4/26/2021 I suffered a seizure bi have no history nor symptomology of seizure activity, and was hospitalized  for 2 days.
Little soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness in arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Milk allergy and Penicillin allergy. Concomitant products included ROSUVASTATIN and PAROXETINE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little soreness in arm). At the time of the report, PAIN IN EXTREMITY (Little soreness in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication reported also included vitamins and minerals.  Patient took second shot (lot 004M20A) on 20-Feb-2021 and the Moderna booster (lot 058F21A) on 30-Nov-2021.  Patient stated that first dose was really low, like a normal shot.  No treatment medications were reported.
Within 2 hours noted swelling and warmth. At 2 days, redness and rash progressively covering half of upper arm. Pain in axilla but no lymphadenopathy. Treated for possible cellulitis with KEFLEX.
Per MD note: The rash is starting to resolve. She does not have any itching or any other discomfort. The rash had appeared on her right arm> left arm,  both the palms of her hands and the inner thighs.
2nd dose-18-APR-2021,Dose 3-AUG-2021; Elevated sedimentation rate; This spontaneous case was reported by a consumer and describes the occurrence of RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation rate) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-18-APR-2021,Dose 3-AUG-2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Bursitis in 2015, Tendon disorder NOS in 2015 and Knee arthroscopy in November 2015. Concurrent medical conditions included Neuropathy since 2015, Rheumatoid arthritis, Allergy NOS, Blood cholesterol increased, Stomach discomfort and Blood pressure management. Concomitant products included SIMVASTATIN (ZOCOR) for Blood cholesterol increased, GABAPENTIN (NEURONTIN) for Neuropathy, METHOTREXATE for Rheumatoid arthritis, ESOMEPRAZOLE SODIUM (NEXIUM MUPS [ESOMEPRAZOLE SODIUM]) and FAMOTIDINE (PEPCID AC) for Stomach discomfort, FOLIC ACID, VITAMIN D3 and MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) for Supplementation therapy.   In 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.8ML, 1 in 14 D. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40MG/0.4ML, 1 in 14 D. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, the patient experienced RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation rate). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-18-APR-2021,Dose 3-AUG-2021). At the time of the report, RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation rate) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-18-APR-2021,Dose 3-AUG-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Red blood cell sedimentation rate: 53 MM/HR. In February 2022, Red blood cell sedimentation rate: 39 MM/HR. In 2022, Red blood cell sedimentation rate: 29 MM/HR.         Patient took Hyzaar (HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM) 50mg/12.5mg orally on an unknown date for unspecified blood pressure condition. Percocet for unknown indication. It was unknown if patient was enrolled in COVID-19 vaccine trial. Causality for Humira (Adalimumab) 40MG/0.4ML: The reporter's causality for the event of Elevated sed rate 2021 Elevated sed rate onset in Feb-2022 with Humira (Adalimumab) 40MG/0.4ML with no reasonable possibility.  No treatment details were reported. 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.
Arm went hard and swollen on day 1  diagnosed with Bell?s palsy day 3 Given 10 day course of steroids and anti virals Got slight movement now on day 14
Red raised bumps around injection site beginning the day after shot and continuing - still hasn't resolved itself.
Adacel (Tdap) as part of a catch-up immunization schedule for an 8-year-old patient with no reported adverse event; Initial information received on 07-Sep-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01268496.  This case involves an 8-year-old child and unknown gender patient to whom Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] (tdap) as part of a catch-up immunization schedule with no reported adverse event.  The patient has received only one dose of DTaP. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown onset and latency, the 8-year-old child patient had a prescription suspect Adacel vaccine at (formulation, strength, dose, lot number, route in unknown administration site) as part of a catch-up immunization schedule (prophylactic vaccination) with no reported adverse event (product prescribing error). Information regarding batch number requested.  It was reported that "health care professional (HCP) asked about administering ADACEL (Tdap) This situation is reported as an off label use as per local labelling due to planned use of Adacel in a patient under 10 years of age. The practice may use Adacel (Tdap) as part of a catch-up immunization schedule for an 8-year-old patient who has previously received only one dose of DTaP. Patient has not yet been administered any Adacel."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I started getting fowl smell and taste and its been ingoing for 7 weeks now. things smell like sewage and fecal
On day 8 post vaccination the injection site became rapidly inflamed, hot to touch, itchy, swollen, tender.  Unsure if injection site reaction versus cellulitis.
Pt recvd vax & pt began to exp a serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup has included numerous tests for collagen vascular disease & has been non-diagnostic;
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 76 years old female patient who experienced fluzone hd given to one patient two times in one day, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2018, the patient received a twice 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ029AB via intramuscular route in the left deltoid. It was a case of actual medication error due to extra dose administered. The patient outcome is reported as Not Applicable for FLUZONE HD given to one patient two times in one day. 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 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. List of documents held by sender: none.
inc temp between 103 & 104.6 parent thinks; mom states hysteria, unconsolable crying, eyes rolled back in head;
Information has been received from a consumer concerning his 67 year old wife with allergic reactions to CIPRO and sulfa and no pertinent medical history who was vaccinated with the first dose of PNEUMOVAX 23 (lot number reported as 665763/1296Y, invalid for PNEUMOVAX 23 but is a valid lot number for VARIVAX (Merck) (MSD)) "at least 5 years ago". On 16-SEP-2009 at 10:00 AM the patient was vaccinated with the second 0.5mL dose of PNEUMOVAX 23 IM. Concomitant vaccination administered on the same day included influenza virus vaccine (manufacturer unknown). Other concomitant therapy included SYNTHROID and ALTACE. At the time of the vaccination, the patient experienced pain at the injection site, but assumed that it was from paving the vaccine injected. About two hours later, she had "extreme pain" at the injection site. The pain on a scale of 1 to 10, was rated as a 12. On 16-SEP-2009 the patient went to an unspecified clinic and was given DILAUDID (description unknown) for the pain, but it was not effective. A nurse at the clinic said that the injection site was given too high up on the arm. On the morning of 17-SEP-2009, the patient went to the ER at the hospital. The patient could barely move her arm and her arm was hot to the touch. At the hospital she was given TORADOL (description unknown) for the pain. It was noted that the patient had also been vomiting (17-SEP-2009), "but that may be from the TORADOL." A x-ray test was performed (results not reported). At the time of the report, the patient was recovering. Additional information has been requested.
Mild swelling with redness near injection site first noticed 9 days after vaccine was administered. Area is about 2in x 3in, warm to touch, no itchiness, pain,  or soreness.
Patient received a Moderna COVID-19 vaccine that had expired 5 hours prior to being administered. Patient has yet to be revaccinated but recommendation to obtian a full titer to assess immunization efficacy at a later date. Patient had a titer taken about a month later and was found to be appropriately immunized. No adverse effects are documented in future notes.
SECOND DOSE OF JYNNEOS WAS ADMINISTERED ON DAY 22 INSTEAD OF DAY 28 (INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
Client experienced excruciating pain in left arm within a few hours of administration. Describes pain as muscular. Client has full range of motion of joint. No swelling, redness, or warmth noted on 11/7/2022. Client continues to experience extreme pain especially with movement of extremity. Lidocaine patches provide some relief. Tylenol and Motrin provide little relief.  Encouraged client on 11/07/2022 to follow up with primary care provider for additional evaluation and treatment.
Patient experienced arm soreness and redness from shoulder to elbow at approximately 12 hours post -vaccination. She complained of being extremely tired. She took some Tylenol for the pain and was planning on taking a nap. Advised her to follow up with PCP or go to the ER if symptoms worsened or especially if she experienced a fever, nausea, chest tightness, difficulty breathing, etc. Explained that these are common side effects but to seek medical help if persistent or worsening.
after vaccination pt became very pale in office, near syncope. laid down and observed for 20 minutes after injections and then was fine.
Nausea followed by loss of consciousness for about 5 minutes. Upon consciousness, racing heartbeat, followed by profuse sweating (through my clothes as well as dripping down chest and back).
Information has been received from a registered nurse concerning a 70 year old female with hypertension and hypercholesterolaemia and no drug allergies who on 18-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (659411/0293X). There was no concomitant medication. On 23-JUN-2008 the patient developed unspecified itching and hives. The patient sought treatment with an unspecified provider who prescribed BENADRYL and a follow up appointment on 01-JUL-2008. No other symptoms or treatment reported. At the time of this report, the patient's unspecified itching and hives persisted. No product quality complaint was involved. Additional information has been requested.
Pt is under the recommended age of 18. Pt is 17 years old and thus not yet cleared under the FDA's EUA to receive this vaccine. Patient was under observation for 30 minutes post injection. Pt observed again 1 hour post-injection with no adverse symptoms. Error realized several hours later; approximately 3 hours post-injection. Reported error to direct supervisor. Called patient with telephone and left voicemail requesting call back from patient. Will continue to try to notify and follow up with patient.
This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 15-AUG-2013, the patients were vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 18-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality was related.
This spontaneous report was received from a physician via a company representative referring to approximately two patients of unknown age and gender. No information was provided regarding the patients past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not  provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (lot number and expiration date were not provided). The physician stated that there are two patients "that he knows of" who have developed herpes zoster after being vaccinated with ZOSTAVAX reconstituted with sterile diluent (STERILE DILUENT) on two separate unspecified dates. The outcome of herpes zoster was unknown. Causality assessment was not  provided. A product quality complaint (PQC) was not involved. Additional information has been requested.
Her period came on 7Sept2021 but it was 35 days cycle; missed her periods on July and August; March2021 her period was really light; Planning to get pregnant; issues with her menstrual cycle which is not normal; was tired; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (missed her periods on July and August), HYPOMENORRHOEA (March2021 her period was really light), MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle), PLANNING TO BECOME PREGNANT (Planning to get pregnant) and MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PLANNING TO BECOME PREGNANT (Planning to get pregnant), MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) and FATIGUE (was tired). In March 2021, the patient experienced HYPOMENORRHOEA (March2021 her period was really light). In July 2021, the patient experienced AMENORRHOEA (missed her periods on July and August). On 07-Sep-2021, the patient experienced MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle). At the time of the report, AMENORRHOEA (missed her periods on July and August), HYPOMENORRHOEA (March2021 her period was really light), MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle), PLANNING TO BECOME PREGNANT (Planning to get pregnant), MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) and FATIGUE (was tired) outcome was unknown.            The patient states that since the second dose, she had issues with her menstrual cycle. She never had issues with her period until this vaccine. She states she had her periods both times when she got the vaccine   No concomitant medications were reported   Treatment included Acupuncture